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From the 3/29/2024 release of VAERS data:

Found 47,313 cases where Vaccine is HPV4

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Case Details

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VAERS ID: 259545 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-07-11
Onset:2006-07-11
   Days after vaccination:0
Submitted: 2006-07-11
   Days after onset:0
Entered: 2006-07-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Dehydration, Dysarthria, Fall, Headache, Hyperventilation, Injection site pain, Laboratory test abnormal, Muscle spasms, Speech disorder, Syncope, Syncope vasovagal, Vision blurred, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Allergic rhinitis, spring pollens/ragweed/dust/mold
Allergies:
Diagnostic Lab Data: LABS: WBC 11.7, neutros 84, lymphs 9.7.
CDC Split Type:

Write-up: Immediately after injection complained of severe pain at site. Fell off table and fainted for approximately 10 - 15 seconds. Hyperventilated and cried progressing Chvostek''s sign in hands and feet. Rebreathing into a bag progressing to clearing of symptoms. Complained of headache, blurry vision; Vision test was normal. Vomiting x 1 in parking lot and speech was momentarily inarticulate. Sent to ER. At ER neuro exam was normal except for word recall "coffee instead of coughing" "Sired instead of tired." Continued complaint of headache. Vomited x 2. All symptoms spontaneously cleared approximately 6 hours after incident. Overnight hospitalization for observation. Neurological evaluation before discharge was normal. Diagnosis also included dehydration. No fluids were taken from 7/10/2006 PM until IV in ER. Anion gap noted on chemistries and concentration of urine obtained after several hours of hydration. Discharge diagnosis: Dehydration, Vasovagal syncope secondary to shot vs pain at injection site. 7/17/06 Medical records received from reporter/provider which included vax record, office note of 7/11 & neuro consult of 7/15 by MD who also saw her in the hospital on 7/11-12. Neuro report indicates the CT scan of head was WNL & that dx is syncope probably precipitated by pain of vax injection along w/dehydration (no fluid intake since evening of 7/10 until IVF given in ER). As of 7/15 patient continued to have throbbing HA when bending down & also c/o strong heart beats ocassionally. PMH: dehydration requiring hospitalization at age 3 yo. Also has hx of mild anxiety. Family hx: patient''s mother has Fuch''s disease (genetic degenertive corneal disease which her mother also had) & patient''s father has depression. There are no siblings. It was noted that she had 3 episodes of emesis following vax along w/ sustaining mild concussion when fell from exam table which was characterized by brief episode of aphasia, slurred speech & possible right facial paresis noted only by patient''s mother./ss 10/27/06 Received medical records from hospital which reveal patient seen in ER after LOC with head trauma. Noted to have slurred speech, word finding difficulty, HA & emesis x 2 which resolved after several hours. Admitted for overnight observation. Given IVF & IV Toradol. Head CT was WNL. Neurology consult done which was essentially WNL with mild generalized weakness, speech intact & mental status clear. Final dx: LOC with head trauma, vasovagal syncope.


VAERS ID: 260144 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: California  
Vaccinated:2006-07-25
Onset:2006-07-25
   Days after vaccination:0
Submitted: 2006-07-25
   Days after onset:0
Entered: 2006-07-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0144F / UNK RA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Dyskinesia, Hypertonia, Hypoaesthesia, Hypotonia, Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Hypokalaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Viral with low grade fever
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: BP 90/30 90/62 110/70 110/60, BG 114 Pulse OX 99, Strep culture neg.
CDC Split Type:

Write-up: Patient received Hep A in right arm. Then received HPV in left arm. C/O pain & numbness. Started walking down hall fainted and had tonic/clonic movement for 15 sec.


VAERS ID: 260907 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-07-18
Onset:2006-07-18
   Days after vaccination:0
Submitted: 2006-07-19
   Days after onset:1
Entered: 2006-08-01
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Injection site swelling, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: human papilloma virus, genital warts
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Swelling immediately after vaccine was administered, also rash. Ice pack was applied for 5 minutes and swelling decreases. Rash was still visible, but cream was applied. This is in follow-up report(s) previously submitted on 8/10/2006. Information has been received from a physician concerning a 17 year old female who on an unspecified date was vaccinated with 0.5 ml dose of GARDASIL. Subsequently, the patient experienced painful, swelling "the size of a golf balll" at the injection site. Unspecified medical attention was sought. No diagnostic laboratory studied were performed. The patient recovered by "the next day." Additional information has been requested.


VAERS ID: 261359 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: California  
Vaccinated:2006-07-13
Onset:0000-00-00
Submitted: 2006-07-14
Entered: 2006-08-10
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 LA / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1920AA / 1 LA / -
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2457AA / 6 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Lymphadenopathy, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dizzy, nauseated, developed axillary lymphadenopathy on side with Menactra inoculation.


VAERS ID: 261575 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: California  
Vaccinated:2006-07-12
Onset:2006-07-12
   Days after vaccination:0
Submitted: 2006-08-10
   Days after onset:29
Entered: 2006-08-15
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0607USA041063

Write-up: Information has been received from a physician concerning a 24 year old female with no medical history and no drug allergies who "last week" on approximately 12-JUL-2006 was vaccinated with HPV vaccine rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml). Concomitant therapy that day included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The vaccines were administered in different arms. Subsequently, "12 hours after vaccination" the patient developed a rash throughout her whole body that lasted for two days. Unspecified medical attention was sought. The patient recovered two days after injection. Additional information has been requested.


VAERS ID: 261576 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-07-19
Onset:2006-07-19
   Days after vaccination:0
Submitted: 2006-08-10
   Days after onset:22
Entered: 2006-08-15
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0607USA04314

Write-up: Information has been received from a physician concerning an approximately 16 year old female who on 19-JUL-2006 was vaccinated with HPV rLI 6 11 16 18 VLP vaccine (yeast). It was reported that "immediately after the injection", on 19-JUL-2006, the patient experienced pain and stinging at the injection site that lasted about 2 minutes and radiated the arm. The patient also reported feeling faint following the injection and experienced swelling. It was reported that the swelling went down but the pain persisted. Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 261577 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-07-27
Onset:2006-07-27
   Days after vaccination:0
Submitted: 2006-08-10
   Days after onset:14
Entered: 2006-08-15
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Loss of consciousness, Syncope, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0607USA05727

Write-up: Information has been received from a registered nurse and a physician concerning a 16 year old female no medical history and no drug allergies who on 27-JUL-2006 was vaccinated intramuscularly in the right deltoid with the first dose of HPV rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F). There were no concomitant medications. At the time of vaccination the patient experienced extreme pain at the injection site and fainted. The nurse reported that "the onset of the pain was immediate and lasted for 1 and a half to 2 minutes and then the patient passed out for 15 to 20 seconds and then was all right". The physician reported that the patient had a vasovagal syncopal episode, was not incontinent, and experienced no post- ictal state. Unspecified medical attention was sought. Subsequently, the same day the patient recovered from the extreme pain at the injection site and vasovagal syncopal episode. The patient did not wish to continue the series as a result of the adverse experience. Additional information has been requested. 01/05/2007 This is in follow-up to report(s) previously submitted on 8/10/2006. Information has been received from a registered nurse and a physician concerning a 16 year old female no medical history and no drug allergies who on 27-JUL-2006 at 13:30 was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (0.5 ml) (lot # 653650/0702F). There were no concomitant medications. At the time of vaccination the patient experienced extreme pain at the injection site and fainted. The nurse reported that "the onset of the pain was immediate and lasted for 1 1/2 to 2 minutes and then the patient passed out for 15 to 20 seconds and then was all right". The physician reported that the patient had a vasovagal syncopal episode, was not incontinent, and experienced no post-ictal state. Unspecified medical attention was sought. Subsequently, that same day the patient recovered from the extreme pain at the injection site and vasovagal syncopal episode. The patient did not wish to continue the series as a result of the adverse experience. Additional information has been requested.


VAERS ID: 261578 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-07-27
Onset:2006-07-27
   Days after vaccination:0
Submitted: 2006-08-10
   Days after onset:14
Entered: 2006-08-15
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0607USA05775

Write-up: Information has been received from a physician and registered nurse concerning a 21 year old female with no medical history of drug allergies who on 27-JUL-2006 was vaccinated intramuscularly in the left deltoid with the first dose of HPV rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F). Concomitant therapy included possible hormonal contraceptives (unspecified). On 27-JUL-2006 the patient experienced extreme pain at the injection site. The onset of the pain was immediate and lasted for 5 to 6 minutes and then resolved. Unspecified medical attention was sought. It was reported that the patient does not wish to continue the series of vaccinations. Additional information has been requested.


VAERS ID: 261579 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-07-28
Onset:2006-07-28
   Days after vaccination:0
Submitted: 2006-08-10
   Days after onset:13
Entered: 2006-08-15
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA00186

Write-up: Information has been received from a physician concerning a 14 year old female who on 28-JUL-2006 was vaccinated with HPV rLI 3 11 16 18 VLP vaccine (yeast). Concomitant vaccination on 28-JUL-2006 included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. The patient stated that following vaccination on 28-JUL-2006, she " experienced a great deal of pain at the injection site". Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 262070 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-08-14
Onset:2006-08-22
   Days after vaccination:8
Submitted: 2006-08-24
   Days after onset:2
Entered: 2006-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OrthoTricyclen-Lo
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient developed a fine, red rash over torso and legs with itching reported on8/22/2006.


VAERS ID: 262096 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2006-08-14
Onset:2006-08-14
   Days after vaccination:0
Submitted: 2006-08-21
   Days after onset:7
Entered: 2006-08-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637C / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Chills, Cyanosis, Dizziness, Pallor, Pyrexia, Visual disturbance
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 1 hr after vaccination, pt reported to feel dizzy, weak, vision went black for a few seconds, got pale with purple lips x 1/2hr. Felt better after drinking OJ. Then got temp 101F and chills x 1 day.


VAERS ID: 262242 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Washington  
Vaccinated:2006-08-23
Onset:2006-08-23
   Days after vaccination:0
Submitted: 2006-08-28
   Days after onset:5
Entered: 2006-08-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0706R / 2 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Fall, Fracture, Injury, Loss of consciousness, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Osteoporosis/osteopenia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vasovagal syncope shortly after receiving hep A and Gardasil vaccine, fell, hit nose on a drawer, loss of consciousness, sent to ER in transport broke nose.


VAERS ID: 262243 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Washington  
Vaccinated:2006-07-25
Onset:2006-07-25
   Days after vaccination:0
Submitted: 2006-08-28
   Days after onset:34
Entered: 2006-08-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injury, Loss of consciousness, Syncope, Syncope vasovagal, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: MRI next AM nl
CDC Split Type:

Write-up: Vaccine given after physical. Pt fainted, vasovagal, hit head on carpeted cement floor. Loss of consciousness 1 min, had tonic posturing of right hand only some shaking.


VAERS ID: 262482 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Georgia  
Vaccinated:2006-07-25
Onset:2006-07-26
   Days after vaccination:1
Submitted: 2006-08-31
   Days after onset:36
Entered: 2006-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Military       Purchased by: Unknown
Symptoms: Fatigue, Feeling hot, Injection site hypersensitivity, Injection site mass, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hard painful lump at site of injection, red, site is hot to the touch. Pt states feeling "tired & run down" since injection.


VAERS ID: 262451 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: California  
Vaccinated:2006-08-17
Onset:2006-08-18
   Days after vaccination:1
Submitted: 2006-08-28
   Days after onset:10
Entered: 2006-09-01
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0608USA04945

Write-up: Information has been received from a physician and a medical assistant concerning an 18 yr old female with no pertinent medical history or allergies, who on 17Aug06 was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5ml) (lot 653650/0702F). There was no concomitant therapy. Subsequently, on 18Aug06 the pt developed a rash and hives. It was reported that this was not an injection site rash. The pt presented to her physician''s office on 18Aug06 with hives all over her body. She was treated with oral diphenhydramine hydrochloride (Benadryl). It was also reported that the pt went to the ER twice on 19Aug06 and 20Aug06 and was treated with intravenous methylprednisolone sodium succinate (Solu Medrol) for the hives and welts all over her body and was released (it was also reported that the pt was given IV saline). The pt was scheduled to have a follow up visit with her physician within a week. At the time of this report, the pt had not recovered. The rash and generalized urticaria were felt to be other important medical events. Additional information has been requested.


VAERS ID: 262735 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2006-07-31
Onset:2006-08-13
   Days after vaccination:13
Submitted: 2006-09-07
   Days after onset:25
Entered: 2006-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0697F / 1 GM / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR 42107AA / 1 GM / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia, Proteinuria, Red blood cell sedimentation rate increased
SMQs:, Acute renal failure (broad), Peripheral neuropathy (narrow), Systemic lupus erythematosus (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (broad), Noninfectious myocarditis/pericarditis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI of brain, cervical, thoracic and lumbosacral spine, drug screen, pregnancy test, sed rate, Blood count, blood chemistries, Lumbar Puncture.
CDC Split Type:

Write-up: Vaccine was given on July 31 2006. She began having numbness and tingling in her feet and hands on or around August 13th or 14th, which persisted and slightly worsened until she was seen in our office on August 21st. Her neurological examination was normal, she had an elevated sedimation rate (39), mild protienuria, otherwize normal labs. MRI of her lumbosacral spine showed a (possibly old, chronic) subarachnoid cyst. She was referred to a neurologist and was seen on August 25th and was found to have weakened severely and was admitted to PICU for suspected Guillian-Barre syndrome which was confirmed by lumbar puncture. She was treated with IVIG with rapid improvement and has gone home. She is slowly improving and has residual weakness. Medical records including neurology received/reviewed. Final diagnosis is GBS. Was treated with IVIG as indicated on VAERS form. Per records pt has residual weakness. 12/19/06-progress notes received for and DC Summary DC DX: GBS.


VAERS ID: 262742 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Virginia  
Vaccinated:2006-08-01
Onset:2006-08-01
   Days after vaccination:0
Submitted: 2006-09-05
   Days after onset:35
Entered: 2006-09-08
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / UNK UN / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Injection site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0608USA06904

Write-up: Information has been received from a physician concerning a 15 year old female patient who in August 2006, was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine. Prior to administration, the patient received the following concomitant therapy: hepatitis A vaccine and meningococcal ACYW conjugate vaccine. The patient had a mild seizure after receiving HPV rL1 6 11 16 18 VLP vaccine injection. She also complained of a great deal of pain at injection site. Medical attention was sought. It was reported that the patient recovered 1 day after the event. Her mother called the physician at home 1 day after the injections to state that the patient was fine. Upon internal review, mild seizure was considered to be an other important medical event (OMIC). Additional information has been requested.


VAERS ID: 262743 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-08-22
Onset:2006-08-23
   Days after vaccination:1
Submitted: 2006-09-05
   Days after onset:13
Entered: 2006-09-08
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest discomfort, Erythema, Feeling hot, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0608USA05911

Write-up: Information has been received from a nurse concerning her 17 year old daughter with asthma who on 8/22/06 was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine (0.5ml). On 8/23/06 the patient developed a swollen thumb and her palms became red and hot. The patient later developed a tightness in her chest. The patient was immediately taken to a physician (an allergist who was the mother''s employer) who immediately gave the patient a huge dose of cetirizine hydrochloride and acetaminophen as an intervention. The patient was not hospitalized and did not got to the emergency room. It was unknown if the affected site was the same arm that the vaccine was given in. The patient subsequently recovered from the red and hot palms, swollen thumb, and chest tightness on an unspecified date. The red and hot palms, swollen thumb and chest tightness were felt to be other important medical events. Additional information has been requested.


VAERS ID: 262785 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-08-10
Onset:2006-08-15
   Days after vaccination:5
Submitted: 2006-09-08
   Days after onset:24
Entered: 2006-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Movement disorder
SMQs:, Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 09/01/06 pt call with c/o decreased ROM in L arm 5 days after injection administration to current date. Tx with Naproxen x 10 days and Tylenol #3.


VAERS ID: 262809 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Georgia  
Vaccinated:2006-08-23
Onset:2006-08-27
   Days after vaccination:4
Submitted: 2006-09-06
   Days after onset:10
Entered: 2006-09-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypokinesia, Lymphadenopathy, Skin nodule
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Sulfonamide allergy
Allergies:
Diagnostic Lab Data: Computed axial 8/29/06 lump having 2 smaller and 1 larger lymph nodes involved. LABS: all WNL. CT of chest/abd/pelvis revealed 14mm circumscribed noe in left supraclavicular node & several less than 1 cm nodes in bilateral axillary areas; mesenteric adenopathy cluster of 1-1.5cm nodes; 12 mm node in left inguinal region. Surgical biopsy/path report: benign lymph node with non-specific reactive changes including immunoblasts with associated negative flow cytometry.
CDC Split Type: WAES0608USA06930

Write-up: Information had been received from a healthcare worker concerning a 17 year old female pt with a sulfonamide allergy who on 8/23/06 was vaccinated IM in left upper arm with a dose of HPV rL1 6 11 16 18 VLP vaccine yeast, lot 653736/089F. There was no concomitant medication. it was reported that 5 days after vaccination, on 8/27/06, the pt developed lymph node swelling in the clavicle area, described as grape size. The pt complained of interference of upper arm movement and felt something was present in the clavicle area. Unspecified blood work was done. On 8/29/06 a CAT scan was performed and lump was described as having 2 smaller and 1 larger lymph nodes involved. On 8/30/06 the pt was scheduled for surgery to have the lymph nodes removed and biopsied. As of the report date, the pt had not recovered. The reporter felt that the lymph node swelling and interference with upper arm movement were other important medical events (OMIC). Additional information has been requested. 10/13/06 Received medical records from hospital which reeal patient seen in ER 8/29/06 for enlarged lymph node left supraclavicular area which was tender to palpation. Final Dx: lymphadenopathy. 8/31/06 surgical biopsy done of left node & several other lymph nodes were palpated & sent to lab.


VAERS ID: 262847 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2006-09-06
Onset:2006-09-06
   Days after vaccination:0
Submitted: 2006-09-11
   Days after onset:5
Entered: 2006-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2117AA / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Injection site warmth, Joint range of motion decreased, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: yearly examination
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient said right deltoid area, became red, swollen, quarter size hard knot, achy, painful to raise arm. Knot was hot to touch.


VAERS ID: 262872 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-09-02
Onset:2006-09-02
   Days after vaccination:0
Submitted: 2006-09-02
   Days after onset:0
Entered: 2006-09-12
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 08007 / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Syncope, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: vital signs stable
CDC Split Type:

Write-up: Immediately after vaccine administration patient had syncopal episode with tonic posturing fell from table. Responded with gentle stimulation versus normal 5 minutes post regaining full consciousness.


VAERS ID: 263024 (history)  
Form: Version 1.0  
Age: 1.51  
Sex: Male  
Location: North Carolina  
Vaccinated:2006-09-11
Onset:0000-00-00
Submitted: 2006-09-11
Entered: 2006-09-13
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1751AB / 4 RL / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08682H / 3 LL / IM

Administered by: Private       Purchased by: Unknown
Symptoms:
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Wrong vaccine was given Gardasil was given instead of Hep A by mistake.


VAERS ID: 263032 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-07-07
Onset:2006-07-20
   Days after vaccination:13
Submitted: 2006-08-24
   Days after onset:35
Entered: 2006-09-14
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2069AA / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Dehydration, Difficulty in walking, Gait disturbance, Guillain-Barre syndrome, Laboratory test abnormal, Paraesthesia, Psychomotor hyperactivity
SMQs:, Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Demyelination (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad), Dehydration (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Adderall
Current Illness:
Preexisting Conditions: Attention deficit disorder.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Guillain Barre. She was well on day of immunization but later said she was weak and several months this was not objectively noticed then, but shortly after the vaccine. 9/28/06 Received medical records from neurologists which reveal patient seen by PCP 7/31/06 with complaint of loss of strength over past 3 mos. Labs were done by PCP & showed mild dehydration & elevated neutrophils, eos were absent. Patient referred to neuro & initial eval on 8/3 reveals patient noted weakness beginning in June which had progressively worsened. Symptoms included tingling sensation at tip of fingers & significant weakness to the point she could not do her own hair. Birth history was WNL & only PMH is of ADD & has been on Adderall for about 1 year as well as BCP. Exam showed definite weakness of all extremities, esp upper extremities, & neck. Reflexes were absent in legs. Gait was normal but had difficulty taking steps w/o support & could not rise from sitting w/o help. Normal CPK made dx difficult & EMG/NCS was done on 8/4 which was strongly positive for GBS & copy of test included with records. Treated with IVIG x 2 days & placed in rehab facility on 8/5/06 for eval & therapy then received home PT. Seen by neuro next on 8/24 which showed improvement but still with weakness especially in the hands. Now able to rise from sitting on floor w/o support. Still no reflexes in legs. Complete but slow recovery was expected at that time/ss 9/28/06 Received medical records from hospital which reveal patient admitted 8/4/-8/6/06 for IVIG & PT./ss


VAERS ID: 263185 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: New York  
Vaccinated:2006-08-29
Onset:2006-08-29
   Days after vaccination:0
Submitted: 2006-08-31
   Days after onset:2
Entered: 2006-09-19
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dysphagia
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair, Allegra, Flovent, Rhinocort
Current Illness:
Preexisting Conditions: Asthma, Penicillin allergy.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2 hours after Gardasil Administration pt developed inability to swallow. Advised to take Benadryl by covering physician and go to ER. In ER not given EPI but Solumedrol to take for 5 days.


VAERS ID: 263200 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-07-25
Onset:2006-07-25
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:51
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA00410

Write-up: Information has been received from a pharmacist concerning her daughter who on approximately 25-JUL-2006 was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). On approximately 25-JUL-2006 the patient experienced soreness at the injection site that lasted approximately one week and at the time of this report had not resolved. Additional information has been requested.


VAERS ID: 263201 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:2006-08-02
Onset:2006-08-02
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:43
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA01129

Write-up: Information has been received from a registered nurse concerning a female who on 02-AUG-2006 was vaccinated with the first dose of HPV rLi 3 11 16 18 VLP vaccine (yeast). It was reported that the patient fainted "shortly after receiving the vaccination". The nurse did not feel the experience was vaccine related and stated "the patient was very uneasy with the idea of an injection". The patient subsequently recovered "shortly after fainting". Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 263202 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Colorado  
Vaccinated:2006-08-03
Onset:2006-08-04
   Days after vaccination:1
Submitted: 2006-09-14
   Days after onset:41
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Pruritus, Rash, Rash papular, Skin burning sensation, Skin ulcer
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARITIN, vitamins (unspecified)
Current Illness:
Preexisting Conditions: MEDICAL HISTORY: fever, CONCURRENT CONDITIONS: seasonal allergy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0608USA01355

Write-up: Information has been received from a registered nurse concerning a 14 year old female with seasonal allergies who was exposed to roseola on 25-JUL-2006 and had a fever on 02-AUG-2006. On 03-AUG-2006, the patient was vaccinated intramuscularly with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F). Concomitant therapy included loratadine (CLARITIN) and vitamins (unspecified). On 04-AUG-2006, the patient developed an extensive rash. The patient discovered the rash at 7 am on the back of her legs. It was reported that the rash spread to her back and shoulders and had started to spread to her abdomen. The rash consisted of non vesicular papular single lesions that were slightly larger than a pinpoint and too numerous to count. The lesions were described as "burning and itchy". Unspecified medical attention was sought. At the time of the report, the patient''s rash persisted. Additional information has been requested.


VAERS ID: 263203 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-08-09
Onset:2006-08-09
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:36
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Influenza like illness, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0608USA02569

Write-up: Information has been received form a physician concerning a 29 year old female with no pertinent medical history and no history of drug reactions allergies who on 8/9/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653937/0637F) inappropriate schedule of vaccina administration. There was no concomitant medication. On 8/9/06 the pt experienced a fever, nausea, body aches, joint pains and experienced flu like symptoms. Unspecified medical attention was sought. At the time of this report, the pt was recovering from the fever, nausea, body aches, joint pains and flu like symptoms.


VAERS ID: 263204 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2006-07-18
Onset:2006-07-18
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:58
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0640F / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Deafness, Dizziness, Dysarthria, Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness, Pallor, Shock, Skin papilloma, Speech disorder, Syncope, Tinnitus, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri cyclen Lo
Current Illness:
Preexisting Conditions: Pap smear abnormal, Dysplasia, Breast Prosthesis user. 7/18/07-records received-HX papular condyloma.
Allergies:
Diagnostic Lab Data: Blood pressure 7/18/06 130/80 records received 7/18/07-Positive yeast vaginal culture. BX on 5/30/07-mild sysplasia/HPV
CDC Split Type: WAES0608USA02804

Write-up: Initial and follow up information has been received from a 21 year old female with breast implants and had a history of abnormal pap test and dysplasia and from a nurse practitioner. On 7/18/06 the pt was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653650/0640F). Concomitant therapy included ethinyl estradiol + norgestimate (Ortho Lo). On 7/18/06, immediately following vaccination, the pt experienced slurred speech for approx 3 to 4 minutes and reported that she felt as if her body went into shock. She noted that her fingers curled into a fist and her fingers and hands stiffened up. She reported that the later symptoms lasted for approx 25 to 30 minutes. Also approx two weeks after receiving the vaccination, she began to have some pain and stiffness in her upper left arm and shoulder in the same arm she had received the injection. Unspecified medical attention was sought. At the time of this report, the pain and stiffness in the left arm and shoulder had not resolved. The pt also reported that although she had never had nay type of genital warts in the past, on approx 8/4/06 she noted she had small genital warts which were confirmed by her health care professional. In follow up th nurse practitioner reported conflicting information that what the pt described was not what she and another nurse witnesses. The nurse practitioner stated that following the injection the pt appeared pale and almost fainted. The pt became woozy and could speak clearly. The pt was attended to by both the nurse practitioner and another nurse. The pt was diagnosed with having a near syncopal episode. The pt was treated with a cool compress and she recovered quickly and was noted as fine afterwards. The pts blood pressure was fine noted at 130/80 mmHg. it was reported that the pt did not experience any drop in hart rate, did not loose consciousness, did not seize and did not experience wheezing. The nurse practitioner did not see what she would describe as any adverse reaction to the vaccines and described the pt as being very dramatic. It was further reported that the pt reported seeing genital warts to the nurse practitioner, however, the nurse did not feel these were related to the vaccine. Additional information has been requested. 7/18/07-records received. HX papular condyloma. on 8/21/06-note indicated aftr 1st vaccine had a near syncope episode with no LOC. C/O slurred speech tingling in hands. Outbreak of condyloma. 1/4/10 Lack of concentration, hearing loss, blurred vision-ringing in ears. All of these we are aware of.


VAERS ID: 263205 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-08-08
Onset:2006-08-11
   Days after vaccination:3
Submitted: 2006-09-14
   Days after onset:34
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0608USA02806

Write-up: Information has been received from a nurse concerning two female pts (WAES0609USA01112) who on approx 8/8/06 were vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (lot not provided). It was reported that after receiving the vaccinations both pts fainted. Additional information regarding the pts was not provided. Additional information has been requested.


VAERS ID: 263206 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2006-08-14
Onset:2006-08-14
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:31
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified)
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: body temperature 08/14/06 "low grade fever"
CDC Split Type: WAES0608USA03642

Write-up: Information has been received from a physician concerning an 18 year old who on 14-AUG-2006 was vaccinated (yeast). Concomitant therapy included an unspecified therapy ("ESTRASTEP"). On 14-AUG-2006 the patient experienced profuse nausea, vomiting, low grade fever and myalgia. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested.


VAERS ID: 263207 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-08-08
Onset:2006-08-09
   Days after vaccination:1
Submitted: 2006-09-14
   Days after onset:36
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI CYCLEN
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA03841

Write-up: Information has been received from a nurse practitioner concerning a 20 year old female who on 08-AUG-2006 was vaccinated with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN). Following the vaccination, on an unspecified date in August 2006, the patient experienced diarrhea. Unspecified medical attention was sought. At the time of this report, the outcome of the diarrhea was unknown. Additional information has been requested.


VAERS ID: 263208 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-14
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0608USA03934

Write-up: Information has been received from a physician concerning a pt who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast. Subsequently the pt experienced hives. No further details were provided, and at the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 263209 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-08-15
Onset:2006-08-15
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:30
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Hyperhidrosis, Tuberculin test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified)
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Tuberculin skin test
CDC Split Type: WAES0608USA03961

Write-up: Information has been received from a nurse concerning a 19 year old female with no pertinent medical history or drug reactions allergies who on 8/15/06 was vaccinated IM with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653650/0702F). Concomitant therapy included Menactra. On an unspecified date the pt was given tuberculin purified protein derivative. On 8/15/06, 5 minutes after vaccination with HPV rL1 6 11 16 18 VLP vaccine yeast, the pt became faint. The pt was given water and chocolate as treatment. Subsequently, the pt recovered on 8/15/06. Additional information has been requested. 01/05/2007 Initial and follow-up information has been received from a nurse concerning a 19 year old female patient with no pertinent medical history or drug reactions/allergies who on 15-AUG-2006 at 9:00 AM was vaccinated intramuscularly with the first dose of GARDASIL (lot #653650/0702F). Concomitant therapy included "MENACTRA". On an unspecified date the patient was given tuberculin purified protein derivative. On 15-AUG-2006, within 10 minutes of receiving the vaccination, the patient became very faint and sweaty which lasted for approximately 60 seconds. The patient remained in the office for 45 minutes and was given water and chocolate as treatment. Subsequently, the patient recovered on 15-AUG-2006. No further information is expected.


VAERS ID: 263210 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-08-15
Onset:2006-08-15
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:30
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WELLBUTRIN, PEPCID, PAXIL
Current Illness:
Preexisting Conditions: Penicillin allergy, drug hypersensitivity
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0608USA03962

Write-up: Information has been received from a nurse concerning a 20 year old female with a penicillin allergy, drug hypersensitivity to cefaclor (CECLOR) and no other pertinent medical history reported. On 15-AUG-2006, the patient was vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0702F). Concomitant therapy included paroxetine HCL (PAXIL), bupropion HCL (WELLBUTRIN) and famotidine. It was reported that the patient became faint within 5 minutes of vaccination with HPV rLi 6 11 16 18 VLP vaccine (yeast). The patient was given a soda to drink as treatment. There were no laboratory diagnostic studies performed. On 15-AUG-2006, the patient recovered from the event. Additional information has been requested.


VAERS ID: 263211 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-08-11
Onset:2006-08-12
   Days after vaccination:1
Submitted: 2006-09-14
   Days after onset:33
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified)
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA03973

Write-up: Initial and follow up has been received from a healthcare worker in a physician''s office concerning her 19 year old daughter who was a student and an unspecified person at the physician''s office. On 11-AUG-2006, at 11:15 am, the patient was vaccinated intramuscularly in the deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0702F). Other concomitant therapy included an unspecified therapy (''LO-L"). On 12-AUG-2006 (previously reported as 14-AUG-2006) the patient developed pain in her right arm and ribcage on the same side where the vaccine was administered. On 16-AUG-2006, the patient had recovered from the events. No further information is available.


VAERS ID: 263212 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2006-08-14
Onset:2006-08-14
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:31
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0608USA04253

Write-up: Information has been received from a registered nurse concerning a 19 year old female with no pertinent medical history or drug reactions/allergies who on 14-AUG-2006 was vaccinated subcutaneously with "the standard dose" of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653736/0689F). There was no concomitant medication. ON 15-AUG-2006 the patient developed a rash on her face and experienced itching on her face. It was reported that the rash was only on the patient''s face and not at the injection site or any other part of her body. The patient was instructed to take diphenhydramine hydrochloride (BENADRYL). On 17-AUG-2006, in the morning, the patient was instructed to take diphenhydramine hydrochloride (BENADRYL). On 17-AUG-2006, in the morning, the patient called her physician''s office and reported that "it was responding to diphenhydramine hydrochloride (BENADRYL) but had not fully recovered". The patient was scheduled to be seen by her physician on 17-AUG-2006. Additional information has been requested.


VAERS ID: 263213 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-08-17
Onset:2006-08-17
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:28
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 AR / IM

Administered by: Private       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0608USA04330

Write-up: Information has been received from a physician concerning a 14 year old female with no pertinent medial history or drug reactions/allergies, who on 17-AUG-2006 was vaccinated intramuscularly with HPV rLI 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702F). There was no concomitant medication. On 17-AUG-2006, 15 minutes after receiving the vaccination, the patient "passed out" in the car on her way home. The patient was driven back to the physician''s office, where she "woke up and was given soda and cold compresses". There was no reactions at the injection site and the patient had no additional reactions. Additional information has been requested. 01/05/2007 Initial and follow-up information has been received from a physician concerning a 14 year old female with no pertinent medical history or drug reactions/allergies, who on 17-AUG-2006 at 10:00 AM was vaccinated intramuscularly in the arm with the first dose of GARDASIL (lot # 653650/0702F). There was no concomitant medication and no illnesses a time of vaccination. On 17-AUG-2006, at 10:10 AM, the patient "passed out" in the car on her way home. It was reported that following vaccination, the patient went to her car and as her mother was driving, the patient passed out. The mother drove right back to the physician''s office with the patient, and the patient was carried into the office by a physician at which time she was awake. The patient lied down and was given soda and a cold compress to her forehead. It was reported that the "patient was only out a matter of 2 minutes before coming to". There was no reaction at the injection site and the patient had no additional reactions. No further information is expected.


VAERS ID: 263214 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2006-08-16
Onset:2006-08-16
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:29
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA04456

Write-up: Information has been received from a registered nurse concerning an 18 year old female who on 16-AUG-2006 was vaccinated intramuscularly in the deltoid with HPV rLi 6 11 16 18 VLP vaccine (yeast) (0.5 ml). The patient subsequently experienced severe injection site pain. It was reported that the patient remarked that the injection really hurt and that the pain flew down her arm. The patient rubbed her arm for a few minutes after receiving the injection. The patient subsequently went home and the nurse had not heard back from the patient. The patient was to be followed by her physician''s office. The nurse also reported that she had not agitated the syringe prior to injection. At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 263215 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: California  
Vaccinated:2006-08-10
Onset:2006-08-10
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:35
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRINESSA
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0608USA04457

Write-up: Information has been received from a physician concerning an 18 year old female with no pertinent medical history or drug reactions/allergies, who on 10-AUG-2006 was vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F). Concomitant therapy included ethinyl estradiol/norgestimate (TRINESSA). On 10-AUG-2006 the patient experienced multiple episodes of vomiting. Unspecified medical attention was sought. Subsequently, the patient recovered from the vomiting within 48 hours. Additional information has been requested.


VAERS ID: 263216 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:2006-08-17
Onset:2006-08-17
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:28
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 AR / IM

Administered by: Private       Purchased by: Private
Symptoms: Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0608USA04465

Write-up: Information has been received from a physician concerning a 15 year old female with no pertinent medical history or drug reactions/allergies, who on 17-AUG-2006 was vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F). There was no concomitant medication. On 17-aug-2006 the patient experienced nausea. Unspecified medical attention was sought. At the time of this report, the patient''s nausea persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/14/2006. Information has been received from a physician concerning a 15 year old female with no pertinent medical history or drug reactions/allergies, who on 17-AUG-2006 at 3:00 PM was vaccinated intramuscularly in the deltoid with the first dose of GARDASIL (lot # 653650/0702F). There were no illnesses at time of vaccination. There was no concomitant medication. On 17-AUG-2006 at 6:00 PM the patient experienced severe nausea. The patient subsequently recovered from the nausea on 21-AUG-2006. No further information is expected.


VAERS ID: 263217 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2006-08-18
Onset:2006-08-18
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:27
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0608USA04485

Write-up: Information has been received from a nurse concerning an 18 year old female with no known allergies and no other pertinent medical history reported. On 18-AUG-2006, the patient was vaccinated intramuscularly in the deltoid with a 0.5 ml "single dose prefilled syringe" of HPV rLi 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0702F). There were no concomitant medication reported. On 18-AUG-2006, the patient developed severe injection site pain with HPV rLi 6 11 16 18 VLP vaccine (yeast) injection. The patient remarked that "it hurt and felt that the injection went to her head". The nurse reported that the patient felt faint immediately after the vaccination. The nurse had the patient lay down. It was reported that the patient "got up after 1 minute and said that she was ok.". The nurse reported that the "patient left the office immediately after this and the nurse was following up with the patient later today to make sure that the patient was ok." The nurse reported that she had not agitated the syringe prior to injection. The patient sought unspecified medical attention. There were no laboratory diagnostic studies performed. On 18-AUG-2006, the patient recovered from the events. Additional information has been requested.


VAERS ID: 263218 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Female  
Location: California  
Vaccinated:2006-07-27
Onset:2006-07-27
   Days after vaccination:0
Submitted: 2007-01-06
   Days after onset:163
Entered: 2006-09-19
   Days after submission:109
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site reaction
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Herpes labialis
Preexisting Conditions: Herpes virus infection
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA04520

Write-up: This is in follow-up to report(s) previously submitted on 9/14/2006. Initial and follow-up information has been received from a physician concerning a 52 year old female with a history of a "herpes outbreak" two weeks ago. On 17-JUL-2006. "10 days prior" to receiving GARDASIL (yeast), the patient had taken acyclovir 200 mg. On 27-JUL-2006, the patient was vaccinated intramuscularly with the first dose of 0.5 mL of GARDASIL (yeast). It was reported that the patient had "2 herpes lesions on her inner labia" at the time of vaccination. On 27-JUL-2006, the patient developed a neck ache, eyelashes fell out, "a decrease memory for people" and excessive dry eye. On 27-AUG-2006 the patient developed a migraine with vomiting (previously reported that the patient had "burning at the injection site"). The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested.


VAERS ID: 263219 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-14
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Influenza like illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA05355

Write-up: Information has been received from a physician concerning a female (age not reported) who on an unspecified date, was vaccinated intramuscularly with the first dose of 0.5 ml of HPV rLi 6 11 16 18 VLP vaccine (yeast). The day after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast), the patient developed "flu-like symptoms" (date unknown). The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested.


VAERS ID: 263220 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-08-21
Onset:2006-08-21
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:24
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI CYCLEN
Current Illness:
Preexisting Conditions: CONCURRENT CONDITIONS: drug hypersensitivity
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0608USA05414

Write-up: Information has been received from a 22 year old female with an allergy to meperidine hydrochloride (DEMEROL) who on 21-AUG-2006 was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN). On 21-AUG-2006, following the vaccination, the patient fainted. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Additional information has been requested.


VAERS ID: 263221 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Arizona  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-14
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site vesicles
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0609USA00390

Write-up: Information has been received from a registered nurse concerning a female patient who in 2006 was vaccinated with her first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently, she was vaccinated with her second dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently, she developed a blister at the injection site. Medical attention was sought. The patient''s outcome was unknown. Additional information has been requested. Follow-up informatin received 4-11-08, indicated that the patient was being treated with an unspecified vaccine, and not Gardasil as previously reported. Therefore, WAES #0609USA00390 is being deleted from our files on HPV rL1 6 11 16 8 VLP vaccine (yeast). This report was previously sent to PLA V501 on 09/14/06.


VAERS ID: 263222 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Arizona  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-14
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site vesicles
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0609USA00391

Write-up: Information has been received from a registered nurse concerning a female patient who in 2006 was vaccinated with her first dose of GARDASIL. Subsequently, she was vaccinated with her second dose of GARDASIL (yeast). Subsequently, she developed a blister at the injection site. Medical attention was sought. The patient''s outcome was unknown. Additional information has been requested. Follow up information indicated that the patient was being treated with an unspecified vaccine, and not GARDASIL as previously reported. Therefore, WAES #0609USA00391 is being deleted from our files on GARDASIL. This report was previously sent to PLA V501 on 14-SEP-2006.


VAERS ID: 263223 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-08-08
Onset:2006-08-11
   Days after vaccination:3
Submitted: 2006-09-14
   Days after onset:34
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0609USA01112

Write-up: Information has been received from a nurse concerning two female patients who on approximately 08-AUG-2006 were vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast).


VAERS ID: 263224 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-14
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA05808

Write-up: Information has been received from a licensed practical nurse concerning female college students 9exact number of patients unspecified) who were vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently the patients experienced injection site (deltoid) pain. At the time of this report, the outcome of the event was unknown. Further attempts are being made to identify the exact number of patients and identifiers of the patients involved in this report.


VAERS ID: 263225 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-07-19
Onset:2006-07-19
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:57
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Injection site pain, Pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA06029

Write-up: Information has been receiving from a registered nurse concerning a 15 year old female with no medical history who on 19-JUL-2006 was vaccinated in the right deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F). Subsequently, on approximately 19-JUL-2006, the patient experienced burning at the injection site that lasted approximately 60 to 90 seconds and her arm became red and painful enough to cause the patient to cry. The patient subsequently recovered from the pain in the extremity, erythema, and injection site irritation. Additional information has been requested. The registered nurse also reported that the patient''s sister experienced pain in the extremity, erythema, and injection site irritation following vaccination with HPV rLi 6 11 16 18 VLP vaccine (yeast) (LOT#653937/0637F).


VAERS ID: 263226 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: New York  
Vaccinated:2006-07-27
Onset:2006-08-03
   Days after vaccination:7
Submitted: 2006-09-14
   Days after onset:42
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Influenza, Influenza like illness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA06089

Write-up: Information has been received from a physician concerning a 24 year old female patient who in approximately August 2006, was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced pain in joints and developed low grade fever. Unspecified medical attention was sought. The patient''s outcome was unknown. Additional information has been requested. 01/05/2007 Follow up information has been received, the physician reported that the patient was recovered from her symptoms and stated "all it was was a one day flu". Additional follow up information has been received from the physician concerning her 24 year old daughter, a student, who on 27-JUL-2006 was vaccinated IM in left arm with her first dose of GARDASIL, lot #653735/0688F. It was reported that on 03-AUG-2006 she developed flu like symptoms. No further information is available.


VAERS ID: 263227 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2006-08-07
Onset:2006-08-07
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:38
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YAZ
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0608USA06260

Write-up: Information has been received from a 20 year old female patient who on 07-AUG-2006 was vaccinated intramuscularly with her first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702F). Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). The patient stated that "right after getting the shot" she experienced pain in the upper arm on and off throughout the day. She also stated that the pain"feels like she has a knife in her arm". Unspecified medical attention was sought. The patient was treated with Ibuprofen. As of the report date, she was recovering. Additional information has been requested.


VAERS ID: 263228 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2006-08-25
Onset:2006-08-25
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:20
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Skin burning sensation
SMQs:, Peripheral neuropathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA06297

Write-up: Information has been received from a nurse practitioner concerning a 27 year old female who on 25-AUG-2006 was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast), lot#653650/0702F. During the administration of the vaccine, part of the fluid went into the patient''s arm, the patient''s arm, the patient pulled away and the remainder went on the skin (no adverse reaction noted). The patient complained of burning during administration. Medical attention was sought. The patient received a repeat dose with no burning noted. Patient''s status was reported as recovered. Additional information has been requested.


VAERS ID: 263229 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-07-19
Onset:2006-07-19
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:57
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA06310

Write-up: Information has been received from a registered nurse concerning a 17 year old female with no medical history who on 19-JUL-2006 was vaccinated in the right deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F). Subsequently on approximately site that lasted approximately 60 to 90 seconds and her arm became red and painful enough to cause the patient to cry. The patient subsequently recovered from the pain in the extremity, erythema, and injection site irritation. Additional information has been requested. The registered nurse also reported that the patient''s sister experienced pain in the extremity, erythema,and injection site irritation following vaccination with HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F).


VAERS ID: 263230 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: New York  
Vaccinated:2006-07-27
Onset:2006-08-01
   Days after vaccination:5
Submitted: 2006-09-14
   Days after onset:44
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA06470

Write-up: Information has been received from a physician concerning a 19 year old female patient who in approximately August 2006, was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently,the patient experienced pain in joints and developed low grade fever. Unspecified medical attention was sought. The physician reported that the patient was recovered from her symptoms and stated "all it was was a one day flu. Additional information is expected.


VAERS ID: 263231 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: New York  
Vaccinated:2006-08-01
Onset:2006-08-01
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:44
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Influenza, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA06471

Write-up: Information has been received from a physician concerning an 18 year old male patient who in approximately August 2006, was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced pain in joints and developed low grade fever. Unspecified medical attention was sought. The patient''s outcome was unknown. Additional information has been requested. Follow up information has been received: the physician reported that the patient was recovered from his symptoms and stated "all it was was a one day flu". Additional information is expected.


VAERS ID: 263232 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-08-21
Onset:2006-08-21
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:24
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 UN / -

Administered by: Public       Purchased by: Private
Symptoms: Laboratory test abnormal, Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI CYCLEN
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: diagnostic laboratory 08/21/2006 "comprehensive metabolic panel tests", electrocardiogram 08/21/06, absolute neutrophil 08/21/06 7.9 K/ul 2.0-609, total urine ketones 08/21/06 $g-80 negative, urine bacteria screen 08/21/2006 4+, urine WBC count 08/21/06 30-40 hpf 0-2/hpf, urine microscopic 08/21/06, urinalysis 08/21/06, glomerular filtration 08/21/06, complete blood cell 08/21/06
CDC Split Type: WAES0608USA06478

Write-up: Information has been received from an other health professional concerning a 26 year old female in sales with no pre-existing allergies, birth defects or medical conditions reported. On 21-AUG-2006, in the pm, the patient was vaccinated in the left deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702F). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN). There were no illness noted at the time of vaccination. On 21-AUG-2006, in the pm, the patient experienced an unspecified adverse event. The patient went to the emergency room and it was reported that she "went home that day". On 21-AUG-2006, the patient underwent a complete blood count (CBC), comprehensive metabolic panel, estimated glomerular filtration rate (GFR), urine microscopic analysis, urinalysis and an electrocardiogram (EKG). On 21-AUG-2006, the patient''s laboratory data revealed an absolute neutrophil count noted as 7.9 K/ul, urine ketones noted as $g-80, a urine white blood cell count noted as 30-40/hpf and urine bacteria noted as 4+. On 21-AUG-2006, the patient recovered from the events. Additional information has been requested.


VAERS ID: 263233 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Michigan  
Vaccinated:2006-08-07
Onset:2006-08-07
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:38
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0696F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0608USA06605

Write-up: Information has been received from a 26 year old female licensed practical nurse with no pertinent medical history and no known allergies or adverse drug reactions reported who on 07-AUG-2006 was vaccinated intramuscularly with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0696F). There were no concomitant medications reported. The licensed practical nurse reported that she received HPV rLi 6 11 16 18 VLP vaccine (yeast) in her deltoid from a pre-filled syringe. It was reported that when the injection was completed, the nurse administering it "let go of the plunger before taking it out of her arm" and the "spring shot the syringe out of the arm like a dart". It was reported that "some fluid leaked out of her arm". The licensed practical nurse reported that it "stung a little when the vaccine was administered" and then resolved in a few moments. The area of the spill was cleansed with alcohol. The patient sought unspecified medical attention. There were no laboratory diagnostic studies performed. At the time of this report, the patient had recovered from the events. Additional information has been requested.


VAERS ID: 263235 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-08-18
Onset:2006-08-23
   Days after vaccination:5
Submitted: 2007-01-05
   Days after onset:135
Entered: 2006-09-19
   Days after submission:108
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0608USA06869

Write-up: This is in follow-up to report(s) previously submitted on 9/14/2006. Information has been received from a physician concerning a 23 year old female with no known drug allergies was vaccinated intramuscularly on 18-AUG-2006 at 15:00 in the deltoid muscle with GARDASIL (yeast). On 24-AUG-2006 the patient developed a rash with itching and minimal swelling on the back of her neck, arms, ribs, back and behind her left knee. Follow up information stated that the patient was treated with Benadryl, 50 mg and topical hydrocortisone cream. It was reported that on 24-AUG-2006 the patient had recovered. Additional information is not expected.


VAERS ID: 263236 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Arizona  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-14
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site vesicles
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA06941

Write-up: Information has been received from a registered nurse concerning a female patient who in 2006 was vaccinated with her first dose of GARDASIL. Subsequently, she was vaccinated with her second dose of GARDASIL. Subsequently, she developed a blister at the injection site. Medical attention was sought. The patient''s outcome was unknown. Follow-up information received 4-11-08 indicated that the patient was being treated with an unspecified vaccine, and not GARDASIL as previously reported. Therefore, WAES #0608USA06941 is being deleted from our files on GARDASIL. This report was previously sent to PLA V501 on 09/14/06.


VAERS ID: 263237 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Rhode Island  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-14
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site reaction
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0608USA07071

Write-up: Information has been received from a nurse practitioner concerning an unspecified number of patient''s who were vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast) and complained of burning during administration. The patient''s outcomes were not reported. Additional information has been requested.


VAERS ID: 263238 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Washington  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-14
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0609USA00001

Write-up: Information has been received from a physician concerning three patients (age and gender not reported) who on an unspecified date, in the morning, were vaccinated with GARDASIL vaccine. Subsequently, the patients fainted after receiving GARDASIL vaccine (date unknown). It was reported that the patients had not eaten anything. At the time of this report, the outcome of the events were unknown. Additional information has been requested.


VAERS ID: 263239 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-14
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0609USA00041

Write-up: Information has been received from a registered nurse concerning 3 patients 9age and gender not reported) who on an unspecified date were vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently the patients developed injection site pain (date unknown). The patients sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested.


VAERS ID: 263240 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: California  
Vaccinated:2006-08-30
Onset:2006-08-30
   Days after vaccination:0
Submitted: 2006-10-06
   Days after onset:37
Entered: 2006-09-19
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Nausea, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TORADOL
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0609USA00066

Write-up: Information has been received from a physician concerning a 26 year old female who on 30-AUG-2006 was vaccinated intramuscularly in her right arm with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included ketorolac tromethamine (TORADOL). On 30-aUG-2006, the patient felt "dizzy" after the injection. The patient was then given a ketorolac tromethamine (TORADOL) injection and she "passed out" after receiving that injection (also reported as "dizziness followed by syncope"). It was reported that the patient was seeing the physician or her pain shot. The syncope occurred after her pain injection. The physician believed this was a vaso vagal response. It was reported that "it was not known if the patient was that she was scheduled to receive". The patient sought unspecified medical attention. It was reported that "she did not her second shot yet". On 30-AUG-2006, "a few minutes after", the patient recovered from the events. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/14/2006. Initial and follow up information has been received from a physician concerning a 26 year old white female with no other pertinent medical history reported. It was reported that the patient was seeing the physician for her pain shot. On 30-AUG-2006, the patient was vaccinated intramuscularly in her right arm with a 0.5 mL dose of GARDASIL (Lot # 653650/0702F). Subsequently, the patient felt dizzy immediately afterward. It was reported that the patient received a concomitant injection in her right hip reported as TORADOL and she passed out after receiving that injection. The patient developed loss of consciousness times 1 to 2 minutes, followed by diaphoresis, nausea and sedation event consistent with vaso-vagal reaction. The patient sought unspecified medical attention. On 30-AUG-2006, "a few minutes after", the patient had fully recovered from the events. No further information is available.


VAERS ID: 263241 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-08-29
Onset:2006-08-29
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:16
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0589F / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Doxycycline; ALLEGRA-D; hormonal contraceptives; AMBIEN
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA00077

Write-up: Information has been received from a physician concerning a female patient in her early 20''s who was vaccinated with her first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced a high amount of pain and swelling at the injection site. Medical attention was sought. Subsequently, the patient recovered. Additional information has been requested. 01/05/2007 Follow up information has been received from a physician concerning a 24 year old female who on 29-AUG-2006 at 9:00 a.m. was vaccinated in the left arm with her first dose of GARDASIL, lot #653736/0589F. Concomitant therapy included AMBIEN, doxycycline, ALLEGRA-D, and unspecified oral contraceptive pills. Following the vaccination, on 29-AUG-2006 at 9:00 a.m. the patient experienced pain (burning) in her left arm plus swelling and tenderness x 3 days. Additional information is not expected.


VAERS ID: 263242 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-14
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Pallor
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0609USA00264

Write-up: Information has been received from a physician concerning a 23 year old female. It was reported that it was "not known if the patient was pregnant, if she was taking any other medications or had a history of drug reactions or allergies." On an unspecified date, the patient was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). It was reported that the patient felt "light headed and dizzy" after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast). The patient also "turned very pale", but did not faint. At the time of this report, the outcome of the events were unknown. Additional information has been requested.


VAERS ID: 263243 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-14
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0609USA00265

Write-up: Information has been received from a nurse in a physician''s office concerning a female patient "in her 20''s" who on an unspecified date was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). It was reported that the patient "fainted" after being given HPV rLi 6 11 16 18 VLP vaccine (yeast) (date unknown). At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 263244 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-14
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0609USA00266

Write-up: Information has been received from a nurse in a physician''s office concerning a female patient "in her 20''s" who on an unspecified date was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). It was reported that the patient "fainted" after being given HPV rLi 6 11 16 18 VLP vaccine (yeast) (date unknown). At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 263256 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Maine  
Vaccinated:2006-08-29
Onset:2006-08-31
   Days after vaccination:2
Submitted: 2006-09-19
   Days after onset:19
Entered: 2006-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Fungal infection, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Celexa 40mg 1 1/2 tabs po q day
Current Illness: none known
Preexisting Conditions: none known
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: About 2 days after administration of Gardasil pt reported onset of intense itching under armpit same side, has now been present for about 3 weeks, not improving. Possibly reaction to Gardasil vs fungal infection -avoid any irritants, no creams of soaps or deodorants -fungal cream twice a day -will report this as adverse event to Gardasil -reeval in 1 week Medications Added to Medication List This Visit: 1) Ketoconazole 2 % Crea (Ketoconazole) .... Apply twice a day


VAERS ID: 263314 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: California  
Vaccinated:2006-08-28
Onset:2006-08-29
   Days after vaccination:1
Submitted: 2006-09-19
   Days after onset:21
Entered: 2006-09-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 LA / -
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2557AA / 1 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Headache, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Allergic rhinitis, RAD
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: On 8/29/06 pt woke up in am to rash on face and fever of 103. Rash not itchy. Treatment Tylenol or Motrin for fever. On 8/30/06 Pt continues with rash on face off and on and also fever continues. Temperature ranging 99.2 - . Also complains of headache.


VAERS ID: 263332 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2006-09-18
Onset:2006-09-19
   Days after vaccination:1
Submitted: 2006-09-20
   Days after onset:1
Entered: 2006-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Arthralgia, Pain
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Right hypothenar eminence (thumb) started aching approximately 24 hours after shot administered, then the right wrist ached badly (i.e arthralgia). No other etiology of pain identified. Anaprox DS (Naproxen) and split provided.


VAERS ID: 263354 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2006-09-06
Onset:2006-09-06
   Days after vaccination:0
Submitted: 2006-09-19
   Days after onset:13
Entered: 2006-09-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptions.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0609USA02500

Write-up: Information has been received from a nurse practitioner concerning a 17 year old female with no other pertinent medical history, adverse drug reactions or allergies reported. On 9/6/06, at 3:30pm, the pt was vaccianted IM with the first dose of 0.5ml of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 654540/0800F). Concomitant therapy included an unspecified hormonal contraceptives (also reported as birth control). On 9/6/06, the pt developed a mild seizure right after receiving HPV rL1 6 11 16 18 VLP vaccine yeast. The pt came to and immediately fainted again. The pt sought unspecified medical attention. It was reported that the pt had not eaten anything all day. After eating, the pt felt better. On 9/6/06, the pt had fully recovered from the events. Upon internal review, the mild seizure was considered to be an other important medical event. Additional information has been requested.


VAERS ID: 263370 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Kansas  
Vaccinated:2006-08-24
Onset:2006-08-25
   Days after vaccination:1
Submitted: 2006-09-21
   Days after onset:27
Entered: 2006-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 GM / IM

Administered by: Private       Purchased by: Other
Symptoms: Breast disorder female, Tenderness
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri cyclen LO x 6 years.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Extreme Breast tenderness x 4 days.


VAERS ID: 263539 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: California  
Vaccinated:2006-09-22
Onset:2006-09-22
   Days after vaccination:0
Submitted: 2006-09-25
   Days after onset:3
Entered: 2006-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 2 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Seasonal
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt fainted.


VAERS ID: 263612 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-09-01
Onset:2006-09-08
   Days after vaccination:7
Submitted: 2006-09-25
   Days after onset:17
Entered: 2006-09-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Blister, Erythema, Hypersensitivity, Rash erythematous
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singular, Zyrtec
Current Illness: NONE
Preexisting Conditions: Seasonal allergic rhinitis.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Raised erythematous patchy rash of left shoulder (Behind left deltoid muscle) with slight vesicles. Also similar linear rash on left leg (appearance of delayed hypersensitivity) rash began 1 week after injection.


VAERS ID: 263740 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Missouri  
Vaccinated:2006-09-01
Onset:2006-09-08
   Days after vaccination:7
Submitted: 2006-09-21
   Days after onset:13
Entered: 2006-09-29
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 UN / -

Administered by: Private       Purchased by: Private
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth Control Seasonal
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Itchy bumps, 1 on arm, 1 on breast, 1 on back.


VAERS ID: 263743 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Missouri  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-21
Entered: 2006-09-29
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 UN / -

Administered by: Private       Purchased by: Private
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Itchy bumps 1 on back, 1 on arm, 1 on leg.


VAERS ID: 263750 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-09-14
Onset:2006-09-21
   Days after vaccination:7
Submitted: 2006-09-27
   Days after onset:6
Entered: 2006-09-29
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0641F / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Joint range of motion decreased, Pain
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Phentermine 37.5 mg as needed
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: One week post injection, complain of achy arm where injection was given, difficult to raise arm, no swelling or redness at injection site.


VAERS ID: 263751 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: New York  
Vaccinated:2006-08-25
Onset:2006-08-26
   Days after vaccination:1
Submitted: 2000-09-26
   Days after onset:2160
Entered: 2006-09-29
   Days after submission:2194
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site reaction, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin
Current Illness: NONE
Preexisting Conditions: possible polycystic ovary syndrome
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Rash at injection site at 24 hours after administration, then rash on other arm (at corresponding site)


VAERS ID: 263754 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2006-09-25
Onset:2006-09-25
   Days after vaccination:0
Submitted: 2006-09-25
   Days after onset:0
Entered: 2006-09-29
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUSPAR, ATIVAN, CELEXA
Current Illness: NONE
Preexisting Conditions: Penicillin
Allergies:
Diagnostic Lab Data: took two BENADRYL
CDC Split Type:

Write-up: Hives on neck and chest, injection site red, warm to touch, itching at area and on palms of hands.


VAERS ID: 263862 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-09-28
Onset:2006-09-29
   Days after vaccination:1
Submitted: 2006-10-02
   Days after onset:3
Entered: 2006-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Anorexia, Back pain, Fatigue, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Fatigue, Headache, Backaches, Temp 103, no appetite, x 3 days then was ok no treatment.


VAERS ID: 263878 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Georgia  
Vaccinated:2006-10-02
Onset:2006-10-02
   Days after vaccination:0
Submitted: 2006-10-02
   Days after onset:0
Entered: 2006-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. ? / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: A few minutes after injection, patient began to feel faint and dizzy while standing up. Sitting down did not alleviate symptoms of nausea, so patient was moved to a bed to lie down. After about 10 minutes of laying down, patient was back to normal.


VAERS ID: 263895 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Maine  
Vaccinated:2006-09-25
Onset:2006-09-25
   Days after vaccination:0
Submitted: 2006-09-29
   Days after onset:4
Entered: 2006-10-03
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Oedema peripheral, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Wellbutrin XL; lithium carbonate; Risperdal
Current Illness: Asthma; Polycystic ovaries; Cold
Preexisting Conditions: Asthma; Polycystic ovaries; cold
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0609USA06568

Write-up: Initial and follow up information has been received from a registered nurse concerning an 18 year old female with asthma, polycystic ovaries and no known allergies or adverse drug reactions reported. On 25-SEP-2006, the patient was vaccinated intramuscularly with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653735/0688F). Concomitant therapy included bupropion HCL (WELLBUTRIN XL), lithium carbonate and risperidone (RISPERDAL). That evening, on 25-SEP-2006, the patient developed left arm swelling and difficulty breathing. It was reported that the difficulty breathing could be due to the patient having a cold and being an asthmatic. On 26-SEP-2006 the patient developed facial swelling. The patient sought unspecified medical attention. It was reported that a nurse practitioner and physician were doing an assessment and consultation. On an unspecified date, the patient had the assessment and consultation and her symptoms were not considered to be serious. At the time of this report, the patient was recovering from th events. The reporter considered the events to be serious as other important medical events (date unknown). Additional information is not expected.


VAERS ID: 263930 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2006-09-28
Onset:2006-09-28
   Days after vaccination:0
Submitted: 2006-10-03
   Days after onset:5
Entered: 2006-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 08001F / 1 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Injection site warmth, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: FEVER, SITE WARM TO TOUCH, PAIN NOTED WITH MOVEMENT OF EXTREMITY.


VAERS ID: 264066 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2006-09-25
Onset:2006-09-25
   Days after vaccination:0
Submitted: 2006-10-03
   Days after onset:8
Entered: 2006-10-06
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 RA / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2108AA / 1 RA / -
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2556AA / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Injection site induration, Injection site reaction, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prozac, Abilify, Lamictal.
Current Illness:
Preexisting Conditions: allergies, sinusitis, Bipolar disorder.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 2 separate reactions Tdap 6x4 1/2" area hot to touch. Induration of biceps upper arm started day of injection given seen in office 9/28/06, Gardasil 3 1/2 x 3" hot to touch started 3 days after shot for both ice and Ibuprophen.


VAERS ID: 264172 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2006-10-02
Onset:2006-10-06
   Days after vaccination:4
Submitted: 2006-10-09
   Days after onset:3
Entered: 2006-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2114AA / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2559BA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Urticaria (hives) developed 4 days after vaccines were given covered torso and extremities, extremely itchy. Pt was given Benadryl Zyrtec, Prednisone orally and took a bath with baking soda.


VAERS ID: 264204 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2006-09-12
Onset:2006-09-13
   Days after vaccination:1
Submitted: 2006-09-22
   Days after onset:9
Entered: 2006-10-10
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Coma, Mental impairment, Sinus arrhythmia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Disorders of sinus node function (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lithium, Propanolol, Prozac, Seraguel, Clozapine, Ritalin, Aviane, Keflex.
Current Illness: NONE
Preexisting Conditions: Bipolar DS, ADHS, left hydronephrosis.
Allergies:
Diagnostic Lab Data: At ER 9/13/06 EKG sinus arrhythmia, chest X ray NL, CT head normal, CBC, U/A, Lytes and toxic screen neg NL.
CDC Split Type:

Write-up: 09/13/06 pt went to school where she developed hives at 10am. She was sent home, mom came home and found pt unresponsive and called 911. Pt seen at ER. Became responsive and talking well at ER. Exam WNL. DX''d changed mental status sent home.


VAERS ID: 264209 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: California  
Vaccinated:2006-09-27
Onset:2006-09-27
   Days after vaccination:0
Submitted: 2006-10-02
   Days after onset:5
Entered: 2006-10-10
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. B229AA / 1 RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y1067 / 2 LA / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0816F / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR AC52B002AA / 5 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Cellulitis, Injection site reaction
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Cellulitis at injection site


VAERS ID: 264366 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-08-10
Onset:0000-00-00
Submitted: 2006-10-06
Entered: 2006-10-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Joint range of motion decreased
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA00433

Write-up: Information has been received from a physician concerning a 19 year old female who in early August 2006, was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast) (0.5 ml). The physician reported that at the time of vaccination, the patient experienced injection site pain. The patient later experienced decreased range of motion in the arm she received the vaccination. It was reported that the patient''s arm hurt when she raised it above her head. At the time of this report, the patient''s injection site pain, decreased range of motion in arm pain persisted. Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 264367 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-09-01
Onset:0000-00-00
Submitted: 2006-10-06
Entered: 2006-10-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0609USA00663

Write-up: Information has been received from a nurse concerning a female who on 01 Sep 2006 was vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702P). The nurse reported that she was very unhappy with the syringe. The nurse reported that she "had received no instructions, and upon using the syringe for the first time, the safety device activated as soon as she pushed all the way down on the plunger, and it hit the patient in the arm". The nurse also reported that she had not read the product insert prior to administering the vaccine, as it was not available in the carton, and as soon as she administered the full dose of vaccine, she immediately let go of the plunger. She also reported that "it was loud, which scared the patient, and the needle coil sprang out and hurt the patient. The patient was kept in the office longer than normal since the coil hit the patient against her arm and hurt her. Unspecified medical attention was sought. The nurse was able to administer the entire dose of vaccine. On 05-Sep-2006 the patient had recovered.


VAERS ID: 264368 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Oregon  
Vaccinated:2006-08-31
Onset:2006-08-31
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:127
Entered: 2006-10-11
   Days after submission:86
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Injury, Medical device complication, Medication error, Scratch
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA00688

Write-up: Information has been received from a medical assistant concerning a 23 year old female with no pertinent medical history or drug reaction/allergies, who on 8/31/06 was vaccinated IM with a pre filled syringe HPV rL1 6 11 16 18 VLP vaccine yeast (lot 654540/0800F). There was no concomitant therapy. The medical assistant reported that the spring action activated so forceful the needle and spring popped out of the clients left arm and scratched her. It was reported that all the vaccine was administered and that the pts left arm was washed with soap and water. She also reported that the pt did not bleed. No further details were provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/6/2006. Initial and follow-up information has been received from a medical assistant concerning a 23 year old white female with no partinent medical history of drug reactions/allergies, who on 31-AUG-2006 at 2:00 PM was vaccinated intramuscularly in the left deltoid with the first dose of a pre-filled syringe of GARDASIL (Lot # 654540/0800F). There was no concomitant therapy and no illnesses at time of vaccination. The medical assistant reported that "when the needle safety device was activated, it came down so forceful that the needle and syringe popped out of the client''s left arm, struck the patient, and scratched her." The reporter stated that the "syringe deployed as it should have, but was unexpected" by the health care provider. It was reported that the plunger was released before removing the needle from the arm of the patient. The reporter stated that there was no damage noted to the syringe. It was reported that all of the vaccine was administered and that the patient''s left arm was washed with soap and water and a bandaid was placed over the puncture site and scratch. The reporter also stated that the patient did not bleed and taht there was no adverse reaction to the patient. The patient subsequently recovered. No further information is expected.


VAERS ID: 264369 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-08-22
Onset:2006-08-23
   Days after vaccination:1
Submitted: 2006-10-06
   Days after onset:44
Entered: 2006-10-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA00704

Write-up: Information has been received from a registered nurse concerning a female pt (age not provided) who on approx 8/22/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (lot not provided). The nurse reported that a day and half after receiving the vaccine, on approx 8/23/06 the pt developed what appeared to be hives. Unspecified medical attention was sought. Subsequently, the p0t recovered from the hives. Additional information has been requested.


VAERS ID: 264370 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Wisconsin  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-06
Entered: 2006-10-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA01030

Write-up: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of 0.5 ml of HPV rL1 6 11 16 18 VLP vaccine yeast. It was reported that the pt fainted after the injection (date unk). The pt sought unspecified medical attention. AT the time of this report, the pt had recovered from the event (date unk). Additional information has been requested.


VAERS ID: 264371 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-08-16
Onset:2006-08-16
   Days after vaccination:0
Submitted: 2006-10-06
   Days after onset:51
Entered: 2006-10-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA01051

Write-up: Information has been received from a physician concerning her 13 year old daughter who on approx 8/16/06, (also reported as within the past 2-3 weeks) was vaccinated with a 0.5ml dose of HPV rL1 6 11 16 18 VLP vaccine yeast. the physician reported that her daughter experienced soreness at injection site for a couple of days after receiving HPV vaccine. The pt sought unspecified medical attention. At the time of this report, the outcome of the event was unk. Additional information has been requested.


VAERS ID: 264372 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Female  
Location: Montana  
Vaccinated:2006-09-07
Onset:2006-09-07
   Days after vaccination:0
Submitted: 2006-10-06
   Days after onset:29
Entered: 2006-10-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dysgeusia, Hyperhidrosis, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA01437

Write-up: Information has been received from a licensed practical nurse concerning a 27 year old female with no pertinent medical history or drug reactions. allergies, who on 9/7/06 was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653736/0689F). Concomitant therapy included ethinyl Estradiol norgestimate (Ortho Tri Cyclen). On 9/7/06, immediately after receiving the vaccine, the pt experienced a metallic taste in her mouth, nausea and sweating. The nurse had the pt lay down for a little while and the pt started to feel better. No further details were provided. At the time of this report, the pt was recovering. Additional information has been requested.


VAERS ID: 264373 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-06
Entered: 2006-10-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Pyrexia, Rash, Rash macular
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Body temp between 99 and 103 degrees.
CDC Split Type: WAES0609USA01470

Write-up: Information has been received from a physician concerning a female who on an unspecified date was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine yeast (0.5ml). Concomitant therapy included Dtap. The day after vaccination with HPV the pt developed a blotchy rash which lasted for three days (site of rash not specified). It was also reported that the pt experienced a fever with a temp between 99 and 103 degrees during the same three day period. Unspecified medical attention was sought. At the time of this report, the pt was recovering from the rash and fever. Additional information has been requested.


VAERS ID: 264374 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Washington  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-06
Entered: 2006-10-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Hypoxia
SMQs:, Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA01524

Write-up: Initial and follow up information has been received from a physician concerning a female pt (age not reported) who on an unspecified date, in the morning, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (date unknown). It was reported that the pt felt dizzy and was administered oxygen. The pt was observed for 30 minutes (previously reported that the pt had not eaten anything. At the time of this report, the pt had recovered from the events (date unk). The physician assessed the events as non serious and reported that she was unsure of the causality of the events. No further information is available.


VAERS ID: 264375 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Washington  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-06
Entered: 2006-10-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA01525

Write-up: Initial and follow up information has been received from a physician concerning a female pt (age not reported) who on an unspecified date, in the morning, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast. Subsequently, the pt fainted after receiving HPV vaccine (date unk). It was reported that the pt felt dizzy and was kept for observation (previously reported that the pt had no eaten anything). At the time of this report, the pt had recovered from the events (date unk). The physician assessed the events as non serious and reported that she was unsure of the causality of the events. No further information is available.


VAERS ID: 264376 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Arizona  
Vaccinated:2006-08-30
Onset:2006-09-02
   Days after vaccination:3
Submitted: 2006-10-06
   Days after onset:34
Entered: 2006-10-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdominal discomfort, Aphthous stomatitis, Herpes simplex, Malaise, Myalgia, Nausea, Pharyngolaryngeal pain, Pyrexia, Skin ulcer, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Herpes simplex virus, 09/13/06, Oral T 1 +; Herpes simplex virus, 09/13/06, Finger T 1 +; body temp, 09/06/06, 102F; body temp 09/08/06, 98.9F.
CDC Split Type: WAES0609USA01979

Write-up: Information has been received from a physician concerning a 22 year old female with no pertinent medical history and no allergies, who on 8/30/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast. On 9/2/06 the pt developed a canker sore on her lip and sore throat. On 9/6/06 she experienced nausea, vomiting, malaise, a temperature of 102F and developed a herpetic ulcerative ring on her left ring finger. It was also reported that the pt experienced myalgia. Unspecified medical attention was sought/ Subsequently, it was reported on 9/8/06 that the symptoms were subsiding, the lesion on the pts lip had crusted and her temp was 98.9F. 01/05/2007 Follow up information received stated that on 02-SEP-2006 the patient also developed gastrointestinal upset. Lab work completed on 13-SEP-06 included positive cultures for Herpes simplex type 1 isolated in oral swab and on the patients finger. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested.


VAERS ID: 264377 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Missouri  
Vaccinated:2006-09-05
Onset:2006-09-06
   Days after vaccination:1
Submitted: 2006-10-06
   Days after onset:30
Entered: 2006-10-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Skin discolouration, Sunburn
SMQs:, Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA02094

Write-up: Information has been received from a certified medical assistant concerning a 19 year old female with no pertinent medical history and no known allergies or adverse drug reactions reported. On 9/5/06, the pt was vaccinated IM with one dose of HPV rL1 6 11 16 18 VLP vaccine yeast. Concomitant therapy included Ortho Tri Cyclen. It was reported that the pt woke up the next morning and her skin was pink from head to toe. There was no rash, no pain, no itching, no swelling and no hives. It was reported that her only symptom was a sunburn like appearance to her skin. the pt sought unspecified medical attention. On 9/7/06 in the evening, the color began to subside. As of 9/8/06 her skin was reported as looks better and the pt was noted as recovering. Additional information has been requested.


VAERS ID: 264556 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Indiana  
Vaccinated:2006-10-05
Onset:2006-10-05
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:8
Entered: 2006-10-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2239AA / 2 LA / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0223F / 2 LA / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Pain in right upper arm from time of administration of vaccine and continuing 8 days.


VAERS ID: 264585 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2006-10-10
Onset:2006-10-10
   Days after vaccination:0
Submitted: 2006-10-16
   Days after onset:6
Entered: 2006-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Peripheral coldness
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt experienced paleness, sweating, cold hands, nausea, dizziness and lightheadedness.


VAERS ID: 264674 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-09-14
Onset:2006-09-14
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:29
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA04329

Write-up: Information has been received from a physician concerning an 18 year old female who on 14-SEP-2006 was vaccinated intramuscularly with a first 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). About an hour after receiving the vaccine, the patient developed shortness of breath and a fever. The patient was directed to the emergency room. It was noted that the patient''s symptoms improved "on therapy" (unspecified). No product quality compliant was involved. Shortness of breath and fever were considered to be other important medical events. Additional information has been requested. (OMIC)


VAERS ID: 264675 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Hepatitis
SMQs:, Hepatitis, non-infectious (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA05710

Write-up: Information has been received from a physician concerning a pt who was vaccinated with a dose of HPV vaccine yeast. Subsequently the pt experienced a recurrence of hepatitis and abdominal pain. The physicians office manager reported that the pt tested positive for hepatitis after receiving the vaccine. The pts outcome was not reported. Recurrence of hepatitis and abdominal pain were considered to be other important medical events (OMIC). Additional information has been requested.


VAERS ID: 264688 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-10-03
Onset:2006-10-04
   Days after vaccination:1
Submitted: 2006-10-12
   Days after onset:8
Entered: 2006-10-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA03769

Write-up: Information has been received from a physician concerning a 16 year old female who on 10/3/06 was vaccinated with 0.5ml of HPV. On 10/4/06, the pt developed muscle aches, fever and shortness of breath. The pt went to the ER. It was unknown if the pt was hospitalized. At the time of this report, the outcome of the event was unknown. The physician considered the events to be serious as other important medical events (OMIC). Additional information has been requested.


VAERS ID: 264695 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-08-30
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0609USA02204

Write-up: Information has been received from a physician assistant concerning an 18 year old female with on 8/30/06 was vaccinated with the first dose of HPV (lot 653650/0702F). The physician assistant reported that the pt received the first dose of HPV, about 12 days ago, and she still experiencing injection site pain. The pt sought unspecified medical attention. It was reported that the pt was being treated with ibuprofen (Advil). At the time of this report, the pt had not recovered from the event. The reporter considered the event to be serious as an other important medical event (OMIC). Additional information has been requested.


VAERS ID: 264696 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Hampshire  
Vaccinated:2006-09-27
Onset:2006-09-27
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:16
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Medication error
SMQs:, Extravasation events (injections, infusions and implants) (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0609USA07424

Write-up: Information has been received from a registered nurse concerning a female (age not reported) with on known allergies or adverse drug reactions reported. On 9/27/06, the pt was vaccinated IM in the left deltoid with 1 ml (2 vials) of HPV vaccine (lot 0B37F). Concomitant therapy included a tetanus toxoid shot in the other arm. Subsequently, the pt experienced arm hurting. The registered nurse confirmed that the pain was at the injection site. The pt has not mentioned any other symptoms. The pt sought unspecified medical attention. The intervention to prevent serious criteria was 800 mg, of Motrin. The registered nurse reported that she did not know if the event would have worsened or improved without the intervention of Motrin. On 9/28/06, the pt returned to the physicians office and was fine, however her arm still hurt. At the time of this report, the pt had not recovered from the event. The reporter considered the event to be serious as an other important medical event (OMIC). Additional information has been requested.


VAERS ID: 264703 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2006-10-11
Onset:2006-10-12
   Days after vaccination:1
Submitted: 2006-10-12
   Days after onset:0
Entered: 2006-10-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 2 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Acne, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI-CYCLEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Rash/Pimple like on fact and neck. This is in follow-up to report (s) previously submitted on 11/14/2006. Initial and follow-up information has been received from a health professional concerning a 23 year old female with no known allergies who on 11-OCT-2006 at 9:00 was vaccinated with a second dose of GARDASIL (lot # 653978/0955P), intramusculary in the deltoid. Concomitant therapy included ORTHO TRI-CYCLEN. On 12-OCT-2006 at 9:00 AM the patient experienced ''face/neck rash, pimple like stinging.'' It was also received from the FDA through the Freedom of Information Act. There is no additional information. Additional information has been requested.


VAERS ID: 264738 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA01527

Write-up: Initial and follow up information has been received from a physician and a registered nurse in the physicians office concerning a pt (age and gender not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast. The physician reported that the pt experienced soreness, pain at injection site after receiving HPV. The registered nurse reported that she had spoken with the physician who felt that the soreness was not really a reaction or a problem. It was reported that the physician did not feel it was an adverse effect, just soreness at the injection site. At the time of this report, the outcome of the event was unk. Additional information has been requested.


VAERS ID: 264739 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: New York  
Vaccinated:2006-08-30
Onset:2006-09-09
   Days after vaccination:10
Submitted: 2006-10-13
   Days after onset:34
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Fungal infection, Pruritus genital, Vaginal infection
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin
Current Illness:
Preexisting Conditions: Diabetes
Allergies:
Diagnostic Lab Data: Vaginal gram stain vaginal swab came back positive for yeast.
CDC Split Type: WAES0609USA02200

Write-up: Information has been received from a licensed practical nurse concerning a 13 year old female with diabetes and no known adverse drug reactions or allergies reported. On 8/30/06, the pt was vaccinated IM with a 0.5ml dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653937/0637F). Concomitant therapy included insulin. On 9/9/06 the pt developed a yeast infection. It was reported that the pt had vaginal itching since receiving HPV It was reported that the pt underwent a vaginal swab which came back positive for yeast. The pt was being treated with Monistat. the pt was treated with the over the counter medication and was not required to follow up with the physician at this time. According to the licensed practical nurse, the physician did not feel that HPV was the cause of the yeast infection and that it was the pts mother who inquired about the event. At the time of this report, the pt had recovered from the yeast infection (date unk). No further information is available.


VAERS ID: 264740 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Female  
Location: California  
Vaccinated:2006-09-05
Onset:2006-09-05
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:38
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Infection, Injection site mass, Injection site reaction, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Wellbutrin, Lasix
Current Illness:
Preexisting Conditions: Abortion, Pregnancy, Drug hypersensitivity.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA02222

Write-up: Information has been received from a 42 year old female with hypersensitivity to SOMA and a history of two pregnancies, and two unspecified abortions who on 9/5/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (0.5ml). Concomitant therapy included Lasix and Wellbutrin. The pt reported that on 9/5/06 she developed an injection site reaction. The pt reported that the reaction was like straph infection and described the reaction as looking like and itching like a big mosquito bite. The pt had not yet contacted her physician. At the time of this report, the pt had not yet recovered from the injection site reaction. No further information is expected.


VAERS ID: 264741 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: North Dakota  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Injection site pain, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA02251

Write-up: Information has been received from a licensed practical nurse concerning a female pt who on an unspecified date was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine yeast. Subsequently the pt experienced pain, numbness, and at tingly feeling all the way down to her fingertips. The events occurred in the arm in which the pt received the vaccination. Unspecified medical attention was sought. The pt subsequently recovered from the events. Additional information has been requested.


VAERS ID: 264742 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-09-12
Onset:2006-09-12
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:115
Entered: 2006-10-17
   Days after submission:80
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 2 GM / IM

Administered by: Private       Purchased by: Other
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Hypoaesthesia facial, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Medication errors (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA02498

Write-up: Information has been received from a physician concerning a 22 year old female pt who on 9/12/06 was vaccinated IM into the upper left buttock with a dose of GARDASIL, lot 653650/0702F. There was no concomitant medication. Approx one hour post vaccination the pt experienced numbness and tingling on the right side of her face. Medical attention was sought. No other symptoms were noted. As of the report date, the pt was recovering. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/13/2006. Information has been received from a physician concerning a 22 year old female patient who on 12-SEP-2006 was vaccinated IM into the upper left buttock with a dose of GARDASIL lot #653650/0702F. There was no concomitant medication. Approximately one hour post vaccination the patient experienced numbness and tingling on the right side of her face. Medical attention was sought. No other symptoms were noted. As of the report date, the patient was recovering. Follow up information has been received concerning the 22 year old female with no medical history who on the morning of 12-SEP-2006 was vaccinated IM into the upper left buttock with her second dose of GARDASIL, lot #653650/0702F. It was reported that right facial numbness developed within 1 hour after the injection. No diagnostic/laboratory tests were performed. The patient was reported to be recovered from right facial numbness. Additional information is not expected.


VAERS ID: 264743 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-09-11
Onset:2006-09-12
   Days after vaccination:1
Submitted: 2006-10-31
   Days after onset:49
Entered: 2006-10-17
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Feeling abnormal, Headache, Malaise, Mydriasis
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zithromax, Wellbutrin, Klonopin, Lexapro, Nicomide, Minocycline.
Current Illness:
Preexisting Conditions: Syncope, Anxiety.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA02502

Write-up: Information has been received from a registered nurse concerning a 21 year old female with syncope, anxiety and no known allergies reported. On 9/11/06, the pt was vaccinated IM with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653650/0702F). Concomitant therapy included Lexapro, Wellbutrin, Klonopin, Nicomide, and Zithromax. On 9/12/06 when the pt woke up, she complained of her pupils being dilated, a headache, light headed and reported that she feels like something in not quite right. It was reported that it was unknown if the pt had eaten that day. The pt sought unspecified medical attention. At the time of this report, the pt had not recovered from the events. Additional information has been requested.


VAERS ID: 264744 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-09-12
Onset:2006-09-12
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:31
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA02785

Write-up: Information has been received from a pharmacy intern concerning a female who on 9/12/06 the pt experienced nausea and vomiting. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unk. Additional information has been requested.


VAERS ID: 264745 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Maine  
Vaccinated:2006-08-31
Onset:2006-09-06
   Days after vaccination:6
Submitted: 2006-10-13
   Days after onset:37
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 UN / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Unintended pregnancy, Viral infection
SMQs:, Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Zoloft
Current Illness: Breast lump, Flu symptoms, Pregnancy NOS ( LMP = Unknown), Depression.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Urine beta human 09/06/06 positive.
CDC Split Type: WAES0609USA02871

Write-up: Information has been received through the pregnancy registry from a nurse practitioner concerning a 15 year old female with no known drug allergies, and with depression who on 8/31/06 at 3:00pm was vaccinated IM in the right deltoid with the first dose of GARDASIL (lot 653937/0637F). Illnesses at the time of vaccination included flu symptoms and a breast lump. Concomitant therapy included Zoloft. Other vaccinations given on 9/6/06 included Tdap. On 9/6/06 the pt was seen at her physician with a complaint of continued viral illness. It was reported that the pt was aware that she was pregnant but did not disclose this information to her health care provider until after vaccination. A urine pregnancy test was performed and found to be positive. The pt was advised no to receive the second dose of HPV. At the time of this report, the outcome of the viral illness and vaccine exposure during pregnancy was not known. Follow-up information has been received from the patient''s OB-GYN. A nurse reported that the patient was last seen at 28 weeks gestation on 12-JAN-2007. At that time, she was transfered to the department of maternal-fetal medicine at a local hospital. A nurse at the maternal-fetal medicine department reported that the patient delivered via vaginal delivery a "healthy baby boy but had gastroschisis". The baby was born on 07-APR-2007 and APGAR scores were 8 and 9 at one and five minutes, respectively. The nurse was unable to provide the infant''s birhtweight and indicated that infants born with this congenital anomaly are generally hospitalized for 12 weks. The nurse could not confirm when and if thin infant had been discharged from the hospital. Additional information has been requested.


VAERS ID: 264746 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-09-11
Onset:2006-09-11
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:32
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash maculo-papular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA03257

Write-up: Information has been received from a physician concerning a female patient who on 11-SEP-2006 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The physician reported that within 24 hours of receiving the vaccine the patient developed a maculo papular rash all over the body. Medical attention was sought. The patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 264747 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA03270

Write-up: Information has been received from a nurse practioner concerning her 20 year old daughter who on an unspecified date was vaccinated with 0.5 mL of HPV rL1 6111618 VLP vaccine (yeast). It was reported that "right after she got it", the patient developed severe arm pain (date unknown). The patient sought unspecified medical attention. At the time of this report, the patient was recovering from the event. Additional information has been requested.


VAERS ID: 264748 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Indiana  
Vaccinated:2006-09-12
Onset:2006-09-13
   Days after vaccination:1
Submitted: 2006-10-13
   Days after onset:30
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0641F / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MICROGESTIN FE
Current Illness:
Preexisting Conditions: Sulfonamide allergy
Allergies:
Diagnostic Lab Data: Body temp 09/13/06 103.6 degr
CDC Split Type: WAES0609USA03694

Write-up: Initial and follow up information has been received from a physician concerning a 20 year old female patient with sulfonamide allergy who on 12-SEP-2006 at 13:45 p.m. was vaccinated IM in the left deltoid with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), lot #653650/0641. Concomitant therapy included ethinyl estradiol (+) ferrous fumarate (+) norethindrone acetate (MICROGESTIN FE). On the early morning of 13-SEP-2006 the patient developed a fever to 103.6 degrees F, and generalized body aches. Medical attention was sought. On 18-SEP-2006, the patient recovered. Additional information is not expected.


VAERS ID: 264749 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-09-06
Onset:2006-09-06
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:37
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0640F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Feeling abnormal, Malaise, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0609USA04154

Write-up: Information has been received from a nurse practioner concerning a female patient (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, the patient fainted post vaccination. She stated that it "felt like the medicine traveled through my system at time of injection". Subsequently, the patient recovered from the syncope and abnormal feeling. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink (soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional has been requested. 01/05/2007 Information has been received from a nurse practitioner concerning a 22 year old female patient who on 06-SEP-2006 at 14:00 was vaccinated with the first dose of GARDASIL (Lot# 653650/0640F). Subsequently, the patient fainted 30 minutes post vaccination. She stated that it "felt like the medicine traveled through my system at time of injection". Subsequently, the patient recovered from the syncope and abnormal feeling. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink(soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional information has been requested.


VAERS ID: 264750 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Female  
Location: New York  
Vaccinated:2006-09-18
Onset:2006-09-18
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:25
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain lower, Dizziness, Fatigue, Headache, Nausea, Ultrasound pelvis
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified), LEXAPRO, FLOVENT, lorazepam, AMBIEN
Current Illness: Epilepsy; Asthma; Drug hypersensitivity; Convulsion disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Pelvic ultrasound, R/O ovarian cyst
CDC Split Type: WAES0609USA04248

Write-up: Information has been received from a 28 year old female patient with epilepsy, asthma and an allergy to carbamazepine (TEGRETOL) who on 18-SEP-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included escitalopram oxalate (LEXAPRO), lorazepam, "lomectol," zolpidem tartrate (AMBIEN), and fluticasone propionate (FLOVENT). The patient stated that since her vaccination she has been experiencing dizzy, tired, has headaches and felt nauseous. No medical attention was sought. As of the report date the patient has not recovered. Additional information has been requested. 01/05/2007 Follow up information has been received from a physician concerning the patient with a seizure disorder who on 18-SEP-2006 at 9:50 a.m. received her second dose of GARDASIL, lot # 653937/0637F, in the left deltoid. The physician reported that the patient complained of right lower quadrant pain and mild nausea after receiving the vaccine. A pelvic sonogram was performed to rule out ovarian cyst. The patient had not yet recovered. Additional information is not expected.


VAERS ID: 264751 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-08-01
Onset:2006-08-01
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:73
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. UNK / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EFFEXOR
Current Illness: Sulfonamide allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA04418

Write-up: Information has been received from a licensed practical nurse concerning a female patient with sulfonamide allergy who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced a fever for four days. Unspecified medical attention was sought. No further details were provided. Additional information has been requested. This is a follow-up to report (s). Information has been received from a physician concerning his 19 year old daughter with a sulfonamide allergy and no other pertinent medical history reported. In August 2006, the patient was vaccinated with the first dose of GARDASIL by another health care professional. Concomitant therapy included EFFEXOR. In approximately August 2006, "about 4 days after being vaccinated", the patient developed a primary herpetic gingivostomatitis on her lips. The patient sought unspecified medical attention. All symptoms had resolved. At the time of this report. The patient had recovered from the event (date unknown). Additional information has been requested.


VAERS ID: 264753 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-09-11
Onset:2006-09-12
   Days after vaccination:1
Submitted: 2006-10-13
   Days after onset:31
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 653735/0688F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Pyrexia, Rash vesicular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA04898

Write-up: Information has been received from a physician concerning a 17 year old female with no history of varicella virus vaccine live vaccination and an unknown history of varicella, who on 11-SEP-2006 was vaccinated intramuscularly with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. The physician reported that on 12-SEP-2006 "the next day, the patient developed a low grade fever and a vesicular rash on her neck and shoulders of about 15-20 lesions." The patient was treated with acetaminophen (TYLENOL). All of her symptoms resolved within 3-4 days (approximately 15-SEP-2006). Additional information has been requested.


VAERS ID: 264754 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA04922

Write-up: Information has been received from a certified medical assistant concerning a female patient between the age of 15 to 18 who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient complained of stinging. It was noted that the stinging was only for a moment and resolved quickly. The reporter felt that the stinging could be from the vaccine being cold. No other problems were noted with the administration. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 264755 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-09-20
Onset:2006-09-21
   Days after vaccination:1
Submitted: 2006-10-13
   Days after onset:22
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO, RITALIN
Current Illness:
Preexisting Conditions: Concurrent conditions: connective tissue disorder, thrombocytopenia, depression, drug hypersensitivity
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA05006

Write-up: Information has been received from a medical assistant concerning a 25 year old female with connective tissue disorder, thrombocytopenia, depression and allergy to ZITHROMAX who on 20-SEP-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) IM in the deltoid described as "pre-filled syringe one time." Concomitant therapy included escitalopram oxalate (LEXAPRO) and methylphenidate HCl (RITALIN). On 21-SEP-2006 the patient experienced fever of 100 degrees F. The patient sought unspecified medical attention. The patient''s fever of 100 degrees F. persisted. Additional information has been requested.


VAERS ID: 264756 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-09-18
Onset:2006-09-18
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:25
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site reaction
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA05009

Write-up: Information has been received from a nurse practitioner concerning a female who on 18-SEP-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced injection site reaction. The patient sought unspecified medical attention. Injection site reaction persists. Additional information has been requested.


VAERS ID: 264757 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Missouri  
Vaccinated:2006-09-01
Onset:2006-09-08
   Days after vaccination:7
Submitted: 2006-10-13
   Days after onset:35
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 653937/0637F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraception
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA05017

Write-up: Information has been received from a physician and a registered nurse concerning a 25 year old female who on 01-SEP-2006 was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 08-SEP-2006, one week after vaccination, the patient developed "small bumps under her skin" at the injection site. The patient sought unspecified medical attention. Subsequently, the patient fully recovered.


VAERS ID: 264759 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-09-07
Onset:2006-09-07
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:36
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0609USA05508

Write-up: Information has been received from a physician concerning a 21 year old female who on an unknown date was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not provided). Subsequently, the patient developed "swelling feet" for an unspecified amount of time after receiving the injection. At the time of this report the patient was recovering. Additional information has been requested.


VAERS ID: 264760 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site inflammation, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0609USA05516

Write-up: Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not provided). Subsequently, the patient experienced burning and pain at the injection site. Unspecified medical attention was sought. It was unknown at the time of the report if the patient had recovered. Additional information has been requested.


VAERS ID: 264761 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-08-15
Onset:2006-08-15
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:59
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0641F / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2151AC / 1 LA / IM

Administered by: Private       Purchased by: Military
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TUBERSOL, Aventis Pasteur, C2250AB
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0609USA05927

Write-up: Information has been received from a physician concerning his "around 18" year old daughter who was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included a dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX). Subsequently, the patient experienced numbness in her arms and lower extremities. Unspecified medical attention was sought. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information has been requested. 01/05/2007 Information has been received from a physician and health professional concerning an 18 year old female student with no medical history or allergies, who on 15-AUG-2006 at 09:00 was vaccinated IM into the right arm with a 0.5 ml first dose of GARDASIL (lot# 653650/0641F). Concomitant therapy included a first IM dose into the left arm of ADACEL (batch # C2151AC) and TUBERSOL (batch#C2250AB). On 15-AUG-2006 at 12:00, the patient experienced numbness in her arms and lower extremities. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. On 21-AUG-2006, the patient recovered completely. Additional information is not expected.


VAERS ID: 264762 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-09-25
Onset:2006-09-25
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:18
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Concurrent conditions: penicillin allergy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA05955

Write-up: Information has been received from a physician concerning a 26 year old female with a penicillin allergy who on 25-SEP-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Immediately post-vaccination, the patient experienced hives. The patient was treated with oral diphenhydramine hydrochloride (BENADRYL) and symptoms lessened. No diagnostic studies were performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 264763 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Indiana  
Vaccinated:2006-09-22
Onset:2006-09-22
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:21
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site swelling, Lymphadenopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA07045

Write-up: Information has been received from a physician concerning a 17 year old female patient who on 22-SEP-2006 was vaccinated IM with a first 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. On 22-SEP-2006 the patient developed swollen lymph nodes in the neck and groin, swelling at injection site and low grade fever. The patient sought unspecified medical attention. It was reported that the patient was recovering. Additional information has been requested.


VAERS ID: 264765 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Wyoming  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 653650/0696F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA07284

Write-up: Information has been received from a registered nurse concerning a female between the ages of 14 to 21 years old who was vaccinated IM into the deltoid region with a first 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced extreme pain during injection. No medical attention was sought. About 15 to 20 minutes after injection, the patient was improving. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 264766 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA07368

Write-up: Information has been received from a certified medical assistant concerning a female patient between the age of 15 to 18 who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient complained of stinging. It was noted that the stinging was only for a moment and resolved quickly. The reporter felt that the stinging could be from the vaccine being cold. No other problems were noted with the administration. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 264767 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA07369

Write-up: Information has been received from a certified medical assistant concerning a female patient between the age of 15 to 18 who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient complained of stinging. It was noted that the stinging was only for a moment and resolved quickly. The reporter felt that the stinging could be from the vaccine being cold. No other problems were noted with the administration. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 264768 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Loss of consciousness, Neurological examination, Pain, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA07370

Write-up: Information has been received from a certified medical assistant concerning a female patient between the age of 15 to 18 who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 658556/1060U). Subsequently, the patient complained of stinging. It was noted that the stinging was only for a moment and resolved quickly. The reporter felt that the stinging could be from the vaccine being cold.Approximately 10 minutes post vaccination, the patient got pale, lightheaded and passed out. Unspecified medical attention was sought. It was reported that the patient rested and a neurological check was performed. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 264769 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0609USA07371

Write-up: Information has been received from a certified medical assistant concerning a female patient between the age of 15 to 18 who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient complained of stinging. It was noted that the stinging was only for a moment and resolved quickly. The reporter felt that the stinging could be from the vaccine being cold. No other problems were noted with the administration. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 264770 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA07372

Write-up: Information has been received from a certified medical assistant concerning a female patient between the age of 15 to 18 who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient complained of stinging. It was noted that the stinging was only for a moment and resolved quickly. The reporter felt that the stinging could be from the vaccine being cold. No other problems were noted with the administration. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 264771 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA07427

Write-up: Information has been received from a physician''s office concerning a female patient was was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The reporter indicated that using the prefilled syringe was "painful and startling" to the patient. Her outcome was not reported. A product quality complaint was not involved. Additional information has been requested.


VAERS ID: 264772 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-09-27
Onset:2006-09-28
   Days after vaccination:1
Submitted: 2006-10-13
   Days after onset:15
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA08050

Write-up: Information has been received from a 27 year old female with no other pertinent medical history and no known allergies or adverse drug reactions reported. On 27-SEP-2006, the patient was vaccinated with 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included unspecified hormonal contraceptives (reported as "birth control"). On 28-SEP-2006, the patient developed red, itchy and swollen hands and feet. The patient sought unspecified medical attention. At the time of this report the patient was recovering from the events. Additional information has been requested.


VAERS ID: 264773 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-09-25
Onset:2006-09-25
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:18
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA08058

Write-up: Information has been received from the mother of a female patient in her "early 20''s" with no relevant medical history who on 25-SEP-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 mL). There was no concomitant medication. On 25-SEP-2006, the patient experienced "a lot of pain and nausea." The pain was described as a stinging feeling when the medication was being injected. The patient subsequently recovered from the pain and nausea one hour after vaccination. Medical attention was not sought. Additional information has been requested.


VAERS ID: 264774 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: New York  
Vaccinated:2006-09-26
Onset:2006-09-26
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:17
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Medication error, Pain
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Concurrent conditions: cervical dysplasia, colposcopy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA08128

Write-up: Information has been received from a nurse practitioner concerning a 23 year old female with mild cervical dysplasia with colposcopy and no known allergies or adverse drug reactions reported. On 26-SEP-2006, the patient was vaccinated with the first dose of 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication reported. It was reported that the pre-filled syringe had been stored at 34F. On 26-SEP-2006 the patient developed severe pain during administration with lightheadedness and dizziness. The patient was laid on the exam table and given ibuprofen (MOTRIN) for pain. The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the events. Additional information has been requested.


VAERS ID: 264775 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Colorado  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Medication error, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA08561

Write-up: Information has been received from a registered nurse concerning a 25 year old female who in 2006 (date not reported) was vaccinated with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The nurse reported having "the syringe jam and could not administer the vaccine." The vaccine was given using a second syringe. The nurse also reported that the patient experienced "muscle pain in her arm, the arm of the jammed syringe." At the time of this report, the patient had not recovered. Additional information has been requested.


VAERS ID: 264776 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Missouri  
Vaccinated:2006-09-01
Onset:2006-09-01
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:42
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Body temp, 09/??/2006, 102 degrees F
CDC Split Type: WAES0610USA00329

Write-up: Information has been received from a physician concerning an 18 year old female patient who in September 2006 was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently in September 2006 the patient developed 102 degree temperature and chills. Medical attention was sought. The patient was recovering. Additional information has been requested.


VAERS ID: 264777 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA00388

Write-up: Information has been received from an LPN concerning a female patient who was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced pain in her arm in excess of 5 days. There was no swelling or rash, only the pain. Medical attention was sought. The pain was reported to have improved on therapy. It was unknown whether this was an injection site reaction. Additional information has been requested.


VAERS ID: 264778 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: North Dakota  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA00698

Write-up: Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain, numbness, and a tingly feeling all the way down to her fingertips. The events occurred in the arm in which the patient received the vaccination. Unspecified medical attention was sought. The patient subsequently recovered from the events. Additional information has been requested.


VAERS ID: 264779 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: North Dakota  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA000699

Write-up: Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain, numbness and a tingly feeling all the way down to her fingertips. The events occurred in the arm in which the patient received the vaccination. Unspecified medical attention was sought. The patient subsequently recovered from the events. Additional information has been requested.


VAERS ID: 264780 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: North Dakota  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA00700

Write-up: Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain, numbness, and a tingly feeling all the way down to her fingertips. The events occurred in the arm in which the patient received the vaccination. Unspecified medical attention was sought. The patient subsequently recovered from the events. Additional information has been requested.


VAERS ID: 264781 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: North Dakota  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA00701

Write-up: Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain, numbness, and a tingly feeling all the way down to her fingertips. The events occurred in the arm in which the patient received the vaccination. Unspecified medical attention was sought. The patient subsequently recovered from the events. Additional information has been sought.


VAERS ID: 264782 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA00860

Write-up: Information has been received from a physician concerning a female patient "between the ages of 11 and 16 years old" who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Within 1 to 2 days after receiving HPV rL1 6 11 16 18 VLP vaccine (yeast), the patient developed a fever and headache (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested. Information has been received from physician concerning a female patient "between the ages of 11 and 16 years old" who on an unspecified date was vaccinated GARDASIL. Within 1 to 2 days after receiving GARDASIL, the patient developed a fever and headache (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested. Upon review of the file. WAES #0610USA00860 has been found to be a duplicate oWAES #0610USA01164. Therefore, WAES #0610USA00860 is being deleted from our files on GARDASIL.


VAERS ID: 264783 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-09-19
Onset:2006-09-19
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:108
Entered: 2006-10-17
   Days after submission:80
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 UN / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2559 / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: body temp 09/19/06 101 -
CDC Split Type: WAES0610USA01164

Write-up: Information has been received from a physician concerning an 11 year old female patient who on an unspecified date was vaccinated IM with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Within one to two days after administration, the patient developed headache and fever. No medical attention was sought. Her outcome was not reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/13/2006. Information has been received from a physician concerning a 11 year old female patient who on an unspecified date was vaccinated IM with her first dose of GARDASIL. Within one to two days after administration, the patient developed headache and fever. No medical attention was sought. Her outcome was not reported. Follow up information has been received regarding the 11 year old white female with no medical history who at 2:30 p.m. on 19-SEP-2006 was vaccinated in the right arm with her first dose of GARDASIL, lot #653735/0688F. She received her first dose of ADACEL in the left arm at the same time. At 7:00 p.m. on the same day, she developed a headache. She woke up during the night with severe headache. Fever was approximately 101-102. On the afternoon of 20-SEP-2006 she was better and able to attend school. It was reported that she recovered from headache and fever on the afternoon of 20-SEP-2006. Additional information is not expected. This is a consolidation of two reportes concerning the same patient. WAES #0160USA00860 was previously submitted on 13-OCT-2006.


VAERS ID: 264784 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA01349

Write-up: Information has been received from a physician concerning a female patient "between the ages of 11 and 16 years old" who on an unspecified date was vaccinated with GARDASIL. Within 1 to 2 days after receiving GARDASIL, the patient developed a fever and headache (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/13/2006. Information has been received from a physician concerning a female patient "between the ages of 11 and 16 years old" who on an unspecified date was vaccinated with GARDASIL. Within 1 to 2 days after receiving GARDASIL, the patient developed a fever and headache (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested. Upon review of the file, WAES #0610USA01349 has been found to be a duplicate of WAES #0610USA03614. Therefore, WAES #0610USAUSA01349 is being deleted from our files on GARDASIL.


VAERS ID: 264785 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA01350

Write-up: Information has been received from a physician concerning a female patient "between the ages of 11 and 16 years old" who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Within 1 to 2 days after receiving HPV rL1 6 11 16 18 VLP vaccine (yeast), the patient developed a fever and headache (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested. Upon review of the file, WAES #0610USA0135 has been found to be a duplicate of WAES #0610USA03615. Therefore, WAES # 0610USA0135 is being delated from our files on GRDASIL.


VAERS ID: 264786 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Missouri  
Vaccinated:2006-09-01
Onset:2006-09-08
   Days after vaccination:7
Submitted: 2006-10-13
   Days after onset:35
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 653937/0637F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site reaction
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0610USA03087

Write-up: Information has been received from a physician and a registered nurse concerning a 25 year old female who on 01-SEP-2006 was vaccinated IM with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 08-SEP-2006, one week after vaccination, the patient developed "small bumps under her skin" at the injection site. The patient sought unspecified medical attention. Subsequently, the patient fully recovered. Additional information has been requested.


VAERS ID: 264787 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA03614

Write-up: Information has been received from a physician concerning a 13 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, the patient developed headache and fever. Her outcome was not reported. Additional information has been requested. This is a consolidation of two reports concerning the same patient. WAES# 0610USA01349 was previously submitted on 13-Oct-2006.


VAERS ID: 264788 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-09-27
Onset:2006-09-28
   Days after vaccination:1
Submitted: 2007-05-21
   Days after onset:235
Entered: 2006-10-17
   Days after submission:216
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Body temperature normal, Eye pain, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Body temp, 09/28/06, 100
CDC Split Type: WAES0610USA03615

Write-up: Information has been received from a physician concerning a 16 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, the patient developed headache and fever. Her outcome was not reported. Additional information has been requested. Follow up information has been received concerning the patient with no medical history who on 27-SEP-2006 at 2:00 p.m. received her first dose of GARDASIL, lot #653735/0688F, in the right arm. On 28-SEP-2006 at 8:00 a.m. the patient developed headache and fever (approximeately 100 oral temperature). The patient complained of headache pain behind eyes that was relieved by ADVIL. It was reported that on 29-SEP-2006 she recovered. Additional information is not expected. This is a consolidation of two reports concerning the same patient. WAES # 0610USA01350 was previously submitted on 13-OCT-2006.


VAERS ID: 264789 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Wyoming  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 653650/0696F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA03622

Write-up: Information has been received from a registered nurse concerning a female between the ages of 14 to 21 years old who was vaccinated IM into the deltoid region with a first 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced extreme pain during injection. The patient had to lie down for a short time period until the pain subsided. No medical attention was sought. About 15 to 20 minutes after injection, the patient was improving. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 264790 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Wyoming  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 653650/0696F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA03624

Write-up: Information has been received from a registered nurse concerning a female between the ages of 14 to 21 years old who was vaccinated IM into the deltoid region with a first 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced extreme pain during injection. No medical attention was sought. About 15 to 20 minutes after injection, the patient was improving. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 264791 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Malaise, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA03816

Write-up: Information has been received from a nurse practitioner concerning a female patient (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient fainted post vaccination. She stated that it "felt like the medicine traveled through my system at time of injection." Subsequently, the patient recovered from the syncope and abnormal feeling. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink (soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional information has been requested.


VAERS ID: 264792 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA03817

Write-up: Information has been received from a nurse practitioner concerning a female patient (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient fainted post vaccination. Subsequently, the patient recovered from the syncope. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink (soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional information has been requested.


VAERS ID: 264793 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA03818

Write-up: Information has been received from a nurse practitioner concerning a female patient (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient fainted post vaccination. Subsequently, the patient recovered from the syncope. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink (soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional information has been requested.


VAERS ID: 264950 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2006-09-19
Onset:2006-10-03
   Days after vaccination:14
Submitted: 2006-10-16
   Days after onset:13
Entered: 2006-10-19
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0039F / 1 LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0296R / UNK RA / SC

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Hypoaesthesia, Lymphadenopathy, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Valve Proplase in distant past, neg heart cath 2 yrs ago.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 09/19/2006 MMR and HBV adm 1, 10/03/2006 swollen glands, numbness and tingling of arm and legs bilat. Pt called hotline and states she was told this was from the MMR. 10/15/06 chest pain. Pt wonders if this is related to immunizations.


VAERS ID: 264959 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: New York  
Vaccinated:2006-10-16
Onset:2006-10-16
   Days after vaccination:0
Submitted: 2006-10-19
   Days after onset:3
Entered: 2006-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0741F / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Bradycardia, Coma, Heart rate irregular, Musculoskeletal stiffness, Pallor, Syncope, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Scheduled for cardiac and Neuro follow up. LABS: IgG was only positive for Lyme dx which was considered negative.
CDC Split Type:

Write-up: Administred VAQTA, then GARDASIL, immediately after GARDASIL child became unresponsive, stiff, pale about 30 sex. Child lost bladder control, pulse 46-55 after event, child alert and aware after events. 11/27/06 Received medical records from provider/reporter which reveal patient had LOC, tonic/clonic movements & loss of bladder control after received 2nd GARDASIL vax. HR was 46-55. This was the 3rd episode of LOC within a year (1st after tetanus shot, 2nd after finding a tick & 3rd after 2nd dose of GARDASIL). PCP recommended cardiac & neuro w/u. Received cardiac consultation which revealed final dx: probable fainting. Holter monitor was WNL. Awaiting neuro consult.


VAERS ID: 264992 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:2006-10-16
Onset:2006-10-18
   Days after vaccination:2
Submitted: 2006-10-19
   Days after onset:1
Entered: 2006-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK RA / -
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2572AA / UNK LA / -

Administered by: Private       Purchased by: Unknown
Symptoms: Blister, Eosinophil count increased, Herpes simplex, Herpes simplex serology negative, Lip swelling, Swelling face
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: eosinophil count, 11/16/06, 11%; serum herpes simplex, 11/02.06, 5.6; HSV type1 and/or 2, 10/19/06, 11%; Herpes simplex virus, 10/19/06, negat.
CDC Split Type:

Write-up: Received Tdap and HPV vaccine on 10/16/2006 noticed some blisters at the corner of mouth and swelling of lower lip on the evening of 10/18/2006 and facial swelling around eyes on 10/19/06. No fever, headache, dizziness or any GI symptoms. Information has been received from nurse manager in a physician''s office concerning a 15 year old female who on 16-OCT-2006 at 1600 was vaccinated in the right deltoid with the first dose of GARDASIL (lot # 653937/0637P). Concomitant therapy that day included DTP. Subsequently, the patient experienced an allergic reaction, her face and body began to swell. The physician recommended the patient take an unspecified dose of BENADRYL. After raking BENADRYL the patient''s face and body swelling "went down". On 20-OCT-2006 it was reported that "the swelling became worse again". At the time of this report the patient had not recovered from the event. Follow up information was received from the patient''s physician which stated that on 18-OCT-2006 the patient developed blisters in the corners of her mouth and swelling of her lip and face and she was seen in the office. She was treated with acyclovir for possible herpes simplex. Laboratory results from 19-OCT-2006 included HSV type 1 and/or 2 was 11% and Herpes simplex virus culture was negative. On approximately 23-OCT-2006 the patient was considered to have recovered from these events. On 02-NOV-2006 the patient reported swelling on her face and lower lip again. Laboratory results that same day included serum herpes simplex type 1 IgG Ab 5.6 and a eosinophil count of 11%. The physician reported that the patient recovered from these events on an unspecified date. This report was identified from a line listing obtained on request by the Company. A 15 year old female with no pre-existing conditions was vaccinated in 16-OCT-2006, intramuscularly into the right arm with GARDASIL (lot#653937/0637F). Concomitant therapy that day included DTAP (Lot # C2572AA), vaccinated into the left arm (route unknown). The patient noticed on the evening of 18-OCT-2006, some blisters at the corner of her mouth and swelling of lower lip and facial swelling around her eyes ib 19-OCT-2006. There was no reported fever, headche, dizziness or any gastrointestinal symptoms. Additional information has been requested.


VAERS ID: 265013 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2006-10-09
Onset:2006-10-16
   Days after vaccination:7
Submitted: 2006-10-17
   Days after onset:1
Entered: 2006-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Headache, Injection site reaction, Pruritus, Thermal burn
SMQs:, Anaphylactic reaction (broad), Accidents and injuries (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro, Effexor, Yasmin, HCTZ, Elmiron, Parida Plus, Claritin.
Current Illness:
Preexisting Conditions: Sulfa Allergy, Hypertension, Intestinal cystitis.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Localized reaction at injection site right del itching and burning beginning 7 day post injection, also headache. Txd symptoms with Benadryl, Tylenol, Hydrocortisone cream.


VAERS ID: 265107 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: New York  
Vaccinated:2006-10-19
Onset:2006-10-19
   Days after vaccination:0
Submitted: 2006-10-19
   Days after onset:0
Entered: 2006-10-23
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Dizziness, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: After receiving Gardasil vaccine #1 pt immediately became lightheaded, weak and sweaty. SX lasted approx 5 minutes. (OMIC). Per 60 day follow up: Patient received GARDASIL # 2 on 2/20/07, uneventful.


VAERS ID: 265305 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-10-16
Onset:2006-10-16
   Days after vaccination:0
Submitted: 2006-10-24
   Days after onset:8
Entered: 2006-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. UNKNOWN / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Difficulty in walking, Muscle rigidity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho-tricyclene Low
Current Illness: None.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: According to my daughter, the following happened: 1. Shot was given between 1100-1115 am 2. Proceed to wait a few minutes with doctor in room and then went to check out 3. Between 1120-1125 am...she passed out in doctors office. 4. Day 2-4: tightness in muscles especially around lower legs. Also tigtness in arms, but not as bad as legs. 5. Hard time walking after first waking up in morning and gradually loosens up after she starts moving around. 6. I suggested to her to take a Tylenol to help with muscle tightness and to massage calves prior to getting out of bed to help loosen them up.


VAERS ID: 265338 (history)  
Form: Version 1.0  
Age: 1.03  
Sex: Male  
Location: Michigan  
Vaccinated:2006-10-13
Onset:0000-00-00
Submitted: 2006-10-17
Entered: 2006-10-25
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR V2175HA / 1 UN / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB099CB / 1 UN / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0212R / 4 UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B22930D / 4 LL / IM

Administered by: Private       Purchased by: Public
Symptoms:
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None Stated


VAERS ID: 265357 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2006-10-13
Onset:2006-10-20
   Days after vaccination:7
Submitted: 2006-10-25
   Days after onset:5
Entered: 2006-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0660F / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approximately 7 days after HPV IM, L deltoid became very sore, painful to abduct. Nosig soreness at 24 hours after IM. On exam is tender deep in muscle and is enlarged. No surface redness. No induration.


VAERS ID: 265372 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: California  
Vaccinated:2006-10-06
Onset:2006-10-06
   Days after vaccination:0
Submitted: 2006-10-23
   Days after onset:17
Entered: 2006-10-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Eye swelling, Pruritus, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA09738

Write-up: Information has been received from a physician concerning a 24 year old female pt with no known allergies or reportable medical history who on 10/6/06 was vaccinated IM with a 0.5ml dose of HPV. Several hours later, on 10/6/06 the pt called the office with complaints of swollen puffy eyes, some itching but no rash and blurry vision. The pt was seen in the office that evening on 10/6/06 and was given a dose of Benadryl and was sent home. The pt took a nap for the blurry vision and upon awakening the next morning the pt fully recovered. Blurry vision was considered to be disabling according to the physician since the pt was unable to perform her normal task. Additional information has been requested.


VAERS ID: 265384 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: New York  
Vaccinated:2006-10-23
Onset:2006-10-23
   Days after vaccination:0
Submitted: 2006-10-23
   Days after onset:0
Entered: 2006-10-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0966P / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Few minutes after receiving Gardasil vaccine patient had vaso vagal type reaction, weak, dizzy, hot, sweaty. Felt like she was going to faint.


VAERS ID: 265435 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-10-17
Onset:2006-10-17
   Days after vaccination:0
Submitted: 2006-10-26
   Days after onset:9
Entered: 2006-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0641F / 1 RA / -

Administered by: Private       Purchased by: Unknown
Symptoms: Acne
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Papules used BENADRYL and cortisone. Pt experienced severe case of hives over torso and legs ankle and feet. Hives lasted 4 days. Pt was given BENADRYL.


VAERS ID: 265676 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-10-17
Onset:2006-10-22
   Days after vaccination:5
Submitted: 2006-10-26
   Days after onset:4
Entered: 2006-10-31
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Anxiety, Cough, Hypersensitivity, Hypoaesthesia, Paraesthesia, Psychomotor hyperactivity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Thyroid, Potassium levels done. Given flu vaccine 10/27/06
CDC Split Type:

Write-up: Fever, cough, numb, and tingling all over, acted hyperactive loopy, taking OTC cold remedies, MD suggested Claritin and nasal spray for allergies, may need anti anxiety and anti depressant for ADHD, anxiety.


VAERS ID: 265756 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Missouri  
Vaccinated:2006-08-01
Onset:2006-08-03
   Days after vaccination:2
Submitted: 2006-11-01
   Days after onset:90
Entered: 2006-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Doxycycline,Zoloft,Yasmin
Current Illness: none
Preexisting Conditions: Depression & Anxiety, Migraine Headaches, Acne, Exzema, Seasonal Allergies.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient complained of Left arm numbness after receiving injection. Lasted less than 48 hours.


VAERS ID: 265801 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Washington  
Vaccinated:2006-10-25
Onset:2006-10-25
   Days after vaccination:0
Submitted: 2006-10-26
   Days after onset:1
Entered: 2006-11-01
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 LA / -

Administered by: Private       Purchased by: Unknown
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reports she vomited 1 time approximately 4 hours following injection of Gardasil. Patient''s mother reports that the patient vomited following the first injection in series.


VAERS ID: 265808 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-10-06
Onset:2006-10-07
   Days after vaccination:1
Submitted: 2006-10-30
   Days after onset:23
Entered: 2006-11-01
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chills, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Estrostep
Current Illness: NONE
Preexisting Conditions: allergic to Penicillin.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Nausea and vomiting, fever 99 degrees F- 100 degrees F, chills for 3 days.


VAERS ID: 265839 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Ohio  
Vaccinated:2006-09-20
Onset:2006-10-09
   Days after vaccination:19
Submitted: 2006-10-30
   Days after onset:21
Entered: 2006-11-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 12/12/06-records received-EMG study on 10/10/2006: nerve conduction studies of right peroneal and tibila nerves were normal. F wave latencies were normal but some blocking was present. Conclusion: study consistent with mild Guillain Barre Syndrome. Glucose on 9/30/06 148, albumin 30, CK 30.
CDC Split Type: WAES0610USA11542

Write-up: Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated with the first dose of HPV vaccine. subsequently the pt developed lower extremity weakness and was hospitalized for two days with Guillain [[name]]. The pt received treatment with gamma globulin during her hospitalization. At the time of this report, the pt was back to school and was 99% recovered having only some area of numbness to her lower extremities. The physician did not believe that the pt was on any other medications at the time and had no further details to provide. Additional information has been requested. Mild Guillane [[name]] Syndrome. EMG study on 10/10/2006: nerve conduction studies of right peroneal and tibial nerves were normal. F wave latencies were normal but some blocking was present. Conclusion: study consistent with mild Guillain [[name]] Syndrome. 12/12/06-records received from facility. DX Mild Guillain [[name]] Syndrome. 12/28/06-DC Summary received DC DX: Mild Guillain [[name]] Syndrome. 1.5 week duration of tingling below kness and above ankle bilaterally. Pain with walking. Office note for DO 12/28/06 from pediatric neurologist:continues to have tingling from elbow to hands, improving. On Neurontin 100 mg tabs 1 three times per day. Has pain across shoulders and neck also lower back. Will order labs.


VAERS ID: 265955 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: California  
Vaccinated:2006-10-21
Onset:2006-10-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2006-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 2 RA / SC

Administered by: Private       Purchased by: Private
Symptoms: Hypoaesthesia, Injection site pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Per pt arm where Gardasil was administered felt painful then numb and then pt fainted for a few seconds.


VAERS ID: 266325 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2006-08-30
Onset:2006-08-30
   Days after vaccination:0
Submitted: 2006-11-01
   Days after onset:63
Entered: 2006-11-08
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0696F / 1 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Complaints of pain in right arm initially after 1st Gardasil injection. States right arm hurt for 1 month after shot was given.


VAERS ID: 266371 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:2006-10-03
Onset:2006-10-06
   Days after vaccination:3
Submitted: 2006-11-06
   Days after onset:31
Entered: 2006-11-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen LO
Current Illness:
Preexisting Conditions: Hypersensitivity.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA14679

Write-up: Information has been received from a physician and the mother of a 15 year old female with a history of hypersensitivity reactions to allergens. On 10/3/06, the pt was vaccinated IM with the first dose of 0.5ml of HPV vaccine (lot 653650/0702F. Concomitant therapy included Ortho Tri Cyclen LO started on 10/6/06. On 10/06/06, the pt developed widespread itching and hives of both upper and lower extremities. The pt did not experience respiratory symptoms. The pt was self treated with Benadryl with only mild improvement. A nurse in the local ER was consultated by phone but the pt did not require hospitalization. The symptoms resolved after one week and the pt had not experienced further problems. On 10/13/06 the pt had recovered from the event. The physician considered the event to be serious as disabling. Additional information has been requested.


VAERS ID: 266497 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Indiana  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2006-11-10
   Days after onset:11
Entered: 2006-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Disorientation, Dizziness, Dyspnoea, Nausea, Syncope, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Advil, Benadryl, Tylenol
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient fainted in waiting area less than five minutes after receiving Gardasil injection. Patient disoriented and c/o difficulty breathing when roused. C/O nausea, dizziness. Sent to ER & diagnosed as vasovagal syncope. Patient c/o sores in genital area 3 days post vaccination. Upon visit to doctor, diagnosed with Condyloma.


VAERS ID: 266541 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2006-09-13
Onset:2006-09-14
   Days after vaccination:1
Submitted: 2006-11-10
   Days after onset:57
Entered: 2006-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702P / 1 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Angioneurotic oedema, Face oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Angioedema lips for one month by history from pt.


VAERS ID: 266568 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2006-10-25
Onset:2006-10-25
   Days after vaccination:0
Submitted: 2006-11-01
   Days after onset:7
Entered: 2006-11-13
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Irritability, Rash
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Fussy body rash X 24 hours following vaccination. Cleared spontaneously.


VAERS ID: 266581 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Virginia  
Vaccinated:2006-10-13
Onset:2006-10-13
   Days after vaccination:0
Submitted: 2006-11-08
   Days after onset:26
Entered: 2006-11-13
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2165CA / 3 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood pressure decreased, Bradycardia, Heart rate irregular
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Fever~DTP (no brand name)~1~1.17~In Patient
Other Medications: Allegra, Nasolcrom, Acne meds, Bactrim
Current Illness: NONE
Preexisting Conditions: Acne, allergies to raw peaches, carrot, potatoes, kiwi, apples, cherries.
Allergies:
Diagnostic Lab Data: Skin prick tested for allergies.
CDC Split Type:

Write-up: Vasovagal RXN. Pt HR decreased to 50 and BP decreased.


VAERS ID: 266592 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-10-31
Onset:2006-11-01
   Days after vaccination:1
Submitted: 2006-11-06
   Days after onset:5
Entered: 2006-11-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2199AA / 5 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B011CA / 6 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Rash, Rash papular, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Fine red, papular, pruritic rash on 1st and 2nd digits both hands and dorsum both feet.


VAERS ID: 266639 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Maine  
Vaccinated:2006-11-08
Onset:2006-11-08
   Days after vaccination:0
Submitted: 2006-11-13
   Days after onset:5
Entered: 2006-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 RA / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1808AA / 1 LA / -

Administered by: Private       Purchased by: Other
Symptoms: Erythema, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CONCERTA 54mg
Current Illness: NONE
Preexisting Conditions: Attention-deficit Hyperactivity disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 10.4 cm X 7.0 cm area of redness. Swelling and tenderness. Complain of burning at site left deltoid.


VAERS ID: 266717 (history)  
Form: Version 1.0  
Age: 37.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-09-25
Onset:2006-09-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2006-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / UNK - / -

Administered by: Private       Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OVCON
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Developed rash all over body gradually subsided after few days.


VAERS ID: 266734 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: California  
Vaccinated:2006-10-03
Onset:2006-10-06
   Days after vaccination:3
Submitted: 2006-11-09
   Days after onset:34
Entered: 2006-11-14
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 - / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Hives all over 3 days after injection. No treatment.


VAERS ID: 266774 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2006-10-12
Onset:2006-10-19
   Days after vaccination:7
Submitted: 2006-11-14
   Days after onset:26
Entered: 2006-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 08668F / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site pain, Shoulder pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yaz, Zoloft, Bactrim DS
Current Illness: None
Preexisting Conditions: Depression
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient developed left shoulder pain at the deltoid corresponding to the site of injection. This began about 1 week after injection and has lasted for 3 weeks. It is 7/10 in severity and requires anti-inflammatories.


VAERS ID: 266788 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Oregon  
Vaccinated:2006-11-13
Onset:2006-11-13
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:1
Entered: 2006-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dizziness, Fatigue, Panic reaction
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Advair
Current Illness: odd cough & migranes per patient history
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient c/o: dizziness, lightheaded, feels as if she is going to have a panic attack, very fatigued.


VAERS ID: 266889 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Michigan  
Vaccinated:2006-10-25
Onset:2006-10-26
   Days after vaccination:1
Submitted: 2006-11-16
   Days after onset:21
Entered: 2006-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2256AA / UNK UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1948AA / 1 UN / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B012AA / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Dehydration, Hypersensitivity, Muscle spasms, Pyrexia
SMQs:, Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Nasocort, Zyrtec, Allergy injections.
Current Illness:
Preexisting Conditions: Allergic Rhinitis. PMH: environmental allergens. Eczema. Roavirus at age 2 months.
Allergies:
Diagnostic Lab Data: Labs: Glucose 118, CO2 21, C-reactive protein 1.8.
CDC Split Type:

Write-up: Pt received injections 10/25/06. Flu and HPV in one thigh. Tdap and Menactra in other thigh unk which thigh each given. Pt then went to allergist and received allergy injection in each arm. Admitted 10/26/06 for fever 103, dehydration and muscle cramping, sent home 10/27/06. DC DX: allergic reaction. 2 day history of fever. On same day as immunizations she received routine allergy shots. Immunizations received in thighs and allergy injections in arms. Complained of arms puffed and welted evening prior to admission, became painful. Also blotchiness on legs. Complained of pain in legs. Headache since immunizations, myalgias and arthralgias especially to shoulder area. Neck pain, prickly sensaton in feet. Previous immunization reacion 3 weeks ago with pain and symptomatic problems. PMH: environmental allergens. Eczema. Roavirus at age 2 months. PE: Extremities, there is injection site visible. No rash, erythema or exudate noted around the injection sites. No other rashes.


VAERS ID: 267030 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-11-15
Onset:2006-11-15
   Days after vaccination:0
Submitted: 2006-11-16
   Days after onset:1
Entered: 2006-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Disorientation, Dyskinesia, Eye movement disorder, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Adderall XL 30mg q day Depo Provera 150mg q 3 months
Current Illness: none
Preexisting Conditions: NKA none
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Within a minute of giving injection in rt deltoid, pt experienced pallor, syncope, rolling back of the eyes followed by jerky movements of upper & lower extremities. After 5 seconds, she became responsive, but disoriented to place. Pt stated that she had not eaten much all day.


VAERS ID: 267409 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Washington  
Vaccinated:2006-09-18
Onset:2006-09-18
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:57
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Medication error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Obesity
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA07330

Write-up: Initial and follow up information has been received from a nurse practitioner concerning a 25 year old female customer service representative. On 9/18/06, the pt was vaccinated in the right deltoid with the first dose of 0.5ml of HPV vaccine (lot 653937/0637F). There were no other illnesses noted at the time of vaccination. The nurse practitioner reported that the pt was severely obese and when she received the HPV vaccine, the medication dribbled down her arm. It was report that upon removal of the needle, blood tinged fluid flowed from the injection site. The nurse practitioner was unable to estimate the amount but assumed the pt received less than the full dose. The plan was to re inject the pt with a full dose. At the time of this report, the outcome of the events were unk. Additional information has been requested.


VAERS ID: 267410 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-07-19
Onset:2006-07-19
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:118
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0697F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Malaise, Mood swings
SMQs:, Dementia (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives
Current Illness:
Preexisting Conditions: Papilloma viral infection, Penicillin allergy, Asthma.
Allergies:
Diagnostic Lab Data: Serum Epstein Barr neg
CDC Split Type: WAES0610USA01137

Write-up: Information has been received from a nurse concerning a 21 year old female with asthma, unspecified drug reaction to Penicillin and Amoxicillin and might have been exposed to papilloma viral infection. On 7/19/06, the pt was vaccinated IM with the first dose of HPV vaccine (lot 653650/0697F). Concomitant therapy included unspecified hormonal contraceptives. Subsequently, the pt experienced fatigue, was sick and had mood swings for two months. It was reported that the pt felt rotten after receiving HPV vaccine. (date unk). The pt sought unspecified medical attention. The pt underwent a test for mononucleosis that came back neg (date unk). It was reported that the pt felt better two weeks before the second dose of HPV was due to be administered (date unk). It was reported that the pt does not want to receive the second and third dose of HPV vaccine. At the time of this report, the pt had recovered from the events (date unk). Additional information has been requested.


VAERS ID: 267411 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-10-02
Onset:2006-10-02
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:43
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0610USA01138

Write-up: Information has been received from a physician concerning a 17 year old female pt with on past medical history who on 10/2/06 was vaccainted with a dose of HPV vaccine, lot 653735/0688F. Concomitant therapy included an unspecified flu shot. It was reported that after receiving HPV vaccine, the pt passed out. Medical attention was sought. the pt recovered the same day. No further information is available.


VAERS ID: 267412 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-09-26
Onset:2006-09-26
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:49
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0610USA01157

Write-up: Information has been received from physician concerning a 17 year old female with no other pertinent medical history reported and no known allergies or adverse drug reactions reported. On 9/26/06 the pt was vaccainted with HPV vaccine (lot 653735/0688F). There were no concomitant medications reported. Subsequently, the pt passed out after receiving the vaccine. The pt sought unspecified medical attention. On 9/26/06, the pt had recovered from the event. Additional information has been requested.


VAERS ID: 267413 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA01483

Write-up: Information has been received from a registered nurse concerning an adult pt who was vaccinated with a dose of HPV vaccine. The pt complained of pain while being injected using the pre filled syringe. The nurse reported that another pt did not complain of pain when a normal syringe was used. The nurse suggested the pre filled needles may be dull causing pain during injection. The pts outcome was not reported. A product quality complaint was involved. No further information is available.


VAERS ID: 267414 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-09-14
Onset:2006-09-14
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:61
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 UN / -

Administered by: Private       Purchased by: Private
Symptoms: Lymphadenopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA01561

Write-up: Information has been received from a healthcare professional concerning a 15 year old female student who on 9/14/06 at 3:00 pm was vaccinated in the right hip with her first dose of HPV vaccine, lot 654540/0800F. On 9/18/06 the pt developed low grade fever and swollen glands. Her outcome was unk. The reporter indicated the pt would be evaluated at her next vaccination. Additional information has been requested.


VAERS ID: 267415 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Female  
Location: Washington  
Vaccinated:2006-10-02
Onset:2006-10-02
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:43
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0640F / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal Contraceptives
Current Illness:
Preexisting Conditions: Pap Smear abnormal, Loop electrosurgical excision procedure, seasonal allergy, penicillin allergy.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0610USA02296

Write-up: Information has been received from a registered nurse and a medical assistant concerning a 27 year old female with seasonal allergies, a possible penicillin allergy and had a history of an abnormal Papanicolaou smear and loop electrosurgical excision procedure. On 8/2/06, the pt was vaccinated IM in the arm with the first 0.5ml pre filled syringe dose of HPV Vaccine (lot 653650/0640F). Concomitant therapy included unspecified hormonal contraceptive (reported as birth control pills). Following the first vaccination, the pt did not experience any adverse reactions. On 10/2/06, the pt was vaccinated with the second dose of HPV vaccine. On 10/2/06, 12 hours after the vaccination, the pt woke up in the middle of the night with right red, itchy hands and feet (also reported as soaked them in ice). It was reported that the symptoms were better the afternoon of the vaccination. On 10/3/06, the pt took Benadryl. The pt sought unspecified medical attention. On 10/4/06, the registered nurse spoke with the pt in the afternoon and all symptoms had resolved. The medical assistant note that the pt had no immediate severe symptoms. The medical assistant reported that there was no mention of seriousness of events in the pts chart and reported that the events did not look like they were serious. The registered nurse further reported that she would not classify the events as serious. Additional information has been requested.


VAERS ID: 267416 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-10-01
Onset:2006-10-02
   Days after vaccination:1
Submitted: 2006-11-14
   Days after onset:43
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0610USA03498

Write-up: Information has been received from a physician concerning her 18 year old daughter who on 10/01/2006 was vaccinated with HPV vaccine IM in right deltoid. On 10/2/06, within 24 hours, the pt experienced itchy rash on her elbows, feet, buttocks and back. She was given Benadryl and topical steroid cream to treat the symptoms. The pts itchy rash on her elbows, feet, buttocks and back persisted. Additional information has been requested.


VAERS ID: 267417 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site anaesthesia, Injection site reaction, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA03730

Write-up: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of HPV (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient''s had the same experience (WAES #''s 0610USA04384, 0610USA04385 and 0610USA04386). Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient''s had the same experience (WAES #''s 0610USA04384, 0610USA04385 and 0610USA04386). Additional information is not expected.


VAERS ID: 267418 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Virginia  
Vaccinated:2003-09-01
Onset:2006-09-29
   Days after vaccination:1124
Submitted: 2007-01-05
   Days after onset:98
Entered: 2006-11-16
   Days after submission:50
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Biopsy, Cervical dysplasia, Colposcopy, Colposcopy abnormal, DNA antibody positive, Endocervical curettage, Laboratory test abnormal, Loop electrosurgical excision procedure, Polymerase chain reaction, Smear cervix abnormal
SMQs:, Systemic lupus erythematosus (broad), Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Cercical low grade squamous intraepithelial lesions.
Allergies:
Diagnostic Lab Data: 07-DEC-2004: "ASC-H". 04-APR-2005 colposcopy biopsy negative for lesion, discrepancy noted - biopsy was of less severity than the Papanicolaou (PAP) test result and repeat colposcopy, PAP, and endocervical curettage (ECC) (among other choices) were needed per protocol. 21-SEP-2005 low grade squamous intraepithelial lesions (LSIL). 13-OCT-2005 colposcopy cervical intraepithelial neoplasia (CIN) -1. 25-JAN-2006 atypical squamous cell of undetermined significance (ASCUS) (HPV+). 30-MAR-2006 CIN-2. 12-MAY-2006 loop electrosurgical excision procedure (LEEP) = CIN-1 overall. 24-JUL-2006 PAP negative.; biopsy, 04/04/05, PCR negative for all 4 vaccine types; colposcopy, 04/04/05, see narrative; colposcopy, 03/30/06, CIN-2;colposcopy, 10/13/05, CIN-1; diagnostic laboratory, 10/??/03, PCR negative to all 4 vaccine types; diagnostic laboratory, 12/07/04, "ASC-H"; diagnostic laboratory, 01/25/06, atypical squamous cell of undetermined significance; loop electrosurgical, 02/12/06; CIN-1 overall; diagnostic laboratory, 09/21/05, low-grade squamous intraepithelial lesions; diagnostic laboratory, 02/06?/03, seronegative and PCR negative to all 4 vaccine types; Pap test, 07/24/06, negative; cervix HPV DNA assay, 09/29/06, positive for high risk HPV; Pap test, 09/29/06, low grade squamous intraepithelial lesions
CDC Split Type: WAES0610USA04009

Write-up: Information has been received spontaneously from a gynecologist concerning a 22 year old female patient who had participated in an HPV study. On 29-SEP-2006 the patient tested positive for high risk HPV. The patient''s outcome was unknown. Upon internal request, the patient was unblinded on 25-OCT-2006, she received her first dose of HPV on 06-FEB-2003, her second dose in March 2003, and her third dose in September 2003. She showed strong conversion to all 4 vaccine types. At baseline the patient had been seronegative and polymerase chain reaction test (PCR) negative to all 4 vaccine types. In October 2003 she had been PCR negative to all 4 vaccine types. An April 2005 PCR result from a biopsy was negative for the 4 vaccine types. Additional study results: 07-DEC-2004: "ASC-H". 04-APR-2005 colposcopy biopsy negative for lesion, discrepancy noted - biopsy was of less severity than the Papanicolaou (PAP) test result and repeat colposcopy, PAP, and endocervical curettage (ECC) (among other choices) were needed per protocol. 21-SEP-2005 low grade squamous intraepithelial lesions (LSIL). 13-OCT-2005 colposcopy cervical intraepithelial neoplasia (CIN) -1. 25-JAN-2006 atypical squamous cell of undetermined significance (ASCUS) (HPV+). 30-MAR-2006 CIN-2. 12-MAY-2006 loop electrosurgical excision procedure (LEEP) = CIN-1 overall. 24-JUL-2006 PAP negative. At this point the patient had completed the study. She went to her own doctor and had another abnormal pap positive HR HPV test. The specific cytological diagnosis and the PCR test reports as positive for high risk type but did not indicate which specific HPV type. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2006. Information has been received spontaneously from a gynecologist concerning a 22 year old female patient who had participated in an HPV study. On 29-SEP-2006 the patient tested positive for high risk HPV. The patient''s outcome was unknown. Upon internal request the patient was unblinded on 25-OCT-2006, she received her first dose of HPV on 06-FEB-2003, her second dose in March 2003, and her third dose in September 2003. She showed strong conversion to all 4 vaccine types. At baseline the patient had been seronegative and polymerase chain reaction test (PCR) negative to all 4 vaccine types. In October 2003 she had been PCR negative to all 4 vaccine types. An April 2005 PCR result from a biopsy was negative for the 4 vaccine types. Additional study results: 07-DEC-2004: "ASC-H". 04-APR-2005 colposcopy biopsy negative for lesion, discrepancy noted - biopsy was of less severity than the Papanicolaou (PAP) test result and repeat colposcopy, PAP, and endocervical curettage (ECC) (among other choices) were needed per protocol. 21-SEP-2005 low grade squamous intraepithelial lesions (LSIL). 13-OCT-2005 colposcopy cervical intraepithelial neoplasia (CIN) -1. 25-JAN-2006 atypical squamous cell of undetermined significance (ASCUS) (HPV+). 30-MAR-2006 CIN-2. 12-MAY-2006 loop electrosurgical excision procedure (LEEP) = CIN-1 overall. 24-JUL-2006 PAP negative. At this point the patient had completed the study. She went to her own doctor and had another abnormal pap positive HR HPV test. The specific cytological diagnosis and the PCR test reports as positive for high risk type but did not indicate which specific HPV type. Follow up information has been received from a physician who provided laboratory tests regarding the patient''s positive high risk HPV and abnormal PAP status post LEEP after receiving active vaccine # 3. The cytology report indicated abnormal PAP/Biopsy within 3 years: narrative description was low grade squamous intraepithelial lesion. An HPV DNA, low/high risk test was performed; result was positive for HPV high risk. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006; 1/5/2007. Information has been received spontaneously from a gynecologist concerning a 22-year-old female patient who had participated in an GARDASIL study, on 29-SEP-2006 the patient tested positive for high risk HPV. The patient''s outcome was unknown. Upon internal request the patient was unblinded on 25-OCT-2006, she received her first dose of GARDASIL dose in September 2003. She showed strong conversion to all 4 vaccine types. At baseline the patient had been seronegative and polymerase chain reaction test negative to all 4 vaccine types. In October 2003 she had been PCR negative to all vaccine types. AN April 2005 PCR result from a biopsy was negative for the vaccine types. Additional study results: 07-DEC-2004 "ASC-H". 04-APR-2005 colposcopy biopsy vegative for lesion, descrepancy noted - biopsy was of less severity than the papanicolaou test result and repeat colposcopy, PAP, and endocervical curettage (among other choices) were needed per protocol. 21-SEP-2005 low-grade squamous intraepithelial lesions.; 13-OCT-2005 colposcopy cervical intracithelial neoplasia -1; 25-JAN-2006 atypical squamous cell of undetermined significance (HPV+); 30-MAR-2006 CIN-2; 12-MAY-2006 loop electrosurgical excision procedure = CIN-1 overall; 24-JUL-2006 PAP negative. At this point the patient had completed the study. She went to her own doctor and had another abnormal pap positive HR HPV test. The specific cytological diagnosis and the PCR test reports as positive for high risk type but did not indicate which specific HPV type. Follow up information has been received from a physician at a student health center who provided laboratory test regarding the patient ''s positive high risk HPV and abnormal PAP status post LEEP after receiving active vaccing x 3. The cytology report indicated abnormal PAP/Biopsy within 3 years; narrative description was low grade squamous intraepithelial lesion. An HPV DNA, low/high risk test was performed, result was positive for HPV high risk. This is a consolidation of 4 reports concerning the same patient. Additional information is not expected. It has been determined that WAES0704USA00327, 0704USA00561 and 0704USA00572 are duplicates of WAES0610USA04009, WAES #0601USA04009 was previously submitted on 14-NOV-2006 and on 05-JAN-2007.


VAERS ID: 267419 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Immediate post-injection reaction, Injection site anaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA04384

Write-up: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of HPV (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient''s had the same experience (WAES #''s 0610USA04385, 0610USA04386 and 0610USA03730). Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006. Initial and follow up information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient''s had the same experience (WAES # WAES0610USA04385, WAES0610USA04386, and 0610USA03730). Additional information is not expected.


VAERS ID: 267420 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0610USA04385

Write-up: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5ml dose of HPV (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient''s had the same experiences (WAES #''s 0610USA04384, 0610USA04386 and 0610USA03730). Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a health professional concerning a female patientt who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patients had the same experience (WAES #''s 0610USA04384, 0610USA04356 and 0610USA03730). Additional information is not expected.


VAERS ID: 267421 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site anaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA04386

Write-up: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 mL dose of GARDADIL (lot #653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patients had the same experience (WAES0620USA04384, WAES0610USA04385 and WAES0610USA03730). Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patients had the same experience (WAES #''s 0610USA04384, 0610USA04385 and 0610USA03730). Additional information is not expected.


VAERS ID: 267422 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-09-27
Onset:2006-09-27
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:48
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Injection site pain, Pain, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VICODIN TABLETS; OVCON 35; SKELAXIN
Current Illness:
Preexisting Conditions: Migraine; Sulfonamide allergy; Drug hypersensitivity
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0610USA04983

Write-up: Information has been received from a 26 year old female medical assistant (not CMA) with migraines, sulfonamide allergy and drug hypersensitivity to over the counter cold medications, who on 27-SEP-2006, was vaccinated IM with a 0.5ml dose of HPV (lot # 653735/0688F). Concomitant therapy included ethinyl estradiol/norethindrone (OVCON 35), netaxalone (SKELAXIN) and acetaminophen/hydrocodone bitartrate (VICODIN TABLETS). On 27-SEP-2006, the patient experienced severe pain at the injection site while the medication was being injected. The medical assistant also reported the pain as a sore bruised feeling that lasted for 4 to 5 days. On approximately 27-SEP-2006, the patient also experienced slight fever for 4 to 5 days. On 04-OCT-2006, she had physical therapy and the sore bruised feeling came back. Subsequently, the medical assistant recovered, however it was unknown if she recovered from the sore bruised feeling that came back on 04-OCT-2006. There was no product quality complaint involved. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 267423 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Tennessee  
Vaccinated:2006-10-06
Onset:2006-10-06
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:39
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA05062

Write-up: Information has been received from a registered nurse concerning a female patient who on 06-OCT-2006 was vaccinated in the right arm with the first dose of HPV (lot # not provided). On 06-OCT-2006, the patient experienced lightheadedness and numbness in her left arm. Unspecified medical attention was sought. Subsequently, that same day the patient recovered from lightheadedness and numbness in her left arm and was able to leave the office. Additional information has been requested.


VAERS ID: 267424 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: California  
Vaccinated:2006-10-05
Onset:2006-10-05
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:40
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER 0688F / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0602F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Muscle spasms, Pain
SMQs:, Dystonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA06133

Write-up: Information has been received from a physician concerning a 14 year old female patient who on 05-OCT-2006 was vaccinated IM with a dose of HPV. Concomitant therapy included hepatitis A virus vaccine (unspecified), administered at the same time and in the same arm. The physician reported that the patient was experiencing "severe spasmatic pain in her arm", and that the muscle would tense up for a 5 to 10 minute time frame. An hour later the pain would subside. Medical attention was sought. The patient recovered the next day, 06-OCT-2006. Additional information has been requested.


VAERS ID: 267425 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-10-02
Onset:2006-10-02
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:43
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WELLBUTRIN XL; CATAFLAM; PAXIL
Current Illness: Anxiety; Depression; Mass
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0610USA06154

Write-up: Information has been received from a physician concerning a 25 year old female with anxiety, depression and a lump in her vagina who on 02-OCT-2006 was vaccinated with IM in the upper arm with a 0.5 mL first dose of HPV (lot 653978/0955F). Concomitant therapy included bupropion HCl (WELLBUTRIN XL), diclofenac potassium (CATAFLAM) and paroxetine HCl (PAXIL). On 02-OCT-2006, ten minutes post vaccination, the patient passed out for a few seconds. The patient received unspecified medical attention. Subsequently, on 02-OCT-2006, the patient recovered. Additional information has been requested. 01/05/2007 Information has been received from a physician concerning a 25 year old female with anxiety, depression and a lump in her vagina who at 8:30 AM on 02-OCT-2006 was vaccinated intramuscularly in the upper right arm with a 0.5 ml first dose of GARDASIL (lot 653978/0955F). Concomitant therapy included WELLBUTRIN XL, CATAFLAM and PAXIL. The patient stated that she faints when given shots. On 02-OCT-2006, ten minutes post vaccination, the patient passed out for a few seconds. The patient felt fine after vaccination. The patient was advised to sit in the waiting room for at least 10 minutes before driving. Someone went to check on the patient, and the patient stated she thought she went out. The patient walked to a room to lie down. The patient felt fine later, left office, and was considered recovered. No additional information is expected.


VAERS ID: 267426 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0610USA06214

Write-up: Information has been received from a physician concerning her 15 year old daughter who was vaccinated with HPV. Subsequently, the patient experienced red dots/rashes on her ankles, elbows, and buttocks. Subsequently, the patient recovered from red dots/rashes on ankles, elbows, and buttocks. Therapy with HPV was not re-introduced. Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a physician concerning her approximately 18 year old student daughter (previously reported as her 15 year old daughter) who was vaccinated with a first dose of GARDASIL. Subsequently, 48-72 hours after the first dose, the patient experienced red dots/rashes on her ankles, elbows, and buttocks, also reported as an itchy rash on ankles and abdomen. The patient was treated successfully with BENADRYL and recovered from red dots/rashes on ankles, elbows, and buttocks, also reported as an itchy rash on ankles and abdomen within 24 hours. Before the second dose of GARDASIL, the patient was pre-medicated with CLARITIN. No rash or other adverse experience was noted. Additional information is not expected.


VAERS ID: 267427 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-09-30
Onset:2006-10-01
   Days after vaccination:1
Submitted: 2006-11-14
   Days after onset:44
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / 2 UN / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Facial palsy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA08291

Write-up: Information has been received from a physician concerning an 11 year old female who was the daughter of a nurse that works in his office. On 30-SEP-2006 the patient was vaccinated with a 0.5 ml dose of GARDASIL (lot #654540/0800F). At that same time, the patient received a second dose of FLUMIST. On 01-OCT-2006 the patient had a "funny feeling in her face." By 03-OCT-2006 "her face was crooked on one side and becoming paralyzed." The patient was treated with an unspecified steroid medication and was reported to be "feeling better," but the symptoms were not totally gone. The patient was seen by a neurologist and was diagnosed with Bell''s Palsy. The physician reported that one year ago, the patient was given FLUMIST and had no adverse reactions. At the time of this report, the patient was recovering from the events. The physician reported that it was his opinion that "Bells Palsy was caused by FLUMIST and not GARDASIL." Additional information has been requested.


VAERS ID: 267428 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Delaware  
Vaccinated:2006-09-21
Onset:2006-09-21
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:54
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Penicillin allergy; Sulfonamide allergy
Preexisting Conditions: Hypersensitivity reaction
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA08303

Write-up: Information has been received from a nurse concerning a 21 year old female with a history of an allergic reaction to penicillin and sulfonamide who on 21-SEP-2006 was vaccinated with HPV. On 21-SEP-2006, following vaccination, the patient broke out in hives all over her upper body particularly in the face, chest, and arms. Unspecified medical attention was sought. Subsequently, the patient recovered on 26- SEP-2006. Additional information has been requested.


VAERS ID: 267429 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-10-05
Onset:2006-10-05
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:40
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 - / -

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Injection site erythema, Injection site hypersensitivity, Injection site mass, Malaise, Pruritus, Pyrexia, Thermal burn
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Latex allergy; Drug hypersensitivity; Iodine allergy
Preexisting Conditions: Vaccination adverse reaction
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA08337

Write-up: Information has been received from a physician and a 22 year old white female certified medical assistant with latex allergy, drug hypersensitivity to pertussis and iodine allergy and a history of unspecified adverse reaction after first dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (at less than 1 year of age. On 05-OCT-2006, at 4:00 PM,. the patient was vaccinated, into the right arm, with a first dose of HPV (lot # 653978/0955F). On 05-OCT-2006, at 4:00 PM, the patient experienced burning "as if the arm was cut with razor blade and alcohol was poured on cut," and it "hurt really bad." The patient also developed dizziness, numbness in her lower arm, fever, fatigue, and malaise. She reported that her arm swelled up 2 times the normal size and was red. She developed a dime size lump and redness at the injection site that was itchy when touched or pressed on. Unspecified medical attention was sought. At the time of the report, the dime size lump, redness and itching at the injection site persisted. No further information is available.


VAERS ID: 267430 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-10-05
Onset:2006-10-06
   Days after vaccination:1
Submitted: 2006-11-14
   Days after onset:39
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 - / -

Administered by: Public       Purchased by: Public
Symptoms: Abdominal pain, Dysuria, Vaginal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0610USA08344

Write-up: Information has been received from a certified medical assistant concerning a 16 year old female who on 05-OCT-2006 was vaccinated with a first dose of HPV (lot # 653735/0688F). There was no concomitant medication. on 06-OCT-2006 the patient experienced sharp pain around the abdomen area and vaginal area and intense pain during urination. It was reported that the pain was on and off. It was reported that the patient was going to go to the physician''s office to be evaluated. At the time of the report, the patient''s outcome was unknown. Additional information has been requested. 01/05/2007 Initial and follow-up information has been received from a certified medical assistant concerning a 16 year old female who on 05-OCT-2006 was vaccinated with a first dose of GARASIL (lot #653735/0688F). There was no concomitant medication. On 06-OCT-2006 the patient experienced sharp pain around the abdomen area and vaginal area and intense pain during urination. It was reported that the pain was on and off. It was reported that the patient was going to go to the physician''s office to be evaluated. At the time of the report, the patient''s outcome was unknown. Additional information is not available.


VAERS ID: 267431 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: California  
Vaccinated:2006-10-04
Onset:2006-10-04
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:41
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0610USA08391

Write-up: Information has been received from a registered nurse concerning a 12 year old female with no past medical history who on approximately 10/4/06 was vaccinated, into the arm, with a 0.5ml dose of HPV vaccine. Concomitant therapy included a dose of Hep A vaccine. It was reported that the nurse rubbed the childs arm after the vaccination and the child passed out. The physician thought that it was a vasovagal reaction and revived her with ammonia. On approximately 10/04/06, the pt recovered. Additional information has been requested.


VAERS ID: 267432 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-10-11
Onset:2006-10-11
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:34
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Private       Purchased by: Public
Symptoms: Hypoaesthesia, Injection site reaction
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma, drug Hypersensitivity.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0610USA09277

Write-up: Information has been received from a physician concerning a 12 year old female with asthma and Advair allergy who on 10/11/06 was vaccinated with HVP vaccine. Concomitant therapy that day included varicella virus vaccine and influenza vaccine. On 10/11/06 the pt experienced numbing at injection site and around arm. The pt recovered. Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 267433 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Flushing
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified)
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0610USA09299

Write-up: Information has been received from a nurse concerning her 15 year old niece who was vaccinated with HPV rL1 6 11 18 VLP vaccine (yeast) (0.5 ml). Subsequently, "soon after having injections", the patient experienced dizziness and flushing "about ten minutes after her injections". It was reported that the patient received HPV rL1 6 11 16 18 VLP vaccine (yeast) with "other shots" and blood work. The patient recovered ;about 15 minutes after injections". Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 267434 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-08-30
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Influenza like illness
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA09300

Write-up: Information has been received from a 22 year old female nurse consumer who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced stomach ache and flu-like symptoms "for about a week''. The patient recovered. No further information is available.


VAERS ID: 267435 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2006-10-11
Onset:2006-10-12
   Days after vaccination:1
Submitted: 2006-11-14
   Days after onset:33
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI-CYCLEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA09303

Write-up: Information has been received from a physician concerning a 22 year old female who on 11-Oct-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot#653978/0955F) (0.5ml), intramuscularly. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). On 12-Oct-2006 the patient experienced "rash on her face and neck". Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 267436 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: California  
Vaccinated:2006-10-05
Onset:2006-10-06
   Days after vaccination:1
Submitted: 2006-11-14
   Days after onset:39
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Muscle spasms, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA09554

Write-up: Information has been received from a physician concerning a 14 year old female student who on 05-Oct-2006 was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot#653735/0688F). Concomitant therapy given at the same time in the same arm included a dose of hepatitis A virus vaccine (unspecified). On 06-Oct-2006, the patient experienced extremely severe cramping pain in arm at the vaccine site intermittently over about 16 hours following vaccination. The episodes lasted about 30 minutes each and were incapacitating. During the time between episodes the patient was completely pain free. The episodes continued through the night with the same intensity. The episodes stopped abruptly the next morning and there was no reoccurrence. Additional information has been requested.


VAERS ID: 267437 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA10123

Write-up: Information has been received from a physician concerning a patient who was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced numbness at the injection site and numbness around the arm. Additional information has been requested.


VAERS ID: 267438 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-10-09
Onset:2006-10-16
   Days after vaccination:7
Submitted: 2006-11-14
   Days after onset:29
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site mass, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified)
Current Illness:
Preexisting Conditions: CONCURRENT CONDITIONS: Hypertension; General symptom
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA10767

Write-up: Information has been received from a health professional concerning a 22 year old female with hypertension and "an interstitial problem" NOS who on 09-Oct-2006 was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Concomitant therapy included unspecified therapy. On 16-Oct-2006 the patient developed a "quarter size knot at the injection site that was warm to touch". Medical attention was sought and the patient was treated with diphenhydramine hydrochloride (BENADRYL). It was reported that the patient will discontinue the vaccination series. At the time of this report the patient had not recovered from the event. Additional information has been requested.


VAERS ID: 267439 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA10773

Write-up: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). The physician reported that the patient "was administered the shot and then fainted/passed out". Unspecified medical attention was sought. The physician reported that the patient recovered from the event. Additional information has been requested.


VAERS ID: 267440 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Virginia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA11270

Write-up: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, following the vaccination, the patient fainted. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 267441 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2006-10-18
Onset:2006-10-18
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:27
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0640F / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Accidental exposure, Burning sensation, Erythema, Medical device complication, Skin warm
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORTAB, WELLBUTRIN SR, BIAXIN, trazodone hydrochloride
Current Illness:
Preexisting Conditions: CONCURRENT CONDITIONS: Penicillin allergy
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA11279

Write-up: Information has been received from an office manager and a 42 year old female medical assistant with a Penicillin allergy who on 18-Oct-2006 went to place the needle on the HPV rL1 6 11 16 18 VLP vaccine (yeast0 (Lot#653650/0640F) pre-filled syringe and the medication squirted "out of the syringe" into the air. Concomitant therapy included bupropion HCl (WELLBUTRIN SR), Clarithromycin (BIAXIN), acetaminophen/hydrocodone bitartrate (LORTAB) and Trazodone HCl. The medication did get on her hands and she was experiencing burning and had redness on her index finger. It was warm to touch. At the time of this report, the patient was recovering from the events and the redness was decreasing. Additional information has been requested. It was reported that the patient who was scheduled to received HPV came back the next week and received a dose of HPV which was not in a prefilled syringe, without any problems. The patient had no side effects. Additional information has been requested.


VAERS ID: 267442 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2006-10-10
Onset:2006-10-11
   Days after vaccination:1
Submitted: 2006-11-14
   Days after onset:34
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified), CLARINEX
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0610USA11390

Write-up: Initial and follow up information has been received from a physician concerning a 17 year old white female student with no pre-existing medical conditions. On 10-Oct2006, at 4 PM, the patient was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#654540/0800F). Concomitant therapy included an unspecified therapy (reported as "over-the-counter acne medication''). There were no illnesses noted at the time of vaccination. The physician reported that when the patient left the office she was fine. That same day, the patient had been given desloratadine (CLARINEX) without positive result, by her mother and without physician consultation. On 11-Oct-2006, at 4 PM, the patient developed a rash which appeared on the ear tips, face, elbows, knee caps and around the belly button area. On 14-Oct-2006, the patient went to the emergency room (ER) but was not admitted for an overnight stay. The patient was treated with prednisone. The physician reported that she did not see the patient. The physician reported that the patient "had hives" and was given the steroids in the emergency room which she considered to be routine. At the time of this report, the patient had not recovered from the event. The physician considered the event to be non-serious. Additional information is expected.


VAERS ID: 267443 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-10-03
Onset:2006-10-03
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:42
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Loss of consciousness, Muscle contractions involuntary
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA11404

Write-up: Information has been received from a 23 year old female who on 03-OCT-2006 was vaccinated with a 0.5 mL dose of GARDASIL. The patient reported that the vaccine was given in the front part of the thigh muscle. Subsequently, the muscle contracted and the patient passed out due to pain. Unspecified medical attention was sought. When the patient woke up, she reported that she "felt fine." On 03-OCT-2006, the patient recovered from the events. Additional information is not expected.


VAERS ID: 267444 (history)  
Form: Version 1.0  
Age: 30.0  
Sex: Female  
Location: California  
Vaccinated:2006-09-11
Onset:2006-09-11
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:64
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LO/OVRAL
Current Illness:
Preexisting Conditions: CONCURRENT CONDITIONS: Anxiety
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0610USA11829

Write-up: Information has been received from an LPN concerning a 30 year old female patient with anxiety who on 11-Sep-2006 was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), lot#654540/0800F. Concomitant therapy included ethinyl estradiol/norgestrel (LO/OVRAL). After receiving the vaccination on 11-Sep-2006, the patient complained of a lot of pain under the arm pit and also on the left arm (injection arm). The arm hurt on and off, especially during workouts and while sleeping. the pain wakes up the patient in the middle of the night. She sought medical attention and was told to take Ibuprofen, apply ice to the area, and no upper body exercises. The nurse stated the patient was still having moderate pain 4 weeks after the injection, and that she probably would not receive further doses. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.


VAERS ID: 267445 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Upper respiratory tract infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA11832

Write-up: Information has been received from a nurse practitioner concerning a female (age not reported) who on an unspecified date was vaccinated with a 0.5 ml dose of HPV vaccine. Subsequently the pt developed an upper respiratory infection. The pt sought unspecified medical attention. The nurse practitioner stated that she told the pt when the pt called the office that she did not feel the upper respiratory infection was caused by the HPV vaccine. No further information was provided at the time of this report. Additional information has been requested.


VAERS ID: 267446 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-10-16
Onset:2006-10-16
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:29
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Diarrhoea, Irritable bowel syndrome, Loss of consciousness, Nausea, Pain, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dermotologic Unsp, Hormonal contraceptives.
Current Illness:
Preexisting Conditions: Food allergy, Irritable bowel syndrome.
Allergies:
Diagnostic Lab Data: Diagnostic lab 10/19/06
CDC Split Type: WAES0610USA11838

Write-up: Information has been received from the mother of a 24 year old female with irritable bowel syndrome and food allergies to 28 different foods, including yeast and corn who on 10/16/06 was vaccinated with HPV Vaccine. Concomitant therapy included Hormonal contraceptives (unspecified) and dermotologic (unspecified). On 10/16/06 the pt experienced nausea, diarrhea, aches, and vomiting which continued for three days without changes. On 10/19/06, it was reported that the pts irritable bowel syndrome was also triggered by the above events. On 10/19/06 the pt underwent a blood test (usually very well tolerated), however following the blood test on 10/19/06, the pt passed out and vomited, Unspecified medical attention was sought. The pts mother stated that she would be contacting her daughters physician with the listed allergies. At the time of this report, the pt was recovering from the events. Additional information is not expected.


VAERS ID: 267447 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Connecticut  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Influenza like illness, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA11954

Write-up: Information has been received from a nurse concerning a female pt who on an unspecified date was vaccinated IM with HPV vaccine (it was reported that it was uncertain whether this was the pts first dose). Subsequently, the day after vaccination, the pt experienced flu-like symptoms, felt horrible and felt very sick for a few days. At the time of this report, the pt had no more flu-like symptoms. Additional information has been requested.


VAERS ID: 267448 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-08-22
Onset:2006-08-22
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:84
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA12079

Write-up: Information has been received from a 38 year old female pt who on 8/22/06 was vaccainted IM with a dose of HPV vaccine. The reporter stated that on 8/22/06 I had pain for two months after the injection. Medical attention was sought. The pt was recovering. A product quality complaint was not involved. Additional information has been requested. Follow up information has been received from a physician concerning the 24 year old patient (previously reported as 38). The patient was complaining of pain, right hip: was seen by the nurse and the doctor; however there was no clinical indication of any problem. The patient was recovered.


VAERS ID: 267449 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Colorado  
Vaccinated:2006-09-01
Onset:2006-09-06
   Days after vaccination:5
Submitted: 2006-11-14
   Days after onset:69
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 1 RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Local swelling, Lymphadenitis, Lymphadenopathy, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA12091

Write-up: Information has been received from a physician concerning a 21 year old female who in approximately September 2006 was vaccinated with the first dose of GARDASIL (lot # not provided). On an unspecified date in approximately September the patient developed swelling in her lymph nodes and groin. Unspecified medical attention was sought. At the time of this report it was unknown if the patient had recovered. Additional information has been requested. 01/05/2007: This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a physician concerning a 21 year old female with seasonal asthma and no known drug allergies who on 04-SEP-2006, was vaccinated with an intramuscular injection in the onterolateral right thigh of the first dose of GARDASIL (Lot # 0689F). On 06-SEP-2006 the patient developed swelling in her lymph nodes and groin. The patient was seen in her physicians office and a large (7.3 cm), soft, tender femoral lymph node was noted near the injection site. There was no evidence of cellulitis or drainage. THe patient was diagnosed with lymphadenitis and was given asthma precautions. THe patient was seen in the office on 09-SEP-2006 and the area was still tender and the swelling was noted to have decreased slightly. The patient was seen again in the office on 10-NOV-2006 and the lymphadenitis had not yet fully resolved. The doctor noted that the second vaccination would be delayed until the lymphadenitis had completely resolved. Additional information has been requested.


VAERS ID: 267450 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Female  
Location: California  
Vaccinated:2006-10-03
Onset:2006-10-12
   Days after vaccination:9
Submitted: 2006-11-14
   Days after onset:33
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0696F / UNK UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA12097

Write-up: Information has been received from a physician concerning a 27 year old female who on 10/3/06 was vaccinated with the first dose of HPV Vaccine (lot nor provided). On 10/12/06 the pt experienced a very sore arm. The physician advised the pt to take Advil and apply ice to the area. At the time of the report it was unk if the pt had recovered. Additional information has been requested. Follow up information received stated that as appriximately 03-NOV-2006 the patient recovered from the event.


VAERS ID: 267451 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Missouri  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA12132

Write-up: Information has been received from a physician concerning a 15 year old female who was vaccainted with the first dose of HPV vaccine (lot # not provided). Subsequently the pt experienced low grade fever. The physician reported that the pt received Tylenol and felt better. Subsequently, the pt recovered from the low grade fever. Additional information has been requested.


VAERS ID: 267452 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Missouri  
Vaccinated:2006-10-16
Onset:2006-10-17
   Days after vaccination:1
Submitted: 2006-11-14
   Days after onset:28
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA12445

Write-up: Information has been received from a physician concerning a 15 year old female who on 10/16/06 was vaccinated with an IM HVP vaccine (lot 653978/0955F). On 10/17/06 the pt was sent home from school because she developed a fever of 102F and nausea. the physician reported that after 12 hours the pt recovered and returned to school the next day symptoms free. Additional information is not expected.


VAERS ID: 267453 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Connecticut  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-11-14
Entered: 2006-11-16
   Days after submission:367
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0610USA12537

Write-up: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced dizziness and nausea within a few minutes post vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested.


VAERS ID: 267454 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Iowa  
Vaccinated:2006-09-22
Onset:2006-09-27
   Days after vaccination:5
Submitted: 2006-11-14
   Days after onset:48
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTOX: DIPHTHERIA TOXOIDS (NO BRAND NAME) / UNKNOWN MANUFACTURER C2491AA / 1 LA / IM
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB0583A / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 LA / IM
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0610USA12643

Write-up: Information has been received from a physician concerning a female in her 20''s with intermittent problems with asthma and no known drug allergies, who on 22-SEPT-2006 at 13:00 was vaccinated IM into the left deltoid with a first dose of GARDASIL (Lot #653650/0702F). Concomitant therapy given that day included a first dose of DTaP (unspecified) given IM into the left arm, a first dose of TWINRIX (lot# AHABB0583A) given IM into the right arm and a first dose of typhoid vaccine. On 27-SEP-2006, the patient experienced intense itching all oer her body. The patient self medicated with BENADRYL. The itching was mostly on theinside of her legs and her back. She was treated with ZYRTEC. No diagnostic laboratory tests were pereformed. Subsequently, the patient fully recovered. No product qualitycomplaint was involved. It was noted that the vaccines were administered at different anatomical sites. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. Additional information has been requested.


VAERS ID: 267455 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-09-28
Onset:2006-09-29
   Days after vaccination:1
Submitted: 2006-11-14
   Days after onset:46
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 653978/0955F / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0610USA12794

Write-up: Information has been received from a registered nurse concerning a 12 year old white female with no know drug allergies, who on 28-SEP-2006 at 14:30 was vaccinated IM into the right deltoid with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). (Lot #653978/0955F). On 29-SEP-2006 at 08:00 the patient experienced a "large red rash area near the injection site, 1x1cm red around injection site and 3x2cm spot in the superior lateral site area, and red raised spot inferior and lateral to the injection site." No diagnostic laboratory studies were performed. The patient was treated with cool compresses, ibuprofen (Advil) or ibuprofen (Motrin) and cetirizine hydorchloride (Zyrtec) every 6 to 8 hours. The patient was told to go to the emergency room if her condition worsened. Subsequently, the patient recovered as there was no more follow up phone calls to the office. Additional information is not expected.


VAERS ID: 267456 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:2006-10-20
Onset:2006-10-20
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:25
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA13009

Write-up: Information has been received from a physician concerning a female patient who on 20-OCT-2006 was vaccinated with the first dose of GARDASIL. Subsequently the patient developed severe arm pain at the injection site. At the time of this report, the outcome of the event was unknown. No further details were provided. Additional information has been requested. 01/05/07: This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a physician and a nurse concerning a female patient who on 20-OCT-2006 was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced severe arm pain at the injection site. There was no redness and no swelling. The nurse reported that the pre-filled syringe "popped" when attempting to use it, causing the patient pain. The nurse then used another syringe which "worked fine". At the time of this report, the patient had not yet received her second vaccination. Additional information has been requested.


VAERS ID: 267457 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2006-10-10
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aldara
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0610USA13029

Write-up: Information has been received from a midwife registered nurse concerning a female with genital warts who "within the last few weeks" was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included imiquimod (Aldara). Subsequently "within the last few weeks" the patient experienced "swelling in genital warts". At the time of the report the patient was recovering. Unspecified medical attention was sought. Other information has been requested.


VAERS ID: 267458 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Female  
Location: New York  
Vaccinated:2006-10-24
Onset:2006-10-24
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:21
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 AR / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Vaccination complication
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA13156

Write-up: Information has been received from a registered nurse concerning a female who on 24 Oct 2006 was vaccinated with Gardisil (yeast) (Lot #654540/0800F). The nurse reported that on 24 Oct 2006 the pre-filled syringe of the vaccine malfunctioned and small amount sprayed out of the syring while she was withdrawing the syringe and the patient received an incomplete dose of the vaccine. She thought most of the dose was administered. The patient also stated that "the vaccination hurt." Unspecified medical attention was sought. At the time of this report the patient''s outcome was unknown. Additional information has been requested. 01/05/2007 Information has been received from a registered nurse concerning a 18 year old female who at 12:30 on 24-OCT-2006 was vaccinated intramuscularly in the deltoid with GARDASIL (Lot#654540/0800F). The nurse reported that on 24-OCT-2006 the pre-filled syringe of the vaccine malfunctioned and a small amount sprayed out of the syringe while she was withdrawing the syringe and the patient received an incomplete dose of the vaccine. She thought most of the dose was administered. The patient also stated that "the vaccination hurt". Unspecified medical attention was sought. At the time of this report the patient''s outcome was unnknown. Additional information has been requested.


VAERS ID: 267459 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-10-17
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Groin pain, Lymphadenopathy
SMQs:, Osteonecrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0610USA13171

Write-up: Information has been received from a triage nurse concerning a female (age unknown) with no other pertinent medical history reported. On approximately 17 Oct 2006, the patient was vaccinated with a 0.5mL dose of Gardisal (yeast). There were no concomitant medications reported. On an unspecified date, the patient contacted the nurse complaining about pain and swelling of the lymph nodes, in the groin area on her right side. Unspecified medical attention was sought. At the time of this report, the outcome of the events were unknown. Additional information has been requested.


VAERS ID: 267460 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Influenza like illness, Malaise, Myositis
SMQs:, Rhabdomyolysis/myopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA13175

Write-up: Information has been received from a physician concerning a female who was vaccinated IM with a 0.5ml first dose of Gardisal. Approximately 3 to 4 days after the vaccination, the patient experienced "myacitis", malaise and flu like symptoms and went to the emergency room. Subsequently, the patient recovered. Additional information has been requested.


VAERS ID: 267461 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2006-08-20
Onset:2006-08-20
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:86
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0610USA13556

Write-up: Information has been received from a health professional concerning a 17 year old female with no medical history or allergies, who on 20 Aug 2006 and 20 Oct 2006 was vaccinated IM with a first and second 0.5mL dose of Gardisal (yeast), respectively (first dose lot # 654540/0800F and second dose lot # 653736/0868F). There was no concomitant medication. On 20 Aug 2006, the patient experienced nausea and emesis. On 20 Oct 2006, the patient again experienced immediate nausea and vomiting. On 21 Oct 2006 the patient experienced low grade fever. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. Subsequently, the patient recovered from emesis. At the time of this report, the patient''s low grade fever persisted and the outcome of nausea was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 267462 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA14105

Write-up: Information has been received from a Registered Nurse concerning an adult patient who was vaccinated with a dose of Gardisal. The patient complained of pain while being injected using the prefilled syringe. The nurse reported that another patient did not complain of pain when a "normal" syringe was used. The nurse suggested the pre-filled needles may be dull causing pain during injection. The patient''s out come was not reported. A product quality complaint was involved. No further information is available.


VAERS ID: 267463 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA14150

Write-up: Information has been received from a nurse practitioner concerning a female who was vaccinated intramuscularly with a dose of Gardisil. The nurse practitioner reported that the patient "experienced a vasovagal reaction and felt woozy and fainted within 5 minutes of the injection." Unspecified medical attention was sought. At the time of the report, the patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 267464 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-10-11
Onset:2006-10-21
   Days after vaccination:10
Submitted: 2006-11-14
   Days after onset:24
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site induration, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA14291

Write-up: Information has been received from a physician concerning a 12 year old female who on 11 Oct 2006 was vaccinated with the first dose of 0.5mL of Gardisil (Lot # 653937/0637F). On 21 Oct 2006, the patient developed a know on the arm with no rash and no redness. On 24 Oct 2006, the patient developed throbbing pain around the arm that the injection was administered. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested.


VAERS ID: 267465 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Washington  
Vaccinated:2006-08-28
Onset:2006-08-28
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:78
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA14316

Write-up: Information has been received from a physician concerning a 16 year old female patient who on 28 Aug 2006 was vaccinated with a first dose of Gardisil. On 28 Aug 2006 the patient experienced vomiting within four hours of receiving the vaccination. Outcome was not reported. On 25 Oct 2006, the patient was vaccinated with a second dose of Gardisil. On 25 Oct 2006 the patient experienced vomiting within four hours of receiving the vaccination. On 25 Oct 2006, the patient recovered from vomiting. Additional information has been requested. Initial and follow-up information has been received from a physician and a licensed practical nurse concerning a 16 year old female patient who on 28-AUG-2006 was vaccinated with a first dose of GARDASIL 0.5 ml IM. On 28-AUG-2006, the patient experienced vomiting within four hours of receivng the vaccination. The patient recovered on 28-AUG-2006. On 25-OCT-2006, the patient was vaccinated with a second dose of GARDASIL 0.5 ml IM. On 25-OCT-2006 the patient experienced vomiting within four hours of receiving the vaccination. The mother felt that the vomiting was flu related for the first dose, however the vomiting happened again after the second dose. The patient recovered on 25-OCT-2006. No additional information is expected.


VAERS ID: 267466 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Alabama  
Vaccinated:2006-08-28
Onset:2006-09-22
   Days after vaccination:25
Submitted: 2007-04-06
   Days after onset:196
Entered: 2006-11-16
   Days after submission:140
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Band neutrophil percentage decreased, Body temperature increased, Chills, Eosinophil percentage, Epstein-Barr virus antibody negative, Epstein-Barr virus antigen positive, Epstein-Barr virus test negative, Headache, Herpes simplex, Herpes simplex serology positive, Insomnia, Laboratory test abnormal, Lymphocyte percentage, Lymphocyte percentage decreased, Monocyte percentage, Neutrophil percentage decreased, Pain, Pyrexia, Rhinorrhoea, White blood cell count abnormal
SMQs:, Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen
Current Illness:
Preexisting Conditions: Medical History: Vaginosis bacterial, yeast infection
Allergies:
Diagnostic Lab Data: body temp 101-103F; clinical seriology test, 10/23/06, positive; serum Epstein Barr 10/23/2006 negative, serum herpes simplex 10/23/06 positive; serum herpes simplex negative; WBC count normal; absolute blood atypical, 10/23/06, 13%, 0-6, high; band neutrophil count, 10/23/06, 5.0%, 0-5; eosinophil count, 10/23/06, 1.0%, 0-5; lymphocyte count, 10/23/06, 32.0%, 15-43; monocyte count, 10/23/06, 7.0%, 5-15; neutrophil count, 10/23/06, 42.0%, 43-75, Low; body temp, 101-103F; white blood cell, 10/23/06, moderate smudge cells; serum Epstein-Barr VCA, 10/23/06, positive; serum Epstein-Barr VCA, 10/23/06, - negative; serum EBNA antibody, 10/23/06, - positive; serum herpes simplex, 10/23/06, - positive; serum herpes simplex 10/23/06, 7.41 X1000 4.8 - 10.8 normal
CDC Split Type: WAES0610USA14581

Write-up: Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28 Aug 2006 was vaccinated IM in left deltoid with her first dose of Gardisil vaccine (yeast) lot #653736/0689F. Concomitant therapy included ethinyl estradiol/norgestimate (Ortho Tri-Cyclen). ON 22 Sep 2006 the patient developed fever, which she reported was "off and on". She described the fever as spiking at night after 6-7pm. Her fevers would reach 101-103 F and they resolved with rest plus the use of acetaminophen (Tylenol). After " a couple days or so", the fevers would reappear. Other symptoms included headache, hot and cold chill, body aches, waking in the night. The CMA stated that the patient reported these symptoms to the physician''s office on 23 Oct 2006. Laboratory tests performed on that date included HSV(herpes simplex virus) IGG type 1 (positive); HSV IGG type 2 (negative); and EBV(Epstein-Barr virus) (negative). It was reported "EBN was positive". Also reported was "sed rate and CBC=white blood cell count was normal". The patient was to be seen the following week to determine whether the fevers continued. Follow up information indicated that when the patient was seen on 30 Oct 2006 she received a second dose of Gardisil. The CMA noted that the patient was fine "so far". Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28-AUG-2006 was vaccinated IM in left deltoid with her first dose of GARDASIL lot #653736/0689F. Concomitant therapy included ORTHO TRI-CYCLEN. On 22-SEP-2006 the patient developed fever, which she reported was "off and on". She described the fever as spiking at night after 6-7 p.m. Her fevers would reach 101-103 F and they resolved with rest plus the use of TYLENOL. After "a couple days or so", the fevers would reappear. Other symptoms included headache, hot and cold chills, body aches, and waking in the night. The CMA stated that the patient also took unspecified allergy and cold medicine for a runny nose during the past month. The patient reported these symptoms to the physician''s office on 23-OCT-2006. Laborary tests performed on that date included HSV (herpes simplex virus) IGG type 1 (positive); HSV IGG type 2 (negative) ; and EBV (Epstein-Barr virus) (negative). It was reported "EBN was positive". Also reported was "sed-rate and CBC = white blood cell count was normal". The patient was to be seen the following week to determine whether the fevers continued. Follow up information indicated that when the patient was seen on 30-OCT-2006 she received a second dose of GARDASIL. The CMA noted that the patient was fine "so far". Additional follow up information has been received from a physician concerning the 21 year old black female student who on 28-AUG-2006 at 11:30 a.m. was vaccinated IM in left arm with her first dose of GARDASIL lot #653736/0689F. The physician reported that the patient made an appointment on 23-OCT-2006 with fever X 2 weeks. Diagnostic laboratory tests were performed, including positive EBNA (Epstein-Barr virus nuclear antigen antibody) and EBV VCA IgG (Epstein-Barr viral capsid antigen immunoglobulin G antibody), which indicated past infection. EBV VCA IgM (Epstein-Barr viral capsid antigen immunoglobulin M antibody) was negative (see laboratory data section for other results). The patient had mononucleosis. The physician indicated she had recovered. Additional information is not expected.


VAERS ID: 267467 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:2006-10-26
Onset:2006-10-26
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:19
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blister, Oral mucosal blistering, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA14848

Write-up: Information has been received from a physician concerning a female patient who on 26-OCT-2006 was vaccinated IM with a first dose of GARDASIL. On 26-OCT-2006 the patient experienced swelling as well as blisters in mouth and on the neck. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 267468 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA14937

Write-up: Information has been received from a physician concerning a female teenager who was vaccinated IM with a first dose of Gardisil. The patient "passed out" when she received the injection. The physician is planning to give the doses as recommended. Unspecified medical attention was sought. Shortly after vaccination, the patient recovered. No product quality complaint was involved. Additional information is not expected.


VAERS ID: 267469 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: California  
Vaccinated:2006-10-23
Onset:2006-10-23
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:165
Entered: 2006-11-16
   Days after submission:140
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Mononucleosis syndrome, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: body temp 10/23/06 102, body temp 10/26/06 100.
CDC Split Type: WAES0610USA14943

Write-up: Information has been received from a physician concerning an 18 year old female who on 23 Oct 2006 was vaccinated with 0.5mL of Gardisil (yeast). There were no concomitant medications reported. On 23 Oct 2006, the patient developed a high fever of 102 degrees after receiving shot of Gardisil. The temperature continued for three days and was now noted at 100 degrees. The patient also developed achy legs. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the events. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006. Initial and follow up information has been received from a physician concerning an 18 year old white female student who on 23-OCT-2006 was vaccinated intramuscularly in the arm with the first 0.5 mL dose of GARDASIL. There were no concomitant medications reported. On 23-OCT-2006, the patient developed a high fever of 102 degrees after receiving shot of GARDASIL. The temperature continued for three days and on 26-OCT-2006 was noted at 100 degrees. The patient also developed achy legs. On 30-OCT-2006, that next week, the patient was diagnosed with mononucleosis. At the time of this report, the outcome of the events were unknown. Additional information has been requested.


VAERS ID: 267470 (history)  
Form: Version 1.0  
Age: 30.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Amenorrhoea, Incorrect dose administered
SMQs:, Fertility disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA14944

Write-up: Information has been received from a physician assistant in her "late thirties" who on an unspecified date was vaccinated intramuscularly with the first dose of Gardisil vaccine (yeast). The physician assistant reported that she did not get her period the first month after the Gardisil vaccine. It was unknown if the patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown as " the patient was not due yet for her next menstrual cycle". Additional information has been requested.


VAERS ID: 267471 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA14972

Write-up: Information has been received from a nurse practitioner concerning a patient who was vaccinated with a dose of Gardisil vaccine (yeast). The nurse practitioner reported that the patient "experienced a vasovagal reaction and felt woozy and fainted within 5 minutes of the injection." At the time of the report, the patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 267472 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2006-10-25
Onset:2006-10-27
   Days after vaccination:2
Submitted: 2006-11-14
   Days after onset:18
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Laboratory test abnormal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: body temp 10/27/06 -about 99
CDC Split Type: WAES0610USA15118

Write-up: Information has been received from a physician concerning a "15 or 16 year old" female who on approximately 25 Oct 2006 or 26 Oct 2006 was vaccinated intramuscularly in the deltoid with Gardisil. On approximately 27 Oct 2006, the patient developed a low grade fever of about 99 and dizziness. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested.


VAERS ID: 267473 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-10-31
Onset:2006-10-31
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA15293

Write-up: Information has been received from a registered nurse concerning a female (age not reported) with no other pertinent medical history and no known allergies or adverse drug reactions reported. On 31-OCT-2006, the patient was vaccinated intramuscularly with GARDASIL. There were no concomitant medications reported. Subsequently, the patient experienced a cut which was less than 1/4 inch when the syringe was pulled out from the patient. It was reported that the patient had received the full dose. The patient sought unspecified medical attention. The registered nurse reported that the cut was very minor. At the time of this report, the patient was recovering from the events. Additional information has been requested.


VAERS ID: 267474 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Dyspnoea, Tension, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA15327

Write-up: Information has been received from a physician concerning a female age "14 or 15 years old" who on an unspecified date was vaccinated with the first dose of 0.5 ml of GARDASIL. After vaccination, the patient felt faint. It was reported that the patient felt dizzy, had difficulty breathing (also reported as "had a short of breath feeling"), felt like her throat was closing and looked tense. Her lungs were clear, there was no wheezing, no signs or symptoms of swelling, no facial or eye swelling and her blood pressure was stable. The physician reported that she thought this looked like a "slight reaction." The patient was given diphenhydramine hydrochloride (BENADRYL) as a precaution. The physician reported that the events were resolving that same day. It was reported that the patient "experienced similar symptoms not relating to vaccines and felt the symptoms may have been more panic driven than anything else." At the time of this report, the patient had recovered from the events (date unknown). The physician reported that she did not feel that the treatment with diphenhydramine hydrochloride (BENADRYL) was needed to prevent serious criteria and did not feel that this experience was life-threatening to the patient. Additional information has been requested.


VAERS ID: 267475 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: New York  
Vaccinated:2006-10-24
Onset:2006-10-25
   Days after vaccination:1
Submitted: 2006-11-14
   Days after onset:20
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZITHROMAX
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA00528

Write-up: Initial and follow-up information has been received from a physician concerning a 26 year old female with no other pertinent medical history and no known allergies or adverse drug reactions reported. On 24-OCT-2006 the patient was vaccinated intramuscularly in the deltoid with the first "1 vial" dose of GARDASIL (lot #653938/0954F). Concomitant therapy included azithromycin (ZITHROMAX). It was reported that on 24-OCT-2006, the patient had been vaccinated with the third dose of TWINRIX. On 25-OCT-2006, "within a day after immunization," the patient experienced blurry vision in both eyes. The patient sought unspecified medical attention. The patient was told by the physician to come to the office to be evaluated but had not. As of 02-NOV-2006, nine days after receiving GARDASIL, the physician reported that the blurred vision was "getting much better." Additional information has been requested.


VAERS ID: 267476 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Ohio  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:15
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA00600

Write-up: Information has been received from a registered nurse concerning a 13 year old female who on 30-OCT-2006 was vaccinated with GARDASIL. Subsequently, the patient experienced redness in her face and had vomited. The patient sought unspecified medical attention. At the time of this report, the patient was recovering from the event. Additional information has been requested.


VAERS ID: 267478 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:15
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA00698

Write-up: Information has been received from a physician concerning a 21 year old female who on 30 Oct 2006 was vaccinated with 0.5mL of Gardisil (Lot# 653736/0689F). On 30 Oct 2006, the patient developed a vasovagal reaction and passed out within one minute post vaccination. The patient was revived with an ammonia inhalant. No other symptoms were noted. Unspecified medical attention was sought. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested.


VAERS ID: 267479 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: California  
Vaccinated:2006-10-01
Onset:2006-10-01
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:44
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Hives, food allergies.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA00701

Write-up: Information has been received from a certified medical assistant and a physician concerning a 25 year old female with a history of hives due to orange juice who in approximately Oct 2006, a couple of weeks ago, was vaccainted with a 0.5ml first dose of HPV vaccine (lot 653736/0689F). There was no concomitant medication. Approximately 30 minutes after the vaccination, the pt experienced severe itching all over her body. It was reported that there was no rash. Unspecified medical attention was sought. Subsequently, the pt recovered after approximately 2 days. Additional information has been requested.


VAERS ID: 267480 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Oregon  
Vaccinated:2006-08-24
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Human papilloma virus test positive, Smear cervix
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Migraine
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Pap Test
CDC Split Type: WAES0611USA00721

Write-up: Information has been received from a licensed practical nurse concerning a 15 year old female with migraines and no known allergies or adverse drug reactions reported. On approx 8/31/06, the pt was vaccinated with the first dose of HPV vaccine. On an unspecified date, the pt was noted to be positive for an unknown number of high risk human papilloma virus types. The pt underwent a pap test (date and results not reported). The pt sought unspecified medical attention. a colposcopy was planned for the pt. At the time of this report, the pt had not recovered from the event. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2006. Information has been received from a licensed practical nurse concerning a 16 year old female subject with migraines and no known allergies or adverse drug reactions reported. On 24-AUG-2006, the patient was vaccinated with the first dose of GARDASIL. On an unspecified date, the patient was noted to be positive for an unknown number of high risk human papilloma virus types. The patient underwent a PAP (date and results not reported). The patient sought unspecified medical attention. A colposcopy was planned for the patient. At the time of this report, the patient had not recovered from the event. Additional information has been requested.


VAERS ID: 267481 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: New York  
Vaccinated:2006-10-01
Onset:2006-10-01
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:44
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA00728

Write-up: Information has been received from a nurse practitioner concerning a female pt who in Oct 2006, was vaccinated IM with a dose of HPV Vaccine. Subsequently in Oct 2006, she experienced lightheadedness, weakness, pallor, and sweating, No medical attention was sought. The nurse practitioner indicated the pt was doing fine. No product quality complaint was involved. Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a Nurse Practitioner concerning a 20 year old female patient who in October 2006, was vaccinated IM with a dose of GARDASIL. Subsequently, she experienced nausea, lightheadedness /lightheaded feeling/dizziness, weakness, pallor, and sweating but did not lose consciousness. No medical attention was sought. The nurse practitioner indicated the patient was "doing fine" and that she recovered after 20 minutes. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 267482 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:2006-10-01
Onset:2006-10-01
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:44
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pallor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA00729

Write-up: Information has been received from a nurse practitioner concerning a female pt who in Oct 2006, was vaccinated IM with a dose of HVP vaccine. Subsequently in Oct 2006 she experienced lightheadedness, weakness, pallor and sweating. No medical attention was sought. The nurse practitioner indicated the pt was doing fine. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 267483 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: California  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:15
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Ocular hyperaemia, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Glaucoma (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0611USA00732

Write-up: Information has been received from a nurse concerning an 18 year old female who on 30-OCT-2006 was vaccinated with the first dose of GARDASIL. On 30-OCT-2006 the patient developed a "rash on the palm of her hand and also red, itchy eyes." The patient sought unspecified medical attention. The nurse reported that the patient had recently purchased new eye makeup. At the time of this report, the outcome of the events were unknown. Additional information has been requested. 04/06/2007 This is in follow-up to report(s) previously submitted on 11/14/2006. Initial and follow up information has been received from a nurse concerning an 18 year old female student with no pre-existing medical conditions and no known allergies reported. On 30-OCT-2006, at approximately 9:30 AM, the patient was vaccinated with the first dose of GARDASIL (Lot# 653650/0702F). There were no illnesses noted at the time of vaccination. On 30-OCT-2006, at 11:00 AM, the patient developed swollen eyes and rash to hands and feet (previously reported as a "rash on the palm of her hand" and also red, itchy eyes). The patient sought unspecified medical attention. The patient reported that she had a new makeup product applied several days around the injection. The patient went to the school clinic after the onset of symptoms. The patient was treated with ALLEGRA and the symptoms improved in approximately 24 hours. On 31-OCT-2006, the patient had recovered from the events. Additional information has been requested.


VAERS ID: 267484 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:15
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA00924

Write-up: Information has been received from a registered nurse concerning a female (age not reported) who on 10/30/06 was vaccainted with HPV vaccine. Subsequently, the pt experienced redness in her face and had vomited. The pt sought unspecified medical attention. At the time of this report, the pt was recovering from the event. Additional information has been requested.


VAERS ID: 267486 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Connecticut  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA02365

Write-up: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with GARDASIL. Subsequently the patient experienced dizziness and nausea within a few minutes post-vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested.


VAERS ID: 267487 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Connecticut  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA02366

Write-up: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with GARDASIL. Subsequently, the patient experienced dizziness and nausea within a few minutes post-vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested.


VAERS ID: 267488 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Connecticut  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA02367

Write-up: Information has been received from a physician concerning a female pt who on an unspecified date was vaccinated with HPV vaccine. Subsequently the pt experienced dizziness and nausea within a few minutes post vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested.


VAERS ID: 267489 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Connecticut  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA02368

Write-up: Information has been received from a physician concerning a female pt who on an unspecified date was vaccainted with HPV vaccine. Subsequently the pt experienced dizziness and nausea within a few minutes post vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested.


VAERS ID: 267490 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Virginia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA02471

Write-up: Information has been received from a registered nurse concerning a female pt who on an unspecified date was vaccinated with HPV vaccine. Subsequently, following the vaccination, the pt fainted. At the time of this report, the outcome of the event was unk. Additional information has been requested.


VAERS ID: 267491 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Virginia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA02472

Write-up: Information has been received from a registered nurse concerning a female pt who on an unspecified date was vaccinated with HPV vaccine. Subsequently, following the vaccination, the pt fainted. At the time of this report, the outcome of the event was unk. Additional information has been requested.


VAERS ID: 267080 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-08-31
Onset:2006-10-03
   Days after vaccination:33
Submitted: 2006-11-14
   Days after onset:42
Entered: 2006-11-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Feeling cold, Haemorrhage, Hot flush, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Insulin, Synthroid
Current Illness:
Preexisting Conditions: Diabetes, Hypothyroidism.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA02762

Write-up: concerning a 19 year old female with diabetes and hypothyroidism on 8/31/06 was vaccainted IM with a first dose of HPV vaccine. Concomitant therapy included an insulin pump, Levothyroxine (Synthroid) and (Loworval). On 10/3/06 (also reported as a month later), the pt experienced hot flushes and cold flashed, nausea, a temp less than 100F and abnormal bleeding. On 11/4/06, the pt experienced right lower quadrant abdominal pain and was hospitalized. She has had a CAT scan, MRI, laparoscopy and a few ultrasounds of the area but all have been neg. The pt was treated wit IV fluids. At the time of this report, the pt had not recovered. No product quality complaint was involved. Right lower quadrant abdominal pain was considered to be an other important medical event (OMIC). Additional information has been requested.


VAERS ID: 267100 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2006-11-08
Onset:2006-11-08
   Days after vaccination:0
Submitted: 2006-11-10
   Days after onset:2
Entered: 2006-11-17
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nuvaring, Allegra D, Albuterol, Nasonex
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received vaccination early in AM. Called later that afternoon and was itching all over. took Benadryl which helped.


VAERS ID: 267171 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2006-11-10
Onset:2006-11-11
   Days after vaccination:1
Submitted: 2006-11-17
   Days after onset:6
Entered: 2006-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2244AA / 2 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 08668F / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Facial palsy, Hypoaesthesia, Pain, Paralysis
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: INfluenza vaccine and Human Papilloma VIrus vaccines given November 10 about 11:45 AM. Patient woke up with numbness on right side of face on November 11. Presented to Emergency Room on November 12 with Bells Palsy of right side of face. Unable to move right side of face. Unable to close right eye. Previously healthy, no symptoms on day of vaccine administration. Received MR from pediatrician revealing a healthy 12 year old in for well-child exam. 24 hours after Flu and Gardasil vax. child developed numbness, pain, and inability to move the right side of face. Assessment: Facial Nerve Palsy-unclear etiology. Child was sent by car to Minneapolis Children''s ER to be evaluated. ER report received: DX: Bell''s Palsy


VAERS ID: 267197 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2006-11-13
Onset:2006-11-14
   Days after vaccination:1
Submitted: 2006-11-16
   Days after onset:2
Entered: 2006-11-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Facial palsy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ortho tricylic Meds-Ortho Tri-Cyclen
Current Illness: Well woman exam. C/o some discomfort in the mastoid area behind her right ear x2 days.
Preexisting Conditions: None PMH: None noted except for dysmenorrhea. NKA.
Allergies:
Diagnostic Lab Data: Lymes, CBC, CRP, CMP, Sed rate. Labs and Diagnostics: All normal.
CDC Split Type:

Write-up: Bell''s Palsy right occurred 24 hours after injection of Gardasil. Previously healthy. MR received revealing an 18 yr. old in for well-woman exam with only c/o some discomfort in the mastoid area behind her right ear x2 days. The following day she presented with right-sided facial droop. HPI: Pt awoke morning following Gardasil vax. and had difficulty with spitting out her toothpaste. No pain or visual loss. No extremity weakness or paresthesias. Most obvious upon smiling. Able to wrinkle forehead and puff cheeks. Good sensation. Txd with Famvir, Solu-medrol and Refresh Tears. Assessment: Bell''s Palsy.


VAERS ID: 267288 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-09-29
Onset:2006-09-30
   Days after vaccination:1
Submitted: 2006-11-15
   Days after onset:46
Entered: 2006-11-20
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Throat tightness, Tongue oedema, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin, Macrobid
Current Illness: Urinary tract infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA03232

Write-up: Information has been received from a physicians assistant concerning a 25 year old female who on 9/29/06 was vaccinated with a first dose of HPV vaccine. Concomitant suspect therapy initiated a few days prior included nitrofurantoin (Macrobid) for the treatment of a urinary tract infection (dose not reported). Other concomitant therapy included drospirenone + ethinyl Estradiol (Yasmin). On 9/20/06 the pt called the physicians office to state that she had developed hives. The physicians office referred her to the ER where she was placed on methylprednisolone (Medrol Dosepak). The pt was not hospitalized. On 10/2/06 the pt called the physicians office to report that her tongue was swelling and her throat was closing. The pt was immediately referred to the ER where she was given epinephrine (Epi Pen). The pt was not hospitalized. On 1/04/06 the pt recovered. Hives, tongue swelling and throat closing were considered to be disabling, immediately life threatening and other important medical events (OMIC). The physicians assistant reported that they were not sure if the reactions was to the HPV or the Macrobid. Additional information has been requested.


VAERS ID: 267319 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Georgia  
Vaccinated:2006-09-29
Onset:2006-10-08
   Days after vaccination:9
Submitted: 2006-11-09
   Days after onset:32
Entered: 2006-11-20
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Biopsy done on 11/9/06.
CDC Split Type:

Write-up: Pruritus - rash began on lower extremities 1.5 weeks following the first vaccine for HPV. The rash then spread to trunk, back and arms over the next week. Rash began as singular lesions which coalesced it places.


VAERS ID: 267524 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2006-11-02
   Days after onset:1
Entered: 2006-11-21
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Coumadin
Current Illness:
Preexisting Conditions: Von Willebrands, MRSA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Total body itching


VAERS ID: 267525 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2006-11-02
   Days after onset:1
Entered: 2006-11-21
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Allegra D
Current Illness:
Preexisting Conditions: Seasonal Allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Total body itching.


VAERS ID: 267726 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: California  
Vaccinated:2006-11-06
Onset:2006-11-06
   Days after vaccination:0
Submitted: 2006-11-20
   Days after onset:14
Entered: 2006-11-27
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Convulsion, Fall, Injury, Syncope, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Convulsion
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA03470

Write-up: Information has been received from a physician and a medical assistant concerning a 14 year old female with a history of a prior seizure (on an unk date about a year ago during a hair cut) who on 11/6/06 was vaccinated IM in the deltoid with the second dose of HPV vaccine (lot not provided). It was reported that the pt had no difficulties when the first dose of the vaccine was administered on an unspecified date. On 11/6/06 the medical assistant administered the vaccine, then turned to discard the needle. The pt fainted, fell from the exam table, hit her head on the floor and had a seizure. Paramedics were called, a cervical collar was placed on the pt and she was transported to the ER. The pt was evaluated in the ER, a CT scan was performed which was reported as normal. The pt was discharged to home from the ER and instructed to follow up with neurology. The medical assistant stated that the physician felt that the pt had a vasovagal response after receiving the vaccine and that the seizure was a result of the head trauma which the pt suffered from the fall off the exam table. It was reported that the physician felt that the seizure was related to the head trauma and not related to the vaccine. The medical assistant also reported that the physician felt the pt had recovered from the event. Upon internal medical review the seizure was felt to be an important medical event (OMIC). Additional information has been requested.


VAERS ID: 267782 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Alabama  
Vaccinated:2006-11-13
Onset:2006-11-13
   Days after vaccination:0
Submitted: 2006-11-13
   Days after onset:0
Entered: 2006-11-27
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Effexor XR
Current Illness: Dyspnea; Tonsillitis
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Overall fine body rash for past 2 days. Pt has a concomitant tonsillitis onset 2 days ago - negative strep


VAERS ID: 267795 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: California  
Vaccinated:2006-11-09
Onset:2006-11-09
   Days after vaccination:0
Submitted: 2006-11-22
   Days after onset:13
Entered: 2006-11-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / UNK RA / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2119AA / UNK GM / -

Administered by: Private       Purchased by: Unknown
Symptoms: Agitation, Anger, Crying, Depression, Pain, Suicide attempt
SMQs:, Suicide/self-injury (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (narrow), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200603096

Write-up: Seriousness criteria other medically significant (OMIC). Initial report received from the pts mother via a health care professional, on 11/14/06. A 14 year old female pt, received on 11/9/06, Menactra (lot number U2119AA), into the right deltoid (dose and route of administration not reported). The pt received on the same day (11/9/06) Gardasil (lot number 0688F) into the left deltoid, as concomitant vaccination (dose and route of administration not reported). The pt had no history of depression. At the eve of vaccination, 11/9/06, the pt had arm soreness (the reporter was unsure which arm). The pt also became very depressed, frustrated, angered, crying and attempted to cut her wrists with scissors. The wrist site described as scratch by the reporter. At the time of this report, 11/14/06, there had been no ER or medical doctor MD visits for the pt and the pts outcome was unk. No corrective treatment was reported.


VAERS ID: 267822 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-11-14
Onset:2006-11-15
   Days after vaccination:1
Submitted: 2006-11-17
   Days after onset:2
Entered: 2006-11-27
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 2 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Malaise, Periorbital oedema, Pruritus, Swelling face, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Benzaclin, Minocin, Orthotricyclen, Prozac
Current Illness: NONE
Preexisting Conditions: Acne, Anxiety, depression, TSS (11/05)
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt suddenly did not feel well at 9:30 am 11/15 went to bathroom, noticed face very red, followed by intense itching - presented to clinic 1 hr after sxs started, developed swollen lips, edema around eyes and throat constriction. Epi 0.05 ml SQ immediately. 3 min later, pt improved.


VAERS ID: 267926 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2006-11-22
Onset:2006-11-22
   Days after vaccination:0
Submitted: 2006-11-22
   Days after onset:0
Entered: 2006-11-29
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient fainted after administration of vaccine.


VAERS ID: 267957 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: New York  
Vaccinated:2006-09-18
Onset:2006-10-02
   Days after vaccination:14
Submitted: 2006-11-19
   Days after onset:48
Entered: 2006-11-29
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain, Hypoaesthesia, Injection site pain, Pain
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Mild Pulmonary Valve stenosis, stable.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Left arm pain, numbness from elbow to entire hand, started about 2 week safer receiving Gardasil in that arm. Pain is intermittent and 5-10 in intensity. She dose have other symptoms of abdominal pain, and right arm pain, so it is unclear whether vaccine is a factor.


VAERS ID: 267997 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-09-22
Onset:2006-09-23
   Days after vaccination:1
Submitted: 2006-11-29
   Days after onset:67
Entered: 2006-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Grand mal convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Insulin Meds: Lantus insulin and Novolog.
Current Illness:
Preexisting Conditions: Type 1 Diabetes. NKDA
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: EKG shows sinus arythmia, Drug and pregnancy screens (-), other labs WNL including serum glucose, CXR-normal, head CT-(-). Labs and Diagnostics: UA significant for $g1000mg/dl glucose and 40 ketones. HgbA1C 8.8, otherwise unremarkable.
CDC Split Type:

Write-up: Patient awoke morning after vaccination with grand mal seizure. Her mother took her to a local hospital and she was transferred to another hospital and then to another. MR received from 1st ER visit which reveals a 15 yr old brought in by her mother with c/o confusion, disorientation, and facial distortion on the morning following her Gardasil vax. PE: Significant for confusion and disorientation, otherwise normal. Patient was transfered to another hospital to be followed by a pediatric neurologist, Clinical impression : Altered mental status. MR received from 2nd hospital. Pt. transfered to PICU with a diagnosis of altered mental status. Still somewhat confused but improving upon admission. Improvement in mental status over the next 24 hours and she was transfered to a regular pediatric floor, oriented x3 and with no focal deficits. Discharge DX: New onset seizures (probably 2'' to hypoglycemia per face sheet).


VAERS ID: 267995 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Missouri  
Vaccinated:2006-11-20
Onset:2006-11-24
   Days after vaccination:4
Submitted: 2006-11-29
   Days after onset:5
Entered: 2006-11-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / UNK LA / -

Administered by: Private       Purchased by: Private
Symptoms: Oedema peripheral, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 2nd dose Patient medicine on 11-20-06 and complain of swelling in lips, hands, and feet.


VAERS ID: 267996 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Unknown  
Location: Missouri  
Vaccinated:2006-11-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2006-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / UNK LA / -

Administered by: Private       Purchased by: Unknown
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 2nd dose Patient complain of pain.


VAERS ID: 268017 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2006-09-27
Onset:2006-09-27
   Days after vaccination:0
Submitted: 2006-11-29
   Days after onset:63
Entered: 2006-11-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyskinesia
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient developed jerking in upper extremity a few hours after administration of vaccine. Patient was medicated with VALIUM which led to resolution of symptoms.


VAERS ID: 268036 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Iowa  
Vaccinated:2006-11-28
Onset:2006-11-28
   Days after vaccination:0
Submitted: 2006-11-30
   Days after onset:2
Entered: 2006-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Abdominal pain lower, Gastrointestinal disorder, Laboratory test abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ortho Tri-Cyclen Lo
Current Illness: none
Preexisting Conditions: PMH: none Allergies: none
Allergies:
Diagnostic Lab Data: Labs and Diagnoatics: WBC''s 11.0, Abdominal CT shows a thickened appendix at the base of the cecum with surrounding inflammation c/w acute appendicitis.
CDC Split Type:

Write-up: Less than 3 hours following the vaccination she developed severe abdominal cramps and vomited. Subsequently had persistent abdominal pain that eventually localized to the right lower quadrant. A CT of the abdomen was performed the evening of 11/29/06 which revealed appendicitis. A surgical consultation was requested and days of hospitalization are unknown yet at this time. Student health office note of 11/28/06 recording administration of GARDASIL #1 on this date. Hospital record received revealing a 20 year old woman who developed crampy abdominal pain centered in the right lower quadrant 1 day following her GARDASIL vax. Patient had appendectomy and was dischaged home the following day. DX: Appendicitis. She recovered her 2nd GARDASIL vaccination here on 2/8/2007.


VAERS ID: 268146 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-11-27
Onset:2006-11-28
   Days after vaccination:1
Submitted: 2006-12-01
   Days after onset:3
Entered: 2006-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Private       Purchased by: Unknown
Symptoms: Dizziness, Vertigo
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ortho-Evra patch
Current Illness:
Preexisting Conditions: Previous abnormal pap. PMH: abnormal PAP smear, otherwise healthy. Allergies: NKA.
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: significant for a serum glucose of 146 (after IV with dextrose) and K+ of 3.3. UA showed 2+blood, 5-10 WBCs. UC showed mixed urogenital flora. HCG (-). CT of brain (-).
CDC Split Type:

Write-up: Gardasil administered 11/27/06, dizziness 11/28/06, severe vertigo 11/29/06, hospitalized 11/29/06-12/01/06. MR received for ER admit for c/o dizziness, vertigo, and vomiting x2 days beginning within 24 hours of Gardasil vax. PE: WNL and in no distress as long as she holds still. Txd with IV fluids, Valium and Antivert. D/Cd home on Meclizine after 48 hours. Discharge DX: Acute vertigo, possible adverse reaction to Gardasil vaccine. 02/05/2007 Tag-2 received. No new codes.


VAERS ID: 268143 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Washington  
Vaccinated:2006-11-22
Onset:2006-11-30
   Days after vaccination:8
Submitted: 2006-12-03
   Days after onset:3
Entered: 2006-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Areflexia, Arthropathy, Blood product transfusion, CSF glucose normal, CSF white blood cell count increased, Computerised tomogram abnormal, Cough decreased, Dysstasia, Fall, Gait disturbance, Guillain-Barre syndrome, Headache, Hypokinesia, Increased bronchial secretion, Mechanical ventilation, Motor dysfunction, Muscular weakness, Paraesthesia, Peroneal nerve palsy, Residual urine, Retching, Sinusitis, Staphylococcal infection, Urinary tract infection, Wean from ventilator
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 67 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Zyrtec prn, guaifenesin prn, tylenol prn
Current Illness: I don''t have this info
Preexisting Conditions: None that I''m aware of
Allergies:
Diagnostic Lab Data: Elevated protein in CSF; clinical symptoms suggestive of Guillain-Barre syndrome (primarily motor weakness, some altered sensation) Head CT normal except for sinusitis. Coag negative staph UTI. CSF: protein 64, glucose 57 and 7WBC. EMG on 12/5 demonstrated severe neuropathy, appeared to be a more severe form of Guillain-Barre with Miller-Fisher variant with a lot of bulbar symptoms.Bronchoscopy demonstrated H.flu left lower lobe pneumonia.
CDC Split Type:

Write-up: Pt admitted to hospital on 12/1/06 with chief complaint of ascending weakness bilaterally, upper and lower extremities. Neuro consult diagnosed Guillain-Barre syndrome. Pt received the Gardasil vaccine on 11/22/06. Resident MD asked pharmacist to write up possible ADR of Guillain-Barre from this vaccine. 02/21/2007 records received and reviewed for DOS:12/1/06-02/06/2007 DC DX:Severe form of Guillain-Barre syndrome after HPV vaccine and possible URI. Respiratory failure with prolonged mechanical ventilation and tracheostomy tube placement. Haemophilus influenzae, left lower lobe pneumonia, coag negative staph UTI. Hypertension. Tachycardia associated with dysautonomia now resolved. Presented to PCP with URI around Thanksgiving with associated sinus infection. Began having numbness and tingling in hands days of admission as well as back pain, headache and greater problems walking and began falling over. Able to wiggle her toes but with great difficulty. Pneumococcal vaccine in September/October. HPV vaccine on 11/22/06. Mother has possible MS and possible lupus. Neuro exam:Weakness of deltoid bilaterally, weakness of lower extremities with grade 4/5 weakness at hip flexor, 4/5 hip extension, 4/5 knee flexion, 4+/5 knee extension and 3+/5 plantar flexion. Deep tendon reflexes absent in all extremities even with augmentation. Plantar responses downgoing. Gait abnormal some degree of pelvic girdle weakness and foot drop bilaterally.Began IVIG. On day 2 began developing post void residuals. Vital capacity deteriorated on day 3 to 2.2 increasing difficulties with secretions as her gag and cough diminished. Able to move only jaw and eyes. Intubated and placed on fentanyl and versed. Developed HTN. Developed neuropathic pain. At discharge able to stand with assistance. Off vent on 1/26/07. Tachycardia and hypertension associated with autonomic dysfunction now resolved at discharge. Did not completely recover as of Feb 2007 when she was discharged from a rehabilitation institute. Still needing physical & speech therapy. Diagnosis, Guillain-Barre syndrome Per annual follow up information: Unfortunately, since this was a courtesy injection and pt is not our pt we have not seen this pt since and I can not say for sure if she is fully recovered-Sorry. Per 60 day follow up: Unfortunately-pat is seen by another provider & we only did the shot as a courtesy so we have not seen the pt since- Have heard through the grapevine that pt is in Rehab now & off the ventilator & standing to walk again. Per 60 day follow up: Did not completely recover as of Feb 2007 when she was discharged from a rehabilitation institute. Still needing physical & speech therapy. Diagnosis: GUILLAIN-BARRE syndrome


VAERS ID: 268161 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Male  
Location: Colorado  
Vaccinated:2006-11-16
Onset:2006-11-17
   Days after vaccination:1
Submitted: 2006-11-29
   Days after onset:12
Entered: 2006-12-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Gait disturbance, Headache, Muscular weakness, Pyrexia, Sensation of heaviness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Migraines
Allergies:
Diagnostic Lab Data: Body temp 11/17/06 101.3F and 99.5F
CDC Split Type: WAES0611USA05427

Write-up: Information has been received from an investigator concerning a 12 year old male with migraine headaches who entered a study. On approx 6/16/06 and 8/16/06 and on 11/16/06 at 16:15 the pt was vaccinated with a first, second and third dose of HPV vaccine. On 11/17/06 the pt woke up at 6:40 and went to the bathroom and he reported that he had trouble walking. He returned to bed. The pts father woke him up at 7:45 and noted that he had a fever of 101.3F. the pt stated that his arms and legs were heavy feeling and he didn''t think he could walk. the pt experienced muscle weakness. The pts parents call the physician and were advised to take the pt to the ER. The pt went to the ER via ambulance. When the pt arrived the ER his temp was 99.5F (Pt was treated with Advil at home. It was noted that the pts neurosigns were normal and the pt reported to have a headache but refused Imetrex. the pt was discharged and no further tests were done. On 11/17/06 the pt recovered. The reporting investigator felt that muscle weakness was related to study therapy. Muscle weakness was considered to be an other important medical event (OMIC).


VAERS ID: 268189 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2006-11-29
Onset:2006-11-29
   Days after vaccination:0
Submitted: 2006-11-30
   Days after onset:1
Entered: 2006-12-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 2 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood pressure increased, Dizziness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: After second dose of a 3 dose series, pt blood pressure increased from normal baseline of 100/60 to 185/135 approx 15-20 minutes after receiving the Gardasil. Pt had near syncopal episode. PT recovered very quickly after ward.


VAERS ID: 268271 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-11-09
Onset:2006-11-19
   Days after vaccination:10
Submitted: 2006-12-01
   Days after onset:12
Entered: 2006-12-05
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Laboratory test abnormal, Myalgia, Rash, Skin discolouration, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec, Hormonal contraceptives.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Medical panel neg, trace hemoglobin 11/20/06, rapid streptococcus positive; WBC count elevated 11/20/06.
CDC Split Type: WAES0611USA06121

Write-up: Information has been received from a physician concerning a 19 year old female with no pertinent medical history or drug reactions allergies, who on 11/9/06 was vaccinated at her OB/GYN''s office with HPV vaccine. Concomitant therapy included Zyrtec and oral hormonal contraceptives (unspecified). On 11/19/06 the pt developed a rash on the injection site arm, but not at the injections site. On 11/19/06 the pt also experienced extreme myalgia in all four extremities and her hand was discolored (purple). On 11/20/06 lab testing revealed a positive Rapid streptococcal test and the pt was placed on unspecified antibiotics. Other lab findings revealed a neg medical panel, a complete blood count revealed an elevated WBC count with a shift to the left, and a urinalysis was neg but with a trace hemoglobin. At the time of this report, the pt was recovering. The physician felt that one or more of the events were disabling. Additional information has been requested.


VAERS ID: 268272 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Illinois  
Vaccinated:2006-08-16
Onset:2006-11-15
   Days after vaccination:91
Submitted: 2006-12-01
   Days after onset:16
Entered: 2006-12-05
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives
Current Illness:
Preexisting Conditions: Penicillin allergy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA06373

Write-up: Information has been received from a physician concerning a 21 year old female with an allergy to penicillin. Who on 8/16/06 was vaccinated with the first dose of HPV vaccine. Concomitant therapy included unspecified birth control pills (since 2005). On 11/22/06 the pt was seen by the physician and was scheduled to receive her second dose of HPV vaccine. At that time the pt reported to the physician that the week prior (date not specified) she had suffered a seizure. The physician clarified that the pt had no prior history of seizures and that the pts general health was very good. The physician did not give the pt the second dose of vaccine because she was unsure if the seizure could have been related to the first dose of the vaccine. At the time of this report the pt had recovered from the seizure. Upon internal review the seizure was felt to be an other important medical event (OMIC). Additional information has been requested.


VAERS ID: 268286 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-11-30
   Days after onset:34
Entered: 2006-12-05
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Injection site rash, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA06133

Write-up: Information has been received from a registered nurse concerning a 13 year old female with an allergy to amoxicillin who on 10/27/06 was vaccinated IM with the first dose of HPV vaccine (lot 653650/0702F). There was no concomitant medications. On 10/27/06 approx 10 minutes after the injection, the pt started to break out in a rash around the injection site. The pt then started to wheeze. The pt was given Benadryl and Depo Medrol injection. however continued to wheeze. The wheeze was then relieved by a unit of Xopenex nebulizer treatment, but after ten minutes the pt started to wheeze again. The pt went to the ER and was admitted to the hospital. The nurse reported that th event was that of a standard allergic reaction. The pt was released from the hospital the next day, however had to continue with albuterol inhaler and prednisone therapy. The pt recovered by 10/29/06 and had not experienced any further complications. The nurse reported that the pt would not be receiving any further vaccinations with HPV vaccine. The events were felt to be other important medical events (OMIC) and immediately life threatening. Additional information has been requested.


VAERS ID: 268287 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2006-09-25
Onset:0000-00-00
Submitted: 2006-11-30
Entered: 2006-12-05
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Epistaxis, Headache, Platelet count decreased, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Idiopathic thrombocytopenic purpura.
Allergies:
Diagnostic Lab Data: Head computed axial 9/6 unspecified, spinal tap 9/06 results unspecified. Platelet count 9/06 43000
CDC Split Type: WAES0611USA06464

Write-up: Information has been received from a physician concerning a 21 year old female with no history of drug reactions/allergies, and a history of idiopathic thrombocytopenic purpura who on 9/25/06 was vaccinated IM with HPV vaccine (Lot 653735/0688F). There was no concomitant medications. In Sept 2006, a few days after vaccination the pt experienced a headache, nose bleed and developed thrombocytopenia. The pts platelet count on an unspecified date was 43,000. The pt was hospitalized and received platelet transfusion. A CT of the head and lumbar puncture were performed, however the results were unspecified. The pt subsequently recovered on an unspecified date. The reporting physician felt that one or more of the events was an other important medical event (OMIC) and life threatening. Additional Information has been requested.


VAERS ID: 268288 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Colorado  
Vaccinated:2006-11-21
Onset:2006-11-21
   Days after vaccination:0
Submitted: 2006-11-30
   Days after onset:9
Entered: 2006-12-05
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA07061

Write-up: Information has been received from a physician concerning a 17 year old female who on 11/21/06 was vaccinated with an initial dose of HPV Vaccine IM in the deltoid. On 11/21/06, after the initial dose, the pt experienced a seizure. The pt was alert shortly after the event and was sent to the emergency department as a precaution. It is unk if the pt was admitted to the hospital. The pt is recovering from seizure. The pt will not continue with subsequent doses of vaccine. Upon internal review, seizure was considered an other important medical event (OMIC). Additional information has been requested.


VAERS ID: 268415 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2006-10-03
Onset:2006-10-03
   Days after vaccination:0
Submitted: 2006-10-27
   Days after onset:24
Entered: 2006-12-06
   Days after submission:40
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Injection left deltoid with HPV vaccine, immediate pain, transient finger tingling. Pain persists with movement and pressure only, 10/27/06.


VAERS ID: 268459 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-12-05
Onset:2006-12-05
   Days after vaccination:0
Submitted: 2006-12-06
   Days after onset:1
Entered: 2006-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cold sweat, Difficulty in walking, Disorientation, Dizziness, Dyskinesia, Gait disturbance, Headache, Hyperventilation, Pallor, Paraesthesia, Tinnitus, Tremor
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Dyskinesia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: Shellfish
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: With in five minutes of administration complaint of headache, then felt faint. I had my daughter sit down in the waiting room with her head down before we walked out. Not thinking this had anything to do with the vaccine. We walked out the door and she began have difficlty walking, weaving, I asked her if she was okay and she could only respond yes. I took her arm and tried to turn her back to the Doctor''s office and she collapsed on the ground. Though, she remainded conscious her eyes were glazed and was disoriented. It happened that another lady was leaving the office and I asked for her assitance to walk her back inside. The nurse immediately had us put her on an exam table. I do not think she was able to hear a blood pressure. At this point, my daughter was extremely pale, clammy, shallow rapid breathing, weak pulse, able to anwser questions. She stated her ears were ringing and that she had tingling in her feet. The doctor naturally examined her as well. They treated her with oral fluids, rest and some sugar cookies(the only thing they had). I am not sure the exact time the vaccine was administered. I believe it was around 5pm. When we left the doctors office, it was 5:45, my daughter felt weak and was shaky (visible). On the drive home she experienced visible muscle contractions in her arms and legs. Legs and arms were involuntarily jerking. This lasted approximately 10 minutes. By 6:00pm she felt "normal".


VAERS ID: 268483 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-09-05
Onset:2006-09-05
   Days after vaccination:0
Submitted: 2006-12-04
   Days after onset:90
Entered: 2006-12-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 2 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Abortion, Laboratory test abnormal, Unintended pregnancy
SMQs:, Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Papanicolaou smear abnormal.
Allergies:
Diagnostic Lab Data: Colposcopy 9/06, ultrasound 9/06/06 no fetal pole, ultrasound 9/20/06 16P 5 wk 3 days.
CDC Split Type: WAES0610USA00280

Write-up: Information has been received from a healthcare worker for the pregnancy registry for HPV vaccine concerning a 22 year old female pt whit a history of abnormal pap who on 6/29/06 was vaccainted with her first dose of HPV vaccine , lot 653650/0697F. On 9/5/06 the pt was vaccinated with her second dose of HPV vaccine, lot 653650/0702F. The reporter indicated that the pt received the 2nd vaccination but did not realize she was about 6 weeks pregnant at the time. Medical attention was sought. An ultrasound and colposcopy was performed. The reporter indicated that there was no fetal pole at the time of the ultrasound and that it would be repeated. There was no adverse experience reported. Follow up information has been received from a physician concerning the female pt, whose last menstrual period was approximately 9/9/06. The estimated date of conception was 8/30/06. An ultrasound performed 9/20/06 showed 16P 5 wk 3 days. This is the pts first pregnancy. The estimated delivery date is 5/21/07. Follow up information has been received. On 11/8/06 the pt underwent an elective termination of her pregnancy at 12 week from LMP. Upon internal review, elective termination of pregnancy was considered to be an other important medical event (OMIC). Additional information is not expected.


VAERS ID: 268513 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2006-12-04
Onset:2006-12-05
   Days after vaccination:1
Submitted: 2006-12-06
   Days after onset:1
Entered: 2006-12-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2094AA / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Injection site reaction, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Allergic to Septra
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Local pruritic reaction at injection site without erythema, edema left deltoid.


VAERS ID: 268544 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: California  
Vaccinated:2006-12-05
Onset:2006-12-06
   Days after vaccination:1
Submitted: 2006-12-07
   Days after onset:1
Entered: 2006-12-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK - / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2457AA / UNK - / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Dizziness, Headache, Insomnia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CT Scan
CDC Split Type:

Write-up: Several hours after vaccines given pt complained of HA and dizziness, insomnia. Next am s/s worse fainted. taken by paramedics to Hospital ER on 12/6/06.


VAERS ID: 268587 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Female  
Location: California  
Vaccinated:2006-09-27
Onset:2006-10-13
   Days after vaccination:16
Submitted: 2006-12-09
   Days after onset:57
Entered: 2006-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Contusion, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergic to penicillin, which I told the doctor.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approx. two weeks after I received the HPV vaccine I started breaking out in red bumps mostly all over my lower body and now I have this weird purple spots on my right thigh. It has itched me so bad that I have bruises all over my legs.


VAERS ID: 268628 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:2006-10-01
Onset:2006-10-01
   Days after vaccination:0
Submitted: 2006-12-06
   Days after onset:66
Entered: 2006-12-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Convulsions
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA07474

Write-up: Information has been received from a physician concerning a female pt with seizures who in approx Oct 2006, about two months ago, was vaccinated IM with a first 0.5ml dose of HPV vaccine. Right after receiving the vaccination, the pt started to have seizures every day for about two weeks after receiving the vaccine. It was noted that the pt already has seizures but had them once or twice a week not everyday. Subsequently, the pt recovered. Upon internal review, seizures was considered to be an other important medical event (OMIC). Additional information has been requested.


VAERS ID: 268992 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Michigan  
Vaccinated:2006-11-22
Onset:2006-11-30
   Days after vaccination:8
Submitted: 2006-12-15
   Days after onset:15
Entered: 2006-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zithromax, Orthotrycyclen
Current Illness: Dysmonorrhea, Sinusitis
Preexisting Conditions: Allergy to Cephalosporins, Penicillin and Sulfa
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: One week after injection, pt. has had a patchy, dry, erythemous rash 1 cm. in circumference show up intermittently on trunk and extremities. Rash remits and recurs. No history of rash.


VAERS ID: 269196 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Dizziness, Joint stiffness
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: CONCURRENT CONDITIONS: Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA04345

Write-up: Information has been received from a physician concerning a female (age not reported) with rheumatoid arthritis who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient developed dizziness, stiffness in joints and abdominal cramping. The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested.


VAERS ID: 269013 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-11-07
Onset:2006-11-08
   Days after vaccination:1
Submitted: 2006-12-13
   Days after onset:35
Entered: 2006-12-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 UN / -

Administered by: Private       Purchased by: Other
Symptoms: Diplopia, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Ocular motility disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Cardiac murmur, migraine.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA00854

Write-up: Information has been received from a health professional concerning a 28 year old female speech language assistant with no illness at the time of the vaccination and a history of cardiac murmur and migraine who on 07 Nov 2006 was vaccinated with first dose of HPV vaccine (lot 653735/0688F) in the right deltoid at approximately 1100 hours. On 08 Nov 2006, the patient called the medical facility and complained of experiencing blurred vision. On 09 Nov 2006, the patient experienced seeing double. The patient was told to go to the emergency room immediately. On 12 Nov 2006, the patient recovered. It was reported that the events required medical/surgical intervention (other important medical Events) (OMIC). No further information is available.


VAERS ID: 269038 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: New York  
Vaccinated:2006-10-31
Onset:2006-11-02
   Days after vaccination:2
Submitted: 2006-12-14
   Days after onset:42
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Chest discomfort, Chest pain, Condition aggravated, Dyspnoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol, Advair
Current Illness:
Preexisting Conditions: MEDICAL HISTORY: Immunization, Vomiting, Fever, Adverse drug reaction, Abdominal cramp. CONCURRENT CONDITIONS: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA01965

Write-up: Information has been received from a licensed practical nurse concerning a 14 year old female with asthma, no allergies and a history of vomiting, fever and abdominal cramps after a flu vaccination each time she was vaccinated. The nurse reported that the patients asthma was under good control for more than six months. She also noted that due to the side effects of the flu vaccination, the patient refused to received any more flu shots. On 31 Oct 2006 the patient was vaccinated intramuscularly with a first dose of HPV vaccine (lot 653938/0954F). concomitant therapy included Advair and albuterol inhaler prn. On 02 Nov 2006 the patient had an asthma attack. She developed chest tightening, wheezing and chest pain. The symptoms began after playing basketball. She used her albuterol inhaler with no relief. She went to the ER and was given albuterol and Advair. An EKG and chest X ray were preformed. The patient was not hospitalized. The nurse felt that this asthma attack was an isolated event. She noted that the patients physician felt that it was probably a coincidence that it was after the HPV vaccination. On 04 Nov 2006 the patient recovered. No product quality complaint was involved. The reporter did not considered this asthma attack to be permanently disabling, but that it was disabling because the patient missed school and the shortness of breath during the attack would be considered disabling. Asthma attack was considered to be an other important medical event (OMIC). Additional information has been requested.


VAERS ID: 269162 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Wyoming  
Vaccinated:2006-10-10
Onset:2006-10-10
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:178
Entered: 2006-12-18
   Days after submission:108
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Influenza like illness, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA12076

Write-up: Initial and follow up information has been received from a Registered Nurse concerning a white female patient who on the afternoon of 10 Oct 206 was vaccinated IM with her first dose of Gardasil (yeast), lot #653650/0720F, and experienced flu-like symptoms and vomiting. No medical attention was sought. Within a day or two, the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2006. Initial and follow up information has been received from a Registered Nurse concerning a white female patient who on the afternoon of 10-OCT-2006 was vaccinated IM with her first dose of GARDASIL, lot #653650/0702F, and experienced flu-like symptoms and vomiting. No medical attention was sought. Within a day or two, the patient recovered. Follow up information indicated that the patient received her second dose of GARDASIL and had no adverse experience. Additional information is not expected.


VAERS ID: 269163 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA15083

Write-up: Initial and follow up information has been received from a Nurse Practitioner concerning an approximately 22 year old female patient who in October 2006, was vaccinated IM with a dose of Gardasil (yeast). Subsequently, she experienced nausea, lightheadedness/lightheaded feeling/dizziness, weakness, pallor, and sweating but did not lose consciousness. No medical attention was sought. The nurse practitioner indicated the patient was "doing fine", and had recovered after 20 minutes. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269164 (history)  
Form: Version 1.0  
Age: 48.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-10-31
Onset:2006-10-31
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:44
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Haemorrhage, Injection site induration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: aspirin
Current Illness:
Preexisting Conditions: Condyloma, dysplasia
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA00994

Write-up: Information has been received from a health professional concerning an approximately 48 year old female patient with condyloma with mild to moderate dysplasia who on 31 Oct 2006 was vaccinated IM into the deltoid with a second 0.5mL dose of Gardasil (yeast) (lot # 653978/0955F). Concomitant therapy included aspirin. It was reported that after the nurse gave the injection blood immediately ran out of the site and it was hard and lumpy. It was reported that the nurse used proper placement technique and a standard 1 inch needle (not the prefilled device). The patient had no problems with the first dose. The patient did not report any discomfort from the hard and lumpy area. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 269165 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA01091

Write-up: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 mL dose of Gardasil (yeast). Subsequently, the patient fainted. Unspecified medical attention was sought. A short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269166 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-10-19
Onset:2006-10-19
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:56
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site mass, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA01331

Write-up: Information has been received from a medical assistant concerning a 24 year old female with no other relevant history reported. On 19 Oct 2006, the patient was vaccinated with the first dose of Gardasil (yeast). There were no other concomitant medications reported. On 19 Oct 2006, the patient developed some initial itching at the injection site that resolved (date unknown). On 02 Nov 2006, the patient reported that she awoke with a large red bump at the injection that was itchy "this developed about 13 days post dose". The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested.


VAERS ID: 269167 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-10-04
Onset:2006-10-04
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:184
Entered: 2006-12-18
   Days after submission:108
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Vulvovaginal pruritus
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Asthma
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA01335

Write-up: Information has been received from a nurse concerning a 12 year old female who on 30 Seo 2006 was vaccinated with the first 0.5 mL dose of Gardasil reported as "oral". On 01 Oct 2006, the patient developed intense vaginal itching. The patient sought unspecified medical attention. On 03 Oct 2006, the patient recovered from the event. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2006. Information has been received from a medical assistant (previously reported as a nurse) concerning a 15 year old female student (previously reported as a 12 year old) with asthma. On 04-OCT-2006, at 4:30 PM, (previously reported as 30-SEP-2006), the patient was vaccinated in the left deltoid with the first 0.5 mL dose of GARDASIL (Lot # 654540/0800F). There were no illnesses noted at the time of vaccination. On 04-OCT-2006 (previously reported as 01-OCT-2006), at 6:30 PM, the patient developed intense vaginal itching which continued to the day after. It was reported then it stopped abruptly on Day# 3. On 06-OCT-2006, the patient had recovered from the event. Additional information has been requested.


VAERS ID: 269168 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:155
Entered: 2006-12-18
   Days after submission:108
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Hypoaesthesia, Injection site anaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA01381

Write-up: Information has been received from a female physician assistant (age not reported) who on an unspecified date was vaccinated with 1 dose of 0.5 ML of Gardasil (yeast) (Lot#653978/0955F). The physician assistant reported that after she was injected with Gardasil (yeast) she felt numbness from the injection site progress all the way to her fingers. Unspecified medical attention was sought. At the time of this report, the physician assistant had recovered from the event (date unknown). Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2006. Initial and follow-up information has been received from a white, 26 year old female, physician assistant whose reported weight was 130 pounds and whose reported height was 67 inches, with no pre-existing allergies or illness who on 01-NOV-2006 was vaccinated intramuscularly (IM) into the left deltoid muscle with the first dose of 0.5 mL dose of GADASIL (Lot # 653978/0955F). The physician assistant reported she felt numbness and tingling down through her left arm and into her hand as GARDASIL vaccine was administered. It was reported that there were no long term effects, all signs and symptoms resolved in a few minutes. Unspecified medical attention was sought. At the time of this report, the physician assistant had recovered. Additional information has been requested.


VAERS ID: 269169 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Illinois  
Vaccinated:2006-09-21
Onset:2006-09-21
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:84
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Oedema peripheral, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA01393

Write-up: Information has been received from a health professional concerning a her 19 to 21 year old daughter who on approximately 21 Sep 2006 "about 6 weeks ago" was vaccinated IM with a first dose of Gardasil (yeast). Within 5 to 6 hours of vaccination, the patient developed hives and swelling of her hands and feet. The patient was given (Benadryl) and the symptoms began to heal. Subsequently, the patient recovering. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269170 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA01398

Write-up: Information has been received from a physician concerning the experience of another physician''s patient. On an unspecified date, a 12 year old female was vaccinated with a dose of Gardasil (yeast). Subsequently the patient developed a rash on her arm. Unspecified medical attention was sought. At the time of the report, the patient''s outcome was unknown. Additional information is not expected.


VAERS ID: 269171 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Indiana  
Vaccinated:2006-11-02
Onset:2006-11-03
   Days after vaccination:1
Submitted: 2006-12-14
   Days after onset:41
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA01551

Write-up: Information has been received from a physician concerning a female who on an unspecified date received the first dose of Gardasil (yeast) (Lot # not provided). On 02 Nov 2006 the patient was vaccinated with the second dose of Gardasil (yeast) (Lot # not provided). On 03 Nov 2006 the patient experienced joint pain and developed a rash. Unspecified medical attention was sought. At the time of this report the patient was recovering from the event. Additional information has been requested.


VAERS ID: 269172 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: North Dakota  
Vaccinated:2006-11-01
Onset:2006-11-02
   Days after vaccination:1
Submitted: 2007-04-06
   Days after onset:154
Entered: 2006-12-18
   Days after submission:108
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0640F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Joint swelling, Pain, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPO-PROVERA
Current Illness: Hypersensitivity
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA01557

Write-up: Information has been received from a physician concerning a 14 year old female who on 01-Nov-2006 was vaccinated with 0.5 ml of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0640F). At the same time, the patient received medroxyprogesterone acetate (DEPO-PROVERA) " in glut". On 01-Nov-2006 (conflicting information also reported as 02-Nov-2006), the patient developed body aches. On 03-Nov-2006 the patient developed hives all over body and also experienced ankle swelling. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2006. Initial and follow up information has been received from a physician and a registered nurse concerning a 14 year old female student with an unspecified allery reported as "unknown antibiotic". On 01-NOV-2006, at 4:00 PM, the patient was vaccinated intramuscularly in the left arm with the first 0.5 mL dose of GARDASIL (Lot #653650/0640F). At that same time, the patient received DEPO-PROVERA "in glut". On 02-NOV-2006, the patient developed body aches, swollen ankles and itchy hives on stomach and arms (previously reported as hives all over body). The patient followed up with the physician. At the time of this report, the outcome of the events were unknown. Additional information has been requested.


VAERS ID: 269173 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: South Carolina  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA01833

Write-up: Information has been received from a health professional concerning a female patient who was vaccinated with a first 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The next morning, the patient felt sick to her stomach. It was noted that once she went to school she felt better. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269174 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-11-02
Onset:2006-11-02
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:154
Entered: 2006-12-18
   Days after submission:108
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0696F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA02205

Write-up: Information has been received from a nurse concerning a 19 year old female patient who is the daughter of one of the office employees, who on 02-Nov-2006 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0696F). Concomitant therapy included hormonal contraceptives (unspecified). On 02-Nov-2006 the patient developed nausea, low grade fever, achiness and a headache post vaccination. It was reported that these events continued into the evening on 02-Nov-2006. On 03-Nov-2006, the next morning the patient had recovered from all of the events. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2006. Information has been received from a nurse concerning a 19 year old female patient who is the daughter of one of the office employees, who on 02-NOV-2006 was vaccinated with the first dose of GARDASIL (Lot # 653650/0696F). Concomitant therapy included hormonal contraceptives (unspecified). On 02-NOV-2006 the patient developed nausea, dizziness, low grade fever, achiness and a headache post vaccination. It was reported that these events continued into the evening on 02-NOV-2006. On 03-NOV-2006, the next morning the patient had recovered from all of the events. Additional information has been requested.


VAERS ID: 269175 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:48
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA02227

Write-up: Information has been received from a Nurse Practitioner concerning a female patient who on 27-Oct-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient fainted in the office, hit her head on the floor and required stitches. Medical attention was sought. At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269176 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA02302

Write-up: Information has been received from a nurse concerning a female who was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced numbness and pain in her arm. The patient sought unspecified medical attention. Subsequently, the patient recovered from pain in injection arm and is recovering from the numbness. Additional information has been requested.


VAERS ID: 269177 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA02316

Write-up: Information has been received from a physician concerning a female (NOS) who was vaccinated on an unknown date intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently the patient fainted. Subsequently, the patient recovered from the syncope. Additional information has been requested.


VAERS ID: 269178 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-10-26
Onset:2006-10-26
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:49
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Feeling abnormal
SMQs:, Dementia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA02584

Write-up: Information has been received from a health professional concerning a 20 year old female who on 26-Oct-2006 was vaccinated "in the right hip" with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot#654540/0800F). Within 15 minutes, the patient experienced a "funny feeling" in upper right thigh. The patient said "the feeling was gone later that day". No medical attention was sought. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269179 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA02839

Write-up: Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite tingling" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269180 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-11-02
Onset:2006-11-03
   Days after vaccination:1
Submitted: 2007-04-06
   Days after onset:153
Entered: 2006-12-18
   Days after submission:108
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthropod bite, Menorrhagia, Migraine, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA02908

Write-up: Information has been received from an office manager concerning a 14 year old female who on 02-Nov-2006 was vaccinated intramuscularly in the arm with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 03-Nov-2006 the patient started her menses and experienced a migraine. On 06-Nov-2006 the patient experienced a rash on her vaccinated arm which also spread to her face. Unspecified medical attention was sought. The patient was treated with diphenhydramine (BENADRYL) and the rash had subsided. AT the time of report, the patient was recovering from the migraine. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2006. Information has been received from an office manager concerning a 14 year old female with no pertinent medical history who on 02-NOV-2006, at 15:00, was vaccinated intramuscularly in the left arm with a 0.5 ml first dose of GARDASIL. On 03-NOV-2006 the patient started her menses and experienced a migraine. On 06-NOV-2006 the patient developed hives on her vaccinated arm which also spread to her face. Unspecified medical attention was sought. The patient was treated with BENADRYL and the rash had subsided. At the time of report, the patient was recovering from the migraine. Follow-up reported that the patient had a new puppy with fleas. The pediatrician diagnosed that the rash was due to flea bites and not due to an allergy. The patient was expected to received the second dose in January 2007. No product quality complaint was involved. Additional information is not available.


VAERS ID: 269181 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Indiana  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Face oedema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA02920

Write-up: Information has been received from a physician concerning a 13 year old female who was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced swelling in her face, stomach was extended with fluids and her lower extremities were swollen. Unspecified medical attention was sought. The patient was put on "hydrosteroids". She is scheduled for a follow-up visit the week of November 13th. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269182 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Smear cervix abnormal
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Pap test - positive
CDC Split Type: WAES0611USA03319

Write-up: Information has been received from a physician concerning a female patient who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient''s pap smear came out positive. Medical attention was sought. Her outcome was unknown. Additional information has been requested.


VAERS ID: 269183 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA03411

Write-up: Information has been received from a physician concerning a 20 year old female who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 ml). Subsequently, two weeks following vaccination, the patient experienced pain at the injection area. The patient also complained of pain in the same area when lifting her arm. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested.


VAERS ID: 269184 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-11-02
Onset:2006-11-09
   Days after vaccination:7
Submitted: 2006-12-14
   Days after onset:35
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Injection site pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA03416

Write-up: Information has been received from a physician concerning an approximately 18 year old female who on approximately 02-Nov-2006 was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On week after vaccination, on approximately 09-Nov-2006, the patient experienced pain at the injection site, and had redness, soreness and swelling. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested.


VAERS ID: 269185 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Illinois  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA03436

Write-up: Information has been received from a physician concerning a female patient (demographics not provided) who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently the patient developed a rash on her face and stomach. The patient sought unspecified medical advice. Additional information has been requested.


VAERS ID: 269186 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Oregon  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:45
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL, LEXAPRO, CLARITIN
Current Illness:
Preexisting Conditions: CONCURRENT CONDITIONS: Depression, Anxiety, Penicillin allergy, Sulfonamide allergy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA03446

Write-up: Information has been received from a nurse practitioner concerning an 18 year old female with low level depression and anxiety and penicillin allergy and sulfonamide allergy who on 30-Oct-2006 was vaccinated intramuscularly in the right deltoid with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot#653978/0955F). Concomitant therapy included escitalopram oxalate (LEXAPRO), loratadine (CLARITIN) acetaminophen (TYLENOL). On 30-Oct-2006, following vaccination, the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered and no other symptoms were noted. Additional information has been requested.


VAERS ID: 269187 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Arizona  
Vaccinated:2006-09-12
Onset:2006-09-12
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:93
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESOGEN
Current Illness:
Preexisting Conditions: CONCURRENT CONDITIONS: Polycystic ovarian syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA03478

Write-up: Information has been received from a physician concerning an 15 year old female with a history of polycystic ovary syndrome, who on 12-Sep-2006 was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#654540/0800F). Subsequently, shortly after receiving the vaccination the patient fainted. Subsequently, the patient recovered from the syncope. Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 269188 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Colorado  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA03479

Write-up: Information has been received from a physician''s assistant concerning a 11 year old female who on unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently the patient developed swollen lymph nodes in groin her area. Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 269189 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-11-08
Onset:2006-11-08
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:36
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Anxiety, Hyperhidrosis, Injection site erythema, Injection site swelling, Lymphadenopathy, Nausea, Pain, Paraesthesia, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: CONCURRENT CONDITIONS: Anxiety
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA03485

Write-up: Information has been received from a physician concerning his daughter, a 19 year old female who at 15:00 on 08-Nov-2006 "was feeling great anxiety" before receiving an intramuscular injection with the vaccination HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#654540/0800F). On 08-Nov-2006 after receiving the vaccination the patient experienced throbbing pain, a tingling sensation down length of her arm, elbow, wrist, jaw line and down her neck, fever, swelling and redness at the injection site, was "terribly itchy", had veins protruding, swollen glands, nausea and "felt hot and sweaty" (the patient was reported to be afebrile). Unspecified medical attention was sought. At the time of the report it was unknown if the patient had recovered. Additional information is not expected.


VAERS ID: 269190 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:2006-11-07
Onset:2006-11-07
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:37
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Migraine
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: CONCURRENT CONDITIONS: Asthma, Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA03521

Write-up: Information has been received from a physician concerning a 15 year old female with asthma and penicillin allergy who on 26-Sep-2006 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#not provided). Concomitant therapy included hormonal contraceptives (unspecified). On 07-Nov-2006 the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#6537361/0868F). That same day the patient experienced a migraine with a "blinded spot in one eye", dizziness and was "seeing stars". She was treated with aspirin. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested.


VAERS ID: 269191 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Utah  
Vaccinated:2006-09-05
Onset:2006-09-05
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:100
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Menstrual disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA03555

Write-up: Information has been received from a physician concerning an 11 year old female who on 05-Sep-2006 was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On approximately 05-Sep-2006, the patient noted her menstrual cycle increased from every month to every two weeks. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 269192 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-11-07
Onset:2006-11-07
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:149
Entered: 2006-12-18
   Days after submission:108
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Fall, Laceration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Anorexia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA04002

Write-up: Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with Gardasil (yeast). It was reported that the patient was sitting on a bench and when the personnel left the room, the patient apparently fainted and ended up falling off bench. It was reported that it was unsure if the patient had broken her nose but there was blood. At the time of this report, the outcome of the events were unknown. The physician feels that the patient "might be anorexic and had not had anything to eat all day hence the fainting". No further information is available. This is in follow-up to report (s) previously submitted on 12/14/2006. Initial and follow up information has been received from a physician concerning a 16 year old (previously reported as 14 year old) white female. On 07-NOV-2006, at 10:02 AM, the patient was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 653735/0688F). On 07-NOV-2006, at 10:03 AM, the patient was sitting on a bench and when the personnel left the room, the patient fainted and ended up falling off the bench. It was reported that the patient had hit her nose when she fell and developed a small laceration (previously reported that it was unsure if the patient had broken her nose but there was blood). The patient came to quickly with no other sequelae. It was reported that the patient had not eaten breakfast. On 07-NOV-2006, the patient had recovered from the events. The physician feels that the patient "might be anorexic and had not had anything to eat all day hence the fainting". No further information is available.


VAERS ID: 269193 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: New York  
Vaccinated:2006-10-31
Onset:2006-10-31
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:44
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Sensation of heaviness
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA04222

Write-up: Information has been received from a mother of an 11 year old female who on 31 Oct 2006 was vaccinated with Gardasil (yeast) (0.5 ml). On 31 Oct 2006, 30 minutes following vaccination, the patient''s arm "felt heavy". Subsequently, the patient recovered from the event 30 minutes later. Medical attention was not sought. Additional information has been requested.


VAERS ID: 269194 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2006-10-24
Onset:2006-10-24
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:164
Entered: 2006-12-18
   Days after submission:108
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 2 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain, Suprapubic pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0611USA04226

Write-up: Information had been received from a physician concerning a patient who on an unspecified date was vaccinated with the second dose of Gardasil (yeast). Subsequently the patient experienced abdominal pain and suprapubic pain that radiated to the vaginal region. No further details were provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2006. Information has been received from a physician concerning a patient who on 24-OCT-2006 was vaccinated intramuscularly with the second dose of GARDASIL (lot # 653937/0637F). Subseqently on 24-OCT-2006, the patient experienced abdominal pain. The abdominal pain was described as being located at the umbilicus to genital area. The abdominal pain spontaneously resolved 3 days after the vaccination. No further details were provided.


VAERS ID: 269195 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-09-08
Onset:2006-09-08
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:210
Entered: 2006-12-18
   Days after submission:108
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 2 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Injection site swelling, Wrong technique in drug usage process
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA04279

Write-up: Initial and follow up information has been received from a vaccine coordinator concerning a female (age not reported) who on an unspecified date was vaccinated with 0.5 mL of Gardasil (yeast). Subsequently, the patient experienced pain at the injection site. It was reported that the vaccine hurt the patient more when injected into the arm rather than the upper thigh, hip area. It was reported that the "pain was so great that the patient said they would not finish the series". The patient sought unspecified medical attention. The shot was from a pre-filled safety syringe. The vaccine coordinator thinks "the pain may have something to do with the technique because the shots given from the single dose vials have not experienced as much pain". It was further reported that "she was unsure if the extreme pain was caused by the vaccine, injection site or the technique used with the safety syringes." At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2006. Initial and follow up information has been received from a vaccine coordinator concerning a 26 year old female who on 08-SEP-2006 was vaccinated in the left deltoid with the second 0.5 mL dose of GARDASIL (Lot # 654540/0800F). On 08-SEP-2006, the injection site area filled up with fluid with tennis ball size swelling per the patient. It was reported that the duration was "a couple hours". It was previously reported that the patient had developed pain at the injection site. It was reported that the vaccine hurt the patient more when injected into the arm rather than the upper thigh, hip area. It was reported that the "pain was so great that the patient said they would not finish the series". The shot was from a pre-filled safety syringe. The vaccine coordinator thinks "the pain may have something to do with the technique because the shots given from the single dose vials have not experienced as much pain". It was further reported that "she was unsure if the extreme pain was caused by the vaccine, injection site or the technique used with the safety syringes". The patient stated that this "was not a big deal but preferred the injection in her leg". At the time of this report, the outcome of the events were unknown. Additional information has been requested.


VAERS ID: 269197 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-11-12
Onset:2006-11-12
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:32
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Xalatan
Current Illness:
Preexisting Conditions: Glaucoma
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA04349

Write-up: Information has been received from a physician and a nurse concerning a 21 year old female with glaucoma who on 09 Sep 2006 was vaccinated with a first dose of Gardasil (yeast). Concomitant therapy included Xalatan. On 12 Nov 2006, the patient was vaccinated IM, in the right deltoid, with a 0.5 ml second dose of Gardasil (yeast) (lot #653736/0868F). On 12 Nov 2006, 13 hours after the vaccination, the patient developed a rash on both arms. The patient used alcholol on these areas and the rash went away. On approximately 12 Sep 2006, at an unspecified time, the patient developed hives. The hives were itchy and "looked like slap marks all over her body" including her legs, abdomen, back and face. The welts were raised and swollen. The patient was treated with Benadryl. At the time of the report, the patient was recovering from the hives. There were laboratory or diagnostic tests performed. It was reported that the patient had no reactions after the first dose of Gardasil (yeast). Additional information has been requested.


VAERS ID: 269198 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: New York  
Vaccinated:2006-11-01
Onset:2006-11-09
   Days after vaccination:8
Submitted: 2006-12-14
   Days after onset:35
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug hypersensitivity, Erythema, Injection site cellulitis, Oedema peripheral, Pain in extremity, Skin warm, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA04358

Write-up: Information has been received from a physician concerning a 11 year old female who on 01-Nov-2006 was vaccinated with a 0.5 ml first dose of Gardasil (yeast) (lot #653938/0954F). On 09 Nov 2006 the patient developed cellulitis in the arm where vaccine was administered. Unspecified medical attention was sought. At the time of the report, the patient was recovering from the cellulitis. Additional information has been requested. This is in follow-up to report9s0 previously submitted on 12/14/2006. Entitle and follow-up information has been received from a physician concerning a 11 year old female student with a cephalosporin allergy who on 01-NOV-2006 was vaccinated with a 0.5 ml first dose of GRDASIL (lot # 653938/0954F). On 09-NOV-2006 the patient developed cellulites in the arm where vaccine was administrated. The patient''s arm was red, hot, swollen, painful and tender. The patient sought medical attention. A complete blood cell count and x-ray were performed (results in reported). It was reported that the patient had an allergic reaction to cephalexin "once started." Subsequently, the patient recovered from cellulites. Follow-up information reported the physician considered cellulites to be disabling event. Additional information has been requested.


VAERS ID: 269199 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Virginia  
Vaccinated:2006-11-13
Onset:2006-11-13
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:31
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Hyperhidrosis, Incorrect route of drug administration, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA04373

Write-up: Information has been received from a registered nurse concerning her 16 year old daughter who on 13 Nov 2006 was vaccinated with her first dose of Gardasil (yeast). The patient''s mother reported that she was vaccinated subcutaneously. Conflicting information was received from the administering licensed practical nurse who reported that she was positive the patient was vaccinated intramusculaurly into the deltoid area and not subcutaneously. On 13 Nov 2006, a few minutes after the vaccine was administered, the patient experienced nausea, dizziness and sweating. Unspecified medical attention was sought. Subsequentely, the patient recovered from nausea, dizzines and sweating in a few minutes. Additional information has been received from a registered nurse. The nurse reported that her fellow nurse gave the dose of Gardasil (yeast) IM instead of subcutaneous. Additional information has been requested.


VAERS ID: 269200 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Oedema, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: diarrhea, vomiting
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA04378

Write-up: Information has been received from a nurse practitioner concerning a 19 year old female who on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil (yeast). The patient was experiencing vomiting and diarrhea and had no fever prior to receiving the vaccination. Subsequently, the patient developed swelling of hands and feet and her face got puffy after receiving Gardasil (yeast). The patient sought medical attention and was treated with an unspecified antihistamine. Subsequently, the swelling went away, and the patient was considered recovered. Additional information has been requested.


VAERS ID: 269201 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA04542

Write-up: Information has been received from a physician concerning a female patient who was vaccinated IM with a first dose of Gardasil (yeast). Subsequently the patient developed a shooting pain down her arm where she received the injection. Reportedly the physician does not think this is an adverse experience. Subsequently, the patient recovered from shooting pain down her arm in less than a minute. The patient does not want to come back for a second injection. Additional information has been requested.


VAERS ID: 269202 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Smear cervix abnormal
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Pap test 10/?/06-abnormal
CDC Split Type: WAES0611USA04578

Write-up: Information has been received from a physician concerning a female who in October 2006, was vaccinated with the first dose of Gardasil (yeast) (0.5mL). In approximately October 2006, "shortly after the injection", the patient was examined and learned that she developed an abnormal PAP. Unspecified medical attention was sought. No further details were provided. Additional information has been requested.


VAERS ID: 269203 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Arizona  
Vaccinated:2006-11-13
Onset:2006-11-13
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:31
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Decreased appetite, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA04596

Write-up: Information has been received from a nurse practitioner concerning a 20 year old female who on 13-NOV-2006 was vaccinated intramuscularly with the first dose of Gardasil (yeast) (Lot # not provided). On 13-NOV-2006 the patient experienced nausea, vomiting and decreased appetite. Unspecified medical attention was sought. At the time of this report it was unknown if the patient had recovered from these events. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2006. Follow-up information from the nurse practitioner indicated that the patient recovered. Additional information is not expected.


VAERS ID: 269204 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-11-08
Onset:2006-11-09
   Days after vaccination:1
Submitted: 2006-12-14
   Days after onset:35
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA04681

Write-up: Information has been received from a physician concerning a 16 year old female who on 08 Nove 2006 was vaccinated intramuscularly with the first dose of Gardasil (yeast) (Lot # not provided). On 09 Nov 2006 it was reported that the patient developed hives. Unspecified medical attention was sought. At the time of this report it was unknown if the patient had recovered. Additional information has been requested.


VAERS ID: 269205 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-09-26
Onset:2006-09-26
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:192
Entered: 2006-12-18
   Days after submission:108
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Oedema peripheral, Pruritus, Rash generalised, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0611USA04701

Write-up: Information has been received from a registered nurse concerning a 22 year ld white female student with no other medical history, no known allergies or adverse drug reactions reported. On 26 Sep 2006, at 12:300 PM, the patient was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil (yeast) (Lot# 653736/0689F), within 2 hours of the injections the patient developed full body hives, itching and swelling of hands and feet. The patient took Benadryl every 4 hours and the symptoms were gone within 24 hours. At the time of this report, the patient had recovered from the events. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2006. Initial and follow up information has been received from a registered nurse concerning a 23 year old (previously reported as 22 year old) white female student with no other medical history, no known allergies or adverse drug reactions reported. On 26-SEP-2006, at 3:00 PM, the patient was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL (Lot # 653736/0689F). There were no illnesses noted at the time of vaccination. On 26-SEP-2006, at 4:00 PM, the patient developed a rash over body (previously) reported as full body hives and had itching) and had swelling of hands and feet. The patient took BENADRYL every 4 hours and the rash was gone within 24 hours. On 27-SEP-2006, the patient had recovered from the events. Additional information has been requested.


VAERS ID: 269206 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Washington  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / -

Administered by: Other       Purchased by: Other
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA04818

Write-up: Information has been received from a consumer who is a company representative concerning her 20 year old daughter who on an unspecified date was vaccinated with the second dose of Gardasil (yeast). The patient''s mother reported that the vaccination caused the patient to feel faint, and she experienced nausea with chills and sweating. The patient was kept in the office until she felt better. No further details were provided. Additional information has been requested.


VAERS ID: 269207 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA04882

Write-up: Information has been received from a practice manager concerning a female patient who on an unspecified date was vaccinated with Gardisal (yeast). Subsequently, following vaccination, the patient experienced syncope. Unspecified medical attention was sought. No further details were provided. At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 269208 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: phobia
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA04906

Write-up: Information has been received from a physician concerning a female who was "shot phobic" who on an unspecified date was vaccinated with Gardasil (yeast) (0.5ml). Subsequently, following vaccination, the patient fainted. Unspecified medical attention was sought. The patient subsequently recovered. Additional information has been requested.


VAERS ID: 269209 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Washington  
Vaccinated:2006-11-13
Onset:2006-11-13
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:31
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Pain, Tinnitus
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hearing impairment (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Pencillin allergy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA05100

Write-up: Information has been received from a registered nurse at an OB/GYN''s office concerning a 14 year old female with penicillin allergy who on 13 Nov 2006 was vaccinated intramuscularly in the left deltoid with Gardasil (yeast) (lot #653938/0954F). There was no concomitant medication. On 13 Nov 2006 the patient experienced pain in the vaccinated arm, headache, dizziness, fatigue, weakness and ringing in the ears. The patient sought treatment from her pediatrician. At the time of this report the patient''s pain in the arm, headache, dizziness, fatigue, weakness and ringing in the ears persisted. Additional information has been requested.


VAERS ID: 269211 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2006-11-14
Onset:2006-11-15
   Days after vaccination:1
Submitted: 2006-12-14
   Days after onset:29
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / UNK - / -

Administered by: Private       Purchased by: Other
Symptoms: Abnormal behaviour, Euphoric mood, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Penicillin allergy, drug hypersensitivity
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA05160

Write-up: Information has been received from a registered nurse concerning a 13 year old female with a penicillin allergy and drug hypersensitivity to Zithromax. On 14 Nov 2006, the patient was vaccinated with Gardasil (yeast) ( Lot # 653978/0955F). There were no concomitant medications reported. On 15 Nov 2006, the patient was noted to be very emotional, nauseated, felt dazed and "high". The patient sought unspecified medical attention. No treatment was required. On 16 Nov 2006, the patient had recovered from the events. Additional information has been requested.


VAERS ID: 269212 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Paraesthesia, Sensation of heaviness
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA05398

Write-up: Information has been received from a physician concerning a female patient who was vaccinated with a first 0.5 ml Gardasil (yeast). Subsequently the patient experienced a tingle and heaviness. Unspecified medical attention was sought. After twenty minutes the tingle and heaviness went away. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269213 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Viral infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Positive HPV test
CDC Split Type: WAES0611USA05651

Write-up: Information has been received from a physician concerning a 25 year old female who on an unspecified date was vaccinated with HPV Vaccine. One week later, the patient was noted to have a positive human papilloma virus infection (date unknown). It was reported that the physician dose not know when the vaccine was given or the dose because she did not administer the vaccine in her office. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested.


VAERS ID: 269214 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Menstruation irregular
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA05682

Write-up: Information has been received from a health professional concerning a 20 year old female who on an unspecified date was vaccinated with a dose of HPV Vaccine. Subsequently, the patient experienced three menstrual periods during the next month. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269215 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-11-08
Onset:2006-11-09
   Days after vaccination:1
Submitted: 2006-12-14
   Days after onset:35
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0697F / 1 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA05796

Write-up: Information has been received from a physician concerning a 16 year old female with no known drug allergies who on 08 Nov 2006, at 4:00 PM, was vaccinated IM with the first dose of HPV vaccine. On 09 Nov 2006, the patient developed a drug rash. The patient sought unspecified medical attention. On 14 Nov 2006, the patient was recovered from the drug rash. Additional information is not expected.


VAERS ID: 269216 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:43
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA05836

Write-up: Information has been received from a nurse practitioner concerning a female (age not reported) who on approximately 01 Nov 2006 was vaccinated with the first dose of HPV vaccine. On approximately 01 Nov 2006, the patient developed total body itching. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 269217 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Oregon  
Vaccinated:2006-09-27
Onset:2006-09-27
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:78
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Pain ankle
Preexisting Conditions: Hypersensitivity; Attention deficit/hyperactivity disorder
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA06105

Write-up: Information has been received from a physician''s nurse concerning a 15 year old female who on 27 Sep 2006 was vaccinated intramuscularly with HPV vaccine (lot # 653937/0637F). On 28 Sept 2006 the patient experienced nausea, fever and soreness at the injection site. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown.


VAERS ID: 269218 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site reaction, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA06106

Write-up: Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with HPV vaccine. Subsequently, one week later, the patient developed welts on the arm where the shot was administered. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 269219 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2006-11-14
Onset:2006-11-15
   Days after vaccination:1
Submitted: 2006-12-14
   Days after onset:29
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Influenza like illness, Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA06158

Write-up: Information has been received from a registered nurse concerning a 20 year old female with no pertinent medical history or drug reactions/allergies who on 14 Nov 2006 was vaccinated intramuscularly with HPV Vaccine. There was no concomitant medications. On 15 Nov 2006, about 24 hours later, the patient developed erythema at the injection site and experienced flu like symptoms. Unspecified medical attention was sought. Subsequently, the patient recovered from the erythema at injection site and flu like symptoms within 72 hours. Additional information has been requested.


VAERS ID: 269220 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:45
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 2 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Computerised tomogram normal, Dysaesthesia, Electromyogram normal, Hypoaesthesia, Insomnia, Nerve conduction studies normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Nerve compression; Insomina; Pain in leg; Cervical pain; Dysaesthesia; Chronic anxiety
Preexisting Conditions: Nerve compression. Motor vehicle accident; Cervical cancer; Lumbar laminectomy
Allergies:
Diagnostic Lab Data: breast biopsy; computed axial, normal, 01/??/06; electromyography, Normal, 12/06/06; magnetic resonance, Normal, 01/??/06; magnetic resonance, C-spine normal, 10/??/06; nerve conduction study, Normal, 12/06/06.
CDC Split Type: WAES0611USA06372

Write-up: Information has been received from a nurse concerning a female patient (age not reported) with a nerve compression (NOS) who on an unknown date in October 2006, was vaccinated intramuscularly in the left deltoid with the second dose of HPV Vaccine (date of first dose and Lot # were not provided). On an unknown date in Oct 2006, the patient experienced numbness in her left arm. The patient was referred to a neurologist, because of her history of pinched nerve. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested. 04/06/07: This is in follow-up to report (s) previously submitted on 12/14/2006. Initial and follow up information has been received from a nurse and a physician concerning a 24 year old female patient with nerve compression (NOS), cervical pain, chronic anxiety, insomina and leg pain and a history of "localized cervical cancer (diagnoses February, 2006)", lumbar laminectomy and a motor vehicle accident (NOS) who at 10:00 on 30-OCT-2006, was vaccinated intramuscularly in the left deltoid with the second dose of HPV rL1 11 16 18 VLP vaccine (yeast) (Lot#653650/0702P), (date of first dose and Lot # were not provided) no concomitant therapies were reported by the OB/GYN. It was reported that at 10:30 am post-vaccination the patient experienced left upper extremity paresthesias and numbness. The patient was seen for follow up by the OB/GYN for the event on 09-NOV-2006 and was referred to a neurologist, because of her history of a pinched nerve. On 29-NOV-2006 the patient was seen by a neurologist. The patient reported the following concurrent medications at that time: cyclobenzaprine hydrochloride (MSD), metaxalone (Skelaxin), acetaminophen (+) hydrocodone bitartrate (Vicodin), oxycodone, alprazolam (Xanax) and diclofenac. conduction studies and electromyography (EMG) with follow-up somatosensory evoked potential studies of the left arm. The patient was seen by the neurologist for a follow up appointment on 06-DEC-2006. The neurologist noted that "she continued to have insomnia, arm pain, dysesthesias, etc which she dates from her motor vehicle accident." The results of her nerve conduction studies and EMG were normal. Her somatosensory evoked potential studies through the brachial plexus and cervical spinal cord were also normal. The neurologist noted "we cannot find an organic explanation for the patient''s arm pain complaint''s." The neurologist recommended the "Tincture of time" and symptomatic treatment at a pain center. At the time of this report the patient had not recovered from the event. Additional information has been requested.


VAERS ID: 269221 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Arizona  
Vaccinated:2006-11-08
Onset:2006-11-08
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:36
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 UN / -

Administered by: Private       Purchased by: Private
Symptoms: Blood pressure decreased, Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Allergic reaction to antibiotics.
Allergies:
Diagnostic Lab Data: Blood pressure 11/08/06 low.
CDC Split Type: WAES0611USA06802

Write-up: Information has been received from a health professional concerning a female patient with an allergy to amoxicillin and clavulanate potassium who on 08 Nov 2006 at 11:00 AM was vaccinated in the right deltoid with the first dose of HPV vaccine. (Lot #654540/0800F) There was no illnesses at the time of vaccination. On 08 Nov 2006, at 1PM, following vaccination, the patient became lightheaded. Then while walking out of the office, the patient had a syncopal episode. It was reported that there was no detectable seizure activity and the patient was not post ictal. The patient''s blood pressure was low, however not documented. The patient subsequently recovered with elevation of her feet and after five minutes, the patient was sent home. Additional information has been requested.


VAERS ID: 269222 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-11-24
Onset:2006-11-24
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:132
Entered: 2006-12-18
   Days after submission:108
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR U2197AA / 6 UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Immediate post-injection reaction, Injection site oedema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Asthma
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0611USA07057

Write-up: Information has been received from a nurse concerning a female who was vaccinated with a first dose of HPV vaccine. It was reported that immediately upon administration of the vaccine, the patient developed excessive swelling near the injection site. Unspecified medical attention was sought. At the time of the report, the patient''s outcome was unknown. This is in follow-up to report(s) previously submitted on 12/14/2006. Initial and follow-up information has been received from a nurse and a physician concerning a 21 year old white female student with asthma who on 24-NOV-2006, at 12:00 p.m., was vaccinated IM, into the right arm, with a first dose of GARDASIL (lot #654389/0961F) concomitantly with a sixth dose of FLUZONE (lot #U2197AA) IM, into the left arm. On 24-NOV-2006, at 12:01 p.m., the patient developed immediate swelling at the injection site. The patient recovered on the same day. There were no laboratory or diagnostic tests performed. Additional information is not expected.


VAERS ID: 269223 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2007-01-04
Onset:2007-01-05
   Days after vaccination:1
Submitted: 2007-04-06
   Days after onset:90
Entered: 2006-12-18
   Days after submission:108
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Breast tenderness, Nipple pain
SMQs:, Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA07064

Write-up: Information has been received from a female health professional who was vaccinated with HPV vaccine 0.5ml. Subsequently the patient experienced extremely sore nipples that lasted 4 days. The patient recovered from extremely sore nipples. The health professional plans on receiving the next two vaccine injections. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2006. Initial and follow-up information has been received from a 25 year old female secretary/receptionist who is the patient (previously reported as a female health professional). On an unspecified date, the patient was vaccinated with a first dose of GARDASIL 0.5 ml. Subsequently the patient experienced extremely sore nipples and slight breast tenderness, starting the day after injection, and lasting approximately 4 days. 04-JAN-2007 the patient was vaccinated with her second dose of GARDASIL. On 05-JAN-2007 the patient experienced slight breast tenderness and extremely sore nipples that lasted for approximately 4 days. The patient plans on receiving the series of vaccine injections. Additional information is not expected.


VAERS ID: 269224 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-11-27
Onset:2006-11-28
   Days after vaccination:1
Submitted: 2006-12-14
   Days after onset:16
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Chest discomfort, Chest pain, Erythema, Hypoaesthesia, Injection site erythema, Injection site oedema, Oedema, Pain, Paraesthesia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YASMIN, Minocycline
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA07269

Write-up: Information has been received from a nurse practitioner concerning an 18 year old female with a history of drug reaction/allergy to VICODIN who on 27 Nov 2006 was vaccinated with first dose of HPV vaccine injection into left arm. Concomitant therapy included influenza virus vaccine (unspecified) injection also administered the same day on 27 Nov 2006 into her left arm, YASMIN, Minocycline. On 28 Nov 2006, the patient experienced tingling, swelling, and redness in her left arm and hand. She also experienced swelling and redness in her right hand thumb, and some soreness in her chest and upper body area. The patient sought medical attention. No diagnostic tests were performed. Additional information was obtained from the nurse practitioner via phone call. The patient was vaccinated with HPV vaccine and a flu vaccine on 27 Nov 2006 in her left arm by her primary care physician. The patient was seen in her clinic less than 24 hours later experiencing swelling and numbness of fingers, and chest wall discomfort. The patient was seen for follow upon 29 Nov 2006 and all symptoms had resolved. Additional information has been requested.


VAERS ID: 269225 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:2006-11-22
Onset:2006-11-22
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:22
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA07277

Write-up: Information has been received from a physician concerning a female with on approximately 22 Nov 2006 was vaccinated with a 0.5ml dose of HPV vaccine. On 22 Nov 2006 the patient fainted. Unspecified medical attention was sought. At the time of the report, the patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 269226 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-11-08
Onset:2006-11-15
   Days after vaccination:7
Submitted: 2006-12-14
   Days after onset:29
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Acne
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA07365

Write-up: Information has been received from a nurse practitioner concerning an 18 year old female who on 08 Nov 2006 was vaccinated with a 0.5ml dose of HPV vaccine. Within one week the patient developed facial acne. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269227 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA07417

Write-up: Information has been received from the mother of a 21 year old female with penicillin allergy who in 2006 was vaccinated with HPV vaccine. There was no concomitant medication. The patient''s mother stated that following vaccination, her daughter was sick. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No further information is expected.


VAERS ID: 269228 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: New York  
Vaccinated:2006-11-01
Onset:2006-11-28
   Days after vaccination:27
Submitted: 2006-12-14
   Days after onset:16
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Private       Purchased by: Other
Symptoms: Skin papilloma, Viral infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Trichloroacetic acid
Current Illness:
Preexisting Conditions: Vaginal papilloma; Comdyloma
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA07426

Write-up: Information has been received from a nurse practitioner concerning a 16 year old female with vaginal papilloma who in approximately November 2006, was vaccainted with HPV vaccine. Concomitant therapy included trichloroacetic acid. The nurse practitioner reported that the patient was treated wit trichloroacetic acid (strength unspecified) for existing vaginal warts one week after vaccination with HPV vaccine (the warts were existing prior to the vaccination with HPV Vaccine). Three weeks after the trichloroacetic acid treatment, on 28 Nov 2006, the warts appeared raised and very red, which was much different than normal treatment with trichloroacetic acid. Unspecified medical attention was sought. At the time of this report, the patient had not yet recovered. Additional information has been requested.


VAERS ID: 269229 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives.
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA07504

Write-up: Information has been received from a nurse practitioner concerning a patient who was vaccinated with a dose of HPV vaccine. Concomitant therapy included birth control pills. Subsequently, the patient experienced a full body rash. At the time of this report, the patient''s outcome was unknown. The reporter felt that full body rash was not related to therapy with HPV vaccine. Additional information has been requested.


VAERS ID: 269230 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-11-16
Onset:2006-11-26
   Days after vaccination:10
Submitted: 2006-12-14
   Days after onset:18
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Loestrin
Current Illness:
Preexisting Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA07518

Write-up: Information has been received from a nurse practitioner concerning a 16 year old female with a penicillin allergy who on 16 Nov 2006 was vaccainted with a first 0.5ml dose of HPV vaccine. Concomitant therapy included LOESTRIM. On 26 Nov 2006 the patient broke out into hives. The patient was treated with a steroid and was doing fine. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269231 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Missouri  
Vaccinated:2006-09-01
Onset:2006-11-21
   Days after vaccination:81
Submitted: 2006-12-14
   Days after onset:23
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Face oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA07529

Write-up: Information has been received from a nurse in a physician''s office concerning a 17 year old female who in approximately September 2006, was vaccinated with the second 0.56ml dose of HPV vaccine. On 21 Nov 2006, the patient developed swelling of lips and swelling of face. The patient sought unspecified medical attention. On 22 Nov 2006 within 24 hours, the patient had recovered from the events. Additional information has been requested.


VAERS ID: 269232 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:43
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA07572

Write-up: Information has been received from a physician concerning a female patient in her 20''s who in November 2006, was vaccinated with a dose of HPV vaccine. Immediately after administration, the patient passed out. Medical attention was sought. Subsequently, the patient recovered. The physician explained that another physician from a different office administered the vaccination to the patient. Additional information has been requested. There was no product quality complaint involved.


VAERS ID: 269233 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA07579

Write-up: information has been received from a health professional concerning a female patient who was vaccinated with a first dose of HPV Vaccine. Subsequently as the patient was leaving the examination room, the patient fainted. Unspecified medical attention was sought. The patient recovered shortly after fainting. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269234 (history)  
Form: Version 1.0  
Age: 38.0  
Sex: Female  
Location: Indiana  
Vaccinated:2006-09-11
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Nasal congestion, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COMBIVENT, CLARITIN D
Current Illness:
Preexisting Conditions: Seasonal allergy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA07581

Write-up: Information has been received from a physician''s assistant concerning a 38 year old female with seasonal allergy and no pertinent medical history who on 11 Sep 2006 was vaccinated intramuscularly with a 0.5ml dose of HPV vaccine (lot #653650/0702F). Concomitant therapy included COMBIVENT and CLARITIN D. The patient reported that within days after 11 Sep 2006, she had to use her inhaler on and off since then. The patient called the physician''s office and reported a runny nose and stuffiness since the vaccination with symptoms that continued. The patient took allergy medicine and inhaler without relief. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. In follow-up it was reported by the physician''s assistant that the patient had generalized shortness of breath on 10-NOV-2006. The patient needed to use her inhaler, which she had not needed to do in over two years. The patient reported that she did not get any relief from loratadine (+) pseudoephedrine sulfate. At the time of the report, it was unknown, if the patient recovered.


VAERS ID: 269235 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:2006-11-28
Onset:2006-11-28
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:16
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, High-pitched crying, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00007

Write-up: Information has been received from a nurse concerning a female co worker (age not reported) who on 28 Nov 2006 was vaccinated intramuscularly in the deltoid with the first single dose vial of HPV vaccine. The nurse reported that the patient had an experience during and immediately after being vaccinated. The nurse reported that when the patient was given the shot, she started screaming almost immediately and reported that she did not feel well. The nurse also reported that the patient felt like she was going to pass out and was feeling nauseated. The patient was sent home from work and was now out a second day from work. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown as the patient had not returned to work. Additional information has been requested.


VAERS ID: 269236 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00214

Write-up: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5ml dose of HPV vaccine. Subsequently, the patient fainted. Unspecified medical attention was sought. A short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269237 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00215

Write-up: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5ml dose of HPV vaccine. Subsequently, the patient fainted. Unspecified medical attention was sought. A short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269238 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00216

Write-up: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dose of HPV vaccine. Subsequently the patient fainted. Unspecified medical attention was sought. a short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269239 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00217

Write-up: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dos of HPV vaccine. Subsequently, the patient fainted. Unspecified medical attention was sought. A short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269240 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:2006-11-16
Onset:2006-11-18
   Days after vaccination:2
Submitted: 2006-12-14
   Days after onset:26
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00232

Write-up: Information has been received from a physician concerning a female patient who on approximately 16 Nov 2006 was vaccinated with a 0.5ml IM dose of HPV vaccine. Two days later dosage, on approximately 18 Nov 2006 the patient developed a rash at injection site. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2006. The patient was told to take BENADRYL and to make appointment. The patient never kept appointment and the office is "unable to contact her".


VAERS ID: 269241 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00272

Write-up: Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with a 0.5 ml dose of Gardasil vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite stinging" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269242 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00273

Write-up: Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with 0.5 ml dose of Gardasil vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite stinging" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality was involved. Additional information has been requested.


VAERS ID: 269243 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00274

Write-up: Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with a 0.5 ml dose of Gardasil vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite stinging" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269244 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00275

Write-up: Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with a 0.5 ml dose of Gardasil vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite stinging" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269245 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00276

Write-up: Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with 0.5 ml dose of Gardasil vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite stinging" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269246 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00277

Write-up: Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified ) was vaccinated IM with a 0.5 ml dose of Gardasil vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite stinging" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269247 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00278

Write-up: Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with 0.5 ml dose of Gardasil vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite stinging " at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269248 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2006-11-22
Onset:2006-11-24
   Days after vaccination:2
Submitted: 2006-12-14
   Days after onset:20
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Decreased appetite, Medication error, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Papilloma viral infection
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA00308

Write-up: Information has been received from a 19 year old female with a history of papilloma viral infection and no known allergies or adverse drug reactions reported. On 22 Nov 2006, the patient was vaccinated with Gardasil vaccine (yeast). There were no concomitant medications reported. On 24 Nov 2006, the patient reported "feeling sick to her stomach, developed nausea and had trouble eating starting two days after receiving Gardasil vaccine (yeast) and the experience had lasted until now". The patient reported that there was a "possibility she could be pregnant", but would not know until 05 Dec 2006. At the time of this report, the patient had not recovered from the events. Additional information has been requested.


VAERS ID: 269249 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Michigan  
Vaccinated:2006-11-03
Onset:2006-11-29
   Days after vaccination:26
Submitted: 2006-12-14
   Days after onset:15
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Discomfort, Lymphadenopathy, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: penicillin allergy
Allergies:
Diagnostic Lab Data: complete blood cell "normal"; throat culture "results pending"
CDC Split Type: WAES0612USA00311

Write-up: Information has been received from a registered nurse concerning a 24 year old female with a penicillin allergy and had no other pertinent medical history reported. On 03 Nov 2006, the patient was vaccinated intramuscularly in the right deltoid with a 0.5 mL of Gardasil vaccine (yeast) (Lot # 653736/0868F). There were no concomitant medications reported. On 29 Nov 2006, the patient was examined by the physician and was complaining of swelling of the right cervical lymph node and low grade fever. The physician ordered a complete blood count (CBC), which was normal. On 30 Nov 2006, the patient was re-examinined and the right cervical lymph node had increased in size and the patient had developed swelling of the right axillary lymph nodes, peri-sternal discomfort and extreme malaise. The physician ordered a throat culture and results were pending. The patient was being referred to her internist for follow up. Unspecified medical attention was sought. At the time of this report, the patient had not recovered from the events. Additional information has been requested.


VAERS ID: 269250 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-11-29
Onset:2006-11-30
   Days after vaccination:1
Submitted: 2006-12-14
   Days after onset:14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chest pain, Injection site anaesthesia
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: fluconazole
Current Illness: Vaginal candidiasis
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA00328

Write-up: Information has been received from a nurse practitioner concerning a 23 year old female who on 29 Nov 2006 was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil vaccine (yeast) (lot#654389/0961F). Concomitant therapy included fluconazole which was started on 29 Nov 2006 for a pre-existing infection. On 29 Nov 2006 the patient experienced chest pains described as subclavian and numbing at the injection site. Unspecified medical attention was sought. Subsequently, the patient recovered from the subclavian chest pains and numbing at the injection site on 30 Nov 2006. Additional information has been requested. 04/06/2007 This is in follow-up to report(s) previously submitted on 12/14/2006. Initial and follow-up information has been received from a nurse practitioner concerning a 24 year old female with no past medical history, who on 29-NOV-2006 at 9:00 AM was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (lot #654389/0961F). Illness at time of vaccination included vaginal candidiasis. Concomitant therapy included fluconazole which was started on 29-NOV-2006. On 30-NOV-2006, at 12:00 AM, the patient experienced right sided arm numbness along with right sided burning sensation in her chest (described as subclavian). The patient had 5-6 episodes during the night. The patient stated the sensations were resolved by the time she reported it to her physician in the AM of 30-NOV-2006. No further information is expected.


VAERS ID: 269251 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00342

Write-up: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with Gardasil vaccine (yeast). Subsequently the patient experienced dizziness and blurry vision "a short time after her vaccination". Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. No further details were provided. Additional information has been requested.


VAERS ID: 269252 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2006-11-22
Onset:2006-11-23
   Days after vaccination:1
Submitted: 2006-12-14
   Days after onset:21
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00352

Write-up: Information has been received from a physician concerning an approximately 19 year old female who on 22 Nov 2006 was vaccinated with a 0.5 ml dose of Gardasil vaccine (yeast). On 23 Nov 2006, the patient experienced a sore arm for 2 days. It was noted that it started to get better however on 27 Nov 2006 the pain at the injection site returned with radiating pain to the shoulder and shoulder blade. There was no redness or swelling at the site. The patient stated that "it felt like a heavy weight is on my arm." Unspecified medical attention was sought. The patient''s pain at the injection site with radiating pain to the shoulder and shoulder blade persisted. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269253 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-11-24
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA00385

Write-up: Information has been received from a female consumer who on 24 Nov 2006 "one week ago" was vaccinated with a dose of Gardasil vaccine (yeast). Subsequently the patient experienced bruising at injection site and a low grade fever. No medical attention was sought. No diagnostic laboratory studies were performed. The patient''s bruising at injection site and low grade fever persisted. No product quality complaint was involved. Additional information is expected.


VAERS ID: 269254 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00389

Write-up: Information has been received from a nurse practitioner concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil vaccine (yeast). Subsequently, the patient developed "total body itching" (date unknown). At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 269255 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Missouri  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / -

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00393

Write-up: Information has been received from a nurse in a physician''s office concerning a 15 year old female who in approximately September 2006, was vaccinated with the second 0.5 mL dose of Gardasil vaccine (yeast). On an unspecified date, the patient developed joint pain. Within 24 hours, the patient had recovered from the event (date unknown). Additional information has been requested.


VAERS ID: 269256 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA00967

Write-up: Information has been received from a physician concerning a female (NOS) who was vaccinated on an unknown date intramuscularly with Gardasil vaccine (yeast) (Lot# not provided). Subsequently the patient fainted. Subsequently, the patient recovered from the syncope. Additional information has been requested.


VAERS ID: 269257 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA00968

Write-up: Information has been received from a physician concerning a female (NOS) who was vaccinated on an unknown date intramuscularly with Gardasil vaccine (yeast) (Lot# not provided). Subsequently the patient fainted. Subsequently, the patient recovered from the syncope. Additional information has been requested.


VAERS ID: 269258 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00978

Write-up: Information has been received from a health professional concerning a female patient who was vaccinated with a first dose of Gardasil vaccine (yeast). Subsequently as the patient was leaving the examination room, the patient fainted. Unspecified medical attention was sought. The patient recovered shortly after fainting. No product quality was involved. Additional information has been requested.


VAERS ID: 269259 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00979

Write-up: Information has been received from a health professional concerning a female patient who was vaccinated with a first dose of Gardasil vaccine (yeast). Subsequently as the patient was leaving the examination room, the patient fainted. Unspecified medical attention was sought. The patient recovered shortly after fainting. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269260 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00980

Write-up: Information has been received from a health professional concerning a female patient who was vaccinated with a first dose of Gardasil vaccine (yeast). Subsequently as the patient was leaving the examination room, the patient fainted. Unspecified medical attention was sought. The patient recovered shortly after fainting. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269261 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Arizona  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA00986

Write-up: Information has been received from a physician concerning an adolescent female (NOS0 who on an unspecified date was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, shortly after receiving the vaccination the patient fainted. Subsequently, the patient recovered from the syncope. Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 269262 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Arizona  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA00987

Write-up: Information has been received from a physician concerning an adolescent female (NOS0 who on an unspecified date was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, shortly after receiving the vaccination the patient fainted. Subsequently, the patient recovered from the syncope. Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 269263 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:2006-11-08
Onset:2006-11-08
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:36
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Hyperhidrosis, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA01084

Write-up: Information has been received from a Nurse Practitioner concerning a female patient who on 08-Nov-2006 was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, she experienced nausea, light-headed feeling, dizziness, sweating, but did not lose consciousness. No medical attention was sought. The nurse practitioner indicated the patient recovered after 20 minutes. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 269264 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Wyoming  
Vaccinated:2006-08-10
Onset:2006-08-10
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:126
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Influenza like illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: doxycline
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA01119

Write-up: Initial and follow up information has been received from a Registered Nurse concerning a white female patient who on the morning of 10-Aug-2006 was vaccinated IM with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), lot #653650/0702F, and experienced flu-like symptoms. Concomitant medication included doxycline. No medical attention was sought. Within a day or two, the patient recovered. Additional information has been requested. Follow up information indicated that the patient received her second dose of GARDASIL and had no adverse experience. Additional information is not expected.


VAERS ID: 269265 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Wyoming  
Vaccinated:2006-09-08
Onset:2006-09-08
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:97
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Influenza like illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA01120

Write-up: Initial and follow up information has been received from a Registered Nurse concerning a female who on the afternoon of 08-Sep-2006 was vaccinated IM with her first dose of HPV vaccine (yeast), lot #653650/0702F, and experienced flu-like symptoms. No medical attention was sought. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2006. Within a day or two, the patient recovered. Follow up information indicated the patient received her second dose of GARDASIL and had no adverse experience. Additional information is not expected.


VAERS ID: 269346 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: California  
Vaccinated:2006-11-22
Onset:2006-11-26
   Days after vaccination:4
Submitted: 2006-12-19
   Days after onset:23
Entered: 2006-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Allergies-Anox, penicillin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Itching of entire body 4-5 days after vaccination on 11/22/06. Has continued on and off since then.


VAERS ID: 269412 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-12-19
Onset:2006-12-19
   Days after vaccination:0
Submitted: 2006-12-19
   Days after onset:0
Entered: 2006-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B012AA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1065F / 2 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: atenolol - but not taken today
Current Illness: none
Preexisting Conditions: anxiety syncope
Allergies:
Diagnostic Lab Data: Bp 117/68 HR 85 after incident
CDC Split Type:

Write-up: Patient felt dizzy after dTaP, Varicella, and HPV administration. She had a syncopal episode lasting seconds, immediately recoverd with stable vital signs. To note patient has a past medical history significant for syncope and did not take her atenolo that morning. She was sent to the ER for fluids and further monitoring.


VAERS ID: 269481 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: California  
Vaccinated:2006-12-21
Onset:2006-12-21
   Days after vaccination:0
Submitted: 2006-12-21
   Days after onset:0
Entered: 2006-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hives after given HPV.


VAERS ID: 269633 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-09-14
Onset:2006-11-01
   Days after vaccination:48
Submitted: 2006-12-19
   Days after onset:48
Entered: 2006-12-27
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dry eye, Visual disturbance
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin
Current Illness:
Preexisting Conditions: Dysfunctional uterine bleeding, Anemia.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA01371

Write-up: Information has been received from a medical assistant concerning an 18 year old female with a history of dysfunctional uterine bleeding (DUB) and anaemia who on 14 Sep 2006 was vaccinated with HPV vaccine (lot 0800F, batch 654540), 0.5 ml, IM, once. Concomitant therapy included Yasmin. In approximately November 2006 (last couple weeks), the patient experienced extreme eye dryness after receiving HPV vaccine. The patient''s eye was so dry that she had a hard time seeing. On an unspecified date, the patient sought unspecified medical attention. Eventually, the patient had a duct implant put in her eyes by a specialist to help with the dryness. The patient was recovering from the event of extreme eye dryness. Extreme eye dryness was considered to be disabling and an other important medical event (OMIC). Additional information has been requested.


VAERS ID: 269646 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:2006-10-03
Onset:2006-10-03
   Days after vaccination:0
Submitted: 2006-12-26
   Days after onset:84
Entered: 2006-12-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site reaction, Pain, Urticaria, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Therapy unspecified
Current Illness:
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA02735

Write-up: Information has been received from a female physician assistant (age not reported) who on 03 Oct 2006 was vaccinated intramuscularly with the first 0.5ml dose of HPV vaccine. Concomitant therapy included an unspecified therapy for asthma. On 03 Oct 2006, immediately after receiving the HPV vaccine, she developed extreme pain on her skin and broke out in hives all over her body. The physician assistant stated that it felt like a cat clawing on her skin. The physician assistant went to the emergency room and was treated with asthma medication but was not admitted. No ER date was provided. On an unspecified date, the patient was recovering from the events. On 05 Dec 2006, the patient was vaccinated with a second dose of HPV vaccine. Subsequently, the patient developed an outbreak of hives in a circle around the site of injection. At the time of this report, the outcome of the event was unknown. The physician assistant considered the events of extreme pain on her skin and broke out in hives all over her body to be other important medical events as the patient was treated with asthma medication in the ER (OMIC). Additional information has been requested.


VAERS ID: 269687 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Missouri  
Vaccinated:2006-12-11
Onset:2006-12-11
   Days after vaccination:0
Submitted: 2006-12-18
   Days after onset:7
Entered: 2006-12-27
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Dizziness, Nausea, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: blood pressure 12/11/2006 - 100/52
CDC Split Type: WAES0612USA02339

Write-up: 2:30 gave injection. 2:40 Patient complained of being dizzy and nauseous. Laid patient down with wet cloth on head, gave water. 2:50 took blood pressure 100/52. Patient complains of shakiness. 3:05 No better took to urgent care. This is in follow-up to report (s) previously submitted on 1/16/2007. Initial and follow-up information has been received from a health professional concerning an 17 year old female with no known allergies, who on 11-DEC-2006 at 2:30 PM was vaccinated intramuscularly in the right gluteal with the first dose of GARDASIL (lot # 653938/0954F). There were no illnesses at the time of vaccination. On 11-DEC-2006, at 2:40 PM, following vaccination, the patient complained of feeling dizzy, and nauseous (it was also reported that the patient felt weak). The patient did not faint. The patient laid down with a wet cloth on her head and was given water. At 2:50 PM, the patient''s blood pressure was noted to be 100/52 and the patient complained of shakiness. At 3:50 PM, the patient had not improved, and was taken to an urgent care facility. The patient was evaluated at the urgent care and released to home. The patient subsequently recovered on 11-DEC-2006. No further information is expected.


VAERS ID: 269692 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-11-22
Onset:2006-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2006-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Abasia, Chills, Pain, Rash, Rash macular, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: complete blood count, PT/PTT
CDC Split Type:

Write-up: The patient presented to the ER complained of rash, pain, swelling to lower extremities bilaterally. She had developed a maculopapular rash after the vaccination. She was discharged home on Percoat/Prednisone. Chills and unable to walk.


VAERS ID: 269696 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: New York  
Vaccinated:2006-12-21
Onset:2006-12-21
   Days after vaccination:0
Submitted: 2006-12-21
   Days after onset:0
Entered: 2006-12-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1208F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Immediate after Gardasil given pt developed 4cm bright red area at injection site.


VAERS ID: 269716 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Washington  
Vaccinated:2006-12-14
Onset:2006-12-14
   Days after vaccination:0
Submitted: 2006-12-15
   Days after onset:1
Entered: 2006-12-27
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Dizziness, Dyspnoea, Flushing, Nausea
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE- given Benadryl
CDC Split Type:

Write-up: 1 hour after receiving HPV vaccine became dizzy, skin sensation of burning and flushing all over. Nausea with SOB with talking. Generalized weakness.


VAERS ID: 269778 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: California  
Vaccinated:2006-12-11
Onset:2006-12-20
   Days after vaccination:9
Submitted: 2006-12-20
   Days after onset:0
Entered: 2006-12-28
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 2 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Pregnancy test false positive
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: urine pregnancy test in office (12-20-06) positive
CDC Split Type:

Write-up: Patient pregnancy unbeknownst to provider when vaccine administered. Patient didn''t divulge pregnancy test at home. Was positive one month prior.


VAERS ID: 269784 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2006-12-12
Onset:2006-12-13
   Days after vaccination:1
Submitted: 2006-12-21
   Days after onset:8
Entered: 2006-12-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin
Current Illness:
Preexisting Conditions: Loestrin, Suprax, Pediazol.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient developed hives starting at injection site and spreading over entire body. + itching. No respiratory symptoms. Patient used Benadryl without relief and was referred to her PCP for follow up.


VAERS ID: 269820 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2006-12-27
Onset:2006-12-28
   Days after vaccination:1
Submitted: 2006-12-28
   Days after onset:0
Entered: 2006-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 2 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Headache, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none known
Preexisting Conditions: Allergy Amoxicillin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient fainted after receiving her second dose of Gardisil Vaccine. Patient c/o headache and pain in back of her head. Returned to office 12/28/06 for exam. Still c/o head pain. To call office prn with followup.


VAERS ID: 269916 (history)  
Form: Version 1.0  
Age: 31.0  
Sex: Female  
Location: New York  
Vaccinated:2006-12-18
Onset:2006-12-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2007-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1161F / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Pruritus generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None Drug hypersensitivity
Preexisting Conditions: Allergic to depacote, Lortab, nuerontin, valicum,
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt called 12/20/06 and reported that on the evening of 12/18/06 she developed generalized itching and hives, no other symptoms. She was instructed to take 25mg Benadryl Q 6H when needed. No further vaccinations will be administered per Dr.p report has been received from a registered nurse concernng a 31 year old female with drug allergies to DEPAKOTE, LORTAS, NEURONTIN, VALIUM and FIORICET. On 18-DEC-2006 (also reported as 18-DEC-1976) the patient was vaccinated with her first dose of GARDASIL (Lot number 65450/1161F) intramuscularly in the left deltoid. On 18-DEC-2006 in the eveneing, the patient experienced generalized itching and hives. The patient was instructed to take BENADRYL 25 mg every 6-8 hours until the itching subsided. The patient was informed that she will not be receiving the additional 2 vaccinations. Additional informationis not expected.


VAERS ID: 269922 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Virginia  
Vaccinated:2006-11-13
Onset:2006-11-13
   Days after vaccination:0
Submitted: 2006-12-29
   Days after onset:46
Entered: 2007-01-02
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Fracture, Injury, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Osteoporosis/osteopenia (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec, Yasmin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA02987

Write-up: Information has been received from a 21 year old female with no pertinent medical history or drug reactions/allergies, who on 13 Nov 2006 was vaccinated intramuscularly with HPV Vaccine. Concomitant therapy included Zyrtec and Yasmin. On 13 Nov 2006, following vaccination, the patient felt nauseous and dizzy. As she went out of the room to check out, the patient fainted and broke her nose and got a cut under eye. The patient reported that she was on the floor for seven to eight minutes before she woke up. The patient reported that she had to get her nose fixed and received some stitches afterward. At the time of this report, the patient was recovering. Upon internal review, the facial bones fracture which required surgery was felt to be an other important medical event (OMIC). Additional information has been requested.


VAERS ID: 269923 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-10-01
Onset:2006-10-01
   Days after vaccination:0
Submitted: 2006-12-29
   Days after onset:89
Entered: 2007-01-02
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthritis, Joint swelling, Myalgia, Urinary tract infection, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin, Minocin.
Current Illness:
Preexisting Conditions: Papilloma viral infection, Acne.
Allergies:
Diagnostic Lab Data: 10/06 viral antibody titer positive for Parvo virus, Epstein Barr virus 10/06 Positive, Cytomegalovirus 10/06 positive.
CDC Split Type: WAES0612USA03674

Write-up: Information has been received from a physician concerning her 18 year old daughter with a history of HPV and acne who at the beginning of October 2006, was vaccinated with a dose of HPV vaccine. Concomitant therapy included Yasmin and Minocin. One week later, the patient developed a urinary tract infection. Two weeks after vaccination, she had an acute onset of arthritis. She had significant swelling of her finger joints and generalized myalgia. She had blood work to include viral antibody titers which were positive for parvo virus, Epstein Barr and Cytomegalovirus. The patient was treated with steroids and anti inflammatory drugs. At the time of the report she had not recovered. The reporter considered the events to be disabling and other important medical events (OMIC). Additional information has been requested.


VAERS ID: 271132 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2006-12-11
Onset:2006-12-13
   Days after vaccination:2
Submitted: 2007-01-16
   Days after onset:34
Entered: 2007-01-02
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA03120

Write-up: Information has been received from a Nurse Practitioner concerning an 18 year old female who on 11 Dec 2006 was vaccinated with the first dose of Gardasil (yeast) (Lot # 653736/0868F). Concomitant therapy included hormonal contraceptives (unspecified). Within 48 hours post vaccination, on approximately 13 Dec 2006 the patient experienced a severe headache. The patient sought unspecified medical attention. The headache was treated with Tylenol and resolved "in one day". Additional information has been requested.


VAERS ID: 270005 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Virginia  
Vaccinated:2007-01-03
Onset:2007-01-03
   Days after vaccination:0
Submitted: 2007-01-03
   Days after onset:0
Entered: 2007-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB259CA / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2491AA / 1 RA / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z0664 / 1 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortha Evra
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient became very light headed and dizzy w/in moment of vaccine. Patient was observed and released.


VAERS ID: 270033 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Virginia  
Vaccinated:2006-12-28
Onset:2006-12-28
   Days after vaccination:0
Submitted: 2006-12-28
   Days after onset:0
Entered: 2007-01-04
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Depo Provera times 2 years
Current Illness: NONE
Preexisting Conditions: Latex
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 15 minutes after IM injection of Gardasil in right arm. Patient developed hives on her neck right side continued to move up on face. 20 minutes post injection rash and then itching over neck, face and back. Benadryl used IM. Vital signs remained stable.


VAERS ID: 270034 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-12-28
Onset:2006-12-28
   Days after vaccination:0
Submitted: 2006-12-28
   Days after onset:0
Entered: 2007-01-04
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Hot flush, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nuva ring
Current Illness: NONE
Preexisting Conditions: Ibuprofen
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient complain of nausea, light-headed, hot flashes, right after injection. Told patient to lay down on back on the table, took some water about 25 minutes recheck BP and pulse. Ok to leave.


VAERS ID: 270061 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-12-21
Onset:2006-12-21
   Days after vaccination:0
Submitted: 2007-01-03
   Days after onset:13
Entered: 2007-01-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Blindness transient, Dizziness, Headache, Pallor
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: CONCURRENT CONDITIONS: Drug hypersensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA03857

Write-up: information has been received from the mother of a 19 year old female with a drug hypersensitivity to unspecified antibiotics. On 21 Dec 2006, the patient was vaccinated with the first dose of HPV vaccine. There were no concomitant medications reported. On 21 Dec 2006, the patient felt like her head was going to burst, she looked pale and was possibly going to faint. The patient developed temporary blindness that lasted about two minutes. The patient sought unspecified medical attention. On 21 Dec 2006, the patient had recovered from the events, "after a few minutes". Upon internal review, the temporary blindness was considered to be an other important medical event (OMIC). Additional information has been requested.


VAERS ID: 270062 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-10-25
Onset:0000-00-00
Submitted: 2007-01-03
Entered: 2007-01-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abortion, Ectopic pregnancy, Laboratory test abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Pregnancy; live birth, Pregnancy NOS (LMP unknown), irregular periods.
Allergies:
Diagnostic Lab Data: Serum alpha human 12/06 85
CDC Split Type: WAES0612USA04054

Write-up: Information has been received from a licensed practical nurse concerning a 25 year old female with no drug reactions/allergies, and unknown date of last menstrual period due to irregular periods and a history of 2 live children (number of pregnancies was not reported) who on 25 Oct 2006 was vaccinated with first dose of HPV vaccine. There was no concomitant medication. The patient sought medical attention. Around 25 Nov 2006, (Thanksgiving time), the patient presented to the office. She had an ectopic pregnancy, went to the emergency room and was administered methotrexate to abort the child. She was monitored for several hours and released. The patient was not hospitalized. It was unk if the patient was pregnant when she was vaccinated with HPV Vaccine due to irregular periods, unknown LMP. At the time of reporting, the patient was recovering, her quantitative HCG was at 85, it should be at 2, but was going downward. The reporter felt that the event required intervention to prevent serious criteria (other important medical event) (OMIC). This report is part of the pregnancy registry. Additional information has been requested.


VAERS ID: 270063 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-12-01
Onset:2006-12-01
   Days after vaccination:0
Submitted: 2007-01-02
   Days after onset:32
Entered: 2007-01-04
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Headache, Nausea, Rash, Upper respiratory tract infection, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Oral immunotherapy SLIT
Current Illness: NONE
Preexisting Conditions: Premature twin, environmental allergies.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 12/01/2006 Nausea, headache, urticaria 12/04/2006. URI symptoms developed after rash. Treated with Benadryl, Prednisone, and Zyrtec. Phone call 1 week later, rash completely gone, urticaria due to vaccine VS intercurrent URI.


VAERS ID: 270065 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-12-28
Onset:2007-01-02
   Days after vaccination:5
Submitted: 2007-01-03
   Days after onset:1
Entered: 2007-01-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / UNK RA / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1974AB / UNK LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Headache, Hypoaesthesia, Muscle rigidity, Neck pain
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Arthritis (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: UNK
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 17 year old female received Menactra on 12/28/06. On 1/2/06, patient reported pain in neck and head with non-specific bilateral numbness sensation and pain present in lower extremities (thighs, calves, feet (soles)). Bilateral knee and ankle tendon reflexes normal. Also bilateral calf tightness reported.


VAERS ID: 270086 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-03
Onset:2007-01-03
   Days after vaccination:0
Submitted: 2007-01-04
   Days after onset:1
Entered: 2007-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2638AA / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site oedema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Warm to touch with slight elevation at injection site to LT deltoid.


VAERS ID: 270093 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: New York  
Vaccinated:2006-12-26
Onset:0000-00-00
Submitted: 2006-12-26
Entered: 2007-01-05
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1208F / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Feeling hot, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 10 minutes after receiving Gardasil #1-patient became dizzy,hot, blacked out. Patient recovered completely after 20 minutes.


VAERS ID: 270112 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: California  
Vaccinated:2006-12-26
Onset:2006-12-27
   Days after vaccination:1
Submitted: 2007-01-05
   Days after onset:9
Entered: 2007-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Eye oedema, Oedema peripheral, Pain, Pruritus, Rash, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Adderall, Zoloft, Yasmin, Procardia
Current Illness: none
Preexisting Conditions: Attention deficit disorder, depression, allergy to pediazole
Allergies:
Diagnostic Lab Data: Elevated WBC likely due to steroids.
CDC Split Type:

Write-up: Pt given vaccine on 12/26. Began to experience generalized pruritis and mild rash on 12/17. By 12/28 had severe urticarial rash requiring oral steroids. Rash did not improved with steroids and antihistamines, and pt developed edema of hands, feet and eyes and some respiratory symptoms on 12/31. Given IV decadron with relief by an outside provider. Symptoms improving but persistent mild rash at time of my recent re-evaluation on 1/2/07. Her hands remain sore.


VAERS ID: 270141 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-01-03
Onset:2007-01-03
   Days after vaccination:0
Submitted: 2007-01-03
   Days after onset:0
Entered: 2007-01-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: History of Turners Syndrome.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient passed out/fainted within 5 minutes of HPV Gardasil injection. She came to with smelling salts then fainted again. Ambulance called, transported patient to local hospital.


VAERS ID: 270145 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Virginia  
Vaccinated:2006-11-20
Onset:2006-11-22
   Days after vaccination:2
Submitted: 2006-12-18
   Days after onset:26
Entered: 2007-01-08
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2240A / 2 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2159A / 1 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Flushing, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nevacor, Birth control pills, Celexa, Clontin
Current Illness:
Preexisting Conditions: No known allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2006034630

Write-up: Initial report received from a health care professional in the USA on 12 December 2006. A 18 year old, female patient (with a medical history of no known allergies) developed a flushed, red and itchy face, 2 days after she received Fluzone (lot number U2240AA) intramuscularly in the left deltoid, Menactra (lot number U2159AA) intramuscularly in the right deltoid and Gardasil (lot number unknown) on 20 November 2006. On 24 November 2006, the patient called to reports red spots on hands. The patient did not have any illness at the time of the vaccination. She was treated with Benadryl. She was not seen at the doctor''s office and has moved. It was reported that she recovered.


VAERS ID: 270235 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2007-01-03
Onset:2007-01-03
   Days after vaccination:0
Submitted: 2007-01-03
   Days after onset:0
Entered: 2007-01-09
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2108AA / 1 LA / ID

Administered by: Private       Purchased by: Private
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Nausea, Pallor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prozac, Trisprintac
Current Illness:
Preexisting Conditions: Depression
Allergies:
Diagnostic Lab Data: Labs drawn just prior to vaccines (routine).
CDC Split Type:

Write-up: Patient received vaccines, then felt nauseous, dizzy, was pale and diaphoretic, BP decreased to 80/50, pt placed supine with feet elevated, given Benadryl 20 mg PO, sips water, felt better after about 1 hour.


VAERS ID: 270237 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-12-28
Onset:2006-12-30
   Days after vaccination:2
Submitted: 2007-01-02
   Days after onset:3
Entered: 2007-01-09
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0960F / 1 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B012AA / 7+ LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Erythema, Feeling hot
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Quarter sized area red and hot to touch at injection site of Tdap. Advised to apply cold compress by on call doctor.


VAERS ID: 270241 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-05
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0697F / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA04678

Write-up: Information has been received from a health professional concerning a patient who may have been vaccinated with a dose of with HPV vaccine (yeast) (lot#653650/0697F) in which while preparing the syringe for administration, the safety syringe activated prematurely. It was reported that she may have touched the side of the syringe near the fingers and the activated the safety device. It was also reported that the second syringe scared the patient when it pooped down. No further information is available.


VAERS ID: 270242 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Indiana  
Vaccinated:2006-12-01
Onset:2006-12-01
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:35
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA00294

Write-up: Information has been received from a physician concerning a female patient (age and demographics not reported) who on 01-Dec-2006 was vaccinated with the first dose of HPV vaccine (yeast) (Lot# not reported). On 01-Dec-2006 immediately after being vaccinated the patient developed widespread hives. No respiratory difficulty was noted. The patient was transported to the emergency room for evaluation and was not admitted to the hospital. At the time of this report the patient had not recovered from the hives. Additional information has been requested.


VAERS ID: 270243 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Indiana  
Vaccinated:2006-12-01
Onset:2006-12-01
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:35
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Pallor, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPO-PROVERA
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00383

Write-up: Information has been received from a health professional concerning a female patient who on 01-Dec-2006 was vaccinated IM with a 0.5 ml dose of HPV vaccine (yeast). It was noted that medroxyprogesterone acetate (DEPO-PROVERA) may have been given concomitantly. On 01-Dec-2006 the patient developed hives and turned pale white. She was admitted to the emergency room and there was no further information if she will be admitted. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 270244 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-05
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00435

Write-up: Information has been received from a physician concerning a 14 year old female who was vaccinated with a 0.5ml dose of HPV vaccine. Subsequently the patient developed a rash 10 minutes after vaccination. The patient was treated with antihistamine. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 270245 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2006-10-01
Onset:0000-00-00
Submitted: 2007-01-05
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Malaise, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00436

Write-up: Information has been received from a health professional who was told by her sister in law that in October 2006, a 24 month old patient was vaccinated by mistake with HPV vaccine. It was reported that the patient became very ill and began vomiting and developed a high fever. It was reported that the patient recovered. Additional information has been requested.


VAERS ID: 270246 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Ohio  
Vaccinated:2006-11-27
Onset:2006-11-27
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:39
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 GM / IM

Administered by: Other       Purchased by: Other
Symptoms: Discomfort, Injection site discomfort, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA00441

Write-up: Information has been received from a registered nurse concerning her 19 year old daughter with no medical history or drug allergies who on 27 Nov 2006 was vaccinated intramuscularly in the mid top gluteal region with a first dose of HPV Vaccine. There was no concomitant medication. On 27 Nov 2006 the patient mentioned that the site of injection hurt and caused discomfort. The patient was uncomfortable for 24 hours. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 270247 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2006-11-28
Onset:2006-11-29
   Days after vaccination:1
Submitted: 2007-01-05
   Days after onset:37
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Muscular weakness, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CIPRO
Current Illness:
Preexisting Conditions: Urinary tract infection.
Allergies:
Diagnostic Lab Data: Eosinophil count 11/29/06 complete blood cell 1/29/06, WBC count 11/29/06 all normal.
CDC Split Type: WAES0612USA00464

Write-up: Information has been received from a physician concerning a 19 year old female with a urinary tract infection who on 28 Nov 2006 at 10:15 was vaccainted IM in the left deltoid with the first dose Gardasil (lot#653938/0954F). Concomitant therapy included CIPRO. On 29 Nov 2006 the patient developed a rash on her face and weakness in her legs and arms. Laboratory results completed the same day included complete blood cell count, blood eosinophilic leukocyte count and white blood cell count which were all normal. Subsequently, the patient "slowly" recovered from the rash and weakness in her arms and legs. Additional information has been requested.


VAERS ID: 270248 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Arizona  
Vaccinated:2006-12-01
Onset:2006-12-01
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:35
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives
Current Illness:
Preexisting Conditions: Allergic reaction to antibiotics
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA00467

Write-up: Information has been received from an nurse concerning a 21 year old female with allergic reaction to antibiotics (Septra) who on 01 Dec 2006 was vaccinated intramuscularly in the left deltoid with HPV vaccine. Concomitant therapy included hormonal contraceptives (unspecified). On 01 Dec 2006 about three hours post vaccination the patient developed blurry vision in her left eye. No other symptoms were reported. Unspecified medical attention was sought. At the time of this report the patient had not recovered from the blurry vision. Additional information has been requested.


VAERS ID: 270249 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-11-29
Onset:2006-11-30
   Days after vaccination:1
Submitted: 2007-01-05
   Days after onset:36
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 2 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Dysgeusia, Headache
SMQs:, Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Adderall Tablets. Zoloft
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA00474

Write-up: Information has been received from a nurse concerning a 17 year old female who on 29 Nov 2006 was vaccinated with the second dose (first dose date not reported) Gardasil (Lot 653938/0954F). Concomitant therapy included Adderall tablets and Zoloft. On 30 Nov 2006 the patient experienced dizziness, a bad taste in her mouth and a headache. It was reported that the patient was able to attend school that day. The patient''s dizziness and bad taste and headache persisted. It was noted that the patient did not have adverse events after her first dose of Gardasil. The patient sought unspecified medical attention. Additional information has been requested. Follow up information received from a nurse practitioner stated that the vaccination that the patient received on 29-NOV-2006 intramuscularly in her right deltoid was the first dose of GRDASIL (Lot# 653938/0954F), not the second as previously reported. It was also reported that the patient had recovered from the dizziness and bad taste in her mouth. Additional information not requested.


VAERS ID: 270250 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Unknown  
Location: Florida  
Vaccinated:2006-11-27
Onset:2006-11-28
   Days after vaccination:1
Submitted: 2007-01-05
   Days after onset:38
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Pruritus
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA00494

Write-up: Information has been received from a physician concerning a 24 year old patient who on 27 Nov 2006 was vaccinated in the arm with the first dose of HPV Vaccine. There was no concomitant medications. On 28 Nov 2006, it was reported that the patient developed generalized itching throughout her body. The patient called the physician on the following day and reported she was itchy. The physician stated that she believed the patient experienced an allergic reaction and dose not want to give the second and third shot. It was reported that the patient sought unspecified medical attention. It was reported that a couple of days later, the patient had recovered. Additional information has been requested.


VAERS ID: 270251 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:65
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00495

Write-up: Information has been received from a physician concerning a female in her early 20''s who sometime in mid November was vaccinated with her first dose of HPV Vaccine. It was reported that within 24 hours the patient experienced numbness in one of her legs and in her arm. The physician stated the patient still had numbness and that it had been over a week now and it had not subsided. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 270252 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-05
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Pharyngeal oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00605

Write-up: Information has been received from a physician concerning a patient who was vaccinated with a 0.5 ml dose of HPV Vaccine. Subsequently, the patient experienced throat swelling. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 270253 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Ohio  
Vaccinated:2006-09-25
Onset:2006-09-26
   Days after vaccination:1
Submitted: 2007-01-05
   Days after onset:101
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Blister, Fluid retention, Injection site erythema, Injection site oedema, Urinary bladder rupture
SMQs:, Severe cutaneous adverse reactions (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA00669

Write-up: Information has been received from a nurse concerning a 17 year old female with no medical history or allergies, who on 25 Sept 2006 was vaccinated IM into the left deltoid with a first 0.5ml dose of HPV vaccine (lot 653735/0688F). There was no concomitant medication. Twenty four hours after vaccination, the patient experienced redness and swelling at the injection site and one vesicle was fluid filled and ruptured. Unspecified medical attention was sought. No diagnostic studies were performed. Subsequently, the patient recovered. The nurse stated that the physician will discontinue the therapy and will not be administering any further doses of this vaccine to this patient. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 270254 (history)  
Form: Version 1.0  
Age: 38.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:65
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / UNK - / -

Administered by: Private       Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00784

Write-up: Information has been received from a medical assistant concerning a female (age not reported) who (approximately one month ago) in approximately November 2006, was vaccinated with Gardasil (yeast). On 04 Dec 2006, the patient just now experienced redness and swelling at what the patient believes is the injection site. The patient had not yet been seen at the office at the time of the reporting. The outcome of the event was unknown. Additional information has been requested. Additional information was received from the medical assistant. On 04-DEC-2006, the patient reported redness and puffiness at the site. On 11-DEC-2006, the patient was examined by the physician. The area inflamed was similar than one half inch diameter. The patient was given antibiotics for one week. No diagnostic tests were performed. On an unspecified date, the patient recovered. No additional information is expected.


VAERS ID: 270255 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: California  
Vaccinated:2006-11-03
Onset:2006-11-03
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:63
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Hypoaesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA00785

Write-up: Information has been received from a physician concerning an 18 year old female with no pertinent medical history or drug reactions/allergies, who on 03 Nov 2006 was vaccinated with Gardasil (yeast) (0.5 ml). There was no concomitant medication. On 03 Nove 2006 the patient experienced shortness of breath, chest pain, chest tightness and numbness in the arm that lasted approximately 30 minutes. Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 270257 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-08-16
Onset:2006-08-16
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:142
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00928

Write-up: Initial and follow up information has been received from an RN concerning an 18 year old white female student who on 16 Aug 2006 was vaccinated with her first dose of Gardasil (yeast). It was reported that she experienced pain at injection site several days post injection. On 13 Oct 2006 the patient received her second dose of Gardasil (yeast), IM, lot #653736/0689F. After the injection the patient complained of pain at injection site with radiating pain even at shoulder blade area several days post injection. Medical attention was sought. On 16 Oct 2006 the patient recovered from injection site pain and radiating pain. Additional information is not expected.


VAERS ID: 270258 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-12-05
Onset:2006-12-05
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:31
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 2 - / -

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure decreased, Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Midrin
Current Illness:
Preexisting Conditions: Penicillin allergy; Drug hypersensitivity; Smoker; Kidney infection; Renal disorder; Immunisation
Allergies:
Diagnostic Lab Data: Blood pressure, 12/05/06, 98/50; Blood pressure, 12/05/06, 130/8; Blood pressure, 12/05/06, 104/6; Blood pressure, 12/05/06, 94/51; Blood pressure, 12/05/06, 160/9
CDC Split Type: WAES0612USA00948

Write-up: Information has been received from an RN concerning an 18 year old female patient with allergies to penicillin and morphine who on an unspecified date was vaccinated with her first dose of Gardasil (yeast). Concomitant therapy included Midrin. The patient was " a little lightheaded" during the first injection. On 05 Dec 2006 the patient was vaccinated with her second dose of Gardasil vaccine (yeast), lot # 653937/0637F. She developed syncope less than 10 minutes after the second injection was given. Her blood pressure dropped and she did not awake for 15 minutes. The patient was sent to the emergency room, and the nurse reported she was not sure if she recovered. Additional information has been requested.In follow up it was reported that the patient "felt faint" and that the patient "did faint" after her first injection with GRDASIL. The following significant reaction to GRDASIL was reported after her second injection: the patient began hyperventiling, complaining of headache, nausea, and feeling hot. She covered her eyes and was not answering questions, only nodding. There was no history of panic attacks, however she had been seen by another physician earlier that week and prescribed acetaminophen (+) dichloralphenazone(+) isometheptene mucate for migraine headache. She was lying down on the exam room table and was provided with a cool pack, cold juice, blanket and dark room. The nurse tool vital signs (see blood pressure measurements in laboratory data section). Her symptoms appeared to resolve and she "feel asleep?", but then apparently awoke in another panic and had a repeat of the same symptoms, worse then before. After attempts to calm the patient/stabilizing in the office failed, the decision was made to her go tot the ER for further evaluation. There was no evidence of anaphylaxis. The patient was reported as recovered from feeling hot, headache, hyperventilation, and nausea on 05-DEC-2006. Assessment of patient on 05-DEC-2006 included adverse effects of drug and panic disorder. Additional information not expected.


VAERS ID: 270259 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-11-21
Onset:2006-12-05
   Days after vaccination:14
Submitted: 2007-01-05
   Days after onset:31
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Anogenital warts, Smear cervix abnormal
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri-Cyclen Lo
Current Illness:
Preexisting Conditions: papanicolaou smear abnormal, genital wart
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00964

Write-up: Information has been received from a Certified Medical Assistant concerning a 22 year old female patient with genital warts and history of abnormal Pap smears who on 21 Nov 2006 was vaccinated IM in the left deltoid with her first dose of Gardasil (yeast), lot #653736/0868F. Concomitant therapy included Ortho Tri-Cyclen Lo. The patient called to report that prior to the vaccination she had 2 undiagnosed "bumps" in the vulva area. Two weeks after the vaccination, on 05 Dec 2006, the patient had an increase in amount of genital warts (3 more "bumps" appeared in the surrounding area). Medical attention was sought. The patient had undergone a Pap smear and cervical biopsy on 21 Nov 2006 (results were not reported). At the time of the report the patient had not recovered. Additional information has been requested. Follow-up information has been received concerning the female student with genital warts who on 21-NOV-2006 at 2:00 p.m. had received her first dose of GRDASIL, lot # 653736/0868F. The patient stated she had a history of bumps in vaginal area, and was never diagnosed with any disease. On 05-DEC-2006 the bumps increased in size and number. The patient was positive for HPV 6. On 15-JAN-2007 at 3:00 p.m. she was vaccinated IM in left deltoid with her second dose of GRDASIL, lot # 655617/1447F. Her outcome was unknown. Additional information is not expected.


VAERS ID: 270260 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-11-15
Onset:2006-11-17
   Days after vaccination:2
Submitted: 2007-04-06
   Days after onset:139
Entered: 2007-01-09
   Days after submission:86
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00981

Write-up: Information has been received from a physician concerning a female patient who was vaccinated IM with a first dose of Gardasil (yeast). Subsequently, the patient developed a few hives in the upper abdominal area. It was noted that the patient plans to continue with the vaccine series by getting the second and third dose as recommended. Unspecified medical attention was sought. On 04 Dec 2006, the patient recovered. No product quality complaint was involved. Additional informatio has been requested. This is in follow-up to report (s) previously submitted on 1/5/2007. Information has been received from a physician concerning a 26 year old female patient who on 15-NOV-2006 was vaccinated IM into the left deltoid with a first dose of GARDASIL (lot # 653938/0954F). On 17-NOV-2006, the patient developed a few hives in the upper abdominal area. It was noted that the patient plans to continue with the vaccine series by getting the second and third dose as recommended. The patient was treated with BENADRYL. On 04-DEC-2006, the patient recovered. No product quality complaint was involved. The physician stated that it was highly unlikely that hives were from the vaccine because hives developed 48 hours later. Additional information is not expected.


VAERS ID: 270261 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-05
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA00993

Write-up: Information has been received from a nurse practitioner concerning an approximately 22 year old female patient who in 2006 was vaccinated with a first dose of Gardasil (yeast). In 2006, the patient experienced a raised, red, itchy lump at the injection site. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 270262 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Missouri  
Vaccinated:2006-11-01
Onset:2006-11-23
   Days after vaccination:22
Submitted: 2007-01-05
   Days after onset:43
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0612USA01065

Write-up: This is in follow-up to report(s) previously submitted on 1/5/2007. Information has been received from a physician concerning a 23 year old female who on 01-NOV-2006 was vaccinated, in the left arm, with a first dose of GARDASIL (lot #653938/0954F). On approximately 23-NOV-2006, the patient developed swelling in her lymph node in her axilla (previously reported as swelling in her lymph node area). Unspecified medical attention was sought. On approximately 03-JAN-2007, the patient recovered. Additional information is not available.


VAERS ID: 270263 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Georgia  
Vaccinated:2006-10-10
Onset:0000-00-00
Submitted: 2007-01-05
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / UNK UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alopecia, Attention deficit/hyperactivity disorder, Blood albumin normal, Blood thyroid stimulating hormone, C-reactive protein normal, Eating disorder, Full blood count normal, Metabolic function test, Red blood cell sedimentation rate normal
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERALL XR
Current Illness: Attention deficit/hyperactivity disorder; Bulimia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Diagnostic laboratory, CMP within normal limits; diagnostic laboratory, WESR within normal limits; diagnostic laboratory, pre albumin within normal limits; complete blood cell, within normal limits; serum C-reactive protein, within normal limits; serum TSH, within normal limits
CDC Split Type: WAES0612USA01067

Write-up: Information has been received from a licensed practical nurse concerning a 17 year old female with an eating disorder and attention deficit/hyperactivity disorder who on 10 Oct 2006, was vaccinated with a dose of Gardasil. The patient was concomitantly vaccinated with a dose of Menactra. Concomitant therapy included unspecified therapy for ADHD. Subsequently, the patient experienced thinning of hair/alopecia. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/5/2007. Information has been received from a licensed practical nurse concerning a 17 year old female student with bulima and attention deficit/hyperacticity disorder who on 15-SEP-2006 (previously reported as 10-OCT-2006), was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL (lot 653735/0688F). The patient was concomitantly vaccinated with a dose of MENACTRA. Concomitant therapy included ADDERALL XR. Subsequently, the patient experienced thinning of hair/alopecia. The patient was seen in the office and thinning hair was noted. Laboratory evaluations revealed that CMP, complete blood count, thyroid stimulating hormone, c-reactive protein, WESR, and pre-albumin were all within normal limits. It was reported that the physician was having the patient monitor the condition. At the time of this report, the patient had not recovered. No additional information is expected.


VAERS ID: 270264 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2006-11-06
Onset:2006-11-06
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:60
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Nausea, Pruritus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA01069

Write-up: Information has been received from a physician and a nurse concerning a 25 year old female who on 06 Nov 2006 was vaccinated intramuscularly with the first single dose vial of Gardasil. On 06 Nov 2006, that evening, the patient developed itching all over her body, but no rash was associated with it. The physician and nurse reported that the patient also developed nausea. Unspecified medical attention was sought. The nurse told the patient to try some over the counter Benadryl to treat the itching as was recommended by the physician. There was no lot number provided. At the time of this report, the outcome of the events were unknown. Additional information has been requested.


VAERS ID: 270265 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Female  
Location: Georgia  
Vaccinated:2006-10-10
Onset:2006-10-20
   Days after vaccination:10
Submitted: 2007-04-06
   Days after onset:168
Entered: 2007-01-09
   Days after submission:86
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Hypotrichosis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA01074

Write-up: Information has been received from a licensed practical nurse concerning a 9 year old female with no pertinent medical history or drug reactions/allergies, who on 05 Sept 2006 and 03 Nov 2006 was vaccinated with the first and second doses of Gardasil (lot 653735/0688F). There was no concomitant medication. Subsequently the patient experienced thinning of hair or alopecia. Unspecified medical attention was sought. At the time of this report the patient had not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/5/2007. Initial and follow-up information has been received from a licensed practical nurse concerning a 9 year old female with no pertinent medical history or drug reaction/allergies, who on 10-OCT-2006 was vaccinated intramuscularly with the first dose of GARDASIL (0.5 ml) (lot # 653735/0688F). There was no concomitant medication. Subsequently, approximately ten days after vaccination on approximately 20-OCT-2006, the patient''s mother noticed a balding spot behind the patient''s ear. The patient used a steroid cream on the area and had an appointment with a dermatologist. It was reported that the patient has some hair re-growth but not in the whole area. The patient''s mother was unsure about the completion of the recommended vaccine schedule. No further information is expected.


VAERS ID: 270266 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-05
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA01254

Write-up: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of HPV Vaccine (Lot not provided) Subsequently, the day after she was vaccainted the patient developed a sort of rash all over her body. The physician recommended that the patient treat the rash with Benadryl, which the patient did. subsequently, the rash resolved and no additional treatment was needed. Additional information has been requested.


VAERS ID: 270267 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2006-12-05
Onset:2006-12-08
   Days after vaccination:3
Submitted: 2007-01-05
   Days after onset:28
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Menstruation irregular
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives.
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA01380

Write-up: Information has been received from a 25 year old female consumer who on 05 Dec 2006 was vaccainted with HPV vaccine. Concomitant therapy included hormonal contraceptives (unspecified). The consumer stated that her period is normally 7 days long, and it started on 04 Dec 2006. On 08 Dec 2006, her period ended. two days earlier than normal. The consumer did not seek medical attention and stated the adverse experience did not improve. Additional information has been requested.


VAERS ID: 270268 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-12-08
Onset:2006-12-08
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:28
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Fear, Pallor, Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Fear
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA01386

Write-up: information has been received from a physician concerning a 16 year old female who on 08 Dec 2006 was vaccinated in the arm with a pre filled syringe of HPV Vaccine. There was no concomitant medication. On 08 Dec 2006, immediately following the vaccination, the patient turned white and nearly passed out. The patient was not hospitalized and was not pregnant. Subsequently, the patient fully recovered. The physician felt that the events were not a result of the vaccine, however a result of the patient being afraid of injections. Additional information has been requested.


VAERS ID: 270269 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Arizona  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:65
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA01528

Write-up: Information has been received from a physician concerning an 18 or 19 year old female patient who in approximately Nov 2006, was vaccinated with a dose of HPV vaccine. Concomitant suspect therapy included YAZ, an oral contraceptive, which was started at the same time (dose and duration not reported). Subsequently, the patient developed papillary rash and pruritis on lower extremities after Gardasil injection. Medical attention was sought. It was reported that the rash went away after therapy with YAZ was discontinued. Additional information has been requested.


VAERS ID: 270270 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-12-05
Onset:2006-12-05
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:31
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA03803

Write-up: Information has been received from an RN concerning a female patient who on 05 Dec 2006 was vaccainted with her first dose of HPV vaccine. While she was receiving the injection she developed syncope and a drop in blood pressure. The nurse reported that the patient recovered and was sent home after 30 minutes. Additional information has been requested.


VAERS ID: 270271 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Arizona  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-05
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES012USA03878

Write-up: Information has been received from a physician concerning a patient who was vaccinated with a dose of HPV Vaccine and developed rash and pruritus. The patient''s outcome was unknown. Additional information had been requested.


VAERS ID: 270291 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Georgia  
Vaccinated:2006-12-28
Onset:2007-01-07
   Days after vaccination:10
Submitted: 2007-01-09
   Days after onset:2
Entered: 2007-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / UNK RL / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1974AB / UNK LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: not provided
Current Illness: unknown
Preexisting Conditions: not provided
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Reporter states 19 year old female received Menactra on 12/28/06. On Jan. 7, 2007, patient reported tingling sensation from feet to thighs. Returned to school. Will be seen by physician.


VAERS ID: 270301 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-15
Onset:0000-00-00
Submitted: 2007-01-08
Entered: 2007-01-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA00254

Write-up: Information has been received from a nurse practitioner concerning a 19 year old female who on 15 Dec 2006 was vaccainted with her first dose of HPV Vaccine. Subsequently the patient experienced welts on her legs, itching and redness of her injection site arm. The patient was treated with BENADRYL, and she recovered. The patient sought unspecified medical attention. The reporter considered the patient''s welts on her legs, itching and redness of her injection site arm to be other important medical events. Additional information has been requested.


VAERS ID: 270302 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: New York  
Vaccinated:2006-11-20
Onset:2006-11-20
   Days after vaccination:0
Submitted: 2007-01-08
   Days after onset:49
Entered: 2007-01-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion, Unintended pregnancy
SMQs:, Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Miscarriage, Abortion spontaneous.
Allergies:
Diagnostic Lab Data: 12/04/06 blood work positive for pregnancy, 11/20/06 negative for pregnancy, 11/20/06 fluid in pelvis no IUP seen, Urine beta human positive.
CDC Split Type: WAES0612USA01040

Write-up: Initial and follow up information has been received from a licensed practical nurse through the manufacturer pregnancy registry concerning a 24 year old female with a history of two miscarriages in the past and not planning on being pregnant, a spontaneous abortion (March 2006) and no known allergies reported. On 20 Nov 2006, the patient was vaccinated intramuscularly in the left deltoid with the first 0.5ml dose of HPV vaccine (lot #653978/0955F). On 20 Nov 2006, the patient had a pelvic ultrasound performed due to pelvic pain. The pelvic ultrasound revealed fluid in pelvis and no intrauterine pregnancy was seen (previously reported as was negative for pregnancy). On an unspecified date, post vaccination, the patient presented to the office stating that she took a urine home pregnancy test and it was positive. On 04 Dec 2006, the patient had blood work drawn which revealed positive for pregnancy. The patient was approximately 6 weeks gestation with last menstrual period noted as approximately 21 Oct 2006. The patient was scheduled for a follow up blood test on 07 Dec 2006 and an ultrasound and blood lab was scheduled on 11 Dec 2006. On 17 Dec 2006 the patient experienced spontaneous abortion. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Upon internal review, the spontaneous abortion was considered to be an other important medical event (OMIC).


VAERS ID: 270322 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-12-21
Onset:2007-01-05
   Days after vaccination:15
Submitted: 2007-01-10
   Days after onset:5
Entered: 2007-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0960F / UNK LA / -

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Joint range of motion decreased
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho tricyclen LO
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Pt seen by doctor on 1/6/07 no swelling or redness good ROM REC NSAIDS and warm compresses. RTO 1-2 weeks
CDC Split Type:

Write-up: 01/05/07 pt called c/p left arm still sore after 2 weeks after receiving vaccine unable to raise arm over head denies redness or swelling.


VAERS ID: 270352 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2007-01-10
Onset:2007-01-10
   Days after vaccination:0
Submitted: 2007-01-10
   Days after onset:0
Entered: 2007-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: PT HAS FLU LIKE ONE OR 2 WEEKS PREVIOUS IN GOOD HEALTH AT TIME OF VACCINE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: HPV , Pt with good health.
CDC Split Type:

Write-up: Pt has dizziness and then pass out at the office. She was kept for observation her; VS were stable and then discharge home. She still feeling dizziness after later phone call.


VAERS ID: 270357 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-10
Onset:2007-01-10
   Days after vaccination:0
Submitted: 2007-01-10
   Days after onset:0
Entered: 2007-01-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / UNK RA / -

Administered by: Public       Purchased by: Unknown
Symptoms: Feeling hot, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt c/o being hot and sweaty. Pt laid down on exam bed and given water. Pt stayed in clinic for 30 mins and stated she was feeling fine.


VAERS ID: 270358 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2007-01-09
Onset:2007-01-09
   Days after vaccination:0
Submitted: 2007-01-10
   Days after onset:1
Entered: 2007-01-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1213F / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hives


VAERS ID: 270362 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-10-11
Onset:2006-11-01
   Days after vaccination:21
Submitted: 2007-01-10
   Days after onset:70
Entered: 2007-01-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Decreased appetite, Dehydration, Diarrhoea, Gastrointestinal disorder, Lymphadenopathy, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: YAZ
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA00486

Write-up: Information has been received from a nurse practitioner concerning an 18 year old female with no pertinent medical history and no drug reactions or allergies who on 11 Oct 2006 was vaccinated with the first, 0.5 ml dose of HPV vaccine. Concomitant therapy included YAZ. On 11 Dec 2006, the patient received the second, 0.5ml dose of HPV vaccine (lot 653650/0696F). About three weeks after the first dose, approximately 01 Nov 2006, the patient experienced Gastrointestinal problems including, diarrhea, vomiting and decreased appetite. The patient had a swollen right intraglandular lymph node. The patient had lost 12 pounds since the start of her symptoms. The patient was hospitalized overnight and treated for dehydration with intravenous fluids on 12 Nov 2006, 18 Nov 2006 and 31 Dec 2006. laboratory evaluation revealed normal complete blood count and normal ultrasound of the pelvic area. The patient was referred to a gastrointestinal physician but had not been examined yet. At the time of the report, the patient had not recovered. The patient sought medical attention. The reporter considered the patients gastrointestinal problems, diarrhea, vomiting, decreased appetite, swollen right intraglandular lymph node, lost 12 pounds, and dehydration to be disabling. The reporter considered the patients gastrointestinal problems, diarrhea, vomiting, decreased appetite, swollen right intraglandular lymph node, lost 12 pounds, and dehydration to be other important medical events (OMIC). Additional information has been requested.


VAERS ID: 270365 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: New York  
Vaccinated:2006-11-27
Onset:2006-11-28
   Days after vaccination:1
Submitted: 2007-01-10
   Days after onset:43
Entered: 2007-01-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB141AA / 1 - / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 09546 / 1 - / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1932AB / 1 - / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1052F / 2 - / SC

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Feeling hot, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Right deltoid erythematous, warm and tender.


VAERS ID: 270405 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Idaho  
Vaccinated:2006-11-20
Onset:2006-12-05
   Days after vaccination:15
Submitted: 2007-01-11
   Days after onset:37
Entered: 2007-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alopecia, Pruritus, Thermal burn
SMQs:, Anaphylactic reaction (broad), Accidents and injuries (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Postpartum x 8 weeks when vaccinated
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: States feeling like her head was burning and itching. States hair has been steadily been falling out starting 2 weeks post vaccine and continuing over the past two months.


VAERS ID: 270411 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Female  
Location: Missouri  
Vaccinated:2007-01-11
Onset:2007-01-11
   Days after vaccination:0
Submitted: 2007-01-11
   Days after onset:0
Entered: 2007-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 142AA / 1 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Nausea, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient felt faint, nauseated, pale. Patient laid down symptoms resolved after 10 minutes.


VAERS ID: 270413 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Indiana  
Vaccinated:2007-01-11
Onset:2007-01-11
   Days after vaccination:0
Submitted: 2007-01-11
   Days after onset:0
Entered: 2007-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Five minutes after injection patient became nauseous and vomited. Pulse 100. BP 118/76. Patient waited 20 minutes after vomiting. Felt fine. Left office.


VAERS ID: 270433 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2007-01-03
Onset:2007-01-03
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:2
Entered: 2007-01-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2271AA / UNK LA / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / UNK RA / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2116AA / UNK LA / -

Administered by: Private       Purchased by: Other
Symptoms: Injection site erythema, Injection site warmth, Skin ulcer, Tenderness
SMQs:, Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Latex allergy.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Left Deltoid 5cm x 3 1/2 cm circular erythematous tender and warm to touch lesion arm very tender.


VAERS ID: 270528 (history)  
Form: Version 1.0  
Age: 37.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-10-09
Onset:2006-10-22
   Days after vaccination:13
Submitted: 2007-01-12
   Days after onset:82
Entered: 2007-01-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion, Medication error, Unintended pregnancy
SMQs:, Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA06403

Write-up: Information has been received through the manufacturer pregnancy registry and from a medical assistant concerning a 37 year old female who on 09-OCT-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (lot # 653736/0868F). It was reported that on 22-OCT-2006 "the patient discovered she was 7 weeks pregnant) method of confirmation of pregnancy was reported to be a pap smear. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information was received from a medical assistant who reported that on 15-DEC-2006 the patient experienced vaginal spotting. That same day the patient was seen by her obstetrician who performed an abdominal ultrasound. The ultrasound confirmed that there was no fetal heartbeat. On an unspecified date a total serum human chorionic gonadotropin test was performed, results not provided. On 18-DEC-2006, the patient underwent an uncomplicated uterine dilation and curettage as an outpatient. On 02-JAN-2007 the patient was seen by her obstetrician for a post-operative exam which revealed that the patient had a full recovery without complications. The patient was advised to return to full regular activity. Upon internal review, the spontaneous abortion was considered to be an other medical event (OMIC). Additional information has been requested.


VAERS ID: 270529 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2006-11-16
Onset:2006-11-16
   Days after vaccination:0
Submitted: 2007-01-12
   Days after onset:57
Entered: 2007-01-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion, Medication error, Unintended pregnancy
SMQs:, Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Depo-Provera; Nasonex
Current Illness:
Preexisting Conditions: Pregnancy (LMP = 10/28/2006); Seasonal allergy; Contraception
Allergies:
Diagnostic Lab Data: beta-human chorionic 11/16/06 - negative; beta-human chorionic 12/05/06 - positive
CDC Split Type: WAES0612USA00985

Write-up: Information has been received from a registered nurse for the pregnancy registry for Gardasil concerning an 18 year old white female with seasonal allergies and no medical history, who on 16-NOV-2006 was vaccinated IM with a 0.5 ml dose of Gardasil (lot# 654540/0800F). Concomitant therapy included Depo-Provera and Nasonex. On 16-NOV-2006, the patient''s pregnancy test was negative. On 05-DEC-2006, the patient''s pregnancy test was positive. It was noted that the patient may have an abortion but that was not related to the vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information indicated that the patient''s LMP was on 28-OCT-2006 (estimated delivery date is 04-AUG-2007). On 03-JAN-2007 (reported as 03-JAN-2006), the patient had an elective termination. Upon internal review, elective termination was considered to be an other important medical event (OMIC). No further information was available.


VAERS ID: 270531 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2006-12-19
Onset:2006-12-19
   Days after vaccination:0
Submitted: 2007-01-12
   Days after onset:24
Entered: 2007-01-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 UN / -

Administered by: Private       Purchased by: Other
Symptoms: Blood pressure decreased, Convulsion, Crying, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sulfamethoxazole(+)trimethoprim
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 12/19/06: 90/60; Blood glucose, 12/19/06: normal; Total heartbeat count, 12/19/06: 62
CDC Split Type: WAES0701USA00376

Write-up: Information has been received from the mother of a 17 year old female patient with acne and pertinent medical history and drug reactions/allergies reported as none who on 19-DEC-2006 was vaccinated with an initial dose of Gardasil, injection in the left upper arm. Concomitant therapy included sulfamethoxazole/trimethoprim. On 19-DEC-2006, the patient experienced two seizures after receiving the Gardasil vaccine. The patient''s mother reported that the patient "blacked out" about one to two minutes after receiving the injection and was unconscious for about a minute before she experienced the first seizure. The patient had felt nauseous when she had regained consciousness. The patient''s mother then reported that the patient "blacked out again" and had the second seizure which was more "severe". When the patient came out of it she started crying. The patient''s mother reported that the physician kept them at the office for about three hours to watch her and she was given water. The patient was instructed to see a neurologist. Subsequently at the time of this report, the patient recovered from seizures. Seizures was considered to be an other important medical event (OMIC). Additional information has been requested.


VAERS ID: 270532 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-01-03
Onset:2007-01-03
   Days after vaccination:0
Submitted: 2007-01-12
   Days after onset:9
Entered: 2007-01-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blindness transient, Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concerta
Current Illness:
Preexisting Conditions: Penicillin allergy; latex allergy Status post Kawasaki disease two weeks after developing chicken pox, attention deficit/hyperactivity disorder.
Allergies:
Diagnostic Lab Data: CT of brain: normal Urine toxicology normal WBC 6.6, polys 85, lymphocytes 6, monocytes 6, eosinophils 2. Total protein over albumin is 6.9/4.2, calcium 9.2, magnesium 1.9. EEG: normal.
CDC Split Type: WAES0701USA00620

Write-up: Information has been received from a physician concerning a 12 year old female with a penicillin allergy and latex allergy who on 03-JAN-2007 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL. Concomitant therapy included Concerta. Later that evening, on 03-JAN-2007, the patient developed nausea and vomited once. At approximately 07:00 am on 04-JAN-2007, the patient developed a headache and temporal blindness that lasted approximately 40 seconds. The patient was taken to the emergency room. At 10:03 am, the patient had a second incidence of headache and temporal blindness that also lasted approximately 40 seconds. At the time of this reported, the patient was stable but was to be admitted to the hospital for observation. At the time of this report, the outcome was unknown. Additional information has been requested. 01/22/07-records received and reviewed from Medical Center for DOS 01/0407-transferred with DX of new onset seizures to another Hospital. Records requested. CT brain without contrast: negative exam, recommend MRI. 01/30/07-rcords received for DOS 01/04-01/05/07 DC DX: 1. Vasovagal response secondary to dehydration 2. Syncope secondary to #1. Hospital Course: Transferred from Med Ctr. Admitted with vomiting decreased oral intake since yesterday, complained of blindness and severe headaches this morning with fever of 101.4. Experienced 35-45 second of complaining of blindness, loss of consciousness and staring episode at Med Ctr. PMH: Status post Kawasaki disease two weeks after developing chicken pox, attention deficit/hyperactivity disorder.


VAERS ID: 270548 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2006-11-22
Onset:2006-11-26
   Days after vaccination:4
Submitted: 2007-01-08
   Days after onset:43
Entered: 2007-01-16
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2241AA / 3 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Pruritus, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Four days following the Gardasil vaccine, the patient developed a rash all over her body that was itchy and skin colored. It seemed to be worse on the arm of injections site. The patient received an antihistamine and cortisone creme.


VAERS ID: 270598 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Pruritus
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA01070

Write-up: Information has been received from a physician concerning a female who was intramuscularly, vaccinated with the second dose of HPV vaccine. Subsequently the patient developed an anaphylactic reaction (swelling of the throat, itching of hands and feet). At the time of the report, it was not reported if the patient recovered. The physician determined that the patient''s anaphylactic reaction (Swelling of the throat, itching of hands and feet) was considered to be immediately life threatening, disabling and an other important medical event. Additional information has been requested.


VAERS ID: 270606 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-02
Onset:2007-01-03
   Days after vaccination:1
Submitted: 2007-01-05
   Days after onset:2
Entered: 2007-01-17
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1095F / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1405F / 2 RA / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site cellulitis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: CBC normal
CDC Split Type:

Write-up: Cellulitis at injection site right upper arm.


VAERS ID: 270610 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-11
Entered: 2007-01-17
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 5 mins after receiving Gardasil pt had vasovagal symptoms, lasted approx 5-10 min.


VAERS ID: 270611 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Missouri  
Vaccinated:2007-01-03
Onset:2007-01-04
   Days after vaccination:1
Submitted: 2007-01-09
   Days after onset:5
Entered: 2007-01-17
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Flushing, Malaise, Skin warm, Somnolence, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 01/04/07 pt started getting sick around 2pm, her face was warm and flush, no recorded fever, threw up one time. Fell asleep until 5pm woke up ate a little dinner went back to sleep until next morning.


VAERS ID: 270631 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: California  
Vaccinated:2006-11-09
Onset:2006-11-09
   Days after vaccination:0
Submitted: 2007-01-17
   Days after onset:69
Entered: 2007-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2609AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site warmth, Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: HA, sinus pressure no temp
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt stated post last vaccine admin. arm was hot to touch and sore


VAERS ID: 270766 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2007-01-08
Onset:2007-01-08
   Days after vaccination:0
Submitted: 2007-01-17
   Days after onset:9
Entered: 2007-01-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Grand mal convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Allegra, Hormonal contraceptives, Singulair.
Current Illness:
Preexisting Conditions: Sulfonamide allergy
Allergies:
Diagnostic Lab Data: Diagnostic laboratory 01/08/07 unspecified.
CDC Split Type: WAES0701USA01029

Write-up: Information has been received from a 27 year old female consumer with sulfa drug allergy and pertinent medical history reported as none who on 08 Jan 2007 was vaccainted with GARDASIL (lot # not reported) 0.5ml injection. Concomitant therapy included Montelukast sodium, ALLEGRA and birth control (unspecified). The consumer reported that on 08 Jan 2007, she had a grand mal seizure after receiving GARDASIL. Medical attention was sought. Unspecified blood test were performed. At the time of reporting, the outcome was unspecified. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.


VAERS ID: 270784 (history)  
Form: Version 1.0  
Age: 13.5  
Sex: Female  
Location: Oregon  
Vaccinated:2006-12-22
Onset:2006-12-22
   Days after vaccination:0
Submitted: 2007-01-08
   Days after onset:17
Entered: 2007-01-18
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Erythema, Pallor, Palpitations, Pyrexia, Rash, Rash macular
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: History of Dysplasia (hips)
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 5 hours after receiving HPV pt had low grade fever (99), felt dizzy, pale, had a blotchy red rash on both arms (upper) onto back. No rash elevation, no hives. Pt went to bed, rash was gone by am without further side effects. During episode heart was also pounding.


VAERS ID: 270836 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-28
Onset:2006-12-28
   Days after vaccination:0
Submitted: 2007-01-18
   Days after onset:21
Entered: 2007-01-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Nausea
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Convulsion
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA01415

Write-up: Information has been received from a registered nurse concerning an 18 year old female with a history of two past episodes of seizures (one occurred in 8th grade and another occurred when the patient had her ears pierced) who on 28-Dec-2006 was vaccinated with a first dose of HPV vaccine (yeast) (lot 654389/0961F). The nurse reported that after the dose was administered, the patient felt nausea and while she was lying down, she experienced a "20 second seizure". The patient received unspecified medical attention. The nurse stated that the series would not be completed. At the time of this report, the outcome was unknown. Upon internal review, the patient''s seizure was considered an other important medical event. Additional information has been requested.


VAERS ID: 270907 (history)  
Form: Version 1.0  
Age: 38.0  
Sex: Female  
Location: Ohio  
Vaccinated:2007-01-04
Onset:2007-01-05
   Days after vaccination:1
Submitted: 2007-01-09
   Days after onset:4
Entered: 2007-01-22
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0741R / 1 LA / -

Administered by: Other       Purchased by: Other
Symptoms: Pain in extremity, Pyrexia, Rash macular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: J-Pouch (Ileo-anal anastmosis), Crohn''s Disease
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Pain in left arm started four hours after injection could not life or move arm without pain. 24 hours after injection had elevated temp of 100.5 and red blotches below the injection site (but not at the injection site). 72 hours after injection temperature returned to normal and pain was slowly diminishing. 96 hours after injection pain is gone, red blotches are fading. 10 days after injection, red blotches are gone.


VAERS ID: 270913 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2007-01-08
Onset:2007-01-11
   Days after vaccination:3
Submitted: 2007-01-15
   Days after onset:4
Entered: 2007-01-22
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0697F / 1 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Chest X-ray normal, Chest pain, Dyspnoea, Electrocardiogram normal
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Depo (also given same day).
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Neg EKG and Neg CXR
CDC Split Type:

Write-up: 36 hrs after vaccine pt had severe chest pain and SOB. Went to ER, Neg EKG and neg CXR. Symptoms resolved on their own.


VAERS ID: 270914 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2007-01-10
Onset:2007-01-11
   Days after vaccination:1
Submitted: 2007-01-16
   Days after onset:5
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 2 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Injection site oedema, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Risperdal
Current Illness:
Preexisting Conditions: NKDA pt has asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt''s mother called MD office stating that about 36 hrs after 2nd injection, the patient experienced swelling in her right arm that radiated down her arm into finger tips with middle of her back on right side. Her father is MD gave her 10 mg Prednisone with 800 mg Motrin. This was repeated by Dr next day. Manufacturer rep notified.


VAERS ID: 270917 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-12-14
Onset:2006-12-15
   Days after vaccination:1
Submitted: 2006-12-21
   Days after onset:6
Entered: 2007-01-22
   Days after submission:32
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chills, Dizziness, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: High fever, shaky, shills, rigors, dizzy.


VAERS ID: 270920 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-01-11
Onset:2007-01-14
   Days after vaccination:3
Submitted: 2007-01-16
   Days after onset:2
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nuvaring, Allegra 180 mg
Current Illness: NONE
Preexisting Conditions: Seasonal allergies
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Pruritic rash covering majority of body neck down.


VAERS ID: 271101 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Michigan  
Vaccinated:2006-10-16
Onset:2006-10-16
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:92
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Laboratory test abnormal, Pregnancy test positive, Ultrasound abdomen abnormal, Ultrasound uterus, Vaginitis bacterial
SMQs:, Retroperitoneal fibrosis (broad), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRILOSEC OTC mg; vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = 9/11/2006); Gastrooesophageal reflux; Dyspepsia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: ultrasound 12/19/06 - gest age 24.7 weeks, beta-human chorionic 10/31/06 - positive ; diagnostic laboratory, "CF Carrier Screen" Negative
CDC Split Type: WAES0612USA01297

Write-up: This is in follow-up to report(s) previously submitted on 1/16/2007. Initial and follow-up information has been received from a physician through the Merck pregnancy registry concerning a 17 year old female with episodic reflux and dyspepsia and no known drug allergies and no previous pregnancies who on 16-Oct-2006 was vaccinated intramuscularly with the first dose of GARDASIL (0.5 ml) (lot # 653735/0688F). Concomitant therapy included PRILOSEC OTC and prenatal vitamins. From 20-Oct-2006 to 26-Oct-2006 the patient was placed on therapy with FLAGYL 500 mg twice daily for bacterial vaginitis. On 31-Oct-2006 the patient was found to have a positive pregnancy test. LMP was 11-Sep-2006. Unspecified medical attention was sought and the patient was placed on prenatal vitamins. On 19-Dec-2006, an ultrasound revealed gestational age 24.7 weeks which was not consistent with the estimated date of last menstrual period (LMP). On an unspecified date a Cystic Fibrosis carrier screen was performed, results were negative. On 22-MAR-2007 she delivered a normal, healthy male baby weighing 6 pounds 3 ounces and 18 1/2" long, with a head circumference of 33.5 cm, and APGAR scores of 9 at one and five minutes. The patient''s labor and delivery was uncomplicated. No other symptoms were noted. At the time of this report, the outcome of the events was unknown. Additional information has been requested.


VAERS ID: 271102 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Colorado  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-04-06
Entered: 2007-01-22
   Days after submission:73
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Sneezing
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA01594

Write-up: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with 0.5 ml of Gardasil vaccine (yeast). Subsequently, the patient sneezed consistently for 12 hours. The patient sought unspecified medical attention. It was reported that the patient recovered "12 hours after it started" (date unknown). Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007. Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with 0.5 mL of GARDASIL (lot # not reported). Subsequently, the patient sneezed consistently for 12 hours. The patient sought unspecified medical attention. It was reported that the patient recovered "12 hours after it started" (date unknown). Additional information was received from the physician who reported that the patient did not return for follow-up. The reaction was not typical (sneezing/runny nose for about 24 hours). The events may or may not be related to therapy with GARDASIL. No further information is available.


VAERS ID: 271103 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2006-10-20
Onset:2006-10-26
   Days after vaccination:6
Submitted: 2007-01-16
   Days after onset:82
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 AR / UN

Administered by: Private       Purchased by: Other
Symptoms: Blood test, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: blood pressure, 10/26/06, 118/6; diagnostic laboratory - "blood work" results not reported; respiratory rate, 10/26/06, 20; vital sign, 10/26/06, 92, pulse
CDC Split Type: WAES0612USA01650

Write-up: This is in follow-up to report(s) previously submitted on 1/16/2007. Information has been received from a "nurse" via a company representative and follow up information has been received from a licensed practical nurse concerning an 18 year old female student who on 26-OCT-2006, was vaccinated in the arm with a first dose of GARDASIL (Lot# 653735/0688F). The nurse reported that the patient experienced nausea and dizziness the same day as the vaccination. Follow up information from the nurse also indicated that the patient had experienced nausea, shaking and a "stoned feeling" on 26-OCT-2006. The patient returned to the office and was stable with no urticaria, no erythema, no swelling. Her blood pressure was 118/62, pulse 92 and respiration 20. It was reported that the patient had "blood work" done (results not reported). It was not known whether the patient recovered. The patient sought unspecified medical attention. Subsequently, on the same day, 26-OCT-2006, the patient recovered. Additional information is not expected.


VAERS ID: 271104 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA01717

Write-up: Information has been received from a physician concerning a 22 year old female who was vaccinated with a dose of Gardasil vaccine (yeast). Subsequently, after receiving the vaccination, the patient developed red lesions around the injection site on her arm. On an unspecified date, the patient recovered. Additional information has been requested.


VAERS ID: 271105 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-12-13
Onset:2006-12-13
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:34
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Hyperhidrosis, Hypotension, Immediate post-injection reaction, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: vital sign 12/13/06 - normal
CDC Split Type: WAES0612USA02247

Write-up: Information has been received from a registered nurse concerning a female patient who on 13-Dec-2006 was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil vaccine (yeast) (0.5 ml) (lot#654389/0961F). There was no concomitant medication. On 13-Dec-2006, shortly after vaccination, the patient fainted and her skin color was pale. The patient was aroused by shaking her right arm and with smelling salts. The patient''s vital signs were found to be normal upon discharge from the office. No further details were provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2007. Follow up information received from the physician stated that on 13-DEC-2006 the injection of GARDASIL was administered by a medical assistant. It was reported that immediately after receiving the vaccination the patient had a syncopal episode. It was reported that the patient became hypotensive (actual blood pressure measurement not provided) and diaphoretic and responded to ammonia salts, being placed in the Trendelenburg and hydration, taken by mouth. It was reported that patient recovered from the event. Additional information has been requested.


VAERS ID: 271106 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2006-12-11
Onset:2006-12-12
   Days after vaccination:1
Submitted: 2007-01-16
   Days after onset:35
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Hepatitis C
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA02255

Write-up: Information has been received from a nurse at a physician''s office concerning a female patient with a history of hepatitis C who on 11-Dec-2006 was vaccinated with Gardasil vaccine (yeast). On 12-Dec-2006 the patient reported that she had developed swelling of her hands. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information is not expected.


VAERS ID: 271107 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-10-26
Onset:2006-10-31
   Days after vaccination:5
Submitted: 2007-04-06
   Days after onset:156
Entered: 2007-01-22
   Days after submission:73
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 2 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Epstein-Barr virus test positive, Infectious mononucleosis
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Asthma, penicillin allergy, Sulfonamide allergy
Preexisting Conditions: Infectious mononucleosis
Allergies:
Diagnostic Lab Data: serum Epstein-Barr virus 10/31/06 - positive
CDC Split Type: WAES0612USA02256

Write-up: Information has been received from a registered nurse concerning an 18 year old female patient with asthma, penicillin allergy, sulfonamide allergy and a history of infectious mononucleosis in December 2005, who on 21-Oct-2006 was vaccinated with the second dose of Gardasil vaccine (yeast) (lot# 654540/0800F). There was no concomitant medication. It was reported by the patient''s mother that one week following vaccination, on approximately 28-Oct-2006 the patient developed mononucleosis which had been confirmed by a blood test taken at the university the patient attended. Unspecified medical attention was sought, however the patient received no treatment. At the time of this report the patient had not yet recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007. Information has been received from a registered nurse concerning an 18 year old female student with asthma, penicillin allergy, sulfonamide allergy and a history of infectious mononucleosis in December 2005, who on 26-OCT-2006 was vaccinated in the left arm with the second dose of GARDASIL (lot #654540/0800F). There was no concomitant medication and no illnessess at the time of vaccination. It was reported that on 31-OCT-2006 the patient tested positive for mononucleosis at the university she attended. Unspecified medical attention was sought, however the patient received no treatment. At the time of this report, the outcome of the event was unknown. No further information is expected.


VAERS ID: 271108 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2006-12-08
Onset:2006-12-09
   Days after vaccination:1
Submitted: 2007-01-16
   Days after onset:38
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Breast swelling
SMQs:, Angioedema (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA02283

Write-up: Information has been received from a physician concerning a 24 year old female with no pertinent medical history or drug reactions/allergies, who on 08-Dec-2006 was vaccinated intramuscularly with Gardasil vaccine (yeast) (0.5 ml) (lot#653736/0868F). Concomitant vaccination given on an unspecified date included influenza virus vaccine (unspecified). Other concomitant medication included hormonal contraceptives (unspecified).On 09-Dec-2006, one day after receiving the Gardasil vaccine (yeast), the patient experienced breast swelling. It was reported that there was no significant pain, however the patient could not lie on her breast. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Additional information has been requested.


VAERS ID: 271110 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-11-27
Onset:2006-12-01
   Days after vaccination:4
Submitted: 2007-01-16
   Days after onset:46
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0641F / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA02345

Write-up: Information has been received from a physician concerning a 16 year old female who on approximately 27-Nov-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (0.5 ml) (lot#653650/0641F). Concomitant vaccination the same day included Fluvirin vaccine. It was reported that " a few days after receiving the vaccination", on approximately 01-Dec-2006, the patient experienced dizziness when standing and walking and experienced a headache. Unspecified medical attention was sought. Subsequently, the patient recovered from the dizziness and headache on an unspecified date. Additional information has been requested.


VAERS ID: 271111 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-10-26
Onset:2006-10-26
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:82
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site irritation
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA02408

Write-up: Information has been received from a consumer concerning her 11 year old daughter who on 26-Oct-2006 was vaccinated IM with "one shot" of Gardasil vaccine (yeast). The patient felt like it was burning. She is recovering on an unspecified therapy. No further information is available.


VAERS ID: 271112 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2006-10-01
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Lymphadenopathy
SMQs:, Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA02416

Write-up: Information has been received from a pharmacist concerning her 13 year old daughter who in approximately October 2006 was vaccinated intramuscularly in the upper deltoid of left arm with the first dose if Gardasil vaccine (yeast). On an unspecified date, the patient developed lots of pain and tenderness in her arm around the injection site for a few days after receiving Gardasil vaccine (yeast). The pharmacist reported that her daughter developed three swollen and tender lymph nodes on her left side of her neck. The lymph nodes were really swollen for about three weeks and the tenderness lasted for about two weeks. The pharmacist was planning to have her daughter vaccinated again with the second of Gardasil vaccine (yeast) some time around 25-Dec-2006. At the time of this report, the patient had recovered from the events "about three weeks after the first dose". Additional information has been requested.


VAERS ID: 271113 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-12-13
Onset:2006-12-13
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:34
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Headache, Lymphadenopathy, Neck pain, Pyrexia, Sinusitis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO ORTHO TRI CYCLEN LO ALLEGRA ADVAIR SINGULAIR
Current Illness: Cold; Mycotic allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: body temperature, 12/13/06, 101.4 degrees F, fever body temperature, 12/13/06, 99.1 degrees F
CDC Split Type: WAES0612USA02568

Write-up: This is in follow-up to report(s) previously submitted on 1/16/2007. Information has been received from a certified medical assistant concerning a 19 year old female with a mold allergy who on 13-Dec-2006 was vaccinated IM into the left deltoid with a 0.5 ml dose of Gardasil vaccine (yeast) (lot# 654540/0800F). Concomitant therapy included Advair, Allegra, montelukast sodium, Ortho-Tri-Cyclen Lo and Lexapro. Illness at the time of vaccination included a cold. On 13-Dec-2006 the patient experienced a fever of 101.4 degrees F, head pain, neck pain and swollen glands. Her fever decreased to 99.1 degrees F. On 14-Dec-2006, she called the office to report these events. The patient was seen in the office and was diagnosed with sinusitis and the doctor said it was not related to the vaccine. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information is not expected.


VAERS ID: 271114 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Vermont  
Vaccinated:2006-11-30
Onset:2006-11-30
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:47
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA02571

Write-up: Information has been received from a nurse practitioner concerning a 17 year old female with no medical history or allergies, who on 30-Nov-2006 was vaccinated IM with a 0.5 ml dose of Gardasil vaccine (yeast). Concomitant therapy included an unspecified hormonal contraceptives (unspecified). On 30-Nov-2006, the patient experienced severe injection site pain. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 271115 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Vermont  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA02573

Write-up: Information has been received from a nurse practitioner concerning a 20 year old female with no medical history or allergies, who was vaccinated IM with 0.5 ml dose of Gardasil vaccine (yeast). Concomitant therapy included unspecified hormonal contraceptives (unspecified). Subsequently, the patient experienced severe injection site pain at the time of immunization. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 271116 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: New York  
Vaccinated:2006-11-24
Onset:2006-11-25
   Days after vaccination:1
Submitted: 2007-04-06
   Days after onset:131
Entered: 2007-01-22
   Days after submission:73
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Acne
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Upper respiratory tract infection
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA02574

Write-up: Information has been received from a physician concerning a 22 year old female who on an unknown date was vaccinated with a first dose of Gardasil vaccine (yeast). Subsequently, the patient broke out with acne all over her face. Unspecified medical attention was sought. No diagnostic studies were performed. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007. Information has been received from a physician concerning a 22 year old female student with a recent upper respirtatory infection and no allergies, who on 24-NOV-2006 was vaccinated IM into the left arm with a first dose of GARDASIL (lot # 653938/0954F). On 25-NOV-2006, the patient broke out with acne all over her face. It was noted that the patient and her mother stated that the patient does not usually suffer from acne. Unspecified medical attention was sought. No diagnostic studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information is not expected.


VAERS ID: 271117 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Allergy to vaccine
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Papilloma viral infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA02604

Write-up: Information has been received from a physician concerning a female (age not reported) who was "positive for one strain of papilloma viral infection". On an unspecified date, the patient was vaccinated intramuscularly with the first "single dose vial" of Gardasil vaccine (yeast). Subsequently, the patient developed an "allergic reaction". The patient was sought unspecified medical attention. The patient was treated with a "steroid dose pack". At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 271118 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Michigan  
Vaccinated:2006-09-27
Onset:2006-09-28
   Days after vaccination:1
Submitted: 2007-01-16
   Days after onset:110
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Acne, Dry skin, Hypersensitivity, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Allegra
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA02630

Write-up: Information has been received from the mother of a 14 year old female who on 27 Sep 2006 was vaccinated with a dose of Gardasil. Vaccination the same day included a dose of influenza virus vaccine (unspecified). Concomitant therapy included Allegra. On 28 Sep 2006, the next day, the patient developed little, itchy bumps on her legs and pimple like bumps on her back. The patient''s mother reported that it may or may not have been an allergic reaction, or it "could have been" dry skin. The patient takes therapy with Allegra every day, although, the mother was unsure if the patient had taken it the day of the vaccination. Unspecified medical attention was sought. Subsequently, the patient fully recovered the same day. No other vaccinations have been given. Additional information has been requested.


VAERS ID: 271119 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-12
Onset:2006-12-12
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:35
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA02666

Write-up: Information has been received from a physician concerning a female who on 12 Dec 2006 was vaccinated with a "full" dose of Gardasil. At the time of administration, a small amount of bleeding was reported at the injection site. The bleeding was controlled prior to the patient leaving the physician''s office on 12 Dec 2006. The patient called the office the day (13 Dec 2006) and reported that she had bled from the injection site and that the "blood had run down her arm". The patient feels that she did not get the full vaccination because of the bleeding problem. It was reported that the patient sought unspecified medical attention. As of 13 Dec 2006, the patient had recovered from bleeding at the injection site. Additional information has been requested.


VAERS ID: 271120 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2006-10-21
Onset:2006-10-21
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:87
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site oedema, Smear cervix, Smear cervix abnormal, Smear cervix normal, Vaginitis bacterial
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data: cervical smear, 12/8/06, + High risk HPV types; cervical smear 11/04, negative; cervical smear 12/09/05, negative.
CDC Split Type: WAES0612USA02744

Write-up: Information has been received from a nurse practitioner concerning a 19 year old female with an allergy to penicillin who on 21 Oct 2006 was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil (Lot #653650/0702F). Concomitant therapy included hormonal contraceptives (unspecified). On 21 Oct 2006 the patient experienced minor redness and swelling at the injection site, which later resolved. On 08 Dec 2006 the patient presented with bacterial vaginosis and had a positive pap smear test for high risk HPV types. It was noted that on an unspecified date in November 2006 and on 09 Dec 2005 the patient''s pap smear tests were negative. Subsequently, unspecified medical attention was sought and the patient had not recovered from positive pap smear test. Additional information has been requested.


VAERS ID: 271121 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:2006-10-19
Onset:2006-12-14
   Days after vaccination:56
Submitted: 2007-04-06
   Days after onset:112
Entered: 2007-01-22
   Days after submission:73
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA02748

Write-up: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil. Subsequently, the patient developed an "adverse reaction". No details were given of the adverse experience. At the time of this report, the outcome of the event was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007. Initial and follow up information has been received from a licensed practical nurse (previously reported as registered nurse) and the mother of a 15 year old female student. On 19-OCT-2006, the patient was vaccinated in the left deltoid with the first dose of GARDASIL (Lot # 653736/0689F). The mother reported that on 14-DEC-2006, her daughter had been ill since the shot. The patient sought unspecified medical attention. It was reported that the primary care physician (PCP) had advised against getting another shot. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested.


VAERS ID: 271122 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:76
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0945F / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA02774

Write-up: Information has been received from a Nurse Practitioner concerning a 15 year old female patient who was vaccinated with her first dose of Gardasil. Subsequently, the patient experienced prolonged dizziness. Medical attention was required. The patient recovered. The nurse practitioner reported that she was unsure if the 2nd dose of Gardasil should be administered. Additional information has been requested.


VAERS ID: 271123 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-11-01
Onset:2006-11-17
   Days after vaccination:16
Submitted: 2007-04-06
   Days after onset:139
Entered: 2007-01-22
   Days after submission:73
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR AC52B007AA / 1 UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2157BA / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood glucose, Dizziness, Laboratory test, Ophthalmological examination, Ophthalmological examination abnormal, Panophthalmitis, Urine analysis
SMQs:, Anticholinergic syndrome (broad), Optic nerve disorders (broad), Corneal disorders (broad), Vestibular disorders (broad), Ocular infections (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Lyme disease, Ear infection, Reactive airway disease None
Allergies:
Diagnostic Lab Data: diagnostic urinalysis ophthalmogical exam blood glucose blood glucose, 12/08/08, 120; urine bilirubin test, 12/08/06, 1+, negative, abnormal; urine leukocyte esterase, 12/08/06, 1+, negative, abnormal; urine protein, 12/08/06, trace, negative, abnormal; urine urobilinogen, 12/08/06, 1+, negative, abnormal
CDC Split Type: WAES0612USA02786

Write-up: Information has been received from a nurse practitioner concerning an 11 year old female with a history of Lyme disease, and ear infection, "reactive airways" and no known allergies or adverse drug reactions reported. On 01-Nov-2006, the patient was vaccinated intramuscularly with 0.5 ml of Gardasil vaccine (yeast). Subsequently, the patient developed dizziness for about three weeks. It was reported that the patient "had some lab studies done and was referred to a neurologist (she had not seen him yet). The laboratory diagnostics included blood sugar, a urinalysis and vision screening (results not reported). The nurse practitioner reported that there were some family issues that were occurring also be a cause. The patient was referred to an eye physician because she failed her school eye exam. At the time of this report, the patient was recovering from the events. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007. Initial and follow-up information has been received from a nurse practitioner concerning an 11 year old female student with a history of lyme disease, and ear infection, "reactive airways" and no known allergies or adverse drug reactions reported. On 01-NOV-2006, at approximately 16:30, the patient was vaccinated intramuscularly, into the right arm, with 0.5 mL first dose of GARDASIL (lot #653938/0954F) concomitantly with an intramuscular first dose of TRIPEDIA (lot #AC52B007AA) into the left arm and an intramuscular first dose of MENECTRA (lot # U2157BA) into the left arm. On approximately 17-NOV-2006 the patient developed dizziness. The patient was seen in the doctors office on 08-DEC-2006. It was reported that the patient "had some lab studies done and was referred to a neurologist (she had not seen him yet)". The laboratory diagnostics included blood sugar (105 on 08-DEC-2006), a urinalysis and vision screening. The results of vision screening test not reported. The nurse practitioner reported that there were some family issues that were occuring that could also be a cause. The patient was referred to an eye physician because she failed her school eye exam. At the time of this report, the patient was recovering from the events. No further information is available. This is in follow-up to report(s) previously submitted on 1/16/2007. Initial and follow up information has been received from a Nurse Practitioner concerning an 11 year old female student with no medical history who on 01-NOV-2006 at approximately 5:00 p.m. was vaccinated IM in right arm with her first dose of GARDASIL, lot #653938/0954F. Subsequently, the patient experienced prolonged dizziness. The patient was seen in the office on 08-DEC-2006 complaining of dizziness, she was unsure of the onset date but it was after the injection. Her blood glucose (non-fasting) was 120 (see laboratory data section for abnormal urinalysis results). She was referred to a neurologist. Per follow up one week later, the patient was doing better. The Nurse Practitioner reported that she was unsure if the 2nd dose of GARDASIL should be administered. Additional information is not expected.


VAERS ID: 271124 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2006-12-07
Onset:2006-12-07
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:40
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA02801

Write-up: Information has been received from a physician concerning a female (NOS) who on approximately 07-Dec-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided). Immediately after receiving the injection on approximately 07-Dec-2006 the patient developed hives in the same arm where she received the injection. The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the hives.


VAERS ID: 271125 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Colorado  
Vaccinated:2006-12-14
Onset:2006-12-14
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:33
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0697F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: amoxicillin influenza virus vaccine
Current Illness:
Preexisting Conditions: sulfonamide allergy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA02807

Write-up: Information has been received from a physician concerning a 15 year old female with sulfonamide allergy who on 14-Dec-2006 was vaccinated with a first dose of Gardasil vaccine (yeast) (lot#653650/0697F) pre-filled syringe IM into the left deltoid. Concomitant vaccination on 14-Dec-2006 included a dose of influenza virus vaccine (unspecified) (manufacturer unknown). On 14-Dec-2006 the patient experienced broke out in rash all over her body. There was no fever associated with the rash. It was unclear if there was any local rash or reaction at the injection site. At the same visit the patient was given amoxicillin for an unknown reason. As of 15-Dec-2006 the rash persisted. Additional information has been requested.


VAERS ID: 271126 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: New York  
Vaccinated:2006-11-16
Onset:2006-11-17
   Days after vaccination:1
Submitted: 2007-04-06
   Days after onset:139
Entered: 2007-01-22
   Days after submission:73
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Full blood count normal, Injection site pain, Red blood cell sedimentation rate normal
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Allergic reaction to antibiotics
Allergies:
Diagnostic Lab Data: complete blood cell 11?/??/06 - normal erythrocyte 11?/??/06 - normal
CDC Split Type: WAES0612USA02899

Write-up: Information has been received from a physician concerning a 20 year old female with an allergy to antibiotics who on 16-Nov-2006 was vaccinated with a first dose of Gardasil vaccine (yeast). On 17-Nov-2006 the patient developed pain at the injection site. The patient began to have joint pain throughout her body. The location of the joint rotated and was in her right knee at the time of this report. Laboratory evaluations revealed that erythrocyte sedimentation rate and complete blood count were normal. The patient was to be seen by a neurologist. The physician reported that she would most likely hold off on the second dose of Gardasil vaccine (yeast). At the time of this report, the patient''s joint pain persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007. Information has been received from a physician concerning a 20 year old female with an allergy to antibiotics who on 16-NOV-2006 was vaccinated with a first dose of GARDASIL. On 17-NOV-2006 the patient developed pain at the injection site. The patient then began to have joint pain throughout her body. The location of the joint rotated and was in her right knee at the time of this report. Laboratory evaluations revealed that erythrocyte sedimentation rate and complete blood count were normal. The physician reported that the patient was seen by a rheumatologist, but she did not have the details of the visit. The physician reported that the patient cancelled her appointment to received her second dose of GARDASIL. At the time of this report, the patient''s joint pain persisted. Additional information has been requested.


VAERS ID: 271127 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2006-10-17
Onset:2006-10-17
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:91
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Nausea, Upper respiratory tract infection
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NUVARING ACIPHEX
Current Illness: Gastroesophageal reflux
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA02924

Write-up: Information has been received from a nurse practitioner concerning a 20 year old female with gastric reflux who on 17-Oct-2006 was vaccinated IM with a first dose of Gardasil vaccine (yeast) (lot#653735/0688F). Concomitant therapy included Nuvaring and Aciphex. That evening the patient experienced quite a bit of nausea and a headache. It was noted that the patient couldn''t study. On 18-Oct-2006, the nausea was gone. The patient thought that her headache was due to new contacts. On 19-Oct-2006, the patient''s headache went away after she took her contacts out. One month later the patient experienced a upper respiratory infection but the nurse practitioner did not think it was related to the vaccine. Unspecified medical attention was sought. No diagnostic laboratory studies were involved. At the time of this report the outcome of upper respiratory infection was unknown. No product quality complaint was involved. Additional information has been requested. The patient stated that the nausea was a small price to pay for protection. On 18-Dec-2006, the patient was vaccinated into the left deltoid with a second dose of GARDASIL (lot# 654885/1424F). No product quality complaint was involved. Additional information is not expected.


VAERS ID: 271128 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-12-11
Onset:2006-12-11
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:36
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug hypersensitivity, Face oedema, Lip swelling, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YASMIN
Current Illness:
Preexisting Conditions: HYPERSENSITIVITY
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA02952

Write-up: Information has been received from a registered nurse concerning a 51 year old female with an allergy to benzoyl peroxide who on 11-Dec-2006 was vaccinated intramuscularly with the first dose of Gardasil vaccine (yeast). Concomitant therapy included Yasmin. On 14-Dec-2006 the patient began to experience muscle aches, and on 17-Dec-2006 the patient began experiencing swelling of her face and lips, but no rash. The patient treated herself with Benadryl and was scheduled to see her physician on 18-Dec-2006. At the time of this report, the muscle aches and swelling of her face and lips persisted. Additional information has been requested.


VAERS ID: 271129 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-12-15
Onset:2006-12-15
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:32
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Laboratory test, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: diagnostic laboratory 12/??/06 - results not provided
CDC Split Type: WAES0612USA02967

Write-up: Information has been received from a physician concerning a 19 year old female with no persistent medical history or drug reactions/allergies, who on 15-Dec-2006 was vaccinated with Gardasil vaccine (yeast) (0.5 ml). There was no concomitant medication. On 15-Dec-2006, following vaccination, the patient developed a red itchy rash "all over". Unspecified medication attention was sought. At the time of this report the patient had not recovered. No additional information is available.


VAERS ID: 271130 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Female  
Location: South Dakota  
Vaccinated:2006-08-14
Onset:2006-08-14
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:155
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Dry skin, Dysgeusia, Feeling hot and cold, Influenza like illness, Nasopharyngitis, Nausea, Weight decreased, White blood cell count, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Taste and smell disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified) EXCEDRIN MIGRAINE dextroamphetamine AVIANE IMITREX TABLETS
Current Illness: Narcolepsy, Migraine
Preexisting Conditions: Cervical dysplasia, Papilloma viral infection
Allergies:
Diagnostic Lab Data: WBC count 10/04*06 - WNL
CDC Split Type: WAES0612USA03013

Write-up: Information has been received from a physician and a registered nurse concerning a 27 year old female with narcolepsy and migraines and a history of cervical dysplasia and papilloma viral infection, and no known allergies, who on 14-Aug-2006 was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil vaccine (yeast) (lot#653937/0637F). Concomitant therapy included "a medication for narcolepsy", Imitrex tablets, Excedrin Migraine, Aviane and dextroamphetamine. On 14-Aug-2006, following the vaccination, the patient experienced flu-like symptoms, nausea, hot and cold sensations, weight loss, decreased energy, cold respiratory symptom, dry skin, and a taste of iron in her mouth. On 04-Oct-2006, the patient was seen by her primary care physician and her white blood count was noted to be within normal range. The patient received the second dose of Gardasil vaccine (yeast) in the right deltoid on 20-Oct-2006. On 14-Dec-2006 the patient called her physician''s office and stated that she was experiencing the same type of flu-like symptoms and thought it was related to the vaccine. At the time of this report, the patient had not recovered . Unspecified medical attention was sought. The nurse reported that the patient missed work or school due to the symptoms, however the nurse did not feel the events were serious. It was recommended to the patient not to receive the third dose of Gardasil vaccine (yeast). Additional information has been requested. This is in follow-up report (s) previously submitted on 1/16/2007. Incormation has been received from a physician and regeistered nurse concerning a 27 year old female teacher with narcolepsy and migraines and a history of cervical dysplasia and papilloma viral infection, and no known allergies, who on 14-AUG-2006 was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL (lot # 653937/0637F). There were no illnesses at the time of vaccination. Concomitant therapy included sumatripan succinate (IMITREX TABLETS), acetaminophen-aspirin-caffeine (EXCEDRIN MIGRAINE), AVIANE and dextroamphetamine. On 15-AUG-2006, following the vaccination, the patient experienced flu-like symptoms, nausea, hot and cold sensations, weight loss of 5-7 pounds, decreased energy, cold respiratory symptom, dry skin, and a taste of iron in her mouth. On 04-OCT-2006, the patient was seen by her primary care physician and laboratory findings revealed a low red blood cell count of 4.06, a high mean corpuscular volume (MCV) of 97.5, a prothrombin time of 13.1 seconds, and a international normalized ration of 1.2. The patient''s white blood was to be within normal range. On 20-OCT-2006, the patient was vaccinated with the second dose of GARDASIL (0.5 ml) (lot # 653937/0637F) in the right deltoid. On 14-DEC-2006 the patient called her physicain''s office and stated that she was experienceing the same symptoms and thought it was related to the vaccine. At the time of this report, the patient had not recovered. The nurse reported that the patient missed a day of work due to the symptoms, however the nurse did not feel the events were serious. It was recommended to the patient not to receive the third dose of GARDASIL. No further information is expected.


VAERS ID: 271131 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Indiana  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Amenorrhoea
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA03102

Write-up: Information has been received from a physician concerning a female patient (demographics not provided) who on an unspecified date was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided). Subsequently the patient experienced a missed menstrual period. The patient sought unspecified medical attention. At the time of this report the patient had not recovered from the missed menstrual period. Additional information has been requested.


VAERS ID: 271133 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Maine  
Vaccinated:2006-11-07
Onset:2006-11-07
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:149
Entered: 2007-01-22
   Days after submission:73
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Dyspnoea, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASACOL
Current Illness: Crohn''s disease; Drug hypersensitivity; Allergic reaction to antibiotics
Preexisting Conditions: PANIC ATTACK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA03130

Write-up: Information has been received from a nurse concerning a 24 year old female with a history of panic attacks who on 07-Nov-2006 was vaccinated with a 0.5 ml dose of Gardasil vaccine (yeast) (lot#653938/0954F). Concomitant therapy included Asacol. On 07-Nov-2006 later that night, the patient experienced tachycardia and difficulty breathing. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007. Information has been received from a nurse concerning a 24 year old female data assistant with Crohn''s disease and allergies to CLINDAMYCIN and CODEINE a history of panic attacks who on 07-NOV-2006 at 14:30 was vaccinated into the right deltoid with first a 0.5 ml dose of GARDASIL (lot # 653938/0954F). Concomitant therapy included ASACOL. On 07-NOV-2006 later that night, the patient experienced tachycardia and difficulty breathing. No other symtoms were noted. Unspecified medical attention was sought. On 08-NOV-2006, the patient recovered. No product quality complaint was involved.


VAERS ID: 271134 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2006-12-19
Onset:2006-12-19
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:28
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug administered at inappropriate site, Pain, Sciatic nerve injury, Sciatica
SMQs:, Drug abuse and dependence (broad), Accidents and injuries (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA03131

Write-up: SCIATICA; DRUG ADMINISTERED AT INAPPROPRIATE SITE. Information has been received from a nurse practitioner concerning a female patient who on 19-DEC-2006 was vaccinated IM into the dorsogluteal muscle with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medications. On 19-DEC-2006, the patient experienced sciatic nerve pain (noted that when the patient was vaccinated the sciatic nerve was hit). The pain went up her back and then it crossed over to the middle onto the left back. The pain occurred right after the injection. It was noted that there was no bruising or inflammation. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 271135 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Military
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA03151

Write-up: Information has been received from a clinical coordinator at a doctor''s office concerning a female who was vaccinated with a first and second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 ml). Subsequently, the patient fainted after receiving both doses. The patient recovered. There were no relevant diagnostic test or laboratory data. Additional information has been requested.


VAERS ID: 271136 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Unknown  
Vaccinated:2006-11-22
Onset:2006-11-22
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:55
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Liver disorder
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA03152

Write-up: Information has been received from a consumer concerning her 53 year old father with liver problems and no drug allergies who on 22-NOV-2006 inadvertently received HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 ml), orally. There was no concomitant medication. Subsequently, "in late November" the patient experienced nausea, dizziness and weakness. At the time of the report, the patient had not recovered. There were no relevant diagnostic tests or laboratory data. Additional information is not expected.


VAERS ID: 271137 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-18
Onset:2006-12-18
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:29
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA03188

Write-up: Information has been received from a registered nurse concerning her 20 year old daughter with no medical history or allergies, who on 18-DEC-2006 was vaccinated IM with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. On 18-DEC-2006, the patient experienced throbbing pain in her arm. Unspecified medical attention was sought. No diagnostic studies were performed. At the time of this report, the patient''s pain was subsiding. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 271138 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA03315

Write-up: Information has been received from an office manager concerning a 17 year old female patient who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast), 0.5 mL, injection. concomitant medication was not reported. Subsequently on an unspecified date, the patient fainted after she received the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient sough unspecified medical attention. The office manager stated that the patient did not have anything to eat prior to receiving the injection. Subsequently on an unspecified date, the patient recovered from the event. Additional information has been requested.


VAERS ID: 271139 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA03323

Write-up: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast), 0.5 mL, injection. Concomitant medication was not reported. Subsequently on an unspecified date, the patient developed a rash while being administered HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient sough unspecified medical attention. The outcome of the event was not reported. Additional information has been requested.


VAERS ID: 271140 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: New York  
Vaccinated:2006-12-18
Onset:2006-12-20
   Days after vaccination:2
Submitted: 2007-01-16
   Days after onset:27
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 654540/1161F / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pruritus
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro, Prevacid, Toprol XL tablets, Singulair
Current Illness:
Preexisting Conditions: Asthma; Depression; Drug hypersensitivity
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA03353

Write-up: Information has been received from a nurse concerning a 19 year old female patient with asthma, depression and allergies to valproate sodium, diazepam, gabapentin and acetaminophen (+) butalbital (+) caffeine who on 18-DEC-2006 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLF vaccine (yeast), 1pt #654540/1161F. Concomitant therapy included montelukast sodium (MSD), escitalopram oxalate, lansoprazole, and metoprolol succinate. On 20-DEC-2006 the patient called the office and stated that the injection site was itchy. Medical attention was sought. The physician''s office to follow up with patient, her outcome was unknown. Additional information has been requested.


VAERS ID: 271141 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-01
Onset:2006-12-01
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:46
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Influenza like illness, Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA03390

Write-up: Initial and follow-up information has been received from a health professional concerning a 14 year old female who in "early" December 2006, was vaccinated with Gardasil. There was no concomitant medication. Subsequently in "early" December 2006, the patient experienced flu-like symptoms and pain for about 4 days after injection. The sought unspecified medical attention. No diagnostics were performed. Subsequently, in "mid-December" the patient recovered from flu-like symptoms and pain for about 4 days after injection. Additional information has been requested.


VAERS ID: 271142 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-13
Onset:2006-12-13
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:34
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA03396

Write-up: Information has been received from a clinical manager concerning a female who on "13-DEC-2006 or 14-DEC-2006" was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). On 13-DEC-2006, or 14-DEC-2006, the patient fainted almost immediately after receiving the vaccination. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 271143 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-01
Onset:2006-12-01
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:46
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Vaccination complication
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0612USA03521

Write-up: Information has been received from a registered nurse concerning a female (age not reported) who in approximately December 2006, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). In approximately December 2006, when administering the vaccine with the prefilled syringe, the nurse release the spring before removing the syringe, therefore causing the patient pain at the injection site. No additional information was available at the time of reporting. No further information is available. This is in follow-up to report(s) previously submitted on 1/16/2007. Additional information was received from the registered nurse via telephone who reported that the patient received the full dose of the GARDASIL. No additional information is expected.


VAERS ID: 271144 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA03533

Write-up: Information has been received from a nurse practitioner concerning a 22 year old female with pertinent medical history and drug reaction/allergies not reported who on an unspecified date was vaccinated with the initial dose of Gardasil injection. Concomitant medication was not reported. In December 2006 ( a few weeks ago), the patient fainted after Gardasil was administered. The patient sought unspecified medical attention. The outcome of the event was not reported. Additional information has been requested.


VAERS ID: 271145 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-12-19
Onset:2006-12-19
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:107
Entered: 2007-01-22
   Days after submission:73
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Flushing
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Desogen, Allegra, Motrin, Zantac
Current Illness: Hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: blood pressure, 12/19/06, 101/6 mmHg
CDC Split Type: WAES0612USA03566

Write-up: Information has been received from a licensed practical nurse concerning a 20 year old female who had hypersensitivity reported as "Motrin for allergies". On 19 Dec 2006, the patient was vaccinated intramuscularly with the firs "single dose vial" of Gardasil (Lot # 653938/0954F). Concomitant therapy included Motrin, Desogen, Allegra and Zantac. On 19 Dec 2006, "almost immediately after vaccination", the patient became a little flushed in the face and had to take a minute to sit and gather herself together. The patient was noted to have a blood pressure of 101/65 mmHg (date unknown). The patient sought unspecified medical attention. It was reported that the patient" improved within seconds". On 19 Dec 2006, the patient had recovered from the event. The licensed practical nurse reported that they were planning to vaccinate for the second and third dose as indicated in the "PI". Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007. Information has been received from a licensed practical nurse concerning a 20 year old female who had hypersensitivity reported as MOTRIN for allergies" and no illness at the time of vaccination. On 19-Dec-2006, the patient was vaccinated intramuscularly with the first "single dose vial" of GARDASIL (Lot # 653938/0954F). Concomitant therapy included MOTRIN, DESOGEN, ALLEGRA and ZANTAC. On 19-DEC-2006, "almost immediately after vaccination", the patient became a little flushed in the face, experienced dizziness, and had to take a minute to sit and gather herself together. The patient was noted to have a blood pressure of 101/65 mmHg (date unknown). Vital signs taken were very similar to those taken during the exam. It was reported that the patient "improved within seconds". On 19-DEC-2006, the patient had recovered from the event and left the office without further incident. The licensed practical nurse reported that they were planning to vaccinate for the second and third dose as indicated in the "PI". No additional information is expected.


VAERS ID: 271146 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-11-27
Onset:2006-12-01
   Days after vaccination:4
Submitted: 2007-01-16
   Days after onset:46
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 72222 / UNK - / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0641F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness postural, Headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA03644

Write-up: Information has been received from a physician concerning an 18 year old white female who on 27 Nov 2006 was vaccinated with Gardasil (lot number 653650/0641F). Concomitant therapy on 27 Nov 2006 included Fluvirin. On 01 Dec 2006 the patient experienced dizziness with walking or standing. On 02 Dec 2006 the patient experienced headache on top of her head. Subsequently, the patient recovered from dizziness with walking or standing and headache on top of her head. A prescription treatment was given for the experiences (not specified). Additional information is not expected.


VAERS ID: 271147 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Oregon  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Burning sensation, Pain
SMQs:, Peripheral neuropathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA03827

Write-up: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with Gardasil. Subsequently, following vaccination, the patient experienced pain and a burning sensation in the arm. Unspecified medical attention was sought. At the time of this report, the patient''s pain and burning sensation in the arm persisted. Additional information has been requested.


VAERS ID: 271148 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-12-18
Onset:2006-12-22
   Days after vaccination:4
Submitted: 2007-01-16
   Days after onset:25
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Anogenital warts, Pain
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro
Current Illness:
Preexisting Conditions: sulfonamide allergy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0612USA03830

Write-up: Information has been received from a pharmacist and a 25 year old female patient with sulfonamide allergy reporting that on 18 Dec 2006 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Lexapro. Four days later, on approximately 22 Dec 2006, the patient developed painful genital warts. The patient''s painful genital warts persisted and she sought unspecified medical attention. Additional information has been requested.


VAERS ID: 271149 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Pennsylvania  
Vaccinated:2006-08-25
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Herpes virus infection
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA03950

Write-up: Information has been received from a certified medical assistant concerning a patient who on 25 Aug 2006 was vaccinated with a first dose of Gardasil, intramuscularly. Subsequently the patient developed a herpes virus infection. The patient''s pediatrician had concluded that the infection was not due to Gardasil. It was also reported that the patient''s second dose was delayed because some time after the first dose, because she developed the herpes virus infection. Additional information has been requested.


VAERS ID: 271150 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA04030

Write-up: Information has been received from a female patient (age not reported) who on an unspecified date was vaccinated with the initial dose of Gardasil. Concomitant medication was not reported. In December 2006, the patient experienced really bad diarrhea after receiving the first dose of Gardasil. The outcome of the event was not reported. No further information is available.


VAERS ID: 271151 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Private       Purchased by: Other
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0612USA04034

Write-up: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date, the patient almost fainted immediately after receiving Gardasil. The nurse at the physician''s office stated that the girl seemed "afraid of needles." The outcome of the event was not reported. Additional information has been requested.


VAERS ID: 271152 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / -

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Lymphadenopathy, Nausea, Pharyngolaryngeal pain, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA04148

Write-up: Information has been received from a physician via a company representative concerning a female (age not reported) who, on an unspecified date, was vaccinated with a first dose o Gardasil (Lot # not reported). The physician reporeted that after the first dose, the patient experienced nausea, diarrhea and vomiting. The physician also reported that after the second dose of Gardasil, the patient experienced a sore throat and swollen glands. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.


VAERS ID: 271153 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-12-20
Onset:2006-12-24
   Days after vaccination:4
Submitted: 2007-01-16
   Days after onset:23
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA04161

Write-up: Information has been received from a consumer concerning her 14 year old daughter who on 20 Dec 2006 was vaccinated with a first dose of Gardasil. On 24 Dec 2006, the patient developed a full body rash. The patient did not seek medical attention for her experience. At the time of this report, the patient had not recovered. Additional information has been requested. 5/14/2010 Follow up: The patient was seen in the emergency room. A physician in the emergency room indicated that it did not look like a vaccine reaction. The physician prescribed prednisone for the rash. The rash resolved overnight. The patient subsequently recovered on 25-DEC-2006 or 26-DEC-2006. No additional information is expected.


VAERS ID: 271154 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Indiana  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA04171

Write-up: Information has been received from a female pharmacist who was vaccinated IM with a second dose of Gardasil. The pharmacist reported that she did not feel the second injection. The patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 271155 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2006-11-22
Onset:2006-11-22
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:55
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00013

Write-up: Information has been received from a physician concerning a female patient who on 22 Nov 2006 was vaccinated with a 0.5 ml dose of Gardasil. On approximately 22 Nov 2006, the physician reported that the patient experienced reaction a "tendonitiis like" pain near the injection site. It was noted that there were no signs of cellulitis and the pain has not been responsive to OTC non-steroidal medication. At the time of this report, the patient had not recovered. Additional information has been requested.


VAERS ID: 271156 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Ohio  
Vaccinated:2006-12-27
Onset:2006-12-30
   Days after vaccination:3
Submitted: 2007-01-16
   Days after onset:17
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Rash
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00040

Write-up: Information has been received from a 26 year old female pharmacist who on 27 Dec 2006 was vaccinated with a 0.5 mL dose of Gardasil. On 30 Dec 2006, the patient developed bumps on skin, located mainly on the back, sporadic on the chest, 5-6 noted, and also on belly: none on legs. The pharmacist reported that they were painful and "felt like bruises," The patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 271157 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-11-29
Onset:2006-11-29
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:48
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness: Hypersensitivity, migraine
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0701USA00048

Write-up: Information has been received from the mother of an 11 year old female with an allergy to Rondec and migraines who on 25 Oct 2006 was vaccinated intramuscularly with the first dose of Gardasil. Concomitant therapy included an unspecified migraine therapy. The mother reported that her daughter received the second dose of Gardasil approximately 35 days after receiving the first dose. The mother was informed by her physician that it was "okay" and that the patient did not have to restart the series. The mother also reported that following the second vaccination, on 30 Nov 2006, her daughter experienced pain in the arm in which she was vaccinated. Unspecified medical attention was sought. The patient subsequently recovered from the pain on an unspecified date. Additional information has been requested. Conflicting information received from the patient''s physician reported that there was no adverse reaction experienced. No addtional information is expected.


VAERS ID: 271158 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-27
Onset:2006-12-27
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:20
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia oral, Lip swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00101

Write-up: Information has been received from a nurse practitioner concerning a 15 year old female who on 27 Dec 2006 was vaccinated with a first dose of Gardasil concomitantly with a dose of influenza virus vaccine (unspecified) using a different injection site. On 27 Dec 2006, approximately 2 hours after the vaccination, the patient experienced swelling and numbness in her lower lip. On approximately 29 Dec 2006, the patient recovered without treatment. Additional information has been requested.


VAERS ID: 271159 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:2006-12-27
Onset:2006-12-27
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:20
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00109

Write-up: Information has been received from a nurse concerning a female who on approximately 27 Dec 2006 was vaccinated with a second dose of Gardasil. On approximately 27 Dec 2006 the patient developed swelling in the arm. The patient was treated with Benadryl. At the time of the report, the patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 271160 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-12-04
Onset:2006-12-05
   Days after vaccination:1
Submitted: 2007-01-16
   Days after onset:42
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00115

Write-up: Information has been received from an office manager concerning a 16 year old female who on 04 Dec 2006 was vaccinated IM, into the left deltoid, with 0.5 ml second dose of Gardasil (lot #653736/0868F). On 05 Dec 2006 the patient developed an itchy rash on her arm. The patient was treated with Benadryl and the rash was gone the on the night of 05 Dec 2006. On 06 Dec 2006, the patient recovered. The office manger reported that there was no adverse reaction after the patient''s first dose of Gardasil. Additional information has been requested.


VAERS ID: 271161 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-04
Onset:2006-12-05
   Days after vaccination:1
Submitted: 2007-01-16
   Days after onset:42
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / 2 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA00119

Write-up: Information has been received from a physician concerning a teenage female who on 04 Dec 2006 was vaccinated with the second dose of Gardasil (lot#653736/0868F), IM injection. Concomitant medication was not reported. On 05 Dec 2006, the patient developed a rash on her forearms. The physician reported that the patient was seen by another physician in the office, who prescirbed Benadryl to treat the rash. The outcome of the event was not reported. Additional information has been requested.


VAERS ID: 271162 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-12-05
Onset:2006-12-05
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:42
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1162F / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA00120

Write-up: Information has been received from an RN concerning a 21 year old female patient who on 23 Oct 2006 was vaccinated IM with her first dose of Gardasil, lot #654540/1162F. On approximately 27 Dec 2006 the patient was vaccinated with her 2nd dose of Gardasil. On 27 Dec 2006 the patient developed a painful injection site after vaccination and also developed a red rash going up and then down her arm and around the injection site. She was given Benadryl and advised to keep an ice pack on it for the rest of the day. As of the report date the patient was recovering. Additional information has been requested. Follow up information has been received concerning the female patient who on 05-DEC-2006 at 1:30 p.m. was vaccinated IM in Left arm with her second dose of GARDASIL, lot # 654540/1162F. On the same day (not 27-DEC-2006 as previously reported), after the vaccination, the patient''s arm became red at the site of injection. Within 5 minutes the redness traveled up her arm and down to her elbow. A rash appeared. The area was warm to touch and painful. BENADRYL 25 mg PO was given. The patient''s arm remained sor for seven days. Additional information is not expected.


VAERS ID: 271164 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-10-20
Onset:2006-12-19
   Days after vaccination:60
Submitted: 2007-01-16
   Days after onset:28
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO EVRA
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA00156

Write-up: Information has been received from a registered nurse concerning a 15 year old female who on 20-Oct-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided). Concomitant therapy included Ortho Evra. On 19-Dec-2006 the patient was diagnosed with mononucleosis by her primary care physician. The patient sought unspecified medical attention. At the time of this report the patient''s mononucleosis persisted. The reporter felt that the mononucleosis was not related to therapy with Gardasil vaccine (yeast). Additional information has been requested.


VAERS ID: 271165 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-12-01
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Amenorrhoea
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA00223

Write-up: Information has been received from a physician concerning a 12 year old female who on 01-Dec-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided).On unspecified date in December, 2006, the patient separate two periods (dates not provided). The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested.


VAERS ID: 271166 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Kentucky  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ibuprofen ALEVE
Current Illness:
Preexisting Conditions: HYPERSENSTIVITY
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA00226

Write-up: Information has been received from a health professional concerning a 19 year old female with a hypersensitivity to "sepna" who on an unspecified date was vaccinated (at another unspecified physicians office) with the first dose of Gardasil vaccine (yeast) (lot# not provided). Concomitant therapy included naproxen sodium (Aleve) and ibuprofen. Subsequently, the patient reported that she experienced itching and swelling at the injection site which spread to her body. The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested.


VAERS ID: 271167 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Hepatitis acute, Liver function test abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: STRATTERA CONCERTA
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: hepatic function tests 70
CDC Split Type: WAES0701USA00228

Write-up: Information has been received from a physician concerning a 12 year old female who on an unspecified date was vaccinated intramuscularly with the first dose of Gardasil vaccine (yeast) (lot# not provided). Concomitant therapy included Strattera and Concerta. Subsequently, the patient presented to the reporting physicians office for her second dose of Gardasil vaccine (yeast) and the patient''s mother reported that the patient had been diagnosed with "acute immune hepatitis". The physician reported that the patient was asymptomatic, looked fine and was not sick. The physician did not give the second dose of the vaccine at that time based on the report from the mother. The physician reported that she is watching the patient''s liver function tests which have progressively risen to 70. The reporting physician felt that the auto immune hepatitis was not related to therapy with Gardasil vaccine (yeast). Additional information has been requested.


VAERS ID: 271168 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-12-14
Onset:2006-12-14
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:112
Entered: 2007-01-22
   Days after submission:73
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 6537360868F / 2 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Hypersensitivity, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00462

Write-up: Information has been received from an RN concerning a patient who has an allergic reaction after being vaccinated with a dose of Gardasil vaccine (yeast). The patient''s outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007. Initial and follow up information has been received from an RN concerning a 16 year old female student who on 14-DEC-2006 at 5:00 P.M. was vaccinated IM in left deltoid with her second dose of GARDASIL, lot #653736/0868F. The patient developed an allergic reaction after being vaccinated (onset reported as the morning of "05-DEC-2006"), an itchy rash on the inside of her arms. She was treated with BENADRYL and recovered. Additional information is not expected.


VAERS ID: 271169 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-01
Onset:2006-12-01
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:46
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK GM / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Vaccination complication
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00932

Write-up: Information has been received from a registered nurse concerning a female who in approximately December 2006, was vaccinated with Gardasil vaccine (yeast). In approximately December 2006, when administering the vaccine with the pre-filled syringe, the nurse released the spring before removing the syringe, therefore causing the patient pain at the injection site. No additional information was available at the time of reporting. No further information is available. 5/14/2010 Follow up: Additional information has been received rom the registered nurse via telephone. The nurse reported that the patient received the full dose of GARDASIL. No additional information is expected.


VAERS ID: 271170 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA00967

Write-up: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil vaccine (yeast), 0.5 ml, injection. Concomitant medication was not reported. Subsequently on an unspecified date, the patient developed a rash while being administered Gardasil vaccine (yeast). The patient sought unspecified medical attention. The outcome of the event was not reported. Additional information has been requested.


VAERS ID: 271171 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Indiana  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Menstruation irregular
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA01303

Write-up: Information has been received from a physician concerning a female (demographics not provided) who on an unspecified date was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided). Subsequently the patient experienced a missed menstrual period. The patient sought unspecified medical attention. At the time of this report the patient had not recovered from the missed menstrual period. Additional information has been requested.


VAERS ID: 271273 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Ohio  
Vaccinated:2006-12-26
Onset:2006-12-26
   Days after vaccination:0
Submitted: 2007-01-16
   Days after onset:21
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: No adverse effect, Wrong drug administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0612USA04046

Write-up: Information has been received from a health professional and a pharmacist concerning a 13 year old patient who on an unspecified date was vaccinated with a dose of Zostavax. Unspecified medical attention was sought. The patient was not experiencing any know symptoms. it was reported that the error was not a result of product confusion. The patient''s vaccination history reported to include a first dose of varicella virus vaccine live on an unspecified date, but not a second dose of varicella virus vaccine live. There was no product quality complaint involved. No further information was available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2007. Information has beenreceived from a health professional, a pharmacist and a physician concerning a 13 year old female who on 26-DEC-2006 was vaccinated with a dose of ZOSTAVAX (Merck) (reported to be an overdose) instead of GARDASIL. The treating physician reported that the patient was vaccinated with a dose of ZOSTAVAX (Merck) instead of a dose of VARIVAX (Merck). Medical attention was sought. One week after vaccination, on 02-JAN-2007, the patient developed what the physician described as a zoster rash, which was also reported to be a "raging case of chicken pox" by the office manager. It was reported that the zoster rash did not cause itching, but the patient experiecned general fatigue and pain in the muscles and joints of the knees, hips and shoulders. The patient was started on an unspecified antiviral therapy. It was reported that the physician would try to swab the lesion but the patient had already left the office. On an unspecified date the rash cleared but as of 24-JAN-2007 the muscle and joint pain continued. The patient was scheduled to have a follow up appointment on 29-JAN-2007. The patient''s vaccination history was reorted to include a first dose of VARIVAX (Merck)on an unspecified date, but not a second dose of VARIVAX (Merck). It was reported that the administering employee did not follow the 5 R''s, did not ask for assistance from another health care professional and "did not know what she was doing." It was confirmed that this was not a case of product confusion. There was no product quality complaint involved. No further information was available. Additional information has been requested.


VAERS ID: 271281 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: No adverse effect, Wrong drug administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00186

Write-up: Information has been received from a health professional and a pharmacist concerning a 20 year old patient who on an unspecified date was vaccinated with a dose of Zostavax vaccine instead Gardasil vaccine (yeast). Unspecified medical attention attention was sought. The patient was not experienced any known symptoms. It was reported that the error was not a result of product confusion. There was no record of the patient ever receiving Varicella virus vaccine live. There was no product quality complaint involved. No further information was available. Additional information has been requested. 6/17/10 It was reported that the administering employee did not follow the 5 R''s, did not ask for assistance from another health care professional and "did not know what she was doing." It was confirmed that this was not a case of product confusion. No further information was available.


VAERS ID: 270964 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-20
Onset:2006-12-20
   Days after vaccination:0
Submitted: 2007-01-22
   Days after onset:33
Entered: 2007-01-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0961F / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Syncope, Vaccine positive rechallenge
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Migraine
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA01090

Write-up: Initial and follow-up information has been received from a physician concerning a year old female with no known allergies and a history of "occasional" migraines who on an unspecified date was vaccinated with the first dose of GARDASIL (yeast) (lot number 654540/0800F). Concomitant therapy included hepatitis A virus vaccine (unspecified). Subsequent to the first dose, the patient experienced fainting and "signs of seizure". Clinical outcome was not reported. On 20-DEC-2006 (also reported as 20-DEC-2007), the patient was vaccinated with a second dose of GARDASIL (yeast) (lot number 654389/0961F). On 20-DEC-2006 (also reported as 20-DEC-2007), the patient experienced fainting. Clinical outcome was not reported. Signs of seizure was considered an other important medical event. Additional information has been requested.


VAERS ID: 270965 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: New York  
Vaccinated:2007-01-04
Onset:2007-01-04
   Days after vaccination:0
Submitted: 2007-01-22
   Days after onset:18
Entered: 2007-01-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0962F / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Dyspnoea, Influenza, Pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA02133

Write-up: Information has been received from a registered nurse concerning a 19 year old female who on 04-JAN-2007 was vaccinated with a first dose of Gardasil (yeast) (0.5 ml) (lot # 654510/0962F). Subsequently, on 04-JAN-2007, the patient was rushed to the emergency room with symptoms of body aches, breathing problems and a temperature of 103. The patient was released from the emergency room within 12 hours. The nurse reported that the emergency room physician believed that the above reaction was due to influenza. The patient recovered. The reporter considered the patient''s experience to be disabling. Additional information has been requested.


VAERS ID: 270972 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-10
Onset:2007-01-10
   Days after vaccination:0
Submitted: 2007-01-19
   Days after onset:9
Entered: 2007-01-23
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Erythema, Pruritus, Throat irritation, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC-D, NUVARING, NASAREL
Current Illness: Rhinitis allergic, asthma, gastric ulcer, anemia, migraine
Preexisting Conditions: General symptoms
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA01386

Write-up: Information has been received from a nurse practitioner concerning a 24 year old female with allergic rhinitis, asthma, gastric ulcer, anemia and migraine and a "history of high-risk HPV'' who on 10-JAN-2007 was vaccinated with the second dose of Gardasil vaccine (yeast) (lot#655165/1425F), 0.5 ml, one time, IM. Concomitant therapy included NUVARING, ZYRTEC-D and NASAREL. Initial vaccination of Gardasil vaccine (yeast) was received on 16-NOV-2006. On 10-JAN-2007, the patient developed throat tickle, chest redness, itchiness, chest and neck hives and intermittent shortness of breath 15 minutes after administration of Gardasil vaccine (yeast). The patient was administered BENADRYL and the symptoms resolved after 10 minutes. The patient left the office in good condition without residual problems. Throat tickle, chest redness, itchiness, chest and neck hives and intermittent shortness of breath were considered to be other important medical events. Additional information has been requested.


VAERS ID: 271007 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-16
Onset:2007-01-16
   Days after vaccination:0
Submitted: 2007-01-18
   Days after onset:2
Entered: 2007-01-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1424F / 1 LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Injection site nerve damage, Muscle spasms, Tension
SMQs:, Dystonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Cipro Hives
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt called on call phone 1/17/07 at 8PM C/O tenseness and spasms to left neck increase spasms when turning head to left. Went to ER that night and was told a nerve may have been hit. Given inj of Valium and anti inflammatory was RX''d Naproxen.


VAERS ID: 271011 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Female  
Location: Wisconsin  
Vaccinated:2007-01-11
Onset:2007-01-11
   Days after vaccination:0
Submitted: 2007-01-12
   Days after onset:1
Entered: 2007-01-24
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0962F / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Chills, Headache, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Oral contraceptives, Zyrtec, Zomig
Current Illness: NONE
Preexisting Conditions: Seasonal, environmental allergies, migraine HA, Eczema, Allergies to pineapple, tomatoes, bananas.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Onset fever 103.0-103.6 F (orally) 6 hours post injection chills, mild headache, mild pain at injection site. Resolved by 12 hours, except for mild pain at injection site.


VAERS ID: 271014 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-16
Onset:2007-01-17
   Days after vaccination:1
Submitted: 2007-01-18
   Days after onset:1
Entered: 2007-01-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / UNK LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2082AA / UNK LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1154F / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Injection site erythema, Injection site oedema, Injection site pain
SMQs:, Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pain, redness, swelling on (L) upper arm, feels weak no fever.


VAERS ID: 271016 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-01-17
Onset:2007-01-17
   Days after vaccination:0
Submitted: 2007-01-17
   Days after onset:0
Entered: 2007-01-24
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1208F / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Dizziness, Flank pain, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt C/O severe L flank pain with nausea, dizziness 10 min after receiving vaccine.


VAERS ID: 271056 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: New York  
Vaccinated:2007-01-11
Onset:2007-01-11
   Days after vaccination:0
Submitted: 2007-01-23
   Days after onset:12
Entered: 2007-01-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Loss of consciousness, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOSAMAX, calcium (unspecified)
Current Illness: Osteopenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA01725

Write-up: Information has been received from a registered nurse concerning a 21 year old female with osteopenia who on 11-JAN-2007 was vaccinated with Gardasil vaccine (yeast) (lot#655165/1425F), intramuscularly in the left arm. Concomitant therapy included FOSAMAX and calcium (unspecified). Subsequently, on 11-JAN-2007, the patient "passed out", "fainted", was dizzy and nauseated. The patient recovered. There were relevant diagnostic or laboratory tests. It was noted that the patient had eaten before vaccination. Unspecified medical attention was sought. The reporter considered the patient''s experience to be disabling because the patient was incapacitated for a short time. Additional information has been requested.


VAERS ID: 271092 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-01-15
Onset:2007-01-15
   Days after vaccination:0
Submitted: 2007-01-24
   Days after onset:9
Entered: 2007-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Loss of consciousness, Road traffic accident
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: H/X nasal congestion
Preexisting Conditions: Depression, 1x syncope 06/06 migraines
Allergies:
Diagnostic Lab Data: NONE CT cervical spine:minor scoliosis convex left. 24 hour ambulatory EEG:No epileptiform activity or persistent focal asymmetries occurred.
CDC Split Type:

Write-up: About 1-2 hrs after vaccination, while driving, lost consciousness, crashing into a car and mailboxes before regaining consciousness. 01/31/07-records received and reviewed. Neuro consult 1/17/07. Assessment:episodes of loss of consciousness. Differential diagnoses could include Juvenile Myoclonic Epilepsy, complicated migraine or cardiac arrhythmia. Holter monitor to evaluate for dysrhythmia. Psychotherapy with respect to her depression and medical management. PMH:This past summer had an episode where she suddenly got dizzy with the onset of sharp headache and then lost consciousness. She go back up and then blacked out again. No tongue biting or urinary incontinence. Disorientation lasted few minutes. Felt tired and achy but no further dizziness. In October 2006, episode of dizziness without loss of consciousness. Lips turned blue and whole body numb and tingling, greater on right side than left side. Head injury in October with concussion, confusion and dazed afterwards. EEG in October 2002 normal, MRI in March 2003 normal. On 1/15/07 while driving she was unaware that she had hit two mailboxes and a car. Half hour before accident she received HPV and noted swelling and throbbing at injection site. Experienced headache with this. Reports some occasional body jerks, especially noted at night when she is tired. PMH: depression, migraines which started in middle school, eczema, asthma and chicken pox.


VAERS ID: 271096 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-01-10
Onset:2007-01-10
   Days after vaccination:0
Submitted: 2007-01-20
   Days after onset:10
Entered: 2007-01-25
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Private       Purchased by: Private
Symptoms: Blood pressure decreased, Disorientation, Fall, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Shortly after administration of vaccine, patient loss consciousness, fell from exam table to floor. Was out for 2-3 minutes, was very disoriented and seemed to have difficult time waking. Blood pressure was checked about 5 minutes later when move back to table. Had dropped from initial measurement of 100/70 to 80/40-patient rested for approximately 30 minutes and pressure went back up to 90/70. Patient allowed to leave. Patient has no history of any reactions to injections.


VAERS ID: 271177 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: New York  
Vaccinated:2007-01-13
Onset:2007-01-13
   Days after vaccination:0
Submitted: 2007-01-24
   Days after onset:11
Entered: 2007-01-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0962F / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram normal, Convulsion, Electrocardiogram normal, Fall, Fatigue, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: chest x-ray 01/13/07 - normal, computed axial 01/13/07 - normal, electrocardiogram 01/13/07 - normal
CDC Split Type: WAES0701USA02032

Write-up: Information has been received from a health professional concerning a 16 year old female who on 11-NOV-2006 was vaccinated intramuscularly with 0.5 ml of the first dose of GARDASIL vaccine (yeast) (lot#654510/0962F) and had no difficulties with the vaccine. On 13-JAN-2007 the patient was given her second dose of GARDASIL vaccine (yeast) (lot# not provided). Within a few moments of receiving the vaccine the patient experienced a seizure, had a very brief loss of consciousness and fell to the floor. The patient was sent to the emergency room for evaluation. The patient was not admitted to the hospital. While in the emergency room she had a CT scan, chest-x-ray and unspecified blood work. The results of these tests were all negative. The patient was seen for a follow-up appointment by the physician on 16-JAN-2007. The patient reported that she was tired, however had not suffered any additional seizures. The patient was referred for a neurology consult. The physician considered the event to be life-threatening. At the time of this report the patient had not recovered from the events. Additional information has been requested.


VAERS ID: 271178 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-11
Onset:2007-01-11
   Days after vaccination:0
Submitted: 2007-01-24
   Days after onset:13
Entered: 2007-01-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Dermographism, Gait disturbance, Laboratory test, Oedema peripheral, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: diagnostic laboratory 01/11?/07 - results not reported
CDC Split Type: WAES0701USA01948

Write-up: Information has been received from a physician concerning her 20 year old daughter who on 11-JAN-2007 was vaccinated IM with a 0.5 ml dose of GARDASIL vaccine (yeast) (lot#653938/0954F). Concomitant therapy included Yasmin. On 11-JAN-2007, fifteen minutes after the vaccination, welts appeared on the patient''s neck and spread all over the body. Dermatographia resulted all over the patient''s body, her hands and feet were swollen, and she experienced arthritic pain in her joints. It was reported that the patient was not able to walk because of the pain. The patient was treated with Zyrtec, dexamethasone and hydroxyzine. Unspecified blood tests were performed (results not reported). At the time of this report, the patient was not recovered. Welts, dermatographia, peripheral swelling, arthritic-like joint pain and the patient''s inability to walk were considered to be disabling events. Additional information has been requested.


VAERS ID: 271180 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Utah  
Vaccinated:2007-01-23
Onset:2007-01-23
   Days after vaccination:0
Submitted: 2007-01-25
   Days after onset:2
Entered: 2007-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0906F / 2 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Headache, Injection site rash
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~0.00~In Patient
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: pt had a rash at the injection site, and had a severe headache


VAERS ID: 271302 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Kansas  
Vaccinated:2007-01-09
Onset:2007-01-10
   Days after vaccination:1
Submitted: 2007-01-19
   Days after onset:9
Entered: 2007-01-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1162F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tegretol, Ovcon 35
Current Illness: NONE
Preexisting Conditions: Seizure disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Gardasil given 1/9/07. On 1/10/07 complained of lightheadedness, nausea. Ran fever 1/13, 1/14, 1/15.


VAERS ID: 271334 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Arizona  
Vaccinated:2007-01-23
Onset:2007-01-24
   Days after vaccination:1
Submitted: 2007-01-26
   Days after onset:2
Entered: 2007-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1209F / 2 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1424F / 1 GM / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2002AC / 1 GM / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2689AA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1144F / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site inflammation, Injection site irritation, Injection site vesicles
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Gardasil was given in office. Pt. reported only some irritation at site following the administration of vaccine. The following day she developed local erythema and sm. blister. She was seen again in the office on 1/25/07. Superficial blister/inflammation of approx. 0.5 x 1.5cm was noted. No cellulitis noted. Area was lt. pink in color. Advised pt. to keep area clean and dry, apply antibiotic oint. if desired. Only local treatment needed. No further treatment anticipated.


VAERS ID: 271341 (history)  
Form: Version 1.0  
Age: 1.27  
Sex: Female  
Location: Tennessee  
Vaccinated:2007-01-25
Onset:2007-01-25
   Days after vaccination:0
Submitted: 2007-01-26
   Days after onset:1
Entered: 2007-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / 2 UN / ID
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 2 UN / ID

Administered by: Unknown       Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was administered a vaccination of gardasil by accident instead of the scheduled comvax. It was administer on 1/25/06. It has been only one and no symptoms have been observed. Gardasil is approved for patients of 9 years to 26 years. No studies have been done for a patient of 15 months.


VAERS ID: 271365 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Kansas  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2007-01-26
   Days after onset:86
Entered: 2007-01-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA02456

Write-up: Information has been received from a health professional concerning a 22 year old female patient who on approximately 01-NOV-2006 was vaccinated with a first IM dose of GARDASIL vaccine (yeast). On approximately 01-NOV-2006 the patient experienced seizure. The reporter had no further information. It was noted that patient was 2 weeks late for her second dose of GARDASIL vaccine (yeast) and had not yet received it. Upon internal review, seizure is considered an other important medical event. Additional information has been requested.


VAERS ID: 271366 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Unknown  
Location: Connecticut  
Vaccinated:2006-11-10
Onset:2006-11-11
   Days after vaccination:1
Submitted: 2007-01-26
   Days after onset:76
Entered: 2007-01-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Crohn's disease
SMQs:, Gastrointestinal premalignant disorders (narrow), Ischaemic colitis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Crohn''s disease
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03418

Write-up: Information has been received from a physician concerning a patient (age and gender unknown) with Crohn''s disease who on 10-NOV-2006 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil vaccine (yeast) (Lot # 653978/0955F). On 11-NOV-2006 the patient had a flair up of Crohn''s disease after receiving the Gardasil vaccine (yeast). The flair up was so severe that the patient had to be out of school for a month. The patient sought unspecified medical attention. No product quality complaint was involved. At the time of this report, the patient was recovering. The flair up of Crohn''s disease was considered to be disabling. Additional information has been requested.


VAERS ID: 271367 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-26
Entered: 2007-01-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03718

Write-up: Information has been received from a physician concerning a female (age unspecified) with unspecified history of drug reaction/allergies and no pertinent medical history who on an unspecified date was vaccinated with Gardasil vaccine (yeast) (lot# not reported) 0.5 ml by injection. Concomitant therapy was not reported. Subsequently, the patient experienced a seizure after the injection of Gardasil vaccine (yeast). Medical attention was sought. At the time of reporting, the patient had recovered. Upon internal review, seizure was determined to be an Other Important Medical Event. Additional information has been requested.


VAERS ID: 271368 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-11
Onset:2007-01-13
   Days after vaccination:2
Submitted: 2007-01-26
   Days after onset:13
Entered: 2007-01-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NUVARING, ALLEGRA
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA02394

Write-up: Information has been received from a nurse practitioner concerning a 20 year old female who on 11-Jan-2007 was vaccinated with Gardasil vaccine (yeast), intramuscularly. Concomitant therapy included Allegra and Nuvaring. On 13-Jan-2007 the patient had a "rash from her neck down". The patient was seen in the emergency room and was given Prednisone. At the time of the report, the patient was recovering. The reporter was considering giving the patient Benadryl and Prednisone before the next vaccination with Gardasil vaccine (yeast). The patient''s experience was considered to be an other medical event. Additional information has been requested.


VAERS ID: 271369 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:2007-01-10
Onset:2007-01-10
   Days after vaccination:0
Submitted: 2007-01-26
   Days after onset:16
Entered: 2007-01-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA03376

Write-up: Information has been received from a Registered Nurse concerning a female patient (demographics not reported) who on 10-JAN-2007 was vaccinated intramuscularly with the first dose of Gardasil vaccine (yeast) (lot # not provided). Concomitant therapy included BOOSTRIX and hepatitis A virus vaccine (manufacturer unknown). On 10-JAN-2007 immediately post vaccination the patient "passed out and went into a seizure." The patient sought unspecified medical attention. At the time of this report it was not reported if the patient had recovered from her experience. Upon internal review the seizure was considered to be an other medical event. Additional information has been requested.


VAERS ID: 271387 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Delaware  
Vaccinated:2007-01-26
Onset:2007-01-26
   Days after vaccination:0
Submitted: 2007-01-29
   Days after onset:3
Entered: 2007-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient got dizzy, passed out.


VAERS ID: 271411 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2007-01-10
Onset:2007-01-12
   Days after vaccination:2
Submitted: 2007-01-24
   Days after onset:12
Entered: 2007-01-29
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Computerised tomogram normal, Grand mal convulsion, Postictal state
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair
Current Illness: NONE
Preexisting Conditions: seasonal allergies, asthma
Allergies:
Diagnostic Lab Data: Ct- Brain Nec Labs received 3/1/07-strep screen negative for group A strep. CBC WNL except for lymphocyte 21.6. CT cranial-no intracranial abnormality. Some evidence her for mild paranasal sinus disease particularly on the left side
CDC Split Type:

Write-up: 48 hours post injection-appeared to have witnessed tonic clonic seizures with postictal phase lasting less than 1 min. 03/01/07-records received from facility for DOS 01/12/2007-DX fainting. 03/01/07-records received from facility for DOS 01/12/2007-DX fainting.


VAERS ID: 271456 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Missouri  
Vaccinated:2007-01-15
Onset:2007-01-17
   Days after vaccination:2
Submitted: 2007-01-29
   Days after onset:12
Entered: 2007-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0694F / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2638AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Mild erythema and edema to Left deltoid. Prescribed over the counter Motrin 400 mg every 6-8 hours as needed.


VAERS ID: 271470 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-24
Onset:0000-00-00
Submitted: 2007-01-30
Entered: 2007-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2310AA / 2 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2209AA / 1 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Seeing provider for eczema
Preexisting Conditions: eczema no allergies noted
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Child attended Karate class and instructor was tapping the injection not knowing that the child had received immunizations the day before. Red swollen the size of a baseball at site of injection on right deltoid. Area was tender to touch.


VAERS ID: 271473 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Missouri  
Vaccinated:2007-01-17
Onset:2007-01-21
   Days after vaccination:4
Submitted: 2007-01-30
   Days after onset:9
Entered: 2007-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 2 LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Computerised tomogram normal, Confusional state, Disorientation, Drug screen negative, Electroencephalogram normal, Feeling abnormal, Full blood count normal, Laboratory test, Thyroid function test normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro
Current Illness: none
Preexisting Conditions: Depression
Allergies:
Diagnostic Lab Data: CBC, chemistry profile, thyroid tests, drug screen, head CT, EEG - all tests were NORMAL
CDC Split Type:

Write-up: Awoke from nap on 01/21/2007 and was disoriented and confused. Taken to the ER where multiple tests were performed. This last several hours. Psychiatry was consulted as well. Patient states she felt funny the next day, but was ok by 01/23/2007.


VAERS ID: 271476 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-26
Onset:2007-01-29
   Days after vaccination:3
Submitted: 2007-01-30
   Days after onset:1
Entered: 2007-01-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 1 RA / ID

Administered by: Military       Purchased by: Military
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: I have seasonal allergies, as well as allergies to animals, dust, plants, grasses, and trees.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: I began to itch 3 days after my vaccination shot. At first, I thought it was my eczema acting up, but then I began to itch and scratch all over my arms, underarms, legs, and on my hip bones. Hives have appeared on these areas. i applied flucinonide on the itchy areas, but they still remain itchy. I will see the doctor tomorrow, but I do not believe I can see the doctor who recommended the vaccination.


VAERS ID: 271531 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-30
Entered: 2007-01-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04270

Write-up: Information has been received from a registered nurse (also reported as a physician) concerning a female who was vaccinated with her first dose of Gardasil vaccine (yeast) 0.5 ml. Subsequently the patient had a seizure. Subsequently, the patient recovered from the seizure. Therapy with Gardasil vaccine (yeast) will not be reintroduced. Upon internal review, seizure was considered an other important medical event. Additional information has been requested.


VAERS ID: 271532 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2007-01-16
Onset:2007-01-16
   Days after vaccination:0
Submitted: 2007-01-30
   Days after onset:14
Entered: 2007-01-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Hypersensitivity, Oxygen saturation normal
SMQs:, Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: ASTHMA
Allergies:
Diagnostic Lab Data: pulse oximetry-within normal limits
CDC Split Type: WAES0701USA03520

Write-up: Information has been received from a LPN concerning a 17 year old female with asthma who on 16-JAN-2007 was vaccinated with a first dose of Gardasil vaccine (yeast). On 16-JAN-2007 the patient experienced burning in her chest and lungs. The patient was seen at an Urgent Care facility and her lungs were found to be clear and her oxygen saturation was within normal limits. The Urgent Care physician''s impression was that the patient experienced some type of allergic reaction. The patient was treated with Tylenol and Benadryl and instructed to come back if the symptoms did not improve or if they exacerbated. The LPN felt that there was a possibility of hospitalization at the time, however, at the time of this report, the patient was recovering and improving on treatment. No product quality complaint was involved. The reporter felt that allergic reaction was an other important medical event. Additional information has been requested.


VAERS ID: 271541 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-01-25
Onset:2007-01-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2007-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 653735/0688F / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Presyncope, Trendelenburg position
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Information has been received from a nurse concerning a 12 year old femmale who on 25-JAN-2007 was vaccinated with GARDISIL, lot # 653735/0688P in the left arm (second dose). On 25-JAN-2007 after receiving vaccine and getting off table felt dizzy walked to appointment desk and became very "oozy" almost fainted mom caught her put in trendelenberg position, given orange juice quickly felt better. Additional information has been requested.


VAERS ID: 271545 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Michigan  
Vaccinated:2006-12-27
Onset:2007-01-04
   Days after vaccination:8
Submitted: 2007-01-31
   Days after onset:27
Entered: 2007-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: allegra
Current Illness: none
Preexisting Conditions: allergic to peanuts
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: One week after the injection,my daughter broke out with big hives,rash and itching. She was put on predizone.That did not sseem to help very much. It is a little over a month and she is better but still breaks out with red bumps and hives.


VAERS ID: 271559 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-01-17
Onset:2007-01-25
   Days after vaccination:8
Submitted: 2007-01-31
   Days after onset:6
Entered: 2007-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1046F / 2 LA / SC

Administered by: Public       Purchased by: Private
Symptoms: Pruritus, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Asmarx, Albuterol, Florim cream
Current Illness: NONE
Preexisting Conditions: Eczema, Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Started with signs of chicken pox 8 days after vaccine over entire back, neck, front, abdomen. No comitant symptoms no fever, no stomach symptoms, no pain, no cough, no runny nose, no sore throat. Positive puritis.


VAERS ID: 271577 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-04
Onset:2007-01-22
   Days after vaccination:18
Submitted: 2007-01-28
   Days after onset:6
Entered: 2007-02-01
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ovcon-35
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: On 1/4/2007, pt was given first dose of Gardasil vaccine. Also, on that day, changed OCP from Lo-ovral to Ovcon-35 because of spotting. Presnted 1/22/07 with pruitic rash consisting of tine erythematous papules on arms/legs/trunk


VAERS ID: 271583 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Maryland  
Vaccinated:2007-01-08
Onset:2007-01-08
   Days after vaccination:0
Submitted: 2007-01-31
   Days after onset:23
Entered: 2007-02-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy, Pregnancy test positive, Ultrasound scan, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Celexa, Risperdal
Current Illness:
Preexisting Conditions: Abdominal pain, Rectal bleeding, Papilloma viral infection, Sexually transmitted disease, Termination of pregnancy elective.
Allergies:
Diagnostic Lab Data: ultrasound 01/18/2007 - 7 week 3 day gestational dates urine beta-human 01/08?/07
CDC Split Type: WAES0701USA01621

Write-up: Initial and follow up information has been received from a health professional concerning a 20 year old female patient with a history of 2 therapeutic abortions (2000 and 2004) abdominal pain, mild rectal bleeding, papilloma viral infection and sexually transmitted disease who on 08-JAN-2007 was vaccinated IM into the left deltoid with a second 0.5 ml of Gardasil vaccine (yeast) (lot#655619/1427F). Concomitant therapy included Risperdal and Celexa. The patient was reportedly pregnant at this time and did not tell the office. An HCG pregnancy test was done. The patient is scheduled for a prenatal visit on 19-JAN-2007. Her LMP was approximately 11-OCT-2006 and EDD 19-JUL-2007. An ultrasound on 18-JAN-2007 for gestational dates revealed of 7 weeks of 7 weeks and 3 days. The patient had an elective termination on 23-JAN-2007. There was no further information available. The patient received a first 0.5 ml dose of Gardasil vaccine (yeast) (lot#654540/0800F) on 23-OCT-2006 IM into the left deltoid. Upon internal review, elective termination was considered to be an other important medical event. Additional information has been requested.


VAERS ID: 271607 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-01-29
Onset:2007-01-30
   Days after vaccination:1
Submitted: 2007-02-01
   Days after onset:2
Entered: 2007-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 2 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Pruritus, Rash, Swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: itching, swelling and hivelike rash with bumps on face the 1st day. next day, rash over face, neck, chest, upper arms. worse with exposure to cold air. resolved after warming about 15-20 min 1st day. 2nd day resolved with benadryl 25mg x 1.


VAERS ID: 272493 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-01
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03497

Write-up: Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 271629 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-01-19
Onset:2007-01-19
   Days after vaccination:0
Submitted: 2007-01-30
   Days after onset:11
Entered: 2007-02-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dizziness, Erythema, Nausea, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received 1st dose of Gardasil vaccine and the next day her arm got red and swollen and she experienced nausea and dizziness. 4 days later she reports arm continued to swell and be painful, but denies fever or chills. Patient was advised to take dihenhydramine and use ice on the area.


VAERS ID: 271631 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: New York  
Vaccinated:2007-01-06
Onset:2007-01-07
   Days after vaccination:1
Submitted: 2007-01-29
   Days after onset:22
Entered: 2007-02-02
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 1210F / 1 - / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1424F / 1 - / -

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain upper, Headache, Malaise, Pruritus, Rash generalised, Sneezing, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Very severe skin rash covering the entire body. Itchy skin, some sneezing scratchy throat. Headache, stomach ache overall feeling of being unwell. After 4 days rash not gone. Treatment: Benadryl every 5 hours, Aveeno baths.


VAERS ID: 271650 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-01-09
Onset:2007-01-14
   Days after vaccination:5
Submitted: 2007-02-02
   Days after onset:19
Entered: 2007-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 5 days after being administered the 2nd in a series of Gardasil developed hives requiring Benadryl and a visit to local ER. No facial edema, difficulty breathing or SOB occurred


VAERS ID: 271654 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: South Dakota  
Vaccinated:2007-01-24
Onset:2007-01-30
   Days after vaccination:6
Submitted: 2007-02-02
   Days after onset:3
Entered: 2007-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0960F / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR 61784AA / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Abdominal pain, Abdominal pain upper, Aphthous stomatitis, Malaise, Oral pain, Pain, Pharyngolaryngeal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Adderal and Seroquel
Current Illness: none
Preexisting Conditions: good physical health
Allergies:
Diagnostic Lab Data: Started not feeling well 1/30/07 pm. Stayed home the next day (1/31/07)due to above listed complaints. That evening she developed bad stomach pain. Taken to ER to rule out appendicitis-felt much better the next day but then began developing mouth sores.
CDC Split Type:

Write-up: Canker type sores in mouth still present. Complained of sore throat,achy,abdominal pain, general malaise the past couple of days but feeling better yesterday. Important to note is that she has a boyfriend who may have been infected with HG (herpes gladitorium)-his wrestling team had "ringworm" and "staph" and now area wrestlers are showing up with HG which is said to be confused often times with staph skin infections. Cold sores are common with HG and are contagious of course, so it might be possible that she contracted the sores by kissing her boyfriend who may have been infected with HG?? Not sure and can''t prove that he was infected.


VAERS ID: 271695 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2007-01-29
Onset:2007-02-02
   Days after vaccination:4
Submitted: 2007-02-05
   Days after onset:3
Entered: 2007-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011UEXP21MAR09 / 1 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Hypersensitivity, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoxetine, Zometa, Trisprintec
Current Illness: NONE
Preexisting Conditions: Depression, No prior allergies
Allergies:
Diagnostic Lab Data: Allergic reaction, unspecified
CDC Split Type:

Write-up: Patient complained of itchy rash on legs/arms for 3-4 days. She presented 2 days after the shot with raised hives on legs, feet and hands. She was placed on Medrol dose pack, Atarax, 100 1 qd


VAERS ID: 271697 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-01-17
Onset:2007-01-17
   Days after vaccination:0
Submitted: 2007-01-29
   Days after onset:12
Entered: 2007-02-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1162F / 1 GM / -

Administered by: Private       Purchased by: Public
Symptoms: Electrocardiogram, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: EKG-ne
CDC Split Type:

Write-up: Patient suffered a vasovagal (syncope) reaction after vaccine given. Sent to ER


VAERS ID: 271819 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-01-29
Onset:2007-01-31
   Days after vaccination:2
Submitted: 2007-02-01
   Days after onset:1
Entered: 2007-02-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1447F / 1 UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2158AA / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2 days after giving Menactra and HPV vaccine #1, pt developed L shoulder and L arm pain, with ok strength but pain with motion.


VAERS ID: 271892 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Ohio  
Vaccinated:2007-02-05
Onset:2007-02-05
   Days after vaccination:0
Submitted: 2007-02-05
   Days after onset:0
Entered: 2007-02-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1280F / 1 RA / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 00144 / 1 RA / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2157BA / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Fatigue, Feeling abnormal, Loss of consciousness, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was receiving Gardasil, Hep A and Then Menactra. Right after administering the Menactra she said I feel funny and passed out. She was out for about 10 seconds. Then vomited 1x. Said she felt really tired.


VAERS ID: 271896 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: New York  
Vaccinated:2007-01-26
Onset:2007-01-26
   Days after vaccination:0
Submitted: 2007-02-06
   Days after onset:11
Entered: 2007-02-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Aphasia, Blood electrolytes normal, C-reactive protein normal, Chills, Computerised tomogram normal, Full blood count normal, Nuclear magnetic resonance imaging normal, Pharyngolaryngeal pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: computed axial 01/30/07 - negative, magnetic resonance 01/30/07 - negative, complete blood cell 01/30/07 - negative, serum c-reactive 01/30/07 - negative, serum electrolytes test 01/30/07 - negative, temperature measurement 01/30/07 - fever
CDC Split Type: WAES0702USA00217

Write-up: Information has been received from a physician concerning a 24 year old female with no pertinent medical history and no history of drug reactions/allergies who on 26-JAN-2007 was vaccinated with Gardasil vaccine (yeast) (lot# not reported), IM. There was no concomitant medication. On 26-JAN-2007, the patient developed a sore throat, fever, and chills later that evening. She went to the emergency room on 30-JAN-2007 where she exhibited expressive aphasia. A computed tomography (CT) scan showed nothing. She was admitted to the hospital where she a neurology consult. All tests have come up negative (CT scan, magnetic resonance imaging, complete blood count, electrolytes, and C-reactive protein). The physician stated that the patient has 3 chinchilla pets and one of them has a fungal infection which is currently being treated with myconazole spray. The physician consulted the veterinarian as well as an infectious disease specialist. The physician saw the patient today and she was able to form some sentences. The physician is observing the patient and will order some additional tests. The physician reported the event will be a disability if this adverse event continues. Additional information has been requested.


VAERS ID: 271904 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-04
Onset:2007-01-16
   Days after vaccination:12
Submitted: 2007-02-02
   Days after onset:17
Entered: 2007-02-07
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. DPHVA017A / UNK LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2091AA / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest X-ray normal, Erythema multiforme, Genital pruritus female, Lip swelling, Pneumonia, Pyrexia, Rales, Rash, Urine analysis normal
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200700247

Write-up: Initial report received on 26 January 2007, from another manufacturer, under the reference number B0454855A, concerning a patient. A 12 year old female patient, was enrolled in the other manufacturers study and received on 04 January 2007 a dose of Menactra (lot number U2091AA) intramuscular intro the left upper deltoid and the first dose of study vaccine of Gardasil (lot number DHPVA017A). Since 16 January 2007, since 12 days post administration, the patient had been experiencing pneumonia and developed erythema multiforme and was hospitalized. The patient had been to th e(study) office two days prior to admission with fever, swollen lips and vaginal itch. Exam failed to reveal significant findings other than rales over left posterior lung fields (urine analysis and chest X ray were normal). A clinical diagnosis of rash fitting description of erythema multiform was made. The patient was discharged with symptomatic treatment. She was seen in emergency room the next day and admitted on 18 January 2007 for intravenous treatment (rochepin). The event was unresolved at the time of reporting. The other manufacturer''s investigator considered that there was a reasonable possibility that th erythema multiforme may have been caused by Gardasil and Menactra and was due to pneumonia.


VAERS ID: 271932 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Arizona  
Vaccinated:2007-02-07
Onset:2007-02-07
   Days after vaccination:0
Submitted: 2007-02-07
   Days after onset:0
Entered: 2007-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U22522A / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0960F / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR UE552AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose, Blood glucose normal, Blood pressure normal, Convulsion, Electrocardiogram, Electrocardiogram normal, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: EKG, Blood sugar
CDC Split Type:

Write-up: Patient had a vasovagal syncopal episode with seizure seconds after receiving the vaccine. Checked blood sugar and BP and EKG and everything looked normal. Observed patient in clinic and no problems after.


VAERS ID: 271999 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2007-01-15
Onset:2007-01-20
   Days after vaccination:5
Submitted: 2007-02-06
   Days after onset:17
Entered: 2007-02-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / UNK LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR V1974AM / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Abnormal sleep-related event, Barium swallow, Chest X-ray, Dyskinesia, Electroencephalogram, Full blood count, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: EEG, CBC, SMAC, chest x-ray and barium swallow
CDC Split Type:

Write-up: Gardasil and Menactra given 1/11/07 beginning 1/22/07 jerking, tremors, shaking episodes occurring only during sleep


VAERS ID: 272010 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Illinois  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-08
Entered: 2007-02-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram abnormal, Dizziness, Nausea, Vertigo
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: computed axial - vertigo
CDC Split Type: WAES0702USA00543

Write-up: Information has been received from a nurse concerning a female patient (age unknown) who, on an unspecified date, was vaccinated with a 0.5 ml dose of Gardasil vaccine (yeast). The day after vaccination, the patient felt dizzy and lightheaded and experienced nausea. The patient was admitted to the hospital for 2 days. A CT scan performed at the hospital revealed vertigo. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 272037 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: California  
Vaccinated:2007-02-08
Onset:2007-02-09
   Days after vaccination:1
Submitted: 2007-02-09
   Days after onset:0
Entered: 2007-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Petechiae
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 14 y/o girl had distal swelling of both hands with erythema and some petechiae within one day of receiving 1st dose of gardasil. No other symptoms. Mother gave benadryl


VAERS ID: 272065 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-02-07
Onset:2007-02-07
   Days after vaccination:0
Submitted: 2007-02-09
   Days after onset:2
Entered: 2007-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0012U / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Blood glucose normal, Body temperature decreased, Dizziness, Dyspnoea, Headache, Heart rate increased, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE per patient
Preexisting Conditions: ASTHMA
Allergies:
Diagnostic Lab Data: blood glucose 86 mg/dl, temperature 97.1, pulse 88 and regular, BP 110/76 SpO2 99%
CDC Split Type:

Write-up: Headachem dizziness, increased heart rate, light-headness, shortness of breath. Symptoms began approximately 40 minutes after vaccination.


VAERS ID: 272066 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Female  
Location: California  
Vaccinated:2007-02-09
Onset:2007-02-09
   Days after vaccination:0
Submitted: 2007-02-09
   Days after onset:0
Entered: 2007-02-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0012U / 2 RA / -

Administered by: Public       Purchased by: Private
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: R arm sore at injection site


VAERS ID: 272080 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-02
Onset:2007-01-06
   Days after vaccination:4
Submitted: 2007-02-09
   Days after onset:34
Entered: 2007-02-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Haematoma, Injection site cellulitis, Injection site erythema, Injection site haematoma, Injection site induration, Injection site pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sarafem, Hormonal contraceptives.
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA05054

Write-up: Information has been received from a physician concerning her daughter, a 19 year old female who on 13-OCT-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (lot#653938/0954F) without any difficulties. On 02-JAN-2007 the patient received the second dose of Gardasil vaccine (yeast) (lot#654389/0961F). Concomitant therapy included fluoxetine HCl (SARAFEM) and "Femcon" (NOS). On approximately 06-JAN-2007 the patient developed a tender reddened firm area in her upper arm around the injection site that "hurt her to sleep on". On an unspecified date the patient went to the emergency room and was diagnosed with cellulitis and treated with Cephalexin (Keflex). After 10 days of treatment with cephalexin was completed the patient''s "reddened firm area went down and was less tender". However, with 48 hours of stopping the therapy with cephalexin the area was "reddened, firm and tender". After 5 days the patient was seen at her university health services office, who "refused to treat her for cellulitis and referred her back to her gynecologist who gave her the vaccine". On approximately 01-FEB-2007 the patient was then seen by the internist who diagnosed her with a hematoma. At the time of this report the cellulitis was considered resolved and the hematoma was resolving. The physician reported that the patient will continue with the third vaccination in her other arm. The reporting physician consider the cellulitis to be a serious other medical event. Additional information has been requested.


VAERS ID: 272081 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: New York  
Vaccinated:2007-01-25
Onset:2007-01-26
   Days after vaccination:1
Submitted: 2007-02-09
   Days after onset:14
Entered: 2007-02-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Dermatitis, Erythema, Lethargy, Nausea, Rash papular, Rash pruritic, Skin lesion, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Benadryl; Prevacid; Nasacort; Ovar; Prevacid; Xopenex
Current Illness: Concurrent conditions: Asthma; Pennicillin allergy; allergy to legumes; Drug Hypersensitivity; Ehlers- Oanlos syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00186

Write-up: Information has been received from a registered nurse concerning her 11 year old daughter with asthma, penicillin allergy and drug hypersensitivity to cephalexin (KEFLEX) who on 25-JAN-2007 was vaccinated with a dose of Gardasil vaccine (yeast). Concomitant therapy included lansoprazole (PREVACID), triamcinolone acetonide (NASACORT) and diphenhydramine HCl (BENADRYL). On 26-JAN-2007 the patient developed nausea, lethargy and a rash with pruritus on back. Unspecified medical attention was sought. There was no laboratory or diagnostic tests performed. At the time of the report, the patient was recovering. The registered nurse considered nausea, lethargy and pruritic rash to be disabling events. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/9/2007; 5/28/2007. On 26-Jan-2007, it was reported that the patient "may have had swollen glands in her neck area." On 27-Jan-2007 the patient experienced lethargy. On 28-Jan-2007, the patient developed nausea and a rash with pruritus on back. The paiten took BENADRYL and "felt that this helped." On 30-Jan-2007, the patient was seen by a dermatologist, fulll cutaneous examination revealed that the left scapular back had a diffuse area of scale and erythema. the right upper abdomen had on 0.6 cm erythematous lesion with a central erythematous papule. The left abdomen had2 similar 0.6 cm lesions that were slightly more urticarial in their erythema. the remainder of the complete cutaneous examination failed to reveal any additional nuspicion or active lesions. Impression include dermatitis, fever papular urticaria and to consider hypersensitivity. The patient was treated with CUTIVATE. The dermatologist did not feel that the reaction was necessarily related to GARDASIL and recommended that she compete her vaccination course. On 29-Mar-2007, the patient was vaccinated with her second dose of GARDASIL ("lot # 02446"). The patient''s mother, a registered nurse reported that she developed hives on her forearms, trunk and buttocks. The patient did not seek medical attention for the hives. At the time of the report, the patient recovered. The dermatologist felt that since the patient may have a sensitivity to beans and other legumes this may be the source of the eruption. The physician considered the events to be non-serious (previously reported as disabling events by the registered nurse). No further information is available. This report no longer meets the criteria for expidited submission to the FDA. Follow-up information reported that the events were considered to be non serious. Medical records are available upon request.


VAERS ID: 272082 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Utah  
Vaccinated:2007-01-25
Onset:2007-01-28
   Days after vaccination:3
Submitted: 2007-02-09
   Days after onset:12
Entered: 2007-02-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Public       Purchased by: Private
Symptoms: Fatigue, Injection site pain, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0702USA00410

Write-up: Information has been received from a Nurse Practitioner concerning a 19 year old white female who on 25-JAN-2007 was vaccinated intramuscularly with Gardasil (lot number not provided). On 28-JAN-2007 the patient experienced injection site pain and fatigue and developed pruritus and hives on her whole body. The patient was seen on an unspecified date by her primary care physician (contact information not provided) and treated with Vistaril 50 mg, PO every 6 hours and "comfort measures". On an unspecified date the patient was considered to have recovered from the hives, injection site pain and fatigue. The reporter considered the pruritus and hives to be serious other medical events. Additional information has been requested.


VAERS ID: 272106 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-01-04
Onset:2007-01-12
   Days after vaccination:8
Submitted: 2007-02-06
   Days after onset:25
Entered: 2007-02-12
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Headache, Somnolence, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE? Fluticasone?
Current Illness: NONE
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data: NONE - no testing performed by school
CDC Split Type:

Write-up: Mother reported that on 1/12/07 patient was found in dorm room shaking rapidly, unarousable for several minutes, dizzy when she did awaken and complain of headache next day. College infirmary said normal BP and neuro status intact. Patient denies use of any alcohol or drugs.


VAERS ID: 272108 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Kansas  
Vaccinated:2007-01-25
Onset:2007-01-26
   Days after vaccination:1
Submitted: 2007-02-02
   Days after onset:7
Entered: 2007-02-12
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 00110 / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Headache, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC, oral contraceptive pill
Current Illness: NONE
Preexisting Conditions: Seasonal allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headache, nausea, vomiting, subjective fever.


VAERS ID: 272155 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Maryland  
Vaccinated:2007-02-06
Onset:2007-02-07
   Days after vaccination:1
Submitted: 2007-02-12
   Days after onset:5
Entered: 2007-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0960F / UNK RA / IM
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1704DA / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Injection site induration, Injection site pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Required ER TX plus 2 additional MD office visits RX Prednisone.
CDC Split Type:

Write-up: 5cm tender induration at site (R biceps) with redness extending entire fore arm and pain at site of injection (Gardasil).


VAERS ID: 272166 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-03
Onset:0000-00-00
Submitted: 2007-01-31
Entered: 2007-02-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1424F / 1 - / IM
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 1 - / -
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR 205722 / 1 - / IM

Administered by: Military       Purchased by: Unknown
Symptoms: Pregnancy test negative, Pregnancy test positive
SMQs:, Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt had negative pregnancy test 1/3/07, given smallpox vaccine and HPV. Had positive pregnancy test 1/27/07.


VAERS ID: 272170 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2006-12-04
Onset:0000-00-00
Submitted: 2007-02-06
Entered: 2007-02-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 2 RA / -

Administered by: Private       Purchased by: Other
Symptoms: Computerised tomogram, Injection site induration, Injection site pain, Nerve injury
SMQs:, Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin
Current Illness:
Preexisting Conditions: PCOS
Allergies:
Diagnostic Lab Data: CT Scan
CDC Split Type:

Write-up: Knot on arm after x 2 days, nerve damage, pain at site.


VAERS ID: 272173 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Virginia  
Vaccinated:2006-11-22
Onset:2006-12-01
   Days after vaccination:9
Submitted: 2007-02-09
   Days after onset:70
Entered: 2007-02-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 2 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Episodes of transient paralysis.


VAERS ID: 272191 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-21
Onset:2006-12-21
   Days after vaccination:0
Submitted: 2007-02-12
   Days after onset:53
Entered: 2007-02-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypokinesia, Pain in extremity
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives
Current Illness:
Preexisting Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00017

Write-up: Information has been received from a physician concerning a 20 year old female with a penicillin allergy and no other reported health history who on 21-DEC-2006 was vaccinated with a first dose of Gardasil (lot # 654389/0961F) (0.5 ml), intramuscularly. Concomitant therapy included birth control pills. Subsequently, she had experienced severe pain in the arm since the vaccination. She was unable to raise her arm more than a 45 degree angle. She had been seen by her family physician who diagnosed her with "Frozen Arm Syndrome". it was reported that she would be seen by an orthopedic surgeon in a few days. It was noted that the patient is "thin build, weighed 119 pounds and was five feet six inches tall. It was noted that there was no previous injury to area or to arm. Unspecified medical attention was sought. At the time of the report, the patient was considered to be not recovered. The patient''s experiences were considered to be disabling. Additional information has been requested.


VAERS ID: 272192 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-11-01
Onset:2007-01-01
   Days after vaccination:61
Submitted: 2007-02-12
   Days after onset:42
Entered: 2007-02-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose increased, Diabetes mellitus, Pollakiuria, Thirst
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Blood glucose 674
CDC Split Type: WAES0702USA00726

Write-up: Information has been received from a physician and the mother of a 12 year old female who in November 2006, was vaccinated intramuscularly with the first dose of Gardasil. It was reported that the patient returned to the physician''s office to receive her second dose of Gardasil and the patient''s mother mentioned to the physician that her daughter had recently complained of always being thirsty, frequent urination and her blood sugar was noted as 674. In January 2007, the patient was diagnosed with diabetes and was hospitalized. The patient was in the hospital for several days and was released (date unknown). At the time of this report, the outcome of the event was unknown. It was unknown if the patient received her second dose of Gardasil. Additional information has been requested.


VAERS ID: 272196 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: New York  
Vaccinated:2007-02-07
Onset:2007-02-07
   Days after vaccination:0
Submitted: 2007-02-13
   Days after onset:6
Entered: 2007-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB115BA / UNK - / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / UNK - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Blood pressure decreased, Fall, Head injury, Loss of consciousness, Scan brain, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Allergic to Ceclor
Allergies:
Diagnostic Lab Data: Brain/C spin CT negative.
CDC Split Type:

Write-up: Approx 2-5 minutes after receiving vaccines patient passed out while getting dressed. There was no witness to the event. Patient lost consciousness and fell from the seated position hitting head in 3 places. Blood pressure had dropped. Patient had a short episode of tremors during the recovery phase. Patient was allowed to rest and rehydrate until blood pressure returned to normal (100/80) 30 minutes later.


VAERS ID: 272208 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-02-07
Onset:2007-02-08
   Days after vaccination:1
Submitted: 2007-02-13
   Days after onset:5
Entered: 2007-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0186U / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Malaise, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen PRN
Current Illness:
Preexisting Conditions: Sulfa allergy, headaches, overweight, Metrol/ Menorrhagia.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pruritis, Malaise


VAERS ID: 272216 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-11-07
Onset:2006-11-07
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:99
Entered: 2007-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1213R / 2 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 08005 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Malaise, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: On 11/7/2006, Patient was administered Hepatitis B vaccine (dose #2) and Gardasil (dose #1), and developed severe nausea and vomiting approximately 12 hours later, lasting for approximately 1 hour. Patient felt ill the following day, then recovered. No rash, no fevers. No other reactions. No prior reactions to HepB vaccine.


VAERS ID: 272217 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Maryland  
Vaccinated:2007-01-24
Onset:2007-01-24
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:21
Entered: 2007-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1162F / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Malaise, Nausea, Retching, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient administered vaccine, then developed severe nausea and vomiting including "dry heaves" approximately 6 hours later, lasting for approximately 1 hour. Patient felt ill the following day, and had vomiting x1 that morning. Then patient fully recovered,


VAERS ID: 272237 (history)  
Form: Version 1.0  
Age: 39.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-01-30
Onset:0000-00-00
Submitted: 2007-02-08
Entered: 2007-02-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0014U / 2 RA / -

Administered by: Private       Purchased by: Unknown
Symptoms:
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: See note (attached) 02/15/2007-record received and reviewed. Office visit of 02/08/07-Assessment. Allergic reaction on chest back and left arm. Patient thinks it is related to Gardasil. Received treatment in Mexico. Treated with Betamethasone. Diagnosed with erythema multiforme. Right arm at injection site is not irritated or edematous. Allergic reaction mostly in the contralateral side.


VAERS ID: 272245 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2007-02-09
Onset:2007-02-10
   Days after vaccination:1
Submitted: 2007-02-14
   Days after onset:4
Entered: 2007-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 2 - / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Oedema, Pruritus, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: oral contraceptives
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 16 year old female developed edema, rash and pruritus within 24 hours of receiving second Gardasil shot.


VAERS ID: 272267 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Maryland  
Vaccinated:2007-01-26
Onset:2007-01-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2007-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Nausea, dizziness


VAERS ID: 272272 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Washington  
Vaccinated:2006-10-20
Onset:2006-10-20
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:117
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion threatened, Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Foetal non-stress test, No adverse effect, Pregnancy, Ultrasound scan, Wrong drug administered
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hospitalisation: premature labour, yeast infection, artificial rupture of membrane, abortion threatened. Pregnancy NOS (LMP=3/1/2006), kidney infection, smoker, premature labour, cervical dysplasia, cervical incompetence, allergic reaction to antibiotic, hypersensitivity
Allergies:
Diagnostic Lab Data: Test, Date, Value, Unit, Normal Range, Comment diagnostic nonstress test, 06/26/06, "maternal serum alphafetoprotein-in range normal" fetal nonstress test, 11/15/06 fetal nonstress test, 11/15/06 fetal nonstress test, 11/16/06 fetal nonstress test, 11/20/06 ultrasound, 04/21/06, "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus" ultrasound, 04/14/06, "positive intrauterine pregnancy (IUP), gestational sac only, negative fetal heart tone, right corpu ultrasond, 05/02/06, "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus" ultrasound, 05/02/056, "gestational age, threatened abortion" ultraound, 11/06/06, "amniotic fluid index=28.4" "rule out ruptured membranes"
CDC Split Type: WAES0610USA12632

Write-up: Initial and follow up information has been received through the Merck regulatory pregnancy registry from a registered nurse at a health department and an unspecified family member concerning a 23 year old white female smoker who was 34 weeks pregnant with cervical incompetence, allergies to erythromycin and moxifloxacin hydrochloride (AVALOX) and had a history of premature labour from a prior pregnancy, a history of 3 pregnancies and 2 live births, a yeast infection, a threatened abortion, "ruptured membranes/delivery" and cervical dysplasia that had required a LEEP surgery, however, this procedure was not performed as the patient became pregnant. On 14-APR-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), gestational sac only, negative fetal heart tone, right corpus". On 21-APR-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus". On 02-MAY-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus" and "gestational age, threatened abortion". On 26-JUN-2006, the patient underwent a maternal serum alphafetoprotein (MSAFP) which revealed "in range normal". It was reported that on an unspecified date, the patient had been hospitalized due to "lower back contractions". The patient had been diagnosed with a kidney infection and was advised to see her primary care physician for a flu shot. On 17-OCT-2006, (conflicting information also reported as 20-OCT-2006), the patient went to her physician and received one dose of 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast) administered intramuscularly instead of the flu shot. Concomitant therapy included prenatal vitamins and unspecified therapies (reported as "tributylene", "suflexan" and "cyclomenzaprene"). On 16-OCT-2006 (conflicting information also reported as 20-OCT-2006), the patient was not having any adverse reaction. It was reported that the patient had already been experiencing pre-term labour, prior to receiving the shot. The patient sought unspecified medical attention. On 24-OCT-2006, the patient received a 1 cc flu shot. On 02-NOV-2006, the patient received betamethasone (CELESTONE), 12 mg, intramuscularly to "decrease contractions". On 06-NOV-2006, the patient underwent an ultrasound which revealed "amniotic fluid index=28.4" and "rule out ruptured membranes". On 15-NOV-2006, 16-NOV-2006, and 20-NOV-2006, the patient underwent a fetal nonstress test (NST) (results not reported). On an unspecified date, the patient received acetaminophen/codeine phosphate (TYLENOL WITH CODEINE #3) for migraines. At the time of this report, the outcome of the events were unknown. The reporter stated that the patient had been hospitalized "prior to receiving the hpv rl1 6 11 16 18 vlp vaccine (yeast) vaccination for an unrelated kidney infection and lower back contractions". Additional information has been requested.


VAERS ID: 272273 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-08-01
Onset:2006-08-01
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:197
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: plantar warts
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA05105

Write-up: Information has been received from a physician concerning an approximately 17 year old female with plantar warts since August 2005 who in August 2006, was vaccinated with fist dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. In September 2006, the patient received second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) 1 month after the first dose. The patient sought medical attention. The physician noted as of 16-NOV-2006, the patient''s plantar warts resolved. The patient noticed that the plantar warts resolved (on an unspecified date in 2006) after the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) was received. A different physician administered the HPV rL1 6 11 16 18 VLP vaccine (yeast). No other information was available at the time of reporting. Additional information was received from the physician who reported that is not an adverse event. The warts had been present for 2 years and were refractory to liquid nitrogen, imiquimod (ALDARA CREAM), and laser treatment. Additional information is not expected.


VAERS ID: 272274 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-12-15
Onset:2006-12-15
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:61
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 427U7AA / 1 - / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK - / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 - / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 - / SC

Administered by: Private       Purchased by: Private
Symptoms: Inappropriate schedule of drug administration, Pyrexia, Wrong drug administered
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Test, Date, Value, Unit, Normal Range, Comment-body temp, 12/17/06, slight fever
CDC Split Type: WAES0612USA02803

Write-up: Initial and follow up information has been received from a physician and an office manager concerning a 12 month old white female patient with no past medical history who on 15-DEC-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant vaccinations on the same day included a first dose of measles-mumps-rubella vaccine (MSD) SC into the left leg, Hib conj vaccine (OMPC) (manufacturer unknown) and a first dose of varicella virus vaccine live (MSD) SC into the left leg. Other concomitant vaccinations included a first dose of influenza virus split virion 3v vaccine inactivated (FLUZONE) (lot# 427U7AA) IM into the right leg. It was reported that the patient received HPV rL1 6 11 16 18 VLP vaccine (yeast) by accident. She was supposed to receive a dose of pneumococcal 4 6B 9V 14 18C 23F conj vaccine (CRM197) (PREVNAR). The reporter stated that the products were clearly labeled; there was not a confusion of products. It was "lack of education" of the medical assistant working on the office. The parents reported the patient had slight fever on 16-DEC-2006 (also reported as the 17-DEC-2006). Subsequently, the patient was seen in the office on 18-DEC-2006 and had recovered from slight fever. There were no there reported problems or "any other adverse events." Additional information is not expected.


VAERS ID: 272275 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-27
Onset:2006-12-27
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:49
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / -

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00257

Write-up: Information has been received from a nurse concerning her daughter, a 13 year old female who on 27-DEC-2006 was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 27-DEC-2006 the patient developed dizziness and nausea. The patient''s dizziness and nausea persisted. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 272276 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: New York  
Vaccinated:2006-12-08
Onset:2006-12-08
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:68
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 UN / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / 1 UN / -
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / -

Administered by: Private       Purchased by: Private
Symptoms: Fall, Feeling abnormal, Headache, Injury, Loss of consciousness, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA00266

Write-up: Information has been received from a physician concerning a 12 year old female with no illness at the time of vaccination who on 08-DEC-2006 was vaccinated with a 0.5 ml first dose of Gardasil (yeast) (lot 653938/0954F). On 08-DEC-2006, the patient was concomitantly vaccinated with a first dose of Menatra, a dose of influenza virus vaccine (unspecified) and a dose of Boostrix. On 08-Dec-2006, the patient fainted shortly after vaccination. She fell from a standing position and hit the back of head on the floor. She was unconscious for approximately 30 seconds,a and then was dazed and pale. The patient was "ok" after a few minutes. The patient complained of a headache, frontal to occipital. The patient was "ok" at home later that evening. The patient recovered with no sequalae on 08-DEC-2006. Additional information is not expected.


VAERS ID: 272277 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Tennessee  
Vaccinated:2006-11-01
Onset:2006-12-21
   Days after vaccination:50
Submitted: 2007-02-14
   Days after onset:55
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Human papilloma virus test positive
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: diagnostic laboratory 12/21/06 - "HPV DNA" test positive for type 16
CDC Split Type: WAES0701USA00386

Write-up: Information has been received from a female patient who in November 2006, was vaccinated with the second dose of Gardasil (yeast). It was reported that the patient received the first vaccination in September 2006. On 21-Dec-2006, the patient underwent an "HPV DNA" test. The results indicated that the patient tested positive for HPV type 16. The patient sought unspecified medical attention. The patient''s outcome was not reported. Additional information has been requested.


VAERS ID: 272278 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:2006-12-01
Onset:2006-12-01
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:75
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Body temperature increased, Cough, Pyrexia, Sinus congestion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Cold; upper respiratory tract infection
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: body temperature 12/01?/06 101.5
CDC Split Type: WAES0701USA00406

Write-up: Information has been received from a physician concerning a 24 year old female patient with NKDA who on 01-DEC-2006 was vaccinated into the left deltoid with a first dose of Gardasil (yeast) (lot#653978/0955F). At the time of vaccination the patient had "mild URI symptoms and a cold" with no fevers. In the week following vaccination, the patient developed a temperature of 101.5 and her URI progressed to sinus congestion and cough. Additional information has been requested.


VAERS ID: 272279 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Washington  
Vaccinated:2006-12-01
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1424F / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00410

Write-up: Information has been received from a physician concerning a 14 year old female who in approximately December 2006, " a few weeks ago," was vaccinated with a dose of Gardasil (yeast) (lot#654885/1424F). Subsequently, "after her first shot" the patient developed hypertension. The patient sought unspecified medical attention. The patient''s outcome was not reported. Additional information has been requested.


VAERS ID: 272280 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-01-03
Onset:2007-01-03
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:42
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA00415

Write-up: Information has been received from a physician concerning a 15 year old female who on 03-Jan-2007 was vaccinated with a 0.5 ml dose of Gardasil (yeast). There was no concomitant medication. On 03-Jan-2007, after receiving the vaccination, the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.


VAERS ID: 272281 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2006-10-24
Onset:2006-11-01
   Days after vaccination:8
Submitted: 2007-02-14
   Days after onset:105
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Laboratory test normal, Menstruation irregular
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: diagnostic laboratory, 02/??/07, ok, unspecified tests
CDC Split Type: WAES0701USA00441

Write-up: Information has been received from a nurse practitioner and certified medical assistant concerning a 13 year old female who on 24-OCT-2006 was vaccinated intramuscularly into the left deltoid with a first 0.5 mL dose of Gardasil (yeast) (lot# 653937/0637F). There was no concomitant medication. She was administered a second 0.5 ml dose of Gardasil (yeast), intramuscularly (Lot # 653735/0688F) into the right detoid on 26-DEC-2006. There was no illness at the time of vaccination. It was reported that the patient, who has had her regular menses since the age of 10, had not had her regular menses in November 2006 or December 2006. The medical assistant further reported that the patient''s menses stopped in October 2006 after the first dose and she had no menses in November or December 2009. she started her meneses in January 2007 and in Febraury 2007, saw a physician for tests (unspecified). All was reported to be ok. The patient reported no other problems and was not reported to be pregnant. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. All was reported to be ok. The patient reported no other problems and was not reported to be pregnant. Addtional information is not expected.


VAERS ID: 272282 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00481

Write-up: Information has been received from a registered pharmacist, also the patient, via a company representative, concerning herself. The pharmacist reported that during her second dose of Gardasil (yeast), she experienced a tremendous amount of stinging. She also noted that the second day after vaccination she was still very sore. Additional information has been requested.


VAERS ID: 272283 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00488

Write-up: Information has been received from a nurse practitioner concerning four patients who were vaccinated with Gardasil (yeast). Subsequently the four patients experienced a fainting episode. At the time of the report, it was not reported if the four patients recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.


VAERS ID: 272284 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Ohio  
Vaccinated:2006-12-07
Onset:2006-12-07
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:69
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 2 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Activities of daily living impaired, Asthenia, Body temperature normal, Contusion, Hyperaemia, Injection site pain, Pain, Pain in extremity, Tenderness, X-ray limb normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown X-ray, 01/04/07, shoulder-no bony abnormalities or myositis ossificans; Body temp, 12/20/06, 97.4
CDC Split Type: WAES0701USA00569

Write-up: Information has been received from a physician concerning a 15 year old female who on 07-DEC-2006 was vaccinated intramuscularly with a second dose of GARDASIL. On 07-Dec-2006 the patient experienced significant arm pain, including through the passive motion. The physician reported that the patient was sent to see an orthopedic physician on 03-JAN-2007 because the patient was a dancer and could not dance with extreme pain. At the time of this report, the outcome was unknown. It was also reported that the patient was vaccinated with a first dose of GARDASIL on 12-OCT-2006 and there was no adverse experience with this initial dose. No product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up informtion has been received froma physician and medical records concerning a 15 year old female who on 07-DEC-2006 was vaccinated intramuscularly with a second dose of GARDASIL vaccine (Lot number 653938/0954F). On 07-DEC-2006 the patient experienced significant arm pain, including through passive motion, limitating activities. The patient was again seen in the physicia''s office on 14-DEC-2006 still with "arm hurting". During physical examination, it was noted that the patient had a "small 1 cm greenish older bruise with no palpable mass in the deltoid area". The patient was treated with ALEVE, 2 tablets orally twice a day as necessary for pain. The patient returned to the physician''s office on 20-DEC-2006 still with "arm sore, still unable to move to do some dance" (previously reported as could not dance with extreme pain). Physical examination noted the deltoid area with no palpable mass, tenderness to palpation by report but with no wincing or guarding, and slight hyperemia". The physician referred the patient to an orthopedic physician. The patient was seen in the orthopedic physician''s office on 04-Jan-2007. According to the orthopedic physician''s office notes, the patient''s pain was localized to the injection site over the mid aspect of the deltoid muscles. This pain was associated with any overhead lifting and some weakness. There was no pain with rest. An x-ray of the shoulder are showed no evidence of bony abnormalities or myositis ossificans. The orthopedic physician''s assessment was that the patient had "a little residual irritation from the injection site, and the pain may be associated with some residual muscle spasms". The patient was prescribed FLEXERIL. It was also reported that the patient was vaccinated with a first dose of GARDASIL vaccine on 12-OCT-2006 and there was no adverse experience with this initial dose. Follow-up received on 7-FEB-2007 contained the following adverse experiences: rotational scoliosis (4-JAN-2007), and pharyngitis (20-DEC-2006). Additional informatinis not expected.


VAERS ID: 272285 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Amenorrhoea
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00596

Write-up: Information has been received from a registered nurse concerning a female (age not reported) who an unspecified date was vaccinated intramuscularly with a 0.5 ml dose of Gardasil (yeast) (lot number not reported). The nurse reported that the patient, after receiving the Gardasil (yeast), did not receive her next expected period. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.


VAERS ID: 272286 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Arizona  
Vaccinated:2007-01-02
Onset:2007-01-02
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:43
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / SC

Administered by: Other       Purchased by: Other
Symptoms: Incorrect route of drug administration, Injection site bruising, Injection site reaction, Injection site swelling
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Drug abuse and dependence (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00601

Write-up: Information has been received from al licensed practical nurse concerning a 17 year old female with no pertinent medical history, who on 02-JAN-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. The nurse reported that the patient received the vaccination via the subcutaneous route and on 02-JAN-2007, developed in injection site reaction. The reaction was described as being that of a swollen and bruised injections site on the patients shoulder. Unspecified medical attention was sought. The patient subsequently recovered on 03-JAN-2007.


VAERS ID: 272287 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Michigan  
Vaccinated:2006-12-29
Onset:2006-12-29
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:97
Entered: 2007-02-15
   Days after submission:49
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Fall, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00616

Write-up: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil. subsequently, following vaccination, the patient loss consciousness. The patient regained consciousness after a few minutes. Unspecified medical attention was sought. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Information has been received from a physician and a medical assistant concerning a 15 year old female with no past medical history, who on 29-DEC-2006, at 11:15 AM was vaccinated in the right arm with the first dose of GARDASIL (0.5 ml). There were no illnesses at time of vaccination. Subsequently, following vaccination, on 29-DEC-2006 at 11:20 AM the patient felt week and dizzy, then stated that she felt sick to her stomach. The patient suddenly fell forward into her mother''s arms, and passed out. The patient was passed out for less then a minute. The patient was given something to eat and drink and was kept in the office for 30 minutes. After the 30 minutes, the patient stated that she was fine. No further information is expected.


VAERS ID: 272288 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Menstruation irregular
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00621

Write-up: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL. Subsequently, following the second vaccination, the patient experienced irregular periods. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 272289 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: South Carolina  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA00644

Write-up: Information has been received from a physician concerning a female (age not reported) with pertinent medical history and drug reactions/allergies not reported who on an unspecified date was vaccinated with the first dose of Gardasil, injection, 0.5ml. Concomitant medications was not reported. Subsequently on an unspecified date, the patient developed a rash on her chest and arm after receiving the first dose of Gardasil. The physician gave the patient an antihistamine (unspecified) and the rash on her chest and arm cleared in about 20 minutes. Subsequently the same day, the patient recovered from rash on her chest and arm. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a physician concerning a 23 year old, female student with no pertinent medical history who on an unspecified date was vaccinated, intramuscularly, into the deltoid with the first dose of GARDASIL injection 0.5 ml. Concomitant medication was not reported. Subsequently on an unspecified date, the patient developed a rash on her chest and arm after receiving the first dose of GARDASIL. The physician gave the patient an antihistamine (unspecified) and the rash on her chest and arm cleared in about 20 minutes. Subsequently the same day, the patient recovered from the rash on her chest and arms. Additional information is not available.


VAERS ID: 272290 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-09-06
Onset:2006-09-06
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:161
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Allergic reaction to antibiotics.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA00697

Write-up: Information has been received from a registered nurse concerning a 21 year old female with pertinent medical history reported as none and allergic reaction to some antibiotics who on 06-SEP-2006 was vaccinated with the first dose of Gardasil. Concomitant medication was reported as none. On approximately 06-SEP-2006, the patient developed injection site pain that lasted 3 days following vaccination with Gardasil. On an unspecified date, the patient sought unspecified medical attention. On approximately 08-SEP-2006, the patient recovered from injection site pain. The patient had not received her second dose of Gardasil. Additional information has been requested.


VAERS ID: 272291 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2006-12-30
Onset:2007-01-01
   Days after vaccination:2
Submitted: 2007-02-14
   Days after onset:44
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1208F / 1 - / IM

Administered by: Private       Purchased by: Public
Symptoms: Pregnancy test negative, Uterine haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Urine beta human 01/01/07 negative
CDC Split Type: WAES0701USA00701

Write-up: Information has been received from a registered nurse and physician assistant certified concerning a 16 year old female with on known drug allergies, no illness at time of being vaccinated, and no medical history who on 30-DEC-2006 was vaccinated with first dose of Gardasil (lot #654741/1208F) intramuscularly left deltoid at 1400 hours. There was no concomitant medication. On 01-JAN-2007, at 1400 hours the patient experienced abnormal uterine bleeding (Spotting) uncomplicated and sought medical attention. The patient already had her period (normal menses 27-DEC-2006) and had been "spotting all during this past week". They thought pregnancy was possible so they administered a urine pregnancy test (negative) and she was not pregnant. She had no abdominal pain and no previous history of abnormal uterine bleeding. The outcome of the uterine bleeding was not reported. Additional information has been requested.


VAERS ID: 272292 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA00702

Write-up: Information has been received from a registered nurse concerning her niece a female (age not reported) with pertinent medical history and drug reactions/allergies not reported who in 2006 was vaccinated with the first and second doses of Gardasil, IM (1st and 2nd dose over a two month period). Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced vomiting and diarrhea after the first and second doses of Gardasil series. The patient sought unspecified medical attention. The nurse reported that the patient does not plan to have the third dose as recommended. Subsequently on an unspecified date, the patient recovered from vomiting and diarrhea. Additional information has been requested.


VAERS ID: 272293 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-19
Onset:2006-12-28
   Days after vaccination:9
Submitted: 2007-02-14
   Days after onset:48
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Headache, Injection site rash, Tenderness
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tetanus toxoid
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA00749

Write-up: Information has been received from a physician and the mother of a 12 year old female with pertinent medical history and drug reactions/allergies reported as none who on 19-DEC-2006 was vaccinated with the first dose of Gardasil (lot #655165/1425F). concomitant therapy included tetanus toxoid. On 28-DEC-2006, the patient experienced a rash at the injection site right after receiving the vaccination. The patient also experienced mild headaches almost immediately. A few days later the patient''s headaches became more intense. The patient still experienced intermittent headaches but the severity has not decreased. On 31-DEC-2006, the patient presented to the physician office and complained that she had a headache for four days. The patient was told by the physician to increase the dosage of Motrin. On 01-JAN-2007, the patient presented to the physician office again and stated that she was not better and still had a headache. The physician stated when the patient pressed over her sinus area it seemed tender. The patient was treated with oral antibiotics. The patients headache persisted. Additional information has been requested.


VAERS ID: 272294 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Washington  
Vaccinated:2007-01-04
Onset:2007-01-05
   Days after vaccination:1
Submitted: 2007-02-14
   Days after onset:40
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Burning sensation, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA00770

Write-up: Information has been received from a pharmacy intern concerning an 18 year old female with no pertinent medical history and no known adverse drug reactions and no known allergies reported. On 04-JAN-2007, the patient was vaccinated intramuscularly in the left arm with the first 0.5ml dose of Gardasil (lot #653736/0689F). There were no concomitant medications reported. On 05-JAN-2007, in the morning, the patient developed tingling in the fingers of her left hand with pain in the fingertips when touching anything. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow up information has been received from a pharmacy intern concerning an 18 year old female student with no pertinent medical history and no known adverse drug reactions and no known allergies reported. On 04-JAN-2007, at 4:55 PM, the patient was vaccinated intramuscularly in the left deltoid with the first 0.5 mL dose of GARDASIL (Lot # 653736/0689F). There were no concomitant medications reported. There were no known illnesses at the time of vaccination. On 05-Jan-2007, at 9:30 AM, upon waking in the morning, the patient developed a tingling, burning sensation on fingers (previously reported as tingling in the fingers of her left hand with pain in fingertips when touching anything). It was reported that the events spontaneously resolved by the following morning. On 06-JAN-2007, the patient had recovered from the events. No further information is available.


VAERS ID: 272295 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: New York  
Vaccinated:2006-12-22
Onset:2006-12-29
   Days after vaccination:7
Submitted: 2007-02-14
   Days after onset:47
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Sulfonamide allergy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA00778

Write-up: Information has been received from a physician concerning a female (age not reported) with a sulfonamide allergy and no other pertinent medical history reported. On 22-DEC-2006, the patient was vaccinated with 0.5ml of Gardasil ( Lot #655165/1425F). There were no concomitant medications reported. On 29-DEC-2006, one week after the injection, the patient developed a rash on her arms, legs and abdomen. The patient sought unspecified medical attention. It was reported that the rash had since cleared up but the date was unknown. At the time of this report, the patient had recovered from the event. Additional information has been requested. 5/14/10 Follow up: The patient took Benadryl for 24 hours and itching resolved. No diagnostic laboratory tests were performed. On 12-JAN-2007, the patient had recovered completely. Additional information is not expected.


VAERS ID: 272296 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: New York  
Vaccinated:2006-12-27
Onset:2007-01-02
   Days after vaccination:6
Submitted: 2007-02-14
   Days after onset:43
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZITHROMAX
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA00786

Write-up: Information has been received from a physician concerning a 25 year old female with no drug allergies who on 27-Dec-2006 was vaccinated with the first dose of Gardasil (yeast). Concomitant therapy included ZITHROMAX. Subsequently, on an unspecified date, the patient experienced nausea and dizziness. The patient did not seek medical attention. No diagnostic studies were performed. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. 5/14/10 Follow up: Subsequently, on 02-JAN-2007, the patient experienced headache, nausea and dizziness. The patient repsonded to Phenergan and Transderm scop. No diagnostic studies were performed. On 04-JAN-2007, the patient recovered from headache, nausea and dizziness. No product quality complaint was involved. No additional information is expected.


VAERS ID: 272297 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2006-10-13
Onset:2006-10-13
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:124
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Drug hypersensitivity
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0701USA00800

Write-up: Information has been received from a physician concerning a 15 year old female patient who was vaccinated with a first and second dose of Gardasil (yeast). Subsequently the patient fainted 15 minutes after each vaccination. Unspecified medical attention was sought. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow up information has been received from a physician and a nurse practitioner concerning a 16 year old female with drug hypersensitivity to CECLOR who on 13-OCT-2006, at 15:00 was vaccinated, IM into the left arm with a first dose of GARDASIL (lot# 653978/0955F). The patient fainted 15 minutes after vaccination. On 13-Oct-2006, the patient recovered on her own with mild dizziness, oriented times 3. On 13-DEC-2006, at 15:30 the patient was vaccinated, IM into the right arm with a second dose of GARDASIL (lot# 654389/0961F). She again fainted 10 minutes after vaccination. On 13-DEC-2006, the patient recovered on her own, oriented time 3. There were no laboratory or diagnostic test performed. No further information is available.


VAERS ID: 272298 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA00828

Write-up: Information has been received from a registered nurse concerning a 23 year old female office employee in her office with drug reactions/allergies and pertinent medical history reported as unspecified who on an unspecified date was vaccinated with first dose of Gardasil (yeast) (lot# not reported) intramuscularly. Concomitant therapy was unspecified. On an unspecified date, the patient was vaccinated in the gluteal area and she experienced injection site pain. The patient sought medical attention. At the time of reporting, the outcome of the event was unspecified. No other information was provided. Additional information has been requested.


VAERS ID: 272299 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-10-24
Onset:2006-10-24
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:113
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 AR / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Influenza like illness, Nausea, Pain, Stomach discomfort
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0701USA00832

Write-up: Information has been received from a nurse practitioner concerning her 18 year old daughter with drug reactions/allergies and medical history reported as unspecified who in approximately 2007 was vaccinated with second dose of Gardasil (yeast) (lot # not reported) 0.5 ml intramuscularly. Concomitant medication was unspecified. In approximately 2007, after the second dose of Gardasil (yeast), the patient experienced dizziness, and stomach upset. They were flu-like symptoms. The patient sought medical attention. At the time of reporting, the patient had recovered. No additional information was available at the time of reporting. Additional has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Information has been received from a nurse practitioner (NP) concerning her 18 year old daughter with drug reactions/allergies and medical history reported as unspecified who on 24-OCT-2006 was vaccinated with first dose of GARDASIL vaccine (lot # not reported) 0.5 ml intramuscularly in the deltoid. Concomitant medications was unspecified. On 24-OCT-2006, the patient experienced body aches and nausea. The outcome of the events was not reported. In approximately 2006, the patient received second dose of GARDASIL vaccine (lot # not reported 0.5 ml IM. Subsequently, the patient experienced dizziness, and stomach upset. They were flu-like symptoms. The patient sought medical attention. At the time of reporting, the patient had recovered. No additional information was available at the time of reporting. No other information is expected.


VAERS ID: 272301 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2007-01-05
Onset:2007-01-05
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:40
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness: Nervousness
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00872

Write-up: Information has been received from a physician concerning a 20 year old female who on 05-JAN-2007 was vaccinated intramuscularly with the first dose of Gardasil (yeast). Concomitant therapy included hormonal contraceptives (unspecified). The physician reported that the patient was extremely nervous about getting the shot. Later that evening, within 12 hours, the patient broke out in hives. The physician told the patient to go to the emergency room (ER). The patient went to the ER and was given BENADRYL for the hives. The physician reported that the patient was fine, but does not plan to give the patient anymore shots. There was no lot number provided. At the time of this report, it was noted that the patient was "fine after she had received BENADRYL. Additional information has been requested.


VAERS ID: 272302 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Michigan  
Vaccinated:2006-11-20
Onset:2006-11-22
   Days after vaccination:2
Submitted: 2007-02-14
   Days after onset:84
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Acne
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00894

Write-up: Initial information has been received from a physician via a company representative and follow-up information has been received from the physician concerning a 14 year old female student who, on 20-NOV-2006, was vaccinated with a 0.5 ml dose of Gardasil (yeast) (lot# not reported). There was no concomitant medication. Subsequently, on approximately 22-NOV-2006 or 23-NOV-2006, the patient developed a bad acne breakout. The physician reported that the patient developed "giant pimples" the likes of which she''d not experienced previously. The patient was reported to have been using over the counter acne wash which had been working well up to this point. The patient was put on oral antibiotics and given a topical wash for the breakout, which occurred on her face, chest and back. The patient''s acne breakout was continuing at the time of the report. Additional information has been requested.


VAERS ID: 272303 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-10-20
Onset:2006-11-05
   Days after vaccination:16
Submitted: 2007-02-14
   Days after onset:101
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0588F / 1 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: amoxicillin
Current Illness: Pharynigitis, Rhinitis allergic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00975

Write-up: Information has been received from a physician concerning a 15 year old female patient with allergic rhinitis who on 20-OCT-2006 was vaccinated intramuscularly in the morning with a first dose of Gardasil (yeast) (lot#653735/0688F). Illness at the time of vaccination included pharynigitis. Concomitant therapy included amoxicillin. In the evening of 05-NOV-2006, three weeks after vaccination, the patient developed shortness of breath. The patient had no history of asthma. Subsequently, on an unspecified date, the patient recovered. Additional information is not expected.


VAERS ID: 272304 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: California  
Vaccinated:2006-11-10
Onset:2006-11-10
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:96
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Bronchospasm, Cough
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol, ZYRTEC, tetanus toxoid
Current Illness: Asthma, Allergic eczema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA00990

Write-up: Information has been received from a registered nurse concerning a 13 year old female with asthma and allergic eczema who on 10-NOV-2006 at 12:00PM, was vaccinated in the right arm intramuscularly with a first 0.5 ml dose of Gardasil (yeast) (lot#653978/0955F). Concomitant suspect vaccination included a dose of tetanus toxoidon 10-NOV-2004. Other concomitant therapy included albuterol and ZYRTEC. There was no illness at the time of vaccination. On 10-Nov-2006 the patient experienced bronchospasm 20 minutes after receiving Gardasil (yeast). It was also reported that the patient developed a cough but she did not vomit. The patient used her albuterol inhaler and then rested and was recovered on the same day, 10-NOV-2006. No vomiting and no other anaphylaxis type reaction was noted. Additional information is not expected.


VAERS ID: 272305 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-01-08
Onset:2007-01-09
   Days after vaccination:1
Submitted: 2007-02-14
   Days after onset:36
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol, hormonal contraceptives
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA01015

Write-up: Information has been received from a registered nurse concerning an 18 year old female with asthma and no known allergies or adverse drug reactions reported. On 08-JAN-2007, the patient was vaccinated intramuscularly with the first 0.5 ml dose of Gardasil (yeast) (lot#655165/1425F). Concomitant therapy included hormonal contraceptives (unspecified) and albuterol. On 09-JAN-2007, the patient developed a rash on her back and chest. The patient sought unspecified medical attention. The patient was being treated with BENADRYL. At the time of this report, the patient had not recovered from the event.


VAERS ID: 272306 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: New York  
Vaccinated:2006-12-22
Onset:2006-12-22
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:54
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1424F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Feeling abnormal, Malaise, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen
Current Illness: Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA01016

Write-up: Information has been received from a physician concerning a 19 year old female with a penicillin allergy and no other pertinent medical history reported. On 22-DEC-2006, the patient was vaccinated intramuscularly with one dose of Gardasil (Lot #654885/1424F). Concomitant therapy included Ortho Tri Cyclen. On 22-DEC-2006, the patient felt nauseous shortly after administration. The patient then fainted for approximately 10 seconds while she was at the office. The patient remained in the office until she felt "normal" again. The patient then went home where later she felt sick again. The patient went to the emergency room and was then released. It was reported that there were no laboratory diagnostics performed at the physician''s office and it was unknown it any were performed in the emergency room. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested.


VAERS ID: 272307 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-11-09
Onset:2006-11-09
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:97
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Chills, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: penicillin (unspecified)
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: test, date, value unit, normal range, comment body temp, 11/10/06, 102.7 degr
CDC Split Type: WAES0701USA01050

Write-up: Information has been received from a physician concerning a 20 year old female patient with no allergies or medical history who on 09-NOV-2006, was vaccinated with the first 0.5 L, dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot unspecified). Concomitant therapy included penicillin. On 09-NOV-2006, at 1:30 P.M., the patient developed chills and fever of 102.7 degrees on 10-NOV-2006 at 7:00 P.M. The patient did not seek medical attention. The patient treated herself with acetaminophen (TYLENOL). The patient''s symptoms lasted until noon on 11-NOV-2006. Additional information has been requested.


VAERS ID: 272308 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2006-12-29
Onset:2006-12-29
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:97
Entered: 2007-02-15
   Days after submission:49
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1424F / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA01079

Write-up: Information has been received from a physician concerning an 18 year old female with pertinent medical history and drug reaction/allergies not reported who on 29-DEC-2006 was vaccinated with the first dose of Gardasil (Lot #654885/1424F), injection, 0.5ml. Concomitant medication was not reported. ON 29-DEC-2006, the patient developed hives within hours of receiving the first dose of Gardasil. The physician reported that the hives became more generalized within 24 hours. On 29-DEC-2006, therapy with human papillomavirus vaccine was discontinued. Subsequently on an unspecified date, the patient recovered from hives. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Information has been received from a physician concering his daughter an 18 year old female with pertinent medical history and drug reactions/allergies not reported who on 29-DEC-2006 was vaccinated with the first dose of GARDASIL (lot #654885/1424F), injection, 0.5 mL. Concomitant medication was not reported. On 29-DEC-2006, the patient developed hives at the injection site within hours of receiving the first dose of GARDASIL. The physician reported that "the hives became more generalized within 24 hours" and the patient "then developed hives on her trunk and knee the next day." On 29-DEC-2006, therapy with human papillomavirus vaccine was discontinued. Subsequently 48 hours after the vaccination, the patient recovered from hives. Additional information has been requested.


VAERS ID: 272309 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Arizona  
Vaccinated:2007-01-08
Onset:2007-01-08
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:37
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Therapy unspecified, erythromycin
Current Illness:
Preexisting Conditions: Pregnancy NOS (LMP Unknown) allergy to animal
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA01084

Write-up: Information has been received from a consumer through the pregnancy registry concerning a 15 year old daughter with pet allergies who on 08-JAN-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included prenatal medication (therapy unspecified) and erythromycin. On 08-JAN-2007, the patient was vaccinated with Gardasil and the patient was 14 weeks pregnant. The clinic administered the vaccine without confirming if her daughter was pregnant. The consumer stated that her daughter has experienced nausea since she received Gardasil. The physician did not administer the vaccine to the patient as she received the vaccination at a clinic. On 08-JAN-2007 therapy with Gardasil was discontinued. The outcome of the events was not reported. Additional information has been requested.


VAERS ID: 272310 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-08
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness, Paraesthesia
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA01086

Write-up: Information has been received from a physician''s assistant concerning a female who on 08-JAN-2007 was vaccinated intramuscularly with a dose of Gardasil. Subsequently the patient passed out and experienced tingling sensation from her shoulder to her fingertips. It was reported that the patient did not seek medical attention. At the time of the report, the patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 272311 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy, Vaccine positive rechallenge
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA01095

Write-up: Information has been received from a physician concerning a 14 year old female who was vaccinated with the first dose of Gardasil. Subsequently the patient experienced swollen lymph nodes on the same side as the injection two days after receiving the injection. The patient recovered from the swollen lymph nodes after the first injection with Gardasil. Two days after the second dose of Gardasil, the patient again experienced swollen lymph nodes on the same side as the injection. Clinical outcome related to the second occurrence of swollen lymph nodes in unknown. Additional information has been requested.


VAERS ID: 272312 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2007-01-02
Onset:2007-01-02
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:43
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA01236

Write-up: Information has been received from a health professional concerning a female pharmacist who on 02-JAN-2007 was vaccinated with a second dose of Gardasil. On 02-JAN-2007, the patient experienced a strong stinging sensation during vaccination. After vaccination, her arm swelled and was very sore at the injection site. On 03-JAN-2007, the patient recovered. It was reported that the patient did not experience any of these symptoms with the first vaccination with Gardasil. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. No further information is expected.


VAERS ID: 272313 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-12-27
Onset:2006-12-27
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:49
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK None
Allergies:
Diagnostic Lab Data: UNK None
CDC Split Type: WAES0701USA01335

Write-up: Information has been received from a registered nurse and a physician via a company representative concerning an 18 year old female who on 27-DEC-2006 was vaccinated intramuscularly with one dose of GARDASIL (lot 653978/0955F). On 27-DEC-2006 the patient passed out after getting GARDASIL. The patient sought unspecified medical attention. It was not reported if the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a registered nurse via a company representative concerning an 18 year old female student with no reported allergies who on 27-DEC-2006, at 9:30AM. was vaccinated intramuscularly into the left deltoid with a first dose of GARDASIL vaccine (Lot# 653978/0955F). There was no illness at the time of vaccination. Initial information indicated that on 27-DEC-2006 the patient passed out after getting GARDASIL vaccine. Follow-up information from the nurse clarified that the "patient felt faint after the injection but did not faint". The patient told the nurse that she had not eaten so they gave her some "coke" and after she sat for 15 minutes she felt better. The patient was reported as recovered on 27-DEC-2006. Additional information is not expected.


VAERS ID: 272314 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-11-21
Onset:2006-11-27
   Days after vaccination:6
Submitted: 2007-02-14
   Days after onset:79
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Anogenital warts, Haemoglobin
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin
Current Illness: Surgery
Preexisting Conditions: Papanicolaou smear abnormal
Allergies:
Diagnostic Lab Data: Hemoglobin
CDC Split Type: WAES0701USA01358

Write-up: Information has been received from a nurse practitioner concerning her daughter, a 20 year old female with possible human papilloma virus prior to May 2006 who had an abnormal Papanicolaou (PAP) smear and colposcopy, June 2006 who on 21-NOV2006 was vaccinated with a 0.5ml dose of Gardasil. Concomitant therapy included Yasmin. On 27-NOV-2006, the patient developed genital warts. The patient required laser surgery on 08-JAN-2007. Laboratory evaluation included hemoglobin. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.


VAERS ID: 272315 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: California  
Vaccinated:2006-11-10
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Muscle spasms
SMQs:, Dystonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA01378

Write-up: This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a physician concerning a 16 year old female patient with on pertinent medical history or drug reactions/allergies, who on 10-NOV-2006 was vaccinated intramuscularly with the first dose of Gardasil (0.5 ml) (lot #653937/0637F). There was no concomitant medication. Subsequently, on an unspecified date, the patient experienced severe cramping after her last menstruation which she had never experienced before. Unspecified medical attention was sought. The physician stated that no further doses of Gardasil will be given until further information was received. At the time of this report, the patient was recovering. No further information is expected. This is one of several report(s) received from the same source.


VAERS ID: 272316 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: California  
Vaccinated:2006-11-10
Onset:2006-11-12
   Days after vaccination:2
Submitted: 2007-02-14
   Days after onset:94
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Contusion
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA01392

Write-up: Information has been received from a physician and a certified medical assistant concerning a 14 year old female with no pertinent medical history who on 10-NOV-2006 was vaccinated IM with a first dose of Gardasil (lot #653937/0637F). There was no concomitant medication. On 12-NOV-2006 the patient developed "bad bruise". Unspecified medical attention was sought. On approximately 29-NOV-2006, the patient recovered. There were no laboratory or diagnostic tests performed. The physician reported that no further doses of Gardasil will be given until further information is received. Additional information has been requested. 5/14/10 Follow up: repored that medical attention was not sought. On approximately 29-NOV-2006, the patient recovered. There were no laboratory or diagnostic tests performed. The physician reported that no further doses of GARDASIL will be given until further information is received.


VAERS ID: 272317 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-12-22
Onset:2006-12-22
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:54
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA01401

Write-up: Information has been received from a registered nurse concerning a 20 year old female who on 22-DEC-2006 was vaccinated with Gardasil (yeast) (lot number 653978/0955F). On 22-DEC-2006 the patient passed out after vaccination. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a registered nurse concerning a 20 year old female student with no reported allergies who, at 10:00AM on 22-DEC-2006, was vaccinated into the left deltoid with a first dose of GARDASIL (Lot# 653978/0955F). There was no illness at the time of vaccination. On 22-DEC-2006, after the vaccination, the patient felt faint and passed out for a short time. The nurse reported that the patient was watched closely and felt fine after a while and then left the office, recovered the same day, 22-DEC-2006. Additional information is not expected.


VAERS ID: 272318 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-08
Onset:2007-01-10
   Days after vaccination:2
Submitted: 2007-02-14
   Days after onset:35
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA01402

Write-up: Information has been received from a physician concerning a 19 year old female who on 08-Jan-2007 was vaccinated with Gardasil (yeast) (lot number 655165/1425F) 0.5 ml intramuscularly. On 10-JAN-2007 the patient experienced 102 degrees F fever, chills and body aches for "the past 10 hours". The patient''s 102 degrees F fever and chills and body aches persisted. Additional information has been requested.


VAERS ID: 272320 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-01-09
Onset:2007-01-09
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:36
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Syncope
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0701USA01412

Write-up: Information has been received from an R.N. concerning a 19 year old female patient who on 09-JAN-2007 was vaccinated IM with a dose of GARDASIL (lot #653978/0955F) and felt dizzy and lightheaded. Medical attention was sought. At the time of the report the patient was recovering. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Follow up information has been received concerning the 20 year old female student who on 09-JAN-2007 at 9:30 a.m. was vaccinated IM in left deltoid with her first dose of GARDASIL, lot #653978/0955P. After the first injection, the patient felt faint. On 06-MAR-2007 at 10:00 a.m. The patient was vaccinated IM in left deltoid with her second dose of GARDASIL, lot #655619/1427P. After the second injection, the patient did faint. She went out approximately 5 minutes, came to and then felt fine. The patient stated she "does this for all injections, even eye drops". She was reported as recovered on 08-MAR-2007. Additional information is not expected.


VAERS ID: 272321 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:2007-01-08
Onset:2007-01-08
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:37
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA01532

Write-up: Information has been received from a physician concerning a female who on 08-JAN-2007 was vaccinated IM with a dose of Gardasil (yeast). It was noted that the patient fainted during the administration of the vaccine, the patient outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 272322 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA01535

Write-up: Information has been received from a physician concerning a female patient who was vaccinated with Gardasil (yeast). Subsequently the patient fainted. Unspecified medical attention was sought. At the time of this report the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 272323 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Ohio  
Vaccinated:2007-01-04
Onset:2007-01-04
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:41
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Feeling abnormal
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA01567

Write-up: Information has been received from a registered nurse concerning a 26 year old female with no medical history or allergies, who on 04-JAN-2007 was vaccinated IM with a 0.5 ml dose of Gardasil (yeast). There was no concomitant medication. On 04-JAN-2007 the patient felt dizzy and had a sensation of hands being pressed down on her head. No other symptoms were noted. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. The symptoms lasted about 15 to 20 minutes and then resolved. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 272324 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA01586

Write-up: Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of Gardasil (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 272325 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Iowa  
Vaccinated:2006-09-01
Onset:2006-09-01
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:166
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Inflammation, Nuclear magnetic resonance imaging, Pain in extremity, Radiculitis brachial
SMQs:, Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: magnetic resonance - narrative
CDC Split Type: WAES0701USA01747

Write-up: Information has been received from a nurse practitioner concerning a female who on an unspecified date was vaccinated with the first dose of Gardasil (yeast). Subsequent following vaccination, the patient experiences extreme pain in the arm and inflammation. The patient underwent physical therapy and was diagnosed as having brachial neuritis. It was not specified if the series of Gardasil (yeast) would be completed. At the time of this report, the patient was recovering from the brachial neuritis. Additional information has been requested.


VAERS ID: 272326 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: New York  
Vaccinated:2006-10-04
Onset:2006-10-07
   Days after vaccination:3
Submitted: 2007-02-14
   Days after onset:130
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 0659F / UNK UN / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Vaccine positive rechallenge, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA01772

Write-up: Information has been received from a registered nurse concerning a 16 year old female with an aspirin allergy who on 04-OCT-2006 at 16:00 and 11-DEC-2006 at 14:30 was vaccinated IM into the right deltoid with a first and second dose of Gardasil (first dose lot #653736/0689F, second dose lot #654510/0962F). Concomitant therapy given on 04-OCT-2006 and 11-DEC-2006 included a dose of Havrix. Three days after the first dose, the patient vomited for 2 days and was out of school. Three days after the second dose the patient threw up a lot more for 2 days and was out of school. The nurse was concerned about this patient and considered her condition to be disabling since she missed school for two days after each dose. Unspecified medical attention was sought. No diagnostic laboratory studied were performed. No product quality complaint was involved. Additional information is not expected.


VAERS ID: 272327 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-12-21
Onset:2006-12-21
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:55
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamins (unspecified)
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA01775

Write-up: Information has been received from a licensed practical nurse concerning a female with no pertinent medical history and no known allergies who on 21-DEC-2006 was vaccinated into the right arm with a 0.5 ml first dose of Gardasil (yeast) (lot#654389/0961F). Concomitant therapy included unspecified over the counter vitamin supplements. Subsequently the patient experienced severe deep pain in her right shoulder. Unspecified medical attention was sought and there was no treatment given. At the time of the report, the patient had not recovered. Additional information has been requested.


VAERS ID: 272328 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: New York  
Vaccinated:2007-01-07
Onset:2007-01-07
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:38
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: diabetes, eczema
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA01778

Write-up: Information has been received from a physician concerning a 12 year old female with diabetes and eczema who on approximately 07-JAN-2007 was vaccinated with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) concomitantly with a dose of an unspecified vaccine. On approximately 07-JAN-2007, later in the night, the patient developed hives all over her body, mostly on her legs. Unspecified medical attention was sought. At the time of the report, the patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 272329 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA01779

Write-up: Information has been received from a physician concerning a female who was vaccinated with a first dose of Gardasil (yeast). Subsequently the patient complained of pain and then fainted within minutes of administration. Subsequently, the patient recovered without any additional treatment. Additional information has been requested.


VAERS ID: 272330 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-11-02
Onset:2006-12-01
   Days after vaccination:29
Submitted: 2007-02-14
   Days after onset:75
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: HIV test false positive
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Serum HIV-1 p24, 12/06, false positive
CDC Split Type: WAES0701USA01810

Write-up: Information has been received from a physician concerning a 17 year old female with no medical history or allergies, who on 14-AUG-2006 on 02-NOV-2006 was vaccinated IM with a first and second 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. In December 2006, the patient had a false positive HIV result. It was noted that the physician stated that the patient had no risk factors for HIV. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 272331 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Washington  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA01889

Write-up: Information has been received from a registered nurse concerning a female patient who on an unknown date was vaccinated intramuscularly with the first dose of 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, it was reported that the felt faint post vaccination. The patient sought unspecified medical attention. At the time of this report, it was unknown if the patient had recovered from the event. Additional information has been requested.


VAERS ID: 272332 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Washington  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA01890

Write-up: Information has been received from a registered nurse concerning a female patient who on an unknown date was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, it was reported that the patient felt faint post vaccination. The patient sought unspecified medical attention. At the time of this report, it was unknown if the patient had recovered from the event.


VAERS ID: 272333 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-12
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA01933

Write-up: Information has been received from a registered nurse concerning a 13 year old female who on 12-DEC-2006 was vaccinated with her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain down her arm one month after receiving her second dose. The patient''s pain down her arm persisted. Additional information has been requested.


VAERS ID: 272334 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-12
Onset:2007-01-12
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:33
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA01947

Write-up: Information has been received from a physician concerning a 13 year old female who on 12-JAN-2007 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5 ml intramuscularly. The patient fainted when she got outside in the parking lot of the physician''s office (also reported as within 10 minutes). The patient was brought back into the physician''s office and "let rest for a while". The physician checked the patient''s blood pressure (no details provided). The physician noted that the patient is "fine now". Additional information has been requested.


VAERS ID: 272335 (history)  
Form: Version 1.0  
Age: 38.0  
Sex: Female  
Location: California  
Vaccinated:2006-12-07
Onset:2006-12-08
   Days after vaccination:1
Submitted: 2007-02-14
   Days after onset:68
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Fluid retention, Weight increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0701USA01976

Write-up: Information has been received from a medical assistant concerning a 38 year old female with edema who on 07-DEC-2006 "between 9 a.m. and 5 p.m." was vaccinated IM, into the right deltoid, with a 0.5 ml first dose of GARDASIL vaccine. Concomitant therapy included hormonal contraceptives (unspecified). On 08-Dec-2006 the patient "gained 13 pounds of water weight". Medical attention was sought and the patient was treated with unspecified diuretics. On approximately 29-Dec-2006, the patient recovered from "gained 13 pounds of water weight". Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. On 29-DEC-2006, the patient recovered from weight gain and edema. Additional information is not expected.


VAERS ID: 272336 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-12-14
Onset:2006-12-14
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:62
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0701USA01977

Write-up: Information has been received from a licensed practical nurse concerning a female who on 19-SEP-2006 was vaccinated intramuscularly (IM) with a first 0.5 ml dose of GARDASIL vaccine. Subsequently the patient experienced pain at the injection site. Unspecified medical attention was sought. It was reported that the patient did not return to complete the schedule. Additional information has been requested. This is in follow-up to report (s) previously received on 2/14/2007. On 14-DEC-2006, the patient was vaccinated with IM GARDASIL vaccine (lot # 654389/0961F) in the right deltoid. On 14-DEC-2006, the patient experienced pain in her arm, difficulty moving and lifting arm. The patient reported recovery from difficulty moving and lifting arm on 28-DEC-2006. The patient reported recovery from arm pain on 14-JAN-2007. Additional information is not expected.


VAERS ID: 272337 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-11-16
Onset:2006-11-16
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:90
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Discomfort, Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Anemia
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA02079

Write-up: Information has been received from a health professional concerning a 21 year old female patient with a history of anemia who on 16-NOV-2006 was vaccinated SC with a first 0.5 ml dose of Gardasil (yeast) (lot#653938/0954F). The patient reported feeling lightheaded and uncomfortable after the first dose was given. No further information was provided. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a health professional concerning a 21 year old female patient with a history of anemia who on 16-NOV-2006 was vaccinated SC with a first 0.5 ml dose of GARDASIL (lot # 653938/0954F). Follow up information reported that the vaccination was administered by the IM route. The initial report of being vaccinated SC was charted incorrectly. The patient''s chart was corrected by the nurse who gave the injection. The patient reported feeling lightheaded and uncomfortable after the first dose was given. No further information was provided. No further information was available.


VAERS ID: 272338 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-12-28
Onset:2007-01-01
   Days after vaccination:4
Submitted: 2007-02-14
   Days after onset:44
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Arteriogram carotid, Dizziness, Echocardiogram, Loss of consciousness, Paraesthesia
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: carotid artery 01/05/07 - result not reported, echocardiography 01/11/07 - result not reported
CDC Split Type: WAES0701USA02086

Write-up: Information has been received from a nurse concerning an 18 year old female with pertinent medical history and drug reactions/allergies unspecified who on 28-DEC-2006 was vaccinated with Gardasil (yeast) (lot# not reported) injection. Concomitant therapy unspecified. On 01-Jan-2007, the patient passed out. Medical attention was sought. The patient later reported that she was experiencing light headedness and tingling in her hands and feet on 02-JAN-2007. The patient was referred to a cardiologist. The patient had a carotid ultrasound and echocardiogram performed on 05-JAN-2007 and 11-JAN-2007, respectively (results not reported). At the time of reporting, the tingling in her hands and feet persisted. No further information was available at the time of reporting. Additional information has been requested.


VAERS ID: 272339 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dysmenorrhoea
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Therapy unspecified, Menactra, Dtap
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA02093

Write-up: Information has been received from a physician concerning a female who was vaccinated, intramuscularly with the first, 0.5 ml dose of Gardasil. The patient concomitantly received Menactra and Dtap. The patient complained that her subsequent menstrual period was "much more painful than usual" with severe menstrual cramping. The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient recovered. Additional information has been requested.


VAERS ID: 272340 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: California  
Vaccinated:2006-10-11
Onset:2006-10-11
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:126
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 652809/1008F / UNK - / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2002AC / UNK - / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2455AA / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site anaesthesia, Injection site pain, Paraesthesia, Similar reaction on previous exposure to drug
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA02111

Write-up: Information has been received from registered nurse concerning a 11 year old female who on 11-OCT-2006 at 15:30, was vaccinated with the first dose of Gardasil (yeast) (lot number 654540/0800F) intramuscularly in the left deltoid. Concomitant vaccinations included hepatitis A vaccine (inactive) (MSD) (lot number 652809/1008F) intramuscularly in the right deltoid, meningococcal ACYW conj vaccine (MENACTRA) (lot number U2002AC) intramusculary in the right deltoid and (ADACEL) (lot number C2455AA) intramuscularly in the left deltoid. On 11-OCT-206 the patient stated that her arm tingled and felt numb at the injection site (arm not specified). Tingling and numbness lasted one hour. After that the patient stated the arm was just sore at the injection site. On 27-DEC-2006 was vaccinated with the second dose of Gardasil vaccine (yeast). On 27-DEC-2006 the patient again experienced arm tingled at injection site, but it "just lasted a few minutes". Additional information is not expected.


VAERS ID: 272341 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Washington  
Vaccinated:2006-11-16
Onset:2006-11-16
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:90
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0701USA02175

Write-up: Information has been received from a registered nurse concerning a female patient who on approximately 16-Nov-2006, "about two months ago," was vaccinated with a 0.5 ml dose of GARDASIL vaccine. On approximately 16-Nov-2006, the patient developed swelling of the arm (unspecified) after the injection and experienced pain "in her whole arm." The patient sought unspecified medical attention. The patient''s arm pain persisted. although, the outcome of the patient''s arm swelling was unknown. Additional information has been requested. This is in follow-up to report (s) previously received on 2/14/2007. Additional information received from the registered nurse indicated that the patient was vaccinated at another physician''s office and provided no additional information. No additional informatin is expected.


VAERS ID: 272342 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Washington  
Vaccinated:2006-11-11
Onset:2006-11-11
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:95
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Injection site swelling, Tenderness
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: hypersensitivity
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA02181

Write-up: Information has been received from an R.N. concerning a 22 year old female patient with an allergy to codeine who on 11-NOV-2006 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast); and according to the nurse, developed severe swelling on the injection site arm after the first dose. The patient received the first vaccination at another office and no information was available on where the first vaccination was administered or the physician involved in the first vaccination. On 16-JAN-2007 the patient was seen in the office. She was breast feeding, and was reported to have been breast feeding when the first vaccination was administered. The patient reported that she had developed an egg shaped swelling at the injection site on the left upper arm that lasted for more than one week after the first vaccination. No timeline on the development of the swelling in relation to the vaccination was available. The arm was still bruised and tender 2 months after the first vaccination. The second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) has not been administered. At the time of the report, the patient was recovering. Additional information has been requested.


VAERS ID: 272343 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-01-15
Onset:2007-01-15
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:30
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Local swelling, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA02188

Write-up: Information has been received from a RN concerning a 13 year old female patient who on 15-Jan-2007 was vaccinated IM with a dose of Gardasil, lot #6536978/0955F. Several hours later, the patient experienced pain and swelling at injection site and extending into her hand. There were no other symptoms noted. Medical attention was sought. At the time of the report the patient was recovering. Additional information has been requested. 5/14/10 Follow up information has been received from a physician concerning the female student with no medical history who on 15-JAN-2007 was vaccinated IM in right deltoid with her first dose of GARDASIL, lot #653978/0955F. 24 hours later the patient presented with complaints of numbness and swollen thumb at the arm where shot was given. The physician stated "No reaction at the site of injection. Also itching." The patient recovered from numbness and swollen thumb at the arm where shot was given and itching. Additional information is not expected.


VAERS ID: 272344 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA02260

Write-up: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil. Subsequently, following vaccination, the patient lost consciousness. The patient regained consciousness after a few minutes. Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 272345 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA02261

Write-up: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil (0.5 ml). Subsequently, following vaccination, the patient lost consciousness. The patient regained consciousness after a few minutes. Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 272346 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA02262

Write-up: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil (0.5 ml). Subsequently, following vaccination, the patient lost consciousness. The patient regained consciousness after a few minutes. Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 272347 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Ohio  
Vaccinated:2006-12-27
Onset:2006-12-27
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:49
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1424F / 1 UN / -

Administered by: Private       Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA02336

Write-up: Information has been received from a registered nurse concerning a 19 year old female who on 27-DEC-2006 was vaccinated in the arm (unspecified) with the first dose of Gardasil (lot #654885/1424F). There was no concomitant medication. On 24-DEC-2006, the patient developed a rash up and down both arms. The patient''s rash was treated with Benadryl. Subsequently, after three days, the patient recovered from the rash. It was reported that the event did not require an emergency room/doctor visit. Additional information is not expected.


VAERS ID: 272348 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Amenorrhoea
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA02347

Write-up: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil (lot number not reported). The nurse reported that the patient, after receiving the Gardasil, did not received her next expected period. The patient sought unspecified medical attention. At the time of this report. the outcome was unknown. Additional information has been requested.


VAERS ID: 272349 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Menstruation delayed
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA02348

Write-up: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with dose (lot number not reported). The nurse reported that the patient, after receiving the Gardasil, did not received her next expected period. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.


VAERS ID: 272350 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Virginia  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:105
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site irritation, Loss of consciousness, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives, influenza virus vaccine
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA02369

Write-up: Information has been received from a 24 year old female with an unremarkable medical history and no known allergies or adverse drug reactions reported. In November 2006, the patient was vaccinated intramuscularly in the left arm with the first 0.5 ml dose of Gardasil. concomitant therapy included influenza virus vaccine (unspecified) and hormonal contraceptives (unspecified). In November 2006, right after she received her first injection of Gardasil, the patient vomited and the passed out. The patient developed burning at injection site. The patient sought unspecified medical attention. It was reported that the patient was alright after about 20 minutes after the injection. The patient plans to receive her second shot on 17-JAN-2007. In November 2006, the same day that the first dose of the vaccine was administered, the patient had recovered from the events. Additional information has been requested.


VAERS ID: 272351 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: New York  
Vaccinated:2007-01-08
Onset:2007-01-10
   Days after vaccination:2
Submitted: 2007-02-14
   Days after onset:35
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Micronor
Current Illness:
Preexisting Conditions: Blood pressure high, sulfonamide allergy.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA02390

Write-up: Information has been received from a physician concerning a 20 year old female with high blood pressure and an allergy to sulfa. On 08-Jan-2007, the patient was vaccinated intramuscularly with a first 0.5 ml dose of Gardasil (lot #655619/1427F). Concomitant therapy included Micronor. On 10-JAN-2007, the patient developed intermittent hives. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested.


VAERS ID: 272352 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Washington  
Vaccinated:2007-01-15
Onset:2007-01-15
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:30
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Corticosteroids (unspecified); Hormonal contraceptives
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0701USA02393

Write-up: Initial an dfollow up information has been received from a physicia''s assistant and a 26 year old female with a drug hypersensitivity to tetracycline, prochlorperazine maleate (COMPAZINE) and doxycycline and no other pertinent medical history reported. On 15-JAN-2007, at 8:03 AM, the patient was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL vaccine (Lot# 655165/1425F). Concomitant therapy included a "steroid shot" and unspecified hormonal contraceptives. On 15-JAN-2007, the patient developed a terrible rash. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested. This is in follow-up to report previously received on 2/14/2007. There were no illnesses noted at the time of vaccination. That same day, the patient developed a terrible rash. On 16-JAN-2007, the patient went to the emergency room and was treated with unspecified steroids. On 17-JAN-2007, the patient followed up with the physician assistant and there was no significant rash noted at the time. At the time of this report, the patient had recovered fromthe event (date unknown). Additional information has been requested.


VAERS ID: 272353 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Michigan  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:105
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 653650/0702F / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Dysgeusia, Vaccine positive rechallenge
SMQs:, Taste and smell disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA02404

Write-up: Information has been received from a licensed partner nurse concerning her 20 year old white daughter student with pertinent medical history and drug reactions/allergies reported as unspecified who on 01-NOV-2006 was vaccinated with first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 653650/0702F) IM left arm at 1500 hours. On approximately 17-JAN-2007, the patient was vaccinated with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not reported). Following each dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), the patient experienced a metallic taste. The metallic taste was more pronounced after the first dose. The patient sought medical attention. Subsequently, the patient recovered. No other information was available at the time of reporting. Additional information was received from the licensed practical nurse. The patient complained of strong "metal" taste at the back of her tongue immediately after the first injection. This odd taste sensation lasted somewhere between 30 and 60 seconds and then slowly disappeared after 2 to 3 minutes. No additional information is expected.


VAERS ID: 272354 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Injection site swelling, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA02411

Write-up: Information has been received from a physician concerning several females who on unspecified dates were vaccinated with Gardasil 0.5 ml by injection. Subsequently, several patients fainted after receiving Gardasil and several patients experienced pain and swelling at the injection site. Medical attention was sought. The outcome of the events was unspecified. No additional information is available.


VAERS ID: 272355 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: New York  
Vaccinated:2006-10-26
Onset:2006-11-15
   Days after vaccination:20
Submitted: 2007-02-14
   Days after onset:91
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Biopsy skin, Dermatitis contact, Rash, Rash papular, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Acne vulgaris
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Skin biopsy, 11/17/06, irritant contact dermatitis
CDC Split Type: WAES0701USA02415

Write-up: Information has been received from a physician''s assistant concerning a 15 year old female who on unspecified dates was vaccinated intramuscularly in the arm with the first and second dose of Gardasil. Within 24 hours of receiving the first and second dose of Gardasil the patient developed a localized rash on the forearm. It was reported that the patient went to a dermatologist for the rash. It was reported that the events disappeared after a day or so. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Information has been received from a physician''s assistant concerning a 14 year old female with acne vulgaris who on 26-OCT-2006 was vaccinated intramuscularly in the left arm with the first dose of GARDASIL (653978/0955F). Concomitant therapy included the influenza vaccine. On 15-NOV-2006 and the 16-NOV-2006, the patient was seen in the physician''s office with a rash on the left forearm with red, raised, tender patches. The patient used NEOSPORIN and was referred to a dermatologist. On 17-NOV-2006, the patient was seen by a dermatologist. A punch biopsy of the left dorsal forearm was done which was consistent with an irritant contact dematitis. The patient subsequently recovered. On 27-DEC-2006, the patient was vaccinated with the second dose of GARDASIL (655165/1425F). On 30-DEC-2006, the patient developed the same type of rash on her right leg. The rash lasted two weeks and then resolved spontaneously. Additional information is not expected.


VAERS ID: 272356 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-12-22
Onset:2006-12-22
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:54
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0701USA02455

Write-up: This is in follow-up to report(s) previously submitted on 2/14/2007; 4/6/2007. Information has been received from a physician concerning a female patient with NKDA or preexisting medical conditions who on 22-DEC-2006, at 1:15 PM, the patient was vaccinated in the right arm with a 0.5 ml dose of GARDASIL (lot # 654389/0961F). Subsequently, several hours after the vaccination, she experienced localized right arm pain, developed a rash which was described as hives or her chin. Subsequently, on an unspecified date, the patient recovered from the events without treatment. The patient sought unspecified medical attention. Additional information is not expected. Additional information has been requested


VAERS ID: 272357 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2007-01-19
Onset:2007-01-30
   Days after vaccination:11
Submitted: 2007-02-14
   Days after onset:15
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1447F / 2 - / -

Administered by: Private       Purchased by: Other
Symptoms: Injection site irritation, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA02651

Write-up: Information has been received from a registered nurse concerning "several" patients who were vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patients subsequently complained of a little arm soreness after the vaccination. All patients recovered from arm soreness. On unknown dates, patients were vaccinated with second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patients experienced pain, swelling and irritation at injection site. The nurse noted that she used 3 or 4 different lots, and the patients were complaining that "it hurt quite a bit when the medicine was being injected into the arm". The nurse further commented that the patients did not complain about this with the first dose. The patients went home after the office visit. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.


VAERS ID: 272366 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-02-08
Onset:2007-02-09
   Days after vaccination:1
Submitted: 2007-02-15
   Days after onset:6
Entered: 2007-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1161F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt recived vaccine 5pm 2/8/07. Pt begain vomiting and diarrhea 4am 2/9/07. Pt had no fever. Pt given IV fluids.


VAERS ID: 272384 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-03
Onset:2007-01-05
   Days after vaccination:2
Submitted: 2007-01-05
   Days after onset:0
Entered: 2007-02-15
   Days after submission:41
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0651F / UNK LA / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 2 RA / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1140F / 2 LA / -

Administered by: Private       Purchased by: Other
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Left upper, outer arm, 4 cm induration with erythema. Benadryl, Motrin RTC


VAERS ID: 272387 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Unknown  
Location: Washington  
Vaccinated:2007-02-15
Onset:2007-02-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2007-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011V / 3 RA / -
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B009AA / 1 LA / -

Administered by: Private       Purchased by: Unknown
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: URI and pharyngitis
Preexisting Conditions: Exercise induced asthma.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: C/O dizziness "can''t breath" observed tremor of hands states heart beating rapidly (AP=72/min)


VAERS ID: 272477 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Ohio  
Vaccinated:2007-01-15
Onset:2007-01-17
   Days after vaccination:2
Submitted: 2007-02-14
   Days after onset:28
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B009AA / 1 RA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1893AA / 1 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Injection site erythema, Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0701USA02867

Write-up: Information has been received from a registered nurse concerning a female patient who was vaccinated with a dose of GARDASIL concomitantly with a dose of MENACTRA and a dose of DTaP. Subsequently the patient developed knot at the injection site where she received DTaP. It was reported that the patient with a knot or "raised area" that was 1 and 1/2 inches long. At the time of the report, the patient''s outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a registered nurse concerning a 13 year old female who on 15-JAN-2006 was vaccinated, into the left deltoid, with a first dose of GARDASIL vaccine (lot #654389/0961F) concomitantly with a first dose of MENACTRA vaccine (lot #U1893AA) in the left deltoid and first dose of BOOSTRIX (lot #AC52B009AA) into the right deltoid. There were no concomitant medications. On 17-JAN-2007, the patient developed knot at the injection site where she received BOOSTRIX. It was reported that the patient presented with redness and a knot of "raised area" that was 1 and 1/2 inches long. Follow-up reported that the patient had mild erythema (no swelling) at the injection site of GARDASIL vaccine and MENACTRA. The patient was seen in the physician''s office on 17-JAN-2007. At the time of the follow-up report, the patient''s outcome was unknown. Additional information is not expected.


VAERS ID: 272478 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Connecticut  
Vaccinated:2007-01-17
Onset:2007-01-17
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:28
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Influenza like illness, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA02982

Write-up: Information has been received from a physician concerning a female who on 17-JAN-2007 was vaccinated with a 0.5 ml first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 17-JAN-2007 the patient experienced flu-like symptoms described as malaise and myalgia. Unspecified medical attention was sought. At the time of the report, the patient was recovering. Additional information is not expected.


VAERS ID: 272479 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: New York  
Vaccinated:2006-12-21
Onset:2006-12-21
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:55
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 653735/0688F / 2 - / -

Administered by: Private       Purchased by: Private
Symptoms: Blood pressure normal, Dizziness, Flushing, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: blood pressure, 12/21/06, 102/60
CDC Split Type: WAES0701USA03006

Write-up: Information has been received from a health professional concerning a 21 year old white female with no medical history, who on 21-DEC-2006 was vaccinated in the left deltoid with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 653735/0688F). There were no illnesses at the time of vaccination. On 21-DEC-2006, following vaccination, the patient felt faint and queasy and her face appeared flush. The patient''s blood pressure was 102/60. The patient was given a cold drink of water and a cold compress and remained seated for 10 minutes and subsequently felt fine. The patient stated that "needles make her scared". No further information is expected.


VAERS ID: 272480 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-11-08
Onset:2006-11-08
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:98
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site discolouration, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MINOCIN
Current Illness: Acne
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA03029

Write-up: Information has been received from a registered nurse concerning a 21 year old female with no past medical history and no drug allergies who on 08-NOV-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 653978/0955F) (0.5 ml), intramuscularly in the left deltoid. Concomitant therapy included minocycline HCl (MINOCIN). On 08-NOV-2006 the patient experienced skin discoloration around injection site. The discoloration was slightly lighter than her skin color and was shaped like a "C" to the other side was 20 mm. The area was not raised or sore. She mentioned that she had some mild soreness at the injection site for one to two days after the vaccine was initially administered. The patient had no other symptoms. There were no relevant diagnostic tests performed. Unspecified medical attention was sought. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a registered nurse concerning a 21 year old female with acne and no drug allergies who on 08-NOV-2006 at 1:20 PM was vaccinated with a first dose of GARDASIL (lot # 653978/0955F) (0.5 ml), intramuscularly in the left deltoid. Concomitant therapy included MINOCIN. On 08-NOV-2006 the patient experienced skin discoloration around left deltoid (injection site). The discoloration was slightly lighter than her skin color and was shaped like a "C" to the other side was 20 mm. The area was not raised or sore. She mentioned that she had some mild soreness at the injection site for one to two days after the vaccine was initially administered. The patient had no other symptoms. The area was still noticed approximately 8 weeks after vaccination, and denied other adverse reactions. Subsequently on 26-JAN-2007, the area was inspected. C shape was now a complete circle with center the same color as surrounding skin. After close inspection, the area was the same size and shape by Band aide used to cover injection site with lightened area corresponding to the adhesive on the Band aide. The patient received a second dose of GARDASIL on 26-JAN-2007. There were no noticeable skin changes at the time of the report. There were no relevant diagnostic tests performed. it was reported to be unknown if the patient recovered. Additional information has been requested.


VAERS ID: 272482 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-14
Onset:2006-12-14
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:62
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Fatigue
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03080

Write-up: Information has been received from a physician concerning a female who on 14-DEC-2006 was vaccinated by injection with the first dose of HPV vaccine (yeast). On 14-DEC-2006 the patient experienced fatigue after HPV vaccine (yeast) was administered. The patient received the second dose of HPV vaccine (yeast) on 15-JAN-2007 and did not experience any further symptoms. The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient had recovered. Additional information is not expected.


VAERS ID: 272483 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Hawaii  
Vaccinated:2007-01-18
Onset:2007-01-18
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:27
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA03099

Write-up: Information has been received from a physician concerning a 17 year old female with no pertinent medical history and no drug reactions/allergies who on approximately 18-JAN-2007 was vaccinated with GARDASIL (lot # not reported) injection, 0.5 ml, in her left upper arm. There was no concomitant medication. On 18-JAN-2007, the patient developed pain and soreness in both sides of her hips. The patient sought medical attention. No lab diagnostic tests were performed. The patient stated that as of 18-JAN-2007, she only feels pain when she touches the side of her hips. At the time of reporting the outcome was unspecified. No other information was provided by the physician. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Additional information was received from the physician via telephone call. The physician reported that the patient had not returned for follow-up visit, therefore it was unknown if the patient recovered. Additional information has been requested.


VAERS ID: 272484 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Alabama  
Vaccinated:2006-12-21
Onset:2006-12-21
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:55
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA03182

Write-up: Information has been received from an office manager concerning a 16 year old female who on 21-DEC-2006 was vaccinated in the arm (unspecified) with the first dose of HPV vaccine (yeast). There was no concomitant medication. On approximately 21-DEC-2006, after receiving the vaccination, the patient developed a "knot" at the injection site. The patient sought unspecified medical attention. The "knot" at the patient''s injection site persisted. Additional information has been requested.


VAERS ID: 272485 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Michigan  
Vaccinated:2006-12-22
Onset:2006-12-22
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:54
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2141AA / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood pressure normal, Dizziness, Feeling hot, Visual acuity reduced
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Otitis; Sore throat; Nasal congestion; Runny nose; Penicillin allergy; Allergic reaction to antibiotics
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: blood pressure, 12/22/06, 98/60, normal
CDC Split Type: WAES0701USA03195

Write-up: Information has been received from a registered nurse concerning a 14 year old female with no fever, otitis (diagnosed on 22-DEC-2006), mild sore throat, congestion, runny nose, amoxicillin and erythromycin allergy who on 22-DEC-2006 was vaccinated with the first dose of GARDASIL (lot # 653938/0954F), IM. Concomitant therapy included the first dose of MENACTRA (lot # U2141AA), IM. On 22-DEC-2006 after the vaccine while at the check out window, the patient stated that she felt hot, felt her vision was fading and felt faint. The registered nurse held her arm and walked with her back to an exam room where she had her lay down and elevated her legs on two pillows for 15 minutes. The patient''s feeling passed. When the patient first returned to the exam room the physician checked her and then checked her when she felt better. After 15 minutes of lying down, the patient then sat up for 5 minutes. Her blood pressure was taken and was normal 98/60. Subsequently, the patient recovered from the events that same day. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. It was reported that there was no diagnostic work-up performed, the patient was not hospitalized nor was an outpatient and the patient fully recovered before she left the physician''s office. On 21-FEB2007, the patient was vaccinated with the second dose of GARDASIL and had no side effects. Additional information is not expected.


VAERS ID: 272486 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-05
Onset:2007-01-05
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:40
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Urinary tract infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA03348

Write-up: Information has been received from a physician concerning a 14 year old female patient who on approximately 05-JAN-2007 was vaccinated at another physicians office with HPV vaccine (yeast) (lot # not provided). On an unspecified date in January 2007, the patient was seen by the reporting physician for a suspected urinary tract infection (lab results not provided). The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested.


VAERS ID: 272487 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2007-01-15
Onset:2007-01-15
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:30
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 09611F / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Immediate post-injection reaction, Loss of consciousness, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Sulfonamide allergy, Penicillin allergy.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 01/15/07 96/72; total heartbeat count, 01/15/07, 104; pulse oximetry, 01/15/07 99%
CDC Split Type: WAES0701USA03429

Write-up: Information has been received from a registered nurse concerning a 14 year old female who on 15-JAN-2007 was vaccinated, intramuscularly with the first dose of HPV vaccine (yeast), (lot # 654389/0961F). On 15-JAN-2007 the patient fainted after receiving the vaccination. The patient was seen in the Emergency Room (ER) following vaccination and "no problems were found". At the time of the report, it was unspecified, if the patient recovered. Additional information was received on 11-APR-2007. The registered nurse indicated that on 15-JAN-2007 the patient''s blood pressure was 56/72 and heart rate was 104. On 15-JAN-2007, at 15:10, the patient was vaccinated with her first dose of Gardisil intramuscular (left deltoid), became pale immediately, laid down for approximately 5 minutes, got up, started walking down the hall, and passed out. The patient was taken to an ER, oxygen saturation was 99% (no other vital signs were taken). It was noted that the patient did report nausea. The patient did not experience rashes, hives, or difficulty breating. The patient was not ill at the time of vaccination. Additional information is not expected.


VAERS ID: 272488 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Indiana  
Vaccinated:2006-11-22
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1447F / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nuvaring, Prevacid, minocycline hydrochloride
Current Illness:
Preexisting Conditions: Allergic to antibiotics
Allergies:
Diagnostic Lab Data: cervical smear, 01/03/07 (+), positive for HPV
CDC Split Type: WAES0701USA03430

Write-up: Information has been received from a registered nurse concerning a 19 year old female with allergy to cefaclor (CECLOR) who on 22-NOV-2006 was vaccinated with the first dose of HPV vaccine (yeast). Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING), lansoprazole (PREVACID) and minocycline HCl. On 03-JAN-2007, the patient had a cervical (PAP) smear. The patient tested positive for Papilloma viral infection (HPV). On 11-JAN-2007, the patient was vaccinated with the second dose of HPV vaccine (yeast). (Lot # 655617/1447F). The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient recovered. Additional information has been requested.


VAERS ID: 272489 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-01
Onset:2007-01-01
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:44
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Injury, Loss of consciousness, Neurological examination normal
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: neurological, 01/07, comment: "was ok"
CDC Split Type: WAES0701USA03436

Write-up: Information has been received from a registered nurse via a company representative concerning a 16 year old female who, "the other night", was vaccinated with a first dose of HPV vaccine (yeast) (lot# not reported). The nurse reported that girl passed out in the office and hit her head after receiving a first dose of vaccine. The girl was unconscious in the office waiting room 3 to 4 minutes. It was reported that the patient was "revived" by using ammonia inhalant, and "seemed to take longer than expected to regain consciousness." The patient was administered an office neurological exam which was "ok and the patient was sent home", reported as recovered. The nurse also reported that it was unclear if this injection was painful. Additional information has been requested.


VAERS ID: 272490 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Michigan  
Vaccinated:2006-11-29
Onset:2006-11-29
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:77
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 653938/0954F / 1 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood pressure normal, Body temperature increased, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: emotional problems
Allergies:
Diagnostic Lab Data: blood pressure, 11/29/06 112/70; body temp, 11/29/06 100.1f
CDC Split Type: WAES0701USA03460

Write-up: Information has been received from a registered nurse concerning a 16 year old female student with emotional issues (in counseling) who on 29-NOV-2006, at 4:00 PM, was vaccinated IM into the left arm with a first dose of HPV vaccine (yeast) (lot# 653938/0954F). There was no illness at the time of vaccination. It was reported that the vaccination was given while the patient was sitting. A few second after the injection, the patient said "oh", and leaned to the right slowly to a reclined position and remained conscious but stiffened. She was awake. The doctor checked on her and stated that she was having a vagal response. After reclining 5-10 minutes, she said she was ok. Her blood pressure was 112/78 and temperature was 100.1F. The nurse noted that the patient was dressed in multiple layers and a hat and she had no had lunch. The patient was considered recovered on the same day, 29-NOV-2006. Additional information is not expected.


VAERS ID: 272491 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-11-29
Onset:2006-12-01
   Days after vaccination:2
Submitted: 2007-02-14
   Days after onset:75
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Erythema, Flushing, Hot flush, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: ovarian cyst; penicillin allergy; sulfonamide allergy; drug hypersensitivity
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA03483

Write-up: Information has been received from a mother of a 16 year old female patient with "cysts in her ovaries", and allergies to penicillin, sulfa, cefaclor (CECLOR) and erythromycin ethylsuccinate (+) sulfisoxazole acetyl (PEDIAZOLE) who on 29-NOV-2006 was vaccinated with HPV vaccine (yeast), "in her hip". There was no concomitant medication. Subsequently, "within 2 to 3 days after receiving the injection." the patient developed "hot flushes", fainted, felt dizzy, and nausea. The patient was also "red and flushed" in her face since receiving the injection. The patient was experiencing the "hot flushes" almost every day. It was also reported that the patient had been vaccinated with Tdap "whooping cough" injection (manufacturer unknown) on 05-JAN-2007 and the patient experienced swelling, itching and "a knot" at the injection site for the last "two to three weeks." At the time of the report, the patient was reportedly not recovered. Additional information has been requested.


VAERS ID: 272492 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness, Pain
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA03485

Write-up: Information has been received from a registered nurse concerning an adolescent female (age not reported) who on an unspecified date was vaccinated with the first dose of HPV vaccine (yeast). Subsequently, the patient passed out or was unconscious (date unknown). It was reported that the vaccination was "somewhat painful". The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). The nurse reported that there were a total of 4 cases of adolescent females that passed out or were unconscious after receiving the first dose of HPV vaccine (yeast) out of 130 total doses administered by the office. Additional information has been requested.


VAERS ID: 272494 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03498

Write-up: Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of HPV vaccine (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 272495 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03499

Write-up: Information has been received from a physician concerning a female between 15 and 16 year old who was vaccinated with a 0.5 ml dose of HPV vaccine (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 272496 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03500

Write-up: Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of HPV vaccine (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 272497 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-04
Onset:2006-12-04
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:72
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site discolouration
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03503

Write-up: Information has been received from a clinical trial coordinator concerning a female health care worker (age not reported) at a study site. On 04-DEC-2006, the patient was vaccinated in the left deltoid with the first dose of HPV vaccine (yeast) outside of the study. Subsequently, the patient developed discoloration. A band aid was placed over the injection site. As of 12-JAN-2007, there was still obvious discoloration to the area with visible outline of the band aid. The patient stated that she had never had this happen with a band aid before. At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 272498 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Colorado  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pruritus, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03511

Write-up: Information has been received from a nurse in a doctor''s office concerning a female who was vaccinated with a first dose of HPV vaccine (yeast). Subsequently the patient''s hands and feet swelled and had itchiness at the injection site. The patient refused to come in for the second vaccine. The patient recovered. Unspecified medical attention was sought.


VAERS ID: 272499 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-11-29
Onset:2006-11-29
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:77
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Hot flush, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: penicillin allergy; sulfonamide allergy; allergic reaction to antibiotics
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03514

Write-up: Information has been received from a medical assistant concerning a 16 year old female with a penicillin, sulfonamide and cefaclor (CECLOR) allergy who on 29-NOV-2006 was vaccinated with a dose of HPV vaccine (yeast). It was reported that ever since she was given the vaccine, the patient experienced hot flashes and nausea. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 272500 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Washington  
Vaccinated:2007-01-18
Onset:2007-01-19
   Days after vaccination:1
Submitted: 2007-02-14
   Days after onset:26
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy, No reaction on previous exposure to drug, Pain, Pharyngitis streptococcal
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03531

Write-up: Information has been received from a immunization coordinator nurse concerning a 26 year old female nurse in her office who on 18-JAN-2007 was vaccinated in the arm with a second dose of HPV vaccine (yeast). Subsequently the patient experienced "general achiness" throughout her body and swollen lymph glands. Unspecified medical attention was sought. At the time of the report, the patient''s outcome was unknown. It was reported that the patient "did not respond like this" after her first dose of HPV vaccine (yeast). Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/24/2007. On 19-JAN-2007, the patient was diagnosed with strep throat. Unspecified medical attention was sought. At the time of the report, the patient''s outcome was unknown. It was reported that the patient "did not respond like this" after her first dose of GARDASIL. The registered nurse reported that the patient''s strep throat was not related to GARDASIL. No further information is available.


VAERS ID: 272501 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-12-01
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03620

Write-up: Information has been received from a nurse concerning her 16 year old daughter who in approximately December 2006, was vaccinated with her first dose of HPV vaccine (yeast). Subsequently, the patient developed three nosebleeds. Medical attention was sought. The patient was recovering. Additional information has been requested.


VAERS ID: 272502 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2007-01-18
Onset:2007-01-18
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:27
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 655165/1425F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness, Nausea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOESTRIN 24 FE; iron (unspecified)
Current Illness:
Preexisting Conditions: contraception; routine health maintenance; iron deficiency anaemia
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA03757

Write-up: This is a follow up to report (s) previoulsy submitted on 2/14/2007. Information has been received from a nurse practitioner concerning a 20 year old female on contraception, and supplements with iron deficiency anaemia and no allergies, who on 18-JAN-2007 was vaccinated IM with a first dose of HPV vaccine (yeast) (lot# 655165/1425F). Concomitant therapy included ethinyl estradiol/norethindrone acetate (LOESTRIN 24FE) and iron (unspecified). Two hours after, the patient called the office and complained of nausea and vomiting. The patient came into the office the next day because her vomiting lasted throughout the night and she stated that she passed out. By the time she came to the office she was doing better. No diagnostic studies were performed. At the time of this report, the patient was recovered. No product quality complaint was involved. Additional information has been requested. In follow-up it was reported that the patient''s symptoms of nauea, vomiting and fainting lasted several hours and improved without treatment. The patient recovered on 18-JAN-2007. Additional information is not expected.


VAERS ID: 272503 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-01-23
Onset:2007-01-23
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:22
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 LA / IJ

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure decreased, Dizziness, Pallor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood pressure, 01/23/07, 120/8; Blood pressure 01/23/07, 90/50
CDC Split Type: WAES0701USA03883

Write-up: Information has been received from a nurse concerning a 14 year old female who on 23-JAN-2007 was vaccinated with the first dose of GARDASIL vaccine (lot number not provided). The nurse reported that after the patient received the vaccination she turned pale "within 10 minutes of vaccination". The nurse reported that the patient''s blood pressure was 120/80 prior to vaccination and her blood pressure dropped to 90/50 about ten minutes after the patient was vaccinated. The nurse reported that the patient was sent to the Emergency Room (ER) at the hospital nearby for treatment and observation. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and followup information has been received from a registered nurse concerning a 14 year old female who had finished menses and had heavey dysmenorrhea on 23-JAN-2007 was vaccinated IM in the left deltoid at 10:20 with her first dose of GARDASIL vaccine (Lot # 653918/0954F). Concomitant therapy included TOPRANIL. On 23-H+JAN_2007, at 10:30 the patient turned pale became dizzy and lightheaded after being vaccinated and her blood pressure fropped to 90/50 blood pressure prior to vaccination was 104/64. She was given fluids and something to eat and the dizziness did not improve. She was sent to the Emergency Room for evaluation. The ER report was normal. At the time of the report her blood pressure stayed under 100. No further informaion is available.


VAERS ID: 272504 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-01-05
Onset:2007-01-06
   Days after vaccination:1
Submitted: 2007-02-14
   Days after onset:39
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 2 UN / -

Administered by: Private       Purchased by: Private
Symptoms: Pain of skin, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Unspecified congenital anomaly of heart; Hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03895

Write-up: Information has been received from an L.P.N. concerning a 13 year old female student with a congenital heart defect and allergy to contrast dye who on the morning of 05-JAN-2007 between approximately 9-11 a.m. was vaccinated in the left upper arm with her second dose of Gardasil (yeast), lot#654389/0961F. In the p.m. of 06-JAN-2007 the patient developed skin tender and some skin "bumps" with pruritis X 2 days. It was reported that on 09-JAN-2007, the patient recovered. No further information is available.


VAERS ID: 272505 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-01-01
Onset:2007-01-01
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:44
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1208F / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA03908

Write-up: Information has been received from a physician concerning a female (demographics not reported) who on an unspecified date was vaccinated with Gardasil (yeast) (Lot# not provided). Subsequently the patient developed hives. At the time of this report it was unknown if the patient had recovered from the hives. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Follow up information received stated that the patient developed hives after receiving the second dose of GARDASIL (Lot # not provided) on an unspecified date in approximately January, 2007. The patient was treated in the physicians office with a dose of an unspecified antihistamine. At the time of this report it was not reported if the patient had recovered from the event. Additional information has been requested.


VAERS ID: 272506 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-10-01
Onset:2006-10-01
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:136
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03939

Write-up: Information has been received from two nurses at a physician''s office concerning a female (age not reported) who in October 2006 was vaccinated with the first dose of Gardasil (yeast). In October 2006, the patient developed excessive vaginal bleeding (during her period). The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested.


VAERS ID: 272507 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-20
Onset:2007-01-20
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:25
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / -
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Blood human chorionic gonadotropin, Drug exposure during pregnancy, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP =unknown)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: beta-human chorionic
CDC Split Type: WAES0701USA03942

Write-up: Information has been received from a physician through the pregnancy registry concerning a 15 year old female who on approximately 20-JAN-2007 was vaccinated intramuscularly with 0.5 ml of Gardasil (yeast). On that same day, concomitant therapy included Menactra and Adacel. It was reported that shortly after getting home, the patient developed nausea and vomiting. The patient was seen by the physician and found also to be pregnant. On an unspecified date, the patient underwent a pregnancy test. At the time of this report, the outcome of the events were unknown. Additional information has been requested. 07/08/2008 No further information is expected.


VAERS ID: 272508 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: New York  
Vaccinated:2006-12-29
Onset:2006-12-29
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:47
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1424F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Hypokinesia, Injection site urticaria, Malaise, Pain in extremity, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK; Flintstones Plus Iron; Cryselle
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: UNK; None
CDC Split Type: WAES0701USA03959

Write-up: This is in follow-up to report(s) previously submitted on 2/14/2007; 4/6/2007. Information has been received from a physician concerning an 18 year old female with no past medical history who on 29-DEC-2006 at 10:00 AM was vaccinated with a first dose of GARDASIL (yeast) (lot # 654885/1424F), intramuscularly in the left arm. Concomitant therapy included CRYSELLE and "Flintstones multivitamins." There was no illness at the time of vaccination. On 29-DEC-2006 at 5:00 PM the patient initially developed hives around injection site, but then developed approximately 10 hives over entire body." It was also reported that the patient developed malaise and fever, also had a sore arm such that she felt she couldn''t move it for 24 hours. It was also reported that there were no other symptoms reported. There were no relevant diagnostic tests or laboratory date. The patient recovered on 30-DEC-2006. In follow up it was reported that the patient had been given a 2nd dose of GARDASIL with ZYRTEC and BENADRYL administration and had no reaction. Additional information is not expected. This is in follow-up to report(s) previously submitted on 2/14/2007. It was reported that "used 1% hydrocortisone cream but no oral meds, resolved by next day".


VAERS ID: 272509 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: New York  
Vaccinated:2007-01-16
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Chest pain, Dyspnoea, Epigastric discomfort, Respiratory disorder, Smear cervix
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PEPCID; (therapy unspecified)
Current Illness: Penicillin allergy; Rash; Fever; Nulliparous; Smoker; Acne; Overweight
Preexisting Conditions: Appendectomy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA03962

Write-up: Information has been received from the father of an 18 year old female with a penicillin allergy noted as rash and fever. On 16-JAN-2007, the patient was vaccinated intramuscularly in the deltoid, with the first dose of Gardasil (yeast). There were no concomitant medications reported. On 18-JAN-2007, the patient developed epigastric pressure and discomfort. On 19-JAN-2007, the patient was examined by her physician and was prescribed famotidine. On 21-JAN-2007, the patient complained of difficulty and discomfort breathing which worsened on 22-JAN-2007. On 23-JAN-2007, the patient was planning to seek medical attention, at her local school infirmary. At the time of this report, the patient had not recovered from the events. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a physician concerning an overweight 18 year old female with a penicillin allergy noted as rash and fever, acne, smoking, a history of an appendectomy and a family history of the mother (age 45) with ovarian cancer (currently undergoing chemotherapy). On 16-JAN-2007, at 6:32 P.M., the patient was vaccinated intramuscularly in the left deltoid, with the first dose 0.5 ml of GARDASIL. Concomitant therapy included topical medications for acne. On the 16-JAN-2007 the patient had a Pap test done with reflex HPV. On 17-JAN-2007 (previously reported as 18-JAN-2007) the patient complained of a week history of a band of abdominal pain across her abdomen which was associated with chest pain. She denied any burning or back wash of food or fluid coming up in her chest, although occasionally she had this chest pain. There were no foods that aggravated her and she followed a healthy diet. The patient had normal bowel movements and her last period was 2 weeks prior. On examination, the patient was in no acute distress; her abdomen was soft, non-tender, nondistended; no hepatosplenomegaly or masses. The physician''s impression was abdominal pain/possible mild viral gastritis. The patient was prescribed famotidine (MSD) 20 mg, twice a day. She was to avoid caffeine and acidic foods or large meals before bed. On 21-JAN-2007, the patient complained of difficulty and discomfort breathing which worsened on 22-JAN-2007. On 23-JAN-2007, the patient was planning to seek medical attention, at her local school infirmary. At the time of this report, the patient had not recovered from the events. Additional information is not expected.


VAERS ID: 272510 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Virginia  
Vaccinated:2007-01-19
Onset:2007-01-21
   Days after vaccination:2
Submitted: 2007-02-14
   Days after onset:24
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0701USA03965

Write-up: Information has been received from a physician concerning a 26 year old female who on 19-JAN-2007 was vaccinated intramuscularly in left arm (upper outer quadrant) with the first dose of GARDASIL vaccine (lot # 655619/1427F). On approximately 21-JAN-2007, "within about three days", the patient reported that both her arms were itchy and red. The patient sought unspecified medical attention. The physician reported that she told the patient to take some BENADRYL to treat the symptoms. The physician reported that she did not plan to re-vaccinate the patient with GARDASIL vaccine. No lot number was provided. At the time of this report, the outcome of the event was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Additional information was received from a health professional. Lot number was provided and added to the report. The injection site was more affected that the opposite arm. The outcome was not reported. No additional information is expected.


VAERS ID: 272511 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-11-08
Onset:2006-12-18
   Days after vaccination:40
Submitted: 2007-02-14
   Days after onset:58
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Pelvic pain
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03968

Write-up: Information has been received from a licensed visiting nurse through the pregnancy registry concerning a 18 year old female who became pregnant during the 3-dose of Gardasil (yeast). On 08-NOV-2006, the patient was vaccinated with the first dose of Gardasil (yeast). It was reported that the patient was not pregnant when she received her first dose of Gardasil (yeast). On 18-DEC-2006, the patient developed pelvic pain. The patient was seen in the emergency room. At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a licensed visiting nurse through the pregnancy registry concerning a 18 year old female who became pregnant during the 1-dose series of GARDASIL. On 08-NOV-2006, the patient was vaccinated with the first dose of GARDASIL. It was reported that the patient was not pregnant when received her first dose of GARDASIL. On 11-DEC-2006, the patient developed pelvic pain. The patient was scan in the emergency room. At the time of this report, the outcome of the events were unknown. Follow-up information indicated that the patient vaginally delivered a full-term, healthy, and normal baby on an unspecified date. Additional information is not expected.


VAERS ID: 272512 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Rash erythematous, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03978

Write-up: Information has been received from a Pharm D healthcare student concerning a female (age not reported) who on an unspecified date was vaccinated with her first dose of Gardasil (yeast). Two weeks post vaccination, the patient developed a full body rash with tiny, erythematous papules. The patient sought unspecified medical attention. The pharmacist stated that the he has no other information, as the nurse had the chart. At the time of this report, the outcome of the event was unknown. Additional information is not expected.


VAERS ID: 272513 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: California  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:105
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04026

Write-up: Information has been received from a physician concerning a 16 year old female who "about 2 months ago" in approximately. November 2006, was vaccinated, intramuscularly (IM), into the deltoid muscle with the first 0.5 ml, dose of Gardasil (yeast). "About 2 months ago". in approximately, November 2006, on the same day of injection, the patient developed swelling at the site of injection. The patient reported that the swelling at the injection site subsided (date not reported). The patient sought unspecified medical attention. The patient received the 2nd dose recently without incident. The latter dose was administered (IM) in the thigh. Additional information has been requested.


VAERS ID: 272514 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04058

Write-up: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with HPV vaccine (yeast). Subsequently, following vaccination, the patient fainted. The patient fully recovered. No further details were provided. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. No further information is available.


VAERS ID: 272515 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA04068

Write-up: Information has been received from a physician concerning a female who was vaccinated with a first dose of HPV vaccine (yeast). Subsequently the patient complained of pain and then fainted within minutes of administration. Subsequently, the patient recovered without any additional treatment. Additional information has been requested.


VAERS ID: 272516 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04069

Write-up: Information has been received from a physician concerning a female who was vaccinated with a first dose of HPV vaccine (yeast). Subsequently the patient complained of pain and then fainted within minutes of administration. Subsequently, the patient recovered without any additional treatment. Additional information has been requested.


VAERS ID: 272517 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Oregon  
Vaccinated:2006-11-01
Onset:2006-12-01
   Days after vaccination:30
Submitted: 2007-02-14
   Days after onset:75
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: HIV test, HIV test negative, HIV test positive
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: serum HIV-1 gag, 12/06, positive; serum HIV-1 gag, equivocal; serum HIV-1 gag, negative
CDC Split Type: WAES0701USA04101

Write-up: Information has been received from a health professional concerning a 17 year old female who in November 2006, was vaccinated with a first dose of HPV vaccine (yeast). In December 2006, the patient tested positive for human immunodeficiency virus (HIV). The HIV test was performed in December 2006 when the patient donated blood. Unspecified medical attention was sought. The patient had 2 subsequent HIV tests. The first test was "equivocal" and the second test was negative. It was reported that the patient was not sexually active and did not use intravenous (IV) drugs. At the time of the report, the patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 272518 (history)  
Form: Version 1.0  
Age: 36.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2006-12-11
Onset:2006-12-26
   Days after vaccination:15
Submitted: 2007-02-14
   Days after onset:50
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 2 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Inappropriate schedule of drug administration, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO
Current Illness: Sulfonamide allergy; Irritable bowel syndrome; Drug hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04136

Write-up: Information has been received from a 36 year old female with sulfonamide allergy and irritable bowel syndrome who on 11-DEC-2006 was vaccinated with a second 0.5 mL of HPV vaccine (yeast). Concomitant therapy included escitalopram oxalate (LEXAPRO). In December 2006, " few days after" receiving the vaccination, the patient broke out in hives and a rash on her chest. The patient sought unspecified medical attention. Subsequently, after three weeks, the patient recovered from the hives and rash. It was reported that the patient did not have a reaction after vaccination with the first dose of HPV VLP vaccine (yeast). Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a medical assistant and a 36 year old female with an allergy to sulfonamide and ATROSEPT and irritable bowel syndrome who on 11-DEC-2006 was vaccinated with a second 0.5 mL dose of GARDASIL (lot #654540/0800F). The patient received the first vaccination on 06-OCT-2006 (lot #654540/1162F). Concomitant therapy included LEXAPRO. On 26-DEC-2006, the patient broke out in hives and a rash on her chest. It was reported that the rash and urticaria required an emergency room/doctor visit. Subsequently, in February 2007, the patient recovered from the hives and rash. It was reported that the patient did not have a reaction after vaccination with the first dose of GARDASIL. Additional information is not expected.


VAERS ID: 272520 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2007-01-16
Onset:2007-01-17
   Days after vaccination:1
Submitted: 2007-04-06
   Days after onset:78
Entered: 2007-02-15
   Days after submission:49
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Burning sensation, Chest discomfort, Hypersensitivity, Lung disorder, Palpitations, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Asthma; Drug hypersensitivity
Preexisting Conditions: Distress gastrointestinal
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04212

Write-up: Information has been received from a nurse practitioner concerning a female who was vaccinated with a 0.5 ml dose of Gardasil (yeast). Subsequently the patient developed an "allergic reaction". Unspecified medical attention was sought. At the time of the report, the patient''s outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a nurse practitioner and a licensed practical nurse concerning a 17 year old female student with asthma and drug hypersensitivity to BEXTRA (gastrointestinal distress) who on 16-JAN-2007, at 16:05, was vaccinated, intramuscularly, into the left deltoid, with a first dose of GARDASIL (lot #655619/1427F). On 17-JAN-2007 the patient called the physician''s office with complaint of "lungs burning" and felt like she had heartburn. She reported that she felt her heart was racing and had developed blurry vision. The patient went to urgent care and told by the physician that the events were a possible reaction to GARDASIL. The patient was advised to take BENADRYL and TYLENOL PM. It was reported that the patient was resting comfortably after she was seen in urgent care. On 18-JAN-2007, she had some residual chest tightness. The patient did not experience shortness of breath or difficulty breathing. Subsequently, the patient recovered. No further information is available.


VAERS ID: 272521 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Injection site reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04254

Write-up: Information has been received from a licensed practical nurse concerning approximately 14 patients who was vaccinated with Gardasil (yeast). Subsequently the patients experienced injection site reaction including pain. The reactions resolved "after a couple of days". Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.


VAERS ID: 272522 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES 0701USA04279

Write-up: Information has been received from a health professional concerning a female patient who was vaccinated IM with a 0.5 ml "recent" dose of HPV vaccine (yeast). Subsequently the patient called the practice and reported swelling in both arms and she wanted to be seen by the physician. No further information was provided. Additional information has been requested.


VAERS ID: 272523 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Virginia  
Vaccinated:2007-01-05
Onset:2007-01-05
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:40
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure, Dizziness, Electrocardiogram, Fatigue, Heart rate increased, Hypertension, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Vestibular disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Depo-Provera
Current Illness:
Preexisting Conditions: collapse of lung
Allergies:
Diagnostic Lab Data: Diagnostic test: blood pressure, 01/05/07, 138/6; electrocardiogram, 01/05/07, tachy; Lab Results: total heartbeat count, 01/05/07, 145
CDC Split Type: WAES0701USA04282

Write-up: Information has been received from a physician concerning a 20 year old female with a history of collapse of left lung (September 2006 for which she recovered) who on 05-JAN-2007 was vaccinated with a first IM dose of HPV vaccine (yeast). Concomitant therapy on 05-JAN-2007 included a dose of medroxyprogesterone acetate (DEPO-PROVERA). On 05-JAN-2007 the patient experienced dizziness, tiredness, tachycardia and high blood pressure. The patient has been on medroxyprogesterone acetate since July 2006 and has not experienced any of these symptoms. Her pulse rate has been as high as 145 at rest and blood pressure was 138/85 and an EKG showed tachycardia. Blood work was done and results not provided. She is scheduled to have pulmonary function tests on 07-FEB-2007 and will be seeing a cardiologist "in the future." The patient''s dizziness and tiredness and tachycardia and high blood persisted. Additional information has been requested.


VAERS ID: 272524 (history)  
Form: Version 1.0  
Age: 32.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-12-11
Onset:2006-12-11
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:115
Entered: 2007-02-15
   Days after submission:49
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Inappropriate schedule of drug administration, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04404

Write-up: Information has been received from a physician concerning a 32 year old female with no pertinent medical history or drug reactions/allergies, who on an unspecified date was vaccinated with Gardasil (yeast) (0.5 ml). There was no concomitant medication. Subsequently, 30 minutes after vaccination, the patient developed redness and itchiness on the palms of her hands, soles of her feet, and in a "band around her waist". The patient also developed "8 red spots on the left side of her truck". The redness, itchiness, and red spots lasted for approximately 5 days and then disappeared. It was reported that nothing occurred at the injection site. Unspecified medical attention was sought. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a physician concerning a 32 year old female with no pertinent medical history or drug reactions/allergies, who on 11-Dec-2006 was vaccinated intramuscularly with the first dose of GARDASIL (0.5 ml) (Lot # 653735/0688F). There was no concomitant medication and no illness at time of vaccination. Subsequently, approximately 15 minutes after vaccination, on 11-DEC-2006, the patient developed erythema and pruritus on the palms of her hands, soles of her feet, and an erythmatous band around her waist. It was also reported that the patient also developed "8 red spots on the left side of her trunk". The redness, itchiness, and red spots lasted for approximately 5 days and then disappeared. It was reported that nothing occurred at the injection site. No further information is expected.


VAERS ID: 272525 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04413

Write-up: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil (yeast) (0.5 ml). Subsequently, following vaccination, the patient lost consciousness. It was reported that the patient regained consciousness after a "couple of minutes". Unspecified medical attention was sought. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Conflicting follow-up from the physician''s office manager stated that the office had no knowledge of a patient with a reaction to GARDASIL. No further information is expected.


VAERS ID: 272526 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-01
Onset:2007-01-01
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:44
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04415

Write-up: Information has been received from a nurse practitioner concerning a 14 year old female with no pertinent medical history and no history of drug reactions/allergies in January 2007 was vaccinated with the first dose of Gardasil (yeast) (Lot # not reported) 0.5 ml injection. There was no concomitant medication. In January 2007, the evening she received her first dose of Gardasil (yeast), she experienced rapid heart beat. Medical attention was sought. She had the same experience 24 hours later. The patient has not had another experience since then. Additional information has been requested.


VAERS ID: 272527 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: South Dakota  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-04-06
Entered: 2007-02-15
   Days after submission:49
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04429

Write-up: Information has been received from a registered nurse concerning a couple of females with unspecified pertinent medical history and unspecified drug reactions/allergies who on an unspecified date were vaccinated with first dose of Gardasil (yeast) (lot # not reported), 0.5 ml, IM. Concomitant therapy was not specified. On an unspecified date, the patients experienced tingling in their fingers of the arm being injected while getting the injection. The tingling resolved within a couple of minutes of receiving the shot. Medical attention was sought. At the time of reporting, the patients had recovered. The patients plan on getting was sought. At the time of reporting, the patients had recovered. The patients plan on getting their second and third doses of Gardasil (yeast). Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Information has been received from a registered nurse concerning a couple of females with unspecified pertinent medical history and unspecified drug reactions/allergies who on an unspecified date were vaccinated with first dose of GARDASIL (lot # not reported), 0.5 ml, IM. Concomitant therapy was not specified. On an unspecified date, the patients experienced tingling in their fingers of the arm being injected while getting the injection. The tingling resolved within a couple of minutes of receiving the shot. Medical attention was sought. At the time of reporting, the patients had recovered. The patients plan on getting their second and third doses of GARDASIL. Additional information was received from the registered nurse via telephone who reported that there might be 4 patients but was not sure. Additional information was received from the registered nurse who reported that the event involved a few girls, number unknown. The patients complained of hand numbness right after the injection. No specific patient identifiers were known. The outcome of the hand numbness was not reported. No additional information is expected.


VAERS ID: 272528 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-01-18
Onset:2007-01-18
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:77
Entered: 2007-02-15
   Days after submission:49
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pruritus generalised, Smear cervix abnormal
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LO/OVRAL, SYNTHROID
Current Illness: Hypothyroidism
Preexisting Conditions: Papanicolaou smear abnormal
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04447

Write-up: Information has been received from a physician concerning a 26 year old female with hypothyroidism and a history of papanicolaou smear abnormal and no history of drug reactions/allergies who on 06-NOV-2006 was vaccinated with first dose of Gardasil (yeast) 0.5 ml IM. On 18-JAN-2007, the patient was vaccinated with a second dose of Gardasil (yeast) (lot # not reported). Concomitant therapy included SYNTHROID and LO/OVRAL. On 18-JAN-2007, fourty-five minutes after receiving the second dose, the patient experienced generalized itching. No additional symptoms were noticed. Medical attention was sought. The physician prescribed BENADRYL and the symptoms resolved. The patient fully recovered on 18-JAN-2007. No further information was available at the time of reporting. Additional information has been requested. This is in follow-upinformation has been received from a physician and a nurse concerning a 26 year old female with hypothyroidism and a history of papanicolaou smear abnormal and no history of drug reactions/allergies who on 06-NOV-2006 was vaccinated with first dose of GARDASIL 0.5 ml IM. On 18-JAN-2007, the patient was vaccinated with a second dose of GARDASIL (lot # not reported). Concomitant therapy included SYNTHROID and LO/OVRAL. On 18-JAN-2007, forty-five minutes after receiving the second dose, the patient experienced generalized itching. No additional symptoms were noticed. Medical attention was sought. The physician prescribed BENADRYL and the symptoms resolved. The patient fully recovered on 18-JAN-2007. No further information was available at the time of reporting. In follow-up it was reported, the patient had no reaction after the first dose of GARDASIL. After the 2nd dose, the patient left the office and later experienced a slight resolved. The patient had no other allergic symptoms. Additional information has been requested.


VAERS ID: 272530 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-10-01
Onset:2006-10-01
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:136
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Vaccine positive rechallenge, Vertigo
SMQs:, Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04475

Write-up: Information has been received from a registered nurse concerning an 18 year old female with no medical history who in October 2006 or November 2006 was vaccinated with her second dose of HPV VLP vaccine (yeast) (0.5 mg), intramuscularly. There was no concomitant medication. Subsequently, the patient experienced intermittent vertigo 5 days later. The patient was "recently" administered her third dose of HPV VLP vaccine and was "now" experiencing constant vertigo. It was noted that the patient had a family history of vertigo. There were no laboratory or diagnostic tests performed. At the time of the report, the patient had not recovered. Additional information has been requested.


VAERS ID: 272531 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-31
Onset:2006-12-31
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:45
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / -

Administered by: Other       Purchased by: Other
Symptoms: Meningism, Musculoskeletal stiffness
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04481

Write-up: Information has been received from a nurse concerning a 17 year old female who at the "end of December" was vaccinated with a second dose of HPV VLP vaccine (yeast) (0.5 ml). Subsequently, the patient experienced meningitis like symptoms and cervical neck stiffening. Unspecified medical attention was sought. At the time of the report, th patient was recovering. Additional information is not expected.


VAERS ID: 272532 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2007-01-15
Onset:2007-01-15
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:30
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1447F / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Sulfonamide allergy
Preexisting Conditions: loss of consciousness
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04509

Write-up: Information has been received from a laboratory technician concerning a 26 year old female who on 15-JAN-2007 was vaccinated with a first dose of HPV vaccine (yeast). Ten minutes after the vaccination, the patient passed out at the check out for an unspecified time. The patient said that she always passes out after she gets an injection. Unspecified medical attention was sought. On 15-JAN-2007, the patient recovered without incident. No product quality complaint was involved. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow up information has been received from a healthcare provider concerning a 26 year old female with an allergy to sulfa drugs who on 15-JAN-2007, at 8:23 was vaccinated with a first dose of GARDASIL (lot#655617/1447F) in the right deltoid. Ten minutes after the vaccination, the patient passed out at the check out for an unspecified time. The patient said that she always "passes out" after she gets an injection. Unspecified medical attention was sought. On 15-JAN-2007, the patient recovered without incident. No product quality complaint was involved. No further information is available.


VAERS ID: 272533 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-01-24
Onset:2007-01-24
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:71
Entered: 2007-02-15
   Days after submission:49
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Immediate post-injection reaction, Injection site warmth, Mobility decreased, No reaction on previous exposure to drug, Oedema peripheral, Paraesthesia, Skin discolouration, Skin warm
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: therapy unspecified, Ritalin
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0701USA04530

Write-up: Information has been received from a registered nurse concerning her 22 year old daughter with no allergies who on 24-JAN-2007 was vaccinated with HPV VLP vaccine (yeast). Concomitant therapy included methylphenidate HCl (RITALIN) and "pregnancy shot" (name unknown). On 24-JAN-2007 the patient immediately "felt her fingers tingle and her arm got hot." Later that evening her "fingers turned white and blue." She then went back to the physician who instructed her to "wrap it in warm packs." The patient also took diphenhydramine HCl (BENADRYL). The nurse stated that her daughter''s arm was getting better, but she still had trouble picking up her arm to her shoulder area. At the time of the report, the patient was recovering. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Information has been received from a registered nurse concerning her 22 year old "healthy" daughter with no medical history and no allergies who on 24-JAN-2007 was vaccinated with GARDASIL. Concomitant therapy included RITALIN and "pregnancy shot"(name unknown). There was no illness at the time of vaccination. On 24-JAN-2007 the patient immediately "felt her fingers tingle and her arm got hot." Later that evening her "fingers turned white and blue." She then went back to the physician who instructed her to "wrap it in warm packs." The patient also took BENADRYL. The nurse stated that her daughter''s arm was getting better, but she still had trouble picking up her arm to her shoulder area. Follow-up information reported that the patient stated that "her arm stung became hot at time of injection, tingled down to her fingers", same arm shot given in deltoid. Later hand and fingers (that arm) swollen, white across knuckles. She put warm packs on it at home, next day felt better difficult to left arm above shoulder height. The patient recovered 2-3 days later. It was noted that the patient had no adverse events following previous vaccinations. Additional information is not expected.


VAERS ID: 272535 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood test, Immediate post-injection reaction, Injection site erythema, Injection site nodule, Laboratory test, Nerve conduction studies, Nerve injury, Nuclear magnetic resonance imaging, Pain, Similar reaction on previous exposure to drug
SMQs:, Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK; GLUCOPHAGE
Current Illness: Diabetes; Drug hypersensitivity
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK; magnetic laboratory; diagnostic laboratory; nerve conduction study
CDC Split Type: WAES0701USA04555

Write-up: This is in follow-up to report(s) previously submitted on 2/14/2007; 7/6/2007. Information has been received from a nurse concerning a 19 year old female with diabetes and a reaction to ROBITUSSIN who in mid-December 2006, was vaccinated intramuscularly with a second dose of GARDASIL. Concomitant therapy included GLUCOPHAGE. On an unspecified date, the patient developed immediate redness at the injection site and a knot was noticed at the injection site 1 to 2 days post injection. The patient also experienced pain "right after the injection." The patient''s mother noted that the pain following the first dose was not as severe as the pain experienced after the second dose. The nurse reported that the patient did not see her family physician and the family physician suspected "nerve damage." It was not specified whether or not the patient had a reaction the first time she was vaccinated with HPV VLP vaccine (yeast). The nurse reported that they were following up with the patient to make sure she was okay. On an unspecified date, magnetic resonance imaging (MRI), blood work and a nerve conduction study were performed (results not provided) to make sure there was no nerve damage. Unspecified medical attention was sought. At the time of this report, the patient was still experiencing pain "some days worse than others". No product quality complaint was involved. Additional information is not expected.


VAERS ID: 272536 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-01-03
Onset:2007-01-03
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:42
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04565

Write-up: Information has been received from a physician concerning his 15 year old daughter who on 03-JAN-2007 was vaccinated with a first dose of HPV VLP vaccine (yeast). On 03-JAN-2007 the patient fainted and experienced soreness at the injection site. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 272537 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-02-23
Onset:2007-02-23
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:9
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Hyperhidrosis, Pallor, Paraesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK; blood pressure, 02/23/07, 110/7 mm/Hg; pulse oximetry, 02/23/07, 98%; total heartbeat count, 02/23/07, 116bpm
CDC Split Type: WAES0701USA04582

Write-up: Information has been received from a physician concerning a female patient who in "the week of 22-JAN-2007" was vaccinated IM with a 0.5 ml dose of HPV VLP vaccine (yeast). After vaccination, the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a registered nurse concerning a 15 year old female patient who on 23-FEB-2007, at 3:35PM, (previously reported as approximately 22-JAN-2007) was vaccinated IM, left arm, with a 0.5 ml of GARDASIL (lot # 653735/0688F). That same day, the patient was leaving the office when she complained of dizziness; she was extremely pallor, perspiring and had tingling in both hands and subsequently fainted. The patient''s blood pressure was 110/70 mmHg, pulse 116bpm, and her oxygen saturation was 98%. The patient was given oxygen and she stayed at the office for 45 minutes. Subsequently, the patients symptoms subsided and the patient recovered. No product quality complaint was involved. Additional information is not expected.


VAERS ID: 272578 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-12-13
Onset:2006-12-13
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:63
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Mass, Tenderness
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0701USA04602

Write-up: Information has been received from a 25 year old female office manager who on 13-DEC-2006 was vaccinated with a first 0.5 mL dose of GARDASIL vaccine. On 13-DEC-2006, the patient developed a small bump under the skin that was tender after receiving the vaccination. The patient sought unspecified medical attention. At the time of this report, the patient''s small, tender bump under the skin persisted. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.


VAERS ID: 272579 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Washington  
Vaccinated:2006-11-29
Onset:2006-11-29
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:127
Entered: 2007-02-15
   Days after submission:49
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 654540/0800F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Headache, Pharyngeal hypoaesthesia, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Evra
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04623

Write-up: Information has been received from a registered nurse concerning a 20 year old female with an allergy to amoxicillin (AUGMENTIN) who on 29-NOV-2006 was vaccinated IM, into the deltoid, with a first dose of HPV VLP vaccine (yeast) (lot # 654540/0800F). Concomitant therapy included ORTHO EVRA. Approximately 1 minute after the vaccination, the patient reported that her "throat felt constricted." Subsequently, the patient recovered after 5 minutes. On 25-JAN-2007 the patient was vaccinated with a second dose of dose of HPV VLP vaccine (yeast). Five seconds after the vaccination, the patient experienced "numbness in the throat" that lasted a short duration. The patient reported that she developed an intense headache 30 minutes after the vaccination that lasted until she went to bed. On 26-JAN-2007, the patient recovered from the headache. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a registered nurse concerning a 20 year old female with an allergy to AUGMENTIN who on 29-NOV-2006 was vaccinated intramucularly, into the deltoid, with a first dose of GARDASIL (lot # 654540/0800F). Concomitant therapy included ORTHO EVRA. Within 1 minute after the vaccination, the patient felt "tightness in throat" and lightheadedness. Subsequently, the patient recovered after 5 minutes. On 25-JAN-2007 the patient was vaccinated, intramuscularly with a second dose of GARDASIL (lot #654540/0800F). As the vaccine was administered the patient experienced "momentary numbness at the throat area of neck" that lasted a few seconds. Twenty minutes after the vaccination, while the patient was on the road, she called the physician''s office to report she had developed an intense frontal headache. There were no visual problems and it was not interrupting her ability to function. The headache that lasted until she went to bed. On 26-JAN-2007, the patient recovered from the headache. There were no laboratory or diagnostic tests performed. Additional information is not expected.


VAERS ID: 272580 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2006-08-25
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: pregnancy
Preexisting Conditions: Cervical dysplasia, Caesarean section; Urinary tract infection; blood pressure high, sulfonamide allergy, drug hypersensitivity
Allergies:
Diagnostic Lab Data: serum beta-human, 09/20/06, (+), positive for pregnancy
CDC Split Type: WAES0701USA04643

Write-up: Information has been received from a registered nurse through a Merck Pregnancy Registry concerning a 23 year old female with allergies to sulfamethoxazole (+) trimethoprim (BACTRIM) and nitrofurantoin (MACROBID) high blood pressure but no current blood pressure medication. Rhesus antibodies (RH) negative, and a history of cervical dysplasia, urinary tract infections and Caesarian (C) section for first child, year 2006, who on 25-AUG-2006 was vaccinated with HPV vaccine (yeast). The nurse reported that the patient was scheduled for a leep procedure, due to cervical dysplasia on 20-SEP-2006 and before the procedure a blood serum pregnancy test was taken, and result was positive for pregnancy. Additional information has been requested.


VAERS ID: 272581 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Georgia  
Vaccinated:2007-01-18
Onset:2007-01-18
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:27
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04649

Write-up: Information has been received from a physician concerning a 15 year old female who approximately 18-JAN-2007 was vaccinated by injection with a 0.5 mL dose of HPV vaccine (yeast). Lot # unspecified by reporter). There was no concomitant medication. Subsequently, it was reported that five minutes after the injection the patient fainted. The patient was taken to the emergency room (ER) but no admitted to the hospital. The physician did not think the HPV vaccine (yeast) caused the patient to faint, as much as severe anxiety from the shot. At the time of the report, the patient had recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a physician concerning a 15 year old female who on approximately 18-JAN-2007 was vaccinated by injection with a 0.5 mL dose of GARDASIL, (Lot # unspecified by reporter). There was no concomitant medication. Subsequently, it was reported that five minutes after the injection the paitent fainted. The patient was taken to the Emergency Room (ER) but not admitted to the hospital. The physician did not think the GARDASIL caused the patient to faint, as much as severe anxiety from the shot. At the time of the report, the patient had recovered. In follow-up it was reported, that the patient had some anxiety about the vaccine injection. The actual injection went well, and the patient seemed to tolerate "ok". Five minutes later in the waiting room the patient slumped to the floor and was minimally responsive to verbal instructions, we immediately administered BENADRYL and epinephrine and called emergency. The patient''s vitals remained within normal ranges during the entire episode, she was transferred to the hospital and did well with no further treatment. It was reported that the patient recovered on the same day. Additional information has been requested.


VAERS ID: 272582 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04667

Write-up: Information has been received from a physician concerning a female patient who was vaccinated with a dose of HPV vaccine (yeast). Subsequently, the patient fainted. Her outcome was not reported. Additional information has been requested.


VAERS ID: 272583 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Washington  
Vaccinated:2006-12-11
Onset:2006-12-11
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:65
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blister, Burning sensation, Herpes zoster, Urticaria
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YASMIN 28; Sulfamethoxazole
Current Illness: Smoker
Preexisting Conditions: Rash; Diarrhoea; Chickenpox
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04672

Write-up: Information has been received from a nurse practitioner concerning an 18 year old female patient who was vaccinated with her first dose of HPV vaccine (yeast) and had no adverse side effects. Subsequently, she was vaccinated with her 2nd dose of HPV vaccine (yeast) and within 24 hours broke out in hives, which developed into shingles. Medical attention was sought. As of the report date, the patient was recovering. Additional information has been requested. Follow up information has been received from a Certified Medical Assistant and medical records concerning a 17 year old female stundent with current tobacco use and a history of rash with CEFZIL and CECLOR, diarrhoea with AUGMENTIN and chickenpox who on 11-DEC-2004 at 2:35 p.m. was vaccinated IM in left arm with her second dose of GARDASIL, lot #653735/068HF. Concomitant therapy included YASMIN 28 and Sulfamethoxazole and trimethoprim. The reporter indicated that the patient developed hives post injection, then on 18-DEC-2006 was seen at an urgent care clinic for shingles, which was not felt to be related to the immunization. The patient recovered on an unspecified date. According to medical notes from 18-DEC-2006. Patient states she''s here for compains of a rash on her back and under her right armpit, and she describes the pain as an 8/10. States it started last Wednesday (13-DEC-2006) but it''s gotten much worse. States she had the 2nd HPV immunization last Monday, and they wonder if this might be a reaction to it. "It was also reported that the patient did have a burning/pain sensation prior to 13-DEC-2006 and prior to the administration of GARDASIL and blistering. The blisters were in clumps/painful, and were aggravated by touching. The patient stated she was under a lot of stress with school and that she had some low grade fevers. Her assessment was shingles, right T5 dermatone - increase vesicles in patches along the T5 dermatone. She was treated with VALTREX. 1 tablet 3 times daily and Tylenol with Codeine #3). 1 tablet every 4 hours as needed for pain. Additional information is not expected.


VAERS ID: 272584 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:110
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / UNK AR / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04679

Write-up: Information has been received from a registered nurse concerning an approximately 23 year old female who was vaccinated with HPV vaccine (yeast). The registered nurse reported that she had another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm she the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn''t even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved and the patient was sent home. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a registered nurse concerning an approximately 23 year old female (patient 1 of 4) with no known drug allergies, who on 27-OCT-2006 was vaccinated IM into the deltoid area with a dose of GARDASIL (lot# 653938/0954F). The registered nurse reported that she and another nurse had given "numerous" GARDASIL vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The bleeding only lasted a few seconds. The nurse further commented that there was "nothing wrong with the patient, she didn''t even notice" and "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Pressure was applied and a bandaid. Bleeding resolved and the patient was sent home. Additional information is not expected.


VAERS ID: 272585 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-01-11
Onset:2007-01-12
   Days after vaccination:1
Submitted: 2007-02-14
   Days after onset:33
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0962F / 2 AR / IM

Administered by: Public       Purchased by: Other
Symptoms: Arthralgia, Bone pain, Joint stiffness
SMQs:, Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AUGMENTIN; APRI
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04682

Write-up: Information has been received from a pharmacist concerning a 20 year old female who on 25-JAN-2007 was vaccinated with a second dose of HPV vaccine (yeast) 0.5 ml intramuscularly. Subsequently the patient experienced joint and bone pain. The patient sought unspecified medical attention. The patient is recovering from joint and bone pain. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a pharmacist concerning a 20 year old female with no known drug allergies who on 07-NOV-2006 was vaccinated with a first dose of GARDASIL intramuscularly in the deltoid. On 11-JAN-2007 (also reported as 24-JAN-2007), the patient was vaccinated with the second dose of GARDASIL (Lot number 654510/0962F) 0.5 ml intramuscularly in the deltoid. Concomitant therapy included APRI ORD and AUGMENTIN. On 12-JAN-2007 the patient experienced joint stiffness, bone pain and severe joint pain. On 26-JAN-2007, the patient recovered from joint stiffness, bone pain and severe joint pain. Additional information is not expected.


VAERS ID: 272586 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-19
Onset:2007-01-19
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:26
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site cyst
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04690

Write-up: Information has been received from a registered nurse concerning an "18 or 19" year old female who on 19-JAN-2007 was vaccinated with the first dose of HPV vaccine (yeast). On 19-JAN-2007, the patient developed a cyst at the injection site. The patient sought unspecified medical attention. The patient was referred to a dermatologist. At the time of this report, the outcome of the event was unknown. Additional information is not expected.


VAERS ID: 272587 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES001USA04694

Write-up: Information has been received from a licensed practical nurse concerning approximately 75 female patients who were vaccinated IM with 0.5ml doses of Gardasil. Subsequently the patients experienced pain at the injection site. Unspecified medical attention was sought. Subsequently, the patients recovered. Attempts are being made to obtain additional identifying information regarding the patients mentioned in this report. Additional information will be provided when available.


VAERS ID: 272588 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness, Pain
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04695

Write-up: Information has been received from a registered nurse concerning an adolescent female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil vaccine. Subsequently, the patient passed out or was unconscious (date unknown). It was reported that the vaccination was "somewhat painful". The patient sought unspecified medical attention. At the tiem of this report, the patient has recovered from the event (date unknown). the nurse reported that there were total of 4 cases of adolescent females that passed out or were unconscious after receiving the first dose of Gardasil out of 130 total doses administered by the office. Additional information has been requested.


VAERS ID: 272589 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness, Pain
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04696

Write-up: Information has been received from a registered nurse concerning an adolescent female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil. Subsequently, the patient passed out or was unconscious (date unknown). It was reported that the vaccination was "somewhat painful". The patient sought unspecified medical attention. At the time of this report, the patient has recovered from the event (date unknown). The nurse reported that there were total of 4 cases of adolescent females that passed out or were unconscious after receiving the first dose of Gardasil out of 130 total doses administered by the office. Additional information has been requested.


VAERS ID: 272590 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Menstruation irregular
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04697

Write-up: Information has been received from a physician concerning a female who on an unspecified date was vaccinated intramuscularly with the second dose of Gardasil. Subsequently, following the second vaccination, the patient experienced irregular periods. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 272591 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-10-01
Onset:2006-10-01
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:136
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04698

Write-up: Information has been received from two nurses at a physician''s office concerning one of the nurses'' daughter (age not reported). On an unspecified date, the patient was vaccinated with the first dose of Gardasil. Subsequently, the patient developed excessive vaginal bleeding (during her period). At the time of this report, the outcome of the event was unknown. Additional information has been requested.


VAERS ID: 272592 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: California  
Vaccinated:2006-12-15
Onset:2006-12-29
   Days after vaccination:14
Submitted: 2007-02-14
   Days after onset:47
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Fungal infection, Immune system disorder, Pharyngolaryngeal pain, Rash, Sinusitis, Vaginal infection, Vulvovaginal candidiasis
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04758

Write-up: Information has been received from a physician concerning a female (age not reported) with no medical history and no known allergies reported on 15-Dec-2006 (previously reported as being approximately JAN-2007 and 15-Feb-2006), the patient was vaccinated with Gardasil intramusculary (Lot # 653735/0688F). Subsequently, the patient developed a weakened immune system, yeast infection, sore throat, sinusitis and had a rash on her leg that was lasting several days. At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007, 4/6/2007. Initial and follow up information has been received. There were no known illnesses noted at the time of vaccination. On approximately 29-Dec-2006, two weeks after vaccination, the patient developed a rash on her legs, lasting two weeks, sinusitis (previously reported to have developed a weakend immune system), a sore throat, and condidal vaginitis. On 26-Jan-2007, the patient had recovered from the events. The patient was seen by her physician when the symptoms had resolved. No further information is availble. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow up information has been received from a physician concerning a 25 year old female with no medical history and no known allergies reported. On approximately 15-JAN-2007 (conflicting information also reported as 15-FEB-2008), the patient was vaccinated intramuscularly with the first dose of GARDASIL (Lot# 653735/0688F). There were no known illnesses noted at the time of vaccination. On unspecified dates, soon after the vaccination, the patient developed a sore throat (previously reported to have developed a weekend immune system and sinusitis). The patient then developed a rash on her legs lasting two weeks and then a yeast infection (vaginitis). On 26-JAN-2007, the patient had reported from the events. No further information is available.


VAERS ID: 272593 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Georgia  
Vaccinated:2007-01-29
Onset:2007-01-25
Submitted: 2007-02-14
   Days after onset:20
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04778

Write-up: Information has been received from a physician concerning a 21 year old female on antibiotics for condition unspecified, and pertinent medical history and drug reactions/allergies unspecified who on approximately 29-JAN-2007 was vaccinated with first dose of Gardasil (lot # not reported) IM. Concomitant suspect therapy included Antimicrobial (unspecified). The physician reported that the patient sought medical attention (called the office) to report that she had hives (on approximately 25-JAN-2007). The patient had been on antibiotics for a couple of days prior to receiving Gardasil. The physician felt the hives may be related more to the antibiotics than the vaccine. The outcome of the hives was unspecified. no further information was available at the time of reporting. Additional information has been requested.


VAERS ID: 272594 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Indiana  
Vaccinated:2007-01-25
Onset:2007-01-28
   Days after vaccination:3
Submitted: 2007-02-14
   Days after onset:17
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin, Wellbutrin
Current Illness:
Preexisting Conditions: Penicillin allergy.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04781

Write-up: Information has been received from a certified medical assistant concerning a 21 year old female with penicillin allergy who on 25-JAN-2007 was vaccinated with first dose of Gardasil (lot #654702/0011U), 0.5 ml IM in the deltoid. Concomitant therapy included Yasmin and Wellbutrin. On 28-JAN-2007, three days later, the patient woke up with a rash on her entire body. The patient sought medical attention. The patient took Benadryl, but it had not improved. The medical assistant reported that the patient stated the rash is the same over her entire body, the injection site is not any worse than the rest of her body. At the time of reporting, the patient''s rash persisted. No further information was available at the time of reporting. Additional information has been requested.


VAERS ID: 272595 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: New York  
Vaccinated:2007-01-16
Onset:2007-01-27
   Days after vaccination:11
Submitted: 2007-02-14
   Days after onset:18
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 655165/1425F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04794

Write-up: Information has been received from a physician concerning a 24 year old female with no pertinent medical history and no known adverse drug reactions or allergies reported. On 16-JAN-2007, the patient was vaccinated with the first dose of Gardasil (yeast). There were no concomitant medications reported. On 27-JAN--2007, the patient developed a rash on her arms and legs. At the time of this report, the outcome of the event was unknown. Additional information has been requested. This is in follow-up information has been rceived from a physician concerning a 24 year old female with no pertinent medical history and no known adverse drug reactions or allergies reported. On 25-JAN-2007 (previously reported as 15-JAN-2007), at approximately 5:45 p.m. the patient was vaccinated IM in the left deltoid with the first dose of GARDASIL (lot #6551565/1425P). There were no concomitant medications reported. On 28-JAN-2007 (previously reported as 27-JAN-2007), the patient developed a red, itchy rash on her arms and legs, reported as worse on the side the patient received her vaccination. The patient was treated with BENADRYL, as directed by the physician. On 01-FEB-2007, the physician spoke to the patient and reported that, at the time of the call, there was improvement of the patient''s rash. No additional information is expected.


VAERS ID: 272596 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Indiana  
Vaccinated:2006-12-01
Onset:2006-12-16
   Days after vaccination:15
Submitted: 2007-02-14
   Days after onset:60
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Erythema nodosum
SMQs:, Hypersensitivity (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OVCON 50
Current Illness: Amenorrhea, Hirsutism, Allergic reaction to antibiotics
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04857

Write-up: information has been received from a physician concerning a 17 year old female with amenorrhea, hirsutism and a CECLOR allergy who on 01-DEC-2006 was vaccinated IM with a first dose of Gardasil (yeast). The patient received Menactra concomitantly. Other concomitant therapy included Ovcon 50. On 16-DEC-2006 the patient developed erythema nodosum. The patient sought unspecified medical attention. The patient was treated with a course of steroids and has fully recovered. No laboratory diagnostic tests were performed. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 272597 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-18
Onset:2007-01-28
   Days after vaccination:10
Submitted: 2007-02-14
   Days after onset:17
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04897

Write-up: Information has been received from a physician concerning his 20 year old female daughter with no other pertinent medical history reported. On 18-JAN-2007, the patient was vaccinated IM with the first 0.5 ml dose of Gardasil (yeast). There were no concomitant medications reported. On 28-JAN-2007, the patient developed unilateral supraclavicular lympadenopathy. There were no other symptoms reported. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested.


VAERS ID: 272598 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Georgia  
Vaccinated:2007-01-25
Onset:2007-01-27
   Days after vaccination:2
Submitted: 2007-02-14
   Days after onset:18
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04926

Write-up: Information has been received from a physician concerning a female patient who on 26-JAN-2007 was vaccinated with a dose of Gardasil (yeast). On 27-JAN-2007 the patient developed a rash on her arm, chest and back. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 272599 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: South Dakota  
Vaccinated:2007-01-29
Onset:2007-01-29
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:16
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1447F / 2 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Dizziness, Impaired driving ability, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol, ORTHO TRI-CYCLEN, ADVAIR
Current Illness: Penicillin allergy
Preexisting Conditions: Ovarian cyst, Asthma
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0701USA04931

Write-up: This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a healthcare provider concerning her 20 year old daughter who was a student with a penicillin allergy who on 29-JAN-2007, at 08:10, was vaccinated intramuscularly into the left deltoid with a second dose of GARDASIL (Lot # 655617/1447F). Concomitant therapy included Ortho Tri Cyclen, albuterol and Advair. On 29-JAN-2007 at 13:00 ("later in the day") the patient was driving and developed dizziness ("very dizzy") and nausea which lasted about 4 hours. She could no longer drive so the passenger took over driving. No laboratory diagnostic studies were performed. On 29-JAN-2007 the patient recovered. A first dose of GARDASIL was given IM on 22-NOV-2006. Additional information is not expected.


VAERS ID: 272600 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-11-13
Onset:2006-12-01
   Days after vaccination:18
Submitted: 2007-02-14
   Days after onset:75
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Dyspnoea, Muscle spasms, Vaginal haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPO-PROVERA
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA04984

Write-up: Information has been received from a 22 year old female certified medical assistant who on 12-SEP-2006 was vaccinated IM with the first dose of Gardasil (yeast) (Lot#653735/0688F). On 13-NOV-2006 the patient received the second dose of Gardasil (yeast) (Lot#653735/0688F). Concomitant therapy included Depo-Provera. On an unspecified date in December 2006, the patient began with vaginal bleeding "on and off for several weeks. On 13-JAN-2007 the patient started with a flow that was very heavy lasting seven days, with cramping and shortness of breath. At the time of this report it was unknown if the patient had recovered from the events. Additional information has been requested.


VAERS ID: 272601 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Virginia  
Vaccinated:2007-01-18
Onset:2007-01-18
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:27
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA04996

Write-up: Information has been received from a physician concerning a female (age not reported) with pertinent medical history and drug reactions/allergies unspecified who on approximately 18-JAN-2007 was vaccinated with Gardasil (yeast) (lot # not reported). On approximately 18-JAN-2007, the patient experienced a rash all over her body. The outcome of the rash was unknown. Additional information has been requested.


VAERS ID: 272602 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-29
Onset:2007-01-29
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:16
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Disturbance in attention, Feeling abnormal
SMQs:, Dementia (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA05003

Write-up: Information has been received from a 23 year old female emergency medical attention with a penicillin allergy who on 29-JAN-2007 was vaccinated IM with a second 0.5 ml dose of Gardasil (yeast). On 29-JAN-2007 the patient reported feeling "weird or slow in the head" and "can not concentrate or think clearly". The patient received a first IM 0.5 dose of Gardasil (yeast) on 12-DEC-2006. Additional information has been requested.


VAERS ID: 272603 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA05006

Write-up: Information has been received from a pharmacist concerning a 10 year old female vaccinated with a first 0.5 ml dose of Gardasil (yeast). Two days later, the patient developed a rash behind her knees and on her chest. Unspecified medical attention was sought. At the time eof this report, the patient''s outcome was unknown. No product quality was involved. Additional information has been requested.


VAERS ID: 272604 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA05007

Write-up: Information has been received from a registered nurse concerning a female, pediatric patient who was vaccinated with Gardasil (yeast), (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 272605 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2006-12-13
Onset:2006-12-13
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:63
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Dry mouth
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA05035

Write-up: Information has been received from a physician concerning a patient who was vaccinated with Gardasil (yeast). Subsequently the patient experienced dry mouth. Additional information has been requested.


VAERS ID: 272606 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-12-28
Onset:2007-01-26
   Days after vaccination:29
Submitted: 2007-02-14
   Days after onset:19
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 653735/0688F / 1 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Dysmenorrhoea, Dyspnoea, Groin pain, Menorrhagia
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Osteonecrosis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA05041

Write-up: Information has been received from a health professional concerning a 12 year old white female who on 28-DEC-2006 was vaccinated intramuscularly with the first dose of HPV vaccine (yeast) (lot# 653735/0688F). Concomitant therapy included varicella virus vaccine live (MSD) received on 08-DEC-2006 and Menactra vaccine received on 27-NOV-2006. On approximately 26-JAN-2007 the patient experienced an extremely heavy menstrual cycle with more cramps than previous cycles, one episode of pain in the groin area and shortness of breath while at basketball practice. At the time of this report it was unknown if the patient had recovered from these events.


VAERS ID: 272607 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-26
Onset:2007-01-28
   Days after vaccination:2
Submitted: 2007-02-14
   Days after onset:17
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA05044

Write-up: Information has been received from a nurse concerning a female with diabetes who on 26-JAN-2007 was vaccinated with the second dose of Gardasil (yeast). On 28-JAN-2007 the patient experienced a big knot, redness and puffiness at the injection site. The patient sought medical attention. The patient is recovering from a big knot, redness and puffiness at the injection site. Additional information has been requested.


VAERS ID: 272608 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2007-01-29
Onset:2007-01-29
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:16
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Dyspnoea, Malaise, Nausea, Panic attack, Paraesthesia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Panic attack
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA05047

Write-up: Ths is in follow-up to report (s) previously submitted on 2/14/2007. Information has been received from a Certified Nurse Midwife concerning a 20 year old female who is "prone to panic attacks" who on 29-JAN-2007 at 11:15 am was vaccinated IM with the first dose of Gardasil (yeast) (Lot # not provided). At 7:30 pm that same evening the patient experienced a panic attack with severe nausea, vomiting and difficulty breathing and went to the emergency room. The patient was not admitted to the hospital. At the time of this report it was unknown if the patient had recovered from the events. Additional information has been requested. Information has been received from A Certified Nurse Midwife concerning a 20 year old female with an anxiety disorder who is "prone to panic attacks" who on 29-JAN-2007 at 11:15 am was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 654702/0011U). At 7:10 pm that same evening the patient experienced a panic attack with severe nausea, vomiting and difficulty breathing and went to the emergency room. The patient was not admitted to the hospital. At the time of this report it was unknown if the patient had recovered from the events. Follow up information received stated that the patient presented to the emergency room at 10:00 pm on 29-JAN-2007 with complaints of dizziness, nausea, malaise and parethesias. The patient was treated with PHENERGAN 50 mg and discharged home from the emergency room. Subsequently the patient recovered from the events. Additional information has been requested.


VAERS ID: 272609 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Washington  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA05074

Write-up: Information has been received from a receptionist at a physician''s office concerning a 23 year old female who "about a month ago" in approximately December 2006 was vaccinated with a first dose of Gardasil. Subsequently, the patient developed a sore arm. Additional information has been requested.


VAERS ID: 272610 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Georgia  
Vaccinated:2007-01-26
Onset:2007-01-26
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:19
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00039

Write-up: Information has been received from a physician concerning a female patient who on 26-JAN-2007 was vaccinated with a first dose of Gardasil (yeast). On 26-JAN-2007 the patient experienced itching and a rash around the area of the arm and the back of the knee. The rash continued to worsen and medication was ordered to treat the rash. At the time of this report, the patient''s outcome was unknown. It was noted that the patient will not receive the second and third dose of the vaccine. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Information has been receivced from a physician concerning a female patient who on 26-JAN-2007 was vaccinated with a first dose of GARDASIL. On 26-JAN-2007 the patient experienced itching and a rash around the area of the arm and the back of the knee. The nurse stated that the rash began in the crevices of the elbows and knees and progressed to other parts of the body before the medicine was ordered to stop the itching. The rash continued to worsen and medication was ordered to treat the rash. At the time of this report, the patient''s outcome was unknown. It was noted that the patient will not receive the second and third dose of the vaccine. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 272611 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00126

Write-up: Information has been received from a registered nurse concerning an approximately 23 year old female (patient 2 of 4) who was vaccinated with Gardasil (yeast). The registered nurse reported that she another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn''t even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved and the patient was sent home. Additional information has been requested.


VAERS ID: 272612 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00127

Write-up: Information has been received from a registered nurse concerning an approximately 23 year old female (patient 3 of 4) who was vaccinated with Gardasil. The registered nurse reported that she and another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn''t even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved ant the patient was sent home. Additional information has been requested.


VAERS ID: 272613 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00128

Write-up: Information has been received from a registered nurse concerning an approximately 23 year old female (patient 4 of 4) who was vaccinated with HPV vaccine (yeast). The registered nurse reported that she and another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn''t even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved and the patient was sent home. Additional information has been requested.


VAERS ID: 272614 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-03-07
Onset:2007-03-11
   Days after vaccination:4
Submitted: 2007-02-14
   Days after onset:25
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0188U / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Hypoaesthesia, Loss of consciousness, Paraesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00129

Write-up: Information has been received from a physician concerning a female patient who in "the week of 22-JAN-2007" was vaccinated IM with a 0.5 ml dose of HPV vaccine (yeast). After vaccination, the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted 02/14/2007. Information has been received from a physician and a nurse concerning a 15 year old female patient who on 07-MAR-2007, at 2:10, (previously reported as approximately 22-JAN-2007) was vaccinated IM, left deltoid, with a 0.5 ml dose of GARDASIL (lot # 657006/0188U). The patient reportedly had one prior dose of GARDASIL (date unknown). On 11-MAR-2007, late at night/early AM, the patient got up and on the way back to bed, she felt numbness and tingling in her legs then "blacked out for a few minutes". The patient said a friend woke her up. She felt tired all day. Later that afternoon, the patient went to her room, she didn''t feel right. She complained of tingling and numbness in her legs and arms, which lasted 5-10 minutes. Subsequently, the patient recoverd from her symptoms. No product quality complaint was involved. Additional information is not expected.


VAERS ID: 272615 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-01-03
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Fatigue, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0702USA00130

Write-up: Information has been received from a physician concerning a 14 year old female patient with no medical history or allergies, who on 03-JAN-2007 and on 06-MAR-2007 was vaccinated with a first and second 0.5 ml dose of GARDASIL, respectively (second dose lot# 653735/0688F given IM). Concomitant therapy given on 03-JAN-2007 included a dose of MENACTRA. There was no illness at the time of vaccination. On approximately 03-JAN-2007, the patient experienced fatigue and subsequently recovered. After the second vaccination on 06-MAR-2007, the patient experienced nausea and extreme fatigue. After one of the vaccination the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. Additional information is not expected.


VAERS ID: 272616 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: New York  
Vaccinated:2007-01-22
Onset:2007-01-29
   Days after vaccination:7
Submitted: 2007-04-06
   Days after onset:66
Entered: 2007-02-15
   Days after submission:49
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 655617/1447F / 2 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00144

Write-up: Information has been received from a physician concerning a 15 year old female with no past medical history who on 22-JAN-2007 was vaccinated IM with a second 0.5 ml dose of HPV vaccine (yeast) (lot #655617/1447F). There was no concomitant medication. On 29-JAN-2007 the patient developed erythema and mild tenderness at the site of injection. There was no fever. She sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow up information has been received from a physician concering a 15 year old female student with no past medical history and no adverse events following prior vaccinations who on 22-JAN-2007 was vaccinated IM with a second 0.5ml dose of GARDASIL (lot # 655617/1447F). There was no concomitant medication. On 29-JAN-2007 the patient developed erythema, swelling and mild tenderness at the site of injection. There was no fever. She recovered on an unspecified date. Additional information is not expected.


VAERS ID: 272617 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-01-11
Onset:2007-01-21
   Days after vaccination:10
Submitted: 2007-02-14
   Days after onset:24
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Lymph node pain, Malaise
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00147

Write-up: Information has been received from a physician concerning an approximately 20 year old female, with no medical history, who on 11-JAN-2007 was vaccinated intramuscularly with a first dose of HPV vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 21-JAN-2006 the patient developed bilateral tender lymph nodes and malaise. Unspecified medical attention was sought. At the time of the report, the patient''s bilateral tender lymph nodes and malaise persisted. There were no laboratory or diagnostic tests performed. Additional information has been requested.


VAERS ID: 272618 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-23
Onset:2007-01-26
   Days after vaccination:3
Submitted: 2007-02-14
   Days after onset:19
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 654702/0011U / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00149

Write-up: Information has been received from a physician concerning a 19 year old female who on 23-JAN-2007 was vaccinated with a 0.5 ml first dose Gardasil (lot #654702/011U). On 26-JAN-2007 the patient developed a rash on her stomach. Medical attention was sought and the patient was told to take diphenhydramine hydrochloride (BENADRYL). There were no laboratory or diagnostic tests performed. Subsequently, the patient recovered from rash on her stomach. Additional information is not expected.


VAERS ID: 272619 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-01-26
Onset:2007-01-27
   Days after vaccination:1
Submitted: 2007-02-14
   Days after onset:18
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 655619/1427F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: sulfonamide allergy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00160

Write-up: Information has been received from a registered nurse from a hospital infusion center concerning a 22 year old female with sulfa allergy and no pertinent medical history who on 26-JAN-2007 was vaccinated with first dose of Gardasil (lot# 655619/1427F), 0.5 ml, IM in left deltoid. There was no concomitant medication. On 27-JAN-2007, Saturday morning, the patient called and reported she experienced pain at the injection site and the pain had increased. The patient sought medical attention. No diagnostic tests were performed. On 31-JAN-2007, the patient experienced pain and tingling down her left arm. At the time of reporting, the patient had no recovered. The patient was referred to her primary physician for follow-up. Additional information has been requested.


VAERS ID: 272620 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-28
Onset:2007-01-28
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:17
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Injection site erythema, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00167

Write-up: Information has been received from a registered nurse concerning a female (age not reported) with pertinent medical history and drug reactions/allergies reported as unspecified who on 28-JAN-2007 was vaccinated with Gardasil (lot# not reported), 0.5 ml IM. Concomitant therapy was unspecified. On approximately 28-JAN-2007, the patient experienced redness at the injection site with tingling in her arms. The condition progressed to tingling in her fingers with numbness in both arms and fingers. The patient sought medical attention. At time of reporting, the patient had not recovered. Additional information has been requested.


VAERS ID: 272621 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: California  
Vaccinated:2006-01-17
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00193

Write-up: Information has been received from a consumer concerning her 19 year old daughter who on approximately 17-JAN-2006 was vaccinated with a dose of Gardasil. Subsequently the patient developed a "rash from head to toe." It was reported that the patient had followed up with her physician. At the tiem of the report, the patient''s rash persisted. Additional information is not expected.


VAERS ID: 272622 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Injection site pain, Similar reaction on previous exposure to drug
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES07002USA00197

Write-up: Information has been received from a nurse practitioner concerning a 21 year old female who on unspecified dates was vaccinated intramuscularly with the first and second doses of Gardasil. Subsequently, the patient experienced dizziness and injection site stinging following the first vaccination and injection site stinging following the second vaccination. It was reported that the events occurred immediately after vaccination and resolved after about 5 minutes. Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 272623 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tetanus toxoid
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00207

Write-up: Information has been received from a nurse practitioner concerning a 16 year old female who on an unspecified date was vaccinated intramuscularly with the first dose of Gardasil. Concomitant therapy included a tetanus toxoid shot. Immediately with vaccination, the patient developed injection site stinging and the patient passed out for a few seconds. The patient sought unspecified medical attention. The nurse practitioner reported that the patient was fine after a few seconds and was able to drive home. Thee was no lot number provided. Additional information has been requested.


VAERS ID: 272624 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Nervous system disorder, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00208

Write-up: Information has been received from a nurse practitioner concerning a 17 year old female who was vaccinated, intramuscularly with HPV vaccine. The nurse reported that the patient was having "neurological problems" after receiving the vaccine. The reporter stated that the patient explained she was having "pain and numbness" in her extremities. The reporter stated the patient was going to see a neurologist. At the time eof the report, it was unknown, if the patient recovered. Additional information has been requested.


VAERS ID: 272625 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00262

Write-up: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with GARDASIL. Subsequently, following vaccination, the patient fainted. The patient fully recovered. No further details were provided. No further information is available.


VAERS ID: 272626 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0702USA00263

Write-up: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with HPV vaccine. Subsequently, following vaccination, the patient fainted. The patient fully recovered. No further details were provided. Additional information has been requested. This is in follow-up to report (s) submitted on 2/14/2007. No futher information is available.


VAERS ID: 272627 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0702USA00264

Write-up: Information has been received from a registered nurse concerning a female patient who on unspecified dates was vaccinated with the first and second doses of HPV vaccine. Subsequently, following each vaccination, the patient vomited. The patient fully recovered. No further details were provided. Additional information has been requested.


VAERS ID: 272628 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-12
Onset:2007-01-14
   Days after vaccination:2
Submitted: 2007-02-14
   Days after onset:31
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Pain, Skin lesion
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00274

Write-up: Information has been received from a physician concerning a female patient who on 12-JAN-2007 was vaccinated with a dose of HPV vaccine. On 14-JAN-2007 the patient experienced painful raised lesions on the arm where the vaccine was administered. Unspecified medical attention was sought. The patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 272629 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-12
Onset:2007-01-14
   Days after vaccination:2
Submitted: 2007-02-14
   Days after onset:31
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 655619/1427F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Rash, Skin lesion
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE; Unknown
CDC Split Type: WAES0702USA00304

Write-up: This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a physician concerning a 25 year old female who on 12-JAN-2007 was vaccinated IM in the right deltoid, with a first 0.5 ml dose of HPV vaccine (lot#655619/1427F). There was no concomitant medication. On 14-JAN-2007 the patient developed raised erythematous papules with tenderness (previously described as skin eruptions, lesions), on the axilla of the right arm. It was reported that the patient was treated with Benadryl. The patient reported the patient''s lesions continued for two weeks and were worsening. At the time of the report, the patient had not recovered. Additional information has been requested. Follow up information indicated that labs (not specified) had been obtained and the results had not yet been received. The physician indicated the outcome of the erythematous and tender papules was unknown. Additional information has been requested.


VAERS ID: 272630 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-01-24
Onset:2007-01-24
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:21
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 GM / -

Administered by: Other       Purchased by: Other
Symptoms: Drug administered at inappropriate site, Injection site rash, Rash
SMQs:, Anaphylactic reaction (broad), Drug abuse and dependence (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00307

Write-up: Information has been received from the mother of a 22 year old female, via a consumer (friend), who on approximately 24-JAN-2007 was vaccinated in the buttock with the first dose of HPV vaccine. On approximately 24-JAN-2007 the patient developed an initial rash at the injection site, which went away. A few days later, approximately 27-JAN-2007 the patient developed a rash on her entire trunk, spreading form her crotch to her shoulders. The patient''s mother was thought to be a nurse, who administered the injection to her daughter at home after she picked up the vaccine from her daughter''s physician. It was also reported that the mother of the patient had picture of her daughter''s rash. At the time of the report the patient had not recovered from the rash on her trunk. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 272631 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-30
Onset:2007-01-31
   Days after vaccination:1
Submitted: 2007-02-14
   Days after onset:14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / -

Administered by: Other       Purchased by: Other
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptive
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00321

Write-up: Information has been received from a registered nurse concerning a female (age not reported) who on 30-JAN-2007 was vaccinated with the second 0.5 mL dose of HPV vaccine. Concomitant therapy included unspecified hormonal contraceptives. On 31-JAN-2007, the patient developed a rash under skin that covered entire body except her legs. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. The nurse did mention that the patient "did not have a reaction to the first injection of HPV vaccine. Additional information has been requested.


VAERS ID: 272632 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-26
Onset:2007-01-26
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:19
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00348

Write-up: Information has been received from a 22 year old female healthcare worker who on 26-JAN-2007 was vaccinated with HPV vaccine. The patient stated that the "HPV stung a lot as it was being administered." Unspecified medical attention was sought. The patient recovered. Additional information has been requested.


VAERS ID: 272633 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00596

Write-up: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated by HPV vaccine, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sough unspecified medical attention. Additional information has been requested


VAERS ID: 272634 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / ID

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00597

Write-up: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injections. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 272635 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00598

Write-up: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 272636 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00599

Write-up: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 272637 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00600

Write-up: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 272638 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00601

Write-up: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 272639 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00602

Write-up: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the tiem of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 272640 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00603

Write-up: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 272641 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00604

Write-up: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sough unspecified medical attention. Additional information has been requested.


VAERS ID: 272399 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-02-01
Onset:2007-02-02
   Days after vaccination:1
Submitted: 2007-02-07
   Days after onset:5
Entered: 2007-02-16
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0962F / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1892AA / 1 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B007AA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1065F / 2 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Dizziness, Headache, Hypotension, Somnolence, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Early in the am of 2/2/2007, patient woke with sudden onset of vomiting, dizziness, and severe headaches. Seen by primary care physician later in the day with noticeable hypotension. Remained in bed over the weekend, sleeping most of the time and taking Motrin for headache.


VAERS ID: 272430 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-10-31
Onset:2006-11-30
   Days after vaccination:30
Submitted: 2007-02-14
   Days after onset:76
Entered: 2007-02-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Laboratory test, Pregnancy, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Propranolol Hydrochloride
Current Illness: Pregnancy NOS (LMP= 11/30/2006), Migraine
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: diagnostic laboratory 11?/??/06 -
CDC Split Type: WAES0702USA01168

Write-up: Information has been received from a 26 year old female consumer with migraine headaches, who on approximately 31-OCT-2006 ("end of October or beginning of November 2006"), was vaccinated with the first dose of Gardasil (yeast). Concomitant therapy included propranolol HCL for migraine headaches. Subsequently, the patient "became pregnant at the end of November 2006," and reported " a normal pregnancy with no adverse side effects". The approximate LMP date was 30-NOV-2006, with an estimated due date of 06-SEP-2007. Additionally, on approximately 28-DEC-2006 ("approximately six weeks ago"), the patient was diagnosed with lupus (not further specified), and daily injections of LOVENOX were initiated as treatment. Unspecified blood tests were performed (results not reported). At the time of the report, the patient had not recovered. Upon internal review, the patient''s diagnosis of lupus was considered to be an other important medical event. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 272431 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-12
Onset:2007-01-13
   Days after vaccination:1
Submitted: 2007-02-14
   Days after onset:32
Entered: 2007-02-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Brain scan normal, Computerised tomogram normal, Condition aggravated, Dystonia, Pain, Tic, Torticollis
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (broad), Dystonia (narrow), Ocular motility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives, Prevacid
Current Illness: Drug hypersensitivity
Preexisting Conditions: Dystonic reaction
Allergies:
Diagnostic Lab Data: head computed axial 01/13/07 - negative
CDC Split Type: WAES0702USA00888

Write-up: Information has been received from a health professional concerning a 14 year old female with allergies to Prozac and Seroquel and a history of dystonic reaction involving the right arm, right leg and neck in 2006 caused by an allergic reaction to Seroquel who on 12-JAN-2007 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified) and Prevacid. On 13-JAN-2007 the patient experienced a tic disorder involving her head and neck. The patient also had a rapid, involuntary, spasmodic dystonic reaction and torticollis like movement that appeared painful and continued during sleep. On 13-JAN-2007, the patient was examined in the emergency room and was given Benadryl and Ativan and was released. A CT scan of the brain was negative. On 15-JAN-2007, she was examined by her primary care physician and was given Benadryl IM. She was later examined on 15-JAN-2007 by a neurologist and was given Cogentin IM and was started on oral benztropine mesylate (MSD). ON 17-JAN-2007, 19-JAN-2007, and 05-FEB-2007, the patient was also examined by a neurologist. On 19-JAN-2007 the symptoms began to resolve and on 05-FEB-2007 completely resolved. The patient will continue with Cogentin until 19-FEB-2007. Tic disorder, rapid, involuntary, spasmic dystonic reaction and torticollis like movement were considered to be other important medical events and disabling. Additional information has been requested.


VAERS ID: 272569 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:2007-01-25
Onset:2007-01-27
   Days after vaccination:2
Submitted: 2007-02-19
   Days after onset:23
Entered: 2007-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500438P / UNK NS / IN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0960F / UNK LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: will be getting tsh, ferritin, and cbc
CDC Split Type:

Write-up: pt recieved HPV #1 on 1/25/07 since vaccine has had period for past 22 days. has not had issues with vaginal bleeding between period before vaccine.


VAERS ID: 272720 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-02-01
Onset:2007-02-01
   Days after vaccination:0
Submitted: 2007-02-19
   Days after onset:18
Entered: 2007-02-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Haemorrhage, Rectal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Accidents and injuries (narrow), Ischaemic colitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA02439

Write-up: Information has been received from a health professional concerning her 13 year old female cousin with pertinent medical history and drug reactions/allergies not specified who in approximately February 2007, was vaccinated with Gardasil (Lot # not reported) 0.5 ml. Concomitant therapy was unspecified. In approximately February 2007, the patient experienced "internal bleeding throughout her body" after being vaccinated with Gardasil. The bleeding presented initially as bruising and most recently as rectal bleeding. Medical attention was sought. On an unspecified date, the patient was hospitalized. At the time of reporting, the patient had not recovered. The patient''s internal bleeding, bruising, and rectal bleeding were reported as immediately life threatening and disabling events No further information was available at the tiem of reporting. Additional information has been requested.


VAERS ID: 272739 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-02-10
Onset:2007-02-11
   Days after vaccination:1
Submitted: 2007-02-12
   Days after onset:1
Entered: 2007-02-20
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 2 - / IM

Administered by: Public       Purchased by: Private
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: high Fever~DTaP (no brand name)~2~0.33~In Patient
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Nausea and vomiting 4:30 am 2-11-07 to 5:00 pm


VAERS ID: 272740 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Kansas  
Vaccinated:2007-02-08
Onset:2007-02-08
   Days after vaccination:0
Submitted: 2007-02-12
   Days after onset:4
Entered: 2007-02-20
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Hyperaesthesia, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Generalized itching started the evening of vaccine. Increased in sensitivity, esp in scalp over next 3 days. Broke out in hives 3 days after vaccine-both arms and face. Given po Benadryl with improvement. Hives gone after 2 doses of Benadryl. Rx for Zyrtec started.


VAERS ID: 272771 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-02-07
Onset:2007-02-09
   Days after vaccination:2
Submitted: 2007-02-20
   Days after onset:11
Entered: 2007-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0962F / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Culture throat negative, Rash erythematous, Rash papular, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: THROAT CULTURE TO RULE OUT STREP PN 2/13/07. RESULTS WERE NEGATIVE
CDC Split Type:

Write-up: AFEBRILE ERYTHEMATOUS FINE PAPULAR PRURITIC RASH ON CHEST, LEGS, BACK AND ABDOMEN BEGINNING 2 DAYS POST VACCINATION. PRURITITS AND ERYTHEMA RESPONDED TO ORAL BENADRYL.


VAERS ID: 272785 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-02-19
Onset:2007-02-19
   Days after vaccination:0
Submitted: 2007-02-20
   Days after onset:1
Entered: 2007-02-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2644AA / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0942R / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Keartosis Pilaris
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 5 minutes after Pt received vaccines, fainted LOC lasted about 5 seconds then pt dizzy and lightheaded for about 5-10 min and relieved by 10 min resting supine then 5 min sitting and drinking gatorade/eating cheese crackers.


VAERS ID: 272792 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Maine  
Vaccinated:2007-02-11
Onset:2007-02-11
   Days after vaccination:0
Submitted: 2007-02-20
   Days after onset:9
Entered: 2007-02-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Drug screen negative, Dysstasia, Feeling drunk, Incoherent, Lethargy, Urine analysis normal
SMQs:, Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Penicillin allergy, Drug hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: urinalysis 02/11/07 clear, urine drug screen 02/11/07 normal
CDC Split Type: WAES0702USA02702

Write-up: Information has been received from a licensed practical nurse concerning an 18 year old female with a penicillin allergy and allergy to BENADRYL who on 11-FEB-2007 was vaccinated at another practice with a first dose of Gardasil. There was no concomitant medication. On 11-FEB-2007, 30 minutes after the vaccination, the patient "felt lethargic and could not stand on her own". "She looked like she was drunk and she did not make any sense when she spoke". The patient went to an emergency department and was released. She was reported to have no rash or breathing problems. It was also reported that a urinalysis was clear and drug test was normal. She was reported to have recovered 12 hours after the vaccination./ The reporter felt that the patient''s symptoms were disabling. Additional information has been requested.


VAERS ID: 272793 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-08-01
Onset:0000-00-00
Submitted: 2007-02-20
Entered: 2007-02-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Amniocentesis, Drug exposure during pregnancy, Foetal disorder, Pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 11/3/2006)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Amniocentesis, Ultrasound
CDC Split Type: WAES0702USA01359

Write-up: Information has been received from a medical assistant concerning her 18 year old daughter with family history free from abnormalities who in August 2006, was vaccinated with Gardasil (lot # not reported) injection, IM. Concomitant therapy included varicella virus vaccine live (lot # not reported) given in September 2006). The patient sought medical attention. At the time of reporting, the patient was 4 months pregnant (estimated last menstrual period 03-NOV-2006 and estimated date of delivery 10-AUG-2007). Her unborn child has fetal abnormalities which were detected shortly after vaccination with Gardasil and varicella virus vaccine live. On an unspecified date, the patient had ultrasounds and amniocentesis performed. Additional information was received from the patient''s mother via telephone call who reported that her daughter is currently under the care of perinatologist. Additional information has been requested.


VAERS ID: 272821 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: California  
Vaccinated:2007-02-05
Onset:2007-02-06
   Days after vaccination:1
Submitted: 2007-02-06
   Days after onset:0
Entered: 2007-02-21
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1424F / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Nausea, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: came in for lump on stomach, was hit while playing basketball
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Pt received Gardasil on Feb 5 2007 in pm. She went home the next day she woke up 6:00 am with dizziness, legs shaking, nauseated, feeling faint lasting 3 days unable to go to school. The fourth day she felt better.


VAERS ID: 272847 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Colorado  
Vaccinated:2007-02-15
Onset:2007-02-18
   Days after vaccination:3
Submitted: 2007-02-21
   Days after onset:3
Entered: 2007-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0962F / 1 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Injection site pain, Injection site rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Routine Pap smear
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: HPV vaccine given 2/15/07. PT called office 2/20/07 with reports of "breaking out from vaccine". States on 2/18 she had hives on waist up, dry and flaky. Only "pain and pimple" at injection site (R arm). Pt denied any other changes in detergents, soap, food, perfume, lotion, etc. Pt told to take Benadryl.


VAERS ID: 272851 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Female  
Location: Kansas  
Vaccinated:2007-02-21
Onset:0000-00-00
Submitted: 2007-02-21
Entered: 2007-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2272AA / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1208F / 2 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1301F / 2 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The HPV vaccine was given to a 7 yr. old girl.


VAERS ID: 272865 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-01-11
Onset:2007-01-12
   Days after vaccination:1
Submitted: 2007-02-21
   Days after onset:40
Entered: 2007-02-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / 1 - / -

Administered by: Private       Purchased by: Private
Symptoms: Non-consummation, Pregnancy test negative, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Denies sexual activity, PG test neg.
CDC Split Type:

Write-up: Vaginal bleeding started day after receiving Gardasil vaccine. Bleeding is persistent (Moderate-severe) and still present LMP 12/28/02 ended 01/02/07. Onset menses 10 year age.


VAERS ID: 272876 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-02-08
Onset:2007-02-08
   Days after vaccination:0
Submitted: 2007-02-09
   Days after onset:1
Entered: 2007-02-22
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 00134 / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Burning sensation, Incorrect dose administered, Injection site erythema, Injection site pain, Injection site rash, Vaccination complication
SMQs:, Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho-tricyclen, Synthroid
Current Illness:
Preexisting Conditions: egg allergy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient received partial dose of vaccine in left deltoid due to defective syringe. Pt immediately complained of a burning sensation on her arm where the medication ran (down her arm) I cleansed her entire upper arm with alcohol-pt relieved little relief. The she stated it was sore at about a 2 inch radius from the injection site. Pt was discharged in mother''s care to monitor her. Pt''s mother was contacted around 10:00 am the next day-stated-evening of 02/08/07, pt had severe pain at site and gave 2 500mg doses of Acetaminophen to relieve pain. Mother stated site looked red and raised-similar to a bee sting reaction. She also stated it was gone upon waking and pt now only complaining of moderate site pain with little swelling and redness. Pt to return in 3 days for reevaluation.


VAERS ID: 272889 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-02-12
Onset:2007-02-12
   Days after vaccination:0
Submitted: 2007-02-21
   Days after onset:9
Entered: 2007-02-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0014U / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA02754

Write-up: Information has been received from a nurse practitioner concerning a 17 year old female with penicillin allergy who on 12-FEB-2007 was vaccinated with Gardasil 0.5ml intramuscularly (lot number 653736/0014U). There was no concomitant medication. On 12-FEB-2007, 45 to 60 minutes post vaccination, the patient called the physician''s office stating that she had hives on her arms and legs. The treatment was Benadryl. On 13-FEB-2007, the patient was seen at the physician''s office and still had hives on her arms and legs but no shortness of breath. No other treatment was given. The hives were improving. Hives on arms and legs were considered an other important medical event. Additional information has been requested.


VAERS ID: 272895 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Maryland  
Vaccinated:2007-02-20
Onset:2007-02-20
   Days after vaccination:0
Submitted: 2007-02-22
   Days after onset:2
Entered: 2007-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 02634 / 2 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Arrhythmia, Blood pressure, Computerised tomogram, Dyspnoea, Dysstasia, Electrocardiogram, Fall, Feeling hot, Fluid replacement, Heart rate, Hyperhidrosis, Hyperventilation, Injury, Loss of consciousness, Nausea, Paraesthesia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: I take Ortho Try Cyclen Lo, daily and a multi-vitamin
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: CAT Scan, EKG, blood pressure, heart rate
CDC Split Type:

Write-up: I received the vaccination at approximately 8:20 AM and felt nothing (my arm slightly ached where the vaccine had been injected, but I felt nothing out of the ordinary post-injection). I walked over to the check-in counter to schedule my third a final injection in the series and put on my jacket. I remember the nurse saying 8:00 AM on Wednesday, June 20 and then the next thing I remember is being surrounded by people on the floor of the office. I blacked out while standing up and hit the left side of my body (mainly my lower jaw, neck, and clavicle) and when my body hit the floor the center, back of my head slammed to the floor. No one actually saw what parts of my body hit where during the fall because the nurse was behind the counter sitting at the computer (below eyesight of my fall) and patients in the waiting room were seated behind a wall. Based on where I remember standing before blacking out and where my body hurt after waking up, I think I am pretty certain I know what was hit. After waking up the doctor and several nurses helped me sit up and recommended calling an ambulance to have my head checked out. At first I declined because I did not think I had any serious problems, but after I tried standing and could not, I agreed to the ambulance. My face was tingly, I had trouble breathing (when I first woke up I was hyperventilating), I was sweating, and my legs were not stable. The EMT arrived and took my blood pressure and decided I should go to the emergency room for a check-up. When we arrived at the ER my head and lower jaw were throbbing from the fall. The ER staff gave me an IV for hydration and ran the typical tests (blood pressure, heart rate, etc.), an EKG, and later received a CAT scan. After returning from the CAT Scan I was still a bit shaken but was breathing normal. My left arm ached from the injection (my right arm ached after the first injection in series, so I ignored that aches). After being in the hospital for at least two hours I suddenly blacked out again. My sister was sitting with me and said my face turned a green/yellow shade. I remember feeling nauseas and becoming very hot and it was very hard to breath. My sister called the nurse who came and hooked me up to the heart monitors and also started another IV. Awhile later the nurse came back and said I had probably had an arrhythmia, but they were not sure. I stayed in the ER for the remainder of the day and nothing else happened. I was later discharged and told I had had an arrhythmia (I was never told what may have happened in the morning, but it too was most likely an arrthmia). I told everyone after arriving at the ER I had received my second injection in the Gardasil series that morning and had eaten a small breakfast (I assumed I would eat a larger one when I arrived at work). The staff said they were not certain of side effects of Gardasil as it was so new, but they were very certain the blacking out happening on the same day as the vaccination was just coincidence. My mother was reading about Gardasil and came across the following: "Deaths ? Across the clinical studies, 17 deaths were reported in 21,464 male and female subjects. The events reported were consistent with events expected in healthy adolescent and adult populations?In addition, there were 2 cases of sepsis, 1 case of pancreatic cancer, and 1 case of arrhythmia in the group that received GARDASIL, and 1 case of asphyxia in the placebo group." This particular page is what prompted me to write to VAERS. Arrthmia is a documented "serious" side effect of Gardasil and the office staff at my OB/GYN and at the Hospital ER were not aware my condition was connected to the injection.


VAERS ID: 272911 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Female  
Location: New York  
Vaccinated:2007-02-17
Onset:2007-02-17
   Days after vaccination:0
Submitted: 2007-02-22
   Days after onset:5
Entered: 2007-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B008AA / 2 RA / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1447F / 2 LA / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1948AA / 2 RA / -

Administered by: Private       Purchased by: Public
Symptoms: No adverse effect, Wrong drug administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: none-realized Dtap was given instead of Tdap


VAERS ID: 272940 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-12-22
Onset:2006-12-22
   Days after vaccination:0
Submitted: 2007-02-22
   Days after onset:62
Entered: 2007-02-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Insomnia, Medical device complication, Musculoskeletal pain, Pain, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: X-ray 02/12?/07 - No bony abnormalities
CDC Split Type: WAES0702USA03448

Write-up: Information has been received from a physician and an office manager concerning a 17 year old female with asthma who on 22-DEC-2006 was vaccinated IM, into the left arm, with a 0.5 ml first dose of Gardasil (lot#654540/0800P). It was reported that at the end of the administration the "safety spring plunger snapped back and caused the patient pain." The office manager explained that this incident was due to human error, the physician was unfamiliar with safety mechanism. On 22-DEC-2006, the patient experienced left shoulder pain and difficulty sleeping on her left arm. On approximately 12-FEB-2007, the patient saw an orthopedic surgeon. The patient underwent an X-ray which revealed no bony abnormality. The orthopedic surgeon recommended that the patient go to physical therapy. At the time of the report, the patient had not recovered. The physician considered the left shoulder pain and difficulty sleeping on her left arm to be disabling events. Additional information has been requested.


VAERS ID: 272942 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-22
Entered: 2007-02-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Immune system disorder
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA02738

Write-up: Information has been received from a nurse concerning her niece (age not reported) who on an unspecified date was vaccinated with Gardasil injection. Concomitant therapy was unspecified. Subsequently, the patient experienced "immune system shut down" after receiving the vaccination. The patient had sought medical attention. On an unspecified date, the patient was hospitalized and at the time of reporting it was unknown how long the patient was hospitalized or if she was still in the hospital. It was unspecified if the patient had recovered. The nurse felt that the "immune system shut down" was considered to be immediately life-threatening. Additional information has been requested.


VAERS ID: 272976 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Maryland  
Vaccinated:2007-02-15
Onset:2007-02-16
   Days after vaccination:1
Submitted: 2007-02-23
   Days after onset:7
Entered: 2007-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Fatigue, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin
Current Illness: cold
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 2-22-07 pt reported feeling dizzy and tired, nauseous, and arm just stopped hurting yesterday, symptoms started day after injection, no lump, no bump at site


VAERS ID: 272978 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Virginia  
Vaccinated:2007-02-16
Onset:2007-02-16
   Days after vaccination:0
Submitted: 2007-02-20
   Days after onset:4
Entered: 2007-02-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1424F / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Headache, Muscular weakness, Nausea, Paraesthesia, Photophobia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mircette-28
Current Illness: mild viral URI
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approx. 2 hours after receiving HPV vaccine pt. developed tingling in left arm (vaccine given in left arm) and then in left leg. At times both extremities felt slight "weak". Pt developed severe right sided headache with nausea and photophobia


VAERS ID: 272983 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: New York  
Vaccinated:2007-02-19
Onset:2007-02-20
   Days after vaccination:1
Submitted: 2007-02-20
   Days after onset:0
Entered: 2007-02-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 00116 / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Nausea, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient received Gardasil vaccine in P.M. during night, nausea, vomited x 1, then fainted. Temperature 100.7


VAERS ID: 272989 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Virginia  
Vaccinated:2007-01-31
Onset:2007-01-31
   Days after vaccination:0
Submitted: 2007-02-23
   Days after onset:23
Entered: 2007-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0012U / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Pregnancy, Pregnancy test positive
SMQs:, Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: (+) pregnancy
CDC Split Type:

Write-up: Patient has positive pregnancy test on 2-22-07. Cancel all future doses.


VAERS ID: 273013 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2007-02-20
Onset:2007-02-22
   Days after vaccination:2
Submitted: 2007-02-26
   Days after onset:4
Entered: 2007-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. ? / 2 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Herpes zoster, Pain, Paraesthesia, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOOVRAL
Current Illness: NONE KNOWN
Preexisting Conditions: NONE KNOWN
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: ON 2/22/07 PATIENT STARTED WITH TINGLY,ITCHY AREA ON BACK THAT BECAME A RAISED ,RED RASH ON BACK. IT IS MOSTLY ON ONE SIDE MORE THAN THE OTHER AND IS VERY PAINFUL AND CAUSES HER LEFT SIDE TO BE TINGLY. SHE WENT TO THE WALK-IN BECAUSE IT WAS THE WEEKEND AND THEY DIAGNOSED HER WITH SHINGLES. SHE WAS STARTED ON A COURSE OF VALTREX TO TAKE TID FOR ONE WEEK. SHE IS FOLLOWING UP WITH HER PRIMARY CAE M.D. WHO IS POSSIBLY TO DO LAB WORK.


VAERS ID: 273026 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2007-02-12
Onset:2007-02-12
   Days after vaccination:0
Submitted: 2007-02-23
   Days after onset:11
Entered: 2007-02-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0186U / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Fall, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA02831

Write-up: Information has been received from a physician and a nurse in the physician''s office concerning a 14 year old female who on 12-FEB-2007 was vaccinated with the first 0.5ml dose of Gardasil. within two minutes of receiving the shot, the patient passed out. it was reported that as she was falling to the ground, it was observed that she was having a seizure. The seizure was described as a "drawing of the right arm". The patient did not have full body tremors. The seizure lasted approximately one minute. The patient was sent to the emergency room, however, was reported as being "Fine" when she left the office. The patient was not admitted to the hospital. The nurse did not know of any treatment given in the ER and believed that the patient was just observed and released. The physician reported that the patient was fine after being released from the emergency room. On 12-FEB-2007, the patient has recovered from the events. It was reported that the patient had no history of seizures and the nurse stated that the patient will continue with the Gardasil series. Upon internal reviews, seizure was considered to be an other important medical event. Additional information has been requested.


VAERS ID: 273065 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: North Dakota  
Vaccinated:2007-02-08
Onset:2007-02-10
   Days after vaccination:2
Submitted: 2007-02-22
   Days after onset:12
Entered: 2007-02-26
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 72004 / 1 LA / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1282F / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1822AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cervix disorder, Contusion, Discomfort, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Depression, low back pain
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2 days after receiving vaccines started having sharp, stabbing pain, and bruising in cervix area. Muscles ache and burn also inner thighs. No fever, no vaginal discharge. Still having discomfort 12 days afterwards. No sexually active.


VAERS ID: 273099 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: New York  
Vaccinated:2007-02-22
Onset:2007-02-22
   Days after vaccination:0
Submitted: 2007-02-23
   Days after onset:1
Entered: 2007-02-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB141AA / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1426F / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2158AA / 1 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B007AA / 1 LA / IM

Administered by: Private       Purchased by: Public
Symptoms:
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: records received 4/5/07-CBC:66 neutrophils. 24.6 lymphocytes.
CDC Split Type:

Write-up: None Stated 03/05/07-records received from facility: seen in ED for allergic reaction to vaccines. HX of cough, wheezing and SOB few hours prior to ED visit, symptoms began 30 minutes after vaccines. Initially returned to PCP with c/o chest tightness, difficulty breathing, treated with epipen and benadryl and sent to ED. No swelling of mouth, lips or tongue. Allergies to cat (owns a cat). Uses nasonex for nasal congestion. VS P: 141, resp 20 BP 130/91. Treated with solu medol and ranitidine. Tremors, difficulty breathing. PE unremarkable. Lungs clear, no rhonchi, no wheezes. Admitted for IV steroid treatment.


VAERS ID: 273103 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-02-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2007-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Rash on shoulders, chest and back


VAERS ID: 273112 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Indiana  
Vaccinated:2006-12-21
Onset:2007-02-02
   Days after vaccination:43
Submitted: 2007-02-21
   Days after onset:19
Entered: 2007-02-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 2 - / -

Administered by: Private       Purchased by: Private
Symptoms: Blister, Herpes virus infection, Hordeolum
SMQs:, Severe cutaneous adverse reactions (broad), Ocular infections (narrow), Hypersensitivity (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2/2/07 Vesicles near eyebrow, sty in eyelid - found to be possible herpes. Treated with Valtrex.


VAERS ID: 273116 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Maryland  
Vaccinated:2007-02-20
Onset:2007-02-20
   Days after vaccination:0
Submitted: 2007-02-22
   Days after onset:2
Entered: 2007-02-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2168CA / 2 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 1 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Dizziness, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metronidazole 100 mg/day
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: symptoms started 2-20-07 at 7pm. 1st noticed bumps on arms. She now has hives on her abdomen, face, neck and arms. She also felt faint at times.


VAERS ID: 273177 (history)  
Form: Version 1.0  
Age: 31.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-12
Onset:2006-12-12
   Days after vaccination:0
Submitted: 2007-02-27
   Days after onset:77
Entered: 2007-02-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Convulsion, Dyspnoea, Headache, Incoherent, Influenza like illness, Malaise, Nausea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GLUCOPHAGE
Current Illness: Type II diabetes mellitus, Sulfonamide allergy, Drug hypersensitivity, Penicillin allergy
Preexisting Conditions: Gastric bypass, gastric stapling reversal, asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0702USA03479

Write-up: Information has been received from a licensed practical nurse concerning a 31 year old female with type II diabetes mellitus, sulfa, morphine, DEMEROL and penicillin allergy and a history of gastric bypass (1994), reverse gastric bypass (1996) and mild asthma who on 12-DEC-2006 was vaccinated with her first dose of Gardasil (lot #653978/0955F), 0.5 ml, IM. Concomitant therapy included metformin HCL (GLUCOPHAGE). On 12-DEC-2006 less than one hour after receiving her first dose of Gardasil, the patient developed "Flu-Like" symptoms. The patient stated that she had a headache and nausea but was not sure if she had a fever. About ten hours after the initial vaccine was administered the patient had a convulsive seizure. The seizure lasted about 2 minutes. The patient was not coherent and was breathing heavy. After the seizure, the patient continued to fell ill and had no memory of the seizure. The patient did not go to the hospital. The patient''s husband was an EMT, so he attended to her but did not given her any medication. The patient had no prior history of seizures. The next day the patient felt better. Upon internal review, convulsive seizure was considered to be an other important medical event. Additional information has been requested.


VAERS ID: 273206 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Utah  
Vaccinated:2007-01-22
Onset:2007-01-29
   Days after vaccination:7
Submitted: 2007-02-28
   Days after onset:30
Entered: 2007-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2177AA / UNK RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 2 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Fatigue, Headache, Muscular weakness, Myalgia, Vaccination complication
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: seizure~Vaccine not specified (no brand name)~1~0.00~Patient|aeizure~Vaccine not specified (no brand name)~1~0.00~Sibling
Other Medications:
Current Illness:
Preexisting Conditions: Pertussis vaccine. 3/7/07 records received Seizure as infant after pertussis vaccine and never completed the series. Mononucleosis at age 16. Migraines.
Allergies:
Diagnostic Lab Data: Severe reaction Gardasil and Influenza vaccine given. Labs:WNL. Rheumatoid factor negative. CK 64 repeat CK 65.
CDC Split Type:

Write-up: Patient had myalgias at day 7 post vaccine. Severe headache global x <24 hours. Severe muscle weakness. Severe fatigue, symptoms routine except headache which disappeared in 24 hours. 03/07/8/07-records received from rheumatology consultation for DOS 03/02/07-Impression: Myalgias, dysethesias hands and feet, increased fatigability, oral ulceration/cankers;possible rare reaction to either flu or Gardasil. Rule out vasculitis, lupus and other connective tissue disease. C/O severe body pain, weakness, headache lasted 1 day but has had persistent generalized muscle pain. Transient numbness in hand, face and feet. Eyes feel sore, some twitching of eyelids. PMH: Seizure as infant after pertussis vaccine and never completed the series. No recurrence of seizure and did not appear to be febrile seizure. Mother has multiple sclerosis. PE:Muscles tender to palpation pretty uniform throughout body, not so much in hands as in forearms, arms, trunks, legs, calves.


VAERS ID: 273207 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-12-28
Onset:2006-12-28
   Days after vaccination:0
Submitted: 2007-02-28
   Days after onset:62
Entered: 2007-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1208F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yaz birth control
Current Illness: NONE reported
Preexisting Conditions: NKDA; no birth defects; no medical conditions
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2-27-07 Patient stated "I had redness in my right arm that went down to right hand and knuckles, then it started in left arm and hand it was very itchy. Started 30-45 min after injection given.


VAERS ID: 273209 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2007-02-16
Onset:2007-02-20
   Days after vaccination:4
Submitted: 2007-02-21
   Days after onset:1
Entered: 2007-02-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 01874 / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1968AA / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2689AA / 1 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Sensation of heaviness, Skin burning sensation
SMQs:, Peripheral neuropathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Legs burning and hurt next a.m. Tuesday, arms heavy was better on Wednesday, still with something that was gone on Thursday, burning feeling was gone on Wednesday p.m.


VAERS ID: 273263 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: New York  
Vaccinated:2007-02-27
Onset:2007-02-28
   Days after vaccination:1
Submitted: 2007-03-01
   Days after onset:1
Entered: 2007-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1426F / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2136AA / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Body temperature increased, Pain, Pyrexia, Rhinorrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR 5 MG QHS AND ALBUTEROL MDI 2 INHALATIONS PRN AMD ASMANEX INHALER 1 INHALATION A DAY
Current Illness: NONE
Preexisting Conditions: BRONCHIAL ASTHMA; NO ALLERGIES
Allergies:
Diagnostic Lab Data: TEMP= 101.0
CDC Split Type:

Write-up: FEELING ACHY AND FEVER (101.0) 48HRS AFTER ADMINISTRATION ALONG WITH VOMITTING X6 THAT NIGHT AND TWICE THE FOLLOWING MORNING. MILD RUNNY NOSE, NO COUGHING, NO WHEEZING, NO HIVES,NO DIARRHEA, MILD ABDOMINAL CRAMPING. NO LETHARGY, NO BEHAVIORAL CHANGES, NO JOINT PAIN OR MUSCLE WEAKNESS. ADMINISTERED IBUPRIFEN 400 MG PO AT 11AM ON 03-01-07. ADVISED SYMPTOMATIC CARE AND SEEK EMERGENCY SERVICE IF SYMPTOMS PERSIST OR WORSEN.


VAERS ID: 273294 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: New York  
Vaccinated:2007-01-30
Onset:2007-02-03
   Days after vaccination:4
Submitted: 2007-03-02
   Days after onset:27
Entered: 2007-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blister, Erythema, Rash, Skin warm
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Combivent inhaler, Advantage inhaler, Spiriva inhaler.
Current Illness: NONE
Preexisting Conditions: Asthma, Emphysema
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 4 days after receiving Gardasil vaccine 1st injection patient c/o red, hot rash on both hands and upper thighs, rash on thighs with small blisters lasted approx 1 hour then subsided this went on daily for the next 10 days each time lasting 1 hour.


VAERS ID: 273305 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-02-16
Onset:2007-02-16
   Days after vaccination:0
Submitted: 2007-02-16
   Days after onset:0
Entered: 2007-03-02
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Convulsion, Fall, Head injury, Injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK labs received 3/9/07.CT head:normal C Spine unremarkable
CDC Split Type:

Write-up: Pt received Gardasil and within a minute, pt fainted while sitting on table, fell of and hit her head on a drawer handle, pt began to seize. Called 911, she was stabilized by EMS. 03/05/07-records received from PCP:Five minutes after administration of vaccine episode of eyes rolling back, fell off exam table and struck neck and head on cabinet drawers. Unresponsive to voice with stiffening of all extremities. Event lasted 30 seconds, afterwards alert oriented and recalled speaking to urse prior to event. Glucose 76, O2 sats 99% on RA. BP after episode 99/52, pulse 49. Transported to ER. 03/09/07-records received from facility for DOS 2/16/07-DX:Syncope. Post syncopal seizure.


VAERS ID: 273357 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2007-01-05
Onset:2007-01-05
   Days after vaccination:0
Submitted: 2007-03-01
   Days after onset:55
Entered: 2007-03-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Malaise, Pallor, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA04223

Write-up: Information has been received from physician concerning a 16 year old female patient who on approximately 05-JAN-2007 ("7 weeks ago") was vaccinated with the first dose, 0.5ml, IM, of Gardasil. There was no concomitant medication. The physician reported that the patient stated she "did not feel well when checking out and turned white and fainted when being taken back into the examining room." The physician clarified that the patient "did not lose consciousness or hit her head because he caught the patient." He confirmed the patient fainted "within 5 minutes" of the vaccination, and remained "groggy for up to 30 minutes" after the vaccination. The patient was then "considered recovered," and left the office. The physician considered the events to be disabling. Additional information has been requested.


VAERS ID: 273362 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:2007-02-19
Onset:2007-02-19
   Days after vaccination:0
Submitted: 2007-02-20
   Days after onset:1
Entered: 2007-03-02
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0186U / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Bradycardia, Chills, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, chills, bradycardia, vomiting.


VAERS ID: 273390 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2006-12-21
Onset:2006-12-21
   Days after vaccination:0
Submitted: 2007-02-27
   Days after onset:68
Entered: 2007-03-05
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Pallor
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Mom states patient was fine right after shot #1, but felt faint, looked pale on way out of office - came back to exam room and laid down x 20 minutes then was fine. Mom reports this today when returning for shot #2.


VAERS ID: 273415 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Colorado  
Vaccinated:2006-11-08
Onset:0000-00-00
Submitted: 2007-03-05
Entered: 2007-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / SANOFI PASTEUR C2609AA / 1 RA / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2255AAA / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Injection site reaction, Pigmentation disorder
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yaz, Celexa
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received first vaccine on 11/08/2006 never reported it until 03/01/. Area where she got Gardasil injection and tender and Hypo-pigmented. Left Arm 32mm x 24 mm 11/08/2006 Right Arm 22 x 25 mm 01/08/2007


VAERS ID: 273426 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-02-12
Onset:2007-03-04
   Days after vaccination:20
Submitted: 2007-03-05
   Days after onset:1
Entered: 2007-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1111R / 2 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Atrial septal defect, Cardiac arrest, Cough, Nasopharyngitis, Oxygen supplementation, Respiratory arrest, Somnolence, Urinary tract infection, Ventricular hypertrophy, Viral myocarditis, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Opportunistic infections (broad), Noninfectious myocarditis/pericarditis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 19 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Echocardiogram:dilated right ventricle. severely decreased biventricular systolic function. mild tricuspid/mitral insufficiency. atrial septum bulges. small pleural effusion right.
CDC Split Type:

Write-up: Vaccine administration date 2/12/2007, varicella dose #2 and Gardisil dose #1 administered concurrently. No symptoms until March 4th when in AM noted by mother to have a cold/URI symptoms with cough. Emesis at 11 after soup at 10, napping when mom at home at 3 PM but difficult to arouse. Called 911 and started rescue breathing. Paramedics initially called in stable VS''s but required active CPR on gurney by time came into ED. In disorganized vfib in ER-resusc''d with PALS then consulted cardiology for ECMO. Cannulated for VA ECMO - on full flow support after 1.5 hours. Heart completely akinetic. Went to cath lab to get biopsies, CAD''s and assessment of integrity of heart with very poor tone/strength to heart muscle noted; presumed acute viral myocarditis. Has gotten IVIG. Can''t assess neurologic function due to significant drug load. Remains with very disorganized rhythym today; to consider EPS study; also studying family for possible inherited rhythym disturbances. 03/20/07-partial records received from facility, patient remains in hospital. Received ECMO support for cardiac arrest secondary to myocarditis. Endomyocardial biopsy: acute lymphocytic myocarditis with scattered eosinophils. 04/25/07-DC Summary received for DOS 03/04-03/23/07-DC DX: Cardiac arrhythmia. Myocarditis. Per information received from annual follow up, off all CHF medications; very minimal residual orgainc brain syndrome; responding to PT/OT & counseling.


VAERS ID: 273430 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-03-01
Onset:2007-03-02
   Days after vaccination:1
Submitted: 2007-03-05
   Days after onset:3
Entered: 2007-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1208F / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1860AA / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2340AA / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient awakened early 3/2/07 with fever, chills, nausea and headache. L arm at injection site was tender and puffy. Temperatures ranged from 100.8 to 102.0 throughout the day. 3/3/07-c/o nausea, headache and temp of 100.0 3/4/07- c/o headache and stiff neck. 3/5/07-c/o headache


VAERS ID: 273433 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Missouri  
Vaccinated:2007-02-26
Onset:2007-03-02
   Days after vaccination:4
Submitted: 2007-03-05
   Days after onset:3
Entered: 2007-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Burning sensation, Musculoskeletal pain, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: birth control pill
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: No medical treatment sought at this time. If doesn''t resolve, will seek attention.
CDC Split Type:

Write-up: The 2nd injection in November nearly caused my daughter to pass out. She had to lie down & drink some water. The third injection on Feb. 26 was the most painful, with a burning sensation flowing down her arm toward her hand. Approximately 5 days after the injection, she began experiencing very sharp pain in the shoulder she received the injection in. Continues to be in moderate pain, especially with movement of shoulder.


VAERS ID: 273453 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2007-03-05
Onset:2007-03-05
   Days after vaccination:0
Submitted: 2007-03-05
   Days after onset:0
Entered: 2007-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 01884 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient fainted.


VAERS ID: 273469 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-01
Onset:2007-01-01
   Days after vaccination:0
Submitted: 2007-03-05
   Days after onset:63
Entered: 2007-03-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0012U / 1 UN / -

Administered by: Private       Purchased by: Other
Symptoms: Grand mal convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA04695

Write-up: Information has been received from a physician, via a company representative, concerning a 16 year old female patient who in January 2007 ("last month"), was vaccinated with the first dose, 0.5ml, of Gardasil. The physician reported that in January 2007 ("last month"), the patient experienced a grand mal seizure after receiving her first dose. In addition, the physician reported that the "patient has no history of seizures and was taken to the ER. The physician did not know if the patient was admitted. It was unknown if the patient recovered. Upon internal review, grand mal seizure was determined to be an other medical event. Additional information has been requested.


VAERS ID: 273472 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Illinois  
Vaccinated:2007-02-27
Onset:2007-02-28
   Days after vaccination:1
Submitted: 2007-03-02
   Days after onset:2
Entered: 2007-03-06
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 01874 / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site mass, Injection site pain, Myalgia, Neuralgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BCP (YAZ)
Current Illness: NONE
Preexisting Conditions: records received 7/19/07-HX complication after appedectomy in 2002. HX migraines. Nephrolithiasis.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pain of muscle/nerve, neck, arm, and upper back. Very tender arm at injection site and knot at injection site. Put on Prednisone and Mobic by doctor after exam of site and pain. 7/19/07-records received-notes from 3/4/07-C/O pain in neck and difficulty moving her head. Received injection in right arm. Symptoms were worse next day, thought it might be neuritis and was started on Medrol dose pack. Pain also in left shoulder and her entire body hurts. Instructed if symptoms increased to go to ED.


VAERS ID: 273475 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-11-20
Onset:2006-12-01
   Days after vaccination:11
Submitted: 2007-01-29
   Days after onset:59
Entered: 2007-03-06
   Days after submission:36
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Amenorrhoea
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient states she missed her menses the month after administration of her first Gardasil injection. Another nurse says she heard another patient say the same thing happened to her, but she couldn''t remember the second patient''s name in order to fill another report.


VAERS ID: 273503 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Oregon  
Vaccinated:2007-02-26
Onset:2007-02-26
   Days after vaccination:0
Submitted: 2007-03-05
   Days after onset:7
Entered: 2007-03-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHAVB113AA / 2 RA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHBVB261AA / 3 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1208F / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Dyspnoea, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: hives, swelling~ ()~~10.00~In Sibling
Other Medications: Stratera, Yazmine, 25 mg diphenhydramine QHS prn
Current Illness: poss. slight CAD
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: ABN CBC-WBC; Monocytes 12.8%; Lymphocytes 50.7; granulocytes 365; other values WNL
CDC Split Type:

Write-up: Ct c/o feeling of throat tightening up and difficulty breathing approx 3 1/2-4 hrs of receiving vaccinations. Went to bed and next am awake with throat tightness and breathing trouble, but left eye was swollen shut, right eye puffy, hands and arms swollen bilat., temp 100.9, earlobes also swollen, rash with red blotchness right hand. No local reaction, no arthralgia, ct saw pcp on 2/27/07. Treated with Benadryl 50mg a 6 hour x 2-3 days. Improved substantially by 3/27


VAERS ID: 273505 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-02-23
Onset:2007-02-23
   Days after vaccination:0
Submitted: 2007-03-06
   Days after onset:11
Entered: 2007-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1426F / 2 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: allergic to strawberries
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Aftershot, patient developed pain on the side of the body (left) that shot was administered, over left arm, left trunk, and left leg. There was no local redness, swelling, or pain at site of vaccine itself. The patient was treated with Motrin and ice and resolved after 24 hours.


VAERS ID: 273513 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2006-12-14
Onset:2006-12-14
   Days after vaccination:0
Submitted: 2007-03-06
   Days after onset:82
Entered: 2007-03-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Neck pain, Pain in extremity, Pain in jaw
SMQs:, Retroperitoneal fibrosis (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI-CYCLEN
Current Illness: Penicillin allergy
Preexisting Conditions: Drug rash
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0703USA00049

Write-up: Information has been received from a physician concerning a 17 year old female patient with a history of rash after taking amoxicillin, who on 14-DEC-2006 was vaccinated with the first dose, 0.5 ml, in the right arm, of Gardasil. Concomitant therapy included (ORTHO TRI-CYCLEN). In December 2006 (date not specified), the patient "experienced pain at left angle of jaw, neck pain and mid back pain. "The physician reported that the "mother treated daughter with ibuprofen and within 36 hours symptoms improved. The physician stated "the client did not report this reaction at the time. "On 20-FEB-2007 a second dose , 0.5ml, in the left arm, of Gardasil was administered. On 25-FEB-2007, the patient called the office, "complaining of pain at left angle of jaw, mid back pain, and pain in the right deltoid, upper aspect of the right arm, the opposite arm" of where she received the vaccination. At the time of this report it was unknown if the patient had recovered. The physician considered the events to be significantly disabling. Additional information has been requested.


VAERS ID: 273522 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Ohio  
Vaccinated:2007-02-09
Onset:2007-02-09
   Days after vaccination:0
Submitted: 2007-03-01
   Days after onset:20
Entered: 2007-03-07
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Asthenia, Injection site anaesthesia, Injection site pain, Tenderness
SMQs:, Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: possible migraines-not diagnosed yet by neuro. says right arm numbness with migraines
Allergies:
Diagnostic Lab Data: sent to ped neurology at clinic
CDC Split Type:

Write-up: Teen reports today pain at injection site for 1 week, then pain resolved and noticed numbness at site, which then went down to fingers, and involving entire arm. Transient, sometimes causing weakness. Site today tender to touch but location varies during exam. Full ROM


VAERS ID: 273538 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2007-02-23
Onset:2007-02-24
   Days after vaccination:1
Submitted: 2007-03-01
   Days after onset:5
Entered: 2007-03-07
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 01874 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Myalgia, Pharyngolaryngeal pain, Streptococcus serology, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: NONE
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Pt developed arthralgia, swelling and myalgia involving hands, fingers, elbow joint, toes and ankle joints in 2x hrs after vaccination. Also pt developed sore throat 4 days after immunization. This is in follow-up to report (s) previously submitted on 4/6/2007. Initial and follow-up information has been received from a registered nurse concerning a 17 year old female, with no pertinent medical history who on 23-Feb-2007 was vaccinated with the first dose of GARDASIL (lot # 656049/0187U). On 07-Feb-2007 patient developed arthralgia, myalgia and sore throat. The patient was seen by a pediatrician on 01-Mar-2007. The patient will not receive GARDASIL in the future. NSAID therapy was recommended. No blood work was performed. The patient was advised to return in 1 week if not better. The patient had not returned to date. Patient''s outcome was unkn own. Additional information has been requested.


VAERS ID: 273547 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Virginia  
Vaccinated:2007-02-21
Onset:2007-02-22
   Days after vaccination:1
Submitted: 2007-02-23
   Days after onset:1
Entered: 2007-03-07
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Body temperature decreased, Headache, Influenza like illness, Neck pain
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Amoxicillin, PCN
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headaches, low grade temp 100 degrees, neck pain, flu-like symptoms. Patient was treated by her family.


VAERS ID: 273553 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2007-02-13
Onset:2007-02-20
   Days after vaccination:7
Submitted: 2007-02-27
   Days after onset:7
Entered: 2007-03-07
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0014U / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (Loestrin 24)
Current Illness: NONE
Preexisting Conditions: NONE - NKDA, NKA
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: C/0 rash/hives starting on arms, wrists spread to face and legs 7-9 days post injection. Treatment prescribed by primary care MD, -----$g, Medrol pack ---$g, -----$g rash/hives disappeared within 24 hours of start of treatment.


VAERS ID: 273565 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Indiana  
Vaccinated:2007-03-07
Onset:2007-03-07
   Days after vaccination:0
Submitted: 2007-03-07
   Days after onset:0
Entered: 2007-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: demulen, ketek, aquatab
Current Illness: dry skin
Preexisting Conditions: allergy Tetracycline record received 3/9/07-prior HX tetracycline allergy.
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Within 1 hour of receiving vaccination she developed diffuse urticaria. responded to injected benadryl and depomedrol. 03/09/07-records received. for DOS 3/7/07-developed whole body hives and itching, chest felt heavy. Current medication Ketek. PE: WNL except for confluent hives on arms


VAERS ID: 273578 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Oregon  
Vaccinated:2007-02-26
Onset:2007-02-26
   Days after vaccination:0
Submitted: 2007-03-07
   Days after onset:9
Entered: 2007-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9187U / 1 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Headache, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Sulfa, noreo, Prednisone
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 15 minutes after vaccine - had generalized "itching" feeling every where. She rubbed, hives bright red presented. Took liquid 50 mg Benadryl 1 hr later, no hives, no itchiness but a bad headache.


VAERS ID: 273583 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2007-02-21
Onset:2007-02-22
   Days after vaccination:1
Submitted: 2007-02-28
   Days after onset:6
Entered: 2007-03-07
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0013U / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt developed rash over torso following day after vaccine administered. Rash worsened over week (red patches, itching). Referred to dermatologist given RX clobetasol Propionate and Zyrtec.


VAERS ID: 273631 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-26
Onset:2007-01-23
   Days after vaccination:28
Submitted: 2007-03-07
   Days after onset:43
Entered: 2007-03-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Balance disorder, Clumsiness, Coordination abnormal, Demyelination, Diplopia, Hemiparesis, Hypoaesthesia, Hypoaesthesia facial, Lumbar puncture, Nuclear magnetic resonance imaging abnormal
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad), Ocular motility disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: magnetic resonance 02/23/07 - revealed demyelination (other results not available), spinal tap 02/23/07 - (other results not available)
CDC Split Type: WAES0702USA04566

Write-up: Information has been received from a physician concerning a 15 year old female with no pertinent medical history and no drug reactions or allergies, who on 26-DEC-2006 was vaccinated with a 0.5 mL dose of Gardasil (Lot not reported). There was no concomitant medication. On 23-Jan-2007 the patient developed numbness of her face which eventually spread to her hands and legs. The patient was treated with prednisone and acyclovir. The numbness partially cleared but she then developed double vision, weakness of her right side, unbalance, decreased coordination and clumsiness of her hands. The patient sought unspecified medical attention. On 23-FEB-2007 the patient had a magnetic resonance imaging (MRI), which revealed demyelination and a spinal tap (results not available yet). The physician stated that the patient was starting to get better but was told the patient''s parents stopped the Gardasil vaccine series. The dose of Gardasil vaccine was administered by the patient''s primary care physician (PCP). The reporter considered the patient''s numbness of her face, hands and legs, double vision, weakness of her right side, imbalance, decreased coordination, clumsiness of her hands and demyelination to be other important medical events. Additional information has been requested.


VAERS ID: 273640 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Maine  
Vaccinated:2007-02-26
Onset:2007-02-26
   Days after vaccination:0
Submitted: 2007-02-28
   Days after onset:2
Entered: 2007-03-08
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / UNK LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1932AB / UNK RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0889F / UNK RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Nausea, Pain, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NKDA-Eczema
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Right arm red, swollen, has fever, nausea, body aches, no rash or hives.


VAERS ID: 273677 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-01-12
Onset:2007-01-12
   Days after vaccination:0
Submitted: 2007-03-07
   Days after onset:54
Entered: 2007-03-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Hypokinesia, Injection site pain
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin, Zyrtec prn
Current Illness: NONE
Preexisting Conditions: seasonal allergies
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: At one month post injection pt was having continued pain at injection site. At two months, not much improvement. Difficulty moving arm. Refused 2nd and 3rd injection because of this reaction.


VAERS ID: 273691 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: New York  
Vaccinated:2006-12-11
Onset:2006-12-21
   Days after vaccination:10
Submitted: 2007-03-08
   Days after onset:77
Entered: 2007-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2166MA / 2 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1163F / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Electroencephalogram, Nuclear magnetic resonance imaging
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: seizure~HPV (Gardasil)~2~12.30~In Patient
Other Medications:
Current Illness:
Preexisting Conditions: Developmental delay. PMH: developmental delay-non progressive. Occasional h/a. Lyme Disease age 5. Allergy to nuts, hives from Amoxicillin.
Allergies:
Diagnostic Lab Data: MRI and EEG.. Labs and Diagnostics: Brain MRI WNL. EEG WNL. Fragile X test with normal karyotype.
CDC Split Type:

Write-up: First seizure 10 days after first gardasil vaccine. Two months later, second seizure episode 16 days after second gardasil. 08/22/2008 MR received from Neuro consult dated 12/22/06 (as well as some past hx.) Assessment: 1st Seizure. Most likely a complex partial seizure with secondary generalization. Pt was trying to speak but unable to do so, then had a 30-40 sec grand mal seizure which may have begun in the legs. Neuro exam WNL. 9/11/2008 2 ER recs received dated 12/21/2006 and 6/16/2007 with DX: 1st seizure and seizure. Pt 1st presented 12/21/06 following 30-40 sec seizure. Seen 6/17/07 after 2 episodes of lip quivering and feeling of throat closing which was a similar aura with last grand mal seizure. C/o headache after.


VAERS ID: 273705 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-31
Onset:2007-02-15
   Days after vaccination:46
Submitted: 2007-03-08
   Days after onset:21
Entered: 2007-03-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Infectious mononucleosis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA04624

Write-up: Information has been received from the mother of a 18 year old female consumer who in late December 2006, was vaccinated 0.5 mL IM with her first dose of Gardasil. The patient came down with mononucleosis on 15-FEB-2007. Unspecified Blood work was performed. The patient was reported as recovered on 19-FEB-2007. No further information is available.


VAERS ID: 273706 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-11-24
Onset:2006-11-24
   Days after vaccination:0
Submitted: 2007-03-08
   Days after onset:104
Entered: 2007-03-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Contusion, Idiopathic thrombocytopenic purpura, Infectious mononucleosis, Injection site haematoma, Petechiae, Platelet count increased, Platelet count normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Gingival bleeding; Heavy periods; Sore throat; Steroid therapy; infectious mononucleosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: platelet count 12/12/06 $g5 150-400, platelet count 01/29/07 150-400 normal
CDC Split Type: WAES0703USA00022

Write-up: Information has been received from a physician at health conference, concerning her 15 year old daughter with a history of bleeding gums (attributed to orthodontic braces) previous 7 days, menstruation heavier 7 days earlier, slight sore throat approximately 1 week prior, and infectious mononucleosis showed possible acute infection, but seroconversion did not occur until 05-FEB-2007, possibly delayed by prolonged steroid treatment. On 03-OCT-2006, the patient was vaccinated with first dose of HPV vaccine. No reaction occurred. On 24-NOV-2006, the patient was vaccinated with second dose of HPV vaccine (lot # not reported), one month after the first dose. No reaction occurred. On 12-DEC-2006, poliovirus vaccine boosterix injection was given. A 5cm bruise developed within 4 hours. On 12-DEC-2006, the patient was hospitalized with a platelet count greater than 5. Signs included: 4 cm hematoma at the site of immunization left upper arm, few petechiae on lower abdomen, no hepato-splenomegaly. Provisional diagnosis of immune thrombocytopenia (ITP) was made. The patient was treated with Prednisone 75 mg stat, 3 weeks of 50 mg Prednisone, followed by decreasing dose over the next month. By 29-JAN-2007, the patient''s platelet count slowly returned to normal. The physician commented: "This is case of ITP, probably due to infectious mononucleosis, but diagnosed 18 days after the second dose of HPV vaccine (symptoms started approximately 10 days after the vaccine). I am hopeful it was due to Glandular fever but an interesting co-incidence and an unusual presentation of "IW." Additional information has been requested.


VAERS ID: 273722 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Arizona  
Vaccinated:2007-01-29
Onset:0000-00-00
Submitted: 2007-02-27
Entered: 2007-03-09
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1208F / 1 - / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Fatigue, Hypotrichosis, Loss of consciousness, Malaise, Night sweats
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tricycline Lo
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 1 hour after injection, pt passed out in class x 15 seconds. Felt "sick and exhausted" rest of the day. Coordination was off. Has experienced night sweats since injection and feels hair is thinning.


VAERS ID: 273740 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Colorado  
Vaccinated:2007-03-05
Onset:2007-03-05
   Days after vaccination:0
Submitted: 2007-03-07
   Days after onset:2
Entered: 2007-03-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB143BK / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1062F / 2 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Erythema, Injection site vesicles, Oedema peripheral, Pain in extremity, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Right upper arm red, hot, swollen 18 cm x 18 cm the circumference of arm. 5 small fluid filled vesicles around injection site. Patient c/o pain in effected arm. No systemic s/s. Doctor name reported examined patient and recommended Advil for pain ice to effected area. Advised to go to E.R. if symptoms worsened or systemic involvement occurs and contact PCP.


VAERS ID: 273750 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Idaho  
Vaccinated:2007-03-08
Onset:2007-03-08
   Days after vaccination:0
Submitted: 2007-03-09
   Days after onset:1
Entered: 2007-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0012U / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1249F / 1 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pruritus generalised, Rash maculo-papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Orthocyclen
Current Illness: None
Preexisting Conditions: Allergy to sulfa
Allergies:
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Patient started intching, mostly on trunk, last night; woke up itching all over and has rash (fine maculopapular rash) all over; given hydroxyzine for itching;


VAERS ID: 273751 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: North Carolina  
Vaccinated:2007-03-02
Onset:2007-03-03
   Days after vaccination:1
Submitted: 2007-03-09
   Days after onset:6
Entered: 2007-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER NA / 1 RL / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NA / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia, Rash macular, Vomiting, Wrong drug administered
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: n/a
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Wrong Vaccination was give. My son was given the HPV vaccine which is for women 18-26 years old. So far just normal post vaccine responses. Some blotching of skin, fever, and vomiting. Pediatric office contacted me on March 8th to report the wrong vaccination administration


VAERS ID: 273768 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:2007-03-05
Onset:2007-03-05
   Days after vaccination:0
Submitted: 2007-03-09
   Days after onset:4
Entered: 2007-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0181U / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Abdominal pain, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient complained of abdominal pain about 3 hours after receiving vaccines then the next day had nausea and dizziness.


VAERS ID: 273789 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-03-09
Onset:2007-03-10
   Days after vaccination:1
Submitted: 2007-03-12
   Days after onset:1
Entered: 2007-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 00130 / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1968AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Chills
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prevacid 30mg Q day / Allegra
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Elevated temp and chills approx. 16 hours after vaccine given


VAERS ID: 273808 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-01-19
Onset:2007-01-20
   Days after vaccination:1
Submitted: 2007-02-01
   Days after onset:12
Entered: 2007-03-12
   Days after submission:38
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0962F / 1 UN / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Asthenia, Headache, Hypersomnia, Hypoaesthesia, Hypokinesia, Laboratory test, Pain in extremity, Paraesthesia, Sensory disturbance, Vision blurred
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: all tests came back normal records received 3/30/07-EKG normal. CXR normal.
CDC Split Type: M12007004

Write-up: 1/31/07 tc from mother-states patient had HPV vaccine 1/19/07 on 1/20/07 c/o achy arms. Developed headache that comes and goes and blurred vision the comes and goes. On 1/26/07 c/o weakness-couldn''t move-went to hosp ER-was in ER for 8 hours. No convulsion for use of symptoms. Able to move now but has charge of sensation of left side. Mom states had been sleeping a lot. 2/21/07-Return call from mom. Completed form with available info, lasted 6 days-numbness/tingling. 03/30/07-records received from reporter. PE:WNL Pain when walking able to walk with some poor effort on examination but grossly normal musculoskeletal exam. Dehydration, musculoskeletal pain. Orthostatic blood pressure mostly likely due to poor oral intake. Sore throat and nasal congestion. Numbness in toes and feel and intermittent blurring of vision and seemed confused. Tired. Mother concerned about possible bipolar disorder. Multiple stressors in home life. Recommended mental health care provider


VAERS ID: 273813 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2007-02-20
Onset:2007-02-20
   Days after vaccination:0
Submitted: 2007-02-23
   Days after onset:3
Entered: 2007-03-12
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB129AA / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 1 RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Incorrect dose administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Adderall XR 20 mg daily ADD, Tetracycline 500 mg BID acne
Current Illness: ADD, Right ankle sprain, Acne
Preexisting Conditions: left elbow cracking
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Adult dose of Hepatitis A given (1440 elu) instead of pediatric dose of Hepatitis A (720 elu)


VAERS ID: 273817 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Virginia  
Vaccinated:2007-02-26
Onset:2007-02-26
   Days after vaccination:0
Submitted: 2007-03-12
   Days after onset:13
Entered: 2007-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1424F / 1 LA / -

Administered by: Other       Purchased by: Other
Symptoms: Burning sensation, Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Psoriasis
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Within 1/2 hr of receiving injection pt complained of face itching. Within 1 hour face and neck burning red and itchy. Given Benadryl at school. Slept several hours, still complaining of itching when she woke up. Resolved without further treatment.


VAERS ID: 273848 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2007-02-28
Submitted: 2007-03-12
   Days after onset:11
Entered: 2007-03-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion, Abortion spontaneous, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Pregnancy NOS (LMP = unknown).
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0703USA00274

Write-up: Information has been received from a registered nurse through a pregnancy registry concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. The patient was pregnant, and on 28-FEB-2007 the patient had a miscarriage or abortion after receiving the first dose of Gardasil. The patient sought unspecified medical attention. At the time of this report, the nurse was unsure if the patient had a miscarriage or abortion. Upon internal review, the patient''s miscarriage or abortion was considered an other important medical event. Additional information has been requested.


VAERS ID: 273852 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-02-26
Onset:2007-02-27
   Days after vaccination:1
Submitted: 2007-03-07
   Days after onset:8
Entered: 2007-03-13
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 00116 / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had Gardasil (1st injection of series) on 2/26/07 10:00 am, 24 hours later developed pink rash on arms. torso and neck. Patient complain of itching, denies using any new meds or products. Patient came in for OV with doctor, was given Medrol dose pack.


VAERS ID: 273861 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-02-28
Onset:2007-03-02
   Days after vaccination:2
Submitted: 2007-03-03
   Days after onset:1
Entered: 2007-03-13
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0960F / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2172AA / 1 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Imipramine
Current Illness: NONE
Preexisting Conditions: Enuresis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approximately 10 cm local reaction of redness and swelling Left arm. Treatment: warm soaks.


VAERS ID: 274290 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2007-01-16
Onset:2007-01-16
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:56
Entered: 2007-03-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB143BA / 1 LA / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 LA / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1968AA / 1 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Dyskinesia, Fall, Hyperhidrosis, Pain in extremity, Staring
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA03295

Write-up: Information has been received from a licensed practical nurse concerning a 16 year old female student with no pertinent medical history who on 16-Jan-2007, at 14:45, was vaccinated, into the left deltoid, with a first dose of Gardasil (lot #655619/1427F) concomitantly with a first dose of Havrix (lot AHAVB143BA) in the left arm and a first dose of Menactra (lot U1968AA) into the right deltoid. On 16-Jan-2007, at 14:45, while sittings on table, the patient complained of severe pain in the left arm. As the patient was complaining, she fell forward, and the licensed practical nurse laid her down. The patient''s eyes were fixed staring at the ceiling and her body started jerking wildly and thrashing. The patient went from jerking and trashing to "jumping up and asking what happened." The patient was guided back to the table and her body started jerking and thrashing with her eyes fixed on the ceiling and non-reactive. Subsequently, the patient came to diaphoretic. In January 2007, the patient recovered. No further information is available.


VAERS ID: 273907 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Virginia  
Vaccinated:2007-01-22
Onset:2007-01-22
   Days after vaccination:0
Submitted: 2007-03-13
   Days after onset:49
Entered: 2007-03-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: amitriptyline hydrochloride
Current Illness: Pregnancy NOS (LMP = Unknown) Drug hypersensitivity
Preexisting Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: urine beta-human - positive for pregnancy
CDC Split Type: WAES0701USA04414

Write-up: Information has been received from a licensed practical nurse, for the Pregnancy Registry for Gardasil concerning a 25 year old female with drug hypersensitivity to ENTEX, erythromycin, codeine, LORTAB, and IMITREX and a history of pregnancy who on 21-NOV-2006 was vaccinated with first dose of Gardasil (lot # 654702/0011U) IM. On 22-JAN-2007, the patient was vaccinated with second dose of Gardasil (lot # 654702/0011U), IM. Concomitant therapy included amitriptylline hydrochloride. The patient sought medical attention. On an unspecified date, urine beta-human chorionic gonadotropin test was positive for pregnancy. The patient''s last menstrual period was December 2006 (gestation: first trimester), expected date of delivery is approximately September 2007. No other information was available at the time of reporting. Additional information was received from a health professional from the physician''s office via telephone. It was reported that the patient terminated her pregnancy (date not reported), not because of Gardasil but for other reasons. The outcome of the induced abortion was not reported. Upon internal review, abortion induced was determined to be an Other Important Medical Event. No additional information is expected.


VAERS ID: 273908 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Illinois  
Vaccinated:2007-01-03
Onset:2007-02-11
   Days after vaccination:39
Submitted: 2007-03-13
   Days after onset:29
Entered: 2007-03-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Eosinophil count increased, Headache, Neck pain
SMQs:, Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: eosinophil count 02/11/07 - elevated
CDC Split Type: WAES0703USA00867

Write-up: Information has been received from a registered nurse concerning a 16 year old female who on 03-JAN-2007 was vaccinated with Gardasil (lot # not reported). On 11-FEB-2007, the patient experienced neck pain, and headache. Medical attention was sought. The patient was hospitalized. The patient had an "eosinophil type reaction" also. Laboratory evaluation revealed elevated eosinophils. The outcome of the neck pain, headache, and eosinophil type reaction was snot reported. No further information was available at the time of reporting. Additional information has been requested.


VAERS ID: 273909 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Ohio  
Vaccinated:2007-03-05
Onset:2007-03-05
   Days after vaccination:0
Submitted: 2007-03-13
   Days after onset:7
Entered: 2007-03-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Eye infection, Eye swelling, Face and mouth X-ray normal, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Ocular infections (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: nasal sinus X-ray 03/05/07 - negative
CDC Split Type: WAES0703USA01199

Write-up: Information has been received from a physician concerning a 17 year old female who on 05-MAR-2007 was vaccinated IM with the first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On 05-MAR-2007, two hours post-vaccination, the patient developed swollen eyes and face and went to an emergency room. The patient underwent sinus films, which were noted to be negative, and was administered BENADRYL and unspecified antibiotics for a possible eye infection. The patient was released that same evening. On 07-MAR-2007, the physician contacted the patient and reported that there was "not much improvement." The patient''s swollen eyes and face persisted. Eye and face swelling were reported as other important medical events. Additional information has been requested.


VAERS ID: 273915 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-03-05
Onset:2007-03-05
   Days after vaccination:0
Submitted: 2007-03-05
   Days after onset:0
Entered: 2007-03-14
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 02634 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Hyperhidrosis, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOESTRIN 24
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Appeared patient fainted just after vaccine was given, sl diaphoretic pale, recovered quickly after ammonia inhaler was used. Patient rested water was given, left office feeling well.


VAERS ID: 273916 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2006-08-31
Onset:2006-08-31
   Days after vaccination:0
Submitted: 2007-03-08
   Days after onset:189
Entered: 2007-03-14
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0640F / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Loss of consciousness, Scan brain, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: CT- brain - normal
CDC Split Type:

Write-up: Patient walked to lobby after shot and passed out, then body shook. She was helped back to exam room and observed. She hit back of head and no bump forward. Iced area for 30 minutes. She left in 45 minutes in good condition. Ct scan normal next day.


VAERS ID: 273919 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2007-02-23
Onset:2007-02-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2007-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0012U / 2 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Two days after injection, complained of joint pains, myalgia not relieved with use if Ibuprofen missed 2 days of school.


VAERS ID: 273920 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Wyoming  
Vaccinated:2006-09-29
Onset:2006-09-30
   Days after vaccination:1
Submitted: 2007-03-06
   Days after onset:157
Entered: 2007-03-14
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. P0688F / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Oedema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Allergy to Keflex and Motrin
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 1st Injection with slight erythema and edema. 2nd Injection noted slight edema and erythema, then next am woke with swollen area over most of deltoid area, continue to increase over next 24 hours - arm swollen from elbow to shoulder and continues for 8 days. Resolved completely.


VAERS ID: 273922 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-03-05
Onset:2007-03-05
   Days after vaccination:0
Submitted: 2007-03-07
   Days after onset:2
Entered: 2007-03-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1424F / UNK RA / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 1397F / UNK RA / SC
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2720AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature increased, Fatigue, Pharyngolaryngeal pain, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC
Current Illness: Vague RLQ abd pain
Preexisting Conditions: Depression, seasonal allergies
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Six hours s/p injections developed fever, rash up right arm, right side of neck and face. Also developed sore throat in 24 hours. Temp = 102. Rash responded to Benadryl except for local injection sites. Is having RLQ pain but that started before injections. Generally feels fatigued as well. No rash on left arm.


VAERS ID: 273925 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: New York  
Vaccinated:2006-11-22
Onset:2006-11-29
   Days after vaccination:7
Submitted: 2007-03-08
   Days after onset:99
Entered: 2007-03-14
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth Control
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient c/o arm swelling 7 days after 1st injection.


VAERS ID: 273927 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-03-08
Entered: 2007-03-14
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / UNK - / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1974AM / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Hives come days after vaccine, red on arm.


VAERS ID: 273929 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2007-03-05
Onset:2007-03-05
   Days after vaccination:0
Submitted: 2007-03-05
   Days after onset:0
Entered: 2007-03-14
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / 2 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Tinnitus
SMQs:, Anticholinergic syndrome (broad), Hearing impairment (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: "Dizziness, ringing in ears" per patient. Treatment: Patient laid down for 15-20 minutes, sx''s resolved. Vital signs were stable before, during and after sx''s.


VAERS ID: 273930 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-03-06
Onset:2007-03-07
   Days after vaccination:1
Submitted: 2007-03-08
   Days after onset:1
Entered: 2007-03-14
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 3 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Erythema, Nausea, Oedema peripheral, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Swelling and redness of arm. Swelling approximately 5 cm, erythema $g 26cm also nausea, vomiting, increase temp. This is in follow-up report (s) previously submitted on 4/6/2007. Information has been received from a 24 year old female and her physician. On 06-MAR-2007, the patient was vaccinated intramuscularly with a 0.5 ml third dose of GARDASIL. The physician reported that this was the patient''s first dose of GARDASIL. The patient had no relevant medical history or illness at the time of vaccination. Concomitant therapy included YASMIN. The patient mentioned that she did not have any problems with dose 1 or 2 and that these doses were given in the outer part of her arm. She reported that the third dose was given less in the outer area and towards the inner arm but still in the muscle. On 06-MAR-2007, the patient experienced red, sore lump at the injection site. The physician reported that on 07-MAR-2007, the patient developed swelling and redness of the arm with swelling of approximatley 5 cm and erythema greater than 26 cm. On 07-MAR-2007, the patient experienced nausea, started to throw up, and she developed a fever. On 09-MAR-2007, the patient went tot he emergency room due to continued vomiting and dizziness. She was treated with intravenous fluid and was released at approximatley 04:00 pm. As of 12-MAR-2007, the patient continued to experience dizziness and nausea. At the time of this report, the outcome was unknown as per the physician. Additional information has been requested.


VAERS ID: 273935 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: New York  
Vaccinated:2007-01-04
Onset:2007-01-05
   Days after vaccination:1
Submitted: 2007-03-08
   Days after onset:62
Entered: 2007-03-14
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / 1 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth Control
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Pt stated she had slight fever after 1st shot.


VAERS ID: 273969 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2007-02-09
Onset:2007-02-09
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:32
Entered: 2007-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0013U / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Antinuclear antibody, Full blood count, Headache, Pain, Pain in extremity, Viral test
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: CBC, ESR, Lyme, WB, ANA, DS DNA pending
CDC Split Type:

Write-up: C/O pain in extremities and headaches since administration of Gardasil (HPV Vaccine), constant pain, rated 6-7/10 on pain scale. Does not interfere with daily activity.


VAERS ID: 273976 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: South Dakota  
Vaccinated:2007-02-14
Onset:2007-02-27
   Days after vaccination:13
Submitted: 2007-03-14
   Days after onset:14
Entered: 2007-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pain, Pruritus, Skin tightness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho-tryclen Lo
Current Illness: none
Preexisting Conditions: allergies to cedar wood products & Demerol
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: erythema, pruritis, edema of palms, soles, fingertips, Pain with flexion of fingers, skin taut & shiny. symptoms started 2/27/07 continued though 3/1/07. Treated with ibuprofen 200 mg two tabs every 4-6 hours and diphenhyrdamine 25 mg at bedtime.


VAERS ID: 274024 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Alabama  
Vaccinated:2007-02-09
Onset:2007-02-23
   Days after vaccination:14
Submitted: 2007-03-15
   Days after onset:19
Entered: 2007-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0012U / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site induration, Muscle atrophy
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Celebrex Minocycline
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Area of induration and questionable muscle atrophy appeared 2 weeks after vaccine was administered. Increased to 1 inch diameter over 7-10 day period.


VAERS ID: 274035 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Nevada  
Vaccinated:2007-03-14
Onset:2007-03-14
   Days after vaccination:0
Submitted: 2007-03-15
   Days after onset:1
Entered: 2007-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0188U / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Heart rate normal, Hypoaesthesia, Paraesthesia, Rash macular, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Approximately 30 secs after vaccine was administered, pt became light headed and dizzy. Nurse had pt lay flat and administered ice pack to back of neck. Pulse normal. Ten minutes later, nurse asked how pt was feeling, she complained of still being dizzy and that both arms felt numb/ tingly. Pulse rechecked, left arm slower than right. Both of patient''s arms began to shake. Red blotches noted on patient''s chest and neck. The nurse practioner in the office was called and came to eval patient. Nurse practioner ordered Benedryl 25mg to be given.


VAERS ID: 274044 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2007-03-15
Onset:2007-03-15
   Days after vaccination:0
Submitted: 2007-03-15
   Days after onset:0
Entered: 2007-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1447F / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin tightness
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: About 2 minutes after vaccine (Gardasil, 2nd dose), patient noticed pain, swelling/tightness of upper arm near vaccine, and streaks of slightly swollen reddened skin out to about 4 cm surrounding injection site. Subsided within 8 minutes. Treatment was MD assessment and Claritin 10mg reditab.


VAERS ID: 274068 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-02-28
Onset:2007-02-28
   Days after vaccination:0
Submitted: 2007-03-15
   Days after onset:14
Entered: 2007-03-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 UN / -
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Fall, Head injury, Orthostatic intolerance, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0703USA00641

Write-up: Information has been received from a pharmacist concerning an 18 year old female patient who on 28-FEB-2007 was vaccinated with a first dose of Gardasil, Lot #653735/0688F. Concomitant therapy included Menomune. The patient fainted 10 minutes after injection Gardasil. The patient fell and hit her head when she fainted. The patient then had a seizure for 30 seconds after she fell after fainting. The patient was slow to wake and was Orthostatic (time line was unspecified). The patient also vomited twice (no time line). The patient recovered later in the day. The reporter considered the events to be disabling. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.


VAERS ID: 274069 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Washington  
Vaccinated:2007-02-08
Onset:2007-02-18
   Days after vaccination:10
Submitted: 2007-03-15
   Days after onset:24
Entered: 2007-03-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Crying, Pain in extremity
SMQs:, Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METADATE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0703USA01160

Write-up: Information has been received from a medical assistant and a nurse practitioner concerning an 11 year old female with no relevant medical history reported who on 08-FEB-2007 was vaccinated intramuscularly in the right deltoid wit a 0.5 ml dose of Gardasil (lot 654702/0011U). Concomitant therapy included METADATE. On approximately 18-FEB-2007 or 19-FEB-2007, the patient developed upper right arm pain. The patient was seen on 21-FEB-2007 and 02-MAR-2007 for the upper arm pain. The pain occurred on the whole outer portion of the upper arm. The patient has no fever. Office notes indicated that "normal flexion of the elbow without problems with bilateral strength. Normal anterior and posterior rotation of shoulder. Normal internal and external rotation of shoulder. Active abduction of only 90 degrees, stopping due to pain. Able to rotate full 180 degrees with passive range but crying due to tears. Diagnosis was arm pain without reduction of strength, secondary to HPV injection. "The patient was treated with ibuprofen 350mg every 6 hours for 4 to 5 days. The nurse practitioner reported that she assumed the patient recovered from the arm pain because the patient did not return for a follow-up visit scheduled on 08-MAR-2007. The nurse practitioner considered the patient''s upper arm pain an other important medical event as the patient''s pain lasted longer that the indicated time frame of 48 hours for this experience. Additional information has been requested.


VAERS ID: 274070 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Indiana  
Vaccinated:2007-03-07
Onset:2007-03-07
   Days after vaccination:0
Submitted: 2007-03-15
   Days after onset:7
Entered: 2007-03-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Allergic reaction to antibiotics
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0703USA01336

Write-up: Information has been received from a physician concerning a female (age not reported) with a history of allergic reaction to antibiotics who on 07-MAR-2007 was vaccinated with first dose of Gardasil (lot # not reported) injection. On 07-MAR-2007, after being vaccinated, the patient broke out in severe hives and her airway began to close. Medical attention was sought. The physician administered an injection of Benadryl. The patient was admitted to the emergency room, it was unknown if the patient was admitted to the hospital. On 08-MAR-2007, the patient recovered. No further information was provided. Upon internal review, airway began to close was considered to be an other important medical event. No further information is available.


VAERS ID: 274071 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Ohio  
Vaccinated:2007-03-05
Onset:2007-03-05
   Days after vaccination:0
Submitted: 2007-03-15
   Days after onset:9
Entered: 2007-03-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Dysphonia, Eye swelling, Laboratory test, Nasal congestion, Swelling face, Tenderness, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: diagnostic laboratory - respiratory panel
CDC Split Type: WAES0703USA01473

Write-up: Information has been received from a physician concerning a 17 year old female who on 05-MAR-2007 was vaccinated by injection with the first dose of Gardasil. It was reported that the patient experienced an adverse experienced 2 hours after receiving Gardasil. The patient went to the emergency room with a swollen face and eyes, no fever reported. The patient received eye drops and BENADRYL. On 06-MAR-2007 the patient returned to the clinic with tender and a "little puppy eyes". On 07-MAR-2007 the patient had an itchy throat and her eyes were still tender. On 08-MAR-2007, the patient sounded "nasal". The pat6ient sought unspecified medical attention. The physician added an antibiotic and the patient was still taking diphenhydramine hydrochloride. The patient has a "respiratory panel". The physician reported that the patient will not continue the series. At the time of the report, it was unknown if the patient recovered. The physician considered swollen face and eyes, tender eyes, itchy throat, and sounded "nasal" to be other important medical events.


VAERS ID: 274084 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-02-19
Onset:2007-02-19
   Days after vaccination:0
Submitted: 2007-03-11
   Days after onset:20
Entered: 2007-03-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB19AA / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 001N / UNK UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1968AA / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1497F / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Laceration, Oxygen saturation, Syncope, Tooth repair
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: PO2 99%
CDC Split Type:

Write-up: 2-19-07 child had well check up, received vaccines of Gardasil, Hep A, Menactra, Varicella. Approx at 3:00pm had syncopal episode on the way out of the office. First aid rendered for lip laceration. B/P and vital signs checked, reverse trendelenburg position. Sent to dental office for tooth repair.


VAERS ID: 274087 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Ohio  
Vaccinated:2007-03-05
Onset:2007-03-05
   Days after vaccination:0
Submitted: 2007-03-12
   Days after onset:6
Entered: 2007-03-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Anxiety, Computerised tomogram, Confusional state, Dyspnoea, Electrocardiogram, Erythema, Fall, Full blood count, Loss of consciousness, Neck injury, Scan brain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yaz birth control
Current Illness:
Preexisting Conditions: Abnormal uterine bleeding, irregular menstruation, Menorrhagia, Pelvic pain.
Allergies:
Diagnostic Lab Data: In emergency room CT head, brain, CT neck soft tissue, BMP, CBC, EKG.
CDC Split Type:

Write-up: Syncope episode at checkout window 4 min after Gardasil vaccine given. Upon forward fall, pt sustained blow to anterior aspect of neck on our counter top. Unconscious for approx 30-60 sec, then alert but confused as to what happened for about 1 min. Labored breathing and anxiety approx 4-5 min then relaxed. Red raised mark on soft tissue of anterior neck. Remained in supine position with neck neutral at still. EMS here within 10 min. To ER pre EMS with cervical collar and neck immobilizer on.


VAERS ID: 274109 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2006-11-08
Onset:2006-11-08
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:125
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / UNK - / -

Administered by: Other       Purchased by: Private
Symptoms: Accidental exposure, Incorrect dose administered, Sensory disturbance, Vaccination complication
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: food allergy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA02972

Write-up: Initial and follow up information has been received from a nurse practitioner concerning a 22 year old female student with no acute illness or chronic disease and food allergy to eggplant who on 08 Nov 2006, at 14:00, was vaccinated witha second dose of Gardasil. It was reported that the patient pulled away during adminstration due to "strange sensation" and a significant amount medication went down the patient''s arm. It was estimated that only one third to one half of the dose was administered. It was reported that the patient had to repeat the second. On 08 Nov 2006, the patient recovered from the event. No further information is available.


VAERS ID: 274110 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Georgia  
Vaccinated:2007-01-25
Onset:2007-01-25
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:47
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1424F / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Cold compress therapy, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00386

Write-up: Informatio has been received from a physician''s assistant concerning a 22 year old female who on 25 Jan 2007 was vaccinated IM with a second 0.5 ml dose of Gardasil. On approximately 25 Jan 2007, the patient experienced a 1.3 inch area of swelling, redness, tenderness and itchiness at the injection site. The patient notified the physician''s assistant 5 days after vaccination. It was unknown when the events started. The patient was treated with cool compresses and antihistamines with unknown results. No diagnostic laboratory studies were performed. Subsquently the patient recovered from swelling, redness, pain and tenderness at the injection site. It was also reported that on 07 Nov 2006, the patient was vaccinated with a first dose of Gardasil. No product quality complaint was involved. Additional information is not expected.


VAERS ID: 274111 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Maryland  
Vaccinated:2007-01-26
Onset:2007-01-31
   Days after vaccination:5
Submitted: 2007-03-14
   Days after onset:41
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0014U / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00395

Write-up: Information has been received from a licensced practical nurse concerning a 25 year old female with no medical history or allergies, who on 26 Jan 2007 was vaccinated a first dose of with Gardasil (yeast) (lot#653736/0014U). Concomitant therapy included hormonal contraceptives (unspecified). On 31 Jan 2007 (also reported as four to five days later), the patient developed hives. The patient went to her primary care physician for treatment of the hives. She was prescribed prednisone and Benadryl. Later that day, she went to the emergency room. On 01 Feb 2007 the patient told the nurse her hives were worse. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 274112 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Utah  
Vaccinated:2007-01-14
Onset:2007-02-01
   Days after vaccination:18
Submitted: 2007-03-14
   Days after onset:40
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 2 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site discolouration, Similar reaction on previous exposure to drug, Skin discolouration
SMQs:, Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin
Current Illness: Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0702USA00416

Write-up: This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a physician concerning a 19 year old female with penicillin allergy who on 02-NOV-2006 was vaccinated intramuscularly in the right arm with GARDASIL (Lot # not provided). Concomitant therapy included Yasmin. On 14-JAN-2007 the patient received her second vaccination of GARDASIL (Lot #653735/0688F) intramuscularly in the left arm. On approximately 09-NOV-2006 the patient experienced a lighter coloring of the skin at the injection site. It was reported that the patient did not experience any itching or swelling. On approximately 21 Jan 2007 the patient experienced lighter coloring of the skin at the injection site. Follow up information confirmed that on 01-FEB-2007 the patient experienced lighter coloring of the skin at the injection site. At the time of this report the patient''s skin discoloration in both arms had not resolved. Additional information has been requested.


VAERS ID: 274113 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: New York  
Vaccinated:2007-02-01
Onset:2007-02-01
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:40
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure normal, Dizziness, Fall, Heart rate normal, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0702USA00435

Write-up: Information has been received from a physician concerning a 21 year old female with no known allergies who on 01-FEB-2007 was vaccinated intramuscularly in the right deltoid with Gardasil (lot # not provided). The physician reported that after administering the injection she "turned around literally for a second" and when she turned back to the patient she found her "on the floor, with her rear in the air". The physician stated that she called for her assistant for help and the patient was already conscious, "she was only out for a second". The patient reported to the physician that she felt dizzy and felt like she instantly went to sleep. The physician reported that the patients blood pressure and pulse were normal (actual measurements not provided). The physician reported that the patient was observed in the office, had no additional episodes and considered to have recovered from the event and sent home. The physician stated that she did not feel the event was disabling and would continue the series of vaccination of Gardasil with the patient, but would have her reclined when administering future vaccinations. Additional information has been requested.


VAERS ID: 274114 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2007-01-11
Onset:2007-01-11
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:61
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Syncope
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00437

Write-up: Information has been received from a physician concerning a 26 year old female with a history of syncope when giving blood, who on 11-Jan-2007 was vaccinated with Gardasil (lot #653978/0955F). It was reported that the patient fainted 15 minutes after vaccination. The patient subsequently recovered. No further details were provided. Additional information has been requested.


VAERS ID: 274115 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2007-01-11
Onset:2007-01-11
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:61
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dysgeusia
SMQs:, Taste and smell disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0702USA00457

Write-up: Information has been received from a physician concerning a 25 year old female with no pertinent medical history or drug reactions/allergies, who on approximately 11-Jan-2007 was vaccinated with Gardasil (0.5 ml). The physician reported that 30 seconds following vaccination, the patient experienced an intense metal taste in her mouth, however immediately recovered. No further details were provided. Additional information has been requested.


VAERS ID: 274116 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Indiana  
Vaccinated:2006-11-29
Onset:2006-11-29
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:104
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Injection site erythema, Injection site rash
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00487

Write-up: Information has been received from a physician via a company representative, concerning a 16 year old female who on approximately 02-Dec-2006 was vaccinated IM in the left arm with Gardasil. After receiving the injection, the patient went to school and later during the day, she got very dizzy "that she almost passed out.". She also developed a red rash and bumps all over the site of the left arm where the dose was administered and had to go home. Subsequently, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow up information has been received from a physician, concerning a 16 year old female patient who at 3:15 pm on 29-NOV-2006 (previously reported as approximately 02-DEC-2006) was vaccinated with 0.5ml, IM in the right deltoid (previously reported as left arm), with the first dose of GARDASIL (lot # 653736/0868F). There was no known illness at the time of vaccination. After receiving the injection, the patient went to school and later during the day, she got very dizzy and "felt like passing out." She also developed a red rash and bumps all over the site of the left arm where the dose was administered and had to go home. Follow up information from the physician added that on approximately 30-NOV-2006, the patient also experienced a light edema and itching. The patient was treated with (ZITHROMAX Z-PAK), and subsequently recovered (date not specified). No further information is available.


VAERS ID: 274117 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-03-14
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Scleroderma
SMQs:, Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00560

Write-up: Information has been received from an office staff member concerning a 14 year old female relative who, on an unspecified date, was vaccinated with a first dose of Gardasil. A couple of days after vaccination, the patient was diagnosed with scleroderma, an autoimmune disease. The patient was referred to a specialist and was currently being treated. At the time of this report, the patient''s scleroderma persisted. No product quality complaint was involved. Additional information is not expected.


VAERS ID: 274118 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: California  
Vaccinated:2006-12-22
Onset:2006-12-22
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:81
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0454F / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood glucose normal, Dizziness, Gait disturbance
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Postpartum state; Shellfish allergy
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK; vital sign, 12/22/06, normal; blood sugar, 12/22/06, 110
CDC Split Type: WAES0702USA00572

Write-up: Information has been received from a nurse practitioner, via a company representative, concerning an approximately 22 year old female who was 6 weeks post partum and had completed a pelvic exam followed by the vaccination of the first dose (dose unspecified) of Gardasil. The nurse reported that 45 minutes after the appointment, the patient began to experience dizziness. The sensation of movement/dizziness" made it difficult for the patient to walk and persisted for about four hours, then abruptly resolved with no lingering effects. The patient sought unspecified medical treatment. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow up information has been received from a nurse practitioner, concerning a 21 year old female patient, with a shellfish allergy who was 6 weeks post partum who on 23-DEC-2006 had completed a pelvic exam at the visit, who was then vaccinated, IM at 3:30pm, with the first dose of GARDASIL (Lot # 653938/0954F). The nurse reported that at 4:00 pm (previously reported as 45 minutes after the appointment), the patient began to experienced dizziness. The patient was observed in the nurse''s clinic and was then sent to the same day clinic for observation. The patient''s vital signs were reported to be normal, and a random blood sugar was 110 (units not specified). The sensation of movement/dizziness" made it difficult for the patient to walk and persisted for about four hours, then abruptly resolved with no lingering effects. No further information was expected.


VAERS ID: 274119 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-12-08
Onset:2007-01-01
   Days after vaccination:24
Submitted: 2007-03-14
   Days after onset:71
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Vaginal swelling
SMQs:, Angioedema (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Human papilloma virus infection.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00582

Write-up: Information has been received from a physician concerning a 22 year old female with a history of human papilloma virus infection who on 08-DEC-2006 was vaccinated with Gardasil. In January 2007, the patient experienced swelling of her vaginal walls. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been requested.


VAERS ID: 274120 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-11-21
Onset:2006-11-21
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:112
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Fatigue, Influenza, Insomnia
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Inderal
Current Illness: Syncope
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0702USA00593

Write-up: This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a Certified Medical Assistant concerning a 24 year old female patient with neurocardiogenic syncope who on 21-NOV-2006 was vaccinated IM with her first dose of Gardasil, lot #653938/0954F. Concomitant therapy included INDERAL. On 21-NOV-2006 the patient experienced insomnia for one month following the administration of Gardasil. She later had the flu from being run down and lack of sleep. The patient desired a prescription for sleep after her next injection. Unspecified medical attention was sought. The patient was reported as recovered. Additional information is not expected.


VAERS ID: 274121 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-03-14
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00609

Write-up: Information has been received from a physician concerning a female (age not reported) who on an unspecified date, was vaccinated with a second dose of Gardasil. Subsequently the patient became dizzy and had some vomiting. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.


VAERS ID: 274122 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-02-01
Onset:2007-02-01
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:40
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0013U / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Body temperature increased, Dizziness, Myalgia, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aortic incompetence, Migraine
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00724

Write-up: Initial and follow up information has been received from an LPN and the mother of a 12 year old female patient with aortic insufficiency and migraine headaches who on 01-FEB-2007 was vaccinated IM with her first dose of Gardasil, lot #654741/0013U. There was no concomitant medication. Subsequently, the patient experienced dizziness and developed an elevated temperature. It was also reported that the patient felt weak and had muscle aches for several days. The side effects eventually disappeared. However on 21-FEB-2007, the patient woke up with breast rashes. As of 21-FEB-2007 breast rashes persisted. Additional information has been requested.


VAERS ID: 274123 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2007-02-01
Onset:2007-02-01
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:40
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site rash, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin
Current Illness: Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00727

Write-up: Information has been received from a registered nurse concerning a 19 year old female student (63 inches, 112 lbs) with no illness at the time of vaccination and with a penicillin allergy. On 01-FEB-2007, at approximately 14:00 PM, the patient was vaccinated in the left arm with the first 0.5 mL dose of HPV (lot# 655619/1427F). Concomitant therapy included Yasmin. On that same day, at 4:00 PM, the patient developed a rash on her left arm from the injection site to the elbow and a rash also on her right arm (unspecified where on her right arm). The patient sought unspecified medical attention. The physician prescribed over-the-counter Benadryl and contacted the patient the next day for follow up. The patient reported that she was fine. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested. Additional infromation is not expected.


VAERS ID: 274124 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: New York  
Vaccinated:2007-02-01
Onset:2007-02-01
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:40
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1162F / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Dyskinesia, Eye movement disorder, Incorrect dose administered, Medical device complication, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK; None
Current Illness:
Preexisting Conditions: UNK; None
Allergies:
Diagnostic Lab Data: UNK; None
CDC Split Type: WAES0702USA00744

Write-up: Information has been received from a licensed practical nurse concerning a 15 year old female with no medical history or allergies, who on 05-FEB-2007 was vaccinated with a dose of HPV (lot# 654540/1162F). On 05-FEB-2007 the nurse reported that the vaccine prefilled syringe malfunctioned. The nurse pushed the plunger down, the spring never activated and when she pulled the syringe out of the patient''s arm some of the liquid sprayed on the table and on the wall. The patient was not re-activated because of her reactions which were she "felt woozy" and her eyes were fluttering, and her whole body was shaking. It was noted that the patient did not lose consciousness. The patient will come back in two months to get re-vaccinated. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a licensed practical nurse concerning a 15 year old female with no medical history or allergies, who on 01-FEB-2007 was vaccinated with a dose of GARDASIL (lot# 654540/1162F). On 01-FEB-2007 the nurse reported that the vaccine prefilled syringe malfunctioned. The nurse pushed the plunger down, the spring never activated and when she pulled the syringe out of the patient''s arm some of the liquid sprayed on the table and on the wall. The patient was not re-vaccinated because of her reactions which were that she "felt dizzy" and her eye rolled upward, and her whole body was jerking. Upon calling the patient''s name, her eyes opened wide and focused on her mother and the nurse. Her body stopped jerking and she stated, "I just feel dizzy." It was noted that the patient did not lose consciousness. The patient rested a while on the exam table and walked out of the office on her own. The mother was instructed to call the office if anything appeared to be out of the ordinary. No call was received. The patient will come back in two months to get re-vaccinated. On 01-FEB-2007, the patient recovered. Additional information is not expected.


VAERS ID: 274125 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Georgia  
Vaccinated:2007-01-09
Onset:2007-01-09
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:63
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / 1 UN / IM

Administered by: Other       Purchased by: Private
Symptoms: Erythema, Flushing, Hot flush, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CYMALTA; PREVACID; ZELNORM; LAMISIL
Current Illness: Allergic reaction to anitbiotics
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0702USA00772

Write-up: This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been received from medical assistant via a company representative concerning the 26 year old female medical assistant who, on an unspecified date, was vaccinated with a dose of HPV. The medical assistant reported that after her vaccination with HPV, "her face turned very red and hot". The medical assistant recovered on an unspecified date. The patient (medical assistant) sought unspecified medical attention. Additional information has been requested. Information has been received from medical assistant via a company representative concerning the 26 year old female medical assistant with an allergy to LEVAQUIN who on 09-JAN-2007 at 5:00 PM, was vaccinated IM into the deltoid with a first dose of GARDASIL (Lot# 6353736/0868F). Concomitant therapy included CYMBALTA, PREVACID, LAMISIL and ZELNORM. There was no illness at the time of vaccination. The medical assistant reported that after her vaccination with GARDASIL at 5:00PM on 09-JAN-2007, "her face turned very red and hot". She also reported that she felt flushing sensation on her face, neck and chest turned beet red like a severe sunburn that lasted about 2 hours, recovered 09-JAN-2007. Additional information is not expected.


VAERS ID: 274126 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: California  
Vaccinated:2007-01-29
Onset:2007-01-31
   Days after vaccination:2
Submitted: 2007-03-14
   Days after onset:41
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Contusion
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00785

Write-up: Information has been received from a medical assistant concerning a 16 year old female who on 29-JAN-2007 was vaccinated IM in the right arm with a first 0.5mL dose of HPV. There was no concomitant medication. On approximately 31-JAN-2007 the developed bruises located on her right forearm and right upper arm. The reporter stated that "the patient noticed the bruises 2 days after the day of vaccination." At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 274127 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2007-01-06
Onset:2007-01-06
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:66
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Drug administered at inappropriate site, Injection site mass
SMQs:, Drug abuse and dependence (broad), Extravasation events (injections, infusions and implants) (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00858

Write-up: Information has been received from a registered nurse concerning a female who on 06-JAN-2007 was vaccinated with a first dose of Gardasil (yeast) (0.5 ml), intramuscularly. On 06-JAN-2007 the patient had a lump at injection site. It was reported that one month later the patient still had lump at injection site. Unspecified medical assistant was sought. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. The physician felt that the adverse event occurred due to "placement" versus the GARDASIL. The physician also mentioned to the nurse that the vaccine might have been administered "too far over on the leg". In follow-up, the registered nurse reported that the physician decided that the vaccine was given in an incorrect site in the thigh and confirmed that it was an administration error rather than a vaccine adverse event. Additional information is not expected.


VAERS ID: 274128 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-12-01
Onset:2006-12-08
   Days after vaccination:7
Submitted: 2007-03-14
   Days after onset:95
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bacterial test negative, Computerised tomogram normal, Decreased activity, Diarrhoea, Headache, Mononucleosis heterophile test negative, Nausea, Nuclear magnetic resonance imaging normal, Paraesthesia, Sinusitis, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNKNOWN
Current Illness:
Preexisting Conditions: UNKNOWN
Allergies:
Diagnostic Lab Data: computed axial, 12/06; magnetic resonance, 12/06 records received 5/1/07-MRI negative, lab work normal. CT head and MRI of head negative. Normal abdominal ultrasound. Doppler normal of kidneys, normal upper GI series. negative lyme, negative beta HCG. Normal stool cultures. Strep culture negative.
CDC Split Type: WAES0702USA00866

Write-up: Information has been received from a pharmacy student concerning a 16 year old female who on December 2006, was vaccinated IM with a first 0.5 ml dose of HPV. Concomitant therapy included given the same day included a dose of influenza and a dose of Menactra. Seven days after vaccination, the patient experienced headache, nausea, vomiting and diarrhea. The patient was treated with Nexium and Phenergan tablets/suppositories. On 13-DEC-2006 the patient experienced a sinus infection and was placed on a Z-pack. All symptoms resolved except the headache. On 19-JAN-2007, the patient was seen by a neurologist and was placed on Prednisone for 10 days. He also ordered Tazepam to help her sleep since the headaches were keeping her awake and Endocet for the headache pain. The patient has missed a lot of school and is sedentary. She was also complaining of tingling in the hands and legs. The following tests have come back negative: CAT scan, MRI, Lyme and "mono" workup. At the time of this report, the patient had not recovered from tingling in the hands and legs and headache. No product quality complaint as involved. Additional information has been requested. 04/10/07-records received from neurologists for DOS 2/6/07-DX: muscular headaches with some functional overlay. Doubt side effect of Gardasil. C/O headaches, back pain, GI problems recent urinary symptoms, difficulty urinating and dysuria. C/O visual symptoms including blurry vision and spots before her eyes. PE: pain in neck, pain with deep palpation of right popliteal fossa. Walks normally. 05/01/07-records received from facility for DOS 02/09-02/12/07-DC DX: Vomiting and Abdominal Pain. HX 2month of chronic somatic complaints including nausea, epigastric discomfort, diffuse soft tissue and joint pain, vomiting, periodic shortness of breath and recent urinary symptoms. Labs, liver enzymes elevated in context of multiple Tylenol usage as an outpatient due to her pain.Hospital course included discontinuance of Tylenol and Percocet. LFTs steadily trended downward and she did not have pain or vomiting.


VAERS ID: 274129 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Idaho  
Vaccinated:2006-12-01
Onset:2006-12-01
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:102
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Paraesthesia oral
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Drug hypersensitivity
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00905

Write-up: Information has been received from a physician concerning a 20 year old female with allergy to unspecified medications who in approximately December 2006, around 2 months ago, was vaccinated with the first dose of HPV (lot #not reported). Concomitant medications were unspecified. In approximately December 2006, five minutes after receiving the first dose of the vaccine, the patient experienced tingling around her mouth and numbness that lasted for 20 minutes. The patient sought medical attention. The patient was then sent home and had no further problems. The patient did not continue the vaccination series because of the reaction. At the time of reporting, the patient had recovered. No further information was available at the time of reporting. Additional information has been requested.


VAERS ID: 274130 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-02-05
Onset:2007-02-06
   Days after vaccination:1
Submitted: 2007-03-14
   Days after onset:35
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Chills, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00914

Write-up: Information has been received from a certified medical assistant concerning a 24 year old female that works in the same office On 05-FEB-2007, the patient was vaccinated with a first dose of HPV. There were no concomitant medications. On 06-FEB-2007 the patient developed severe nausea, vomiting and chills. Unspecified medical attention was sought. At the time of the reporter, the patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 274131 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-03-14
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Presyncope
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Uknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0702USA00920

Write-up: Information has been received from a certified medical assistant (C.M.A) concerning approximately 19 female patients who were vaccinated with 0.5 mL dose of Gardasil (yeast). (Lot # not reported). Subsequently the patient experienced pain at the injection site lasting for about a week. The C.M.A also reported that another patient experienced pain at the injection site lasting for about a week and reported that she almost passed out from the pain (WAES0702USA04000). Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is in follow-up to report (s) previously submitted on 3/14/2007. Informationhas been received from a certified medical assistant (C.M.A.) concerning a female patient between the ages of 11 to 15 years old who on an unspecified date was vaccinated with a 0.5 mL dose of GARDASIL vaccine, (Lot # not reported). Subsequently the patient experienced pain at the injection site lasting for about a week. This is one of several reports from the same source. Additional information has been requested.


VAERS ID: 274132 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-02-01
Onset:2007-02-01
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:40
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Autoimmune disorder
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00923

Write-up: Information has been received from an office manager who was the mother of an 18 year old female patient with an unspecified auto immune disorder who in approximately February 2007 was vaccinated with a dose of HPV. The patient developed a "huge" red circle a few inches in diameter on her arm where she was vaccinated. There was a "lot" of swelling and the patient put ice on it all week. Medical attention was sought. The patient was recovering as of the report date. No further information is available.


VAERS ID: 274133 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2007-01-26
Onset:2007-02-05
   Days after vaccination:10
Submitted: 2007-03-14
   Days after onset:36
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Multiple allergies
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00992

Write-up: Information has been received from a physician, via a company representative concerning a 25 year old female with a history of allergies to "many products," who on 26-JAN-2007 was vaccinated with the first dose of Gardasil (yeast). On 05-FEB-2007 the patient called the physician after she developed hives. The patient believed the hives were "caused by the vaccination," though the development and timing of the onset of the hives was unclear. The patient was instructed to take BENADRYL as treatment. Additional information has been requested.


VAERS ID: 274134 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Connecticut  
Vaccinated:2007-02-05
Onset:2007-02-05
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:36
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Deafness, Dizziness, Injection site pain, Sudden hearing loss
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hearing impairment (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00994

Write-up: Information has been received from a registered nurse, via a company representative, concerning a female who on 05-FEB-2007 was vaccinated with a dose of Gardasil (yeast) in one arm and possibly a meningococcal vaccine (unspecified) in the other arm. Subsequently the patient felt faint, experienced a temporary loss of hearing, and also experienced pain from the injection. The nurse indicated that the patient''s "fair hair (red or blonde) made them more susceptible to the adverse events." The patient was observed in the office and after a short time recovered and left. Additional information has been requested.


VAERS ID: 274136 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-03-13
Onset:2007-03-14
   Days after vaccination:1
Submitted: 2007-03-16
   Days after onset:2
Entered: 2007-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 02434 / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Blister, Pain
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Blister, area looks burned. Pain at blistered site. Appears to be lower than site of injection. Patient denies other injury. Treated with tylenol #3 and omnicef. Will follow up with doctor next week.


VAERS ID: 274146 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Maryland  
Vaccinated:2007-03-08
Onset:2007-03-08
   Days after vaccination:0
Submitted: 2007-03-16
   Days after onset:7
Entered: 2007-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1447F / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Psych meds not prescribed by this MD
Current Illness: None - Was here for a physical/Well check
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient Seen on 3/14/07 for complaints of pain and swelling at the site of the Gardasil vaccine given on the left upper arm. Injection administered on 3/8/07


VAERS ID: 274169 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: California  
Vaccinated:2007-03-14
Onset:2007-03-14
   Days after vaccination:0
Submitted: 2007-03-16
   Days after onset:2
Entered: 2007-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0181U / 2 LA / -

Administered by: Private       Purchased by: Other
Symptoms: Injection site swelling, Rash generalised, Similar reaction on previous exposure to drug, Swelling face, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Received Gardasil #2, developed swelling around injection site after 2-5 minutes. That evening she developed hives on body and extemities-Mom gave Benadryl. Rash subsided but left side of face swollen but improved later in the day. 2 months ago 1st Gardasil given; she developed hives. Mom thought it was due to other allergies. Has been getting all over rash and swollen face since then.


VAERS ID: 274180 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-01-23
Onset:2007-01-23
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:49
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site rash, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Multiple allergies
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00996

Write-up: Information has been received from a registered nurse, concerning a 13 year old female with multiple allergies, who on 23-JAN-2007 was vaccinated IM in the right arm, with the first dose of Gardasil (yeast) (Lot # 655165/1425F). There was no concomitant medication. Approximately five to ten minutes later, the patient developed a rash that "started at the injection site and then spread to the arm and the whole body." Treatment with ZYRTEC was immediately given in the office, and the patient was instructed to take BENADRYL at home, if needed. The nurse reported that "rash was mild and self-limiting," and remarked "it was easily treated with antihistamine and resolved soon after treatment was given." He clarified that "this was a mild reaction," and he did not feel the patients condition would have required hospitalization or threatened her safety. The mother of the patient wanted her daughter to receive the subsequent doses of the vaccine, however the nurse stated he felt the patient''s system was "sensitized" and believed a second dose would be "too risky." Additional information has been requested.


VAERS ID: 274182 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:2007-01-29
Submitted: 2007-03-14
   Days after onset:43
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA01031

Write-up: Information has been received from a nurse concerning a female who was vaccinated with Gardasil. Subsequently, "within last week or week and a half," the patient developed a fever and was admitted to the hospital for 24 hours. Additional information is not expected.


VAERS ID: 274183 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Illinois  
Vaccinated:2007-02-06
Onset:2007-02-06
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:35
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1424F / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Allergic reaction to antibiotics
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA01062

Write-up: Information has been received from a registered nurse concerning an 18 year old female, with no pertinent medical history with allergies to erythromycin and sulfamethoxazole (+) SEPTRA who on 06-FEB-2007 was vaccinated with Gardasil (yeast), (Lot # 654885/1424F). There was no concomitant medication. On 06-FEB-2007 the patient developed chest pain when taking deep breaths. No other symptoms. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.


VAERS ID: 274184 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Missouri  
Vaccinated:2006-12-01
Onset:2006-12-01
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:102
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Incorrect route of drug administration, Injection site pain
SMQs:, Drug abuse and dependence (broad), Extravasation events (injections, infusions and implants) (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA01074

Write-up: Information has been received from a licensed practical nurse concerning a female (age not reported) who in December 2006, was vaccinated with Gardasil (yeast) which may have been given by the SQ route or a partial SQ route. Subsequently, the patient developed slight injection site soreness (date unknown). The nurse reported that the nurse who administered this vaccination was left handed and his technique appeared "odd" and it may have looked like a SQ injection when it was really intramuscular. The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested.


VAERS ID: 274185 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-03-14
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA01078

Write-up: Information has been received from a female medical assistant who was vaccinated IM, into the arm, with a first dose of Gardasil (yeast). Subsequently the patient experienced had pain in the arm that lasted a few minutes after vaccination. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.


VAERS ID: 274186 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:2007-01-02
Onset:2007-01-02
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:93
Entered: 2007-03-16
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Anxiety, Dizziness, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Chest pain; Penicillin allergy
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: respiratory rate - clear, total heartbeat count - 82
CDC Split Type: WAES0702USA01091

Write-up: Information has been received from a nurse practitioner concerning a 15 year old female who was vaccinated IM with a first dose of Gardasil (yeast) (lot# 653938/0954F). Subsequently, the patient experienced diaphoresis, and felt faint moments after the injection. The patient;s lungs were clear and her pulse was 82. The patient went to the emergency room and was evaluated as being normal. The patient was released from the emergency room; however, the patient went to her primary care physician for evaluation. The physician determined that the patient was fine. The patient''s mother called the nurse practitioner and said that her daughter gets extremely anxious with injections which may have contributed to the symptoms. In addition, the patient also had an empty stomach at the time of vaccination. The patient''s mother and the felt that the patient is eligible to receive the subsequent doses of the vaccine. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007; 4/6/2007. Information has been received from a nurse practitioner concerning a 15 year old female with a penicillin allergy and chest pain who was vaccinated IM with a first dose of GARDASIL (lot# 653938/0954F). The patient had no illness at time of vaccination. Subsequently, the patient experienced diaphoresis, and felt faint moments after the injection. The patient''s lungs were clear and her pulse was 82. The patient went to the emergency room and was evaluated as being normal. The patient was released from the emergency room; however, the patient went to her primary care physician for evaluation. The physician determined that the patient was fine. The patient''s mother called the nurse practitioner and said that her daughter gets extremely anxious with injections which may have contributed to the symptoms. In addition, the patient also had an empty stomach at the time of vaccination. The patient''s mother and the physician felt that the patient is eligible to receive the subsequent doses of the vaccine. Subsequently, the patient recovered. No product quality complaint was involved. On 06-MAR-2007, additional information was received from the nurse practitioner. On 02-JAN-2007, at 1030am, after the patient''s first dose of GARDASIL the patient became very diaphoretic and felt that she was going to pass out. The patient''s lungs were clear and heart rate was regular. The patient stated that she had chest pain, but indicated that this was happening prior to event. The patient was seen in an emergency room for evaluation. Subsequently, the patient recovered from diaphoresis, feeling faint, feeling anxious, and chest pain. No additional information is expected. This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been received from a nurse practitioner concerning a 15 year old female (134 lbs) with a penicillin allergy and chest pain who was vaccinated IM with a first dose of GARDASIL (lot # 653938/0954F). The patient had no illness at the time of vaccination. Subsequently, the patient experienced diaphoresis, and felt faint moments after the injection. The patient''s lungs were clear and her pulse was 82. The patient went to the emergency room and was evaluated as being normal. The patient was released from the emergency room; however, the patient went to her primary care physician for evaluation. The physician determined that the patient was fine. The patient''s mother called the nurse practitioner and said that her daughter gets extrememly anxious with injections which may have contributed to the symptoms. In addition, the patient also had an empty stomach at the time of vaccination. The patient''s mother and the physician felt that the patient is eligible to receive the subsequent doses of the vaccine. Subsequently, the patient recovered. No product quality complaint was involved. On 06-MAR-2007, additional information was received from the nurse practitioner. On 02-JAN-2007, at 1030 am, after the patient''s first dose of GARDASIL the patient became very diaphoretic and felt that she was going to pass out. The patient''s lungs were clear and heart rate was regular. The patient stated that she had chest pain, but indicated that this was happening prior to event. The patient was seen in an emergency room for evaluation. Subsequently, the patient recovered from diaphoresis, feeling faint, feeling anxious, and chest pain. Additional information has been requested.


VAERS ID: 274187 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-02-06
Onset:2007-02-06
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:35
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0960F / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Erythema, Hypoaesthesia, Injection site pain, Local reaction
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA01096

Write-up: Information has been received from a health professional concerning a 16 year old female with no medical history who on 06-FEB-2007 was vaccinated IM in to the right deltoid with a 0.5 ml dose of Gardasil (yeast) (lot # 654535/0960F). There was no concomitant medication. On 06-FEB-2007 after vaccination the patient developed a local reaction. She experienced 30 seconds of dizziness. The local reaction started with pain at the injection site that radiated down her arm and her entire arm was red. After the patient subsided the arm went numb and then the patient was fine. The entire episode lasted only 5 minutes and the patient seemed fully recovered. Additional information is not expected.


VAERS ID: 274188 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-03-14
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA01154

Write-up: Information has been received from a physician via a company representative, concerning a female patient who was vaccinated with either a first dose or second of GARDASIL. Subsequently the patient experienced nausea after vaccination. The patient recovered within a day. The patient sought unspecified medical attention. This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow-up information has been received from a physician, concerning a female patient who was vaccinated with either a first or second dose of GARDASIL (date not specified). The physician stated the patient''s father mentioned that his daughter experienced nausea after vaccination. The physician reported that the patient recovered within a day. The physician did not believe the nausea was caused by GARDASIL. The patient sought unspecified medical attention. No further information is expected.


VAERS ID: 274189 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Virginia  
Vaccinated:2006-11-06
Onset:2006-11-06
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:127
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0013U / 2 - / -

Administered by: Private       Purchased by: Private
Symptoms: Head injury, Inappropriate schedule of drug administration, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA01175

Write-up: Initial and follow up information has been received from a licensed practical nurse via a company representative, concerning a 12 year old white female student, who on 06 Nov 2006 was vaccinated in the right deltoid with 0.5 ml of the first dose of Gardasil. There was no concomitant medication. There was no illness at the time of vaccination. The patient passed out in the physician''s waiting room after receiving the vaccination. The patient stated she did not eat breakfast. Upon awakening, the patient was given crackers and soda, and stated she felt better. On 05 Feb 2007, three months after the first dose, the patient was vaccinated in the left deltoid with the second dose of Gardasil. After the second vaccination, the mother called and reported her daughter had passed out at home and hit her head. The patient did not receive medical attention, but her physician was informed. The patient recovered the same day, 05 Feb 2007. Additional information is not expected.


VAERS ID: 274190 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: New York  
Vaccinated:2007-02-07
Onset:2007-02-07
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:34
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Pruritus, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA01180

Write-up: Information has been received from a physician via a company representative, concerning a 19 year old female who on 07 Feb 2007 was vaccinated with an 0.5 ml dose of Gardasil. By the evening of the same day, the patient developed a "rash from head to toe and itching." The patient has not recovered at the time of this report. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 274191 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-01-25
Onset:2007-01-25
   Days after vaccination:365
Submitted: 2007-03-14
   Days after onset:47
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Fungal infection
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA01217

Write-up: Information has been received from a 22 year old female health professional who on 25 Jan 2006 was vaccinated with a first dose of Gardasil. The patient reported that within 24 hours of vaccination she experienced a yeast infection. It was reported that the patient sought medical attention for this event. The patient recovered after approximately 2 days. Patient would complete her vaccination series. Additional informatio has been requested.


VAERS ID: 274192 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:132
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / -

Administered by: Other       Purchased by: Other
Symptoms: Antinuclear antibody negative, Bacterial test negative, Blood test, Syphilis test positive
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: sexually active
Allergies:
Diagnostic Lab Data: Diagnostic laboratory, 11/06, negative, sexually transmitted disease; lyme disease assay, 11/06, Normal; rapid plasma reagin, 11/06, 1-256, High; serum ANA, 11/06, Normal; rapid plasma reagin, 11/06, positive but lower; FTA-ABS, 11/06, Negative.
CDC Split Type: WAES0702USA01225

Write-up: Information had been received from a physician and a Registered Nurse concerning a 16 year old female who was sexually active. In August 2006, the patient was vaccinated with the first dose of Gardasil, at the end of November 2006 with the second dose. She received the vaccination at the pediatrician''s office. The patient was tested for syphilis " a couple of days" later. The patient''s Rapid Plasma Reagin (RPR) test titers were 1-256 (high), with a negative Fluorescent Antibody Absorption (FTA) test. The patient was tested again approximately one week later and the RPR titers were still high but lower. The physician mentioned that the patient underwent other antibody tests such as serum antinuclear antibodies (ANA) test, and Lyme disease test. The results were normal for those tests. The physician stated that the patient had not been sick with the flu nor mononucleosis, and that the patient had tested negative for other sexually transmitted diseases. Additional information has been requested.


VAERS ID: 274193 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:2006-11-13
Onset:2006-11-13
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:120
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1203F / 1 - / -

Administered by: Military       Purchased by: Other
Symptoms: Diarrhoea, Epstein-Barr virus test, Full blood count, Lethargy, Nausea, Pseudomononucleosis
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Epstein-Barr virus, 2/5/07; complete blood cell, 2/5/07
CDC Split Type: WAES0702USA01274

Write-up: Information has been received from a health professional concerning a 15 year old female on 13 Nov 2006 was vaccinated with a first dose of Gardasil. There were no concomitant medications. On approximately 13 Nov 2006 the patient experienced nausea, lethargy and "mono like symptoms." Subsequently, the patient recovered. On 03 Feb 2007, the patient was vaccinated with a second dose of Gardasil. On 03 Feb 2007 the patient experienced nausea, marked lethargy, "mono like symptoms" and diarrhea for 2 days after the vaccination. On 05 Feb 2007, the patient returned to the doctors office and underwent a complete blood cell count and an Epstein-Barr virus antibodies screen. It was reported that "mono" was ruled out. At the time of the report, the patient was recovering. Additional information has been requested.


VAERS ID: 274194 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Connecticut  
Vaccinated:2007-01-31
Onset:2007-01-31
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:41
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Injection site pain, Sudden hearing loss
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hearing impairment (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA01291

Write-up: Information has been received from a registered nurse, via a company representative, concerning a female who on approximately 31 Jan 2007 was vaccinated with a dose of Gardasil in one arm and possibly a meningococcal vaccine (unspecified) in the other arm. Subsequently the patient felt faint, experienced a temporary loss of hearing, and also experienced pain from the injection. The nurse indicated that the patient''s "fair hair (red or blonde) made them more susceptible to the adverse events." The patient was observed in the office and after a short time recovered and left. Additional information has been requested.


VAERS ID: 274195 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-01-04
Onset:2007-01-04
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:68
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / 1 - / -

Administered by: Private       Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yaz, Miralax, Zelnorm
Current Illness:
Preexisting Conditions: dizziness
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA01321

Write-up: Information has been received from a registered nurse concerning a 21 year old white female with no known drug allergies or illness at the time of vaccination who on 01 Jan 2007 was vaccinated in the right deltoid with a 0.5 mL first dose of Gardasil. Concomitant therapy included Yaz, Zelnorm and Miralax. On 04 Jan 2007, the patient became lightheaded and had to lie down after receiving Gardasil vaccination. The patient stated that she had gotten lightheaded after injections in the past. She also did not have much to eat that morning. The patient did not lose consciousness and remained alert and responsive. The patient was given some peanut butter crackers and coke and subsequently felt better and recovered. Additional information is not expected.


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