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| Case Details |
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: presented to ED with Ventricular tachycardia. Preliminary autopsy finding of myocarditis. 4/3/07 Spoke w/ME who stated prelim COD as acute myocarditis, presumably viral. States patient had PMH of heart murmur which was evaluated by ped cardiologist who found mild aortic & mitral valve insufficiency & regurgitation. ME states did not see evidence of that on autopsy but did find cardiomegaly. Also states patient had been taken to ER on day of death for abdominal pain w/fever & was dx w/gastroenteritis. CXR at that time revealed cardiomegaly. No EKG or cultures were done. Was d/c to home & continued to not feel well. Parent found patient in bathroom unresponsive at approx 2AM & was transported to a second ER where she expired. ME states patient had approx 2 week hx of cough & runny nose prior to death. 6/12/07 Received final Autopsy Report which reveals COD as acute probable viral etiology myocarditis & manner of death as natural. 6/29/07 Received ER records from hospital where patient expired which reveal patient was in respiratory arrest & had been intubated by EMS. ACLS measures were unsuccessful & patient pronounced. 8/24/07 Received cardiology consult which reveals patient evaluated for heart murmur in 2005 which had been diagnosed for long time but never evaluated. Patient admitted to palpitations & nervousness. Patient history did not reveal any evidence of rheumatic fever. Antibiotic endocarditis prophylaxis recommended prior to dental & surgical procedures. Patient was to f/u w/cardiology in 2-3 yearrs to document progress of valvular insufficiency. FINAL Cardiology DX: Aortic & mitral valve insufficiency of unknown etiology. | ||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medical event. The original reporting source was not provided. A standar lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expaned lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS number is 275438. | ||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician''s assistant (PA), via a company representative, concerning a female patient who was vaccinated (date unspecified) with a dose of Gardasil the PA reported that "the patient died of a blood clot 3 hours after getting the Gardasil vaccine." The PA clarified that the patient was not vaccinated at her office. Additional information has been requested. | ||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? Yes Write-up: Onset of symptoms on 3/1/07: fever, sore throat, cough, and myalgia. Respiratory failure on 3/6/07. 6/1/07 Received Death Certificate from epidemiologist which reveals COD asmultiorgan system failure and influenza B viral sepsis with contributing cause of staphyloccoccal secondary infection. Medical records included w/death certificate indicate patient was transferred to higher level of care on 3/6, was intubated & in PICU w/pneumonia & ARDS. Reportedly had been in good health until 3/1/07 when she developed sore throat, nasal congestion, rhinnorhea & low grade fever. COntinued to worsen & developed myalgias, chest pain & nonproductive cough w/higher fever. Seen by PCP on 3/5 & rapid strep was neg & dx was probable influenza. Sent home & developed nausea, vomiting & diarrhea as well as petechial rash over abdomen. Taken to outlying ER on 3/6 & found to be in respiratory failure, intubated & transferred to higher level of care. Respiratory status declined further & was placed on oscillator & ECMO. Peds ID consult done. Consult states had HPV vax at PCP on 3/2 & no other recent vaccines. 6/1/07 Received fax medical & vaccine records from CDC who had contacted provider. Reveals that on 1/2/07, patient received TDaP & HPV. On 3/2/07 received HPV #2. VAERS database updated w/same. On day of vax patient also dx w/right CTS, migraine HA, scoliosis. She was referred to Neuro & PT for the CTS & HA. | ||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? Yes Write-up: Information has been received from a licensed visiting nurse via a nurse practitioner. The nurse practitioner was told by a friend that a female patient was vaccinated with Gardasil and two weeks alter developed a blood clot. Subsequently the patient died. The cause of death was from the blood clot. The reporting licensed visiting nurse considered the blood clot to be immediately life-threatening and disabling. Additional information has been requested. | ||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? Yes Write-up: Information has been received from a nurse practitioner who heard from an emergency room (ER) nurse that an 11 year old female was vaccinated "within in the past month" in approximately May 2007 with a first dose of Gardasil. Subsequently, 3 days after vaccination the patient presented to an ER. She experienced cardiac arrest, required lung bypass (ECMO) and "may not have expired." It was also reported by the same nurse that the physician from the hospital said that "the death was due to an anaphylactic reaction to Gardasil." The anaphylactic reaction and cardiac arrest were considered to be life threatening by the reporter. Additional information has been requested. | ||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician who attended a conference that mentioned two patients who were vaccinated with Gardasil. Subsequently the patients died. The cause of death not reported. 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. | ||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a nurse practitioner concerning a 22 year old female patient with no pertinent medical history or drug allergies who on 21-MAY-2007, was vaccinated IM with a 0.5ml dose of Gardasil (Lot# 657736/0389U). Concomitant therapy included hormonal contraceptives (unspecified) ("MERCET"). On 23-MAY-2007, the patient died suddenly. The cause of death was unknown. Unspecified medical attention was sought. Laboratory diagnostic studies included an autopsy which showed no findings. No product quality complaint was involved. The reporter stated that Gardasil did not cause the patient''s death. Additional information is not expected. 7/2/08-records received-Adverse effect of drugs.Toxicology survey findings:urine positive for methadone, benzodiazepines, benzoylecgonine (from cocaine), cannabinoids, nicotine, diphenhydramine and naproxen. | ||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning a female who on an unknown date was vaccinated with the first dose of Gardasil (yeast, unknown lot number) and in July 2007, was vaccinated with the second dose of Gardasil. In September 2007, the patient died. No further details or symptoms were known regarding the patient''s death. The physician mentioned that an autopsy would be done however, had not received the results yet. The reporting physician felt that the patient''s death was not related to therapy with Gardasil. Additional information has been requested. 10/11/2007 Patient demographics provided by CDC. 10/15/07 Received vax record from pcp. VAERS database updated w/same. 10/15/07 Received pcp & hospital medical records from CDC which reveal patient experienced vomiting with elevated blood sugars who became unresponsive & pulseless. CPR started & taken to ER on 9/19/07. Resuscitation was unsuccessful & patient pronounced 9/19/07. 10/26/07 Reviewed autopsy report which reveals COD as diabetic ketoacidosis & manner of death as natural. Patient had been found by parent unresponsive at home. History of severe diabetes mellitus. Vitreous glucose 667 (H). | ||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: This case was received from a health care professional on 10 October 2007. Additional information was received from a newspaper article. An 18-year-old female patient received a meningococcal vaccine (name, manufacturer, and lot number not reported) on an unspecified date. The patient, who was a college freshman, travelled on 05 October 2007 to visit her family for the weekend. She reportedly felt "slightly ill" upon her arrival, and subsequently took an aspirin and went to bed, awakening at 1:30pm the following afternoon ''appearing refreshed". She became feverish again that night, and awoke at 1:00am the morning of 07 October 2007 with chills and a severe headache, complaining that "my head is about to explode". She was taken to a local hospital, where a CAT scan of the brain revealed meningococcal disease in her brain and brain stem. She was immediately transferred to another hospital, and died that evening of 07 October 2007 due to complications of meningitis. The health department noted that "lab tests have not yet confirmed the strain of meningitis" but that it was "likely the type not prevented by the vaccination". Past medical history and concomitant medications were unknown: it was not known if the patient was ill at the time of vaccination. 10/18/07 Patient name received from FDA. 10/18/07 Received death certificate from funeral home which states COD as brain death due to cerebral herniation and meningoencephalitis. 10/26/07 Received vax record from pcp which indicates patient received HPV & Menactra on 5/10/2007. VAERS database updated w/same. Vax record indicates patient also received 2nd dose of HPV 6/13/2007, Lot # 0523U, left arm. 11/27/07 Reviewed hospital medical records which reveal patient experienced HA, fever & neck pain x 1 day. Had come home from college 10/5 & developed chills next day. Seen in outlying ER where LP showed high pressure, grossly purulent CSF growing meningococcus. Intubated & IV antibiotics started & transferred to higher level of care. Neurosurgery & ID consults done. Pupils dilated & nonreactive. Diffuse cerebral edema leading to brain herniation & death. 12/4/07 Reviewed ER medical records which reveal patient seen 10/7/2007. Patient experienced pale, nausea, fever, chills, HA, neck stiffness, back ache & photophobia. Temp in ER max 104.7 Became nonresponsive w/posturing in ER. Intubated. Started on IV antibiotics & transferred to higher level of care. | ||||||||||||||||||||||||
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