|
| VAERS ID: |
275428 (history) |
| Form: |
Version 1.0 |
| Age: |
12.0 |
| Sex: |
Female |
| Location: |
New York |
| Vaccinated: | 2007-03-01 |
| Onset: | 2007-03-07 |
| Days after vaccination: | 6 |
| Submitted: |
2007-04-02 |
| Days after onset: | 25 |
| Entered: |
2007-04-02 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HEPA: HEP A (VAQTA) / MERCK & CO. INC. |
1280F / 2 |
RA / IM |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0263U / 1 |
LA / IM |
| VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. |
0943R / 2 |
RA / SC |
Administered by: Unknown Purchased by: Unknown
Symptoms: Autopsy,
Myocarditis,
Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2007-03-08
Days after onset: 1
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: aortic and mitral valve insufficiency, unknown aetiology
Allergies:
Diagnostic Lab Data: ER LABS of 3/8/07: ABG pH 7.23, po2 62. Serum glucose 353, Creat 1.7, albumin 2.6, total protein 4.9, SGPT 62, SGOT 359. Blood c/s was neg. 2005 Cardiology LABS: echocardiogram revealed mild mitral valve & aortic valve insufficiency. Mitral valve leaflets were slightly thickened.
CDC Split Type:
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. |
|
| VAERS ID: |
275438 (history) |
| Form: |
Version 1.0 |
| Age: |
19.0 |
| Sex: |
Female |
| Location: |
California |
| Vaccinated: | 2007-03-12 |
| Onset: | 2007-03-26 |
| Days after vaccination: | 14 |
| Submitted: |
2007-04-02 |
| Days after onset: | 7 |
| Entered: |
2007-04-02 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0263U / 1 |
LA / IM |
Administered by: Other Purchased by: Other
Symptoms: Convulsion,
Echocardiogram abnormal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2007-03-26
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC Split Type: WAES0705USA05011
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. |
|
| VAERS ID: |
275990 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2007-04-10 |
| Entered: |
2007-04-11 |
| 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: Death,
Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES0704USA00721
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. |
|
| VAERS ID: |
278865 (history) |
| Form: |
Version 1.0 |
| Age: |
15.0 |
| Sex: |
Female |
| Location: |
Arizona |
| Vaccinated: | 2007-03-02 |
| Onset: | 2007-03-02 |
| Days after vaccination: | 0 |
| Submitted: |
2007-05-17 |
| Days after onset: | 75 |
| Entered: |
2007-05-17 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1424F / 2 |
LA / IM |
Administered by: Unknown Purchased by: Unknown
Symptoms: Cough,
Influenza,
Myalgia,
Pharyngolaryngeal pain,
Pyrexia,
Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad)
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 2007-03-16
Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Topamax
Current Illness:
Preexisting Conditions: PMH: migraine headaches. Family HX: younger sister also w/strep neg sore throat. Letter from school that group A strep infections present.
Allergies:
Diagnostic Lab Data: Influenza B isolated by viral culture. Specimen sent to CDC for antigenic characterization. LABS: Throat & urine c/s neg. Blood & endotrachael c/s + for MRSA. Nasal swab + for influ B virus. Lymph node c/s were neg. from PCP office, Strep A was neg.
CDC Split Type:
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. |
|
| VAERS ID: |
279592 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2007-05-24 |
| Entered: |
2007-05-24 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death,
Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? Yes
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: WAES0705USA01964
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. |
|
| VAERS ID: |
280163 (history) |
| Form: |
Version 1.0 |
| Age: |
11.0 |
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 2007-05-01 |
| Onset: | 2007-05-04 |
| Days after vaccination: | 3 |
| Submitted: |
2007-05-31 |
| Days after onset: | 27 |
| Entered: |
2007-06-01 |
| 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: Anaphylactic reaction,
Cardiac arrest,
Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad)
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES0705USA04839
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. |
|
| VAERS ID: |
282747 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Unknown |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2007-06-22 |
| Entered: |
2007-06-25 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES0706USA02351
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. |
|
| VAERS ID: |
287888 (history) |
| Form: |
Version 1.0 |
| Age: |
22.0 |
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 2007-05-21 |
| Onset: | 2007-05-23 |
| Days after vaccination: | 2 |
| Submitted: |
2007-08-10 |
| Days after onset: | 79 |
| Entered: |
2007-08-13 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0389U / UNK |
UN / IM |
Administered by: Other Purchased by: Other
Symptoms: Autopsy,
Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2007-05-23
Days after onset: 0
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 7/2/08-records received-HX of heroin and prescription drug abuse.
Allergies:
Diagnostic Lab Data: autopsy - no findings
CDC Split Type: WAES0708USA00407
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. |
|
| VAERS ID: |
291804 (history) |
| Form: |
Version 1.0 |
| Age: |
17.0 |
| Sex: |
Female |
| Location: |
Ohio |
| Vaccinated: | 2007-07-13 |
| Onset: | 2007-09-01 |
| Days after vaccination: | 50 |
| Submitted: |
2007-10-01 |
| Days after onset: | 30 |
| Entered: |
2007-10-02 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1427F / 2 |
LA / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2007-09-19
Days after onset: 18
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: IDDM, uncontrolled. Smoker. anemia.
Preexisting Conditions: Unknown PMH: IDDM, uncontrolled. Smoker. Right buttock abscess 8/31/07. Anemia. Father w/diabetes. ALLERGIES: PCN, cipro, ultram (hives).
Allergies:
Diagnostic Lab Data: Unknown Vitreous glucose 667 (H).
CDC Split Type: WAES0709USA04400
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). |
|
| VAERS ID: |
293388 (history) |
| Form: |
Version 1.0 |
| Age: |
18.0 |
| Sex: |
Female |
| Location: |
New York |
| Vaccinated: | 2007-06-13 |
| Onset: | 2007-10-06 |
| Days after vaccination: | 115 |
| Submitted: |
2007-10-12 |
| Days after onset: | 6 |
| Entered: |
2007-10-17 |
| Days after submission: | 5 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0389U / 2 |
RA / UN |
Administered by: Other Purchased by: Other
Symptoms: Chills,
Computerised tomogram abnormal,
Death,
Headache,
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? Yes
Date died: 2007-10-08
Days after onset: 2
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: Medical history and concomitant medications not reported; it was unknown if the patient was ill at time of vaccination.
Allergies:
Diagnostic Lab Data: 07/Oct/2007: Brain CT showed meningococcal disease ER LABS: CT scan & CXR WNL. WBC 14.9 (H), Neutros 87.2 (H), lymphs 6.4 (L). Creatinine 1.2 (H), ALT 27 (L). CSF WBC 4455 (H), RBC 171 (H), neutros 100% (H), glucose 29 (L), protein 371 (H). Blood & urine cultures neg. CSF (+) neisseria meningitidis. Hospital LABS: bronchoscopy & echocardiogram done prior to organ donation were WNL. CSF gram stain revealed neisseria species. WBC 19.1, neutros 86 (H), lymphs 5 (L). CRP 19.3 (H).
CDC Split Type: 200703414
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. |
|
| VAERS ID: |
297528 (history) |
| Form: |
Version 1.0 |
| Age: |
12.0 |
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 2007-09-15 |
| Onset: | 2007-10-06 |
| Days after vaccination: | 21 |
| Submitted: |
2007-11-20 |
| Days after onset: | 45 |
| Entered: |
2007-11-23 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Unknown Purchased by: Unknown
Symptoms: Death
SMQs:
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 2007-10-06
Days after onset: 0
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: WAES0711USA02619
Write-up: Information has been received from a physician''s assistant concerning a 12 year old female with no reported medical history who on approximately 15-SEP-2007 was vaccinated with Gardasil. It was noted that this was not where the vaccine was administered, rather they were the patient''s family physician. On 06-OCT-2007 the patient died in her sleep. No further information was provided. No lot number was given. Additional information has been requested. |
|
| VAERS ID: |
300066 (history) |
| Form: |
Version 1.0 |
| Age: |
26.0 |
| Sex: |
Female |
| Location: |
Texas |
| Vaccinated: | 2007-11-12 |
| Onset: | 0000-00-00 |
| Submitted: |
2007-12-14 |
| Entered: |
2007-12-17 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0106U / 2 |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2007-11-25
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: Obesity
Preexisting Conditions: Asthma, morbid obesity, smoker, occasional ETOH. OCP unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA02658
Write-up: Information has been received from a physician concerning a large female who received one dose of Gardasil. Subsequently, the patient was found dead in her truck from a blood clot that traveled from her legs to her lungs. The cause of death was reported to be a blood clot. Additional information has been requested. 3/5/08 Autopsy states COD as pulmonary thromboembolus w/deep vein thrombosis of right leg & obesity as contributing factor. |
|
| VAERS ID: |
305606 (history) |
| Form: |
Version 1.0 |
| Age: |
17.0 |
| Sex: |
Female |
| Location: |
New York |
| Vaccinated: | 2008-02-20 |
| Onset: | 2008-02-22 |
| Days after vaccination: | 2 |
| Submitted: |
2008-02-25 |
| Days after onset: | 3 |
| Entered: |
2008-02-25 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1968U / 3 |
LA / IM |
Administered by: Private Purchased by: Other
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2008-02-22
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin daily birth control
Current Illness:
Preexisting Conditions: No known drug allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: Sudden unattended death. Autopsy results pending (inconclusive 2/25/08). 2/26/08 Reviewed pcp medical records & vax records which reveal patient received HPV#1 0469U 7/16/07 & HPV#2 09300 9/17/07. In 11/20/07, noted to have left sided head pain intermittently along with lightheadedness; dx w/tension HA. HPV#3 was scheduled for 1/16/2008 but postponed due to no parental signature. Returned to office 1/24/08 for left wrist pain from cheerleading injury s/p ER vs for same on 1/19/08. Patient last seen in office by nurse only on 2/20 for HPV #3, no notes for visit. PMH: kicked in face by horse in past (undated) & had contusion on cheek; acne vulgaris, started Yasmin & topicals 4/07 w/improvement after multiple other drug failures; 1/19/08 wrist contusion from cheerleading. 5/2/08 Autopsy report states COD as undetermined. Autopsy states patient had intermittent HAs x 2 mo & had been on BCP x 1 year for acne. Found w/small facial laceration from striking flower pot when fell. The autopsy was neg for all findings. Scene indicated sudden death from collapse & fall. Suspected long QT interval syndrome w/fatal arrhythmia rather than new onset seizure in patient w/no history of either. Suggested testing family members. |
|
| VAERS ID: |
307394 (history) |
| Form: |
Version 1.0 |
| Age: |
13.0 |
| Sex: |
Female |
| Location: |
California |
| Vaccinated: | 2007-03-01 |
| Onset: | 2007-05-25 |
| Days after vaccination: | 85 |
| Submitted: |
2008-03-19 |
| Days after onset: | 299 |
| Entered: |
2008-03-19 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0187U / 3 |
- / - |
Administered by: Unknown Purchased by: Unknown
Symptoms: Abdominal pain,
Amyotrophic lateral sclerosis,
Electromyogram abnormal,
Lumbar puncture,
Muscular weakness,
Nerve conduction studies abnormal,
Neuropathy,
Nuclear magnetic resonance imaging,
Paralysis flaccid,
Respiratory failure,
Sleep study abnormal,
Swelling,
Urinary incontinence,
Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 2009-03-15
Days after onset: 660
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 24 days
Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none 4/8/08-recor ds received-PMH: attention deficit hyperactivity disorder and congenital strabismus. Migraines. Cognitive delay, developmental delay and motor delay. Allergies:strawberries cause an itch. In May sustained injury with pain in leg which improved but never returned completely to normal. 4/16/08-records received-PMH: Pityriasis lichennoides. Allergy to strawberries causes itching. Attention deficit disorder.
Allergies:
Diagnostic Lab Data: EMG and nerve conduction studies suggest motor neuronopathy vs neuropathy 4/8/09-records received- EEG normal. MRI brain showed slightly prominent cerebellar fissures but otherwise normal. MRI spine normal. West Nile, hepatitis B were negative. Urine organic acids elevated lactic acid. T4 and TSH normal. Heavy metal screen normal. Acylcarnitine profile normal. CSF protein elevated 54, lymphocytes 86 and monocytoid cells 14. CSF amino acids showed nonspecific variations from normal of serine, alanine, citrulline, valine, methionine, beta aminoisobutyric acid, lysine and histidine. triglycerides 429. December 2007 EMG and nerve conduction studies with dignosis of multifocal motor neuropathy. MRI at that time showed nerve root enhancement. 4/16/08-records received-EEG normal. MRI brain and spine normal. Elevated lactic acid level in urine. Sleep study mild obstructive sleep apnea syndrome with one episode of hypoxemia without hypoventilation worse in REM sleep and supine. MRI of lumbar spine mild enhancement of lumbar nerve roots however this was done after a lumbar puncture and findings may be secondary to lumbar puncture. 4/16/08-CPK increased of 313 and slightly elevated anticardiolipin IgM of 20.3. EEG normal. MRI brain and spine normal. Elevated lactic acid level in urine. LP: mildly elevated protein of 46 with normal glucose. MRI of lumbar spine mild enhancement of lumbar nerve roots however this was done after a lumbar puncture and findings may be secondary to lumbar puncture.
CDC Split Type:
Write-up: Progressive muscle weakness resulting in flaccid paresis of all 4 extremities, respiratory insufficiency. 4/8/08-records received for DOS 2/4-2/17/08-DC DX: autoimmune motor neuropathy, provisional. Possible motor neuron disease. Admission 3/14-3/25/08-DC DX: Muscular weakness. Seizures. Received IVIG, treated with plasmapheresis. Admitted with C/O progressive muscular weakness over the 3 weeks prior to admission increased immunomodulation. Seizure after completion of solumedrol. Remained post ictal for several hours. No diagnosis made during this admission. Genetic evaluation for mitrochondrial disease sent to include evaluation for Pompe disease. In May sustained injury with pain in leg which improved but never returned completely to normal. Developed worsening limping and loss of strength in distal left lower extremity. Between August and October of 2007 developed symptoms in right arm. Received IVIG at that time and again January 2008 with improvement in right handed tremor but worsening function status especially in ambulation, stair climbing and standing from seated position. Feb 4-17 2008 hospitalized received plasmapheresis with improved ability to stand for short periods. C/O headaches and nausea. She may have chronic inflammatory demyelinating myopathy versus a multifocal motor neuropathy. After discharge to follow up with specialist in ALS. 4/16/08-records received-for DOS 1/2-1/3/08-DC DX: Multifocal neuropathy versus chronic demyelinating polyneuropathy. LP: mildly elevated protein of 46 with normal glucose. Unable to perform activities of daily living. IVIG treatment. PE: left lower and right upper extremity weakness and atrophy with some mild weakness of right lower extremity. 4/16/08-clinical consult case review template received: CPK increased of 313 and slightly elevated anticardiolipin IgM of 20.3. DX: chronic inflammatory demyelinating polyneuropathy. 1/2/08-urinary incontinence may have been due to her reduced ability to mobilize given her leg weakness. Plasmapheresis. 3/14/08-admitted for progressively worsening weakness and increased immunomodulation. During treatment with IV Solu-Medrol, one seizure and was post-ictal for several hours. Shortness of breath with vital capacity of 48%. Restrictive and obstructive component to her lung involvement. 4/5/08-DX: primary muscular atrophy the syndrome of progressive lower motor neuron loss. Third seizure during sleep study. Currently on a trial of Cytoxan. Impression: ten month history of progressive muscular weakness with lower motor neuron signs and status post multiple different trials of immunosuppressant medications. 4/16/08-records received-for DOS 1/2-1/3/08-DC DX: Multifocal neuropathy versus chronic demyelinating polyneuropathy.Unable to perform activities of daily living. IVIG treatment. PE: left lower and right upper extremity weakness and atrophy with some mild weakness of right lower extremity. 6/17/09 Autopsy report received from CDC - DOS 3/17/09 Clinical Diagnosis: Atypical progressive lower motor neuron disease, ventilator dependence, gastrostomy tube, hypercalcemia, seizures. I. Extensive demyelination, involving the lateral and anterior columns of the cervical, thoracic and lumbar spinal cord, with macrophage and lymphocytic infiltration. Severe loss of motor neurons, cervical, thoracic, and lumbar spinal cord. Rare neurons with amorphous cytoplasmic inclusions, frontal cortex, substantia nigra, locus ceruleus, medulla oblongata, and spinal cord. Neurogenic atropy, skeletal muscle. II. Acute brochopneumonia, lungs. III. Mild steatosis, liver. IV. Gastrostomy tube, stomach, in proper position. Follow-up: Paralysis - involving 4 extremities trunk and possibly the diaphragm given that her FVC = 27%. She also has significant persistent nausea / vomiting, intermittent abdominal pain, and extremity swelling. Her condition continues to deteriorate and now she is on BIPAP. |
|
| VAERS ID: |
309233 (history) |
| Form: |
Version 1.0 |
| Age: |
12.0 |
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 2007-04-27 |
| Onset: | 2007-06-22 |
| Days after vaccination: | 56 |
| Submitted: |
2008-04-09 |
| Days after onset: | 292 |
| Entered: |
2008-04-10 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HEPA: HEP A (VAQTA) / MERCK & CO. INC. |
0250U / 2 |
LA / - |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0384U / 2 |
LA / UN |
Administered by: Other Purchased by: Other
Symptoms: Arrhythmia,
Brain death,
Brugada syndrome,
Convulsion,
Death,
Electrocardiogram,
Electrocardiogram QT prolonged,
Headache,
Life support,
Rash
SMQs:, Torsade de pointes/QT prolongation (narrow), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Congenital and neonatal arrhythmias (narrow), Conduction defects (narrow), Torsade de pointes, shock-associated conditions (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2007-06-29
Days after onset: 7
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: LAMICTAL; KEPPRA; vitamins (unspecified)
Current Illness:
Preexisting Conditions: Convulsion; Arrhythmia
Allergies:
Diagnostic Lab Data: electrocardiogram
CDC Split Type: WAES0804USA00429
Write-up: Information has been received from a consumer concerning her 12 year old daughter with a history of seizures and heart arrhythmias, who on 25-JAN-2007 was vaccinated with a first dose of Gardasil. On 27-APRIL-2007 the patient was vaccinated with a second dose of Gardasil. Concomitant therapy included LAMICTAL, vitamins (unspecified) and KEPPRA. Subsequently, the patient began to have seizures, developed a rash on her arm, and was complaining about headaches. On 22-JUN-2007 the patient experienced a heart arrhythmia and was hospitalized. Due to the arrhythmia the patient was placed on life support and died on 29-JUN-2007. The patient''s mother reported that the patient had an electrocardiogram (EKG) about 5 years ago to test for prolonged QT syndrome. The test came back normal. It was reported that at that time the patient was in and out of the emergency room due to having seizures periodically. The patient had been seeing a neurologist and had not had any seizures for about two years until she received the second dose of Gardasil. The patient''s mother reported after her daughter''s death and burial she had received copies of her daughter''s medical records. Throughout the reports it showed that for the past five years the patient had prolonged QT syndrome, and proguda syndrome "which causes seizures and heart arrythmias." The patient''s cause of death was prolonged QT syndrome, brain death, and proguda syndrome. No product quality complaint was involved. The seizures, rash, headaches, heart arrythmias, prolonged QT syndrome, brain death, and proguda syndrome were considered to be other important medical events. Additional information is not available. |
|
| VAERS ID: |
310262 (history) |
| Form: |
Version 1.0 |
| Age: |
20.0 |
| Sex: |
Female |
| Location: |
North Carolina |
| Vaccinated: | 2008-04-01 |
| Onset: | 2008-04-05 |
| Days after vaccination: | 4 |
| Submitted: |
2008-04-17 |
| Days after onset: | 12 |
| Entered: |
2008-04-21 |
| Days after submission: | 4 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1978U / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Autopsy,
Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2008-04-05
Days after onset: 0
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: None
Allergies:
Diagnostic Lab Data: autopsy, 04/??/08, ruled out suicide or anything suspicious; diagnostic laboratory, 04/??/08, toxicology results unknown. 7/16/09 Pathology report received Receipt 02/23/09 Sign-out 07/06/09. Single focus of mononuclear inflammation of the epicardium. No molecular evidence of infection with enteroviruses or adenoviruses. Liver shows focal nodular hyperplasia. Lung is congested. Enterovirus group RT-PCR (-) Adenovirus group PCR (-).
CDC Split Type: WAES0804USA02336
Write-up: Information has been received from a physician concerning a 20 year old female with no medical history reported, who on 01-APR-2008 was vaccinated with a dose of Gardasil. On 05-APR-2008, the patient died four days after receiving Gardasil. The patient sought unspecified medical attention. An autopsy was performed which ruled out suicide and anything suspicious. The cause of death is currently unknown and they are performing toxicology tests to try to determine the cause. No product quality complaint was involved. The reportable physician considered death to be immediately life-threatening and disabling. Additional information has been requested.7/14/08-autopsy report received-COD:Undetermined. Died unexpectedly while working as a health aid. Postmortem examination reveals focal nodular hyperplasia in liver; this finding though significant, cannot accoutn for sudden death. There is no evidence of pregnancy. Toxicology analysis negative. Based on history, autopys, and toxicological examination, cause of death is undetermined. |
|
| VAERS ID: |
316983 (history) |
| Form: |
Version 1.0 |
| Age: |
17.0 |
| Sex: |
Female |
| Location: |
New Hampshire |
| Vaccinated: | 2008-05-28 |
| Onset: | 2008-06-12 |
| Days after vaccination: | 15 |
| Submitted: |
2008-06-16 |
| Days after onset: | 4 |
| Entered: |
2008-06-23 |
| Days after submission: | 7 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0928U / 1 |
LA / UN |
Administered by: Private Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2008-06-12
Days after onset: 0
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: Seizures PMH: ''problems w/alcohol''.
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: Death 9/9/08 Death certificate states COD as idiopathic seizure disorder. 8/5/08 Reviewed ER medical records of 6/12/2008. Records reveal patient found unresponsive, prone on her bed when parent went to awake for school. Last seen at bedtime. Pupils fixed & dilated, cyanotic & pale, incontinent of urine, developed pulmonary edema during resuscitation. Unable to resuscitate. |
|
| VAERS ID: |
317757 (history) |
| Form: |
Version 1.0 |
| Age: |
15.0 |
| Sex: |
Female |
| Location: |
Indiana |
| Vaccinated: | 2008-06-13 |
| Onset: | 2008-06-15 |
| Days after vaccination: | 2 |
| Submitted: |
2008-06-27 |
| Days after onset: | 12 |
| Entered: |
2008-06-27 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1447U / 1 |
LA / UN |
Administered by: Unknown Purchased by: Unknown
Symptoms: Cardiomegaly,
Death,
Passive smoking,
Splenomegaly,
Toxicologic test normal
SMQs:, Cardiac failure (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2008-06-15
Days after onset: 0
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: overweight PMH: recurrent colds/sore throat, neg strep.
Allergies:
Diagnostic Lab Data: toxicology and other test came back negative expect trace amount of nicotine (father heavy smoker)
CDC Split Type:
Write-up: Death -coroner says enlarged heart & enlarge spleen 7/4/08 Reviewed PCP medical records of 1999-6/2008 which included vax record. In 8/2007, c/o of tiredness & loss of appetite. Monospot (-). On day of vax, patient was well, weight noted as 237, otherwise no complaints. 7/8/08 Autopsy report states COD as arrhythmia due to cardiomyopathy.States anatomic findings of obesity, pulmonary edema, mild & left ventricular hypertrophy w/myocardial nuclear enlargement. Patient had been found non-responsive by family. EMS found patient cyanotic w/rigor & no further resuscitation was performed. Family reported patient had been well earlier in the evening. Albuterol inhaler was found at scene but no suspicious features at scene. |
|
| VAERS ID: |
318491 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2008-07-07 |
| Entered: |
2008-07-08 |
| 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: Death,
Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: Sulfonamide allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA08737
Write-up: Information has been received from a physician who was told by a patient''s mother that a female patient with a sulfa allergy who on an unspecified date was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported), which was well tolerated. On an unspecified date, the patient was vaccinated with a second dose of GARDASIL (lot number, injection site and route not reported). Subsequently the patient died. The cause of death was reported as allergic reaction to GARDASIL. The physician stated that the patient who died was not her patient and she knew no further details. Follow-up information was received from the physician who reported that a other of one of her patients had said to her, that she "thought" she read this report on the internet. The physician asked the patient''s mother to find out where she read the report. The patient''s mother could not find the report and did not know where to locate the source information. Additional information has been requested. |
|
| VAERS ID: |
319533 (history) |
| Form: |
Version 1.0 |
| Age: |
21.0 |
| Sex: |
Female |
| Location: |
Maryland |
| Vaccinated: | 2008-06-03 |
| Onset: | 2008-06-20 |
| Days after vaccination: | 17 |
| Submitted: |
2008-07-17 |
| Days after onset: | 27 |
| Entered: |
2008-07-17 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0053X / 3 |
LA / IM |
Administered by: Unknown Purchased by: Unknown
Symptoms: Autopsy,
Death,
Spleen disorder
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2008-06-20
Days after onset: 0
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: Reported allergy to penicillin and cephid 3/5/09-records received-Allergic to penicillin.
Allergies:
Diagnostic Lab Data: None - apparently healthy young woman 8/22/08-records received-cardiac blood neg for ethanol; urine (+) for ethanol=16 mg/dl; liver (+) for acetaldehyde (incidental finding). 3/5/09-records received-pap smear normal. 2/4/09-records received-CBC WNL, chemistry WNL. 2/12/08 ECG abnormal mild tricuspid regurgitation, 2D Doppler frequent premature ventricular contractions. 4/30/09-records received-lung specimen showed diffuse edema and intraalveolar hemorrhages. Staphylococcus aureus negative.
CDC Split Type:
Write-up: Pt received her 3rd and final dose of HPV vaccine on 6/3/08. Per mother patient was found dead, in bed on 6/22/08, in her dorm room at an out-of-state college. According to the autopsy the patient had been dead for about 48 hours. According to mother autopsy was negative except for splenic inflammation. 8/22/08 Autopsy report also states Final Diagnoses: Cardiac arrest, cause undetermined w/recent history of PAC w/otherwise normal EKG; normal echocardiogram 2/08; no evidence of myocarditis; acute pulmonary edema; slight splenomegaly; cardiac blood neg for ethanol; urine (+) for ethanol=16 mg/dl; liver (+) for acetaldehyde (incidental finding). 3/5/09-records received for DOS 8/22/07-seen for routine visit and first annual pap test..PE normal. First HPV vaccine administered. 2/4/09-records received for DOS 11/20/07-C/O chronic PAC and irregular heart beat. |
|
| VAERS ID: |
319809 (history) |
| Form: |
Version 1.0 |
| Age: |
22.0 |
| Sex: |
Female |
| Location: |
California |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2008-07-18 |
| Entered: |
2008-07-21 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death,
Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? Yes
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: WAES0807USA03098
Write-up: Information has been received from a medical assistant concerning a 22 year old female with no known medical history and no known allergies who was vaccinated with GARDASIL. Subsequently the patient experienced an unexplainable death. The mother of the patient found her daughter unresponsive and dead in her bed. It was noted that this death was reported to VAERS and the death was not caused by GARDASIL. It is unknown if medical attention was sought. The medical assistant considered the death to be disabling and life-threatening. No further information is available. |
|
| VAERS ID: |
319810 (history) |
| Form: |
Version 1.0 |
| Age: |
15.0 |
| Sex: |
Female |
| Location: |
Illinois |
| Vaccinated: | 2007-08-06 |
| Onset: | 2007-09-20 |
| Days after vaccination: | 45 |
| Submitted: |
2008-07-18 |
| Days after onset: | 302 |
| Entered: |
2008-07-21 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0012U / 3 |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Convulsion,
Death,
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? Yes
Birth Defect? No
Died? Yes
Date died: 2007-09-20
Days after onset: 0
Permanent Disability? Yes
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. PMH: 1 prior seizure 8/2007. 4/28/09 Additional records received from PCP at CDC''s request. Pt in for OV 1/30/07 with c/o allergy sx and requesting HPV#1-given 0012U. Returned 3/22/07 for HPV#2-given 1427F with Boostrix AC52B012AA. Mild URI 4/25/07. OV 6/12/07 in F/U to ER visit for seizure on 6/11/07. Syncope noted. Sent for tests. OV 6/28/07 Echo and blood work reportedly WNL. Syncope again noted. PE WNL. OV 7/5/07 EEG normal. EIA? Retuned 8/6/07 for HPV#3 given 0012U. PFTs reportedly normal.
Allergies:
Diagnostic Lab Data: Unknown. Labs and Diagnostics: Tox screen (-).
CDC Split Type: WAES0807USA02139
Write-up: Information has been received from a certified medical assistant concerning a 14 year old female who was vaccinated with a first dose of GARDASIL and experienced syncope. She was taken to an emergency room and released. The patient was vaccinated with a second dose of GARDASIL (unspecified time). Subsequently, the patient experienced her first seizure (unspecified time) and was taken to the emergency room (no further details provided). The patient was vaccinated with a third dose of GARDASIL at 15 years old. Approximately 27-JUN-2008, two weeks after the third dose, the patient developed a complication. She was taken to the hospital by ambulance but passed away during the transport from an unknown cause. The physician has asked the mother for the autopsy report. The reporting medical assistant considered the syncope, seizure and "a complication" were considered to be immediately life-threatening and disabling. Additional information has been requested. 2/13/09 Autopsy report received. COD: Seizure Disorder. Summary Diagnoses: Clinical history of seizure disorder. Pulmonary congestion and edema. Passive visceral congestion. 2/20/2009 ER received from CDC. Pt presented to ER via EMS following witnessed seizure activity with fall from standing. Upon EMS arrival pt had agonal respirations and was pulseless in V-fib at 650. Upon arrival in ER unresponsive, pupils fixed and dilated, no cardiac activity. Resuscitation unsuccessful and pt expired. |
|
| VAERS ID: |
320559 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Unknown |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2008-07-25 |
| Entered: |
2008-07-28 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES0806USA08705
Write-up: Initial and follow up information has been received from a physician, who was told by one of his patients, that the mother of a consumer was told by a neurologist that there were 4,400 kids who have died following vaccination with GARDASIL. No product quality complaint was involved. Attempts are being made to verify the existence of patients. Additional information has been requested. |
|
| VAERS ID: |
320909 (history) |
| Form: |
Version 1.0 |
| Age: |
21.0 |
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2008-07-30 |
| Entered: |
2008-07-31 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / 3 |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death,
Fatigue,
Injection site pain,
Viral infection
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? Yes
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: WAES0807USA04740
Write-up: Information has been received from a physician concerning a 22 year old female who on an unspecified date was vaccinated with her third dose of GARDASIL. Subsequently the patient experienced soreness at the injection site and fatigue. The outcome of soreness at the injection site and fatigue was not reported. Two months after receiving her third dose of GARDASIL, the patient died. The cause of death was "viral insult to the heart". Unspecified medical attention was sought. Follow-up information was received via telephone call from the physician. The patient was a family member. She did not have the vaccination dates or lot numbers since she did not give them. The physician reported that the patient''s mother thought that the patient died related to GARDASIL. She did not have the cause of death. The physician refused to provide patient information, information was gave to the coroner. The physician considered "viral insult to the heart" to be immediately life-threatening and disabling. Additional information has been requested. |
|
| VAERS ID: |
320910 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2008-07-30 |
| Entered: |
2008-07-31 |
| 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: Death
SMQs:
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES0807USA04504
Write-up: Information has been received from a physician concerning his patient''s daughter who on an unspecified date was vaccinated with a dose of GARDASIL. The patient''s mother told to the physician that her daughter died in her dorm room 4 days after receiving the dose. The physician did not have much information because he did not administer the vaccine and the patient''s daughter was not his patient. The reporter did not know the name of the physician who administered the vaccine. The physician considered the event to be life threatening. Additional information has been requested. |
|
| VAERS ID: |
321696 (history) |
| Form: |
Version 1.0 |
| Age: |
16.0 |
| Sex: |
Female |
| Location: |
Missouri |
| Vaccinated: | 2008-03-31 |
| Onset: | 2008-04-03 |
| Days after vaccination: | 3 |
| Submitted: |
2008-08-08 |
| Days after onset: | 127 |
| Entered: |
2008-08-08 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1487U / 2 |
LA / IM |
Administered by: Private Purchased by: Private
Symptoms: Cardiac arrest,
Computerised tomogram,
Convulsion,
Cough,
Death,
Dyspnoea,
Fall,
Headache,
Hypotonia,
Laboratory test,
Loss of consciousness,
Respiratory tract congestion,
Syncope,
Tremor,
Upper respiratory tract congestion,
X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (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), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Parkinson-like events (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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2008-04-07
Days after onset: 4
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: 3/31 ROCEPHIN; 3/31 ZITHROMAX
Current Illness: Sore throat
Preexisting Conditions: Hx of pharyngitis; Bacterial Meningitis at 17 mons
Allergies:
Diagnostic Lab Data: lab work, Cat scans, X-rays
CDC Split Type:
Write-up: To Whom It May Concern: My daughter went to our nurse practitioner at Health Care Center on March 31, 2008 for a sore throat. She complained of her throat for about two days prior. Pt would get pharyngitis and strep about twice a year since she was 13. She received a shot of ROCEPHIN in the office on March 31st as well she was given a prescription for ZITHROMAX (Z-PAK) at the same time. I''m not sure exactly what time her appointment was it was around 11:00 am. that day. She dropped off her prescription at the pharmacy and I picked up on my way home. She took her first dose of ZITHROMAX on the 31st. She stayed home from school the next two days. She slept late both days which is not abnormal for her. In the evenings we played rummy, she was congested and coughing a little. She complained of a headache the next night and I gave her some ibuprofen. On Wednesday April 3rd she went to school, (school gets out at 3:05 p.m.) after school she went to tract practice. Her tract practice was a short one, I know she ran but I''m not sure how much. She stopped at a convenience store on the way home from school and got a Red Bull. She went home and changed clothes for work. She called me between 4:30 and 5:00 p.m. on her way to work to tell me about the road being blocked due to rain where we live. She parked her car and was walking the short distance into where she works she collapsed and started seizing. A lady in the drive through told the owner that she had fallen and he went out immediately. He said she was shaking, the employees inside called 911 and then me. The owner told me she stopped shaking and took a few strained breaths and then went limp. The police officer arrive within three minutes, he was a first responder. He did not check for a pulse or attempt CPR (I am in the process of getting a police report as well). Just as I got there an off duty paramedic arrived and started CPR. It took quite awhile before the ambulance arrived; she had been down too long. I later learned that they did not get her heart started until just before the ambulance arrived at the hospital. Pt officially died on April 7th, the decision was made on April 6th that she become an organ donor. My daughter was a very healthy, vibrant, and beautiful person! Any other information you need I will do my best to provide. I STILL have not received the autopsy report. I did talk to them Friday and they said it would be within the next two weeks. Sincerely, pt''s mother 9/19/08 Autopsy report states COD as apparent cardiac rhythm disturbance of undetermined etiology. Report states pathologic findings of: hx of sudden fall & cardiac arrest; subgaleal hemorrhage, fontoparietal scalp; tongue abrasions c/w tooth marks; hx of recent illness; agonal seizures; bilateral cerebral edema; catecholamine induced myotoxicity; bilatreral lobar pneumonia; organ & tissue harvesting. |
|
| VAERS ID: |
322250 (history) |
| Form: |
Version 1.0 |
| Age: |
22.0 |
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2008-08-14 |
| Entered: |
2008-08-15 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / 3 |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA01968
Write-up: Information has been received from a registered nurse (R.N.) concerning a 22 year old female (a relative of another employee) who was vaccinated with a third dose of GARDASIL. Subsequently the patient died. The cause of death was unknown. Additional information has been requested. |
|
| VAERS ID: |
323430 (history) |
| Form: |
Version 1.0 |
| Age: |
20.0 |
| Sex: |
Female |
| Location: |
Utah |
| Vaccinated: | 2007-07-13 |
| Onset: | 2008-04-01 |
| Days after vaccination: | 263 |
| Submitted: |
2008-08-26 |
| Days after onset: | 147 |
| Entered: |
2008-08-27 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM |
AHAVB143AA / 1 |
RA / IM |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0522U / 1 |
RA / IM |
| TDAP: TDAP (ADACEL) / SANOFI PASTEUR |
C2734AA / 1 |
LA / IM |
Administered by: Other Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis,
Asthenia,
Intensive care,
Motor neurone disease,
Muscle contractions involuntary,
Muscular weakness,
Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dystonia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2008-08-21
Days after onset: 142
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC Split Type: WAES0808USA03969
Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillain Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the [[name]] or off the bed, difficulty lifting [[name]] off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved [[name]] weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her [[name]]. Approx 3 [[name]] after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her [[name]] w/o LOC. Had neck & shoulder discomfort. 3 [[name]] later was unable to raise arms above her [[name]] & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subsequently transferred to higher level of care. |
|
| VAERS ID: |
324002 (history) |
| Form: |
Version 1.0 |
| Age: |
16.0 |
| Sex: |
Female |
| Location: |
Ohio |
| Vaccinated: | 2008-02-26 |
| Onset: | 2008-03-12 |
| Days after vaccination: | 15 |
| Submitted: |
2008-09-03 |
| Days after onset: | 175 |
| Entered: |
2008-09-03 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1266U / 3 |
RA / IM |
Administered by: Unknown Purchased by: Unknown
Symptoms: Autopsy,
Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2008-03-12
Days after onset: 0
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 noted
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Full Autopsy done. Immediate cause of death was massive pulmonary embolus. Secondary was Type 1 Diabetes (previously undiagnosed). Vitreous Humor glucose was 767 9/4/08-records received- Vitreous glucose 767.
CDC Split Type:
Write-up: Sudden death occured on 3/12/2008. 9/4/08-records received-Cause of Death:cardiovascular collapse as a consequence of pulmonary emboli, dehydration and diabetic ketacidosis. |
|
| VAERS ID: |
325063 (history) |
| Form: |
Version 1.0 |
| Age: |
17.0 |
| Sex: |
Female |
| Location: |
Kansas |
| Vaccinated: | 2008-07-24 |
| Onset: | 2008-08-01 |
| Days after vaccination: | 8 |
| Submitted: |
2008-09-12 |
| Days after onset: | 42 |
| Entered: |
2008-09-15 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1740U / 1 |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Abdominal pain,
Chest pain,
Death,
Pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2008-08-04
Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: erythromycin
Current Illness: Acne
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown LABS: WBC 10.3(H). Troponin greater than 100(H) & CPK 5492(H), CKMB 313.1(H) c/w infectious myocarditis, possibly viral. TSH 0.09(L). CRP 38.3(H). BNP 533(H). ANA neg. ASO 200(+). CXR abnormal w/water bottle appearing heart. Sodium 132(L), potassium 3.7(L), bicard 18(L), BUN 29(H), creatinine 1.3(H). AST 832(H), ALT 211(H). Urine drug screen neg. Blood c/s neg. MRSA screen neg.
CDC Split Type: WAES0809USA00837
Write-up: Information has been received from a physician concerning a 17 year old female with acne who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included erythromycin, solution, topical. On 04-AUG-2008, the patient experienced abdominal pain, chest pain and aching everywhere and was hospitalized. On 05-AUG-2008, the patient experienced myocarditis and died. Diagnosis was myocarditis but the doctor said it was not related to GARDASIL. The last time she was seen in this office was 2005. No additional information at this time. Additional information has been requested. 10/01/08 Death certificate states COD as myocarditis & CHF as contributing factor. 9/22/08 Reviewed PCP medical records. Reveals patient experienced abdominal pain, chest pain & aching everywhere. Expired 8/5/08 w/viral infection of the heart. Concomitant med was erythomycin topical solution for acne. Patient noted to be in good health on day of vaccination. 4/2/09 Received hospital medical records for 8/3-8/4/2008. FINAL DX: deceased secondary to severe nonischemic cardiomyopathy secondary to viral myocarditis Records reveal patient experienced fever, chills, feeling unwell x 2-4 days. Presented to ER w/abdominal & chest pain, weakness, dizziness, hypotensive, tachycardia, SOB, respiratory distress w/hypoxemia, azotemia, shocklike symptoms. EKG w/diffuse ST changes & ST elevations. Dx w/acute anteroseptal MI Emergent cardiac cath revealed EF 23% & balloon pump placed. Intensive care, deteriorated, V-tach, decompensation, extensive resuscitation efforts failed. |
|
| VAERS ID: |
334611 (history) |
| Form: |
Version 1.0 |
| Age: |
19.0 |
| Sex: |
Female |
| Location: |
Illinois |
| Vaccinated: | 2008-11-26 |
| Onset: | 2008-12-08 |
| Days after vaccination: | 12 |
| Submitted: |
2008-12-10 |
| Days after onset: | 2 |
| Entered: |
2008-12-10 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. |
500569P / UNK |
- / - |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0070X / 3 |
LA / - |
| MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR |
U2730AA / UNK |
RA / - |
Administered by: Unknown Purchased by: Unknown
Symptoms: Autopsy,
Death,
Headache,
Malaise
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2008-12-08
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known. ?? oral contraceptive or an antibiotic for acne.
Current Illness: None.
Preexisting Conditions: Acne. PMH: PCN allergy. Acne. On OCs (Yaz). 12/10/2008 Recived records from health center via CDC. Seen 11/3/08 with c/o sore throat, cough, muscle aches and nasal d/c. PE (+) for pharyngeal erythema, purulent nasal drainage, nasal turbinate changes, and lymphadenopathy. Assessment: Probable viral URI with ? sinusitis. Tx: Biaxin.
Allergies:
Diagnostic Lab Data: Autopsy performed 12-9-08 was unrevealing per family verbal report to me; no signs of intracranial bleed, meningitis, cardiomyopathy, trauma. Toxicology report still pending at this time. Post-mortem tox screen (-).
CDC Split Type:
Write-up: Patient, a previously healthy 19 year-old female college freshman died suddenly yesterday, approximately 10 days after receiving Gardasil & menningococcal vaccines. Vaccines were administered by a medical provider in her hometown while she was home for the Thanksgiving holiday, sometime around 11-28-08. She had a medical appointment pending for 12-8-08 (the day of her death) with the Student Health Service; medical clerk had entered "possible seizure" as the reason for making the appointment. Patient had no history of epilepsy. She complained of a headache and not feeling well in the 24 hours prior to her death. She went to bed at 10:30 PM on 12-7-08, in her dorm room with a roomate. She appeared to still be sleeping the next morning when her roomate left for class. Her body was discovered still in bed around 5 PM that day (12-8-08) with rigor mortis. No history of substance abuse, alcohol intake, or depression or other mental health issues. She was a happy, achieving student. This report is filed by a friend of patient''s parents, who is a physician (board certified internal medicine & geriatrics). Report also filed online today with the FDA. Patient''s mother can be reached at home for additional details. Memorial service & funeral 12-12-08 and 12-13-08. Only known past medical history requiring physician attention was facial acne. 12/10/2008 Recived records from health center via CDC. Seen 11/3/08 with c/o sore throat, cough, muscle aches and nasal d/c. PE (+) for pharyngeal erythema, purulent nasal drainage, nasal turbinate changes, and lymphadenopathy. Assessment: Probable viral URI with ? sinusitis. Tx: Biaxin. Received from CDC via email: The patient had no previous health problems. She was a freshman and was seen at the college health clinic only once on 11/3/08 for sinusitis. She was on Yaz birth control pills and a topical acne medication. After the death, police questioned her roommate who said that the pt did go out on the evening of 12/6/08 and had a few alcoholic drinks, but not an excessive amount. She had a HA the next day and thought it was from the alcohol. She had a PCN allergy and was a non smoker. 12/11/2008 Records received from PCP. HPV#1 1/18/2008. HPV#2 3/28/2008. Vaccines deferred 7/29/2008 2'' to oral prednisone usage for acne (with Bactrim). Seen 8/15/08 for sore throat, runny nose. DX: Pharyngitis s/p steroid tx. Returned for vaccines 11/26/2008 in good health with normal exam. Additional record also received from health center for scheduled appt on 12/8/08. Pt reported 2 episodes (one 1 month ago and one on the day of death) of waking up in a cold sweat, having urinated in the bed, feeling the urge to vomit, dizzy with trouble reading. Appt made for ? seizure. Pt did not arrive for appt. 3/3/09 Autopsy report received. COD: Unable to ascertain after autopsy, microscopic, toxicologic and chemical evaluation. |
|
| VAERS ID: |
336473 (history) |
| Form: |
Version 1.0 |
| Age: |
18.0 |
| Sex: |
Female |
| Location: |
Tennessee |
| Vaccinated: | 2007-08-07 |
| Onset: | 2007-09-01 |
| Days after vaccination: | 25 |
| Submitted: |
2008-12-23 |
| Days after onset: | 479 |
| Entered: |
2009-01-05 |
| Days after submission: | 13 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HEPA: HEP A (VAQTA) / MERCK & CO. INC. |
0804F / 1 |
LA / IM |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0171U / 1 |
LA / IM |
| MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR |
U2207AA / 1 |
RA / IM |
| TDAP: TDAP (ADACEL) / SANOFI PASTEUR |
C2457AA / 1 |
LA / IM |
Administered by: Private Purchased by: Private
Symptoms: Asthenia,
Biopsy muscle,
Death,
Dysphagia,
Fatigue,
Headache,
Immunoglobulin therapy,
Muscle atrophy,
Myalgia,
Nuclear magnetic resonance imaging,
Pain in extremity,
Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), 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), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 2009-03-23
Days after onset: 569
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Iron-deficiency anemia
Allergies:
Diagnostic Lab Data: muscle biopsy; MRI separate. Dx clinical myositis
CDC Split Type:
Write-up: Onset increased muscle pain, fatigue, weakness, dysphagia, weight loss. Pt requiring Prednisone IVIG every q monthly. Methotrexate headache, muscle atrophy. 2/6/09 Received PCP medical records of 11/11/08-1/20/09. FINAL DX: polymyositis, likely MCV4 vaccine related; osteomalacia; neuropathy; pernicious anemia; tachycardia; ataxia; Budd-Chiari syndrome; dermatomyositis. Records reveal patient experienced muscle weakness, paresthesias, leg pain. Referred to Neuro & Rheum. Tx w/PT & meds including methotrexate, imuran, steroids, enbrel, bicillin, IVGG. Had to drop out of college due to illness. 04/6/2010 Patient''s condition never improved and she died on 3/23/2009. |
|
| VAERS ID: |
337242 (history) |
| Form: |
Version 1.0 |
| Age: |
20.0 |
| Sex: |
Female |
| Location: |
New Mexico |
| Vaccinated: | 2008-01-14 |
| Onset: | 2008-11-15 |
| Days after vaccination: | 306 |
| Submitted: |
2009-01-09 |
| Days after onset: | 55 |
| Entered: |
2009-01-14 |
| Days after submission: | 5 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1060U / 2 |
RA / UN |
Administered by: Unknown Purchased by: Unknown
Symptoms:
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2008-11-15
Days after onset: 0
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: No medical problems-- no allergies -- No drug use, alcohol or smoking. Had all her medical check ups!!!
Allergies:
Diagnostic Lab Data: 1/29/09-records received-COD-undetermined. krk 6/23/09-pathology report received: autopsy tissues without evidence of an infectious process. 6/26/09 Medical records received DOS 10/29/07 to 1/14/08. LABS and DIAGNOSTICS: PAP Tests (-).
CDC Split Type:
Write-up: My daughter had her 3rd GARDASIL vaccine in Sept. She was a very healthy young lady, she went to take a shower and died. Autopsy report states undermined death. There was no sign of trauma to the body to indicate a fall. She had pointed the shower head away from her and she got down on her knees and put her head on the edge of the tub and passed away. This has been a living nightmare for her family. She is not the only one to have had problems and death from this vaccine. Please I beg you to please take it off until it can be further tested. -not tested long enough to begin with- There will be others that will die if the cause is not found. 1/29/09-records received-COD-undetermined. 6/26/09 Medical records received DOS 10/29/07 to 1/14/08. Assessment: Immunizations and Contraceptive Management. HPV#1 10/29/07 LA Merck Lot# 1062U |
|
| VAERS ID: |
337797 (history) |
| Form: |
Version 1.0 |
| Age: |
18.0 |
| Sex: |
Female |
| Location: |
New Mexico |
| Vaccinated: | 2007-01-03 |
| Onset: | 2007-08-31 |
| Days after vaccination: | 240 |
| Submitted: |
2009-01-21 |
| Days after onset: | 509 |
| Entered: |
2009-01-21 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0955F / 1 |
LA / IM |
Administered by: Unknown Purchased by: Unknown
Symptoms: Abnormal behaviour,
Fatigue,
Headache,
Hypersomnia,
Menorrhagia,
Menstrual disorder,
Metrorrhagia,
Muscle spasms
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Dystonia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2007-08-31
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling
Other Medications: Nasonex (Pseudovent 400 substituted for Entex 400 120 capsule),Claritan, Triamcinolene Acetonide cream for rash on wrist.
Current Illness: Went in for sinisitus, and had a sore throat. She had bad sinus allergies. But they still gave her the shots.
Preexisting Conditions: Seasonal allergies. None other.
Allergies:
Diagnostic Lab Data: 4/7/09-path report received-multiple tissues with extensive autolysis and bacterial overgrowth. Molecular evidence of a Clostridium sp.
CDC Split Type:
Write-up: Headaches, periods were very erratic. She would have them every 14 days @times, and others just spotting. Very bad cramps and periods were heavier after the 1st Gardasil shot. Wasn''t her normal spunky and happy self. She was very tired and the last few weeks before she passed away, sheslept alot during the day which she never did. Never had any other problems prior to the Gardasil shots. She recieved all three shots in the series. Last shot was 5-2-2007. 2/9/09-autopsy report received-COD-undetermined by autospy and toxicology.3/18/09-records received-well visit C/O contact dermatitis, nasal congestion, itchy sore throat times 2-3days. HPV4 lot#1424 F received 1/3/07 in right deltoid. Lot #0384U received 5/2/07 left deltoid and 12/2/08 lot#0955F left deltoid. |
|
| VAERS ID: |
339771 (history) |
| Form: |
Version 1.0 |
| Age: |
13.0 |
| Sex: |
Female |
| Location: |
Illinois |
| Vaccinated: | 2008-04-28 |
| Onset: | 2008-10-26 |
| Days after vaccination: | 181 |
| Submitted: |
2009-02-09 |
| Days after onset: | 106 |
| Entered: |
2009-02-18 |
| Days after submission: | 9 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1978U / 3 |
UN / UN |
Administered by: Private Purchased by: Private
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2008-10-26
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Bloodclot~HPV (Gardasil)~3~13.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions: 5/7/09-records received-5/7/09-records received-office visit 4/21/00-evaluation for dehydration, vomiting, sore throat and febrile. Impression strep pharyngitis. 9/2/05-routine physical. Assessment:overweight. Office visit 1/4/08-C/O lump in neck noticed in 9/07. Intermittently hurts. Assessment:mild lymphadenopathy.
Allergies:
Diagnostic Lab Data: 3/9/09-records received-WBC 17.3.
CDC Split Type:
Write-up: She developed a pulmonary embolism after having 3 rounds of vaccine GARDASIL. She was a healthy, active teenager. 2/23/09-autopsy report received immediate cause:Massive pulmonary embolism. Mild cardiomegaly. Last several days C/O cough and congestion. 3/9/09-ED records received for DOS 10/26/08-presented in full cardiac arrest after suffering a full and prolonged cardiac arrest, aystole. Expired. |
|
| VAERS ID: |
343777 (history) |
| Form: |
Version 1.0 |
| Age: |
11.0 |
| Sex: |
Unknown |
| Location: |
Virginia |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2009-04-08 |
| Entered: |
2009-04-09 |
| 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: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES0904USA00201
Write-up: Information has been received from a physician concerning an 11 year old patient who was vaccinated with GARDASIL (lot number, route and site not reported). Subsequently the patient died. Additional information has been requested. |
|
| VAERS ID: |
344160 (history) |
| Form: |
Version 1.0 |
| Age: |
11.0 |
| Sex: |
Female |
| Location: |
Georgia |
| Vaccinated: | 2009-03-31 |
| Onset: | 2009-03-31 |
| Days after vaccination: | 0 |
| Submitted: |
2009-04-14 |
| Days after onset: | 14 |
| Entered: |
2009-04-15 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM |
AHAVB262A / 1 |
UN / UN |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0570X / 1 |
UN / UN |
| MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR |
U2670AA / 1 |
UN / UN |
| TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS |
AC52B029AA / 1 |
LA / IM |
Administered by: Other Purchased by: Other
Symptoms: Arthralgia,
Blood test abnormal,
Death,
Pyrexia,
Streptococcal bacteraemia,
Streptococcus identification test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2009-04-03
Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: sore throat 4/24/09 PCP records received which reveal 11yr WCC 3/31/09 with no medical c/o. Vax given- Hep A, Gardasil, TDaP and MCV4.
Preexisting Conditions: PMH: foot swelling. Sickle-cell trait.
Allergies:
Diagnostic Lab Data: diagnostic laboratory, a group A strep in the blood was found. Labs 4/1/09: CBC with WBCs 11.1 73% segs, 13.1% lymphs, 12.6% monos. UA WNL Labs 4/3/09: CK 116. LDH 389. Na+ 131. K 3.1. Cl 94. CO2 18.6. Anion gap 21.5. Glucose 170. Albumin 3.3. Globulin 4.2. AST 132. ALT 90. Aldolase 22.3. WBCs 8.4 with 16% bands, 12% lymphs. Abnormal RBC morphology. Hgb 11.1. Hct 33.6. MCV 70.3. MCH 23.4 UA (+) for 100 Glucose, urobilinogen 8.0, (+) reducing subst. UC (+). Blood cx (+) Strep pyogenes Group A. CXR ? bronchitis or atypical pneumonia.
CDC Split Type: WAES0904USA01011
Write-up: Information has been received from a physician concerning an 11 year old female who on 30-MAR-2009 (last week) was vaccinated with the first dose of GARDASIL. Concomitant therapy included VAQTA, MENACTRA and DTAP (unspecified) on the same day. Patient complained about sore throat a week prior to vaccination. A week later some kind test was performed and it showed that a group A strep in the blood was found. On approximately 30-MAR-2009, after getting the first dose of GARDASIL the patient experienced fever and pain in the hip after getting the vaccine. The patient died on 03-APR-2009. The patient sought unspecified medical attention. Additional information has been requested. 4/24/09 ER record received for DOS 4/1/09 with dx: Fever. Pediatric Viral syndrome. Pt presented with L hip pain and fever. PE (+) for tenderness over L anterior thigh. Tx with analgesic and d/c. 4/24/09 ER record received for DOS 4/3/09 with dx: Post-vaccination reaction. Pt presented again to ER with fever of 102''F, body aches, inability to walk 2'' to leg pain, nausea, vomiting, rash and polymyagias. PE (+) for extremity pain and swelling, rash, as well as not sleeping and acting differently. Transferred to higher level of care. 4/24/09 MR received for DOS 4/3-4/2009 with Final DX: Necrotizing fasciitis (gram (+) cocci with septic shock). Pt expired 4/4/09. Pt admitted from local facility for eval of fever with difficulty ambulating. Neuro/ortho consults on arrival with probable dx: infectious myositis. Tx with IV abx however IV access was lost and pt became hypotensive and with eveidence of septic shock with cardiovascular instability. Pt intubated and despite extensive resuscitation efforts pt expired. 4/24/09 Autopsy report received with COD: Necrotizing Fasciitis (Gram (+)) with septic shock. |
|
| VAERS ID: |
344385 (history) |
| Form: |
Version 1.0 |
| Age: |
16.0 |
| Sex: |
Female |
| Location: |
California |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2009-04-17 |
| Entered: |
2009-04-20 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? Yes
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: WAES0904USA02014
Write-up: Information has been received from an office manager that the physician heard from the physician''s colleague that a 16 year old female colleague''s patient was given an unspecified dose of GARDASIL (Lot not reported) on a Friday and on Monday the patient passed away (specific dates were unknown). The reporter considered the event as disabling and life threatening. Additional information has been requested. |
|
| VAERS ID: |
345435 (history) |
| Form: |
Version 1.0 |
| Age: |
21.0 |
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2009-04-30 |
| Entered: |
2009-05-01 |
| 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: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0904USA03499
Write-up: Information has been received via the internet concerning a 21 year old female who was vaccinated with GARDASIL. The patient died 4 days after vaccination. The cause of death was unknown. No further information is available. |
|
| VAERS ID: |
350666 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2009-07-01 |
| Entered: |
2009-07-02 |
| 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: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES0906USA05296
Write-up: Information has been received from a physician concerning his/her daughter''s co-worker''s daughter who on an unknown date was vaccinated with GARDASIL. It was reported that the patient died after receiving a dose of GARDASIL. The cause of death was not reported. Attempts to verify the existence of an identifiable patient and reporter have been unsuccessful. No further information is available. |
|
| VAERS ID: |
350967 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Unknown |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2009-07-07 |
| Entered: |
2009-07-08 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Unknown Purchased by: Unknown
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES0907USA00328
Write-up: It was reported from an article published on 29-JUN-2009 that there were 27 deaths in 2008 said to be associated with GARDASIL. This is one of several reports received from the same source. 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. |
|
| VAERS ID: |
351970 (history) |
| Form: |
Version 1.0 |
| Age: |
37.0 |
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 2009-05-08 |
| Onset: | 2009-06-22 |
| Days after vaccination: | 45 |
| Submitted: |
2009-07-20 |
| Days after onset: | 28 |
| Entered: |
2009-07-21 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / 1 |
UN / IM |
Administered by: Unknown Purchased by: Unknown
Symptoms: AIDS encephalopathy,
Acute respiratory failure,
Aphasia,
Blood HIV RNA increased,
Blood pressure fluctuation,
Brain death,
Brain herniation,
Brain oedema,
CD4 lymphocytes decreased,
CSF culture negative,
CSF glucose decreased,
CSF protein increased,
CSF test normal,
Computerised tomogram abnormal,
Condition aggravated,
Confusional state,
Death,
Dysarthria,
Encephalitis,
Endotracheal intubation,
HIV antibody positive,
HIV infection,
Haematocrit decreased,
Haemoglobin decreased,
Heart rate irregular,
Hypoaesthesia,
Hyporeflexia,
Lumbar puncture abnormal,
Lymphocyte count decreased,
Lymphocyte percentage decreased,
Mental status changes,
Migraine,
Monocyte percentage increased,
Neutrophil percentage increased,
Nuclear magnetic resonance imaging brain abnormal,
Pleocytosis,
Pupil fixed,
Red blood cell count decreased,
Red blood cell sedimentation rate increased,
Unresponsive to stimuli,
White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 2009-07-02
Days after onset: 10
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: None
Current Illness: HIV infection
Preexisting Conditions: Migraine; Amphetamine abuse; Bell''s palsy
Allergies:
Diagnostic Lab Data: head computed axial tomography, 06/22/2009, see narrative; spinal tap, 06/23/2009, see narrative; spinal tap, 06/23/2009, normalization of glucose; magnetic resonance imaging, 06/23/2009, brain: see narrative; head computed axial tomography, 07/02/2009, brain: see narrative; magnetic resonance imaging, diffuse cerebral edema with leptomeningeal enhancement; plasma HIV RNA quantification, 03/17/2009, HIV infected; plasma HIV RNA quantification, 06/12/2009, 45310 copies/ml; blood CD4 count, 06/23/2009, 263 cells/mm3; WBC count, 06/24/2009, 3.3 k/ul, low; blood CD4 count, 06/24/2009, 308 cells/mm3; hematocrit, 06/24/2009, 32.3 %, low; hemoglobin, 06/24/2009, 10.9 g/dl, low; WBC count, 06/25/2009, 2.6 k/ul, low; absolute lymphocyte count, 06/25/2009, 0.9 k/ul, low; absolute neutrophil count, 06/25/2009, low; hematocrit, 06/25/2009, low; hemoglobin, 06/25/2009, low; monocyte count, 06/25/2009, high; red blood cell count, 06/25/2009, 3.65 million/u, low; WBC count, 06/26/2009, 3.1 k/ul, low; hematocrit, 06/26/2009, 30.5 %, low; hemoglobin, 06/26/2009, 10.9 g/dl, low; red blood cell count, 06/26/2009, 3.69 million/u, low; erythrocyte sedimentation rate, 06/26/2009, 47 mm/hr, high; WBC count, 06/28/2009, 3.3 k/ul, low; hematocrit, 06/28/2009, 33.4 %, low; hemoglobin, 06/28/2009, 11.5 g/dl, low; absolute lymphocyte count, 07/01/2009, 0.7 k/ul, low; lymphocyte count, 07/01/2009, 9.2 %, low; neutrophil count, 07/01/2009, 67.6 %, high; lymphocyte count, 07/02/2009, 12.8 %, low; neutrophil count, 07/02/2009, 82.0 %, high; blood CD4 count, 391 cells/mm3
CDC Split Type: WAES0907USA01529
Write-up: Information has been received from an investigator concerning a 37 year old female with HIV and a history of migraine headaches and methamphetamine abuse for 20 years who entered a study. On 08-MAY-2009 the patient was enrolled in A5240 and vaccinated IM with the first dose of GARDASIL, 0.5ml, in deltoid. On 22-JUN-2009 the patient developed the following adverse events: altered mental status grade 3 (dysarthria, anomia, confusion); headache grade 3 (presented to HD 22-JUN-09 with AMS, HA). CT angle of head showed diffuse cerebral edema); left hand numbness grade 2. On 02-JUL-2009 the patient developed decreased neurological reflexes grade 4 (life threatening), pupils fixed and dilated bilaterally grade 4 (life threatening), and death. The report was as follows: The patient presented to emergency department on 22-JUN-2009 with migraine-like headache, left hand numbness, dysarthria and anomia. CT read as normal, patient discharged, the patient returned on 23-JUN-2009 with persistent headache, anomia. At that time, she was not on treatment for HIV and her CD4 count was 263. She was admitted to the neurology service and empirically treated with antibiotics for bacterial and HSV meningitis. Lumbar puncture showed borderline low glucose, elevated protein and a lymphocytic pleocytosis without red blood cells, CSF tests for EBV, HSV, VZV, Cryptococcus, VDRL, AFB smear were negative as well as CSF culture for bacteria, fungus and mycobacteria. CSF cytology was negative, flow cytometry was not performed. JC virus PCR was ordered, but results not reported. Toxoplasma IgG was negative. Blood cultures, coccidioidomycosis titers, serum cryptococcal antigen, RPR were all negative. Prior quantiferon testing in 2004 was positive without subsequent isoniazid treatment chest X ray during admission was negative as were 2 sputum for AFB smear and culture. MRI showed diffuse cerebral edema with leptomeningeal enhancement. Repeated lumbar puncture showed normalization of glucose. During the hospitalization, her symptoms had improved. Discharged to home 29-JUN-2009 with diagnosis of resolving viral meningitis vs. HIV encephalopathy. Initial consideration had been made of TB meningitis but her symptomatic improvement without TB treatment made this less likely. HIV treatment was not started during the hospitalization but was planned pending reevaluation after discharge and final review of all cultures and pending test. Re-presented emergency department on 01-JUL-2009 complained of worsening headache, symptoms and confusion; discharged as it was thought her symptoms were consistent with previous status. Returned to emergency department that night with confusion and altered mental status. At 5 AM on 02-JUL-2009, she acutely became unresponsive in the emergency room, requiring intubation and was noted to have fixed, dilated pupils bilaterally. Emergent head CT revealed diffuse cerebral edema and herniation. Pronounced brain dead of unknown cause on 02-JUL-2009. Post mortem pending, would take up to 8 weeks at this site before results were available. Relevant diagnostic tests conducted at the time of death occurred were as follows: On 22-JUN-2009, computerized tomography (CT, CT Scan, CAT Scan) of head: diffuse cerebral edema: 3 am left ICA aneurysm; bilat symm, optic nerve sheath distention. On 23-JUN-2009, magnetic resonance imaging (MRI) of brain: with contrast, diffuse supratentorial leptomeningeal enhancement, consistent with leptomeningitis. Diffuse sulcal effacement. Vague non enhancing T2/FLAIR hyperintensity multiple sites suggestive of infectious or toxic/metabolic etiology or PML. 02-JUL-2009, computerized tomography (CT, CT Scan, CAT Scan) of brain, profound diffuse sulcal effacement throughout cerebral hemispheres and posterior fossa. Severe downward tonsillar herniation and severe upward transtentorial herniation with compression of brainstem. The reporting investigator felt the event death was not related to study therapy. Study therapy association for the other events was not reported. Follow up information has been received from medical records. The patient had a past medical history significant for migraine headaches and HIV (new diagnosis, not on antiretrovirals, recent CD4 count 263 to 381), substance abuse, recent Bell''s palsy January 2009 and no known drug allergies. She was on no medications upon admission. The patient''s CD4 count on 24-JUN-2009 was 308 and a viral load on 12-JUN-2009 was 45310, diagnosed in March of 2009 and currently not on antiretroviral therapy. She was currently living in a drug rehab facility. The patient also had a history of past methamphetamine abuse and had been sober since March of 2009. The patient also had a questionable psychiatric history with a potential diagnosis of anxiety, borderline personality disorder, and depression. The patient also had a history of migraine disorders. She presented with a headache typical of her migraines but with additional features of left hand numbness, dysarthria, and anomia. The patient underwent a CT scan which was negative in the ED, and was initially sent home, and re-presented the next day with similar headache with anomia without hand numbness. A lumbar puncture was performed in the ED, remarkable for lymphocytic pleocytosis and decreased glucose, as well as elevated protein, and an MRI showed evidence for meningoencephalitis. The patient was admitted to the neurology service for further work up. The patient was hospitalized from 23-JUN-2009 to 28-JUN-2009. She was initially placed on vancomycin, cefapime, acyclovir, and ampicillin for bacterial meningitis treatment and HIV encephalitis treatment. When the results of the lumbar puncture were obtained, the antibiotics were discontinued and the patient remained on acyclovir until her PCR came back as negative. Infectious disease was consulted and upon discussion with them, the most likely differential diagnosis of the patient''s encephalitis was HIV encephalitis. Initially, a diagnosis of possible TB meningitis/encephalitis was entertained given the slightly low glucose. However, given that the glucose normalized on repeat lumbar puncture, the improvement of the patient''s condition throughout the hospitalization, and relatively benign course of the patient''s encephalopathy, it was felt that TB was much less likely. Lymphoma was still a possibility for the patient''s symptoms, and cytology was pending, although this was felt to be a much less likely diagnosis. The patient was discharged back to her program, with plans for close followup: retroviral therapy was to be initiated and she was to be followed up in neurology within 1 to 2 weeks. The discharge diagnosis on 28-JUN-2009 was human immunodeficiency virus (HIV) encephalopathy. Discharge medications included IMITREX, amlodipine, compazine (10 mg PO Q8H, PRN nausea/vomiting), ibuprofen (PRN headache). The patient was hospitalized again on 02-JUL-2009 with acute mental status changes. She was brought to the ED and around midnight or 12:15 on 02-JUL-2009 and it was noted at that time that the patient seemed to again have worsening headache, worsening confusion, as well as progressive acute mental status changes. Neurology was not contacted regarding the patient as the ED felt that the previous work up was satisfactory from a neurological standpoint. Primary medicine evaluated the patient, and it was determined she would be taken to their service. It was noted at 5:30 a.m. that the patient had a CT requested by the primary medicine serve to the ED prior to her transition up to the floor. Subsequently after that, the patient was noted at approximately 6 a.m. to have fixed pupils bilaterally and a change in blood and change in heart rate from an atypical bradycardia in the 40''s to a tachycardia. It was thought that the patient would be unable to protect her airway, and the decision was made to intubate the patient. The patient was subsequently successfully intubated after several tries. She was noted to have an acute decrease in her blood pressure to a hypotension of 50''s/40''s. It was then thought the patient was acutely decompensating, and the decision to place a central line was made in collaboration between the ED and the ICU staff. The ICU staff became involved at approximately 6:20 a.m. during the tail end of the intubation period. Central line was placed in the jugular vein. At the same time, the patient''s systolic blood pressure returned to the 110s. It was then noted that the patient was moving toward hypertension, and her dopamine was weaned from 10 to 5 and subsequently settled to about 8. She was brought to CT scan and subsequently to the floor. The initial read by the on-call radiologist demonstrated what appeared to be some mild edema, but otherwise negative. At approximately 8:30 the patient was being rounded on the ICU by the faculty and staff, and staff had noted dilated pupils bilaterally while in the ED after intubation and presented this to the team. During the examination by the attending physician, the radiology attending came and noted that the original read had missed important information regarding the patient''s clinical status. The attending contributed that the patient, in fact, did demonstrate a herniation of the posterior brain tissue into the spinal cord region. The patient was initially said to have decreased neurological reflexes in the ED, and this was corroborated and simultaneously neurosurgery and neurology were contacted and activated regarding the patient. Stat orders for mannitol and decadron were sent and administered to the patient. After evaluation by neurology and neurosurgery, it was determined that the patient in fact had suffered brain death. Intervention was discontinued around 10 a.m. and subsequently neurological evaluation for brain death commenced and terminated with determination of brain death at 1 p.m. on the afternoon of July 2, 2009. Support was withdrawn at approximately 1 p.m. The patient''s family was present and requested autopsy to be performed. The following laboratory tests were performed during the patient''s hospitalizations: sodium of 136, potassium 4.3, chloride of 95, BUN of 12, creatinase of 0.61 and glucose of 111. The patient had an IMR of 1.1, PT of 29.6, white count 7.9, hemoglobin and hematocrit 12.8 and 37.7 respectively with a platelet count in the upper 200s. The patient had blood cultures drawn that were pending, and urinalysis demonstrated 1+ protein, glucose, and bacteria with 0 to 2 white blood cells and 0 to 2 red blood cells. The patient also had a lumbar puncture from 29-JUN-2009 this showed 30 white blood cells and 3 red blood cells in tube 1 and 25 white blood cells and 2 red blood cells in tube 4 that were both lymphocyte predominant. The patient had several studies done in addition, ALF was 23, ABT 20, alkaline phosphatase 57, and total bilirubin 0.4 with a direct bilirubin of 0.1. The patient''s urine pregnancy was negative, urine was positive for opiates, and the patient had a serology from a previous admission that showed cocci and crypto negative. The patient also had a lactate of 4.6, protein 0.7, albumin 9.4, calcium 9.4, lipase 24. The patient was also noted to have a viral load of hepatitis C less than 3200, but also had positive hepatitis C antibodies. Hepatitis B and hepatitis A were found to be negative. A chest x-ray on the patient failed to demonstrate focal lesions, although there was mild left-sided hilar congestion. A CT scan of the head that was noncontract demonstrated herniation and edema. ECG demonstrated sinus bradycardia. CT neuro angiogram performed 22-JUN-2009, Impression: 1. Diffuse bilateral sulcal effacement of the cerebral hemispheres without herniation. This is suggestive of diffuse cerebral swelling with causes including toxic, metabolic, or infectious etiologies. 2. Bilateral symmetric optic nerve sheath distention without clear elevation of the optic discs suggestive of elevated intracranial pressure (ICP) correlate with fundoscopic exam findings and/or clinical symptoms referable to elevated ICP. 3. Incidentally noted 3 mm left supraclinoid ICA aneurysm, medially directed, may be a carotid cave aneurysm. 4. No acute large vessel territory ischemia or infarct, intracranial hemorrhage or extra-axial collection. There is no abnormal parenchymal or leptomeningeal enhancement. MRI brain scan with contrast performed 23-JUN-2009. Impression: diffuse sulcal effacement suggesting diffuse swelling. There is FLAIR hyperintensity and prominent enhancement within sulci. This may be due to vessel crowding within the narrowed sulci. However, a leptomeningeal process such as meningitis can also look like this. Correlation with CSF analysis is recommended. 2. Vague enhancing T2/FLAIR hyperintensity in the bilateral frontal white matter, left greater than right subinsular white matter, the left brachium pontis, the bilateral medial thalami, bilateral anteromedial temporal lobes. Diagnostic considerations include infectious etiologies such as HIV encephalopathy, herpes encephalitis, progressive multifocal leukoencephalopathy, or toxic/metabolic etiology. All medical records are available upon request. 9/8/09 Autopsy report received. DOD 7/2/09 Acute cerebrovascular event with uncal and tonsillar herniation due to severe and extensive CNS vasculitis. Additional clinical information abstracted: Migraines, history of substance / methamphetamine use, Bell''s palsy, altered mental status, HIV infection. Extensive vasculitis affecting blood vessels in leptomeniniges and throughout the brain and spinal cord. Severe hypoxic ischemic encephalopathy. Chronic meningitis. Heavy and congested lungs. Renal cortical scars, right and left kidneys, suggestive of prior infectious process. Reactive lymphadenopathy of axillary and paraaortic lymph nodes. |
|
| VAERS ID: |
356938 (history) |
| Form: |
Version 1.0 |
| Age: |
19.0 |
| Sex: |
Female |
| Location: |
Oklahoma |
| Vaccinated: | 2008-07-21 |
| Onset: | 2008-09-12 |
| Days after vaccination: | 53 |
| Submitted: |
2009-09-10 |
| Days after onset: | 363 |
| Entered: |
2009-09-10 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
17400 / 3 |
LA / IM |
Administered by: Unknown Purchased by: Unknown
Symptoms: Chest pain,
Death,
Dizziness,
Dyspnoea,
Fatigue,
Feeling cold,
Headache,
Muscle spasms,
Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2008-09-12
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~~0.00~Patient
Other Medications: Yaz until 3/17/08. Femcon beginning 3/17/08. Anaprox as needed.
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None. I do have copies of all medical history from 01/08/2004 to the time of her death that I can provide if needed. The Medical Examiners office will have tissue samples until 4/2010.
CDC Split Type:
Write-up: Headache, Nausea, dizziness, chilling, tiredness, shortness of breath, complained of chest plain, severe cramps. 9/14/09 Received vaccine & PCP medical records which reveal patient seen 12/5/07 & 2/27/08 with sore throat, fever, chills, fatigue, body aches, productive cough w/yellow sputum & HA. Dx both times w/acute bronchitis & tx w/antibiotics & cough syrup. 9/25/09 Autopsy report received DOD 09/12/2008. Acute Cardiac Arrhythmia of Unknown Etiology. Addtional information abstracted: Heart with focal microscopic ischemic changes, pulmonary congestion and edema. Rare petechiae: conjunctival, periorbital and laryngeal. Resuscitation related sternal fracture. |
|
| VAERS ID: |
361629 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Unknown |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2009-10-19 |
| Entered: |
2009-10-20 |
| 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: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES0910USA00269
Write-up: Information has been received from an office manager and a consumer who reported that she had seen reports of deaths following GARDASIL on television. This is one of two cases from the same source. This is a hearsay report in the absence of an identifiable patient. All telephone attempts to obtain follow up information have been unsuccessful. |
|
| VAERS ID: |
373314 (history) |
| Form: |
Version 1.0 |
| Age: |
23.0 |
| Sex: |
Unknown |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2009-12-14 |
| Entered: |
2009-12-15 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / 3 |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES0912USA00907
Write-up: Information has been received from a consumer who saw a report on the internet about a 23 year old patient who was vaccinated with 3 doses of GARDASIL. Subsequently the patient died, the cause of the death was unknown. This is one of several reports received from the same source. Additional information has been requested. |
|
| VAERS ID: |
373315 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Unknown |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2009-12-14 |
| Entered: |
2009-12-15 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / 3 |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES0912USA01166
Write-up: Information has been received from a consumer who saw a report on the internet concerning two patients (unspecified ages) who were vaccinated with 3 doses of GARDASIL (dates were not reported). Subsequently the patients died, the cause of death was unknown. This is one of several reports received from the same source. This is a hearsay report, attempts are being made to obtain identifying information to distinguish individual patients. Additional information has been requested. |
|
| VAERS ID: |
380740 (history) |
| Form: |
Version 1.0 |
| Age: |
13.0 |
| Sex: |
Female |
| Location: |
Washington |
| Vaccinated: | 2009-08-25 |
| Onset: | 2009-10-01 |
| Days after vaccination: | 37 |
| Submitted: |
2010-02-18 |
| Days after onset: | 140 |
| Entered: |
2010-02-18 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. |
500673P / UNK |
NS / IN |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0671Y / 1 |
AR / IJ |
Administered by: Private Purchased by: Other
Symptoms: Death,
Decreased activity,
Fall,
Headache,
Hypoaesthesia,
Loss of control of legs,
Menstruation irregular,
Oedema peripheral,
Paraesthesia,
Peripheral coldness,
Sensory loss,
Unresponsive to stimuli
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2009-10-17
Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Trileptol and Keppra
Current Illness: My daughter had a seizure disorder that came on with her periods.
Preexisting Conditions: Patient had a pre-existing seizure disorder which she was on trileptol and Keppra to control the seizures.
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: Patient received the HPV as well as the flu nasal spray on Aug 25th. I first declined getting her the vaccination but her doctor ensured me that it was safe. I had declined the same vaccination a year earlier at the downtown public health center. Patient was getting ready for school and was standing by her closet, and all of a sudden she fell, she lost total control of her legs. She went to school and could not engage in any of the activities because of the numbness in her legs and the swelling of her foot. She also, started to get a really bad headache. Days later she woke up out of her sleep complaining of a severe headache, which usually she gets if she has a seizure but she hadn''t had a seizure this night. She continued to say she had not feeling in her foot and tingling feeling in her leg. After I examined her foot I noticed it was swollen. The next morning I called her doctors office and made her doctors appointment for Oct 23rd. During the month of October she had irregular periods. My daughter never made it to Oct 23rd, which as also her birthday. She passed on Oct. 17th, I found her cold unresponsive in her room at 7am, which I went in to wake her up to take her morning pills. |
|
| VAERS ID: |
383175 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Unknown |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2010-03-19 |
| Entered: |
2010-03-22 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES1003USA02519
Write-up: Information has been received from a consumer via an internet newspaper concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL. It was reported that a parent can be guilty because if he had known about the side effects, then he might not have allowed the pediatrician to vaccinate the child, which resulted in death (cause of death unspecified). It was unknown if the patient sought medical attention. It was also reported that polysorbato 80 or tween 80 that is a chemical that causes infertility in mice and aluminum which is neurological toxin are in GARDASIL. This is one of several reports from the same source. Additional information is not expected. |
|
| VAERS ID: |
385303 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 2010-03-01 |
| Submitted: |
2010-04-15 |
| Days after onset: | 44 |
| Entered: |
2010-04-16 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / 3 |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2010-03-01
Days after onset: 0
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: WAES1004USA01848
Write-up: Information has been received from a Nurse at the physician''s office who heard from another Nurse that a patient came in to the office to receive the third dose of GARDASIL and the friend of the patient told her not to get the third dose because she knew of another girl that received the third dose of GARDASIL and died "within the last month" (cause of death not reported). It was unknown if the patient sought medical attention. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested. |
|
| VAERS ID: |
387160 (history) |
| Form: |
Version 1.0 |
| Age: |
16.0 |
| Sex: |
Female |
| Location: |
Hawaii |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2010-05-10 |
| Entered: |
2010-05-11 |
| 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: Autopsy,
Death,
Headache
SMQs:
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 2009-10-24
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: WAES1005USA00536
Write-up: Information has been received from a physician who found out from another treating physician who was also the father of the patient, concerning a 16 year old female patient who on an unknown date, was vaccinated with a dose of GARDASIL. Subsequently the patient developed a severe headache. Then the patient went to sleep that night and passed away. The autopsy was performed which revealed no cause of death. It is unknown if the patient sought medical attention. Severe headache was considered to be immediately life-threatening. Additional information has been requested. |
|
| VAERS ID: |
391439 (history) |
| Form: |
Version 1.0 |
| Age: |
18.0 |
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2010-06-24 |
| Entered: |
2010-06-25 |
| 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: Condition aggravated,
Convulsion,
Death
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? Yes
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Convulsion
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1006USA02143
Write-up: Information has been received from a Registered Nurse concerning an 18 year old female patient with a history of seizures prior to GARDASIL, who on an unspecified date was vaccinated with a dose of GARDASIL. The nurse advised that the patient experienced seizure and subsequent death after receiving GARDASIL. It was not advised which injection in the series caused the adverse experience or how the injection was administered. The health care professional was contacted by telephone and call would not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number and date of event. Seizure was considered to be disabling and immediately life-threatening. Additional information has been requested. |
|
| VAERS ID: |
393575 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Unknown |
| Location: |
Unknown |
| Vaccinated: | 2008-08-08 |
| Onset: | 0000-00-00 |
| Submitted: |
2010-07-23 |
| Entered: |
2010-07-26 |
| 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: Drug exposure during pregnancy,
Premature baby
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES0810USA02499B1
Write-up: Information has been received from a consumer concerning her daughter, who on 08-AUG-2008 was vaccinated with the first dose of GARDASIL, 0.5 mL, intramuscular while she was 2 months pregnant. The consumer stated her daughter was almost five and a half to six months pregnant when she started having pains in her side, went to the doctor and was told everything was ok and went home. The next week her pains started again and then felt like contractions, and when she went to the doctor she was already dilated around four or more centimeters and they couldn''t stop her contractions. The consumer reported that the baby was born and then died (No further details provided). The mother''s experience is reported in WAES 0810USA02499. Upon internal review, preterm labor was determined to be an other important medical event. Additional information has been requested. |
|
| VAERS ID: |
397437 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
New York |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2010-09-02 |
| Entered: |
2010-09-03 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / IM |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? Yes
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: WAES1008USA04132
Write-up: Information has been received from a physician that he heard from a parent of one of his patients who also heard from elsewhere concerning a female who was vaccinated with a 0.5ml dose of GARDASIL, IM. "Some time passed, then she died". The cause of death was not reported. The patient received unspecified medical attention. Died was considered to be disabling and immediately life-threatening. No further information is available. |
|
| VAERS ID: |
403759 (history) |
| Form: |
Version 1.0 |
| Age: |
10.0 |
| Sex: |
Male |
| Location: |
New Jersey |
| Vaccinated: | 2010-09-09 |
| Onset: | 2010-09-17 |
| Days after vaccination: | 8 |
| Submitted: |
2010-10-15 |
| Days after onset: | 28 |
| Entered: |
2010-10-18 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HEPA: HEP A (VAQTA) / MERCK & CO. INC. |
0568Z / UNK |
RA / UN |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1778Y / UNK |
RA / UN |
| MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR |
UA3058AA / UNK |
LA / UN |
| TDAP: TDAP (ADACEL) / SANOFI PASTEUR |
C3476AA / UNK |
LA / UN |
Administered by: Unknown Purchased by: Private
Symptoms: Asthenia,
Death,
Malaise
SMQs:, Guillain-Barre syndrome (broad)
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 2010-09-20
Days after onset: 3
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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:
Write-up: Mother called me on 9-17-10 afternoon that her son is sick and feeling very weak. I recommended the mother to take him to nearest ER as the patient was about 50 miles away and mother took him to ER where he was transferred to another hospital. |
|
| VAERS ID: |
405821 (history) |
| Form: |
Version 1.0 |
| Age: |
15.0 |
| Sex: |
Male |
| Location: |
New Jersey |
| Vaccinated: | 2010-08-30 |
| Onset: | 2010-09-27 |
| Days after vaccination: | 28 |
| Submitted: |
2010-10-27 |
| Days after onset: | 30 |
| Entered: |
2010-10-28 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1333Y / 1 |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 2010-09-27
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR
Current Illness: Cardiac disorder; Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1010USA02704
Write-up: Information has been received from a physician concerning a 15 year old male with asthma and "cardiac history" (unspecified) who on 30-AUG-2010 was vaccinated with GARDASIL (Lot number 665607/1333Y). Concomitant therapy included LIPITOR. On 27-SEP-2010 the patient died while playing hockey. The physician reported "awaiting autopsy results". At the time of report no further information was available. The reporter considered death to be life-threatening. A lot check has been initiated. Additional information has been requested. |
|
| VAERS ID: |
405998 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2010-10-28 |
| Entered: |
2010-10-29 |
| 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: Unevaluable event
SMQs:
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES1010USA02400
Write-up: Information has been received from a physician who reported in a magazine article regarding Cervical Cancer and in the article physician stated that "GARDASIL has caused 70 young healthy girls to die right after receiving the vaccine due to neurological problems. CERVARIX is covering three other HPV strains and it has been proven." No further AE information filed. There was no specific patient information, physician information, or date of death for the 70 patients in the article. Neurological problems considered to be immediately life-threatening. 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. |
|
| VAERS ID: |
406289 (history) |
| Form: |
Version 1.0 |
| Age: |
19.0 |
| Sex: |
Female |
| Location: |
Michigan |
| Vaccinated: | 2010-08-06 |
| Onset: | 2010-08-19 |
| Days after vaccination: | 13 |
| Submitted: |
2010-11-02 |
| Days after onset: | 75 |
| Entered: |
2010-11-02 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0640Z / 2 |
LA / IM |
Administered by: Unknown Purchased by: Private
Symptoms: Grand mal convulsion,
Sudden death
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), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2010-08-19
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: seizure~HPV (Gardasil)~1~19.42~Patient
Other Medications:
Current Illness:
Preexisting Conditions: Autism
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: Patient had her first Gardasil shot on 02/15/2010. On 02/19/2010, she had a Grand Mal seizure. She had her 2nd shot on 08/06/2010. She died on 08/19/2010. Medical Examiner listed cause of death as Sudden unexpected death associated with Seizure Disorder. |
|
| VAERS ID: |
412247 (history) |
| Form: |
Version 1.0 |
| Age: |
14.0 |
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 2007-08-01 |
| Onset: | 0000-00-00 |
| Submitted: |
2010-12-07 |
| Entered: |
2010-12-08 |
| 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: Adverse event,
Convulsion,
Death,
Fatigue,
Hypoaesthesia,
Initial insomnia,
Mood altered,
Ovarian cyst,
Paraesthesia,
Respiratory arrest,
Syncope,
Urinary tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), 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), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES1012USA00781
Write-up: Information has been received from a physician via a consumer who provided the physician with a link to a forum. The information was received from the patient''s mother, from the link, concerning her healthy 14 year old daughter who in August 2007, January 2008, and June 2008, was vaccinated with a first, second and third dose of GARDASIL (lot # not provided). It was reported that the patient experienced several symptoms including numbness and tingling in her fingers and toes, fatigue, a really hard time falling asleep, urinary tract infections, ovarian cyst, moody, trouble getting out of bed and seizures. The patient had had upwards of 150 seizures following her third shot in June 2008. During her seizures she stopped breathing for periods of 30 to 40 seconds. The patient was diagnosed with Neurocardiogenic syndrome and seizures. It was reported that the patient died due to ovarian cyst. The reporter felt that the patient''s symptoms were related to vaccination with GARDASIL. Upon internal review, the seizures were considered to be other important medical events "seizures" as an other important medical event. No further information is available. |
|
| VAERS ID: |
412282 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2010-12-08 |
| Entered: |
2010-12-09 |
| 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: Unevaluable event
SMQs:
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? Yes
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: WAES1011USA03821
Write-up: Information has been received from a nurse practitioner, who mentioned a magazine''s article concerning 70 young female patients who, on an unspecified date, were vaccinated with a dose of GARDASIL (lot #, expire date and route not reported), 0.5 ml. On an unspecified date the patients died from "neurological causes" after being given GARDASIL. "Neurological disorders" were considered to be immediately life-threatening and disabling by the nurse practitioner. Additional information has been requested. This is one of two reports from the same source. Attempts are being made to verify the existence of identifiable patients. This is one of two reports from the same source. |
|
| VAERS ID: |
413697 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2010-12-28 |
| Entered: |
2010-12-29 |
| 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: Unevaluable event
SMQs:
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? Yes
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: WAES1012USA02761
Write-up: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the second dose of GARDASIL (lot number not provided). The physician was visiting his dentist and was talking to the dental hygienist about GARDASIL. The dental hygienist said she had a friend whose daughter died after getting the second dose of GARDASIL. It was unknown if the patient sought medical attention. The reporter considered death to be disabling and life-threatening. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, lot number, date of event, hospital name (if applicable), and healthcare provider name and contact information. Additional information has been requested. |
|
| VAERS ID: |
417137 (history) |
| Form: |
Version 1.0 |
| Age: |
17.0 |
| Sex: |
Female |
| Location: |
Tennessee |
| Vaccinated: | 2011-01-04 |
| Onset: | 2011-02-02 |
| Days after vaccination: | 29 |
| Submitted: |
2011-02-08 |
| Days after onset: | 6 |
| Entered: |
2011-02-18 |
| Days after submission: | 10 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0096Z / 2 |
RA / IM |
| MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR |
U3432AA / 1 |
LA / IM |
Administered by: Public Purchased by: Public
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2011-02-02
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NORINYL
Current Illness: none
Preexisting Conditions: Hay fever; Animal fur
Allergies:
Diagnostic Lab Data:
CDC Split Type: TN1101
Write-up: Patient deceased within 30 days of vaccine administration. |
|
| VAERS ID: |
419237 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2011-03-21 |
| Entered: |
2011-03-22 |
| 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: Unevaluable event
SMQs:
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES1103USA02079
Write-up: Information has been received from a website concerning thousands of other young girls who on unspecified dates were vaccinated with a dose of GARDASIL (lot # not reported). The girls have experienced "life-destroying side effects" or death following their HPV vaccines. Life-destroying side effects were considered to be immediately life-threatening. This is one of two reports from the same source. No further information is available. |
|
| VAERS ID: |
421582 (history) |
| Form: |
Version 1.0 |
| Age: |
17.0 |
| Sex: |
Male |
| Location: |
Unknown |
| Vaccinated: | 2010-11-01 |
| Onset: | 2010-11-01 |
| Days after vaccination: | 0 |
| Submitted: |
2011-04-21 |
| Days after onset: | 171 |
| Entered: |
2011-04-22 |
| 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: Death,
Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? Yes
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: WAES1104USA02226
Write-up: Information has been received from a nurse practitioner concerning a patient''s nephew, a 17 year old male consumer who she "thought" was vaccinated with a dose of GARDASIL (lot number not provided) in November 2010. The nurse practitioner stated that two weeks after the patient received the dose of GARDASIL, approximately November 2010 (also reported as "two weeks ago" on approximately 01-APR-2011), the patient died of sudden cardiac death on the lacrosse field. Unspecified medical treatment was given. It was unspecified if any lab diagnostic test were performed. The cause of death was sudden cardiac death. Sudden cardiac death was considered to be immediately life-threatening and disabling by the reporting nurse practitioner. Additional information has been requested. |
|
| VAERS ID: |
425513 (history) |
| Form: |
Version 1.0 |
| Age: |
18.0 |
| Sex: |
Female |
| Location: |
Idaho |
| Vaccinated: | 2011-04-26 |
| Onset: | 2011-04-28 |
| Days after vaccination: | 2 |
| Submitted: |
2011-04-29 |
| Days after onset: | 1 |
| Entered: |
2011-06-16 |
| Days after submission: | 48 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0886Z / 1 |
LA / IM |
| VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. |
1492Z / 2 |
RA / IM |
Administered by: Private Purchased by: Private
Symptoms: Completed suicide,
Death
SMQs:, Suicide/self-injury (narrow)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2011-04-28
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO CYCLEN
Current Illness: (1) Depression/chronic; (2) ADHD; (3) acne severe
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type:
Write-up: None known -suicidal ideation denied at visit 4/26 - known chronic depression she elected to stop her medications when she turned 18. Committed suicide 04/28/11. Hung herself. |
|
| VAERS ID: |
425598 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2011-06-16 |
| Entered: |
2011-06-17 |
| 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: Death,
Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES1106USA01652
Write-up: A consumer reported that he/she read an internet concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot # , dose and route not reported). On an unspecified date, the patient died of "clot blood" eight hours after vaccination. This is one of several reports from the same source. No further information is available. |
|
| VAERS ID: |
425680 (history) |
| Form: |
Version 1.0 |
| Age: |
17.0 |
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 2007-06-01 |
| Onset: | 2007-06-01 |
| Days after vaccination: | 0 |
| Submitted: |
2011-06-17 |
| Days after onset: | 1477 |
| Entered: |
2011-06-20 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / 1 |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death,
Loss of consciousness,
Resuscitation
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? Yes
Date died: 0000-00-00
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: WAES1106USA01650
Write-up: A consumer reported that he/she obtained the information from internet concerning a 17 years old woman who in June 2007 was vaccinated the first dose of GARDASIL. In the afternoon of the same day, in June 2007, the patient was found unconscious (without signs of life) by her mother. The doctor from the emergency crew attempted resuscitation, but without success. The cause of death was unspecified. This is one of several reports received from the same source. No further information is available. |
|
| VAERS ID: |
429007 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2011-08-05 |
| Entered: |
2011-08-08 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
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: WAES1108USA00348
Write-up: Information has been received from a consumer concerning her daughter who was vaccinated with GARDASIL. The consumer reported that he had nothing to live for because GARDASIL killed his daughter. It was unknown if the patient sought medical attention. No further information is available. |
|
| VAERS ID: |
430780 (history) |
| Form: |
Version 1.0 |
| Age: |
14.0 |
| Sex: |
Female |
| Location: |
California |
| Vaccinated: | 2011-03-28 |
| Onset: | 2011-04-11 |
| Days after vaccination: | 14 |
| Submitted: |
2011-08-23 |
| Days after onset: | 134 |
| Entered: |
2011-08-23 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR |
U3741AA / 1 |
LA / UN |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0565Z / 3 |
LA / UN |
Administered by: Public Purchased by: Public
Symptoms: Arrhythmia,
Autopsy,
Blood culture positive,
Body fluid analysis,
Cardiac failure,
Cardiomyopathy,
Death,
Drug screen negative,
Microscopy,
Streptococcus test positive,
Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2011-04-11
Days after onset: 0
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: Mildly overweight; concern for idiopathic scoliosis
Allergies:
Diagnostic Lab Data: Autopsy, including microscopy slides. Heart blood culture showed alpha streptococcus (not Strep. pneumoniae, not enterococcus sp., not Strep. bovis). Femoral blood and vitreous humor samples showed no drugs on complete drug screen. Vitreous panel (Glucose - 32 mg/dL, Sodium - 137 mmol/L, Potassium - 15.2 mmol/L, Chloride - 124 mmol/L, Urea Nitrogen 13 mg/dL and Creatinine - 1.3 mg/dL)
CDC Split Type:
Write-up: Found dead in bed in a.m. by family. Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy. Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death. |
|
| VAERS ID: |
437735 (history) |
| Form: |
Version 1.0 |
| Age: |
18.0 |
| Sex: |
Female |
| Location: |
Massachusetts |
| Vaccinated: | 2011-01-07 |
| Onset: | 2011-04-01 |
| Days after vaccination: | 84 |
| Submitted: |
2011-10-11 |
| Days after onset: | 193 |
| Entered: |
2011-10-11 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / 2 |
- / IM |
Administered by: Unknown Purchased by: Other
Symptoms: Condition aggravated,
Death,
Differential white blood cell count normal,
Ecchymosis,
Haematocrit normal,
Haemoglobin normal,
Haemorrhage intracranial,
Idiopathic thrombocytopenic purpura,
Mean cell volume normal,
Petechiae,
Platelet count decreased,
Red blood cell morphology normal,
White blood cell count normal
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2011-07-06
Days after onset: 96
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: Immune thrombocytopenic purpura, diagnosed in 1995 and in remission from 2004 to 2011 following treatment with Rituximab in 2004.
Allergies:
Diagnostic Lab Data: Petechiae and ecchymoses noted by patient and family in early April (exact date not known). CBC on 04/26/2011 included platelet count 5000; WBC 5.4 with normal differential, Hgb 12.8, Hct 37.2, MCV 87.9; normal RBC morphology.
CDC Split Type:
Write-up: Relapse of ITP: 18 year-old female with immune thrombocytopenic purpura, diagnosed in 1995 and in remission from 2004 to 2011 following treatment with Rituximab. Relapse in early April, 2011, followed administration of Gardasil vaccine on 10-26-10 and 1-7-11. Relapse of ITP led eventually to death from intracranial hemorrhage on 07/06/2011. |
|
| VAERS ID: |
437999 (history) |
| Form: |
Version 1.0 |
| Age: |
18.0 |
| Sex: |
Male |
| Location: |
Ohio |
| Vaccinated: | 2011-07-22 |
| Onset: | 2011-07-27 |
| Days after vaccination: | 5 |
| Submitted: |
2011-10-12 |
| Days after onset: | 77 |
| Entered: |
2011-10-13 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HEPA: HEP A (VAQTA) / MERCK & CO. INC. |
0126AA / UNK |
UN / UN |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0841AA / 2 |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Asphyxia,
Completed suicide,
Death,
Drug screen negative,
Toxicologic test normal
SMQs:, Suicide/self-injury (narrow), Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2011-07-27
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SEPTRA
Current Illness: Acne
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: diagnostic laboratory, ?/?/11, toxic screen indicated that there were no medications involved in the patient''s death.
CDC Split Type: WAES1110USA00917
Write-up: Information has been received from a physician concerning an 18 year old male patient with acne and no drug allergy or reaction who on 16-MAY-2011 was vaccinated with the first dose of GARDASIL (Lot number 668554/0306AA; Expired date: 10-MAY-2013) and a dose of VAQTA (Lot number: 670377/0126AA; Expired date: 07-DEC-2013, dose in series unknown). On 22-JUL-2011, the patient received the second dose of GARDASIL (Lot number 668262/0841AA; Expired date: 18-APR-2013). Concomitant therapy included SEPTRA. Follow up phone call from the physician was received. The physician reported that the patient had no medical history. The last time he saw the patient was on 22-JUL-2011, when the patient received his second dose of GARDASIL. The physician also reported that there was no indication from the patient that he was troubled. On 27-JUL-2011 the patient committed suicide. The cause of death was asphyxiation by hanging. The death report that the physician received was that the patient had a normal examination. The Toxic screen indicated that there were no medications involved in the patient''s death. The patient''s mother had asked the physician if GARDASIL could have caused her son to commit suicide. The physician reported to the patient''s mother that he did not feel that GARDASIL was the cause of her son''s suicide. The physician stated that he was not aware of any reported deaths by suicide that were related to GARDASIL. Lot checks have been initiated for 668554/0306AA, 668262/0841AA for GARDASIL and 670377/0126AA for VAQTA. Additional information has been requested. |
|
| VAERS ID: |
442402 (history) |
| Form: |
Version 1.0 |
| Age: |
15.0 |
| Sex: |
Male |
| Location: |
Oregon |
| Vaccinated: | 2011-10-17 |
| Onset: | 2011-10-17 |
| Days after vaccination: | 0 |
| Submitted: |
2011-11-14 |
| Days after onset: | 28 |
| Entered: |
2011-11-14 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1262AA / UNK |
RA / IM |
| MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR |
U4006AA / UNK |
RA / IM |
| TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS |
AC52B072EA / UNK |
RA / IM |
Administered by: Private Purchased by: Public
Symptoms: Death,
Pain,
Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2011-10-20
Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Depakote, Lyrica, Diazapam, Adderall
Current Illness: No
Preexisting Conditions: Seizure Disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: Initial soreness and swelling. Death 10/20/2011. |
|
| VAERS ID: |
449334 (history) |
| Form: |
Version 1.0 |
| Age: |
19.0 |
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 2009-01-01 |
| Onset: | 2011-08-27 |
| Days after vaccination: | 968 |
| Submitted: |
2012-02-09 |
| Days after onset: | 166 |
| Entered: |
2012-02-10 |
| 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: Amyotrophic lateral sclerosis,
Death,
Gene mutation identification test positive
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2011-08-27
Days after onset: 0
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: Gene mutation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: diagnostic laboratory, genetic mutation (FUS): positive
CDC Split Type: WAES1202USA00710
Write-up: Information has been received from a physician concerning a 19 year old female who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported, dose number unknown). Approximately a year and a half prior to developing the onset of rapidly progressive ALS (amyotrophic lateral sclerosis). It was unknown if the patient was on any medications or had concomitant vaccinations. Patient died within a year of symptom onset. Patient was found to be positive for a genetic mutation (FUS) recently recognized as associated with early-onset, rapidly progressive ALS. Her parents also had the mutation. It was not reported if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested. |
|
| VAERS ID: |
450655 (history) |
| Form: |
Version 1.0 |
| Age: |
12.0 |
| Sex: |
Female |
| Location: |
Michigan |
| Vaccinated: | 2012-02-23 |
| Onset: | 0000-00-00 |
| Submitted: |
2012-02-27 |
| Entered: |
2012-02-28 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HEPA: HEP A (VAQTA) / MERCK & CO. INC. |
1441AA / 2 |
LA / IM |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1495AA / 3 |
LA / IM |
Administered by: Private Purchased by: Private
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2012-02-26
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:
CDC Split Type:
Write-up: None at time of service. Pt. expired 2-26-12. |
|
| VAERS ID: |
451701 (history) |
| Form: |
Version 1.0 |
| Age: |
30.0 |
| Sex: |
Female |
| Location: |
Maryland |
| Vaccinated: | 2011-03-25 |
| Onset: | 2011-06-05 |
| Days after vaccination: | 72 |
| Submitted: |
2012-03-12 |
| Days after onset: | 281 |
| Entered: |
2012-03-14 |
| Days after submission: | 2 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AHPVA102AB / 2 |
LA / UN |
Administered by: Other Purchased by: Other
Symptoms: Abdominal pain,
Exploratory operation,
Hepatic mass,
Hepatic neoplasm malignant non-resectable,
Jaundice,
Laboratory test,
Laparotomy,
Nausea,
Palliative care,
Pruritus generalised,
Terminal state,
Ultrasound abdomen abnormal,
Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Liver malignant tumours (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2011-12-24
Days after onset: 202
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: On 8/30/2011 subject reported by phone that she had started on 6/5/2011 with diffuse abdominal pain of moderate-to-severe intensity, nausea, vomits, generalized pruritus, and jaundice. Abdominal sonogram on 7/22/2011 showed a mass in the liver. Local hospital admission (7/23/2011) and testing led to referral to national hospital and exploratory laparotomy (8/8/2011), and discovery of liver tumor (5 cm diameter) in the portal vein bifurcation with infiltration of the extrahepatic bile duct. Tumor was unremovable. She was discharged 8/11/2011 with treatment against pruritus and referral to Oncology (appt 9/7/2011). On 12/22/2011 subject was in terminal phase, receiving palliative care at home; diagnosis was liver cancer. |
|
| VAERS ID: |
451703 (history) |
| Form: |
Version 1.0 |
| Age: |
28.0 |
| Sex: |
Female |
| Location: |
Maryland |
| Vaccinated: | 2005-02-16 |
| Onset: | 2010-06-03 |
| Days after vaccination: | 1933 |
| Submitted: |
2012-03-12 |
| Days after onset: | 648 |
| Entered: |
2012-03-14 |
| Days after submission: | 2 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS |
VX10787 / 3 |
LA / UN |
Administered by: Other Purchased by: Other
Symptoms: Chemotherapy,
Colitis,
Hysterectomy,
Mass excision,
Metastasis,
Ovarian cancer stage III,
Ovarian disorder,
Pelvic discomfort,
Pelvic pain,
Stomach mass,
Ultrasound ovary abnormal
SMQs:, Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Ovarian malignant tumours (narrow), Uterine and fallopian tube tumours of unspecified malignancy (broad), Noninfectious diarrhoea (broad), Non-haematological malignant tumours (narrow), Immune-mediated/autoimmune disorders (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2011-10-23
Days after onset: 507
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: Between June-August 2010, subject started with pain/discomfort in pelvic region. She consulted her local primary care center and was diagnosed and treated for colitis. After symptomology progressively worsened she was given a sonogram (8/25/2010) that showed "shadows on ovaries". Following readmission (8/30/2010), surgeons on 9/1/2010 removed a mass apparently started in the stomach; they told subject''s sister it was invasive cancer. Hospital admission and multiple chemotherapy courses took place in 9/2010 and 10/2010, then total hysterectomy (1/28/2011) and more chemo (5/2011). On 6/22/2011 she was admitted with diagnosis of ovarian cancer stage III C. Was taking Hyoscine, methadone, and bisacodyl as necessary. |
|
| VAERS ID: |
453010 (history) |
| Form: |
Version 1.0 |
| Age: |
16.0 |
| Sex: |
Female |
| Location: |
Kentucky |
| Vaccinated: | 2012-03-20 |
| Onset: | 2012-03-29 |
| Days after vaccination: | 9 |
| Submitted: |
2012-04-04 |
| Days after onset: | 6 |
| Entered: |
2012-04-04 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0692AA / 2 |
RA / IM |
Administered by: Private Purchased by: Public
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2012-03-29
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Loestrin 1/20mg one daily. Cetraxal 0.2% solution 2 drops bid for 7 days
Current Illness: none
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: Undetermined cause death occurred nine days after 2nd injection of Gardasil. 1st dose on 01/31/2012. |
|
| VAERS ID: |
457904 (history) |
| Form: |
Version 1.0 |
| Age: |
14.0 |
| Sex: |
Male |
| Location: |
Wisconsin |
| Vaccinated: | 2012-06-04 |
| Onset: | 2012-06-07 |
| Days after vaccination: | 3 |
| Submitted: |
2012-06-21 |
| Days after onset: | 14 |
| Entered: |
2012-06-22 |
| Days after submission: | 1 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1224AA / 2 |
LA / IM |
Administered by: Other Purchased by: Other
Symptoms: Completed suicide,
Death,
Gun shot wound
SMQs:, Suicide/self-injury (narrow), Accidents and injuries (narrow), Hostility/aggression (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2012-06-07
Days after onset: 0
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: Unknown
CDC Split Type: WAES1206USA02932
Write-up: Information has been received from a physician concerning a 14 year old male with no pertinent medical history and no drug allergies who was vaccinated intramuscularly with the first and second 0.5ml dose of GARDASIL (Lot# not reported) respectively on 02-APR-2012 and 04-JUN-2012. There was no concomitant medication. On 07-JUN-2012 the patient committed suicide. He shot himself in head. Physician stated this young male was happy go lucky, healthy, and never had any psychiatric issues in the past. It was not known if the patient sought for medical attention. On 07-JUN-2012 the patient died of suicide. Additional information has been requested. |
|
| VAERS ID: |
464953 (history) |
| Form: |
Version 1.0 |
| Age: |
19.0 |
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2012-09-13 |
| Entered: |
2012-09-13 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / 1 |
UN / SYR |
Administered by: Military Purchased by: Other
Symptoms: Central nervous system infection,
Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA003315
Write-up: Information has been received from a receptionist of the registered nurse, concerning rumor going around that a 19 years old girl who on an unspecified date received the first shot of GARDASIL (dose, route and lot # not reported), developed a brain infection, and passed away. The patient died this summer, June/July 2012. The reporter was not even 100% sure if the patient had had the GARDASIL shot because the nurses found that there was no record of the patient in local registry for GARDASIL patients. They were assuming that she was vaccinated out of state because she had joined the military (unspecified). The patient might have gotten vaccinated by the military. Another part of the rumor that was going around was that "the girl was fine one day, not the next, and it must be the GARDASIL shot that did this". The time from receiving the GARDASIL shot to the time of her death was unknown. It was unknown if she had any adverse experience from the GARDASIL or if it caused the brain infection. Additional information has been requested. |
|
| VAERS ID: |
471590 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Unknown |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2012-10-26 |
| Entered: |
2012-10-26 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA012210
Write-up: This spontaneous report as received from a consumer, who learned from a foreign radio channel of fatal cases after GARDASIL vaccination in one country (1210USA012211) and a second country (2 fatal cases, 1210HKG011628) and in a third country (3 fatal cases, this case). The reporter himself experienced serious adverse events (1210HKG011385). This report refers to three patients of unknown age. The patients were vaccinated with GARDASIL (date and route of administration not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients died. No details for death are available. The relatedness for death is unknown for GARDASIL. Additional information has been requested. |
|
| VAERS ID: |
482344 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2013-01-23 |
| Entered: |
2013-01-23 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1301USA010664
Write-up: This spontaneous report as received via social media refers to a female patient of unknown age, who on an unspecified date was vaccinated with a dose of GARDASIL (dose and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The other reported that the patient died after vaccination. The relatedness for the adverse event was unknown for GARDASIL. This is one of the several reports from the same source. Additional information is not expected. |
|
| VAERS ID: |
482352 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2013-01-23 |
| Entered: |
2013-01-23 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1301USA010666
Write-up: This spontaneous report as received via social media who reported multiple patients (unknown age and gender) who on an unspecified date were vaccinated with a dose of GARDASIL (dose and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that on an unspecified date, the patients died from the vaccine. No treatment information was reported. At the time of the report, the patients outcome for the adverse event was fatal. The relatedness for the adverse event was related for GARDASIL. This is one of the several reports from the same source. Additional information is not expected. |
|
| VAERS ID: |
485188 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Unknown |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2013-02-21 |
| Entered: |
2013-02-21 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1302USA006176
Write-up: This spontaneous report as received from internet referred to three patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL (Lot#, dose/frequency, route and duration were unspecified). Then on an unknown date the patients died (three deaths have been reported along with more reports of paralysis in girls who had gotten the poorly tested HPV vaccine). The date and cause of death were not reported. It was unknown whether autopsy was done. This is one of several reports that received from the same source. Additional information has been requested. |
|
| VAERS ID: |
485757 (history) |
| Form: |
Version 1.0 |
| Age: |
11.0 |
| Sex: |
Female |
| Location: |
New York |
| Vaccinated: | 2013-02-19 |
| Onset: | 2013-02-19 |
| Days after vaccination: | 0 |
| Submitted: |
2013-02-25 |
| Days after onset: | 6 |
| Entered: |
2013-02-28 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS |
AHAVB677CA / UNK |
UN / UN |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
H016238 / UNK |
UN / UN |
| MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR |
U42927 / UNK |
UN / UN |
| TDAP: TDAP (ADACEL) / SANOFI PASTEUR |
U4431BA / UNK |
UN / UN |
Administered by: Private Purchased by: Unknown
Symptoms: Cardiac arrest,
Crying,
Death,
Endotracheal intubation,
Respiratory arrest,
Skin discolouration
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2013-02-20
Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DILANTIN; Phenobarb
Current Illness: Medical record - cough - resp sym x 5 days (doc denies)
Preexisting Conditions: Microcephaly; seizure
Allergies:
Diagnostic Lab Data: See reverse
CDC Split Type:
Write-up: 2/19/13 23:24 Pt brought in by ambulance in cardiac arrest, "mother states pt has been having cough & URI symptoms since 5 days - seen by doctor 2/19/13 & given 4 vaccines. Pt sleeping & crying - suddenly pt turned white & was not breathing - 911 called & intubated. Doctor states he was not aware of any illness & child''s DILANTIN level was 1.0. No lab found in medical record child revived & transfer to another hospital where child died on 2/20/13. |
|
| VAERS ID: |
489163 (history) |
| Form: |
Version 1.0 |
| Age: |
0.2 |
| Sex: |
Unknown |
| Location: |
Virginia |
| Vaccinated: | 0000-00-00 |
| Onset: | 2013-01-25 |
| Submitted: |
2013-04-15 |
| Days after onset: | 79 |
| Entered: |
2013-04-15 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / 2 |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death,
Foetal exposure during pregnancy,
Toxicologic test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2013-01-25
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1304USA006581
Write-up: Information has been received from a mother for GARDASIL, a Pregnancy Registry product, concerning her 8 week old baby. On an unknown date in December 2011 the mother was vaccinated with the first dose of GARDASIL (lot number 0626AA) (dose, route and injection site were not reported). On 28-FEB-2012, the mother was vaccinated with the second dose of GARDASIL (lot number, dose, route and injection site were not reported). On 23-MAR-2012 the mother found she was pregnant and on 26-NOV-2012 she delivered the infant. The baby was born on 26-NOV-2012, and died on 25-JAN-2013. Toxicology tests are being run to see the cause of death. The action taken and causality of death was not provided. The mother''s information was captured in MARRS # 1304USA006478 (Parent-Child Link). Additional information is not expected. |
|
| VAERS ID: |
492468 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2013-05-24 |
| Entered: |
2013-05-24 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1305USA013443
Write-up: This spontaneous report as received from a female consumer via company representative who refers to her niece. On an unknown date the patient was vaccinated with GARDASIL (route, dose, number of doses, lot# not reported). As was reported that on an unknown date the patient died from complications while using GARDASIL. No more information were provided. Additional information has been requested. |
|
| VAERS ID: |
494024 (history) |
| Form: |
Version 1.0 |
| Age: |
18.0 |
| Sex: |
Male |
| Location: |
Texas |
| Vaccinated: | 2012-01-25 |
| Onset: | 2012-01-25 |
| Days after vaccination: | 0 |
| Submitted: |
2013-06-12 |
| Days after onset: | 503 |
| Entered: |
2013-06-12 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
1397AA / 1 |
LA / IM |
| MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR |
U4032AA / 2 |
LA / IM |
Administered by: Public Purchased by: Public
Symptoms: Cerebral haemorrhage,
Coma,
Death,
Haematemesis,
Injection site bruising,
Leukaemia,
Oropharyngeal pain,
Pyrexia,
Unresponsive to stimuli
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2012-02-10
Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: None known
Current Illness: None known
Preexisting Conditions: None known
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: On 1/25/2012, as per mother patient developed a black bruise to the left upper arm where vaccines had been administered that covered most of the entire upper arm. On February 1, 2012, he developed a sore throat and fever that lasted a week. On February 7, 2012 at 11 am he reported to hospital. As per mother, patient was non-responsive and was throwing up blood-tinged saliva. He was flown out due to an internal hemorrhage. He was admitted to hospital at around 3 pm. After admission, he remained unresponsive. As per mother, the internal cerebral hemorrhage was too advanced and the patient was not a candidate for surgery so patient eventually became comatose. He passed away on 2/10/2012 at 2 am. Final diagnosis was cerebral hemorrhage and leukemia. As per parent, the client had no previous history of illnesses at the time of vaccination on 1/25/2012. |
|
| VAERS ID: |
495540 (history) |
| Form: |
Version 1.0 |
| Age: |
31.0 |
| Sex: |
Female |
| Location: |
Maryland |
| Vaccinated: | 2006-05-02 |
| Onset: | 2012-09-25 |
| Days after vaccination: | 2338 |
| Submitted: |
2013-06-28 |
| Days after onset: | 276 |
| Entered: |
2013-06-28 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS |
VX17027 / 1 |
LA / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2012-09-25
Days after onset: 0
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: Subject was enrolled in Vaccine Trial and received 3 doses of CERVARIX. Following closeout from CVT in 12/17/2010, patient continued in Extended Follow-up Study (since 8/1/2011). At study visit on 6/21/2013, parents-in-law of patient reported she passed away at home on 9/25/2012. Patient has hx of severe dilated cardiomyopathy starting in 2008, and suffered severe respiratory illnesses and a stroke in 2010 and 2011, respectively. Cause of death was believed to be related to her underlying heart condition and not related to vaccination. |
|
| VAERS ID: |
500225 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Unknown |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2013-08-23 |
| Entered: |
2013-08-23 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Convulsion,
Loss of consciousness,
Seizure like phenomena
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? Yes
Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308USA010574
Write-up: This spontaneous report as received from a consumer''s mother refers to a patient of unknown age. The reporter''s daughter experienced seizure-like reaction, the patient convulsed for "2-3 seconds" and then "passed out" for a "few seconds" after receiving first dose of GARDASIL. (Captured in case 1308USA009926). The patient''s mother called the office after her child''s reaction and stated that she has done some research (source unknown) and found out that seizure-like reaction was common after GARDASIL administration and she also found from her research that someone has died from GARDASIL reaction and was concerned. In this unconfirmed AE report was reported on an unknown date this patient was vaccinated with GARDASIL (dosing information and route are unknown). On an unknown date this patient experienced GARDASIL reaction. The outcome of GARDASIL reaction was reported as fatal. No reporter causality provided. No consent to contact physician. Additional information is not expected. |
|
| VAERS ID: |
501081 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 2013-08-22 |
| Onset: | 2013-08-25 |
| Days after vaccination: | 3 |
| Submitted: |
2013-08-30 |
| Days after onset: | 5 |
| Entered: |
2013-08-30 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 2013-08-25
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308USA014250
Write-up: This spontaneous report as received from a health care worker refers to a female patient of unknown age. On 22-AUG-2013 the patient was vaccinated with a dose of GARDASIL (dose, route, lot number not provided). On 25-AUG-2013 the patient was found dead in her dorm room. The cause of dead had not been specified. Additional information has been requested. |
|
| VAERS ID: |
501663 (history) |
| Form: |
Version 1.0 |
| Age: |
17.0 |
| Sex: |
Female |
| Location: |
Michigan |
| Vaccinated: | 2013-08-09 |
| Onset: | 2013-08-22 |
| Days after vaccination: | 13 |
| Submitted: |
2013-08-30 |
| Days after onset: | 8 |
| Entered: |
2013-09-06 |
| Days after submission: | 7 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
H020848 / 1 |
UN / IM |
| MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR |
U4584BA / 2 |
UN / IM |
Administered by: Unknown Purchased by: Unknown
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2013-08-22
Days after onset: 0
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: No known allergies.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201309264
Write-up: Initial report was received 26 August 2013 from a health care professional. A 17-year-old female patient with no known allergies had received a second dose intramuscular injection of MENACTRA, lot number U4584BA and a first dose intramuscular injection of GARDASIL (manufacturer Merck, lot number H020848) (sites of administration not reported) on 09 August 2013, and 13 days later on 22 August 2013, the patient died. There was no contact with the physician after MENACTRA had been given. The patient had previously received a first dose injection of MENACTRA on 04 September 2008. The reporter had been contacted by the county medical examiner who informed the reporter about the death and requested the patient''s medical history. The reporter contacted the CDC (Centers for Disease Control and Prevention) who told them to call and report the event to VAERS. No additional information was provided at the time of the report. Documents held by sender: None. |
|
| VAERS ID: |
505344 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2013-10-02 |
| Entered: |
2013-10-02 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310USA000561
Write-up: Information has been received from a consumer via a website concerning a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot#, dose, and route not provided). On an unknown date, the patient died in her shower. The patient was so healthy prior to the vaccination. The post mortem result stated cause of death unknown. This is one of several reports received from the same source. Additional information has been requested. |
|
| VAERS ID: |
505350 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2013-10-02 |
| Entered: |
2013-10-02 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / 3 |
UN / SYR |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310USA000491
Write-up: Information has been received from a consumer via a website concerning a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot#, dose, and route not provided). On an unknown date, the patient died 40 hours after her third shot of GARDASIL. The patient had been so healthy prior to the vaccination. The post mortem result stated cause of death unknown. This is one of several reports received from the same source. Additional information has been requested. |
|
| VAERS ID: |
505364 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2013-10-02 |
| Entered: |
2013-10-02 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310USA000562
Write-up: Information has been received from a consumer via a website concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (lot#, dose, and route not provided). On unknown date, the patient died in her bath. The patient had been so healthy prior to the vaccination. The post mortem result stated a cause of death unknown. Additional information has been requested. |
|
| VAERS ID: |
510130 (history) |
| Form: |
Version 1.0 |
| Age: |
14.0 |
| Sex: |
Male |
| Location: |
California |
| Vaccinated: | 2013-08-19 |
| Onset: | 2013-08-20 |
| Days after vaccination: | 1 |
| Submitted: |
2013-10-26 |
| Days after onset: | 67 |
| Entered: |
2013-10-29 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
H020062 / 2 |
LA / IM |
Administered by: Private Purchased by: Private
Symptoms: Autopsy,
Cardiac arrest,
Death,
Myocarditis,
Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2013-08-20
Days after onset: 0
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: Autopsy.
CDC Split Type:
Write-up: Victim was found unresponsive/cardiac arrest in bed at home in the morning of 8/20/13. Autopsy showed cause of death was myocarditis. |
|
| VAERS ID: |
511528 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2013-11-06 |
| Entered: |
2013-11-06 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Acute hepatic failure,
Death
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311USA000822
Write-up: This spontaneous report as received from a consumer via a twitter refers to his/her daughter of unknown age. On an unknown date the patient was vaccinated with GARDASIL, reported as "Merck HPV vaccine" (dose, frequency, route, lot# and expiration date unknown). On an unknown date the perfectly healthy patient died 2 weeks after vaccine acute liver failure. The reporter considered the vaccine murdered his/her daughter. Upon internal review, vaccine acute liver failure was considered to be medically significant. Additional information has been requested. |
|
| VAERS ID: |
513554 (history) |
| Form: |
Version 1.0 |
| Age: |
14.0 |
| Sex: |
Female |
| Location: |
Minnesota |
| Vaccinated: | 2012-08-31 |
| Onset: | 2012-12-20 |
| Days after vaccination: | 111 |
| Submitted: |
2013-11-15 |
| Days after onset: | 330 |
| Entered: |
2013-11-18 |
| Days after submission: | 3 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. |
AJ2024 / 5 |
NS / IN |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
H010649 / 2 |
LA / IM |
Administered by: Other Purchased by: Other
Symptoms: Cardiopulmonary bypass,
Death,
Dyspnoea,
Influenza,
Oropharyngeal pain,
Pulmonary oedema,
Pyrexia,
Transfusion,
Wheezing
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)
Life Threatening? Yes
Birth Defect? No
Died? Yes
Date died: 2013-01-08
Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: 2013SA114788
Write-up: Initial report was received on 07 November 2013 from a nonhealth care provider from an unverified internet source. A 14 year-old female patient (date of birth not reported) had received on an unspecified date in August 2012 a Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and five months later on 08 January 2013 "died from complications of infection with Influenza Type A". The patient was evaluated at and urgent care with a bad sore throat, treated with Prednisone and was sent home. The sore throat evolved into a serious fever that included shortness of breath and wheezing. The patient''s lungs filled with fluid and was hospitalized. The patient had a heart and lung bypass with an "ACMO" machine and blood transfusions. Diagnostic and laboratory testing were not reported. The patient''s outcome was fatal. Documents held by sender: none. |
|
| VAERS ID: |
513728 (history) |
| Form: |
Version 1.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2013-11-19 |
| Entered: |
2013-11-19 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / SYR |
Administered by: Other Purchased by: Other
Symptoms: Death
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311USA007759
Write-up: This spontaneous report as received from a consumer (patients mother) via an unspecified person from an Immunization Coalition and company representative refers to a female patient of unknown age. No information regarding the patients medical history was provided. On an unknown date the patient was vaccinated with GARDASIL injection. Dose and route of administration were not provided. No concomitant medication was reported. In the email from the Immunization Coalition was stated that an unspecified mother claimed that her daughter died in 2008 as a result of GARDASIL. Additional information has been requested. |
|
| VAERS ID: |
514814 (history) |
| Form: |
Version 1.0 |
| Age: |
20.0 |
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
2013-11-26 |
| Entered: |
2013-11-26 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / 3 |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Death,
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? Yes
Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311USA011110
Write-up: This spontaneous report as from an other via social media who obtained the information from a campaign against the HPV vaccine and released a video, who reported that a 20 year old female patient prior to receiving GARDASIL was healthy, vibrant and fun-loving. It was reported that the patient''s physician gave her all the right reasons to receive GARDASOL. On an unknown date, was vaccinated with a dose of GARDASIL (dose and route not reported). Prior to receiving GARDASIL there was no mention of GARDASIL side effects. On an unspecified date, the patient began fainting and days later was found dead in bed. It was reported that it was no coincidence that the patient died after receiving GARDASIL. This is one of several reports received from the same source. No further information is available. |
|
| VAERS ID: |
515434 (history) |
| Form: |
Version 1.0 |
| Age: |
16.0 |
| Sex: |
Male |
| Location: |
Louisiana |
| Vaccinated: | 2013-05-23 |
| Onset: | 2013-07-04 |
| Days after vaccination: | 42 |
| Submitted: |
2013-12-03 |
| Days after onset: | 152 |
| Entered: |
2013-12-03 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
H016238 / 1 |
LA / IM |
Administered by: Private Purchased by: Unknown
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2013-07-04
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALBUTEROL
Current Illness: No illnesses at time of vaccination
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: Sudden death. He was perfectly healthy. This vaccination is the only thing I can think of that would have caused this. Everything else in his life was normal, the same. |
|
| VAERS ID: |
518872 (history) |
| Form: |
Version 1.0 |
| Age: |
15.0 |
| Sex: |
Female |
| Location: |
Michigan |
| Vaccinated: | 2013-11-21 |
| Onset: | 2014-01-04 |
| Days after vaccination: | 44 |
| Submitted: |
2014-01-10 |
| Days after onset: | 6 |
| Entered: |
2014-01-10 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. |
BJ2156 / 2 |
NS / IN |
| HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
J007354 / 3 |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Autopsy,
Death,
Headache
SMQs:
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2014-01-04
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERALL XR; CELEXA
Current Illness: Anxiety; Attention deficit/hyperactivity disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA002324
Write-up: This spontaneous report as received from nurse refers to a 14 year old female patient with attention deficit disorder and anxiety and with no drug reaction or allergies. On 14-JUL-2011 the patient was vaccinated with first dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided), on 25-JUL-2012 patient received second dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided) and on 21-NOV-2013 patient received third dose of recalled GARDASIL (lot number: J007354, expiration date 20-FEB-2016) (dose and route of administration were not provided). Secondary suspect therapy included FLUMIST which was given on 21-NOV-2013. Concomitant therapies included ADDERALL XR and CELEXA. It was reported that patient complained of headache on 04-JAN-2014 and she went to bed early that night. It was reported that "she never woke up". Patient died on 04-JAN-2014. Nurse has not been informed of the autopsy result so she could not determinate cause of death. Lab diagnostic studies were not performed. It was also reported that approximately 27 doses of the recalled lot of GARDASIL were also administered at reporter''s facility but she has not heard of any other adverse effects. The outcome of headache was unknown. The relatedness between death, headache and GARDASIL was unknown. Additional information has been requested. |
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