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This is VAERS ID 502329

Case Details

VAERS ID: 502329 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-05
Onset:2013-05-08
   Days after vaccination:3
Submitted: 2013-09-12
   Days after onset:127
Entered: 2013-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Death, Neurological decompensation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-05-08
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309COL004119

Write-up: This spontaneous report as received from a regulatory authority (AE13CO0200) refers to an 11 year old female patient. On 05-MAY-2013 the patient was vaccinated with her first and only dose of GARDASIL, 0.5 ml, intramuscular (site and lot number not provided). Three days after, on 08-MAY-2013, the patient experienced fever, seizures, neurological deterioration and death. The outcome of seizures, fever and neurological deterioration was reported as fatal. The cause of death was not reported. According to the investigation performed by the regulatory authority, the patient was healthy previous to the vaccination; the events were experienced only after the vaccination. No evidences of external issues as the cause of the events were found. As additional information, no samples of cerebrospinal fluid were taken (in order to discard meningitis). The causal relationship was not reported. Upon internal review, seizures was medically significant. Additional information has been requested.


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