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Administered by: Other Purchased by: Other
Life Threatening? No
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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