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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Case received from Health Authorities on 10-MAY-2011 under the reference number L201102-356. Case medically confirmed. A 12-year-old female patient had received the second dose of GARDASIL (batch n.NM14120, lot n. NJ51180 in left deltoid area) via intramuscular route at 12:00 on 11-APR-2011 and in the same day, at 17:00 the patient experienced nausea, dizziness, headache and somnolence that resolved on 12-APR-2011. No relevant clinical history known. Family history: uncle with epilepsy. The patient had previous history of AE to the vaccine against the pandemic flu (manufacturer unknown) on 21-DEC-2009 with vomiting, tremor, fainting and prostration. The patient had also received H1N1 like virus on 21-DEC-2010 via intramuscular route for prophylaxis. The patient had received the first dose of GARDASIL (batch n.NM14120, lot n. NJ51180 in left deltoid area) via intramuscular route on 02-FEB-2011 and post-vaccination the patient presented with lipothymy during seconds, tremor during minutes and vomiting (food content) without other manifestations. The AEs also included prostration during about 1 hour (see case E2011-01255 (WAES #1102USA03388). The patient had fully recovered. Case is closed. the events were considered to be disabling. Other business partner numbers include E2011-02916. No further information is available.
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