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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: Information has been received from Sanofi Pasteur MSD (E2013-10704) on 11-DEC-2013. Case was received from a non health care professional via the Health Authorities in a foreign country on 11-DEC-2013 under the reference MPA-2013-000265. Case is not medically confirmed. Primary source was a consumer. A 15-year-old female patient with no medical history reported, had received the unspecified dose number in series of GARDASIL (batch number not reported) via not reported route and site of administration on 15-Feb-2009. On 27-Apr-2009, the patient developed weakness of limbs. On 03-Nov-2009, the patient developed nightly hallucinations and cramps. The patient had also received the unspecified dose number in series of GARDASIL (batch number not reported) via not reported route and site of administration on 03-09-2010 (contradictory: HA mentioned 03-Sep-2013 in the narrative). On 01-Jan-2011, the patient additionally developed fully developed epileptic seizures. The patient was hospitalised. The patient reported "feels like I am falling. I try to scream but cannot open my mouth." "During the seizure I develop foaming at the mouth, has urine output, bite my tongue and hallucinate." The day after she was very tired and suffered from flu-like symptoms. She was treated with lamotrigine (Other MFR) due to the events. It was unknown how many doses of GARDASIL she had received. Upon medical review the company judged relevant to code the following adverse events: tiredness and flu-like symptoms which were not reported. According to the HA, the events were possibly related to the vaccination. The case was regarded serious by the consumer, because of hospitalization, life threatening reaction and continuing disability.
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