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Life Threatening? No
Write-up: Information has been received from SPMSD (IE-1577272925-E2013-09803) on 26-NOV-2013. This cases was received from health authority in a foreign country on 21-Nov-2013. IMB REF 2013-018774. The case is medically confirmed. A 13 year old female patient, received a third dose of GARDASIL (batch number not reported) by intramuscular route, site of administration not reported and an injection of BOOSTRIX (batch number AC37B062AQ) by intramuscular route, dose in series and site of administration not reported, on 21-MAR-2012. On 28-MAR-2012, several days after vaccination, the patient collapsed and was subsequently diagnosed with myalgic encephalomyelitis with severe symptoms. The patient attended hospital for ongoing management and has had extensive investigations (no results reported). The patient previously received a first dose of GARDASIL (batch number not reported), by intramuscular route, site of administration not reported, on 19-SEP-2011 and a second dose of GARDASIL (batch number not reported), by intramuscular route, site of administration not reported, on an unspecified date. At the time of reporting, the patient was not recovered. The IMB considered that case serious due to the patient''s disability and to be medically significant.
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