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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur (MFR # IE-1577272925-2016001778) on 01-MAR-2016. This is the initial spontaneous report received from a Community Care Doctor via (Ref no. -025996) on 26-FEB-2016 which concerns a 15 year old female patient who experienced headache, nausea, lethargy, malaise, abdominal pain and fatigue following vaccination with GARDASIL. Concomitant medications: None. Medical history/concurrent conditions: Nil. the patient was vaccinated with three 0.5 ml doses of GARDASIL all via intramuscular route on 29-SEP-2011 (batch ni. NP26080/lot # NM26350, exp March 2013, Dose 1), 29-NOV-2011 (batch no. G005669, exp 31-JUL-2013, dose 2) and 13-MAR-2012 (batch no. G005669, exp: 31-JUL-2013, dose 3). Post vaccination, reported as 09-JUL-2013, the patient developed headache, nausea, lethargy, malaise, abdominal pain and fatigue. the reporter indicated that the patient''s symptoms are ongoing and the patient is unable to attend school due to the lethargy and exhaustion. the patient has been seen by her GP and was referred to a paediatrician with a query re possible ME. Corrective treatment: Nil. the reporter assessed the causal relationship between the adverse reaction and GARDASIL as unknown. the patient''s outcome was reported as Not Recovered/Not Resolved.
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