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Life Threatening? No
Write-up: This case was received from the health authority on 10-Sep-2013. IMB ref 2013-018105. This case is medically confirmed as it was reported by a general practitioner. A 17 year old female patient, with a medical history of dermatillomania which is continuing and impetigo, received on 02-Dec-2010 a second dose of GARDASIL, (batch number not reported) intramuscularly, site of administration not reported and on 25-Feb-2010, an injection of PANDEMRIX, (batch number not reported) intramuscularly, dose number and site of administration not reported. The patient has since developed fatigue and has missed a lot of school. The fatigue was initially noted in Jan-2011. The patient has no symptoms of narcolepsy. The reporter indicated that she is not sure of the cause of the patient''s fatigue. The reporter got a second opinion and it was felt the reaction to be more psychological. It was reported the patient previously received the first dose of GARDASIL (batch number not reported), intramuscularly on 06-Oct-2010 and a third dose on 15-Mar-2011. The patient was concomitantly treated with FYBOGEL Citrus (Ispaghula husk) 1 tablet daily orally and mebeverine HCL (generic) orally since 10-Oct-2011 for irritable bowel syndrome, SANOMIGRAN (pizotifen) 1.5 mg daily orally since 06-Jan-2012 for headache, terbinafine (generic) 250 mg daily for fungal infection since 13-Apr-2012 and with TETRALYSAL (lymecycline) 300 mg daily orally for acne from 02-Jul-2012 to 17-Jan-2013. The reporter indicated that the patient has been prescribed various medications over the last few years for headaches and irritable bowel syndrome but the reporter is unsure if the patient took them. (As no information was provided on the onset for the events, the Company matched the IMB report regarding the coded AE). Upon internal review the Company judged relevant to code "reaction to be more psychological", LLT: psychological disorder NOS. At the time of reporting, the patient was recovering from fatigue. The IMB considered that case serious due to be medically significant.
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