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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur (MSD) (SPM) (MFR control number IE-1577272925-2016001389) on 18-FEB-2016. This case was received from the health authority on 16-FEB-2016 under reference number IE-HPRA-2016-025878. Initial report was received by the RA on 01-FEB-2016 from a member of the public (patient''s mother and also a HCP) which concerns a 13 year old female patient who experienced Fatigue, Arthralgia, Skin striae, Abdominal pain, Pyrexia, Headache and Cognitive disorder following vaccination with GARDASIL. Concomitant medications: None. Medical history/concurrent conditions: Nil. The patient was vaccinated with 3 doses of GARDASIL via IM route, including one dose received on 19-SEP-2011 (only one vaccination date provided). Approximately 4 weeks post vaccination, the patient experienced chronic fatigue, joint pains, stretch marks, severe headaches, reduced cognition, abdominal pain and pyrexia. The reporter indicated that the patient has had multiple hospital admissions and multiple GP and consultant visits. At the time of reporting the patient''s symptoms were persisting. The patient outcome was reported as not recovered/not resolved.
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