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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD [IE-1577272925-2016000289] on 20-JAN-2016. This case was received from the health authority on 15-JAN-2016. Ref. IE-HPRA-2016-025590. Initial report was received by the HPRA on 01-JAN-2016 from a member of the public which concerns a 13 year old female patient who experienced Fatigue, Headache and Viral infection following vaccination with GARDASIL. Concomitant medications: BOOSTRIX on 24-MAR-2014. Medical history/concurrent conditions: Asthma. The patient was vaccinated with three doses of GARDASIL via IM route between 16-SEP-2013 and 21-MAR-2014 (batch/lot numbers H019633; expiry date: 31-MAY-2015, J005033; expiry date: 31-AUG-2015 and J004978 expiry date: 31-AUG-2015). Immediately post vaccination, on 21-MAR-2014, the patient experienced extreme fatigue, headaches and frequent viral type illness. Corrective treatment: Analgesia, TOPAMAX and herbal tonics. The reporter indicated that the patient''s quality of life is severely affected. At the time of reporting the patient''s symptoms were persisting.
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