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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MRF: IE-1577272925-20160012270) on 15-FEB-2016. This case was received from the health authority on 15-Feb-2016. Ref IE-HPRA-2016-025874. Initial report was received by the RA on 31/Jan/2016 from a member of the public which concerns a 13 year old female patient who experienced Malaise, Arthralgia, Pyrexia, Headache and Decreased appetite following vaccination with GARDASIL. Concomitant medications: Diphtheria Tetanus and Pertussis vaccine (brand unspecified) given on 05/11/2015. Medical history/concurrent conditions: Nil. Previously a very healthy child. The patient was vaccinated with GARDASIL via IM route on 05/Nov/2015. Post vaccination; the patient became very unwell on 07/Nov/2015, presented with achy joints and high temperature on 08/Nov/2015. She felt very weak, also headache, and no appetite.. The reported indicated that the patient was in bed for 7 days and all sporting activity was curtailed for 1 month following this reaction. Corrective treatment: Analgesia and bed rest. At the time of reporting the patient had made a complete recovery. Upon internal review the vaccine DTP was considered to be suspect.
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