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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from business partner sanofi Pasteur MSD on 20-OCT-2016. This case was received from the HPRA on 14-Oct-2016 under reference number IE-HPRA-2016-028106 Initial report was received by the HPRA on 02/Oct.2016 from a member of the public (MOP) (patient herself) which concerns a 13 year old female patient who experienced asthenia, abdominal pain upper, lymphadenopathy, pyrexia, arthropathy, ear pain, fibromyalgia and sleep disorder following vaccination with GARDASIL. Concomitant medications: None. Medical history/concurrent conditions: None reported. The patient was vaccinated with dose 1 of GARDASIL on 05/Oct/2010 (batch no. NN01990 exp 05/2012) and dose 2 on 13/Dec/2010 (batch no. NN33040 exp 01/2013). Post vaccination the patient experienced weakness that day and was resolved, then severe stomach pain after a coupe of weeks, developed swollen glands and high temperatures. The reporter indicated that she has since developed a lot of joint problems and ear pains. The reporter indicated that she has all the symptoms of fibromyalgia however blood results are inconclusive. The patient cannot also go the full day without a sleep and has chronic sleep problems. Corrective treatment: Unspecified help with joints, swollen glands and sleep. At the time of reporting the patient''s symptoms were ongoing.
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