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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from business partner SPMSD (MFR# IE-1577272925-E2014-09751) on 22-OCT-2014. Serious case received from the regulatory authority under reference IE HPRA ADR 2014 021799 on 17/Oct/2014. This case is not medically confirmed as the reporter was a consumer. A 12-year-old female patient, no concomitant medication reported, received an injection of GARDASIL (batch number/ Lot number not reported), dose 1, 2, 3, site and route not reported, on the Sep/2011, Nov/2011 and Apr/2012 respectively. Following vaccination, on unreported date, the patient experienced bouts of tonsillitis, hypersensitivity, purple feet, generalised fatigue, "massive" headache. The reporter stated that the patient had continued to miss days at school and was unable to partake in her usual activities. The time to onset of the patient''s symptoms was unknown by the reporter. The reporter stated that the patient''s symptoms were initially considered viral. The patient had attended her GP and had been for a number of investigations including metabolic, genetic and lupus testing, the results of which were negative. Her endocrine status was found to be normal. She had been attending counseling since her parents'' separation. Medical history included underlying conditions including possible gender dysmorphia and sensory issues (hypersensitivity to physical contact with labels on clothing, hair brushes). The patient had been diagnosed as barely on the autistic spectrum. The patient''s father has Asperger''s syndrome. At this time of the reporting the outcome was not recovered. The regulatory authority considered the case serious for disability and other medically significant reasons.
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