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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (Manufacturer control number E2014-03331) on 15-APR-2014. This case was received from health authority on 10-Apr-2014. GB-MHRA ADR 22488410. The case is medically confirmed. A 12 year old female patient, with no medical history reported, received an injection of GARDASIL (batch number and lot # J007399 and expiry date 29-FEB-2016) intramuscularly, dose in series and site of administration not reported, on an unreported date and on unreported dates after vaccination, the patient experienced huge pupils for over 24 hours, she felt very unwell for 48 hours and had vomited 3 times. At the time of reporting, the patient has recovered from all the adverse events. The regulatory authority considered that case serious due to the patient''s disability.
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