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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from SPMSD (manufacturer control# E2014-01344) on 17-FEB-2014. This case was received from health authority on 12-Feb-2014. GB-MHRA ADR 22411680. The case is medically confirmed. The case is linked to the case E2014-01347 (same patient, same product, same reporter, several same adverse events). A 12 year old female patient, with no medical history reported, received a first dose of GARDASIL (batch number J005923, lot number J005923, expiration date: 28-FEB-2016) 0.5 mL intramuscularly, site of administration not reported, on 11-Nov-2013. On 21-Nov-2013, the patient experienced pyrexia, prolonged vomiting, malaise and fatigue. On unreported dates, the patient also had no appetite and vomiting caused gastritis. The patient had 2 weeks school absence due to these symptoms. The patient''s parents were very concerned about girl''s health and suspected reaction to GARDASIL. The patient was treated with paracetamol. On 05-Dec-2013, the patient had recovered from pyrexia. On 28-Jan-2014, she had recovered from fatigue. On 29-Jan-2014, she had recovered from malaise. At the time of reporting, the outcome for appetite lost and gastritis was unknown. The regulatory authority considered that case serious due to the patient''s disability.
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