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Life Threatening? No
Write-up: Information has been received from SPMSD (manufacturer control number E2014-01379) on 18-FEB-2014. This case was received from health authority in a foreign country on 13-FEB-2014. GB-MHRA ADR 22414463. The case is medically confirmed. A 13 year old female patient, with medical history of allergy to nuts, received an injection of GARDASIL, (batch number J005626) 0.5 mL intramuscularly, dose in series and site of administration not reported, on 12-NOV-2013. On 06-DEC-2013, the patient developed sore throat, hoarse voice and lethargy with symptoms worsening, following vaccination. The patient was unable to attend school full time and was experiencing prolonged periods of lethargy. General practitioner has diagnosed chronic fatigue syndrome and myalgic encephalopathy which started on 06-DEC-2013, and referred to paediatricians for further investigation and management. At the time of reporting, the patient has not recovered from all the adverse events. The regulatory authority considered that case serious due to the patient''s disability.
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