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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (E2013-10115) on 16-DEC-2013. This case was received from a nurse via a company representative in the foreign country on 21-Nov-2013. This case is medically confirmed. A female patient of unknown age received an injection fo GARDASIL (batch number not reported), route and site not reported, on an unreported date. On an unreported date, post vaccination, the patient developed a rash. The rash was not diagnosed by the reporter but by the patient''s GP who attributed it to GARDASIL. The patient outcome was not reported. Follow-up information received on 16-Dec-2013 from a nurse. The 12 year old patient had a medical history of allergy to dust and cats. She received a first dose GARDASIL (batch/lot number H008259) 0.5 mL by intramuscular route in the left arm. On 01-Dec-2013, the patient experienced severe pain/sore arm, on 07-Dec-2013, she experienced severe swollen arm and on 12-Dec-2013, the patient also experienced severe pain in mobilising arm, severely restricting daily activities like dressing and mild hard lump in tissue at injection site. She received corrective treatment with anti-inflammatories, pain killers and cold compress. No information about the previous reported adverse event "rash" was provided. The reporter considered the relation of sore arm to vaccine as possible. For all the other adverse events, the reporter considered the relationship to vaccine as possible and probable (both ticked, only coded as probable upon internal review by the company). At the time of reporting, the patient had not recovered from all adverse events. The reporter considered that case serious due to the patient''s disability.
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