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Life Threatening? No
Write-up: Information has been received from SPMSD (MFR control # E2013-11100) on 23-DEC-2013. This case was received from health authority in the foreign country on 19-Dec-2013. GB-MHRA ADR 22354576. This case is medically confirmed. A 12 year old female patient, with no medical history reported, received a first dose of GARDASIL (batch and lot number H008259) 0.5 mL by intramuscular route, site of administration not reported, on 16-Nov-2013. The patient was initially fine, had no pain or swelling. Two weeks after the vaccination on an unreported date, the patient experienced swollen and painful arm with restrictive mobility as it was very sore to mobilize. The patient was unable to lift her arm above head or to dress herself. The pain progressed from moderate to severe. On an unspecified date, the patient experienced small hard lump which could be felt in tissue. There was no redness at injection site, break in tissue, no rash, itching nor temperature. The patient received concomitant treatment with antihistamines. At the time of reporting, the patient had not recovered from restrictive mobility, painful and swollen arm and the outcome for small hard lump was unknown. The MHRA considered that case serious due to the patient''s disability.
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