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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # DE-1577272925-E2014-04013) on 13-MAY-2014. Case was received from a physician on 08-May-2014. Case is medically confirmed. A 14-year-old female patient (weight: 45.2 kg; height: 152 cm) received a first dose of GARDASIL (lot-no. J000396, Exp. Date: 31-JUL-2015 - this batch was not released by HA for SPMSD) IM into the deltoid muscle on 20-Jun-2013. One day later, on 21-Jun-2013, she developed lymphoedema of the right upper ankle joint. During the further course the oedema was spreading to the right lower leg. On 20-Aug-2013 the patient received the second dose of GARDASIL (lot-no. J001201, Exp. Date: 04-JUL-2015) IM into the deltoid muscle. The patient was hospitalised from 12-to 27-Sep-2013, the report was not provided. On 17-Oct-2013 duplex sonography showed lymphoedema grade II. On 18-Oct-2013 diagnosis of lymphoedema of the upper ankle joint was confirmed by phlebography. Since 17-Feb-2014 she additionally developed lymphoedema of the right wrist. On 24-Feb-2014 she received the third dose of GARDASIL (lot-no. J004473, Exp. Date: 12-OCT-2015) IM into the deltoid muscle. The patient was treated with support stockings and lymph drainage twice a week. Since Feb-2014 the patient additionally developed depressive episodes due to lymphoedema. She was treated with psychotherapy. At the time of reporting the patient had not recovered and the reporter assessed a "persisting damage". According to the reporter, the reaction was possibly related to vaccination.
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