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Life Threatening? No
Write-up: Muscle/tissue atrophy at injection site almost immediately apparent - after 5 months approximately has not resolved. Patient had Kenalog injection 2 days prior at another injection site. This is in follow-up report(s) previously submitted on 9/15/2008. Intial and follow-up inforamtion has been recieved froma a nurse practitioner concerning a 11 year old female with no pertinent medical history or history of drug reactions or drug allergies who on 30-OCT-2007 was vaccinated witht he first does of GRADASIL. On aaproximately 03-MAR-2008, "two days prior to" the second vacciantion of GRADASIL, the patient had recieved triamcinolicne acetonide injrction in the gluteal area, "another injection site", for the treatment of allergian. On 05-MAR-2008 the patient was vaccianted intramuscularly in theleft arm woth the second 0.5ml dose of GRADASIL (lot no. 655604/0052X). Concomitant therapy included drospirenous (+) ethinyl entradiol, loratadine and imphatamine espartate.amphetamineSO4/dex. On the same day, "almost immediately after her second immunization", the patient developed pain and muscle tissue atrophy at the injection site. On 01-AUG-2008, the patient was vaccinated witht he third dose of GRADASIL. As of 01-AUG-08, it was reportedthat the patient was recovering from the injection site pain. As of 08-SEP-2008, it was reported that muscle tissue athrophy at the injection site still persisted "five months later". The patient sought unspecified medical attention via office visist. Muscle tissue athrophy at the injection site was considered to be disabling and pther important medical event. Additional information is not expected.
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