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Life Threatening? No
Write-up: Information has been received from a registered nurse concerning a female with no pertinent medical history who on 01-JUN-2007 was vaccinated intramuscularly in the right deltoid with a second dose of Gardasil (Lot #0210U). There was no illness at the time of vaccination. The patient''s mother reported the patient''s arm had been sore since injection 01-JUN-2007 and the pain extended to the elbow. A small induration could be felt at the site. The patient was treated with ADVIL, gabapentin, LIDODERM patches, prednisone, and ice. On 06-JUL-2007 and 16-JUL-2007 the patient was seen in the physician''s office. On 05-AUG-2007 an magnetic resonance imaging (MRI) was performed on the right humerus findings of the proximal humerus are nonspecific and can be related to trauma, infection or neoplasm and should be correlated with clinical findings. There is synovitis of the Glenohumeral joint, which again could be reactive, post-traumatic, or infectious in etiology. On 30-AUG-2007, it was noted that the patient was doing "much better." It was reported that the patient had no problems with the first injection of Gardasil. It was reported that the patient''s sister had the Gardasil injections with no problems. The nurse considered the painful arm and injection site induration to be persistent and significant disabling events. Additional information has been requested.
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