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Life Threatening? No
Write-up: Information has been received from a physician concerning an 11 year old female patient with no known drug allergies and no past medical history, who on 08-JAN-2008 was vaccinated intramuscularly into the left deltoid with the second dose of Gardasil (Lot # 659439/1267U). There was no concomitant medication, and no other shots were received that day. No trauma to the arm was reported. On 09-JAN-2008 the patient developed pain at the injection site pain radiating down to the fingertips, swelling of the left upper arm, numbness, tingling and weakness in the hand. The patient was seen on 26-FEB-2008 and treated with over the counter medication ADVIL which decreased the pain. Diagnostic testing included an MRI indicating a 5x11x9 millimeter and a small focus edema 1 to 2 centimeters deep in the subcutaneous fat of the lateral upper left arm. No abnormal bone marrow or muscle. Re-evaluation on 02-APR-2008 revealed tenderness over biceps, no erythema, no warmth, and no palpable cord. Neurovascular exam was intact. It was also reported that she had no problems on 05-NOV-2007 with the first dose of Gardasil. The reporting physician considered the injection site pain radiating down to the fingertips, swelling of the left upper arm, numbness and tingling and weakness in the hand to be disabling and another important medical event. Additional information has been requested.
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