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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information ahs been received from a registered nurse concerning a 14 year old female with a "cardiac history" and no drug reactions/allergies who on 26-FEB-2007 was vaccinated intramuscularly in the right arm one dose of VAQTA (lot # 656320/1281F). Concomitant therapy included GARDASIL, ADACEL and MENACTRA. On 26-FEB-2007 the patient experienced an injection site reaction from the vaccination. The reaction consisted of redness, swelling and pain in the right arm. The patient sought unspecified medical attention. The patient was seen by the physician on 01-MAR-2007 and was still having the symptoms. No diagnostic laboratory tests were performed. At the time of the report the patient was recovering. There was no product quality complaint. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the CBER and was released by the regulatory agency. Additional information has been requested.
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