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Life Threatening? No
Write-up: Information has been received from a health professional concerning a 24 year old female with a penicillin allergy who on 03-MAR-2007 was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil (Lot#654702/0011U). Concomitant therapy included CYCLESSA. On 04-MAR-2007 post vaccination the patient started spotting, menstrual cycle. It was reported that the patient is not pregnant. At the time of this report the spotting, menstrual cycle persisted. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Follow up information received from a health professional stated that the dose of GARDASIL was from Lot # 654510/0962F, not lot # 654702/0011U as perviously reported. It was also reported that the patient recovered from the event on 15-Mar-2007. Additional information is not expected.
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