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Life Threatening? No
Write-up: Information has been received from a registered nurse concerning a 20 year old female, with no medical history or history of drug reactions/allergies who on 12-MAR-2007 was vaccinated with 0.5 ml intramuscular Gardasil (lot# 654741/0013U). Concomitant therapy included Alesse. Subsequently the patient experienced nausea and vomiting. Patient outcome was unknown. No lab testing was performed. Additional information has been requested. The registered nurse reported that 3 other patients'' experiences after Gardasil administration (WAES 0703USA02859, WAES 0703USA02797, WAES0703USA02815). This is in follow-up to report (s) previously submittedon 4/13/2007. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biological Evaluation & Research, and was released.
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