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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a health professional concerning a 17 year old female who on 02-JAN-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 654741/0013U). Concomitant therapy included ZOLOFT and ADDERALL TABLETS. It was reported that since receiving her vaccination 02-JAN-2007 the patient has experienced premenstrual low abdominal cramping for a week prior to her menstrual period. The patient was examined by a physician on 12-MAR-2007 and there were no abnormal findings. No treatment was recommended. The reporter requested a lot check. Additional information has been requested. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot couples with the standards of the center, and was released. The registered nurse reported that 3 other patients experiences after GARDASIL administration (WAES 0703USA02859, WAES 0703USA02815, WAES0703USA02840). Additional information is not expected.
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