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Life Threatening? No
Write-up: Information has been received from a registered nurse and physician assistant certified concerning a 16 year old female with on known drug allergies, no illness at time of being vaccinated, and no medical history who on 30-DEC-2006 was vaccinated with first dose of Gardasil (lot #654741/1208F) intramuscularly left deltoid at 1400 hours. There was no concomitant medication. On 01-JAN-2007, at 1400 hours the patient experienced abnormal uterine bleeding (Spotting) uncomplicated and sought medical attention. The patient already had her period (normal menses 27-DEC-2006) and had been "spotting all during this past week". They thought pregnancy was possible so they administered a urine pregnancy test (negative) and she was not pregnant. She had no abdominal pain and no previous history of abnormal uterine bleeding. The outcome of the uterine bleeding was not reported. Additional information has been requested.
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