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Write-up: Information has been received from a physician, via a company representative, concerning an 18 year old female patient who was vaccinated with the first dose (date and dose unspecified) of Gardasil. The physician reported her approximately 3 hours after the vaccination was administered, the patient called and stated she had experienced some dizziness. At the time of this report, it was unknown if the patient had recovered. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a physician, via a company representative, concerning a 17 year old (previously reported as 18 year old) female patient who on 09-MAY-2007, was vaccinated from a pre-filled syringe, with the first dose of GARDASIL (Lot #654540/1161F). Concomitant therapy included SYNTHROID; there were no concomitant vaccines administered. The physician reported that approximately 3 to 4 hours after the vaccination was administered, the patient began to feel weak and dizzy, and had to lie down; she recovered within several hours. The physician clarified that the patient had not consulted the office at the time of the event, but later reported it at a return visit to the office. At the time of this report, it was confirmed that the patient had fully recovered. No further information is expected.
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