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Life Threatening? No Write-up: Information has been received from a physician concerning a 22 year old female pt who on 9/12/06 was vaccinated IM into the upper left buttock with a dose of GARDASIL, lot 653650/0702F. There was no concomitant medication. Approx one hour post vaccination the pt experienced numbness and tingling on the right side of her face. Medical attention was sought. No other symptoms were noted. As of the report date, the pt was recovering. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/13/2006. Information has been received from a physician concerning a 22 year old female patient who on 12-SEP-2006 was vaccinated IM into the upper left buttock with a dose of GARDASIL lot #653650/0702F. There was no concomitant medication. Approximately one hour post vaccination the patient experienced numbness and tingling on the right side of her face. Medical attention was sought. No other symptoms were noted. As of the report date, the patient was recovering. Follow up information has been received concerning the 22 year old female with no medical history who on the morning of 12-SEP-2006 was vaccinated IM into the upper left buttock with her second dose of GARDASIL, lot #653650/0702F. It was reported that right facial numbness developed within 1 hour after the injection. No diagnostic/laboratory tests were performed. The patient was reported to be recovered from right facial numbness. Additional information is not expected. | ||||||||||||||||||||
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