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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Initial and follow-up information has been received from a physician concerning a 26 year old female with no known medical history and allergies to penicillin, amoxicillin and Biaxin who on 27-DEC-2006 was vaccinated intramuscularly with a second 0.5 mL dose of Gardasil (Lot #653937/0637F). There was no concomitant medication. Subsequently, on an unspecified date, the patient developed a quarter size area of redness at the injection site. No laboratory diagnostic tests were performed. Approximately one month after the injection was given, the patient recovered. It was also noted that on 30-Apr-2007, the patient was vaccinated with a dose of GARDASIL (Lot # 657622/0386U). On an unspecified date, the patient developed redness, swelling. On an unknown date, the patient recovered.No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. Additional information is not expected.
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