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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This is in follow-up to report (s) previously submitted on 5/14/2007 Information has been received from a company representative, reporting in a literature article (article name and author not specified) concerning a 22 year old female who was vaccinated with a dose or doses of GARDASIL (date unspecified). According to the article, the woman "became infected with the 4 strains of HPV, "although she was "involved in the studies" for GARDASIL and had shown a "strong conversion" during the studies. Additional information has been requested. Follow up information confirmed that only one patient was identified or involved with the events (WAES #0610USA04009). Therefore, WAES # 0704USA00327 is being deleted from our files. No further information is expected. This report was previously sent in a monthly submission to PLA V501 on 14-MAR-2007.
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