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Life Threatening? No
Write-up: Information has been received from a physician, via a company representative concerning a female patient who on approximately 21 Feb 2007 ("last week") was vaccinated with the first dose of Gardasil. The physician reported that the "patient came back a few days after first dose of (Gardasil) and complained arm pain, swelling, fever and nausea" (approximately 23 Feb 2007). The physician confirmed that the patient had recovered "after a few days" (approximately 26 Feb 2007). The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 03/14/2007. Initial and follow up information has been received from a physician, concerning a 20 year old female student with allergies to ZITHROMAX and CLARITIN who on 22-FEB-2007 (previously reported as approximately 21-FEB-2007) was vaccinated with the first dose, 0.5ml. IM, of GARDASIL (Lot # 654702/0011U). The physician reported 10 hours after injection the patient developed a swollen left arm then fever, nausea and vomiting. The physician clarified that the "patient did not seek medical care for these problems," but that she reported them to him at the next visit (28-FEB-2007) (previously reported as the "patient came back a few days afte first dose"). The physician confirmed that the patient had recovered from the swollen arm, fever, neausea and vomiting on 28-FEB-2007 (originally reported as recovered "after a few day," approximately 26-FEB-2007). No further informaton is expected.
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