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Life Threatening? No
Write-up: Information has been received from a physician concerning her daughter, a 19 year old female who on 13-OCT-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (lot#653938/0954F) without any difficulties. On 02-JAN-2007 the patient received the second dose of Gardasil vaccine (yeast) (lot#654389/0961F). Concomitant therapy included fluoxetine HCl (SARAFEM) and "Femcon" (NOS). On approximately 06-JAN-2007 the patient developed a tender reddened firm area in her upper arm around the injection site that "hurt her to sleep on". On an unspecified date the patient went to the emergency room and was diagnosed with cellulitis and treated with Cephalexin (Keflex). After 10 days of treatment with cephalexin was completed the patient''s "reddened firm area went down and was less tender". However, with 48 hours of stopping the therapy with cephalexin the area was "reddened, firm and tender". After 5 days the patient was seen at her university health services office, who "refused to treat her for cellulitis and referred her back to her gynecologist who gave her the vaccine". On approximately 01-FEB-2007 the patient was then seen by the internist who diagnosed her with a hematoma. At the time of this report the cellulitis was considered resolved and the hematoma was resolving. The physician reported that the patient will continue with the third vaccination in her other arm. The reporting physician consider the cellulitis to be a serious other medical event. Additional information has been requested.
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