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Life Threatening? No
Write-up: Information has been received from a physician concerning an approximately 12 year old female patient with sulfonamide allergy who was vaccinated with her first dose of Gardasil and had a "slight" reaction with a red swelling rash at injection site. In March 2007, she was vaccinated IM with her second dose Gardasil and had "a more extreme" rash. Unspecified medical attention was sought. The patient''s outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician concerning 13 year old female patient wit ha sulfonamide allergy who on 12-JAN-2007 was vaccinated IM into the left arm with her first dose of GARDASIL (lot # 653937/0637F). She had a "slight" reaction with a red swelling rash at the injection site, a red bumpy rash on arms around breast and "mouth burned." On 14-MAR-2007, she was vaccinated IM into the left arm with her second dose of GARDASIL (lot #655617/1447F). Two days later on 16-MAR-2007 the patient developed the same reaction, described as a red, bumpy "more extreme" rash on arms, around breast and "mouth burned." Additional information has been requested. This is a consolidation of two reports concerning the same patient. It has been determined that WAES # 0705USA00322 is a duplicate of WAES # 0704USA05691. Therefore WAES # 0705USA00322 is being deleted from our files and the information consolidated into WAES # 0704USA05691.
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