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Life Threatening? No
Write-up: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient developed a mass under her skin at injection site. the patient''s mass persisted. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information have been received from a physician concerning a 26 year old female with a Sulfonamide (BACTRIM) allergy to who on 19-FEB-2007 was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL (Lot #655126/0087U). Subsequently, on 29-MAR-2007 the patient called her physician and reported that she had developed a mass under her skin at injection site. On 02-APR-2007 the patient had an ultrasound of the area which was negative. The patient reported that she also had pain in the area in her triceps when working out. It was reported that after the use of heat/massage the area increased in size from approximately the size of dime to an area the size of a quarter. On 07-MAY-2007 the patient was seen by the physician who reported that the lump felt like an injection site granuloma <10mm. The physician reported that there were no deformities, color changes or tenderness with deep palpatation. At the time of this report the patient had not recovered. Additional information has been requested.
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