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Life Threatening? No
Write-up: Information has been received from a physician concerning a female patient who was vaccinated with Gardasil. Subsequently the patient experienced severe swelling and redness at the injection site. Subsequently, the patient recovered. Additional information has been requested. 03/18/2010 follow up - OEDEMA PERIPHERAL; ERYTHEMA; HYPERSENSITIVITY; SKIN WARM; PAIN IN EXTREMITY; INJECTION SITE BRUISING This is in follow-up to report (s) previously submitted on 06/14/2007 Initial and follow-up information has been received from a physician concerning a 26 year old white female with no pertinent medical history who on 31-JAN-2007 was vaccinated with a first dose of HPV rL1 6 11 18 VLP vaccine (yeast) (lot# 654540/1162P) Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLES). On 31-Jan-2007. Immediately after the vaccination, the patient developed a severe allergic reaction with erythema. Severe swelling and warmth of the left arm and bruising at the injection site. There was no dyspnea, wheezing or throat swelling. Ice was applied to the patient''s arm. The patient recovered from severe allergic reaction with erythema, severe swelling and warmth of the left arm and bruising at the injection site. It was reported that the patient''s arm remained sore for approximately 1 week. The second dose of HPV ILI 6 11 16 18 VLP vaccine (yeast) was not given. No further information is available.
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