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Life Threatening? Yes
Write-up: Information has been received from a physician concerning a 19 year old female who on 22-AUG-2007 was vaccinated by injection with the first 0.5 mL dose of Gardasil. On 22-AUG-2007, after the patient received her first dose of Gardasil experienced "anaphylactic reactions including swelling of the throat." The patient sought unspecified medical attention. Subsequently, the patient recovered from anaphylactic reactions and swelling of the throat. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. In follow-up it was reported by the physician concerning a 19 year old female with no illness at the time of vaccination and no pre-existing allergies, birth defects, or medical conditions whose reported weight was 130 pounds and whose reported height was 66 inches who on 22-AUG-2007at 3:00 p.m., was vaccinated by injection into the left arm with the first 0.5 mL dose of GARDASIL, (lot # 686094/05240). It was reported that 15 minutes after the vaccine was administered the patient had throat swelling, itching, vomiting x 1. The patient was treated for "anaphylaxis" with SOLU-MEDROL, BENADRYL and prednisone. There was no decrease in blood pressure (BP) and no changes in respiratory status. The patient recovered on 22-AUG-2007. The reporter determined the patient''s anaphylactic reaction to be immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. in addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
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