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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a physician via a company representative, concerning a 16 year old female who on approximately 02-Dec-2006 was vaccinated IM in the left arm with Gardasil. After receiving the injection, the patient went to school and later during the day, she got very dizzy "that she almost passed out.". She also developed a red rash and bumps all over the site of the left arm where the dose was administered and had to go home. Subsequently, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow up information has been received from a physician, concerning a 16 year old female patient who at 3:15 pm on 29-NOV-2006 (previously reported as approximately 02-DEC-2006) was vaccinated with 0.5ml, IM in the right deltoid (previously reported as left arm), with the first dose of GARDASIL (lot # 653736/0868F). There was no known illness at the time of vaccination. After receiving the injection, the patient went to school and later during the day, she got very dizzy and "felt like passing out." She also developed a red rash and bumps all over the site of the left arm where the dose was administered and had to go home. Follow up information from the physician added that on approximately 30-NOV-2006, the patient also experienced a light edema and itching. The patient was treated with (ZITHROMAX Z-PAK), and subsequently recovered (date not specified). No further information is available.
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