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Life Threatening? No
Write-up: Information has been received from a Nurse Practitioner (N. P.) concerning a 23 year old female patient who on 19-MAR-2007 was vaccinated with a first dose of Gardasil (yeast). About two hours later the patient developed itchiness. On the morning of 20-MAR-2007 the patient broke out in hives about the size of a half dollar and they were painful. The NP reported that they treated the patient with a methylprednisolone (MEDROL DOS-PACK) and sterile triamcinolone acetonide (KENOLOG-40) high dose steroid. The patient was improving , but they will not continue the Gardasil vaccination series for the patient. Patient to be followed up. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow-up information has been received from a Nurse Practitioner and Medical Assistant concerning a 23 year old female with allergies to penicillin and OMNICEF for which she carried an epinephrine pen; who on 19-MAR-2007 at 12:30 pmwas vaccinated with a first dose of GARDASIL IM in right deltoid (lot# 656049/0187U). She had no illness at the time of the vaccination. On 19-MAR-2007, about 2 hours post-vaccination, the patient experienced itchiness. On 20-MAR-2007 at 03:00 (AM or PM not specified) the patient broke out in painful, itchy hives about the size of a half dollar. The hives were all over her body, and were worse around the hairline and joints. The reporter stated that they treated the patient with small dose of methylprednisolone at first then high dose taper, IM sterile KENOLOG-40 high dose steroid and for itching ATARAX. The NP reported that they will not continue with the GARDASIL vaccination series for the patient. Follow up report indicated that on 27-MAR-2007 the patient completely recovered. No additional information is expected.
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