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Life Threatening? No Write-up: Information has been received from a Registered Nurse (R.N.) concerning a 15 year old female patient who on 15-FEB-2007 was vaccinated with a first dose of Gardasil lot #655619/1427F. On 17-FEB-2007 the patient developed a fever of 105 degrees and experienced headaches, nausea, vomiting, body aches, abdominal pain and she was "flush all over". These symptoms lasted for ten days before dissipating. On 22-FEB-2007 five days after the adverse symptoms began, the patient was given cetirizine hydrochloride (ZYRTEC) and patient said she felt a little better and her headaches stopped. The nurse who provided this information works in a health department and the name of the patient''s prescribing physician was not provided. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report(s0 previously submitted on 6/14/2007. Inital and follow up information has been received from a health care professional concerning a 15 year old female student with sulfonamide allergy who in 15-FEB-2007, at 02:30 PM was vaccinated IM in the left deltoid with a first dose of GARDASIL vaccine (yeast) Lot #659619/1427F. On 17-FEB-2007, the patient developed a fever of 105 degrees and experienced headaches, nausea, vomiting, body aches, abdominal pain and she was "flush all over. These symptoms lasted for ten dayus before dissipating. On 22-FEB-2007 five days after the adverse symptoms began, the patient was given ZYRTEC and patient said she felt a little better and her headaches stopped. The nurse who provided this information woks in a health department and the name of the patient''s prescribing physician was not provided. Subsequently, the patient recovered. In follow up it was indicated thta on 18-FREB-2007 patient had severe headache not relieved with acetaminophen or ibuprofen (previously reported that headache started on 17-FEB-2007 and stopped on 22-FEB-2007. Patient had fever 105 degrees x2 days then fever 102 degrees x3 days. It was mentioned that on 18-FEB-2007 patient also had body aches, flushed skin, joint pain, nausea, vomiting. Symptoms lasted approximately 10 days. Lab drawn with normal complete blood cell count. It was reported that patient required x2 doctor''s visit. The patient recovered. No additional information was expected. | ||||||||||||||||||||
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