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Life Threatening? No
Write-up: Information has been received from a 21 year old female with no pertinent medical history and no history of drug reactions/allergies who on 09-FEB-2007 was vaccinated with first dose of Gardasil (yeast ) (lot # not reported) injection. Concomitant therapy included cefdinir (OMNICEF), cetirizine hydrochloride (ZYRTEC), dexamethasone/tobramycin (TOBRADEX), cough, cold, and flu therapies ("VIGRAMOX") and antihistamine (unspecified). On 09-MAR-2007, the patient was vaccinated with second dose of Gardasil (yeast) (lot # not reported) injection. No concomitant therapy at the time of receiving the second dose of the vaccine. On approximately 09-FEB-2007, following the first injection, the patient experienced slight redness and itching which were gone by the next day (approximately 10-FEB-2007). Medical attention was sought. Also she had a "hard bump" at the injection site which lasted for approximately two weeks (approximately 23-FEB-2007) before going away. The hard bump felt like a knot in her skin. On 09-MAR-2007, the patient received second injection of Gardasil vaccine only one month after the first dose. At the time of reporting, she has not had any adverse experience following the second injection of vaccine. Additional information has been requested.
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