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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: Information has been received from a nurse practitioner concerning a 25 year old female with no medical history and no drug allergies, who on 06-JUN-2007 was vaccinated with a first dose of Gardasil (Lot# 658094/0524U). Subsequently, the patient developed local irritation. Concomitant therapy included "creatine" (CREATINE POWDER), "glutamine", "omnijust", and omeprazole (PRILOSEC). On 07-AUG-2007 the patient was vaccinated intramuscularly with a 0.5 mL second dose of Gardasil. On 07-AUG-2007 eight and a half hours after receiving the vaccination the patient developed hives and experienced difficulty breathing. The reaction occurred while she was running outdoors. The patient went to the emergency room and was released after being treated intravenously with diphenhydramine hydrochloride (BENADRYL). The patient recovered on an unspecified date. No product quality complaint was involved. The patient''s difficulty breathing was considered to be life threatening. Additional information has been requested.
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