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Life Threatening? No
Write-up: Information has been received from a registered nurse concerning a 19 year old female patient with a history of cholecystectomy (FEBRUARY 2005) and no allergies who on 06-AUG-2007, was vaccinated IM with a first 0.5ml dose of Gardasil (Lot # 658282/0929U). Concomitant therapy included ethinyl estradiol/norethidrone (OVCON). About 2 hours after receiving the vaccine, the patient experienced severe abdominal pain, nausea, vomiting and diarrhea. The patient stated that the area that hurts was about 2 inches from her belly button. The patient was prescribed atropine sulfate (+) diphenoxylate hydrochloride (LOMOTRIL) and promethazine hydrochloride (PHENERGAN). It was reported that the next day the patient called the office and her stomach pain had gotten worse. On a scale of 1 to 10 the patient felt her pain was a six. Laboratory diagnostic studies given on 07-AUG-2007 included a CBC and a thyroid study. Both were reported as normal. The patient no longer has diarrhea but was still experiencing nausea and vomiting. The outcome of severe abdominal pain was unknown. No product quality complaint was involved. Severe abdominal pain, nausea, vomiting and diarrhea were considered to be disabling. Additional information has been requested.
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