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Life Threatening? Yes
Write-up: Information has been received from a registered nurse concerning a 10 week old formula fed female with no medical history or allergies who on 18-APR-2007 was vaccinated with a 2 ml oral dose of Rotateq (lot # 656196/0026U). There was no concomitant medication. On 21-APR-2007 the patient developed vomiting. She was seen in the ER that day. She was admitted to the hospital with intussusception. Barium procedure to open the bowel was unsuccessful. Surgery was required. On 23-APR-2007 the baby was discharged from the hospital. At the time of the report the patient was recovering. There was no product quality complaint involved. The patient''s intussusception was considered to be life threatening and an other important medical event. Additional information has been requested. 05/29/2007 MR received for 2 night ER admit for c/o abdominal pain, vomiting and bloody diarrhea. Hx of diarrhea x 5 days prior to emesis and bloody diarrhea. PE: Irritable infant in moderate distress. Abdomen distended, tender to palpation. Unable to reduce with BE so pt. had surgical reduction of ileocolic intussusception and appendectomy. Final DX: Intussusception.
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