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Life Threatening? No
Write-up: Information has been received from a physician concerning an 8 month old white female patient who was vaccinated with a first, second and third oral dose of Rotateq on 28-JUL-2006 (Lot # 654504/0695F), 28-AUG-2006 (Lot # 654504/0695F), and 25-OCT-2006 (654665/1017F). the patient had no medical history, no known drug allergies and was not on any concomitant medication. On 17-NOV-2006 the patient was seen in the doctors office and was diagnosed with intussusception. The patient was admitted to hospital that same day, where she underwent emergency surgery. On 22-NOV-2006, the patient was discharged from the hospital. on 07-DEC-2007, the patient was seen in the doctors office for a well-visit and was considered recovered from the intussusception. There was no product quality complaint involved. Additional information has been requested. 3/22/07 Received medical records from hospital which reveal patient experienced intermittent abdominal pain associated w/vomiting approx 24 hours prior to admit on 11/17/06-11/22/06. Seen by PCP who noted bloody stool & tender abdomen. Barium enema performed at outlying facility but failed to reduce IS noted in mid transverse colon near splenic flexure. Then transferred to higher level of care where air reduction enema was also unsuccessful. Peds Surg consult obtained. Taken to OR where ileocolic resection w/primary anastomosis was performed. Progressed slowly but steadily, oral diet tolerated by d/c to home w/o further complication except for oral thrush which was treated. FINAL DX: Ileocecal intussusception w/necrotic bowel, surgically reduced w/bowel resection.
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