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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: Information has been received from a a physician concerning a 7 month old female with no drug allergies who on 16-JUL-2007 was vaccinated with a 2ml oral dose of Rotateq. On 14-AUG-2007 the patient developed intussusception characterized by vomiting, low grade fever, and bloody diarrhea. Medical attention was sought via emergency room visit and the patient was hospitalized. Numerous tests (unspecified), confirmed a diagnosis of intussusception and a partial iliac resection was performed. Subsequently the patient was noted to still be hospitalized and recovering. There was no product quality complaint. The event was also considered to be immediately life-threatening and other important medical event (surgery) by the reporter. Additional information has been requested. 08/31/2007 Received hospital medical records of 8/14-8/22/2007. FINAL DX: Intussusception w/terminal ileum perforation & necrosis. Records reveal patient experienced fever & decreased oral intake x 4 days, 1 day of bilious emesis & 1 episode of bloody stool. Taken to OR for exp laparotomy, small bowel resection & appendectomy. Admitted to PICU post operatively. Received IV antibiotics via PICC line & was weaned from mech ventilation successfully. TPN started & progressed to oral feeds. Tolerated feeds well & stooling normally. D/C to home w/pcp & peds surg f/u. 10/2/07 Received vax record from hospital which reveals patient did not receive RO on any date. 5/1/08 Received PCP medical records for 1/24/07-3/3/08 which included vax record different from that received from hospital. but still confirm that patient did not receive Rotateq vaccine at any time. 7/27 visit for wheezing, runny nose & cough x 3 days. 8/13 visit, had been out of state. Had vomiting & fever x 2 days & seen in ER out of state x 2. Lethargic & seen in local Er day before. Dx w/viral gastroenteritis. 8/16 notified of hospitalization. 8/31 f/u hospitalization vs progressing well. Returned 9/6, 10/18, 10/29, 11/26, facial cellulitis, atopic dermatitis w/wheezing, couth & runny nose.
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