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Life Threatening? No
Write-up: Information has been received from a physician concerning a 4 month old male, with no reported medical history, who on 9/28/06 was vaccinated with a first 2 ml oral dose of Rotavirus vaccine (lot 654970/0777F). Concomitant vaccines administered on the same day included a dose of Prevnar, a dose of Hib and a dose of Pediarix. It was reported that, on approx 9/30/06, the pt initially presented with edpsodic excruciating abdominal pain and was diagnosed with colic at the ER of the hospital. The next day the pt presented with bilious emesis and bloody diarrhea. No treatment was given, the pt was sent directly to the tertiary care hospital. The physician didn''t know the exact date, but he thought 10/2/06 sounded right. The physician reported that the pt had 2 days of signs of symptoms prior to going to the hospital. The pt had an air contrast enema which revealed the intussusception. He stated that the pt spent 12 hours at the hospital prior to the study being performed. It was reported that the pt developed intussusception with perforation. It was noted that at the time of report the pt was recovering, but had not been released from the hospital. The pts mother told the reporter that the pt was receiving his second blood transfusion. The reporter noted that since the pt received two blood transfusions, he thought that the pt possibly had surgery and was planning on contacting the physician at the hospital No product quality complaint was involved. No other information was provided. Additional information has been requested. 10/26/06 Received medical records from hospital which reveal patient admitted to ER with fever, vomiting & blood in stool for 1-2 day. Patient failed an air enema & underwent open laparotomy, open reduction & incidental appendectomy on 10/2/06. Intussusception of sigmoid colon was reduced only to mid transverse colon. Findings at surgery included difficult to reduce intussussception, markedly edematous distal ileum & serosal tears of cecum. Had transient respiratory distress & was in PICU fro
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