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Life Threatening? No
Write-up: Information has been received from a physician concerning a 21-week-old female with no medical history who on 16-JAN-2007 (lot #655174/0848F) and 30-MAR-2007 (lot #656187/1237F) was vaccinated PO with the first and second 2.0 mL doses, respectively, of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). They physician reported that on 11-APR-2007, the patient developed intussusception. The physician noted that there was no adverse event involved after the patient was vaccinated with the first dose. At the time of this report, the outcome was unknown. Upon internal review, intussusception was determined to be an other important medical event. Additional information has been requested.12/20/07-records received for DOS 4/11-4/14/07-DC DX: Intussusception. Reduced by Barium contrast enema. Acute episode of vomiting, nonbloody nonbilious, approximately 20 episodes of emesis and an episode of abdominal pain. Lethargic, tachycardic with poor peripheral perfusion. Following enema patient passed a current jelly stool in ED.
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