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Life Threatening? No
Write-up: Information has been received from a physician concerning a 4 month old female who on approximately 06-NOV-2007 was vaccinated PO with the second 2.0 ml dose of Rotateq (no lot number provided). Concomitant drug therapy included "antimicrobial (unspecified)." On 20-NOV-2007 two and a half weeks after being vaccinated, the patient experienced intussusception characterized by an abnormal stool and was hospitalized for a total of 3 days. A barium enema test was performed and the patient underwent surgery to repair the intussusception." On 23-NOV-2007 the patient was released from the hospital. Subsequently, the patient recovered. There was no product quality complaint. The physician also considered intussusception to be an other important medical event (surgery). Additional information has been requested. 1/11/08 Reviewed hospital medical records which reveal patient experienced irritability, black stools & bilious emesis x 12 hours which progressed to bloody stools. Went to outlying ER where gastrograffin enema reveals IS that could not be reduced despite 3 attemps. Transferred to higher level of care for surgical management. Admitted 11/20-11/23/2007. On admit, lethargic, distended abdomen w/epigastric mass palpablel. To OR for exp lap, no bowel resection needed. Did well post op & d/c to home. Final DX: intussusception, surgically reduced. 1/22/08 Reviewed vax record.
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