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Life Threatening? No
Write-up: Information has been received from a physician concerning a 17 week old female with no pertinent medical history or drug allergies who on 02-NOV-2007 and 28-DEC-2007 was vaccinated PO with her first and second doses of RotaTeq (lot# 657459/0509U, 656387/0971U). There was no concomitant medication. On 28-DEC-2007 the patient experienced intussusception and was hospitalized on 03-JAN-2008. The intussusception was resolved with a barium enema. The patient did not require surgical interventions. On approximately 06-JAN-2008 2-3 days after hospitalization, the patient was discharged home and was noted to be recovered. On 14-JAN-2008 the patient was seen for a follow-up visit with the physician and her exam was normal. On that same day after the exam, therapy with RotaTeq was discontinued by the physician. There was no product quality complaint. Additional information has been requested. 01/25/2008 Vax record received and data entered. 01/29/2008 MR received for ER visit 1/3/08. Infant to ER with screaming, vomiting, and listlessness. No po intake that day. Impression: Viral syndrome. Vomiting. Child transfered to another facility for further care. 03/27/2008 MR received for DOS 01/4-6/2008 with D/C DX: Intussusception. Infant presented to local hospital with lethargy, decreased po intake and vomiting. Pt later had a bloody stool. IS noted on Abd US. Air contrast enema successful in reducing IS. Pt began taking PO well and became more alert and was d/c home.
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