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Life Threatening? No
Write-up: Information has been received from a physician concerning an 8 month old male with reflux and history of "MSPI type" diet with no other medical history or drug allergies who on 22-MAR-2007, 24-MAY-2007 and 25-JUL-2007 was vaccinated PO with his first, second and third doses (lot# 656381/0875U) of Rotateq. Concomitant vaccinations administered on 25-JUL-2007 included a dose of DTaP, a dose of poliovirus vaccine inactivated (unspecified) and a dose of (Prevnar). Other concomitant drug therapy included nizatidine (AXID) drops for reflux. On 04-OCT-2007 the patient experienced intussusception and was hospitalized. Medical attention was sought through the physician. Labs and abdominal x-rays were performed. A barium enema was also performed to reduce the intussusception. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested. 10/26/07 Patient demographics provided by CDC. 10/30/07 Reviewed vax records which confirms RO dose & lot as reported & provides other vax info. VAERS database updated w/same. 11/2/07 Received hospital medical records which reveal patient experienced bilious vomiting x 2 days & 1 episode of bloody stool. Seen by pcp, sent to ER when vomiting persisted. Admitted 10/4-10/5/2007. Noted to have exanthem, lethargy, reduced oral intake & urine output. Progressed well s/p enema reduction & d/c to home. FINAL DX: Intussusception, enema reduced. Records faxed to CDC.
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