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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: Information has been received from a registered nurse concerning a 25-week-old female with no pertinent medical history and no drug reactions/allergies who on 16-MAY-2007 and 12-JUL-2007 was vaccinated PO with the first and second 2mL doses of Rotateq (Lot #''s 656385/0030U and 657292/0551U, respectively). There was no concomitant medication. On 04-SEP-2007 the patient experienced symptoms of intussusception. The patient initially experienced vomiting that was followed by bloody diarrhea 12 hours later. The patient was brought to the emergency room and then transferred to another hospital. The intussusception was treated with a barium enema and the patient was discharged on 05-SEP-2007. On 05-SEP-2007, the patient recovered from intussusception. There were no lab diagnostic studies performed. No further information is available. There was no product quality complaint. The event was considered to be immediately life-threatening and other important medical event by the reporter. Additional information has been requested. 9/28/07 Received hospital x 2 medical records which reveal patient seen in outlying ER for intermittent abdominal pain, vomiting, lethargy, pallor, dehydration & bloody diarrhea. Transferred to higher level of care for successful air contrast enema reduction. Admitted & d/c on 9/5/2007 w/o complication. FINAL DX: Intussusception, enema reduced. 10/5/07 Received vax record. VAERS database updated w/same. Records faxed to CDC.
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