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Life Threatening? No
Write-up: Information has been received from a physician concerning a 6 month old female who on 09-NOV-2007 and 10-JAN-2008 was vaccinated with her first and second doses of Rotateq (lot# 656841/1168U, 657673/0904U). In March 2008 (date unknown) the patient experienced intussusception and was hospitalized (length of stay unknown). Therapy with Rotateq was discontinued. There was no product quality complaint. Follow-up information from the reporting physician indicated that the 6 month old female with no current conditions or medical history who on 10-JAN-2008 was vaccinated with her second dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of Comvax (OMPC) (MSD), a dose of DTaP, a dose of poliovirus vaccine inactivated (unspecified) and a dose of PREVNAR. On 03-MAR-2008 the patient started with symptoms of vomiting which was the only symptom. There was no diarrhea. The patient was hospitalized for three or four days and had no stool in the hospital. An upper GI was performed questioning reflux but no reflux was noted. A barium enema was performed and the patient was diagnosed with intussusception. The event was not life-threatening. The patient was due back in the office this month and the physician was unsure if she was going to give the third dose of Rotateq. Subsequently, the patient recovered. The physician stated that there was no way she''ll know if Rotateq caused the intussusception. Additional information has been requested. 4/28/08-records received-for DOS 3/3-3/5/08-DX DC: Intussusception. Presented with 5 episodes vomiting bilious. Decreased urine output. No diarrhea. Mildly dehydrated.
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