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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 10 month old female with an ear infection in February 2008, and no drug allergies who on 03-JUL-2007, 05-SEP-2007 and 06-NOV-2007 was vaccinated PO with her first, second and third doses of ROTATEQ (lot# 656391/0238U, 657049/0503U, 657518/1192U). Concomitant drug therapy included AUGMENTIN for the ear infection in February 2008. On 10-MAR-2008 the patient experienced vomiting and received a diagnosis of gastroenteritis and was subsequently hospitalized. The nurse was reading the patient''s chart and also noted that the patient had intussusception which was "reduced by air." Laboratory diagnostic studies included flat x-ray on 12-MAR-2008. The patient was discharged from the hospital on 14-MAR-2008, but had no other information about the hospitalization. Subsequently the patient recovered. There was no product quality complaint. No other information available. Gastroenteritis and intussusception were also considered to be immediately life-threatening by the physician. Additional information has been requested. 5/27/08-records received for DOS 3/10-3/12/08-admitted with refractory vomiting for 3 days. Admitted for rehydration. NG placement. Transferred to speciality hospital. 7/15/08-records received for DOS 3/12/08-DX: intussusception. Ultrasound revealed intussusception.
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