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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: Information has been received from a physician concerning a 24 week old male with no pertinent medical history who on 16-NOV-2007 and 18-JAN-2008 was vaccinated with his first and second doses of ROTATEQ (lot# 657671/0902U, 657635/0770U). On 07-MAR-2008 the patient experienced illness with vomiting for 24 hours and was seen in the physician''s office on 08-MAR-2008. On 08-MAR-2008 the patient was diagnosed with intussusception characterized by vomiting, dehydration and abdominal pain and was hospitalized for one night for observation. There was no diarrhea or blood in the stool reported. The patient was treated with IV rehydration in the emergency room. The intussusception was successfully reduced via air enema. It was noted that on 18-MAR-2008 the patient received the third dose of ROTATEQ (lot# 659917/0017X). Therapy with ROTATEQ was discontinued. On 09-MAR-2008 the patient was discharged from the hospital and was recovered. There was no product quality complaint. Intussusception was also considered to be immediately life-threatening and an other important medical event by the physician. Additional information has been requested. 4/28/08-records received for DOS 3/8-3/9/08-DC DX: Intussusception. Presented to ED with 1 1/2 day C/O vomiting, dehydration and fever 101. No currant jelly or bloody stools.
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