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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: Information has been received from a consumer concerning her 8 month old son, with no medical history and no allergies, who was vaccinated with a first and second oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live on 8/15/06 and 9/14/06, respectively. Concomitant therapy included ranitidine HCl and cetirizine hydrochloride. it was reported that on the evening of 10/22/06 the patient was lethargic, had blood in his stool, was vomiting with dried black blood, and was dehydrated. A physician diagnosed the patient with intussusception that was about 8mm in length on the morning of 10/23/06 and was hospitalized. It was reported that the patient had to have emergency surgery for a bowel resection. The reporter noted that the surgeon indicated that the patient also had a swollen lymph node about the size of a shooter marble and he believed that it may have been related to the experience. At the time of the report, it was noted that the patient was doing much better. The patient''s experience was considered to be immediately life-threatening and disabling by the reporter. Additional information has been requested. 11/27/06 Received medical records from hospital which reveal patient admitted 10/23/06 with nausea, vomiting & colicky symptoms. Barium enema did not reduce IS & patient taken to surgery for reduction of IS with ileocecal resection & appendectomy. Continued to improve w/o further complication & was d/c to home on 10/27/06. PMH: GERD, URIs Final Dx: Intussusception (IS) and chronic reflux. Patient was readmitted for overnight observation & hydration on 10/28-10/29/06 after running a fever of 102 for approx 1 day. It was felt to be a viral infection./ss
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