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Life Threatening? No
Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of ileocolic intussusception in a 10-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. On 4 March 2008, and 6 May 2008, the subject received 1st dose and 2nd dose of ROTARIX (oral), lot numbers not provided. On 30 November 2008, 7 months after 2nd vaccination with ROTARIX, the subject experienced vomiting and liquid stools. On 2 December 2008, the subject was admitted to emergency room with dehydration, hyperemic pharynx and fever without abdominal complications. After admission, he showed one stool with mucus and blood. No more clinical data was reported in the file. On 3 December 2008, surgery was performed and ileocolic intussusception was found and reduced by taxis without complications. Relevant laboratory test showed the following; on 2 December 2008; hemoglobin: 10.6 g/dL, platelets count: 205000/mm3, leucocytes count: 7400/mm3, lymphocytes percentage: 32% and neutrophils count: 2.4%. On 3 December 2008, relevant results included; hemoglobin: 16 g/dL, hematocrit: 47%, blood glucose: 100 mg/dL and prothrombin: 12 sec. Radiologic studies were not reported in the subject''s file. The subject was treated with ranitidine hydrochloride (RANITIDINE), trimethoprim (TRIMETHOPRIM), amikacin (AMIKACINE), furazolidone (FUROXONE) and metronidazole. On 10 December 2008, since post surgical evolution was adequate, the subject discharged without pharmaos and in good clinical conditions. The physician considered the events unrelated to vaccinations with ROTARIX.
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