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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocecal intussusception in a 6-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. On 18 March 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 11 May 2008, 54 days after vaccination with ROTARIX, the subject started with vomiting. The patient was admitted at ER on 11 May 2008 and showed at physical exam dehydration, hyperemic pharynx, abdominal distension, oral intake reduced. On 12 May 2008, the subject experienced bloody stools, fever, biliary vomiting and decreased gastrointestinal peristalsis. Abdominal x-ray showed distended small bowel, air-fluid levels and intestinal obstruction. Surgery was done on 13 May July 2008. Ileocecal intussusception in ileocecal valve was found, reduced by taxis with appendectomy without complications. The subject was treated with DIPHENIDOL, PARACETAMOL and TRIMETHOPRIM. On 19 May 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information requested therefore the case has been closed.
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