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Life Threatening? No
Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocolic intussusception in a 6-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. Previous and/or concurrent vaccination included ROTARIX (GlaxoSmithKline, oral) given on 11 June 2008. On 11 August 2008 the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 2 October 2008, 52 days after vaccination with ROTARIX, the subject started with abdominal pain, vomiting and bloody stools. The patient was admitted to ER on 3 October 2008 and showed at physical exam irritability, fever, dehydration, palpable abdominal sausage shaped mass, bloody stools and bowel sounds decreased. The subject was hospitalised. Intussusception was diagnosed by clinical features. Laparotomy was done on 4 October 2008. Ileo-ceco-colic intussusception was found, with necrosis which required resection of 3 cm ileon and ascendant colon; term-to-term anastomosis was made without complications. The physician considered the events were clinically significant (or requiring intervention). Laboratory tests performed showed the following results: Leukocytes count: 10.1 UI/mm3; Platelets count: 230 000 /mm3. The subject was treated with Ampicillin, Amikacine, Metamizole and metoclopramide. On 15 October 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 was requested therefore the case has been closed.
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