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Life Threatening? Yes
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline. Previous and/or concurrent vaccination included DTPA-HIB; manufacturer unspecified; intramuscular; given on 17 April 2008 and 17 June 2008; HEP B; manufacturer unspecified; intramuscularly; given on 30 January 2008 and 17 April 2008; ROTARIX; GlaxoSmithKline; oral given on 17 April 2008; PNEUMOVAX; manufacturer unspecified; intramuscular; given on 17 April 2008 and 17 June 2008; tuberculosis vaccine; manufacturer unspecified; intradermal; unknown deltoid given on 30 January 2008. On 17 June 2008, the subject received 2nd dose of ROTARIX (oral), lot number not provided. On 20 June 2008, 3 days after vaccination with ROTARIX, the subject experienced abdominal pain with bloody stools like current jelly stool and continuing vomiting. He was brought to hospital. At clinical examination, an abdominal mass was found. On 20 June 2008, surgery was performed and ileocolic intussusception was found and resolved by taxis without complication. However, the subject presented characteristics of intestinal obstruction and dehiscence of surgery injury, leading to 2nd surgery on 24 June 2008. The surgery revealed a 15 cm intestinal perforation of ileocecal valve, leading to intestinal resection and ileostomy. The subject was hospitalised for 14 days and the physician considered the events were life threatening and clinically significant (or requiring intervention). On 3 July 2008, the subject was discharged from hospital in good clinical condition. At the time of reporting the events were resolved with the following sequelae (intestinal resection and ileostomy). The physician considered the events were possibly related to vaccination with ROTARIX.
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