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Life Threatening? Yes
Write-up: This case was reported by a physician and described the occurrence of ileocecocolic intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included bacillus calmette-guerin vaccine (non-gsk); manufacturer unspecified; intradermal; unknown deltoid given on 17 June 2007; combined DTaP-IPV-HIB; manufacturer unspecified; intramuscular; given on 4 August 2007, 15 October 2007 and 13 December 2007; Hep B; manufacturer unspecified; intramuscular; given on 17 June 2007, 14 August 2007 and 13 December 2007; ROTARIX; GlaxoSmithKline; oral given on 4 August 2007; pneumococcal vaccine, unspecified; manufacturer unspecified; intramuscular; given on 4 August 2007 and 15 October 2007. On 15 October 2007, the subject received 2nd dose of ROTARIX (oral), lot number not provided. On 14 January 2008, 91 days after vaccination with 2nd dose of ROTARIX, the subject experienced abdominal pain and diarrhea, leading to hospitalisation. The physical examination found the subject irritable, dehydrated with Morcilla''s sign. The abdominal X-ray revealed air-fluid levels. The subject was hospitalised for 4 days and the physician considered the events were life threatening and clinically significant (or requiring intervention). On 15 January 2008, a surgery was performed and ileocecocolic intussusception without vascular complication was found and reduced by taxis without complication. No bowel resection was performed. On 17 January 2008, the events were resolved and the subject was discharged from hospital in good clinical condition. The physician considered the events were possibly related to vaccination with ROTARIX.
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