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Life Threatening? Yes
Write-up: This case was reported by a physician and described the occurrence of ileocolic intussusception in a 10-month-old female subject who was vaccinated with ROTARIX, GlaxoSmithKline. The subject had no relevant medical history. Previous and/or concurrent vaccination included DTAP-IPOL-HIB (manufacturer unspecified, intramuscular) given on 3 December 2007, 5 February 2008 and 4 April 2008; HEP B (manufacturer unspecified, intramuscular) given on 24 September 2007, 3 December 2007 and 4 April 2008; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 24 September 2007. On 5 March 2008, the subject received 1st dose of ROTARIX (1 ml, oral). Lot number not provided. On 3 August 2008, 5 months after vaccination with ROTARIX, the subject started with abdominal pain, vomiting, and bloody stools. The subject was hospitalized on 4 August 2008 with data of intestinal obstruction. The diagnosis of intussusception was confirmed by abdominal x-ray. The surgery was done on 5 August 2008. Ileocolic intussusception was resolved by intestinal resection of 40 cm without complication. The patient had good response and favorable evolution. The physician considered the events were life threatening and clinically significant (or requiring intervention). Abdominal radiography was performed and showed non-specific abnormalities, fluid levels and dilated bowel loops. The X-ray did not showed visible intussusception or soft tissue mass. Air or liquid contrast Enema performed did not demonstrate invagination of the intestine. Abdominal ultrasound was not done in diagnostic procedures. On 18 August 2008, the events were resolved and the subject was discharged. The physician considered the events were possibly related to vaccination with ROTARIX.
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