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Life Threatening? Yes
Write-up: This case was reported by the regulatory authority (reference RN0700227) and described the occurrence of intussusception of intestine in a 6.5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). At the time of ROTARIX administration, no other vaccine was co-administered, no concurrent medication was taken. At the time of events, the subject weighted 8 kg and measured 71 cm. On 08 December 2006, the subject received a 1st dose of ROTARIX (batch A41DA194B, oral). There was no vomiting or diarrhea episode at the time of vaccination. On 14 April 2007, four months after vaccination with ROTARIX, the subject was hospitalized for abdominal pain and vomiting without rectorrhagia due to an acute ileocolic intussusception (unspecified diagnostic test). Intussusception was reduced by air enema under general anaesthesia. Bowel movements passed normally on day two. The regulatory authority reported that the events were life threatening. According to the method of assessment, the relationship between vaccination with ROTARIX and the reported event was dubious.
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