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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by the regulatory authority (BX20100405) and described the occurrence of intussusception of intestine in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant past medical history. On 15 January 2010, the subject received an unspecified dose of ROTARIX (batch unknown, oral). On 02 February 2010, 18 days after vaccination with ROTARIX, the subject presented with febricula and abdominal pain leading to hospitalisation. Ultrasound scan confirmed diagnosis of acute intussusception of intestine. Intussusception was reduced by enema. On 05 February 2010, febricula and abdominal pain resolved. From 18 to 19 March 2010, the subject was again hospitalized for a new episode of abdominal pain probably unrelated to previous intussusception. A virosis was evoked (incidental events). ROTARIX has not been readministered. According to the method of assessment, the relationship between the reported events and vaccination with ROTARIX was dubious.
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