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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a physician via sales representative and described the occurrence of intussusception in a 9-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 6 November 2008 the subject received unspecified dose of ROTARIX (unknown), lot number unknown. The subject experienced intussusception. Therefore on 11 November 2008 the subject underwent a surgery. At the time of reporting the outcome of the event was unspecified. Follow up received on 07 January 2008: Subject''s family history did not include intussusception or bowel abnormalities. The subject did not have previous intra-abdominal surgery. On 11 November 2008 the subject onset ileocolic intussusception till spleen angle. Relevant test performed on 11 November included abdominal X-ray which confirmed intussusception and showed fluid levels and dilated bowel loops; the abdominal ultrasound showed visible intussusception. The same day the subject underwent a surgery. No resection was required. The subject survived. The vaccination with ROTARIX was discontinued. The outcome of the event remained unspecified. Follow up received on 10 February 2009: On 10 November 2008 the subject started vomiting and not drank anymore in the night. On 11 November 2008 the subject had bloody diarrhea and afterwards passive ++. Therefore he was brought to the emergency department. Relevant test included also echo abdomen and contrast enema. On 18 November 2008 the subject was discharged in good general conditions. On 25 November 2008 the subject underwent a control. The subject was fully recovered.
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