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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a physician and described the occurrence of ileocolic intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included bacillus calmette-guerin vaccine (non-gsk); non-GSK manufacturer; intradermal; given on 12 September 2007; DTAP-IPV-HIB; manufacturer unspecified; intramuscular; given on 12 November 2007 and 24 January 2008; HEP B; manufacturer unspecified; intramuscular; given on 12 September 2007 and 12 November 2007. The subject was healthy. On 24 January 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 29 January 2008, 5 days after vaccination with ROTARIX, the subject experienced abdominal pain with bloody stools, increased peristalsis, abdominal distension and irritability. He was brought to the emergency ward. The morcilla sign was positive. On 30 January 2008, the abdomen X-ray showed fluid levels and dilated bowel loops as well as non-specific abnormalities and intestinal obstruction. A laparatomy was performed and ileocolic intussusception was found and treated by taxis without complications. The subject was hospitalised for 5 days and the physician considered the events were clinically significant (or requiring intervention). On 2 February 2008, the events were resolved and the subject was discharged from hospital in good conditions. The physician considered the events were almost certainly related to vaccination with ROTARIX. No further information was available. This case has therefore been closed.
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