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Life Threatening? Yes
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX, GlaxoSmithKline. Previous vaccination included INFANRIX HEXA, GlaxoSmithKline; intramuscular, 1st dose left low inferior member given on 4 December 2007; PREVENAR; Wyeth Labs; intramuscular, 1st dose; right low inferior member given on 4 December 2007. On 3 January 2008 the subject received 1st dose of ROTARIX (oral). On 08 February 2008 the subject received the second dose of INFANRIX HEXA and PREVENAR. On 9 February 2008, 37 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised and the physician considered the event was life threatening and clinically significant (or requiring intervention). Relevant test results included abdominal x-ray which showed fluid levels and dilated bowel loops and the abdominal ultrasound showed a visible intussusception or soft tissue mass. The subject was treated with surgery on 10 February 2008. Intussusception was demonstrated at surgery. The subject required bowel resection. It was reported that complications occurred at radiological procedure but no details were provided. At the time of reporting the outcome of the event was unspecified. The physician considered the event was almost certainly related to vaccination with ROTARIX. In the follow up received on 25 April 2008 it was mentioned that the physician did not report and signs nor symptoms. Besides it was clarified that the complication at radiological procedure was an intestinal track perforation. On 15 April 2008 the subject was fully recovered.
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