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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a physician (via a sales representative) and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 3 June 2008, the subject received unspecified dose of ROTARIX (unknown) lot number not provided. On 11 June 2008,8 days after vaccination with ROTARIX, the subject was hospitalized due to severe intussusception. At the time of reporting the outcome of the event was unspecified. Follow up information received on 24 December 2008 from the physician: Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given in May 2008. On 11 June 2008, 8 days after vaccination with ROTARIX, the subject experienced ileocolic intussusception which was reduced by surgery on 11 June 2008. The subject was hospitalized and the physician considered the event was clinically significant (or requiring intervention). Laboratory tests were performed on 11 June 2008 and showed the following results: Abdominal x-ray: fluid levels and dilated bowel loops; Abdominal ultrasound: visible intussusception or soft tissue mass; White blood cells: 17 600 /mm3; Neutrophiles: 87%; CRP: 0.4. At the time of reporting the event was resolved. The physician considered the event was probably related to vaccination with ROTARIX. No further information expected; the case has been closed.
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