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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 intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 29 September 2008 the subject received unspecified dose of ROTARIX (oral) lot number not provided. On 4 October 2008, 5 days after vaccination with ROTARIX, the subject experienced intussusception which was resolved by single contrast enema. The physician considered the event was clinically significant (or requiring intervention). Relevant test results included abnormal ultrasound. On 4 October 2008, the event was resolved. The physician considered the event was possibly related to vaccination with ROTARIX. Follow up received on 20 November 2008: The physician that reported intussusception was not the physician who vaccinated the child. The reporter refused to give the name of the pediatrician who followed up the baby since birth. Then further details about vaccination could not be obtained. Five days post vaccination the subject developed lethargy, fatigue, loss of appetite, intractable crying and bloody stool. Relevant test included abdominal x-ray which demonstrated invagination of the intestine by air/liquid contrast enema. Abdominal ultrasound showed visible intussusception or soft tissue mass and demonstration of an intra-abdominal mass with specific characteristic features that is proven to be reduced by hydrostatic enema on post-reduction ultrasound.
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