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Life Threatening? No
Write-up: This case was reported by a physician and described the occurrence of ileo-caeco-colic intussusception in an 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history. Previous vaccination included hepatitis B vaccine recombinant (manufacturer unspecified, intramuscular) ; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 29 December 2007. On 7 March 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided; On 4 May 2008, 58 days after vaccination with ROTARIX, the subject was taken to emergency room and started with abdominal pain, colic, 8 episodes of vomiting, 2 bloody stools like black currant jelly, fever and 1 tonic-clonic seizure. The initial diagnosis was gastroenteritis but the occurrence of bloody stools corroborated the diagnosis of intussusception which was confirmed by abdominal x-ray. The surgery was done on 4 May 2008. Ileo-caeco-colic intussusception was resolved by taxis without intestinal resection and complication. The patient had good response and favorable evolution. Abdominal radiography performed did not show abnormalities, visible intussusception or soft tissue mass, fluid levels and dilated bowel loops. Air or liquid contrast Enema performed did not demonstrate invagination of the intestine. Abdominal ultrasound was not done in diagnostic procedures. The physician considered the events were clinically significant (or requiring intervention). On 7 May 2008, the events were resolved and the patient was discharged. The physician considered the events were unrelated to vaccination with ROTARIX. Additional information has been requested.
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