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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 ileo-ceco-colic intussusception in a 5-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history. Previous and/or concurrent vaccination included DTPa-IPV-HIB (manufacturer unspecified, intramuscular) given on 12 December 2007, 15 February 2008 and 15 April 2008; pneumococcal vaccine, unspecified (manufacturer unspecified, intramuscular) given on 12 December 2007 and 15 February 2008; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 25 October 2007. On 12 December 2007, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 3 April 2008, 113 days after vaccination with ROTARIX, the subject was taken to ER with gastric intolerance with 5 episodes of vomiting and 2 bloody stools like black currant jelly. The diagnosis was done clinically. Surgery was performed on 3 April 2008 and showed ileo-ceco-colic intussusception resolved by taxis with prophylactic appendectomy without resection and complication. The patient had good response and was discharged on 6 April 2008. No abdominal x-ray, ultrasound or scan was performed. The physician considered the events were clinically significant (or requiring intervention). On 6 April 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.
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