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Life Threatening? No
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 7-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP-IPV-HIB (manufacturer unspecified, intramuscular) given on 8 October 2007 and 13 February 2008; hepatitis B vaccine recombinant (manufacturer unspecified, intramuscular) given on 8 October 2007 and 13 February 2008; influenza virus vaccine (manufacturer unspecified, intramuscular) given on 7 August 2007 and 7 February 2008; pneumococcal vaccine, unspecified (manufacturer unspecified, intramuscular) given on 6 November 2007; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 7 August 2007. On 8 October 2007 the subject received 1st dose of ROTARIX (oral). On 9 March 2008, 5 months after vaccination with ROTARIX, the subject experienced irritability, gastric vomiting, 9 x), fetid liquid stools. On 10 March 2008, the subject presented bloody stools, abdominal distension and continued vomiting. The subject went to the emergency room presenting dehydration, irritability, a few wheezing, decreased peristalsis and abdominal pain without palpable mass. Relevant test performed on 11 March 2008 included abdominal x-ray with air fluid levels which showed very dilated intestinal loops. The same day the subject underwent a surgery where it was found ileocecal intussusception and it was reduced by taxis. The subject also had an appendectomy. During surgery the subject had hypovolemia and he was sent to pediatric intensive care unit for hemodinamic monitoring. He presented ileo reflux improvement for 36 hours. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with AMPICILLIN, pain medication and gastric protection. On 18 March 2008, the subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX.
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