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Life Threatening? No
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 9-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject''s medical history included hypothyroidism, interventricular communication of travelucat type and untreated serious pulmonary stenosis. Previous and/or concurrent vaccination included DTaP and HIB (manufacturer unspecified, intramuscular) given on 10 January 2008 and 14 March 2008; hepatitis B vaccine recombinant (manufacturer unspecified, intramuscular) given on 7 November 2007 and 10 January 2008; ROTARIX (GlaxoSmithKline, oral) given on 10 January 2008; Bacillus calmette-guerin vaccine (non-GSK manufacturer, intradermal) given on 7 November 2007. On 14 March 2008 the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 24 July 2008, 4 months after vaccination with ROTARIX, the subject started with vomiting, fever and abdominal strain. She was admitted at the emergency unit at the hospital in August. The subject experienced dehydration and bowel peristalsis decreased. Abdominal x-ray was performed and showed hydroaeral levels and a poor distribution of gas. An exploring laparotomy was realized finding an ileo-ileal intussusception with a necrosis of an ileon of 40cm Meckel diverticulum. A non communicated ileostomy was done and after a good evolution patient was out from hospital on 18th August 2008. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. The physician considered the events were possibly related to vaccination with ROTARIX.
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