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Life Threatening? Yes
Write-up: This case was reported by a physician in a frame of a study and described the occurrence of ileocolic intussusception in a 10-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). When the events started the subject was 6-month-old. On 7 August 2007 the subject received 1st dose of ROTARIX (oral). The 2nd dose schedule which should be given on 07 October 2007 was discontinued. The subject was on no other medication and had no relevant medical history nor allergy. On 21 November 2007, 106 days after vaccination with ROTARIX, the subject presented bloody stool (6-8 times/day), vomiting (6 times/day) and fever. On 25 November the subject was brought to hospital. Subject''s physical examination showed pallor, jelly red stools and abdominal distention. Abdominal x-ray showed distended intestinal loops. The same day the subject underwent a surgery. Intussusception was confirmed and resolved. Also ileostomy (20cm) was performed due to ileal necrosis and prophylactic appendectomy. On 29 November 2007 the subject was transferred to another hospital in bad conditions with persisting bloody stools and abdominal distention. Therefore a 2nd surgery was performed finding generalised peritonitis due to 3 intestinal perforation, 3-termino anastomosis were done. On 03 December 2007 a 3rd surgery was done due to opened anastomosis. On 06 December 2007 the 4th surgery was performed due to intestinal fistula. The subject was treated with total parenteral nutrition due to short intestine syndrome. The subject evolution was bad. The subject was hospitalised and the physician considered the events were disabling and life threatening. The subject was treated with AMPICILLIN, amikacin, clindamycin, metronidazole, Ranitidine, methimazole. The physician considered the events were unrelated to vaccination with ROTARIX. The subject died on 14 March 2008 from sepsis. An autopsy was not performed.
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