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Life Threatening? No
Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with Rotarix (GlaxoSmithKline). Previous and/or concurrent vaccination included Pentaxim, Sanofi Pasteur MSD (intramuscular; left thigh) given on 6 December 2007, 8 January 2008 and 5 February 2008; Heberboivac, Heber Biotec (intramuscular; right thigh) given on 6 December 2007, 8 January 2008; Rotarix (GlaxoSmithKline; oral) given on 8 January 2008. On 5 February 2008 the subject received 2nd dose of Rotarix (oral). The subject was healthy and responded well to previous vaccinations without experienced any adverse event. On 8 February 2008, 3 days after vaccination with Rotarix, the subject developed symptoms of bloody stools and vomiting. The subject was taken to the emergency room as the subject got worse. Relevant test included abdominal x-ray which showed dilated gas-filled bowel loops in central abdomen with fluid levels, gas visible in descending colon, obstruction of ileus, no visible air in bowel walls, heart and lung fields appear normal. The physician advised her admission but the subject''s parents apparently refused it. On 09 February 2008 the subject was taken back to hospital where resuscitation was started but the subject passed away on the same day at 9:00. The autopsy was being planned for the 12th February 2008. The subject died due to intussusception which was probably related to vaccination with Rotarix. Follow up received on 26 February 2008: After a phone communication the subject''s parents did not want to give a copy of the autopsy. The subject''s mother mentioned that all the documentation of the autopsy was frozen. According to the subject''s mother the autopsy report stated that the subject died due to obstruction of the ileum caused by the Rotarix. Follow up received on 22 April 2008: The autopsy report (performed on 12 February 2008) stated: Cause of death included bowel obstruction with intussusception and necrosis of the small bowel. Subject''s age: 3month-old and 17 days. Length: 60 cm. Mass approximately: 5 kg. Subject''s physique under average. Subject''s nutrition good. Secondary postmortem changes: rigor mortis. External appearance of body and condition of limbs: abdominal distention with blue discolouration of skin over abdomen. No external injuries visible. Trachea: no foreign object''s in trachea. Peritoneal cavity: abdominal distention and ascites. Intestine and mesentery: intussusception of small bowel with acute bowel obstruction and necrosis of small bowel. The medical certificate of death stated: Immediate cause: intestinal obstruction. Underlying cause: intussusception.
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