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Life Threatening? No
Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline) for prophylaxis. Concurrent and or previous medical conditions included intussusception in May 2008 which was resolved by taxis in explorer laparotomy. Further information was not available in the file. On 21 May 2008 the subject received 1st dose of ROTARIX (oral). On 12 July 2008, 52 days after vaccination with the 1st dose of ROTARIX, the subject experienced ileocolic intussusception, which was also resolved by taxis without complications, post explorer laparotomy, intestinal resection was not performed. On 21 July 2008 the subject received 2nd dose of ROTARIX (oral). On 30 August 2008, 40 days after the 2nd dose of ROTARIX the subject presented irritability, gastrobiliar vomiting (more than 10 times), abdominal pain, and sanguinolent stools. The same day she was admitted to the emergency room with somnolence, pallor abdominal pain, decreased peristalsis, palpable abdominal mass and rectal tact with expulsion of current jelly stools. Relevant test included abdominal ultrasound which showed evidence of intussusception. The medical surgeon treated her with Diazepam for abdominal relaxation. He could palpate in ileocecal area abdominal mass which was reduced successfully and slowly with normal procedure in retrograde direction. On 31 August 2008 the subject showed clinical improvement with just slow peristalsis, without any sanguinolent stool. The subject presented a good evolution with good oral acceptance. The same day abdominal x-ray showed improvement in the intestinal air distribution. On 03 September 2008 the subject discharged in franc resolution. The subject was treated with cefotaxime, metronidazoloe, Metamizole, Ranitidine, paracetamol, Trimethoprin and diazepam. At the time of reporting the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX. In the follow up received on 23 September 2008 it was confirmed that there were relapse of intussusceptions. In May the subject had the 1st intussusception. It was unknown if the event occurred before or after vaccination. The subject showed irritability and gastrobiliar vomiting. Intussusception was resolved in another hospital. The clinical file was not available. The outcome date and laboratory tests were unknown. On 11 July 2008 the subject presented irritability, vomiting and current jelly stools. On 12 July 2008 the 2nd intussusception type ileocolic was detected and corrected by surgical taxis. On 15 July 2008 the event was resolved. On 30 August 2008, the subject presented 3rd intussusception which was resolved with external manoeuvre reduction with sedation (diazepam), surgical correction was not required. Follow up received on 05 December 2008 from the physician: On 6 October 2008, 77 days after vaccination with 2nd dose of ROTARIX, the subject started with biliary vomiting and current jelly stool. The subject was admitted at ER with abdominal pain, pallor, bowel peristalsis decreased, irritability and decreased gastrointestinal peristalsis. Abdominal x-ray showed intestinal occlusion, air-fluid levels and lack of air in rectal ampulla. The subject was hospitalized for surgery on 7 October 2008, ilecolic intussusception was found without complications. One adhesion was found (from caecum to terminal ileum) resolved by lysis. Ileocolic intussusception was resolved by taxis without intestinal resection. The physician considered the events were disabling. Relevant tests performed on 7 October 2008 showed the following results: Hemoglobin: 10.5 g/dl; Leukocytes: 13 400/mm3; Platelets: 295 000 /mm3; Potassium: 4.9 mEq/1; Sodium: 146 mEq/1; Blood group: 0+. The subject was treated with cefotaxime, metronidazole, Metamizol, Ranitidine, diazepam and Ketorolac. The subject had a goiod recuperation and was discharged on 11 October ingood clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX.
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