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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 ileo-ileo-caeco-colic intussusception in a 6-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history and no allergy. Previous and/or concurrent vaccination included ROTARIX (GlaxoSmithKline, oral) given on 17 January 2008. On 12 March 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 11 May 2008, 60 days after vaccination with ROTARIX, the subject experienced nausea, vomiting, fever and one liquid stool. She was taken to emergency room with pallor, dehydration, hyperemic pharynx and abdominal zone with increased peristalsis. 15 hours later, the patient showed evidence of abdominal distention, irritability, more vomiting and diarrhea. Abdominal x-ray performed on 14 May 2008 showed liquid air levels and lack of distal air. The subject was hospitalized and surgery was done on 15 May 2008. Ileo-ileo-caeco-colic intussusception was found on descendent colon resolved by taxis and appendectomy without complication. The subject showed good evolution. Laboratory tests were performed on 14 May 2008 and showed the following results: Hemoglobin: 11 g/dl; Hematocrit: 35%; Leukocytes: 7530 /mm3; Neutrophils: 29%; Platelets: 527000 /mm3; Lymphocytes: 57%; Chloride: 94 mEq/l. The subject was treated with ranitidine, metoclopramide, paracetamol, cefotaxime, metronidazole, amikacin, dipyrone and ampicillin trihydrate. On 21 May 2008, the events were resolved and the subject was discharged. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information expected; the case has been closed.
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