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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 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. The subject had no concomitant medication. On 27 October 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 24 December 2008, 58 days after vaccination with the 1st dose of ROTARIX, the subject experienced vomiting, bloody stools, abdominal pain and fever. On 25 December 2008, the subject was admitted at ER; physical exam reported irritability, fever, cervical adenopathy, hyperemic pharynx, abdominal pain and increased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Lab tests were performed on 26 December 2008 and showed the following: Hemoglobin: 10.2 g/dL; Platelets: 219000/mm3; Prothrombin time: 11.3 Seconds; Leucocytes: 13500/mm3. Abdominal X-ray was performed and showed distention loops and gas/liquid levels. Intussusception was suspected and confirmed by laparotomy on 26 December 2008; Ileocecal intussusception was found and reduced by taxis without complications. Lab tests were performed on 27 December 2008 and showed the following: Potassium: 5.6 mEq; Sodium: 135. Lab tests were performed on 28 December 2008 and showed the following: Potassium: 5 mEq; Sodium: 136. The subject was treated with AMOXICILLIN, trimethoprim + sulfamethoxazol, Metamizol, Ampicillin, metoclopramide and paracetamol. On 29 December 2008, the events were resolved. The vaccination course with ROTARIX was discontinued because of the intussusception. The physician considered the events were unrelated to vaccination with ROTARIX.
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