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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 an 8-month-old male subject who was vaccinated with ROTARIX (oral) given on 9 June 2008. The subject was previously healthy; he had no relevant medical history or allergy. Previous vaccination included ROTARIX (GlaxoSmithKline). On 1 August 2008, the subject received the 2nd dose of ROTARIX (oral, lot number not provided). On 25 December 2008, 5 months after vaccination with the 2nd dose of ROTARIX, the subject experienced abdominal pain, nausea, vomiting and irritability. On 26 December 2008, the subject was admitted at ER. Physical exam reported vomiting, current jelly stool and decreased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Lab tests were performed and showed the following: Leucocytes: 15800 IU; Neutrophils: 77%; Platelets: 400000 IU; Hemoglobin: 12 mg/dL; Prothrombin time: 12.5 Seconds: Partial thromboplastin time: 23.3 Seconds; Sodium: 141 mEq/dL; Potassium: 4.6 mEq/dL; BUN: 13 mg/dL; Creatinine: 0.3 mg/dL; Glucose: 128 mg/dL. X-ray was performed and showed intestinal loops distention and bad gas distribution. Intussusception was suspected and confirmed by laparatomy on 27 December 2008. Ileocecocolic intussusception was found and reduced by taxis without complications. The subject was treated with Ranitidine. After recovery, the subject was discharged on 30 December 2008 in good clinical conditions. On 30 December 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.
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