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Life Threatening? No
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline. The subject had no relevant medical history. On 16 January 2009, the subject received 2nd dose of ROTARIX (1 ml, oral). Lot number not provided. On 19 January 2009, 3 days after vaccination with ROTARIX, the subject was taken to hospital with fever and abdominal distension. The initial diagnosis was conscience disorder but the occurrence of 2 bloody stools like jelly corroborated the diagnosis of intussusception which was confirmed by abdominal ultrasound. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). Laboratory tests were performed and showed the following: Serum electrolytes: normal; Blood culture: normal; Complete blood count: normal. Abdominal ultrasound showed visible intussusception or soft tissue mass. Abdominal X-ray and air or liquid contrast Enema were not done in diagnostic procedures. The surgery was done by laparotomy and intussusception was resolved without intestinal resection and complication. The patient had good response and favorable evolution. On 22 January 2009, the events were resolved and the patient was discharged. The physician considered the events were possibly related to vaccination with ROTARIX.
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