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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history. On an unspecified date the subject received 1st dose of ROTARIX (1 ml, oral). Lot number not provided. On 2 December 2008, at an unspecified time after vaccination with ROTARIX, the subject experienced bloody stools, vomiting, nausea, hyporexia, irritability, abdominal distention. On 5 December 2008, the subject was taken to emergency room with dehydration, abdominal pain, morcilla sign positive and bowel peristalsis decreased. An abdominal X-ray was performed on 5 December 2008. Ileocolic intussusception was suspected and confirmed by laparotomy, performing taxis without complications. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). Plain abdominal radiograph showing fluid levels AND dilated bowel loops. Plain abdominal radiograph showing non-specific abnormalities. No abdominal scan or ultrasound was performed. On 11 December 2008, the events were resolved. The subject was discharged in good medical condition. The physician considered the events were almost certainly related to vaccination with ROTARIX.
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