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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of ileocolic intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was under no other medication and had no relevant medical history nor allergy. The subject was healthy. On 13 December 2007, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 9 January 2008, 27 days after vaccination with ROTARIX, the subject experienced vomiting and bloody stools. She was brought to the emergency ward where the physical examination revealed bowel sounds decreased and current jelly stools. Intussusception was suspected. On 10 January 2008, surgery was performed and ileocolic intussusception was found and reduced by taxis without complication. The subject was hospitalised for 5 days and the physician considered the events were clinically significant (or requiring intervention). On 13 January 2008, the events were resolved and the subject was discharged from hospital in good clinical condition. The physician considered the events were possibly related to vaccination with ROTARIX.
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