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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by two physicians, including one via a GSK sales representative and described the occurrence of invagination of intestine in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was not a premature baby. He had no relevant past medical condition of digestive malformation. One week before the vaccination with ROTARIX, the subject presented with cough and rhinitis. On 08 September 2006, the subject received a 1st dose of ROTARIX (batch number not available, oral). On 10 September 2006, two days after vaccination, the subject did not feel good and according to his parents he developed blood in urine. At the emergency unit, urinary analysis was negative and full blood cell count and thorax X-ray were normal. In the night between 10 and 11 September 2006, he vomited twice. On 11 September 2006, in the morning, the subject did not feel good and was grumpy. According to his parents, he presented with blood in stools. Clinical examination showed pain on palpation at right hypochondrium level. He was thus hospitalized. Echography and X-ray with therapeutic enema were performed and confirmed the diagnosis of invagination of intestine. Quickly, the subject was discharged from hospital and the events were resolved. At the time of reporting, the subject was in good health condition. The reporters'' causality assessment was unknown. Follow up received on 11 October 2006 from the hospital physician: The subject and his family had no past medical history of intussusception. At the hospital, clinical symptomatology evoked acute invagination of intestine. Abdominal echography and X-ray with therapeutic enema confirmed invagination of right colon. The events resolved on 11 September 2006 after the therapeutic enema. The reporter (hospital physician) considered that the invagination of intestine was possibly related to the vaccination with ROTARIX. Vaccination course has been discontinued. Follow-up information was received on 27 November 2006 by the agency (LL0600318) and reported that according to the foreign method of imputability, the events were dubiously related to ROTARIX vaccine. Follow up of 23 November 2007: This case has been closed; no more information will be available. Follow-up of 02 April 2010 by the agency: Correction of ROTARIX vaccination date: 07 September 2006 instead of 08 September 2006. Time to onset of intussusception was thus 3 days instead of two days. No new information was received.
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