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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 10-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included ROTARIX (GlaxoSmithKline; oral) given on 18 March 2008. On 16 July 2008, the subject received the 2nd dose of ROTARIX (oral). On 15 October 2008, 91 days after vaccination with the 2nd dose of ROTARIX, the subject experienced intussusception. Transmission of an infectious agent via a medicinal product was suspected. The subject presented in ER. On 16 October 2008, abdominal USG was performed and showed intussusception. The physician considered the events were life threatening and clinically significant (or requiring intervention). On 27 October 2008, emergency laparotomy was done to save life. The subject was well after surgery. On 27 October 2008, the events were resolved. The physician considered the events were almost certainly related to vaccination with ROTARIX. This case was associated to a product complaint.
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