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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 invagination of intestine in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on an unspecified date. On 13 October 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. At an unspecified time after vaccination with ROTARIX, the subject experienced invagination of intestine. The subject was hospitalised and had a surgery. At the time of reporting the outcome of the event was unspecified. Follow up information received on 17 November 2008 from the physician: On 16 October 2008, 3 days after vaccination with ROTARIX, the subject experienced fever, bleeding and bloody stools. The subject was hospitalised. Invagination of intestine was diagnosed and resolved by surgery on 20 October 2008. The physician considered the events were life threatening and clinically significant (or requiring intervention). On 20 October 2008, the events were resolved.
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