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Life Threatening? Yes
Write-up: This case was reported by a healthcare professional, via another manufacturer (Merck) and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX ;GlaxoSmithKline;oral given when the subject was 2-months-old. On an unspecified date, at 4-months-old, the subject received 2nd dose of ROTARIX (oral). Approximately one month after vaccination with ROTARIX, the subject experienced intussusception. This case was assessed as medically serious by GSK. The subject was treated with surgery. At the time of reporting the outcome of the event was unspecified. Follow-up information received from healthcare professional on 18 May 2010: Previous and/or concurrent vaccination included DTPA-POLIO-HIB (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010; either ENGERIX B or RECOMBIVAX ;manufacturer unspecified given on 12 January 2010 and 9 March 2010; ROTARIX ;GlaxoSmithKline;oral given on 12 January 2010; PREVNAR (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010. On 9 March 2010 the subject received 2nd dose of ROTARIX (oral). On 9 April 2010, 31 days after vaccination with ROTARIX, the subject experienced intussusception, vomiting and abdominal pain. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). Relevant test results included abdominal ultrasound on 09 April 2010 which revealed intussusception. The subject was treated with surgical repair. On 15 April 2010, the events were resolved. Relationship of the events to vaccination with ROTARIX was not specified, but the healthcare professional identified ROTARIX as the suspect product.
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