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Life Threatening? No
Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). There were no reported concomitant medications or relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccination included DAPTACEL (non-gsk) (Sanofi) given on 8 July 2009; PREVNAR (non-gsk) (Wyeth Labs) given on 8 July 2009; IPOL (non-gsk) (Sanofi) given on 8 July 2009. On 8 July 2009 the subject received 1st dose of ROTARIX (1 ml; oral). The lot number was reported as A41OA733A. On 15 July 2009, 7 days after vaccination with ROTARIX, the subject experienced intussusception and "severe" vomiting. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. The healthcare professional considered the events were probably related to vaccination with ROTARIX. 10/2/09 Hospital records, DC summary, received DOS 7/16/09 to 7/17/09. Assessment: Intussusception. Presented to ER with 2 days of increased vomiting, fussiness, and decreased stooling, no wet diapers. Fever, respirations and heart rate elevated. Rash below chin. Abdomen rigid. Symptoms resolved with air enema. Some ascites. ICD-9 Codes: 560.0 Intussusception, 276.51 Dehydration. Follow-up information received on 21 August 2009 indicated that the events began on 15 July 2009 and resolving by the following day, 16 July 2009. The subject received an enema for treatment and symptoms resolved. In the reporter''s opinion, the events were probably related to treatment with ROTARIX. The child did not receive bowel resection.
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