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Life Threatening? No
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history. Previous and/or concurrent vaccination included DTaP-IPV-HIB (manufacturer unspecified, intramuscular) given on 22 November 2007 and 22 January 2008; Hep B (manufacturer unspecified, intramuscular) given on 20 September 2007, 22 November 2007 and 22 March 2008; ROTARIX (GlaxoSmithKline, oral) given on 22 January 2007, pneumococcal vaccine (manufacturer unspecified, intramuscular) given on 22 November 2007 and 22 January 2008; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 20 September 2007. On 22 November 2007, the subject received 1st dose of ROTARIX (1 ml, oral). Lot number not provided. On 3 January 2008, 42 days after vaccination with ROTARIX, the subject was taken to ER, with colicky abdominal pain and 2 evacuations without mucus or blood with initial diagnosis of acute enteritis. After evaluation, intestinal intussusception was diagnosed. The surgery was done on 3 January 2008 and showed ileo-colic intussusception resolved by taxis without resection and complication. The subject had good response and favorable evolution. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). The physician did not have any data about diagnostic procedure. No abdominal X-ray or ultrasound was performed. On 6 January 2008, the events were resolved by surgery and the patient was discharged. After the next vaccination with ROTARIX the events did not recur. The physician considered the events were possibly related to vaccination with ROTARIX.
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