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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 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical or family history. Previous and/or concurrent vaccination included bacillus calmette-guerin vaccine (manufacturer unspecified, intradermal) given on 24 December 2007; DTaP-IPV-HIB (manufacturer unspecified, intramuscular) given on 22 February 2008 and 22 April 2008; Hep B(manufacturer unspecified, intramuscular) given on 22 February 2008 and 22 April 2008; ROTARIX (GlaxoSmithKline, oral) given on 22 February 2008; pneumococcal vaccine (manufacturer unspecified) given on 22 February 2008 and 22 April 2008. On 22 April 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. on 22 June 2008, 61 days after vaccination with ROTARIX, the subject started with abdominal pain, irritability and hyporexia. The subject was hospitalized and invagination of intestine was diagnosed by clinical data. No x-ray or ultrasound was performed. Intestinal invagination type ileocecocolic without vascular complications was found and resolved by taxis without complications. The physician considered the events were life threatening and clinically significant (or requiring intervention). On 24 June 2008, the events were resolved and the subject was discharged in good conditions. The physician considered the events were possibly related to vaccination with ROTARIX. No further information expected, the case has been closed.
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