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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 male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had genetic antecedents of cardiopathy. Previous and/or concurrent vaccination included DTaP-IPV-HIB (manufacturer unspecified, intramuscular) given on 7 March 2008; Hep B (manufacturer unspecified, intramuscular) given on 19 December 2007 and 7 March 2008; pneumococcal vaccine (manufacturer unspecified, intramuscular) given on 7 March 2008; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 19 December 2007. On 7 March 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 13 March 2008, 6 days after vaccination with ROTARIX, the subject was taken to ER with rhinorrhea, conjunctival secretions, fever, irritability and 2 bloody stools like black current jelly. Intussusception was suspected. The patient was hospitalized. On 14 March 2008, ileo-ileo-cecolic intussusception was diagnosed with resolved by taxis with appendectomy without resection and complication. The subject had good response and favorable evolution. The physician considered the events were clinically significant or requiring intervention). Abdominal X-ray was performed and showed fluid levels and dilated bowel loops. Air or Liquid contrast enema did not show visible intussusception or soft tissue mass, or invagination of intestine, or specific abnormalities. On 26 March 2008, the events were resolved by surgery and the patient was discharged. The physician considered the events were possibly related to vaccination with ROTARIX.
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