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Life Threatening? No
Write-up: This case was reported by a physician in the frame a study and described the occurrence of ileocolic intussuception in a 5-month-old female subject who was vaccinated with ROTARIX. The subject was on no other medications and had no relevant medical history or allergy. Previous and/or concurrent vaccination included combined DTaP and HepB and IPV (manufacturer unspecified, intramuscular) given on 11 November 2008; ROTARIX given on 11 August 2008. On 11 November 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 26 November 2008, 15 days after vaccination with ROTARIX, the subject started with billiard vomiting, hemorrhagic residue in vomiting, fever, irritability and current jelly stool. The patient was admitted at ER on 26 November 2008 and showed at physical exam hypoactive, abdominal pain to palpation, abdominal mass, Dance sign positive, bowel sounds decreased and rectal tact with rectal mass. The subject was hospitalized. Abdominal X-ray showed bad air distribution and an intestinal loop only. Intussusception was diagnosed by clinical features and abdominal x-ray. Surgery was done on 27 November 2008. Ileocolic intussusception was found, reduced by taxis with a prophylactic appendectomy without complications. The subject was treated with Amikacine, Ranitidine, and Metamizole. On 30 November 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were possibly related to vaccination with ROTARIX. No additional information requested therefore the case has been closed.
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