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Life Threatening? No
Write-up: This case was reported by a physician in the frame of pass study and described the occurrence of intussusception in an 8-month-old male subject who was vaccinated with ROTARIX. The subject had no relevant medical history or allergy. Previous vaccination included ROTAVIRUS vaccine (oral) given on 29 march 2008. On 29 March 2008, the subject received a 2nd dose of ROTARIX (oral, lot number not provided). On 3 December 2008, 6 months after vaccination with 2nd dose of ROTARIX, the subject experienced gastroalimentary vomiting, liquid and bloody stools. The subject received ambulatory treatment with AMPICILLIN trihydrate (AMPICILLIN) and PARACETAMOL (acetaminophen) secondary to rhinopharyngeal infection without improvement. On 5 December 2008, the subject was hospitalised. Physical exam reported pallor, abdominal distention with mass in descendent colon and rectal tact with abundant blood and open sphincter. Lab test were performed and showed the following Glucose: 92mg/dL; Creatinine: 0.4mg/dL; Urine specific gravity: 1.010; Hemoglobin:11.9 g/dL; Hematocrit: 34.8%; Platelets count: 35900/mm3; Prothrombin time:11.2 seconds; International normalized ratio: 0.95; Fibrinogen: 405 g/dL. Abdominal X- ray was performed and showed only loops dilatation. Diagnosis of intussusception was made. Surgery was performed on 5 December 2008. Intussusception Ileocolic and congested appendix was found and resolved by taxis, appendectomy was done with adentis mesenteric findings. The subject had bad evolution, he presented intestinal occlusion with abdominal distention, pain to palpitation, decreased bowel sounds, gasrobilary vomiting and fever. On 7 December 2008, abdominal X-ray was performed and showed ileon loops dilatation and paralytic ileus. On 9 December 2008, surgery was performed again, wall hematoma, thrombosis in 6 cm length mesentery, congestion and dilatation in sigmoid and descendent colon were found. it was resolved by anterograde decompressor colonic and aspiration of coagula with good evolution. The subject was treated with AMIKACIN, RANITIDINE, METRONIDAZOLE; METOCLOPRAMIDE(METOCLOPRAMID); FRUSEMIDE (FUROSEMIDE) , CEFOTAXIME and KETOROLAC TROMETAROL ( KETOROLAC). On 16 December 2008, the subject was discharged. On 16 December 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.
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