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Life Threatening? No
Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileo-colic intussusception in a 8-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. Previous and/or concurrent vaccination included ROTARIX (GlaxoSmithKline, oral) given on 15 February 2008. On 16 April 2008; the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 8 July 2008, 83 days after vaccination with ROTARIX, the subject started with abdominal pain, vomiting and poor oral intake. On 9 July 2008, he was taken to ER. At physical exam, he experienced abdominal pain to palpation, abdominal mass in transverse colon, bowel sounds decreased, bloody stools and rectal tract with blood and empty rectal ampulla. On 9 July 2008, abdominal x-ray was performed and showed lack of air in intestine, right side, lack of air in distal zone and dilated bowel loop. On 9 July 2008, pneumo-enema was done and showed invagination to transverse colon which was reduced in the first intent with success without complication. The subject was hospitalised and discharged in good clinical conditions on 31 July 2008. Laboratory tests were performed on 9 July 2008 and showed the following results: Hemoglobin: 13 g/dl; Hematocrit: 37.7%; Platelets: 384 000/mm3; Leukocytes: 9600/mm3; Neutrophils: 63%; PT: 10.8 sec; PTT: 27.5 sec; Glucose: 93 mg/dl; Sodium: 131 mEq/l; Potassium: 4 mEq/l; Urinary pH: 6; Urinary exam: leukocytes negative, bacteria negative, nitrites negative. The subject was treated with amikacin, metronadizole, ranitidine hydrochloride and METAMIZOLE. On 13 July 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.
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