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Life Threatening? No
Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of ileocecocolic intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history. Concurrent medical conditions included penicillin allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 1 December 2007. On 21 February 2008 the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 29 April 2008, 68 days after vaccination with ROTARIX, the subject started with bloody stools, fever, irritability, vomiting and pallor. The patient was admitted at ER on 30 April 2008 and showed at physical exam abdominal pain, fever, current jelly stool and sausage shaped abdominal mass. Intussusception was suspected. Ileocecocolic intussusception was confirmed by laparotomy, with appendix necrosis, reduced by taxis and appendectomy without complications. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). Tests were performed on 30 April 2008 and showed the following results: Hemoglobin: 11.5 mg/dl; Hematocrit: 34.8 %; Leukocytes: 12 700/mm3; Neutrophils: 12 300/mm3; Platelets: 407 000/mm3; Prothrombine time: 13.4 sec. The subject was treated with Amikacine, metronidazole, Metamizole, Ranitidine and AMBROSOL. On 6 May 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information requested therefore the case has been closed.
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