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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 5-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 18 July 2008. On 18 September 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 17 October 2008, 29 days after vaccination with ROTARIX, the subject started with hyporexia, bloody stools and nausea. The patient was admitted at ER on 20 October 2008 and showed at physical exam abdominal distension, irritability, impaired peristalsis and current jelly stool. The subject was hospitalised. Intussusception was diagnosed by abdominal x-ray. Laparotomy was done on 20 October 2008. Ileocecal intussusception was found, reduced by taxis without complication. The treatment given was not available in the clinical chart. Tests were performed on 20 October 2008 and showed the following results: Hemoglobin: 10.8 g/dl; Platelets count: 478000/mm3; PT: 13 sec; PTT: 32 sec; Blood group: O Rh+. On 23 October 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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