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Life Threatening? No
Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 5 February 2010 and 12 March 2010, the subject received 1st dose and 2nd dose of ROTARIX (route unknown, batch number not provided). On 2 May 2010, 51 days after vaccination with 2nd dose of ROTARIX and 86 days after vaccination with 1st dose of ROTARIX, the subject experienced ileocecal invagination of 12 cm, proctorrhagia, vomiting and lymphadenopathy (presence of lymph nodes confirmed via echography). The subject was hospitalised. He was treated with injection of contrast product (via rectum) to reduce the invagination but it was only partially successful. Then, he was operated in order to reduce completely the invagination which was fully successful without any resection of the intestine. On 3 May 2010, 52 days after vaccination with 2nd dose of ROTARIX and 87 days after vaccination with 1st dose of ROTARIX, the subject experienced fever. They excluded any post operation complication. On 4 May 2010, 53 days after vaccination with 2nd dose of ROTARIX and 88 days after vaccination with 1st dose of ROTARIX, the subject experienced diarrhea. A stool analysis was performed and showed the presence of adenovirus. At the time of reporting, the events were resolved. According to the pediatrician, this was a mechanical invagination due to the presence of lymph nodes. Further information has been expected.
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