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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 PASS study and described the occurrence of ileo-ileal intussusception in a 6-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 vaccination included ROTARIX (GlaxoSmithKline, oral) given on 21 July 2008. On 22 September 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 3 December 2008, 72 days after vaccination with ROTARIX, the subject started with vomiting, bloody stools, fever and abdominal pain. The patient was admitted at ER on 4 December 2008 and showed at physical exam abdominal pain and bowel sounds decreased. Abdominal x-ray suggested intestinal obstruction. Ileo-ileal intussusception was confirmed by laparotomy and reduced by taxis without complications. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). The subject was treated with AMIKACIN, AMPICILLIN TRIHYDRATE and PARACETAMOL. On 11 December 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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