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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a regulatory authority (foreign Regulatory Authority # DHH2301N2008-42013) and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKilne). Concurrent medications included Vitamin D. On 15 July 2008, the subject received 1st dose of ROTARIX intramuscular at an unknown injection site instead of orally. The lot number was not provided. On 23 July 2008, 8 days after vaccination with ROTARIX, the subject experienced ileo-ileal intussusception twice, followed by 2 episodes of ileo-colic intussusception within 6 days. The subject was hospitalised. The biology tests performed were normal. Stool culture was negative. No virology test was performed. The subject was treated with surgery. During the surgery, a Meckel''s diverticulum was found. On 30 July 2008, the events were resolved. The vaccination course with ROTARIX was discontinued.
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