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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a regulatory authority ((clinical) # 016761344) and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 27 March 2008, the subject received unspecified dose of ROTARIX (oral, lot number not provided). On 1 April 2008, 5 days after vaccination with ROTARIX, the subject experienced intussusception. The patient showed crying and screaming in intermittent episodes, pallor and sweating. The abdomen was hard and painful to palpation in right hemi-abdomen. He also showed vomiting, irritability with delay in his feedings and bloody stools. For these reasons he was taken to the Emergency room. The subject was hospitalised. On 2 April 2008, abdominal X-ray was performed and showed compatible findings with intestinal intussusception. Opaque enema was performed: Ileo-ceco-colic intussusception was reduced by hydrostatic pressure, with good oral tolerance 20 hours later. On 3 April 2008, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with ROTARIX. No further information is expected as this is the only information the Regulatory Authority has, therefore this case has been considered closed.
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