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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of intussusception of intestine in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline), and PREVENAR (Wyeth labs). According to the physician, the subject had no intestinal malformation. On 01 July 2008, the subject received a 1st dose of ROTARIX (oral, batch number A41CA571A), a 1st dose of INFANRIX HEXA (batch number not available) and a 1st dose of PREVENAR (batch number not available). On 03 July 2008, two days after vaccinations, in the morning, the subject developed fever, which resolved the same day. On 05 July 2008, the subject presented with loss of appetite, followed by blood and mucus in stool. In the evening, the subject was hospitalized. Two echographies were performed and diagnosis of intussusception of intestine on 7 centimeters was made. An enema was performed without efficacy. On 06 July 2008, in the morning, the subject underwent a surgery to reduce intussusception, without resection. At the time of reporting, the outcome of the events was unspecified. The reporter''s causality assessment was unspecified. INFANRIX HEXA and PREVENAR were suspected only for fever and ROTARIX for all the events.
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