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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: This female subject was enrolled in a study 103366. On 08 December 2008, she received the 1st dose of ROTARIX (po). On 23 August 2008, the subject received a dose of ENGERIX B. On 04 September 2008, the subject received a dose of BCG (ID). On 30 October 2008, the subject received a dose of INFANRIX HEXA. Medical conditions at the time of the event included gastroenteritis. On 09 December 2008, one day after the 1st dose of ROTARIX, this three-month-old subject developed intussusception. The subject was hospitalised and the event was life-threatening. The subject was treated with Cotrimoxazole, ampicillin trihydrate, gentamicin sulphate, metronidazole and hydration therapy. The event improved on an unspecified date. The investigator considered that there was a reasonable possibility that the intussusception may have been caused by ROTARIX and that the event was possibly due to medical conditions. Investigator comments on 15 December 2008: loose bowel movement characterized as mucoid, blood streaked, yellowish occurring 8-9 episodes per day occurred 24 hours after ROTARIX administration. Consult done 3 days after ROTARIX administration, treated as infectious diarrhea given cotrimoxazole and oral rehydration solution. Current jelly stool noted few hours prior to admission. Hydration done and given oral antibiotics upon admission. 14 days prior to intussusception, the subject did not develop respiratory tract infection and had no change in feeding regimen (breast feeding). Abdominal ultrasound was not performed. On 14 December 2008, abdominal x ray showed bowel ileus. Air-fluid contrast enema and surgery were not performed. Symptoms from intussusception report form: vomiting, diarrhea, bloody stool or bright red stool, blood on rectal examination, red currant jelly stool, abdominal pain, lethargy.
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