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Life Threatening? No
Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. Previous vaccinations included combined diphtheria, tetanus, whole cell pertussis, hepatitis B and Haemophilus type b vaccine (manufacturer unspecified; intramuscular; unknown) given on 19 March 2008; influenza virus vaccine (manufacturer unspecified; intramuscular; unknown) given on 19 March 2008; live attenuated oral poliomyelitis vaccine (manufacturer unspecified; oral) given on 19 March 2008 and live attenuated human rotavirus vaccine (GlaxoSmithKline; oral) given on 12 November 2007. On 15 January 2008, the subject received the 2nd dose of ROTARIX (oral, lot number not provided). On 19 April 2008, 95 days after vaccination with the 2nd dose of ROTARIX, the subject experienced abdominal pain and liquid stools. Thereafter she showed hyporexia, nausea, vomiting and current jelly stools. On 20 April 2008, she was admitted on ER. Physical exam reported abdominal pain, pallor, palpable mass, Dance sign, absent peristalsis and rectal tract with expulsion of fresh bloody stools. Laboratory tests were performed on 20 April 2008 and showed the following: Leucocytes: 4200/mm3 (normal range: 5000-15000). Abdominal X-ray showed air-fluid levels. Barium enema was done; fluoroscopy control showed pass contrast medium through ileocecal valve to distal ileum; therefore ileocecolic intussusception was resolved (by exit). The subject was treated with AMPICILLIN, AMIKACINE, metronidazole and RANITIDINE. The subject had a good clinical evolution. The subject was discharged on 24 April 2008 with frank recuperation. On 24 April 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.
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