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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 5-month-old female subject who was vaccinated with ROTARIX, (GlaxoSmithKline). The subject had no relevant medical history or allergy. Previous and/or concurrent vaccination included ROTARIX (GlaxoSmithKline, oral) given on 13 August 2008, combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (manufacturer unspecified; intramuscular) given on 20 October 2008; pneumococcal vaccines (manufacturer unspecified; intramuscular) given on 20 October 2008. On 20 October 2008, the subject received 2nd dose of ROTARIX (oral, lot number not provided). On 3 November 2008, 14 days after vaccination with 2nd dose ROTARIX, the subject experienced liquid stools, bloody stools, abdominal pain, intolerance to oral feeding and gastrobialry vomiting. On 4 November 2008, the subject was hospitalised. Physical exam reported abdominal mass in mesogastrium, decreased bowel sounds and rectal blood. Lab tests were performed and showed the following: Hemoglobin: 10.4 g/dL; Albumin: 1.9 g/dL; Total protein: 3.9 g/dL; Calcium: 8 mg/dL. Diagnosis of intussusception was made by clinical features. On 04 November 2008, surgery was performed; Ileocecolic intussusception was found and resolved by taxis. Prophylactic appendectomy was done without complications. On 8 November 2008, lab tests was performed and showed the following: Hemoglobin: 11.5 g/dL. The subject was treated with KETOROLAC, CEFTRIAXONE, AMIKACIN, METRONIDAZOLE, RANITIDINE, and NALBUPHINE. The subject had good evolution; she was discharged on 9 November 2008 in good clinical conditions. On 11 November 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.
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