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Administered by: Private Purchased by: Public
Life Threatening? Yes
Write-up: This case was reported by a physician, via a GSK representative and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations. Concurrent vaccinations included PENTACEL (non-GSK) (Sanofi) given on 27 May 2009; PREVNAR (Wyeth Labs) given on 27 May 2009. On 27 May 2009 the subject received 2nd dose of ROTARIX (1 ml, oral). The lot number was reported as "A41SA697A". On 4 June 2009, 8 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalized for 4 days and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with intravenous fluids and barium enema. On 8 June 2009, the event was resolved. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. Assessment: Intussusception. Patient presented with vomiting and has not tolerated any po intake. Prior ER visits. Restless, cries, screams. Appears uncomfortable, listless, abdomen tender to palpation, red stool noted during rectal exam. Dry lips. Skin warm, dry to touch. Air enema reduction of ileocolic intussusception. Subsequent exploratory laparoscopy and reduction of ileoileal intussusception ICD-9 Codes: 560.0 789.00, 789.07, 787.02, 792.1
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