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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a physician concerning a 23 week old male, with no significant medical history, who, on 16-Jun-2006 was vaccinated with an oral, 2.0 ml, first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653661/0146F). Concomitant vaccination administered on 16-Jun-2006 included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of Hib conj vaccine (tetanus toxoid) (ACTHIB), and a dose if hepatitis B virus vaccine rHBsAg (yeast). On 14-Jul-2006 the patient was vaccinated with a second 2.0 ml oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). There were no concomitant vaccinations given on 14-Jul-2006. In July 2006 the patient was noted to have fallen out of a shopping cart. On 02-Aug-2006 the patient developed a fever. The patient was taken to the emergency room where an x-ray and labs (not further specified) were normal. No formal diagnosis was made and the patient was simply thought to have a virus. On 17-Aug-2006 the patient was vaccinated with a third 2.0 ml oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). Concomitant vaccinations administered on 17-Aug-2006 included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of Hib conj vaccine (tetanus toxoid) (ACTHIB), a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) and a dose of poliovirus vaccine inactivated (IPOL). On 28-Sep-2006 the patient developed vomiting and irritability. The patient was subsequently hospitalized due to persistent vomiting. While hospitalized intussusception was diagnosed and reduced via Barium enema. The patient recovered within 24 hours and was discharged to home. At the time of the report the patient was noted to be doing fine by the physician. The physician indicated that he would provide additional information, including medical records if it became available. No product quality complaint was involved. No other information was provided. Additional information has been requested.
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