Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines.
OBJECTIVE: To assess the safety of currently licensed diphtheria-tetanus-acellular pertussis (DTaP) vaccines in the United States by using data from the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
METHODS: We searched VAERS for US reports of DTaP vaccinations occurring from January 1, 1991, through December 31, 2016, and received by March 17, 2017. We reviewed available medical records for all death reports and a random sample of reports classified as nondeath serious. We used Empirical Bayesian data mining to identify adverse events that were disproportionally reported after DTaP vaccination.
RESULTS: VAERS received 50 157 reports after DTaP vaccination; 43 984 (87.7%) of them reported concomitant administration of other vaccines, and 5627 (11.2%) were serious. Median age at vaccination was 19 months (interquartile range 35 months). The most frequently reported events were injection site erythema (12 695; 25.3%), pyrexia (9913; 19.8%), injection site swelling (7542; 15.0%), erythema (5599; 11.2%), and injection site warmth (4793; 9.6%). For 3 of the DTaP vaccines, we identified elevated values for vaccination errors using Empirical Bayesian data mining.
CONCLUSIONS: No new or unexpected adverse events were detected. The observed disproportionate reporting for some nonserious vaccination errors calls for better education of vaccine providers on the specific indications for each of the DTaP vaccines.
|投稿者||Moro, Pedro L; Perez-Vilar, Silvia; Lewis, Paige; Bryant-Genevier, Marthe; Kamiya, Hajime; Cano, Maria|
|組織名||Immunization Safety Office, Division of Healthcare Quality Promotion and;email@example.com.;Center for Biologics Evaluation and Research, Food and Drug Administration,;Silver Spring, Maryland; and.;Immunization Safety Office, Division of Healthcare Quality Promotion and.;Epidemiology Intelligence Service, Meningitis and Vaccine Preventable Diseases;Branch, National Center for Immunization and Respiratory Diseases, Centers for;Disease Control and Prevention, Atlanta, Georgia.;Infectious Disease Surveillance Center, National Institute of Infectious;Diseases, Tokyo, Japan.|