Adverse event occurrence following use of tetanus, diphtheria and acellular pertussis adsorbed vaccine - Tdap -, São Paulo, SP, Brazil, 2015-2016
Epidemiol Serv Saude. 2020;29(2):e2019280.
doi: 10.5123/s1679-49742020000200027.
Epub 2020 May 11.
[Article in
English,
Portuguese]
Affiliations
- 1 Coordenadoria de Ciência, Tecnologia e Insumos Estratégicos de Saúde, Secretaria de Estado da Saúde, São Paulo, SP, Brasil.
- 2 Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brasil.
- 3 Faculdade de Saúde Pública, Universidade de São Paulo, São Paulo, SP, Brasil.
- 4 Coordenadoria de Controle de Doenças, Secretaria de Estado da Saúde, São Paulo, SP, Brasil.
Abstract
Objective to describe occurrence of adverse events following immunization (AEFI) with Tdap vaccine during pregnancy. Methods this was a descriptive study using data from reports by participants in an effectiveness and immunogenicity study conducted in two hospitals in São Paulo, SP, Brazil, from 2015 to 2016. Results of the 201 mothers included in the study, 48 (23.9%) had at least one AEFI; 60 symptoms related to Tdap use were identified - pain (22.4%), swelling (2.5%), fever (1.5%), somnolence (1.0%), redness (0.5%), vomiting (0.5%), headache (0.5%), local reaction (0.5%), and fatigue (0.5%); no rare, very rare, or extremely rare adverse events were reported; all events were considered to be expected, as they are described in the vaccine package insert; outcome of all events was recovery without sequelae. Conclusion Tdap vaccine in the form adopted by the National Immunization Program is safe; no unexpected adverse events were identified among vaccinated pregnant women.
Publication types
-
Research Support, Non-U.S. Gov't
MeSH terms
-
Adult
-
Brazil
-
Diphtheria-Tetanus-acellular Pertussis Vaccines / administration & dosage
-
Diphtheria-Tetanus-acellular Pertussis Vaccines / adverse effects*
-
Female
-
Humans
-
Immunization Programs*
-
Pregnancy
-
Vaccination / adverse effects*
-
Vaccination / methods
-
Young Adult
Substances
-
Diphtheria-Tetanus-acellular Pertussis Vaccines