Adverse event occurrence following use of tetanus, diphtheria and acellular pertussis adsorbed vaccine – Tdap –, São Paulo, SP, Brazil, 2015-2016 ^*

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.

Diphteria-Tetanus-acellular Pertusis Vaccines; Drug-Related Side Effects and Adverse Reactions; Safety; Surveillance