Avaliação dos eventos adversos pós-vacina Tetravalente. Brasil, 2002

Monteiro, SAMG. Avaliação dos eventos adversos pós -vacina Tetravalente.
Brasil, 2002 – 2005./ Evaluation of DTP/Hib post-vaccine adverse events.
Brazil, 2002 – 2005. [dissertation]. Cuiabá (BR): Instituto de Saúde Coletiva,
Universidade Federal de Mato Grosso; 2007.
ABSTRACT
Objective: To analyze the DTP/Hib adverse events following imm unisation
(DTPH-AEFI) reported in the country from its introduction to the Brazilian
Public Health System in 2002 up to 2005. Methods: Cross-sectional study.
The population in the study covered children less than one year in age who
received at least one dose of the DTP/Hib vaccine in the Brazilian Health
Services. The data source was the Vaccine Adverse Events Vigilance System
- VAEVS of the National Immunization Program . Results: 11,558 cases of
DTPH-AEFI were reported, resulting in a reporting rate of 34.0 cases per
100,000 applied doses, with heterogeneous distribution in Federal State s (6,0
– 141,0). Only 36.6% of Brazilian municipalities presented reports of DTPH -
AEFI. 65.3% of the reported cases were classified as serious events. Only the
time interval of less than one hour (OR=7.4) and between one and six hours
(OR=3.7) showed association with the case severity. The gender of the patient
and the vaccine dose did not present association statistics with the case
severity. Amongst the 14,241 reported cases, the most frequently DTPH -AEFI
reported was the Hypotonic-Hyporesponsive Episode (HHE), Fever and
Generalized Convulsive Seizure. The evolution to cure without side -effects
occurred in 98.7% of the reported cases. The death rate with temporal
association with the vaccine was 0.04 cases per 100,000 applied doses.
Conclusions: An increase of reports occurred after the introduction of
DTP/Hib combined vaccine, resulting in higher reporting rates DTPH-AEFI
than DTP vaccine in Brazil, when applied isolated or simultaneously to anti -Hib
in different injection sites. However, these rates were lower than the ones
described in DTP vaccine classical researches. The expressive percentage of
serious cases may be due to a reporting bias caused by the val orization of
serious cases in relation to non-serious cases. The database did not allow the
qualitative analysis of investigation of serious cases. The data found indicates
the necessity of new strategies to increase the surveillance sensibility and
reach more homogeneity to VAEVS in Brazil.
Keywords: vaccine, DTP/Hib vaccine, DTPw/Hib vaccine, DTPH vaccine,
DTP vaccine, adverse events, vigilance, surveillance.