DPT post vaccine adverse events surveillance and seriousness predictors: State of São Paulo , 1984-2001 / Vigilância de eventos adversos pós-vacina DPT e preditores de gravidade: Estado de São Paulo, 1984-2001

AUTOR(ES)

Fabiana Ramos Martin de Freitas

DATA DE PUBLICAÇÃO

2005

RESUMO

Objective: Describe the DPT post vaccine adverse events (DPT- PVAE) notified in the state of São Paulo between 1984 and 2001; identify seriousness predictors of these events; evaluate the DPT Post Vaccine Adverse Events Vigilance System (DPT- PVAEVS).Methods: Descriptive and exploratory study of seriousness predictors. The case definition adopted was that of the PVAEVS, being it the data source as well. The evaluation of the DPT- PVAEVS was conducted according to the methodology proposed by the Centers for Disease Control and Prevention. To identify the predictors, non-conditional logistical regression was used.Results: 6266 cases were identified, of which 53% were serious, 29,5% were hospitalized; the most frequent events were: fever <39,5ºC, hypotonic-hyporresponsive episode, local reaction and convulsion. In around 75% of the cases, the event occurred during the first six hours after vaccination. They were show to be independently associated to the gravity: the time interval inferior to one hour between the application of the vaccine and the event (OR=2,1), first dose administered (OR=5,8), personal (OR=2,2) and family (OR=5,3) neurological history. The PVAE passive system is simple, flexible, of low sensitivity, yet useful describing different types of PVAE, identifying reatogenic lots and offering subsidies to the elaboration of technical norms.Conclusions: Despite the limitations, the PVAE passive systems constitute the main instrument to study the safety of vaccines during the post license period. Nevertheless, the incorporation of new technologies is advisable, among which are municipalities and sentinel units. Besides this, it is advisable to include the introduction of the acellular DPT vaccine as a discussion point of the periodic reviews of the immunization calendar.

ASSUNTO(S)

vacinas dpt vaccine vigilância adverse events vaccines eventos adversos vigilance vacina dpt

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