title: Surveillance for adverse events after DTwP/Hib vaccination in Brazil: sensitivity and factors associated with reporting.
abstract: We estimated the sensitivity, i.e., the proportion of all cases of adverse events following immunization (AEFIs) reported to the Brazilian passive surveillance for adverse events following immunization (PSAEFI) with the diphtheria-tetanus-whole-cell pertussis-Haemophilus influenzae type b (DTwP/Hib) vaccine, as well as investigating factors associated with AEFIs reporting. During 2003-2004, 8303 AEFIs associated with DTwP-Hib were reported; hypotonic-hyporesponsive episodes (HHEs), fever and convulsions being the most common. Cure without sequel was achieved in 98.4% of the cases. The mean sensitivity of the PSAEFI was 22.3% and 31.6%, respectively, for HHE and convulsions, varying widely among states. Reporting rates correlated positively with the Human Development Index and coverage of adequate prenatal care, correlating negatively with infant mortality rates. Quality of life indicators and the degree of organization of health services are associated with greater PSAEFI sensitivity. In addition to consistently describing the principal AEFIs, PSAEFI showed the DTwP/Hib vaccine to be safe and allayed public fears related to its use.
authors.affiliation: Collective Health Institute, Federal University of Mato Grosso, Av. Fernando Correia da Costa, s/n, Campus Universitário, 78060-900 Cuiabá, Mato Grosso, Brazil. sandramoreiramonteiro@gmail.com
authors.forename: Sandra Aparecida Moreira Gomes
authors.initials: SA
authors.lastname: Monteiro
authors.forename: Olga Akiko
authors.initials: OA
authors.lastname: Takano
authors.forename: Eliseu Alves
authors.initials: EA
authors.lastname: Waldman
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D001938:Brazil; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D005334:Fever / Q000453:epidemiology; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D006302:Health Services Research; D006801:Humans; D006967:Hypersensitivity / Q000453:epidemiology; D015994:Incidence; D007223:Infant; D008297:Male; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012640:Seizures / Q000453:epidemiology; D012680:Sensitivity and Specificity
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C080881:diphtheria-tetanus-pertussis-haemophilus b conjugate vaccine