Surveillance for adverse events after DTwP/Hib vaccination in Brazil: Sensitivity and factors associated with reporting

• Published in: Vaccine Vol. 28; no. 18; pp. 3127 - 3133
• Main Authors: Monteiro, Sandra Aparecida Moreira Gomes, Takano, Olga Akiko, Waldman, Eliseu Alves
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 19.04.2010; Elsevier; Elsevier Limited
• Subjects: Adverse Drug Reaction Reporting Systems - statistics & numerical data; Age; Allergy and Immunology; Applied microbiology; Biological and medical sciences; Brazil; Diphtheria; Diphtheria-tetanus-pertussis vaccine; Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage; Diphtheria-Tetanus-Pertussis Vaccine - adverse effects; DTwP/Hib vaccine; Female; Fever - epidemiology; Fundamental and applied biological sciences. Psychology; Haemophilus Vaccines - administration & dosage; Haemophilus Vaccines - adverse effects; Health facilities; Health Services Research; Humans; Hypersensitivity - epidemiology; Immunization; Immunization programmes; Incidence; Infant; Infant mortality; Male; Microbiology; Mortality; Primary care; Product Surveillance, Postmarketing - methods; Quality of life; Seizures - epidemiology; Sensitivity and Specificity; Tetanus; Vaccination/adverse effects; Vaccine safety; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); South America; Brazil; America; Vaccine safety; Vaccination/adverse effects; DTwP/Hib vaccine; Diphtheria-tetanus-pertussis vaccine; Immunization programmes; Immunization; Sensitivity; Toxicity; Vaccination; Mixed vaccine
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2010.02.059

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.