Adverse events following yellow fever immunization: Report and analysis of 67 neurological cases in Brazil.
Neurological adverse events following administration of the 17DD substrain of yellow fever vaccine (YEL-AND) in the Brazilian population are described and analyzed. Based on information obtained from the National Immunization Program through passive surveillance or intensified passive surveillance, from 2007 to 2012, descriptive analysis, national and regional rates of YFV associated neurotropic, neurological autoimmune disease, and reporting rate ratios with their respective 95% confidence intervals were calculated for first time vaccinees stratified on age and year. Sixty-seven neurological cases were found, with the highest rate of neurological adverse events in the age group from 5 to 9 years (2.66 per 100,000 vaccine doses in Rio Grande do Sul state, and 0.83 per 100,000 doses in national analysis). Two cases had a combination of neurotropic and autoimmune features. This is the largest sample of YEL-AND already analyzed. Rates are similar to other recent studies, but on this study the age group from 5 to 9 years of age had the highest risk. As neurological adverse events have in general a good prognosis, they should not contraindicate the use of yellow fever vaccine in face of risk of infection by yellow fever virus.
Bio-Manguinhos, Fiocruz, and CIFAVI (National Interinstitutional Committee for Pharmacovigilance in Vaccines and other Immunobiologicals), Brazil. Electronic address: rmenezes@bio.fiocruz.br.
Reinaldo de Menezes
Rde M
Martins
Bio-Manguinhos, Fiocruz, and Institute of Scientific and Technological Communication and Information in Health, Fiocruz, Brazil.
Ana Luiza Braz
AL
Pavão
Pharmacovigilance Unit, Clinical Advisory Unit, Bio-Manguinhos, Fiocruz, Brazil.
Patrícia Mouta Nunes
PM
de Oliveira
Qualified Person Responsible for Pharmacovigilance, Pharmacovigilance Unit, Clinical Advisory Unit, Bio-Manguinhos, Fiocruz, Brazil.
Paulo Roberto Gomes
PR
dos Santos
Adverse Events Following Immunization Group, MoH, and Member of CIFAVI, Brazil.
Sandra Maria D
SM
Carvalho
Adverse Events Following Immunization Group, Rio Grande do Sul, and Consultant to CIFAVI, Brazil.
Renate
R
Mohrdieck
Fluminense Federal University, and Consultant to CIFAVI, Brazil.
Alexandre Ribeiro
AR
Fernandes
Immunizations Program, São Paulo, and Consultant to CIFAVI, Brazil.
Helena Keico
HK
Sato
Brazilian National Regulatory Agency and Member of CIFAVI, Brazil.
Patricia Mandali
PM
de Figueiredo
Clinical Advisory Unit, Bio-Manguinhos, Fiocruz, Brazil.
Vanessa Dos Reis
Vdos R
von Doellinger
Bio-Manguinhos, Fiocruz, Brazil.
Maria da Luz Fernandes
Mda L
Leal
Policy and Strategy Council, Bio-Manguinhos, Fiocruz, Brazil.
Akira
A
Homma
Clinical Advisory Unit, Bio-Manguinhos, Fiocruz, Brazil.
Maria de Lourdes S
Mde L
Maia
D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D001938:Brazil; D002493:Central Nervous System Diseases / Q000139:chemically induced*; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D015004:Yellow Fever / Q000517:prevention & control*; D022341:Yellow Fever Vaccine / Q000008:administration & dosage* / Q000009:adverse effects*; D055815:Young Adult
D022341:Yellow Fever Vaccine
Adverse event; Neurological autoimmune disease; Neurological disease; Neurotropic disease; Yellow fever vaccine