Prevalence of errors causing events allegedly attributable to vaccination/immunization: systematic review and meta-analysis

Tavares, Laís Oliveira de Moraes; Silva, Marla Ariana; Oliveira, Bianca Rabelo de; Amaral, Gabriela Gonçalves; Guimarães, Eliete Albano de Azevedo; Couto, Renê Oliveira; Oliveira, Valéria Conceição de

doi:10.1590/1983-1447.2024.20230097.en

Laís Oliveira de Moraes Tavares

formal analysis

conceptualization

data curation

validation

visualization

writing – original draft

writing – review & editing

investigation

methodology

software

Universidade Federal de São João del-Rei (UFSJ). Programa de Pós-Graduação em Enfermagem. Divinópolis, Minas Gerais, Brasil.

http://orcid.org/0000-0002-6603-775X

Marla Ariana Silva

data curation

validation

visualization

writing – original draft

writing – review & editing

Universidade Federal de São João del-Rei (UFSJ). Programa de Pós-Graduação em Enfermagem. Divinópolis, Minas Gerais, Brasil.

http://orcid.org/0000-0003-0136-7122

Bianca Rabelo de Oliveira

data curation

validation

visualization

writing – original draft

writing – review & editing

Universidade Federal de São João del-Rei (UFSJ). Departamento de Enfermagem. Divinópolis, Minas Gerais, Brasil.

http://orcid.org/0000-0002-8999-6558

Gabriela Gonçalves Amaral

validation

visualization

writing – original draft

writing – review & editing

Universidade do Estado de Minas Gerais (UEMG). Departamento de Ciências da Reabilitação e Saúde. Divinópolis, Minas Gerais, Brasil.

http://orcid.org/0000-0002-9629-2815

Eliete Albano de Azevedo Guimarães

formal analysis

conceptualization

validation

visualization

writing – original draft

writing – review & editing

investigation

methodology

Universidade Federal de São João del-Rei (UFSJ). Programa de Pós-Graduação em Enfermagem. Divinópolis, Minas Gerais, Brasil.

http://orcid.org/0000-0001-9236-8643

Renê Oliveira Couto

formal analysis

conceptualization

validation

visualization

writing – original draft

writing – review & editing

investigation

methodology

software

Universidade Federal de São João del-Rei (UFSJ). Programa de Pós-Graduação em Ciências Farmacêuticas. Divinópolis, Minas Gerais, Brasil.

http://orcid.org/0000-0002-3748-3427

Valéria Conceição de Oliveira

project administration

formal analysis

conceptualization

validation

visualization

writing – original draft

writing – review & editing

investigation

methodology

funding acquisition

Universidade Federal de São João del-Rei (UFSJ). Programa de Pós-Graduação em Enfermagem. Divinópolis, Minas Gerais, Brasil.

http://orcid.org/0000-0003-2606-9754

Corresponding author:
Valéria Conceição de Oliveira E-mail: valeriaoliveira@ufsj.edu.br

Associate editor:

Carlise Rigon Dalla Nora

Editor-in-chief:

João Lucas Campos de Oliveira

The authors declare that there is no conflict of interest.

Authors - Year	Country	Type of study Level of evidence	Objective	Study period	Population studied
Study 12626. Chiu P, Huang W, Huang S, Chih Y, Chen C. Program Errors in Taiwan’s mass immunizations against pandemic A/H1N1. Taiwan Centers Dis Control. 2010;26(15):268-75. (2010)	China	Epidemiological, descriptive LE^*= VI	Determine types of errors and assess critical contributors to the error	11/2009 to 02/2010	General population vaccinated with H1N1
Study 22424. Moro PL, Harrington T, Shimabukuro T, Cano M, Museru OI, Menschik D, et al. Adverse events after Fluzone® Intradermal vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2011-2013. Vaccine . 2013;31(43):4984-7. doi: https://doi.org/10.1016/j.vaccine.2013.08.001 https://doi.org/10.1016/j.vaccine.2013.0... (2013)	United States	Epidemiological, descriptive LE^*=VI	Characterize ESAVI† after administration of the trivalent intradermal inactivated influenza vaccine reported to the United States Adverse Event Reporting System (VAERS‡)	07/2011 to 02/2013	Population vaccinated with Fluzone Intradermal vaccine
Study 32323. Moro PL, Winiecki S, Lewis P, Shimabukuro TT, Cano M. Surveillance of adverse events after the first trivalent inactivated influenza vaccine produced in mammalian cell culture (Flucelvax®) reported to the Vaccine Adverse Event Reporting System (VAERS), United States, 2013-2015. Vaccine . 2015;33(48):6684-8. doi: https://doi.org/10.1016/j.vaccine.2015.10.084 https://doi.org/10.1016/j.vaccine.2015.1... (2015)	United States	Epidemiological, descriptive LE^*=VI	Evaluate adverse events following administration of trivalent subunit inactivated influenza vaccine reported to the United States Adverse Event Reporting System (VAERS‡)	07/2013 to 03/2015	General population vaccinated with Flucevax
Study 466. Bisetto LHL, Ciosak SI. Analysis of adverse events following immunization caused by immunization errors. Rev Bras Enferm. 2017;70(1):87-95. doi: https://doi.org/10.1590/0034-7167-2016-0034 https://doi.org/10.1590/0034-7167-2016-0... (2017)	Brazil	Cross-sectional, descriptive LE^*=VI	Analyze the occurrence of ESAVI† resulting from immunization errors, in Paraná, from 2003 to 2013	01/2003 to 12/2013	General population vaccinated in Paraná
Study 588. Braga PCV, Silva AEBC, Mochizuki LB, Lima JC, Sousa MRG, Bezerra ALQ. Incidence of post-vaccination adverse events in children. J Nurs UFPE on line. 2017;11(Suppl 10):4126-35. doi: https://doi.org/10.5205/1981-8963-v11i10a231174p4126-4135-2017 https://doi.org/10.5205/1981-8963-v11i10... (2017)	Brazil	Cross-sectional, descriptive LE^*=VI	Analyze ESAVI† occurring in children under five years of age	07/2012 to 06/2013	Children under five years of age
Study 62525. Suragh TA, Lewis P, Arana J, Mba-Jonas A, Li R, Stewart B, et al. Safety of bivalent human papillomavirus vaccine in the US vaccine adverse event reporting system (VAERS), 2009-2017. Br J Clin Pharmacol. 2018;84(12):2928-32. doi: https://doi.org/10.1111/bcp.13736 https://doi.org/10.1111/bcp.13736... (2018)	United States	Epidemiological, descriptive LE^*=VI	Review reports submitted to the United States ESAVI Reporting System† (VAERS‡) following bivalent human papillomavirus vaccine from 2009 to 2017 to increase knowledge about its safety	01/2009 to 12/2017	General population vaccinated with bivalent human papillomavirus vaccine
Study 71212. Reed L, Tarini BA, Andreae MC. Vaccine administration error rates at a large academic medical center and its affiliated clinics - Familiarity matters. Vaccine. 2019;37(36):5390-6. doi: https://doi.org/10.1016/j.vaccine.2019.07.027 https://doi.org/10.1016/j.vaccine.2019.0... (2019)	United States	Epidemiological, descriptive LE^*=VI	Track and describe the absolute number of vaccine administration errors and corresponding error rates over time and by patient age and vaccine type	01/2016 to 12/2017	Children and teenagers from 0 to 19 years old
Study 877. Barboza TC, Guimarães RA, Gimenes FRE, Silva AEBC. Retrospective study of immunization errors reported in an online Information System. Rev Latino Am Enfermagem. 2020;28:e3303. doi: https://doi.org/10.1590/1518-8345.3343.3303 https://doi.org/10.1590/1518-8345.3343.3... (2020)	Brazil	Cross-sectional descriptive LE^*=VI	Analyze immunization errors reported in Goiás between 2014 and 2017	08/2014 to 12/2017	General population vaccinated in Goiás
Study 92121. Santos LCB, Silva HS, Borja-Oliveira CR, Chubaci RYS, Gutierrez BAO. Eventos adversos pós-vacinação em idosos no Estado de São Paulo, Brasil, de 2015 a 2017. Cad Saude Publica. 2021;37(4):e00084820. doi: https://doi.org/10.1590/0102-311X00084820 https://doi.org/10.1590/0102-311X0008482... (2021)	Brazil	Cross-sectional, descriptive LE^*=VI	Analyze the prevalence of ESAVI† in elderly people; raise reported events; identify the vaccines that caused events and verify ESAVI† and the vaccines administered that led to hospitalizations in the State of São Paulo, Brazil, in the years 2015 to 2017	01/2015 to 12/2017	Elderly vaccinated in São Paulo
Study 101010. Silveira IO, Silva TPR, Luvisaro BMO, Silva RB, Gusmão JD, Vimieiro AM, et al. Adverse events following immunization in pregnant women from Minas Gerais. Rev Saude Publica. 2021;55:24. doi: https://doi.org/10.11606/s1518-8787.2021055002592 https://doi.org/10.11606/s1518-8787.2021... (2021)	Brazil	Epidemiological, descriptive LE^*=VI	Analyze the distribution of ESAVI† in pregnant women in the state of Minas Gerais, between 2015 and 2019	01/2015 to 12/2019	Pregnant women vaccinated in Minas Gerais
Study 112222. Silva RB, Silva TPR, Sato APS, Lana FCF, Gusmâo JD, Souza JFA, et al. Adverse events following immunization against SARS-CoV-2 (covid-19) in the state of Minas Gerais. Rev Saúde Pública. 2021;55:66. doi: https://doi.org/10.11606/s1518-8787.2021055003734 https://doi.org/10.11606/s1518-8787.2021... (2021)	Brazil	Epidemiological, descriptive LE^*=VI	Analyze ESAVI† against SARS-CoV-2 (COVID-19§) in the state of Minas Gerais, Brazil.	01/20/2021 to 03/05/2021	General population

Study - Year	Number of doses administered	Number of immunization errors that caused ESAVI^*	Prevalence of immunization errors that caused ESAVI* (per 10,000 doses)
Study 12626. Chiu P, Huang W, Huang S, Chih Y, Chen C. Program Errors in Taiwan’s mass immunizations against pandemic A/H1N1. Taiwan Centers Dis Control. 2010;26(15):268-75. (2010)	15,000,000	5	0.003
Study 22424. Moro PL, Harrington T, Shimabukuro T, Cano M, Museru OI, Menschik D, et al. Adverse events after Fluzone® Intradermal vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2011-2013. Vaccine . 2013;31(43):4984-7. doi: https://doi.org/10.1016/j.vaccine.2013.08.001 https://doi.org/10.1016/j.vaccine.2013.0... (2013)	4,700,000	12	0.026
Study 32323. Moro PL, Winiecki S, Lewis P, Shimabukuro TT, Cano M. Surveillance of adverse events after the first trivalent inactivated influenza vaccine produced in mammalian cell culture (Flucelvax®) reported to the Vaccine Adverse Event Reporting System (VAERS), United States, 2013-2015. Vaccine . 2015;33(48):6684-8. doi: https://doi.org/10.1016/j.vaccine.2015.10.084 https://doi.org/10.1016/j.vaccine.2015.1... (2015)	5,600,000	23	0.041
Study 466. Bisetto LHL, Ciosak SI. Analysis of adverse events following immunization caused by immunization errors. Rev Bras Enferm. 2017;70(1):87-95. doi: https://doi.org/10.1590/0034-7167-2016-0034 https://doi.org/10.1590/0034-7167-2016-0... (2017)	82,527,255	604	0.073
Study 588. Braga PCV, Silva AEBC, Mochizuki LB, Lima JC, Sousa MRG, Bezerra ALQ. Incidence of post-vaccination adverse events in children. J Nurs UFPE on line. 2017;11(Suppl 10):4126-35. doi: https://doi.org/10.5205/1981-8963-v11i10a231174p4126-4135-2017 https://doi.org/10.5205/1981-8963-v11i10... (2017)	419,689	14	0.334
Study 62525. Suragh TA, Lewis P, Arana J, Mba-Jonas A, Li R, Stewart B, et al. Safety of bivalent human papillomavirus vaccine in the US vaccine adverse event reporting system (VAERS), 2009-2017. Br J Clin Pharmacol. 2018;84(12):2928-32. doi: https://doi.org/10.1111/bcp.13736 https://doi.org/10.1111/bcp.13736... (2018)	723,502	23	0.318
Study 71212. Reed L, Tarini BA, Andreae MC. Vaccine administration error rates at a large academic medical center and its affiliated clinics - Familiarity matters. Vaccine. 2019;37(36):5390-6. doi: https://doi.org/10.1016/j.vaccine.2019.07.027 https://doi.org/10.1016/j.vaccine.2019.0... (2019)	1,431,206	8	0.056
Study o 877. Barboza TC, Guimarães RA, Gimenes FRE, Silva AEBC. Retrospective study of immunization errors reported in an online Information System. Rev Latino Am Enfermagem. 2020;28:e3303. doi: https://doi.org/10.1590/1518-8345.3343.3303 https://doi.org/10.1590/1518-8345.3343.3... (2020)	12,362,298	47	0.038
Study 92121. Santos LCB, Silva HS, Borja-Oliveira CR, Chubaci RYS, Gutierrez BAO. Eventos adversos pós-vacinação em idosos no Estado de São Paulo, Brasil, de 2015 a 2017. Cad Saude Publica. 2021;37(4):e00084820. doi: https://doi.org/10.1590/0102-311X00084820 https://doi.org/10.1590/0102-311X0008482... (2021)	15,196,080	1	0.001
Study 101010. Silveira IO, Silva TPR, Luvisaro BMO, Silva RB, Gusmão JD, Vimieiro AM, et al. Adverse events following immunization in pregnant women from Minas Gerais. Rev Saude Publica. 2021;55:24. doi: https://doi.org/10.11606/s1518-8787.2021055002592 https://doi.org/10.11606/s1518-8787.2021... (2021)	871,070	18	0.207
Study 112222. Silva RB, Silva TPR, Sato APS, Lana FCF, Gusmâo JD, Souza JFA, et al. Adverse events following immunization against SARS-CoV-2 (covid-19) in the state of Minas Gerais. Rev Saúde Pública. 2021;55:66. doi: https://doi.org/10.11606/s1518-8787.2021055003734 https://doi.org/10.11606/s1518-8787.2021... (2021)	940,013	7	0.074

[1] Corresponding author:
Valéria Conceição de Oliveira E-mail: valeriaoliveira@ufsj.edu.br

Brasil

Brasil

Prevalence of errors causing events allegedly attributable to vaccination/immunization: systematic review and meta-analysis

Prevalencia de errores causantes de acontecimientos supuestamente atribuibles a la vacunación/inmunización: revisión sistemática y metanálisis

ABSTRACT

Objective:

Method:

Results:

Conclusion: