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Vaccine adverse event reporting system (VAERS): Evaluation of 31 years of reports and pandemics’ impact

BACKGROUND: Vaccine adverse event reporting system (VAERS) was established in the United States (U.S.) as an early warning system with a main purpose of collecting post-marketing Adverse events following immunizations (AEFIs) reports to monitor the vaccine safety and to mitigate the risks from vacci...

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Autores principales: Almadani, Ohoud A., Alshammari, Thamir M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9805973/
https://www.ncbi.nlm.nih.gov/pubmed/36601511
http://dx.doi.org/10.1016/j.jsps.2022.10.001
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author Almadani, Ohoud A.
Alshammari, Thamir M.
author_facet Almadani, Ohoud A.
Alshammari, Thamir M.
author_sort Almadani, Ohoud A.
collection PubMed
description BACKGROUND: Vaccine adverse event reporting system (VAERS) was established in the United States (U.S.) as an early warning system with a main purpose of collecting post-marketing Adverse events following immunizations (AEFIs) reports to monitor the vaccine safety and to mitigate the risks from vaccines. During the coronavirus diseases 2019 (COVID-19) pandemic, VAERS got more attention as its important role in monitoring the safety of the vaccines. The aim of this study was to investigate VAERS patterns, reported AEFI, vaccines, and impact of different pandemics since its inception. METHODS: This was an observational study using VARES data from 2/7/1990 to 12/11/2021. Patterns of reports over years were first described, followed by a comparison of reports statistics per year. Furthermore, a comparison of incidents (death, ER visits, etc.) statistics over years, in addition to statistics of each vaccine were calculated. Moreover, each incident's statistics for each vaccine were calculated and top vaccines were reported. All analyses were conducted using R (Version 1.4.1717) and Excel for Microsoft 365. RESULTS: There were 1,396,280 domestic and 346,210 non-domestic reports during 1990–2021, including 228 vaccines. For both domestic and non-domestic reports, year of 2021 had the highest reporting rate (48.52 % and 70.33 %), in addition a notable change in AEFIs patterns were recorded during 1991, 1998, 2000, 2006, 2009, 2011, and 2017. AEFIs were as follow: deaths (1.00 % and 4.08 %), ER or doctor visits (13.37 % and 2.27 %), hospitalizations (5.84 % and 27.78 %), lethal threat (1.42 % and 4.38 %), and disabilities (1.4 % and 7.96 %). Pyrexia was the top reported symptom during the past 31 years, except for 2021 where headache was the top one. COVID-19 vaccines namely Moderna, Pfizer-Biontech, and Janssen were the top 3 reported vaccines with headache, pyrexia, and fatigue as the top associated AEFIs. Followed by Zoster, Seasonal Influenza, Pneumococcal, and Human papillomavirus vaccines. CONCLUSIONS: The large data available in VARES make it a useful tool for detecting and monitoring vaccine AEFIs. However, its usability relies on understating the limitations of this surveillance system, the impact of governmental regulations, availability of vaccines, and public health recommendations on the reporting rate.
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spelling pubmed-98059732023-01-03 Vaccine adverse event reporting system (VAERS): Evaluation of 31 years of reports and pandemics’ impact Almadani, Ohoud A. Alshammari, Thamir M. Saudi Pharm J Original Article BACKGROUND: Vaccine adverse event reporting system (VAERS) was established in the United States (U.S.) as an early warning system with a main purpose of collecting post-marketing Adverse events following immunizations (AEFIs) reports to monitor the vaccine safety and to mitigate the risks from vaccines. During the coronavirus diseases 2019 (COVID-19) pandemic, VAERS got more attention as its important role in monitoring the safety of the vaccines. The aim of this study was to investigate VAERS patterns, reported AEFI, vaccines, and impact of different pandemics since its inception. METHODS: This was an observational study using VARES data from 2/7/1990 to 12/11/2021. Patterns of reports over years were first described, followed by a comparison of reports statistics per year. Furthermore, a comparison of incidents (death, ER visits, etc.) statistics over years, in addition to statistics of each vaccine were calculated. Moreover, each incident's statistics for each vaccine were calculated and top vaccines were reported. All analyses were conducted using R (Version 1.4.1717) and Excel for Microsoft 365. RESULTS: There were 1,396,280 domestic and 346,210 non-domestic reports during 1990–2021, including 228 vaccines. For both domestic and non-domestic reports, year of 2021 had the highest reporting rate (48.52 % and 70.33 %), in addition a notable change in AEFIs patterns were recorded during 1991, 1998, 2000, 2006, 2009, 2011, and 2017. AEFIs were as follow: deaths (1.00 % and 4.08 %), ER or doctor visits (13.37 % and 2.27 %), hospitalizations (5.84 % and 27.78 %), lethal threat (1.42 % and 4.38 %), and disabilities (1.4 % and 7.96 %). Pyrexia was the top reported symptom during the past 31 years, except for 2021 where headache was the top one. COVID-19 vaccines namely Moderna, Pfizer-Biontech, and Janssen were the top 3 reported vaccines with headache, pyrexia, and fatigue as the top associated AEFIs. Followed by Zoster, Seasonal Influenza, Pneumococcal, and Human papillomavirus vaccines. CONCLUSIONS: The large data available in VARES make it a useful tool for detecting and monitoring vaccine AEFIs. However, its usability relies on understating the limitations of this surveillance system, the impact of governmental regulations, availability of vaccines, and public health recommendations on the reporting rate. Elsevier 2022-12 2022-10-07 /pmc/articles/PMC9805973/ /pubmed/36601511 http://dx.doi.org/10.1016/j.jsps.2022.10.001 Text en © 2022 The Author(s) https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Original Article
Almadani, Ohoud A.
Alshammari, Thamir M.
Vaccine adverse event reporting system (VAERS): Evaluation of 31 years of reports and pandemics’ impact
title Vaccine adverse event reporting system (VAERS): Evaluation of 31 years of reports and pandemics’ impact
title_full Vaccine adverse event reporting system (VAERS): Evaluation of 31 years of reports and pandemics’ impact
title_fullStr Vaccine adverse event reporting system (VAERS): Evaluation of 31 years of reports and pandemics’ impact
title_full_unstemmed Vaccine adverse event reporting system (VAERS): Evaluation of 31 years of reports and pandemics’ impact
title_short Vaccine adverse event reporting system (VAERS): Evaluation of 31 years of reports and pandemics’ impact
title_sort vaccine adverse event reporting system (vaers): evaluation of 31 years of reports and pandemics’ impact
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9805973/
https://www.ncbi.nlm.nih.gov/pubmed/36601511
http://dx.doi.org/10.1016/j.jsps.2022.10.001
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