Cargando…

Characteristics and Comparison of Adverse Events of Coronavirus Disease 2019 Vaccines Reported to the United States Vaccine Adverse Event Reporting System Between 14 December 2020 and 8 October 2021

BACKGROUND: This study assessed and compared the frequency and type of adverse events (AEs) of the Pfizer-BioNTech, Moderna, and Janssen coronavirus disease 2019 (COVID-19) vaccines reported in the Vaccine Adverse Event Reporting System (VAERS). METHODS: A retrospective analysis examined VAERS repor...

Descripción completa

Detalles Bibliográficos
Autores principales: Zou, Chenyu, Xue, Xiangzhong, Qian, Jingjing
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9016134/
https://www.ncbi.nlm.nih.gov/pubmed/35449806
http://dx.doi.org/10.3389/fmed.2022.826327
_version_ 1784688462963671040
author Zou, Chenyu
Xue, Xiangzhong
Qian, Jingjing
author_facet Zou, Chenyu
Xue, Xiangzhong
Qian, Jingjing
author_sort Zou, Chenyu
collection PubMed
description BACKGROUND: This study assessed and compared the frequency and type of adverse events (AEs) of the Pfizer-BioNTech, Moderna, and Janssen coronavirus disease 2019 (COVID-19) vaccines reported in the Vaccine Adverse Event Reporting System (VAERS). METHODS: A retrospective analysis examined VAERS reports between 14 December 2020 and 8 October 2021 and focused on AE reports related to COVID-19 vaccines and AE outcomes [e.g., emergency room (ER) visits after being vaccinated, hospitalization, prolongation of existing hospitalization, life-threatening events, disability, birth defect, and death]. Reporting odds ratios (RORs) and Breslow-Day statistics were used to compare AE reporting between COVID-19 and non-COVID vaccines and between individual COVID-19 vaccines. RESULTS: A total of 604,157 AEs of COVID-19 vaccines were reported, including 43.51% for the Pfizer-BioNTech vaccine, 47.13% for the Moderna vaccine, and 9.12% for the Janssen COVID-19 vaccine. About 12.56% of patients visited ER after being vaccinated, 5.96% reported hospitalization, and 1.52% reported life-threatening events. Among the number of death cases (n = 7,674; mean age = 73), 2,025 patients (26.39%) had hypertension and 1,237 (16.12%) patients had cancer. RORs between COVID-19 vaccines and non-COVID vaccines identified increased ROR in ER visits, hospitalization, and life-threatening events. The results of the Breslow-Day statistics indicated heterogeneities between the disproportionality of reports across the four serious AE outcomes (i.e., ER visits, hospitalization, life-threatening events, and disability) between individual COVID-19 vaccines. CONCLUSION: Most current VAERS reports showed that the most commonly reported AEs of COVID-19 vaccines were mild. Cases with a mortality outcome tended to occur in older adults with underneath conditions. Close ongoing surveillance in the safety of COVID-19 vaccines is critical and will inform the use of individual COVID-19 vaccines. Given the known limitations associated with the passive spontaneous reporting system, such as VAERS, our findings need to be further assessed and verified through longitudinal, large healthcare data systems.
format Online
Article
Text
id pubmed-9016134
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Frontiers Media S.A.
record_format MEDLINE/PubMed
spelling pubmed-90161342022-04-20 Characteristics and Comparison of Adverse Events of Coronavirus Disease 2019 Vaccines Reported to the United States Vaccine Adverse Event Reporting System Between 14 December 2020 and 8 October 2021 Zou, Chenyu Xue, Xiangzhong Qian, Jingjing Front Med (Lausanne) Medicine BACKGROUND: This study assessed and compared the frequency and type of adverse events (AEs) of the Pfizer-BioNTech, Moderna, and Janssen coronavirus disease 2019 (COVID-19) vaccines reported in the Vaccine Adverse Event Reporting System (VAERS). METHODS: A retrospective analysis examined VAERS reports between 14 December 2020 and 8 October 2021 and focused on AE reports related to COVID-19 vaccines and AE outcomes [e.g., emergency room (ER) visits after being vaccinated, hospitalization, prolongation of existing hospitalization, life-threatening events, disability, birth defect, and death]. Reporting odds ratios (RORs) and Breslow-Day statistics were used to compare AE reporting between COVID-19 and non-COVID vaccines and between individual COVID-19 vaccines. RESULTS: A total of 604,157 AEs of COVID-19 vaccines were reported, including 43.51% for the Pfizer-BioNTech vaccine, 47.13% for the Moderna vaccine, and 9.12% for the Janssen COVID-19 vaccine. About 12.56% of patients visited ER after being vaccinated, 5.96% reported hospitalization, and 1.52% reported life-threatening events. Among the number of death cases (n = 7,674; mean age = 73), 2,025 patients (26.39%) had hypertension and 1,237 (16.12%) patients had cancer. RORs between COVID-19 vaccines and non-COVID vaccines identified increased ROR in ER visits, hospitalization, and life-threatening events. The results of the Breslow-Day statistics indicated heterogeneities between the disproportionality of reports across the four serious AE outcomes (i.e., ER visits, hospitalization, life-threatening events, and disability) between individual COVID-19 vaccines. CONCLUSION: Most current VAERS reports showed that the most commonly reported AEs of COVID-19 vaccines were mild. Cases with a mortality outcome tended to occur in older adults with underneath conditions. Close ongoing surveillance in the safety of COVID-19 vaccines is critical and will inform the use of individual COVID-19 vaccines. Given the known limitations associated with the passive spontaneous reporting system, such as VAERS, our findings need to be further assessed and verified through longitudinal, large healthcare data systems. Frontiers Media S.A. 2022-04-05 /pmc/articles/PMC9016134/ /pubmed/35449806 http://dx.doi.org/10.3389/fmed.2022.826327 Text en Copyright © 2022 Zou, Xue and Qian. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medicine
Zou, Chenyu
Xue, Xiangzhong
Qian, Jingjing
Characteristics and Comparison of Adverse Events of Coronavirus Disease 2019 Vaccines Reported to the United States Vaccine Adverse Event Reporting System Between 14 December 2020 and 8 October 2021
title Characteristics and Comparison of Adverse Events of Coronavirus Disease 2019 Vaccines Reported to the United States Vaccine Adverse Event Reporting System Between 14 December 2020 and 8 October 2021
title_full Characteristics and Comparison of Adverse Events of Coronavirus Disease 2019 Vaccines Reported to the United States Vaccine Adverse Event Reporting System Between 14 December 2020 and 8 October 2021
title_fullStr Characteristics and Comparison of Adverse Events of Coronavirus Disease 2019 Vaccines Reported to the United States Vaccine Adverse Event Reporting System Between 14 December 2020 and 8 October 2021
title_full_unstemmed Characteristics and Comparison of Adverse Events of Coronavirus Disease 2019 Vaccines Reported to the United States Vaccine Adverse Event Reporting System Between 14 December 2020 and 8 October 2021
title_short Characteristics and Comparison of Adverse Events of Coronavirus Disease 2019 Vaccines Reported to the United States Vaccine Adverse Event Reporting System Between 14 December 2020 and 8 October 2021
title_sort characteristics and comparison of adverse events of coronavirus disease 2019 vaccines reported to the united states vaccine adverse event reporting system between 14 december 2020 and 8 october 2021
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9016134/
https://www.ncbi.nlm.nih.gov/pubmed/35449806
http://dx.doi.org/10.3389/fmed.2022.826327
work_keys_str_mv AT zouchenyu characteristicsandcomparisonofadverseeventsofcoronavirusdisease2019vaccinesreportedtotheunitedstatesvaccineadverseeventreportingsystembetween14december2020and8october2021
AT xuexiangzhong characteristicsandcomparisonofadverseeventsofcoronavirusdisease2019vaccinesreportedtotheunitedstatesvaccineadverseeventreportingsystembetween14december2020and8october2021
AT qianjingjing characteristicsandcomparisonofadverseeventsofcoronavirusdisease2019vaccinesreportedtotheunitedstatesvaccineadverseeventreportingsystembetween14december2020and8october2021