PMID- 35449806 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220716 IS - 2296-858X (Print) IS - 2296-858X (Electronic) IS - 2296-858X (Linking) VI - 9 DP - 2022 TI - 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. PG - 826327 LID - 10.3389/fmed.2022.826327 [doi] LID - 826327 AB - 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. CI - Copyright (c) 2022 Zou, Xue and Qian. FAU - Zou, Chenyu AU - Zou C AD - Department of Health Outcomes Research and Policy, Harrison School of Pharmacy, Auburn University, Auburn, AL, United States. FAU - Xue, Xiangzhong AU - Xue X AD - Department of Health Outcomes Research and Policy, Harrison School of Pharmacy, Auburn University, Auburn, AL, United States. FAU - Qian, Jingjing AU - Qian J AD - Department of Health Outcomes Research and Policy, Harrison School of Pharmacy, Auburn University, Auburn, AL, United States. LA - eng PT - Journal Article DEP - 20220405 PL - Switzerland TA - Front Med (Lausanne) JT - Frontiers in medicine JID - 101648047 PMC - PMC9016134 OTO - NOTNLM OT - COVID-19 vaccine OT - VAERS OT - adverse event reporting OT - surveillance OT - vaccine safety COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2022/04/23 06:00 MHDA- 2022/04/23 06:01 PMCR- 2022/04/05 CRDT- 2022/04/22 06:32 PHST- 2021/11/30 00:00 [received] PHST- 2022/03/04 00:00 [accepted] PHST- 2022/04/22 06:32 [entrez] PHST- 2022/04/23 06:00 [pubmed] PHST- 2022/04/23 06:01 [medline] PHST- 2022/04/05 00:00 [pmc-release] AID - 10.3389/fmed.2022.826327 [doi] PST - epublish SO - Front Med (Lausanne). 2022 Apr 5;9:826327. doi: 10.3389/fmed.2022.826327. eCollection 2022.