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ABSTRACT
Introduction
The rapid development of COVID-19 vaccines has provided crucial tools for pandemic control, but the occurrence of vaccine-related adverse events (AEs) underscores the need for comprehensive monitoring.
Methods
This study analyzed the Vaccine Adverse Event Reporting System (VAERS) data from 2020–2022 using statistical methods such as zero-truncated Poisson regression and logistic regression to assess associations with age, gender groups, and vaccine manufacturers.
Results
Logistic regression identified 26 System Organ Classes (SOCs) significantly associated with age and gender. Females displayed especially higher odds in SOC 19 (Pregnancy, puerperium and perinatal conditions), while males had higher odds in SOC 25 (Surgical and medical procedures). Older adults (>65) were more prone to symptoms like Cardiac disorders, whereas those aged 18–65 showed susceptibility to AEs like Skin and subcutaneous tissue disorders. Moderna and Pfizer vaccines induced fewer SOC symptoms compared to Janssen and Novavax. The zero-truncated Poisson regression model estimated an average of 4.243 symptoms per individual.
Conclusion
These findings offer vital insights into vaccine safety, guiding evidence-based vaccination strategies and monitoring programs for precise and effective outcomes.
Abbreviations
| AE | = | adverse event |
| BMI | = | body mass index |
| CDC | = | the Centers for Disease Control and Prevention |
| CI | = | confidence interval |
| COPD | = | chronic obstructive pulmonary disease |
| CSV | = | Comma-Separated-Value |
| CVT | = | cerebral venous thrombosis |
| DO | = | Human Disease Ontology |
| FDA | = | the Food and Drug Administration |
| GBS | = | Guillain-Barré Syndrome |
| HLGT | = | High Level Group Term |
| HLT | = | High Level Term |
| ICH | = | the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use |
| ICU | = | intensive care unit |
| IQR | = | interquartile range |
| LLT | = | lowest Level Term |
| MedDRA | = | Medical Dictionary for Regulatory Activities |
| mRNA | = | messenger Ribonucleic acid |
| OR | = | odds ratio |
| PT | = | Preferred Term |
| ROR | = | reporting odds ratio |
| SOC | = | System Organ Class |
| SSI | = | surgical site infection |
| VAERS | = | Vaccine Adverse Event Reporting System |
Declaration of Interests
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
A reviewer on this manuscript has disclosed that they are currently receiving funding from Moderna for a study not related to COVID-19 vaccine (or any vaccines). Peer reviewers on this manuscript have no other relevant financial or other relationships to disclose.
Author contributions
CT and YC took the lead in designing the experiments, with YL contributing to the experimental design. YL and YD were responsible for data collection. YL and SL conducted data analysis, while YL handled data visualization. WT performed data validation. YL and JL were involved in drafting the manuscript, with CT offering research support. CT and SL edited and reviewed the manuscript. All authors have reviewed and approved the final manuscript.
Data availability
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Acknowledgments
We are sincerely grateful to Dazheng Zhang and Jiayi Tong for their advice at the early stages of this project.
Supplementary material
Supplemental data for this article can be accessed online at https://doi.org/10.1080/14760584.2023.2292203