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- Of these serious reports, 21,153 (49.93%) were reported by female patients and 20,275 (47.86%) by male patients.
- For death and serious outcomes after vaccination, the VAERS staff will attempt to obtain additional documentation (e.g., hospital discharge summaries, laboratory reports, death certificates, and autopsy reports).
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- Furthermore, it is crucial to note that VAERS does not validate the causation between COVID-19 vaccines and the AEFIs reported .
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Ruiz-Fresneda MA, Ruiz-Pérez R, Ruiz-Fresneda C, Jiménez-Contreras E. Differences in global scientific production between new mRNA and conventional vaccines against COVID-19. Moss P, Berenbaum F, Curigliano G, Grupper A, Berg T, Pather S. Benefit-risk evaluation of COVID-19 vaccination in special population groups of interest. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. A global database of COVID-19 vaccinations.
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In our study, this relationship could not be assessed due to the lack of patient-specific data on infection history, particularly in relation to its potential impact on safety outcomes. This remains an important factor to consider in future research, as variant-specific dynamics may provide further insights into vaccine safety outcomes. Variants such as Alpha, Delta, and Omicron introduced changes in viral transmissibility, immune evasion, and disease severity, potentially influencing both vaccine effectiveness and safety profiles (124). Future research should explore the temporal relationship between these AEFI to rule out the possibility that patients were already infected, albeit asymptomatically, at the time of vaccination. Despite the emergence of variants like Omicron, which have reduced vaccine effectiveness against symptomatic infections, these vaccines still provide robust protection against severe outcomes (121, 122). Therefore, during vaccination campaigns, it is expected that deaths from other causes will continue to occur, sometimes closely following vaccination, without necessarily being related to it.
Over 40% of cases reported one or more serious AEFI. Although regulatory authorities, healthcare professionals, and vaccine recipients already know most of these reactions, our study provides a detailed examination of their patterns. Our findings reveal several safety concerns, notably the high frequency and co-occurrence of systemic reactions. Correspondence analysis biplot illustrating the relationship between adverse events following immunization (AEFI) and vaccine versions.
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There have been instances where patients with MD who were stable experienced vertigo following vaccination 56,59. Figure 4 displays the case-reporting rate and the individual SOC-reporting rate, specifically for Moderna. However, starting from December 2021, the reporting rate for the other AEFIs decreased significantly over time, while the reports of death remained relatively consistent. Figure 2 presents trends in the serious case–reporting rate proportion and the top 10 AEFIs reported related to serious reports in VAERS. Furthermore, the reporting rate of VAERS and SOC symptoms decreased over time, demonstrating that COVID-19–related AEFIs gradually improved. Notably, in 2022, the reporting rate for Janssen (0.0009) was significantly higher compared to any other COVID-19 vaccine manufacturer from 2020 to 2022.
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Among the vaccine manufacturers, Janssen had the highest reporting rate, followed by the unknown manufacturer, Novavax, Moderna, and Pfizer-BioNTech in that order. For the Janssen vaccine, the top 5 symptoms reported were headache, pyrexia, chills, fatigue, and pain. The results are shown in Figure S2 in Multimedia Appendix 1 (detailed results are available in “Frequency and reporting rate of adverse events” in Multimedia Appendix 2). Additionally, we conducted a separate temporal analysis specifically focusing on AEFIs related to Pfizer-BioNTech and Moderna vaccines.
- Mild sensory symptoms, such as numbness and tingling, are frequently reported in the literature, including cases of Bell’s palsy (58).
- The continuous monitoring of vaccine safety in the general population after licensure (known as post-licensure or post-marketing surveillance) is used to identify and evaluate risk for such AEs after vaccination.4
- Below are some examples of how VAERS data have contributed to public health, listed by some of the major objectives of VAERS.
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- In that case a petitioner must prove through evidence, such as expert witness testimony, medical records, or medical opinion, that the vaccine caused the injury and/or condition.
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Furthermore, we ranked and analyzed the top 10 symptoms reported in serious case reports over time. The COVID Data Tracker contains data on the number of vaccine doses distributed and administered, as well as breakdowns by state, demographic group, and vaccine type . The COVID Data Tracker is a centralized database maintained by the CDC that provides up-to-date information about COVID-19 vaccine administration across the United States . In addition, we curated COVID-19 vaccine administration data from the Centers for Disease Control and Prevention’s (CDC) COVID Data Tracker during the corresponding period. By modeling weekly reported symptoms relative to administration, we accurately assessed temporal variation, identifying associations between time and AEFIs. We begin with descriptive analyses of vaccine administration and VAERS data, examining factors such as gender, age, and manufacturer, with a specific focus on serious reports.
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They found that fever, chills, headache, fatigue, and pain are the most commonly reported AEFIs . A comparative analysis with other countries can provide insights into the generalizability of our findings and the impact of different health care systems and vaccination strategies. Consistent testing protocols and diagnostic criteria across these regions can lead to more uniform reporting of symptoms. Additionally, similarities in health care infrastructure, medical practices, and access to testing facilities may contribute to the observed similarities in the symptoms reported. Individuals residing in close proximity or frequently traveling between regions can contribute to the transmission and dissemination of specific COVID-19 strains, leading to similarities in symptom reporting.