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. 2024 Jul 15:10:e51007.
doi: 10.2196/51007.

Adverse Events of COVID-19 Vaccines in the United States: Temporal and Spatial Analysis

Yiming Li  1 , Jianfu Li  2 , Yifang Dang  1 , Yong Chen  3 , Cui Tao  2
Affiliations

Adverse Events of COVID-19 Vaccines in the United States: Temporal and Spatial Analysis

Yiming Li et al. JMIR Public Health Surveill. .

Abstract

Background: The COVID-19 pandemic, caused by SARS-CoV-2, has had a profound impact worldwide, leading to widespread morbidity and mortality. Vaccination against COVID-19 is a critical tool in controlling the spread of the virus and reducing the severity of the disease. However, the rapid development and deployment of COVID-19 vaccines have raised concerns about potential adverse events following immunization (AEFIs). Understanding the temporal and spatial patterns of these AEFIs is crucial for an effective public health response and vaccine safety monitoring.

Objective: This study aimed to analyze the temporal and spatial characteristics of AEFIs associated with COVID-19 vaccines in the United States reported to the Vaccine Adverse Event Reporting System (VAERS), thereby providing insights into the patterns and distributions of the AEFIs, the safety profile of COVID-19 vaccines, and potential risk factors associated with the AEFIs.

Methods: We conducted a retrospective analysis of administration data from the Centers for Disease Control and Prevention (n=663,822,575) and reports from the surveillance system VAERS (n=900,522) between 2020 and 2022. To gain a broader understanding of postvaccination AEFIs reported, we categorized them into system organ classes (SOCs) according to the Medical Dictionary for Regulatory Activities. Additionally, we performed temporal analysis to examine the trends of AEFIs in all VAERS reports, those related to Pfizer-BioNTech and Moderna, and the top 10 AEFI trends in serious reports. We also compared the similarity of symptoms across various regions within the United States.

Results: Our findings revealed that the most frequently reported symptoms following COVID-19 vaccination were headache (n=141,186, 15.68%), pyrexia (n=122,120, 13.56%), and fatigue (n=121,910, 13.54%). The most common symptom combination was chills and pyrexia (n=56,954, 6.32%). Initially, general disorders and administration site conditions (SOC 22) were the most prevalent class reported. Moderna exhibited a higher reporting rate of AEFIs compared to Pfizer-BioNTech. Over time, we observed a decreasing reporting rate of AEFIs associated with COVID-19 vaccines. In addition, the overall rates of AEFIs between the Pfizer-BioNTech and Moderna vaccines were comparable. In terms of spatial analysis, the middle and north regions of the United States displayed a higher reporting rate of AEFIs associated with COVID-19 vaccines, while the southeast and south-central regions showed notable similarity in symptoms reported.

Conclusions: This study provides valuable insights into the temporal and spatial patterns of AEFIs associated with COVID-19 vaccines in the United States. The findings underscore the critical need for increasing vaccination coverage, as well as ongoing surveillance and monitoring of AEFIs. Implementing targeted monitoring programs can facilitate the effective and efficient management of AEFIs, enhancing public confidence in future COVID-19 vaccine campaigns.

Keywords: ADE; AEFI; COVID-19; COVID-19 vaccine; VAERS; Vaccine Adverse Event Reporting System; adverse drug event; adverse event following immunization; vaccine.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Case-reporting rate and individual SOC-reporting rate associated with COVID-19 vaccines in the United States (2020-2022). SOC: system organ class.
Figure 2
Figure 2
Reporting rates for serious cases and top 10 adverse events in serious cases for COVID-19 vaccines in the United States (2020-2022).
Figure 3
Figure 3
Case-reporting rate and individual SOC-reporting rate for the Pfizer-BioNTech vaccine in the United States (2020-2022). SOC: system organ class.
Figure 4
Figure 4
Case-reporting rate and individual SOC-reporting rate for the Moderna vaccine in the United States (2020-2022). SOC: system organ class.
Figure 5
Figure 5
Reporting rate associated with COVID-19 vaccines in VAERS by state in the United States (2020-2022). VAERS: Vaccine Adverse Event Reporting System.
Figure 6
Figure 6
Serious case–reporting rate associated with COVID-19 vaccines in VAERS by state in the United States (2020-2022). VAERS: Vaccine Adverse Event Reporting System.
Figure 7
Figure 7
(a) Heatmap of the similarity of symptoms following COVID-19 vaccination between regions in the United States (2020-2022). (b) Standard Federal Regions in the United States [49].
Figure 8
Figure 8
(a) Heatmap of the similarity of symptoms in serious reports associated with COVID-19 vaccines between regions in the United States (2020-2022). (b) Standard Federal Regions in the United States [49].
See this image and copyright information in PMC

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