Dataset Information

Safety Profiles of mRNA COVID-19 Vaccines Using World Health Organization Global Scale Database (VigiBase): A Latent Class Analysis.

ABSTRACT:

Introduction

Although messenger RNA (mRNA) vaccines have been developed and widely utilized to mitigate the coronavirus disease (COVID-19) pandemic, it is essential to describe the adverse events (AEs) following immunization. This study aimed to identify the patterns associated with serious AE reports after mRNA COVID-19 vaccination in the World Health Organization (WHO)'s global scale database (VigiBase).

Methods

This study performed a latent class analysis (LCA) of reports of serious AEs following mRNA COVID-19 vaccination from VigiBase between December 28, 2020 , and February 28, 2022 (N = 312878). The Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) terms were selected for LCA. The reporting characteristics in accordance with the cluster were described. We used a multinomial logistic regression model to estimate the association between potential factors and each cluster.

Results

Five clusters of AE reports were distinguished through LCA: infection AEs (cluster 1), cardiac AEs (cluster 2), respiratory/thrombotic AEs (cluster 3), systemic AEs (cluster 4), and nervous system AEs (cluster 5). Compared to cluster 4, cluster 2 had a higher proportion of males (OR 2.98; 95% confidence interval (CI) 2.87-3.09), and cluster 1 had a longer time to onset than other AEs (≥ 14 days) (OR 16.2; 95% CI 15.5-16.9).

Conclusion

Using LCA, we found five clusters of serious AEs following mRNA COVID-19 vaccination. Each cluster was distinguished by potential factors such as age, gender, region, and time to onset. We suggest that monitoring should carefully consider the patterns of young males with cardiac AEs and elderly individuals with thrombosis after respiratory AEs. Our findings could contribute to enhancing understanding of safety profiles and establishing management strategies for serious AEs of special interest following mRNA COVID-19 vaccination.

SUBMITTER: Lee MT

PROVIDER: S-EPMC9753856 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Safety Profiles of mRNA COVID-19 Vaccines Using World Health Organization Global Scale Database (VigiBase): A Latent Class Analysis.

Lee Min-Taek MT Choi Wonbin W You Seung-Hun SH Park Sewon S Kim Jeong-Yeon JY Nam Dal Ri DR Lee Ju Won JW Jung Sun-Young SY

Infectious diseases and therapy 20221215 2

<h4>Introduction</h4>Although messenger RNA (mRNA) vaccines have been developed and widely utilized to mitigate the coronavirus disease (COVID-19) pandemic, it is essential to describe the adverse events (AEs) following immunization. This study aimed to identify the patterns associated with serious AE reports after mRNA COVID-19 vaccination in the World Health Organization (WHO)'s global scale database (VigiBase).<h4>Methods</h4>This study performed a latent class analysis (LCA) of reports of se ...[more]

PMID: 36520333

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Project description:ObjectiveVaccine-associated erythema multiforme (EM) remains under-researched, impacting global vaccine safety evaluations. This study examines the global and regional burden of EM and its association with specific vaccines to optimize vaccination strategies.Subject and methodsWe analyzed data from the WHO pharmacovigilance database on vaccine-associated EM from 1967 to 2023 (n = 131,255,418 reports). Reporting frequencies, reported odds ratios (RORs), and information components (IC) were calculated for 16 vaccines across 170 countries.ResultsWe identified 6,355 cases (males, n = 3,182 [50.07%]) of vaccine-associated EM from a total of 46,378 reports of all-cause EM. While vaccine-associated EM has been consistently reported, there has been a notable increase in reported incidence particularly in 2010 and 2020. Measles, mumps, and rubella vaccines had the highest association with vaccine-associated EM reports (ROR: 8.75 [95% confidence interval, 8.11-9.44]; IC, 3.10 [IC0.25, 2.97]), followed by hepatitis B (8.54 [7.66-9.51]; 3.06 [2.88]), hepatitis A (8.11 [7.01-9.39]; 2.98 [2.74]), typhoid (6.50 [4.75-8.90]; 2.60 [2.07]), encephalitis (5.86 [4.35-7.91]; 2.47 [1.96]), diphtheria, tetanus toxoids, pertussis, polio, and Hemophilus influenza type b (5.70 [5.42-5.99]; 2.46 [2.38]), pneumococcal (5.56 [5.11-6.06]; 2.45 [2.31]), rotavirus (4.96 [4.21-5.84]; 2.29 [2.01]), varicella-zoster (4.44 [3.99-4.95]; 2.13 [1.95]). Vaccine-associated EM reports were more strongly correlated with younger age groups and males. The overall fatality rate of vaccine-associated EM was 0.04%.ConclusionsThe rise in vaccine-associated EM across multiple vaccines, especially in younger populations, highlights the need for closer monitoring and more informed vaccination practices to mitigate adverse reactions.ObjectiveVaccine-associated erythema multiforme (EM) remains under-researched, impacting global vaccine safety evaluations. This study examines the global and regional burden of EM and its association with specific vaccines to optimize vaccination strategies.Subject and methodsWe analyzed data from the WHO pharmacovigilance database on vaccine-associated EM from 1967 to 2023 (n = 131,255,418 reports). Reporting frequencies, reported odds ratios (RORs), and information components (IC) were calculated for 16 vaccines across 170 countries.ResultsWe identified 6,355 cases (males, n = 3,182 [50.07%]) of vaccine-associated EM from a total of 46,378 reports of all-cause EM. While vaccine-associated EM has been consistently reported, there has been a notable increase in reported incidence particularly in 2010 and 2020. Measles, mumps, and rubella vaccines had the highest association with vaccine-associated EM reports (ROR: 8.75 [95% confidence interval, 8.11-9.44]; IC, 3.10 [IC0.25, 2.97]), followed by hepatitis B (8.54 [7.66-9.51]; 3.06 [2.88]), hepatitis A (8.11 [7.01-9.39]; 2.98 [2.74]), typhoid (6.50 [4.75-8.90]; 2.60 [2.07]), encephalitis (5.86 [4.35-7.91]; 2.47 [1.96]), diphtheria, tetanus toxoids, pertussis, polio, and Hemophilus influenza type b (5.70 [5.42-5.99]; 2.46 [2.38]), pneumococcal (5.56 [5.11-6.06]; 2.45 [2.31]), rotavirus (4.96 [4.21-5.84]; 2.29 [2.01]), varicella-zoster (4.44 [3.99-4.95]; 2.13 [1.95]). Vaccine-associated EM reports were more strongly correlated with younger age groups and males. The overall fatality rate of vaccine-associated EM was 0.04%.ConclusionsThe rise in vaccine-associated EM across multiple vaccines, especially in younger populations, highlights the need for closer monitoring and more informed vaccination practices to mitigate adverse reactions.

Dataset Information

Safety Profiles of mRNA COVID-19 Vaccines Using World Health Organization Global Scale Database (VigiBase): A Latent Class Analysis.

Introduction

Methods

Results

Conclusion

Publications

Safety Profiles of mRNA COVID-19 Vaccines Using World Health Organization Global Scale Database (VigiBase): A Latent Class Analysis.

Similar Datasets

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