Evidence map›Paper›PMID 36520333›Full record

ArticleInfectious diseases and therapy2023

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

Min-Taek Lee, Wonbin Choi, Seung-Hun You, Sewon Park, Jeong-Yeon Kim, Dal Ri Nam, Ju Won Lee, Sun-Young Jung

Open access · goldAbstract read
In one paragraph

Article in Infectious diseases and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.1field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 11 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Min-Taek LeeCollege of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-3178-9660
Wonbin ChoiCollege of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0003-4191-6392
Seung-Hun YouCollege of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-2430-6907
Sewon ParkCollege of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0003-0122-9408
Jeong-Yeon KimCollege of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-1187-0605
Dal Ri NamCollege of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-0448-0916
Ju Won LeeCollege of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0003-2956-3344
Sun-Young JungCollege of Pharmacy, Chung-Ang University, Seoul, Republic of Korea. jsyoung@cau.ac.kr.ORCID http://orcid.org/0000-0003-2032-112X
Chung-Ang University · KR

Funding

Government-wide R&D Fund project for infectious disease research (GFID) HG18C0066
6 · The paper itself

Abstract

introductionAlthough 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).

methodsThis 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.

resultsFive 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).

conclusionUsing 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.

Indexed as

ClusterCOVID-19Latent class analysismRNA vaccineSerious adverse eventVigiBase

Identifiers

PMID36520333
PMCPMC9753856
OpenAlexW4311542807

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.