Evidence map›Paper›PMID 35214779›Full record

ArticleVaccines2022

The Safety of mRNA-1273, BNT162b2 and JNJ-78436735 COVID-19 Vaccines: Safety Monitoring for Adverse Events Using Real-World Data.

Soonok Sa, Chae Won Lee, Sung Ryul Shim, Hyounggyoon Yoo, Jinwha Choi, Ju Hee Kim, Kiwon Lee, Myunghee Hong, Hyun Wook Han

Open access · goldAbstract read
In one paragraph

Article in Vaccines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
3.0field-weighted citation impact, top 7% 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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. COVID-19 vaccine induced myocarditis in young males: A systematic review.European journal of clinical investigation · 2023
    Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Article
  6. Article
  7. Virosome: An engineered virus for vaccine delivery.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023
    Review
  8. Review
  9. Article
  10. Review
  11. Article
  12. Asia Pacific perspectives on the second year of the COVID-19 pandemic: A follow-up survey.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2022
    Article
  13. Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022
    Review
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

9 authors at 3 institutions in 1 country.

Soonok SaDepartment of Biomedical Informatics, CHA University School of Medicine, CHA University, Seongnam 13488, Korea.
Chae Won LeeDepartment of Biomedical Informatics, CHA University School of Medicine, CHA University, Seongnam 13488, Korea.ORCID 0000-0002-9380-8230
Sung Ryul ShimDepartment of Biomedical Informatics, CHA University School of Medicine, CHA University, Seongnam 13488, Korea.
Hyounggyoon YooDepartment of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University, Seongnam 13496, Korea.ORCID 0000-0003-2785-4383
Jinwha ChoiDepartment of Pediatrics, Korea University College of Medicine, Seoul 08308, Korea.
Ju Hee KimDepartment of Biomedical Informatics, CHA University School of Medicine, CHA University, Seongnam 13488, Korea.
Kiwon LeeSpidercore Inc., Daejeon 34134, Korea.
Myunghee HongDepartment of Biomedical Informatics, CHA University School of Medicine, CHA University, Seongnam 13488, Korea.ORCID 0000-0002-4573-3625
Hyun Wook HanDepartment of Biomedical Informatics, CHA University School of Medicine, CHA University, Seongnam 13488, Korea.ORCID 0000-0002-6918-5694
CHA University · KRCHA University Bundang Medical Center · KRKorea University · KR

Funding

Ministry of Education 2020R1F1A1068423, NRF-2019M3C7A1032262Ministry of Science and ICTMinistry of Science and ICT 2019-0-00224Ministry of Trade, Industry and Energy 20015086
6 · The paper itself

Abstract

Two mRNA COVID-19 vaccines (mRNA-1273, Moderna; and BNT162b2, Pfizer-BioNTech) and one viral vector vaccine (JNJ-78436735, Janssen/Johnson and Johnson) are authorized in the US to hinder COVID-19 infections. We analyzed severe and common adverse events in response to COVID-19 vaccines using real-world, Vaccine Adverse Effect Reporting System (VAERS) data. From 14 December 2020 to 30 September 2021, 481,172 (50.7 ± 17.5 years, males 27.89%, 12.35 per 100,000 people) individuals reported adverse events (AEs). The median time to severe AEs was 2 days after injection. The risk of severe AEs following the one viral vector vaccine (OR = 1.044, 95% CI = 1.005-1.086) was significantly higher than that after the two mRNA vaccines, and the risk among males (OR = 1.374, 95% CI = 1.342-1.406) was higher than among females, except for anaphylaxis. For common AEs, however, the risk to males (OR = 0.621, 95% CI = 0.612-0.63) was lower than to females. In conclusion, we provided medical insight and clinical guidance about vaccine types by characterizing AEs using real-world data. In particular, COVID-19 mRNA vaccines are safer than viral vector vaccines with regard to coagulation disorders, whereas inflammation-related AEs are lower in the viral vaccine. The risk-benefit ratio of vaccines should be carefully considered, and close monitoring and management of severe AEs is needed.

Indexed as

COVID-19safetysevere adverse eventsvaccines

Identifiers

PMID35214779
PMCPMC8879025
OpenAlexW4212947211

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.