Evidence map›Paper›PMID 34709664›Full record

ArticleJournal of medical virology2022

Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database.

Min Seo Kim, Se Yong Jung, Jong Gyun Ahn, Se Jin Park, Yehuda Shoenfeld, Andreas Kronbichler, Ai Koyanagi, Elena Dragioti, Kalthoum Tizaoui, Sung Hwi Hong and 17 more

Open access · greenAbstract read
In one paragraph

Article in Journal of medical virology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 3 pooled it
3.5field-weighted citation impact, top 6% 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

34 citing papers in PubMed, 3 syntheses or guidelines pooled it, 64 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Inflammatory mediators of mRNA vaccine-induced adverse reactions in mice.Molecular therapy : the journal of the American Society of Gene Therapy · 2026
    Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Article
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

27 authors at 19 institutions in 14 countries.

Min Seo KimCollege of Medicine, Korea University, Seoul, Republic of Korea.ORCID 0000-0003-2115-7835
Se Yong JungDepartment of Pediatrics, Yonsei University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0003-1337-563X
Jong Gyun AhnDepartment of Pediatrics, Severance Children's Hospital, Yonsei University College of Medicine, South Korea.
Se Jin ParkDepartment of Pediatrics, Eulji University School of Medicine, Daejeon, Republic of Korea.
Yehuda ShoenfeldLaboratory of the Mosaics of Autoimmunity, Saint Petersburg State University, Saint-Petersburg, Russian Federation.
Andreas KronbichlerDepartment of Internal Medicine IV, Medical University Innsbruck, Innsbruck, Austria.
Ai KoyanagiResearch and Development Unit, Parc Sanitari Sant Joan de Déu, Universitat de Barcelona, Fundació Sant Joan de Déu, CIBERSAM, Barcelona, Spain.
Elena DragiotiPain and Rehabilitation Centre, and Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
Kalthoum TizaouiLaboratory of Microorganismes and Active Biomolecules, Sciences Faculty of Tunis, University Tunis El Manar, Tunis, Tunisia.ORCID 0000-0001-8524-6058
Sung Hwi HongYonsei University College of Medicine, Seoul, Republic of Korea.
Louis JacobResearch and Development Unit, Parc Sanitari Sant Joan de Déu, Universitat de Barcelona, Fundació Sant Joan de Déu, CIBERSAM, Barcelona, Spain.ORCID 0000-0003-1071-1239
Joe-Elie SalemSorbonne Université, INSERM, CIC-1901 Paris-Est, CLIP² Galilée, UNICO-GRECO Cardio-oncology Program, and Department of Pharmacology, Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
Dong Keon YonDepartment of Pediatrics, Seoul National University Children's Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0003-1628-9948
Seung Won LeeDepartment of Data Science, Sejong University College of Software Convergence, Seoul, Republic of Korea.ORCID 0000-0001-5632-5208
Shuji OginoCancer Immunology and Cancer Epidemiology Programs, Dana-Farber Harvard Cancer Center, Boston, Massachusetts, USA.ORCID 0000-0002-3909-2323
Hanna KimCollege of Medicine, Ewha Womans University, Seoul, Republic of Korea.
Jerome H KimInternational Vaccine Institute, Seoul, Republic of Korea.
Jean-Louis ExclerInternational Vaccine Institute, Seoul, Republic of Korea.
Florian MarksInternational Vaccine Institute, Seoul, Republic of Korea.
John D ClemensInternational Vaccine Institute, Seoul, Republic of Korea.
Michael EisenhutLuton & Dunstable University Hospital, Luton, United Kingdom.
Yvonne BarnettCentre for Health, Performance, and Wellbeing, Anglia Ruskin University, Cambridge, UK.
Laurie ButlerCentre for Health, Performance, and Wellbeing, Anglia Ruskin University, Cambridge, UK.
Cristian Petre IlieQueen Elizabeth Hospital Foundation Trust, King's Lynn, Norfolk, England.
Eui-Cheol ShinLaboratory of Immunology and Infectious Diseases, Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Republic of Korea.ORCID 0000-0002-6308-9503
Jae Il ShinDepartment of Pediatrics, Yonsei University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0003-2326-1820
Lee SmithCentre for Health, Performance, and Wellbeing, Anglia Ruskin University, Cambridge, UK.
International Vaccine Institute · KRYonsei University · KRAnglia Ruskin University · GBBroad Institute · USEulji University · KREwha Womans University · KRInnsbruck Medical University · ATInserm · FRInstitució Catalana de Recerca i Estudis Avançats · ESKorea Advanced Institute of Science and Technology · KRKorea University · KRLinköping University · SELuton and Dunstable Hospital · GBQueen Elizabeth Hospital King's Lynn NHS Foundation Trust · GBSejong University · KRSeoul National University Children's Hospital · KRTel Aviv University · ILTunis University · TNUniversité de Versailles Saint-Quentin-en-Yvelines · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Two messenger RNA (mRNA) vaccines developed by Pfizer-BioNTech and Moderna are being rolled out. Despite the high volume of emerging evidence regarding adverse events (AEs) associated with the COVID-19 mRNA vaccines, previous studies have thus far been largely based on the comparison between vaccinated and unvaccinated control, possibly highlighting the AE risks with COVID-19 mRNA vaccination. Comparing the safety profile of mRNA vaccinated individuals with otherwise vaccinated individuals would enable a more relevant assessment for the safety of mRNA vaccination. We designed a comparative safety study between 18 755 and 27 895 individuals who reported to VigiBase for adverse events following immunization (AEFI) with mRNA COVID-19 and influenza vaccines, respectively, from January 1, 2020, to January 17, 2021. We employed disproportionality analysis to rapidly detect relevant safety signals and compared comparative risks of a diverse span of AEFIs for the vaccines. The safety profile of novel mRNA vaccines was divergent from that of influenza vaccines. The overall pattern suggested that systematic reactions like chill, myalgia, fatigue were more noticeable with the mRNA COVID-19 vaccine, while injection site reactogenicity events were more prevalent with the influenza vaccine. Compared to the influenza vaccine, mRNA COVID-19 vaccines demonstrated a significantly higher risk for a few manageable cardiovascular complications, such as hypertensive crisis (adjusted reporting odds ratio [ROR], 12.72; 95% confidence interval [CI], 2.47-65.54), and supraventricular tachycardia (adjusted ROR, 7.94; 95% CI, 2.62-24.00), but lower risk of neurological complications such as syncope, neuralgia, loss of consciousness, Guillain-Barre syndrome, gait disturbance, visual impairment, and dyskinesia. This study has not identified significant safety concerns regarding mRNA vaccination in real-world settings. The overall safety profile patterned a lower risk of serious AEFI following mRNA vaccines compared to influenza vaccines.

Indexed as

COVID-19Influenza, HumanInfluenza VaccinesAdverse Drug Reaction Reporting SystemsCOVID-19 VaccinesHumansmRNA VaccinesPharmacovigilanceRNA, MessengerWorld Health OrganizationCOVID-19 VaccinesInfluenza VaccinesmRNA VaccinesRNA, MessengerCOVID-19influenza vaccinemRNA vaccinepost-implementation surveillancesafetyVigiBase

Identifiers

PMID34709664
PMCPMC8662238
OpenAlexW3209952628

What OpenQuestion holds

Textmetadata
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.