Evidence map›Paper›PMID 36055877›Full record

ArticleVaccine2022

Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults.

Joseph Fraiman, Juan Erviti, Mark Jones, Sander Greenland, Patrick Whelan, Robert M Kaplan, Peter Doshi

2 registry-linked trialsOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 95 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 2 pooled it
22.9field-weighted citation impact, top 1% 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.

NCT04368728 phase2 / phase3completednot on this map

A phase 1/2/3, placebo-controlled, randomized, observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity, and efficacy of sars-cov-2 rna vaccine candidates against covid-19 in healthy individuals

TypeinterventionalSponsorBioNTech SERan2020 to 2023Enrolled46,969ConditionsSARS-CoV-2 Infection, COVID-19ArmsBNT162b1, BNT162b2, Placebo, BNT162b2SA
NCT04470427 phase3completednot on this map

A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older

TypeinterventionalSponsorModernaTX, Inc.Ran2020 to 2022Enrolled30,415ConditionsSARS-CoV-2ArmsmRNA-1273, Placebo
3 · Its place in the literature

Who cites it

95 citing papers in PubMed, 2 syntheses or guidelines pooled it, 233 citations in OpenAlex.

  1. Pooled it
  2. Vaccines for preventing infections in adults with solid tumours.The Cochrane database of systematic reviews · 2025
    Pooled it
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Efficiency and safety of five different agents forFrontiers in molecular biosciences · 2026
    Article
  10. Review
  11. RNA vaccines: The dawn of a new age for tuberculosis?Human vaccines & immunotherapeutics · 2025
    Review
  12. Review
  13. Article
  14. Review
  15. pDNA Impurities in mRNA Vaccines.Microorganisms · 2025
    Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Article

35 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 2 countries.

Joseph FraimanThibodaux Regional Health System, Thibodaux, LA, USA. Electronic address: josephfraiman@gmail.com.
Juan ErvitiUnit of Innovation and Organization, Navarre Health Service, Spain. Electronic address: jervitil@navarra.es.
Mark JonesInstitute of Evidence-Based Healthcare, Bond University, Gold Coast, QLD, Australia. Electronic address: majones@bond.edu.au.
Sander GreenlandFielding School of Public Health and College of Letters and Science, University of California, Los Angeles, CA, USA. Electronic address: lesdomes@g.ucla.edu.
Patrick WhelanGeffen School of Medicine, University of California, Los Angeles, CA, USA. Electronic address: PWhelan@mednet.ucla.edu.
Robert M KaplanClinical Excellence Research Center, School of Medicine, Stanford University, CA, USA. Electronic address: Bob.Kaplan@stanford.edu.
Peter DoshiSchool of Pharmacy, University of Maryland, Baltimore, MD, USA. Electronic address: pdoshi@rx.umaryland.edu.
Bond University · AUFielding Graduate University · USRegional Health · USStanford University · USUniversity of California, Los Angeles · USUniversity of Maryland, Baltimore · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials.

methodsSecondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest.

resultsPfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI -0.4 to 20.6 and -3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI -23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI -3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39). DISCUSSION: The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.

Indexed as

COVID-19COVID-19 VaccinesmRNA VaccinesAdultClinical Trials, Phase III as TopicHumansRandomized Controlled Trials as TopicRNA, MessengerVaccinationVaccines, SyntheticCOVID-19 VaccinesmRNA VaccinesRNA, MessengerVaccines, SyntheticAdverse events of special interestBrighton CollaborationCoalition for Epidemic Preparedness InnovationsCOVID-19COVID-19 vaccinesModerna COVID-19 vaccine mRNA-1273mRNA vaccinesNCT04368728NCT04470427Pfizer-BioNTech COVID-19 vaccine BNT162b2Safety Platform for Emergency vACcinesSARS-CoV-2Serious adverse eventsVaccines

Identifiers

PMID36055877
PMCPMC9428332
OpenAlexW4293740214

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.