Evidence map›Paper›PMID 26209838›Full record

ReviewVaccine2015

Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).

Tom T Shimabukuro, Michael Nguyen, David Martin, Frank DeStefano

Abstract readReview
In one paragraph

Review in Vaccine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 337 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
337citing papers in PubMed, 4 pooled it
23.8field-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.

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

337 citing papers in PubMed, 4 syntheses or guidelines pooled it, 588 citations in OpenAlex.

  1. Alemtuzumab and thrombotic thrombocytopenic purpura: Analysis of an international surveillance database and systematic literature review.Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis · 2025
    Pooled it
  2. Pneumococcal Vaccine for Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2023
    Guideline
  3. Pooled it
  4. Pooled it
  5. Trial
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  12. Review
  13. Proximal Humerus Osteomyelitis After Influenza Vaccination Administration.Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews · 2026
    Article
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  16. Review
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277 more citing papers are in PubMed but not listed here.

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

4 authors at 3 institutions in 1 country.

Tom T ShimabukuroImmunization Safety Office, Division of Health care Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States. Electronic address: TShimabukuro@cdc.gov.
Michael NguyenOffice of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States.
David MartinOffice of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States.
Frank DeStefanoImmunization Safety Office, Division of Health care Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Center for Biologics Evaluation and Research · USCenters for Disease Control and Prevention · USNational Center for Emerging and Zoonotic Infectious Diseases · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) conduct post-licensure vaccine safety monitoring using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous (or passive) reporting system. This means that after a vaccine is approved, CDC and FDA continue to monitor safety while it is distributed in the marketplace for use by collecting and analyzing spontaneous reports of adverse events that occur in persons following vaccination. Various methods and statistical techniques are used to analyze VAERS data, which CDC and FDA use to guide further safety evaluations and inform decisions around vaccine recommendations and regulatory action. VAERS data must be interpreted with caution due to the inherent limitations of passive surveillance. VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination. CDC makes VAERS data available to the public and readily accessible online. We describe fundamental vaccine safety concepts, provide an overview of VAERS for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and explain how CDC and FDA analyze VAERS data. We also describe strengths and limitations, and address common misconceptions about VAERS. Information in this review will be helpful for healthcare professionals counseling patients, parents, and others on vaccine safety and benefit-risk balance of vaccination.

Indexed as

Adverse Drug Reaction Reporting SystemsProduct Surveillance, PostmarketingCenters for Disease Control and Prevention, U.S.Drug-Related Side Effects and Adverse ReactionsHumansUnited StatesUnited States Food and Drug AdministrationVaccinesVaccinesAdverse effectAdverse event following immunizationAdverse reactionPassive surveillanceSpontaneous reportingVaccinationVaccine adverse eventVaccine Adverse Event Reporting System (VAERS)Vaccine safety

Identifiers

PMID26209838
PMCPMC4632204
OpenAlexW979396035

What OpenQuestion holds

Textmetadata
LicenceTDM
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.