Evidence map›Paper›PMID 33039207›Full record

ArticleVaccine2020

The reporting sensitivity of the Vaccine Adverse Event Reporting System (VAERS) for anaphylaxis and for Guillain-Barré syndrome.

Elaine R Miller, Michael M McNeil, Pedro L Moro, Jonathan Duffy, John R Su

Open access · greenAbstract read
In one paragraph

Article in Vaccine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
2.9field-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

26 citing papers in PubMed, 45 citations in OpenAlex.

  1. Article
  2. Review
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  12. Determinants of COVID-19 vaccine-induced myocarditis.Therapeutic advances in drug safety · 2024
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  14. Review
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  18. COVID-19 Vaccines and Myopericarditis: A Nuanced Story.Journal of personalized medicine · 2022
    Article
  19. Article
  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

5 authors at 2 institutions in 1 country.

Elaine R MillerImmunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States. Electronic address: EMiller@cdc.gov.
Michael M McNeilImmunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.
Pedro L MoroImmunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.
Jonathan DuffyImmunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.
John R SuImmunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.
National Center for Emerging and Zoonotic Infectious Diseases · USCenters for Disease Control and Prevention · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

backgroundUnderreporting is a limitation common to passive surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS) that monitors the safety of U.S.-licensed vaccines. Nonetheless, previous reports demonstrate substantial case capture for clinically severe adverse events (AEs), including 47% of intussusception cases after rotavirus vaccine, and 68% of vaccine associated paralytic polio after oral polio vaccine.

objectivesTo determine the sensitivity of VAERS in capturing AE reports of anaphylaxis and Guillain-Barré syndrome (GBS) following vaccination and whether this is consistent with previous estimates for other severe AEs.

methodsWe estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. We used data from VAERS safety reviews as the numerator, and estimated incidence rates of anaphylaxis and GBS following vaccination from the Vaccine Safety Datalink (VSD) studies as the denominator. We defined reporting sensitivity as the VAERS reporting rate divided by the VSD incidence rate. Sensitivity was reported as either a single value, or a range if data were available from >1 study.

resultsVAERS sensitivity for capturing anaphylaxis after seven different vaccines ranged from 13 to 76%; sensitivity for capturing GBS after three different vaccines ranged from 12 to 64%. For anaphylaxis, VAERS captured 13-27% of cases after the pneumococcal polysaccharide vaccine, 13% of cases after influenza vaccine, 21% of cases after varicella vaccine, 24% of cases after both the live attenuated zoster and quadrivalent human papillomavirus (4vHPV) vaccines, 25% of cases after the combined measles, mumps and rubella (MMR) vaccine, and 76% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine. For GBS, VAERS captured 12% of cases after the 2012-13 inactivated seasonal influenza vaccine, 15-55% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine, and 64% of cases after 4vHPV vaccine.

conclusionsFor anaphylaxis and GBS, VAERS sensitivity is comparable to previous estimates for detecting important AEs following vaccination.

Indexed as

AnaphylaxisGuillain-Barre SyndromeInfluenza A Virus, H1N1 SubtypeInfluenza VaccinesAdverse Drug Reaction Reporting SystemsHumansUnited StatesInfluenza VaccinesAdverse eventPassive surveillanceVaccineVaccine Adverse Event Reporting System (VAERS)Vaccine safety

Identifiers

PMID33039207
PMCPMC11252891
OpenAlexW3092223014

What OpenQuestion holds

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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.