Evidence map›Paper›PMID 33137184›Full record

ArticleThe Journal of infectious diseases2021

Guillain-Barré Syndrome After High-Dose Influenza Vaccine Administration in the United States, 2018-2019 Season.

Silvia Perez-Vilar, Mao Hu, Eric Weintraub, Deepa Arya, Bradley Lufkin, Tanya Myers, Emily Jane Woo, An-Chi Lo, Steve Chu, Madeline Swarr and 7 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Journal of infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Robust Alpha Spending for Unstable Data.Statistics in medicine · 2026
    Article
  4. Article
  5. Article
  6. Observational
  7. Article
  8. Article
  9. Review
  10. Review
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  12. Article
  13. Observational
  14. Article
  15. Guillain-Barré Syndrome After Ad26.COV2.S Vaccination.The American journal of case reports · 2022
    Article
  16. Article
  17. Article
  18. 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

17 authors.

Silvia Perez-VilarCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Mao HuAcumen LLC, Burlingame, California, USA.
Eric WeintraubImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Deepa AryaCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Bradley LufkinAcumen LLC, Burlingame, California, USA.
Tanya MyersImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Emily Jane WooCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
An-Chi LoAcumen LLC, Burlingame, California, USA.
Steve ChuCenters for Medicare & Medicaid Services, Washington, DC, USA.
Madeline SwarrAcumen LLC, Burlingame, California, USA.
Jiemin LiaoAcumen LLC, Burlingame, California, USA.
Michael WerneckeAcumen LLC, Burlingame, California, USA.
Tom MaCurdyAcumen LLC, Burlingame, California, USA.
Jeffrey KelmanCenters for Medicare & Medicaid Services, Washington, DC, USA.
Steven AndersonCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Jonathan DuffyImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Richard A ForsheeCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

backgroundThe Vaccine Safety Datalink (VSD) identified a statistical signal for an increased risk of Guillain-Barré syndrome (GBS) in days 1-42 after 2018-2019 high-dose influenza vaccine (IIV3-HD) administration. We evaluated the signal using Medicare.

methodsWe conducted early- and end-of-season claims-based self-controlled risk interval analyses among Medicare beneficiaries ages ≥65 years, using days 8-21 and 1-42 postvaccination as risk windows and days 43-84 as control window. The VSD conducted chart-confirmed analyses.

resultsAmong 7 453 690 IIV3-HD vaccinations, we did not detect a statistically significant increased GBS risk for either the 8- to 21-day (odds ratio [OR], 1.85; 95% confidence interval [CI], 0.99-3.44) or 1- to 42-day (OR, 1.31; 95% CI, 0.78-2.18) risk windows. The findings from the end-of-season analyses were fully consistent with the early-season analyses for both the 8- to 21-day (OR, 1.64; 95% CI, 0.92-2.91) and 1- to 42-day (OR, 1.12; 95% CI, 0.70-1.79) risk windows. The VSD's chart-confirmed analysis, involving 646 996 IIV3-HD vaccinations, with 1 case each in the risk and control windows, yielded a relative risk of 1.00 (95% CI, 0.06-15.99).

conclusionsThe Medicare analyses did not exclude an association between IIV3-HD and GBS, but it determined that, if such a risk existed, it was similar in magnitude to prior seasons. Chart-confirmed VSD results did not confirm an increased risk of GBS.

Indexed as

AgedAged, 80 and overFemaleGuillain-Barre SyndromeHumansInfluenza, HumanInfluenza VaccinesMaleMedicareOdds RatioRisk AssessmentSeasonsUnited StatesVaccinationInfluenza VaccinesGuillain-Barré syndromeinfluenza vaccinesself-controlled risk intervalsequential testsvaccine safety

Identifiers

PMID33137184
PMCPMC7882024

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.