Evidence map›Paper›PMID 41284649›Full record

ArticlePloS one2025

Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States.

Shelby S Fisher, Arnstein Lindaas, Stella G Muthuri, Patricia C Lloyd, Joann F Gruber, Morgan M Richey, Hai Lyu, Angela S Cheng, Lisa S Kowarski, Mollie M McKillop and 13 more

Abstract read
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. 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

23 authors.

Shelby S FisherRTI International, Durham, North Carolina, United States of America.
Arnstein LindaasAcumen LLC, Burlingame, California, United States of America.
Stella G MuthuriIBM Consulting, Bethesda, Maryland, United States of America.
Patricia C LloydUnited States of America Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America.
Joann F GruberUnited States of America Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America.
Morgan M RicheyRTI Health Solutions, Durham, North Carolina, United States of America.
Hai LyuAcumen LLC, Burlingame, California, United States of America.
Angela S ChengAcumen LLC, Burlingame, California, United States of America.
Lisa S KowarskiIBM Consulting, Bethesda, Maryland, United States of America.
Mollie M McKillopIBM Consulting, Bethesda, Maryland, United States of America.
Christine BuiRTI Health Solutions, Durham, North Carolina, United States of America.
Tainya C ClarkeUnited States of America Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America.
Jeffrey BeersIBM Consulting, Bethesda, Maryland, United States of America.
Timothy BurrellIBM Consulting, Bethesda, Maryland, United States of America.ORCID https://orcid.org/0000-0001-7973-7803
Pablo Freyria DuenasAcumen LLC, Burlingame, California, United States of America.
Yangping ChenAcumen LLC, Burlingame, California, United States of America.
Minya ShengIBM Consulting, Bethesda, Maryland, United States of America.
Richard A ForsheeUnited States of America Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America.
Steven A AndersonUnited States of America Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America.
Yoganand ChillarigeAcumen LLC, Burlingame, California, United States of America.
Mary S AnthonyRTI Health Solutions, Durham, North Carolina, United States of America.ORCID https://orcid.org/0000-0002-5201-1794
Azadeh ShoaibiUnited States of America Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America.
J Bradley LaytonRTI Health Solutions, Durham, North Carolina, United States of America.ORCID https://orcid.org/0000-0003-0994-5820

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNeurologic or immune-mediated conditions have been evaluated as potential adverse events (AEs) in coronavirus disease 2019 (COVID-19) vaccine safety surveillance. To contextualize United States (US) surveillance findings, it is important to quantify the association of AEs with COVID-19 diagnoses among US adults before the introduction of COVID-19 vaccines.

methodsCohort and self-controlled risk interval (SCRI) designs were used in 2 US administrative claims data sources-Merative™ MarketScan® Commercial Database (ages 18-64 years) and Medicare fee-for-service data (ages ≥ 65 years). AEs included Guillain-Barré syndrome (GBS), Bell's palsy, encephalitis/encephalomyelitis, narcolepsy, immune thrombocytopenia (ITP), and transverse myelitis. The cohort (study period, 1 April 2020-10 December 2020) included adults with COVID-19 diagnoses and matched comparators. Inverse probability of treatment-weighted hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated. The SCRI (study period, 1 June 2020-10 December 2020) identified the AEs in risk windows after COVID-19 diagnosis and pre- and postexposure reference windows. Relative incidences (RIs) and 95% CIs were estimated with seasonality-adjusted conditional Poisson regression models accounting for outcome-dependent observation windows.

resultsThe study observed a consistent association between COVID-19 diagnosis and GBS: MarketScan HR = 9.57 (95% CI, 1.23-74.74), RI = 8.53 (95% CI, 2.45-29.7); Medicare HR = 1.97 (95% CI, 1.04-3.74), RI = 4.63 (95% CI, 1.78-12.01). For ITP, the association was weaker, but still consistently elevated: MarketScan HR = 2.06 (95% CI, 1.20-3.53), RI = 1.74 (95% CI, 1.01-3.00); Medicare HR = 1.36 (95% CI, 1.18-1.57), RI = 1.91 (95% CI, 1.60-2.28). For all remaining AEs, there was not consistent evidence of an association with COVID-19, with estimates that were generally modest, imprecise, or varying by study design.

conclusionsCOVID-19 diagnoses were associated with an increased risk of GBS and ITP in both data sources and study designs. Increased risks of other neurologic/immune-mediated AEs cannot be ruled out.

Indexed as

COVID-19COVID-19 VaccinesNervous System DiseasesAdolescentAdultAgedFemaleGuillain-Barre SyndromeHumansMaleMiddle AgedSARS-CoV-2United StatesYoung AdultCOVID-19 Vaccines

Identifiers

PMID41284649
PMCPMC12643290

What OpenQuestion holds

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Registered trials

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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.