Evidence map›Paper›PMID 41910703›Full record

ArticleDrug safety2026

Guillain-Barré Syndrome Following Recombinant Zoster Vaccine in US Medicare Adults Age 65 Years or Older.

Susan Dos Reis, Yueh-Yi Chiang, Alejandro Amill-Rosario, Haeyoung Lee, Abree Johnson, Kathleen Ryan, Driss Oraichi, Harry Seifert, Huifeng Yun, Susan Gamble and 1 more

Abstract read
In one paragraph

Article in Drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

11 authors.

Susan Dos ReisDepartment of Practice, Sciences, and Health Outcomes Research, University of Maryland, Baltimore, 220 Arch Street, 12th Floor, Baltimore, MD, 21201, USA. sdosreis@rx.umaryland.edu.ORCID http://orcid.org/0000-0003-2210-6650
Yueh-Yi ChiangDepartment of Practice, Sciences, and Health Outcomes Research, University of Maryland, Baltimore, 220 Arch Street, 12th Floor, Baltimore, MD, 21201, USA.
Alejandro Amill-RosarioDepartment of Practice, Sciences, and Health Outcomes Research, University of Maryland, Baltimore, 220 Arch Street, 12th Floor, Baltimore, MD, 21201, USA.
Haeyoung LeeDepartment of Practice, Sciences, and Health Outcomes Research, University of Maryland, Baltimore, 220 Arch Street, 12th Floor, Baltimore, MD, 21201, USA.
Abree JohnsonDepartment of Practice, Sciences, and Health Outcomes Research, University of Maryland, Baltimore, 220 Arch Street, 12th Floor, Baltimore, MD, 21201, USA.
Kathleen RyanDepartment of Practice, Sciences, and Health Outcomes Research, University of Maryland, Baltimore, 220 Arch Street, 12th Floor, Baltimore, MD, 21201, USA.
Driss OraichiGSK, Rockville, MD, USA.
Harry SeifertGSK, Rockville, MD, USA.
Huifeng YunGSK, Rockville, MD, USA.
Susan GambleGSK, Rockville, MD, USA.
O'Mareen SpenceGSK, Rockville, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivePre- and post-marketing studies detected Guillain-Barré syndrome following recombinant zoster vaccine. This study evaluated new-onset Guillain-Barré syndrome following recombinant zoster vaccine in older US adults.

methodsUsing the Medicare Chronic Condition Warehouse administrative data, we implemented a self-controlled risk interval case-only design with a 1- to 42-day risk window and a 43- to 84-day control window following recombinant zoster vaccine. Participants were Medicare beneficiaries aged ≥65 years who received at least one dose of the recombinant zoster vaccine two-dose regimen from 2018 to 2020. New-onset Guillain-Barré syndrome was identified using an algorithm requiring an International Classification of Disease, Tenth Revision diagnosis code of G61.0 in the primary position in an inpatient setting or in any other setting followed by an inpatient encounter within 7 days, with no Guillain-Barré syndrome in the preceding 365 days. Conditional Poisson regression models estimated the relative risk and 95% confidence intervals (CIs). We estimated the attributable risk and 95% CI. Sensitivity analyses examined dose-specific effects, 60- to 183-day dose spacing, and coronavirus disease 2019 and seasonality.

resultsOf 3,383,799 eligible participants, 75 experienced new-onset Guillain-Barré syndrome. The primary analysis detected a relative risk of 3.15 (95% CI 1.82, 5.68) and an attributable risk of 6.59 per 1,000,000 doses (95% CI 4.35, 7.96). The dose-specific analysis detected a relative risk of 5.33 (95% CI 2.59, 12.36) for dose 1. The coronavirus disease 2019 and seasonality analyses revealed an increased risk. Dose 2 and the 60- to 183-day dose spacing were not significant.

conclusionsThe elevated risk of new-onset Guillain-Barré syndrome among US Medicare beneficiaries aged ≥65 years was detected after recombinant zoster vaccine dose 1 but not dose 2.

Indexed as

Guillain-Barre SyndromeHerpes Zoster VaccineAgedAged, 80 and overFemaleHumansMaleMedicareUnited StatesVaccines, SyntheticHerpes Zoster VaccineVaccines, Synthetic

Identifiers

PMID41910703
PMCPMC13263215

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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.