Frontiers in Neurology · Published 2026-08-04 · DOI 10.3389/fneur.2026.1814946
Yonglong Su, Yirong Huang, Lili Pan, Honghong Fu, Xun Wang
BackgroundGuillain-Barré syndrome (GBS) remains a critical vaccine safety concern. We conducted a comprehensive pharmacovigilance analysis of 21-year VAERS data to identify vaccine-GBS disproportionality signals and temporal patterns.MethodsWe analyzed 9,755,435 VAERS reports (2004–2024) including 2,216 GBS cases using four disproportionality algorithms (ROR, PRR, IC, EBGM). Time-to-onset was compared between 1,534 GBS and 120,763 non-GBS events using Kaplan–Meier analysis.ResultsTwenty-six vaccines met all four algorithm criteria, predominantly influenza formulations (19/26; RORs 2.4–8.5), validating historical surveillance observations. Novel signals emerged for both RSV vaccines (Arexvy ROR 3.01, Abrysvo ROR 6.82) and zoster vaccine (ROR 3.01), consistent with post-marketing estimates of 3–9 excess cases per million doses. COVID-19 vaccines showed no concordant signals despite established Janssen associations, reflecting denominator dilution from 7.89 million COVID-19 reports (81% of the database). GBS exhibited characteristic delayed onset—median 13 days (IQR 5–29) versus 0 days for non-GBS events (p < 0.001)—with 44.8% of cases occurring 8–30 days post-vaccination, the biologically plausible window for vaccine-triggered autoimmunity. Demographically, GBS reports showed male predominance (OR 2.4) and were overwhelmingly classified as serious outcomes compared with non-GBS reports (76.1% vs. 9.6%, p < 0.001); serious outcomes included death, life-threatening events, hospitalization (new or prolonged), or permanent disability.ConclusionMultiple vaccines showed disproportionate GBS reporting signals with delayed temporal patterns consistent with biological plausibility; because these derive from passive surveillance, they are hypothesis-generating and do not establish causality. Despite rare associations, absolute risks (1–9 per million doses) are far outweighed by disease prevention benefits, supporting current vaccination policies with ongoing surveillance.
Abstract from DOAJ. Public domain (CC0 1.0).
Read the article at the publisher →
Su, Y., Huang, Y., Pan, L., et al. (2026). Temporal and disproportionality analysis of vaccine-associated Guillain-Barré syndrome: a 21-year VAERS study. Frontiers in Neurology. https://doi.org/10.3389/fneur.2026.1814946