Guillan-Barre´ Syndrome Following COVID-19 Vaccines: Analysis of the Vaccine Adverse Event Reporting System (VAERS) Database: An International Journal of Medical Toxicology and Drug Experience

ABSTRACT

Introduction: As part of post-authorization safety surveillance, the European Medicines Agency (EMA) has identified a potential safety concern for Guillain-Barre syndrome (GBS) following COronaVIrusDisease 2019 (COVID-19) vaccines [1,2]. Objective: To assess reports of GBS reported in the Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccination and to evaluate if a COVID-19 vaccine has a lower/higher probability of reporting Individual Case Safety Reports (ICSRs) with GBS in a direct comparison with all other COVID-19 vaccines. Methods: After selecting all ICRSs of GBS following vaccination reported in VAERS from 1 January 2021 to 31 December 2021, we assessed them through the case definition and classification of the Brighton Collaboration (BC). We performed a descriptive analysis. Finally, we used the Reporting Odds Ratio with a 95% of Confidence Interval to investigate disproportional reporting of GBS among the vaccines included in the analysis. Results: 774 ICSRs of GBS have been reported in VAERS, and 279 of them met the BC Case Definition 30 (10.7%) have been evaluated as Definitive, 56 (20.0%) as Probable, and 193 (69.3%) as Possible. COVID-19 Vaccine Pfizer-BioNTech was the most commonly vaccine reported (N = 118;42.3%) followed by COVID-19 Vaccine Moderna (N = 82;29.4%) and COVID-19 Vaccine Janssen (N = 79;28.3%). GBS was more commonly reported for male subjects (N = 143;51.3%) aged between 12 and 20 years (N = 59;21.1%). GBS mainly occurred between the 1st and 12th day following the first dose administration of mRNA vaccines and between the 4th and the 15th day following COVID-19 Vaccine Janssen. COVID-19 Vaccine Janssen was significantly associated with increased risks for GuillanBarre syndrome (ROR 3.47, CI 95% = 2.58-4.65) compared to COVID-19 Vaccine Pfizer-BioNTech and COVID-19 Vaccine Moderna. Conclusion: GBS is an adverse event of special interest for all COVID-19 vaccines requiring specific safety monitoring. GBS is very rare, and the benefit-risk balance of the vaccine remains unchanged.