Global burden of vaccine-associated Guillain-Barré syndrome over 170 countries from 1967 to 2023

Research on Guillain-Barré syndrome (GBS) as a neurological adverse effect of vaccines on a global scale is scarce, highlighting the need for further investigation to evaluate its long-term impact and associated risk factors comprehensively. Hence, this study aims to assess the global burden of vaccine-associated GBS and its associated vaccines. This study utilized data from VigiBase, the World Health Organization global database of adverse event reports of medicines and vaccines, encompassing the period from 1967 to 2023 (total reports, n = 131,255,418) to investigate vaccine-associated GBS. Reported odds ratios (ROR) and information components (IC) were analyzed to assess the association between 19 vaccines and the occurrence of vaccine-associated GBS over 170 countries. We identified 15,377 (8072 males [52.49%]) reports of vaccine-associated GBS among 22,616 reports of all drugs-cause GBS from 1978 to 2023. Cumulative reports of vaccine-associated GBS have been increasing steadily over time, with a notable surge observed since the commencement of COVID-19 vaccines administration in 2020. Most vaccines showed significant associations with GBS such as Ad5-vectored COVID-19 vaccines (ROR, 14.88; IC, 3.66), COVID-19 mRNA vaccines (ROR, 9.66; IC, 2.84), and inactivated whole-virus COVID-19 vaccines (ROR, 3,29; IC 1.69). Influenza vaccines showed the highest association (ROR, 77.91; IC 5.98). Regarding age-and sex-specific risks, the association remained similar regardless of sex, with an increased association observed with advancing age. The mean time to onset was 5.5 days. Amid the COVID-19 pandemic, the reports of GBS surged in response to widespread COVID-19 vaccination. Nonetheless, COVID-19 vaccines exhibited the lowest association compared to other vaccines. Vigilance for at least one-week post-vaccination is crucial, particularly for older adults. Further research is warranted to elucidate the underlying mechanisms linking vaccines and GBS.