Global Burden of Vaccine-Associated Cerebrovascular Venous Sinus Thrombosis, 1968-2024: A Critical Analysis From the WHO Global Pharmacovigilance Database.

Abstract

Despite widespread coronavirus disease 2019 (COVID-19) vaccine use, research on the association between vaccines and cerebrovascular venous sinus thrombosis (CVST) in diverse populations is limited. This study aimed to address this gap. Data from the World Health Organization pharmacovigilance database (1968-2024; total reports = 8,909,484) were used. Reporting odds ratios (RORs) and information components (ICs) were calculated to assess the association between each drug and CVST. In total, 851 cases were identified as vaccine-associated CVST, of which 527 (61.93%) occurred in female patients. Only Ad5-vectored COVID-19 vaccines had the highest ROR and IC value with CVST (ROR, 4.78; 95% confidence interval, 4.34-5.28; IC, 2.15). The risk of CVST increased with age, with the 45-64-years age group having an IC of 1.35, while the 65 years and older group had a higher IC of 2.08. The findings highlight the need for clinicians to recognize the potential risks of CVST and prioritize rigorous monitoring and research to ensure patient safety.