J Korean Med Sci.  2025 Mar;40(11):e101. 10.3346/jkms.2025.40.e101.

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

• Cho J
• Jo H
• Kim H
• Park J
• Pizzol D
• Kim MS
• Woo HG
• Yon DK

• KMID: 2566246
• DOI: http://doi.org/10.3346/jkms.2025.40.e101

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 vaccineassociated 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.

Keyword

Cerebrovascular Venous Sinus Thrombosis; VigiBase; Epidemiology, Pharmacovigilance

Figure

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  Fig. 1 Trends and global distribution of vaccine-associated cerebrovascular venous and sinus thrombosis. Temporal trends (A) and global distribution (B) of vaccine-associated cerebrovascular venous and sinus thrombosis adverse events by continent.

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  Fig. 2 Cumulative number of reports of cerebrovascular venous and sinus thrombosis adverse events per year in association with different vaccines. Temporal cumulative reports of vaccine-associated cerebrovascular venous and sinus thrombosis for overall vaccines (A) and COVID-19 vaccines (B), along with their distribution (C).DTaP-IPV-Hib = diphtheria, tetanus toxoids, pertussis, polio, and Hemophilus influenza type b, COVID-19 = coronavirus disease 2019.aOthers: anthrax, brucellosis, cholera, dengue virus, Ebola, encephalitis, enterovirus 7, hepatitis A, hepatitis B, leptospirosis, meningococcal, measles, mumps, rubella, monkeypox, plague, respiratory syncytial virus, rotavirus diarrhea, smallpox, tuberculosis, typhoid, yellow fever, zoster vaccines.

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