Diana Aguiar de Sousa (Portugal)
Hospital de Santa Maria, University of Lisbon Department of Neurosciences (Neurology)Author Of 1 Presentation
POST-SARS-COV-2-VACCINATION CEREBRAL VENOUS SINUS THROMBOSIS: AN ANALYSIS OF CASES NOTIFIED TO THE EUROPEAN MEDICINES AGENCY
Abstract
Background and Aims
Cerebral venous sinus thrombosis (CVST) has been described after vaccination against SARS-CoV-2. We report clinical characteristics of 213 post-vaccination CVST cases notified to the European Medicines Agency (EMA).
Methods
Data on Adverse Drug Reactions (ADRs) after SARS-CoV-2 vaccination notified until 8 April 2021 under the Medical Dictionary for Regulatory Activities Term ‘Central nervous system vascular disorders’ were obtained from the EudraVigilance database. We compared post-vaccination CVST to 100 European patients with CVST from before the COVID-19 pandemic (2015-2018) derived from the International CVST Consortium.
Results
We identified 213 CVST cases: 187 after ChAdOx1 nCov-19 vaccination and 26 after a mRNA vaccine (25 BNT162b2 and 1 mRNA-1273).. Thrombocytopenia was reported in 107 CVST cases (57%, 95%CI 50-64%) in the ChAdOx1 nCov-19 group, in none in the mRNA vaccine group (0%, 95%CI 0-13%), and in 7 (7%, 95%CI 3-14%) in the pre-COVID-19 group. In the ChAdOx1 nCov-19 group, there were 39 (21%) reported COVID-19 PCR tests performed within 30 days of CVST symptom onset, all were negative. Of the 117 patients with a reported outcome in the ChAdOx1 nCov-19 group, 44 (38%, 95%CI 29-47%) had died, compared to 2/10 (20%, 95%CI 6-51%) in the mRNA vaccine group and 3/100 (3%, 95%CI 1-8%) in the pre-COVID-19 group. Mortality among patients with thrombocytopenia in the ChAdOx1 nCov-19 group was 49% (95%CI 39-60%).
Conclusions
Analysis of EMA data shows that CVST occurring after ChAdOx1 nCov-19 vaccination has a clinical profile distinct from CVST unrelated to vaccination. Thrombocytopenia was associated only with CVST after ChAdOx1 nCov-19 vaccination.