| Case series/case reports  

POST-SARS-COV-2-VACCINATION CEREBRAL VENOUS SINUS THROMBOSIS: AN ANALYSIS OF CASES NOTIFIED TO THE EUROPEAN MEDICINES AGENCY

The authors compared post-vaccination CVST to 100 European patients with CVST from before the COVID-19 pandemic derived from the International CVST Consortium.

 

Cerebral venous sinus thrombosis (CVST) has been described after vaccination against SARS-CoV-2. In this article the authors report clinical characteristics of 213 post-vaccination CVST cases notified to the European Medicines Agency (EMA). Data on Adverse Drug Reactions 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. The authors compared post-vaccination CVST to 100 European patients with CVST from before the COVID-19 pandemic derived from the International CVST Consortium. They identified 213 CVST cases: 187 after AstraZeneca/Oxford (ChAdOx1 nCov-19), vaccination and 26 after a mRNA vaccine (25 Pfizer/BioNTech, BNT162b2 and 1 Moderna, mRNA-1273). Thrombocytopenia was reported in 107/187 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 7/100 (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, and 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%). The authors concluded that CVST occurring after ChAdOx1 nCov-19 vaccination has a clinical profile distinct from CVST unrelated to vaccination. Only CVST after ChAdOx1 nCov-19 was associated with thrombocytopenia.

Krzywicka K, Heldner MR, Sánchez van Kammen M, van Haaps T, Hiltunen S, Silvis SM, Levi M, Kremer Hovinga JA, Jood K, Lindgren E, Tatlisumak T, Putaala J, Aguiar de Sousa D, Middeldorp S, Arnold M, Coutinho JM, Ferro JM. Post-SARS-CoV-2-vaccination Cerebral Venous Sinus Thrombosis: an analysis of cases notified to the European Medicines Agency. Eur J Neurol. 2021 Jul 22. doi: 10.1111/ene.15029.