Post-SARS-CoV-2-vaccination cerebral venous sinus thrombosis: an analysis of cases notified to the European Medicines Agency.

Abstract

BACKGROUND AND PURPOSE:

Cerebral venous sinus thrombosis (CVST) has been described after vaccination against SARS-CoV-2. The clinical characteristics of 213 post-vaccination CVST cases notified to the European Medicines Agency are reported.

METHODS:

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. Post-vaccination CVST was compared with 100 European patients with CVST from before the COVID-19 pandemic derived from the International CVST Consortium.

RESULTS:

In all, 213 CVST cases were identified: 187 after AstraZeneca/Oxford (ChAdOx1 nCov-19) vaccination and 26 after a messenger RNA (mRNA) vaccination (25 with Pfizer/BioNTech, BNT162b2, and one with Moderna, mRNA-1273). Thrombocytopenia was reported in 107/187 CVST cases (57%, 95% confidence interval [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, 39 (21%) reported COVID-19 polymerase chain reaction tests were 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 amongst patients with thrombocytopenia in the ChAdOx1 nCov-19 group was 49% (95% CI 39%-60%).

CONCLUSIONS:

Cerebral venous sinus thrombosis occurring after ChAdOx1 nCov-19 vaccination has a clinical profile distinct from CVST unrelated to vaccination. Only CVST after ChAdOx1 nCov-19 vaccination was associated with thrombocytopenia.

• Authors: Katarzyna Krzywicka, Mirjam R Heldner, Mayte Sánchez van Kammen, Thijs van Haaps, Sini Hiltunen, Suzanne M Silvis, Marcel Levi, Johanna A Kremer Hovinga, Katarina Jood, Erik Lindgren, Turgut Tatlisumak, Jukka Putaala, Diana Aguiar de Sousa, Saskia Middeldorp, Marcel Arnold, Jonathan M Coutinho, José M Ferro
• Journal: European journal of neurology (Eur J Neurol) Vol. 28 Issue 11 Pg. 3656-3662 (11 2021) ISSN: 1468-1331 [Electronic] England
• PMID: 34293217 (Publication Type: Journal Article)
• Copyright: © 2021 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.

Chemical References

• COVID-19 Vaccines
• ChAdOx1 nCoV-19
• BNT162 Vaccine

Topics

• BNT162 Vaccine
• COVID-19
• COVID-19 Vaccines
• ChAdOx1 nCoV-19
• Humans
• Pandemics
• SARS-CoV-2
• Sinus Thrombosis, Intracranial
• Vaccination (adverse effects)