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

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Krzywicka , K , Heldner , M R , Sanchez van Kammen , M , van Haaps , T , Hiltunen , S , Silvis , S M , Levi , M , Kremer Hovinga , J A , Jood , K , Lindgren , E , Tatlisumak , T , Putaala , J , Aguiar de Sousa , D , Middeldorp , S , Arnold , M , Coutinho , J M & Ferro , J M 2021 , ' Post-SARS-CoV-2-vaccination cerebral venous sinus thrombosis : an analysis of cases notified to the European Medicines Agency ' , European Journal of Neurology , vol. 28 , no. 11 , pp. 3656-3662 . https://doi.org/10.1111/ene.15029

Title: Post-SARS-CoV-2-vaccination cerebral venous sinus thrombosis : an analysis of cases notified to the European Medicines Agency
Author: Krzywicka, Katarzyna; Heldner, Mirjam R.; Sanchez van Kammen, Mayte; van Haaps, Thijs; Hiltunen, Sini; Silvis, Suzanne M.; Levi, Marcel; Kremer Hovinga, Johanna A.; Jood, Katarina; Lindgren, Erik; Tatlisumak, Turgut; Putaala, Jukka; Aguiar de Sousa, Diana; Middeldorp, Saskia; Arnold, Marcel; Coutinho, Jonathan M.; Ferro, Jose M.
Contributor organization: HUS Neurocenter
University of Helsinki
Neurologian yksikkö
Department of Neurosciences
Date: 2021-11
Language: eng
Number of pages: 7
Belongs to series: European Journal of Neurology
ISSN: 1351-5101
DOI: https://doi.org/10.1111/ene.15029
URI: http://hdl.handle.net/10138/340542
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.
Subject: COVID-19 vaccine
CVST
EMA
thrombocytopenia
3112 Neurosciences
3124 Neurology and psychiatry
Peer reviewed: Yes
Rights: cc_by_nc
Usage restriction: openAccess
Self-archived version: publishedVersion


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