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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 [Online ahead of print]EJ

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+Show Affiliations

Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.Department of Neurology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. National Institute for Health Research, University College London Hospitals (UCLH), Biomedical Research Centre, London, UK.Department of Hematology and Central Hematology Laboratory Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden. Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Sweden.Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden. Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Sweden.Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden. Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Sweden.Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.Department of Neurosciences and Mental Health, Neurology Service, Hospital de Santa Maria/CHULN, University of Lisbon, Lisbon, Portugal.Department of Internal Medicine and Radboud Institute of Health Sciences (RIHS), Radboud University Medical Center, Nijmegen, The Netherlands.Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.Department of Neurosciences and Mental Health, Neurology Service, Hospital de Santa Maria/CHULN, University of Lisbon, Lisbon, Portugal.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

34293217

Citation

Krzywicka, Katarzyna, et al. "Post-SARS-CoV-2-vaccination Cerebral Venous Sinus Thrombosis: an Analysis of Cases Notified to the European Medicines Agency." European Journal of Neurology, 2021.
Krzywicka K, Heldner MR, Sánchez van Kammen M, et al. Post-SARS-CoV-2-vaccination cerebral venous sinus thrombosis: an analysis of cases notified to the European Medicines Agency. Eur J Neurol. 2021.
Krzywicka, K., Heldner, M. R., Sánchez 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. https://doi.org/10.1111/ene.15029
Krzywicka K, et al. 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; PubMed PMID: 34293217.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post-SARS-CoV-2-vaccination cerebral venous sinus thrombosis: an analysis of cases notified to the European Medicines Agency. AU - Krzywicka,Katarzyna, AU - Heldner,Mirjam R, AU - Sánchez van Kammen,Mayte, AU - van Haaps,Thijs, AU - Hiltunen,Sini, AU - Silvis,Suzanne M, AU - Levi,Marcel, AU - Kremer Hovinga,Johanna A, AU - Jood,Katarina, AU - Lindgren,Erik, AU - Tatlisumak,Turgut, AU - Putaala,Jukka, AU - Aguiar de Sousa,Diana, AU - Middeldorp,Saskia, AU - Arnold,Marcel, AU - Coutinho,Jonathan M, AU - Ferro,José M, Y1 - 2021/07/22/ PY - 2021/07/13/revised PY - 2021/06/15/received PY - 2021/07/15/accepted PY - 2021/7/23/pubmed PY - 2021/7/23/medline PY - 2021/7/22/entrez KW - COVID-19 vaccine KW - CVST KW - EMA KW - thrombocytopenia JF - European journal of neurology JO - Eur J Neurol N2 - 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. SN - 1468-1331 UR - https://www.unboundmedicine.com/medline/citation/34293217/Post-SARS-CoV-2-vaccination_Cerebral_Venous_Sinus_Thrombosis:_an_analysis_of_cases_notified_to_the_European_Medicines_Agency. L2 - https://doi.org/10.1111/ene.15029 DB - PRIME DP - Unbound Medicine ER -