| アブストラクト | 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. |
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| 投稿者 | 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 |
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| 組織名 | 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 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.;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 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. |
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