Author: Krzywicka, Katarzyna; Heldner, Mirjam R.; Sánchez 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, José M.
Title: Postâ€SARSâ€CoVâ€2â€vaccination cerebral venous sinus thrombosis: an analysis of cases notified to the European Medicines Agency Cord-id: m7j0g0nd Document date: 2021_8_4
ID: m7j0g0nd
Snippet: BACKGROUND AND PURPOSE: Cerebral venous sinus thrombosis (CVST) has been described after vaccination against SARSâ€CoVâ€2. The clinical characteristics of 213 postâ€vaccination CVST cases notified to the European Medicines Agency are reported. METHODS: Data on adverse drug reactions after SARSâ€CoVâ€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 databa
Document: BACKGROUND AND PURPOSE: Cerebral venous sinus thrombosis (CVST) has been described after vaccination against SARSâ€CoVâ€2. The clinical characteristics of 213 postâ€vaccination CVST cases notified to the European Medicines Agency are reported. METHODS: Data on adverse drug reactions after SARSâ€CoVâ€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. Postâ€vaccination CVST was compared with 100 European patients with CVST from before the COVIDâ€19 pandemic derived from the International CVST Consortium. RESULTS: In all, 213 CVST cases were identified: 187 after AstraZeneca/Oxford (ChAdOx1 nCovâ€19) vaccination and 26 after a messenger RNA (mRNA) vaccination (25 with Pfizer/BioNTech, BNT162b2, and one with Moderna, mRNAâ€1273). Thrombocytopenia was reported in 107/187 CVST cases (57%, 95% confidence interval [CI] 50%–64%) in the ChAdOx1 nCovâ€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 preâ€COVIDâ€19 group. In the ChAdOx1 nCovâ€19 group, 39 (21%) reported COVIDâ€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 nCovâ€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 preâ€COVIDâ€19 group. Mortality amongst patients with thrombocytopenia in the ChAdOx1 nCovâ€19 group was 49% (95% CI 39%–60%). CONCLUSIONS: Cerebral venous sinus thrombosis occurring after ChAdOx1 nCovâ€19 vaccination has a clinical profile distinct from CVST unrelated to vaccination. Only CVST after ChAdOx1 nCovâ€19 vaccination was associated with thrombocytopenia.
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