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.
N1 - Funding Information: This work received no specific grant from any fundingagency in the public, commercial, or not‐for‐profit sectors. All authors have completed the ICMJE uniform disclosure form. KK, MSK, TH, SMS, MML, KJ and JAKH have nothing to disclose. MRH reports grants from the Swiss Heart Foundation and Bangerter Foundation, travel support from Bayer, and Advisory Board honoraria from Amgen, and being a member of the ESO Board of Directors and of the ESO Education Committee. EL reports academic grants from the Swedish Neurological Society, Elsa and Gustav Lindh's Foundation, P‐O Ahl's Foundation and Rune and Ulla Amlöv's Foundation. TT reports academic grants from Sahlgrenska University Hospital, University of Gothenburg, Sigrid Juselius Foundation, Wennerström Foundation and European Union; advisory board membership/steering committee membership Bayer, Bristol Myers Squibb, Boehringer Ingelheim and Portola Pharma, lecture honorarium from University of Krems, Austria; all outside the submitted work. JP reports grants paid to his institution from the Academy of Finland, Hospital District of Helsinki and Uusimaa, and Finnish Foundation for Cardiovascular Research, consulting fees from Boehringer‐Ingelheim, Bayer and Herantis Pharma, payment for honoraria, lectures, presentations, speakers bureaus, manuscript writing or educational events from Boehringer Ingelheim, Bayer and Abbot, and stock ownership in Vital Signum. DAS reports travel support from Boehringer Ingelheim, DSMB participation for the SECRET trial, and being a member of the ESO Executive Committee. SM reports grants from Bayer paid to her institution, personal fees from Bayer paid to her institution, grants from Pfizer paid to her institution, personal fees from BMS/Pfizer paid to her institution, grants from Boehringer Ingelheim paid to her institution, personal fees from Boehringer Ingelheim paid to her institution, personal fees from Abbvie paid to her institution, personal fees from Portola/Alexion paid to her institution, grants from Daiichi Sankyo paid to her institution, and personal fees from Daiichi Sankyo paid to her institution, outside of the submitted work. MA reports honoraria for lectures from Bayer, AstraZeneca, Covidien and Medtronic, and honoraria for scientific advisory board participation from Amgen, Bayer, BMS, Daiichi Sankyo, Medtronic and Novartis. JMC reports grants paid to his institution from Boehringer Ingelheim and Bayer, and payments paid to his institution for DSMB participation by Bayer. JMF reports fees and DSMB or advisory board participation for Boehringer Ingelheim and consulting fees from Bayer. No other relationships or activities that could appear to have influenced the submitted work. Publisher Copyright: © 2021 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology
PY - 2021/11
Y1 - 2021/11
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.
AB - 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.
KW - COVID-19 vaccine
KW - CVST
KW - EMA
KW - thrombocytopenia
UR - http://www.scopus.com/inward/record.url?scp=85111721796&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/ene.15029
DO - https://doi.org/10.1111/ene.15029
M3 - Article
C2 - 34293217
SN - 1351-5101
VL - 28
SP - 3656
EP - 3662
JO - European journal of neurology
JF - European journal of neurology
IS - 11
ER -