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Comparative risk of cerebral venous sinus thrombosis (CVST) following COVID-19 vaccination or infection: A national cohort study using linked electronic health records

Columbus Ohaeri Orcid Logo, Daniel Rhys Thomas Orcid Logo, Jane Salmon, Simon Cottrell, Jane Lyons, Ashley Akbari Orcid Logo, Ronan Lyons Orcid Logo, Fatemeh Torabi Orcid Logo, Gareth Davies Orcid Logo, Christopher Williams Orcid Logo

Human Vaccines and Immunotherapeutics, Volume: 18, Issue: 6

Swansea University Authors: Jane Lyons, Ashley Akbari Orcid Logo, Ronan Lyons Orcid Logo, Fatemeh Torabi Orcid Logo, Gareth Davies Orcid Logo

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DOI (Published version): 10.1080/21645515.2022.2127572

Abstract

To inform the public and policy makers, we investigated and compared the risk of cerebral venous sinus thrombosis (CVST) after SARS-Cov-2 vaccination or infection using a national cohort of 2,643,699 individuals aged 17 y and above, alive, and resident in Wales on 1 January 2020 followed up through...

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Published in: Human Vaccines and Immunotherapeutics
ISSN: 2164-5515 2164-554X
Published: Informa UK Limited 2022
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URI: https://cronfa.swan.ac.uk/Record/cronfa61672
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Exposures were first dose of Oxford-ChAdOx1 or Pfizer-BioNTech vaccine or polymerase chain reaction (PCR)-confirmed SARS-Cov-2 infection. The outcome was an incident record of CVST. Hazard ratios (HR) were calculated using multivariable Cox regression, adjusted for confounders. HR from SARS-Cov-2 infection was compared with that for SARS-Cov-2 vaccination. We identified 910,556 (34.4%) records of first SARS-Cov-2 vaccination and 165,862 (6.3%) of SARS-Cov-2 infection. A total of 1,372 CVST events were recorded during the study period, of which 52 (3.8%) and 48 (3.5%) occurred within 28&#x2009;d after vaccination and infection, respectively. We observed slight non-significant risk of CVST within 28&#x2009;d of vaccination [aHR: 1.34, 95% CI: 0.95-1.90], which remained after stratifying by vaccine [BNT162b2, aHR: 1.18 (95% CI: 0.63-2.21); ChAdOx1, aHR: 1.40 (95% CI: 0.95-2.05)]. Three times the number of CVST events is observed within 28&#x2009;d of a positive SARS-Cov-2 test [aHR: 3.02 (95% CI: 2.17-4.21)]. The risk of CVST following SARS-Cov-2 infection is 2.3 times that following SARS-Cov-2 vaccine. This is important information both for those designing COVID-19 vaccination programs and for individuals making their own informed decisions on the risk-benefit of vaccination. 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All proposals to use SAIL data are subject to review by an independent Information Governance Review Panel (IGRP). Before any data can be accessed, approval must be given by the IGRP. The IGRP gives careful consideration to each project to ensure proper and appropriate use of SAIL data. When access has been granted, it is gained through a privacy protecting safe haven and remote access system referred to as the SAIL Gateway. SAIL has established an application process to be followed by anyone who would like to access data via SAIL at https://www.saildatabank.com/application-process</notes><college>COLLEGE NANME</college><department>Health Data Science</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HDAT</DepartmentCode><institution>Swansea University</institution><apcterm/><funders>This work was supported by the Con-COV team funded by the Medical Research Council (grant number: MR/V028367/1). This work was also supported by Health Data Research UK, which receives its funding from HDR UK Ltd (HDR-9006) funded by the UK Medical Research Council, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Department of Health and Social Care (England), Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Health and Social Care Research and Development Division (Welsh Government), Public Health Agency (Northern Ireland), British Heart Foundation (BHF), and the Wellcome Trust. This work was also supported by the ADR Wales program of work. The ADR Wales program of work is aligned to the priority themes as identified in the Welsh Government&#x2019;s national strategy: Prosperity for All. ADR Wales brings together data science experts at Swansea University Medical School, staff from the Wales Institute of Social and Economic Research, Data and Methods (WISERD) at Cardiff University and specialist teams within the Welsh Government to develop new evidence that supports Prosperity for All by using the SAIL Databank at Swansea University, to link and analyze anonymized data. ADR Wales is part of the Economic and Social Research Council (part of UK Research and Innovation) funded by ADR UK (grant ES/S007393/1). This work was further supported by the Wales COVID-19 Evidence Centre, funded by Health and Care Research Wales. 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spelling 2022-12-29T13:31:31.3289383 v2 61672 2022-10-28 Comparative risk of cerebral venous sinus thrombosis (CVST) following COVID-19 vaccination or infection: A national cohort study using linked electronic health records 1b74fa5125a88451c52c45bcf20e0b47 Jane Lyons Jane Lyons true false aa1b025ec0243f708bb5eb0a93d6fb52 0000-0003-0814-0801 Ashley Akbari Ashley Akbari true false 83efcf2a9dfcf8b55586999d3d152ac6 0000-0001-5225-000X Ronan Lyons Ronan Lyons true false f569591e1bfb0e405b8091f99fec45d3 0000-0002-5853-4625 Fatemeh Torabi Fatemeh Torabi true false 98490239b86cc892a382416d048cdb3c 0000-0001-9005-1618 Gareth Davies Gareth Davies true false 2022-10-28 HDAT To inform the public and policy makers, we investigated and compared the risk of cerebral venous sinus thrombosis (CVST) after SARS-Cov-2 vaccination or infection using a national cohort of 2,643,699 individuals aged 17 y and above, alive, and resident in Wales on 1 January 2020 followed up through multiple linked data sources until 28 March 2021. Exposures were first dose of Oxford-ChAdOx1 or Pfizer-BioNTech vaccine or polymerase chain reaction (PCR)-confirmed SARS-Cov-2 infection. The outcome was an incident record of CVST. Hazard ratios (HR) were calculated using multivariable Cox regression, adjusted for confounders. HR from SARS-Cov-2 infection was compared with that for SARS-Cov-2 vaccination. We identified 910,556 (34.4%) records of first SARS-Cov-2 vaccination and 165,862 (6.3%) of SARS-Cov-2 infection. A total of 1,372 CVST events were recorded during the study period, of which 52 (3.8%) and 48 (3.5%) occurred within 28 d after vaccination and infection, respectively. We observed slight non-significant risk of CVST within 28 d of vaccination [aHR: 1.34, 95% CI: 0.95-1.90], which remained after stratifying by vaccine [BNT162b2, aHR: 1.18 (95% CI: 0.63-2.21); ChAdOx1, aHR: 1.40 (95% CI: 0.95-2.05)]. Three times the number of CVST events is observed within 28 d of a positive SARS-Cov-2 test [aHR: 3.02 (95% CI: 2.17-4.21)]. The risk of CVST following SARS-Cov-2 infection is 2.3 times that following SARS-Cov-2 vaccine. This is important information both for those designing COVID-19 vaccination programs and for individuals making their own informed decisions on the risk-benefit of vaccination. This record-linkage approach will be useful in monitoring the safety of future vaccine programs. Journal Article Human Vaccines and Immunotherapeutics 18 6 Informa UK Limited 2164-5515 2164-554X COVID19; coronavirus; vaccines; cerebral venous sinus thrombosis; cerebral venous thrombosis 30 11 2022 2022-11-30 10.1080/21645515.2022.2127572 Availability of data and materials:The data used in this study are available in the SAIL Databank at Swansea University, Swansea, UK, but as restrictions apply they are only available to bona fide researchers. All proposals to use SAIL data are subject to review by an independent Information Governance Review Panel (IGRP). Before any data can be accessed, approval must be given by the IGRP. The IGRP gives careful consideration to each project to ensure proper and appropriate use of SAIL data. When access has been granted, it is gained through a privacy protecting safe haven and remote access system referred to as the SAIL Gateway. SAIL has established an application process to be followed by anyone who would like to access data via SAIL at https://www.saildatabank.com/application-process COLLEGE NANME Health Data Science COLLEGE CODE HDAT Swansea University This work was supported by the Con-COV team funded by the Medical Research Council (grant number: MR/V028367/1). This work was also supported by Health Data Research UK, which receives its funding from HDR UK Ltd (HDR-9006) funded by the UK Medical Research Council, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Department of Health and Social Care (England), Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Health and Social Care Research and Development Division (Welsh Government), Public Health Agency (Northern Ireland), British Heart Foundation (BHF), and the Wellcome Trust. This work was also supported by the ADR Wales program of work. The ADR Wales program of work is aligned to the priority themes as identified in the Welsh Government’s national strategy: Prosperity for All. ADR Wales brings together data science experts at Swansea University Medical School, staff from the Wales Institute of Social and Economic Research, Data and Methods (WISERD) at Cardiff University and specialist teams within the Welsh Government to develop new evidence that supports Prosperity for All by using the SAIL Databank at Swansea University, to link and analyze anonymized data. ADR Wales is part of the Economic and Social Research Council (part of UK Research and Innovation) funded by ADR UK (grant ES/S007393/1). This work was further supported by the Wales COVID-19 Evidence Centre, funded by Health and Care Research Wales. Public Health Wales, UKRI-Medical Research Council (MR/V028367/1), UKRI-Economic and Social Research Council (ES/S007393/1). 2022-12-29T13:31:31.3289383 2022-10-28T19:55:08.0462556 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Columbus Ohaeri 0000-0002-6016-3245 1 Daniel Rhys Thomas 0000-0002-2426-5893 2 Jane Salmon 3 Simon Cottrell 4 Jane Lyons 5 Ashley Akbari 0000-0003-0814-0801 6 Ronan Lyons 0000-0001-5225-000X 7 Fatemeh Torabi 0000-0002-5853-4625 8 Gareth Davies 0000-0001-9005-1618 9 Christopher Williams 0000-0002-5092-4987 10 61672__25695__c583054d32374008ab763b6289b16108.pdf 61672_VoR.pdf 2022-11-08T16:04:13.5335974 Output 3696281 application/pdf Version of Record true © 2022 The Author(s). This is an Open Access article distributed under the terms of the Creative Commons Attribution License true eng http://creativecommons.org/licenses/by/4.0/
title Comparative risk of cerebral venous sinus thrombosis (CVST) following COVID-19 vaccination or infection: A national cohort study using linked electronic health records
spellingShingle Comparative risk of cerebral venous sinus thrombosis (CVST) following COVID-19 vaccination or infection: A national cohort study using linked electronic health records
Jane Lyons
Ashley Akbari
Ronan Lyons
Fatemeh Torabi
Gareth Davies
title_short Comparative risk of cerebral venous sinus thrombosis (CVST) following COVID-19 vaccination or infection: A national cohort study using linked electronic health records
title_full Comparative risk of cerebral venous sinus thrombosis (CVST) following COVID-19 vaccination or infection: A national cohort study using linked electronic health records
title_fullStr Comparative risk of cerebral venous sinus thrombosis (CVST) following COVID-19 vaccination or infection: A national cohort study using linked electronic health records
title_full_unstemmed Comparative risk of cerebral venous sinus thrombosis (CVST) following COVID-19 vaccination or infection: A national cohort study using linked electronic health records
title_sort Comparative risk of cerebral venous sinus thrombosis (CVST) following COVID-19 vaccination or infection: A national cohort study using linked electronic health records
author_id_str_mv 1b74fa5125a88451c52c45bcf20e0b47
aa1b025ec0243f708bb5eb0a93d6fb52
83efcf2a9dfcf8b55586999d3d152ac6
f569591e1bfb0e405b8091f99fec45d3
98490239b86cc892a382416d048cdb3c
author_id_fullname_str_mv 1b74fa5125a88451c52c45bcf20e0b47_***_Jane Lyons
aa1b025ec0243f708bb5eb0a93d6fb52_***_Ashley Akbari
83efcf2a9dfcf8b55586999d3d152ac6_***_Ronan Lyons
f569591e1bfb0e405b8091f99fec45d3_***_Fatemeh Torabi
98490239b86cc892a382416d048cdb3c_***_Gareth Davies
author Jane Lyons
Ashley Akbari
Ronan Lyons
Fatemeh Torabi
Gareth Davies
author2 Columbus Ohaeri
Daniel Rhys Thomas
Jane Salmon
Simon Cottrell
Jane Lyons
Ashley Akbari
Ronan Lyons
Fatemeh Torabi
Gareth Davies
Christopher Williams
format Journal article
container_title Human Vaccines and Immunotherapeutics
container_volume 18
container_issue 6
publishDate 2022
institution Swansea University
issn 2164-5515
2164-554X
doi_str_mv 10.1080/21645515.2022.2127572
publisher Informa UK Limited
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
active_str 0
description To inform the public and policy makers, we investigated and compared the risk of cerebral venous sinus thrombosis (CVST) after SARS-Cov-2 vaccination or infection using a national cohort of 2,643,699 individuals aged 17 y and above, alive, and resident in Wales on 1 January 2020 followed up through multiple linked data sources until 28 March 2021. Exposures were first dose of Oxford-ChAdOx1 or Pfizer-BioNTech vaccine or polymerase chain reaction (PCR)-confirmed SARS-Cov-2 infection. The outcome was an incident record of CVST. Hazard ratios (HR) were calculated using multivariable Cox regression, adjusted for confounders. HR from SARS-Cov-2 infection was compared with that for SARS-Cov-2 vaccination. We identified 910,556 (34.4%) records of first SARS-Cov-2 vaccination and 165,862 (6.3%) of SARS-Cov-2 infection. A total of 1,372 CVST events were recorded during the study period, of which 52 (3.8%) and 48 (3.5%) occurred within 28 d after vaccination and infection, respectively. We observed slight non-significant risk of CVST within 28 d of vaccination [aHR: 1.34, 95% CI: 0.95-1.90], which remained after stratifying by vaccine [BNT162b2, aHR: 1.18 (95% CI: 0.63-2.21); ChAdOx1, aHR: 1.40 (95% CI: 0.95-2.05)]. Three times the number of CVST events is observed within 28 d of a positive SARS-Cov-2 test [aHR: 3.02 (95% CI: 2.17-4.21)]. The risk of CVST following SARS-Cov-2 infection is 2.3 times that following SARS-Cov-2 vaccine. This is important information both for those designing COVID-19 vaccination programs and for individuals making their own informed decisions on the risk-benefit of vaccination. This record-linkage approach will be useful in monitoring the safety of future vaccine programs.
published_date 2022-11-30T04:20:40Z
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