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Risk of thrombocytopenic, haemorrhagic and thromboembolic disorders following COVID-19 vaccination and positive test: a self-controlled case series analysis in Wales

Fatemeh Torabi Orcid Logo, Stuart Bedston, Emily Lowthian, Ashley Akbari Orcid Logo, Rhiannon Owen Orcid Logo, Declan T. Bradley, Utkarsh Agrawal, Peter Collins, Rich Fry Orcid Logo, Lucy Griffiths Orcid Logo, Jillian Beggs, Gareth Davies Orcid Logo, Joe Hollinghurst, Jane Lyons, Hoda Abbasizanjani Orcid Logo, Simon Cottrell, Malorie Perry, Richard Roberts, Amaya Azcoaga-Lorenzo, Adeniyi Francis Fagbamigbe, Ting Shi, Ruby S. M. Tsang, Chris Robertson, F. D. Richard Hobbs, Simon de Lusignan, Colin McCowan, Michael Gravenor Orcid Logo, Colin R. Simpson, Aziz Sheikh, Ronan Lyons Orcid Logo

Scientific Reports, Volume: 12, Issue: 1

Swansea University Authors: Fatemeh Torabi Orcid Logo, Stuart Bedston, Emily Lowthian, Ashley Akbari Orcid Logo, Rhiannon Owen Orcid Logo, Rich Fry Orcid Logo, Lucy Griffiths Orcid Logo, Gareth Davies Orcid Logo, Joe Hollinghurst, Jane Lyons, Hoda Abbasizanjani Orcid Logo, Michael Gravenor Orcid Logo, Ronan Lyons Orcid Logo

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DOI (Published version): 10.1038/s41598-022-20118-6

Abstract

There is a need for better understanding of the risk of thrombocytopenic, haemorrhagic, thromboembolic disorders following first, second and booster vaccination doses and testing positive for SARS-CoV-2. Self-controlled cases series analysis of 2.1 million linked patient records in Wales between 7th...

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Published in: Scientific Reports
ISSN: 2045-2322
Published: Springer Science and Business Media LLC 2022
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URI: https://cronfa.swan.ac.uk/Record/cronfa61394
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Abstract: There is a need for better understanding of the risk of thrombocytopenic, haemorrhagic, thromboembolic disorders following first, second and booster vaccination doses and testing positive for SARS-CoV-2. Self-controlled cases series analysis of 2.1 million linked patient records in Wales between 7th December 2020 and 31st December 2021. Outcomes were the first diagnosis of thrombocytopenic, haemorrhagic and thromboembolic events in primary or secondary care datasets, exposure was defined as 0–28 days post-vaccination or a positive reverse transcription polymerase chain reaction test for SARS-CoV-2. 36,136 individuals experienced either a thrombocytopenic, haemorrhagic or thromboembolic event during the study period. Relative to baseline, our observations show greater risk of outcomes in the periods post-first dose of BNT162b2 for haemorrhagic (IRR 1.47, 95%CI: 1.04–2.08) and idiopathic thrombocytopenic purpura (IRR 2.80, 95%CI: 1.21–6.49) events; post-second dose of ChAdOx1 for arterial thrombosis (IRR 1.14, 95%CI: 1.01–1.29); post-booster greater risk of venous thromboembolic (VTE) (IRR-Moderna 3.62, 95%CI: 0.99–13.17) (IRR-BNT162b2 1.39, 95%CI: 1.04–1.87) and arterial thrombosis (IRR-Moderna 3.14, 95%CI: 1.14–8.64) (IRR-BNT162b2 1.34, 95%CI: 1.15–1.58). Similarly, post SARS-CoV-2 infection the risk was increased for haemorrhagic (IRR 1.49, 95%CI: 1.15–1.92), VTE (IRR 5.63, 95%CI: 4.91, 6.4), arterial thrombosis (IRR 2.46, 95%CI: 2.22–2.71). We found that there was a measurable risk of thrombocytopenic, haemorrhagic, thromboembolic events after COVID-19 vaccination and infection.
Item Description: Data availability:The Statistical Analysis plan of this work is available at: https://github.com/HDRUK/DaCVaP/blob/main/Wales/SAP/Workplan%20-%20Vaccine%20Safety.pdf. We also made the code and data to reproduce figures available at: https://github.com/HDRUK/DaCVaP/tree/main/Wales. The main patient-level data sources used in this study are available in the SAIL Databank at Swansea University, Swansea, UK, but as restrictions apply, they are not publicly available. 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: Faculty of Medicine, Health and Life Sciences
Funders: This work was supported by the Medical Research Council [MR/V028367/1]; Health Data Research UK [HDR-9006] which receives its funding from 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; and Administrative Data Research UK which is funded by the Economic and Social Research Council [grant ES/S007393/1]. This work was supported by the Wales COVID-19 Evidence Centre, funded by Health and Care Research Wales. This research is part of the Data and Connectivity National Core Study, led by Health Data Research UK in partnership with the Office for National Statistics and funded by UK Research and Innovation. We also acknowledge the support of the HDR UK BREATHE Hub, funded by the Industrial Strategy Challenge Fund through a grant via Health Data Research UK.
Issue: 1

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