TY - JOUR
T1 - Risk of thrombocytopenic, haemorrhagic and thromboembolic disorders following COVID-19 vaccination and positive test
T2 - a self-controlled case series analysis in Wales
AU - Torabi, Fatemeh
AU - Bedston, Stuart
AU - Lowthian, Emily
AU - Akbari, Ashley
AU - Owen, Rhiannon K
AU - Bradley, Declan T
AU - Agrawal, Utkarsh
AU - Collins, Peter
AU - Fry, Richard
AU - Griffiths, Lucy J
AU - Beggs, Jillian
AU - Davies, Gareth
AU - Hollinghurst, Joe
AU - Lyons, Jane
AU - Abbasizanjani, Hoda
AU - Cottrell, Simon
AU - Perry, Malorie
AU - Roberts, Richard
AU - Azcoaga-Lorenzo, Amaya
AU - Fagbamigbe, Adeniyi Francis
AU - Shi, Ting
AU - Tsang, Ruby S M
AU - Robertson, Chris
AU - Hobbs, F D Richard
AU - de Lusignan, Simon
AU - McCowan, Colin
AU - Gravenor, Michael
AU - Simpson, Colin R
AU - Sheikh, Aziz
AU - Lyons, Ronan A
N1 - Funding Information:
AS is a member of the Scottish Government Chief Medical Officer's COVID-19 Advisory Group and the New and Emerging Respiratory Virus Threats Risk Stratification Subgroup and AstraZeneca's COVID-19 Thrombocytopenia Task Force; all roles are remunerated to AS or his institution. AS received funding from Medical Research Council and HDRUK during the course of this study and is a member of editorial board at BMC medicine. CRS. declares funding from the Medical Research Council, the National Institute for Health Research, the Chief Scientist Office and the New Zealand Ministry for Business, Innovation and Employment and Health Research Council during the conduct of this study. RKO is a member of the National Institute for Health and Care Excellence (NICE) Technology Appraisal Committee (TAC), and has served as a paid consultant to the pharmaceutical industry providing methodological, advice and support unrelated to this research. Other authors have declared no competing interest with this work.
Funding Information:
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.
Funding Information:
This work uses data provided by patients and collected by the NHS as part of their care and support. We would also like to acknowledge all data providers who make anonymised data available for research. We wish to acknowledge the collaborative partnership of DaCVaP consortium which led to this output. We also wish to acknowledge the collaboration that enabled acquisition and access to the data, led by the Swansea University Health Data Research UK team under the direction of the Welsh Government Technical Advisory Cell (TAC) and includes the following groups and organisations: the Secure Anonymised Information Linkage (SAIL) Databank, Administrative Data Research (ADR) Wales, NHS Wales Informatics Service (NWIS), Public Health Wales, NHS Shared Services Partnership and the Welsh Ambulance Service Trust (WAST). All research conducted has been completed under the permission and approval of the SAIL independent Information Governance Review Panel (IGRP) project number 0911.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/9/30
Y1 - 2022/9/30
N2 - 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.
AB - 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.
KW - BNT162 Vaccine
KW - COVID-19/complications
KW - COVID-19 Vaccines/adverse effects
KW - Hemorrhage
KW - Humans
KW - SARS-CoV-2
KW - Thrombocytopenia/epidemiology
KW - Vaccination/adverse effects
KW - Venous Thromboembolism
KW - Wales/epidemiology
U2 - 10.1038/s41598-022-20118-6
DO - 10.1038/s41598-022-20118-6
M3 - Article
C2 - 36180455
SN - 2045-2322
VL - 12
SP - 16406
JO - Scientific Reports
JF - Scientific Reports
IS - 1
M1 - 16406
ER -