Venous Thrombosis Associated with Different Types of SARS-CoV-2 Vaccines in the Netherlands—Results of the TERA Case-Control Study

The magnitude of the risk of venous thromboembolism (VTE) after SARS-CoV-2 vaccines is debated.We included patients with a first VTE in 2021 and controls from a sample of Dutch citizens. Participants completed a questionnaire on VTE risk factors and vaccination, with data linked to Statistics Netherlands. Odds ratios (OR) with 95% confidence intervals (95%CI) expressed the relative rate of VTE within 28 days post-vaccination, adjusted for age, sex, BMI, month of index date, and major VTE risk factors (COVID-19, surgery, cancer, and immobilization). Using previously reported age-stratified VTE incidences, we estimated vaccination's net impact by comparing the number of events attributed to vaccination and prevented by vaccine-induced protection against COVID-19-associated VTE.We included 779 VTE patients and 5,311 controls. mRNA vaccines were not associated with VTE risk (BNT162b2 [Pfizer- BioNTech] vaccine OR 1.0, 95%CI 0.7-1.3; mRNA-1273 [Moderna] vaccine OR 1.4, 95%CI 0.8-2.4). Vector-based vaccines were associated with VTE risk (AZD1222 [AstraZeneca]: OR 1.5, 95%CI 1.0-2.5; Ad26.COV2.S [Johnson & Johnson]: OR 2.9, 95%CI 0.9-9.2). Excluding participants with major VTE risk factors, risks changed (BNT162b2: OR 1.5, 95%CI 1.1-2.1; mRNA-1273: OR 0.8, 95%CI 0.3-2.3; AZD1222: OR 2.0; 95%CI 1.0-3.9; and Ad26.COV2.S: OR 3.4; 95%CI 0.7-15.5). We estimated that SARS-CoV-2 vaccines contributed to approximately 700 VTEs but prevented approximately 3,700 VTEs.SARS-CoV-2 vaccines are associated with VTE, with varying risks between types of vaccines, and by sex and age. On a population level, in the Netherlands in 2021, SARS-CoV-2 vaccination resulted in a net benefit for the number of VTE events.

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Publication Details

Journal
Thrombosis and Haemostasis
Published
2025-08-08
DOI
https://doi.org/10.1055/a-2665-2400
Citations
2
Primary Topic
Heparin-Induced Thrombocytopenia and Thrombosis
Type
article
Field-Weighted Citation Impact
4.01

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article

Venous Thrombosis Associated with Different Types of SARS-CoV-2 Vaccines in the Netherlands—Results of the TERA Case-Control Study

Frits R. Rosendaal, A. Kant, Astrid van Hylckama Vlieg, Willian van Dijk
2 citations
Thrombosis and Haemostasis
Heparin-Induced Thrombocytopenia and Thrombosis
4.01
article

Venous Thrombosis Associated with Different Types of SARS-CoV-2 Vaccines in the Netherlands—Results of the TERA Case-Control Study

Frits R. Rosendaal, A. Kant, Astrid van Hylckama Vlieg, Willian van Dijk
article en
2 citations

Abstract

The magnitude of the risk of venous thromboembolism (VTE) after SARS-CoV-2 vaccines is debated.We included patients with a first VTE in 2021 and controls from a sample of Dutch citizens. Participants completed a questionnaire on VTE risk factors and vaccination, with data linked to Statistics Netherlands. Odds ratios (OR) with 95% confidence intervals (95%CI) expressed the relative rate of VTE within 28 days post-vaccination, adjusted for age, sex, BMI, month of index date, and major VTE risk factors (COVID-19, surgery, cancer, and immobilization). Using previously reported age-stratified VTE incidences, we estimated vaccination's net impact by comparing the number of events attributed to vaccination and prevented by vaccine-induced protection against COVID-19-associated VTE.We included 779 VTE patients and 5,311 controls. mRNA vaccines were not associated with VTE risk (BNT162b2 [Pfizer- BioNTech] vaccine OR 1.0, 95%CI 0.7-1.3; mRNA-1273 [Moderna] vaccine OR 1.4, 95%CI 0.8-2.4). Vector-based vaccines were associated with VTE risk (AZD1222 [AstraZeneca]: OR 1.5, 95%CI 1.0-2.5; Ad26.COV2.S [Johnson & Johnson]: OR 2.9, 95%CI 0.9-9.2). Excluding participants with major VTE risk factors, risks changed (BNT162b2: OR 1.5, 95%CI 1.1-2.1; mRNA-1273: OR 0.8, 95%CI 0.3-2.3; AZD1222: OR 2.0; 95%CI 1.0-3.9; and Ad26.COV2.S: OR 3.4; 95%CI 0.7-15.5). We estimated that SARS-CoV-2 vaccines contributed to approximately 700 VTEs but prevented approximately 3,700 VTEs.SARS-CoV-2 vaccines are associated with VTE, with varying risks between types of vaccines, and by sex and age. On a population level, in the Netherlands in 2021, SARS-CoV-2 vaccination resulted in a net benefit for the number of VTE events.

Thrombosis and Haemostasis
Leiden University Medical Center (NL), Netherlands Pharmacovigilance Centre Lareb (NL)
Ministerie van Volksgezondheid, Welzijn en Sport
Good health and well-being
Openalex Percentile: Top 6%
Heparin-Induced Thrombocytopenia and Thrombosis
4.01
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