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GP Consultations for Venous Thromboembolism (VTE) After mRNA and Adeno-Vector-Based COVID-19 Vaccination—An Exposure-Anchored Self-Controlled Cohort Study Based on Primary Healthcare Data From the Netherlands

  • R. Jajou
  • , E. P. van Puijenbroek
  • , K. Hek
  • , J. A. Overbeek
  • , F. P. A. M. van Hunsel*
  • , Erik Mulder
  • , A. C. Kant
  • *Corresponding author for this work
  • Netherlands Pharmacovigilance Centre Lareb, ‘s-hertogenbosch
  • University of Groningen
  • Netherlands Institute for Health Services Research
  • PHARMO Institute, Utrecht
  • Leiden University

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Introduction: Venous thromboembolism (VTE) is labeled as an adverse effect of the adeno-vector-based vaccines AstraZeneca and Johnson & Johnson. We aimed to study whether there was an increase in general practitioner (GP) consultations for VTE after COVID-19 vaccination. Methods: An exposure-anchored self-controlled cohort study was performed among COVID-19 vaccinated persons aged ≥ 12 years who were registered in the PHARMO Data Network and Nivel Primary Care Database in the Netherlands. The focal window was set at 28 days after each COVID-19 vaccination and the referent window at all time outside the focal window. Adjusted incidence rate ratios (aIRR), adjusting for SARS-CoV-2 infection, were calculated using Poisson regression. Results: In total, 2 133 853 persons were included. The highest increase in GP consultations for VTE was observed after Johnson & Johnson vaccination (aIRR: 3.14, 95% CI: 1.50–6.57), and a slight increase after Pfizer/BioNTech dose 1 (aIRR: 1.24, 95% CI: 1.09–1.40). Risk groups were 12–60 year-olds with increased GP consultations for VTE after Johnson & Johnson (aIRR: 2.30, 95% CI: 1.44–3.69) and Pfizer/BioNTech (aIRR: 1.29, 95% CI: 1.11–1.50), and in specific groups of males aged 12–60 years. Also, females using hormone-containing contraceptives or hormone replacement therapy (HRT) showed increased GP consultations for VTE after AstraZeneca (aIRR: 2.87, 95% CI: 1.13–7.33) and Pfizer/BioNTech (aIRR: 1.48, 95% CI: 1.10–2.01). Conclusion: Increased GP consultations for VTE were observed after both vector and mRNA vaccination, in particular among males, 12–60 year olds, and females using hormone-containing contraceptives or HRT.
Original languageEnglish
Article numbere70317
JournalPharmacoepidemiology and drug safety
Volume35
Issue number1
DOIs
Publication statusPublished - 1 Jan 2026

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

  1. SDG 3 - Good Health and Well-being
    SDG 3 Good Health and Well-being

Keywords

  • COVID-19 vaccination
  • mRNA vaccination
  • primary healthcare data
  • self-controlled cohort study
  • vector vaccination
  • venous thromboembolism

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