Background rates of five thrombosis with thrombocytopenia syndromes of special interest for COVID ‐19 vaccine safety surveillance: Incidence between 2017 and 2019 and patient profiles from 38.6 million people in six European countries
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Abstract
Background: Thrombosis with thrombocytopenia syndrome (TTS) has been reported among individuals vaccinated with adenovirus‐vectored COVID‐19 vaccines. In this study, we describe the background incidence of non‐vaccine induced TTS in six European countries. Methods: Electronic medical records from France, the Netherlands, Italy, Germany, Spain, and the United Kingdom informed the study. Incidence rates of cerebral venous sinus thrombosis (CVST), splanchnic vein thrombosis (SVT), deep vein thrombosis (DVT), pulmonary embolism (PE), and myocardial infarction or ischemic stroke, all with concurrent thrombocytopenia, were estimated among the general population of persons in a database between 2017 and 2019. A range of additional potential adverse events of special interest for COVID‐19 vaccinations were also studied in a similar manner. Findings: A total of 38 611 617 individuals were included. Background rates ranged from 1.0 (95% CI: 0.7–1.4) to 8.5 (7.4–9.9) per 100 000 person‐years for DVT with thrombocytopenia, from 0.5 (0.3–0.6) to 20.8 (18.9–22.8) for PE with thrombocytopenia, from 0.1 (0.0–0.1) to 2.5 (2.2–2.7) for SVT with thrombocytopenia, and from 1.0 (0.8–1.2) to 43.4 (40.7–46.3) for myocardial infarction or ischemic stroke with thrombocytopenia. CVST with thrombocytopenia was only identified in one database, with incidence rate of 0.1 (0.1–0.2) per 100 000 person‐years. The incidence of non‐vaccine induced TTS increased with age, and was typically greater among those with more comorbidities and greater medication use than the general population. It was also more often seen in men than women. A large proportion of those affected were seen to have been taking antithrombotic and anticoagulant therapies prior to their event. Interpretation: Although rates vary across databases, non‐vaccine induced TTS has consistently been seen to be a very rare event among the general population. While still remaining very rare, rates were typically higher among older individuals, and those affected were also seen to generally be male and have more comorbidities and greater medication use than the general population.
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CVST and SVT were selected as markers of potential TTS that could be accurately identified using diagnostic codes.
“Hematologic conditions included cerebral venous sinus thrombosis (CVST), splanchnic vein thrombosis (SVT) and pulmonary embolism (PE); the unusual site thromboses (CVST and SVT) were selected as markers of potential TTS that could be accurately identified using diagnostic codes [17,18].”
From COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals (2024) · cites this paper as [18]
The Outcomes section identifies CVST and SVT with thrombocytopenia as events of interest and says study outcomes were identified using reviewed code lists. The Study limitations section says the recording of TTS in these databases had not been validated and measurement error was expected, so the paper does not establish that diagnostic codes could identify these markers accurately. No page numbers are available in our copy. (LLM, conf=0.87)
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Chuenkitmongkol, S., Solante, R., Burhan, E., Chariyalertsak, S., Chiu, N., DO-VAN, D., Husin, M., Hwang, K., Kiertiburanakul, S., Kulkarni, P. S., et al. (2022) · Research Square · doi:10.21203/rs.3.rs-1575499/v2 · Cited by 1 · see citing works
A Southeast Asia Expert Review of Global Real-World Vaccine Effectiveness Against SARS-CoV-2Preprint
Chuenkitmongkol, S., Solante, R., Burhan, E., Chariyalertsak, S., Chiu, N., DO-VAN, D., Husin, M., Hwang, K., Kiertiburanakul, S., Kulkarni, P. S., et al. (2022) · Research Square · doi:10.21203/rs.3.rs-1575499/v1
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- Authors
- Burn, E., Li, X., Kostka, K., Stewart, H. M., Reich, C., Seager, S., Duarte‐Salles, T., Fernandez‐Bertolin, S., Aragón, M., Reyes, C., Martinez‐Hernandez, E., Marti, E., Delmestri, A., Verhamme, K., Rijnbeek, P., Horban, S., Morales, D. R., & Prieto‐Alhambra, D.
- Affiliations
- University of Oxford (GB)
- Northeastern University (US)
- Real World Solutions, IQVIA Cambridge Massachusetts USA
- Institut Universitari d'Investigació en Atenció Primària Jordi Gol (ES)
- Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol) Barcelona Spain
- Department of Neurology Hospital Clinic and University of Barcelona Barcelona Spain
- Hemostasis and Thrombosis Unit, Hematology Department Hospital Clínico Universitario de Valencia Valencia Spain
- Erasmus MC (NL)
- University of Dundee (GB)
- Corresponding author
- Prieto‐Alhambra, Daniel
- ORCID
- Venue
- Pharmacoepidemiology and Drug Safety
- Publisher
- Wiley
- Published
- 2022-02-27
- Volume
- 31
- Issue
- 5
- Pages
- 495-510
- ISSN
- 1053-8569 (ISSN-L)
- 1099-1557
- PMC
- PMC9088543
- OpenAlex
- W4213188921
- Cited by
- 43
- References
- 38
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 7 · 2023: 11 · 2022: 18 · 2021: 4
- FWCI
- 9.07
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Pharmacoepidemiology and Drug Safety (publishedVersion)
- medRxiv (acceptedVersion, cc-by)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, other-oa)
- Discovery Research Portal (University of Dundee) (submittedVersion, other-oa)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- Zenodo (CERN European Organization for Nuclear Research) (submittedVersion, cc-by)
- Funders
- European Medicines Agency (EMA/2017/09/PE Lot 3)
- Topics
- Health Sciences › Medicine › Surgery › Heparin-Induced Thrombocytopenia and Thrombosis
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Keywords
- thrombosis with thrombocytopenia syndrome, COVID-19 vaccine safety, cerebral venous thrombosis, splanchnic vein thrombosis, deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, thrombocytopenia, adverse events of special interest, age and sex differences, comorbidities, medication use
- MeSH terms
- COVID-19, COVID-19 Vaccines, Humans, Syndrome, Thrombocytopenia, Thrombosis, Incidence
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