EClinicalMedicine (Apr 2023)
Contextualising adverse events of special interest to characterise the baseline incidence rates in 24 million patients with COVID-19 across 26 databases: a multinational retrospective cohort studyResearch in context
- Erica A. Voss,
- Azza Shoaibi,
- Lana Yin Hui Lai,
- Clair Blacketer,
- Thamir Alshammari,
- Rupa Makadia,
- Kevin Haynes,
- Anthony G. Sena,
- Gowtham Rao,
- Sebastiaan van Sandijk,
- Clement Fraboulet,
- Laurent Boyer,
- Tanguy Le Carrour,
- Scott Horban,
- Daniel R. Morales,
- Jordi Martínez Roldán,
- Juan Manuel Ramírez-Anguita,
- Miguel A. Mayer,
- Marcel de Wilde,
- Luis H. John,
- Talita Duarte-Salles,
- Elena Roel,
- Andrea Pistillo,
- Raivo Kolde,
- Filip Maljković,
- Spiros Denaxas,
- Vaclav Papez,
- Michael G. Kahn,
- Karthik Natarajan,
- Christian Reich,
- Alex Secora,
- Evan P. Minty,
- Nigam H. Shah,
- Jose D. Posada,
- Maria Teresa Garcia Morales,
- Diego Bosca,
- Honorio Cadenas Juanino,
- Antonio Diaz Holgado,
- Miguel Pedrera Jiménez,
- Pablo Serrano Balazote,
- Noelia García Barrio,
- Selçuk Şen,
- Ali Yağız Üresin,
- Baris Erdogan,
- Luc Belmans,
- Geert Byttebier,
- Manu L.N.G. Malbrain,
- Daniel J. Dedman,
- Zara Cuccu,
- Rohit Vashisht,
- Atul J. Butte,
- Ayan Patel,
- Lisa Dahm,
- Cora Han,
- Fan Bu,
- Faaizah Arshad,
- Anna Ostropolets,
- Fredrik Nyberg,
- George Hripcsak,
- Marc A. Suchard,
- Dani Prieto-Alhambra,
- Peter R. Rijnbeek,
- Martijn J. Schuemie,
- Patrick B. Ryan
Affiliations
- Erica A. Voss
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands; Janssen Pharmaceutical Research and Development LLC, Titusville, NJ, USA; Corresponding author. Janssen Research & Development, LLC, 920 Route 202, Raritan, NJ, 08869, USA.
- Azza Shoaibi
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Janssen Pharmaceutical Research and Development LLC, Titusville, NJ, USA
- Lana Yin Hui Lai
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Department of Informatics, Imaging & Data Sciences, University of Manchester, Manchester, UK
- Clair Blacketer
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands; Janssen Pharmaceutical Research and Development LLC, Titusville, NJ, USA
- Thamir Alshammari
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; College of Pharmacy, Prince Sattam Bin Abdulaziz University, Alkharj, Kingdom of Saudi Arabia
- Rupa Makadia
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Janssen Pharmaceutical Research and Development LLC, Titusville, NJ, USA
- Kevin Haynes
- Janssen Pharmaceutical Research and Development LLC, Titusville, NJ, USA
- Anthony G. Sena
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands; Janssen Pharmaceutical Research and Development LLC, Titusville, NJ, USA
- Gowtham Rao
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Janssen Pharmaceutical Research and Development LLC, Titusville, NJ, USA
- Sebastiaan van Sandijk
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Odysseus Data Services, Prague, Czechia
- Clement Fraboulet
- Department of Medical Information, Assistance Publique - Hopitaux de Marseille, Marseille, France
- Laurent Boyer
- Department of Medical Information, Assistance Publique - Hopitaux de Marseille, Marseille, France
- Tanguy Le Carrour
- Easter Eggs, Paris, France
- Scott Horban
- Health Informatics Centre, University of Dundee, Dundee, UK
- Daniel R. Morales
- Division of Population Health and Genomics, University of Dundee, Dundee, UK; Department of Public Health, University of Southern Denmark, Odense, Denmark
- Jordi Martínez Roldán
- Hospital del Mar, Department of Innovation and Digital Transformation, Barcelona, Spain
- Juan Manuel Ramírez-Anguita
- Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain; Department of Medicine and Life Sciences, Universitat Pompeu Fabra, Barcelona, Spain
- Miguel A. Mayer
- Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain; Department of Medicine and Life Sciences, Universitat Pompeu Fabra, Barcelona, Spain
- Marcel de Wilde
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands
- Luis H. John
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands
- Talita Duarte-Salles
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol I Gurina (IDIAPJGol), Barcelona, Spain
- Elena Roel
- Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol I Gurina (IDIAPJGol), Barcelona, Spain
- Andrea Pistillo
- Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol I Gurina (IDIAPJGol), Barcelona, Spain
- Raivo Kolde
- University of Tartu, Tartu, Estonia
- Filip Maljković
- Heliant, Belgrade, Serbia
- Spiros Denaxas
- University College London, Institute of Health Informatics, London, UK; Health Data Research UK, London, UK; British Heart Foundation Data Science Centre, London, UK
- Vaclav Papez
- University College London, Institute of Health Informatics, London, UK; Health Data Research UK, London, UK
- Michael G. Kahn
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; University of Colorado Anschutz Medical Campus, Denver, CO, USA
- Karthik Natarajan
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, NY, USA; New York-Presbyterian Hospital, New York, NY, USA
- Christian Reich
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; IQVIA, Falls Church, VA, USA
- Alex Secora
- IQVIA, Falls Church, VA, USA
- Evan P. Minty
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; O'Brien Institute for Public Health, Faculty of Medicine, University of Calgary, Alberta, CA, USA
- Nigam H. Shah
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Stanford School of Medicine, Stanford University, Palo Alto, CA, USA
- Jose D. Posada
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Department of Systems Engineering, School of Engineering, Universidad del Norte, Barranquilla, Colombia
- Maria Teresa Garcia Morales
- Instituto de Investigación, Hospital 12 de Octubre, Madrid, Spain
- Diego Bosca
- VeraTech for Health, Valencia, Spain
- Honorio Cadenas Juanino
- Fundación para la Investigación e Innovación Biosanitaria en Atención Primaria (FIIBAP), Madrid, Spain
- Antonio Diaz Holgado
- Fundación para la Investigación e Innovación Biosanitaria en Atención Primaria (FIIBAP), Madrid, Spain
- Miguel Pedrera Jiménez
- Hospital Universitario 12 de Octubre, Madrid, Spain
- Pablo Serrano Balazote
- Hospital Universitario 12 de Octubre, Madrid, Spain
- Noelia García Barrio
- Hospital Universitario 12 de Octubre, Madrid, Spain
- Selçuk Şen
- Division of Clinical Pharmacology, Department of Medical Pharmacology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Türkiye
- Ali Yağız Üresin
- Division of Clinical Pharmacology, Department of Medical Pharmacology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Türkiye
- Baris Erdogan
- Clinerion, Basel, Switzerland
- Luc Belmans
- Medaman BV, Geel, Flanders, Belgium
- Geert Byttebier
- Medaman BV, Geel, Flanders, Belgium
- Manu L.N.G. Malbrain
- Medaman BV, Geel, Flanders, Belgium; 1st Department Anaesthesiology and Intensive Therapy, Professor Critical Care Research, Medical University Lublin, Lublin, Poland
- Daniel J. Dedman
- Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London, UK
- Zara Cuccu
- Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London, UK
- Rohit Vashisht
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Bakar Computational Health Sciences Institute, University of California San Francisco, San Francisco, CA, USA
- Atul J. Butte
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Bakar Computational Health Sciences Institute, University of California San Francisco, San Francisco, CA, USA; Center for Data-driven Insights and Innovation, University of California Health, Oakland, CA, USA
- Ayan Patel
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Bakar Computational Health Sciences Institute, University of California San Francisco, San Francisco, CA, USA
- Lisa Dahm
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Center for Data-driven Insights and Innovation, University of California Health, Oakland, CA, USA
- Cora Han
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Center for Data-driven Insights and Innovation, University of California Health, Oakland, CA, USA
- Fan Bu
- Department of Biostatistics, University of California, Los Angeles, Los Angeles, CA, USA
- Faaizah Arshad
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Department of Biostatistics, University of California, Los Angeles, Los Angeles, CA, USA
- Anna Ostropolets
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, NY, USA
- Fredrik Nyberg
- School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- George Hripcsak
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, NY, USA; New York-Presbyterian Hospital, New York, NY, USA
- Marc A. Suchard
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Department of Biostatistics, University of California, Los Angeles, Los Angeles, CA, USA; VA Informatics and Computing Infrastructure, US Department of Veterans Affairs, Salt Lake City, UT, USA
- Dani Prieto-Alhambra
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands; Centre for Statistics in Medicine, NDORMS, University of Oxford, Oxford, UK
- Peter R. Rijnbeek
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands
- Martijn J. Schuemie
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Janssen Pharmaceutical Research and Development LLC, Titusville, NJ, USA; Department of Biostatistics, University of California, Los Angeles, Los Angeles, CA, USA
- Patrick B. Ryan
- OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA; Janssen Pharmaceutical Research and Development LLC, Titusville, NJ, USA; Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, NY, USA
- Journal volume & issue
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Vol. 58
p. 101932
Abstract
Summary: Background: Adverse events of special interest (AESIs) were pre-specified to be monitored for the COVID-19 vaccines. Some AESIs are not only associated with the vaccines, but with COVID-19. Our aim was to characterise the incidence rates of AESIs following SARS-CoV-2 infection in patients and compare these to historical rates in the general population. Methods: A multi-national cohort study with data from primary care, electronic health records, and insurance claims mapped to a common data model. This study's evidence was collected between Jan 1, 2017 and the conclusion of each database (which ranged from Jul 2020 to May 2022). The 16 pre-specified prevalent AESIs were: acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, deep vein thrombosis, disseminated intravascular coagulation, encephalomyelitis, Guillain- Barré syndrome, haemorrhagic stroke, non-haemorrhagic stroke, immune thrombocytopenia, myocarditis/pericarditis, narcolepsy, pulmonary embolism, transverse myelitis, and thrombosis with thrombocytopenia. Age-sex standardised incidence rate ratios (SIR) were estimated to compare post-COVID-19 to pre-pandemic rates in each of the databases. Findings: Substantial heterogeneity by age was seen for AESI rates, with some clearly increasing with age but others following the opposite trend. Similarly, differences were also observed across databases for same health outcome and age-sex strata. All studied AESIs appeared consistently more common in the post-COVID-19 compared to the historical cohorts, with related meta-analytic SIRs ranging from 1.32 (1.05 to 1.66) for narcolepsy to 11.70 (10.10 to 13.70) for pulmonary embolism. Interpretation: Our findings suggest all AESIs are more common after COVID-19 than in the general population. Thromboembolic events were particularly common, and over 10-fold more so. More research is needed to contextualise post-COVID-19 complications in the longer term. Funding: None.
