ArticleBMJ (Clinical research ed.)2021
Characterising the background incidence rates of adverse events of special interest for covid-19 vaccines in eight countries: multinational network cohort study.
Article in BMJ (Clinical research ed.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 134 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
134 citing papers in PubMed, 5 syntheses or guidelines pooled it, 211 citations in OpenAlex.
- Methodological challenges using routine clinical care data for real-world evidence: a rapid review utilizing a systematic literature search and focus group discussion.BMC medical research methodology · 2025Pooled it
- Incidence of myopericarditis after mRNA COVID-19 vaccination: A meta-analysis with focus on adolescents aged 12-17 years.Vaccine · 2023Pooled it
- Comparative risk of thrombosis with thrombocytopenia syndrome or thromboembolic events associated with different covid-19 vaccines: international network cohort study from five European countries and the US.BMJ (Clinical research ed.) · 2022Pooled it
- Myopericarditis following COVID-19 vaccination and non-COVID-19 vaccination: a systematic review and meta-analysis.The Lancet. Respiratory medicine · 2022Pooled it
- A Meta-Analysis of 13 Randomized Trials on Traditional Chinese Medicine as Adjunctive Therapy for COVID-19: Novel Insights into Lianhua Qingwen.BioMed research international · 2022Pooled it
- Post-marketing safety surveillance of Haemophilus influenzae Type b conjugate vaccine in children aged 3 months to 5 years in Jiangsu, China.Human vaccines & immunotherapeutics · 2026Observational
- Myasthenia gravis following the initiation of statin therapy: A multinational self-controlled case series study.Journal of internal medicine · 2026Observational
- New-onset autoimmune disease following SARS-CoV-2 infection and mRNA vaccination in Norway: A retrospective cohort study.Journal of internal medicine · 2026Article
- A Regulatory Perspective on a UK Federated Data Network for Medicines and Medical Devices: Lessons from a 'Study-A-Thon'.Therapeutic innovation & regulatory science · 2026Article
- A Scoping Review of Published Literature on the Contributions of the Natural Health Products (NHPs) Industry to Pharmacovigilance for NHPs.Drug safety · 2026Article
- Observed Versus Expected Analysis-How Does It Fit in the Pharmacovigilance Toolkit?Drug safety · 2025Review
- Recommendations to Enable Broader Use of Real-World Evidence to Inform Decision-Making Throughout Pharmacovigilance Signal Management.Pharmacoepidemiology and drug safety · 2025Review
- Evaluation of the impact of defining observable time in real-world data on outcome incidence.Journal of the American Medical Informatics Association : JAMIA · 2025Article
- The early impact of COVID-19 vaccines on major events in cardiac, pulmonary, and thromboembolic disease: a population-based study.The Korean journal of internal medicine · 2025Article
- Article
- Advancing Real-World Evidence Through a Federated Health Data Network (EHDEN): Descriptive Study.Journal of medical Internet research · 2025Article
- Safety and health care utilization following COVID-19 vaccination (BNT162b2) among children and youth with juvenile idiopathic arthritis and inflammatory bowel disease: A population-based study.Paediatrics & child health · 2025Article
- Global estimates of vaccine-associated narcolepsy from 1967 to 2023.Scientific reports · 2025Article
- Background rates of medical events of interest before and during the COVID-19 pandemic: a longitudinal cohort study using claims data.BMJ open · 2025Article
- Data Resource Profile Update: CPRD GOLD.International journal of epidemiology · 2025Article
74 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 7 institutions in 5 countries.
Funding
Abstract
objectiveTo quantify the background incidence rates of 15 prespecified adverse events of special interest (AESIs) associated with covid-19 vaccines.
designMultinational network cohort study.
settingElectronic health records and health claims data from eight countries: Australia, France, Germany, Japan, the Netherlands, Spain, the United Kingdom, and the United States, mapped to a common data model.
participants126 661 070 people observed for at least 365 days before 1 January 2017, 2018, or 2019 from 13 databases.
main outcome measuresEvents of interests were 15 prespecified AESIs (non-haemorrhagic and haemorrhagic stroke, acute myocardial infarction, deep vein thrombosis, pulmonary embolism, anaphylaxis, Bell's palsy, myocarditis or pericarditis, narcolepsy, appendicitis, immune thrombocytopenia, disseminated intravascular coagulation, encephalomyelitis (including acute disseminated encephalomyelitis), Guillain-Barré syndrome, and transverse myelitis). Incidence rates of AESIs were stratified by age, sex, and database. Rates were pooled across databases using random effects meta-analyses and classified according to the frequency categories of the Council for International Organizations of Medical Sciences.
resultsBackground rates varied greatly between databases. Deep vein thrombosis ranged from 387 (95% confidence interval 370 to 404) per 100 000 person years in UK CPRD GOLD data to 1443 (1416 to 1470) per 100 000 person years in US IBM MarketScan Multi-State Medicaid data among women aged 65 to 74 years. Some AESIs increased with age. For example, myocardial infarction rates in men increased from 28 (27 to 29) per 100 000 person years among those aged 18-34 years to 1400 (1374 to 1427) per 100 000 person years in those older than 85 years in US Optum electronic health record data. Other AESIs were more common in young people. For example, rates of anaphylaxis among boys and men were 78 (75 to 80) per 100 000 person years in those aged 6-17 years and 8 (6 to 10) per 100 000 person years in those older than 85 years in Optum electronic health record data. Meta-analytic estimates of AESI rates were classified according to age and sex.
conclusionThis study found large variations in the observed rates of AESIs by age group and sex, showing the need for stratification or standardisation before using background rates for safety surveillance. Considerable population level heterogeneity in AESI rates was found between databases.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.