ArticleVaccine2023
Background rates of 41 adverse events of special interest for COVID-19 vaccines in 10 European healthcare databases - an ACCESS cohort study.
Article in Vaccine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 1 of them a synthesis that pooled it.
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Who cites it
33 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pharmacoepidemiologic Research Based on Common Data Models: Systematic Review and Bibliometric Analysis.JMIR medical informatics · 2025Pooled it
- Safety monitoring of bivalent, quadrivalent, and 9-valent human papillomavirus vaccination in Japan: The vaccine effectiveness, networking, and universal safety (VENUS) study.Human vaccines & immunotherapeutics · 2026Article
- Incidence of Guillain-Barré Syndrome Following COVID-19 Vaccination and SARS-CoV-2 Infection: A Population-Based Cohort Study Using the Valencia Health System Integrated Database (Spain).Pharmaceuticals (Basel, Switzerland) · 2026Article
- Publicly Available Clinical Trial Safety Data: Review and a Call for Standardization and Improved Reporting Practices.Pharmaceutical medicine · 2026Review
- Observed Versus Expected Analysis-How Does It Fit in the Pharmacovigilance Toolkit?Drug safety · 2025Review
- Strengthening Pharmacoepidemiology in a Changing Research Environment: The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).Pharmacoepidemiology and drug safety · 2025Review
- Epidemiology of Thrombotic Thrombocytopenia Syndrome 2011 to 2022: English Sentinel Network Cohort Studies.Drug safety · 2025Article
- An extension of the Benefit Risk Assessment of VaccinEs toolkit to evaluate Comirnaty and Spikevax vaccination in the European Union.European journal of public health · 2025Article
- Addressing bias due to measurement error of an outcome with unknown sensitivity in database epidemiologic studies. A contribution from the ConcePTION project.American journal of epidemiology · 2025Article
- Article
- 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
- Background rates of medical events of interest before and during the COVID-19 pandemic: a longitudinal cohort study using claims data.BMJ open · 2025Article
- Safety and utilisation of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine: a UK post-authorisation active surveillance study.BMJ open · 2025Article
- Cost-effectiveness Analysis of COVID-19 mRNA XBB.1.5 Fall 2023 Vaccination in the Netherlands.Advances in therapy · 2025Article
- Evaluating the Accuracy of Responses by Large Language Models for Information on Disease Epidemiology.Pharmacoepidemiology and drug safety · 2025Article
- Applying two approaches to detect unmeasured confounding due to time-varying variables in a self-controlled risk interval design evaluating COVID-19 vaccine safety signals, using myocarditis as a case example.American journal of epidemiology · 2025Article
- Background incidence rates from electronic healthcare databases for vaccine safety monitoring: review of challenges from the COVID-19 vaccination campaign and proposal for best practices.Frontiers in drug safety and regulation · 2025Article
- Association between COVID-19 Vaccines and Menstrual Disorders: Retrospective Cohort Study of Women Aged 12-55 Years Old in Catalonia, Spain.International journal of environmental research and public health · 2024Article
- Observational
Corrections and comments
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Authors and funding
34 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn May 2020, the ACCESS (The vACCine covid-19 monitoring readinESS) project was launched to prepare real-world monitoring of COVID-19 vaccines. Within this project, this study aimed to generate background incidence rates of 41 adverse events of special interest (AESI) to contextualize potential safety signals detected following administration of COVID-19 vaccines.
methodsA dynamic cohort study was conducted using a distributed data network of 10 healthcare databases from 7 European countries (Italy, Spain, Denmark, The Netherlands, Germany, France and United Kingdom) over the period 2017 to 2020. A common protocol (EUPAS37273), common data model, and common analytics programs were applied for syntactic, semantic and analytical harmonization. Incidence rates (IR) for each AESI and each database were calculated by age and sex by dividing the number of incident cases by the total person-time at risk. Age-standardized rates were pooled using random effect models according to the provenance of the events.
findingsA total number of 63,456,074 individuals were included in the study, contributing to 211.7 million person-years. A clear age pattern was observed for most AESIs, rates also varied by provenance of disease diagnosis (primary care, specialist care). Thrombosis with thrombocytopenia rates were extremely low ranging from 0.06 to 4.53/100,000 person-years for cerebral venous sinus thrombosis (CVST) with thrombocytopenia (TP) and mixed venous and arterial thrombosis with TP, respectively.
interpretationGiven the nature of the AESIs and the setting (general practitioners or hospital-based databases or both), background rates from databases that show the highest level of completeness (primary care and specialist care) should be preferred, others can be used for sensitivity. The study was designed to ensure representativeness to the European population and generalizability of the background incidence rates.
fundingThe project has received support from the European Medicines Agency under the Framework service contract nr EMA/2018/28/PE.
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