Work

Cohort Profile Update: The Adverse Events Questionnaire of Medications and Vaccines (ADE-Q) in the Estonian Biobank

Year: 2026

Type: article

Abstract: The original cohortThe Estonian Biobank (EstBB) [1] is a data-rich national biobank that combines genomic, biomarker, electronic health record (EHR), and questionnaire data to advance science on the genetics of complex and rare diseases, as well as pharmacogenomics.Two major recruitment waves have led to a cohort of 211 000 participants, representing �20% of the Estonian adult population, predominantly of European ancestry.For each participant, extensive demographic, lifestyle, and health-related information, along with biological samples, have been collected.The EstBB database integrates health information obtained from the Estonian Health Insurance Fund, the National Health Information System, and national registries.In addition to structured data on diagnoses, prescriptions, and medical procedures, the EstBB includes detailed, often free-text medical records from hospitals and healthcare providers.Regular linkages to national EHR systems and online surveys ensure that phenotypic data are continuously updated, providing a comprehensive and longitudinal health profile for all participants [2, 3]. What is the reason for the new data collection?Adverse drug events (ADEs), including adverse drug reactions, have become a global concern, affecting a considerable proportion of the population and placing a substantial burden on healthcare systems.In Europe, it is estimated that ADEs account for 2.5%-10.6% of hospital admissions, with higher rates observed among the elderly population [4], often as a result of polypharmacy and chronic conditions [5][6][7].In outpatient settings, the prevalence of ADEs is estimated to range from 5% to 20%, with a considerable proportion leading to emergency-department visits [8].However, these rates are likely an underestimation, as studies have shown that only 6%-10% of ADEs are reported, with Key Features• The Estonian Biobank (EstBB) is a volunteer-based biobank established in 2000 and currently includes >211 000 participants, representing �20% of the Estonian adult population.The EstBB integrates genomic data with metabolomics data, clinical laboratory measurements, longitudinal electronic health records, and questionnaire-based information.• To address gaps in post-marketing pharmacovigilance, we developed the Adverse Events Questionnaire of Medications and Vaccines (ADE-Q) to systematically collect self-reported adverse drug and vaccine events, including adverse events, treatment discontinuation, medication switching, and menstrual cycle (MC) disturbances-phenotypic data that are incompletely captured in routine healthcare data.• A total of 45 782 participants completed the survey (27% response rate).• More than 11 000 participants reported medication-related adverse events and >15 500 reported vaccine-related adverse effects, enabling detailed characterization of overall side-effect profiles across medications, vaccines, and specific drug-side effect pairs, including relatively rare events.• The ADE-Q is a population-scale effort to systematically capture MC disturbances related to medications and vaccines.

Source: International Journal of Epidemiology

DOI: 10.1093/ije/dyag219