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| VAERS | |
|---|---|
| Name | Vaccine Adverse Event Reporting System |
| Abbreviation | VAERS |
| Formed | 1990 |
| Jurisdiction | United States |
| Parent agency | Centers for Disease Control and Prevention and Food and Drug Administration |
VAERS The Vaccine Adverse Event Reporting System is a United States national vaccine safety surveillance program created to collect reports of adverse events that occur after immunization. It functions as a passive post-marketing safety signal detection system intended to identify potential safety concerns for further study and to support regulatory action by agencies such as the Food and Drug Administration and public health bodies such as the Centers for Disease Control and Prevention. The system has been referenced in policy decisions involving vaccines developed by manufacturers including Pfizer, Moderna, and Johnson & Johnson and has been cited in debates involving legislative acts like the National Childhood Vaccine Injury Act of 1986.
VAERS serves as a national early warning system for possible vaccine-related adverse events and operates within a broader landscape of public health surveillance that includes systems like Vaccine Safety Datalink, Clinical Immunization Safety Assessment Project, and international counterparts such as the Yellow Card Scheme in the United Kingdom and EudraVigilance in the European Union. It collects reports from clinicians, vaccine manufacturers, and the public, and its functions intersect with institutions including the Advisory Committee on Immunization Practices, National Institutes of Health, and the World Health Organization. Data from VAERS have influenced regulatory actions taken by the European Medicines Agency and been considered in deliberations by panels such as the Institute of Medicine (now the National Academy of Medicine).
VAERS was established in 1990 as a response to growing attention to vaccine safety following events tied to vaccines administered in the United States during the 1970s and 1980s and after passage of the National Childhood Vaccine Injury Act of 1986. Early development involved collaborations between the Centers for Disease Control and Prevention and the Food and Drug Administration, working alongside stakeholders such as vaccine manufacturers including Merck and GlaxoSmithKline and advocacy groups like the American Academy of Pediatrics and the Informed Consent Action Network. Over time, VAERS has been updated to accommodate electronic reporting, integrated with hospital systems associated with networks like Kaiser Permanente, and adapted during public health emergencies including the 2009 swine flu pandemic and the COVID-19 pandemic, during which the system received unprecedented volumes of reports related to vaccines developed by Moderna, Pfizer–BioNTech, and Johnson & Johnson.
VAERS is jointly administered by the Centers for Disease Control and Prevention and the Food and Drug Administration, with data analysis performed by epidemiologists, biostatisticians, and pharmacovigilance specialists who often collaborate with partners such as the Agency for Healthcare Research and Quality and academic centers including Johns Hopkins University, Harvard University, and the University of California, San Francisco. Operationally, VAERS accepts reports via web-based forms and mail from individuals including clinicians at institutions like Mayo Clinic, hospital systems such as Cleveland Clinic, and manufacturers such as AstraZeneca. The database is made publicly accessible through an online portal used by researchers, journalists, and policymakers from organizations including The New York Times, Reuters, and the Associated Press.
VAERS collects structured and unstructured data fields encompassing patient demographics, vaccine product names often associated with manufacturers like Pfizer, Moderna, or Sanofi, lot numbers, and narrative descriptions of events. The system accepts reports from healthcare providers, vaccine manufacturers (mandatory in some contexts), and the public; reporting obligations and practices are informed by statutes like the National Childhood Vaccine Injury Act of 1986 and by guidance from agencies such as the Centers for Medicare & Medicaid Services. Data elements are coded using standards and terminologies that align with work by organizations such as the World Health Organization and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. VAERS data have been linked for research with administrative datasets from entities like Medicare and private insurers including UnitedHealth Group.
Interpreting VAERS data requires caution because the system is passive and subject to biases such as underreporting, stimulated reporting during media coverage by outlets like CNN and Fox News, and variable data quality influenced by submitters ranging from clinicians at Johns Hopkins Hospital to consumers. Reports to VAERS do not establish causality; assertions of causal links are evaluated using epidemiologic methods employed by institutions such as Harvard Pilgrim Health Care Institute and analytic frameworks from the National Academy of Medicine. Statistical signal detection in VAERS is complemented by active surveillance systems like the Vaccine Safety Datalink and studies conducted by academic partners including Columbia University and Yale University that apply designs such as self-controlled case series and cohort analyses.
VAERS serves multiple purposes: early detection of safety signals that led to regulatory reviews by the Food and Drug Administration, labeling changes endorsed after consultation with the Advisory Committee on Immunization Practices, and public health communications issued by the Centers for Disease Control and Prevention. Notable impacts include surveillance that contributed to investigations of associations between vaccines and adverse events considered by panels at the National Vaccine Advisory Committee and led to research publications in journals affiliated with institutions like The Lancet, New England Journal of Medicine, and JAMA. Data from VAERS have also informed vaccine policy decisions by state health departments such as the California Department of Public Health and have been used by researchers at centers like the Kaiser Permanente Washington Health Research Institute.
VAERS has been the focus of controversy and criticism regarding misinterpretation and misuse by groups including some advocacy organizations and media outlets such as Breitbart News and Infowars, which have sometimes drawn causal inferences from raw reports. Public debate has involved academic critiques published by researchers at Columbia University, Stanford University, and the University of Oxford about limitations like reporting bias, incomplete verification of reports, and challenges in linkage to electronic health records across systems like Epic Systems and Cerner. Regulatory responses involve refinement of guidance by the Food and Drug Administration and methodological updates informed by expert bodies such as the National Academies of Sciences, Engineering, and Medicine and collaborations with international agencies including the World Health Organization.