The Vaccine Adverse Event Reporting System (VAERS), co-managed by CDC and the Food and Drug Administration (FDA), is the national postmarketing safety monitoring system that accepts reports about adverse events that occur after administration of U.S.-licensed vaccines (1,2). On June 30, 2017, CDC and FDA implemented a revised reporting form and a new process for submitting reports to VAERS. Per...

Free-text reporting of Adverse Events Following Immunization (AEFIs) leads to inaccurate and incomplete data. Accurate representation of adverse event is a crucial part of clinical research: it may initiate further investigation of potential problems in vaccine safety or efficacy, and facilitate subsequent dissemination of safety-related information to the scientific community and the public [1...

OBJECTIVE With the use of any drug comes the possibility of unintended consequences which when harmful are referred to as adverse drug reactions (ADRs). The development of national pharmacovigilance systems is the responsibility of all health workers. The aim of this study was to investigate the knowledge of nurses about pharmacovigilance and attitudes about ADR and adverse event reporting. M...

Adverse drug reactions are responsible for mortality and morbidity during medical care. Spontaneous reporting of adverse drug reaction from treating physician plays an important role in assessing the benefit and risk profile of marketed drugs periodically.To assess the knowledge and attitude about adverse drug reaction reporting among the health care professionals working in a tertiary care hos...

OBJECTIVE The purpose of this study was to systematically search the literature for studies reporting serious adverse events following lumbopelvic spinal manipulative therapy (SMT) and to describe the case details. METHODS A systematic search was conducted in PubMed including MEDLINE, EMBASE, CINAHL, and The Cochrane Library up to January 12, 2012, by an experienced reference librarian. Study...

OBJECTIVE To determine whether natural language processing (NLP) can effectively detect adverse events defined in the New York Patient Occurrence Reporting and Tracking System (NYPORTS) using discharge summaries. DESIGN An adverse event detection system for discharge summaries using the NLP system MedLEE was constructed to identify 45 NYPORTS event types. The system was first applied to a ran...