We implemented an automated vaccine adverse event surveillance and reporting system based in an ambulatory electronic medical record to improve underreporting and incomplete reporting that prevails in spontaneous systems. This automated system flags potential vaccine adverse events for the clinician when a diagnosis is entered, prompts clinicians to consider the vaccine as a cause of the condit...

BACKGROUND To identify safety signals by manual review of individual report in large surveillance databases is time consuming; such an approach is very unlikely to reveal complex relationships between medications and adverse events. Since the late 1990s, efforts have been made to develop data mining tools to systematically and automatically search for safety signals in surveillance databases. I...

Since 1996, the scientific community has become aware of 14 reports of yellow fever vaccine (YEL)-associated viscerotropic disease (YEL-AVD) cases and four reports of YEL-associated neurotropic disease (YEL-AND) worldwide, changing our understanding of the risks of the vaccine. Based on 722 adverse event reports after YEL submitted to the U.S. Vaccine Adverse Event Reporting System in 1990-2002...

detection of adverse drug reactions (adrs) in hospitals provides an important measure of the burden of drug related morbidity on the healthcare system. spontaneous reporting of adrs is scare and several obstacles to such reporting have been identified formerly. this study aimed to determine the role of clinical pharmacy residents in adr reporting within a hospital setting.clinical pharmacy resi...

III. LIABILITY AND TRANSPARENCY: UNCOVERING AND POLICING ADVERSE EVENTS 65 A. The Obligation to Disclose Adverse Events 67 1. Refining the parameters of adverse events 69 2. Mandatory adverse event reporting 72 3. Sharpening the adverse event definition 74 4. Improving mandatory reporting 75 5. Bans on confidentiality agreements for adverse event claims 76 B. Malpractice Insurance as a Tool for...

Analysis of spontaneous reports of Adverse Events Following Immunization (AEFIs) is an important way to identify potential problems in vaccine safety and efficacy and summarize experience for dissemination to health care authorities. However, current reporting methods are not sufficiently controlled. While there is general adoption of Medical Dictionary of Regulatory Activities (MedDRA) in the ...