Adverse Events Reporting System

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects and analyzes information from reports of adverse reactions after immunization. Anyone can report to VAERS, and reports are sent in by vaccine manufacturers, health care providers, and vaccine recipients and their parents or guardians. An example of the VAERS and instructions for completing the form are found in Appendix F. Any clinically significant adverse event that occurs after the administration of any vaccine should be reported. Individuals are encouraged to provide the information on the form even if the individual is uncertain if the event was related to the... 

Vaccine safety is monitored by the FDA and CDC through a passive reporting system that allows anyone, health professionals or lay public, to report any event. Health care professionals are bound by federal regulation to report certain adverse events (Table 83-2). Additionally, any serious, life-threatening or unusual reactions should also be reported. The Vaccine Adverse Event Reporting System (VAERS) can be found at http //vaers.hhs.gov. 

VAERS Vaccine Adverse Event Reporting System... 

In any case, injection site responses (erythemia, edema, pain, and tenderness) and systemic responses are both evaluated in subjects (Mathieu, 1997). USFDA also has specific guidance on the tracking and reporting of adverse clinical responses to vaccines. Any adverse events or product problems with vaccines should not be sent to MedWatch but to the Vaccine Adverse Event Reporting System (VAERA), operated jointly by FDA and the national Centers for Disease Control and Prevention. For a copy of the VAERS form, call 1-800-822-7967, or download the form (in PDF format) from www.fda.gov/cber/vaers/vaersl.pdf on FDA s Website. 

Vaccine Adverse Event Reporting System (VAERS) form. For drugs and therapeutic biologies, the MedWatch (3500A) form replaces the 1639 reporting form. 

In response to the National Childhood Vaccine Injury Act of 1988, which required health workers to report vaccine adverse events, the CDC and the FDA collaborated in 1990 to implement the Vaccine Adverse Event Reporting System (VAERS) to monitor the safety of vaccines in both sectors. Health care professionals and parent or other caretakers are encouraged to report all clinically significant vaccine adverse events. Narrative diagnostic reports are reviewed and assigned standard codes using Coding Symbols for a Thesaurus of Adverse Reaction Terms. The source of the vaccines (public versus private provider) is recorded on the form. 

Niu, M.T., Saline, M.E. and Ellenberg, S.S. (1999). Neonatal deaths after hepatitis B vaccine The vaccine adverse event reporting system, 1991-1998. Arch. Pediatr. Adolesc. Med. 153 1279-1282. 

Varrincchio, F. (1998). The vaccine adverse event reporting system. Clin. Toxicology 36 765-768. 

United States Adopted Name Council United States Department of Agriculture United States Environmental Protection Agency United States Pharmacopoeia Vaccine Adverse Event Reporting System Vaccine Safety Data Link World Health Organization... 

USFDA drug adverse event reporting system... 

Adverse drug events (ADE) FDA Adverse Event Reporting System (AERS) http //www.fda.gov/cder/aers/default.htm Safety reports... 

Before a vaccine is given to the general population, all potential adverse events cannot be anticipated. Thus, many vaccines undergo phase IV studies—formal studies on a vaccine once it is on the market. Also the government relies on the Vaccine Adverse Event Reporting System to identify problems after marketing begins. Adapted from an FDA document)... 

NDA requires manufacturers to submit product-labeling language, which describes the proper use, benefits, and risks of the product in question. FDA may also require, as a condition of approval of an NDA or BLA application, that postmarketing studies be conducted to monitor and confirm the safety and efficacy of a product as it is used more widely in clinical practice. In addition, all sponsors or manufacturers are required to monitor and report adverse effects, defined as health effects that may or may not be related to the drug in question. For vaccines, adverse events that occur after immunization must be reported to the Vaccine Adverse Event Reporting System. 

Published case reports on alprazolam show a slightly different profile (266, 267, 268 and 269). Four patients had taken the drug for 4.5 months or less one had also taken chlorpromazine and trazodone and a fifth patient had taken alprazolam (3 mg/day for 26 weeks) and phenelzine (45 mg/day for 13 weeks), abruptly stopping both. According to the FDA s Spontaneous Adverse Event Reporting System, more seizures have been reported with alprazolam than with all other BZDs combined (270). The next highest incidence was reported for lorazepam. The FDA report stated the following ... 

DSHEA severely limited when the FDA could take action to protect the public and what actions could be taken. The burden of proof to show harm is now placed on the FDA. Moreover, dietary supplement manufacturers are not required to report adverse dietary supplement events. In fact, between 1994 and 1999 fewer than 10 of the 2500 adverse events associated with dietary supplements and reported to the FDA were reported by the manufacturer (53). The Office of Inspector General concluded the spontaneous adverse event reporting system has difficulty generating signals of possible public health concern due to limited medical information, product information, manufacturer information, consumer information, and ability to analyze trends (57). One weight loss supplement manufacturer is reported to have withheld from the FDA 14,684 complaints of adverse events regarding ephedra, which included heart attacks, strokes, seizures, and deaths (53). 

To identify case reports containing information on drug and grapefruit juice interaction, the Adverse Event Reporting System (AERS) (2) database... 

U.S. Food and Drug Administration, Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between January-March 2008, FDA. Available online. URL http //www.fda. gov/Oder/aers/potential signals/potential signals 2008Q1. htm. Updated Febru-ary 4, 2009. 

Adverse Event Reporting System Procedures used by the FDA to... 

FDA ESG This document provides an overview of the process of electronic submissions and provides registration and confirmation processes as well as links to electronic submission requirements of the Center for Biologies Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Veterinary Medicine (CVM), the Adverse Events Reporting System (AERS), and the Center for Devices and Radiological Health (CDRH). 

Food and Drug Administration. (1999, July 2). Adverse Event Reporting System (AERS) Freedom of Information (FOI) report. Rockville, MD Center for Drug Evaluation and Research. 

Industry-sponsored and advocacy-related adverse event reporting (AER) agencies address safety-related events to the FDA for dietary supplements (www.SafetyCall.com). These groups submit AERs to the Food and Drug Administration s Center for Food Safety and Applied Nutrition s Adverse Event Reporting System (CAERS) at (http //www.fda.gov/opacom/backgrounders/problem.html). 

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