The role of the Vaccine Adverse Event Reporting system (VAERS) in monitoring vaccine safety. 2004

John K Iskander, and Elaine R Miller, and Robert T Chen
Centers for Disease Control and Prevention, National Immunization Program, Epidemiology and Surveillance Division, Immunization Safety Branch, Atlanta, GA 30333, USA.

The role of the health professional in supporting the national passive surveillance system is essential, as the first hint of a potential problem usually originates with the astute clinician who reports a case to the appropriate source. The investigation that resulted in the voluntary withdrawal of rotavirus vaccine was triggered by nine reports to VAERS of intussuception, eight of which had occurred within 1 week of the first dose of this vaccine. Health professionals have access to the most complete information related to adverse events experienced by their patients. Any index of suspicion that a serious event or death may be related to vaccination is reason for the health professional to submit a VAERS report. Determination of whether an event was caused by the vaccine is not a prerequisite for filing a VAERS report. When in doubt, providers should report to VAERS. VAERS solicits reports for all events temporally related to vaccination, some of which may be coincidental and some of which may merely indicate a change in the frequency of expected events. Post-marketing surveillance relies on health professionals to report suspicious events, thus improving the quality of reported data and contributing significantly to safeguarding public health. Recommendations for healthcare professionals to report to VAERS recently have been incorporated into the Standards for Pediatric Immunization Practices, which are endorsed by multiple professional organizations. Despite the limitations of spontaneous reports, VAERS provides vital information of clinical importance. The identification of signals in adverse event surveillance 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. This process begins with voluntary submission of reports of possible vaccine-associated events to VAERS by the informed and conscientious health professional.

UI MeSH Term Description Entries
D012042 Registries The systems and processes involved in the establishment, support, management, and operation of registers, e.g., disease registers. Parish Registers,Population Register,Parish Register,Population Registers,Register, Parish,Register, Population,Registers, Parish,Registers, Population,Registry
D003140 Communicable Disease Control Programs of surveillance designed to prevent the transmission of disease by any means from person to person or from animal to man. Flatten the Curve of Epidemic,Flattening the Curve, Communicable Disease Control,Parasite Control,Control, Communicable Disease,Control, Parasite
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001424 Bacterial Infections Infections by bacteria, general or unspecified. Bacterial Disease,Bacterial Infection,Infection, Bacterial,Infections, Bacterial,Bacterial Diseases
D001428 Bacterial Vaccines Suspensions of attenuated or killed bacteria administered for the prevention or treatment of infectious bacterial disease. Bacterial Vaccine,Bacterin,Vaccine, Bacterial,Vaccines, Bacterial
D014765 Viral Vaccines Suspensions of attenuated or killed viruses administered for the prevention or treatment of infectious viral disease. Viral Vaccine,Vaccine, Viral,Vaccines, Viral
D014777 Virus Diseases A general term for diseases caused by viruses. Viral Diseases,Viral Infections,Virus Infections,Disease, Viral,Disease, Virus,Diseases, Viral,Diseases, Virus,Infection, Viral,Infection, Virus,Infections, Viral,Infections, Virus,Viral Disease,Viral Infection,Virus Disease,Virus Infection
D015277 Hotlines A direct communication system, usually telephone, established for instant contact. It is designed to provide special information and assistance through trained personnel and is used for counseling, referrals, and emergencies such as poisonings and threatened suicides. Telephone Hotlines,Hotline,Telephone Hotline
D016907 Adverse Drug Reaction Reporting Systems Systems developed for collecting reports from government agencies, manufacturers, hospitals, physicians, and other sources on adverse drug reactions. Adverse Drug Reaction Reporting System,Drug Reaction Reporting Systems, Adverse
D020407 Internet A loose confederation of computer communication networks around the world. The networks that make up the Internet are connected through several backbone networks. The Internet grew out of the US Government ARPAnet project and was designed to facilitate information exchange. World Wide Web,Cyber Space,Cyberspace,Web, World Wide,Wide Web, World

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