The role of the Vaccine Adverse Event Reporting system (VAERS) in monitoring vaccine safety.
ABSTRACT 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.
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ABSTRACT: In preparation for pandemic vaccine safety monitoring, we assessed adverse events reported to the Vaccine Adverse Event Reporting System following receipt of trivalent inactivated influenza vaccines among adults from 1990 through 2005. We calculated reporting rates for nonserious, serious, and neurological adverse events. We reviewed reports of recurrent events and deaths, as well as reports identified through advanced signal detection. The most frequently reported events were local reactions and systemic symptoms. Guillain-Barré syndrome was the most frequently reported serious event (0.70 reports per million vaccinations). Adverse event reporting rates have been reasonably constant over time. No new safety concerns emerged after our review of 15 years of post-licensure surveillance data. These findings provide useful information if pandemic vaccine is rapidly distributed and pre-licensure data are limited.Vaccine 04/2009; 27(15):2114-20. DOI:10.1016/j.vaccine.2009.01.125 · 3.49 Impact Factor
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ABSTRACT: Yellow fever (YF) vaccine has been used for prevention of YF since 1937 with over 500 million doses administered. However, rare reports of severe adverse events following vaccination have raised concerns about the vaccine's safety. We reviewed reports of adverse events following YF vaccination reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) from 2000 to 2006. We used estimates of age and sex distribution of administered doses obtained from a 2006 survey of authorized vaccine providers to calculate age- and sex-specific reporting rates of all serious adverse events (SAE), anaphylaxis, YF vaccine-associated neurotropic disease, and YF vaccine-associated viscerotropic disease. Reporting rates of SAEs were substantially higher in males and in persons aged > or =60 years. These findings reinforce the generally acceptable safety profile of YF vaccine, but highlight the importance of physician and traveler education regarding the risks and benefits of YF vaccination, particularly for travelers > or =60 years of age. Vaccination should be limited to persons traveling to areas where the risk of YF is expected to exceed the risk of serious adverse events after vaccination, or if not medically contraindicated, where national regulations require proof of vaccination to prevent introduction of YF.Vaccine 09/2008; 26(48):6077-82. DOI:10.1016/j.vaccine.2008.09.009 · 3.49 Impact Factor
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ABSTRACT: In the event that a vaccine is available during an influenza pandemic, vaccine safety monitoring will occur as part of comprehensive public health surveillance of the vaccination campaign. Though inactivated influenza vaccines have been widely used in the United States and much is known about their safety profile, attention will need to be paid to both common self-limited adverse reactions and rarer, more serious events that may or may not be causally related to vaccination. The primary surveillance systems used to generate and test hypotheses about vaccine safety concerns are the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), respectively. Examples of recent use of these systems to investigate influenza vaccine safety and enhancements planned for use during a pandemic are presented. Ethical issues that will need to be addressed as part of an overall vaccine safety response include risk communication and injury compensation. Advance planning and the use of available technologic solutions are needed to respond to the scientific and logistic challenges involved in safely implementing mass vaccination during a pandemic.The Yale journal of biology and medicine 11/2005; 78(5):265-75.