The Role of the Vaccine Adverse Event Reporting System (VAERS) in Monitoring Vaccine Safety

Centers for Disease Control and Prevention, National Immunization Program, Epidemiology and Surveillance Division, Immunization Safety Branch, Atlanta, GA 30333, USA.
Pediatric Annals (Impact Factor: 0.61). 10/2004; 33(9):599-606. DOI: 10.3928/0090-4481-20040901-11
Source: PubMed


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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    • "VAERS is a national early warning system to detect possible safety problems in U.S. licensed vaccines. It is a spontaneous, voluntary reporting system for adverse events [1] [14] [15], and therefore no effort is made to search for individuals who experience adverse events and actively collect data, but rather VAERS passively receives information on adverse events from those who choose to report. VAERS is most useful as a hypothesis generating system with the primary goal to detect safety signals [9] that might be related to vaccination. "
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    ABSTRACT: The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) conduct post-licensure vaccine safety monitoring using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous (or passive) reporting system. This means that after a vaccine is approved, CDC and FDA continue to monitor safety while it is distributed in the marketplace for use by collecting and analyzing spontaneous reports of adverse events that occur in persons following vaccination. Various methods and statistical techniques are used to analyze VAERS data, which CDC and FDA use to guide further safety evaluations and inform decisions around vaccine recommendations and regulatory action. VAERS data must be interpreted with caution due to the inherent limitations of passive surveillance. VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination. CDC makes VAERS data available to the public and readily accessible online. We describe fundamental vaccine safety concepts, provide an overview of VAERS for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and explain how CDC and FDA analyze VAERS data. We also describe strengths and limitations, and address common misconceptions about VAERS. Information in this review will be helpful for healthcare professionals counseling patients, parents, and others on vaccine safety and benefit-risk balance of vaccination. Copyright © 2015. Published by Elsevier Ltd.
    Vaccine 07/2015; 33(36). DOI:10.1016/j.vaccine.2015.07.035 · 3.62 Impact Factor
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    • "In Australia, the spontaneous reporting of adverse events following immunisation (AEFI) is the primary mechanism used for post-marketing passive surveillance (PMS) of licensed vaccines. Passive AEFI surveillance is common in many countries, worldwide [1-4]. The process relies on immunisation providers, health professionals, and consumers voluntarily submitting ad-hoc reports to jurisdictional public health and/or federal regulatory authorities [5]. "
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    ABSTRACT: Healthcare provider spontaneous reporting of suspected adverse events following immunisation (AEFI) is central to monitoring post-licensure vaccine safety, but little is known about how healthcare professionals recognise and report to surveillance systems. The aim of this study was explore the knowledge, experience and attitudes of medical and nursing professionals towards detecting and reporting AEFI. We conducted a qualitative study, using semi-structured, face to face interviews with 13 Paediatric Emergency Department consultants from a tertiary paediatric hospital, 10 General Practitioners, 2 local council immunisation and 4 General Practice nurses, recruited using purposive sampling in Adelaide, South Australia, between December 2010 and September 2011. We identified emergent themes related to previous experience of an AEFI in practice, awareness and experience of AEFI reporting, factors that would facilitate or impede reporting and previous training in vaccine safety. Thematic analysis was used to analyse the data. AEFI reporting was infrequent across all groups, despite most participants having reviewed an AEFI. We found confusion about how to report an AEFI and variability, according to the provider group, as to the type of events that would constitute a reportable AEFI. Participants' interpretation of a "serious" or "unexpected" AEFI varied across the three groups. Common barriers to reporting included time constraints and unsatisfactory reporting processes. Nurses were more likely to have received formal training in vaccine safety and reporting than medical practitioners. This study provides an overview of experience and beliefs of three healthcare professional groups in relation to identifying and reporting AEFI. The qualitative assessment reveals differences in experience and awareness of AEFI reporting across the three professional groups. Most participants appreciated the importance of their role in AEFI surveillance and monitoring the ongoing safety of vaccines. Future initiatives to improve education, such as increased training to health care providers, particularly, medical professionals, are required and should be included in both undergraduate curricula and ongoing, professional development.
    BMC Health Services Research 08/2013; 13(1):313. DOI:10.1186/1472-6963-13-313 · 1.71 Impact Factor
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    • "It is operated 0264-410X/$ – see front matter. Published by Elsevier Ltd. doi:10.1016/j.vaccine.2009.01.125 jointly by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) [6] [7] [8] [9]. Although VAERS cannot usually prove causal associations between vaccines and adverse events, it can detect signals to be tested with more rigorous methods [10]. "
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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 · 3.62 Impact Factor
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