The DOI matches its Crossref record; 53 of the 53 references it cites were found in a registry or an index.
Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)
Open accessAbstract
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.
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Cites
Evans, S. J. W., Waller, P. C., & Davis, S. (2001) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.677 · Cited by 1,802
Valvular heart disease associated with fenfluramine-phentermine
Connolly, H. M., Crary, J. L., McGoon, M. D., Hensrud, D. D., Edwards, B. S., Edwards, W. D., & Schaff, H. V. (1997) · New England Journal of Medicine · doi:10.1056/nejm199708283370901 · Cited by 1,632
The Medical Dictionary for Regulatory Activities (MedDRA)
Brown, E. G., Wood, L., & Wood, S. (1999) · Drug Safety · doi:10.2165/00002018-199920020-00002 · Cited by 1,390
Dumouchel, W. (1999) · The American Statistician · doi:10.1080/00031305.1999.10474456 · Cited by 878
Szarfman, A., Machado, S. G., & O??Neill, R. T. (2002) · Drug Safety · doi:10.2165/00002018-200225060-00001 · Cited by 700
The Vaccine Adverse Event Reporting System (VAERS)
CHEN, R., RASTOGI, S., MULLEN, J., HAYES, S., COCHI, S., DONLON, J., & WASSILAK, S. (1994) · Vaccine · doi:10.1016/0264-410x(94)90315-8 · Cited by 498
Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine
Slade, B. A. (2009) · JAMA · doi:10.1001/jama.2009.1201 · Cited by 470
The Vaccine Adverse Event Reporting System (VAERS)
(1994) · Vaccine · doi:10.1016/0264-410x(94)90044-2 · Cited by 392
Understanding vaccine safety information from the Vaccine Adverse Event Reporting System
VARRICCHIO, F., ISKANDER, J., DESTEFANO, F., BALL, R., PLESS, R., BRAUN, M. M., & CHEN, R. T. (2004) · The Pediatric Infectious Disease Journal · doi:10.1097/00006454-200404000-00002 · Cited by 380
Self-citationThe Vaccine Safety Datalink: A Model for Monitoring Immunization Safety
Baggs, J., Gee, J., Lewis, E., Fowler, G., Benson, P., Lieu, T., Naleway, A., Klein, N. P., Baxter, R., Belongia, E., et al. (2011) · Pediatrics · doi:10.1542/peds.2010-1722h · Cited by 349
Cited by
Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons
Shimabukuro, T. T., Kim, S. Y., Myers, T. R., Moro, P. L., Oduyebo, T., Panagiotakopoulos, L., Marquez, P. L., Olson, C. K., Liu, R., Chang, K. T., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2104983 · Cited by 927
Self-citationSchillie, S., Vellozzi, C., Reingold, A., Harris, A., Haber, P., Ward, J. W., & Nelson, N. P. (2018) · MMWR. Recommendations and Reports · doi:10.15585/mmwr.rr6701a1 · Cited by 815
“1 3 US Department of Health and Human Services/Centers for Disease Control and Prevention quality (12,13).”
BackgroundGargano, J. W., Wallace, M., Hadler, S. C., Langley, G., Su, J. R., Oster, M. E., Broder, K. R., Gee, J., Weintraub, E., Shimabukuro, T., et al. (2021) · MMWR. Morbidity and Mortality Weekly Report · doi:10.15585/mmwr.mm7027e2 · Cited by 587
Self-citationShimabukuro, T. T., Cole, M., & Su, J. R. (2021) · JAMA · doi:10.1001/jama.2021.1967 · Cited by 475
Self-citationLiang, J. L., Tiwari, T., Moro, P., Messonnier, N. E., Reingold, A., Sawyer, M., & Clark, T. A. (2018) · MMWR. Recommendations and Reports · doi:10.15585/mmwr.rr6702a1 · Cited by 457
Metadata
- Authors
- Shimabukuro, T. T., Nguyen, M., Martin, D., & DeStefano, F.
- Venue
- Vaccine
- Publisher
- Elsevier BV
- Published
- 2015-08
- Volume
- 33
- Issue
- 36
- Pages
- 4398-4405
- ISSN
- 0264-410X (ISSN-L)
- OpenAlex
- W979396035
- Cited by
- 608
- References
- 53
- FWCI
- 37.02
- Type
- journal article
- Language
- en
- Open access
- green
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