Vaccine Adverse Event Reporting System
The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).[1] VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular vaccine.
VAERS, the
As it is based on submissions by the public, VAERS is susceptible to unverified reports, misattribution,
Origins
The program is an outgrowth of the 1986 National Childhood Vaccine Injury Act (NCVIA), which requires health care providers to report:
- Any event listed by the vaccine manufacturer as a contraindication to subsequent doses of the vaccine.
- Any event listed in the Reportable Events Table that occurs within the specified time period after vaccination. The data are stored electronically by the CDC in the Vaccine Safety Datalink (VSD).
VAERS was established in 1990 and is managed jointly by the FDA and the CDC.[5] It is meant to act as a sort of "early warning system"[6]—a way for physicians and researchers to identify possible unforeseen reactions or side effects of vaccination for further study.[7]
Operation
Higher-priority uses of the data include reports of death and other serious adverse events, recognizing and detecting adverse effects, and finding unexpected adverse events involving new vaccines. The VAERS data are also used to monitor known reactions to vaccines and for vaccine lot surveillance.
Use in research and litigation
Many medical researchers make use of VAERS to study the effects of vaccination. VAERS warns researchers using its database that the data should not be used in isolation to draw conclusions about cause and effect.[11] Nonetheless, raw data from VAERS has been used in vaccine litigation to support the claim that vaccines cause autism.
Litigation related to vaccines and autism has led to an increase in VAERS reports filed by plaintiff's attorneys. A 2006 article in
Public health officials were disappointed to learn that reports of autism to VAERS weren't coming from parents, doctors, nurses, or nurse practitioners; they were coming from personal-injury lawyers ... For the lawyers, VAERS reports hadn't been a self-fulfilling prophecy; they'd been a self-generated prophecy.[13]
Limitations and abuse
Like other spontaneous reporting systems, VAERS has several limitations, including underreporting, unverified reports, inconsistent data quality, and inadequate data about the number of people vaccinated.[14] Due to the program's open and accessible design and its allowance of unverified reports, incomplete VAERS data is often used in false claims regarding vaccine safety.[14][15][16] The Centers for Disease Control and Prevention (CDC) has warned that raw data from VAERS is not enough to determine whether a vaccine can cause a particular adverse event.[17]
For instance, noted anesthesiologist
During the
See also
- FDA Adverse Event Reporting System (FAERS)
- WHO)
- Yellow Card Scheme (UK reporting system)
References
- ^ Bol, Hayley. "Understanding COVID-19 vaccine side effect data". kfyrtv.com. Retrieved October 19, 2021.
- ^ Centers for Disease Control and Prevention, Vaccine Safety Monitoring at CDC, retrieved March 11, 2015.
- PMID 26209838.
- ^ "Vaccine Adverse Event Reporting System (VAERS)". www.cdc.gov. February 27, 2019. Retrieved December 6, 2019.
- ^ S2CID 40587832.
- ^ "How the Vaccine Adverse Event Reporting System (VAERS) works". newswest9.com. September 23, 2021. Retrieved October 19, 2021.
- ^ "The Pfizer-BioNTech vaccine explained: What's in it and how does it work". KELOLAND.com. October 13, 2021. Retrieved October 19, 2021.
- ^ "Intussusception Among Recipients of Rotavirus Vaccine -- United States, 1998-1999". www.cdc.gov. Retrieved November 12, 2020.
- ^ "Vaccines: VPD-VAC/Rotavirus/Rotashield and Intussusception Historical info". www.cdc.gov. April 15, 2019. Retrieved November 12, 2020.
- PMID 11207352.
- ^ "VAERS Data". VAERS.
- S2CID 36547618.
- ^ ISBN 978-0-231-14636-4.
- ^ a b Rizk JG, Barr CE, Rizk Y, Lewin JC. The next frontier in vaccine safety and VAERS: Lessons from COVID-19 and ten recommendations for action. Vaccine. 2021;39(41):6017-6018. doi:10.1016/j.vaccine.2021.08.006
- ^ "Vaccine injury database VAERS considered unreliable, 'subject to biases'". mlive. October 13, 2021. Retrieved October 19, 2021.
- ^ Lyons, Silas. "Setting the record straight: Ad repeated lies about safety of COVID-19 vaccine". Redding Record Searchlight. Retrieved October 19, 2021.
- ^ a b Gabrielle Settles (May 3, 2021). "Federal VAERS database is a critical tool for researchers, but a breeding ground for misinformation". PolitiFact.
- ^ Hall, Harriet (2018). "Diving into the VAERS Dumpster: Fake News about Vaccine Injuries". Skeptical Inquirer. 42 (6): 28–31.
- ^ a b c Goldin, Melissa; Gregory, John; McDonald, Kendrick (May 25, 2021). "How a well-meaning U.S. government database fuels dangerous vaccine misinformation". Newsweek. Archived from the original on August 12, 2021. Retrieved August 6, 2021.
- ^ Khandelwal, Devika; Backovic, Nick; Miller, Edie (August 12, 2021). "California Woman Behind Anti-Vax Site Outperforming Government Database". Logically. Archived from the original on August 12, 2021. Retrieved January 11, 2023.
- medRxiv 10.1101/2021.06.10.21258589v1.
- PMID 33630816.
External links
- vaers.hhs.gov – Vaccine Adverse Event Reporting System (official website). This also contains instructions for downloading the VAERS data.
- Vaccine Adverse Event Report System (VAERS) Overview, FDA
- VAERS request for searching the database
- Galindo, Belkys M., et al."Vaccine-Related Adverse Events in Cuban Children", 1999–2008. MEDICC Review. 2012;14(1):38–43.