Is the US’s Vaccine Adverse Event Reporting System broken?
BMJ 2023; 383 doi: https://doi.org/10.1136/bmj.p2582 (Published 10 November 2023) Cite this as: BMJ 2023;383:p2582
All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
Dear Editor,
Much has been made of VAERS data over the course of the pandemic, with many well funded anti-vaccination sources manipulating data to prove causation which it cannot do. The voluntary reporting has to avoid the many reports of problems which will be co-incidental with vaccination to get to the hypothesis generation it is designed for. I am certain is has struggled, but this report certainly does not show that it is broken.
It reports that ''more than a dozen" people have been contacted who had problems reporting potential side effects. Does this mean 13, or 13,000? I'm assuming it's nearer the former. Of course there will be problems, but by and large it has done its job, and in any case it is not the only source of side effect signals.
This report adds to the avalanche of misleading information which has spread faster than Sars-Cov-2 itself.
VAERS is far from perfect, but how many times better than nothing? Despite the malevolent technique of "VAERS Dumping" to search for and publicise associations, it has served its purpose, particularly given its admittedly too low staffing levels, which in the public sector is hardly news.
The association of tragedies with vaccination is certain to happen and without careful handling adds to the grief of those whose problems have not been caused by the vaccine as well as distracting from the few who have genuinely suffered.
Yours Sincerely,
Dr Colin Bannon
Competing interests: No competing interests
Dear Editor
The Vaccine Adverse Event Reporting System (VAERS), established in 1990 by the CDC and FDA, is a vital tool in the realm of vaccine safety (1). Its primary role, highlighted during the COVID-19 pandemic, is as a passive reporting system that gathers varied data on post-vaccination experiences, crucial for detecting rare adverse events not observed in clinical trials.
VAERS' effectiveness was evident in 1997 when it influenced the modification of the polio vaccine schedule, leading to a marked decrease in vaccine-induced paralysis (2). More recently, it played a key role in identifying myocarditis cases following COVID-19 mRNA vaccines, helping in thorough scientific evaluations and affirming that, for most age groups, the benefits of these vaccines outweigh their risks (3).
However, VAERS is often misunderstood due to its nature of accepting unverified public submissions, leading to misconceptions about the correlation between the number of reports and causality (4). This issue has been amplified in critiques, such as those from the BMJ (5), which highlight VAERS' flaws without fully acknowledging its limitations, thereby potentially affecting public perception of vaccine safety and aiding anti-vaccination groups in misusing VAERS data.
The misuse of VAERS data has been particularly evident during the COVID-19 pandemic. Anti-vaccination activists have leveraged this data to make exaggerated and misleading claims about the safety of these vaccines. For instance, they misinterpreted data to claim specific vaccine lots were more dangerous, dubbing them “hot lots.” This claim was based on flawed logic, disregarding that larger lots naturally have more reports due to the higher number of doses administered (4). Additionally, anti-vaccination activists developed their own VAERS search tools, further fueling misinformation by incorrectly presenting VAERS reports as direct consequences of vaccines, labeling health issues as “side effects” or “vaccine-caused” incidents without established causality (6).
The BMJ article and similar critiques often overlook that VAERS is part of a more extensive vaccine safety monitoring system, including the Vaccine Safety Datalink (VSD) (7) and the Clinical Immunization Safety Assessment Network (CISA) (8). These systems provide more detailed and controlled data, enabling robust statistical analysis of potential vaccine-adverse event links. Unlike VAERS, which relies on voluntary reports, VSD and CISA draw from source medical records, enabling a more accurate and complete data analysis. The synergy between these systems was demonstrated in the investigation of myocarditis reports following COVID-19 vaccinations, offering a clearer perspective on associated risks and benefits.
To address the unique challenges of the COVID-19 pandemic, the CDC introduced V-safe, an app-based system to track short-term side effects, especially in key groups like pregnant women (9). V-safe complements VAERS by allowing registered users to share their post-vaccination experiences, enhancing the CDC's safety monitoring capabilities (10).
Understanding VAERS's role within the broader public health framework is critical. While VAERS has limitations, it provides early signals of potential vaccine-related issues. Responsible engagement with VAERS data, considering its context and constraints, is vital for healthcare professionals, the media, and the public. Public health authorities and educators have the task of promoting informed dialogue about interpreting and using VAERS data correctly.
Despite criticisms highlighting its limitations, VAERS's crucial role in vaccine safety shouldn't be overshadowed. It is a part of a comprehensive safety strategy, working alongside VSD, CISA, and V-safe. These collaborative efforts ensure a robust approach to vaccine safety monitoring. The key responsibility is to engage thoughtfully with VAERS, ensuring vaccine safety and maintaining public trust. Educating the public about VAERS and fostering scientific literacy are essential for upholding public health standards. Responsible use of VAERS data, in conjunction with other systems, is crucial for effectively navigating public health complexities and ensuring the integrity of vaccine safety monitoring.
( ) Yang YT, Reiss DR. Postmarket Vaccine Safety. In: Vaccine Law and Policy. Law for Professionals. Springer, Cham; 2023. doi:10.1007/978-3-031-36989-6_3.
(2) Wattigney WA, Mootrey GT, Braun MM, Chen RT. Surveillance for poliovirus vaccine adverse events, 1991 to 1998: impact of a sequential vaccination schedule of inactivated poliovirus vaccine followed by oral poliovirus vaccine. Pediatrics. 2001;107(5):E83. doi:10.1542/peds.107.5.e83
(3) Gargano JW, Wallace M, Hadler SC, et al. Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021. MMWR Morb Mortal Wkly Rep 2021;70:977–982. DOI: http://dx.doi.org/10.15585/mmwr.mm7027e2
(4) Wadman M. Antivaccine activists use a government database on side effects to scare the public. Science. May 26, 2021. Available from: https://www.science.org/content/article/antivaccine-activists-use-govern....
(5) Block J. Is the US's Vaccine Adverse Event Reporting System broken?. BMJ. 2023;383:2582. Published 2023 Nov 9. doi:10.1136/bmj.p2582
(6) Settles G. How an alternative gateway to VAERS data helps fuel vaccine misinformation. PolitiFact. February 28, 2022. Available from: https://www.politifact.com/article/2022/feb/28/how-alternative-gateway-v....
(7) Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases, Division of Healthcare Quality Promotion. Vaccine Safety Datalink (VSD). CDC website. Updated August 2, 2023. Accessed November 25, 2023. Available from: https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html.
(8) Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases, Division of Healthcare Quality Promotion. Clinical Immunization Safety Assessment (CISA) Project, Vaccine Safety Monitoring – CISA. CDC website. Updated August 17, 2023. Accessed November 25, 2023. Available from: https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html.
(9) Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases, Division of Healthcare Quality Promotion. V-safe. CDC website. Updated October 20, 2023. Accessed November 25, 2023. Available from: https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/v-safe/index....
(10) Myers TR, Marquez PL, Gee JM, et al. The v-safe after vaccination health checker: Active vaccine safety monitoring during CDC's COVID-19 pandemic response. Vaccine. 2023;41(7):1310-1318. doi:10.1016/j.vaccine.2022.12.031
Competing interests: No competing interests
Re: Is the US’s Vaccine Adverse Event Reporting System broken?
Dear Editor,
The CDC’s Vaccine Adverse Event Reporting System (VAERS) is poorly designed and badly implemented. In spite of this, VAERS still produces valid safety signals that could be used to identify dangerous vaccines and harmful batches. Of the multitude of safety signals emitted in the context of the COVID-19 ‘vaccines’ in VAERS, none have been adequately assessed by the CDC.
The purpose of VAERS is to produce signals that will prompt investigations in the form of proportional reporting ratios (PRR), causality assessments, and Bayesian analyses. Since the introduction of COVID-19 ‘vaccines’ in 2020, Drs. Jessica Rose and Josh Guetzkow have been analyzing VAERS data.
Dr. Rose’s published research reveals clusters of cardiovascular and neurological adverse events, reports of rare cancers, statistically-significantly higher reporting rates for hundreds of adverse event types, myocarditis in children, and more, all generated as clear signals from VAERS. [1-3]
Dr. Guetzkow submitted Freedom of Information Act (FOIA) requests to the CDC to determine whether they were doing PRR analyses as they said they would only to discover that they were not. Reporter Zachary Stieber [4] eventually obtained the safety signal analyses (after much back and forth) [5] and it was discovered that there were 770 serious safety signals [6] detected, including myocarditis.
This is the purpose of VAERS: to provide analysts with a tool to investigate vaccine injury. Drs. Rose and Guetzkow (and others) have done this with compelling results proving that, in spite of its flaws, it remains an effective pharmacovigilance system. VAERS has grown even more important due to the discontinuation of the V-Safe system for COVID-19 [7] and the alarming number of adverse event reports in connection with COVID-19 ‘vaccines’.
Ms. Block’s article [8] highlights some of the problems with VAERS that have become apparent since the introduction of COVID-19 ‘vaccines’ - under-staffing, lack of follow up, missing reports, cumbersome user experience, failure to update records, report delays and that the CDC maintains two sets of books (limited public-facing data and complete reports hidden from the public). But these are just the tip of the iceberg.
We draw your attention to several additional concerns.
The CDC hides the fields for type of reporting party, race and pregnancy - claiming that this is required for privacy reasons - even though these data are non-identifying (i.e. one cannot work out the identity of the person just by knowing that information).
The symptom_text field is often a dumping ground for critical information (dates, sex, age, etc.) that is never transferred to the proper respective fields, thus making proper data analysis more difficult for researchers with the raw data, and impossible on the Wonder system.
In November 2022, much of the free text field information was removed from the Foreign Reports [9]. Since the VAERS database does not have a perfect match with foreign reporting systems, their information was often condensed into the symptom_text field. Also removed during this purge were any of the hand-entered text field information like the history, lab data, lot numbers and splttype (which gives the country of origin). This decision to remove reported information leaves researchers in the dark and potentially exposes the public to dangerous products.
Finally, as pointed out in Guetzkow’s work, there seems to be no standardized or objective method for VAERS to track signals. This is the fundamental underlying problem — thousands of safety signals are being reported, but because they are not being properly monitored and analyzed, they are effectively hidden.
VAERS works to flag dangerous products when the data reported therein is properly analyzed and proper assessments are done.
Jessica Rose, PhD; Lizabeth Willner (OpenVAERS.com)
References:
[1] Rose, J. 2021. A report on US Vaccine Adverse Events Reporting System (VAERS) of the COVID-19 messenger ribonucleic acid (mRNA) biologicals. Science, Public Health Policy & the Law. 2:59-80
[2] Rose, J. 2021, Critical Appraisal of VAERS Pharmacovigilance: Is the U.S. Vaccine Adverse Events Reporting System (VAERS) a Functioning Pharmacovigilance System? Science, Public Health Policy & the Law Volume 3:100–129
[3] Jessica Rose, Nicolas Hulscher, & Peter A. McCullough. (2023). DETERMINANTS OF COVID-19 VACCINE-INDUCED MYOCARDITIS. Zenodo. https://doi.org/10.5281/zenodo.8356800
[4] Stieber, Z. CDC Says It Performed Vaccine Safety Data Mining After Saying It Didn’t. https://www.theepochtimes.com/article/exclusive-cdc-says-it-performed-va...
[5] Guetzkow, J. The CDC Gave Me Whiplash https://researchrebel.substack.com/p/the-cdc-gave-me-whiplash?utm_source...
[6] Guetzkow, J. CDC Finally Released Its VAERS Safety Monitoring Analyses for COVID Vaccines via FOIA. https://researchrebel.substack.com/p/cdc-finally-released-its-vaers-safety
[7] https://vsafe.cdc.gov/vsafeportal/s/login/?language=en_US&ec=302&startUR...
[8] Block, J. Is the US's Vaccine Adverse Event Reporting System broken?. BMJ. 2023;383:2582. Published 2023 Nov 9. doi:10.1136/bmj.p2582
[9] Willner, L The Changes to the European/UK VAERS Data https://www.openvaers.com/faq/the-changes-to-the-european-uk-vaers-data
Competing interests: No competing interests