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.
[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
Rapid Response:
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