Karl Jablonowski Testimony

jablonowski-testimony

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April 27, 2026
The Honorable Ron Johnson
Chairman
The Honorable Richard Blumenthal
Ranking Member
Permanent Subcommittee on Investigations
Committee on Homeland Security and Governmental Affairs
United States Senate
Please find below my, Dr. Karl Jablonowski, written testimony for the U.S. Permanent
Subcommittee on Investigations hearing titled, “Unmasked: How Biden Health Officials
Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals.”
Introduction
My research at Children’s Health Defense has been focusing on bringing about an end to
childhood epidemics. In its course I have gained insight into the promise, pitfalls, and failings of
pharmacovigilance systems that the United States relies upon to effectuate pharmaceutical
safety in the population.
A vaccine clinical trial phase 1 and 2 involve up to a few hundred very healthy people, to make
sure it’s safe enough for phase 3, involving a few thousand very healthy people. All of it
orchestrated by the pharmaceutical company that stands to profit. By the time it is FDA
approved, if a bad reaction is uncommon we’re not going to see it in a few-thousand person
study - but, like how not every single cigarette causes cancer, the dangers are still real. We
simply do not know what adverse events will look like in a diverse large population until
vaccines are administered to a diverse large population. In essence, the clinical trial never
ends, it’s just that the population becomes the subjects of the uncontrolled experiment. We had
better be watching awfully closely - that is pharmacovigilance.
Our knowledge of the safety of the mRNA vaccine prior to the issuance of the Emergency Use
Authorization was poor. Pfizer did not perform a drug-drug interaction study, so they had no
idea if the vaccine would interact with another drug and have an effect. Pfizer also did not

perform a cardiovascular toxicity study, or a central nervous system toxicity study, or evaluate
the toxicity of other organs like the liver, kidneys, or even blood toxicity. They did not perform a
genotoxicity study to see if DNA would be affected or a carcinogenicity study to see if the
vaccine may cause cancers. Technically they did a reproductive toxicity study1, but not one that
followed good laboratory practices and would not normally be accepted for approval
considerations. Animal and in vitro studies are not sufficient to substantiate health-related
claims, and neither are poorly tracked mandated population-wide vaccines.
Pharmacovigilance behind-closed-doors should give everyone pause. It is simply too important
to not do it correctly and timely. Lapses can be, and were, catastrophic.
The Promise of the Vaccine Adverse Event Reporting System
VAERS was instituted and administered jointly by the FDA and the CDC as a result of the
National Childhood Vaccine Injury Act of 19862. The impetus of passing the Act was the large
number of our nation’s children being vaccine injured by the childhood DTP vaccine.
There are two major successes of VAERS.
Wyeth-Lederle’s (acquired by Pfizer) RotaShield® was approved in August 1998 as the first
vaccine to prevent rotavirus infections in infants3. It was recommended as a 3-dose series at
2-months, 4-months, and 6-months of age. There was a higher than expected number of
reports for intussusception, a life-threatening bowel obstruction, to VAERS. This initiated a
multi-state investigation that concluded an increase 20-30 times over expected risk 2-weeks
following the first dose and 3-7 times over expected risk 2-weeks after the second dose.
Pre-licensure trials included 5 intussusception cases of the 10,054 vaccinated (all after second
or third dose), and 1 of the 4,633 placebo recipients. Though this represents a higher odds
ratio, it was not deemed statistically significant (unadjusted OR 2.30 (95%CI: 0.27-19.73,
p-value=0.446)4). RotaShield® was suspended in July 1999 and fully withdrawn from the U.S.
market in October 19995.
Lederle Laboratory was the primary manufacturer in the 1990s of the Oral Polio Vaccine (OPV),
recommended at 2-months, 4-months, and 6-months of age. It is a live-virus vaccine. The
wild-type poliovirus is grown in non-human primate (monkey) kidney cells at cold temperatures.
This selects for mutations that allow the virus to replicate well in cooler temperatures, such as
cell cultures or the human gut. The human brain is about 2-degrees celsius warmer than the
core temperature in healthy adults, and the cold-adapted vaccine strain is less likely to thrive in
neural tissue. There is, however, the risk of mutations reverting the virus lineage to a
neurovirulent form, resulting in Vaccine-Associated Paralytic Poliomyelitis (VAPP). By the
mid-1990s, the only polio paralysis cases in the U.S. were vaccine related6. In January 1997,
6 https://www.cdc.gov/mmWR/preview/mmwrhtml/00045949.htm
5 CDC, https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5334a3.htm accessed April 26, 2026
4 https://www.medcalc.org/en/calc/odds_ratio.php
3 https://archive.cdc.gov/www_cdc_gov/vaccines/vpd-vac/rotavirus/vac-rotashield-historical.htm
2 https://www.congress.gov/bill/99th-congress/house-bill/5546
1 Christopher J Bowman et al., "Lack of Effects on Female Fertility and Prenatal and Postnatal Offspring
Development in Rats with bnt162b2, a mRNA-Based COVID-19 Vaccine," Reproductive Toxicology 103, (2021):
28–35, doi: 10.1016/j.reprotox.2021.05.007
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the ACIP changed the recommendation surrounding the poliovirus vaccine based partly on
VAERS reports. The new recommendation excluded OPV in favor of Inactivated Polio Virus
(IPV) vaccine for infants at 2-months and 4-months of age.
The Pitfalls of the Vaccine Adverse Event Reporting System
VAERS is a passive volunteer-based surveillance system. Anyone may submit a VAERS report,
and for any degree of suspicion that an adverse event is related to a vaccine. VAERS reporting
is available to all, and is not limited to the discretion of medical care givers.
Its design may be considered appropriate in 1986, with 1986 technology, where the primary
transmission of documents was the U.S. Postal Service or telefacsimile. In the information-age
there is an unacceptable disconnect between a VAERS report and the medical records of the
affected person.
Biases are inherent in the passive volunteer-based surveillance system, and New Hampshire is
a good example of this. According to VAERS, New Hampshire has the highest per-capita infant
mortality rate in the country7. According to national statistics New Hampshire sits at the second
lowest infant mortality rate in the country. It is reasonable to interpret these seemingly
contradictory statements as both: New Hampshire does a good job in keeping their infant
population healthy, and New Hampshire reports infant deaths to VAERS.
Revealed in Part 58 of the Honorable Ron Johnson’s data release on March 25th, 20269 is an
estimation of how much time is dedicated to each report. On page 8 of the document and slide
8 of Dr. Narayan Nair's presentation titled “Artificial Intelligence and Division of
Pharmacovigilance” is an estimate of “~20,000 serious reports/reviewer (~385 per week)”. This
indicates that a reviewer of serious reports processes an estimated 20,000 per year or an
estimated 385 per week. Assuming a 40-hour work week, this translates into one serious report
every 6 minutes 14 seconds. Dr. Nair notes on the next line, all boldface, “~28-fold increase in
serious adverse events” from pre-Covid era. In a contract between the CDC and General
Dynamics Information Technology (GDIT), the CDC predicted that the “total number of reports
received during periods of peak activity (which are not expected to reflect sustained activity) is
expected to be 1,000 reports per day, with up to 40% of the reports serious.”10 According to
monthly status reports from GDIT, in January 2021, the number of incoming reports rose to over
2,500 per day11. The bottleneck of processing and the magnitude of reports to be processed
11 Children’s Health Defense,
https://childrenshealthdefense.org/wp-content/uploads/CDC.GDIT-Status-reports.pdf accessed April 25,
2026
10 Children’s Health Defense,
https://childrenshealthdefense.org/wp-content/uploads/CDC.GDIT-Contract-Summer-2020.pdf accessed
April 25, 2026
9
https://www.ronjohnson.senate.gov/2026/3/psi-chairman-johnson-reveals-further-evidence-of-biden-admin
istration-downplaying-covid-19-vaccine-safety-risk
8 https://www.ronjohnson.senate.gov/services/files/32FB3363-DFD1-453C-88FC-BE53E324F93E
7
https://rumble.com/v58lqpp-ep.6-right-on-point-podcast-w-wayne-rohde-karl-jablonowski-phd.html?start=7
83
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created a lag-time of several months between report date and input date12. Those months were
the most important several months in pharmacovigilance history.
The largest pitfall of VAERS is that the CDC, which co-administers it, doesn’t even take it, or the
human suffering each report represents, seriously. Of mortalities associated with the COVID-19
vaccine it wrote, one of the worst lines CDC has ever written, in the Lancet - Infectious Disease,
“The concentrated reporting of deaths on the first few days after vaccination follows patterns
similar to those observed for other adult vaccinations. This pattern might represent reporting
bias because the likelihood to report a serious adverse event might increase when it occurs in
close temporal proximity to vaccination.”13 All of VAERS is a collection of adverse events “in
close temporal proximity to vaccination.” Though no critical reader would have the take-away,
the paper was cited by at ACIP’s meeting of May 19, 2022 as supporting “[n]o unusual
clustering of causes of death associated with U.S. authorized COVID-19 vaccines”14.
The Failing of the Vaccine Adverse Event Reporting System
A failed Standard Operating Procedure:
According to the Vaccine Adverse Event Reporting System (VAERS) Standard Operating
Procedures for COVID-19 (as of 29 January 2021)15, section 2.3.1 Proportional Reporting Ratio
(PRR)16, “CDC will perform PRR data mining on a weekly basis or as needed.” The CDC chose
to ignore their own Standard Operating Procedure and not run the distinct analysis during the
early months of the vaccine rollouts.
PRR represents a rudimentary level of sophistication, and is described in Table 417. As Dr. Tom
Shimabukuro puts it, “PRR is a simple (maybe overly simplistic) mathematical calculation.
There are no technical limitations to doing PRR, it’s easy, and there are plenty of data in VAERS
to do PRR whenever we want to and on whichever vaccines we choose.”18 In response to a
Children’s Health Defense FOIA request, the CDC revealed PRR analysis from March 25, 2022
through July 31, 2022. The above e-mail demonstrates that the CDC Immunization Safety
Office members, Dr. Tom Shimabukuro and Dr. John Su, were seemingly unaware that CDC
had been running PRR analysis for 90 days, and would continue to run it for another 38 days.
18 Part 8, p.144,
https://www.ronjohnson.senate.gov/services/files/9F5B0145-6120-4DC7-8451-FB6D31BB0D3F
17 Id. p.16
16 Id. p.16
15Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19,
Centers for Disease Control and Prevention, Jan. 29, 2021,
https://web.archive.org/web/20210319091240/https:/www.cdc.gov/vaccinesafety/pdf/VAERS-v2-SOP.pdf
14 https://www.youtube.com/watch?v=Zhod_rH2Kw8&t=4763s
13 Rosenblum, H. G., Gee, J., Liu, R., Marquez, P. L., Zhang, B., Strid, P., Abara, W. E., McNeil, M. M.,
Myers, T. R., Hause, A. M., Su, J. R., Markowitz, L. E., Shimabukuro, T. T., & Shay, D. K. (2022). Safety of
mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an
observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. The Lancet.
Infectious diseases, 22(6), 802–812. https://doi.org/10.1016/S1473-3099(22)00054-8
12 Rose J. Critical Appraisal of VAERS Pharmacovigilance: Is the U.S. Vaccine Adverse Events Reporting
System (VAERS) a Functioning Pharmacovigilance System?. Science, Public Health Policy and the Law.
2021 Oct 01; v3.2019-2024
https://publichealthpolicyjournal.com/critical-appraisal-of-vaers-pharmacovigilance-is-the-u-s-vaccine-adv
erse-events-reporting-system-vaers-a-functioning-pharmacovigilance-system/
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In response to Children’s Health Defense FOIA request, the CDC stated “[t]he results of the
PRR analysis within the time period mentioned above were generally consistent with empirical
Bayesian data mining, revealing no additional unexpected safety signals.”19 This statement is
hard to reconcile given PRR analysis produced 743 clinically relevant signals and EB data
mining produced 320.
A Standard Operating Procedure that is “dynamic and subject to change without notice”21 is a
failed Standard Operating Procedure.
Failure of Empirical Bayesian Data Mining:
Rosenblum et al.:
Rosenblum et al.22 (Rosenblum) is a study of the first 6 months of the US COVID-19 vaccination
program, utilizing VAERS and v-safe. The study has 14 CDC authors, most of whom are in the
Immunization Safety Office. It was originally23 to include two from the FDA - specifically
contributing EB data mining results - showing nothing of interest as an attestation of safety of
the mRNA vaccines. It was cleared by both CDC (and their Office of Science) and the FDA
before being submitted for publication at The Lancet Infectious Disease. The Lancet’s editor
reviewed it and passed it along to 6 reviewers, an end-product of “the most extensive safety
analysis in U.S. history.”24 Not a single person in this chain questioned the appropriateness of
EB data mining…until, and only, Reviewer #5. They wrote ”[f]or the disproportionality analysis
we have no information on the dataset. What were the vaccines included in the dataset? What
was the proportion of COVID-19 vaccines?...If this proportion is over 90% the possibility of
identifying a signal was likely close to zero.”25
That is: the Immunization Safety Office at the CDC, the people who should know something
about the safety of vaccines, and the EB data mining team at the FDA, the only people running
a surveillance report on VAERS, just tried to get “the most extensive safety analysis in U.S.
history” published and were stopped by Reviewer #5…the only person in this entire chain who
25 Part 9, 1.131,
https://www.ronjohnson.senate.gov/services/files/7DD643F9-BF66-4923-B791-7766870C8856
24 https://www.cdc.gov/vaccine-safety-systems/monitoring/covid-19.html
23 Part 9, p.179-216,
https://www.ronjohnson.senate.gov/services/files/7DD643F9-BF66-4923-B791-7766870C8856
22 Rosenblum, H. G., Gee, J., Liu, R., Marquez, P. L., Zhang, B., Strid, P., Abara, W. E., McNeil, M. M.,
Myers, T. R., Hause, A. M., Su, J. R., Markowitz, L. E., Shimabukuro, T. T., & Shay, D. K. (2022). Safety of
mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an
observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. The Lancet.
Infectious diseases, 22(6), 802–812. https://doi.org/10.1016/S1473-3099(22)00054-8
21 Children’s Health Defense,
https://childrenshealthdefense.org/wp-content/uploads/CDC-letter-re-PRR-v.-EB-Mining.pdf accessed
April 26, 2026
20 Jablonowski, K., Evans, R., Hooker, B., 2025. The Pharmacovigilance Betrayal of the COVID-19 Era.
Medical Research Archives, 13(5). https://doi.org/10.18103/mra.v13i5.6505
19 Children’s Health Defense,
https://childrenshealthdefense.org/wp-content/uploads/CDC-letter-re-PRR-v.-EB-Mining.pdf accessed
April 26, 2026
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seemed to think the limitations of EB data mining means the absence of a signal does not mean
the absence of a hazard.
Because of Reviewer #5, EB data mining and the two FDA authors, were stripped out of this
paper. Dr. David Menschik was one of the FDA authors, and wrote to the first-author “[w]e
acknowledge this in the limitations and understand that there is a considerable bias towards the
null when using our data mining methods in this current, unprecedented situation.”26
The FDA is saying the only system monitoring VAERS doesn’t work in this “unprecedented
situation” - meaning the pathetically tested COVID vaccines pushed onto the country generated
a half-million VAERS reports in the first few months - far outpacing all reports over the last 30
years. This isn’t a blind-spot, the FDA was completely blind to COVID-19 vaccine adverse
events. The CDC chose to ignore their own Standard Operating Procedure and not run a
distinct monitoring program, in favor of the FDAs. It was figuratively, the blind leading the blind
and dressed up as “the most extensive safety analysis in U.S. history.”
Dr. Menschik knew of the limitations prior to publication. In an email to Dr. John Su, he wrote
“disproportionately [sic] scores…can be muted…particularly if both mRNA COVID-19 vaccines
are associated with the same adverse event”, and warned of not putting “excess value on the
absence of a signal”27. He’s probably alluding to myocarditis, which never flagged in the EB
data mining system. To which Dr. John Su responded “[s]ignal detection with VAERS data has
always been tricky business.”28
The first-author, to make sure she got it right, e-mailed Dr. Menschik “...you’re saying that the
sheer volume of COVID-19 vaccine reports basically washes out the possibility of finding
disproportionality…”29 to which Dr. Menschik responded “I think you’ve got the main point...data
mining has blind spots…”30 Again, this isn’t a blind-spot, the FDA was completely blind to
COVID-19 vaccine adverse events. And the CDC wasn’t even looking.
Dr. Menschik was actually the individual who ran the weekly reports and sent them out. In
weekly EB data mining emails to Dr. John Su and Dr. Tom Shimabukuro (both also authors on
the paper). It included attached slides31 that discuss the limitations, the same slides every
single week. Those limitations are, essentially just because we don’t see it, doesn’t mean it’s
not there, and the entire system can be used for screening and hypothesis generation only.
Failure to pass the scrutiny of Reviewer #5 is an indication that the only system monitoring
VAERS fails to monitor for safety. The FDA authors withdrawing their contribution to the study is
an admission, acknowledging that the multimillion dollar per year pharmacovigilance system
isn’t working.
31 Part 10, p160,
https://www.ronjohnson.senate.gov/services/files/F92FBB0A-CCFD-412A-A02D-243AA1844D6E
30 Id. p.120
29 Part 9, p.120-121,
https://www.ronjohnson.senate.gov/services/files/7DD643F9-BF66-4923-B791-7766870C8856
28 Part 3, p.6,
https://www.ronjohnson.senate.gov/services/files/70DB86AF-8620-49A3-ABE2-18FFA3C57968
27 Id. p.178
26 Id. p.126
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Yih et al.:
In October of 2023 CDC asks the FDA if they would like to be co-authors on a tinnitus paper
utilizing EB data mining, Yih et al.32 (Yih).
After reading their plan Dr. Judith Maro, Associate Professor at Harvard, was blunt: “It will be
mostly useless to try to make statements about the COVID vaccines because the database will
have so many COVID reports that you can’t create a comparator.”33
Dr. John Su responded privately, “I don’t know the methods well enough to address Judy’s
comments”34. A co-author, Dr. Nair, wrote “[w]e could report our data mining findings and just
acknowledge this as a limitation (this is what we have done in other papers).”35 And that is what
they did. Yih was published in the American Journal of Otolaryngology, concluding “these
findings do not support an increased risk of tinnitus following COVID-19 vaccination” and
includes EB data mining, for which one of the authors - Dr. Judith Maro, has already said “it will
be mostly useless to try to make statements about COVID vaccines”.
Co-author, Dr. Brian Hooker, and I have submitted a letter to the editor of the publishing journal.
In it we highlight the authors’ dismissive consideration of the masking effect inherent in EB data
mining of COVID-19 vaccines in VAERS. We conclude that the fact-pattern is meritorious of a
review concerning retraction, in part or in whole, of the study. As of this writing, the editor of the
journal has sent it for peer review.
Failure to learn:
The overall theme, not only does CDC not understand the limitations of EB data mining, they
are not learning. Before Rosenblum was written, on myocarditis, Shimabukuro wrote on June
3rd 2021: “This stuff is kind of like a foreign language to me. I get it conceptually, but I can’t
explain the mathematical details.”36 Later (June 22nd), in a direct message to Dr. Frank
DeStefano: “I’m perplexed that myocarditis isn’t alerting for either of the mRNA vaccines. I’m
wondering if it’s getting washed out in the half million reports.”37
37 Part 9, p118,
https://www.ronjohnson.senate.gov/services/files/7DD643F9-BF66-4923-B791-7766870C8856
36 Id. p.104
35 Id. p.108
34 Id. p.108-109
33 Part 4, p109-110,
https://www.ronjohnson.senate.gov/services/files/6102048F-D934-4511-8CA4-DFFB06DE6F8E
32 Yih, W. K., Duffy, J., Su, J. R., Bazel, S., Fireman, B., Hurley, L., Maro, J. C., Marquez, P., Moro, P.,
Nair, N., Nelson, J., Smith, N., Sundaram, M., Vasquez-Benitez, G., Weintraub, E., Xu, S., &
Shimabukuro, T. (2024). Tinnitus after COVID-19 vaccination: Findings from the vaccine adverse event
reporting system and the vaccine safety datalink. American journal of otolaryngology, 45(6), 104448.
https://doi.org/10.1016/j.amjoto.2024.104448
7

Why then use EB data mining as an attestation of safety in Rosenblum, or Yin, or an MMWR
report on the safety in adolescents aged 12-17 years38, or on pregnancy adverse events in the
journal of Vaccine39?
Failure to learn the limitations of EB data mining is disturbing. The Immunization Safety Office
of the CDC has been taught the limitations by: the failure to detect myocarditis in 202140;
Reviewer #5 of Rosenblum in 202241; Dr. Judith Maro in 202342. The office still continues to
publish into 2024 utilizing the lack of EB data mining signal as an attestation of safety.
A simple explanation of EB data mining begins with a Proportional Reporting Ratio, just like the
one the CDC chose not to produce. That will have a lot of false positives, because high ratios
can be driven by very few numbers. So a shrinker is applied that shrinks the high ratios with
few numbers - that method is dependent upon the distribution across the entire database. The
Geometric mean of the posterior distribution is the shrunken estimate of the relative reporting
ratio, for which you flag as a signal if the lower 5th percentile is above 2.
The first limitation is highlighted by Reviewer #5 of Rosenblum. The expected count is based
on a tiny fragment, as VAERS was grossly under-reported over the preceding 30 years. The
observed is based on a huge number of reports, as the pathetically tested COVID-19 vaccines
were pushed onto the country resulting in so many reports that the reporting system ground to a
halt. Prior distributions across the entire dataset is going to dilute everything, or as Reviewer #5
put it, “the possibility of identifying a signal was likely close to zero.”43
The second limitation is that if the sudden surge of VAERS reports was from two vaccines of the
same platform, like mRNA experimental gene therapy, have the same adverse events, as Dr.
Menschik put it “disproportionately [sic] scores…can be muted”.44
The scientific community performs self-correction with varying degrees of success. If it is
performed well in this context, all papers that lean on the lack of a COVID vaccine EB data
mining signal to support safety will be retracted.
Failure in duty:
44 Part 9, 1.178,
https://www.ronjohnson.senate.gov/services/files/7DD643F9-BF66-4923-B791-7766870C8856
43 Part 9, 1.131,
https://www.ronjohnson.senate.gov/services/files/7DD643F9-BF66-4923-B791-7766870C8856
42 Part 4, p109-110,
https://www.ronjohnson.senate.gov/services/files/6102048F-D934-4511-8CA4-DFFB06DE6F8E
41 Part 9, 1.131,
https://www.ronjohnson.senate.gov/services/files/7DD643F9-BF66-4923-B791-7766870C8856
40 Part 9, p118,
https://www.ronjohnson.senate.gov/services/files/7DD643F9-BF66-4923-B791-7766870C8856
39 Moro, P. L., Olson, C. K., Clark, E., Marquez, P., Strid, P., Ellington, S., Zhang, B., Mba-Jonas, A.,
Alimchandani, M., Cragan, J., & Moore, C. (2022). Post-authorization surveillance of adverse events
following COVID-19 vaccines in pregnant persons in the vaccine adverse event reporting system
(VAERS), December 2020 - October 2021. Vaccine, 40(24), 3389–3394.
https://doi.org/10.1016/j.vaccine.2022.04.031
38 Hause AM, Gee J, Baggs J, et al. COVID-19 Vaccine Safety in Adolescents Aged 12–17 Years —
United States, December 14, 2020–July 16, 2021. MMWR Morb Mortal Wkly Rep 2021;70:1053-1058.
DOI: http://dx.doi.org/10.15585/mmwr.mm7031e1
8

Pharmacovigilance over the past several years has been insulting, and many people are
injured. To add more insult to that injury, the e-mail45 that Dr. Nair wrote to Drs. Su and
Shimabukuro “We could report our data mining findings and just acknowledge this as a
limitation”, before that he wrote “We were aware of this limitation before and during the
pandemic. There are many data mining tools and there was some discussion about utilizing a
novel tool to adjust for this. However, we thought it would be problematic to use a brand new,
possibly unvalidated tool in the context of an EUA.” He’s saying that the brand new vaccines
can’t be monitored with a brand new tool.
That statement is made so much worse by knowing what position Dr. Nair once held, Director
and Chief Medical Officer of the Division of Injury Compensation Programs, which administers
the Vaccine Injury Compensation Program and the Countermeasures Injury Compensation
Program. Injuries are only compensated if they can be identified as such.
Dr. Nair ends the email with “You could develop another tool that would compensate for the
greater number of COVID vaccine reports. I am not sure how to do this but you would need a
statistician with DM [data mining] experience. This would be beyond our capabilities at FDA.”
He is describing the work of Dr. Ana Szarfman (who collaborated with Dr. William DuMouchel,
the inventor of EB data mining). He is describing the qualifications of Dr. Ana Szarfman. Dr.
Ana Szarfman has already co-developed the tool, is amply qualified, has sent out numerous
comparable analyses showing uncompensated and compensated signals, and is (at the time)
employed by the FDA.
Failure that became a Betrayal:
The population of the United States is around 340,000,00046. A VAERS search for COVID-19
vaccine adverse event reports for the 50 states and the District of Columbia yields 853,031
(data current as of March 27th, 2026)47. This equates to roughly 1-in-400 Americans filing a
VAERS report of having a VAERS report filed on their behalf.
Filing a VAERS report is an act of hope, and selfless hope at that. Too late for the injured, it is
the hope that the knowledge of one person’s injury and suffering may avert the affliction of
another person’s.
The culmination of those many acts of selfless hope amounted to enough evidence for a
statistically significant signal of myocarditis in young males as early as the week of February
19th, 202148. That was a week before even Dr. Roee Singer, Deputy Director, Division of
48 Delayed Vigilance: A Comment on Myocarditis in Association with the COVID-19 Injections. (2022).
International Journal of Vaccine Theory, Practice, and Research , 2(2), 651.1-651.4.
https://doi.org/10.56098/ijvtpr.v2i2.61
47 United States Department of Health and Human Services (DHHS), Public Health Service (PHS),
Centers for Disease Control (CDC) / Food and Drug Administration (FDA), Vaccine Adverse Event
Reporting System (VAERS) 1990 - 03/27/2026, CDC WONDER On-line Database.
Accessed at http://wonder.cdc.gov/vaers.html on Apr 25, 2026 10:47:32 AM
46 https://www.census.gov/popclock/
45 Part 4, p109-110,
https://www.ronjohnson.senate.gov/services/files/6102048F-D934-4511-8CA4-DFFB06DE6F8E
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Epidemiology, Israel Ministry of Health contacts the CDC stating “From the Israel vaccine
adverse event monitoring team: We are seeing a large number of myocarditis and pericarditis
cases in young individuals soon after [sic] Pfizer COVID-19 vaccine. We would like to discuss
the issue with a relevant expert at CDC.”49 That was months before the citizens of the United
States were made aware of the risk posed by the novel vaccines.
For all its EB data mining efforts, the FDA found merely 3 clinically significant signals for mRNA
vaccines: a rash (mechanical urticaria), exposure via breast milk, and drug ineffective50. CDC
did run a PRR analysis for 4-short months51, and when they did they discovered 743 clinically
significant safety signals including stroke, heavy menstrual bleeding, myocarditis, cardiac arrest,
and death. “For 5-to-11 year-olds, the analysis flagged 56 symptoms, of which 20 are serious,
including myo- and pericarditis. For 12-to-17 year-olds, the analysis flagged 95 symptoms, of
which 45 are serious, also including myo- and pericarditis.”52
This is the betrayal of our time, so vast that we cannot even count its casualties.
The Promise of V-Safe
V-safe is a smart-phone application that prompts users for health check-ins. It constitutes an
active volunteer surveillance system, as it actively engages with the around 10 million
volunteers who agreed to participate with the system. V-safe allows for the surveillance of
subclinical indications of health outcomes associated with vaccination. The vast 10 million
volunteers were distributed demographically and geographically, with the acceptable limitation of
participation dependent upon smart-phone usage circa 2021.
The Pitfalls of V-Safe
V-safe’s protocol document53 from January 28, 2021 describes 10-check-box options for minor
transient conditions (chills; headache; joint pain; muscle or body aches; fatigue or tiredness;
nausea; vomiting; diarrhea; abdominal pain; rash, not including the immediate are around the
injection site), 1-check-box for none, and a free-text field for “other”. This is a system designed
to collect inconsequential data. In the extreme hypothetical, if every one of the 10 million users
checked every one of the 10 boxes every time they were prompted, would it have changed the
multibillion dollar rollout of the emergency use authorized vaccines? My opinion is “no”.
Dr. Renata Engler is distinguished in the study of vaccine-induced myocarditis among U.S.
military members. Amid the possibility of biological warfare in the early 2000s the smallpox
53 p.43,
https://www.hsgac.senate.gov/wp-content/uploads/2025.05.21-PSI-Majority-Staff-Interim-Report-Failure-t
o-Warn.pdf
52 Children’s Health Defense,
https://childrenshealthdefense.org/defender/emails-chd-foia-government-covid-vaccine-injury-reports/
accessed on April 25, 2026
51 Id.
50 Jablonowski, K., Evans, R., Hooker, B., 2025. The Pharmacovigilance Betrayal of the COVID-19 Era.
Medical Research Archives, 13(5). https://doi.org/10.18103/mra.v13i5.6505
49 Jablonowski, K, Hooker, B. (2023). Lock the Doors: The Myocarditis Disaster and a call for the broad
examination of the CDC and FDA. Medical Research Archives, [S.l.], v. 11, n. 5, may 2023. ISSN
2375-1924. https://doi.org/10.18103/mra.v11i5.3907.
10

vaccine was administered to service personnel. Dr. Engler is among the researchers who
characterized the myocarditis outcome of those vaccinations in a clinical review54, a follow-up55,
a prospective study56, and a comparative observational cohort study57. Dr. Engler gave a
presentation to CDC on April 12, 202158. For not including myocarditis into V-safe she had this
to ask: “If you do not ask, you will not see it, but does that mean it does not exist?” Dr. Engler’s
paper “Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the
US Military”59 was accepted for publication 50 days later on June 1, 2021. Over the next years
she would have several more publications on our military’s and nation’s newfound myocarditis
epidemic, including: case definition60, cardiac adverse events61, and relapsing myocarditis62.
The Failing of V-Safe
V-safe succeeded in collecting inconsequential data, which in itself is a failure of
pharmacovigilance. Among its first uses was in Rosenblum63 study of the first 6 months of the
63 Rosenblum, H. G., Gee, J., Liu, R., Marquez, P. L., Zhang, B., Strid, P., Abara, W. E., McNeil, M. M.,
Myers, T. R., Hause, A. M., Su, J. R., Markowitz, L. E., Shimabukuro, T. T., & Shay, D. K. (2022). Safety of
mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an
62 Amodio, D., Manno, E. C., Cotugno, N., Santilli, V., Franceschini, A., Perrone, M. A., Chinali, M., Drago,
F., Cantarutti, N., Curione, D., Engler, R., Secinaro, A., & Palma, P. (2023). Relapsing myocarditis
following initial recovery of post COVID-19 vaccination in two adolescent males - Case reports. Vaccine:
X, 14, 100318. https://doi.org/10.1016/j.jvacx.2023.100318
61 Montgomery, J. R., Hoffman, D. L., Ryan, M. A., Lee, R. U., Housel, L. A., Engler, R. J., Collins, L. C.,
Atwood, J. E., & Cooper, L. T. (2023). Cardiac Adverse Events Following COVID-19 Vaccination in
Patients With Prior Vaccine-Associated Myocarditis. Federal practitioner : for the health care
professionals of the VA, DoD, and PHS, 40(1), 6–10. https://doi.org/10.12788/fp.0354
60 Sexson Tejtel, S. K., Munoz, F. M., Al-Ammouri, I., Savorgnan, F., Guggilla, R. K., Khuri-Bulos, N.,
Phillips, L., & Engler, R. J. M. (2022). Myocarditis and pericarditis: Case definition and guidelines for data
collection, analysis, and presentation of immunization safety data. Vaccine, 40(10), 1499–1511.
https://doi.org/10.1016/j.vaccine.2021.11.074
59 Montgomery, J., Ryan, M., Engler, R., Hoffman, D., McClenathan, B., Collins, L., Loran, D., Hrncir, D.,
Herring, K., Platzer, M., Adams, N., Sanou, A., & Cooper, L. T., Jr (2021). Myocarditis Following
Immunization With mRNA COVID-19 Vaccines in Members of the US Military. JAMA cardiology, 6(10),
1202–1206. https://doi.org/10.1001/jamacardio.2021.2833
58 p.45,
https://www.hsgac.senate.gov/wp-content/uploads/2025.05.21-PSI-Majority-Staff-Interim-Report-Failure-t
o-Warn.pdf
57 Engler, R. J. M., Montgomery, J. R., Spooner, C. E., Nelson, M. R., Collins, L. C., Ryan, M. A., Chu, C.
S., Atwood, J. E., Hulten, E. A., Rutt, A. A., Parish, D. O., McClenathan, B. M., Hrncir, D. E., Duran, L.,
Skerrett, C., Housel, L. A., Brunader, J. A., Ryder, S. L., Lohsl, C. L., Hemann, B. A., … Cooper, L. T.
(2023). Myocarditis and pericarditis recovery following smallpox vaccine 2002-2016: A comparative
observational cohort study in the military health system. PloS one, 18(5), e0283988.
https://doi.org/10.1371/journal.pone.0283988
56 Engler, R. J., Nelson, M. R., Collins, L. C., Jr, Spooner, C., Hemann, B. A., Gibbs, B. T., Atwood, J. E.,
Howard, R. S., Chang, A. S., Cruser, D. L., Gates, D. G., Vernalis, M. N., Lengkeek, M. S., McClenathan,
B. M., Jaffe, A. S., Cooper, L. T., Black, S., Carlson, C., Wilson, C., & Davis, R. L. (2015). A prospective
study of the incidence of myocarditis/pericarditis and new onset cardiac symptoms following smallpox and
influenza vaccination. PloS one, 10(3), e0118283. https://doi.org/10.1371/journal.pone.0118283
55 Eckart, R. E., Love, S. S., Atwood, J. E., Arness, M. K., Cassimatis, D. C., Campbell, C. L., Boyd, S. Y.,
Murphy, J. G., Swerdlow, D. L., Collins, L. C., Riddle, J. R., Tornberg, D. N., Grabenstein, J. D., Engler, R.
J., & Department of Defense Smallpox Vaccination Clinical Evaluation Team (2004). Incidence and
follow-up of inflammatory cardiac complications after smallpox vaccination. Journal of the American
College of Cardiology, 44(1), 201–205. https://doi.org/10.1016/j.jacc.2004.05.004
54 Cassimatis, D. C., Atwood, J. E., Engler, R. M., Linz, P. E., Grabenstein, J. D., & Vernalis, M. N. (2004).
Smallpox vaccination and myopericarditis: a clinical review. Journal of the American College of
Cardiology, 43(9), 1503–1510. https://doi.org/10.1016/j.jacc.2003.11.053
11

US COVID-19 vaccination program. It included a mortality assessment, dismissing “[t]he
concentrated reporting of deaths on the first few days after vaccination” as “reporting bias”.
Instead, they chose to populate the paper with clinically inconsequential findings. The only
figure of the paper is a time series analysis of both Moderna’s and Pfizer-BioNTech’s COVID-19
vaccine, for both dose 1 and dose 2, of: injection-site pain, fatigue, headache, myalgia, chills,
and joint pain.
Though no signal for myocarditis was ever attributed to V-safe, it is with horror that we find 366
individuals typed “myocarditis” in the “other” free-text field64, a condition requiring a medical
diagnosis. The horror is amplified by the nearly 50,000 registrants who typed “chest pain” into
the “other” free-text field.
Children’s Health Defense contractor Thomas Yengst performed a pregnancy analysis on V-safe
data. Of the 10 million participants, 104,556 women checked the pregnant box. Of those,
11,037 (or 10.6%) indicated a pregnancy difficulty. Women who checked the pregnant box and
contributed free-text information numbered 36,981 (or 35.4%) of whom 3,691 (or 10.0%)
indicated a miscarriage. Ten percent miscarriage rate is the upper-bound of pregnancy
outcome before the woman is aware of the pregnancy. That rate drops dramatically after the
fetal heart begins to function. These findings do not, by themselves, constitute a failure to warn,
as the numbers as presented are explainable. These findings do, however, present V-safe’s
failure to explain. The CDC’s and FDA’s preliminary findings65 left Americans with more
questions than answers, questions still unanswered.
The Promise of the Vaccine Safety Datalink
The Vaccine Safety Datalink (VSD) is a collaboration of 13 integrated healthcare organizations
covering over 15.5 million people66. It can detect near-real-time safety issues as they arise and
most frequently use a Rapid Cycle Analysis, for example the first 21 days after vaccination
compared to the subsequent 21 days could detect an adverse event of rapid onset. Its use is
intended to “allow the CDC to adequately monitor vaccine safety in a scientifically rigorous
manner.”67
The datalink includes: birth date, gender, medicaid status, enrollment, immunizations, vaccine
type/manufacturer/lot-number/date-of-administration, hospitalization and outpatient (date, length
of stay, diagnosis code, diagnosis type), gestational age, child’s weight, Apgar score, race, birth
67 Part 8, p.157,
https://www.ronjohnson.senate.gov/services/files/9F5B0145-6120-4DC7-8451-FB6D31BB0D3F
66 p.6, https://www.cdc.gov/acip/downloads/slides-2025-06-25-26/04-Meyer-COVID-508.pdf
65 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., Ellington, S. R., Burkel, V. K., Smoots, A. N., Green, C. J., Licata,
C., Zhang, B. C., Alimchandani, M., Mba-Jonas, A., Martin, S. W., Gee, J. M., … CDC v-safe COVID-19
Pregnancy Registry Team (2021). Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant
Persons. The New England journal of medicine, 384(24), 2273–2282.
https://doi.org/10.1056/NEJMoa2104983
64 Informed Consent Action Network, https://icandecide.org/v-safe-data/ accessed April 25, 2026
observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. The Lancet.
Infectious diseases, 22(6), 802–812. https://doi.org/10.1016/S1473-3099(22)00054-8
12

geography, mother’s date of birth, underlying cause of death, date of death, and patient’s zip
code68.
The Pitfalls of the Vaccine Safety Datalink
Rapid Cycle Analysis is designed to detect adverse events of rapid onset. If the adverse event
has a delayed onset, with a median onset near or beyond the risk interval, Rapid Cycle Analysis
will negate it. Other options that would not be subject to delayed onset negation are rarely
utilized in CDC’s VSD analyses. These include vaccinated vs. unvaccinated direct comparison
and pre-post (medical utilization for the same individual before vaccination and after
vaccination). Both of these types of analyses would require the well-practiced extra-step of
considering differences in healthcare seeking behavior.
The VSD, by nature, can only analyze clinically recognized outcomes, and, by its distribution, is
made up of approximately 50% from California residents.
The largest pitfall of the VSD is not in its design, data, or mode of analysis, but in who is allowed
access. This many million-dollar taxpayer funded resource is not available to any scientist
outside of the 13 Managed Care Organizations (MCO) or the federal government without 13
independent IRB applications approved by all 13 MCOs, an estimated $250,000 per project.
Transparency is simply unattainable, and allows for the poor practice of science free rein over
vaccine safety.
The Failing of the Vaccine Safety Datalink
A true accounting of poor-quality science derived from the VSD, where the skeptical researcher
may not access, would fill volumes. For expediency, it is appropriate to demonstrate from
example.
Eriksen et al.69 (Eriksen) is a study entitled “Lack of Association Between Hepatitis B Birth
Immunization and Neonatal Death”. It includes the notable author Dr. Frank DeStefano, at the
time a medical epidemiologist at the CDC and appointed acting chief of the Immunization Safety
Branch of the National Immunization Program. The study was recently cited by the ironically
named Vaccine Integrity Project70 and former CDC Director Dr. Rochelle Walensky71 in the
71 Ulrich, A. K., Fleming, D. F., Smith, E. A., Anderson, C. J., Mehr, A. J., Redepenning, S. G., Stoddart, C.
J., Moat, L. E., Walensky, R. P., & Lackritz, E. M. (2026). Hepatitis B Vaccination at Birth: Safety,
Effectiveness, and Public Health Benefit. Pediatrics, 10.1542/peds.2025-075783. Advance online
publication. https://doi.org/10.1542/peds.2025-075783
70 Ironically named Vaccine Integrity Project, Center for Infectious Disease Research and Policy,
University of Minnesota,
https://www.cidrap.umn.edu/sites/default/files/searchable-download/Universal%20Hepatitis%20B%20Vac
cination%20at%20Birth%202Dec2025.pdf accessed April 25, 2026
69 Eriksen, E. M., Perlman, J. A., Miller, A., Marcy, S. M., Lee, H., Vadheim, C., Zangwill, K. M., Chen, R.
T., DeStefano, F., Lewis, E., Black, S., Shinefield, H., & Ward, J. I. (2004). Lack of association between
hepatitis B birth immunization and neonatal death: a population-based study from the vaccine safety
datalink project. The Pediatric infectious disease journal, 23(7), 656–662.
https://doi.org/10.1097/01.inf.0000130953.08946.d0
68 Id. p.154
13

journal of the American Academy of Pediatrics as supporting, “[n]o increase in infant deaths
attributed to HepB vaccination”.
Eriksen is a publication utilizing the VSD, specifically the MCOs of both “Southern and Northern
California Kaiser Permanente Health Plans of more than 350,000 live births from 1993 to 1998
and ascertained all deaths occurring under 29 days of age.” The authors compared vaccinated
and unvaccinated neonates who died in the first 29 days, matched on a few characteristics, and
concluded “no significant difference”.
The authors failed to match on gestational age or birthweight. The unvaccinated had a median
gestation of 28 weeks (extreme prematurity) while the vaccinated had 39 weeks of gestation
(full term). The unvaccinated had a median birth weight of 3 pounds while the vaccinated had a
median birth weight of 6.8 pounds. It is inappropriate to consider this a vaccinated and
unvaccinated study, as it is in practice a comparison between full term neonates and extreme
premature and low birthweight neonates.
There are plenty of poor quality studies out there, and this is one of them with an abysmal
conclusion, “[n]o increase in infant deaths attributed to HepB vaccination”, which is an untenable
summary given the study’s design. What I find difficult to reconcile is that Walensky, the former
CDC director, leans on it to assert the safety of the Hepatitis B birth dose. At best she never
read it. Much worse she did and stands by it.
This was her initiative to demonstrate the scientific community is well-functioning, and that it
establishes the Hepatitis B birth dose to be safe. She failed miserably, and in that failing
actually demonstrates the counterpoints. The scientific community is NOT well-functioning
surrounding vaccinations, and that the Hepatitis B birth dose has never been shown to be safe.
Conclusions
No serendipity:
The COVID-19 mRNA vaccines were, by honest accounting, pathetically tested. Prior to EUA
many safety studies (drug-drug interactions, cardiovascular toxicity, central nervous system
toxicity, other organ toxicity, blood toxicity, genotoxicity, carcinogenicity) were skipped. Had they
turned out to be actually safe, it would have been serendipitous, a happy accident. Luck is not a
pillar of public health.
Failure to look:
The largest pharmaceutical rollout in human history was the CDC’s time to shine. More so,
America needed the CDC to shine. When we needed them the most, the CDC chose to ignore
their own SOP and defer to the FDA.
Failure to fix the broken warning system:
The last several years is littered with examples of knowledge that the EB data mining system
was incapable of effectuating pharmacovigilance. With full knowledge of its failures and
14

limitations, the lack of a hypothesis generating signal was still presented as an attestation of
safety.
Failure to protect:
Even if public health institutions had overcome the pharmacovigilance failures and managed to
warn, a warning of an approved product would be insufficient to protect the citizenry. With
professional membership medical organizations (AAP, AMA, ACOG, IDSA, etc.) spinning
narratives of safety, efficacy, and necessity, there is no assurance a warning would be heeded.
The landscape of freedom of choice drastically changed on September 9, 202172. The most
powerful threat to freedom originated domestically from the highest office of the United States
government. Then President Joe Biden proclaimed the vaccines to be “safe”, described “a
pandemic of the unvaccinated”, stated the obvious “this is not about freedom or personal
choice”, and then threatened everyone who would think otherwise with “our patience is wearing
thin.” Public health institutions needed to, and didn’t, counter the coercion under extreme
duress.
What's a freedom for?:
The Freedom of Information Act evasion is uncomfortably well-practiced throughout the
documents produced by the subcommittee. “[M]any considerations not suited to email...”73 and
“I think that because of the FOIAs we may have asked FDA to stop sending these weekly data
mining outputs”74 are overt deprivations of Americans’ freedom.
In the backdrop of evasion, even potentially honest mistakes could also potentially be practiced
evasion. On May 24th, 2021 Dr. Peter Marks forwards an email from Dr. Steve Anderson on a
CMS signal for pulmonary embolism and immune thrombocytopenia to Dr. Rochelle Walensky,
but does so to her non-government email address75. Mistake or evasion is unclear. Why would
the Director of CBER email the Director of CDC to her non-government email address? Why
would he even have that email address?
FOIA evasion is not conduct becoming of a democratic republic, it is conduct of a government
that believes it is beyond oversight of the governed. “Instituted among Men, deriving their just
powers from the consent of the governed”76 depends upon the governed to be able to give
consent. The governed cannot give consent if they are being deceived; not even if they wanted
to - because it wouldn’t be called “consent” it would be called “submission” or “subjugation”.
76 U.S. Declaration of Independence. (1776).
https://www.archives.gov/founding-docs/declaration-transcript
75 Children’s Health Defense,
https://childrenshealthdefense.org/wp-content/uploads/s_r_23-00756-FDA-Equity-Modified.pdf accessed
APril 25, 2026
74 PSI-HHS-000002480132.
73 PSI-HHS-000008251979
72 Miller Center,
https://millercenter.org/the-presidency/presidential-speeches/september-9-2021-remarks-fighting-covid-19
-pandemic accessed April 25, 2026
15

History’s lesson:
Our understanding of signal detection was catapulted forward after the first time a U.S. military
radar detected an enemy aircraft, it was ignored. Those aircraft went on to bomb Pearl Harbor.
America and Congress really needed to know why our navy was destroyed while docked and
our aircraft were destroyed on the ground. The ensuing investigations and growth in
understanding signal detection were needed to ensure Americans would not again be put in
harm’s way by the failure to warn. But 79 years later, it happened again.
All mistakes made are repeatable. Time is allowing for the escape of accountability and
diminishing our opportunity to learn. Either we learn the lessons we need to in order to fix our
flaws from the last pandemic, or a future one. The COVID-19 pandemic created over 100
billionaires in the United States77 and over 1,000 billionaires around the world78. Anything that
profitable is going to repeat.
Sincerely,
Karl Jablonowski, PhD
Director of Science and Research
Children’s Health Defense
78 https://www.equals.ink/p/its-a-great-time-to-be-a-billionaire
Archived at
http://archive.today/2026.04.25-023636/https://www.equals.ink/p/its-a-great-time-to-be-a-billionaire
77 https://nchstats.com/billionaires-in-united-states/
Archived at http://archive.today/2026.04.25-023739/https://nchstats.com/billionaires-in-united-states/
16