grarpamp at gmail.com
Mon Jan 9 23:06:59 PST 2023
CDC Finally Releases VAERS Safety Monitoring Analyses For COVID Vaccines
Professor Josh Guetzkow via Jackanapes Junction
CDC’s VAERS safety signal analysis based on reports from Dec. 14,
2020 – July 29, 2022 for mRNA COVID-19 vaccines shows clear safety
signals for death and a range of highly concerning thrombo-embolic,
cardiac, neurological, hemorrhagic, hematological, immune-system and
menstrual adverse events (AEs) among U.S. adults.
There were 770 different types of adverse events that showed
safety signals in ages 18+, of which over 500 (or 2/3) had a larger
safety signal than myocarditis/pericarditis.
The CDC analysis shows that the number of serious adverse events
reported in less than two years for mRNA COVID-19 vaccines is 5.5
times larger than all serious reports for vaccines given to adults in
the US since 2009 (~73,000 vs. ~13,000).
Twice as many mRNA COVID-19 vaccine reports were classified as
serious compared to all other vaccines given to adults (11% vs. 5.5%).
This meets the CDC definition of a safety signal.
There are 96 safety signals for 12-17 year-olds, which include:
myocarditis, pericarditis, Bell’s Palsy, genital ulcerations, high
blood pressure and heartrate, menstrual irregularities, cardiac valve
incompetencies, pulmonary embolism, cardiac arrhythmias, thromboses,
pericardial and pleural effusion, appendicitis and perforated
appendix, immune thrombocytopenia, chest pain, increased troponin
levels, being in intensive care, and having anticoagulant therapy.
There are 66 safety signals for 5-11 year-olds, which include:
myocarditis, pericarditis, ventricular dysfunction and cardiac valve
incompetencies, pericardial and pleural effusion, chest pain,
appendicitis & appendectomies, Kawasaki’s disease, menstrual
irregularities, vitiligo, and vaccine breakthrough infection.
The safety signals cannot be dismissed as due to “stimulated,”
exaggerated, fraudulent or otherwise artificially inflated reporting,
nor can they be dismissed due to the huge number of COVID vaccines
administered. There are several reasons why, but the simplest one is
this: the safety signal analysis does not depend on the number of
reports, but whether or not some AEs are reported at a higher rate for
these vaccines than for other non-COVID vaccines. Other reasons are
discussed in the full post below.
In August, 2022, the CDC told the Epoch Times that the results of
their safety signal analysis “were generally consistent with EB
[Empirical Bayesian] data mining [conducted by the FDA], revealing no
additional unexpected safety signals.” So either the FDA’s data mining
was consistent with the CDC’s method—meaning they "generally" found
the same large number of highly alarming safety signals—or the signals
they did find were expected. Or they were lying. We may never know
because the FDA has refused to release their data mining results.
Finally! Zachary Stieber at the Epoch Times managed to get the CDC to
release the results of its VAERS safety signal monitoring for COVID-19
vaccines, and they paint a very alarming picture (see his reporting
and the data files here, or if that is behind a paywall then here).
The analyses cover VAERS reports for mRNA COVID vaccines from the
period from the vaccine rollout on December 14, 2020 through to the
end of July, 2022. The CDC admitted to only having started its safety
signal analysis on March 25, 2022 (coincidentally 3 days after a
lawyer at Children’s Health Defense wrote to them reminding them about
our FOIA request for it).
[UPDATE: T Coddington left a link in comments to a website where he
made the data in the Excel files more accessible.]
Like me, you might be wondering why the CDC waited over 15 months
before doing its first safety signal analysis of VAERS, despite having
said in a document posted to its website that it would begin in early
2021—especially since VAERS is touted as our early warning vaccine
safety system. You might also wonder how they could insist all the
while that the COVID-19 vaccines are being subjected to the most
rigorous safety monitoring the world has ever known. I’ll come back to
that later. First I’m going to give a little background information on
the analysis they did (which you can skip if you’re up to speed) and
then describe what they found.
BACKGROUND ON SAFETY SIGNAL ANALYSIS
Back in June 2022, the CDC replied to a Freedom of Information Act
(FOIA) request for the safety signal monitoring of the Vaccine Adverse
Events Reporting System (VAERS)—the one it had said it was going to do
weekly beginning in early 2021. Their response was: we never did it.
Then a little later they said they had been doing it from early on.
But by August, 2022, they had finally gotten their story straight,
saying that they actually did do it, but only from March 25, 2022
through end of July. You can get up to speed on that here.
The analysis they were supposed to do uses what’s called proportional
reporting ratios (PRRs). This is a type of disproportionality analysis
commonly used in pharmacovigilance (meaning the monitoring of adverse
events after drugs/vaccines go to market). The basic idea of
disproportionality analysis is to take a new drug and compare it to
one or more existing drugs generally considered safe. We look for
disproportionality in the number of adverse events (AEs) reported for
a specific AE out of the total number of AEs reported (since we
generally don't know how many people take a given drug). We then
compare to existing drugs considered safe to see if there is a higher
proportion of particular adverse events reported for the new drug
compared to existing ones. (In this case they are looking at vaccines,
but they still use PRR even though they generally have a much better
sense of how many vaccines were administered.)
There are many ways to do disproportionality analysis. The PRR is one
of the oldest. Empirical Bayesian data mining, which was supposed to
be done on VAERS by the FDA, is another. The PRR is calculated by
taking the number of reports for a given adverse event divided by the
total number of events reported for the new vaccine or the total
number of reports. It then divides that by the same ratio for one or
more existing drugs/vaccines considered safe. Here is a simple
So for example, if half of all adverse events reported for COVID-19
vaccines and the comparator vaccine(s) are for myocarditis, then the
PRR is 0.5/0.5 = 1. If one quarter of all AEs for the comparator
vaccine are for myocarditis, then the PRR is 0.5/0.25 = 2.
Traditionally, for a PRR to count as a safety signal, the PRR has to
be 2 or greater, have a Chi-square value of 4 or greater (meaning it
is statistically significant) and there has to be at least 3 events
reported for a given AE. (This also means that if there are tons of
different AEs reported for COVID vaccines that have never been
reported for any other vaccine, it will not count as a safety signal.
I found over 6,000 of those in my safety signal analysis from 2021.
Of course a safety signal does not necessarily mean there is a problem
or that the vaccine caused the adverse event. But it is supposed to
set off alarm bells to prompt closer inspection, as in this CDC
Ah yes, shared with the public — after first refusing to share the
results and months of foot-dragging following repeated FOIA requests!
We will see that the CDC has not done a more focused study on almost
any of adverse events with “new patterns” (AKA safety signals).
SO WHAT DID THE CDC ACTUALLY DO?
The Epoch Times obtained 3 weeks of safety signal analyses from the
CDC for VAERS data updated on July 15, 22 and 29, 2022. Here I will
focus on the last one, since there is very little difference between
them and it is more complete. The safety signal analysis compares
adverse events1 reported to VAERS for mRNA COVID-19 vaccines from Dec.
14, 2020 through July 29, 2022 to reports for all non-COVID vaccines
from Jan 1, 2009 through July 29, 2022.
PRRs are calculated separately for 5-11 year-olds, 12-15 year-olds and
18+ separately. For each age group, there are separate tables for AEs
from all reports, AEs from reports marked serious and AEs from reports
not marked as serious.2 Recall that a serious report is one that
involves death, a life-threatening event, new or prolonged
hospitalization, disability or permanent damage, or a congenital
anomaly. I will focus on the reports for all AE’s.
They also have a table that calculates PRRs by comparing reports for
the Pfizer COVID-19 vaccine to reports for the Moderna vaccine and
vice versa, again for all reports, serious reports only and
non-serious reports. There were no remarkable findings in those
tables, so I will not discuss them. [Edit: I forgot what Norman Fenton
noted in his analysis: the overall proportion of reports with serious
adverse events is 9.6% for Modern compared to 12.6% for Pfizer.] This
isn’t that surprising since both vaccines are very similar and so
should present relatively similar adverse events when compared to each
other, and any differences are likely not large enough to be picked up
by a PRR analysis. [Though the difference in the overall rate of
serious adverse events, which are not specific to a particular type of
event only how serious it is, was significant.]
The CDC seems to have calculated PRRs for every different type of
adverse event reported for all the COVID vaccines examined - though
it’s possible they only analyzed a subset. What seems clear is that,
among the AEs they examined, the only ones included in the tables
satisfy at least one of two conditions: a PRR value of at least 2 and
a Chi-square value of at least 4 (Chi is the Greek letter χ and is
pronounced like ‘kai’). When both conditions were met, they
highlighted the adverse event in yellow, which appears to indicate a
safety signal. There were no COVID vaccine AEs listed with fewer than
3 reported events, though for non-COVID vaccines there were many AEs
listed that had only 1 or 2 reported since 2009. The CDC tables still
include these and highlight them in yellow when the PRR is greater
than 2 and the Chi-square value is great than 4, indicating these
events are counted as safety signals.
WHAT SAFETY SIGNALS DID THE CDC FIND?
I’m going to divide this up by age groups and the Pfizer v. Moderna
comparison. Let’s start with the 18+ group.
There are 772 AEs that appear on the list. Of these, 770 are marked in
yellow and have PRR and Chi-square values that qualify them as safety
signals. Some of these are new COVID-19 related codes, and we would
expect those to trigger a signal since they didn’t exist in prior
years to be reported by other vaccines. So if we take those off, we
are left with 758 different types of non-COVID adverse events that
showed safety signals.
I grouped these 758 safety signals into different categories. The
figure below shows the total number of AEs reported for each of the
major categories of safety signals:
Let’s dig into some of these categories to look at what types of AEs
generated the most number of reports:3
Let’s dig into some of these categories to look at what types of AEs
generated the most number of reports:3
You can peruse the adverse events using the Excel tables provided by
the CDC, which were posted by The Epoch Times and Children’s Health
Defense at the links at the top of this post.
What about The Children?
If there is anything that looks remotely like a bright spot in all of
this is that the list of safety signals for 12-17 and 5-11 year-olds
is much shorter than for 18+. There are 96 AEs that qualify as a
safety signal for the 12-17 group and 67 for the 5-11. When we take
out the new COVID-era AEs, there are 92 safety signals for 12-17
year-olds and 65 for 5-11 year-olds. Here are the most alarming ones:
I don’t know why the list of AE’s is so much shorter for these age
groups. It could be that the list of AE’s for other vaccines for these
age groups is much shorter, so in a case where AEs have been reported
for the mRNA COVID vaccines but not for other vaccines, it will not be
counted as a safety signal by definition.
COMPARISONS TO MYOCARDITIS & PERICARDITIS
We are told that the existence of a safety signal doesn’t necessarily
mean the AE is caused by the vaccine, and I accept that premise. But
the current practice seems to be to ignore safety signals, dismiss
them as noise without any evidence, and stall any investigation into
them as long as possible. The precautionary principle, however,
dictates we should presume that a safety signal indicates causality,
until proven otherwise. Since, it has been acknowledged that the mRNA
COVID vaccines can cause myocarditis and pericarditis (often referred
to as myo-pericarditis), we can take those AEs as a kind of benchmark,
and propose that, at minimum, any AE with a signal of equal or greater
size should be considered potentially causal and investigated more
After dropping the new COVID-era AEs, there are 503 AEs with PRRs
larger than myocarditis (PRR=3.09) and 552 with PRRs larger than
pericarditis (PRR=2.82).5 This means that 66.4% of the AEs had a
bigger safety signal than myocarditis and 77.3% were larger than
pericarditis. You can see what those were by use this Excel file
provided by the CDC and sorting the 18+ tab by the 12/14-07/29 PRR
column (Column E). Then just look at which AEs have PRRs larger than
the ones for pericarditis and myocarditis.
For 12-17 year-olds, there is 1 safety signal larger than myocarditis
(it’s ‘troponin increased’) and 14 safety signals larger than
pericarditis (excluding myocarditis), which include: mitral valve
incompetence, bell’s palsy, heavy menstrual bleeding, genital
ulceration, vaccine breakthrough infection, and a range of indicators
of cardiac abnormalities.
For 5-11 year-olds, the comparison to myo/pericarditis is less
germane, as they seem to suffer less from this side effect. But we can
still make the comparison: there are 7 safety signals larger than
pericarditis, including bell’s palsy, left ventricular dysfunction,
mitral valve incompetence, and ‘drug ineffective’ (presumably meaning
they still got COVID). There are 16 safety signals larger than
myocarditis (excluding pericarditis), which in addition to those
listed above also include: pericardial effusion, diastolic blood
pressure increase, tricuspid valve incompetence, and vitiligo. Sinus
tachycardia (high heart rate), appendicitis, and menstrual disorder
come in just below myocarditis.
Now if we think of a safety signal as having both strength and
clarity, then the PRR can be thought of as an indicator of how strong
the signal is, while the Chi-square is a measure of how clear or
unambiguous the signal is, because it gives us a sense of how likely
the signal is due to chance alone: the larger the Chi-square value,
the less likely the signal is due to chance. A Chi-square of 4 means
there is only a 5% chance the observed signal is due to chance. A
Chi-square of 8 means there is only a 0.5% chance of it being due to
For the 18+ group, there are 57 AEs with a Chi-square larger than
myocarditis (Chi-square=303.8) and 68 with a Chi-square larger than
pericarditis (Chi-square=229.5). Again, you can see what these are by
going the Excel file linked above and sorting on Column D.
For the 12-17 group, there are 4 AEs with a larger Chi-square than
myocarditis (Chi-square=681.5) and 6 larger than pericarditis
For the 5-11 group, there are 22 AEs with a Chi-square larger than
myocarditis (Chi-square=30.42) and 34 AEs with a Chi-square larger
than pericarditis (Chi-square=18.86).
RESPONDING TO OBJECTIONS
Let’s dispense with some of the criticisms used to dismiss VAERS data,
which will undoubtedly be raised if you try to bring the CDC’s
analysis to people’s attention.
Objection: Anybody can report to VAERS. The reports are
unreliable. Anti-vaxxers made lots of fraudulent reports. Nobody was
aware of VAERS in the past, but now they are. So many people were
afraid of the vaccine so they blamed all their health problems on it.
Health workers were required by law to report certain adverse events,
like deaths and anaphylaxis. Etc. Etc.
All of these objections ultimately rely on the notion that VAERS
reports for COVID-19 vaccines have been artificially inflated over
previous years for one reason or another. The thing of it is, though,
that the CDC has a method for distinguishing between artificial
inflation and real signal. The idea is simple: if adverse events are
artificially inflated, they should be artificially inflated to the
same degree. Meaning, the PRRs for all of these safety signals should
be about the same. But even a casual glance at the PRRs in the Excel
file show they vary widely, from as low at 2 to as high as 105 for
vaccine breakthrough infection or 74 for cerebral thrombosis. This
method does not on the number of reports, but the rate of reporting
for certain events out of all events reported. If anything, this
method would tend to hide safety signals in a situation where a new
vaccine generates a very large number of reports.
The CDC has even done us the favor of calculating upper and lower
confidence intervals, meaning that we can be at least 95% confident
that two PRRs are truly different if their confidence intervals don’t
overlap. So for example the lower confidence interval for pulmonary
thrombosis is 19.7, which is higher than the upper confidence interval
for 543 other signals. Artificially inflated reporting cannot explain
why so many different adverse events have large PRRs that are
statistically distinct from one another.
Objection: The safety signals are due to the huge number of COVID
vaccines given out. Never before have we given out so many vaccine
doses. By the end of July, the US had administered something like 600
million vaccine doses to people aged 18+. But the CDC analysis
compares VAERS reports for these doses to all doses for all other
vaccines for this age group since Jan. 1, 2009. But from 2015-2020
there were over 100 million flu doses administered annually to this
age group alone. In previous work, I estimated 538 million doses of
flu given to people 18+ from July 2015-June 2020. The number of flu
and other non-COVID vaccines for this age group administered from Jan
1., 2009 through July 29, 2022 must be well over double this number,
meaning VAERS reports for COVID vaccines are being compared to reports
for at least double the number of doses for other vaccines. In
addition to this, as already noted, the PRR methodology does not
depend, strictly speaking, on the number of doses, but rather the rate
of reporting of a specific AE out of all AEs for that vaccine.
Objection: the vaccines are mainly being given to older people who
tend to have health problems, whereas other vaccines are given to
younger people. This objection is dealt with, since the analyses are
stratified by age groups. It might be still be somewhat valid for the
18+ group, except that in the safety signal analysis I did in the fall
of 2021, I stratified by smaller age bands and still found safety
signals. In any case, this objection is not enough to dismiss the
safety signal analysis out of hand, but rather calls for better and
more refined research.
Objection: The VAERS data is not verified and cannot be trusted.
I’ll be the first person to agree that VAERS is not high quality data,
but if it is completely untrustworthy, then how is it that the CDC
uses these data to publish in the best medical journals such as JAMA
and The Lancet? If the data were worthless, then these journals
shouldn’t accept these papers. In that JAMA paper, they reported that
80% of the myocarditis reports met their definition of myocarditis and
were included in the analysis. Many other reports simply needed more
details for validation. Furthermore, the CDC has the ability and
budget to follow-up on every report VAERS receives to get more details
and even medical records to verify the report.
So if myocarditis shows a clear signal in the CDC’s analysis, and
80% of those reports were apparently high quality enough to be
included in a paper published in one of the world’s top medical
journals, how is it possible that all the rest of the reports are
junk? That all of the other safety signals are meaningless? Answer: it
And since we’re on the topic of safety signals that turned out to
be real, it’s instructive to find appendicitis turn up as a safety
signal in all 3 age groups, since a study published in NEJM based on
medical records of over a million adult Israelis found an increased
risk of appendicitis in the 42 days following Pfizer vaccination (but
not following a positive SARS-CoV-2 PCR test). That study also found
an increase in lymphadenopathy (swollen lymph nodes) after
vaccination, but not after positive COVID test. Lymphadenopathy was
another safety signal.
And that brings us to our last objection to be dispensed with: all
of these AEs were due to COVID. There was an epidemic and so people
were falling ill due to COVID and having all of these problems that
were then blamed on the vaccine. Well to begin with, as we just saw,
at least two of them (appendicitis and lymphadenopathy) do not appear
to have increased risk ratios following a positive SARS-CoV-2 test,
and we know that the mRNA vaccines increase risk of myo/pericarditis
independent of infections. So how can we assume the rest of these are
and dismiss them with the wave of a hand? We can’t. At minimum, they
need further investigation. Furthermore, in the safety signal analysis
I did in 2021, I dropped all VAERS reports where any sign of a
SARS-CoV-2 exposure or infection was indicated on the report, and I
still found large, significant safety signals.
PUTTING IT ALL INTO PERSPECTIVE
The Epoch Times article quotes my esteemed colleague and friend,
Norman Fenton, Professor of Risk Management and an world renowned
expert in Bayesian statistical analysis: “from a Bayesian perspective,
the probability that the true rate of the AE of the COVID-19 vaccines
is not higher than that of the non-COVID-19 vaccines is essentially
zero…. The onus is on the regulators to come up with some other causal
explanation for this difference if they wish to claim that the
probability a COVID vaccine AE results in death is not significantly
higher than that of other vaccines.” (See his post on the CDC analysis
here.) The same is true for all the safety signals they found.
The CDC’s VAERS SOP analysis document lists 18 Adverse Events of
Special Interest says they are going to pay close attention to. In
their 2021 JAMA paper (and similar presentations to ACIP), the
researchers responsible for analyzing the millions of medical records
in the CDC’s Vaccine Safety Datalink (VSD) using the ‘Rapid Cycle
Analysis’ only studied 23 outcomes. A Similar analysis in NEJM from
Israeli researchers focused on only 25 outcomes. Compare this to over
700 safety signals found by the CDC when they finally decided to
look—and that’s not even counting all the adverse events that have
never been reported for other vaccines so cannot ever show a safety
signal by definition. How can the CDC say that these safety signals
are meaningless if almost none of them have been studied any further?
And yet we are assured that these vaccines have undergone the most
intensive safety monitoring effort in history. It’s complete and utter
* * *
Josh Guetzkow is a senior lecturer at The Hebrew University of
Jerusalem. Subscribe to his Substack here.
1) To be precise, the 'adverse events' are for 'preferred terms' (PTs)
which is a type/level of classification used in the Medical Dictionary
for Regulatory Activities (MedDRA), which is the classification system
used by VAERS and in other pharmacovigilance systems and clinical
research for coding reported adverse events. Not all preferred terms
are a symptom or adverse event per se. Some refer to a specific
diagnostic test that was done or a treatment that was given.
2) It's not entirely clear how they divided these up, since there are
clearly AEs that should be considered serious that don't show up in
the serious Excel table — though maybe they don’t come up simply
because they are looking within serious reports. I believe that they
just filtered the reports to include only serious reports or
non-serious reports, then did the safety signal analysis on all the
AE's coded in those reports. The reason I think this is that I used
the MedAlerts Wayback Machine, selected just the serious COVID-19
vaccine reports, and the numbers of total reports was very close to
the one in the table provided by the CDC (MedAlerts actually had a bit
less). The files obtained by the Epoch Times do not include much in
the way of a description as to how the analyses were done, so I had to
infer some details, which might be incorrect. I will try to note when
I am drawing an inference about how the analysis was done.
3) Generally speaking, these figures show the top ten AEs in each
category. In some cases I combined AEs that indicated the same thing,
such as combining ‘heart rate irregular’ with ‘arrythmia.’ [UPDATE:
Note that the charts of all categories, cardiac and thrombo-embolic
events were updated on Jan 7, 2023. The reason is that I had
previously categorized acute myocardial infarction as a cardiac issue
and myocardial infarction as thrombo-embolic. To be consistent, I have
now combined myocardial infarction and acute myocardial infarction
into one AE category in the thrombo-embolic events (which made the
total AEs reported for that category larger than for pulmonary ones)
and then added a different cardiac AE to the cardiovascular AE
category, ventricular extrasystoles, AKA premature ventricular
contraction (PVC), which dependent on frequency and the presence of
other cardiomyopathies is associated with sudden cardiac arrest.]
4) Note that using the myo-pericarditis signal as a yardstick doesn’t
mean that these are the only signals that matter. To give one example,
anaphylactic reactions don’t even show up in the list of safety
signals, even though that was one of the very first risk of the
vaccine that became apparent from day one of the vaccine rollout.
One potential objection to this benchmark is that it is too low of a
bar, since myo-pericarditis appears to disproportionately affect
younger men and so a proper safety signal should be stratified by age
and gender then compared with myocarditis similarly stratified. I
agree, and it is the CDC’s job to do that. But the fact is that any
adverse reaction might disproportionately affect some subgroup of
people, in which case the safety signal for that group would be
similarly faint or diluted when we look at everyone together. So
5) In their Standard Operation Procedures document, the CDC said they
would combine these and related codes together to assess a safety
signal, but never mind – at least they finally got around to doing
6) In this context, the Chi-square is largely driven by the sheer
number of adverse events: the more adverse events reported, including
for the comparator vaccine, the larger the Chi-square. For example,
the PRR for pericarditis and subdural haematoma is the same (2.82),
but there were 1,701 incidents of pericarditis reported for mRNA COVID
vaccines versus 221for the comparator vaccines, with Chi-square of
229.5. For subdural haematoma, these numbers are 162 verus 21, for a
Chi-square of 21.2.
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