Coronavirus: Thread

[grarpamp]

The Feds Pile Up Vaccine 'Adverse Event' Reports As They Decry
Scaremongering Elsewhere

https://openvaers.com/

Since the Food and Drug Administration authorized the first vaccines
for COVID-19 in late 2020, the government and much of the media have
insisted that the medicines developed in record time are safe and
effective. Those who raised questions about them have been routinely
dismissed as conspiracy theorists.

And yet an online database co-administered by the FDA and the Centers
for Disease Control has compiled more than 1.3 million reports of
vaccine-implicated  “adverse events” running the gamut from mild to
severe, including 29,000 deaths.

Representative entries include:

    A 44-year-old male from California with a blood clot in the brain
(CVST) five days after receiving Pfizer vaccine, dose unknown.

    A 31-year-old female from Pennsylvania with heart inflammation
(myocarditis) two days after receiving Moderna’s booster.

    A 58-year-old female from California with blood clots in legs
(DVT) after receiving Johnson & Johnson booster. She reported:

    “Day after booster on 11/16/21 my right leg was aching. 7 days
later on 11/23/21 my sole of my right foot was very painful upon
walking. This resolved 2 days later by 11/25/21. On day 11 (11/26/21)
my ankle was slightly swollen and painful to touch. These symptoms
continued to migrate up my leg to my inner thigh. On 12/13/21 I was
seen by my primary care Doctor and was sent for a d-dimer blood test
which was 1.77. I was seen in vascular dept and ultrasound indicated
multiple DVT from my groin to my ankle.”

These reports are not anecdotes from “anti-vaxxers” on the dark web.
They come from the federal government’s open-source log, the Vaccine
Adverse Event Reporting System. It allows anyone to go online and
report a bad reaction that could be linked to any vaccine, including
those for COVID-19.  (RealClearInvestigations has linked above to
VAERS reports posted at Openvaers.com, an independently run and easier
to navigate database that copies reports verbatim from the CDC’s less
user-friendly “WONDER” system.)

While the reports are unfiltered and unexamined, the idea is that such
public input will allow researchers to identify potential problems.
But the sheer number of reports, and their specificity, have the
attention of concerned scientists and even some politicians like
Senator Ron Johnson of Wisconsin, who has invited people harmed by
vaccines to testify before Congress and advocates compensation for
them.

Johnson's office said he has been admonishing the health authorities
over the VAERS reports for a year. "The senator believes the CDC and
FDA need to take their own adverse event early warning system
seriously and be transparent with the American people," it said in a
statement. "To date, they have not been."

VAERS was created in the late 1980s as an outgrowth of a congressional
mandate to create a system for compensating vaccine victims and their
families. In 2015, the CDC said the average number of annual reports
was roughly 30,000. In 2021, there were nearly 1 million. Given the
large increase during a politically charged pandemic, the usefulness
of VAERS is the subject of great debate even among scientists

Some health experts believe that the number of reports is primarily a
function of increased publicity around the COVID vaccines, a high
number indicating only that many more people are aware of the system
and concerned about potential side effects from the shots. Others say
the number and strong indications in certain symptom categories – such
as the cardiovascular examples cited above – paint a bleaker picture
of the vaccines’ safety.

Dr. Peter McCullough, a renowned cardiologist and academic physician
with over 600 papers published in medical literature, was one of the
first professionals to publicly question the safety of the COVID-19
injections. On April 21, 2021, on his podcast The McCullough Report,
he read out some of the early, alarming statistics from VAERS
including reports of 502 heart attacks, 84 miscarriages, 321 cases of
low blood platelet counts (thrombocytopenia) and 2,342 deaths. For Dr.
McCullough, these numbers were a huge red flag. For comparison, he
cites the last “mass vaccination program” undertaken in the United
States, the 1976 swine flu vaccine. Dr. McCullough noted that there
were approximately 55 million people vaccinated, with an accompanying
500 cases of Guillain-Barré syndrome, and around 25 deaths. “And the
government officials at that time said, ‘we’re going to pull it.’”

Dr. McCullough said that by April 2021, VAERS reports were already so
numerous  that he felt the COVID vaccines should be pulled off the
market. That same month, Fox News host Tucker Carlson voiced doubts
about the vaccines' effectiveness, and Dr. Anthony Fauci, President
Biden's top medical adviser, blasted him for pushing "a typical crazy
conspiracy theory."

As of today, the system has more than 29,000 reports of deaths.

VAERS reports, however, are not hard evidence. Its website explains:
“A report to VAERS generally does not prove that the identified
vaccine(s) caused the adverse event described. It only confirms that
the reported event occurred sometime after vaccine was given. No proof
that the event was caused by the vaccine is required in order for
VAERS to accept the report. VAERS accepts all reports without judging
whether the event was caused by the vaccine.” Some of the FDA and
CDC’s most senior veterans advise caution in interpreting the data.

Susan Ellenberg, PhD, the former Director of the Office of
Biostatistics and Epidemiology at the FDA’s Center for Biologics, told
RCI that “anything that gets reported goes directly into the [VAERS]
system … so mostly what you get is noise.” She said that it’s nearly
impossible to prove causation with this dataset alone. Dr. Walter
Orenstein, formerly the CDC’s director of immunization, concurs. He
said, “That’s why it’s called adverse ‘events’ as opposed to reaction
because reaction implies causation. Event is basically something that
follows.” Elderly people, for example, die regularly; if they are
dying days or weeks after being vaccinated, that does not necessarily
mean the vaccine is killing them.

There are many reasons why the VAERS data is usually insufficient to
prove causality between vaccination and adverse events, including:

    There is no reliable denominator to establish event rates – and no
“control” group against which to measure adverse events.

    Reports are often messy or incomplete.

    Underreporting has been a consistent and documented issue. (One
CDC study shows that the system may capture as few as 12% of adverse
events, meaning the total for COVID-19 vaccines could be as high as
10.8 million.)

    On the other hand, overreporting is also an issue, as noted in
this 2003 CDC review: “Other potential reporting biases include
increased reporting in the first few years after licensure, increased
reporting of events occurring soon after vaccination, and increased
reporting after publicity about a particular known or alleged type of
adverse event.”

    In the case of childhood vaccinations, vaccine sets are
co-administered, making it nearly impossible to know which specific
vaccine caused the adverse event.

So why continue using an unreliable system – apart from the fact it
was required by Congress? Experts agree that VAERS can be extremely
useful in picking up signals of causation, which can be confirmed with
further study, usually employing the government’s other major
monitoring system: the CDC’s Vaccine Safety Datalink. The VSD uses the
combined databases of nine major healthcare systems nationwide,
providing detailed patient data, and the ability to look at control
groups of unvaccinated patients. The downside to the VSD is that
unless an issue comes through the healthcare system, it’s not going to
be reported. So if someone dies at home after being vaccinated, it
won’t make it into VSD, though it might make it into VAERS.

One prime example of VAERS picking up a signal leading to an important
safety discovery occurred in the late 1990s with the RotaShield
vaccine for rotavirus – an ailment that causes diarrhea and vomiting
in the very young. While clinical trials revealed a small number of
cases of intussusception – the sometimes-deadly folding of the
intestine in small children – the  finding was not seen as
prohibitive. Nonetheless, public health researchers flagged it as
something to look for in VAERS as the vaccine was distributed widely.
When reports started piling up in VAERS, it led to a review process,
which ultimately led to the manufacturer pulling the vaccine off the
market and the FDA pulling its license. A clear success for the
system.

In the case of the COVID-19 vaccine products, Dr. Orenstein said VAERS
has been a success, and that the large number of reports has been
helpful in identifying certain issues. “The increased volume may be a
good thing. Because of the increased reporting we’ve been able to
detect causally related problems, with mRNA problems with myocarditis
and pericarditis, and with J&J coagulation problems and
Guillain-Barré, so in essence, VAERS is important.”

Jessica Rose, an independent researcher in Israel, agrees, and has
devoted the past year and a half to putting VAERS under a microscope.
Dr. Rose has a PhD in computational biology from Bar-Ilan University,
a post-doc in molecular biology from Hebrew University, and another in
biochemistry from the Technion, widely considered Israel’s MIT. She
has become a fierce critic of the COVID-19 vaccines and spent
countless hours poring over VAERS reports to craft her articles on the
emergent issues.

For Rose, who has been collaborating with Dr. McCullough, the
information available in the VAERS system on its own is sufficient to
prove causality when it comes to vaccine-induced myocarditis from all
three vaccines, especially the mRNA-based shots from Pfizer and
Moderna. They specifically raise concerns around the high rate of
myocarditis reported among boys ages 12-15. Their paper stating this
was received, peer-reviewed, and accepted by Elsevier, the publisher
of Current Problems in Cardiology, where the piece was to be released.
It was then withdrawn from the site at the discretion of the editor.
No basis was given for the removal. Dr. McCullough described the
situation in detail to Bret Weinstein on his Dark Horse podcast in
December. When asked for comment, Dr. McCullough told
RealClearInvestigations:

    Elsevier, the world's largest medical publisher, has for the first
time in its history started violating publication contracts with
unilateral retractions in the pandemic era. These papers were fully
peer-reviewed, contracted, and published without any threats to
scientific validity. The one thing in common for these retractions –
they provided data on COVID-19 vaccine injuries, disabilities, and
deaths. Thus Elsevier has broken the trust of the consuming public,
doctors, and patients. In addition to legal exposure, Elsevier is
losing ground to MDPI and other publishers that do not engage in
corrupt censorship.

Asked to respond to the cardiologist's comment, Elsevier issued this
statement to RCI: “We do not agree with these assertions; this article
in press was withdrawn following our standard policies which are all
publicly available on our website.”
The Lyme Disease Precedent

Dr. Orenstein and the federal health apparatus now acknowledge that
adverse outcomes like myocarditis, coagulopathies/thrombosis, and
Guillain-Barré have been established as causally related to the
COVID-19 shots in certain cohorts – and that VAERS played a role in
making those connections – but see them as rare.

Former FDA epidemiologist Ellenberg says the sheer number of events in
VAERS may reflect the revival of an old phenomenon: high adverse
publicity around vaccines, similar to what happened with the Lyme
disease vaccine and arthritis.

Lyme disease can cause arthritis. So can aging. When many reports of
arthritis started appearing in VAERS after that vaccine was rolled out
in 1998, bad publicity followed. Ellenberg started receiving phone
calls from lawyers asking her when FDA was going to pull the vaccine.
Ultimately, FDA convened a panel to look into the correlation, and no
causal connection was found. “But because of the publicity, use of the
vaccine waned and eventually the producer took it off the market.”

Regarding the COVID-19 vaccines, Jessica Rose said VAERS shows a grim
picture that has nothing to do with publicity. The reporting system
“is functioning as a pharmacovigilance tool right now,” she said.
“There are an enormous number and range of safety signals being thrown
out.”

In March 2022, after the COVID-19 vaccine had been available for 15
months (462 days), she compared the number of VAERS reports related to
these shots versus those for flu vaccines. Given the greater number of
COVID shots administered during that period, she predicted that “the
rate of reporting in VAERS…should be about twice for COVID than for
flu.” What she found instead was “117.6 times as many reports of
adverse events in the context of the COVID shots.”

Rose is adamant. “This is not about the number of doses, this is about
these products doing more damage [than the flu vaccines],” she said,
“systemic, comprehensive damage that we’ve never seen before. There’s
no doubting that these products are different.” When RCI queried Rose
as to which three adverse events might be most readily proven as being
caused by the vaccine with data posted in VAERS, she replied,
“Myocarditis, Bell’s palsy, and anything related to clotting.

Quietly, large numbers of peer-reviewed studies have been accumulating
in legitimate journals, lending credence to those who believe many
adverse events are occurring, and that they are causally related to
vaccination. Just recently, a study of vaccines in three Nordic
countries revealed a strong correlation between getting the
Astra-Zeneca shot and a higher incidence of cardiovascular injury, and
a lesser but still significant correlation for recipients of the
Pfizer and Moderna products.

Finally, a “preprint” study (not yet peer reviewed) uploaded June 23
and co-authored by Peter Doshi, a senior editor at the British Medical
Journal, as well as physicians from UCLA and Stanford, concludes that
a careful analysis of all available data now suggests that the
benefits of vaccination do not outweigh the potential harms. To make
their calculations, the researchers used data from VAERS as well as
its European equivalent, EudraVigilance, and the WHO’s VigiBase.

But the story remains complicated. For instance, Rose agreed drawing
conclusions is complicated by the lack of data in VAERS about whether
reporting patients have also recovered from COVID. Studies have now
shown that having had COVID also increases the risk of cardiovascular
events in the year after recovery. On the other hand, an Israeli
analysis shows a correlation to vaccine rollout, but not to COVID-19
infection rates.

With such variables, the task of monitoring vaccine safety can seem
almost futile. But Dr. Robert Chen, the creator of VAERS, disagrees.
He believes the system, in concert with the Vaccine Safety Datalink
and other resources, has worked well in alerting the public health
community to issues due to vaccination. He told RCI that “in terms of
its main function of telling you that something is going on, it’s
amazingly effective.”

Dr. Orenstein said the VSD should be expanded if possible as a
complement to VAERS but said that without a single national database,
the current system of monitoring vaccine safety is “as good as it
gets.” For Ellenberg, a statistician by training, “these are horrible,
messy databases. You’re looking for a needle in a haystack.” When
talking to other epidemiologists and encouraging them to create better
systems for analyzing VAERS, Ellenberg said she uses this analogy: “If
you can reduce the whole haystack to a handful of hay, then that makes
your job just a little bit easier.”

Rose acknowledges the messiness of VAERS, but believes it provides
enough information to tell a story of danger. She said that in her
analysis, 60% of VAERS reports describe events within 48 hours of
vaccine administration – one more criteria for causality. Rose said:
“It isn’t on me to prove that these products aren’t safe, this is on
them [CDC, FDA], legally, to prove that these products are safe. And
they’re not doing their jobs.” On that point, a recent public records
request by Josh Guetzkow, Ph.D., and the legal team at Robert F.
Kennedy Jr.’s Children’s Health Defense found that CDC has not been
analyzing the VAERS data on COVID-19 shots using its own stated
methods.

In an email to RCI, the CDC stated, “COVID-19 vaccines are undergoing
the most intense safety monitoring in U.S. history.”



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