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MSc Biology student | 5x first-author academic papers | 100+ articles on
coronavirus | Freelance medical writer

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UNDERREPORTING AND POST-VACCINE DEATHS IN THE VACCINE ADVERSE EVENT REPORTING
SYSTEM (VAERS) EXPLAINED

Shin2021-07-27



EVALUATING THE CLAIMS OF UNSAFE COVID-19 VACCINES BASED ON WHAT HAS BEEN
REPORTED TO VAERS.

Image by Freepik

Vaccine safety is a polarized topic. Many either stay on the side of safe or
unsafe vaccines when the reality isn’t so black and white. A vaccine is a type
of drug. Like antibiotics, birth control pills, statins, and antidepressants,
they all come with risks and hopefully more benefits.



That said, this article will examine if there’s any truth or validity in the
claims that Covid-19 vaccines are unsafe based on what has been reported to the
vaccine adverse event reporting system (VAERS), a passive surveillance system
that monitors vaccine safety in the U.S. beyond clinical trials.


THE UNSAFE COVID-19 VACCINES NARRATIVE

In the rather popular DarkHorse podcast, three people— Bret Weinstein, Ph.D.,
evolutionary biologist, Robert Malone, MD, MS, one of the pioneers of mRNA
vaccine, and Steve Kirsch, MS, founder of seven tech companies — discussed
problems in how the pandemic is handled. One of the problems was vaccine safety
based on VAERS data.

They brought up the graph below that showed a huge spike in post-vaccine deaths
in 2021 compared to previous years in the U.S. And they emphasized that the
Covid-19 vaccines are a reasonable and perhaps the only possible explanation for
these deaths.



(In May 2021, Mr. Tucker Carlson also pushed the same narrative in his show,
Tucker Carlson Tonight, where he announced that nearly 4000 people had died
after getting the Covid-19 vaccine, based on VAERS data. Other sites have also
made similar claims.)

This graph is the one Mr. Kirsch cited in the podcast and article on
trialsitenews.com.Author’s screenshot as of 13 July 2021

Mr. Kirsch also said that this is an underestimate. So, “the public doesn’t know
how many people have died from the vaccine,” he said. “It could be only 1% of
reports that are actually reported…which means 5000 reports translate to 500,000
deaths [but] I don't think it’s that high…but it’s higher. I guarantee that it’s
higher.”



Even that 5000 deaths “is more deaths than for all 70 other vaccines combined
over the last 30 years,” Mr. Kirsch continued. The same applies to the reported
adverse events from the Covid-19 vaccines: “it’s also more than all the other
vaccines over 30 years combined.”

Mr. Kirsch also said that “nobody knows about this VAERS system, and people
aren’t reporting. In fact, when doctors report in, they are told [to not] report
this…We’ve had reports reversed from doctors without the doctor’s consent.”

The trio then discusses the censorship of this issue, where information is
suppressed, and questioning why everyone is staying silent about this danger
signal present in VAERS.


PURPOSE OF VACCINE ADVERSE EVENTS REPORTING SYSTEM (VAERS)

Before we examine the underreporting and post-vaccine deaths issues in VAERS,
let’s have a brief look into what VAERS is supposed to do.



Since we can’t include the entire population in clinical trials forever, VAERS
was created in 1990 for the CDC and FDA to watch for any danger signals of the
vaccine in the U.S. population beyond the clinical trials.

After all, participants enrolled in clinical trials may not reflect the general
population. For example, in the Pfizer mRNA vaccine phase 2/3 clinical trial,
the participants’ median age was 52 years, with only 4.4% being over 75 years
and 0.003% being over 85 years. Although 46% of participants had at least one
underlying medical condition (typically heart, lung, or liver diseases, obesity,
or diabetes), only 0.1 % had dementia, 0.5 % had heart failure, and 1.0 % had
cerebrovascular diseases. Plus, people with immune disorders — such as
autoimmune diseases and late-stage cancers — were excluded.



This is why the safety profile of vaccines cannot be fully known from clinical
trials alone. Real-world data are necessary, which is why surveillance systems
such as VAERS are created.

As VAERS does not contain data from unvaccinated populations, VAERS cannot
confirm if a vaccine caused something. In other words, without a comparison
control group, we don’t know if the adverse events (including deaths) reported
to VAERS are actually coincidences that would have happened regardless of the
vaccine.

As the CDC and VAERS have cautioned, “While very important in monitoring vaccine
safety, VAERS reports alone cannot be used to determine if a vaccine caused or
contributed to an adverse event or illness. The reports may contain information
that is incomplete, inaccurate, coincidental, or unverifiable.”



Thus, the purpose of VAERS is to detect signals of possible vaccine adverse
events, which may generate hypotheses and prompt further investigations.


VAERS UNDERREPORTING

Anyone can report to VAERS, including patients, parents, and healthcare
provides. Healthcare provides are also required by law to do so. But despite
that, underreporting is an acknowledged limitation of VAERS.

Mr. Kirch and other critics of vaccine safety often mention that only 1% of
vaccine-related adverse events are reported. This claim is based on a 2011
report from Harvard Pilgrim Health Care, Inc., which stated that “fewer than 1%
of vaccine adverse events are reported.”

But this data can be misinterpreted easily. The Harvard report examined all
possible reactions to the vaccine, even minor ones like pain and fever, which
are common and expected that many doubt there’s a need to report them.

For more serious vaccine reactions or adverse events, however, underreporting is
not as extreme:

 * A 1995 study found that 68% of poliomyelitis (severe nerve disorder) cases
   from the oral poliovirus vaccine were reported to VAERS (reporting
   sensitivity: 68%). But this number was <1% for non-severe rashes from the
   mumps/measles/rubella (MMR) vaccine. (This data can also be misused to say
   that only <1% of vaccine adverse events get reported).
 * A 2001 study found that 47% of cases of rotavirus vaccine-associated
   intussusception (severe intestinal disorder) were successfully reported to
   VAERS (reporting sensitivity: 47%).
 * A 2013 survey study in the U.S. found that 73% of healthcare providers were
   very or extremely likely to report a serious vaccine adverse event, whereas
   only 13% were keen to report a minor one.
 * A 2020 study tracked the reporting sensitivity of anaphylaxis (severe
   allergic reaction) and Guillain–Barré syndrome (severe nerve disorder) from
   various vaccines. Results (see table below) showed that the reporting
   sensitivity of anaphylaxis ranges from 13–76% from seven different vaccines.
   For Guillain–Barré syndrome, the reporting sensitivity is 12% from the
   2012–2013 influenza vaccine, 15–55% from the 2009 influenza vaccine, and 64%
   from the 2006–2015 human papillomavirus vaccine.

The reporting sensitivity of the Vaccine Adverse Event Reporting System (VAERS)
for anaphylaxis and for Guillain-Barré syndrome.Miller et al. (2020).

Thus, in general, less severe reactions are more likely to be massively
underreported outside of clinical trials. But more severe reactions (or adverse
events) are less likely to get massively underreported.

Yes, it’s just less prone to massive underreporting. In the end, VAERS is not a
perfect system that will catch everything. Does this mean that the vaccine is
less safe than what the available data suggest? Yes, but this isn’t enough to
dismiss vaccines as unsafe drugs. ‘Less safe’ is relative, and it’s usually
relative to an already rare phenomenon.

For example, in the context of current Covid-19 vaccines:

 * The rate of anaphylaxis (severe allergic reaction) is 2.5–4.7 cases per
   million doses of the Pfizer and Moderna mRNA vaccines (≤0.0005%). Assuming a
   reporting sensitivity of 10-50% (a reasonable estimate based on the studies
   presented above), which also means underreporting rate of 50–90%, this rate
   would only be 0.001–0.005%.
 * The rate of vaccine-induced thrombotic thrombocytopenia (VITT; severe blood
   vessel disorder) is 1 case per 26,000 to 127,000 doses of the AstraZeneca DNA
   vaccines (≤0.003%). A 10–50% reporting sensitivity would change this
   percentage to 0.006–0.03%.
 * The rate of Guillain–Barré syndrome (severe nerve disorder) is 7.69 cases per
   million doses of the Johnson & Johnson DNA vaccines (0.00078%). A 10–50%
   reporting sensitivity would adjust the percentage to 0.0016–0.0078%.

(Please note that only the Guillain–Barré syndrome rate is based on what was
reported to VAERS. The rates of anaphylaxis and VITT were determined based on
further research, which means less degree of underreporting.)

(Another note is I’m not sure whether VAERS reports can be reversed without
consent, as Mr. Kirsch claimed in the podcast, as I could not find any info
about it. Maybe a few reports did get reverse due to random system errors, but I
doubt that would make much of a difference in the overall numbers.)

So, admittedly, underreporting is inevitable with VAERS. Probably only <1% of
the minor (non-severe) and 10–50% of serious (severe) vaccine reactions get
reported. But serious vaccine reactions or adverse events are rare and will
still be rare after accounting for underreporting.


POST-VACCINE DEATHS

As mentioned above, the DarkHost podcast, Tucker Carlson Tonight, and many other
sites have mentioned that about 4000–5000 people have died after getting the
Covid-19 vaccine as of May 2021, based on VAERS reports.

While VAERS did receive that many reports of post-vaccine deaths between
December 2020 and May 2021, that numerator alone is misleading without the
denominator. In fact, about 250 million doses of Covid-19 vaccines were
administered during that period, which means that the rate of post-Covid-19
vaccine deaths is about 0.002%.

In fact, the CDC expected 11,440 deaths as early as January 2021, given that
about 1.3 million doses of vaccines were administered to patients in long-term
care facilities. But only 129 post-vaccine deaths were reported to VAERS at that
time, which is 88.7-fold (8870%) lower than expected.

(Although underreporting is expected, it would not be at an extreme rate, as
discussed in the above section, especially when it comes to death.)

At present, the CDC is still transparent about post-vaccine deaths. The CDC
website states that ~6000 post-vaccine deaths have occurred out of the 334
million doses given as of 13 July 2021. This gives the rate of 0.0018%:

Source: Screenshot from the CDC webpage last updated on 13 July 2021.

The same can be said about the huge number of vaccine-related adverse events
reported to VAERS in 2021 (ranging in the hundreds of thousands, although some
of them are minor and non-severe). Given the sheer number of vaccines
distributed during this pandemic, a sharp increase in reports of post-vaccine
deaths and adverse events is expected. Moreover, the numerator (number of
vaccine-related adverse events or deaths) is misleading without the denominator
(number of vaccine doses given).

Importantly, recall that VAERS is not meant to show a cause-and-effect link, as
authorities have repeatedly cautioned. After all, VAERS accepts reports
regardless of whether they are likely or unlikely to be caused by the vaccines,
and bad things — deaths, diseases, and illnesses — happen to people daily.

For example, in 2019, 2.85 million people died in the U.S., which gives an
average of 7,800 deaths per day. So, one can imagine if the most vulnerable
populations are prioritized for vaccination at a massive scale, a drastic spike
in post-vaccine deaths (and other adverse events) will happen.

This isn’t the first time that post-vaccine death reports in VAERS have been
misused. For example, during the 2015 measles outbreak in the U.S., claims of
over 100 deaths caused by the measles vaccine circulated on the internet. The
claim was based on VAERS data. But further examinations of health records,
autopsy reports, and death certificates by the CDC and FDA found no causal
relationship between the measles vaccine and post-vaccine deaths.


IS VAERS ACTUALLY USEFUL?

In the abovementioned 2001 study, cases of rotavirus vaccine-related
intussusception (severe intestinal disorder) were found to be underreported to
VAERS by about 50%. Even before such underreporting was discovered, however, the
initial VAERS signal was enough to prompt authorities to suspend rotavirus
vaccination for further investigations. And the rotavirus vaccine was soon
withdrawn from the market in that same year in 1999. This is the only case of
post-approval vaccine withdrawal thus far.

VAERS has also detected a small increase in febrile seizures (non-severe nerve
disorder) incidents among young children who got the 2010–2011 influenza
vaccine. Thankfully, all children recovered without any long-term health
effects. Further studies, motivated by VAERS signal, have also verified such
association with other influenza vaccines.

During the Covid-19 pandemic, initial reports of severe blood clots from the
AstraZeneca and Johnson & Johnson (J&J) DNA-based vaccines to surveillance
systems like VAERS instigated their suspension, slowing vaccine rollout. After
thorough inspections, a new medical term was coined: vaccine-induced thrombotic
thrombocytopenia (VITT). And we now know the prevalence, cause, and early signs
of VITT and how to treat it.

The possible risk of myocarditis (non-severe heart inflammation) from the Pfizer
and Moderna mRNA vaccines in young men was also first noted by VAERS, and
authorities soon admitted the risk as legitimate.

More recently, VAERS has also caught a possible link between the J&J DNA vaccine
and Guillain–Barré syndrome, where 100 such reports were submitted as of 12 July
2021. During this time, about 13 million doses of the J&J vaccine were
administered. The FDA has soon admitted that Guillain–Barré syndrome may occur
within 42 days of getting the J&J vaccine.

(Despite the known risks of VITT, myocarditis, and Guillain–Barré syndrome,
those Covid-19 vaccines are still being used in most countries because they
offer substantially more benefits than risks.)

So, even with its limitations, VAERS is a useful system. Critics might argue
VAERS may have missed some real vaccine adverse events. Assuming this is true
(which we don’t know, though), such vaccine adverse events would be rarer than
what has been detected. If VAERS can catch vaccine adverse events with incidence
rates of, for example, ≤0.0007% (i.e., 100 reports of Guillain–Barré syndrome
from 13 million doses of J&J vaccine) — or 0.0016–0.007% if the reporting
sensitivity is 10–50% — the hypothetical vaccine adverse events that VAERS would
miss should have an incidence rate of less than that.



Image by rawpixel.com




KEY POINTS

Underreporting happens with the U.S. VAERS, but we need to be careful in noting
that although <1% of minor vaccine reactions get reported, the underreporting
rate of more serious vaccine reactions or adverse events is not that extreme.
Based on existing studies, VAERS’s reporting sensitivity for serious vaccine
adverse events is 10–50% — which also means a 50–90% underreporting rate — but
even this percentage can be misleading. Note that such rates are relative to
serious vaccine adverse events that are rare. Rare events will still be rare,
even with a 90% underreporting rate.

While 6000 post-Covid-19 vaccine deaths have occurred in the U.S. as of July
2021, it’s crucial to note that the denominator is 334 million vaccine doses,
equating to a rate of 0.0018%. Plus, VAERS is not meant to confirm that a
vaccine caused something, but that doesn't stop people from assuming that
Covid-19 vaccines have killed thousands of people in the U.S. About 7,800 people
died in the U.S. every day in 2019, so it’s actually not surprising to see a
spike in post-vaccine deaths in 2021 as mass vaccination is happening,
especially in the vulnerable populations.

All that said, back to the intro, this article is not meant to say that vaccines
are completely safe or unsafe. But the claims that the Covid-19 vaccines are
unsafe based on what has been reported to VAERS are simply misleading.

Thanks for reading, and also read this one if you are interested in under what
circumstances that the Covid-19 vaccines may not be completely safe:

5 Unique Situations When the Covid-19 Vaccine Isn’t Very Safe
There are always statistical outliers, exceptions to the rule.medium.com

This article was previously published in Microbial Instincts.

Follow me to see more articles like this.
Shin
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Shin

MSc Biology student | 5x first-author academic papers | 100+ articles on
coronavirus | Freelance medical writer

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