Thoughts on economics and liberty

To what extent can VAERS be used to estimate covid vaccine side effects/deaths?

My summary conclusion

There is huge transaction cost of reporting information and filling forms. No health professional has the time to fill reports for minor events – and the average “patient” is unlikely to do so, either. For instance, if someone gets well after 20 minutes of the vaccine – or (like my mother) gets pain in the legs for one night, then there is virtually no chance that anyone will fill out forms.

Past evaluations of the reliability of VAERS’s reports for other vaccines have found that:

a) for minor events there is massive under-reporting.

b) serious event reports (e.g. myocarditis) are likely to be broadly accurate – with possibly some under-reporting. We are likely to get some reports that are false, and some serious events are not reported. On balance we can assume serious reports to be broadly in the ballpark of what we see on VAERS.

c) But for deaths, things are very problematic. As I show later in this post, each such case needs an autopsy to rule out coincidence (given so many people die of natural causes each day). Therefore death reports in VAERS are entirely unreliable – i.e. not usable at all. We need autopsies of anyone given a covid vaccine who then dies within 28 days.

VAERS is a self-reporting system

the Vaccine Adverse Event Reporting System, jointly run by the Centers for Disease Control and Prevention and the Food and Drug Administration.

VAERS is not the kind of database you might expect to find on the CDC website. It is a self-reporting system. As Reuters reported, “anyone [in the public] can report events to VAERS,” and so “the database contains unverified information.” [Source]

CDC disclaimers on VAERS point out that the database “may contain information that is incomplete, inaccurate, coincidental or unverifiable,” and that “the inclusion of events in VAERS data does not imply causality.” [Source]

“FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it’s unclear whether the vaccine was the cause.” [Source]

PDF of the reporting form

Download from: https://vaers.hhs.gov/uploadFile/index.jsp

A disclaimer on the CDC’s website says: “The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable”

Vaccines have been four times last year’s

Anyone who receives a vaccine authorized in the United States can report an adverse event to VAERS, as can doctors, family members, and others. That openness ensures VAERS receives plentiful reports—228,000 for COVID-19 vaccines alone since December 2020, more than four times the number received in all of last year for all vaccines. [Source]

CDC claims that virtually no death is genuinely caused by the vaccine

Reports of death after COVID-19 vaccination are rare. More than 386 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through September 20, 2021. During this time, VAERS received 7,899 reports of death (0.0020%) among people who received a COVID-19 vaccine. FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it’s unclear whether the vaccine was the cause. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines. However, recent reports indicate a plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and TTS, a rare and serious adverse event—blood clots with low platelets—which has caused deaths [Source]

Even if these are all genuine, they are pretty small

The number of deaths reported after a COVID-19 vaccination as of 24 May—4863—represents just 0.0017% of more than 285 million doses of vaccine given, the agency notes in a continuously updated statement. [Source]

What’s the anecdotal evidence?

As an emergency medicine doctor in Michigan’s Thumb, Dr. Mark Hamed has seen hundreds of patients with COVID-19, but no one with a bad reaction to a COVID vaccine.

“Not one,” said Hamed, who also is the medical director for the public health departments in Huron, Lapeer, Sanilac, Tuscola, Alcona, Iosco, Ogemaw and Oscoda counties.

That parallels the experience of Dr. Liam Sullivan, an infectious disease specialist at Spectrum Health in Grand Rapids: Countless patients with complications from COVID and very few with complications from the vaccine.

“There’s just no comparison at all,” Sullivan said. “We’ve had how many thousands of (hospital) admissions for COVID-19, and probably less than 10 admissions for some (COVID) vaccine-related thing, I would guess.”[Source]

The problem of coincidence

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. [Source]

The coincidence factor is especially important when, as is the case with the COVID vaccine, so many people are being vaccinated in a relatively short period of time.

As an example, an estimated 2,400 Americans die a day from a heart attack or stroke. With 364 million doses of vaccine administered so far, it’s inevitable some people had fatal strokes or heart attacks shortly after getting a COVID shot. The challenge for VAERS officials is determining whether vaccines increase the probability of those deaths. [Source]

What about studies that have found under-reporting to the VAERS system?

Electronic Support for Public Health – Vaccine Adverse Event Reporting System

Download from here.

Critique: “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.” [Source]

Also: The Reporting Sensitivities of Two Passive Surveillance Systems for Vaccine Adverse Events

I skimmed through this article which made a lot of sense, overall. [I’m not going to summarise it – but recommend everyone read it; for without it my summary conclusion won’t make sense].

This comments on the article is important:

“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” yet you fail to give the denominator for other vaccines. For the Flu alone the number exceeds 250 million for last 3 years and death rate is much much lower. Deaths reported per 100,000 doses comparison would be interesting.

This tells me that there is a strong chance that deaths from covid vaccines are much higher than that for the flu vaccine.

However, the possible coincidence of a death with a vaccine is so high that we can’t possibly assume that all deaths reported in VAERS are from the vaccine. I’d say there is strong over-reporting of deaths in the database – maybe around 20% of the deaths are from the vaccine, but definitely not 50% or more.

What about this paper by Jessica Rose and Mathew Crawford?

https://downloads.regulations.gov/CDC-2021-0089-0024/attachment_1.pdf

I’ve skimmed through this paper and find it to be extremely shoddy with some pretty wild assumptions (which lead to an absolutely absurd conclusion).

Exceptional and otherwise rare events like hospitalisation due to myocarditis are generally reported broadly correctly from what I have cited above.

The claim by Rose and Crawford that “We think that anaphylaxis is an excellent proxy for a serious adverse event that, like a death, should always be reported so we think 41X is the most
accurate number” is problematic for two reasons

a) The estimate of 41 times under-estimation of anaphylaxis is probably off by an order of magnitude.

The JAMA paper that is cited states: “Anaphylaxis was confirmed in 16 employees. … One patient was admitted to intensive care, 9 (56%) received intramuscular epinephrine … All individuals with anaphylaxis recovered without shock or endotracheal intubation.

The 2.47 serious anaphylaxis cases per 10 000 vaccinations (from the JAMA paper) that Rose and Crawford use includes only one ICU admission. That was probably serious enough to make the person/carer put in the effort to lodge a VAERS report. For the rest of them, the anaphylaxis event was likely short-lived and not considered serious enough to report in VAERS. Maybe there is 4-5 times under-reporting of anaphylaxis but not 41 times – such an estimate would be somewhat consistent with prior VAER studies over the past many years. The 41 times is outlandish.

b) Such events cannot be used to estimate the reliability of VAERS for death.
Death after a vaccine is a HUGE event and many carers/relatives can jump to the conclusion that it was linked to the vaccine when it was not (the coincidence issue). They may feel strongly enough to lodge a VAERS report – leading to over-reporting.

In some other cases, the opposite might happen – that the vaccine was the direct cause of death but the associated people assume that something else caused it. Doctors/health providers need to undertake a lot of paperwork to prove causality – and they might be better off not recording the event – leading to under-reporting.

The Rose and Crawford methodology can’t be used to assess deaths. We need detailed autopsies of anyone who dies within, say, 28 days of a vaccine. I don’t think such things happen for any vaccine.

In sum, VAERS data do not provide any meaningful estimates for deaths from vaccines. It would be madness to multiply the VAERS deaths by 41 to estimate actual deaths. Even using the VAERS deaths data directly as a true estimate is fraught. We need autopsies of anyone given a covid vaccine who then dies within 28 days.

What about reports from nursing homes?

There have been sporadic reports of deaths caused by vaccines in nursing homes. Unfortunately we don’t have any published papers on this matter – just one or two newspaper reports and a lot of hearsay from “insiders” who never disclose their identity.

I’m assuming some of these would have been reported in VAERS – and some genuine ones not reported. The problem is there are very small numbers involved for individual nursing homes so we will never be able to conclusively say something about such deaths, either.

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Sanjeev Sabhlok

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