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Doctors who should know better dumpster dive in VAERS

“Dumpster diving” is a term used to describe studies using data from the Vaccine Adverse Events Reporting System database by authors, almost always antivaxxers, who don’t understand its limitations. Last week, non-antivax doctors who should know better fell into this trap when they promoted their study suggesting that COVID-19 mRNA vaccines are more dangerous to children than the disease.

I’ve been writing about how antivaxxers misuse the Vaccine Adverse Events Recording System (VAERS) database dating back to very early in my history as a blogger. VAERS, for those unfamiliar with it, is a database to which anyone can report any adverse event (AE) noted after vaccination. It serves as an early warning system that can generate hypotheses regarding correlations between specific AEs and vaccines, but by its very design cannot test these hypotheses. (I’ll explain in detail later in this post when I discuss the shortcomings of VAERS.) Indeed, out of curiosity, I did some searching of all of my blogs and discovered that the first time that I mentioned VAERS and its shortcomings here was on the old Blogspot version of the blood back in 2005 in the context of a discussion of chelation therapy for autism. Because of its very nature, VAERS is prone to misunderstanding and misuse, and, unsurprisingly, VAERS has become a favorite tool of antivaxxers to claim that vaccines cause whatever AE on which they want to blame vaccines. That’s why, over the years, we’ve mentioned VAERS on many times, and I’ve mentioned it elsewhere many times going back to 2005.

A week and a half ago, VAERS was in the news, and for once it wasn’t because of antivaxxers abusing it. Unfortunately, that makes the misuse of the database all the more potentially damaging. You see, there was a study published as a preprint last week, and it’s being held up as “evidence” that vaccinating 12-17 year olds against COVID-19 is more dangerous than COVID-19 because of post-vaccination myocarditis. It goes along with a common refrain that a lot of physicians who really should know better have been repeating without context and, sadly, even though they are not antivaccine need to be fact-checked as though they were, namely the false narrative that masks and vaccines to mitigate the spread of COVID-19 are at best useless in children or even worse than the disease.

In adding to this refrain, this study contributes material to the antimask and antivaccine movement and falls prey to the same sorts of gross errors observed in studies done by antivaxxers using VAERS data. In this post, in addition to my own observations I’ll cite problems pointed out by others on social media with more expertise than I in the nitty-gritty of these sorts of analyses, to complement my knowledge of VAERS. I will begin by describing how this study is being spun, continue to discuss the history and structure of VAERS, which is absolutely essential to understand why this study is so bad, and then finish by delving into the study itself, using the analysis to make some observations.

Doctors who should know better stumbling through VAERS

As many times as I’ve seen antivaxxers misuse VAERS to try to blame vaccines for autism, sudden infant death syndrome, infertility, and more, I must admit that I was unprepared and profoundly disappointed late last week to see the database abused in a similar fashion by investigators who are not antivaccine (although definitely biased) and then to see their bad science amplified in stories like this one in The Guardian by its science editor Ian Sample (who really should know better), titled “Boys more at risk from Pfizer jab side-effect than Covid, suggests study“:

Healthy boys may be more likely to be admitted to hospital with a rare side-effect of the Pfizer/BioNTech Covid vaccine that causes inflammation of the heart than with Covid itself, US researchers claim.

Their analysis of medical data suggests that boys aged 12 to 15, with no underlying medical conditions, are four to six times more likely to be diagnosed with vaccine-related myocarditis than ending up in hospital with Covid over a four-month period.

Most children who experienced the rare side-effect had symptoms within days of the second shot of Pfizer/BioNTech vaccine, though a similar side-effect is seen with the Moderna jab. About 86% of the boys affected required some hospital care, the authors said.

This study actually suggested nothing of the sort, for reasons that I will explain. In fairness, though, let’s see what the study’s first lead author had to say last week when the study first hit the preprint server medRxiv:

No, I don’t think that Dr. Tracy Høeg (or any of the other authors) is antivaccine. However, it is very clear that she and her co-authors are completely out of their depth here and do not understand how VAERS works, even though Dr. Høeg, a sports and spine medicine specialist, does also have a PhD in Epidemiology and Public Health from University of Copenhagen. She really should know better, but this study demonstrates that she does not, as I will show. As for the rest of the authors, Allison Krug is also an epidemiologist who, again, really should know better, while Dr. John Mandrola is an adult cardiologist with a definite axe to grind who bills himself as a “medical conservative”. As for Josh Stevenson, I had never heard of him before this.

After the original version of this post had been published, I later discovered that Stevenson is a member of the team behind Rational Ground. I have therefore added this addendum, plus some additional Tweets below about this. A brief perusal of Rational Ground website reveals a group dedicated to minimizing the severity of COVID-19 and resisting mask mandates and lockdowns, and his Twitter feed is consistent with that. Interestingly, his Twitter bio does not list his affiliation with Rational Ground, almost as though he didn’t want anyone to know it. Indeed, a Google search of his name plus “COVID” doesn’t bring it up in the first three long pages of results. (Maybe he’s embarrassed, or maybe he doesn’t want people citing his work to be aware of his bias.) Interestingly, no one on the Rational Ground team appears to have anything resembling the necessary expertise to analyze COVID-19 data, including Stevenson, who describes himself as a “data visualization expert who focuses on creating easy to understand charts and dashboards with data” whose “background is in computer systems engineering & consulting, and his Bachelor’s degree is in Audio Engineering.” Quelle surprise.

Unfortunately, even though it’s a preprint that has not yet been peer-reviewed, it’s been picked up by the usual suspects and amplified on social media. For example, Dr. Jay Bhattacharya was ebullient:

Bhattacharya clearly understands VAERS as well as the authors of this paper (i.e., not at all); otherwise, he would not have said anything quite so cringe-inducingly wrong. On the other hand, he is one of the main signatories of the Great Barrington Declaration, which advocated basically doing nothing about the pandemic other than “focused protection” of the “vulnerable,” apparently blissfully unaware that it’s impossible to protect the vulnerable if COVID-19 is spreading unchecked through the entire population.

Dr. Vinay Prasad was even more enthusiastic:

I would hardly call these authors a “dream team” (especially Josh Stevenson, who has no requisite expertise to help carry out such an analysis). I will, however, admit that, unlike Dr. Prasad’s previous characterization of combatting health misinformation as LeBron James “dunking on a 7′ hoop,” deconstructing this paper is a little harder, maybe like dunking on an 8′ hoop, simply because it requires a detailed explanation of how VAERS works and why it can’t be used to do what the authors used it for. I also can’t help but note that Dr. Prasad is well-known for demanding more rigorous data for various medical interventions, such as masking to slow the spread of COVID-19. Yet on this topic, he seems quite happy with a low-quality study that misuses the VAERS database.

Worse, as was pointed out a week ago, the rapidity with which this preprint study made it into major news outlets of a certain ideological bent reeks of astroturfing:

More on that last part later. In the meantime, unsurprisingly, antivax politicians were weaponizing this preprint study:

Let’s dig in and explain what’s wrong with the study. Before I dig into the weeds of the study, its methodology, and its conclusions, though, a brief history of VAERS is necessary to provide context. If you’re already very familiar with VAERS, its proper uses, its weaknesses, and how it’s been misused by antivaxxers, you can probably skip the next section, although you might still at least want to skim it.

A brief history of VAERS and why it is not a reliable data source

VAERS is a bit of an odd beast when it comes to vaccine safety reporting systems. It was established jointly by the FDA and CDC in 1990 as an outgrowth of the National Childhood Vaccine Injury Act of 1986 and was intended as an “early warning system” or, as I like to call it, a “canary in the coalmine”. To accomplish that function, the CDC and FDA designed VAERS as an open system that allows anyone to enter any suspected AE after vaccination. It’s also an open system in that the data are freely available on the VAERS website to search for reports of AEs after vaccination. Anyone can do it. (I have.) Unfortunately, seemingly everyone has, whether they understand VAERS or not.

According to the CDC, the objectives of VAERS are to:

  • Detect new, unusual, or rare vaccine adverse events;
  • Monitor increases in known adverse events;
  • Identify potential patient risk factors for particular types of adverse events;
  • Assess the safety of newly licensed vaccines;
  • Determine and address possible reporting clusters (e.g., suspected localized [temporally or geographically] or product-/batch-/lot-specific adverse event reporting);
  • Recognize persistent safe-use problems and administration errors;
  • Provide a national safety monitoring system that extends to the entire general population for response to public health emergencies, such as a large-scale pandemic influenza vaccination program.

However, there are a lot of caveats, as you can see from the CDC’s own description of VAERS:

Established in 1990, the Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.

VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern.

Then there’s this disclaimer:

VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. 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. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.

The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.

In brief, the key strength of the VAERS database is its open nature, which allows instantaneous reports from anyone, health provider or lay person, which in turn provides the data for rapid hypothesis generation. However, the key weakness of the VAERS database is also its open nature, which can lead to bias and the inclusion of incomplete, inaccurate, coincidental, and unverified information. Indeed, let’s go back to my first mention of VAERS in 2005, which I wrote after learning about a now-famous anecdote from James Laidler:

The chief problem with the VAERS data is that reports can be entered by anyone and are not routinely verified. To demonstrate this, a few years ago I entered a report that an influenza vaccine had turned me into The Hulk. The report was accepted and entered into the database.

Because the reported adverse event was so… unusual, a representative of VAERS contacted me. After a discussion of the VAERS database and its limitations, they asked for my permission to delete the record, which I granted. If I had not agreed, the record would be there still, showing that any claim can become part of the database, no matter how outrageous or improbable.

Since at least 1998 (and possibly earlier), a number of autism advocacy groups have, with all the best intentions, encouraged people to report their autistic children—or autistic children of relatives and friends—to VAERS as injuries from thimerosal-containing vaccines. This has irrevocably tainted the VAERS database with duplicate and spurious reports.

Laidler’s example is not the only one. In 2006, in response to a lot of commenters crying “BS!” after having read about Laidler’s anecdote, another autism advocate also known for combatting antivaccine misinformation then decided to see if he could replicate Laidler’s experience. He could:

VAERS has two ways of submitting a report. Firstly, you could download a PDF, fill it in and post it off. Or, you could do what I elected to do and fill in and submit a report online.

VAERS has a helpful popup which tells you exactly what it needs to know – which are the most important pieces of data it needs. However, the fact that I live in the UK was not deemed of importance. Neither was the fact that I told VAERS that my daughter had been turned into Wonder Woman. The only piece of contact data I submitted was my email address and I wasn’t even asked for that. I submitted it voluntarily.

As Jim Laidler himself once put it:

You see, the VAERS database is not a good source of material for any epidemiological study, a fact acknowledged by the very people who maintain it. The purpose of the VAERS database is to act as a repository for any complications following a vaccination. These complications may be due to the vaccines or may be coincidental, but the VAERS team wants to hear about them all. After all, their purpose is to watch for any unexpected consequences of vaccinations.

This is a statement that, I hope, answers the question that I’m sure many of you have: Why on earth would the CDC and FDA maintain such a flawed database in the first place? I also like to note that, whatever the merits or lack thereof in maintaining a database like VAERS, contrary to the way it is portrayed by antivaxxers, VAERS is by no means the be-all and end-all of vaccine safety monitoring. Antivaxxers love VAERS because its flaws make it easy to use to produce seeming correlations between vaccines and autism (and all the other things they blame vaccines for), but there are other systems that are active surveillance systems, such as the Vaccine Safety Datalink (VSD) and the Clinical Immunization Safety Assessment (CISA) project. These are two of the systems used to test the hypotheses generated by VAERS.

That same year, I discussed how attorneys suing vaccine manufacturers for “vaccine-induced” autism (never mind that vaccines do not cause autism) had gamed the VAERS database for litigation purposes by encouraging their clients to submit reports of autism as an AE after vaccination, thus hugely distorting the database. At the time, I noted how this feature of VAERS makes it inherently unreliable for as a tool for longitudinal studies of the rates of vaccine-related AEs. Regular readers will remember how I keep harping on “baseline rates” of AEs (the rate that would occur in the absence of vaccination). The problems with all studies of VAERS are that there is no “control group” and there is no way of knowing whether the sample in VAERS is a representative one. (In fact, it certainly is not.)

That’s why those of us who’ve written about VAERS like to refer to studies like this as “dumpster-diving” or “garbage in, garbage out”. True, I didn’t invent the term “dumpster diving” to describe these VAERS studies, but I have used it to describe various misuses of VAERS, starting with the father-son duo of Mark and David Geier’s dumpster dive for autism in 2006, followed by other examples like:

There are more examples, of course. Unfortunately, in the age of the COVID-19 pandemic, those of us familiar with this history of VAERS warned that antivaxxers would weaponize the database to blame all sorts of complications on COVID-19 vaccines. Nobody listened. Unfortunately, it has come to pass, as I’ve discussed multiple times on this blog, when antivaxxers have pointed to VAERS to try to blame the vaccine for a “holocaust” or even “depopulation” based on VAERS reports, something I documented as early as February, less than two months after the EUA for the Pfizer vaccine. Indeed, blaming the COVID-19 vaccines for thousands of deaths and a number of other complications based solely on their own analysis of VAERS data is a prominent feature of antivaccine arguments, to the point that Robert F. Kennedy, Jr. maintains a weekly update of fear-mongering VAERS reports.

Into this history boldly strode Høeg et al. It did not go well.

Dumpster-diving for myocarditis

So let’s circle back to the study (“SARS-CoV-2 mRNA Vaccination-Associated Myocarditis in Children Ages 12-17: A Stratified National Database Analysis“) by Høeg et al., who fall prey to the same sorts of missteps in analyzing VAERSas the Geiers, Seneff, Goldman, Miller, and a depressing array of antivaxxers during the 17 years I’ve been blogging and, I’m guessing, before. Things go very wrong right from the first sentence of the abstract that describes the objectives of the study as:

Establishing the rate of post-vaccination cardiac myocarditis in the 12-15 and 16-17-year-old population in the context of their COVID-19 hospitalization risk is critical for developing a vaccination recommendation framework that balances harms with benefits for this patient demographic.

And, near the end of the introduction:

Our primary aim was to stratify post-mRNA vaccination myocarditis by age and vaccination dose within the 12–17-year-old population. Our secondary aim was to provide an updated estimate to complement the CDC’s [2,3,6] and FDA’s [4] findings. Our final aim was to perform a harm-benefit analysis of mRNA COVID-19 vaccination myocarditis with that of COVID-19 hospitalization for children with and without one or more comorbidity at low, moderate, and high 120-day COVID-19 hospitalization rates.

I was half-tempted just to stop right here, throw my hands up, do a dramatic facepalm, and rant that you can’t do this with just VAERS data, much less compare your VAERs-estimated risk of myocarditis between age groups and thencompare that risk to the risk of hospitalization from COVID-19 and leave it at that. (I know. You can do it, but you’ll end up with unreliable results, because by its very nature VAERS does not allow for an accurate estimate of the frequency or incidence of any given AE after vaccination using its public-facing data.) All VAERS can do is to detect potential safety signals that require other monitoring systems to determine if these signals are spurious or represent real correlation and causation by the vaccine. (After all, what have I just spent something like 2,500 words discussing in the context of the history and design of VAERS?) However, I suspect that the authors would become very offended and indignant and then argue that they can indeed do such a thing, pointing to their methods. That leaves me little choice but to go into the weeds of their methods, as noxious as those weeds are. Also, they will point out that the CDC itself has used VAERS data to estimate this frequency, which is true but incomplete and misleading.

That brings me to another point, just as important. Why on earth did these investigators basically repeat the analysis that the CDC and FDA did for a recent meeting of the Advisory Council on Immunization Practices (ACIP), only without all the extra data that ACIP has? Inquiring minds want to know:

Exactly. Unlike Høeg et al., ACIP had access to data adjudicated by investigators at VAERS and the CDC to determine if the AE actually happened and to assess the likelihood that it might have been due to the vaccine. ACIP also had access to up-to-date data from VSD, a far more reliable source. So I echo Dr. Freedman’s sentiment: What on earth did the authors hope to accomplish by, in essence, repeating that analysis, but with unadjudicated and much less complete data? Choosing to do this suggests an ideological bias, that the authors didn’t believe the CDC, FDA, and ACIP. I don’t expect everyone just to take the word of ACIP that its analysis is the be-all and end-all on this question, but a measure of humility is called for. As Dirty Harry once said, “A man’s got to know his limitations”, and the Høeg et al. clearly did not know their limitations or the limitations of the dataset they chose to use. That it was open, convenient, and easily accessible does not excuse them, particularly given that they could have requested the adjudicated dataset:

They could also have gotten access to VSD data. All that’s required is a written protocol approved by an institutional review board (IRB). They did not, which leads to these questions:

And an observation:

Did the authors’ biases lead to this analysis? Who knows? I just know that the result is definitely not good, and the involvement of Josh Stevenson in particular makes this whole study very suspect indeed.

In any discussion of using VAERS data for anything, the search strategy is all, because in any epidemiological study case ascertainment is all. Høeg et al. make a big deal about aligning their inclusion criteria “with the CDC working case definition for probable myocarditis” and “same objective findings of cardiac injury used by the CDC to identify probable cases”, but their search strategy is rather broad:

We searched the Vaccine Adverse Event Reporting System (VAERS) data for females and males ages 12-17 in reports processed from 1/1/2021 through 6/18/2021 with diagnoses of “myocarditis,” “pericarditis,” “myopericarditis” or “chest pain” in the symptom notes and required the term “troponin” in the laboratory data. We defined a CAE using the CDC working case definition for a probable case.[2] Specifically, the symptom of “chest pain” required at least one of the following: diagnosis of myocarditis, peri- or myopericarditis, acute myocardial infarction; elevated troponin; abnormal electrocardiogram (EKG), abnormal echocardiogram (ECHO), or cardiac MRI (cMRI) findings consistent with myocarditis (as defined in Supplement 1). Cases and hospitalizations with an unknown dose number were assigned to dose 1 or dose 2 in the same proportion as the known doses: 15% occurred following dose 1 and 85% occurred following dose 2.

I was also unclear about this:

To compute crude rates per million for doses 1 and 2, our denominators included all children with at least 1 dose of any vaccination and all fully vaccinated children, respectively, as of 6/11/2021[6] to accommodate both reporting lag and a pre-defined 7-day risk window, consistent with the CDC’s analysis.

How can you use all children with at least one dose of any vaccination, given that the only vaccine that a child 12-17 years old can get is the Pfizer vaccine, given that the Moderna vaccine has not been granted an emergency use authorization (EUA) for persons under 18? Also, the Pfizer vaccine wasn’t granted an EUA for the 12-15 year age group until May 10, meaning that any data before that could only apply to 16-17 year olds, who were included in the original Pfizer EUA in December. Thus, for the 12-15 year group, this study only analyzed about five weeks’ worth of data. Surely the analysis could have been carried out to a more recent date, given that VAERS is updated weekly. Moreover, these data all apply largely to before the delta variant took off in the US to become the dominant variant driving infections. Remember, Delta is much more infectious than the original SARS-CoV-2, the coronavirus that causes COVID-19, and that changes the equation markedly. In other words, even if these data turn out to be valid (doubtful), they’re already hopelessly out of date.

This method of case ascertainment immediately led to major criticism from pediatricians, and one pediatric cardiologist in particular by the name of Dr. Frank Han:

Dr. Han also wrote a guest post for one of my favorite blogs discussing this issue, as did Dr. Dan Freedman. For more information, I also refer you to this Twitter thread by another pediatric cardiologist, Dr. Jennifer Huang, who acknowledges that the possibility of myocarditis after vaccination is a scary one for parents. (No one, least of all I, claim otherwise.) She then notes:

Those questions aside, Høeg et al. reported this about cardiac adverse events (CAEs) after COVID-19 vaccination from their analysis:

A total of 257 CAEs were identified. Rates per million following dose 2 among males were 162.2 (ages 12-15) and 94.0 (ages 16-17); among females, rates were 13.0 and 13.4 per million, respectively. For boys 12-15 without medical comorbidities receiving their second mRNA vaccination dose, the rate of CAE is 3.7 to 6.1 times higher than their 120-day COVID-19 hospitalization risk as of August 21, 2021 (7-day hospitalizations 1.5/100k population) and 2.6-4.3-fold higher at times of high weekly hospitalization risk (7-day hospitalizations 2.1/100k), such as during January 2021. For boys 16-17 without medical comorbidities, the rate of CAE is currently 2.1 to 3.5 times higher than their 120-day COVID-19 hospitalization risk, and 1.5 to 2.5 times higher at times of high weekly COVID-19 hospitalization.

In the discussion, Høeg et al. add:

Our post-second-dose-vaccination rates of CAE among adolescent boys aged 12-15 was 162.2/million which exceeded the rates reported by the CDC[2,6] by 143-280% (2.4-3.8 times). Among boys age 16-17, our estimate was 94.0/million, 31.5-41% higher than the CDC estimate. For girls 12-15 years old, our rate was 13.0/million, which was 43-100% higher that the CDC’s estimate.[2,6] Among girls 16-17, our estimate was 13.4/million, which was 47-65% higher than the CDC’s estimate.

I wonder why that might be…

In search of an answer, it didn’t take long for people to notice that there are some rather…questionable…cases included in the analysis by Høeg et al., as Dr. Freedman notes about COVID vaccine associated myocarditis (C-VAM):

The authors claim to use the same methodology as the ACIP review but a brief review raises some suspicions. VAERS ID 1345283 describes a teen with chest pain and right axis deviation on EKG. The report states “no clear diagnosis but a suggestion that it sounded clinically like a viral pericarditis”. Right axis deviation is not one of the criteria used by the ACIP to determine cases of myocarditis or pericarditis (see Table 1). This is the problem with just plugging in search terms (“troponin”, “myocarditis”, etc) to VAERS and not thoroughly reviewing cases. As Ryan Marino said, “this is like thinking that a search for ‘gunshots’ on NextDoor is a way to track gun violence”.

The most glaring examples of cases that were not reviewed in detail by Hoeg et al are the cases with a comorbid infection. This represents a significant confounding variable which makes it impossible to discern with such limited data if the myocarditis was due to the vaccine or the intercurrent illness. VAERS ID 1334617 describes a positive SARS-CoV-2 PCR and VAERS ID 1361923 describes a rhinovirus/enterovirus positive PCR. The authors also include a report of a patient with EBV-positive PCR, serologies pending. These cases were likely excluded by ACIP due to these confounders.

There are other notable cases like VAERS ID 1382338 where the patient is described as encephalopathic to the point of needing intubation for airway protection. Is this a case of C-VAM or a viral infection causing both encephalitis and myocardial injury? VAERS ID 1386269 describes a patient with difficulty walking due to neurological weakness. No mention of any cardiac diagnosis. These cases were likely excluded by ACIP due to incomplete information.

On Twitter last night, Max Kennerly looked at even more:

In the comments after the preprint, Dr. David Goldberg notes:

Although the scientific question that is being address is an important one, I have concerns about the methodology used to adjudicate the outcome. In similar circumstances (e.g., the FDAs Mini-Sentinel Initiative), complex clinical outcomes like this (e.g., acute liver failure) were adjudicated independently by two experts, with a third person serving to break any ties. That seems not to have been done in this study, as there was only one cardiologist involved. Secondly, the clinical data to adjudicate the outcome of myocarditis seems to be insufficient in many cases. Although one could argue “this is the best data we have” sometimes that is not good enough. When the question is so important and politically charged, incomplete/invalid data is sometimes worse than no data. Unless the authors can have two-party adjudication with record review, and classification using standard techniques (e.g., definite vaccine-induced myocarditis, highly likely, probable, possible, not) then there are major methodological concerns with the outcome, and the overall validity of the study.

In fairness, this sort of analysis is difficult—maybe even impossible—to accomplish using VAERS data. Indeed, it is impossible to accomplish using unadjudicated data from VAERS, as Høeg et al. did. However, I like Dr. Goldberg’s point about how incomplete and invalid data can be worse than no data. Moreover, it is not difficult to see how analyzing adjudicated data, as imperfect as such data also are, would come much closer to this ideal than the analysis by Høeg et al.

The most pertinent question of all, however, comes from Roger Sehault:

Why did you choose to compare vaccine related CAE with COVID hospitalizations? Why not compare Vaccine related CAE with COVID CAE? Are we comparing apples to apples?

Why indeed? I’d also ask another question: Why did the authors not choose to compare vaccine-related hospitalizations (which could be gleaned from VAERS and the vast majority of which in children are for CAEs due to suspected myocarditis) with COVID-related hospitalizations?

Again, as many have pointed out, the clinical course of vaccine-associated myocarditis is benign, although frequently it does involve an overnight stay (or up to a few days’ stay) in the hospital for cardiac monitoring. Besides comparing apples to oranges, this sort of analysis makes vaccine-associated myocarditis sound more dangerous than the complications of COVID-19 in children. It leaves out important context that, even if its estimate of risk of myocarditis is valid (and, again, remember that VAERS by its very nature cannot provide a good estimate of any given vaccine AE), children are far more likely to die or suffer serious (and possibly life-long) complications from COVID-19. The authors acknowledge this (sort of) in the text of their study, but it’s buried in the discussion, almost as an afterthought. It’s context that is not in the abstract and therefore goes missing from all the news reports and social media posts touting this study as “scientific evidence” that children should not be vaccinated against COVID-19 because the vaccine is supposedly more dangerous than the disease. I will refer you to Jonathan Howard’s recent post in which he lists much of the recent evidence about COVID-19 vaccination in children. Spoiler alert: Although no one should take this potential AE lightly, thus far the short-term data has been consistently favorable for vaccinating individuals in the 12-17 year old age group.

VAERS: Graveyard of epidemiology (with rare exceptions)

The study by Høeg et al. is a striking example of what can happen when doctors wander into an area where they clearly lack basic critical knowledge, even doctors who are not antivaccine. After over 15 years of experience, I now expect antivaxxers to be tripped up dumpster diving in VAERS, but I do not expect it from investigators who are not antivaccine. Mea culpa. I was wrong this time. However this happened, hubris, bias, ideology, or whatever reason, Høeg et al. inadvertently did exactly the same thing antivaxxers have been doing for years: Dumpster diving in VAERS. They used better statistics than the usual antivaxxer, but the end result was the same. They should be embarrassed.

One very critical rule about research utilizing a database is that the investigators should have a strong understanding of its structure, purpose, and weaknesses. It is clear from this paper that Høeg et al. lacked an understanding of the purpose of VAERS, which is not as a database that can accurately estimate the incidence or prevalence of a given AE after vaccination. By its very design it can’t be used to do that, hence all the post-reporting adjudication and curating that go on behind the scenes at the CDC when analyzing VAERS data. The purposes of VAERS are safety signal detection and hypothesis generation. When reports of a certain AE after vaccination reach a certain threshold, there’s a safety signal, which leads the CDC to investigate first the hypothesis that the AE is actually associated with vaccination (this is where the vaccine-autism hypothesis consistently fails) and then, if there is a correlation, whether that correlation could be an indication of causation. Other databases, active surveillance system databases like the VSD and CISA, are required to test these hypotheses, because again – VAERS data are by the design of the database unsuitable for this purpose.

Surprisingly, given that I often disagree with him, one particular cardiologist gets it (mostly) right. After saying what I just said, that VAERS is only good for signal detection, not epidemiology, he notes:

This is basically where the data appear to be going. There’s a signal. It’s not yet clear how large the risk of myocarditis is in this age group. He also notes:

In fact, the dead giveaway, the aspect of this study that is the “tell” behind the authors’ purpose is that “apples and oranges” comparison between COVID-19 CAEs and hospitalization rates for COVID-19 itself. I didn’t really go into the analysis in this study of risk based on comorbidities given how the core structure of the study was so badly designed, but he’s also mostly correct about that. I would add, though, that comorbidities are important and do need investigation.

I’m sure I will anger some people with my conclusion. I don’t care. It needs to be said. The bottom line is this. This study is a dumpster dive whose only difference from what antivaxxers have been doing with VAERS since before I first started paying attention 17 years ago is that the statistics are better, but that isn’t saying much. However “provaccine” you might be (and I’ll take the investigators’ word that they are, in fact provaccine), when you find yourself doing the sort of poor quality analysis of VAERS data that antivaxxers have been doing at least since 2006, you really need to rethink your approach. Similarly, if you think that a low quality study like this that uses a database for a purpose for which it was never designed is a “bombshell” from a “dream team”, all while demanding ever more rigorous randomized trials for interventions like masking (I’m talking to you, Dr. Prasad, who now, ironically, while accusing critics of this preprint of “tribalism” now expresses a much less glowing assessment of it), you might want to think about the biases that led you to such inconsistency in your standards of evidence.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

88 replies on “Doctors who should know better dumpster dive in VAERS”

I’m confused by the tweet “For boys 12-17 without medical comorbidities, the likelihood of post vax dose 2 CAE is 162.2 & 94.0/million respectively. This… exceeds their expected 120-day COVID-19 hospitalization rate at both moderate (August 21, 2021 rates) & high COVID-19 hospitalization incidence”. Shouldn’t they be comparing AE rates to something more like 240-day COVID-19 hospitalization rate? The shot is supposed to last closer to 8 months isn’t it? So shouldn’t one compare vaccine risk to COVID risk over the period of vaccine effectiveness?

I’m in Australia, and there’s been an issue of political candidates dumpster diving in DAEN (Australia’s version of VAERS) here. One of my teachers from primary school shared with me a “73-page report from the TGA [Therapeutic Goods Administration, essentially our version of the FDA]” detailing all the adverse reactions. On closer inspection, it was actually just a copy-paste of adverse events listed in DAEN and disseminated by the United Australia Party, a fringe right-wing group who are against basically all COVID-19 measures. The adverse events listed included gems such as dandruff, “product lot number issue,” and my personal favourite, “intentional overdose.”

The disclaimer on the VAERS site also says “VAERS receives reports for only a small fraction of actual adverse events.” That means the 7,653 deaths reported to VAERS from the covid shots is more likely 76,530 deaths, or 765,300, or maybe 7,653,000. Even if you think a lot of those deaths were coincidental, that’s still a lot of deaths.

Just based on the numbers reported alone, more deaths have been reported to VAERS from the covid shots than from all other vaccines combined for the last 30 years. It’s not due to more vaccination–it’s due to much higher rate of deaths deported for covid shots. The question is the reason for the massive increase–not the limitations of VAERS, which have been around as long as VAERS has. https://www.bitchute.com/video/lohmbAzoYdfT/

The problem is the massive increase in deaths and other serious injuries reported to VAERS from the covid shots is being concealed from the public and from vaccine consumers. There’s nothing about how VAERS responded to the massive increase in deaths and serious injuries reported to VAERS from the covid shots; whether VAERS generated any hypotheses about it and whether those hypotheses were tested. One ACIP study in January said VAERS didn’t detect any problems–which seems unbelievable–but apparently we’re supposed to blindly believe in Bayesian Voodoo, researchers who conceal the massive increase in VAERS reports; and blog authors with a deep devotion to vaccination.

Yeeeeesssss. There’s been over seven million extra deaths that have somehow escaped detection. What’s that, two percent of the entire population of the US? I realise that you might not have a sense of proportion but you must have a calculator. If you want to convert people to your cult then I suggest you make your statements digestible. The only people you’re dog whistling there are already in the church.

The sad thing is, these people are so far gone into Conspiracyland that the idea that there are millions or hundreds of thousands of deaths from closely watched vaccines that nobody noticed might seem credible to them.

Pfizer made $19 Billion in Q2 this year, or $211 million per day. Some risks of their jab are blood clots & cardiomyopathy. Luckily they make Eliquis for treating blood clots – sales up 13% They also make Vyndaqel to treat cardiomyopathy – sales are up 77% So Pfizer is making money on both sides.

From the CBS interview of Dr. Gottlieb very interesting.

“there was a perception early on in this crisis that the CDC has this, that they would have the capacity to develop a diagnostic test and deploy it and gather the data that we would need and do the analytics to try to gauge, you know, sort of scope out what the contours of the response would be, and they would be able to deploy the diagnostic test and deploy the vaccine and stand up this infrastructure….. (the CDC) there were a lot of policymakers who assumed that they would be able to complete this mission and wrongly assumed what their capabilities were. Now, CDC should have raised their hand and said, we really don’t have this.”

“The initial recommendation that the CDC brought to the White House … was 10 feet, and a political appointee in the White House said we can’t recommend 10 feet,” he said. “Nobody can measure 10 feet, it’s inoperable, society will shut down. So the compromise was around six feet,” …..Probably the single costliest recommendation that CDC made that you had to maintain six feet of distance that wasn’t based on good judgment and good science”

So the single reason why most schools remained shut was because the CDC was telling them they had to keep kids six feet apart. If- if CDC had said you can only- you have to keep kids three feet apart, then a lot of schools would have been able to open. And in fact, when the Biden administration wanted to open schools in the spring, this past spring, they got the CDC to change that guidance from six feet to three feet.

“But when it became three feet, the basis for the CDC’s decision to ultimately revise it from six to three feet was a study that they conducted the prior fall. So they changed it in the spring . They had done a study in the fall where they showed that if you have two masked individuals, two people wearing masks, the risk of transmission is reduced 70 percent with masks if you’re three feet apart. So they said on the basis of that, we can now make a judgment at three feet is an appropriate distance. Which begs the question, if they had that study result in the fall, why didn’t they change the advice in the fall? Why did they wait until the spring?”

“This is how the whole thing feels arbitrary and not science based. So we talk about a very careful, science based process and then these anecdotes get exposed, and that’s where Americans start to lose confidence in how the decisions got made.”

“Pfizer made $19 Billion in Q2 this year, or $211 million per day. Some risks of their jab are blood clots & cardiomyopathy. Luckily they make Eliquis for treating blood clots – sales up 13% They also make Vyndaqel to treat cardiomyopathy – sales are up 77% So Pfizer is making money on both sides.”

Bad move, Pfizer.

They should’ve stayed away from vaccine development and instead enjoyed greater profits from selling drugs to treat cardiovascular complications of Covid-19.

“COVID-19 can result in systemic inflammation, multiorgan dysfunction, and critical illness. The cardiovascular system is also affected, with complications including myocardial injury, myocarditis, acute myocardial infarction, heart failure, dysrhythmias, and venous thromboembolic events.”

http://ncbi.nlm.nih.gov/pmc/articles/PMC7165109/

Lots of $$$ in selling meds to treat those ailments.

But dead Covid-19 patients don’t need medicines at all. So that would be bad for business.
So I suppose that is why they created vaccines, to prevent people dieing from Covid-19.
A really cunning plan. (tongue firmly placed in cheek).

“They should’ve stayed away from vaccine development and instead enjoyed greater profits from selling drugs to treat cardiovascular complications of Covid-19.”

On this RI, someone posted that the drug companies only made a few cents profit from the vaccines. But Pfizer going to make more profit from the vaccine than all the other drugs they market.

Look at one company Moderna it was only started in 2010, it basically had no assets and had produced no other vaccines (but was given 25 million from DARPA (that alone should worry people) for research into RNA therapeutics). The head of the company resigned (of course keeping his stock and options) and went to work for “operation Warp Speed”. Moderna was then given 483 million dollars for the research by ‘operation warp speed’, it’s now worth over 7 billion dollars

Before Covid and their vaccine Moderna was a below 50 dollars a share stock now its is a 450 dollar stock, not bad in 18 month

Of course that’s nothing compared to the 9 new billionaires that were created at Pfizer because of the vaccine.

Why stay away from vaccines??? They are making lots of money from the vaccine and when their vaccine makes people sick or people just get sick from long term effect of Covid (even if those people got the vaccine) they get to make even more money.

It’s a win – win – win for them.

Stock market gains are paid by people who pay the stocks, not customers. You should make difference between profit and revenue, too.
Yep perhaps one should have make better deal with Pfizer. Trump is a quite bad businessman, gone bankrupt multiple times, perhaps this is an explanation.

Julian

https://s21.q4cdn.com/317678438/files/doc_financials/2021/q2/Q2-2021-PFE-Earnings-Release.pdf

“Second-Quarter 2021 Revenues of $19.0 Billion, Reflecting 86% Operational Growth; Excluding BNT162b2(1), Revenues Grew 10% Operationally to $11.1 Billion”

(with covid vaccine 86% operational growth, without covid vaccine only 10% growth)

revenues (millions)
vaccines 9,234
oncologyu 3,145
internal medicine 2,403
hospitals 2,259
iflammation & immunology 1,041
rare disease 895

total revenue 18,977

page 5 and 6 for the a drop in sales most drugs pfizer makes

Aarno read the report on Pfizer for earnings/profit. And thanks for the information that people buy stocks, not customers.

Pfizer was not given any money by the US for R& D and Trump only paid 19.50 per dose for Pfizer, and about 15 dollars for Moderna. (Germany funded the Pfizer and got a better deal, as the US funded Moderna and got a better deal from them. Most other countries paid in the 40 – 50 dollar range some paid less if they were willing to wait longer for the vaccine..

Biden administration is negotiations with drug companies over booster shot price, so will see on that price.

https://www.the-sun.com/news/3049901/how-much-does-pfizer-covid-vaccine-cost/

Ah yes, VAERS. The vaccine adverse response event notification system. The one that seems to have an up to 90% under-report rate for initial adverse response events and which is very bad at catching long term vaccine adverse response events. According to the published literature. But its all we have..

OK, lets looks at the real data for the vaccines in question. From the 505(b)1 clinical trials from the standard approval timeline for new delivery type vaccines. The four to six year timeline data. Oops, does not exists. Because of EUA. OK, lets looks at the accelerated Phase I/II clinical trials data for say BNT162b2. Well you can only get that data if you are acceptable to Pfizer and they have final say on what you do with that data. And as the placebo control group was abandoned very early in the trials that makes any substantive data analysis questionable.i.e. wrong.

So if I understand it correctly we have an article here lambasting people for using low quality data while at the same time accepting unconditionally it seems claims made on what is no quality data. What is little more than science by press release. Yeah, thats a convincing argument.

Well I have been reading VAERS cases since last December, know that math (unlike most bio science people it seems) and know how to the one valid comparison, with other vaccines recorded by the same system, and compared with 505(b)1 trial results data for previous failed mRNA and adenovirus vaccines candidates. Not the published papers that try to put a good gloss on the failure. The actual data.

What VAERS does show is around a 200X times adverse response event rate over the one other mass use vaccines, for influenza. And a pattern of adverse response events that is very similar to other vaccine candidates that were abandoned during 505(b)1 approval trials due to very high adverse event rates. I’m looking at the PSI/PORT numbers, I do not see even close to a 200x mortality risk form SARs CoV 2 against Influenza.

So I will take dumpster diving science over science by press release or straight up Cargo Cult Science any day. Those of us in the hard sciences always knew that the bio-science and especially the social science people could not do math. But by this stage everything involving SARs CoV 2 that is part of the official narrative is verging on pure Lysenkoism. Lysenkoism by people who do not seem to understand the math they are using.

One thing I have learned for reading the individual VAERS cases is just how many of the old people recorded as adverse event mortalities had Alzheimer’s or dementia. Last time I looked it was above 20%. There was no informed consent given for those particular vaccinations. For a vaccine under a EUA.

I am trying to understand your post.

The site you linked to, Vaxopedia is a blog post by a pediatrician. He is the one that wrote the article and dismissed the Harvard study as an old study about drug reactions
“The original claims for under-reporting to VAERS were based on an old study about drug reactions”

Ok fine the study was 11 years ago and vaers has improved, the blog post was from 2 years ago (before covid).

But in researching the actual research listed, under SCOPE

“To create a generalizable system to facilitate detection and clinician reporting of vaccine adverse events, in order to improve the safety of national vaccination programs.”

and under Purpose

“This research project was funded to improve the quality of vaccination programs by improving the quality of physician adverse vaccine event detection and reporting to the national Vaccine Adverse Event Reporting System (VAERS), via the following aims:”

https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf

Vaxopedia is using misinformation or misdirection in it’s post, by claiming it was a study about drug reactions when it was a study about vaccine adverse events.
and offers no evidence or research on the number of adverse events happening.
“People who fail to regard the truth seriously in small matters, cannot be trusted in matters that are great.”

But setting that aside.

VAERS own website has this

VAERS Data Limitations

“”Underreporting” is one of the main limitations of passive surveillance systems, including VAERS. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. The degree of underreporting varies widely.”

Orac if you have research that refutes the 1% or what ever I would be happy to read it, but a personal blog post, that offers no other evidence than its and old study is not science but stuff of a school yard argument.
or maybe “Vicky” was right when she posted

“For the thousandth time, if you don’t like what Orac posts, you don’t have to read it. He isn’t running a science news site, and never claimed to be.”

As to VAERS/CDC

“The CDC doesn’t know what it doesn’t know”

@Charles If you read your own link, it has nothing. It describes a project that did not go anywhere,

“People who fail to regard the truth seriously in small matters, cannot be trusted in matters that are great.”

Be careful that that one doesn’t come back to bite you.

Aarno

“If you read your own link, it has nothing. It describes a project that did not go anywhere,”

The study was linked in the original vaxopedia blog. Which the author of the the story in the blog claimed the following:
“The original claims for under-reporting to VAERS were based on an old study about drug reactions”

I looked up the story and the link and the paper, the blog, which claimed was studying “drug reactions” and not vaccines/VAERS.

from my post

“claiming it was a study about drug reactions when it was a study about vaccine adverse events.
and offers no evidence or research on the number of adverse events happening.
“People who fail to regard the truth seriously in small matters, cannot be trusted in matters that are great.”

I posted the from the report the
SCOPE
and
PURPOSE
both were about vaccines.

From the final report.
‘Adverse events from drugs and vaccines are common, but underreported. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA).
Likewise, fewer than 1% of vaccine adverse events are reported.’

‘Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation.”

The vaxopedia blog was disingenuous at best.

As I posted before

“The CDC doesn’t know what it doesn’t know”

In another post you said
“Number you mentioned is revenue:
https://www.investopedia.com/pfizer-q2-fy2021-earnings-report-recap-5194421
Revenue is not same thing as profit, you know (or perhaps you do not).’

You linked to a report of a report, why didn’t you just look at the original data (2nd quarter report from Pfizer) it’s not like it was hidden, it really doesn’t need to be translated. The actual net profit for Pfizer is placed in the report. I didn’t think that it was necessary to cut and paste the whole 17 page report, as someone asked for a break down of the revenue of Pfizer when I posted that Pfizer was going to make more money from the vaccines then from all their other products combined, which is exactly what the 2nd quarter (and 1st quarter) reports show.

If you have an update on better research on the under reporting to VAERS please link to it. As others have demanded “Supporting evidence required.”

or are you just being argumentative.

@Charles I linked (in previous comment) Prizer investor guidance, which says same thing. Do you really think that blogs for investors mispresent company releases?
Speaking about your link about VAERS underreporting, you yourself copied & pasted statement that it was premilinary, without any followup. What was automatic trigger on EHR record ?

So I will take dumpster diving science over science by press release or straight up Cargo Cult Science any day.

Uh-huh. You might want to reread that lecture a few more times.

Those of us in the hard sciences always knew that the bio-science and especially the social science people could not do math.

Haven’t you already been asked which “hard science” you are “in” and in what capacity?

Professional mis-informers like RFK jr and company ( Children’s Health Defense.org) use VAERS numbers to create fear mongering headlines like yesterday’s about nearly 15 thousand deaths and 700 thousand injuries, 90 thousand of them serious, “due” to the vaccine. People who don’t understand what VAERS is and how it works, read articles like these.
Then, these items are also broadcast by sites like PRN, NN and the High Wire amongst others as well as by activists who share them on social media.

Ah … more meme-sponsored anecdotes from our resident genius
Perhaps you should step away from your Twitter-sponsored hyperlinks for while and get on down in the weeds treating some patients
Talk to a few real physicians.. maybe even gain a broader perspective … but I doubt it
“Believe the Science” indeed lol .. cheers

He is an asshole.

Do I need to elaboratete on someting that very rarly could be a good thing?

Never mind. I hit that. It was not a special moment. I am now so ashamed (not really) I got mine. Not many of ya’ll can say that. Shokka when his butt was wide.

Anecdotes ? Like saying that Hoeg compares vaccine adverse effects to COVID hospitalisation rates. Should she actually use vaccine caused hospitalisations for comparison ? Even you should notice problem there.

FFS carO. The whole point of proper well designed trials and studies is to get as far away from personal opinion as humanly possible.

I will try to hide my sarcasm, but this is very pathetic.

Israel has one of the highest vaccination rates in the world.

However the CDC just recently (13 September 2021) issued a travel warning (level 4 the highest warning) for Israel.

‘If you must travel to Israel, make sure you are fully vaccinated before travel.’

that probably good advise going anywhere but they add…….

“Because of the current situation in Israel, even fully vaccinated travelers may be at risk for getting and spreading COVID-19 variants.”

‘including wearing a mask and staying 6 feet apart from others.’

and of course the CDC is back to 6 feet, even though they have science that shows 3 is ok.

From the CBS interview of Dr. Gottlieb
“CDC made that you had to maintain six feet of distance that wasn’t based on good judgment and good science……“This is how the whole thing feels arbitrary and not science based. So we talk about a very careful, science based process and then these anecdotes get exposed, and that’s where Americans start to lose confidence in how the decisions got made.”

How does any of this make sense, if your vaccinated and the country that you are going to visit is 80-90 percent vaccinated but you are advised by the top health care people that you should not go because you might/will/can get the virus or spread the virus.

https://wwwnc.cdc.gov/travel/notices/covid-4/coronavirus-israel

Israel has one of the highest vaccination rates in the world.

Israel vaccinated early and then stopped. Only 63% of its population is fully vaccinated, which is less than at least 17 other major countries.

https://ourworldindata.org/explorers/coronavirus-data-explorer?zoomToSelection=true&facet=none&pickerSort=asc&pickerMetric=location&Interval=7-day+rolling+average&Relative+to+Population=true&Align+outbreaks=false&country=ARE~PRT~ESP~SGP~DNK~CHL~IRL~CAN~FIN~CHN~USA~BRA~RUS~MEX~JPN~PHL~DEU~GBR~FRA~ITA~ISR~ARG~AUS~BEL~ISL~NLD~NOR~KOR~SWE~URY&Metric=People+vaccinated+%28by+dose%29

60% vaccination might have been OK to stop transmission of the original COVID-19 virus, but >80% will be required to stop transmission of the delta variant.

There is, of course actual studies about vaccine effectiveness:
Lopez Bernal J, Andrews N, Gower C, Gallagher E, Simmons R, Thelwall S, Stowe J, Tessier E, Groves N, Dabrera G, Myers R, Campbell CNJ, Amirthalingam G, Edmunds M, Zambon M, Brown KE, Hopkins S, Chand M, Ramsay M. Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant. N Engl J Med. 2021 Aug 12;385(7):585-594. doi: 10.1056/NEJMoa2108891. Epub 2021 Jul 21. PMID: 34289274; PMCID: PMC8314739.

I will hide my sarcasm while noting that your misleading remarks are a comment on a blog.

Given your evident feeling that Vaxopedia is worthy of contempt because it can be characterized as a blog, a mere comment posted on a blog is of an even lower order of trustworthiness and can be disregarded because, after all, it’s just a comment.

On a blog.

“Doctors who should know better”

“non-antivax doctors who should know better”

“a lot of physicians who really should know better”

“Doctors who should know better”

“science editor Ian Sample (who really should know better)”

“She [Dr. Tracy Høeg PhD] really should know better”

“Allison Krug is also an epidemiologist who, again, really should know better”

“They should be embarrassed.”

The tone of this post sounded so familiar. Having been exposed to your tweets the author reveal was no surprise.

You have a knack for undrstatement. Fuck you so much. We are in trouble here and I just fabricated a .3Kw repulsion field mask that some are going to take issue with after they figure out my pre-emptive athartation is kind of spray it all on you.I am now a walking emmiter. I ai’n’t getting. I might give it but it seems yall don’t mind.

O.k. So that prototype (flyback in a fanny pack) burst into flames. It turns out that only 5-6 watts (now a tiny board out of an old sit on it and copy your butt copier) at 8-12 KV is needed for a nice gentle ionic wind away in all directions.

Hmm. If only everyone would wear any kind of mask, no matter how leaky, my wind would remotely charge it and stop, stick, or repel droplets.

One stud in the heel of a Redwing, drilled through and threaded with the silicon wire. The floors in the stores are all concrete. Electrocutes nicely. No. No capacitance. Not alot of jolt. But the one toe switch for on/off/ground self didn’t work out and the two toe switches take a learning curve.

One must not get too close to a chip reader checkout Intellichip before self grounding.

So, a pain in the ass for the home enthusiast but perhaps big tech will pick up on the idea.

“This research project was funded to improve the quality of vaccination programs by improving the quality of physician adverse vaccine event detection and reporting to the national Vaccine Adverse Event Reporting System (VAERS), via the following aims:”

VAERS, as a passive, unfiltered reporting system allows literally anyone to post a report, no matter how poor. Do you not understand that the stated purpose of the project was to improve reports by physicians, presumably a group better qualified than the population at large, in order to somewhat improve the quality of the information? It would not turn VAERS into something like the VSD system, but would allow those monitoring it to follow more reliable reports. Even with such an improvement, the necessary problems with a system like VAERS will remain.

Darn it. That comment should have included “@Charles”, since the replying level for that section had reached its limit. Where’s the edit function when I need it?

What is your estimate of the number of dead from covid vaccination, Number Wang? The CDC says 7,653 deaths from covid shots have been reported to VAERS; the VAERS site, which is jointly managed by the CDC & FDA, says only a “small fraction” of adverse events are reported, although serious events are “probably” reported more often.

You keep repeating same thing. How many times you have been told VAERS is a passive reporting system, that cannot establish causality. Try better,

Think of it as as similar to an experiment to test macro quantum mechanics. When you make a sufficient number of trials of running head first into a brick wall you’ll eventually make it through to the other side. However, a great many trials are needed (statistically speaking). It helps somewhat to have more people join the experiment,

I don’t estimate the number of deaths.

Repeated ad nauseum, a death reported on VAERs is not a report of a death caused by vaccination. It just isn’t. It’s a report of a death that someone thinks might be associated with the vaccine. Or has happened soon after vaccination so they’ve reported it just in case there is a link. So 7653 deaths reported on VAERs is not the number of people who have died due to the vaccine. Working out which deaths may be linked to the vaccine is what experts have to do.

I was pointing out that you hadn’t even applied common sense to your own opinions. If you’d stuck with 10% reporting rate it would have made more sense. However, do you not think that serious covid vaccine adverse events will be reported more often than usual? Sounds like an obvious likelihood to me. I wouldn’t bother reporting feeling a bit rough for 24 hours but I’d be pretty likely to report some kind of temporary facial paralysis and I’d definitely report a death that I thought was linked to the vaccine. Especially if I knew the vaccine was of an unusual type, quickly developed and a load of loud mouths are spouting off about how dangerous it is.

Your problem is that you are only looking for data to support your opinion rather than formulating an opinion from the data. You pick the worst possible interpretation or opinion of everything and treat it as fact. If your opinion is that all of the VAERs death reports are definitely caused by the vaccine and that this means, due to under-reporting, that 76530 or 765300 people have therefore died due to the vaccine then you are wrong. You’re building a house on a sandy flood plain and scoffing when someone suggests that a concrete plinth a bit higher up the valley is a better bet.

I’m not making any claims whatsoever, Number Wang–I’m just advising people of the massive increase in deaths and serious injuries reported to VAERS from the covid shots. I’m just providing the numbers, obtained from the VAERS database. Like you, I wimped out on making an actual estimate of the number of deaths from covid vaccination.

You’re insinuating a meaning to those increased reports. A very clear insinuation. Without evidence to back it up.

Increased reports should be investigated. Medical organisations and governments and the general population need to know the risks and benefits. However, if the reason for the extra reports is simply due to the scale of the campaign, increased public awareness of the newness of the vaccine and the public debates surrounding it, then all of your insinuations are baseless and harmful. You guys often say that doctors should pay for their crimes. I hope you feel the same about yourself. Every time the anti-vax campaign is proved wrong you’ve cost lives.

I’m just advising people of the massive increase in deaths and serious injuries reported to VAERS from the covid shots.

What people? Here? That’s not going so well. Your massive personal following?

No, Ginny, you’re a nonentity seeking engagement at any cost.

“Given your evident feeling that Vaxopedia is worthy of contempt because it can be characterized as a blog, a mere comment posted on a blog is of an even lower order of trustworthiness and can be disregarded because, after all, it’s just a comment.”

Orac cites his materials and links which support his position or view. Orac represents a quality blog with very good links to science, but in this case he cited a opinion piece that was not well sourced. or well researched.

Dr. Iannelli is the ‘owner’ of the vaxopedia blog, and is a doctor, and the author of the linked material, yet his linked material does not represent the facts as he stated them.

I actual did the research on the link provided to the vaxopedia and researched the links in the vaxopedia blog and found the blog, cites and research that were use and posted one of them.

One commenters on this site actual said
“If you read your own link, it has nothing. It describes a project that did not go anywhere”
Which was the point of my comment on vaxopedia, the link did not go anywhere that the author claimed it went and the links did not offer any evidence of rebuttal on the under counting of VAERS cases. The link was not my link but the link in vaxopedia. Had you taken even 5 minutes of time to link to the site you would have discovered that as well.

I have no opinion of vaxopedia one way or the other, the only time that I had visited the site was to read the evidence put forth by Orac.

I asked if anyone had other research on the numbers of under reported VAERS numbers other than WAGs so far no one has offered any research, even VAERS said that there is an under count I would think that the under count and the extent would be kind of a big deal to the CDC/VAERS and the readers on a web site dedicated to science based medicine but I guess not.

Vickie was right.

Jesus Crist, Stoner, could you please try to figure out how to reply in context? Like, with the red “Reply” button that you bypassed here? It’s not even clear to me that you know who you are replying to half the time.

Firstly, Ginny, as Narad asked, please work out how to reply on the correct thread.

Secondly, VAERS is a passive reporting system. ANYONE can submit a report. Just because a death is reported to VAERS doesn’t mean the vaccine caused the death.

Thirdly, VAERS has been gamed by antivaxxers filing false and duplicate reports. A few years back, the site Just the Vaxx looked at reports of deaths in VAERS post Gardasil administration. They found a lot of unverifiable reports, and a lot of clear duplicate reports.Just because a death is reported to VAERS doesn’t automatically mean that the death even occurred.

It took me less than 2 minutes to report that the Covid vaccine had turned me into a giant insect, and that’s with the time it took to transcribe the first paragraph of ‘The Metamorphosis’ into the correct field.

I’m guessing that highly-motivated cranks could put in a whole lot of false reports in the course of a day or two.

If it was a reply to me then she can’t manage basic reading comprehension either.

The deaths aren’t irrelevant there’s just no evidence linking them to vaccination yet. By pure chance, thousands of people will die fairly soon after vaccination. Especially if they were older or had health complications anyway. Wait until causality is proven, or even just more likely than not (determined by experts not opinionated amateurs), before blaming the vaccine. You may believe that this analysis will never be done by unbiased sources but that doesn’t change the fact that there is no evidence. VAERs cannot provide it.

NW, I’d be more than happy to read any analyses the CDC or FDA comes up with purporting to explain why the massive increase in deaths and serious injuries reported to VAERS from the covid shots is nothing to worry about–if there were any. Heck–I’d even be happy to read any CDC or FDA acknowledgements of the massive increase in deaths and serious injuries reported to VAERS from the covid shots–if there were any.

CDC says this (how many times this must be repeated)
https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html
“VAERS accepts and analyzes reports of possible health problems—also called “adverse events”—after vaccination. As an early warning system, VAERS cannot prove that a vaccine caused a problem. Specifically, a report to VAERS does not mean that a vaccine caused an adverse event. But VAERS can give CDC and FDA important information. If it looks as though a vaccine might be causing a problem, FDA and CDC will investigate further and take action if needed.”

So, Aarno–blind trust is the answer? The CDC & FDA are silent about the massive increase in deaths and serious injuries reported to VAERS from the covid shots–and we can conclude from that silence that all is well? After all, they told us if anything bad came up, they’d investigate, and do something if they needed to. Lol–you and Dorit should get together and write a Blind Trust Guide for the covid vax.

Blind trust is not answer. Answer is thinking. How many deaths would happen among 100 million people evek vaccines ahve not been adminstrated ? Number is not zero.

Yeah, Julian–too bad the “reply” button in my notification email doesn’t seem to get the reply to the right place. I hope you can figure this out. You keep delivering the same rudimentary lecture about VAERS–when if you simply read my blog posts, you’d see those fundamental issues are discussed multiple places.

So, your hypothesis is that more deaths have been reported to VAERS from the covid shots than from all other vaccines combined for the last 30 years, because scammers? Did these scammers get the shot first, then make up an injury? VAERS reports include medical records–seems like falsifying thousands of medical records would require resources most members of the public don’t have. You’d think the CDC & FDA would be all over a huge fraud like that–seeing as how it is making their precious covid shots look like the most dangerous vaccines in history. Instead, they concealed the massive increase from the public and from vaccine consumers.

Ginny, can you point to the portion in the budgets of the CDC or FDA that’s set aside for paying off doctors, nurses, HCWs in general, people administering vaccines, insurance companies, etc, ie anyone and everyone that would be involved in covering up excess mortality from vaccination? Most people in the world would have noticed something was up if lots of people were dying. The Pfizer vaccine is being given in countries around the globe. The CDC/FDA equivalents or other government agencies in those countries would notice the mass death. The blood clotting issue was sussed out incredibly quickly, and there was very little signal to work with with that issue. This would require a global conspiracy. Is that plausible, or is this just antivaccine propaganda pure and simple?

COVID vaccine has been administrated to over hundred million people. How many deaths among hundred million people would happen if vaccines are not administrated ? Zero, obviously.

There were a lot of “signals” about blood clots you apparently never heard about, Solstice–in particular, hundreds of serious blood clot reports to VAERS including about 200 deaths. They didn’t suss anything out quickly–they covered it up hastily. All the public knew about were a handful of VAERS reports and a few deaths. https://www.virginiastoner.com/writing/2021/6/27/blood-clots-amp-covid-shots-its-not-just-a-handful-of-casesits-hundreds-and-the-blood-clot-disorder-tts-is-brand-new

As for paying people off–no need. Their careers are at stake. If you don’t understand that speaking out against vaccines can destroy the career of someone working in the medical field, no wonder you are lost in this sea of disinformation.

@NWO
“There were a lot of “signals” about blood clots you apparently never heard about”

Here, I’ll link what the CDC is saying about this again: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html. The data is there. What’s been covered up?

As for medical personnel having their careers at stake, how many antivax doctors other than Paul Thomas have had their license suspended? Have any had theirs revoked? Have you not been paying attention to what’s happening in Florida, Idaho and elsewhere? Heck, did you not read the article you’re commenting on?

By the way, I congratulate you on finally finding that “reply” button.

@NWO Reporter You should really cite somebody other than Virginia Stoner, If the article has links, cite them directly,
There is actually a study about blood clot reports in VAERS:
Welsh KJ, Baumblatt J, Chege W, Goud R, Nair N. Thrombocytopenia including immune thrombocytopenia after receipt of mRNA COVID-19 vaccines reported to the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2021 Jun 8;39(25):3329-3332. doi: 10.1016/j.vaccine.2021.04.054. Epub 2021 Apr 30. PMID: 34006408; PMCID: PMC8086806.
VAERS data is analysed, you notice. On the top of that, FDA is involved!

By the way, I congratulate you on finally finding that “reply” button.

Just wait until she tries to reply to the foregoing.

Aarno, everything in the Welsh study you provided was consistent with what I wrote in my blood clot paper.

First, the authors discuss a small handful of blood clot cases–less than 30–with no mention whatsoever of the hundreds of other blood clot related deaths and serious injuries reported to VAERS.

Second, there was no mention that the number of blood clot related reports or adverse event reports in general from the covid shots was magnitudes higher than ever before in VAERS 30-year history.

In other words, the authors of this published, peer-reviewed research study facilitated the coverup of the massive increase in deaths and serious injuries reported to VAERS from the covid shots. Thanks for the tip.

@Narad
They say that if Ginny replies to your post there’ll be six more weeks of her reposting the same conspiracy theory.

Okay Ginny.

You keep delivering the same rudimentary lecture about VAERS–when if you simply read my blog posts, you’d see those fundamental issues are discussed multiple places.

I am not giving you clicks. And I suspect that your “discussion” of the issues mentioned multiple times is not the proof you think.

So, your hypothesis is that more deaths have been reported to VAERS from the covid shots than from all other vaccines combined for the last 30 years, because scammers?

Way to twist my words. My point was that there is little to no verification done on VAERS reports, so anyone can post anything, so a bunch of VAERS reports of deaths without hard evidence is hearsay. That some of those reports are fraudulent was a part of that, not the sole explanation.

VAERS reports include medical records–seems like falsifying thousands of medical records would require resources most members of the public don’t have.

Ummmm, a lot of them don’t, actually. Medical records are not required to post a VAERS report. No need to falsify anything.
You are misrepresenting VAERS. It is a passive, not active, system.

“too bad the “reply” button in my notification email doesn’t seem to get the reply to the right place”

This may be the second most interesting interview question I have walked out on today. /s

I’m not really sure how that works, email and I have a troubled past. I just don’t feel like I’m ready to jump back into email. I could bump into Hillary’s missing snuke and boom goes the snuke.

I suspect that the “reply” button in your notification email just takes you here. I suspect that it takes the respectfulinsolence.com session cookie to put in the right place automatically. Which, naturally, you would not have. Unless you were logged in or something. Maybe.

{testing testing} if this shows up in the wrong place then it needs to stuff you up with a cookie first.

ps It also just fucks up sometimes.

Really, Dorit–I’m too far gone in “Conspiracyland?” No–I’m stuck in “Showmeyouranalysesland.” You really think it’s reasonable to believe the massive increase in deaths reported to VAERS from the covid shots is nothing to worry about–just because the CDC & FDA are silent about it? That’s a joke on science, medical ethics and commonsense.

Hey, Ginny, do you want to see a magic trick where I put this completely decontextualized dropping where it belongs? Cripes, if you can’t figure that out and don’t want to figure it out, then at least quote the person you’re attempting to reply to.

Conspiracy theory was that 7000000 people would die without anybody noticing. This is utterly ridiculous statement,
VAERS data is, of course analysed, among others CDC.

Solstice said “The data is there. What’s been covered up?”

So, you want me to explain what I already explained in detail in the link I provided, along with supporting evidence? Sorry to break the news, but you may have to actually read it, because your skills as a psychic are obviously rusty.

If you just didn’t get it an need further evidence of the coverup of the massive increase in deaths and serious injuries reported to VAERS from the covid shots, you can also check out this paper: https://www.virginiastoner.com/writing/2021/8/10/update-on-the-deadly-covid-vaccine-coverup-plus-how-to-estimate-risk-better-than-the-cdc

I’ve heard that this “Virginia Stoner” person is not a reliable source of information. Do you perchance have a more mainstream citation?

Sorry, Solstice–I mistakenly assumed you were capable of using your own logic and reason to evaluate the evidence presented in my paper–which is easily verifiable by doing your own VAERS search.

Your own data shows that reported deths are going down. Do you think that vaccines are becoming sater ? Or it is that because now younger people are vaccinated, so backgrond rate is lower ?
You have still not answered to a simple question: How many deaths you think would happen among 100 million people, without vaccination. Answer to this explains your “code of silence”,

The CDC and FDA together have more than 25,000 employees.

Add in the spouses, children, relatives and friends of those employees and the number surely runs into the the hundreds of thousands.

And yet, the entire CDC and FDA cover up massive death from Covid-19 vaccines.

You’d think there would be lots of whistleblowers coming forward to save themselves and their loved ones, but no.

It’s like I always say, that sweet, sweet Pharma lucre is too good to pass up.

FYI New oped in Washington Post

Opinion: State medical boards should punish doctors who spread false information about covid and vaccines

State medical boards must immediately act to revoke the medical licenses of doctors who use their professional status to deliberately mislead patients for reasons of politics or profit. Thus far, regulatory bodies have largely failed in this duty.

Health-care workers are tired of battling on two fronts — fighting the SARS-CoV-2 virus in our hospitals, and fighting the onslaught of disinformation in the public mind. We represent a group of doctors and other health-care professionals who have created a website — NoLicenseForDisinformation.org — to help identify the most egregious professional offenders. We are encouraging other health-care workers to join our effort, and we hope members of the public will use the website to report bad actors to their individual state medical licensing boards.

This is not a step we ever thought we would have to take, but we feel we have no other choice. We hope that a public expression of overwhelming concern will lead to action around the country. We, and our patients, are relying on those with authority to exercise it and hold medical professionals accountable for their misdeeds.

Nick Sawyer is an emergency medicine physician
Eve Bloomgarden is an endocrinologist
Max Cooper is an emergency medicine physician
Taylor Nichols is an emergency medicine physician
Chris Hickie is a pediatrician

Link:

https://www.washingtonpost.com/opinions/2021/09/21/state-medical-boards-should-punish-doctors-who-spread-false-information-about-covid-vaccines/?utm_source=twitter&utm_medium=social&utm_campaign=wp_opinions

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