VAERS shows 1,900 more cases of myocarditis reported in 2021 than 2020 (US)

And there were ZERO cases in 2020!

Disclaimer: I am not a clinically trained practitioner and for those interested in a more clinical document, see this excellent paper by Jessica Rose, Ph.D., MSc, BSc and Peter McCulloch MD, MPH for the most recent research on the effects of injectable biologicals and incidents of myocarditis

That said, I can analyze large amounts of data and have a critical mind :)

Apologies, this one’s a bit longer than usual.

Myocarditis and Pericarditis

Let’s start by looking at definitions of these conditions from the Mayo Clinic:

• Myocarditis is inflammation of the myocardium or ‘musculature’ of the heart.

• Pericarditis is swelling and irritation of the thin tissue surrounding the heart.

There have been numerous studies and news items about both conditions following the SARS-CoV-2 injection. Research findings on the matter have been subject to cancellation by academic publishers as well as being fact-checked by the so-called and all too frequently, self-appointed fact checkers.

So I’m bracing myself for the onslaught, but here goes.

Comparing incidents per year

I looked at the prevalence of myocarditis and pericarditis after having a SARS-CoV-2 injection and counted instances across all age groups, by sex and age as reported in 2021 for the data I had up to the date of download (30th November 2021) which I’ll refer to as the FOREGROUND data.

This was then compared to a baseline which was considered to be the number of cases of myocarditis and pericarditis in 2020 that were associated with the flu vaccine. I’ll refer to this as the ‘BACKGROUND’ data. 

If we assume that the propensity to report flu vaccine-related myocarditis and pericarditis adverse events in 2020 was the same/similar as the propensity to report SARS-CoV-2 vaccine-related adverse events in 2021 (and they were), and if we adjust for the uptake of flu vaccine in 2020 to match the SARS-CoV-2 vaccine uptake in 2021, we can calculate a factor that shows an increase/decrease in SARS-CoV-2 vaccine-related adverse events associated with myocarditis and pericarditis compared with Flu vaccine-related adverse events of the same type. Sounds good.

The analysis compares adverse events associated with myocarditis and pericarditis reported for the SARS-CoV-2 vaccine over the period since the start of the vaccine roll out in the US: 14 December 2020 to 30 November 2021 (approximately 11.5 months in the FOREGROUND), to the adverse events for myocarditis and pericarditis reported for the Flu vaccine, 1 year earlier, over the period: 01 January 2020 to 13 December 2020, also approximately 11.5 months in the BACKGROUND.

It is important to note that the SARS-CoV-2 virus was present in the population for both time periods, but the SARS-CoV-2 vaccine was only present in the FOREGROUND period.

For all intents and purposes, the only difference between these two time periods is the presence of the SARS-CoV-2 vaccine.  Everything else is the same.  It is the same population demographic, it is the same time duration (11.5 months) and the SARS-CoV-2 virus was present in both cases.

VAERS and the ‘Yellow Card’

VAERS (Vaccine Adverse Event Reporting System) is the US pharmacovigilance system used by individuals and clinicians to report adverse events following vaccination.  It is a system co-sponsored by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC). 

VAERS has data on domestic (US) and foreign patients.  For clarity, the data used in this study has been taken from the US domestic data set.

In the UK (where I am) the pharmacovigilance system here is called the Yellow Card and is maintained by the Medicines & Healthcare and products Regulatory Agency (MHRA).  These data are published and overwritten on a weekly basis and so it is impossible to calculate historical changes as only the latest data is available.  For this reason, the analysis uses VAERS but I also estimate the UK cases for those of us on this side of the pond later.

Comparing apples with apples (sort of)

After cleaning the BACKGROUND (Flu) data there was a total of 9,255 adverse events covering all responses, not just myocarditis and pericarditis after vaccination for the 11.5 months (805 reports per month) and 30 deaths from all causes.

After cleaning the FOREGROUND (SARS-CoV-2) data, there was a total of 625,804 adverse events covering all responses, not just myocarditis and pericarditis after vaccination for the 11.5 months (54,418 reports per month) and 8,066 deaths from all causes.

The main vaccine manufacturers for FOREGROUND are Janssen (Johnson & Johnson), Moderna and Pfizer/BioNTech with a small number of unknowns recorded.

Myocarditis

The total number of myocarditis incidents including unknown manufacturers and including all doses in the FOREGROUND was 1,900 - see below.  The panels show the number of events per manufacturer, split by sex (along the bottom) and dose (on the right axis).

Figure 1 - Myocarditis reports by manufacturer/sex (horizontal) and dose/events (vertical)

After removing unknown manufacturers and restricting the data to at most two doses, this reduced to 1,484 adverse event records split 1,104 (74%) males to 380 (26%) females.

The median age for events recorded with myocarditis was 24 with a median time to the onset of symptoms of 3 days. 3 DAYS!

Pericarditis

The total number of pericarditis incidents including unknown manufacturers and including all doses was 1,399 - see below. 

Figure 2 - Pericarditis reports by manufacturer/sex (horizontal) and dose/events (vertical)

After removing unknown manufacturers and restricting the data to at most two doses in this set, this reduced to 1,107 adverse event records split 677 (61%) males to 430 (39%) females.

The median age for events recorded with pericarditis was 38 with a median time to the onset of symptoms of 5 days. 5 DAYS!

Young males are at most risk

Figure 3 below shows how the 1,484 myocarditis cases were distributed by vaccine dose and by sex.  Of interest and obvious in the bottom-right graph is the bias towards males being affected and in particular, after the second dose. 

Of note, young males under 25 are clearly shown to be most affected. And, whilst there is consensus in the literature that young males suffer more than females from the condition, just look at the increase after the second dose!

Figure 3 - Myocarditis reports by sex/age (horizontal) and dose/events (vertical)

In November, 2021, the CDC published a report from a Pediatric Cardiologist at the Children’s Healthcare of Atlanta that showed the background rate of myocarditis was excessive in 12-24 year old males for dose 2 (16x higher in males aged 18-24) and over 10x higher for females in the same age category, for dose 2.

Figure 4 - Vaccine Adverse Event Reporting System (VAERS): Reporting rates (per 1 million doses administered) of myocarditis after mRNA COVID-19 vaccines, 7-day risk period (source: slide 3).

Note: shaded areas indicate reporting rates are higher than the background rate.

This document went on to say that the CDC is:

“Investigating the long term effects of myocarditis…”

Which is exactly what we would expect from a clinical trial, not a nationwide ‘vaccine’ rollout right?

The follow up 90-day period (yes - just 90 days) extended to 47 patients out of 1,640 reported cases at the time of publication - or 2.8%, of which 74% were reported to have ‘fully recovered’. So that’s that then?

Not much commentary about the severity of the condition, long-term prognosis or the fact that alarms bells should be deafening given the 16x increase in young males!

Figure 4 shows the cases of pericarditis and whilst the number of cases isn’t as high as it was for myocarditis, there is a similar pattern with respect to young males under 25 being affected mostly after the second dose. 

With the UK government recently stating that vaccine efficacy needs ‘boosting’ after three months and the potential impact on young people’s lives, the risks to this demographic are obvious and palpable.

Figure 4 - Pericarditis reports by sex/age (horizontal) and dose/events (vertical)

Correlation and Causation

The time to the onset of symptoms can be seen below in figure 5 for myocarditis (pericarditis followed a similar distribution). Both conditions had a very short timelapse after the last injection and the onset of symptoms associated with these serious adverse events.  As mentioned, in the case of myocarditis the median time to the onset of symptoms was 3 days, whilst for pericarditis it was slightly longer at 5 days.

Figure 5 - Time to the onset of symptoms of myocarditis

One of the most quoted epidemiological tests for causality is Bradford Hill which establishes 9 criteria.  One of which is ‘temporality’, which is to say that ‘exposure’ must precede the onset of ‘disease’ and which is essential in establishing causal inference. 

Whilst this analysis does not apply all criteria, the temporal proximity of the onset of these serious adverse events to having the injectable product cannot be understated.

No cases before SARS-CoV-2 (almost…)

The original intent of the analysis was to compare the BACKGROUND instances against a FOREGROUND set to establish the relative increase or decrease in the number of instances of myocarditis and pericarditis against the backdrop of an approved vaccine (Flu) vs. one authorized for emergency use (SARS-CoV-2). 

This wasn’t possible as there were no cases of myocarditis recorded in the BACKGROUND data. And whilst, the BACKGROUND pericarditis analysis did reveal 1 case, this was for a 70-year-old female, which for the purposes of this analysis, is considered an outlier.

Therefore, it would be fair to assume that instances of pericarditis and myocarditis in large numbers following a vaccine had not been witnessed before the introduction of SARS-CoV-2 suite of injectable products.

Previous work by Rose and McCulloch highlighted that instances of myocarditis were higher in males than females in the 13-23 age group (p<0.0001) with ~80% of cases being in males.  This work also concluded higher rates in second doses and showed higher rates in the Pfizer/BioNTech BNT162b2 product.  My analysis concurs with that finding.

Underreporting is a thing

The VAERS system is known to underreport.  Research by Steve Kirsch and others in the US looking to calculate by how much is backed by a $1M research grant to anyone who can improve the estimate by a factor of 4 or more in either direction. 

To date, no-one has challenged the analysis that puts forward a VAERS Under Reporting Factor (URF) of 41x for serious adverse events like myocarditis and pericarditis. 

If this URF were applied, the adjusted number of reported cases of myocarditis in the US would be 77,900 for the FOREGROUND data and 0 for the BACKGROUND.  For Pericarditis, the adjusted figure would be 57,356 for the FOREGROUND and 41 for the BACKGROUND.

Turning attention to the UK and the Yellow Card data on myocarditis and pericarditis, data locked on 15/12/2021 revealed 843 cases of myocarditis and 652 cases of pericarditis across Pfizer/BioNTech, Moderna and AstraZenica products.  Applying an underreporting factor or 11x (calculated using the same methodology as Kirsch but on MHRA data) would see an adjusted figure of 9,273 cases of myocarditis and 7,172 cases of pericarditis (see below). 

The UK Government themselves have previously stated that they believe the Yellow Card is underreporting and suggested that only 10% of serious side effects were recorded.

They also published information for healthcare professionals on myocarditis and pericarditis which estimated that there were 2,000 hospital admissions for myocarditis in 2017. 

Given the adjusted estimate of 9,273 cases of myocarditis following vaccination using an 11x underreporting rate, this could equate to an increase of at least 4.6x (9,273 / 2,000) in the presence of SARS-CoV-2 vaccines over the background rate. 

This assumes that all 2,000 cases that would have developed myocarditis are within the 9,273 estimate, so I am most likely under calling it.

If we now look at the combined doses given in the UK to the 15th December 2021, we see that there were 98.3M first and second doses administered. 

So assuming the adjusted estimate of 9,273 incidents of myocarditis, this would equate to 94 cases/M doses or 1 case of myocarditis per 10,638 doses.

Is that a risk worth taking?