Pfizer's mid-2021 PVP report to FDA under-counted foreign VAERS cardiac reports by 23X

The revised pharmaco-vigilance plan (PVP) report on myocarditis and pericarditis is a case study of VAERS loopholes

Summary:

• Pfizer’s submitted a revised pharmaco-vigilance plan (PVP) report to the FDA in mid-2021 which analyzed myocarditis and pericarditis reports until ~mid June 2021

• It included an analysis of foreign VAERS, but ignored a vast majority of reports which had been filed by that date

• As a result, they undercounted the total foreign VAERS reports for myocarditis and pericarditis by 23X

• This is because even the “filed” reports were only published to the CDC WONDER VAERS search tool after a long delay

• This revised PVP report actually exposes quite a lot of VAERS loopholes

Note 1: I would like to thank Liz Willner and her team at OpenVAERS for providing me some important information which is missing from the original VAERS CSV files. This analysis could not have been possible without their help.

Note 2: I will resume my previous article about Extracting reported cause of death from VAERS writeups after I finish this series, given that this is clearly much higher priority

In the latest Pfizer document drop, there is a document called “51_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Memo COMIRNATY.pdf“

I will refer to the Pharmacovigilance Plan as PVP (which is the same terminology used by the FDA). So the PVP report refers to the document which reports the results of the Pharmacovigilance Plan.

You can get a copy of the PVP report by searching for the word Pharmacovigilance in the search bar of the Pfizer documents website.

Here is a direct link to the document.

Red flags

In the document, there is a particular paragraph (page 13) which should have raised a lot of red flags for a honest regulator.

Why is this a red flag?

According to Pfizer, out of a total of 1023 reports, only 11 of them came from outside the US.

Earlier in the same document, we also see this.

4 Summary of Pertinent Regulatory History and Prior Marketed Experience

Pertinent regulatory history is shown in Table 1. BNT162b2 has received temporary authorization for emergency supply in 28 countries and conditional marketing authorization in 39 countries. As of August 4, 2021, over 194 million doses of BNT16b2 have been administered to over 88 million individuals in the U.S. under the EUA. Per the sponsor’s Summary Monthly Safety Report (STN 19736.409), approximately (b) (4) doses of BNT162b2 have been shipped worldwide from December 1, 2020 through June 30, 2021, which corresponds to approximately 757,863,718 estimated doses administered.

In other words, there were nearly 4X as many doses administered outside the US compared to within the US.

So how can the number of myocarditis/pericarditis reports from the US be 98.9% of ALL the reports which were received?

Here is how the FDA describes their pharmacovigilance on myocarditis and pericarditis - it does admit higher risk, but is not being completely honest about the scale (emphasis mine)

Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks

Source

Except, the evaluation was not rigorous!

FDA simply rubber-stamped what Pfizer sent in without bothering to do any cross-verification¹.

More clues

Interestingly, Pfizer then goes on to mention that there were only 6 deaths due to myocarditis (3 US and 3 foreign) and even goes on to LIST case summaries of ALL the 6 people who died from myocarditis in the next paragraphs.

This does two things:

a) it creates the false impression of extremely detailed pharmacovigilance

b) it creates the false impression that every single post-vaccine death² is actually being carefully scrutinized by Pfizer

You might remember that the CDC was claiming, as recently as April 2023, that there were zero deaths from the Pfizer vaccine.

If you read the linked article, you can see that this claim is simply not true.

And recently, there has been some more news on this front via

Aussie17

(be sure to read the comments under the article).

BREAKING: Philippines' House of Representative initiates a formal investigation into excess deaths!

How many reports for myocarditis and pericarditis?

I queried my serious-foreign-VAERS-reports search engine to see how many people reported myocarditis and pericarditis after taking the Pfizer vaccine by May 2021.

Here is how you can do it:

First select the months Dec 2020 - May 2021 in the RECVMONTH field (this represents the month corresponding to the RECVDATE field in VAERS)

Since the PVP query was run at the end of June 2021, and it considered reports which had been in the system by 21st June 2021, all these reports technically had at least 21 days to appear in the system.

This is what you will see when you do these filters.

This would give you about 20K reports.

We are only interested in the list of symptoms already listed in the PVP report - “The query was run on June 23, 2021 utilizing the PTs autoimmune myocarditis, autoimmune pericarditis, eosinophilic myocarditis, hypersensitivity myocarditis, myocarditis, pericarditis, pericarditis adhesive, pericarditis constrictive, and pleuropericarditis.“

Of these, we will select only Myocarditis and Pericarditis because they make up nearly 100% of the cardiac symptoms in foreign VAERS for the selected time period.

So next we select Myocarditis and Pericarditis in the SYMPTOMS filter.

This gives us a total of 274 results.

Now filter for Pfizer only: this gives us 258 results.

So there you have it - the total number of foreign VAERS reports was 258.

Pfizer’s PVP report says there were a total of 11 reports of these symptoms in foreign VAERS.

This is an under-reporting factor of 258/11 = 23!

How did we get here?

Consider this: we are nearing the end of 2023, which means it has now been over two years since the FDA got this report³. How come we did not even know about this till now?

You can explain the 25X under-reporting by looking at the last three filters on the search tool - the month the report was published (i.e. became queryable inside CDC WONDER), how many were delayed until after the date the query was run, and how much delay there was between the RECVDATE and the published date⁴.

I will be explaining all the VAERS loopholes which allowed this to happen over the next few articles.

In the meantime, if you would like to put all the pieces of this puzzle together for yourself, I recommend reading the following articles:

1 Delayed reports

DailyClout Researchers Find Pfizer Delayed Recording Vaccinated Deaths

2 Incomplete translation of age information

3 Outright DELETION of VAERS writeups!

The foreign data set was gutted this week in VAERS and the cancer signal was halved, the myocarditis dose 3 response signal was lost and 994 spontaneous abortions/still births were dropped

4 Too little scrutiny of foreign VAERS reports (with respect to their importance)

1. The reason the vaccine pushers are so irritated by the mere existence of VAERS is that it is quite transparent and allows independent analysts to cross-verify the claims of Pharma companies.

2. When I say post-vaccine death, I do literally mean post-vaccine death. I am not even attributing causation. Pfizer in fact uses these six deaths to explain why they do NOT imply causation. In other words, I am simply using all the same yardsticks/benchmarks that the vaccine manufacturers are using.

3. And FDA just kept approving the COVID19 vaccine for all age ranges, and the vaccine has now also ended up on the childhood immunization schedule

4. You expect this number to be close to the pre-COVID average of 7 to 14 days even during normal times, but all the more so during a worldwide vaccine rollout