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Things you should know about the new Pfizer documents
We now have access to 150 documents to date. Here's what is important to know.
There are no explosive “smoking guns” so far that we’ve found in the Pfizer release that our team didn’t know already. For example, we already knew from VAERS of thousands of rare adverse events that were elevated, but people who haven’t looked at VAERS wouldn’t have known that. So this disclosure is useful in that it brings these issues to light yet again.
Even though this data isn’t new, some people are learning this data for the first time, e.g., John Campbell. The data in just one of the 150 documents released so far was sufficient to convince reasonable people, such as John Campbell, that the authorities have lied to us: this is not a safe vaccine.
It is troubling that the FDA wanted to keep this information secret for 75 years. How are they able to release >10,000 pages in a month when earlier the FDA said it would take 75 years to release 200,000 pages. How is this protecting the public? It makes you wonder whose side they are on, doesn’t it? And if you read my earlier post, you know whose side we are on (yeah, that’s right… it isn’t ours).
All the evidence we’ve seen in the releases so far is consistent with a vaccine which is too unsafe for use in humans.
A lot of attention has been paid to to the adverse event document (aka the 5.3.6 document). But the events reported here are no surprise to anyone who has been looking at the VAERS data. The VAERS data is much more useful and it can be used to prove causality.
Few people have realized that the data in the adverse event document appears to be underreported by a factor of 100. I show 3 different ways to estimate this below. However, even without this factor, the list of adverse events is sufficiently large to sway people like Campbell.
Even if the fatality data isn’t adjusted at all by the underreporting factor, the number of deaths exceeds any reasonable stopping condition for a vaccine (more than 1 death per million vaccinated).
There is nothing in these documents that exonerates the vaccines. It is just more data showing how dangerous they are.
Even without the Pfizer documents, there are already way too many unanswered questions, questions that can’t be answered. How do they explain the odd clots in over 90% of an embalmer’s cases? The high rate of unexpected death of young people reported by insurance companies? The deliberate data manipulation of the DMED data? Dr. Peter Schirmacher’s study? The 9 studies that show that the more you vaccinate, the higher the infection and death rates? The high rates of myocarditis (higher than 1 in 100)? The huge number of unexplained deaths in healthy young kids? The large number of soccer players who are dying of heart conditions? Major airlines who know their pilots died from the vaccine but keep it quiet? CDC contractors who are deliberately instructed by the CDC to “protect the vaccine” instead of the people? The incredibly high rates of cancer that suddenly re-emerge with a vengeance after the shot? The neurology practice that reports a 10,000-fold increase in adverse events after the shot? The Israeli Ministry of health survey showing that 4.5% of people who got the vaccine have neurological damage? The mysterious variation by batch numbers? That not a single public health official will debate any of my colleagues on any of these issues? …. The list is almost endless.
About the documents
We've been hard at work going through the Pfizer documents that were released on March 1, 2022.
Pfizer has done a series of drops starting with documents on the 18th of November, 2021 and all the way up to first of March this year.
There are 150 documents so far comprising an estimated 50,000 pages. The documents are all posted here on this third-party portal (it is not run by Pfizer):
So far, they have given us some of their internal code dictionaries, which correspond with various other documents, studies, and spreadsheets and will take some time in order to analyze completely (they use SAS mostly). They have also provided some documents they sent and received from the FDA as well as some of their results of their own clinical animal and human trials. This is a summary of the interesting items we have found so far.
Limitations of our analysis
Since I have a limited staff on this project (me and Kyle), we won’t be able to do everything that others will cover. I am sure that the mainstream media and also the medical community will be all over these documents exposing the corruption in great detail.
OK, I was just kidding. The truth is that the only people who are going to let you know what is really going on in these documents are the people that the mainstream media calls “misinformation spreaders.” Everyone else is going to pretend like nothing is wrong.
Key conclusion: their data doesn’t support their claims
Pfizer’s own data does not support the claim their COVID-19 vaccines are “safe and effective.”
Pfizer seemingly lied to the FDA by claiming their vaccines prevent COVID-19, and the FDA and mainstream media then dutifully lied to the American people repeating this false claim.
Things the documents tell us now
Here are the some of the issues we will cover in this review. More to come as we learn more:
Pfizer claimed repeatedly in their documents to the FDA that their vaccine would “prevent” COVID-19.
Pfizer knew the injection’s adverse effects would increase with more injections of continuing boosters.
Pfizer knew their injections did not stay at the injection site.
Pfizer knew that the vaccinated group reported far more systemic adverse events than the placebo group.
Pfizer knew that the efficacy of the vaccine waned very quickly over time; by as much as 50% in as little as 1 month after the second dose. How come we weren’t warned about that???
Pfizer defended VAERS (because they didn’t want extra reporting cost burdens).
There are six individuals that signed up for two different clinical trials at two different sites which is really odd.
Pfizer knew vaccinated individuals could still catch COVID-19 and test positive.
There are 1,448 pages comprising 9,704 individual subjects who were excluded from the trials. There isn’t enough detail to know why.
Pfizer paid $2,875,842.00 for their application to the FDA. This is more of a point of information for now.
It is troubling that Pfizer redacts information that is not proprietary that would be very helpful in assessing the data such as the number of doses administered in the ADVERSE EVENTS OF SPECIAL INTEREST” (AESI) document (aka the 5.3.6 document).
Pfizer only tests you for COVID if you have at least one symptom. If the vaccine suppresses symptoms (which it apparently does), then it will falsely appear as if the vaccine reduces the number of COVID cases.
How could anaphylaxis not show up in the Phase 3 trial on any of the 44,000 patients, yet show up as a major safety concern in the post-marketing document?!?
The underreporting factor
Nobody has talked about the underreporting factor of the events in the 5.3.6 document. This is the factor that you multiply the reports by in order to get the number of events that actually occurred. Voluntary reporting systems often have an underreporting factor of 10 to 100 or even more depending on the severity of the symptom.
There was no attempt whatsoever to calculate the underreporting factor (URF) by Pfizer in the report. Are you surprised?
I guarantee you, all of these event reports are unreported. But Pfizer is silent on this and of course the CDC is never going to calculate this number because they don’t want anyone to know it either. If you ask them for it, they stonewall you and never provide it. So nobody can do a proper risk benefit analysis, including the CDC. This is not a problem for them since they are not required to produce such a document. Have you ever seen it? What URF did they use? Answer: they assume that VAERS and everything else is fully reported and never bother to calculate the URF. They know this is wrong. This is intentional. Their job is to push the vaccine and ignore all the safety signals.
Because our health authorities, mainstream academia, mainstream press, and members of Congress don’t want to know the underreporting factor (since if people knew that, they’d realize the vaccines are unsafe and it would create vaccine hesitancy), it’s up to the so-called “misinformation spreaders” such as myself to calculate this number.
I’ll do that three different ways, just to show you how large the number is. The smallest URF is 89 (for serious events). The largest URF is over 163 (for less serious events).
URF estimate #1: 89
There were 86M doses given in the US by the end of February according to Google. There were 42,086 case reports but only 13,739 reports were received from the US:
Let’s assume that the deaths are proportionally reported (a reasonable first-order assumption since we don’t have more detailed data).
From page 7, there were 1223 deaths:
So this equates to 398 deaths reported from the US.
However, based on independent estimates, the death rate from the shot is around 411 deaths per million doses (for example, see Mathew Crawford’s analysis of this; I offered $1M to anyone who could prove this was wrong and there were no takers).
So we would have expected to see 411*86=35,346 causal deaths (these are not “background deaths” which we can estimated to be 52M*1%*2/12=86,000 deaths). So we’ll make the assumption that these are just causal deaths since otherwise the URF would be much larger (and we want to be very conservative here).
So a URF estimate of 89.
This means for every 89 real world events, we’ll only get 1 report filed. This is pretty typical for a voluntary adverse event reporting system as was pointed out in the Lazarus report.
In short, if you thought the number of events reported in this report are bad, it’s actually around 89 worse than you previously thought.
URF estimate #2: 115
There is a second independent way to calculate the URF: we can use the anaphylaxis data.
We know from the Blumenthal study that the rates of anaphylaxis are roughly 2.47 per 10,000 doses. So we should expect to see 86M doses*(2.47 anaph/10K doses)=21,242 cases in the US.
But we only saw 184 case reports in the US:
So this is an estimated URF of 115 which is even worse for Pfizer than our previous calculation.
And that’s for the most serious events. For less serious events, the underreporting factor is much much higher.
So the bottom line is that it’s a reasonable bet that the reality is around 100X worse than what is in the reports and we just showed it two different ways.
URF estimate #3: 163
We can use other adverse events as well to show that the Pfizer report is at least 100X underreported.
For example, pulmonary embolism which VAERS shows is elevated by 954X normal.
So at a minimum, we’d expect to see at least the normal rate of pulmonary embolism in that population (even worse since the population would skew to the elderly since they were vaccinated first).
The scientific literature says the normal PE rate is 60 to 70 per 100,000 people per year.
There were 60 reports of PE, but that was worldwide. Only 1/3 of the reports came from the US, so that’s around 20 PE reports for the 56M people who got at least one shot. 700*56=39,200 per year so over 3 months, we’d expect 9,800.
Since we saw only 20 and expected at least 9,800 even for no elevation, that’s an underreporting factor of 490.
However, only a third of the PE’s will happen right after the a specific shot, so it’s more like a URF of at least 163 on this less serious event.
So once again, our URF of 100 for serious events is reasonable.
So we’ve now given you three different ways to show the report is at least 100X underreported.
1. Pfizer claimed repeatedly in their documents to the FDA that their vaccine would “prevent” COVID-19
In this document, they claimed on Page 1, Box 15A: that their application was for a product with the following Proposed Indication for Use: “Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals ≥ 16 years of age”.
Here on Page 3, they make the same claim again, this time in a waiver document that is described in more detail in point number 6. They state, “The proposed indication that is the subject of this initial BLA application is active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older” [emphasis added].
Also in this document on page 1 they again claim that, “The proposed indication is active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. [emphasis added]”
Did Pfizer defraud the FDA by claiming the vaccine they were proposing would “prevent” COVID-19?
2. Pfizer knew the injection’s adverse effects would increase with more injections of continuing boosters
Specifically, on page 24 of this document, they state that, “Local reactions were observed in male and female animals dosed IM with BNT162b2 (V8). The incidence and severity of the reactions were higher after the second or third injections compared with the first injection. The majority of animals had very slight edema or rarely slight erythema after the first dose. After the second or third dose, the severity of edema and erythema increased up to moderate or rarely, severe grades. [emphasis added]”
Clearly they knew the side effects were dose dependent and thus they knew the vaccines were causing these effects.
They also knew that these adverse effects could include such things as muscle necrosis and increased spleen size and weight.
They state, “BNT162b2 (V8)-related higher absolute and relative (to body) spleen weights (up to 1.62x controls) were evident and correlated with the macroscopic observation of increased spleen size...Injection site inflammation was associated with moderate edema, mild myofiber degeneration, occasional muscle necrosis, and mild fibrosis” (page 25).
These terrible reactions, particularly the necrosis, we have seen evidence of in the medical literature after administration of these vaccines in the wider public. Indeed, their own animal studies indicated as much.
Funny, when I was vaccinated they never warned me about any of this. I don’t recall Fauci or Walensky mentioning it either. Do you?
See the following studies for discussions of various forms of necrosis after COVID-19 vaccine administration:
Lal, N., Khan, S. A., Pillai, A. R., & Khan, S. A. (2021). COVID vaccine related lower limb gangrene: the first case report. International Surgery Journal, 8(10), 3204-3207. https://dx.doi.org/10.18203/2349-2902.isj20214026
Kuzumi, A., Yoshizaki, A., Chiba, K., Mitsuo, S., Matsuda, K. M., Norimatsu, Y., ... & Sato, S. (2021). Genital necrosis with cutaneous thrombosis after COVID‐19 mRNA vaccination. Journal of the European Academy of Dermatology and Venereology. https://doi.org/10.1111/jdv.17837
Mishra, S. B., Mahendradas, P., Kawali, A., Sanjay, S., & Shetty, R. (2021). Reactivation of varicella zoster infection presenting as acute retinal necrosis post COVID 19 vaccination in an Asian Indian male. European journal of ophthalmology, 11206721211046485.
Iwai, S., Takayama, K., Sora, D., & Takeuchi, M. (2021). A Case of Acute Retinal Necrosis Associated with Reactivation of Varicella Zoster Virus after COVID-19 Vaccination. Ocular immunology and inflammation, 1-3. https://doi.org/10.1080/09273948.2021.2001541
Gruenstein, D., & Levitt, J. (2021). Skin necrosis at both COVID-19 vaccine injection sites. JAAD Case Reports, 15, 67-68. https://www.jaadcasereports.org/article/S2352-5126(21)00510-5/fulltext
Ramessur, R., Saffar, N., Czako, B., Agarwal, A., & Batta, K. (2021). Cutaneous thrombosis associated with skin necrosis following Oxford‐AstraZeneca COVID‐19 vaccination. Clinical and Experimental Dermatology. https://dx.doi.org/10.1111%2Fced.14819
3. Pfizer knew their injections did not stay at the injection site
As I pointed out back in May of 2021, the injection doesn’t stay at the injection site.
The exact same data is included in the released documents as Byram Bridle obtained in May via FOIA from the Japanese government.
Indeed their own data from animal trials shows that with just one dose over a 48 hour period the vaccine quantity decreases from the injection site and increases substantially in the ovaries, liver, and spleen in particular, but also in adrenal glands, bladder, bone, bone marrow, eyes, large intestine, lymph nodes, pancreas, salivary glands, skin, small intestine, testes, thymus, thyroid, and the uterus.
To be specific, 0.09% of the injection ends up in the ovaries, 1.03% of the injection ends up in the spleen, and around 16.2% of the injection ends up in the liver after 48 hours (page 7 and 8).
Please see the tables on page 8 of this report, which refer to Report Number: 185350, which is referenced on page 2.
Yellow highlighting means the amount of μg lipid equivalent/g of the Pfizer injection increases rather than decreases over the 48hr period they observed. Orange means same as yellow but moderately high compared with others. Red means same as yellow but it is very high compared with all others. Green is where the injection started, and where they claimed it would stay. It clearly decreases over time and shows up other places in your body particularly the liver, ovaries, and spleen.
4. Pfizer knew that the vaccinated group reported far more systemic adverse events than the placebo group
Pfizer’s own reactogenicity data shows that the people receiving the injections of BNT162b2 (30 μg) are anywhere from twice to 25 or more times as likely to have severe systemic events compared with the placebo group.
A quick glance through this data shows just how badly the vaccine affected people compared with the control group. For example, within seven days after each dose, twice as many people (23%) in the vaccinated group suffered systemic events compared with the placebo group (11.3%), while severe fever was noted in the vaccinated group 14 times as much as the placebo group.
5. Pfizer knew that the efficacy of the vaccine waned very quickly over time
While the mainstream media did the best they could at selling the Pfizer vaccine as “safe and effective,” Pfizer’s own data as early as September 19, 2020, showed neither of those things.
In particular, the vaccine efficacy, even for the short period for which it was studied, showed that it waned by as much as 50% in as little as 1 month after the second dose (See S1-Binding and RBD-Binding IgG Levels in the following table).
This information was hidden from the public and was widely denounced as medical misinformation until the “rare breakthrough cases” became so common that they could no longer be denied.
Turns out, they knew the whole time.
They just didn’t tell us for some reason and neither did the FDA or CDC. It was probably just an oversight.
30 μg dose rate
6. Pfizer defended VAERS
Pfizer applied for an FDA waiver to not have to record certain safety data on the injections because they claimed VAERS was the system that would tell us if there were safety issues with the injections. Then the mainstream media disparaged VAERS data for the past year and acted as if it was not as significant as it really was.
In reality, on page 3 and 4 of their waiver request, Pfizer says VAERS is a "robust" system that is "designed to detect safety concerns with vaccines." They even used this excuse for their suffix waiver claiming they didn’t need to have an FDA designated suffix that would help "ensure safe dispensing practices and optimal pharmacovigilance" because the VAERS system was “adequate” and that any other safety reporting requirements would be “redundant and burdensome.”
When they don’t want to do extra work, it is amazing how reliable and accurate VAERS is. But when there are adverse safety signals, then VAERS is junk.
7. There are six individuals that signed up for two different clinical trials at two different sites
We have some real go-getters in this country, we had half a dozen people sign up to be guinea pigs for not just one experimental injection study, but two! According to page 20 of this Pfizer document, “6 Subjects were enrolled into the study more than once”. Unfortunately, their atta-boy attitude did not help the study and Pfizer was forced to eliminate their results stating that, “These subjects will not be included in any analyses.”
That’s comforting, but how they heck did they get past the enrollment process?
8. Pfizer knew vaccinated individuals could still catch COVID-19 and test positive
In this document, Pfizer provides tables of all the different conditions under which people got sick with COVID-19 after the vaccination or placebo was administered. Overall, 12% of reported positive and/or symptomatic cases are individuals who have been vaccinated with either one or two doses of Pfizer (BNT162b2, 30 μg). This means that Pfizer’s claim in their other documents that this vaccine prevents SARS-CoV-2 infection is demonstrably false, and they knew it.
9. There are 1,448 pages comprising 9,704 individual subjects who were excluded from the trials
These people were excluded from the trials for various reasons including not receiving Dose 2 within the predefined window, not receiving all vaccinations as randomized, or having important protocol deviations.
Remember, all the people who never went back for their second shots during 2021?
How many of these individuals in the clinical study didn’t go back for their second shot because of some reaction they may have had?
What we know from my earlier work is that the number of drop outs in the Phase 3 trail were impossibly high in the treatment group. It couldn’t have happened by “bad luck.”
Here’s the slide from an earlier slide deck I did (see slide 33, but the rest of the presentation is awesome too):
Also, this brings to mind the Ventavia Research Group whistleblower whose story was published in the British Medical Journal regarding “poor laboratory management, patient safety concerns, and data integrity issues”.
10. Pfizer paid $2,875,842.00 for their application to the FDA
If you were wondering what it cost Pfizer and what the FDA charged to evaluate this horrid series of reports and clinical studies included in their application, it was around $2.9 million dollars.
11. Redactions of key data
It is troubling that Pfizer redacts information that is not proprietary that would be very helpful in assessing the data such as the number of doses administered in the ADVERSE EVENTS OF SPECIAL INTEREST” (AESI) document (aka the 5.3.6 document).
12. Pfizer only tests you for COVID if you have at least one symptom.
If the vaccine suppresses symptoms (which it apparently does), then it will falsely appear as if the vaccine reduces the number of COVID cases.
2.7.4 Clinical efficacy document contains Table 34 which compares Covid symptoms between vaxxed and unvaxxed.
The vaxxed group have a significantly lower percentage of people who experience several of the hallmark symptoms of Covid: 100% reduction in shortness of breath; 47% fewer reports of fever; 47% fewer reports of cough; 29% reduction in chills; 75% reduction in muscle pain; 11% reduction in sore throat. The only increase was for loss of taste or smell. The vaxxed group actually had a significant rate of experience either of these at +136%.
These could help explain why the vaxxed group are spreading the virus; they simply are unaware that they are sick due to suppression of these important symptoms.
Remember, for the purpose of its study, Pfizer defines a case as first, having at least one symptom followed by a + RT-PCR test.
Without at least one symptom, it appears the RT-PCR test is not done at all.
Therefore, the study should find fewer cases in the vaccinated group, even if the vaccine is completely ineffective in reducing the number of infections.
Anaphylaxis not seen in the trial at all; only seen post-marketing. That’s impossible.
When the shots were administered, people quickly discovered a high rate of anaphylaxis. It’s right there in the 5.3.6 document on page 9:
How could the Pfizer Phase 3 clinical trial not have found that??
Anaphylaxis wasn’t mentioned at all in the Phase 3 trial report despite the fact that it is life threatening.
It wasn’t mentioned in the 6 month follow up study either. That study would have included reactions of the placebo cohort who got the vaccine.
Anaphylaxis occurs at 2.47 events per 10,000 doses so there should have been around 10 events observed for the full-vaccinated treatment group (44,000 doses) and a similar number of events when the placebo group was vaccinated.
So we should have seen 21 anaphylaxis events on average yet there were none reported. This couldn’t happen by chance (very very unlikely).
How does Pfizer explain that?
This is, of course, a rhetorical question as nobody is going to ask them that question and they don’t have to answer it. That’s just the way it works in medicine. You are not allowed to ask questions like this. It’s “science.”
We are teaching our kids to believe whatever the drug companies tell them and not ask questions.
The FDA is never going to ask them to explain it.
Other analyses of the Pfizer data
Dr. Been looks at the “5.3.6 document” which is the post-marketing adverse event data in this 1 hour YouTube video. This is the document with the famous: “LIST OF ADVERSE EVENTS OF SPECIAL INTEREST” (AESI) which has 9 pages of adverse events packed very tightly. My favorite comment on this video is this one: How is it possible that Dr Been, singlehanded, can clearly inform the public, while the US government fails every opportunity? That’s a good question.
We will be publishing more of this information as we have time to go through it with exact links to every page, but we’re sure other independent investigators will look through these documents as well. Specifically, we need people who are skilled in reading these types of pharmaceutical reports and anyone who has good skills with SAS databases.
If you want to work with us, let me know in the comments.
If you find any key items we missed, let me know in the comments. I’ll be updating this document as I learn more, so be sure to check the online version for the latest info (and not what is emailed to you).