Adverse Events are Real: Mass Vaccination Should Have Been Halted by March 2021

We are now a full year into mass vaccination for COVID-19. World-wide, the authorities are telling the people to get injected and injected again, with booster and more booster shots. People are told over and over that the injections are safe and effective. Billions of doses have now been administered globally. (voir version française)

While this massive campaign is underway, there are signs that something very wrong is happening: professional athletes dropping dead on the field; numerous myocarditis among adolescents; incredible numbers of adverse events, including deaths, being reported in pharmacovigilance systems.

Despite the unprecedented number of adverse events, including serious adverse events and deaths, being reported through these systems, public health authorities invariably continue to promote, and often mandate, the injections, without properly informing the population about the risks.

In many countries, measures such as mandates and vaccination passports are being heavy-handedly forced to the population. Some countries such as Austria, Germany and Costa Rica, are now moving towards mandatory injections. 

While this mass vaccination campaign is taking place, there are no signs that it is effective to get us out of this crisis. Many countries with high vaccination rates record high rates of new infections. There are also numerous so called “breakthrough” cases, i.e. jabbed people developing disease, severe disease or death.

Everything points at a limited effectiveness of the mass vaccination campaign, and even more importantly, at major safety issues.

Yet the authorities continue to maintain that everything is fine, and are now pushing for kids, who are at extremely low risk of COVID-19, to get injected. The safe and effective narrative continues, despite the substantial  evidence there may be something very wrong happening.

The Pfizer Worldwide Safety Report

A Worldwide Safety Report by Pfizer was made public thanks to a legal filing by Public Health and Medical Professionals for Transparency, a non-profit seeking to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines.

The report was not supposed to become public. One can indeed read on the first page: “The information contained in this document is proprietary and confidential. Any disclosure, reproduction, distribution, or other dissemination of this information outside of Pfizer, its Affiliates, its Licensees, or Regulatory Agencies is strictly prohibited.”

The confidential report produced by Pfizer, titled “Cumulative Analysis of Post-authorization Adverse Event Reports,” is dated April 30 2021 and covers data up to February 28 2021. Those dates are important; this is not a November or December 2021 document; it’s a document that was compiled in March/April 2021.

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This is a monthly report, and unfortunately, the following reports – there should be 7 other such monthly reports already completed by now – have not been made public.

But don’t expect much more info available any time soon, as the FDA (not Pfizer!) has asked a judge to grant it until at least the Year 2096 to fully release Pfizer’s COVID-19 vaccine data! Yes you read well: unti Year 2096.

https://aaronsiri.substack.com/p/fda-doubles-down-asks-federal-judge

Most data are from the US and the UK. “Most cases (34,762) were received from United States (13,739), United Kingdom (13,404) Italy (2,578), Germany (1913), France (1506), Portugal (866) and Spain (756); the remaining 7,324 were distributed among 56 other countries.”

Mass vaccination started in the US on December 14 2020, following the emergency use authorization granted by the FDA on December 10. The report therefore covers only two and a half months. In the UK, mass vaccination for COVID-19 started on December 8 2020.

In the US for example, according to https://ourworldindata.org/, 8.8% of the eligible population had been vaccinated by February 28 2021, while, by December 5 2021, 59.6% had, i.e. 7 times more today. 

This is not the only reason why the data in this report represent a large under-estimation of the reality. The report relies on adverse events (AEs) “reported spontaneously to Pfizer, cases reported by the health authorities, cases published in the medical literature, cases from Pfizer-sponsored marketing programs, non-interventional studies, and cases of serious AEs reported from clinical studies regardless of causality assessment.”

One of the world’s prominent experts in analyzing adverse events, Jessica Rose, PhD, estimated that the number of adverse events in this Pfizer report represents just 50% of the adverse events reported to VAERS by that date. VAERS mostly covers the US while the Pfizer report is global, even if the bulk of the data mostly originates from a few countries, including the US.  

In addition, there is a massive under-reporting of adverse events in pharmacovigilance systems. One of the most credible estimates of the under-reporting factor is also by Rose, who estimates it at 31, i.e. only about  3% of adverse events occurring in relation with the Covid vaccines being actually reported to the VAERS system in the US.

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Check our interview with Jessica Rose, PhD, about what she found when analyzing VAERS data, including the issue of under-reporting and the question of causality, which she finds to be well established, using the Bradford Hill Criteria for Causation, in a majority of reports.

But even without taking into account any under-reporting, the data released by Pfizer are devastating and demonstrate that, clearly, those injections are not really safe. In history, there has never been a vaccination program allowed to continue with such high numbers of adverse events, including serious ones and deaths.

A Short Visit to the Chamber of Horrors

What does the Pfizer report indicate? Table 1 mentions that there were 42,086 reports by February 28 2021, for a total of 158,893 events. For unexplained reason, there were many more reports for females (29,914) than for males (9,182). Gender was unspecified for 2,990 cases, which indicates clear weaknesses in the data gathering.

Reading the Pfizer report is a bit like visiting a chamber of horrors. Featured are 1833 cases of anaphylaxis, 317 “relevant events” of Vaccine- Associated Enhanced Disease (VAED), including Vaccine- Associated Enhanced Respiratory Disease (VAERD); 270 “pregnancy outcomes” with little details for most of those reports; etc. 

While the injections were at the time focused on the elderly and not allowed in children, there are 34 reports of injections in children aged less than 12, with outcomes such as facial paralysis, lymphadenopathy, malaise, pruritus and swelling. Out of this 34, there were 16 unresolved and 5 unknown outcomes. Myocarditis is not predominant in the report, because there are just 5000 out of 42000 reports for people under age 30, and because of the gender imbalance in the reports.

Now, let’s have a look at the most serious issue: death.

When it comes to fatal outcomes, there are 1,223 deaths reported by Pfizer for this short period. Even within the context of this data, these 1,223 deaths are a clear under-estimate, as there are 11,361 patients “not recovered at the time of report” and 9,400 events for which the outcome is “unknown.”

But even if one disregards the issue of under-reporting, 1,223 deaths indicates a huge safety issue. Any real, serious, regulator should have immediately investigated and stopped the mass vaccination program with these injections.

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Despite this considerable yet heavily under-reported number of deaths, the report includes plenty of wordings such as “did not reveal any significant new safety information” and “does not raise new safety issues.” 

Even the 9 pages long Appendix of this report, which features a “List of Adverse Events of Special Interest,” is worth reading and is most scary. It’s a very long list of “Events of Special Interest” that you really don’t want to ever happen in your life, that of your kids, or to anyone. And yet, it’s what was already known to happen those having been injected back in March/April 2021. Like the rest of the report, this would have been kept confidential and unknown to the public, without the successful freedom of information request filing made by Public Health and Medical Professionals for Transparency. Here is page 1 of this Appendix. Find the other ones in the full report, linked below.

See Page 1Page 2Page 3Page 4Page 5Page 6Page 7Page 8Page 9 of the appendix. Or see the full Appendix as a .pdf.

In the Discussion, Summary and Conclusion sections on page 28-29, the authors note that “the data do not reveal any novel safety concerns or risks requiring label changes and support a favorable benefit risk profile,” which suggests they actually knew before about the devastating adverse events! 

The authors add that “review of the available data for this cumulative PM experience, confirms a favorable benefit: risk balance,” that Pfizer “will continue routine pharmacovigilance” and “will inform the Agency if an evaluation of the safety data yields significant new information.” 

The agency referred to here is the Food & Drug Administration – FDA – which was therefore fully aware, very early on, of the magnitude of the adverse events, but continued to claim publicly the injections were safe.

There is no information provided as to how the company computed its risk:benefit analysis, leading to the bold conclusion that there is a favourable benefit risk balance.

Note that PM stands for “Post Marketing.”

Yes, it’s not only a planetary clinical trial of some experimental injections that is under way, but it’s also and foremost a planetary marketing campaign …

Read the full report here.

Watch Vernon Coleman’s analysis of the report.


You may also want to visit the OpenVaers.org website, that presents / analyzes data from the Vaccines Adverse Events Reporting System. There are already over 1 million COVID related reports!