Under-reporting to VAERS of World ex-US events is just part of the story – using Phase 3 Process 1 and Process 2 trial data data the Under Reporting Factor for VAERS is actually over 80
It is Superbowl day and also the start of the Chinese New Year of the Dragon, signifying growth.
This is a long rant. I have been behaving like a ferret it a warren of rabbit holes for the last day, trying to piece together a “big picture” of actual adverse events that have been inflicted on those receiving just the Pfizer and Moderna C19 mRNA injections of spike venom.
I believe I have uncovered not just the inconsistency between US and World ex-US rates of harms per dose reported to VAERS, but also the possibility that the CDC/FDA can only afford to pay a subcontractor so much money every six months to process adverse event reports – so there is a strict quota of reports processed by the sub-contractor onto VAERS – regardless of how many reports are filed.
The unprocessed reports are held in a “private” part of VAERS to be drawn down only if the CDC/FDA has the money to pay for their release.
Here’s the TLDR (too long didn’t read” snapshot.
This analysis does not focus on deaths reported to VAERS or the overall level of excess deaths in the US or elsewhere that is being looked by experts such as Denis Rancourt. It focuses on the levels of adverse events that SHOULD be reported in public from the VAERS.
Only one report, the initial one, can be submitted to VAERS – no worsening symptoms or a subsequent death can be reported.
Process 2 harms are around double that of Process 1 harms 0 that is, what was injected was a different process and hence a different product. Although the sample size of Process 2 in the Phase 3 Pfizer clinical trials was just a few hundred or so v the 45,000 odd Process 1 population, the harms were indicated at around double for Process 2.
Four months PRIOR to the EUA for the injections in August 2020, the CDC/FDA opted out of verifying and releasing VAERS reports – awarding contracts of around 40 million bucks to General Dynamic IT and Eagle Health Analytics for an anticipated 1,000 a day rate of reporting of adverse events. This despite a national emergency and the CDC/FDA having over 20,000 staff. Peeling off a few thousand during an emergency should have been the preferred course of action, not spending tens of millions of dollars on sub-contractors.
We know that VAERS published public reports of adverse events AND that it maintains a private database of unprocessed VAERS reports.
This analysis does not focus on deaths reported to VAERS or the overall level of excess deaths in the US or elsewhere that is being looked by experts such as Denis Rancourt. It focuses on the Levels of adverse events that SHOULD be reported in public from the VAERS.
I have reported previously that, given the 1 million adverse events on VAERS for the US for 670 million doses administered, that the adverse events reported for billions of Pfizer and Moderna doses administered OUTSIDE the US (which must be reported to VAERS by manufacturers) should be 9.6 million, not the 0.6 million reports showing on VAERS.
This means the adverse events on VAERS should be of the order of 10 million not 1.6 million.
The number of adverse events per dose in the Pfizer Phase 3 clinical trial was around 5,200 for 44,000 doses amongst 22,000 injected trial participants for a to dose regimen.
Process 2 was around twice as harmful – so we can just use the 20% rate of adverse events to reflect the adverse events from Process 2 that was actually injected into arms.
For the 670 million doses injected, around 130 million adverse evets (multiple per person) for Americans. Pfizer and Moderna doses were administered globally, around 6.2 billion times. Indicating around 130 million adverse events were suffered and should have been reported to VAERS.
Given this horrendous incidence of adverse events, I want to point out that estimates of under-reporting and validation of processing of VAERS reports is missing the point.
130 million adverse events have likely been inflicted – so what the hell is going on?
The FDA/CDC and General Dynamics came to an arrangement on a pay per VAERS report QUOTA basis. Regardless of actual adverse events suffered or reported, General Dynamics was told to ONLY report adverse events at a pre-determined rate.
Here’s a table that illustrate the point.
I haven’t seen any details on renewals of contract since February 2022, but the latest ones agree a payment to General Dynamics to process 13,000 adverse events a week. Assuming one hour to process each adverse event report and a 5-day week, it would take a team of 325 to process 13,000 reports a week. Cost at say, 2,000 bucks a week each = 650,000 a week, 33.8 million a year. Weare looking at around at least 100 to 150 million bucks over the last 3 years paid to process a quota.
How many adverse events have been released to the public section of VAERS over the period to February 2022?
From here, scoot down to the cumulative adverse events chart halfway down:
Eyeballing that chart for the dates that coincide with the contracts yields this table:
The key column is the end one that can be compared to the “pay per adverse event report” contract with General Dynamics.
Does it more or less match to the contention that General Dynamics is paid to produce a specific number of adverse events over successive 6-month contract periods and NOT the actual adverse events reports held in “inventory” that number at least 10 million, rather than 1.6 million reports released to “public VAERS”?
Which brings us to the final part of this TLDR section of this article.
There are probably around 130 million adverse events suffered, based on the Process 1 and Process 2 data in the Pfizer Phase 3 clinical trials and over 6 billion Pfizer and Moderna does administered globally.
Given that just 1.6 million have been reported, the Under Reporting Factor is over 80.
Okay, now for the “I have time, spell it out” section.
I posted an article indicating that, given the incidence rate of adverse events posted to VAERS and the number of US injections administered, the pro-rata reports of adverse events for no-US injections should be ten million, not the 600,000 ex-US events posted to VAERS.
Question: If 670 million injections cause 1 million adverse events, how many adverse events would 6.2 billion injections cause? According to reports to VAERS – not 9.6 million but just 600,00 (substack.com)
“650 million Pfizer/BioNTech and Moderna injections in the US resulted in 1 million reports to VAERS.
6.2 BILLION Pfizer/BioNTech and Moderna injections in the World ex-US resulted in just 600,000 reported adverse events.
If the rate of adverse events for 650 million Pfizer and Moderna injections (out of 670 million total) reported to VAERS for the US was scaled to the number of adverse events for the Rest of the World ex-US, there should be 9.5 million adverse events for the world-ex US, not 600,000.
Bottom line: There should be 9.6 million World ex-US adverse events reported to VAERS, not 600,000 which would lift the total adverse events globally to 10 million from 1.6 million.
Global deaths reported to VAERS in total on this basis should be around 130,000 not 35,000.
In February 2023 I posted this:
“A FOIA request revealed, in late August 2020, that the CDC contracted with General Dynamics to handle VAERS reports for COVID-19 vaccines. The contract anticipated up to 1,000 reports per day, with up to 40% of them serious in nature, Josh Guetzkow reported. The value of the year-long contract was $9.45 million.
In March 2021 the contract was amended to process backlogged reports filed through Feb. 28 for an additional $21.5 million. The CDC also contracted Eagle Health Analytics to assist with the processing for an additional $6 million.”
So that’s 31 million bucks to General Dynamics and another 6 million to Eagle Health by March 2021 – three months after the spike venom injections were given EUA. Presumably the 11,000 workers in each of the FDA and CDC could not do this working from home.
Okay. Let’s develop this quota reporting system further.
Check out this article from 30 March 2023 about how adverse events were “contracted out” by quota to General Dynamics.
A couple of points leap out. Adverse events are NOT processed by the CDC/FDA - they are processed under a quota arrangement via a contract with General Dynamics. A company called Eagle Health Analytics “assists”.
First, here’s the Eagle Health part:
“Additionally, I discovered that Eagle Health Analytics was awarded a separate contract by the CDC and FDA dated July 8, 2021. As part of this contract, they are seeking assistance with various things, including medical officers and epidemiologist support for the VAERS program.”
Now check out the deal with General Dynamics IT.
“A 142 page freedom of information request reveals shocking Covid-19 vaccine adverse event contract documents between the CDC, FDA and General Dynamics Information Technology dated August 27, 2020, four months BEFORE the Covid-19 vaccines were introduced to the general population.”
Interesting prescience. The clinical trials had only started the month before, so how could they possibly guess the rate of adverse events (which turned out at around 20% of those double dosed or around 70 million adverse events from the 670 million doses eventually administered).
5,241 related adverse events from 43,826 mRNA injections into 21,926 test subjects with = 24% of those injected and 12% adverse events for each injection.
12% of 670 million doses actually injected = around 80 million adverse events indicated by the Pfizer Phase III clinical trial – and this with Process 1, not the 2-3 times WORSE Process 2 that has all the contaminants in it.
Back to the General Dynamics IT quota of VAERS reports processing contract.
I will list all the contracts posted in the Canadian Independent SubStack for ease – so this means the August 202p is repeated.
Here’s the sequence of contract amendments of that August 2020 contract. over 2021 and the start of 2022.
First contract in August 2020:
“The total number of reports received during periods of peak activity (which are not expected to reflect sustained activity) is expected to be 1,000 reports per day, with up to 40% of the reports serious in nature.”
Okay so a thousand a day, 40% serious - life threatening – as opposed to severe = life threatening – the use of the term “serious” is important.
Anyway, an adverse event report rate in the prescient August 2020 contract was 30,000 a month.
Even the FDA acknowledged that the under-reporting factor was between 10 and 100! From the Canadian Independent SubStack article link.
“It’s worth noting that according to the FDA. “It does not get most reports of adverse events that occur in the United States. Estimates suggest that FDA receives reports of about 1 to 10 percent of the adverse events that occur.” – 1% = an under-reporting factor (URF) of 100, 10% = a URF of 10
Check out what happened via reference to the Pfizer post marketing authorization report for the ten weeks ending 28 February 2021 – not VAERS, but still no hint of an under-reporting factor to be applied to the report as would be the case for VAERS.
Recall that Pfizer alone collected 42,000 adverse event reports (including 1,223 deaths) in the 10 week post marketing authorisation report for the period from mid-December 2020 to end February 2021.- Page 7 here: reissue_5.3.6-postmarketing-experience.pdf (phmpt.org)
The General Dynamics contract budgeted a quota rate for those ten weeks’ worth of 30,000 a month = around 75,000 reports for those ten weeks.
Pfizer had administered 38 million and Moderna 37 million, for a total of 75 million C19 mRNA spike venom injections – so we can double the number of post marketing authorization reports to around 84,000 VAERS reports to end February 2021.
Injections doubled in March 2021 – meaning you can double that Pfizer + Moderna post marketing authorisation report guesstimate adverse event number from 84,000 to 168,000 by end March 2021 compared to the ten weeks to end February 2021.
So, we are at 168,000 adverse events for the number of injections (147 million) administered over the 14 weeks to end March 2021. That’s a six-monthly rate of 312,000. Six months seems to be the usual contract period for the quota of reports processed by General Dynamics IT.
Back to the General Dynamics IT quota of VAERS reports processing contract.
Contract amended in March 2021:
“In March 2021, about three and a half months after the Covid-19 vaccines were introduced to the public, the CDC and FDA amended the contract with General Dynamics Information Technology. The amendment was seeking 6 months of assistance in dealing with a backlog of an estimated 115,000 adverse event reports.”
115,000 per 6 months = 632 a day. 3,800 a month – which seems odd given the likelihood that the monthly equivalent of 84,000 for Pfizer + Moderna adverse events in the post marketing authorization reports + an estimate for March 2021’s doubling of injections to a rate of 312,000 for six months!!!!!
Contract amended four days after the March 2021 contract was signed.
“Four days later the contract is amended again asking General Dynamics Information Technology to now help in dealing with a minimum 25,000 adverse event reports per week for the next 6 months.”
Ok, back on track to process a set amount of adverse event reports that might conform to some sort of reality. 25,000 a week = 650,000 adverse events expected over the next 6 months – more than double the six-monthly rate over the period to 31 March 2021.
This must have been to align with PROJECTED injection uptake in the six months to September 2021 – quite the moving feast!
Here’s the actual (not the CDC/FDA/General Dynamic projected vaxx uptake and adverse events.
377 million Pfizer + Moderna doses, compared to the end March 2021 total doses of 147 million = an increase of 230 million.
Doses administered more than doubled again (+156%) The quota of 660,000 adverse events to be processed in this contract, revised after just 4 days, looks broadly consistent with a constant rate of adverse events expected.
To stress – this does not mean that 660,000 adverse events would occur, just that 660,000 adverse events would be reported – as a minimum. There could well be a million or two million adverse events, but General Dynamics would process a minimum of 660,000.
Note that “adverse events expected#” is now conforming to pre-meditated harms – that is intentional assaults.
Note also that the rate of assaults is determined by contract NOT by the actual assaults inflicted – those are secondary to the General Dynamics IT contract – they will only report adverse events to VAERS at a contracted rate of 600,000 for six months (100,000 per month).
“Another amended contract several months later, on September 24, 2021, between the CDC, FDA, and General Dynamics Information Technology shows the CDC and FDA are now asking the company to process a minimum 13,000 extra adverse event reports per week over the next six months.”
Hmm. 13,000 reports required to be processed over the six months to end March 2022.
Actual doses administered = 541 million, compared to 376 million at end September 2021 an increase of 165 million.
A predicted fall in the 6-month rate of harms from 25,000 a week to September 2021 (contracted in March 2021 to a rate of 13,000 a week to March 2022 (contracted in September 2021).
”They amended the contract again in February 2022, requesting General Dynamics Information Technology to continue assisting with a minimum 13,000 adverse event reports per week for another six months.”
Not so much an amendment as a renewal.
Actual doses administered at end February 2022 and end August 2022 here:
So, here’s the beef.
How many ACTUAL adverse events were sent to General Dynamics for processing? The issue is that General Dynamics are only processing adverse events at the rate they are contracted to produce reports for – and there is a massive backlog of adverse events reports that General Dynamics have not released to VAERS.
Oh, by the way, does anyone have access to the EMA’s data on its adverse reporting system EUDRA/ I haven’t seen any updates to this a year ago:
It has this (Remember ALL Pfizer and Moderna adverse events MUST be reported to VAER and just 600,000 adverse events ex-US have been reported for these international events.
That’s 1.6 million adverse evets just for the EU for 820 million doses using data from here:
Okay, now take a look art this chart of weekly adverse events reported and see if you can if you think it matches a quota of reported adverse events or likely adverse events.
It represents the weekly data for 2023 taken from updates from here – the CDC now reports VAERS data monthly. Monthly “Total adverse events” for months of October 2023 through January 2024 were 8.781, 9,256, 6,100 and 5,250.
Out of interest, US vaxx doses for 31 December 2022, 31 January 2023 and up to the last date on the OurWorldinData system in March 2023 are below:
Enquiring minds want to know how the adverse events reported weekly are more or less the same when there are so few doses being given and 70-90% of adverse events occur within the first few weeks.
Makes you wonder if the CDC stopped reporting the number of doses since it would reveal the quota driven nature of the contracts negotiated with General Dynamics IT to only process a fraction of the reports it has received.
I estimate that given the adverse event rate per dose for the three-month (instead of six month) Pfizer Phase iii clinical trial related adverse event rate of 12% of doses (24% of people receiving two doses each) using the “clean Process 1, that:
Note there will be some people who suffered multiple adverse events from multiple doses.
At a minimum 670 million US doses administered x 12% = 80 million adverse events would have been reported had Process 1 been used. Given 20 people died in the Pfizer Phase 3 clinical trial for 5,200 adverse events we can divide that 80 million by 260 to get to 300,000 or so vaxx deaths IF Process 1 had been used.
At a minimum for 6.2 billion global doses administered x 12% = 744 million adverse events should have been reported. Deaths had Process 1 been used would have been 2.86 million.
Some adjustment to these estimated could be made for the use of Process 2 - used in the real-world v the Process 1 - that was used in the clinical trials.
You could multiply those adverse events using Process 1 estimates of harms by 2-3 times to get the real number of adverse events.
I can’t track down the reference to Levi and Getzkow, but here’s a paper they wrote on the topic.
And an article with mor detail
Keep in mind also that these numbers are for the short term of less than a year. They need to be reconciled, for example, to the excess deaths increase of around 16% per annum for the last four years.
The last three years of excess deaths being dominated by the C19 spike venom injections – killing 1.6 million Americans who would otherwise still be alive today.
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