by Dr. Joseph Mercola, Mercola:
STORY AT-A-GLANCE
- In September 2022, The Epoch Times asked the U.S. Centers for Disease Control and Prevention to release its Proportional Reporting Ratio (PRR) data mining results. The CDC refused. A Freedom of Information Act (FOIA) request has now forced the release of these data, and they are stunning
- The CDC’s PRR monitoring has identified several hundred safety signals, including for Bell’s palsy, blood clots, pulmonary embolism and death. In individuals aged 18 and older, there are 770 safety signals for different adverse events, and more than 500 of them have a stronger safety signal than myocarditis and pericarditis
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- In the 12- to 17-year-old age group there are 96 safety signals, and in the 5- to 11-year-old group there are 66, including myocarditis, pericarditis, ventricular dysfunction, cardiac valve incompetency, pericardial and pleural effusion, chest pain, appendicitis and appendectomies, Kawasaki’s disease and vitiligo
- The proportions of deaths, which were only provided for the 18-plus age group, was 14% for the COVID jabs compared to 4.7% for all other vaccines
- The FDA is also required to perform safety monitoring, using empirical Bayesian data mining. The Epoch Times asked the FDA to release its monitoring results in July 2022 but, like the CDC, the FDA refused, only to admit in December 2022 they’d confirmed the Pfizer shot was linked to pulmonary embolism
In September 2022, The Epoch Times asked the U.S. Centers for Disease Control and Prevention to release its Proportional Reporting Ratio (PRR) data mining results. PRR1 measures how common an adverse event is for a specific drug compared to all the other drugs in the database.
According to the standard operating procedures2,3 for the Vaccine Adverse Event Reporting System (VAERS), which is run jointly by the CDC and the Food and Drug Administration, the CDC is required to perform these data mining analyses.
Not only did the CDC refuse to release the data, but it also provided false information — twice — in response to The Epoch Times’ questions about the monitoring being performed. As reported by The Epoch Times back in September 2022,4 the CDC initially claimed PRR analyses were “outside the agency’s purview” and that no monitoring was being done by them.
Eventually, the agency admitted it was doing PRRs, starting in February 2021, only to later claim they didn’t perform any PRRs until March 2022. The Epoch Times also cited several papers in which the FDA and/or CDC claimed their data mining efforts had come up empty handed.5 Now, we find that was all a pack of lies.
CDC Monitoring Reveals Hundreds of Safety Signals
In reality, the CDC’s PRR monitoring reveals HUNDREDS of safety signals, including Bell’s palsy, blood clots, pulmonary embolism and death — all of which, according to the rules, require thorough investigation to either confirm or rule out a possible link to the shots. As reported by The Epoch Times in early January 2023:6
“The CDC analysis was conducted on adverse events reported from Dec. 14, 2020, to July 29, 2022. The Epoch Times obtained the results through a Freedom of Information Act request after the CDC refused to make the results public …
PRR involves comparing the incidence of a specific adverse event after a specific vaccine to the incidence after all other vaccines. A signal is triggered when three thresholds are met, according to the CDC: a PRR of at least 2, a chi-squared statistic of at least 4, and three or more cases of the event following receipt of the vaccine being analyzed. Chi-squared tests are a form of statistical analysis used to examine data.
The results obtained by The Epoch Times show that there are hundreds of adverse events (AEs) that meet the definition, including serious conditions such as blood clotting in the lungs, intermenstrual bleeding, a lack of oxygen to the heart, and even death. The high numbers, particularly the chi-squared figures, concerned experts.
For many of the events, ‘the chi-squared is so high that, from a Bayesian perspective, the probability that the true rate of the AE of the COVID vaccines is not higher than that of the non-COVID vaccines is essentially zero,’ Norman Fenton, a professor of risk management at Queen Mary University of London, told The Epoch Times in an email after running the numbers through a Bayesian model that provides probabilities based on available information.”
Myopericarditis Is Far From the Only Problem
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). Alas, the PRR monitoring results reveal there are more than 500 other adverse events that have stronger warning signals than either of those conditions.
Josh Guetzkow, an Israeli professor trained in statistics at Princeton University told The Epoch Times:7
“We know that the signal for myocarditis is associated with something that is caused by the mRNA vaccines, so it’s more than reasonable to say that anything with a signal larger than myocarditis/pericarditis should be taken seriously and investigated.”
Guetzkow expanded on his commentary in a January 4, 2023, Substack article.8 Below is a summary list of some of the key findings from the CDC’s PRR analysis. Guetzkow goes deeper in his article, so for more details, I suggest reading it in its entirety.
For even more analyses and commentary, see Fenton’s Substack article, “The CDC’s Data on COVID Vaccine Safety Signals.”9 If you want to investigate the PRR data for yourself, you can download them from The Epoch Times’ January 3, 2023, article.10 You can also find them here.11
| 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,12 “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. |
It’s worth noting that the CDC didn’t perform its first safety signal analysis until March 25, 2022 — 15 months after the shots were rolled out. Why the long wait — especially since the CDC had announced it would begin monitoring in early 2021? Just consider, for a moment, how many lives have been lost because the CDC failed to properly monitor safety, and still drags its feet when it comes to warning people about the risks involved.
FDA Still Refuses to Share Safety Data
The FDA is also required to perform safety monitoring using another technique called Empirical Bayesian data mining. The Epoch Times first asked the FDA to release its monitoring results back in July 2022,13,14 but like the CDC, the FDA refused and insisted the data showed no evidence of serious adverse effects. In other words, “Just trust us. We’re experts.”
According to the FDA, the only potential signal they’d found through April 16, 2021, was for raised body temperature.15 Then, in mid-December 2022 — just four months after The Epoch Times tried to get these data — the FDA announced that pulmonary embolism (blood clots that block blood flow in the lungs) had met the threshold for a statistical signal, and continued to meet the criteria after in-depth evaluation, but it was only linked to the Pfizer jab.16
As noted by The Epoch Times,17 pulmonary embolism is also identified as a signal in the CDC’s PRR analysis for individuals as young as 12, which really ought to strengthen concerns.
The FDA also admitted it had already evaluated three other warning signals: lack of oxygen to the heart, immune thrombocytopenia (a blood platelet disorder) and intravascular coagulation (a type of blood clotting), but none of these continued to meet the threshold after analysis.
If the FDA was evaluating four warning signals, why did they tell The Epoch Times there was no evidence of ill effects, and why did they claim the only potential signal they’d found was slight fever? Are we to believe they discovered these signals after The Epoch Times asked for the monitoring results and then completed four in-depth investigations in four months?
Whatever the truth, it’s clear that both the CDC and FDA are not being transparent. Worse, they’ve hidden data, knowing it could mean the difference between life and death for hundreds of thousands of people.
CDC Has Ignored Clear ‘Death’ Signal
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 series18,19,20 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,21 Kirsch went on to show how “death” should have triggered a signal even when using the CDC’s flawed formula (which is described in its VAERS standard operating procedures manual22). Here’s an excerpt:23
“The formula the CDC uses for generating safety signals is fundamentally flawed; a ‘bad’ vaccine with lots of adverse events will ‘mask’ large numbers of important safety signals … Let me summarize the key points for you in a nutshell: PRR [proportional reporting ratio] is defined on page 16 in the CDC document24 as follows …
A ‘safety signal’ is defined on page 16 in the CDC document as a PRR of at least 2, chi-squared statistic of at least 4, and 3 or more cases of the AE [adverse event] following receipt of the specific vaccine of interest. This is the famous ‘and clause.’ Here it is from the document:
Only someone who is incompetent or is deliberately trying to make the vaccines look safe would use the word ‘and’ in the definition of a safety signal.
Using ‘and’ means that if any one of the conditions isn’t satisfied, no safety signal will be generated. As noted below, the PRR will rarely trigger which virtually guarantees that most events generated by an unsafe vaccine will never get flagged.
The PRR value for the COVID vaccines will rarely exceed 1 because there are so many adverse events from the COVID vaccine because it is so dangerous (i.e., B in the formula is a huge number) so the numerator is always near zero. Hence, the ‘safety signal’ is rarely triggered because the vaccine is so dangerous.”
A Fictitious Example
Using a fictitious vaccine as the example, Kirsch explained how an exceptionally dangerous vaccine will fly under the radar and not get flagged, thanks to this flawed formula:25
