The simple challenge for anyone who thinks that the CDC is just fine using only this signal analysis is to put the actual numbers in a spreadsheet and see.
Oh, don't know which vaccines are proper comparators? Run a sensitivity analysis.
Oh, VAERS is too clunky to make that easy? Yeah, it's a dinosaur, and propositions to modernize it get ignored.
My second article adds some additional discussion of why after age stratification the COVID-19 vaccines dominate the c and d parameters---at least for those who aren't children (possibly them too).
I'm not a mathematician, but I have been analyzing the VAERS data weekly since February. My videos on this are on Bitchute. I did one back in June, 2021 comparing the reported deaths from CV vaccines to the reported deaths of ALL other vaccines going back 30 years. The graph is shocking. Here's the link: https://www.bitchute.com/video/cKTBa3okRs8L/
Thank you. That has been the hallmark of my writing and video-making for decades. I am (among other things) a freelance writer. You can read some of my pandemic-related articles here: https://westernstandardonline.com/author/karen-selick/
Well Karen I am a mathematician and can assure you the PRR is pure rubbish concocted to hide adverse events. It ONLY came into existence when the CDC decided to cook the VAERS books. Think of it as following in the footsteps of the BLS with it's recreated CPI, GDP and Unemployment numbers. Complete lies one and all. It is not difficult to cook the data. Most people never know it. Vaccine efficacy suffers from the problems with scaling as well which I've proved several times. As always it fell on deaf ears.
Question: how do you know the increases were not caused by the fact that the VAERS got better known and therefore was used more for reporting? Especially COVID vaccines and the political debate around it must have increased the motivation to report?
This seems a signal but it would be nice if alternative explanations were more explicitly refuted or acknowledged.
I agree it's possible that VAERS is now better known. However, on the opposite pan of the scale is the fact that whistleblowers have come forward to say that they are being explicitly instructed NOT to file VAERS reports in connection with Covid-19 injections. I've heard this on several occasions. One nurse in a southern US hospital said the nurses and doctors in her hospital were warned not to report anything to VAERS. I believe there was an implied threat that their jobs could be at stake.
CDC are encouraging people to log health details into this v-safe account. Maybe we need to be asking what that is showing rather than VAERS? Maybe people are reporting their and don't think they need to report on VAERS?
Jun 16, 2022Go to vsafe.cdc.gov and click I am here for myself. Click Access my account. Enter your v-safe registration code (the 13-character code you received after completing v - safe registration) or your information as you did when you originally enrolled and select Send Secure Link. You will receive a direct link to your account via text message.
Being better know doesn't even mean better reporting when doctors are backlogged hundreds or even thousands of reports that take substantial time to enter into the system.
It doesn't matter when using PRD/PRR, unless events are not reported in a product and symptom specific manner.
All that matters is the proportion. The difference gives a MUCH better idea of the side effects profile compared to the ratio. The ratio really only serves for signal detection, but NOT to give doctors and patients and idea of the side effects profile.
The entire post-approval pharmacovigilance analysis systems have been sabotaged.
It's full of information, but nothing has come of it. I can't even make statisticians listen. Sad.
That's not the issue here. They are sabotaging the parsing process. The age field was not populated in over 30% of reports that DID have the age specified. It took me one minute to write a simple RegEx to catch ALL these patient ages and I am not even good at RegEx.
Neither are they parsing the LAB_DATA field, which gives clear indication that the vaccines are messing with GnRH!!
Yes, you heard right. The vaccines interact with GnRH. That is why they cause menstruation issues.
It's all right there in the data. PRR is around 5 for LH/FSH disturbances compared with all other vaccines.
Nobody has noticed this yet. It seems like everybody just stopped being interested in the best pharmacovigilance system we have.
We know from the trial reports the exact level of SAEs, assuming none hidden. That implies a 30x umderreproting factor as I computed in another article. The only way to find out the mortality underreporting level is to sample, and for that we need autopsies. But the autopsies are being blocked.
health impact news has reported many stories of some who have wanted to report but have been stopped by higher ups and because of the complexity of the report don't have the time, it takes at least a half hour to complete, and if you stop without completeing it you have to start all over again. vaers is set up to discourage reporting not encourage it. studies estimate only 1-10 percent of injuries and deaths are reported. one study concluded everything needs to be increased by a factor of 41.
"Self-reporting has naturally exploded this year. Duh!"
By how much? Isn't that the responsibility of regulators to find out?
So far, published VAERS researchers show underreporting levels similar to those of the past. The VAERS system is difficult to use, and many health care workers, including doctors, have admitted to starting to file reports, then quitting because they cannot figure it out. It's an old ugly, not-user-friendly database that was intentionally kept in place after spending millions researching better system design.
"Duh" what? Self-reporting might well have exploded this year, but get me some figures, please, and then I'll report them. If you don't have any further information than "duh", don't bother people who are seriously trying to figure things out. It may also be true that doctors are less willing to file reports than in previous years because they've been explicitly warned not to. In Canada, doctors have been warned that they can be de-licensed unless they toe the official line. So which trend has more impact? Duh?
Federal Healthy People website (pre-COVID vax): VAERS reports filers are 36% health care providers, 37% pharmaceutical companies, 10% state vaccination programs, 7% patient or relative, 10% other. Jessica Rose PhD initial analysis of VAERS data re: COVID vax through March 26, 2021, peer-reviewed and published in journal “Science, Public Health Policy and Law”: Report filer %s seem to be missing in the published article but in an oral presentation of her work to Vaccine Choice Canada, Rose stated that COVID vax reports were 28% patient or relative and 72% other (health care providers, pharm. companies, etc.). Studying Rose’s initial and ongoing work on VAERS re: COVID-19 vax is highly recommended.
See my response to Karen Selick below for actual statistics on who reports. Outside the realm of statistics, your apparent attitude that self-reports “don’t count” is repugnant to me as a relative who reported a vaccine injury after the responsible health care providers made it plain they would not report.
Thank you for this vitally important analysis. Like kris alman said, I cannot follow the math, although I do get the drift LOL. I strongly urge you to preface and end these types of posts with a boiled down summary in non-geek language. Or even after each section. It would make the sharing of your content much more impactful.
Dumbed down version, they basically only compare ratio of adverse events not absolute number of events. So a vaccine that has a similar distribution in adverse events than other vaccines, only it happens 1000 times more, will not get detected at all.
This formula is to detect whether a particular adverse event is more common in a specific vaccine. It will do that. They have, and clearly mention, other methods to signal an unusually high number of adverse events overall.
Really? They have methods to signal unusually high numbers and those methods did not trigger an extreme alarm red alert? Those methods must be even more interesting.
I think the core problem here is that the agencies making the calls to authorize and promote certain treatments are the same ones in charge of after-authorization safety monitoring.
What would make a lot more sense would be to have a completely independent agency in charge of after-authorization safety monitoring.
You raise some excellent points. I think there is a logic behind their method that you are missing, however. And that is the issue of "stimulated reporting," which refers to people reporting more adverse events due to increased awareness of the existence of VAERS and/or increased fear surrounding the COVID-19 vaccines due to media exposure of adverse events, awareness of the reporting system, mobilization by vaccine critics, etc.
So their logic is as follows: if the reporting for all events increases by approximately the same amount (say 20x to use your example), then that would be an indication of stimulated reporting, not a safety problem. The method they use to differentiate 'safety signals' from 'stimulated reporting' is if they find a different pattern of increases across different types of events and/or age groups.
Of course in that case they can't distinguish between a vaccine that increases all adverse events across the board vs. stimulated reporting, but then we'd want to ask how likely is it that a vaccine would increase all adverse events by a similar amount across the board?
Anyway, I have done an analysis following examples and guidelines published by the CDC and found a very strong and clear safety signal. You can find the report in pdf format here:
It doesn't seem like this would be the appropriate stage to design stimulated reporting out of the equation in my humble opinion. I for one would not allow CDC to wiggle out of this so easily. They haven't earned that courtesy.
If their number one priority is (or should be) to find safety signals then they have to actually allow for them to exist first and then they can make relevant determinations about their validity. If their number one priority is to protect Big Pharma then what they're doing is fantastic.
At least they're good at something, I guess.
I read through your paper by the way and it's pretty amazing I must say. Also damning as well. Great job.
And great job on this article as well by the way. My take for nearly all of this is that they're lying and they know they're lying. Early on in 2020 I started dissecting the CDC's Covid mortality data and it was clear they were inflating the numbers. They created a kind of Venn diagram overlaying one cause of death over the other so they could double count where they needed to. I made a crude spreadsheet breaking it down but it only served to scare everyone one away as soon as they saw it. Spreadsheets, statistics and math in general are not my strengths but trying to get people to see through the CDC's lies was nearly impossible. At least for me. I wish you much better success. :)
Yes I gathered as much that you didn't think it was stimulated reporting but I think my point is more directed at what we're willing to even allow CDC to claim...with a straight face anyway. I'm sure if we're ever able to hold their feet to the fire (doubtful at this point) they'll come up with that exact excuse or something similar but I simply don't think it's reasonable to even allow them to make the claim.
Thanks. I agree they are lying. It's obvious to anyone with a brain. Interestingly, every mindless skeptic brings up the idea that the reporting is exaggerated, but the CDC itself has not made that claim as far as I know -- yet. Even the statistician who did the risk-benefit analysis at the FDA to approve the child vaccine said there is underreporting to VAERS.
Logically, there would be less people reporting at VAERS or Yellow Card in regard to Covid 'vaccines' as the 'vaccines' were also administered by the army, vets and retrained nurses - people who would have zero no knowledge as to whether the vaccinated person had an AE or died - unlike their GP.
If I'm understanding correctly, the way the CDC defines the variables A, B, C, D is such that the ONLY thing actually compared in the PRR equation is how often a vaccine is followed by a specific side effect A more frequently than it's followed by other side effects B?
So if vaccine X has 100x as many side effects as vaccine Y, but the different classes of side effects retain the same relative frequencies to each other, then X will obviously come across as equally safe as vaccine Y?
(It bewilders me that at this point, there are people who still think the CDC could possibly be some benevolent but confused entity. The CDC is not confused. They want you dead)
"So if vaccine X has 100x as many side effects as vaccine Y, but the different classes of side effects retain the same relative frequencies to each other" - but how realistic is that scenario? We already know that there must be AEs in the system that are not caused by the vaccine, since it's merely a database of bad things that happen *after* (not because of) vaccination. So if they all increase at once by the same proportion, surely that is bound to be due to an increase in reporting? If the number of people who reported headaches doubles, and the number who reported that their cat went missing doubles, you have nothing. But if the number of headaches triples, while the number of missing cats only doubles, then you have a signal. But even then it only shows up as a signal if it's different from other vaccines (not Covid vaccines)
Here is the second trick: it doesn't matter! Suppose the relative frequencies of side effects differ. So you might have PRR=2 for side effect 1, and PRR=0.5 for side effect 2. Then you can say: "Yes, it's true this vaccine is followed by more of side effect 1 than other vaccines, but it's also followed by less of side effect 2 than other vaccines. So it's safe on average."
At no point do you ever mention that this vaccine causes 100x as many side effects as other vaccines. This was simply never part of the equation.
Maybe I didn't explain my point properly - when I asked how realistic it was, I meant how realistic is it that a more dangerous vaccine would get exactly the same relative frequencies of all reported effects, as you suggested? That would be an unthinkable coincidence. It doesn't matter whether it's 2x or 100x, it's never going to happen.
But in your reply, you're now saying that they're averaging all the PRRs for each individual side effect together. Yes that would be disastrous because they'd be discarding almost all of the information, but I didn't see anything in the article that claims they're doing that. I may have missed it.
Per the article: "It is not necessary to scale all of the AEs to hide a signal with this function. The numerator-fraction of the PRR changes only slightly when a handful of AEs scale up, even for extreme values of the scalar, k."
The article also offers plausible data sets and shows you the PRRs they give.
It is evident that the PRR function obfuscates what a different, honest metric could show as a clear, easily understandable signal.
Well this doesn't address the averaging claim you made, but ok let's look at these issues.
Firstly, the part you quoted involves an example where he defines "handful" as *half* of the side effects (2 out of 4). Of course that is going to suppress the signal, but it's totally unrealistic. Look at the appendices of the CDC document - there are pages and pages of AEs (looks like almost 500 AEs to me). These are all things that can happen to a person after (but not necessarily because of) vaccination. They're all going to get reported for all vaccines, and the vast majority of them will be reported in similar proportions because they have nothing to do with the vaccine. Is it likely that a single vaccine will cause half of these to increase and leave the others the same?
Secondly, the article states that the example data given is plausible, but I don't see why. He still uses only 6 AEs. Half of them are still caused by the vaccine. He then says that adding more AEs tends to make the signal even weaker *but only if you make the numbers similar for all vaccines*. Again, this seems to be a good feature of the PRR.
Think about it like this: calculating all the ratios for the AEs for a given vaccine gives you a "profile" of that vaccine showing the relative likelihoods of each AE. Next you need to compare that profile to the profiles for other vaccines which are known to be safe. I'm not a medical scientist or anything but this seems to me like a perfectly reasonable thing to measure.
"Is it likely that a single vaccine will cause half of these to increase and leave the others the same?"
Why is that not plausible? How can you excuse a "safety signal" which completely ignores when this occurs?
A vaccine affects the body at a meta level. A vaccine could directly poison you, but more likely it affects the immune system. This can affect how the body deals with all kinds of issues. It's plausible that a meta-intervention has a wide range of observable effects.
Yes, it's reasonable to measure the ratios. But it's not reasonable to just disregard glaring data about the total number of effects.
It's not "unlikely" if it has happened. VAERS contains 13,000 after-vaccine deaths. A CDC whistleblower who filed a lawsuit claims they're sitting on at least 45,000 deaths from just one of the systems that report to the CDC, and there are 11-12 such systems. The European drug safety database (EudraVigilance) contains comparable numbers of after-vaccine events. When I last checked, it contained 13,000 deaths and 365,000 people with serious effects. That's the number of people, not effects, and these serious effects that are not deaths go up to "cardiac death, recovered".
This has happened. The only question is whether it has happened by accident, or on purpose.
In this case, it appears you are a victim of a cult.
I refer you to the Biderman chart of coercion. This is from work by Albert Biderman, cca 1956, regarding coercive methods used by communist regimes. These same methods are used in cults like Scientology, and by domestic abusers:
Assuming you are a good-faith participant, I suggest that you compare the items in this chart to the actions of governments and reporting in the media. See if you can find any comparisons.
Biderman merely documented coercion methods and clearly stated that the “communists” were using tried and true methods employed by humans for a long time. Nothing new or special about them. The US government uses the same sort of methods at their torture facilities. These methods were long popular with the Christian church too.
But I suppose it is a lot to ask for people to actually read what the man wrote instead of regurgitating something they read on some right wing nutters web site.
You would probably expect A to be independent of B and be higher than it, therefore the PRR would increase as expected if vaccine was causing one or a few AEs relative to total pool...
Because this formula is only one of the various methods in operation and exists to highlight that a particular adverse event is more common. It is ridiculous and baseless to claim it is meant to cover up an overall high incidence of adverse events.
I posted the above comment in July. By now, it is extremely clear that if you continue to comply with what the governments worldwide are doing, you will either die, or you will be completely stripped of ALL of your individuality.
ALL individual sovereignty will be taken away from you, including your ability to decide what happens to your genes.
This is not "right-wing extremists" vs "normal people". This is "normal people" vs "left-wing extremists". If you support what is happening, then you are a left-wing extremist. This is currently three types of people:
(A) The gullible. People who still think that there's some finite number of boosters after which the pandemic will be over. If you haven't yet figured out: the boosters are forever, eternally. If you haven't yet figured out: it doesn't matter if you die from it.
(B) The psychopathic. The people who are perpetuating this want to control the rest of the population, and think this is a great game to be playing, if you're on the winning side of it.
(C) The submissive and masochistic. The above might not sound a problem to you, if you don't have any identity to begin with.
If you do have any identity, then your continued compliance is going to kill it. They will either kill you physically, or they will kill anything worthwhile about your spirit.
Normal people must resist. If you don't resist, you're either gullible, or not normal.
Link to an immensely long video from the American Front-line Doctors group which has been speaking out against everything that is wrong with the 'covid narrative" since very early on in 2020. AFLDs advocated early use of HCQ and other immune boosting therapies which many of the original doctors were using in US hospitals (without CDC or FDA approval) 7 were getting amazingly good results with very few if any High risk or elderly patients dying. the AFLDS has grown immensely since that time with many more doctors joining them and several Solicitors. Simone Gold one of the founders is also a solicitor/Attorney. The AFLDS have also been approached by a CDC whistleblower who has stated that the CDC has been deliberately holding back on covid vaccine deaths by at least a factor of 600% as this whistleblower has made a sworn statement with evidence that the CDC has hidden at least one of the eleven reporting lines with 45,000 covid vaccine deaths recorded which should have been reported on VAERS. the AFLDS has launched legal action against the CDC over this fraud. as well as several other lawsuits in the US over related matters. as Dr Pam Popper is doing with her Stand up State law suits to have closed states, re-opened as Florida, Texas, and south Dakota and a few others as well as many countries which would not go against the constition to enact any of the BS covid mandates: the AFLDS has put out this long video which I've watched on 2x speed due to it's horrendous length but there is a wealth of information about what has happened in the US why it's medical tyranny, illegal unconstitutional etc and would be a great video to edit into seperate speakers as they all have such great information while most people won't bother watching the entire video even on 2x speed :-) https://live.aflds.org/
Please don't write "without CDC or FDA approval" without providing full context-- off label use of approved drugs used to be completely normal and uncontroversial, until the covidocracy arose.
Bla bla and Trump won the election. Law suits shmaw suits. Who cares? Anyone can file suit. 45000 Covid vaccine deaths? What are you even talking about? Loopy loon.
I see the labotomy worked Illy wanker. No mention of your favorite orange clown, or your favorite demented demorat in my comment. Just a pathetic attempt to politicize things is an old tactic for Lobotimized trolls, back to re education camp for you Illy wanker.
Mathew, please get a twitter account so you can promote your analyses. That's how you get readers. I have seen multiple tweeted links to this particular analysis today, but the links need a focal point, namely a twitter presence for you. You need the amplification of all the links pointing back to your twitter account (and additionally because people can then find links to your other articles there).
The article was excellent. My takeaway is that the PRR method suppresses the statistical signal unless there is ONE particular class/type of Adverse Event (AE) that is much worse than other observed AEs. That is a real weakness of PRR. A diffused/diverse misclassification (a human weakness of the AE reporters) then also has an effect that buries signals.
I agree that the PRR can handle individual outlier signals at times, but the logic of "and" vs. "or" in this case looks disturbingly blunt. There should always be absolute magnitudes, or something along those lines, in the mix.
Yes, absolutely agree that absolute magnitudes are what really matters. I guess I just could not resist being "clever" (yeah, ego in action, I admit it) and observing that very concentrated types AEs would/could generate a signal from PRR even if the method overall is not good.
I don’t think he ever claimed that no AE would ever be detected. But even when detecting an AE it could be incorrect. Clearly if a vaccine resulted in 10 deaths after 10billion doses given and no other AE, this formula would detect a signal of harm where there is none
That's why you do a PRD instead. Distribution is distorted, but you can't get absolute numbers from the VAERS db. The search for an underreporting factor is completely absurd.
It's enough to know that 15% more reports from 12-17 year old double-jabbed infected individuals contained the term myocarditis, but only
Of course syndrome distribution is distorted by reporting behaviour. Menstruation issues are underrepresented by a factor of 10, while myocarditis is overrepresented due to the media attention, but the incidence rates of symptoms like headache are almost the same as the reported proportion.
The search for an underreporting factor is really beneath someone of your intellect. Please don't pretend you are an expert on pharmacovigilance data. People are listening to you and people like Steve Kirsch who have obfuscated the truth with their proclaimed expertise through the search for the elusive underreporting factor.
Method: Most commonly used three data mining algorithms (DMAs) (Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR) and Information Component (IC)) were selected and
applied retrospectively in USFDA Adverse Event Reporting System database to detect five confirmed Drug Event Combinations.
Result: Among the three data mining algorithms, Information Component was found to have a
maximum sensitivity (100%) followed by Reporting Odds Ratio (60%) and Proportional Reporting Ratio (40%)
Commonality of Drug-associated Adverse Events Detected by 4 Commonly Used Data Mining Algorithms
Associations with adverse events were analyzed for 16 unrelated drugs, using the proportional reporting ratio (PRR), reporting odds ratio (ROR), information component (IC), and empirical Bayes geometric mean (EBGM).
Improvement in the Analysis of Vaccine Adverse Event Reporting System Database
Lili ZhaoORCID Icon,Sunghun Lee,Rongxia Li,Edison Ong,Yongqun He &Gary Freed
Pages 303-310 | Received 06 Aug 2019, Accepted 20 Apr 2020, Accepted author version posted online: 05 May 2020, Published online: 08 Jun 2020
Thank you. I will take a look through some of these links.
Ultimately, I would have no problem with a system that used PRR as one form of signal. It would sometimes be useful in cases of ordinary AE spikes. This is the "and" vs. "or" issue where PRR here is being used as a necessary (instead of sufficient) condition during an extraordinary circumstance in which AEs are through the roof, causing a mean-reversion of the PRR output.
As suggested, I hope you can boil down this reply in non-geek language. I think it this sentence is the crux of your post (which is a mouthful that I cannot chew!):A safety signal is defined as a PRR of at least 2, chi-squared statistic of at least 4, and 3 or more cases of the AE following receipt of the specific vaccine of interest.
You wrote, "changes were made to the VAERS system and also to safety signal analysis leading up to the experimental mass vaccination program officially targeting COVID-19." Do you know what was in existence beforehand? And, if so, how would the previous safety analysis affect current reporting?
Incidentally, the Morbidity and Mortality Weekly Report (MMWR) is where the CDC posts adverse reactions.
And it's only on July 9, 2021 that they posted it there: Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021
Not so oddly, this was the subject at the MMWR in April 2021: Anxiety-Related Adverse Event Clusters After Janssen COVID-19 Vaccination — Five U.S. Mass Vaccination Sites
The "duh!" implications of what is already expected?
"Vaccine providers should be aware of anxiety-related events after vaccination and observe all COVID-19 vaccine recipients for any adverse reactions for at least 15 minutes after vaccine administration."
Reports of death after COVID-19 vaccination are rare. More than 339 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through July 19, 2021. During this time, VAERS received 6,207 reports of death (0.0018%) among people who received a COVID-19 vaccine. FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it’s unclear whether the vaccine was the cause. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines. However, recent reports indicate a plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and TTS, a rare and serious adverse event—blood clots with low platelets—which has caused deaths.
CDC and FDA are monitoring reports of Guillain-Barré Syndrome (GBS) in people who have received the J&J/Janssen COVID-19 Vaccine. GBS is a rare disorder where the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis. Most people fully recover from GBS, but some have permanent nerve damage. After 12.8 million J&J/Janssen COVID-19 Vaccine doses administered, there have been around 100 preliminary reports of GBS identified in VAERS as of July 12. These cases have largely been reported about 2 weeks after vaccination and mostly in men, many 50 years and older. CDC will continue to monitor for and evaluate reports of GBS occurring after COVID-19 vaccination and will share more information as it becomes available.
Since you asked for commentary on the paper I sent it to a young Harvard educated mathematician whom I respect. His reply is lengthy, but basically comes down to wondering about data sources and about whether or not there are simultaneous datasets being accumulated somewhere else. My reply to him ( I am a physician not a mathematician) is equally lengthy, and as worried as your paper indicates you are, based upon what I know from having assiduously searched for reliable sources of information since spring of 2020. Is there a place where I might send you these comments if he agrees to my copying at least portions of his email?
Thank you. Those additional thoughts were helpful. Knowing that a project took place to fix the system, but was never put in place fits with a few other pieces of the puzzle I've seen.
I've done all the work. Hit me up. I have yet to add explanations because I've never made a website before, but I'll share the code and talk about the data with you.
Thank you for this. When I found this document months ago and began sharing it I knew there was much off about it. There are many other things of concern In it including the fact that they are only looking for preexisting AEs from a list of AEs. Etc.
Thank you again, Mathew. What an excellent analysis. I'm sending to the few people left in my life who are still open minded. I also recommend this excellent in-depth essay about the Covid vaccine, as another excellent piece to share with others who have otherized those who haven't succumbed to the vaccine.
This is actually extremely serious and deserves a serious answer. I've been going over this and it is scary stuff. The only question I have is do they have some special way of classifying the AEs - some grouping such that the b term can't over take the a term to screw up the signal?
Another question: For the PRR it appears that other vaccines would include the other covid vaccines? If that's the case then it is really screwed up, right? The other covid vaccines would dominate the denominator
I have noticed that there has not been a release, that I can find, in the Pfizer documents, on how many shots have been given in total in the US population. So there is no way to find out the percentage of people injured. To me, (with the caveat that I have not devoted days to looking for this number within the pfizer data dump) this indicates they are aware that the percentage, just the gross percentage, is not something they want to disclose.
I haven't been looking lately due to other projects, but if there were any kind of population reference to ground comparisons by, one of the several data beasts would have pointed it out and started a feeding frenzy by now. I look forward to it, if it exists. But even if it does, there is no guarantee it won't be redacted. Have we reached a point at which protecting the Big "Noble" Lie is a matter of national security interest? One way or another, they'll interpret things that way.
Matthew, I think I remember it being redacted from the page I was looking at in the Pfizer data dump....which started me looking....but I cannot find it. I have to just use the past statements by Fauci et al as to how many people have been vaccinated...one or two they never say...and I can't find PErcent moderna, percent Jansen, percent pfizer...oh well.
Must say your explication de texte about how they have manipulated the safety signal to make sure it doesn't appear was brilliant. And horrifying.
Hi Mathew. Here are comments from a fellow PhD Statistician.
Proportional Reporting Ratio (PRR).
"Consider what would happen if an extremely dangerous vaccine were introduced that resulted in 20 times as many AEs of all types as all the other vaccines to which it gets compared [...] The PRR remains invariant in the scaling of adverse events!"
Yes, this is true. It's also kind of beside the point. The PRR is designed to measure whether a specific adverse effect is more common for vaccine X compared to all other vaccines. It's not intended to detect whether vaccine X more often exhibits a specific adverse effect. That might seem strange, it relates to conditional probability which is something that a lot of people struggle with.
When he multiplies by 20 to simulate an "extremely dangerous vaccine", he is making two important mistakes.
First: He is conflating a more dangerous vaccine with one that is more commonly used. The table deals with raw counts, so a vaccine that is used more widely is more likely to generate more adverse effects, simply because it is used more. That's one reason, for instance, that men get in more accidents than women: Because they tend to drive more miles. To take this into account, we need to scale the results. So, the scale-invariance that the author is complaining about is a feature, not a bug. If it wasn't scale-invariant, then we'd be concluding that commonly used vaccines are "more dangerous" simply due to the fact that they are used more. That would be dumb.
Second: If a vaccine is presenting a serious adverse effect that is very common, then it's very unlikely to even make it to the point of being recorded in VAERS. The clinical trials are designed to suss out any frequent adverse effects. The vaccines which "pass" their phase 3 trial are already filtered to not have common adverse effects. So the author's thought experiment of increasing the rate of adverse effect by a factor of 20, 50, or 1000 (!!) is, while a marginally interesting thought experiment, really not talking about a plausible scenario. It'd be like talking about how unsafe it is for a automobiles to be powered by jet engines. Sure, it's technically possible, but it's just not something that we encounter on the roads.
In the paragraph or so above the example spreadsheet, he writes:
And if ratios among AEs change little between vaccines (like for an AE that is the result of the presence of the spike protein) due to correlation, the denominators will change in a manner that is highly similar to the proportional changes in the numerators!
His language here is a bit imprecise (ironic, given his bragging about math), but I think he's basically saying here: If the rate of each AE is approximately the same, then the PRR won't pick up a signal. This is a "WTF moment" because this is exactly the purpose of the PRR. It's designed to see if a particular AE has an outsized frequency in a particular vaccine compared to adverse events in general. He's complaining about the PRR measuring what it's designed to measure (completely beside the point of scale-invariance). It's like computing a median and saying "This is going to be in the middle of all the data points!" as if it's some shocking revelation.
When he says:
Certainly there are conditions that result in safety signals, but these are far at the extremes for the AEs that we most need to understand. [...] Do you kinda get the sense that the PRR function is designed to hide signals of unsafe vaccines, not to identify them?
He is -- again -- complaining about the fundamental premise of the PRR. Just because something has a slightly increased rate does not make it apocalyptic. And again, he seems to be ignoring that this is about relative proportions of AEs, not about baseline proportions of AEs. If there is a common enough, serious AE, it should be getting caught in the phase 3 trial, not in VAERS. With VAERS, we are implicitly talking about extremely rare adverse events.
Not only does the PRR need to get out of line for a safety signal to be generated, the use of 'and' instead of 'or' means that other additional criteria must also be satisfied before the CDC self-reports a safety signal!
This complaint falls flat. This is the criterion to suggest a signal based on PRR. Further on in the document, Section 2.5, they note that there are several sources by which a potential signal can be detected:
FDA empirical Bayesian data mining, through CDC PRR data mining, and through descriptive analysis
The author's article is talking about just one of these. The criticisms he raises about PRR may well be identified through the FDA method, or through "descriptive analysis" - i.e. making some tables. So the little examples he put together to say "OMG! Look how bad the PRR is at detection!" can be caught by an analyst just looking at summary tables. So his entire complaint about PRR is completely invalid, because the things he's complaining about are not being structurally ignored.
In fact, chi-squared statistics are not even supposed to be used on data that is likely to be correlated when causal. Presumption of a negative test result is not a reasonable test standard.
Based on what I can tell, the author is misunderstanding here. The CDC document does not say that they are using a Chi-square test, but a Chi-square statistic. The statistic can be used even if the assumptions of the chi-square test are violated. It would be, at that point, just a measure of the consistency or lack of consistency of the table. It's like calculating a mean, you can do that even if you don't assume a Normal distribution and use a t-test.
Even worse---given that numerous academics, including statisticians, reviewed this document, it is hard to believe that the scale invariance embedded in the definition of PRR, or the logic that includes meeting multiple criteria at the same time, went unnoticed.
Indeed! So if it's "random person with some unspecified mathematical training" arguing that PhD statisticians (edit: whose application area of expertise is precisely this) looked at the same thing and thought it was fine ... then maybe, just maybe, the random person isn't really getting the point or comprehending the whole picture.
tl;dr:
PRR deals with relative rates, because otherwise we would conflate "dangerous" with "common".
This means the scale-invariance the author complains about is a good thing.
The PRR signal detection method is just one of several methods, which means the scale-invariance the author complains about is not hiding potential problems.
Several of the author's points require common side effects, which would likely be detected in a phase 3 trial and prevent approval of the vaccine.
This seems like a long-winded set of reasons motivated by priors. Given that I demonstrated a clear example where a massive death increase does not trigger the only signal, any tl;dr analysis that sidesteps this point is obnoxious.
And any point-of-view that doesn't question why the FDA is doing absolutely nothing to gauge the degree of under-reporting after changing reporting policy from historical VAERS norms seems motivated to protect an irresponsible establishment.
His "First" point is just plain dumb. Yes, we should indeed have signals that scale per dose---not that a/(a+b) has anything to do with that. In fact, that's part of the point if the article...that we need other signals. But if he wants to examine the per dose AEs, they're off the charts. Even the trials themselves reported AEs in the range of 70% to nearly 90%. In particular, the VAERS AEs are, on both absolute and per dose metrics, off the charts.
His second point begins with a nonsensical statement. The greatest clinical benefits of AE recording are the SAEs. Because of course they are! And he missed the memo about the trial stats being done incorrectly, doing things like using an incorrect background rate for Bell's palsy, and not grouping AEs likely to be associated with the spike protein for significance testing.
He is technically correct that a chi-squared statistic can be computed. But for data trends that are likely causally correlated (like using a bunch of vaccines that all have the same primary risk from the spike protein), the results are muted by definition, so detrimental to the goal of identifying a clinically interesting signal.
"he PRR signal detection method is just one of several methods"
They're so numerous that he's not going to share them with us?
His credentialism submarines his sense of superiority. I was already teaching statistical modeling to researchers at the human genome project when I was 17, and don't need to really make a substantial living (in 27 years since I've received less than $330k in wages) is because I outperform all hedge fund returns routinely and by a wide margin. If the PhDs could do that, they wouldn't need the credentials.
People like your PhD friend are further eroding the faith that any of us have in academics to hold the establishment to account, and furthering the instinct many of us have that the institutions suffer from endemic corruption. This doesn't help anything.
It's not that it doesn't trigger a signal, it's that you're asking a signal not designed to measure THAT to do so. Bob's quotation is spot-on. You're making a big deal over a measurement not measuring what it's not supposed to measure.
Bob did such a good job dancing around the statistics i would assume he works for pfizer or the cdc.
say 100,000 brain damage and 100,000 miscarriage/dead babies plug that in would we get any info. with out knowing the details of the macro #s ??
i am a retail Rph. bio-chem and many steps were skipped with this vaccine so we need vars and any other avail. data to make up for 3 years of skipped data and animal testing. i do not know the specific math being discussed but i do know the bio-chem and the virus.
No. Bob demolished everything little Matty had to say in measured adult language. This is how scientists write, not like little Matty with his faux outrage.
Don't be silly. You think you need a complicated algorithm to measure adverse events divided by doses administered?
Because THAT is the metric you seem to claim is being lost.
And, for argument's sake, that metric was being lost, the argument for tracking it isn't to complain that some metric meant to measure something completely different isn't doing a job it was never intended to do.
You just don't understand. Don't you get it? You do not know enough stuff, and you are too dumb to know that you do not know enough. Read what he said. So much for admitting when you are wrong. And look below: all caps. The last refuge of the idiot.
With the EUA, it's as though we have collectively entered into phase 4 trials (also referred to as post marketing surveillance) which are conducted after the drug is already marketed and available to the general public.
While I agree with this statement in the petition...
We believe the FDA should not prematurely grant a license to any COVID-19 vaccine until all necessary efficacy and safety studies are completed and substantial evidence demonstrates the benefits of an individual COVID-19 vaccine product outweigh the harms for the indicated, recipient population. We are concerned that the premature licensure of a COVID-19 vaccine can seriously undermine public confidence in regulatory authorities, particularly if long-term safety issues were to emerge following licensure.
...the EUA absolves liability. That's the dilemma that people face. Informed consent? Hell no!
The petition recommends completing at least 2 years of follow-up of participants originally enrolled in pivotal clinical trials, even if the trials were unblinded and now lack a placebo control.
2 more years???
At this point, half of American adults have been fully vaccinated.
Won't Americans' public confidence of these regulatory institutions be decimated should it turn out the risks (especially after repeated jabs) exceed benefits (even if it's "just" for subgroups of people)?
Dr. Peter McCullough is one of the signatories of this petition. I know that he has been a staunch proponent for outpatient therapies, so I assume that there are physicians and scientists on this list who either have not been vaccinated or are hesitant about boosters or a jab with a new mRNA vaccine.
The White House frames our current situation as a "pandemic of the unvaccinated," while mandating vaccines and shaming those who are vaccine hesitant--at the same time backpedaling on mask freedom for the vaccinated.
What if generic antiviral drugs are already performing as well or better than these vaccines? What if public health policies focus on "bad air" (miasma as the ancient Greeks would call it) and promulgate more effective masks, air filtration and social distancing?
Is plutocratic success when ROI plus RIP = more concentrated wealth and deaths of the deplorables?
I have read that placebo groups were stopped very early on in these trials and that follow up data collection on those jabbed does not meet the requirements initially put into place. If there is any truth to this, we can never know true risk vs benefit. Also, technically, phase 4 cannot be claimed/achieved/enacted w/o FDA approval, and it’s still under emergency use authorization, correct?
To clarify, we are NOT in phase 4 trials, but the VAERS data on EUA authorized vaccines are a treasure trove of signals typical of data that can be gleaned after a vaccine is made widely available to the public. A rotavirus vaccine was suspended in 1999 in response to 15 cases of intussusception (i.e., a bowel obstruction in which one segment of bowel becomes enfolded within another segment) among infants who received RRV-TV.
It is pretty standard practice to end the placebo group early in the case of something that is viewed as lifesaving and where sufficient data has been gathered.
I think we are. The very short time these shots were in phase 3 before they were released by EUA for use population wide does not mean they are safe, as phase 3 clinical trials typically require 1-4 YEARS. Therefore, phase 3 trials are still ongoing and PRR is hiding the true impact of reported AE's.
The very short time these shots were in phase 3 before they were released by EUA for use population wide does not mean they are safe, as phase 3 clinical trials typically require 1-4 YEARS. Therefore, phase 3 trials are still ongoing and PRR is hiding the true impact of reported AE's.
I'm a middling programmer and see flaws in this logic. The "and" is what will throw lower numbers. In addition to this problem, the CDC has very clearly stated that they are *not* gathering data on "breakthrough infections of COVID-19" that do NOT result in hospitalization or death as they claim this is not clinically significant. This is on their website. This is now a huge problem and why they must back track on the previously ditched mask guidance - they have no gathered reliable case data on the vaccinated cases that are spreading within the community, and thus there are no other viable options - and this is not even accounting for those that may be experiencing vaccine enhanced disease (ADE) or various mutations that have yet to be identified. It is irresponsible data and number skewing because they incorrectly presume that if "everybody just gets the vaccine" or more people get it, this disease can be eradicated which is now a statistical impossibility. It is a grave mistake (or evil, as you mentioned) which will cost many lives.
The simple challenge for anyone who thinks that the CDC is just fine using only this signal analysis is to put the actual numbers in a spreadsheet and see.
Oh, don't know which vaccines are proper comparators? Run a sensitivity analysis.
Oh, VAERS is too clunky to make that easy? Yeah, it's a dinosaur, and propositions to modernize it get ignored.
My second article adds some additional discussion of why after age stratification the COVID-19 vaccines dominate the c and d parameters---at least for those who aren't children (possibly them too).
I'm not a mathematician, but I have been analyzing the VAERS data weekly since February. My videos on this are on Bitchute. I did one back in June, 2021 comparing the reported deaths from CV vaccines to the reported deaths of ALL other vaccines going back 30 years. The graph is shocking. Here's the link: https://www.bitchute.com/video/cKTBa3okRs8L/
Karen, I like that your videos are direct and to the point.
Thank you. That has been the hallmark of my writing and video-making for decades. I am (among other things) a freelance writer. You can read some of my pandemic-related articles here: https://westernstandardonline.com/author/karen-selick/
Well Karen I am a mathematician and can assure you the PRR is pure rubbish concocted to hide adverse events. It ONLY came into existence when the CDC decided to cook the VAERS books. Think of it as following in the footsteps of the BLS with it's recreated CPI, GDP and Unemployment numbers. Complete lies one and all. It is not difficult to cook the data. Most people never know it. Vaccine efficacy suffers from the problems with scaling as well which I've proved several times. As always it fell on deaf ears.
Awesome video! I subscribed.
That was great! Thanks.
Question: how do you know the increases were not caused by the fact that the VAERS got better known and therefore was used more for reporting? Especially COVID vaccines and the political debate around it must have increased the motivation to report?
This seems a signal but it would be nice if alternative explanations were more explicitly refuted or acknowledged.
I agree it's possible that VAERS is now better known. However, on the opposite pan of the scale is the fact that whistleblowers have come forward to say that they are being explicitly instructed NOT to file VAERS reports in connection with Covid-19 injections. I've heard this on several occasions. One nurse in a southern US hospital said the nurses and doctors in her hospital were warned not to report anything to VAERS. I believe there was an implied threat that their jobs could be at stake.
Wickedness, abroad on Earth, originating inside our Federal Agencies....
Americans, are you ready to do something about this? Or just keep burying those family and friends??
CDC are encouraging people to log health details into this v-safe account. Maybe we need to be asking what that is showing rather than VAERS? Maybe people are reporting their and don't think they need to report on VAERS?
https://www.cdc.gov › coronavirus › 2019-ncov › vaccines › safety › register-for-v-safe.html
How to Enroll or Access Your V-safe Account | CDC
Jun 16, 2022Go to vsafe.cdc.gov and click I am here for myself. Click Access my account. Enter your v-safe registration code (the 13-character code you received after completing v - safe registration) or your information as you did when you originally enrolled and select Send Secure Link. You will receive a direct link to your account via text message.
Of course it should be better known given the vast scale of the covid vaccination campaign. Were it not, you'd suffer under-reporting.
Being better know doesn't even mean better reporting when doctors are backlogged hundreds or even thousands of reports that take substantial time to enter into the system.
UK MHRA assess ADR reporting at a max of 10%.
It doesn't matter when using PRD/PRR, unless events are not reported in a product and symptom specific manner.
All that matters is the proportion. The difference gives a MUCH better idea of the side effects profile compared to the ratio. The ratio really only serves for signal detection, but NOT to give doctors and patients and idea of the side effects profile.
The entire post-approval pharmacovigilance analysis systems have been sabotaged.
It's full of information, but nothing has come of it. I can't even make statisticians listen. Sad.
That's not the issue here. They are sabotaging the parsing process. The age field was not populated in over 30% of reports that DID have the age specified. It took me one minute to write a simple RegEx to catch ALL these patient ages and I am not even good at RegEx.
Neither are they parsing the LAB_DATA field, which gives clear indication that the vaccines are messing with GnRH!!
Yes, you heard right. The vaccines interact with GnRH. That is why they cause menstruation issues.
It's all right there in the data. PRR is around 5 for LH/FSH disturbances compared with all other vaccines.
Nobody has noticed this yet. It seems like everybody just stopped being interested in the best pharmacovigilance system we have.
We know from the trial reports the exact level of SAEs, assuming none hidden. That implies a 30x umderreproting factor as I computed in another article. The only way to find out the mortality underreporting level is to sample, and for that we need autopsies. But the autopsies are being blocked.
Mathew, I gladly pay for your articles. They are amazing.
But we have to be honest here: You've never analyzed post-approval pharmacovigilance databases. Neither has Steve Kirsch or Jessica Rose.
Stop being so arrogant and start listening to what I am telling you. This is not about self-promotion.
We are missing out on tons of knowledge that can be gathered from the data.
https://pervaers.com
https://help.pervaers.com
Well Jessica and Steve have, you have looked into it as well, but you know as well as I do that none of you have *really* dug into VAERS.
More intentional wickedness. Murder. Democide.
Our Government is killing us, and utilizing our assets, our tax dollars to accomplish this goal.
And using their power to TRY to hide the truth from us, the People, who legally they serve.
Arrest them. Get the Military out and throw Fouci, Birx, Biden, and (maybe even Trump as well,) et al in Guantanamo Bay.
They are Traitors.
The People must STAND UP!
health impact news has reported many stories of some who have wanted to report but have been stopped by higher ups and because of the complexity of the report don't have the time, it takes at least a half hour to complete, and if you stop without completeing it you have to start all over again. vaers is set up to discourage reporting not encourage it. studies estimate only 1-10 percent of injuries and deaths are reported. one study concluded everything needs to be increased by a factor of 41.
check out health impact news, natural news and dr. mercola for reports.
Worst video ever. Self-reporting has naturally exploded this year. Duh!
"Self-reporting has naturally exploded this year. Duh!"
By how much? Isn't that the responsibility of regulators to find out?
So far, published VAERS researchers show underreporting levels similar to those of the past. The VAERS system is difficult to use, and many health care workers, including doctors, have admitted to starting to file reports, then quitting because they cannot figure it out. It's an old ugly, not-user-friendly database that was intentionally kept in place after spending millions researching better system design.
Huh.
"Duh" what? Self-reporting might well have exploded this year, but get me some figures, please, and then I'll report them. If you don't have any further information than "duh", don't bother people who are seriously trying to figure things out. It may also be true that doctors are less willing to file reports than in previous years because they've been explicitly warned not to. In Canada, doctors have been warned that they can be de-licensed unless they toe the official line. So which trend has more impact? Duh?
Federal Healthy People website (pre-COVID vax): VAERS reports filers are 36% health care providers, 37% pharmaceutical companies, 10% state vaccination programs, 7% patient or relative, 10% other. Jessica Rose PhD initial analysis of VAERS data re: COVID vax through March 26, 2021, peer-reviewed and published in journal “Science, Public Health Policy and Law”: Report filer %s seem to be missing in the published article but in an oral presentation of her work to Vaccine Choice Canada, Rose stated that COVID vax reports were 28% patient or relative and 72% other (health care providers, pharm. companies, etc.). Studying Rose’s initial and ongoing work on VAERS re: COVID-19 vax is highly recommended.
I don't know the answers, Karen. But I would not, and you cannot, claim to be "seriously trying to figure things out" unless you know.
See my response to Karen Selick below for actual statistics on who reports. Outside the realm of statistics, your apparent attitude that self-reports “don’t count” is repugnant to me as a relative who reported a vaccine injury after the responsible health care providers made it plain they would not report.
leftist troll and big pharma shill.
Thank you for this vitally important analysis. Like kris alman said, I cannot follow the math, although I do get the drift LOL. I strongly urge you to preface and end these types of posts with a boiled down summary in non-geek language. Or even after each section. It would make the sharing of your content much more impactful.
Dumbed down version, they basically only compare ratio of adverse events not absolute number of events. So a vaccine that has a similar distribution in adverse events than other vaccines, only it happens 1000 times more, will not get detected at all.
This formula is to detect whether a particular adverse event is more common in a specific vaccine. It will do that. They have, and clearly mention, other methods to signal an unusually high number of adverse events overall.
Really? They have methods to signal unusually high numbers and those methods did not trigger an extreme alarm red alert? Those methods must be even more interesting.
I think the core problem here is that the agencies making the calls to authorize and promote certain treatments are the same ones in charge of after-authorization safety monitoring.
What would make a lot more sense would be to have a completely independent agency in charge of after-authorization safety monitoring.
But such vaccines do not exist. Really people! Do you really think you are this smart and others are so dumb? You have no idea how little you know.
Your comment indicates you didn't follow the argumentation in the least bit.
I agree.
yes, please ..
You raise some excellent points. I think there is a logic behind their method that you are missing, however. And that is the issue of "stimulated reporting," which refers to people reporting more adverse events due to increased awareness of the existence of VAERS and/or increased fear surrounding the COVID-19 vaccines due to media exposure of adverse events, awareness of the reporting system, mobilization by vaccine critics, etc.
So their logic is as follows: if the reporting for all events increases by approximately the same amount (say 20x to use your example), then that would be an indication of stimulated reporting, not a safety problem. The method they use to differentiate 'safety signals' from 'stimulated reporting' is if they find a different pattern of increases across different types of events and/or age groups.
Of course in that case they can't distinguish between a vaccine that increases all adverse events across the board vs. stimulated reporting, but then we'd want to ask how likely is it that a vaccine would increase all adverse events by a similar amount across the board?
Anyway, I have done an analysis following examples and guidelines published by the CDC and found a very strong and clear safety signal. You can find the report in pdf format here:
https://tinyurl.com/CovidvFluReport
Feel free to contact me at the e-mail at the top of the report.
I was going to read and reply, but you popped up in my inbox with David W, so I'll read and respond there.
It doesn't seem like this would be the appropriate stage to design stimulated reporting out of the equation in my humble opinion. I for one would not allow CDC to wiggle out of this so easily. They haven't earned that courtesy.
If their number one priority is (or should be) to find safety signals then they have to actually allow for them to exist first and then they can make relevant determinations about their validity. If their number one priority is to protect Big Pharma then what they're doing is fantastic.
At least they're good at something, I guess.
I read through your paper by the way and it's pretty amazing I must say. Also damning as well. Great job.
Thanks. I agree it isn't stimulated reporting and have an updated and expanded article here: https://childrenshealthdefense.org/defender/safety-signals-covid-vaccines-full-transparency-cdc-fda/
And great job on this article as well by the way. My take for nearly all of this is that they're lying and they know they're lying. Early on in 2020 I started dissecting the CDC's Covid mortality data and it was clear they were inflating the numbers. They created a kind of Venn diagram overlaying one cause of death over the other so they could double count where they needed to. I made a crude spreadsheet breaking it down but it only served to scare everyone one away as soon as they saw it. Spreadsheets, statistics and math in general are not my strengths but trying to get people to see through the CDC's lies was nearly impossible. At least for me. I wish you much better success. :)
Yes I gathered as much that you didn't think it was stimulated reporting but I think my point is more directed at what we're willing to even allow CDC to claim...with a straight face anyway. I'm sure if we're ever able to hold their feet to the fire (doubtful at this point) they'll come up with that exact excuse or something similar but I simply don't think it's reasonable to even allow them to make the claim.
Thanks. I agree they are lying. It's obvious to anyone with a brain. Interestingly, every mindless skeptic brings up the idea that the reporting is exaggerated, but the CDC itself has not made that claim as far as I know -- yet. Even the statistician who did the risk-benefit analysis at the FDA to approve the child vaccine said there is underreporting to VAERS.
Logically, there would be less people reporting at VAERS or Yellow Card in regard to Covid 'vaccines' as the 'vaccines' were also administered by the army, vets and retrained nurses - people who would have zero no knowledge as to whether the vaccinated person had an AE or died - unlike their GP.
Great work. have saved a copy to distribute for educational purposes, if that's okay
Thanks. Yes, of course!
If I'm understanding correctly, the way the CDC defines the variables A, B, C, D is such that the ONLY thing actually compared in the PRR equation is how often a vaccine is followed by a specific side effect A more frequently than it's followed by other side effects B?
So if vaccine X has 100x as many side effects as vaccine Y, but the different classes of side effects retain the same relative frequencies to each other, then X will obviously come across as equally safe as vaccine Y?
(It bewilders me that at this point, there are people who still think the CDC could possibly be some benevolent but confused entity. The CDC is not confused. They want you dead)
"So if vaccine X has 100x as many side effects as vaccine Y, but the different classes of side effects retain the same relative frequencies to each other" - but how realistic is that scenario? We already know that there must be AEs in the system that are not caused by the vaccine, since it's merely a database of bad things that happen *after* (not because of) vaccination. So if they all increase at once by the same proportion, surely that is bound to be due to an increase in reporting? If the number of people who reported headaches doubles, and the number who reported that their cat went missing doubles, you have nothing. But if the number of headaches triples, while the number of missing cats only doubles, then you have a signal. But even then it only shows up as a signal if it's different from other vaccines (not Covid vaccines)
"but how realistic is that scenario?"
Here is the second trick: it doesn't matter! Suppose the relative frequencies of side effects differ. So you might have PRR=2 for side effect 1, and PRR=0.5 for side effect 2. Then you can say: "Yes, it's true this vaccine is followed by more of side effect 1 than other vaccines, but it's also followed by less of side effect 2 than other vaccines. So it's safe on average."
At no point do you ever mention that this vaccine causes 100x as many side effects as other vaccines. This was simply never part of the equation.
Maybe I didn't explain my point properly - when I asked how realistic it was, I meant how realistic is it that a more dangerous vaccine would get exactly the same relative frequencies of all reported effects, as you suggested? That would be an unthinkable coincidence. It doesn't matter whether it's 2x or 100x, it's never going to happen.
But in your reply, you're now saying that they're averaging all the PRRs for each individual side effect together. Yes that would be disastrous because they'd be discarding almost all of the information, but I didn't see anything in the article that claims they're doing that. I may have missed it.
Per the article: "It is not necessary to scale all of the AEs to hide a signal with this function. The numerator-fraction of the PRR changes only slightly when a handful of AEs scale up, even for extreme values of the scalar, k."
The article also offers plausible data sets and shows you the PRRs they give.
It is evident that the PRR function obfuscates what a different, honest metric could show as a clear, easily understandable signal.
Well this doesn't address the averaging claim you made, but ok let's look at these issues.
Firstly, the part you quoted involves an example where he defines "handful" as *half* of the side effects (2 out of 4). Of course that is going to suppress the signal, but it's totally unrealistic. Look at the appendices of the CDC document - there are pages and pages of AEs (looks like almost 500 AEs to me). These are all things that can happen to a person after (but not necessarily because of) vaccination. They're all going to get reported for all vaccines, and the vast majority of them will be reported in similar proportions because they have nothing to do with the vaccine. Is it likely that a single vaccine will cause half of these to increase and leave the others the same?
Secondly, the article states that the example data given is plausible, but I don't see why. He still uses only 6 AEs. Half of them are still caused by the vaccine. He then says that adding more AEs tends to make the signal even weaker *but only if you make the numbers similar for all vaccines*. Again, this seems to be a good feature of the PRR.
Think about it like this: calculating all the ratios for the AEs for a given vaccine gives you a "profile" of that vaccine showing the relative likelihoods of each AE. Next you need to compare that profile to the profiles for other vaccines which are known to be safe. I'm not a medical scientist or anything but this seems to me like a perfectly reasonable thing to measure.
"Is it likely that a single vaccine will cause half of these to increase and leave the others the same?"
Why is that not plausible? How can you excuse a "safety signal" which completely ignores when this occurs?
A vaccine affects the body at a meta level. A vaccine could directly poison you, but more likely it affects the immune system. This can affect how the body deals with all kinds of issues. It's plausible that a meta-intervention has a wide range of observable effects.
Yes, it's reasonable to measure the ratios. But it's not reasonable to just disregard glaring data about the total number of effects.
I agree; it's not necessarily plausible that A and B would increase in unison in the way described, in fact extremely unlikely
It's not "unlikely" if it has happened. VAERS contains 13,000 after-vaccine deaths. A CDC whistleblower who filed a lawsuit claims they're sitting on at least 45,000 deaths from just one of the systems that report to the CDC, and there are 11-12 such systems. The European drug safety database (EudraVigilance) contains comparable numbers of after-vaccine events. When I last checked, it contained 13,000 deaths and 365,000 people with serious effects. That's the number of people, not effects, and these serious effects that are not deaths go up to "cardiac death, recovered".
This has happened. The only question is whether it has happened by accident, or on purpose.
Negative
In this case, it appears you are a victim of a cult.
I refer you to the Biderman chart of coercion. This is from work by Albert Biderman, cca 1956, regarding coercive methods used by communist regimes. These same methods are used in cults like Scientology, and by domestic abusers:
https://i.imgur.com/lSjqIsa.jpg
Assuming you are a good-faith participant, I suggest that you compare the items in this chart to the actions of governments and reporting in the media. See if you can find any comparisons.
They are doing every single thing on this chart.
Biderman merely documented coercion methods and clearly stated that the “communists” were using tried and true methods employed by humans for a long time. Nothing new or special about them. The US government uses the same sort of methods at their torture facilities. These methods were long popular with the Christian church too.
But I suppose it is a lot to ask for people to actually read what the man wrote instead of regurgitating something they read on some right wing nutters web site.
On the contrary, sir, to me it seems you may be the more ideologically committed.
You would probably expect A to be independent of B and be higher than it, therefore the PRR would increase as expected if vaccine was causing one or a few AEs relative to total pool...
Because this formula is only one of the various methods in operation and exists to highlight that a particular adverse event is more common. It is ridiculous and baseless to claim it is meant to cover up an overall high incidence of adverse events.
I posted the above comment in July. By now, it is extremely clear that if you continue to comply with what the governments worldwide are doing, you will either die, or you will be completely stripped of ALL of your individuality.
ALL individual sovereignty will be taken away from you, including your ability to decide what happens to your genes.
This is not "right-wing extremists" vs "normal people". This is "normal people" vs "left-wing extremists". If you support what is happening, then you are a left-wing extremist. This is currently three types of people:
(A) The gullible. People who still think that there's some finite number of boosters after which the pandemic will be over. If you haven't yet figured out: the boosters are forever, eternally. If you haven't yet figured out: it doesn't matter if you die from it.
(B) The psychopathic. The people who are perpetuating this want to control the rest of the population, and think this is a great game to be playing, if you're on the winning side of it.
(C) The submissive and masochistic. The above might not sound a problem to you, if you don't have any identity to begin with.
If you do have any identity, then your continued compliance is going to kill it. They will either kill you physically, or they will kill anything worthwhile about your spirit.
Normal people must resist. If you don't resist, you're either gullible, or not normal.
Link to an immensely long video from the American Front-line Doctors group which has been speaking out against everything that is wrong with the 'covid narrative" since very early on in 2020. AFLDs advocated early use of HCQ and other immune boosting therapies which many of the original doctors were using in US hospitals (without CDC or FDA approval) 7 were getting amazingly good results with very few if any High risk or elderly patients dying. the AFLDS has grown immensely since that time with many more doctors joining them and several Solicitors. Simone Gold one of the founders is also a solicitor/Attorney. The AFLDS have also been approached by a CDC whistleblower who has stated that the CDC has been deliberately holding back on covid vaccine deaths by at least a factor of 600% as this whistleblower has made a sworn statement with evidence that the CDC has hidden at least one of the eleven reporting lines with 45,000 covid vaccine deaths recorded which should have been reported on VAERS. the AFLDS has launched legal action against the CDC over this fraud. as well as several other lawsuits in the US over related matters. as Dr Pam Popper is doing with her Stand up State law suits to have closed states, re-opened as Florida, Texas, and south Dakota and a few others as well as many countries which would not go against the constition to enact any of the BS covid mandates: the AFLDS has put out this long video which I've watched on 2x speed due to it's horrendous length but there is a wealth of information about what has happened in the US why it's medical tyranny, illegal unconstitutional etc and would be a great video to edit into seperate speakers as they all have such great information while most people won't bother watching the entire video even on 2x speed :-) https://live.aflds.org/
Please don't write "without CDC or FDA approval" without providing full context-- off label use of approved drugs used to be completely normal and uncontroversial, until the covidocracy arose.
Bla bla and Trump won the election. Law suits shmaw suits. Who cares? Anyone can file suit. 45000 Covid vaccine deaths? What are you even talking about? Loopy loon.
I see the labotomy worked Illy wanker. No mention of your favorite orange clown, or your favorite demented demorat in my comment. Just a pathetic attempt to politicize things is an old tactic for Lobotimized trolls, back to re education camp for you Illy wanker.
Mathew, please get a twitter account so you can promote your analyses. That's how you get readers. I have seen multiple tweeted links to this particular analysis today, but the links need a focal point, namely a twitter presence for you. You need the amplification of all the links pointing back to your twitter account (and additionally because people can then find links to your other articles there).
The article was excellent. My takeaway is that the PRR method suppresses the statistical signal unless there is ONE particular class/type of Adverse Event (AE) that is much worse than other observed AEs. That is a real weakness of PRR. A diffused/diverse misclassification (a human weakness of the AE reporters) then also has an effect that buries signals.
@eduengineer
I agree that the PRR can handle individual outlier signals at times, but the logic of "and" vs. "or" in this case looks disturbingly blunt. There should always be absolute magnitudes, or something along those lines, in the mix.
Really AEs/dose is preferable to absolute magnitudes. But I'm typing a lot quickly.
Aha, you are @EduEngineer on twitter. I'm following and trying to promote this article.
Yes, absolutely agree that absolute magnitudes are what really matters. I guess I just could not resist being "clever" (yeah, ego in action, I admit it) and observing that very concentrated types AEs would/could generate a signal from PRR even if the method overall is not good.
I don’t think he ever claimed that no AE would ever be detected. But even when detecting an AE it could be incorrect. Clearly if a vaccine resulted in 10 deaths after 10billion doses given and no other AE, this formula would detect a signal of harm where there is none
That's why you do a PRD instead. Distribution is distorted, but you can't get absolute numbers from the VAERS db. The search for an underreporting factor is completely absurd.
It's enough to know that 15% more reports from 12-17 year old double-jabbed infected individuals contained the term myocarditis, but only
Of course syndrome distribution is distorted by reporting behaviour. Menstruation issues are underrepresented by a factor of 10, while myocarditis is overrepresented due to the media attention, but the incidence rates of symptoms like headache are almost the same as the reported proportion.
The search for an underreporting factor is really beneath someone of your intellect. Please don't pretend you are an expert on pharmacovigilance data. People are listening to you and people like Steve Kirsch who have obfuscated the truth with their proclaimed expertise through the search for the elusive underreporting factor.
With this level of statistics far beyond my retirement pay grade, I got lost in your data crunching.
Here are a few articles that may be helpful in your critique:
A Comparative Study of Data Mining Algorithms used for Signal Detection in FDA AERS Database
J Young Pharm, 2018; 10(4): 444-449
https://www.researchgate.net/profile/Minnikanti-Satya-Sai/publication/328284057_A_Comparative_Study_of_Data_Mining_Algorithms_used_for_Signal_Detection_in_FDA_AERS_Database/links/5c11ead692851c39ebe92d18/A-Comparative-Study-of-Data-Mining-Algorithms-used-for-Signal-Detection-in-FDA-AERS-Database.pdf
Method: Most commonly used three data mining algorithms (DMAs) (Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR) and Information Component (IC)) were selected and
applied retrospectively in USFDA Adverse Event Reporting System database to detect five confirmed Drug Event Combinations.
Result: Among the three data mining algorithms, Information Component was found to have a
maximum sensitivity (100%) followed by Reporting Odds Ratio (60%) and Proportional Reporting Ratio (40%)
Commonality of Drug-associated Adverse Events Detected by 4 Commonly Used Data Mining Algorithms
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3970098/
Associations with adverse events were analyzed for 16 unrelated drugs, using the proportional reporting ratio (PRR), reporting odds ratio (ROR), information component (IC), and empirical Bayes geometric mean (EBGM).
Improvement in the Analysis of Vaccine Adverse Event Reporting System Database
Lili ZhaoORCID Icon,Sunghun Lee,Rongxia Li,Edison Ong,Yongqun He &Gary Freed
Pages 303-310 | Received 06 Aug 2019, Accepted 20 Apr 2020, Accepted author version posted online: 05 May 2020, Published online: 08 Jun 2020
https://doi.org/10.1080/19466315.2020.1764862
Here's a concerning adverse event:
Sudden Onset of Myelitis after COVID-19 Vaccination: An Under-Recognized Severe Rare Adverse Event
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3841558
Thank you. I will take a look through some of these links.
Ultimately, I would have no problem with a system that used PRR as one form of signal. It would sometimes be useful in cases of ordinary AE spikes. This is the "and" vs. "or" issue where PRR here is being used as a necessary (instead of sufficient) condition during an extraordinary circumstance in which AEs are through the roof, causing a mean-reversion of the PRR output.
As suggested, I hope you can boil down this reply in non-geek language. I think it this sentence is the crux of your post (which is a mouthful that I cannot chew!):A safety signal is defined as a PRR of at least 2, chi-squared statistic of at least 4, and 3 or more cases of the AE following receipt of the specific vaccine of interest.
You wrote, "changes were made to the VAERS system and also to safety signal analysis leading up to the experimental mass vaccination program officially targeting COVID-19." Do you know what was in existence beforehand? And, if so, how would the previous safety analysis affect current reporting?
Incidentally, the Morbidity and Mortality Weekly Report (MMWR) is where the CDC posts adverse reactions.
https://www.cdc.gov/mmwr/Novel_Coronavirus_Reports.html
And it's only on July 9, 2021 that they posted it there: Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021
Not so oddly, this was the subject at the MMWR in April 2021: Anxiety-Related Adverse Event Clusters After Janssen COVID-19 Vaccination — Five U.S. Mass Vaccination Sites
The "duh!" implications of what is already expected?
"Vaccine providers should be aware of anxiety-related events after vaccination and observe all COVID-19 vaccine recipients for any adverse reactions for at least 15 minutes after vaccine administration."
Also do you know anything about eHealthMe? https://www.ehealthme.com/covid-vaccine-list/
e.g. https://www.ehealthme.com/vs/pfizer-biontech-covid-vaccine/death/
On Jul, 23, 2021
179,630 people reported to have side effects after getting Pfizer BioNTech Covid Vaccine.
Among them, 1,762 people (0.98%) have Death.
This is the total number of deaths, related or not to the vaccine
I understand that correlation is NOT causation. Very likely many are true, true and unrelated.
This is an interesting tool that claims to use AI algorithms to mine VAERS. What about their accuracy?
eHealthMe's current totals (reported on Jul, 22 or 23, 2021) are different than what is currently reported at the CDC (Updated July 21, 2021).
Pfizer deaths: 1,762
Moderna deaths: 2,092
J&J deaths: 371
Total: 4225 (vs 6207 at CDC)
Guillain-Barré Syndrome (GBS):
Pfizer: 147
Moderna: 135
J&J: 70
Total: 352 (vs "around 100" at CDC)
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
Reports of death after COVID-19 vaccination are rare. More than 339 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through July 19, 2021. During this time, VAERS received 6,207 reports of death (0.0018%) among people who received a COVID-19 vaccine. FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it’s unclear whether the vaccine was the cause. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines. However, recent reports indicate a plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and TTS, a rare and serious adverse event—blood clots with low platelets—which has caused deaths.
CDC and FDA are monitoring reports of Guillain-Barré Syndrome (GBS) in people who have received the J&J/Janssen COVID-19 Vaccine. GBS is a rare disorder where the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis. Most people fully recover from GBS, but some have permanent nerve damage. After 12.8 million J&J/Janssen COVID-19 Vaccine doses administered, there have been around 100 preliminary reports of GBS identified in VAERS as of July 12. These cases have largely been reported about 2 weeks after vaccination and mostly in men, many 50 years and older. CDC will continue to monitor for and evaluate reports of GBS occurring after COVID-19 vaccination and will share more information as it becomes available.
This article is more a case baffling with bull. Completely incorrect use of the CDC formula and a lot of fancy looking formulas to cover up.
Since you asked for commentary on the paper I sent it to a young Harvard educated mathematician whom I respect. His reply is lengthy, but basically comes down to wondering about data sources and about whether or not there are simultaneous datasets being accumulated somewhere else. My reply to him ( I am a physician not a mathematician) is equally lengthy, and as worried as your paper indicates you are, based upon what I know from having assiduously searched for reliable sources of information since spring of 2020. Is there a place where I might send you these comments if he agrees to my copying at least portions of his email?
Thank you. Those additional thoughts were helpful. Knowing that a project took place to fix the system, but was never put in place fits with a few other pieces of the puzzle I've seen.
https://pervaers.com
I've done all the work. Hit me up. I have yet to add explanations because I've never made a website before, but I'll share the code and talk about the data with you.
knowhatamine@perVAERS.com
Earlyc19treatmentdata@protonmail.com
This mathematician didn’t pick up the entirely incorrect use of the CDC formula?
Thank you for this. When I found this document months ago and began sharing it I knew there was much off about it. There are many other things of concern In it including the fact that they are only looking for preexisting AEs from a list of AEs. Etc.
Interesting thought about the "only preexisting". My mind focused on the fact that their list looked oddly prescient.
"Prescient"? They knew what was going to happen...because they planned it! Oh my!
Thank you again, Mathew. What an excellent analysis. I'm sending to the few people left in my life who are still open minded. I also recommend this excellent in-depth essay about the Covid vaccine, as another excellent piece to share with others who have otherized those who haven't succumbed to the vaccine.
https://thepulse.one/2021/07/27/want-to-get-to-70-vaccine-coverage-mr-president-heres-how-you-do-it/
That is a fantastic piece! Thank you!!!
This is actually extremely serious and deserves a serious answer. I've been going over this and it is scary stuff. The only question I have is do they have some special way of classifying the AEs - some grouping such that the b term can't over take the a term to screw up the signal?
Yes, it is quite serious. It is a destruction of the link between our medical establishment and the precautionary principle.
Another question: For the PRR it appears that other vaccines would include the other covid vaccines? If that's the case then it is really screwed up, right? The other covid vaccines would dominate the denominator
That is exactly the point, yes.
- because the reported AEs for covid vaccines far outweighs any other for the past 20years or so ?
I have noticed that there has not been a release, that I can find, in the Pfizer documents, on how many shots have been given in total in the US population. So there is no way to find out the percentage of people injured. To me, (with the caveat that I have not devoted days to looking for this number within the pfizer data dump) this indicates they are aware that the percentage, just the gross percentage, is not something they want to disclose.
I haven't been looking lately due to other projects, but if there were any kind of population reference to ground comparisons by, one of the several data beasts would have pointed it out and started a feeding frenzy by now. I look forward to it, if it exists. But even if it does, there is no guarantee it won't be redacted. Have we reached a point at which protecting the Big "Noble" Lie is a matter of national security interest? One way or another, they'll interpret things that way.
Matthew, I think I remember it being redacted from the page I was looking at in the Pfizer data dump....which started me looking....but I cannot find it. I have to just use the past statements by Fauci et al as to how many people have been vaccinated...one or two they never say...and I can't find PErcent moderna, percent Jansen, percent pfizer...oh well.
Must say your explication de texte about how they have manipulated the safety signal to make sure it doesn't appear was brilliant. And horrifying.
Good report and Ive tweeted. Thanks for the information and Ive now subscribed
Hi Mathew. Here are comments from a fellow PhD Statistician.
Proportional Reporting Ratio (PRR).
"Consider what would happen if an extremely dangerous vaccine were introduced that resulted in 20 times as many AEs of all types as all the other vaccines to which it gets compared [...] The PRR remains invariant in the scaling of adverse events!"
Yes, this is true. It's also kind of beside the point. The PRR is designed to measure whether a specific adverse effect is more common for vaccine X compared to all other vaccines. It's not intended to detect whether vaccine X more often exhibits a specific adverse effect. That might seem strange, it relates to conditional probability which is something that a lot of people struggle with.
When he multiplies by 20 to simulate an "extremely dangerous vaccine", he is making two important mistakes.
First: He is conflating a more dangerous vaccine with one that is more commonly used. The table deals with raw counts, so a vaccine that is used more widely is more likely to generate more adverse effects, simply because it is used more. That's one reason, for instance, that men get in more accidents than women: Because they tend to drive more miles. To take this into account, we need to scale the results. So, the scale-invariance that the author is complaining about is a feature, not a bug. If it wasn't scale-invariant, then we'd be concluding that commonly used vaccines are "more dangerous" simply due to the fact that they are used more. That would be dumb.
Second: If a vaccine is presenting a serious adverse effect that is very common, then it's very unlikely to even make it to the point of being recorded in VAERS. The clinical trials are designed to suss out any frequent adverse effects. The vaccines which "pass" their phase 3 trial are already filtered to not have common adverse effects. So the author's thought experiment of increasing the rate of adverse effect by a factor of 20, 50, or 1000 (!!) is, while a marginally interesting thought experiment, really not talking about a plausible scenario. It'd be like talking about how unsafe it is for a automobiles to be powered by jet engines. Sure, it's technically possible, but it's just not something that we encounter on the roads.
In the paragraph or so above the example spreadsheet, he writes:
And if ratios among AEs change little between vaccines (like for an AE that is the result of the presence of the spike protein) due to correlation, the denominators will change in a manner that is highly similar to the proportional changes in the numerators!
His language here is a bit imprecise (ironic, given his bragging about math), but I think he's basically saying here: If the rate of each AE is approximately the same, then the PRR won't pick up a signal. This is a "WTF moment" because this is exactly the purpose of the PRR. It's designed to see if a particular AE has an outsized frequency in a particular vaccine compared to adverse events in general. He's complaining about the PRR measuring what it's designed to measure (completely beside the point of scale-invariance). It's like computing a median and saying "This is going to be in the middle of all the data points!" as if it's some shocking revelation.
When he says:
Certainly there are conditions that result in safety signals, but these are far at the extremes for the AEs that we most need to understand. [...] Do you kinda get the sense that the PRR function is designed to hide signals of unsafe vaccines, not to identify them?
He is -- again -- complaining about the fundamental premise of the PRR. Just because something has a slightly increased rate does not make it apocalyptic. And again, he seems to be ignoring that this is about relative proportions of AEs, not about baseline proportions of AEs. If there is a common enough, serious AE, it should be getting caught in the phase 3 trial, not in VAERS. With VAERS, we are implicitly talking about extremely rare adverse events.
Not only does the PRR need to get out of line for a safety signal to be generated, the use of 'and' instead of 'or' means that other additional criteria must also be satisfied before the CDC self-reports a safety signal!
This complaint falls flat. This is the criterion to suggest a signal based on PRR. Further on in the document, Section 2.5, they note that there are several sources by which a potential signal can be detected:
FDA empirical Bayesian data mining, through CDC PRR data mining, and through descriptive analysis
The author's article is talking about just one of these. The criticisms he raises about PRR may well be identified through the FDA method, or through "descriptive analysis" - i.e. making some tables. So the little examples he put together to say "OMG! Look how bad the PRR is at detection!" can be caught by an analyst just looking at summary tables. So his entire complaint about PRR is completely invalid, because the things he's complaining about are not being structurally ignored.
In fact, chi-squared statistics are not even supposed to be used on data that is likely to be correlated when causal. Presumption of a negative test result is not a reasonable test standard.
Based on what I can tell, the author is misunderstanding here. The CDC document does not say that they are using a Chi-square test, but a Chi-square statistic. The statistic can be used even if the assumptions of the chi-square test are violated. It would be, at that point, just a measure of the consistency or lack of consistency of the table. It's like calculating a mean, you can do that even if you don't assume a Normal distribution and use a t-test.
Even worse---given that numerous academics, including statisticians, reviewed this document, it is hard to believe that the scale invariance embedded in the definition of PRR, or the logic that includes meeting multiple criteria at the same time, went unnoticed.
Indeed! So if it's "random person with some unspecified mathematical training" arguing that PhD statisticians (edit: whose application area of expertise is precisely this) looked at the same thing and thought it was fine ... then maybe, just maybe, the random person isn't really getting the point or comprehending the whole picture.
tl;dr:
PRR deals with relative rates, because otherwise we would conflate "dangerous" with "common".
This means the scale-invariance the author complains about is a good thing.
The PRR signal detection method is just one of several methods, which means the scale-invariance the author complains about is not hiding potential problems.
Several of the author's points require common side effects, which would likely be detected in a phase 3 trial and prevent approval of the vaccine.
This seems like a long-winded set of reasons motivated by priors. Given that I demonstrated a clear example where a massive death increase does not trigger the only signal, any tl;dr analysis that sidesteps this point is obnoxious.
And any point-of-view that doesn't question why the FDA is doing absolutely nothing to gauge the degree of under-reporting after changing reporting policy from historical VAERS norms seems motivated to protect an irresponsible establishment.
His "First" point is just plain dumb. Yes, we should indeed have signals that scale per dose---not that a/(a+b) has anything to do with that. In fact, that's part of the point if the article...that we need other signals. But if he wants to examine the per dose AEs, they're off the charts. Even the trials themselves reported AEs in the range of 70% to nearly 90%. In particular, the VAERS AEs are, on both absolute and per dose metrics, off the charts.
His second point begins with a nonsensical statement. The greatest clinical benefits of AE recording are the SAEs. Because of course they are! And he missed the memo about the trial stats being done incorrectly, doing things like using an incorrect background rate for Bell's palsy, and not grouping AEs likely to be associated with the spike protein for significance testing.
He is technically correct that a chi-squared statistic can be computed. But for data trends that are likely causally correlated (like using a bunch of vaccines that all have the same primary risk from the spike protein), the results are muted by definition, so detrimental to the goal of identifying a clinically interesting signal.
"he PRR signal detection method is just one of several methods"
They're so numerous that he's not going to share them with us?
His credentialism submarines his sense of superiority. I was already teaching statistical modeling to researchers at the human genome project when I was 17, and don't need to really make a substantial living (in 27 years since I've received less than $330k in wages) is because I outperform all hedge fund returns routinely and by a wide margin. If the PhDs could do that, they wouldn't need the credentials.
People like your PhD friend are further eroding the faith that any of us have in academics to hold the establishment to account, and furthering the instinct many of us have that the institutions suffer from endemic corruption. This doesn't help anything.
It's not that it doesn't trigger a signal, it's that you're asking a signal not designed to measure THAT to do so. Bob's quotation is spot-on. You're making a big deal over a measurement not measuring what it's not supposed to measure.
No. I'm making a big deal over the fact that THERE ARE NO SIGNALS THAT DON'T GET MASKED AND THAT SHOULD RAISE SOME EYEBROWS, OBVIOUSLY.
Bob did such a good job dancing around the statistics i would assume he works for pfizer or the cdc.
say 100,000 brain damage and 100,000 miscarriage/dead babies plug that in would we get any info. with out knowing the details of the macro #s ??
i am a retail Rph. bio-chem and many steps were skipped with this vaccine so we need vars and any other avail. data to make up for 3 years of skipped data and animal testing. i do not know the specific math being discussed but i do know the bio-chem and the virus.
No. Bob demolished everything little Matty had to say in measured adult language. This is how scientists write, not like little Matty with his faux outrage.
Don't be silly. You think you need a complicated algorithm to measure adverse events divided by doses administered?
Because THAT is the metric you seem to claim is being lost.
And, for argument's sake, that metric was being lost, the argument for tracking it isn't to complain that some metric meant to measure something completely different isn't doing a job it was never intended to do.
Thank you, thank you!
You just don't understand. Don't you get it? You do not know enough stuff, and you are too dumb to know that you do not know enough. Read what he said. So much for admitting when you are wrong. And look below: all caps. The last refuge of the idiot.
Aren’t we technically still in phase 3 of trial right now? All about detection…?
For adults, greenlighting the EUA came after initial reporting from phase 3 trials. This Reuters "fact check" is not a reality check.
https://www.reuters.com/article/factcheck-covid-vaccines-idUSL1N2M70MW
With the EUA, it's as though we have collectively entered into phase 4 trials (also referred to as post marketing surveillance) which are conducted after the drug is already marketed and available to the general public.
Consider a petition co-signed by clinicians and researchers sent June 1, 2021 to delay FDA approval of EUA authorized Covid vaccines. See this link to download the petition: https://www.medpagetoday.com/special-reports/exclusives/93035
While I agree with this statement in the petition...
We believe the FDA should not prematurely grant a license to any COVID-19 vaccine until all necessary efficacy and safety studies are completed and substantial evidence demonstrates the benefits of an individual COVID-19 vaccine product outweigh the harms for the indicated, recipient population. We are concerned that the premature licensure of a COVID-19 vaccine can seriously undermine public confidence in regulatory authorities, particularly if long-term safety issues were to emerge following licensure.
...the EUA absolves liability. That's the dilemma that people face. Informed consent? Hell no!
The petition recommends completing at least 2 years of follow-up of participants originally enrolled in pivotal clinical trials, even if the trials were unblinded and now lack a placebo control.
2 more years???
At this point, half of American adults have been fully vaccinated.
https://usafacts.org/visualizations/covid-vaccine-tracker-states/
Won't Americans' public confidence of these regulatory institutions be decimated should it turn out the risks (especially after repeated jabs) exceed benefits (even if it's "just" for subgroups of people)?
Dr. Peter McCullough is one of the signatories of this petition. I know that he has been a staunch proponent for outpatient therapies, so I assume that there are physicians and scientists on this list who either have not been vaccinated or are hesitant about boosters or a jab with a new mRNA vaccine.
The White House frames our current situation as a "pandemic of the unvaccinated," while mandating vaccines and shaming those who are vaccine hesitant--at the same time backpedaling on mask freedom for the vaccinated.
What if generic antiviral drugs are already performing as well or better than these vaccines? What if public health policies focus on "bad air" (miasma as the ancient Greeks would call it) and promulgate more effective masks, air filtration and social distancing?
Is plutocratic success when ROI plus RIP = more concentrated wealth and deaths of the deplorables?
I have read that placebo groups were stopped very early on in these trials and that follow up data collection on those jabbed does not meet the requirements initially put into place. If there is any truth to this, we can never know true risk vs benefit. Also, technically, phase 4 cannot be claimed/achieved/enacted w/o FDA approval, and it’s still under emergency use authorization, correct?
To clarify, we are NOT in phase 4 trials, but the VAERS data on EUA authorized vaccines are a treasure trove of signals typical of data that can be gleaned after a vaccine is made widely available to the public. A rotavirus vaccine was suspended in 1999 in response to 15 cases of intussusception (i.e., a bowel obstruction in which one segment of bowel becomes enfolded within another segment) among infants who received RRV-TV.
https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5334a3.htm
Pfizer Estimated Study Completion Date : May 2, 2023
https://clinicaltrials.gov/ct2/show/NCT04368728?term=NCT04368728&draw=2&rank=1
Moderna Estimated Study Completion Date : October 27, 2022
https://clinicaltrials.gov/ct2/show/NCT04368728?term=NCT04368728&draw=2&rank=1
J&J (Janssen Vaccines & Prevention B.V. is a Janssen pharmaceutical company of Johnson & Johnson) Estimated Study Completion Date : January 2, 2023
https://clinicaltrials.gov/ct2/show/NCT04505722
My concern is that data collection and follow up in what looks like phase 4 (although technically not), is not what it should be.
It is pretty standard practice to end the placebo group early in the case of something that is viewed as lifesaving and where sufficient data has been gathered.
I think we are. The very short time these shots were in phase 3 before they were released by EUA for use population wide does not mean they are safe, as phase 3 clinical trials typically require 1-4 YEARS. Therefore, phase 3 trials are still ongoing and PRR is hiding the true impact of reported AE's.
The very short time these shots were in phase 3 before they were released by EUA for use population wide does not mean they are safe, as phase 3 clinical trials typically require 1-4 YEARS. Therefore, phase 3 trials are still ongoing and PRR is hiding the true impact of reported AE's.
At last someone who actually mentions the intention and correct use of the formula.
I'm a middling programmer and see flaws in this logic. The "and" is what will throw lower numbers. In addition to this problem, the CDC has very clearly stated that they are *not* gathering data on "breakthrough infections of COVID-19" that do NOT result in hospitalization or death as they claim this is not clinically significant. This is on their website. This is now a huge problem and why they must back track on the previously ditched mask guidance - they have no gathered reliable case data on the vaccinated cases that are spreading within the community, and thus there are no other viable options - and this is not even accounting for those that may be experiencing vaccine enhanced disease (ADE) or various mutations that have yet to be identified. It is irresponsible data and number skewing because they incorrectly presume that if "everybody just gets the vaccine" or more people get it, this disease can be eradicated which is now a statistical impossibility. It is a grave mistake (or evil, as you mentioned) which will cost many lives.
The CDC does not appear to have stated they are not collecting such data.