Summary
v-safe data shows that Observed/Expected ratio for Guillain–Barré syndrome was greater than 1 over a 42-day risk window for both Pfizer and Moderna
This data was already available in v-safe by May 2021. Given that v-safe is supposed to be an active safety surveillance system, why didn’t the CDC (which owns the v-safe data) issue a warning by that date?
Some questions we should now be asking
Was there any active monitoring of v-safe free text entries for the full list of Adverse Events of Special Interest?
if yes, where can the public see documentation of the findings for each adverse event?
if no, why does the CDC claim that v-safe is an “active surveillance program” in the title of the v-safe protocol document?
If GBS had a O/E ratio over 1, doesn’t that imply that the VAERS reports of GBS are more likely to be caused by the mRNA vaccine than not? Why hasn’t the CDC issued any statement about this?
CDC has published multiple papers suggesting that it found no signal in v-safe but all those papers ignored the free text entries. Should the scientific community now demand that the CDC either revise all these publications (based on the free text analysis) or to retract them?
By now, people who follow my work probably know that the vaccine pushers do not really have the skillset to back up their overconfident assertions, to the extent that they sometimes even come up with comically idiotic “discoveries”
I read one such assertion on the Science Based Medicine website recently (emphasis mine):
Claim: The Vsafe system not immediately releasing all available data is evidence of intentional deception
No it isn’t. The V-safe system was essentially created for the COVID-19 immunizations because the previously available systems (VAERS, VSD) were not capable of tracking people over time. V-safe also delivers survey questions directly to the end user in the hopes of getting more survey participation (since it is theoretically more convenient to the user). Registration is completed after completion of the first dose and then the system sends survey questions at several time points. While it is true that V-safe data are not released in full for the general public, any researchers interested in conducting a formal project can most certainly contact the system administrators and start such a project. A part of the V-safe project data was obtained via litigation from Aaron Siri’s law firm, however the way it is displayed to the public is misleading. One data point Siri and his colleagues present is the total number of people reported to have required medical care – which is a little over 800 000. They then state that over 10 million users were registered. Based upon surveying the older immunizations, most medical problems reported that are due to the immunization (such as rotavirus immunization associated intussusception) occur within the first two months after the dose. However, the data dump presents all instances of medical care without controlling for what the medical care actually was. The further away from an immunization you seek medical care, on average, the less likely it was due to the immunization. Siri’s data collection doesn’t even describe what medical care was actually done – I would be worried about a case of Guillain-Barre, but I wouldn’t be so worried about a case of a patient receiving Motrin in the Emergency Department then going home.
Well, as luck would have it, we can actually investigate precisely this question now that some of the data has actually been released.
In the previous article, I mentioned that the actual rate of new incidences of Guillain Barre Syndrome (GBS) is not 8X what was expected
In this article I am going to try and estimate this number, and show why v-safe failed almost entirely as an active safety monitoring system, despite the lower multiplication factor.
What is an active safety monitoring system?
The vaccine pushers nowadays twist and torment definitions until they get something just complex enough to miss the entire point.
This cartoon is a good example of how the word vaccine itself has been redefined:
Let us now ask - what exactly is an active safety monitoring system?
Consider v-safe.
The goal of sending periodic text message reminders to solicit feedback and then collecting all the relevant data, is not for archival reasons, or to showcase your amazing technology.
The real purpose is to at least temporarily suspend the vaccination program if you detect serious danger signals.
You can resume the vaccination program if you find the concern was unwarranted, but this should all be done in a way which is transparent, instead of hiding behind IRB protocols and such.
How many GBS reports should have caused a suspension of the mRNA vaccination rollout?
The v-safe system had about 10 million participants.
Of these, just a little more than 5 million took only the Pfizer vaccine, around 4.93 million took only the Moderna vaccine, and the others took some combination of the rest.
The background incidence rate of GBS is around 2.035 per 100K person years.
We got all this information from an official source, which was in fact used as part of the pharmacovigilance reporting by AstraZeneca.
Note that the Willame et al paper was published in April 2021, which means a reasonably competent health agency should be using these numbers in their May 2021 calculations.
And if they cannot even stay on top of these numbers, what exactly is the point of a health safety regulator?
So how many reports of new incidence of GBS should have triggered a suspension of the mRNA vaccination program?
We can use either a 7 day risk window or a 42 day risk window for the calculations. I am using the 42 day risk window for this article since it matches the recent paper which discussed COVID19 vaccine safety.
Over a 7 day risk window we should observe 1.95 new cases, and over a 42 day risk window we should observe 11.7 new cases, for a cohort of 5 million people.
In other words, if we see more than 2 new cases for a 7 day risk window, or more than 12 new cases for a 42 day risk window, it should have triggered something like the following by March-April 2021:
Do you remember hearing anything like that for the mRNA vaccines related to GBS?
I don’t.
In the previous article I explained why we cannot be sure if the PT_NAME refers to a new incidence of GBS or to a pre-existing condition.
However, I realized that every time the symptom was merely suspected to be a pre-existing condition, the folks who “coded” the symptoms made sure to add that it was a pre-existing disease.
In other words, by simply looking at whether ‘Pre-existing disease’ was coded as one of the symptoms, we can filter for the incidence of new GBS cases.
Generating the GBS dataset
I first created a list of registrants based on those who were ‘coded’ with GBS as the PT_NAME within 42 days of vaccination.
I had to create two temporary tables to run this query efficiently: gbs_full is a list of registrants who were coded with GBS in one of their checkins. moderna_only is a list of registrants who took only the Moderna vaccine.
I then used some Python code to generate a dataset with some additional information which makes it more useful for analysis:
IS_PREEXISTING is set to True if it is coded as a symptom on any of the checkins
CALL_CENTER is set to True if there is an entry in the call center table for the given registrant code
GDIT is set to True if there is an entry in the GDIT table for the given registrant code
SRO_MISSING/SD_MISSING/HCVO_MISSING is the number of SRO/SD/HCVO free text entries which have not yet been published. It is calculated by using the number of SRO/SD/HCVO checkins which have been coded, and subtracting the number of actual SRO/SD/HCVO free text entries published till date.
Reminder:
SRO = Systemic Reaction Other
SD = Symptoms Description
HCVO = Healthcare Visits Other
Check out my introductory article to learn more about these definitions
I also created a similar dataset for Pfizer.
Data analysis
Let us first look at the Moderna dataset.
There are a total of 50 entries.
This means there was at least one free text entry in a checkin which happened within 42 days of vaccination, which was coded as GBS in either the covid_meddra_sro CSV file or the covid_meddra_sd CSV file1.
As I mentioned before, some of these were pre-existing conditions.
So let us filter for IS_PREEXISTING = False
There are a total of 34 such entries
One of the leftmost columns is STARTED_ON which is (approximately) the date that the checkin was submitted within the v-safe app2. It is sorted in ascending order.
As you can see, by the cutoff date of 1st May 2021, there were already 26 entries, which is already more than double the expected number of cases (12).
And Pfizer had 18 cases of GBS reported by 1st May 2021, which is 1.5X the expected number of cases.
Based on these cases, the CDC should have suspended the mRNA vaccines based on the GBS risk, in the same way they did for AstraZeneca. Why didn’t they do it?
AstraZeneca vs mRNA vaccines
Recently AstraZeneca issued an interesting statement to the press:
You might remember that I mentioned this in a previous article:
Recently, David Gorski wrote this in an article citing a recent paper (mildly edited for formatting):
So, what did the investigators find? I’ll summarize. An elevated observed/expected ratio was observed for the following key AESIs: Gillain-Barré syndrome (2.49x elevated OE) following the first dose of the ChAdOx1 vaccine (replication-deficient adenovirus-based vaccine, AstraZeneca). This signal was not observed for the other vaccines.
As you can see, the much cleaner v-safe dataset showed that there was an elevated O/E ratio for both the Moderna and the Pfizer vaccines.
As an aside, in the very same article, David Gorski makes a very bizarre statement which to me perfectly showcases how the brains of these vaccine pushers work.
Bell’s palsy. This is idiopathic and almost always temporary paralysis of one side of the face due to loss of function of the facial nerve. This was one condition that was suspected very early on during the vaccination program.
Well, except for a small problem. The “suspected” anchor text links to a previous article on the SBM website which says the following (emphasis mine):
Obviously, patients need to be followed longer, to see if the incidence over a whole year ends up being worrisome, but at this point it appears unlikely that either the Pfizer/BioNTech or Moderna vaccines cause Bell’s palsy, at least based on the current clinical trials.
There is such a thing as updating your priors, which seems to be a very hard mental habit for the vaccine pushers3.
Clearly, the folks who write for the SBM website don’t particularly care for “updating” their “priors”.
In this case, instead of going back to the earlier article and adding a link to the later one and adding a blurb like “Sorry, my bad, maybe Bell’s Palsy could be caused by the mRNA vaccines”, they instead linked from the later article to the previous one which claims it does not happen! (I would insert some ROFL emoji right here if it was Twitter, but the emoji does not render well on Substack)
After all, updating your priors on a website you have full control over is much easier than going on your “hands and knees begging for forgiveness”, isn’t it?
As of April 2024, the CDC does not think GBS is a risk for the mRNA vaccines (emphasis mine):
Recent CDC studies based on data from the Vaccine Safety Datalink (VSD) and the Vaccine Adverse Event Reporting System (VAERS) have found evidence suggesting an increased risk of GBS among adults 18 years and older after J&J/Janssen COVID-19 vaccination but not after Pfizer-BioNTech or Moderna COVID-19 vaccination. 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.
In addition, when you read the medical literature, you can now see many example of papers which justify mRNA vaccine damage by saying something like (paraphrasing) “But it is worse in the AstraZeneca vaccine”.
One should question whether this conclusion is only possible because no one has actually spent any time analyzing v-safe data4 for Adverse Events of Special Interest.
Questions we should be asking at this point
So this leads to a whole bunch of questions which we should be asking now
Why was there no announcement of GBS as a potential risk based on the v-safe free text entries in mid-2021, by which time nearly all these free text entries had already been submitted?
GBS abruptly ends in May 2021 for Pfizer, and in Aug 2021 for Moderna. This seems a bit unrealistic, especially given that pre-existing disease is still coded as GBS. Did people with pre-existing GBS somehow STOP experiencing any adverse events after August 2021? Or is it more likely that there are some yet-to-be-published free text entries which do mention GBS but were not coded for some reason?
Was there any active monitoring of v-safe free text entries for the full list of Adverse Events of Special Interest?
if yes, where can the public see documentation of the findings for each adverse event?
if no, why does the CDC claim that v-safe is an “active surveillance program” in the title of the v-safe protocol document?
If GBS had a O/E ratio over 1, doesn’t that imply that the VAERS reports of GBS are more likely to be caused by the mRNA vaccine than not? Why hasn’t the CDC issued any statement about this?
CDC has published multiple papers suggesting that it found no signal in v-safe by ignoring the free text entries. Should the scientific community now demand that the CDC either revise all these publications based on the free text information, or retract them?
The CSV file is based on number of days since vaccination. For the most part, if it happens within a week of vaccination, the entry is in the covid_meddra_sro file, and if it happens afterwars, the entry will be in the covid_meddra_sd file.
Sometimes people do start a survey and only finish it a day or so later, but the STARTED_ON date is the same as the submission date for the most part
Personally, I think this is a sign that they don’t want to engage in good faith debates
It is quite notable that the cleanest and perhaps most useful dataset - v-safe - has not even received much scrutiny from the medical community. There have been no open source projects for analyzing v-safe data. No one has sponsored a “Kaggle” contest for v-safe free text mining. Instead, the medical community flocks towards non-transparent data sources supplied by biased gatekeepers who will suffer heavy reputational loss if they are found to be wrong.
"Any researchers interested in conducting a formal project can most certainly contact the system administrators and start such a project. A part of the V-safe project data was obtained *VIA LITIGATION* from Aaron Siri’s law firm....".
Somehow that doesn't strike me as freely accessible, available and openly transparent.
At this stage it's pretty clear that the deal the Pharmaceutical companies and the corrupt Regulators colluded on, was to allow the 2 adenovirus offerings, as well as the 2x mRNA anti-christs to initially give the illusion of choice. Then have AZ and J&J agree to just enough bad press and blackening of their name to justify dumping them, leaving only the mRNA, "just as we planned all along".
More about Guillain-Barré Syndrome caused by Endotoxin in Jabs.
https://geoffpain.substack.com/p/guillain-barre-syndrome-expected