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Pfizer Accidentally Validates VAERS Data
No One Can Credibly Ignore The Data Anymore
Anyone who follows either my Minds or Telegram channels (or who has any interaction with any social media at all) has encountered the ongoing controversies over the safety of the vaccines promoted as the only means of combating the SARS-CoV-2 virus, the pathogen which causes COVID-19.
I have written before about the complete failure of the vaccines to contain the spread of COVID-19, and how the rationales for mandating their use completely ignore the empirical realities of the disease spread in the United States. To call the vaccine claims of efficacy “problematic” is being extremely generous.
Now we have unimpeachable documentation showing that their claims of safety may not even be problematic, but are potentially false. With perverse irony, that documentation is provided by none other than Pfizer, one of the most prominent vaccine manufacturers for the United States.
While final determinations of risk must be left to each individual, the Pfizer data shows quite clearly there are significant risks and dangers attached to the Pfizer vaccine. In so doing, Pfizer has accidentally shown why reports of adverse reactions and events to the COVID vaccines must be taken seriously.
The Vaccines Are SUPPOSED To Be “Safe”
There is no denying that the vaccines are touted as “safe” by the pretty much the entirety of the healthcare establishment. The CDC’s own website says it quite plainly:
What You Need to Know
COVID-19 vaccines are safe and effective.
Millions of people in the United States have received COVID-19 vaccines under the most intense safety monitoring in U.S. history.
CDC recommends you get a COVID-19 vaccine as soon as possible.
If you are fully vaccinated, you can resume activities that you did prior to the pandemic. Learn more about what you can do when you have been fully vaccinated.
Hospital systems and associations are making the safety claim across social media:
There is no ambiguity or imprecision in these statements. We are told explicitly by those who are expected to know these vaccines are safe and can be taken with no concern or hesitancy.
Unfortunately, that message is wrong.
Myocarditis and Pericarditis: The Unexpected Pfizer Risks That Will Not Go Away
Almost as soon as the Pfizer vaccine began seeing wide usage at the beginning of the year, questions of safety emerged. Among the many side effects reported to the Vaccine Adverse Event Reporting System (VAERS) has been myocarditis, an inflammation of the heart muscle that can result in heart damage or even death if untreated, as well as pericarditis, a similarly dangerous inflammation of the membrane that surrounds the heart.
Through November 19 there have been 14,428 reported cases of myocarditis and pericarditis made to VAERS, of which 10,981 are associated with the Pfizer vaccine. The myocarditis and pericarditis reports are roughly 1.5% of the 913,266 reports made to VAERS overall.
Myocarditis and pericarditis are significant as they are one side effect for which the VAERS data has clinical validation, with case studies acknowledging the association between the Pfizer vaccine and the condition. The CDC’s Advisory Committee on Immunization Practices (ACIP) COVID-19 Vaccine Safety Technical (VaST) Work Group, in its open meeting on May 17, concluded that there was a link between cases of myocarditis and both the Pfizer and Moderna vaccines
VaST concluded that there are relatively few reports of myocarditis to date and that these cases seem to occur:
predominantly in adolescents and young adults,
more often in males than females,
more often following dose 2 than dose 1, and
typically within 4 days after vaccination.
Most cases appear to be mild, and follow-up of cases is ongoing.
At a minimum, therefore, reports of myocarditis and pericarditis as a side effect of the Pfizer vaccine (as well as the Moderna one) cannot be dismissed out of hand as being a misreport to VAERS.
This validation matters because there is a strong tendency within the healthcare establishment to dismiss references to the VAERS data when arguing against the proposition the COVID vaccines are “safe”. Some scientists complain that VAERS is being “weaponized” by “anti-vaxxers” to unfairly demonize the vaccines.
The Vaccine Adverse Event Reporting System or VAERS is being misused by anti-vaxxers to terrify the public. It’s a shame because VAERS plays a vital role in detecting important but rare reactions caused by vaccines. The weaponization of VAERS by anti-vaccine activists serves as a reminder that having access to more information does not always lead to better decisions. Information needs to be correctly interpreted to guide us in the right direction.
Media “fact checkers” highlight the passive nature of VAERS reporting to argue that VAERS data cannot show causality
Anyone can report events to VAERS (vaers.hhs.gov/reportevent.html) and a disclaimer on the website of the Centers for Disease Control and Prevention (CDC) says: “The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable” (here). When downloading the data, users are presented with a further disclaimer that the data does not include information from investigations into reported cases. The disclaimer also says “the inclusion of events in VAERS data does not imply causality” (here).
However, the disclaimer quoted should not be taken to mean the data as a whole cannot indicate causality. It means exactly what it says—that the mere inclusion of an event in the VAERS data is not in and of itself proof of causality—but that leaves open the possibility that a broad cross-section of VAERS data can show causality between various categories of events and specific vaccines. In other words, that a specific instance of myocarditis is reported in VAERS does not prove a vaccine was unequivocally the cause, but a significant number of such reports potentially does prove a vaccine can be a cause of myocarditis, and at a minimum indicates a correlation that deserves closer followup and scrutiny.
Despite this demonstrated tendency of the healthcare establishment to dismiss claims of severe adverse events such as myocarditis and pericarditis, the number of such reports has mounted steadily since the COVID vaccines were made widely available at the beginning of the year. The CDC acknowledgements of the link made their way even into mainstream media by late June.
A CDC safety group said there's a "likely association" between a rare heart inflammatory condition in adolescents and young adults mostly after they've received their second Covid-19 vaccine shot, citing the most recent data available.
On November 10, Taiwan suspended the administration of the Pfizer vaccine to children in the 12-17 age bracket, citing emergent risks of myocarditis. For that reason, Taiwan has stopped administering the second dose of the Pfizer vaccine for that age group.
Central Epidemic Command Center (CECC) head Chen Shih-chung (陳時中) said on Wednesday (Nov. 10) that a panel of experts has decided to suspend administering second doses of the Pfizer-BioNTech (BNT) COVID vaccine to children 12-17 years old amid concerns it may increase the risk of myocarditis.
Cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) have been reported after BNT vaccination of children between 12 and 17 years of age. According to U.S. statistics, the risk of youths experiencing myocarditis after receiving the second BNT dose is 10 times higher than after the first dose, CNA reported.
As I commented at the time, Taiwan is no medical backwater. Taiwanese doctors have been at the forefront of research and treatment of COVID-19 from before the pandemic was declared last year. If Taiwan has questions about the vaccines, we are well advised to take their concerns extremely seriously.
Put another way, myocarditis is reported in one to two in every 100,000 people who receive Pfizer.
At a minimum, the available data, both in the media and reported in VAERS, shows a statistically significant risk of myocarditis and pericarditis is associated with the Pfizer vaccine in particular. On that basis alone, the claims of complete vaccine safety are at best somewhat “exaggerated”.
More importantly, the clinical validation of the link between the condition and the vaccines provides a baseline of credibility to the VAERS data. What analysis of that data will reveal is and should be a matter of debate, but what is certain is that this data is real and is relevant. The dismissals by some healthcare professionals of the VAERS data and its use in the ongoing debate over COVID vaccine safety are simply unwarranted.
But Wait! There’s More
In an effort to gain greater understanding of the side effects from the Pfizer vaccine, four days after the vaccine was approved by the FDA on August 23, the group Public Health And Medical Professionals For Transparency made a request for the data submitted by Pfizer as part of the approval process. The FDA’s slow response led to the group filing a lawsuit on September 16, seeking a court order to compel release of the requested documents.
Astoundingly, the FDA responded by requesting until the year 2076—55 years!—to make all of the documents available.
The FDA has asked a federal judge to make the public wait until the year 2076 to disclose all of the data and information it relied upon to license Pfizer’s COVID-19 vaccine. That is not a typo. It wants 55 years to produce this information to the public.
On November 17, the FDA began releasing the documents. which are publicly available on the PHMPT website. One document in particular bears mention, Pfizer’s “Cumulative Analysis of Post-Authorization Adverse Event Reports of [the Vaccine] Received Through 28-Feb-2021”.
As stated in the document, the report is Pfizer’s analysis of adverse events per FDA request.
Reference is made to the Request for Comments and Advice submitted 04 February 2021 regarding Pfizer/BioNTech’s proposal for the clinical and post-authorization safety data package for the Biologics License Application (BLA) for our investigational COVID-19 Vaccine (BNT162b2). Further reference is made to the Agency’s 09 March 2021 response to this request, and specifically, the following request from the Agency.
“Monthly safety reports primarily focus on events that occurred during the reporting interval and include information not relevant to a BLA submission such as line lists of adverse events by country. We are most interested in a cumulative analysis of post-authorization safety data to support your future BLA submission. Please submit an integrated analysis of your cumulative post-authorization safety data, including U.S. and foreign post-authorization experience, in your upcoming BLA submission. Please include a cumulative analysis of the Important Identified Risks, Important Potential Risks, and areas of Important Missing Information identified in your Pharmacovigilance Plan, as well as adverse events of special interest and vaccine administration errors (whether or not associated with an adverse event). Please also include distribution data and an analysis of the most common adverse events. In addition, please submit your updated Pharmacovigilance Plan with your BLA submission.”
This document provides an integrated analysis of the cumulative post-authorization safety data, including U.S. and foreign post-authorization adverse event reports received through 28 February 2021.
This report is Pfizer’s take on the safety data for its own product. Page 6 of the report contains this rather disturbing paragraph:
Cumulatively, through 28 February 2021, there was a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events. Most cases (34,762) were received from United States (13,739), United Kingdom (13,404) Italy (2,578), Germany (1913), France (1506), Portugal (866) and Spain (756); the remaining 7,324 were distributed among 56 other countries.
VAERS has 913,266 adverse events recorded for all three vaccines (Janssen, Moderna, and Pfizer) available in the US through November 19. Pfizer’s own data recorded 17% of that total in just the first two months of the year.
It is important to note at this juncture that Pfizer captured its adverse event data worldwide, while the VAERS data is almost exclusively from the US. Thus the two data sets are not perfectly aligned. However, as VAERS is a passive reporting system with a known issue of underreporting, one may safely presume there are adverse events in the US beyond what is reported in VAERS, and so perfect alignment between the data sets is not possible. Still, the relative quantities and associated time frames yield a perception of the Pfizer vaccine as something that triggers a lot of adverse events. Pfizer has in effect already admitted as such.
Additionally, while the VAERS data has a measure of error built in—it is a passive reporting system with no automatic validation of the data—any erroneous inference of causation based on the data that is in VAERS is countered by the reality of underreporting: not all of the data in VAERS is attributable to one of the vaccines, but VAERS is also not all of the data.
What Else Is In VAERS?
If the myocarditis cases give the VAERS data credibility, and the Pfizer documents give the number of events recorded in VAERS credibility, good science—and good medicine—demand we take a look at what other adverse events are in the VAERS data.
As of November 19, 2021, VAERS reports the following adverse effects for the COVID vaccines used in the US:
19,249 deaths (12,862 attributed to Pfizer).
97,561 hospitalizations (66,657 attributed to Pfizer).
101,372 cases requiring urgent care (61,039 attriubted to Pfizer).
143,276 doctor office visits (78,302 attributed to Pfizer).
8,232 cases of anaphylaxis (6,361 attributed to Pfizer).
11,437 cases of Bell’s Palsy (8,126 attributed to Pfizer).
14,428 cases of myocarditis/pericarditis (10,981 attributed to Pfizer).
This is not an exhaustive list of the side effects from the vaccines reported to VAERS, but it does illustrate both the scale of the adverse events and the dominant share of them attributable to Pfizer’s vaccine product.
Again, we must be clear that the mere inclusion of any one of these events in VAERS does not prove that event was caused by Pfizer’s vaccine, or any of the vaccines. However, when 10,981 people who received the Pfizer vaccine then experience either myocarditis or pericarditis, or when 66,657 of Pfizer vaccine recipients are subsequently hospitalized, or when 12,862 Pfizer vaccine recipients die shortly after vaccination, it is reasonable to ask what role the vaccine played in the event, with the presumption that the vaccine did in fact play a role; it is reasonable to presume until demonstrated otherwise the vaccine does in fact contribute if not cause the event.
Thanks to Pfizer’s own admissions, the VAERS data stands as a running and credible criticism of the relative safety of all three COVID vaccines, and the Pfizer shot in particular. To dismiss the VAERS data now is to ignore what a vaccine manufacturer as already in essence admitted about that data.
Are The Vaccines Safe?
As with all questions regarding risk, deciding whether a vaccine is or is not “safe” is one that must be answered exclusively by a patient and his physician. Even accepting all of the VAERS data uncritically (which is just as irrational as dismissing it uncritically), a patient at high risk of severe COVID infection might plausibly conclude vaccines are the lesser risk. No one should intrude on that decision process but the patient’s own doctor.
Yet the Pfizer documents show that the healthcare establishment has been guilty of a fair bit of dissemblage in touting the COVID vaccines as “safe”. The risks of the vaccines are real, and are considerably more likely than those promoting the vaccines have been willing to admit. For certain patient groups the vaccines are quite likely the greater risk over COVID.
Pfizer has a great deal more data to reveal about its vaccine, but what it has already revealed shows that the various bloviations about the vaccines being “safe” fall somewhere between egregious hyperbole and downright dishonesty.