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July 23, 2022 - Epoch Times
16:35
80K New Pfizer Docs: Why Did So Many Participants With ‘Minor’ Adverse Events Withdraw From Trial?
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Good evening, and right before we dive in, I wanted to quickly mention that just earlier today, over on Epic TV, we published an awesome, exclusive, almost two-hour-long documentary detailing the real story of January the 6th, something that you frankly will never see on the Legacy Media.
If you want to check out that awesome documentary, the link will be right there at the very top of the description box.
And now, let's begin today's actual discussion by talking about the latest trove of Pfizer documents that were just released by the FDA. Or more specifically, what these documents revealed to us about the clinical trials that Pfizer was running prior to getting emergency use authorization.
Now, just for your reference, this was actually the fifth batch of Pfizer documents that were released by the FDA thus far.
The quick backstory here is that the FDA has in their possession approximately 330,000 pages of data which Pfizer submitted to the government in order to get emergency use authorization and then later to actually get full approval for their COVID vaccines.
However, when they were asked by a medical transparency group to hand this data over to the public, the FDA was attempting to slow walk the process.
They were trying to take, quite literally, somewhere between five to seven decades to release all these documents.
They eventually went to court, and the FDA lost.
A federal judge ruled against them, and he ordered the FDA to release all of their documents that they have in their possession by the end of this year.
And as you can see from their release schedule, starting on March 1st of this year, the FDA began to release tens of thousands of pages of documents every single month, with the latest badge being made public on July 1st.
I, in fact, have part of the latest batch right here in my hands, and there's part of it that I would like to specifically highlight, which is a massive 3,611-page confidential document that doesn't even have a title.
It only has a file name, which, for your reference, is FA Interim Narrative Sensitive.
And the reason that I believe that this particular document is so important is because within it, well, it contains the reports of a significant number of Pfizer trial participants who withdrew themselves from the trials and the specific reasons for why they withdrew.
In fact, let's go through some of these cases together.
Although before we do, I wanted to quickly give a big shout out to Dr.
Michael Niverdrakis, who is a researcher based out of Athens, Greece, and he did a lot of the heavy lifting of actually going through these documents and pulling out the most relevant parts.
Furthermore, if you enjoy content like this, I do hope you take a quick moment to smash, smash, smash that like button so this video can be shared out to every more people.
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Now, within this roughly 3,600-page file are the details surrounding 34 withdrawals from Pfizer's clinical trials.
And just for reference, every single one of these 34 trial participants had received 30 micrograms of the Pfizer vaccine, this same exact formulation of which would later go on to get approved.
And of these 34 withdrawals, you can divide them into three broad categories.
You had people who suffered severe adverse events, which were recognized as being likely caused by the vaccine.
You had people who suffered from adverse events which were not recognized as being likely caused by the vaccine.
And then you have a third category of participants who withdrew from the trials for seemingly trivial adverse events, which were attributed at least partially to vaccination.
Let's go through these one by one.
So to start with, within this trove of 3,600 pages, only four of the trial participants who were dropped from the clinical trials were identified as being the result of seemingly serious adverse events, which were classified as being related to the vaccine.
They include, for one, a 56-year-old white female here in the U.S. who was vaccinated with her first dose on August 11th of 2020.
And she withdrew from the study the following day due to generalized pruritus, which is a type of serious itchiness, as well as tachycardia, which is when the heartbeat exceeds 100 beats a minute.
This particular woman had no ongoing health conditions listed, nor did she have any medical history involving heart conditions going into the trial.
And therefore, according to the study investigator, here's what he wrote, quote, There was a reasonable possibility that the pruritus and tachycardia were related to the study intervention, meaning the vaccine.
Then, secondly, there was a 61-year-old Hispanic female, also from the US, who received her first dose of the vaccine on September 25th of 2020.
However, about two weeks later, on October the 14th, she experienced unilateral deafness, meaning that she couldn't hear out of one ear, and she was then withdrawn from the trial the following day.
Her condition lasted for nine days until October the 23rd, when her hearing finally returned.
Now, because going into the study, this woman had no pertinent medical history, the study investigator concluded that, quote, there was a reasonable possibility that the unilateral deafness was related to the study intervention, again, meaning the vaccine.
Then, thirdly, you have the case of a 71-year-old white male, also from the U.S., who was vaccinated as a part of the trial on October 28th of 2020.
However, he was withdrawn from the trial the following day, right after vaccination, because of, quote, a worsening of the depression that was ongoing at the time of the last available report.
Now, despite the fact that this particular man had an ongoing history of depression coming into this trial, the study investigator concluded that, quote, there was a reasonable possibility that the worsening of the depression was related to the study intervention.
And then lastly, the fourth participant was a 36-year-old white female also from the U.S., who was vaccinated on August 26th of 2020.
However, almost immediately afterwards, she began to experience adverse events such as chest tightness, a worsening headache, pain at the injection site, as well as pain in her left arm.
This led her to be withdrawn from the trial just four days after getting vaccinated because the study investigator determined that, quote, And so, there you have it.
Out of the 3,600 pages of documents in this particular file and a total of 34 withdrawals being documented, well, those were the only four that the study investigator determined to have actually been related to the vaccine.
And so then you might naturally ask, what about the others?
What were the details surrounding their withdrawals?
Well, that is a great question.
And the answer is...
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Now, besides the four individuals that we discussed a moment ago, there were many other Pfizer trial participants who suddenly withdrew from the trial after they experienced new medical conditions that did not correspond with anything in their prior medical history.
Nevertheless, the Pfizer study investigators, they determined that these adverse events were quote-unquote not related to the vaccine.
Here are a few examples of these individuals.
You had a 75-year-old white female from the U.S. that was given a vaccination on August 13th of 2020.
However, just six days later, on August 19th, she tragically experienced a transient ischematic attack, otherwise known as a mini-stroke.
According to the documents, this stroke led to her falling down, fracturing her ankle, and experiencing diffuse weakness in the extremities.
And then, six days after the stroke, on August 25th, she was formally withdrawn from the study.
However, according to the study investigator, the cause of her mini-stroke was unspecified.
But nevertheless, it was deemed to not be related to the vaccine.
Here's specifically what was written in the comments section for this patient.
The subject was withdrawn from the study on August 25th of 2020 because of the transient schematic attack that led to muscular weakness, fall, and ankle fracture.
The ankle fracture was ongoing at the time of the last available report.
In the opinion of the investigator, there was no reasonable possibility that the transient schematic attack, muscular weakness, fall, and ankle fracture were related to the study intervention.
Then you had another example, which was a 36-year-old white male from Argentina with no medical history who got his second dose of the vaccine on September the 9th of 2020.
And then just days afterwards, he experienced severe anxiety, mild injection site pain, as well as suspected COVID-19, which was ultimately never positively diagnosed.
Now, according to the comments that were left in the man's record, the study investigator, he determined that, quote, there was no reasonable possibility that the anxiety and suspected COVID-19 were related to the study intervention.
Anxiety was considered related to constitutive features and COVID-19 was suspected as a reactogenic systemic event.
Pfizer concurred with the investigator's causality assessment for suspected COVID-19.
And so again, just in plain English here, despite having no pertinent medical history, including no history of mental illness, this man's severe anxiety was chalked up to being irrelevant to the study and assessment that Pfizer agreed with.
Another example is a 64-year-old white female from the U.S. who received one dose of the vaccine on September 11th of 2020.
However, 19 days later, she was withdrawn from the study because of pain that she was experiencing in the upper abdomen.
Going into the study, her only ongoing medical conditions were asthma and postmenopause.
However, according to the study investigator, this woman's abdominal pain was not related to the vaccine, but instead to gallbladder disease, although there was no further explanation provided as to how they made that determination.
Then there was another example, one that almost quite frankly made me laugh.
It was a 21-year-old woman, a Hispanic woman, right here in the U.S., who received her vaccine dose on September the 12th of 2020.
However, almost immediately, she began to experience a host of problems, including stomach pain, hair loss, elevated body temperature, intermittent chills, irritation, and redness in the left eye, intermittent headaches, nausea, fever, and she also began to lose weight.
But she wasn't kicked out of the trial until almost a month later, on October the 7th, after she found out that she was pregnant.
And in the comments section for this participant, it mentions nothing about all those other adverse events, but it only mentions the fact that the vaccine did not cause her pregnancy.
Here's specifically what it said.
In the opinion of the investigator, there was no reasonable possibility that the pregnancy was related to the study intervention, meaning the vaccine, or clinical trial procedures.
Pfizer concurred with the investigator's causality assessment.
Meaning that, at least according to the investigator, the vaccine did not make her pregnant.
That's good to know.
Now, there are a lot more of these sorts of examples of people who experienced serious adverse events but were not officially attributed to the vaccine.
And if you'd like to read a full list, well, there is a great analysis in a publication called The Defender.
I'll throw a link to them down into the description box below this video.
Regardless, though, there is actually a third category of participants who were withdrawn from the trials that I believe are worth mentioning.
And these are people who were taken out of the vaccine trial for seemingly trivial adverse events, which kind of raises some questions in its own right.
Because in all of these instances, the study investigators attributed these minor adverse events at least partially to vaccination.
Here are a few examples of these withdrawals that were caused, again, by minor events.
You have a 37-year-old white female from Argentina who was vaccinated on August 30th of 2020 and then was withdrawn from the study almost two months later due to injection site pain.
That must have been very persistent pain to still be present two months later.
Then you had the case of a 41-year-old white female from the U.S. who received her vaccination on September 9th of 2020 but was dropped from the trial 15 days later due to injection site dermatitis.
Then you had another case of a 42-year-old white female from Brazil who was vaccinated on August 18th of 2020, but who was then dropped from the trial about 12 days later due to myalgia, which are muscle aches and pain.
Then you have another case of a 44-year-old white female who was dropped from the study on August 25th of 2020, just one day after her vaccination because of, quote, abdominal discomfort, diarrhea, two episodes of it, right eye pain, fatigue, headache, two episodes of that, as well as muscular weakness.
Then you had another case involving a 68-year-old Hispanic female from the U.S. who was vaccinated on September 4th of 2020, but was withdrawn from the trial seven days later because of muscle spasms, which she began to experience on the very same day of her vaccination.
That same woman also reported experiencing other adverse events, such as tenderness at the injection site, as well as a sour taste in her mouth.
And so on and so on.
The list really does go on and on.
There are a lot of these sorts of examples.
And as I mentioned earlier, this does raise a bit of a question.
Are these very mild and very minor adverse events?
Are they the real reason that these people were kicked out of the trial?
Or is there something underlying that's unmentioned here?
Which is the real reason that these people were withdrawn from the clinical trials.
Now, I don't get into speculation, but I do believe that is a question that's worth asking.
Regardless though, there is one other, at least in my opinion, final noteworthy document that came out of the July Pfizer dump.
It's a 2021 document titled Determining RSV Burden and Outcomes in Pregnant Women and Older Adults Requiring Hospitalization.
And for your reference, RSV refers to respiratory syncytial virus.
It's a common respiratory virus which typically causes cold-like symptoms.
And what's interesting to note is that on page 9 of that document that you see up on your screen, well, here's what it says.
Quote, maternal vaccination, in addition to providing benefit to the mother, could provide benefit to the infant through decreasing maternal disease and through the passive transfer of maternal antibody to the infant.
Okay, so that all sounds well and good.
However, in that very same paragraph, here's how the document continues.
Data about the timing and quantity of antibodies transferred across the placenta are limited for COVID-19.
The Advisory Committee on Immunization Practices noted that potential risks of mRNA vaccines to the pregnant person and the fetus are unknown because these vaccines have not been studied in pregnant people.
They advised that if pregnant people are part of a group that is recommended to receive a COVID-19 vaccine, for example, healthcare personnel, they may choose to be vaccinated.
In addition, when making a decision, pregnant people and their healthcare providers should consider the level of COVID-19 community transmission, the patient's personal risk of contracting COVID-19, the risks of COVID-19 to the patient and potential risks to the fetus, the efficacy of the vaccine, the side effects of the vaccine, and the lack of data about the vaccine during pregnancy.
And so, just to put this all into context, this document, which admits that the mRNA vaccines were not studied on pregnant people and that the risks to them, to the fetus as well as the mother, were unknown, is dated March 23rd of 2021, even though the Pfizer vaccine was being administered to the public here in the U.S. under emergency use authorization since December of 2020.
You can make of that what you will.
If you'd like to dig through all these documents for yourself, I'll throw them all down into the description box below this video.
The PDF links will all be down there in the description box below so you can go as deep as you'd like into the story.
And all I ask in return is that if you haven't already, take a quick moment to smash, smash, smash that like button so this video can be shared out to ever more people.
And also, if you haven't already, consider subscribing to this channel as well.
That way we can get this type of honest news content delivered directly into your YouTube feed every single weekday.
Lastly, as I mentioned at the top of the episode, earlier today we published an awesome documentary called The Real Story of January 6th, which reveals some of the truth that's been hidden from the American people.
Because while there is a narrative which has already been set for well over a year around what happened that day by the legacy media, some of the key events and some of the key witnesses have largely been ignored.
That is, until now.
Now, this documentary is, frankly, absolutely awesome, and I should also mention that I have a very small cameo myself in it, and if you'd like to watch it, you can just click on that link.
It'll be at the very top of the description box, and I really hope you do watch it, because it is quite literally a historical account of what happened on that day, and I believe it's worth watching for every single American.
So again, that link will be right there at the very top of the description box.
I hope you check it out.
And then, until next time, I'm your host, Roman from the Epoch Times.
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