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64
FDA Releases More Data On "Adverse Reactions" To Pfizer Vaccine | ZeroHedge (www.zerohedge.com)
posted 4 years ago by DNA1 4 years ago by DNA1 +64 / -0
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▲ 19 ▼
– DNA1 [S] 19 points 4 years ago +19 / -0

Naturally, the rebuttal will be that any vaccine statistically will impact many given the order of magnitude of people being injected.

I'm curious if anyone knows what threshold said people would actually consider unsafe, especially when keeping in mind that the numbers are being underrepresented.

Don't think they've walked back the safe for pregnant women guidance either, but they were aggressive on that during the rollout...

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▲ 27 ▼
– throwawayaccount2037 27 points 4 years ago +27 / -0

The reporting is the main issue, because those responsible for tracking the data weren't recording cardiovascular events, as advised by Pfizer's own administrators.

From their document on page 70:

https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf

8.3.6. Cardiovascular and Death Events Not applicable.

So they didn't advise to record cardiovascular and death events.

From the same document, page 70 (bold for emphasis):

8.3.8. Adverse Events of Special Interest Not applicable

8.3.8.1. Lack of Efficacy Lack of efficacy is reportable to Pfizer Safety only if associated with an SAE

8.3.9. Medical Device Deficiencies Not applicable.

8.5. Pharmacokinetics Pharmacokinetic parameters are not evaluated in this study.

8.6. Pharmacodynamics Pharmacodynamic parameters are not evaluated in this study.

8.7. Genetics Genetics (specified analyses) are not evaluated in this study

8.8. Biomarkers Biomarkers are not evaluated in this study.

8.9. Immunogenicity Assessments Immunogenicity assessments are described in Section 8.1.

So those cytokine storm events? Just ignore them, according to Pfizer.

Now pay attention to what they said they were using to track or not track AE and SAE related incidents for the FDA report:

Reports are submitted voluntarily, and the magnitude of underreporting is unknown. Some of the factors that mayinfluence whether an event is reported include: length of time since marketing, market share of the drug, publicity about a drug or an AE, seriousness of the reaction, regulatory actions, awareness by health professionals and consumers of adverse drug event reporting, and litigation

So Pfizer purposely advising administrators to NOT report certain events combined with the fact that the FDA is admitting they have no idea how much these events are being under-reported, should set off red flags right there.

Further on it says...

Because many external factors influence whether or not an AE is reported, the spontaneous reporting system yields reporting proportions not incidence rates. As a result, it is generally not appropriate to make between-drug comparisons using these proportions; the spontaneous reporting system should be used for signal detection rather than hypothesis testing.

In some reports, clinical information (such as medical history, validation of diagnosis, time from drug use to onset of illness, dose, and use of concomitant drugs) is missing or incomplete, and follow-up information may not be available

So once again, we have no clue and no control studies about efficacy rates, drug mixtures, or medical complications spawning from these things. We just have to trust that they're "safe and effective", even while we have -- even by the FDA's own admission -- no placebo effect data to pull from to test against control studies for natural immunity, previous prescribed medications, etc., etc.

What good is the data then?!

They even admit as much in the next segment, writing...

An accumulation of adverse event reports (AERs) does not necessarily indicate that a particular AE was caused by the drug; rather, the event may be due to an underlying disease or some other factor(s) such as past medical history or concomitant medication.

So the drug masquerading as a vaccine may or may not be causing issues, just the same as Covid may or may not be causing issues, just the same as some other drug someone was taking may or may not be causing issues. So it's all guesswork and a hodgepodge of self-reporting with no way to know for sure what's what? Seriously?

And the most significant part here...

Among adverse event reports received into the Pfizer safety database during the cumulative period, only those having a complete workflow cycle in the safety database (meaning they progressed to Distribution or Closed workflow status) are included in the monthly SMSR. This approach prevents the inclusion of cases that are not fully processed hence not accurately reflecting final information.

So what about every report that WASN'T included in their workflow cycle in the safety database? What about all the culled data? How much data was culled, in fact? What was the average means?

Now let's combine Pfizer's own preamble on the limitations for what sort of data they were actually accruing regarding SAEs, health complications and death-related events, with the fact that the FDA is acknowledging they don't really have a clear-cut data set of samples to pull from, and you can basically see how this is all a game of charades and bull-crap.


TL;DR: It's all junk data because Pfizer isn't actually recording all relevant data points, and culling specific data points that might be of interest to the general public regarding both the efficacy rates and the SAE/death rates associated with the vaccines. In essence, we have no clear data and it's purposely being obfuscated by the powers that be.

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▲ 10 ▼
– Xzal 10 points 4 years ago +10 / -0

Cherry picking data to meet a desired outcome... Hmmmm.

The exact opposite of science.

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▲ 3 ▼
– throwawayaccount2037 3 points 4 years ago +3 / -0

The really crazy part is that even with all the data culling and cherry picking, they still have abysmal death-rates on record for the so-called "vaccines". That alone should make people worried about what the actual numbers are.

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▲ 1 ▼
– deleted 1 point 4 years ago +1 / -0
▲ 11 ▼
– icockmyglock 11 points 4 years ago +11 / -0

Naturally, the rebuttal will be that any vaccine statistically will impact many given the order of magnitude of people being injected.

That's the inverse of the exact argument for why covid is so dangerous that they use to justify the vax.

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▲ 3 ▼
– deleted 3 points 4 years ago +3 / -0
▲ 3 ▼
– Gizortnik 3 points 4 years ago +3 / -0

Honestly, one of the most poignant things I've seen about the vaccine is how careful the pharmacists are being.

Drug store pharmacists don't normally give a shit, though if you get nice ones, they can be helpful and point you in the direction of over-the-counter stuff that can help. If you've ever gotten a Flu shot, you'll notice it's a pretty simple non-event.

However, all the ones around me are exercising extreme caution with the Covid vaccines they have. I had a family member get turned away from a Covid shot for blood pressure, just because he didn't have doctor's approval for the shot. They really do want to keep careful watch on people who've been injected for 45 minutes. They've talked about stories of more than a few people passing out in only a few minutes.

I'm looking at $15 /hr pharmacists who are exercising and abundance of caution and want to talk to you about your medical history before getting the shot, if you're pregnant, if you plan on becoming pregnant, when was your last shot, all sorts of stuff; while the talking head on the corporate news channel is screaming "Mix & Match!!!". It's fucking unnerving that it seems like the low wage drug clerks are being more responsible than anyone else.

It's like finding there's a burglar in your house and calling Walmart security instead of the police... because the police told you that locked doors are terrorism and no human is illegal.

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▲ 2 ▼
– reidj 2 points 4 years ago +2 / -0

The real question is what is the rate of serious adverse effects and how does this compare with other vaccines.

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▲ 2 ▼
– DNA1 [S] 2 points 4 years ago +2 / -0

They've made sure we'll never have the data (see throwawayaccount2037's post among other historical news re: the topic), and keep trivializing VAERS due to its reporting nature.

It's more or less impossible to compare under those parameters, and there is no long-term trial thanks to the control group being vaccinated for 'humanitarian' reasons.

Which is why I ask if anyone has seen a set percentage that would qualify as dangerous by these bad-faith personnel. I'm guessing not.

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▲ 14 ▼
– deleted 14 points 4 years ago +14 / -0
▲ 12 ▼
– current_horror 12 points 4 years ago +12 / -0

This seems like a minor point, or a sardonic joke, but it’s the center of everything. We’ve begun the transition from individual rights to full-blown collectivism, and collectivism is perfectly comfortable with killing people in the name of progress.

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