Risk of Bell's Palsy after covid vaccine?

[Posaunus]

I haven't been affected to date. I'm well traveled. Have 4 kids in public schools. Gone to international swim meets in Tampa for weeks at a time with 800+ swimmers. No masks and no covid. Maybe I already got it and don't know about it. I could be one of those fortunate people with no symptoms.

Now that is a true, informed, statistical analysis. Great supplement to the data and guidance provided by the medical and public health experts. I now feel so much safer!

[brassmedic]

It's a meme. Look it up. I am questioning the veracity of your claim that probability theory and statistics are your specialty. If I had a nickel for everyone on the internet who has claimed to be a specialist in the field they happen to be arguing about...

I enjoyed probability theory in undergraduate school (top in a class of about 200 engineers at Univ of Illinois, Champaign-Urbana). It made getting my Masters Degree a cinch when all of my peers were struggling with stochastic processes and queueing theory. I then used that knowledge over the decades in real world engineering designs (like designing satellite systems, rockets and the like). I also taught a 4 day course to industry for a number of years on statistics. I'm a bit rusty on it nowadays. But I can spot errors and omissions in almost any amateurish reporting/analysis (typically peddled on the trusting pedestrian population). I'm not at all intimidated by others analysis. Most of the time I either learn something or find it amusing. So in closing, I retract my apology and move to the alternate ending "if so ... ____ ____." You can fill in the blanks.

Oh, I didn't realize you took a probability class as an undergrad. Yes, now I see that you're qualified to second-guess all the experts in the world.

[BGuttman]

I guess Patrick outranks me as well. After all, I only spent a 40 year career doing statistically designed experiments and statistical quality control. Shame on me for considering a 1 in 7000 a less likely outcome than 1 in 300

[patrickosmith]

Two words for all the experts out there: conditional probability

https://en.m.wikipedia.org/wiki/Conditional_probability

[WilliamLang]

some people are either dumb or acting stupid on purpose.

[robcat2075]

The people with no symptoms are the reason we have an epidemic.

It's not the people in ICU who are out at the malls and the swimming meets spreading the disease. It's the people who have it but think they don't.

[Wilktone]

There was once a group of trombonists and a group of statisticians riding together. All the trombonists had tickets, but the statisticians only had one ticket between them. Inquisitive by nature, the trombonists asked the statisticians how they were going to get away with such a small sample of tickets when the conductor came through. The statisticians said, "Easy. We have methods for dealing with that." Later, when the conductor came to punch tickets, all the statisticians slipped quietly into the bathroom. When the conductor knocked on the door, the head statistician slipped their one ticket under the door thoroughly fooling the layman conductor. On train home, the statisticians and the trombonists again found themselves on the same train. Always quick to catch on, the trombonists had purchased one ticket between them. The statisticians (always on the cutting edge) had purchased NO tickets for the trip home. Confused, the trombonists asked the statisticians "We understand how your methods worked when you had one ticket, but how can you possibly get away with no tickets?" "Easy," replied the statisticians smugly, "we have different methods for dealing with that situation." Later, when the conductor was in the next car, all the trombonists trotted off to the bathroom with their one ticket and all the statisticians packed into the other bathroom. Shortly, the head statistician crept over to where the trombonists were hiding and knocked authoritatively on the door. As they had been instructed, the trombonists slipped their one ticket under the door. The head statistician took the trombonists' one and only ticket and returned triumphantly to the statistician group. Of course, the trombonists were subsequently discovered and publicly humiliated.

MORAL OF THE STORY: Do not use statistical methods unless you understand the principles behind them.

Here's an interesting web page with a number of personal stories from musicians who came down with Bell's palsy.

https://timsmithtrombone.com/bells-palsy/

[vetsurginc]

Please note none of this discussion applies to Screw Bell's Palsy

[spencercarran]

I enjoyed probability theory in undergraduate school (top in a class of about 200 engineers at Univ of Illinois, Champaign-Urbana). It made getting my Masters Degree a cinch when all of my peers were struggling with stochastic processes and queueing theory. I then used that knowledge over the decades in real world engineering designs (like designing satellite systems, rockets and the like). I also taught a 4 day course to industry for a number of years on statistics. I'm a bit rusty on it nowadays. But I can spot errors and omissions in almost any amateurish reporting/analysis (typically peddled on the trusting pedestrian population). I'm not at all intimidated by others analysis. Most of the time I either learn something or find it amusing. So in closing, I retract my apology and move to the alternate ending "if so ... ____ ____." You can fill in the blanks.

I see your master's-level class on stochastic processes and raise you a doctoral dissertation using Bayesian models to map susceptibility to vaccine-preventable diseases.

[patrickosmith]

Your credentials are truly Impressive! Honestly, no sarcasm intended. But, I'm still going to "wait and see" for at least a few years until the dust settles. And it is in part because of my experience right here from my fellow trombonists. I share one little research report (that should be on interest to any brass player), I ask a few simple questions, and I get slammed for having a reasonable lived experience of no "covid" even with plenty of travel and large family. I shouldn't be allowed to share information with actual data of risks that are important to me. Because why? It might make some people question the wisdom of "jumping in." That kind of dialogue must all be suppressed and whoever shares it must obviously be a lunatic. There is just no other explanation. There is the epitome of censorship.

[Burgerbob]

There is the epitome of censorship.

Nope. That would be the government deleting your posts. You're free to discredit yourself as much as you want, for better or worse.

[brassmedic]

Your credentials are truly Impressive! Honestly, no sarcasm intended. But, I'm still going to "wait and see" for at least a few years until the dust settles. And it is in part because of my experience right here from my fellow trombonists. I share one little research report (that should be on interest to any brass player), I ask a few simple questions, and I get slammed for having a reasonable lived experience of no "covid" even with plenty of travel and large family. I shouldn't be allowed to share information with actual data of risks that are important to me. Because why? It might make some people question the wisdom of "jumping in." That kind of dialogue must all be suppressed and whoever shares it must obviously be a lunatic. There is just no other explanation. There is the epitome of censorship.

Your mind was already made up before you posted, and the reactions you got here have nothing to do with it. The Bell's Palsy thing is old news. It was reported last year, and to this date there is absolutely no evidence that a Covid vaccine can cause it. The rate was commensurate with the incidence of sudden facial paralysis in the general population. You came on the forum with a decidedly non-scientific attempt to lend credence to an opinion you obviously had already formed. And you got slammed for it. And now you want to act like some kind of martyr? Get lost.

[patrickosmith]

Saying it doesn't make it true.

[BGuttman]

The problem with these rare events, like the blood clots with AstraZenica or these Bell's, is that you are losing the statistical confidence in the hypothesis.

We can easily ascertain that the vaccine is 90% effective in preventing COVID infection: there are hundreds of vaccinated people who get breakthrough infections. When we get to an effect with single digits out of tens of thousands of subjects it becomes difficult to establish a true cause and effect.

Certainly it bears some further study. We may discover that there is a subgroup of people who are more susceptible to this problem, like the blood clots tending to be in pre-menopausal women. But we don't know yet.

If you are still concerned, maybe start a program of Ivermectin. Or if you really want to drink Kool Aid, Hydroxychoroquine.

[patrickosmith]

I actually did already have a course of treatment with a malaria-like cocktail to treat babesiosis ( https://www.webmd.com/a-to-z-guides/bab ... -infection ) .

But I prefer gin and tonic with Schweppes which does contain quinine (the natural form of hydroxychloroquine).

[timothy42b]

That kind of dialogue must all be suppressed and whoever shares it must obviously be a lunatic. There is just no other explanation. There is the epitome of censorship.

You posted your opinion publicly. I happen to disagree with it and I stated my reasons. I don't see that as persecution, but the normal course of discussing an issue. If you come here only for validation you will often but not always be disappointed.

On some issues the people taking part may be more evenly split, you do seem to be in the minority on this one, but that still doesn't rise to the level of censorship in my view. Certainly we are more polite here than on many forums.

[patrickosmith]

True enough. Perhaps bordering on bullying by FB standards, but I'm not a snowflake. Thanks for your viewpoint. Now, I shared this information because I hadn't heard it before and thought it of interest (not because I expected validation). My experience here is a valuable reminder that one must continually seek the truth even in the face of adversity. I remain extremely skeptical. I am not going to "jump in" without a lot of evidence that I can verify myself from a variety of sources (this forum being one). Neither does it include repetitive news media reporting, coercion, incentives and certainly not celebrities and government.

[patrickosmith]

Your mind was already made up before you posted, and the reactions you got here have nothing to do with it. The Bell's Palsy thing is old news. It was reported last year...

I still haven't "made up my mind" and I had not heard the "old news" that you say was discredited or debunked. That's a red flag right there. "Oh that was debunked so you don't need to look into it any further." I am very skeptical for good reason. I certainly do not trust the government with my life. There is a lot of conflicting information. Some may call it disinformation but those calling it so may have an agenda. I will continue to seek the truth (me myself and I) from all sources.

[BGuttman]

You really need to look in the overall context of things. If COVID were a minor disease that was localized, wanting to make sure the vaccine was thoroughly vetted is a reasonable quest. But that's not the case here. COVID is a virulent disease, spreads easily, has a high death rate among victims, and threatens to be similar to plagues from the past. This vaccine has been developed under emergency conditions as an attempt to control the disease and it seems to be pretty safe in comparison to allowing the plague to run its course.

If it helps, there has been a report that COVID contributes to ED. Think of it as a "reverse Viagra".

[Doug Elliott]

Some people who got the Moderna shot got Bell's Palsy. That fact was not debunked. But at the same time a similar percentage of people in the world, who didn't have covid and were not in the control group, also got Bell's Palsy. The fact that none of those people happened to be in the control group is meaningless. Bell's Palsy is a rare side effect of being alive.

[patrickosmith]

The missing link for me is the seemingly increased rate of occurrence. These outcomes occurred within days to months after receiving the vaccine. I haven't seen an analysis that addresses this and I haven't yet had the time to do it myself. Everyone here just assumes the experts have done so.

[Doug Elliott]

Lots of people have gotten Bells Palsy within days or months of NOT getting a vaccine, it's certainly not unique to this vaccine.

One thing to consider, that I have not seen addressed, is not about this vaccine specifically but about illness and immune response in general.

The "side effects" of any vaccine (or illness) are similar to the symptoms of the infection. So how much of those symptoms are due to the actual infection and how much are due to the immune response? ... We know that autoimmune diseases are the body reacting to immune responses in a bad way. Fever, chills, sweating, etc are not the disease, but the immune response... necessary to combat the disease. Is Bell's Palsy (in any form or timing) itself an infection, or inflammation as a result of the immune response? In general, do we "feel sick" as part of the immune response, or the disease itself? With some things like malaria, you can recover from the disease but it's the symptoms (uncontrolled shivering) that can kill you.

In any case, immune response is a necessary part of developing immunity so you can ward off or recover the next time you encounter the same pathogen. There's really nothing different about these vaccines from any others except the speed at which they were developed, which is a testament to the current state of medical knowledge. I'm not going to second-guess experts in the field due to conspiracy theories or politics.

[brassmedic]

Your mind was already made up before you posted, and the reactions you got here have nothing to do with it. The Bell's Palsy thing is old news. It was reported last year...

I still haven't "made up my mind" and I had not heard the "old news" that you say was discredited or debunked. That's a red flag right there. "Oh that was debunked so you don't need to look into it any further." I am very skeptical for good reason. I certainly do not trust the government with my life. There is a lot of conflicting information. Some may call it disinformation but those calling it so may have an agenda. I will continue to seek the truth (me myself and I) from all sources.

I didn't say it was debunked. I said it was reported last year, so I don't know why you're pretending this is something that's just being discovered. They looked into it and found that the rate of Bell's Palsy that occurred in the trial subjects was similar to the rate that it occurs in the general population and concluded that the vaccine is unlikely to be the cause, but continued to monitor the situation out of an abundance of caution. The rate of Bell's Palsy occurring after vaccinations is still commensurate with the rate in the general population. If you "haven't had the time" to find this out, perhaps you should make the time. A lot of people here have explained it politely and rationally, and you have petulantly dismissed every single one of them.

[patrickosmith]

... The rate of Bell's Palsy occurring after vaccinations is still commensurate with the rate in the general population. If you "haven't had the time" to find this out, perhaps you should make the time. A lot of people here have explained it politely and rationally, and you have petulantly dismissed every single one of them.

Very well then. Keep in mind this analysis relies on a small sample of data (36,901 subjects) for a relatively rare outcome and a number of simplifying assumptions. And I am having a relaxing non-working day if you gather my meaning. So please do check the numbers. I know I will be checking it later.

Without further ado ...

Question:
What is the *relatively likelihood* of contracting Bell's Palsy for these two conditions:
(Condition A) "after receiving the (Pfizer/Moderna) mRNA injections"
(Condition B) "not receiving the mRNA injections at all."

Answer:
575

You are 575 times more likely to contract Bell's Palsy after receiving these mRNA injections than had you not been injected at all.

So what!? It's a rare thing right? That is true. You probably won't get it anyway since it is so rare. But, still, you are 575 times more likely to get it within a few months of your last injection.

Please feel free to point out any errors, omissions, mistakes, caveats or spin you care to make. I would love it if any of you can find a stupid math mistake, error in reasoning or whatever.

From Wilktone and http://www.neurocntr.com/bells-palsy.php we have 40,000 outcomes per 332,000,000 persons per year. That's an occurrence rate of 0.000120481 per person per year for (Condition B).

From the data provided in the subject report we have 7 outcomes per 36,901 in an average period of 25 days after receiving their last injection (specifically days 3, 9, 22, 28, 32, 37, 48). That's an occurrence rate of 0.000189696 per person per 25 days. (For the sake of the remainder in this group I hope this short-term rate reduces dramatically). Anyway, this translates to an occurrence rate of 0.069239316 per person per year for (Condition A).

The ratio of condition (A) to condition (B) is 575.

[Doug Elliott]

per person per year
or
per person per 25 days?

It looks like you're comparing apples with bushels of apples.
You're basing your figures with no justification, that the 25 day rate will continue for the rest of the year.

And how many people got Bells Palsy after having covid?
after getting any other vaccination?
after having a cold, flu, or other illness or immune system response?

Any of those would be more relevant than comparing the incidence in the general population.

[paulyg]

I’m continually amazed at the breadth of intellects able to play trombone, go about life, and even type out grammatically coherent responses.

[patrickosmith]

Doug,

I'll answer your question from my original statement:
"That's an occurrence rate of 0.000189696 per person per 25 days. (For the sake of the remainder in this group I hope this short-term rate reduces dramatically). Anyway, this translates to an occurrence rate of 0.069239316 per person per year for (Condition A)."

Has anyone gone back to check to see if the short-term rates have decreased, increased or remained the same? That would be useful data.

Patrick

[BGuttman]

This is an extremely rare occurrence given the amount of testing we have had time for. I'm sure that any additional reports of Bell's will be considered. Remember, we have a situation where you have a 1 in 300 chance of dying from COVID and something like 1 in 150 chance of permanent disability from COVID. Which do you want to risk? I got my 2nd Pfizer shot a couple of months ago and I'm still OK (well, there are other health issues that were present long before the outbreak of COVID ...).

[Doug Elliott]

Doug,

I'll answer your question from my original statement:
"That's an occurrence rate of 0.000189696 per person per 25 days. (For the sake of the remainder in this group I hope this short-term rate reduces dramatically). Anyway, this translates to an occurrence rate of 0.069239316 per person per year for (Condition A)."

Has anyone gone back to check to see if the short-term rates have decreased, increased or remained the same? That would be useful data.

Patrick

I know I have better things to do right now than follow this thread or do the math, but that sure doesn't look right to me. And even if it is, I think you're making a lot of assumptions with no basis.
I'm out of here for now.

[patrickosmith]

I made no errors or omissions that I know about. I didn't quantify the statistical error bars. One often needs at least 30 outcomes for a good estimate. Alas this data set had only 7 outcomes. That would be the most likely dart thrown by "the experts."

[Doug Elliott]

Speaking of errors and omissions:

Since the vaccine trials only involved a certain age group, any comparisons to the overall incidence of Bells Palsy necessarily have to include only the same age group. Good luck finding that information.

Without it, those statistics are meaningless.

[greenbean]

Whoa, it looks like an epidemiologist is needed here! I happen to be one....

Here is a quick statistical analysis. I think I have the right numbers. Let me know if not and I will fix it. This is probably what the researchers did as a first pass. Then they would have used a much more sophisticated statistical model. Or, more likely, they realized that they didn't have enough data to draw conclusions with any certainty. So, the "risk ratio" (treated / control) is 7.01. It might be tempting to interpret this as "the rate in the vaccinated group was 7 times the rate in the control group." But looked at the confidence interval (CI) for that point estimate. It is wider than any CI that I reported in my research career. Why? Not enough data! Look at the number of cases this analysis is based on. Seven cases and one case! Tiny data samples like this are subject to natural variability but are also very sensitive to data errors. So, the control group had one case. What if there was really a second case that was incorrectly reported as some other neurological condition. If you put that person back into the analysis (where they belong), it completely changes the results. The estimated rate among the control would double. And maybe the data analyst miscoded some people while working with the data (easy to do). Maybe the 7 cases in the vaccinated group is really 6. Again, that would significantly change the results. These are simple examples, but you get the idea.

Screen Shot 2021-06-05 at 8.42.21 PM.png

Epidemiological studies are subject to a laundry list of possible problems. Yes, this is a randomized trial, but trials suffer from many of the same problems. There are big challenges caused by differential drop out rates and by differences in behaviors that affect ascertainment of disease status. One thing to really watch for in a trial like this would be the fact that the control will have more severe COVID symptoms and would be more likely to end their participation in the study, after being identified as a COVID case and thus being much less likely to have other diagnosis become known. There may have been several control group participants who developed Bells Palsy but were not identified by study staff because they dropped out of the study. And on and on.

[BGuttman]

Thanks, Tom. This is what a lot of us have been trying to say. Figures don't lie, but Liars can Figure.

[Posaunus]

Whoa, it looks like an epidemiologist is needed here!

Fortunately, it was other professional epidemiologists, statisticians, and medical experts who reviewed the extensive clinical trial data for the "experimental" COVID-19 vaccines - and who surely saw and accounted for the Bell's Palsy outliers in that data - before they recommended releasing the vaccines to the general population. These same experts are surely also monitoring the results of the by-now very wide distribution of the vaccines (billions of doses so far), now clearly understood to be safe and effective.

It is those professionals who most of us trust, and on whose recommendations we have willingly been injected to protect ourselves - and others! They surely have more expertise than a TromboneChat member whose claim to fame seems to be that he "enjoyed probability theory in undergraduate school" and "used [his] knowledge over the decades in real world engineering designs (like designing satellite systems, rockets and the like)," but who has not seen the totality of the data used to make the vaccine release recommendations - nor the details or medical history of the Bell's Palsy patients. These recommendations come from sources (people) that I trust to have made their decisions in the best interest of the public - NOT from some politically-inspired arm of "government." [Quoting the O.P.: "I am very skeptical for good reason. I certainly do not trust the government with my life."]

I have no personal knowledge to question the O.P's motives or his fears. But, for some reason, "I am very skeptical."

[greenbean]

Fortunately, it was other professional epidemiologists, statisticians, and medical experts who reviewed the extensive clinical trial data for the "experimental" COVID-19 vaccines - and who surely saw and accounted for the Bell's Palsy outliers in that data - before they recommended releasing the vaccines to the general population. These same experts are surely also monitoring the results of the by-now very wide distribution of the vaccines (billions of doses so far), now clearly understood to be safe and effective.
...

For sure, Dave. Vaccine development is not a new field. Huge investments have been made building the research infrastructure to (relatively) quickly gets vaccines ready. The annual flu vaccine development has been a big part of it. What these companies and the NIHs have done for this Coronavirus crisis has been nothing short of astounding. Could we imagine we would be where we are today?... say, a year ago when the US President (!) was calling it a hoax?

[brassmedic]

What I don't understand is, if someone is convinced that this 7 to 1 differential conclusively proves that those two vaccines greatly increase your risk for developing Bell's Palsy, and isn't just statistical noise, then why not just get the Johnson & Johnson vaccine, which had an equal number of Bell's Palsy cases in the treated and control groups? Unless this isn't really about being concerned and is more about having certain political beliefs.

[patrickosmith]

Hey guys, Tom Rice threw two darts.

1) The small data dart which is true. With only 7 outcomes there is significant statistical error which I have not yet quantified. However, I did not use the much worse method ("7 to 1") that Tom Rice implied. That would introduce much higher error for no reason. I did use the 7 reported outcomes from those who received the mRNA injections out of the 36,901 cases. I agree that is a small number over a limited time period. Nevertheless the markedly increased *rate* of occurrence is alarming when compared to the pre-pandemic rate based on 40,000 outcomes per 332,000,000 persons per year. You see, I did not use that 1 outcome from the placebo group. As many of you correctly pointed out, we have all the data in the world for that case. I used all the data I had and let the numbers speak for themselves.

Additional surveillance of those who received nRNA from the original group of 36,901 might show that the risk rate goes back to the nominal pre-pandemic rate risk.

2) Tom's other dart was that *maybe* some of the 7 who reported Bell's Palsy were *misreporting* the condition, i.e., they didn't actually have Bell's Palsy. While that may be true I assumed that the data in this (peer reviewed?) report is valid. I can't go changing the numbers. That's what people with an agenda try to do and most people correctly see right through that.

[patrickosmith]

Thanks, Tom. This is what a lot of us have been trying to say. Figures don't lie, but Liars can Figure.

I truly hope you aren't actually calling *me* a liar for conducting my own statistical analysis. I'm practically begging anyone to throw darts at it. Until someone can throw a dart that actually sticks, the increased risk is "575 times more likely." The biggest dart is the one I already pointed out: data from only 36,901 person's with only 7 outcomes for a rare condition. One needs 30 for a credible report, 100 for a much higher level of credibility, and 1000s for indisputable reporting.

[patrickosmith]

...this 7 to 1 differential conclusively proves ...

I didn't use the much worse statistical estimate based on 7 to 1 differential to which Tom Rice alluded. I ignored the placebo group and used the pre-pandemic rate offered by Wilktone based on the population of the USA (40,000 outcomes per 332,000,000 person's per year).

[BGuttman]

The problem is still the VERY small sample size. There are not enough instances to create statistical confidence in the outcome.

On the other hand, we have very strong statistical evidence that all of the vaccines tested (this excludes Sputnik and the Chinese) are significantly capable of preventing COVID infection and reducing the consequences of any infection found.

No, I don't call you a liar. I just think you are misinterpreting the information. In fact, you are probably equally at risk of Bell's Palsy whether you get the vaccine or not.

[Wilktone]

The article Patrick linked to in the first post in this thread states:

The FDA pointed out that the cases in the vaccine groups did not represent a frequency above that expected in the general population [1] and concluded that currently available information was insufficient to determine a causal relationship with the vaccine.

This is just an example of the scientific method working itself out in real time. The FDA is taking this seriously out of an abundance of caution, but the risk/benefit to getting vaccinated is quite clear.

Getting vaccinated is much like wearing a mask if you're unvaccinated. It's not so much to protect you, but to protect those around you. If you are able to get the vaccine and there aren't any health reasons why you shouldn't, then I think you have a moral obligation to do so. If your ideological views prohibit that for some reason, then I think the moral thing to do is to continue to wear a mask (assuming that *continue* is the right description here) and socially distance yourself when out.

It is natural to feel some anxiety about a new vaccine and one that was developed and rolled out with such speed. Discussing your concerns on a trombone forum is the absolute wrong place to address this issue. If you don't trust the government, why would you trust a random group of trombonist strangers? Do you trust your doctor? Make an appointment and discuss this issue with your medical provider.

Dave

[patrickosmith]

David Wilken,
You are absolutely right. No more statistical, covid or vaccine discussions with any brass instrumentals. But I reserve the right to introduce a limerick.
Patrick
p.s.
"He said that if they knew so well how things were to be done, they did not need him. He refused to help them further, and vanished."
Wizard's First Rule, Terry Goodkind

[timothy42b]

The problem is still the VERY small sample size. There are not enough instances to create statistical confidence in the outcome.

With a small sample size, we can't assume a normal distribution, and therefore most of the standard statistical tests are not valid. You might be able to get around that using cell means and the Central Limit Theorem but I don't see a way to get that data.

[patrickosmith]

Having had just a bit too much wine
the statistician opted to recline
head in the Frigidaire
feet out in the hot air
On the average he was feeling fine

Source: https://www.familyfriendpoems.com/poem/statistics

[Kingfan]

... It is natural to feel some anxiety about a new vaccine and one that was developed and rolled out with such speed. Discussing your concerns on a trombone forum is the absolute wrong place to address this issue. If you don't trust the government, why would you trust a random group of trombonist strangers? Do you trust your doctor? Make an appointment and discuss this issue with your medical provider.

Dave

I agree. Coming to this forum for information on COVID is like posting on an AMA epidemiologist website a question on trombone mouthpieces. You might get some good information, but...

[patrickosmith]

The people with no symptoms are the reason we have an epidemic.

https://wwwnc.cdc.gov/eid/article/27/4/20-4576_article

Volume 27, Number 4—April 2021
Dispatch
Analysis of Asymptomatic and Presymptomatic Transmission in SARS-CoV-2 Outbreak, Germany, 2020

"In conclusion, our study suggests that asymptomatic cases are unlikely to contribute substantially to the spread of SARS-CoV-2."

[brassmedic]

...this 7 to 1 differential conclusively proves ...

I didn't use the much worse statistical estimate based on 7 to 1 differential to which Tom Rice alluded. I ignored the placebo group and used the pre-pandemic rate offered by Wilktone based on the population of the USA (40,000 outcomes per 332,000,000 person's per year).

So what? That wasn't my question.

[Dennis]

Thanks, Tom. This is what a lot of us have been trying to say. Figures don't lie, but Liars can Figure.

I truly hope you aren't actually calling *me* a liar for conducting my own statistical analysis. I'm practically begging anyone to throw darts at it. Until someone can throw a dart that actually sticks, the increased risk is "575 times more likely." The biggest dart is the one I already pointed out: data from only 36,901 person's with only 7 outcomes for a rare condition. One needs 30 for a credible report, 100 for a much higher level of credibility, and 1000s for indisputable reporting.

A number of darts have been thrown that have in fact stuck.

In terms of time-to-event data, the FDA will require sample sizes large enough to generate at least 100 events in a Phase IIb trial and more in a Phase III trial. Seven or 8 events in a randomized trial is simply insufficient to make any sort of conclusion. Consider that the trials were randomized 1:1 to the two treatments. We observed 8 events. If there is in fact no causal relationship between vaccination and Bell's palsy, a 1:7 split happens about 3.5% of the time. In terms of incidence data, the FDA will require sufficient data to provide 80% to 90% power for the alternative hypothesis.

However, there has been no adjustment made for the data snooping. That is, if we had specified before the fact that Bell's palsy was an adverse event (AE) of special concern, we might have sufficient evidence to conclude that there is an association between the vaccine and Bell's palsy. (I say might, because the exact test used here is just barely significant and any multiplicity adjustment would make the result insignificant. So, if Bell's palsy was the only AE of concern, we'd have the result you have claimed.)

Now, let's address your claimed risk-ratio of 575. The numerator of the risk ratio is suspect (because of the data snooping) and the denominator is wrong. You used the crude incidence rate in the population as the denominator, but the clinical trial was restricted to persons over 18 (or 16 for the Pfizer-BioNTech) vaccine. We know that the risk of Bell's Palsy is highest in the 15 to 45 year-old group. The crude rate is too low: an age-adjusted rate if necessary.

Of course, the real problem here is what Goldberger called micronumerosity. You are trying to reach definitive conclusions on the basis of 8 observations. Insufficient data are insufficient. What the data are sufficient for is to flag Bell's palsy for further monitoring. That is in fact what has happened: the FDA has recommended.

[robcat2075]

The people with no symptoms are the reason we have an epidemic.

https://wwwnc.cdc.gov/eid/article/27/4/20-4576_article

Volume 27, Number 4—April 2021
Dispatch
Analysis of Asymptomatic and Presymptomatic Transmission in SARS-CoV-2 Outbreak, Germany, 2020

"In conclusion, our study suggests that asymptomatic cases are unlikely to contribute substantially to the spread of SARS-CoV-2."

That's one. Not many others seem to agree...



https://www.webmd.com/lung/news/2021011 ... tic-spread

About 59% of transmission comes from people without symptoms, according to a new study published Thursday in JAMA Network Open. This includes 35% from people who infect others before they show symptoms and 24% from people who never develop any symptoms.

https://www.uchealth.org/today/the-trut ... -covid-19/

“Asymptomatic spread definitely plays a role in community spread,” said Dr. David Beckham, an infectious disease specialist who studies viruses in a lab he runs at the University of Colorado School of Medicine.

https://jamanetwork.com/journals/jamane ... le/2774707

Question What proportion of coronavirus disease 2019 (COVID-19) spread is associated with transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from persons with no symptoms?

Findings In this decision analytical model assessing multiple scenarios for the infectious period and the proportion of transmission from individuals who never have COVID-19 symptoms, transmission from asymptomatic individuals was estimated to account for more than half of all transmission.

Meaning The findings of this study suggest that the identification and isolation of persons with symptomatic COVID-19 alone will not control the ongoing spread of SARS-CoV-2.

https://www.uchicagomedicine.org/forefr ... -of-spread

Asymptomatic transmission of COVID-19 contributed significantly to community spread in New York City during the initial phase of the pandemic, according to a new paper from a team of researchers at the University of Chicago...

In the first mathematical model to incorporate data on daily changes in testing capacity, the research team found that only 14% to 20% of COVID-19 individuals showed symptoms of the disease and that more than 50% of community transmission was from asymptomatic and pre-symptomatic cases.

[Doug Elliott]

This website:
https://www.medpagetoday.com/infectious ... cine/92291

talks about facial paralysis side effect in a much larger sample, and more importantly compares it to the incidence from other vaccines.

It looks like the covid vaccines have a very similar - or lower - risk than other vaccines.