Bell's palsy and SARS-CoV-2 vaccines—an unfolding story

[whatbogsends]

Despite geographical and seasonal variations,3, 4 the generally agreed incidence of Bell's palsy is 15–30 cases each year per 100 000 population. Ozonoff and colleagues2
rightly state that the predicted 12-month (annual) incidence of Bell's palsy inferred from mRNA vaccine trials is higher than that reported during the 2-month observation period of these studies. They concluded that the observed incidence of Bell's palsy in the mRNA vaccine arms was 3·5 to seven times higher than expected in the general population. However, safety data were collected for participants with a median follow-up of 2 months after the second dose; therefore, the data refer to an overall observation period of approximately 12 weeks from dose one. Given this, and considering Bell's palsy as the possible outcome of individual doses, the observed incidence in the mRNA vaccine trials would be roughly 1·5 to three times higher than in the general population.

Bell's palsy and SARS-CoV-2 vaccines—an unfolding story - The Lancet Infectious Diseases

I only happened upon this because of personal interest. A vaccinated friend of mine developed Bell's palsy recently. He had the Pfizer vaccine.

It's a non-lethal and treatable malady, but one that is not yet officially acknowledged as a side effect, despite a) having been observed in trials (the assessment of those trials was that it was within the normal rates of occurrence within the general population, although in every trial instance, there were more reported occurrences within the vaccine group than the placebo group) and b) the study cited above.

 

[Ana the Ist]

Despite geographical and seasonal variations,3, 4 the generally agreed incidence of Bell's palsy is 15–30 cases each year per 100 000 population. Ozonoff and colleagues2
rightly state that the predicted 12-month (annual) incidence of Bell's palsy inferred from mRNA vaccine trials is higher than that reported during the 2-month observation period of these studies. They concluded that the observed incidence of Bell's palsy in the mRNA vaccine arms was 3·5 to seven times higher than expected in the general population. However, safety data were collected for participants with a median follow-up of 2 months after the second dose; therefore, the data refer to an overall observation period of approximately 12 weeks from dose one. Given this, and considering Bell's palsy as the possible outcome of individual doses, the observed incidence in the mRNA vaccine trials would be roughly 1·5 to three times higher than in the general population.

Bell's palsy and SARS-CoV-2 vaccines—an unfolding story - The Lancet Infectious Diseases

I only happened upon this because of personal interest. A vaccinated friend of mine developed Bell's palsy recently. He had the Pfizer vaccine.

It's a non-lethal and treatable malady, but one that is not yet officially acknowledged as a side effect, despite a) having been observed in trials (the assessment of those trials was that it was within the normal rates of occurrence within the general population, although in every trial instance, there were more reported occurrences within the vaccine group than the placebo group) and b) the study cited above.

At least you get to sound like Stallone.

 

[Tanj]

Despite geographical and seasonal variations,3, 4 the generally agreed incidence of Bell's palsy is 15–30 cases each year per 100 000 population. Ozonoff and colleagues2
rightly state that the predicted 12-month (annual) incidence of Bell's palsy inferred from mRNA vaccine trials is higher than that reported during the 2-month observation period of these studies. They concluded that the observed incidence of Bell's palsy in the mRNA vaccine arms was 3·5 to seven times higher than expected in the general population. However, safety data were collected for participants with a median follow-up of 2 months after the second dose; therefore, the data refer to an overall observation period of approximately 12 weeks from dose one. Given this, and considering Bell's palsy as the possible outcome of individual doses, the observed incidence in the mRNA vaccine trials would be roughly 1·5 to three times higher than in the general population.

Bell's palsy and SARS-CoV-2 vaccines—an unfolding story - The Lancet Infectious Diseases

I only happened upon this because of personal interest. A vaccinated friend of mine developed Bell's palsy recently. He had the Pfizer vaccine.

It's a non-lethal and treatable malady, but one that is not yet officially acknowledged as a side effect, despite a) having been observed in trials (the assessment of those trials was that it was within the normal rates of occurrence within the general population, although in every trial instance, there were more reported occurrences within the vaccine group than the placebo group) and b) the study cited above.

And what is the take home message for you from this paper? Bearing in mind the risk of Bell's Palsy from actual infection is about 7 times higher

Incidence of Bell Palsy in Patients With COVID-19

 

[JustSomeBloke]

And what is the take home message for you from this paper? Bearing in mind the risk of Bell's Palsy from actual infection is about 7 times higher

Incidence of Bell Palsy in Patients With COVID-19

I would have thought that the take home message was fairly obvious, seeing as the OP alluded to it in their opening post:

It's a non-lethal and treatable malady, but one that is not yet officially acknowledged as a side effect, despite a) having been observed in trials (the assessment of those trials was that it was within the normal rates of occurrence within the general population, although in every trial instance, there were more reported occurrences within the vaccine group than the placebo group) and b) the study cited above.

From that point of view:
1. The vaccine trials were a failure, because they did not identify Bell's Palsy as a side effect.
2. The follow on from point 1, is that those who took the vaccines after the initial trial would have done so without informed consent, because they did not know about the risk of Bell's Palsy.

And the fact that Bell's Palsy may occur in COVID patients is irrelevant. People were told that trials had been completed, but they were not told that Bell's Palsy was a potential side effect. No matter how much you try and spin it, that's a massive failure in the vaccine trials.

Oh well. Never mind. Here in the UK all the vaccine manufacturers have been granted legal immunity, so who cares about medical ethics?

 

[Sodafox]

People were told that trials had been completed

Who said that? I don't watch TV but I've never seen anything that these vaccines passed trials (hence my hesitation)

Oh well. Never mind. Here in the UK all the vaccine manufacturers have been granted legal immunity, so who cares about medical ethics?

True though.

 

[Tanj]

I would have thought that the take home message was fairly obvious

I'm sure you would. That's what Dunning-Kruger does to people.

From that point of view:
1. The vaccine trials were a failure, because they did not identify Bell's Palsy as a side effect.

Bell's Palsy has an incident rate of ~30/100 000. Individual trials were run on 15000 people so you'd see < 10 people with the condition which is not enough to be statistically significant.

Once again the failure is your complete inability to understand even the most basic aspects of science and math.

 

[JustSomeBloke]

Bell's Palsy has an incident rate of ~30/100 000. The trial was run on 15000 people so you'd see < 10 people with the condition which is not enough to be statistically significant.

Once again the failure is your complete inability to understand even the most basic aspects of science and math.

Hahaha! Yes, my understanding of science and maths is so poor, that I mentioned this as a potential problem in another thread before you replied.

Perhaps the failure to identify Bell's Palsy as a side effect was partly as a result of trials with too few participants.

Nice try. But no lollipop for you this time.

 

[Tanj]

Hahaha! Yes, my understanding of science and maths is so poor, that I mentioned this as a potential problem in another thread before you replied.

You got it wrong there as well. Probably goes without saying. Who appointed you head determiner of trial size, exactly? What incidence rate have you decided is an appropriate cutoff? How many people would you have enrolled in these trials?

 

[Nithavela]

I don't know about your country, but over here in germany, temporal paralysis of the facial muscles was listed as one of the possible side effects for mRNA vaccines.

 

[CRAZY_CAT_WOMAN]

I don't know about your country, but over here in germany, temporal paralysis of the facial muscles was listed as one of the possible side effects for mRNA vaccines.

Temporal paralysis of the facial muscles was listed as one of the possible side effects for mRNA vaccines listed here too. I know someone ,that got the flu shot and got Bells palsy , Most dont. And I could understand her issues. But most dont get it. And it's just temporary .

 

[Nithavela]

Temporal paralysis of the facial muscles was listed as one of the possible side effects for mRNA vaccines listed here too. I know someone ,that got the flu shot and got Bells palsy , Most dont. And I could understand her issues. But most dont get it. And it's just temporary .

So, if the side effect was listed, what's the point of this thread?

 

[CRAZY_CAT_WOMAN]

So, if the side effect was listed, what's the point of this thread?

Nothing more than brainwashing , fear tactics.

 

[FireDragon76]

I'm sure you would. That's what Dunning-Kruger does to people.



Bell's Palsy has an incident rate of ~30/100 000. Individual trials were run on 15000 people so you'd see < 10 people with the condition which is not enough to be statistically significant.

Once again the failure is your complete inability to understand even the most basic aspects of science and math.

We might as well go back to using stone knives and bear skins with such revelatory genius at work...

 

[whatbogsends]

And what is the take home message for you from this paper?

Bearing in mind the risk of Bell's Palsy from actual infection is about 7 times higher

Incidence of Bell Palsy in Patients With COVID-19

The take home message is that the risks from the vaccine continue to be greater than they have indicated.

The take home message is that when they say "the vaccine is effective and safe", they are downplaying the risks associated with the vaccine.

The take home message is that for my friend who is now suffering from this, the impact is very real.

 

[cow451]

The take home message is that the risks from the vaccine continue to be greater than they have indicated.

The take home message is that when they say "the vaccine is effective and safe", they are downplaying the risks associated with the vaccine.

The take home message is that for my friend who is now suffering from this, the impact is very real.

The term "safe and effective" is a label for every medication that is allowed in use by the FDA. The term doesn't mean "totally without risk and 100% guaranteed to work".

 

[whatbogsends]

So, if the side effect was listed, what's the point of this thread?

Here's the current CDC fact sheet for the Pfizer vaccine.

Possible Side Effects
In the arm where you got the shot:

• Pain
• Redness
• Swelling

Throughout the rest of your body:

• Tiredness
• Headache
• Muscle pain
• Chills
• Fever
• Nausea

...
Safety Data Summary

• In clinical trials, reactogenicity symptoms (side effects that happen within 7 days of getting vaccinated) were common but were mostly mild. Some people had side effects that affected their ability to do daily activities.
• Side effects (such as fever, chills, tiredness, and headache) throughout the body were more common after the second dose of the vaccine.
• CDC will continue to provide updates as we learn more about the safety of the Pfizer-BioNTech vaccine in real-world conditions.

These side effects happen within a day or two of getting the vaccine. They are normal signs that your body is building protection and should go away within a few days.
------------------------

Drilling down to the reactogenicity symptoms, they eventually get to this:

Bell’s palsy was reported by four vaccine recipients and none of the placebo recipients. The observed frequency of reported Bell’s palsy in the vaccine group is consistent with the background rate in the general population, and there is no basis upon which to conclude a causal relationship.

Pfizer-BioNTech COVID-19 Vaccine Overview and Safety | CDC

The problem, of course, is that per the study i cited in the OP, the observed frequency of Bell's palsy in the clinical trials was 3-7 times the normal rate.

 

[FireDragon76]

Here's the current CDC fact sheet for the Pfizer vaccine.

Possible Side Effects
In the arm where you got the shot:

• Pain
• Redness
• Swelling

Throughout the rest of your body:

• Tiredness
• Headache
• Muscle pain
• Chills
• Fever
• Nausea

...
Safety Data Summary

• In clinical trials, reactogenicity symptoms (side effects that happen within 7 days of getting vaccinated) were common but were mostly mild. Some people had side effects that affected their ability to do daily activities.
• Side effects (such as fever, chills, tiredness, and headache) throughout the body were more common after the second dose of the vaccine.
• CDC will continue to provide updates as we learn more about the safety of the Pfizer-BioNTech vaccine in real-world conditions.

These side effects happen within a day or two of getting the vaccine. They are normal signs that your body is building protection and should go away within a few days.
------------------------

Drilling down to the reactogenicity symptoms, they eventually get to this:

Bell’s palsy was reported by four vaccine recipients and none of the placebo recipients. The observed frequency of reported Bell’s palsy in the vaccine group is consistent with the background rate in the general population, and there is no basis upon which to conclude a causal relationship.

Pfizer-BioNTech COVID-19 Vaccine Overview and Safety | CDC

The problem, of course, is that per the study i cited in the OP, the observed frequency of Bell's palsy in the clinical trials was 3-7 times the normal rate.

That side effect profile is actually very good as far as approved drug treatments go. I mean, asprin and tylenol alone kill way more people than these vaccines ever could, and yet we allow them on pharmacy shelves for just about anybody to buy.

 

[Tanj]

The problem, of course, is that per the study i cited in the OP, the observed frequency of Bell's palsy in the clinical trials was 3-7 times the normal rate.

Nope, not true, that was the inferred frequency in the paper your paper was refuting. Your paper said it was 1.5 to 3 times the normal rate.

"the observed incidence in the mRNA vaccine trials would be roughly 1·5 to three times higher than in the general population "

I mean it's right there, in the abstract. I had a feeling you had misinterpreted it from the OP, hence my question...and my ongoing point about lay people and science.

 

[whatbogsends]

Nope, not true, that was the inferred frequency in the paper your paper was refuting. Your paper said it was 1.5 to 3 times the normal rate.

"the observed incidence in the mRNA vaccine trials would be roughly 1·5 to three times higher than in the general population "

I mean it's right there, in the abstract. I had a feeling you had misinterpreted it from the OP, hence my question...and my ongoing point about lay people and science.

Wrong. 1.5 to 3 per dose, or 3.5 to 7 times higher after receiving both doses.


They concluded that the observed incidence of Bell's palsy in the mRNA vaccine arms was 3·5 to seven times higher than expected in the general population. However, safety data were collected for participants with a median follow-up of 2 months after the second dose; therefore, the data refer to an overall observation period of approximately 12 weeks from dose one. Given this, and considering Bell's palsy as the possible outcome of individual doses, the observed incidence in the mRNA vaccine trials would be roughly 1·5 to three times higher than in the general population (table).

I mean, it's right there, in the abstract. You're the one doing the misinterpretation.

 

[pgp_protector]

Sounds easier to treat then Covid 19 at least.
Bell's palsy - Diagnosis and treatment - Mayo Clinic