IM Doc pt3

[temporaryreality]

Working in date-posted order, here's the next set of comments by IM Doc. Please see the updated link in the topmost IM-Doc related post on this blog to find the current discussion location.

antidlcDecember 16, 2020 at 2:16 pm

https://www.nytimes.com/2020/12/16/health/covid-pfizer-vaccine-allergic-reaction.html
Alaska Health Worker Had a Serious Allergic Reaction After Pfizer’s Vaccine

The person did not have a history of drug allergies. Two similar reactions happened last week in Britain.

A health worker in Alaska had a serious allergic reaction after getting Pfizer’s coronavirus vaccine on Tuesday and was hospitalized, according to three people familiar with official reports of the person’s health. The person was still in the hospital on Wednesday morning, under observation.

Government officials were scrambling on Wednesday to learn more about the case. The worker had no history of drug allergies but it was unclear whether he or she suffered from other types of allergies, according to one person familiar with the case.

With millions of Americans expected to be vaccinated by the end of the year, the incident is likely to prompt federal officials to be even more watchful for any sign of serious side effects. The Alaska recipient’s reaction was believed to be similar to the anaphylactic reactions two health workers in Britain experienced after receiving the Pfizer-BioNTech vaccine last week. Both of them recovered.

 

December 16, 2020 at 3:04 pm

I was in a Grand Rounds webcast this AM –

There is a theory this is happening because of the PEG (polyethylene glycol) fat envelope. I repeat – a theory. PEG is a very common thing in many products – make-up, cosmetics, toothpaste. And there are random patients out there who have pretty severe allergic reactions to it when they put it on their face in the form of makeup. Now imagine a bolus in your veins – and you can see the possible problem.

There are of course countless other issues that could be going on. Have immunologists studied this? I do not know. From the very best I can tell online, the lipid coats are proprietary. Are Pfizer and Moderna going to do a Jonas Salk impression and let the world know their exact make-up for the case of patient safety? Have they already done so and I just cannot find this fact online? I do not know.
 

Amfortas the hippieDecember 16, 2020 at 3:17 pm

when me and mine say “allergies” it means allergic to stuff in the air, from mold spores after a rain to that damned “cedar fever” we all get out here from october to march.
my youngest had them really bad when he was tiny…enough to where we’d pull him out of kinder and drive 50 miles to the nearest hospital once a week to get an allergy shot.
so i had a 5 year old boy, rolling on the floor of the infusion lab, entertaining the chemo patients.
they’d make us wait for 30-40 minutes before leaving…and we carried an epi pen, before medicaid stopped paying for them.
is this sort of “allergy” included when they say people with allergies should be careful, or are in the exclusion group?

 

1. antidlcDecember 16, 2020 at 3:26 pm

   I have the same question.

    
2. IM DocDecember 16, 2020 at 3:33 pm

   This is a very nebulous point at this time.

   The exclusion criteria from the Pfizer trial in the literature was limited to allergies to vaccines and vaccine related chemicals – and any known allergy to a constituent of the actual vaccine in the study. How people were to know that is unclear.

   Once the 2 UK issues occurred, it was broadened out to “severe” allergies in general – if not by pfizer itself by multiple experts – those links have been posted in the past few days. It is still not really clear from Pfizer – at least that I can tell.

IM DocDecember 16, 2020 at 2:47 pm

I felt like I should make a little comment here about the new info coming from the Moderna trial and yet another issue that I think is being irresponsibly handled by our media.

As I was in the Doctor’s Lounge – I heard the following on TV – “What do you say about these vaccines causing Bell’s Palsy?” This is totally irresponsible.

I have heard this described in the past 24 hours as a trend. Again totally, irresponsible.

I have also heard minimization of this from the pro-vaccine crowd. Basically stating nothing more than the usual background noise. I do not believe this is actually the case. I need to really look into the incidence of Bells’ palsy, but this incidence of 7 patients out of the size of these cohorts seems a bit excessive to me just on the face . At this point we have disparate data points in 2 studies who do not really have enough subjects to make any conclusions at this point. No one should refer to this as a trend, yet. And there is certainly no evidence yet of causation. Small cohort sizes make it very difficult to ascertain safety issues like this, important conclusions cannot be made from these small cohorts, and this issue and likely others will now be evaluated on the American Public.

I have not formally read the Moderna study, but it seems to me from overviews that we are determining success by the same metric as the Pfizer study – which is case numbers. Basically flu-like illness. Again, far too rapid studies to determine mortality or morbidity, unfortunately, and case numbers are a fuzzy mirror. I see nothing in the study following other symptoms or manifestations of this disease after the initial illness of flu-like symptoms. I cannot stress too much, in my world, this post-COVID syndrome is becoming a much bigger problem daily. Much much more common than death. I am seeing many Post-COVID patients with a severe fatigue problem, neuro or cardiac issues, or profound depression. And blood clotting issues. I knew about this type of thing in July – these studies were enrolling after that. It would be nice if they would allow their data sets to be opened to see if their vaccines had any effect on these symptoms, or if there was any incidence/prevention of them in the cohorts after the first blush of symptoms. That would be confidence building.

IM DocDecember 16, 2020 at 3:41 pm

A point of correction, the way I see it.

The Phase III trials at least the ones already completed in the past few weeks and reported and voted on by the FDA – are OVER.

You could never ever be giving meds or vaccines or anything to the general public in a PHASE III trial. They require an IRB oversight and an investigator.

This is also not a PHASE IV trial – that is a post marketing study – and the patients still need to be enrolled in a trial. I have no idea how you do a PHASE IV trial in the setting of an emergency use authorization. I do not believe it can be done. I would defer to research gurus that really know how to set up studies.

This is implementation to the public on an emergency use authorization. This has not received formal approval from the FDA in the standard sense. You are correct that side effects and problems are now going to be followed on the public at large. This EUA is unique in that it encompasses all of us. Before this year, I had always pictured these being used to speed things up for critical cancer drugs, etc.

TroyIADecember 16, 2020 at 4:06 pm

I’m not a doctor but thought I would share this link about Bell’s Palsy.

The most potent risk factor in the development of Bell’s palsy is diabetes mellitus. Other risk factors include lyme disease, arterial hypertension, autoimmune inflammatory disorders, viral infections and lipid disturbances.

For the doctors, since the MRNA vaccines are wrapped in lipid nanoparticles could this create enough of a disturbance in select individuals, especially those with other risk factors, that Bell’s Palsy develops?

 

1. IM DocDecember 16, 2020 at 6:56 pm

   This is really very unlikely going to happen.
   No matter if it was pure lard, there is simply not enough fat in an injection to make any difference in the Lipid Panel. Furthermore, the lipid disturbances they are referencing are very remote, very rare lipid problems. I see about 1 Bells Palsy patient every other year or so. It has in my life been diabetics that are out of control that are the primary victims. I honestly do not recall anyone with an inflammatory Bells Palsy. – It is in the textbooks, just not common enough that I would have seen it in 30 years of practice.

   I would also caution you to be very careful about assuming that the vaccine caused the Bells Palsy in these test subjects. That has not been shown to be causative yet at all. There are simply not enough patients in the cohorts.

1. JBird4049December 16, 2020 at 9:00 pm

   Is it possible that some of the post COVID issues is “just” sheer exhaustion and wear on the body? Even though it has been in the States since before March that is still less than a year. Could the actual length for a complete recovery just be very long?

   I ask because I had “only” pneumonia when I was thirty. Three-four weeks of trying to breathe and mostly not eating or sleeping followed by at least two months of slowly getting my energy, stamina, and mental clarity back after I had “recovered.”

   Honestly, I was too exhausted during the illness to even have the mental energy to worry about survival. I don’t think it did anything permanent damage. It just used up all of my body’s resources, which I then had to spend months getting back admittedly while working full time in retail. Fun times.

    
   1. IM DocDecember 17, 2020 at 12:01 am

      I am beginning to think that the virus is able to cause diffuse widespread damage at a micro level in a lot of people.

      I do not think they are worn out in any traditional sense. I think people have been literally damaged. I have one too many 30 year old jock types who cannot get out of bed. They would normally have recovered from regular types of infection in no time.

      This is very troublesome to me. It is way more common out there than death or hospitalizations.

Comments

This is a very nebulous point at this time.

The exclusion criteria from the Pfizer trial in the literature was limited to allergies to vaccines and vaccine related chemicals – and any known allergy to a constituent of the actual vaccine in the study. How people were to know that is unclear.

Once the 2 UK issues occurred, it was broadened out to “severe” allergies in general – if not by pfizer itself by multiple experts – those links have been posted in the past few days. It is still not really clear from Pfizer – at least that I can tell.

This is a very nebulous point at this time.

The exclusion criteria from the Pfizer trial in the literature was limited to allergies to vaccines and vaccine related chemicals – and any known allergy to a constituent of the actual vaccine in the study. How people were to know that is unclear.

Once the 2 UK issues occurred, it was broadened out to “severe” allergies in general – if not by pfizer itself by multiple experts – those links have been posted in the past few days. It is still not really clear from Pfizer – at least that I can tell.

when me and mine say “allergies” it means allergic to stuff in the air, from mold spores after a rain to that damned “cedar fever” we all get out here from october to march.
my youngest had them really bad when he was tiny…enough to where we’d pull him out of kinder and drive 50 miles to the nearest hospital once a week to get an allergy shot.
so i had a 5 year old boy, rolling on the floor of the infusion lab, entertaining the chemo patients.
they’d make us wait for 30-40 minutes before leaving…and we carried an epi pen, before medicaid stopped paying for them.
is this sort of “allergy” included when they say people with allergies should be careful, or are in the exclusion group?

when me and mine say “allergies” it means allergic to stuff in the air, from mold spores after a rain to that damned “cedar fever” we all get out here from october to march.
my youngest had them really bad when he was tiny…enough to where we’d pull him out of kinder and drive 50 miles to the nearest hospital once a week to get an allergy shot.
so i had a 5 year old boy, rolling on the floor of the infusion lab, entertaining the chemo patients.
they’d make us wait for 30-40 minutes before leaving…and we carried an epi pen, before medicaid stopped paying for them.
is this sort of “allergy” included when they say people with allergies should be careful, or are in the exclusion group?

I have the same question.

I have the same question.

I have the same question.

This is a very nebulous point at this time.

The exclusion criteria from the Pfizer trial in the literature was limited to allergies to vaccines and vaccine related chemicals – and any known allergy to a constituent of the actual vaccine in the study. How people were to know that is unclear.

Once the 2 UK issues occurred, it was broadened out to “severe” allergies in general – if not by pfizer itself by multiple experts – those links have been posted in the past few days. It is still not really clear from Pfizer – at least that I can tell.

This is a very nebulous point at this time.

The exclusion criteria from the Pfizer trial in the literature was limited to allergies to vaccines and vaccine related chemicals – and any known allergy to a constituent of the actual vaccine in the study. How people were to know that is unclear.

Once the 2 UK issues occurred, it was broadened out to “severe” allergies in general – if not by pfizer itself by multiple experts – those links have been posted in the past few days. It is still not really clear from Pfizer – at least that I can tell.

This is a very nebulous point at this time.

The exclusion criteria from the Pfizer trial in the literature was limited to allergies to vaccines and vaccine related chemicals – and any known allergy to a constituent of the actual vaccine in the study. How people were to know that is unclear.

Once the 2 UK issues occurred, it was broadened out to “severe” allergies in general – if not by pfizer itself by multiple experts – those links have been posted in the past few days. It is still not really clear from Pfizer – at least that I can tell.

I felt like I should make a little comment here about the new info coming from the Moderna trial and yet another issue that I think is being irresponsibly handled by our media.

As I was in the Doctor’s Lounge – I heard the following on TV – “What do you say about these vaccines causing Bell’s Palsy?” This is totally irresponsible.

I have heard this described in the past 24 hours as a trend. Again totally, irresponsible.

I have also heard minimization of this from the pro-vaccine crowd. Basically stating nothing more than the usual background noise. I do not believe this is actually the case. I need to really look into the incidence of Bells’ palsy, but this incidence of 7 patients out of the size of these cohorts seems a bit excessive to me just on the face . At this point we have disparate data points in 2 studies who do not really have enough subjects to make any conclusions at this point. No one should refer to this as a trend, yet. And there is certainly no evidence yet of causation. Small cohort sizes make it very difficult to ascertain safety issues like this, important conclusions cannot be made from these small cohorts, and this issue and likely others will now be evaluated on the American Public.

I have not formally read the Moderna study, but it seems to me from overviews that we are determining success by the same metric as the Pfizer study – which is case numbers. Basically flu-like illness. Again, far too rapid studies to determine mortality or morbidity, unfortunately, and case numbers are a fuzzy mirror. I see nothing in the study following other symptoms or manifestations of this disease after the initial illness of flu-like symptoms. I cannot stress too much, in my world, this post-COVID syndrome is becoming a much bigger problem daily. Much much more common than death. I am seeing many Post-COVID patients with a severe fatigue problem, neuro or cardiac issues, or profound depression. And blood clotting issues. I knew about this type of thing in July – these studies were enrolling after that. It would be nice if they would allow their data sets to be opened to see if their vaccines had any effect on these symptoms, or if there was any incidence/prevention of them in the cohorts after the first blush of symptoms. That would be confidence building.

A point of correction, the way I see it.

The Phase III trials at least the ones already completed in the past few weeks and reported and voted on by the FDA – are OVER.

You could never ever be giving meds or vaccines or anything to the general public in a PHASE III trial. They require an IRB oversight and an investigator.

This is also not a PHASE IV trial – that is a post marketing study – and the patients still need to be enrolled in a trial. I have no idea how you do a PHASE IV trial in the setting of an emergency use authorization. I do not believe it can be done. I would defer to research gurus that really know how to set up studies.

This is implementation to the public on an emergency use authorization. This has not received formal approval from the FDA in the standard sense. You are correct that side effects and problems are now going to be followed on the public at large. This EUA is unique in that it encompasses all of us. Before this year, I had always pictured these being used to speed things up for critical cancer drugs, etc.

I’m not a doctor but thought I would share this link about Bell’s Palsy.

The most potent risk factor in the development of Bell’s palsy is diabetes mellitus. Other risk factors include lyme disease, arterial hypertension, autoimmune inflammatory disorders, viral infections and lipid disturbances.

For the doctors, since the MRNA vaccines are wrapped in lipid nanoparticles could this create enough of a disturbance in select individuals, especially those with other risk factors, that Bell’s Palsy develops?

I’m not a doctor but thought I would share this link about Bell’s Palsy.

The most potent risk factor in the development of Bell’s palsy is diabetes mellitus. Other risk factors include lyme disease, arterial hypertension, autoimmune inflammatory disorders, viral infections and lipid disturbances.

For the doctors, since the MRNA vaccines are wrapped in lipid nanoparticles could this create enough of a disturbance in select individuals, especially those with other risk factors, that Bell’s Palsy develops?

This is really very unlikely going to happen.
No matter if it was pure lard, there is simply not enough fat in an injection to make any difference in the Lipid Panel. Furthermore, the lipid disturbances they are referencing are very remote, very rare lipid problems. I see about 1 Bells Palsy patient every other year or so. It has in my life been diabetics that are out of control that are the primary victims. I honestly do not recall anyone with an inflammatory Bells Palsy. – It is in the textbooks, just not common enough that I would have seen it in 30 years of practice.

I would also caution you to be very careful about assuming that the vaccine caused the Bells Palsy in these test subjects. That has not been shown to be causative yet at all. There are simply not enough patients in the cohorts.

This is really very unlikely going to happen.
No matter if it was pure lard, there is simply not enough fat in an injection to make any difference in the Lipid Panel. Furthermore, the lipid disturbances they are referencing are very remote, very rare lipid problems. I see about 1 Bells Palsy patient every other year or so. It has in my life been diabetics that are out of control that are the primary victims. I honestly do not recall anyone with an inflammatory Bells Palsy. – It is in the textbooks, just not common enough that I would have seen it in 30 years of practice.

I would also caution you to be very careful about assuming that the vaccine caused the Bells Palsy in these test subjects. That has not been shown to be causative yet at all. There are simply not enough patients in the cohorts.

This is really very unlikely going to happen.
No matter if it was pure lard, there is simply not enough fat in an injection to make any difference in the Lipid Panel. Furthermore, the lipid disturbances they are referencing are very remote, very rare lipid problems. I see about 1 Bells Palsy patient every other year or so. It has in my life been diabetics that are out of control that are the primary victims. I honestly do not recall anyone with an inflammatory Bells Palsy. – It is in the textbooks, just not common enough that I would have seen it in 30 years of practice.

I would also caution you to be very careful about assuming that the vaccine caused the Bells Palsy in these test subjects. That has not been shown to be causative yet at all. There are simply not enough patients in the cohorts.

I am beginning to think that the virus is able to cause diffuse widespread damage at a micro level in a lot of people.

I do not think they are worn out in any traditional sense. I think people have been literally damaged. I have one too many 30 year old jock types who cannot get out of bed. They would normally have recovered from regular types of infection in no time.

This is very troublesome to me. It is way more common out there than death or hospitalizations.

Is it possible that some of the post COVID issues is “just” sheer exhaustion and wear on the body? Even though it has been in the States since before March that is still less than a year. Could the actual length for a complete recovery just be very long?

I ask because I had “only” pneumonia when I was thirty. Three-four weeks of trying to breathe and mostly not eating or sleeping followed by at least two months of slowly getting my energy, stamina, and mental clarity back after I had “recovered.”

Honestly, I was too exhausted during the illness to even have the mental energy to worry about survival. I don’t think it did anything permanent damage. It just used up all of my body’s resources, which I then had to spend months getting back admittedly while working full time in retail. Fun times.

Is it possible that some of the post COVID issues is “just” sheer exhaustion and wear on the body? Even though it has been in the States since before March that is still less than a year. Could the actual length for a complete recovery just be very long?

I ask because I had “only” pneumonia when I was thirty. Three-four weeks of trying to breathe and mostly not eating or sleeping followed by at least two months of slowly getting my energy, stamina, and mental clarity back after I had “recovered.”

Honestly, I was too exhausted during the illness to even have the mental energy to worry about survival. I don’t think it did anything permanent damage. It just used up all of my body’s resources, which I then had to spend months getting back admittedly while working full time in retail. Fun times.

I am beginning to think that the virus is able to cause diffuse widespread damage at a micro level in a lot of people.

I do not think they are worn out in any traditional sense. I think people have been literally damaged. I have one too many 30 year old jock types who cannot get out of bed. They would normally have recovered from regular types of infection in no time.

This is very troublesome to me. It is way more common out there than death or hospitalizations.

I am beginning to think that the virus is able to cause diffuse widespread damage at a micro level in a lot of people.

I do not think they are worn out in any traditional sense. I think people have been literally damaged. I have one too many 30 year old jock types who cannot get out of bed. They would normally have recovered from regular types of infection in no time.

This is very troublesome to me. It is way more common out there than death or hospitalizations.

I am beginning to think that the virus is able to cause diffuse widespread damage at a micro level in a lot of people.

I do not think they are worn out in any traditional sense. I think people have been literally damaged. I have one too many 30 year old jock types who cannot get out of bed. They would normally have recovered from regular types of infection in no time.

This is very troublesome to me. It is way more common out there than death or hospitalizations.