Reactions to Pfizer Vaccine in Juneau

[donaldsc]

Two of the people who received the Pfizer vaccine in Juneau AK had a reaction.  One who had no prior history of any allergies was a serious reaction that required a quick epinephrine shot and overnight hospitalization.  This is different from the 2 cases in England where the people who had reactions had a prior history of allergies.  I looked up how many doses of vaccine Juneau was expecting to receive and it was only 975 doses.  Seems like this is a lot of reactions to only 1000 injections when we have not heard of reactions at any other place.  

 

Couple of thoughts

 

1) Was there a problem with that specific batch of vaccine and if this was the cause, why wasn't the problem found in the manufacturing QC.

 

2) If there are more bad batches of vaccine out there, how many more clusters of bad reactions will occur?

 

3) If the person who had to be hospitalized lived in one of the smaller isolated towns in AK, would they have survived.

 

4) Should the protocol for vaccine injections be changed to require that the injection venue must be required to have the ability to deal with anaphylactic shock.  This may preclude giving the vaccine at drug stores as currently planned.  

 

5) Why wasn't this caught in the trials.

 

6) Why hasn't this cluster of vaccine reactions occurred elsewhere.  

 

I don't have answers to any of these questions but it sure makes one wonder.  Maybe Operation Warp Speed should be renamed Operation Too Fast.

 

DON

 

 

Edited December 17, 2020 by donaldsc

[ColeThornton]

What does this have to do with the Ask a Cruise Question forum?  I'm confused.

[donaldsc]

4 minutes ago, ColeThornton said:

What does this have to do with the Ask a Cruise Question forum?  I'm confused.

 

If you are asking me, consider that everyone who want to go back to cruising is counting on the vaccines to make it possible.  What if there end up being more people who have serious side effects from the shot.  In Juneau, 2 of approximately 1000 people were affected.  Will this reduce the number of people who will be willing to take it.  Anaphylactic shock is a serious and potentially fatal side effect.

 

DON

[neverbeenhere]

But... thousands worldwide have had the vaccine. 
 

 

Fact check: Bell's palsy among COVID-19 trial participants likely unrelated to Pfizer vaccine

[CruiserBruce]

1 hour ago, donaldsc said:

Two of the people who received the Pfizer vaccine in Juneau AK had a reaction.  One who had no prior history of any allergies was a serious reaction that required a quick epinephrine shot and overnight hospitalization.  This is different from the 2 cases in England where the people who had reactions had a prior history of allergies.  I looked up how many doses of vaccine Juneau was expecting to receive and it was only 975 doses.  Seems like this is a lot of reactions to only 1000 injections when we have not heard of reactions at any other place.  

 

Couple of thoughts

 

1) Was there a problem with that specific batch of vaccine and if this was the cause, why wasn't the problem found in the manufacturing QC.

 

2) If there are more bad batches of vaccine out there, how many more clusters of bad reactions will occur?

 

3) If the person who had to be hospitalized lived in one of the smaller isolated towns in AK, would they have survived.

 

4) Should the protocol for vaccine injections be changed to require that the injection venue must be required to have the ability to deal with anaphylactic shock.  This may preclude giving the vaccine at drug stores as currently planned.  

 

5) Why wasn't this caught in the trials.

 

6) Why hasn't this cluster of vaccine reactions occurred elsewhere.  

 

I don't have answers to any of these questions but it sure makes one wonder.  Maybe Operation Warp Speed should be renamed Operation Too Fast.

 

DON

 

 

Lots of "ifs" and other shakey statements here. Perhaps a bit of overreaction.

 

NO evidence of bad batches. Literally, worldwide, several hundred thousand people, probably over half a million, have received the vaccine. Only two cases of severe reactions have been mentioned. If it were bad batches, I would expect more bad reactions.

 

However, the protocol was changed a week or so ago to require the ability to treat an allergic reaction, as well as the screening of people who have had allergic reactions to vaccines in the past. It is noted that one of the two cases in Juneau had no history. It doesn't take a lot to handle the average allergic reaction...paramedic in the field do it all the time...heck, so do people who are actually having the reaction...by using an EpiPen.

 

The trials caught lots of things. But, statistics have to be carefully read. In Pfizer's case, 44K people were vaccinated...22K with the vaccine, and 22K with a placebo. 6 people died...4 who had the placebo! So you have to consider what number of people in a random sample of 22K people will die of any cause (or get Bells Palsy, or any other issue) in the months the subjects were studied. THEN decide the relevancy of the numbers. 

[mom says]

Total overreaction OP. 

 

Here's a link to a fact check article about the Bell's  Palsy cases.  https://www.usatoday.com/story/news/factcheck/2020/12/15/fact-check-bells-palsy-likely-unrelated-pfizer-covid-19-vaccine/6532985002/

 

Basically,  relax.  No need for fear mongering.

 

As for the 2 cases in Juneau, again, to relax.  Allergic reaction is a potential with any vaccination, which is why protocols are in place. In both of these cases the workers were treated with the standard medications and responded well. The worker with the anaphylactic reaction was kept in hospital for observation.  There was nothing wrong with the batch of vaccine. In fact that wasn't a batch, but one box.  A batch would be many more times as much. And any place that provides vaccinations would have the meds necessary to treat an anaphylactic reaction, should it occur. 

 

[rkacruiser]

1 hour ago, donaldsc said:

I don't have answers to any of these questions but it sure makes one wonder.  Maybe Operation Warp Speed should be renamed Operation Too Fast.

 

I understand your concerns and I think your questions are valid ones to ask.  

 

We remain--and I think we will do so for some time--that we remain in the era of "what we do not know will remain what we do not know" for some time with regards to the pandemic and the vaccines.  

 

The data that I am seeing as to the vaccines effectiveness says to me when--and if--I am able to receive the vaccine, I will be willing to do so as long as my doctor says:  "Do it!"  If one has a concern as to whether one should receive the vaccine, one ought to depend upon the views of their personal doctor who knows their health history.  

 

1 hour ago, donaldsc said:

2) If there are more bad batches of vaccine out there, how many more clusters of bad reactions will occur?

 

 

I think I would prefer of the two vaccines that will be, or are, available, I would prefer the Moderna vaccine.  Its need to be kept at a more "reasonable" cold temperature than Pfizer's seems more likely to be successfully achieved than one that needs the extremely cold temperature.  The best choice would be just as effective vaccine that can be kept at room temperature. 

 

1 hour ago, donaldsc said:

I don't have answers to any of these questions but it sure makes one wonder.  Maybe Operation Warp Speed should be renamed Operation Too Fast.

 

If such turns out to be the case, historians likely will not treat decisions made by some of the officials in the current Administration well.  

 

I have faith in the integrity of the drug companies making the vaccines.  They have too much to loose for playing "fast and loose" with their data.  I have less faith, because of the political influence that is being disclosed, on the FDA and the CDC.

 

  

 

 

[clo]

45 minutes ago, neverbeenhere said:

But... thousands worldwide have had the vaccine. 

Right.

[rkacruiser]

11 minutes ago, mom says said:

Basically,  relax.  No need for fear mongering.

 

I wonder if you think my recent post is fear mongering?  It is not intended to be nor do I think that the OP's original post was made to do so.  The questions are valid.  At least, in my opinion; it's OK if you differ.  

 

I REPEAT:  we do not know what we do not know.  When the Salk and Sabin vaccines were discovered, their development and effectiveness were proven over a much longer time than simply "months" as these Covid vaccines have been.  To add to one's questions is the development of a new technology--mRNA--to make the vaccine to be effective.  Plus, one of the two Companies making the vaccine has never produced a marketable product.  

 

It is fair for people to have questions.  It is also realistic that most--if not all--of those questions cannot be answered on December 17, 2020.  Or, in the immediate future.  As I have said, when--and if--my time comes to receive the vaccine made by whatever company, I will do so upon the recommendation of my doctor.  

 

Trying to do "something" positively is better than doing nothing.    

[CruiserBruce]

37 minutes ago, rkacruiser said:

I REPEAT:  we do not know what we do not know.  When the Salk and Sabin vaccines were discovered, their development and effectiveness were proven over a much longer time than simply "months" as these Covid vaccines have been.  To add to one's questions is the development of a new technology--mRNA--to make the vaccine to be effective.  Plus, one of the two Companies making the vaccine has never produced a marketable product.  

 

It is fair for people to have questions.  It is also realistic that most--if not all--of those questions cannot be answered on December 17, 2020.  Or, in the immediate future.  As I have said, when--and if--my time comes to receive the vaccine made by whatever company, I will do so upon the recommendation of my doctor.  

 

Trying to do "something" positively is better than doing nothing.    

mRNA is "sort of new". Moderna has been experimenting with it for about for about 10 years. IIRC, the first potential use was for H1N1, but that ended before a vaccine came to market...I understand the foundation from that situation is allowing this Covid vaccine to develop faster.

[goldengirl123]

1 hour ago, CruiserBruce said:

 Literally, worldwide, several hundred thousand people, probably over half a million, have received the vaccine. 

 

 

 

Just wondering: Are you aware of any source to find out how many people to date (in the general public- not in clinical trials)  in the USA  (or worldwide for that matter)  have received the vaccine since it has been available to the public?   I haven't found anything personally and was wondering if any exists. 

[donaldsc]

1 hour ago, clo said:

Right.

 

It just seems very strange that the only 2 cases of the many injections that have been done in the US occurred in one place and probably with one shipment of the vaccines.  Obviously nobody knows at this point but was there something wrong w that batch.  I would assume that they are checking.

 

DON

[CruiserBruce]

1 hour ago, goldengirl123 said:

 

Just wondering: Are you aware of any source to find out how many people to date (in the general public- not in clinical trials)  in the USA  (or worldwide for that matter)  have received the vaccine since it has been available to the public?   I haven't found anything personally and was wondering if any exists. 

The number is changing rapidly. I know Britain,  Canada and the US are now inoculating people, and millions of doses have been distributed just in those countries alone...not sure of other countries. 

[CruiserBruce]

58 minutes ago, donaldsc said:

 

It just seems very strange that the only 2 cases of the many injections that have been done in the US occurred in one place and probably with one shipment of the vaccines.  Obviously nobody knows at this point but was there something wrong w that batch.  I would assume that they are checking.

 

DON

Perhaps one vial? (There is 5-7 doses in a vial). Perhaps a box (195 planned doses in a box)? A case (950 planned doses in a case)? The most plausible would be a vial was bad, but that is a huge stretch, pretty thinly supported theory.

[capriccio]

1 hour ago, goldengirl123 said:

 

Just wondering: Are you aware of any source to find out how many people to date (in the general public- not in clinical trials)  in the USA  (or worldwide for that matter)  have received the vaccine since it has been available to the public?   I haven't found anything personally and was wondering if any exists. 

 

Data as of December 14: https://www.timesnownews.com/health/article/covid-19-vaccine-list-of-countries-that-have-begun-vaccination/694430

 

[frantic36]

5 hours ago, donaldsc said:

 

If you are asking me, consider that everyone who want to go back to cruising is counting on the vaccines to make it possible.  What if there end up being more people who have serious side effects from the shot.  In Juneau, 2 of approximately 1000 people were affected.  Will this reduce the number of people who will be willing to take it.  Anaphylactic shock is a serious and potentially fatal side effect.

 

DON

 

As a nurse who used to give multiple vaccine injections on a regular basis I will say there is always the risk that people will have a reaction. That is why it is standard practice to get people to stay for preferably 10 minutes post injection. Many would prefer not to of course.

 

So with all the vaccine injections being given out I am not surprised there have been some reactions. My understanding is they are asking people to stay for 15 minutes and people who have a history of severe allergies to wait 30 minutes.

 

These people have been treated and no problems later. I say it is still better than taking the risk of a severe Covid infection.

[Roz]

The person may have been hospitalized for observation as a precaution.  How do you know the person would have died after the epi was administered had they not been hospitalized?

[keywest1]

7 hours ago, frantic36 said:

 

As a nurse who used to give multiple vaccine injections on a regular basis I will say there is always the risk that people will have a reaction. That is why it is standard practice to get people to stay for preferably 10 minutes post injection. Many would prefer not to of course.

 

So with all the vaccine injections being given out I am not surprised there have been some reactions. My understanding is they are asking people to stay for 15 minutes and people who have a history of severe allergies to wait 30 minutes.

 

These people have been treated and no problems later. I say it is still better than taking the risk of a severe Covid infection.

I have a history of anaphylactic reaction to IVP dye.  I am going to ask my doctor what his recommendations are for me to safely be vaccinated.  Then I will follow that guidance and be vaccinated at the earliest time that I can.  Personally, I would rather risk the reaction than to possibly die a slow death from Covid.  Chances of either are very slim, and anaphylaxis can be treated effectively.  Covid--not so much.  Just my personal opinion.

[BlueRiband]

A point to remember about clinical trials is that everyone is pre-screened in some way prior to getting inoculated.   Once mass distribution begins those with previously unknown sensitivity will emerge.   What is the alternative?  Wait the typical 3-5 years for additional testing  while lives are destroyed by the virus directly or by collapsing businesses indirectly?
 

All of us have to make our own risk/ benefit decisions.  

[gooch47]

People can be allergic to anything.  Aspirin?  Dog hair?  Your husband?

 

I'm more concerned that now that the vaccinations are available that people will become complacent and stop taking care to avoid the virus.

[Husky61]

As soon as I can get the vaccine I will do so.

[clo]

3 hours ago, keywest1 said:

I have a history of anaphylactic reaction to IVP dye.  I am going to ask my doctor what his recommendations are for me to safely be vaccinated.  Then I will follow that guidance and be vaccinated at the earliest time that I can.  Personally, I would rather risk the reaction than to possibly die a slow death from Covid.  Chances of either are very slim, and anaphylaxis can be treated effectively.  Covid--not so much.  Just my personal opinion.

Wisdom to the nth degree. Thanks.

[jocap]

People have to sit still for 15 minutes after the injection. Some I know were allowed to sit outside in their cars in the car park, which is patrolled by volunteers such as first responders. Nurses I know, tell me that they have been trained to ask questions about allergies before the injection.

I have a tree nut allergy, but it's never interfered with any injections, but I have to tell the nurse about it before the jab... and it will show on my records.

 

[donaldsc]

One more allergy case in Alaska - https://www.adn.com/alaska-news/2020/12/18/3rd-alaska-health-care-worker-experiences-adverse-reaction-to-covid-19-vaccine/.  Apparently none in other areas.

 

DON

[keywest1]

On 12/18/2020 at 7:16 AM, keywest1 said:

I have a history of anaphylactic reaction to IVP dye.  I am going to ask my doctor what his recommendations are for me to safely be vaccinated.  Then I will follow that guidance and be vaccinated at the earliest time that I can.  Personally, I would rather risk the reaction than to possibly die a slow death from Covid.  Chances of either are very slim, and anaphylaxis can be treated effectively.  Covid--not so much.  Just my personal opinion.

I had my doctor appt this morning.  He advised me to take the vaccine since there are no common ingredients between IVP dye and the vaccine.  He does recommend to all his staff and patients that they wait in their car 20 to 30 minutes after receiving the injection just to be sure they are not going have a severe reaction.  He views the risks as extremely low and less likely than a serious complication from Covid19.  Just my experience, but I am delighted to be able to receive the vaccine when my turn comes.