COVID Reaction to COVID-19 Vaccine (or what to be prepared for)

[symbolipoint]

Some member said in one of the posts on the topic:

So overall, my reaction mostly lasted about 18 hours.

So many of us are looking forward to the side effects, and as bad as they may be, are better than having the real disease. Fever, chills, headache, aches/pains around the body, fatigue - but should be less than a day.

Something to correct in the quote: That poster mistook "side effects" as "reactions". They are not the same. Reactions are what might or might not happen during the first few minutes after being vaccinated, so the vaccinee must stay at the vaccination location for half-hour before leaving, in case reactions need to be treated.

Some few or several HOURS later, the fever or chills or aches and pains and fatigue - those are examples of "side effects".

 

[phinds]

those are examples of "side effects".

I will never forget my first formal introduction to "side effects". I was early on working for Medco, a pharma distribution company and was in the can reading the weekly newsletter when I ran across a statement that one of the medications had a "side effect" of death.

I immediately went to the VP I was working for and said I didn't see how death could be a mere "side effect". She asked me if I thought the medicine was DESIGNED to kill people and of course I said no, so she said "well, see ... if it DOES kill someone, that's a side effect".

 

[symbolipoint]

I will never forget my first formal introduction to "side effects". I was early on working for Medco, a pharma distribution company and was in the can reading the weekly newsletter when I ran across a statement that one of the medications had a "side effect" of death.

I immediately went to the VP I was working for and said I didn't see how death could be a mere "side effect". She asked me if I thought the medicine was DESIGNED to kill people and of course I said no, so she said "well, see ... if it DOES kill someone, that's a side effect".

Well,... at least it is not a "reaction".

 

[vela]

So many of us are looking forward to the side effects, and as bad as they may be, are better than having the real disease. Fever, chills, headache, aches/pains around the body, fatigue - but should be less than a day.

"Looking forward" is probably not the best choice of wording. Perhaps "anticipating" or "expecting"?

 

[phinds]

"Looking forward" is probably not the best choice of wording. Perhaps "anticipating" or "expecting"?

How about "resigned to" ?

 

[symbolipoint]

How about "resigned to" ?

"Looking forward" is probably not the best choice of wording. Perhaps "anticipating" or "expecting"?

How about "resigned to" ?

I was sensing some artistic intent during and after I wrote that, and you's are correct that my wording is not really very perfect for the truth; but for now, I like to leave what I wrote just the way I wrote it.

 

[vela]

I received the second dose of Moderna yesterday morning and have had only mild side effects. Yesterday, my arm was sore, much more than after the first shot. I had a mild headache and fell asleep pretty early. Today, there was still some soreness in my arm, but it's not noticeable now unless I press on my upper arm.

 

[Janus]

My wife has had both shots of the Pfizer and had little side-effects, a bit of a sore arm and tired the next day after the 2nd one. ( she was a bit nervous, as she normally gets a reaction just from a Flu shot.)
I'm scheduled for my first shot next Wed. We'll see how it goes. ( It would be ironic if I have more severe side-effects than my wife, as I tend to be the opposite in that regard. I've never gotten a sore arm even after a tetanus shot.)

 

[Laroxe]

Its strange the way in which people become obsessed with the adverse events (A.E.) of vaccines, particularly new ones. It is however very difficult to get a real idea about the frequency of real adverse effects it seems that if you don't include local injection site pain and reactogenicity symptoms, in the studies, the rates are largely the same between the vaccine and placebo groups.

The big concern now is in the possible link with blood clots, particularly Cerebral Venous Thrombosis, a very rare but dangerous condition. While it seems the possibility of an increased risk of thrombosis generally has largely been discounted, there being no increases in the incidence following vaccination so the spotlight has fallen onto CVT. Unfortunately, this is rare and until now it has generated little interest, it is simply one of the varieties of causes of a stroke and has no great impact on clinical management. Its now considered that the incidence is higher post vaccination than in the general population but the comparison numbers used are rather unreliable and based on newer diagnostic technologies. In fact pre covid, in the studies available, there was already an awareness that this was far more common than previously thought. The current media panic is based on an estimated incidence of CVST in the uk of approx 75 per 20,000,000 people/doses of AZ, only this vaccine is mentioned, despite similar cases being associated with other vaccines and the current investigation of the J&J vaccine following a death.

However in this study of 19 hospitals in the Netherlands, data on CVST were collected between Jan 2008 and Dec 2010 using medical records and National Statistics. Their findings show an overall incidence of 1.32 per 100000 per year, is more than three times higher than the number associated with cases following the AZ vaccine
https://www.ahajournals.org/doi/10.1161/STROKEAHA.112.671453

This study (2005-2011) from Adelaide using the 2011 census data and cases identified by hospitalised discharge codes estimates the risk at around 78.5 per 5,000,000.
https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.116.013617

This Norwegian review states "Recent (pre 2018) studies have reported an incidence of 1-1.5 per thousand per year.". They also say, " The condition is three times more common in women of reproductive age than in men, probably owing to pregnancy the use of oral contraceptives"
https://tidsskriftet.no/en/2018/08/...rombosis-epidemiology-diagnosis-and-treatment

This is important because despite the claims of politicians, science has little impact on policy decisions and in fact most of the scientific advisory groups don't feel that the evidence about the risk of blood clots, justifies controlling the use of any vaccines. Decisions about policy are often effected by wider concerns like the economy, political lobbying and issues like Brexit. Publicity in the media has had a huge effect on public behaviour and is having a huge effect on the vaccination campaigns. It also has a huge effect on peoples perception of vaccine effects, the media reporting of the possible risks of CVT has lead to a huge increase in people seeking medical attention for minor adverse events. Expectations and anxiety often guide peoples experience of adverse events as they focus on symptoms that, if they occurred as part of normal life, might not even be noticed.
My thanks to Barbara Anne Hastings-Asatourian, for all the information and for all the work she does around Covid - for free.

 

[russ_watters]

Its strange the way in which people become obsessed with the adverse events (A.E.) of vaccines, particularly new ones...

The big concern now is in the possible link with blood clots, particularly Cerebral Venous Thrombosis, a very rare but dangerous condition. While it seems the possibility of an increased risk of thrombosis generally has largely been discounted, there being no increases in the incidence following vaccination so the spotlight has fallen onto CVT...

The current media panic is based on an estimated incidence of CVST in the uk of approx 75 per 20,000,000 people/doses of AZ, only this vaccine is mentioned, despite similar cases being associated with other vaccines and the current investigation of the J&J vaccine following a death.

However in this study of 19 hospitals in the Netherlands, data on CVST were collected between Jan 2008 and Dec 2010 using medical records and National Statistics. Their findings show an overall incidence of 1.32 per 100000 per year, is more than three times higher than the number associated with cases following the AZ vaccine

This study (2005-2011) from Adelaide using the 2011 census data and cases identified by hospitalised discharge codes estimates the risk at around 78.5 per 5,000,000.

This Norwegian review states "Recent (pre 2018) studies have reported an incidence of 1-1.5 per thousand per year.". They also say, " The condition is three times more common in women of reproductive age than in men, probably owing to pregnancy the use of oral contraceptives"

This is important because despite the claims of politicians, science has little impact on policy decisions and in fact most of the scientific advisory groups don't feel that the evidence about the risk of blood clots, justifies controlling the use of any vaccines.

[sigh]

The Food and Drug Administration and the Centers for Disease Control and Prevention are recommending the U.S. pause on using the Johnson & Johnson COVID-19 vaccine after reports of blood clots in individuals who received the vaccine...

The health agencies released a statement Tuesday morning recommending the pause “out of an abundance of caution,” saying blood clots still seem to be “extremely rare.” So far, the CDC and FDA are reviewing six reported cases in the U.S.

All six recipients were women between the ages of 18 and 48, with symptoms occurring 6 to 13 days after vaccination, according to the statement. One woman died and one has been hospitalized in critical condition, the New York Times reported....

The type of blood clot reported in individuals who have received the J&J vaccine is called cerebral venous sinus thrombosis (CVST)...

A news conference is scheduled for 10 a.m.

https://www.usatoday.com/story/news...vaccine-after-reports-blood-clots/7200817002/

I jumped on my new eligibility early this morning and scheduled the first vaccine I could get: a J&J shot tomorrow afternoon. The pause hasn't actually happened yet as far as I know, but I'll be in limbo while this gets sorted out/until then. I don't want to be an appointment hog, but I'm going to look for Pfizer/Moderna alternatives.

 

[Ygggdrasil]

Its strange the way in which people become obsessed with the adverse events (A.E.) of vaccines, particularly new ones. It is however very difficult to get a real idea about the frequency of real adverse effects it seems that if you don't include local injection site pain and reactogenicity symptoms, in the studies, the rates are largely the same between the vaccine and placebo groups.

The big concern now is in the possible link with blood clots, particularly Cerebral Venous Thrombosis, a very rare but dangerous condition. While it seems the possibility of an increased risk of thrombosis generally has largely been discounted, there being no increases in the incidence following vaccination so the spotlight has fallen onto CVT. Unfortunately, this is rare and until now it has generated little interest, it is simply one of the varieties of causes of a stroke and has no great impact on clinical management. Its now considered that the incidence is higher post vaccination than in the general population but the comparison numbers used are rather unreliable and based on newer diagnostic technologies. In fact pre covid, in the studies available, there was already an awareness that this was far more common than previously thought. The current media panic is based on an estimated incidence of CVST in the uk of approx 75 per 20,000,000 people/doses of AZ, only this vaccine is mentioned, despite similar cases being associated with other vaccines and the current investigation of the J&J vaccine following a death.

However in this study of 19 hospitals in the Netherlands, data on CVST were collected between Jan 2008 and Dec 2010 using medical records and National Statistics. Their findings show an overall incidence of 1.32 per 100000 per year, is more than three times higher than the number associated with cases following the AZ vaccine
https://www.ahajournals.org/doi/10.1161/STROKEAHA.112.671453

This study (2005-2011) from Adelaide using the 2011 census data and cases identified by hospitalised discharge codes estimates the risk at around 78.5 per 5,000,000.
https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.116.013617

This Norwegian review states "Recent (pre 2018) studies have reported an incidence of 1-1.5 per thousand per year.". They also say, " The condition is three times more common in women of reproductive age than in men, probably owing to pregnancy the use of oral contraceptives"
https://tidsskriftet.no/en/2018/08/...rombosis-epidemiology-diagnosis-and-treatment

This is important because despite the claims of politicians, science has little impact on policy decisions and in fact most of the scientific advisory groups don't feel that the evidence about the risk of blood clots, justifies controlling the use of any vaccines. Decisions about policy are often effected by wider concerns like the economy, political lobbying and issues like Brexit. Publicity in the media has had a huge effect on public behaviour and is having a huge effect on the vaccination campaigns. It also has a huge effect on peoples perception of vaccine effects, the media reporting of the possible risks of CVT has lead to a huge increase in people seeking medical attention for minor adverse events. Expectations and anxiety often guide peoples experience of adverse events as they focus on symptoms that, if they occurred as part of normal life, might not even be noticed.
My thanks to Barbara Anne Hastings-Asatourian, for all the information and for all the work she does around Covid - for free.

It's important to note that the specific type of blood clotting seen in the people receiving the AstraZeneca vaccine is very unusual and has certain characteristics (e.g. they occur in unusual locations and are associated with low platelet levels and antibodies against PF4-Heparin) that make it look much different than the typical type of blood clots observed in the general population (see the two recent NEJM case studies linked below for characterization of the clotting):

Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination
https://www.nejm.org/doi/full/10.1056/NEJMoa2104840

Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination
https://www.nejm.org/doi/full/10.1056/NEJMoa2104882

Science magazine reports at least 222 suspected cases (30 fatalities) among the 34 million that have received the first dose. Given that these occur within 2 weeks of vaccination, the rate of CVST you quote for the Netherlands study (1.32 per 100,000 per year), we would only expect to see ~17 cases in the two weeks following vaccination of 34 million.

As you note then total rate of blood clotting is similar between the general population and people taking other COVID-19 vaccines, but this figure is somewhat misleading as the total rate of blood clotting is much higher than the incidence of the rare AstraZeneca-vaccine induced type of clotting. The most common type of blood clotting occurs at a rate of 1-2 per 1,000 people each year; adding an additional ~6 per million to that rate will not make an appreciable impact on the overall incidence of blood clotting.

Given these data (epidemiological data suggesting an increased rate of severe blood clotting and the specific features of the clotting that suggest that it is vaccine-induced), the European Medicines Agency recently concluded that the unusual blood clots are indeed a side effect of the Oxford-AstraZeneca vaccine, but note that the condition is rare and in most cases the benefits of the vaccine outweigh the risks. Similarly (as @russ_watters noted above), given observation of a small number of similar clot among those getting the Johnson & Johnson vaccine in the US, the FDA has recommended pausing the use of the J&J vaccine (if not just to give providers time to prepare and spread information about how to recognize potential signs of these clots and how to treat them, which is different than other clots due to the clots being associated with low platelet levels).

Given the observation of these clots among people taking the AstraZeneca vaccine and J&J vaccine (both adenoviral vector vaccines) but not among those taking the Pfizer or Moderna vaccines (the mRNA vaccines) or among those who had COVID, it is likely that the clotting issue is associated with adenoviral vectored vacines and not general vaccination against COVID-19 (see this news article from Science for more discussion).

I agree that the condition is rare enough that it is not clear whether this would tip the risk-benefit equation is favor of discontinuing use of the vaccine, though further data would be helpful.

See also my post discussing this issue in another PF thread: https://www.physicsforums.com/threads/oxford-vaccine-clotting.1001834/post-6478992

 

[TeethWhitener]

PSA: If you’re getting the vaccine soon in the US, I would encourage you to sign up for v-safe:
https://vsafe.cdc.gov/en/
It’s the CDC’s adverse events and side effects tracker. They do periodic symptom check-ins to track side effects from all the vaccines currently approved in the US.

 

[symbolipoint]

PSA: If you’re getting the vaccine soon in the US, I would encourage you to sign up for v-safe:
https://vsafe.cdc.gov/en/
It’s the CDC’s adverse events and side effects tracker. They do periodic symptom check-ins to track side effects from all the vaccines currently approved in the US.

I checked the website briefly.
Not everyone has a smartphone.
Not everyone wants to be pushed into having a smartphone.

Outside of that, an organized OFFICIAL method to report side effects would be a good idea.

 

[Tom.G]

OP edited to add Day 18.

Day 18 -
-- - Mild hair loss noted when combing hair in the morning. This tapered off and resolved itself over 7 to 10 days.
/edit:

 

[Ygggdrasil]

I checked the website briefly.
Not everyone has a smartphone.
Not everyone wants to be pushed into having a smartphone.

Outside of that, an organized OFFICIAL method to report side effects would be a good idea.

Why do you assume that the smartphone app is the only way to report side effects and adverse events?

Here's the relevant section of the Pfizer EUA (given out to everyone who receives the Pfizer vaccination):

WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Pfizer-BioNTech COVID-19 Vaccine EUA” in the first line of box #18 of the report form.

In addition, you can report side effects to Pfizer Inc. at the contact information provided below.
Website Fax number Telephone number
www.pfizersafetyreporting.com 1-866-635-8337 1-800-438-1985

You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.

As one would expect, there are plenty of different ways to report adverse events from telephone to website submission form to smarphone app.

In addition to patients reporting adverse events, healthcare providers and vaccine manufacturers are required to report certain adverse events that come to their attention to the FDA/CDC via VAERS.

 

[symbolipoint]

Why do you assume that the smartphone app is the only way to report side effects and adverse events?

Here's the relevant section of the Pfizer EUA (given out to everyone who receives the Pfizer vaccination):
As one would expect, there are plenty of different ways to report adverse events from telephone to website submission form to smarphone app.

In addition to patients reporting adverse events, healthcare providers and vaccine manufacturers are required to report certain adverse events that come to their attention to the FDA/CDC via VAERS.

The vsafe site is not enough. Fine for those with a smartphone but other methods needed for many or some other people.

I looked at the vsafe site briefly; and then another look at clicked one of the links in it, but that seemed to point again only the the use of the vsafe site.

 

[TeethWhitener]

The vsafe site is not enough. Fine for those with a smartphone but other methods needed for many or some other people.

I looked at the vsafe site briefly; and then another look at clicked one of the links in it, but that seemed to point again only the the use of the vsafe site.

There are over 280 million smartphone users in the US, out of a population of about 330 million, for a coverage rate of about 80%. Also of note, there are about 25 million children under 5 in the US. Assuming that very few of those kids own smartphones, that leaves about 10% of the US population not potentially covered by v-safe. You’re welcome to suggest your own solution, [edited out snark] I apologize for any offense, @symbolipoint. This is an important thread and I don’t want to derail it with my bad attitude.

 

[symbolipoint]

There are over 280 million smartphone users in the US, out of a population of about 330 million, for a coverage rate of about 80%. Also of note, there are about 25 million children under 5 in the US. Assuming that very few of those kids own smartphones, that leaves about 10% of the US population not potentially covered by v-safe. You’re welcome to suggest your own solution, but personally I’m tired of doing your homework for you. Maybe I’ll report it as a side effect on my next v-safe check-in.

Nobody needs vsafe. Only they need to use the literature they receive upon being vaccinated, and find contact information on these documents to find who to or where to report side effects. There is no other "Homework" to do.

 

[russ_watters]

PSA: If you’re getting the vaccine soon in the US, I would encourage you to sign up for v-safe:
https://vsafe.cdc.gov/en/
It’s the CDC’s adverse events and side effects tracker. They do periodic symptom check-ins to track side effects from all the vaccines currently approved in the US.

I checked the website briefly.
Not everyone has a smartphone.
Not everyone wants to be pushed into having a smartphone.

That is an unnecessary reaction. For voluntary reporting (of anything), the goal is to get usable responses from as many people as possible*. That means choosing methods that reach the most people in ways that are easiest/most comfortable for the respondents, while maximizing the limited resources of the survey-takers. Yes, obviously, choosing certain methods of reaching people excludes people who don't have access to those methods. It's choices on both sides, none of which are intentional personal affronts.

Point of order, though; while the website says "V-safe is a smartphone-based tool..." I actually don't think that is accurate. As far as I can tell, it's an SMS-based tool. Searching the Google app-store, I don't see a V-safe app, and signing-up for the service the only thing I see that it's going to do is provide text-based alerts/communication. And one can get SMS via a voip service without even a cell phone or smart-phone if they want it (not "pushing", just pointing it out).

Outside of that, an organized OFFICIAL method to report side effects would be a good idea.

What does that mean? The CDC seems like a pretty official organization to me.

*Also, participation rates on such things tend to be very low regardless of approach, which disappoints me. I'm the opposite, and I know I'm the outlier, not the norm. For example, the COVID Alert PA app I have on my smartphone says it has had 871,000 "users since launch", out of a PA population of 12.8 million, or about 6%.

 

[Ygggdrasil]

The vsafe site is not enough. Fine for those with a smartphone but other methods needed for many or some other people.

I looked at the vsafe site briefly; and then another look at clicked one of the links in it, but that seemed to point again only the the use of the vsafe site.

Did you read my post? When I got my vaccine, I was given a sheet of paper (essentially identical to the pdf here), which that shows multiple ways of reporting side effects to the CDC including a two different phone numbers, two different websites, a fax number (talk about methods that not a lot of people will have access to) and the V-safe app. There are plenty of options available to report side effects to the FDA/CDC and to the vaccine manufacturer.

The V-safe site linked in the Pfizer EUA (www.cdc.gov/vsafe.) includes a link to the CDC Vaccine Adverse Event Reporting System site, at which users can report side effects and adverse events via an online form or writeable pdf (presumably people accessing a website would have the ability to submit a report via one of these two methods).

 

[Janus]

[sigh]

https://www.usatoday.com/story/news...vaccine-after-reports-blood-clots/7200817002/

I jumped on my new eligibility early this morning and scheduled the first vaccine I could get: a J&J shot tomorrow afternoon. The pause hasn't actually happened yet as far as I know, but I'll be in limbo while this gets sorted out/until then. I don't want to be an appointment hog, but I'm going to look for Pfizer/Moderna alternatives.

I got my first Pfizer dose yesterday. I went to the Oregon Convention Center, which was convenient as it is close enough that my wife could just drop me off and pick me up, so we didn't have to bother with parking and all that.
I'll have to say that it went very smoothly and was well organized. I didn't even have to get out of the seat where I was sitting out my post-shot waiting period in order to make an appointment for my second dose, as they had someone roaming around with a computer station to schedule it.

Other than a bit of soreness at the injection site, I've had no other side-effects, but I don't think that's unusual with the first dose, as they say it is the second one that can hit you harder. We'll see in three weeks.

 

[Laroxe]

It's important to note that the specific type of blood clotting seen in the people receiving the AstraZeneca vaccine is very unusual and has certain characteristics (e.g. they occur in unusual locations and are associated with low platelet levels and antibodies against PF4-Heparin) that make it look much different than the typical type of blood clots observed in the general population (see the two recent NEJM case studies linked below for characterization of the clotting):

Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination
https://www.nejm.org/doi/full/10.1056/NEJMoa2104840

Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination
https://www.nejm.org/doi/full/10.1056/NEJMoa2104882

Science magazine reports at least 222 suspected cases (30 fatalities) among the 34 million that have received the first dose. Given that these occur within 2 weeks of vaccination, the rate of CVST you quote for the Netherlands study (1.32 per 100,000 per year), we would only expect to see ~17 cases in the two weeks following vaccination of 34 million.

As you note then total rate of blood clotting is similar between the general population and people taking other COVID-19 vaccines, but this figure is somewhat misleading as the total rate of blood clotting is much higher than the incidence of the rare AstraZeneca-vaccine induced type of clotting. The most common type of blood clotting occurs at a rate of 1-2 per 1,000 people each year; adding an additional ~6 per million to that rate will not make an appreciable impact on the overall incidence of blood clotting.

Given these data (epidemiological data suggesting an increased rate of severe blood clotting and the specific features of the clotting that suggest that it is vaccine-induced), the European Medicines Agency recently concluded that the unusual blood clots are indeed a side effect of the Oxford-AstraZeneca vaccine, but note that the condition is rare and in most cases the benefits of the vaccine outweigh the risks. Similarly (as @russ_watters noted above), given observation of a small number of similar clot among those getting the Johnson & Johnson vaccine in the US, the FDA has recommended pausing the use of the J&J vaccine (if not just to give providers time to prepare and spread information about how to recognize potential signs of these clots and how to treat them, which is different than other clots due to the clots being associated with low platelet levels).

Given the observation of these clots among people taking the AstraZeneca vaccine and J&J vaccine (both adenoviral vector vaccines) but not among those taking the Pfizer or Moderna vaccines (the mRNA vaccines) or among those who had COVID, it is likely that the clotting issue is associated with adenoviral vectored vacines and not general vaccination against COVID-19 (see this news article from Science for more discussion).

I agree that the condition is rare enough that it is not clear whether this would tip the risk-benefit equation is favor of discontinuing use of the vaccine, though further data would be helpful.

See also my post discussing this issue in another PF thread: https://www.physicsforums.com/threads/oxford-vaccine-clotting.1001834/post-6478992

Your right, Cerebral and Splanchnic Vein Thrombosis are rare and they seem to share similar pathological, often multifactorial causes of immune mediated coagulopathies. Immunological changes effecting blood clotting factors seem to be a core issue in understanding these clotting disorders and can be linked to other bleeding and clotting disorders seen in both infections and post vaccination. In fact these thrombophilic disorders have often been observed to follow infection, some 7 to 10 days after the onset of symptoms, with with Epstein–Barr virus, Varicella zoster virus, rubella, and influenza virus commonly identified. They have also been reported in children and adolescents following vaccinations for/with influenza, measles-mumps-rubella (MMR), hepatitis B, human papilloma virus, varicella, and diphtheria-tetanus-pertussis (DPT).

Despite the information we already have available we now have a debate, of something presented as a new condition associated with the AZ vaccine, with the risks being misrepresented in articles like that in Science. That reports 222 suspected cases with 30 fatalities, presumably this means 222 strokes, its not a number that can be used for any comparisons. It also says that similar problems have not been seen with the mRNA vaccines, au contraire, in fact the first case to raise concerns was in a Florida Dr. who died of acute thrombocytopenia following the Pfizer vaccine.

I think the fact that the AZ vaccine is currently so important to the global vaccination program the association of this vaccine to clotting disorders needs careful consideration. There have already been highly effective campaigns to discredit this vaccine, the only one produced on a not for profit basis, which has already increased vaccine hesitancy across the world. With this in mind I think its important to examine what is actually said and I think the perception of increased risk is a good starting point. These specific and rare clots are secondary to immune mediate thrombophilic disorders, but are not the only outcome there are other bleeding / clotting events that can be just as dangerous. The way in which these need to be managed is quite different to the more common clotting disorders and significantly effects outcomes.

This first report comes from the independent Drug Safety Research unit which provides an overview and presents data about post Covid vaccination, thrombocytopenia.

https://www.dsru.org/pharmacovigila...porting-in-the-eu-us-and-uk-thrombocytopenia/

The second link provides some very current comparison data and I would suggest seems to indicate that all the vaccines have the potential to cause problems.

https://www.bmj.com/content/373/bmj.n883/rr-1

Its true that the European Medicines Agency have concluded that these clotting disorders are a risk with the AZ vaccine however the wording in their communication is interesting. First is the title, “AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets”, so the conclusion is that there is a possible link. Their recommendation is equally telling, “EMA is reminding healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination. They do not recommend any restrictions on its use.

So the widespread publicity has lead to a situation in which people are reluctant to have the AZ vaccine, based on the belief that the mRNA vaccines are inherently safer. Then as similar issues have been identified in the J&J vaccine, Europe in particular is negotiating to obtain the Sputnick vaccine from Russia, there is no reports of this vaccine causing similar effects (?) despite using the same technology.

I have no problem with using vaccines in a considered way based on possible risks, I think it is sensible to restrict its use in young women who might be more at risk, until the situation becomes clearer. Indeed as more vaccines become available using vaccines in a more strategic way based on evidence should be the norm. However people are not very good at considering relative risks and tend to be guided by their political leaders sadly in this issue the way in which politicians have disrupted the management of the pandemic, has been a disgrace. Being an old cynic I suspect that the finger of blame for the damage will be pointed at the scientific bodies involved.

 

[Ygggdrasil]

Your right, Cerebral and Splanchnic Vein Thrombosis are rare and they seem to share similar pathological, often multifactorial causes of immune mediated coagulopathies. Immunological changes effecting blood clotting factors seem to be a core issue in understanding these clotting disorders and can be linked to other bleeding and clotting disorders seen in both infections and post vaccination. In fact these thrombophilic disorders have often been observed to follow infection, some 7 to 10 days after the onset of symptoms, with with Epstein–Barr virus, Varicella zoster virus, rubella, and influenza virus commonly identified. They have also been reported in children and adolescents following vaccinations for/with influenza, measles-mumps-rubella (MMR), hepatitis B, human papilloma virus, varicella, and diphtheria-tetanus-pertussis (DPT).

The DSRU pre-print you cite notes 42 thrombocytopenic events after administration of 38.4M doses of the Pfizer vaccine and 18 events following 36.7M doses of the Moderna vaccine. Immune thrombocytopenia is estimated to have an incidence of 3.3 per 100,000 adults/year. Therefore, we would expect to see 48 cases of immune thrombocytopenia in the two weeks following administration of a Pfizer dose and and 47 cases in the two weeks following administration of a Moderna dose. These numbers suggest that there is no evidence for an elevated risk of immune thrombocytopenia after administration of either of the mRNA vaccines.

Furthermore, the issue with the AstraZeneca vaccine (and potentially the J&J) vaccine is not immune thrombocytopenia but thrombotic thrombocytopenia. According to data from a meeting of the US CDC's Advisory council on Immunization Practices earlier this week (see this PF post for more information), there were 0 reports of cerebal venous sinous thrombosis (CVST) following 97.9 M doses of the Pfizer vaccine administered, 3 cases following 84.7 M doses of the Moderna vaccine administered and 6 cases following 6.86M doses of the J&J vaccine administered (the AstraZeneca vaccine is not yet authorized for use in the US). Furthermore, none of the cases of CVST following the Moderna vaccien were associated with low platelet counts whereas all six cases of CVST following the J&J vaccine were CVST with thrombocytopenia.

I think the fact that the AZ vaccine is currently so important to the global vaccination program the association of this vaccine to clotting disorders needs careful consideration. There have already been highly effective campaigns to discredit this vaccine, the only one produced on a not for profit basis, which has already increased vaccine hesitancy across the world. With this in mind I think its important to examine what is actually said and I think the perception of increased risk is a good starting point. These specific and rare clots are secondary to immune mediate thrombophilic disorders, but are not the only outcome there are other bleeding / clotting events that can be just as dangerous. The way in which these need to be managed is quite different to the more common clotting disorders and significantly effects outcomes.

There are numerous scientifically valid reasons why the AstraZeneca vaccine was criticized from having used the wrong dose of the vaccine some sites of its initial phase 3 clinical trial, to cherrypicking results showing a higher efficacy from a previous interim analysis rather than reporting the most recent interim analysis showing a slightly lower efficacy, to the current issues with VITT. To suggest that it is being attacked because it is the only vaccine candidate produced on a not for profit basis is an absurd conspiracy theory.

It is unfortunate that the adenoviral vaccine vectors may be subject to problems with VITT, since these can be stored and transported under normal refrigeration (versus the mRNA vaccines that have much stricter cold chain requirements). However, there are other vaccines under development that could hopefully take the place of the adenoviral vaccines, such as the Novavax protein subunit vaccine that has shown very promising results in phase 3 trials. This vaccine can also be shipped and stored under normal refrigeration and protein subunit vaccines are a well established method for vaccination.

The second link provides some very current comparison data and I would suggest seems to indicate that all the vaccines have the potential to cause problems.

https://www.bmj.com/content/373/bmj.n883/rr-1

This article is mostly based on experiments in animals, where the connection to the effects of the vaccines in humans is less clear than looking at the existing real life data of the usage of these vaccines in large human populations.

Its true that the European Medicines Agency have concluded that these clotting disorders are a risk with the AZ vaccine however the wording in their communication is interesting. First is the title, “AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets”, so the conclusion is that there is a possible link. Their recommendation is equally telling, “EMA is reminding healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination. They do not recommend any restrictions on its use.

So the widespread publicity has lead to a situation in which people are reluctant to have the AZ vaccine, based on the belief that the mRNA vaccines are inherently safer. Then as similar issues have been identified in the J&J vaccine, Europe in particular is negotiating to obtain the Sputnick vaccine from Russia, there is no reports of this vaccine causing similar effects (?) despite using the same technology.

I have no problem with using vaccines in a considered way based on possible risks, I think it is sensible to restrict its use in young women who might be more at risk, until the situation becomes clearer. Indeed as more vaccines become available using vaccines in a more strategic way based on evidence should be the norm. However people are not very good at considering relative risks and tend to be guided by their political leaders sadly in this issue the way in which politicians have disrupted the management of the pandemic, has been a disgrace. Being an old cynic I suspect that the finger of blame for the damage will be pointed at the scientific bodies involved.

While I believe that the scientific and medical community does have a responsibility to be on the look out for adverse effects of the vaccines and to be transparent about what we find about the safety of the vaccines (whether good news or bad news), I also agree that it is important to put the risks in context. Overall I agree with you that it sensible to restrict the use of the vaccines in populations that are at low risk of death from COVID-19. If the AstraZeneca vaccine is the only choice versus getting COVID-19 (especially in areas of the world like Latin America which seem to be extremely hard hit by the virus), it absolutely makes sense to promote the use of the AstraZeneca vaccine (and other vaccines). However, we should not try to sweep knowledge of adverse effects of the vaccine under the rug in order to promote widespread vaccination.

 

[AndreasC]

Parents did the first Pfizer shot and the first AZ shot recently. It's been a few days and neither of them had any perceptible side effects.

 

[Laroxe]

Ygggdrasil: I think I might not have been clear about the point I was trying to make in my post, I will address the points you make before trying to clarify my statements.

The point you make about comparisons with the known background rate is important and has been an important issue in the discussions. In fact comparisons of thromboembolic events have been used in the discussions for some time and its only very recently that the data we have has started to suggest that for certain rare disorders the rate may indeed be higher. Having said that it is still considered a possibility rather than confirmed. As I posted earlier the data we have about background rates of problems like CVT is very questionable.
You make the point that we are basically talking about thrombotic thrombocytopenia, well maybe, but in fact its a very specific form of thrombosis, which often occurs along with bleeding. It's a difficult condition to make much sense out of, but virtually everyone agrees it is essentially autoimmune and the risk is modified by a wide range of issues. It's also clear that the condition does occur with both other illnesses and vaccination and there are unexplained cases. It's just a very difficult issue to investigate particularly because of its rarity and the usually poor quality data we are forced to use. These two article discuss related issues, I think an example of one of these is the report of 0 cases after 98million doses, this seems highly unlikely considering the background rate.

https://onlinelibrary.wiley.com/doi/10.1002/ajh.26132

https://www.sciencemediacentre.org/...-to-incidence-after-vaccination-or-influenza/

Of course there were some valid concerns about the initial studies with AZ the way in which data was used was confusing, but it wasn't the scientific concerns that I was talking about. In fact the European Medicines Agency was not saying the vaccine causes these problems, the communication was carefully worded to reflect the current state of knowledge, they were indicating the possibility and that was the right thing to do. It clearly is important that risks are identified and acted on, I think most of the official scientific bodies have done very well on this. Unfortunately, you then have to consider how their guidance was acted upon, or in the case of Europe not acted upon. The various countries in the EU introduced a variety of inconsistent restrictions some making unsupported claims about its safety and efficiency. While the pandemic one again marches freely across Europe, the same people are now in a state of panic that the populations are refusing this vaccine.
The scientific advisors in France have I believe stopped meeting with the president they feel its such a waste of time. Of course there are more vaccines becoming available and this should solve the problem of people overestimating risk based on misinformation. However, in the case of the EU their actions have made it less likely that they will get the new vaccines, the producers are either moving production facilities or simply not signing supply contracts. In this case ill-advised political statements will result in many more deaths and that's the tragedy, good science, needs to be used.

 

[Astronuc]

I just received my second Pfizer vaccination. No immediate effects. So far, I feel fine.

Edit/update: After 10 and nearly 11 hours, I still feel normal. Hopefully, the vaccine was viable.

Coincidentally, my son informed me that one of his coworkers tested positive for Covid-19 (the coworker has had the first of two vaccines about two weeks ago). My son last had contact on Sunday, and he was only informed by management today. We'll be looking at getting him tested, but he may have to wait a few days. Given the mask mandate at work, I'm expecting that he should not have had significant exposure. The next several days will tell.

 

[Laroxe]

I just received my second Pfizer vaccination. No immediate effects. So far, I feel fine.

Yes, I had my second AZ vaccination, didn't even have a sore arm this time.

 

[Astronuc]

24 hours after my second Pfizer vaccination, I feel like I did before the vaccination. No adverse reaction. Only slight pain at the injection site if I press on it.

Edit/update: After 52+ hours, I've had no fever, lethargy or other negative side effects. I feel more or less the same as I did before the 2nd vaccination.

My son had rapid PCR and lab PCR test done today. The rapid test result was negative, but we wait for the lab test, which is considered more accurate. The rapid test does not react to all new variants.

 

[aheight]

In the end it shows that our immune systems REALLY recognize the spike protein on SARS-COV-2!
It also shows that I REALLY REALLY don't want the real thing.

Is that necessarily true? Or is your immune system over-reacting? I've wondered about the possibility of side-effects of the vaccine and the susceptibility to cytokine storm. Any chance people having adverse vaccine effects would have had greater likelihood for adverse effects of the virus if unvaccinated? Like cytokine storm?

Just curious. If so, might be helpful and a tool for encouraging vaccinations in the future.

I received both doses with only minor arm soreness.

 

[Laroxe]

Our immune system certainly can get a bit carried away with things and we have all sorts of mechanisms to keep it under control. When people become very ill due to these mechanisms it usually follows prolonged exposure to high levels of the virus. It seems that this is something the vaccine is very good at preventing, the virus is suppressed quickly. Of course people are very different and respond to infections in different ways, its certainly true that a very rapid reaction, which is more common in younger people, might be experienced as a more severe adverse effects to the vaccine but this hasn't been seen to lead to things like a cytokine storm. So far there is no real evidence that vaccine adverse events, so called reactogenicity reliably predict the longer term protection. As it seems that younger people are more likely to experience these effects because of their rapid immune activation, but are the least likely to become very seriously ill, it would seem any association would be a negative one.
There is another effect that might be worth considering, antibody- dependent enhancement, something the vaccine developers were very aware of and worried about. Luckily this turned out not to be a problem with the vaccines. The link discusses this.
https://blogs.sciencemag.org/pipeli...dent-enhancement-and-the-coronavirus-vaccines