Claim: adverse reactions in Covid vaccine trials are not being recorded

Rory

Senior Member.
As reported by CBS-affiliated KUTV:

Dr. Brian Dressen, Ph.D., is a Utah father, husband and chemist [whose] wife Brianne took part in the Utah-based portion of the U.S. AstraZeneca trial in [November] 2020. She suffered significant neurological injury after the first dose and withdrew from the trial.

[Dressen said]: "Because study protocol requires two doses, she was dropped from the trial, her access to the study app deleted. Her reaction is not described in the recently released clinical trial report. 266 participants are described as having an AE leading to discontinuation, 56 neurological reactions are tallied."

https://kutv.com/news/local/utah-sc...asks-not-to-approve-covid-19-vaccine-for-kids
Content from External Source

So I suppose the questions are: can we find "the recently released clinical trial report"? Can we confirm or deconfirm that her adverse reaction was not included in the report? And, if we can confirm that it wasn't included, what implications does that have?

Also, if, like me, you're interested to know what 'injuries' she suffered exactly - it's reported in many places as above, but I've never seen it with much detail - then her personal account is included here:

5/20/21

I am a previously healthy 39 year old, preschool teacher, hiking and mountaineering on the weekends. Prior history of contracting West Nile at 27, fully recovered. No other history of note. I am pro-science and pro-vaccine, and was thrilled at the opportunity to do my part in ending the pandemic. I received my COVID vaccine 11/4/20 as part of a phase 3 trial with Astra Zeneca.

My initial was tingling down my arm, blurred vision, and sound sensitivity. The first night I had a more typical reaction including a high fever that had resolved by morning. When I got out of bed to get ready for work, I noticed my left foot did not work correctly and I would easily walk into the left of doorways. The sensitivity to sound and blurred vision was still there, accompanied by a strong tinnitus.

Within 48 hours it had progressed to sensitivity of light and touch. The clinic told me I likely had MS and told me to get a neurologist to verify this. The neurologist recommended I go to the ER, one of many visits that would happen over the ensuing months.

The ER ruled out MS, transverse myelitis and sent me home. I could only spend time in a completely dark and quiet room. Even touch was painful. My condition deteriorated over the next 2.5 weeks, to the point where my legs began to have trouble, I had lost 20 lbs from extreme nausea and diarrhea, dizziness, and a strange painful vibrating sensation that would move through my body. The painful pins and needles also progressed from my arm to my other arm and face, I experienced strange overwhelming brain fog, heart rate issues, low fevers and even developed the covid cough. I was admitted to the hospital when I struggled to walk and had become incontinent, where they treated me for a severe migraine which unfortunately did not improve my symptoms. I went home with PT and OT to help me learn how to walk correctly again, and try to work on the cognitive impairments. Every single day for months, my focus was just to survive, countless hours trying to just remind myself to breathe, and just hang on for my kids and hope that it would pass. It was the scariest 3 months of my life.

Like the majority of us who present with these strange GBS or MS like symptoms, my tests were largely unremarkable. I was told over and over again that the doctors haven’t seen anything like this and have no idea what it is.

Some of my symptoms have since resolved, no more fevers, no more sensitivities to light and sound, no more extreme nausea, and paresthesia appears to be improving. Yet, I am still largely housebound, unable to work, or even drive. Over 6 months later, I still have a majority of debilitating symptoms, including strange weakness in my legs, tremors similar to parkinsons, and inability to walk very far. Heavy brain fog persists along with strange pressures in my head. Very painful electrical sensation through my body, tinnitus, and fatigue.

This has severely impacted my life and my family’s life. I have had to hire substitutes to teach my preschool classes. We have also had to refinance our home so we can pay for after-school childcare. We have been trying to right this sinking ship for months. My small children now know me as “sick mom” now and have really struggled with this emotionally. I have missed out on 6+ months of their lives now and I have no idea when it will end.

https://www.c19vaxreactions.com/real-testimonials.html
 
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Rory

Senior Member.
From a safety and efficacy report on Phase 3 of the Astro-Zeneca trial:
  • Between August 28, 2020, and January 15, 2021, a total of 34,117 unique participants were screened, 32,451 of whom met eligibility criteria and underwent randomization to receive the AZD1222 vaccine (21,635 participants) or placebo (10,816 participants)
  • A total of 11,972 participants (37.0%) — 8771 (40.6%) in the AZD1222 group and 3201 (29.7%) in the placebo group — reported 23,538 adverse events. The most common adverse events, occurring in at least 5% of participants within 28 days after any dose in either group, were general pain (8.2% in the AZD1222 group and 2.3% in the placebo group), headache (6.2% and 4.6%, respectively), injection-site pain (6.8% and 2.0%), and fatigue (5.1% and 3.5%)
  • A similar percentage of participants in each group had a serious adverse event within 28 days after any dose: 119 serious adverse events occurred among 101 participants (0.5%) in the AZD1222 group and 59 events among 53 participants (0.5%) in the placebo group. During the entire trial period, a total of 7 adverse events leading to death occurred in 7 participants in the AZD1222 group, and 9 adverse events leading to 7 deaths occurred in the placebo group. No deaths were considered by investigators to be related to the vaccine or placebo. No deaths related to Covid-19 occurred in the AZD1222 group, and two deaths related to Covid-19 occurred in the placebo group
  • AEs with an outcome of death in the AZD1222 group were overdose (n=2), death (unspecified) (n=1), toxic shock syndrome (n=1), accident (n=1), road traffic accident (n=1), and toxicity to various agents (n=1). AEs with an outcome of death in the placebo group were Covid-19 pneumonia (n=2), cardiac arrest (n=1), death (unspecified) (n=1), septic shock (n=1), diabetic ketoacidosis (n=1), hemorrhagic transformation stroke (n=1), ischemic stroke (n=1), and asphyxia (n=1)
  • Conclusion: AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest; the incidences were similar to those observed in the placebo group.
Sources: https://www.nejm.org/doi/10.1056/NEJMoa2105290 and https://www.nejm.org/doi/suppl/10.1056/NEJMoa2105290/suppl_file/nejmoa2105290_appendix.pdf

To summarise: they recorded a lot of adverse reactions - 41% of the study group and 30% of the placebo group - and 14 deaths (7 in each group, but none related to the vaccine or placebo).

I suppose the first question there is: could it be that though they recorded 8771 people in the study group having adverse reactions they excluded Mrs Dressen? I suppose a bigger delve into the data would be necessary to find that out.

(One thing I do notice is that there's a slight difference between the headline figure of 21,635 participants being chosen to receive the vaccine and the figure of 21,587 included in the more detailed supplemental data - 48 people less. So I guess some dropouts or exclusions happened at some point along the way.)
 
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deirdre

Senior Member.
oh she's astra zeneca? would that even be covered by US (FDA) law?

what that mean "her reaction is not described"? how does he know 266 were described as having an AE leading to discontinuation? or that 56 neurological reactions are tallied? is he saying her neurological reaction is not tallied?
 

Landru

Moderator
Staff member
oh she's astra zeneca? would that even be covered by US (FDA) law?

what that mean "her reaction is not described"? how does he know 266 were described as having an AE leading to discontinuation? or that 56 neurological reactions are tallied? is he saying her neurological reaction is not tallied?
It's a US trial of Astra Zeneca
 

deirdre

Senior Member.
No. I'm saying it is a US trial.
how is repeating the same thing helpful? if i knew what you meant the first time, i wouldnt have asked you what you meant.
Now youre telling me US law would not trump British law, but that it is a "US trial".

I guess i'll just pretend to understand you and move on.

edit: add: this is a segue thread from another thread. i might have information that you don't. Perhaps that is the cause of the misunderstanding
 
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Rory

Senior Member.
what does that mean "her reaction is not described"? is he saying her neurological reaction is not tallied?

He seems to be saying that.

how does he know 266 were described as having an AE leading to discontinuation?

There's a table in the supplemental data that summarises incidences of adverse effects:

1637094552585.png

This shows the 266 figure - though I believe that's from the sum total encompassing several trials across several countries.

Why he believes she's not included in that figure I don't know. Underneath this table it is stated that:

"Serious adverse events (SAEs), medically attended adverse events (MAAEs) and adverse events of special interest (AESIs) are reported through trial completion or withdrawal."
Content from External Source

So I take that as saying she should have been included if this was followed.

I also find it interesting that they describe it as "safe". That's not my definition of the word by any stretch.
 
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deirdre

Senior Member.
He seems to be saying that.
one other issue.. i think maybe you should ask Steven Novella about this as he is a neurologist... reading her symptoms, other than the vomiting, walking into door frames and migraine i had the same thing! (wicked migraine after spinal tap but no other time)

but i didnt take any vaccines. i won't go into what i think caused it. But remember i told you the doctors were baffled? well the neurologist said none of the tests indicated it was neurological. (they did continuously test me for lyme's disease for some reason..but makes me wonder about her West Nile...hhmmm)

i'm not saying this is the case with her, but maybe she was put under a different section of reactions? unless they decided she had "conversion disorder" (which sucks the big one and a few doctors i saw thought that about me at first...freakin men!).

Steven Novella discusses here briefly how neurologist determine something is neurological or not
Article:
There are essentially two possibilities left – either this is a new phenomenon currently unknown to neurology, or it represents a conversion disorder, which is essentially psychological.
 

Rory

Senior Member.
Not sure if I can really find any more specific information about Dressen's particular trial, other than that the identifier was NCT04516746 and her facility was probably Velocity Clinical Trials in West Jordan, Utah.

Here's some safety information from AstraZeneca though:

Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country.

https://www.astrazeneca.com/content...e-safety-of-covid-19-vaccine-astrazeneca.html
Content from External Source

Also from the NIH (specifically regarding the US (including Chile and Peru) Phase III trial that Dressen was a part of):

Results from a large clinical trial in the United States and South America indicate that AstraZeneca’s COVID-19 vaccine, AZD1222, is well-tolerated and protects against symptomatic COVID-19 disease, including severe disease or hospitalization. The independent Data and Safety Monitoring Board (DSMB) overseeing the trial identified no safety concerns related to the vaccine.

The DSMB conducted a review of thrombotic events (blood clots) and cerebral venous sinus thrombosis (CVST) among participants and found no increased risk of these conditions in vaccinated participants.

https://www.nih.gov/news-events/news-releases/investigational-astrazeneca-vaccine-prevents-covid-19
Content from External Source

Norway, however, came to somewhat different conclusions, as did The Australian Technical Advisory Group on Immunisation (ATAGI):

"recommend[ing] the COVID-19 Pfizer vaccine (Comirnaty) as the preferred vaccine for those aged 16 to under 60 years. This updates the previous preferential recommendation for Comirnaty over COVID-19 Vaccine AstraZeneca in those aged 16 to under 50 years. The recommendation is revised due to a higher risk and observed severity of thrombosis and thrombocytopenia syndrome (TTS) related to the use of AstraZeneca COVID-19 vaccine observed in Australia in the 50-59 year old age group than reported internationally and initially estimated in Australia.

https://www.health.gov.au/news/atag...-of-covid-19-vaccine-astrazeneca-17-june-2021
Content from External Source

Also, from the European Medicines Agency (EMA):

EMA’s safety committee (PRAC) has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).

So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed.

The PRAC noted that the blood clots occurred in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding.

People who have received the vaccine should seek medical assistance immediately if they develop symptoms of this combination of blood clots and low blood platelets.

https://www.ema.europa.eu/en/news/a...very-rare-cases-unusual-blood-clots-low-blood
Content from External Source

It should be noted that both the ATAGI and the EMA still felt the benefits far outweighed the risks. But it's definitely interesting that AZ and the NIH's initial findings were for "no risk", and that this was later contradicted by findings elsewhere.
 
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deirdre

Senior Member.
But it's definitely interesting that AZ and the NIH's initial findings were for "no risk", and that this was later contradicted by findings elsewhere.
it would be helpful to readers if you added dates to your links. My guess is these issues only showed up as a larger group was using the vaccine. meaning if only 1 per 200,000 people had a certain reaction (i'm making up these numbers) then you wouldnt even begin to wonder until ..what maybe 2 million people?

but the op didnt mention anything that sounded like blood clots
 

deirdre

Senior Member.
ok the brit/swedish vaccine for the US trials was made in "that" baltimore facility.. that answers my "which country's laws" question

Article:
Late-stage trials showed that AstraZeneca’s coronavirus vaccine, which is being manufactured for the United States in Baltimore, was up to 90% effective, the English pharmaceutical company said Monday.


Article:
Last May, the U.S. gave AstraZeneca more than $1 billion to develop and study its Covid-19 vaccine as part of the Trump administration's vaccine initiative, Operation Warp Speed. Because of that agreement, AstraZeneca is contractually bound to apply for an EUA in the U.S.


But..
Article:
For Immediate Release:
August 06, 2021
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

Today, FDA announced that it has found certain lots of Astra Zeneca COVID-19 vaccine drug substance manufactured at the Emergent facility in Baltimore, Maryland, to be acceptable for use for potential export. The AstraZeneca vaccine is not authorized for use in the U.S., but FDA understands that these AstraZeneca lots, or vaccine made from the lots, will now be exported for use. The agency conducted a thorough review of facility records and the results of quality testing performed by the manufacturer and reached its decision based on this review, taking into consideration the current worldwide COVID-19 public health emergency.
 
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deirdre

Senior Member.
other than that the identifier was NCT04516746
this paper mentions that number. it says
Article:
Results: A total of 32,451 participants underwent randomization, in a 2:1 ratio, to receive AZD1222 (21,635 participants) or placebo (10,816 participants). AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest; the incidences were similar to those observed in the placebo group.

....
(Funded by AstraZeneca and others; ClinicalTrials.gov number, NCT04516746.).


which would make it difficult for vaccine takers to prove a link. although with the chart they provide, i'm not sure why they are saying "similar". add: realized there are twice the vax participants
 

Mendel

Senior Member.
Like the majority of us who present with these strange GBS or MS like symptoms, my tests were largely unremarkable. I was told over and over again that the doctors haven’t seen anything like this and have no idea what it is.
Have they explicitly ruled out GBS?
"GBS-like symptoms" are a known side effect because GBS itself is (now) a known, rare side effect; this may have been different back in November.
You can develop GBS after any infection, and a vaccination mimics an infection.
This shows the 266 figure - though I believe that's from the sum total encompassing several trials across several countries.
Did you also see the 162 in the same row?
The placebo patients actually had a greater chance of discontinuing the trial due to an adverse event than the vaccine recipients did.
(The "sum totals" are the big N= in the table header.)

I also find it interesting that they describe it as "safe". That's not my definition of the word by any stretch.
Could you elaborate on what you'd consider safe?
It should be noted that both the ATAGI and the EMA still felt the benefits far outweighed the risks. But it's definitely interesting that AZ and the NIH's initial findings were for "no risk", and that this was later contradicted by findings elsewhere.
It's owed to the fact that it's rare, so you need to study a really large group to detect this. It's a testament to the fact that safety monitoring does not stop when a medication is approved.
 
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Rory

Senior Member.
Have they explicitly ruled out GBS?

Sorry, I don't know the answer to that.

Did you also see the 162 in the same row?

I did. Though the reason I mentioned the 266 figure was in response to Deirdre's question about how Dressen (Mr) knew it.

Could you elaborate on what you'd consider safe?

Sure. Let's say I ask the question "will it put me in a wheelchair or kill me?"

"No" = safe

It's owed to the fact that it's rare, so you need to study a really large group to detect this. It's a testament to the fact that safety monitoring does not stop when a medication is approved.
My guess is these issues only showed up as a larger group was using the vaccine.

I'm not sure about that. AstraZeneca based their conclusion that it wasn't an issue on 17 million people, while Norway - who I believe first hypothesized a link - based it on a few hundred thousand and Australia felt confident that there was an issue after around 3 or 4 million doses (though backed that up using larger numbers from the UK).
 
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deirdre

Senior Member.
who I believe first hypothesized a link - based it on a few hundred thousand
well i can hypothesize a link for anything at any time too. That's why health agencies check against placebos and check against the normal rate in a population.

People/countries also have different genetics, diets, general health status (obesity, lymes disease etc), medications they might be on, health agency guidelines and definitions etc etc. So i dont find it odd that stats on vaccines or covid outcomes would vary.

Australia felt confident that there was an issue after around 3 or 4 million doses
Article:
There is a very low chance of this side effect, which may occur in around 4-6 people in every million after being vaccinated.


that's 16-24 cases out of [your number] 4 million. i'm not a doctor but not sure i would be confident that is absolutly vax related. of course their number i smuch different thant he "estimated risk" chart on the same page. which is weird.

This is me being speculative based on the fact that i (and most people i know) almost never go to the doctor or for physicals. Like recently i had an unexplained odd pain in my calf.. looked up blood clots and it was in the same location as the pics.. but i only thought of blood clot because of all the media around covid. it went away. so was it a muscle strain that felt different then other muscle strains ive had in the past? or a blood clot that went away? or did it just move somewhere i'm not really feeling it? i dont know. but i do know that if i had the vaccine recently i would have gone for an ultrasound.

Article:
Your bone marrow may not make enough platelets if you have any of the following conditions:

Aplastic anemia (disorder in which the bone marrow does not make enough blood cells)
Cancer in the bone marrow, such as leukemia
Cirrhosis (liver scarring)
Folate deficiency
Infections in the bone marrow (very rare)
Myelodysplastic syndrome (bone marrow does not make enough blood cells or makes defective cells)
Vitamin B12 deficiency
Use of certain drugs may also lead to a low production of platelets in the bone marrow.



but as i said, different health agencies/countries might have different criteria of what they consider concerning. or what they consider as "scientific evidence".
 

Rory

Senior Member.
recently i had an unexplained odd pain in my calf.. looked up blood clots and it was in the same location as the pics.. but i only thought of blood clot because of all the media around covid. it went away. so was it a muscle strain that felt different then other muscle strains ive had in the past? or a blood clot that went away? or did it just move somewhere i'm not really feeling it? i dont know. but i do know that if i had the vaccine recently i would have gone for an ultrasound.

That's an excellent point, and I think very valid.

Australia felt confident that there was an issue after around 3 or 4 million doses

Confident enough to recommend people use a different company's vaccine (Pfizer's).

PS That "3 or 4 million" number was an estimate as the report I looked at only had a figure for vaccines combined (was 5.9 million, but seemed like AZ had been more widely used than Pfizer at that time.)


Thanks for those. I was thinking of putting them into a spreadsheet-friendly format and seeing what's most commonly occuring, but not sure the conversion from pdf will be quick enough to bother with. Here are headline figures though:

1637174399491.png

Would be nice to have a "number of people vaccined" column to get a better idea of ratios, etc.

Also, going back to the original purpose of the thread, shall we say that we haven't been able to find any evidence to support or refute Mr Dressen's claim, but that it seems pretty unlikely that his wife's adverse reaction wasn't included in AstraZeneca's figures?
 

Mendel

Senior Member.
Sure. Let's say I ask the question "will it put me in a wheelchair or kill me?"

"No" = safe
Followup question: which of your typical daily activities do you consider safe?

My plan is to pick some of your answers and show there's a remote chance you could die from them, which makes them "not safe" with your criterium.

And the biggest challenge is that, with respect to your health, neither getting vaccinated nor not getting vaccinated is your kind of "safe", but one is still better than the other.

How to be safe:
gettyimages-515575698-f6aa6123db892295a9e4f598e082430fa4b76b8d.jpg
 

Rory

Senior Member.
Followup question: which of your typical daily activities do you consider safe?

My plan is to pick some of your answers and show there's a remote chance you could die from them, which makes them "not safe" with your criterium.

Probably an interesting conversation - even knowing the endpoint - but unfortunately this thread is about Brian Dressen's claim. :)
 

deirdre

Senior Member.
but that it seems pretty unlikely that his wife's adverse reaction wasn't included in AstraZeneca's figures?
i think it depends on what the federal statutes and documentation say. i started reading through some of the FDAs stuff and other journal write ups, but they are very long and a bit confusing for me. (it's more my ADD and i dont want to read carefully.. they are really really long)

if Woodcock is ignoring him (big IF), maybe he should contact Stephen Hahn or someone else who might have an in the whistleblow some stuff.
 

Mendel

Senior Member.
Probably an interesting conversation - even knowing the endpoint - but unfortunately this thread is about Brian Dressen's claim. :)
From post #2 (which might as well have been a postscript to post #1):

  • Conclusion: AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest; the incidences were similar to those observed in the placebo group.
Content from External Source
I also find it interesting that they describe it as "safe". That's not my definition of the word by any stretch.
The topic context is the fight over whether vaccines should be considered safe; and the question of whether something that has a risk of a "serious adverse event" can be considered safe at all.

With your approach (paraphrased: "This could put me in a wheelchair? Heck no, that's not safe!"), the "vaccines are unsafe" side need only point at a credible adverse event throw in some suspicion and scandal for better social media reach ("the truth they don't tell you" when the reason "they" don't tell you that is usually that it's misleading or wrong), and they win.

These guys are looking at the 266 (1.2%) vaccinated dropouts and never mentioning the 162 (1.5%) unvaccinated dropouts (from a group half the size).

But that's a half-truth approach when doing nothing is also unsafe (see e.g. Matthew 25,14-30).
That's why the "safety and efficacy report" defines "safe" as "similar to doing nothing".

However, that approach requires talking about the dangers of Covid, which is uncomfortable for a lot of people (probably the reason why we have Covid denial, mask refusal, and anti-vaxxing in the first place).

This thread exists because of the approach people have to safety.
 
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Rory

Senior Member.
I disagree - the thread is about Brian Dressen's claim that his wife's adverse event was not included in the trial report.

Ie, a claim of fact that should be able to be verified or debunked.

As noted earlier, they are both still "pro-vaccine".
 

deirdre

Senior Member.
The topic context is the fight over whether vaccines should be considered safe; and the question of whether something that has a risk of a "serious adverse event" can be considered safe at all.
the topic is whether astra zeneca (in this case) actually recorded/reported all the adverse events. and whether we can find a way to debunk the claim that they did not report all events with information/documentation available online.

but now that i actually read the link in the OP...
Article:
Dressen addressed the dismissal in his testimony Tuesday, saying “the FDA has known first-hand about her case and thousands of others, the FDA has also stated that their own safety systems are not identifying this issue and that VAERS is not designed to identify any multi-symptom signals. The system is broken.”

My family’s life has changed forever," he added. "The clinical trials are not appropriately evaluating the data, the FDA, CDC and drug companies continue to deflect the persistent and repeated cries for help and acknowledgement, leaving the injured as collateral damage.


and see
1637245975064.png


perhaps his wife's symptoms were recorded but her symptoms all recorded separately? which actually makes sense to me, but i get his point. (still not saying his wife's symptoms are actually neurological)
 

Mendel

Senior Member.
ex: this is from 2011 about new regulations (janet woodcock an author ironically).. and to me it sounds like maybe they dont have to report certain things? https://www.nejm.org/doi/full/10.1056/nejmp1103464#:~:text=Under the new regulation, clinical,to be probably drug-related. but i read it after trying to slog through cfr 312 and cfr 601 and cfr 2011... my brain is mush.
Let me do the source work for you.

A serious, unexpected suspected adverse reaction is an adverse event not previously observed with the drug and that has a reasonable possibility of having been caused by it. The IND sponsor must report such an event within 15 days if it was serious and within 7 days if it was fatal.

To further enhance patient protection, the new regulation states that the sponsor must analyze in the aggregate events that are not interpretable as single cases and report them only if there is an observed imbalance between the drug-treatment group and a control group suggesting that the event is caused by the drug. The regulation also stipulates that IND sponsors should not report events that are study end points (e.g., death or major illnesses) except in unusual cases. Information on these events should be collected and analyzed as specified in the study protocol, usually by an independent data monitoring committee.

Content from External Source
Anything unusual must be reported right away to the FDA.
The exception is if the study was looking for this anyway.
Everything else (that people in this age group normally get) needs to be collected, and compared, and if it's significantly more than expected, it needs to be reported as well.

The "certain things" that don't need to be reported are the adverse events that happen the same in the treatment arm and the control arm of the study; basically, cut out the clutter that would only "distract clinical investigators, the FDA, and IRBs from recognizing genuine drug-safety problems."

The FDA expects that this new approach will reduce reporting-data noise that may mask true signals of significant adverse events, so that what is reported to the FDA, clinical investigators, and IRBs will be more meaningful and relevant to patients' safety.
Content from External Source
This doesn't seem to affect what a company must provide to the FDA to get a drug approved; it looks like this regulation aims to protect people who enroll in drug tests.
 

Rory

Senior Member.
Here are six questions excerpted from a letter sent by Senators Mike Lee and Ron Johnson to the CDC and FDA on behalf of Brianne Dressen:

1. On page 38 of the FDA’s Emergency Use Authorization (EUA) Memorandum for the Pfizer vaccine, it is noted that 1,158 individuals experienced an unsolicited adverse event after receipt of the Pfizer vaccine that resulted in a nervous system disorder. Of those, 185 individuals experienced a disorder not classified as a “headache.” What specific nervous system disorders were experienced by those 185 individuals?

2. On page 42 of the FDA’s EUA Memorandum for the Moderna vaccine, it is noted that 651 individuals experienced an unsolicited adverse event after receipt of the Moderna vaccine that resulted in a nervous system disorder. Of those, 197 individuals experienced a disorder not classified as a “headache.” What specific nervous system disorders were experienced by those 197 individuals?

3. On page 45 of the FDA’s EUA Memorandum for the Janssen vaccine, it is noted that 101 individuals experienced an unsolicited adverse event after receipt of the Janssen vaccine that resulted in a nervous system disorder. Of those, 28 individuals experienced a disorder not classified as a “headache.” What specific nervous system disorders were experienced by those 28 individuals?

4. The European Medical Association has publicized potential risks associated with the Astra Zeneca COVID-19 vaccine that include “nervous system disorders, including immune-mediated neurological conditions.” During the FDA Clinical Trials of the Astra Zeneca Covid-19 vaccine, did any trial participants who were provided the vaccine experience nervous system disorders, including immune-mediated neurological conditions? If so, how many individuals experienced these disorders and what were the specific details surrounding these disorders and conditions?

5. Is the CDC working with physicians and researchers at the FDA, NIH, or other medical research bodies to provide the various individuals, who experienced adverse effects from the receipt of a COVID-19 vaccine, treatment and care? If not, why? If yes, how can patients find and access assistance from these medical physicians and researchers?

6. Is the CDC working with the broader medical community involved in the vaccination of Americans to ensure they are aware of symptoms associated with the unsolicited adverse events (UAES) of COVID-19 vaccines and know how to properly treat these patients and report these events to the CDC?

https://www.abc4.com/news/pdf/pdf-life-altering-injuries-letter-to-cdc-regarding-covid-19-vaccine/
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I wonder if this may explain claims that her adverse reaction wasn't "tallied" by AstraZeneca? To elaborate:

I first heard this claim from Kyle Warner - also injured by the vaccine - in a YouTube conversation with a Dr John Campbell:

There were two people at that DC meeting: Maddie, who was a 12-year-old in a clinical trial for Pfizer - she was dropped after her injury, and so she didn't count towards the data in that trial. And then Brianne [...] was in the AstraZeneca clinical trial and she had an adverse reaction after the first dose, but to 'complete' the trial you had to have both doses so she counted as a 'withdrawal' - even though she had a severe injury and was in the hospital for weeks. So [...] I know that there's some distortion of data.

www.youtu.be/7rZZTPp-eYU?t=1965
Content from External Source

The DC meeting he was talking about was one in which he and several others who believe they were injured by the vaccine met with senators, medical experts and doctors to discuss their cases. This was probably his first meeting with Brianne and Maddie and he was recounting their experiences from memory. I believe he slightly misunderstood what they were saying.

Going back to what Brianne's husband said in the beginning (bolding mine):

"Because study protocol requires two doses, she was dropped from the trial, her access to the study app deleted. Her reaction is not described in the recently released clinical trial report. 266 participants are described as having an AE leading to discontinuation, 56 neurological reactions are tallied."

I'm thinking his issue was not that her reaction wasn't recorded, but that it wasn't described - that her "severe reaction to the vaccine" was simply marked as a "1" in the "withdrew due to AE" column and probably lumped in along with a wide range of conditions, some of which may not have been serious at all, and none of which tell the full tale when noted only as a number: especially for conditions which develop and continue over many subsequent months.

In the case of 12-year-old Maddie de Garay, it's a little easier to find more detailed records:

Within 24 hours of arriving at the trial site with her dad and receiving her second shot, Maddie developed crippling, scream-inducing pain that landed her in the emergency room. She was experiencing abdominal, muscle, and nerve pain, described as the feeling of someone “ripping [her] heart out through [her] neck

Over the next three months, Maddie was admitted to the hospital three times, visited doctors and emergency rooms more than that, and developed additional life-changing symptoms including: gastroparesis, erratic blood pressure, erratic heart rate, memory loss, brain fog, dizziness, fainting, seizures, verbal tics, motor tics, loss of feeling from her waist through her toes, muscle weakness, drastic and adverse changes in her vision, urinary retention, loss of bladder control, and the start of and severely irregular menstrual cycles. Maddie currently has an NG tube and uses a wheelchair for assistance.

The list of “post-vaccination symptoms” that her mother has detailed and tracked in an effort to help her daughter is over 23 pages long (through August 2021). It tells the story of a 12-year-old girl’s life being drastically altered by worsening symptoms that, at times, had her saying she “couldn’t do this anymore” and that she “wanted to give up.”

https://www.sirillp.com/wp-content/...g-Maddie-and-Clinical-Trials-for-Children.pdf
Content from External Source

And here's how her AE was recorded on Pfizer's report of the clinical trial for 12 to 15 year-olds:

One participant experienced an SAE reported as generalized neuralgia, and also reported 3 concurrent non-serious AEs (abdominal pain, abscess, gastritis) and 1 concurrent SAE (constipation) within the same week. The participant was eventually diagnosed with functional abdominal pain. The event was reported as ongoing at the time of the cutoff date.

https://www.fda.gov/media/148542/download (page 30 of 43)
Content from External Source

So while Kyle Warner was incorrect in his interpretations of what he heard at the DC meeting, it does seem that there's a very strong case for the claim that some adverse reactions are being downplayed and underreported.
 
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deirdre

Senior Member.
And here's how her AE was recorded on Pfizer's report of the clinical trial for 12 to 15 year-olds:

the fda link says it is for symptoms up to 30 days after second dose. her moms got 90 days worth of symptoms there.

but (as i said)

unless they decided she had "conversion disorder" (which sucks the big one and a few doctors i saw thought that about me at first...freakin men!).

Article:
Stephanie De Garay told "Tucker Carlson Tonight" Thursday that after reaching out to multiple physicians they claimed her daughter, Maddie De Garay, couldn’t have become gravely ill from the vaccine.

"The only diagnosis we've gotten for her is that it's conversion disorder or functional neurologic symptom disorder, and they are blaming it on anxiety," De Garay told Tucker Carlson. "Ironically, she did not have anxiety before the vaccine."



so i guess you can be "just another hysterical woman" even at age 12!! (<that's sarcasm)
 

NoParty

Senior Member.
...the thread is about Brian Dressen's claim that his wife's adverse event was not included in the trial report.
So you began and titled a thread:
"Claim: adverse reactions in Covid vaccine trials are not being recorded"
to examine a single case?
 

econ41

Senior Member
So you began and titled a thread:
"Claim: adverse reactions in Covid vaccine trials are not being recorded"
to examine a single case?
Maybe I've missed it but I dont see any summary of either what the basis of concern is or why this single (or pair of) exception(s) raise concerns about trial reporting. Yes the incidences are of concern to those affected. The missing linkage is to who should bear responsibility and possible liability.

What should be known and agreed facts include:
These trials are of "vaccines" which are being rapidly developed in face of a major pandemic.
All vaccines (and most other medications) offer benefits but at some risk of "side effects". Those side effects include ones already identified and potentially others that are not yet identified at whatever is the relevant stage of improving knowledge. Valid decisions to use vaccines are based on the probability assessment that the benefits are very much more than the downside risks of side effects.
Any person taking vaccine treatment should do so with "informed consent" >> a topic of some complexity for possible discussion at another time. BUT the "patient" should be aware of the risks and why the benefits outweigh the risks.

The situation with "trials" is different in some parameters.
It involves at least two additional classes of risk which are:
The risk of side effects which are not yet known. (note I said "additional" i.e. it is added to any already known risk which may be outweighed by the benefits.)
The risk - in a blind test involving comparison with a "placebo" - is that the patient will be given the placebo and will NOT receive the benefit of the medication.

Issue #1: TRials are almost always offered to volunteers who should be familiar with the additional risk. Can we confirm that this (or these) affected persons were volunteers - and, in the case of the minor, the actual parents accepted that risk?
Issue #2: The understanding by both - or all three parties - to this trial is a contract. Do we know if the Contract was implied or actually written? I would be very surprised if either the pharmaceutical supplier or the test administrator would proceed without some disclaimer or limitation on liability. Do we know what the status is?
Issue #3: From a very simple position - the affected person failed to meet the criteria for continued involvement in the trial. And withdrew on medical advice. So why should the report as to a trial do any more than report that some participants were not able to continue in the trial?

Now all the preceding comments go to the strict legality of the situation.

I recognise the concerns which are being raised which - in emotive language - "should hold the guilty b...s liable for the harm to the poor innocent victim..."

(No apology for my use of the deliberate CT style emotive hyperbole. :rolleyes: )

So maybe the real central issue for debate is:
"To what extent should parties testing new medications be held liable for any resulting side effects arising during the trial?"
AKA "Who should carry how much of the blame?"

And the related issue "To what extent should risks which may arise in trials be subject to formal contractual agreement as to how liability is shared?"

And, back to the topic, did that occur with this or these examples?
 
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deirdre

Senior Member.
Maybe I"ve missed it but Idont see any summary of either what thebasis of concern is or why this single or pair of exceptions raise concerns about trial reporting. Yes the incidences are of concern to those affected. The missing linkage is to who should bear responsibility and possible liability.
its a segue thread, from the main covid events page. i think he just wanted to buckle down (in a separate thread) and see if there was any actual evidence to back up the claims.
The missing linkage is to who should bear responsibility and possible liability.

that's why i was asking about U.S law vs British law for a british vaccine test in America. because liability was the main jist of the original thread.
 

econ41

Senior Member
its a segue thread, from the main covid events page. i think he just wanted to buckle down (in a separate thread) and see if there was any actual evidence to back up the claims.
Thanks. I followed both the two threads history and the need for a tighter focus on the specific issue.
that's why i was asking about U.S law vs British law for a british vaccine test in America. because liability was the main jist of the original thread.
Yes.
BTW I've edited - completed - the post... my bad habits getting confused between Forum and FaceBook "hot keys". (ctl ENTER is"new line " on FBook and causes a premature post here.)
 

deirdre

Senior Member.
And the related issue "To what extent should risks which may arise in trials be subject to formal contractual agreement as to how liability is shared?"
my guess is that health insurance should cover adverse effects. no?

Article:
Insurance Coverage and Clinical Trials
Find a Clinical Trial
Federal law requires most health insurance plans to cover routine patient care costs in clinical trials under certain conditions. Such conditions include:

You must be eligible for the trial
The trial must be an approved clinical trial
The trial does not involve out-of-network doctors or hospitals, if out-of-network care is not part of your plan
Also, if you do join an approved clinical trial, most health plans cannot refuse to let you take part or limit your benefits.



I agree with the claimants beef that "if" their totality of symptoms are ignored by the study, then the fda doesnt have full information required to approve. *see footnote add

But i think they are seriously muddying the waters of this important issue by wanting costs covered by the manufacturer.

or suggesting the manufacturer or cdc can alleviate their symptoms better than any other doctor. That makes no sense to me.


* i saw this the other day, so my interpretation is that the fda gets alot more raw data than what is in the official filing/report Rory linked above (<my descriptive). This is regarding Pfizer vaccine:
Article:
Yale Professor Dr. Harvey Risch and the University of California’s Dr. Aaron Kheriaty and Dr. Peter McCullough filed a Freedom of Information Act request asking the FDA for the data in August, and their group, the Public Health and Medical Professionals for Transparency, filed a lawsuit requesting the data in September. The agency this week told a court that it had found about 329,000 pages of responsive information, but that it would like to release just 500 pages each month — giving it until 2076 to complete the request. The FDA took just more than 10 weeks, by contrast, to review the data before it approved the vaccine.
 

econ41

Senior Member
Yep, as Deirdre said, it was purely and simply an investigation of a claim.
I'm looking for a solution to the liability issue. The actual illness isn't in doubt. The causality may be but if there is a better way of managing liability it will also need to manage causality. Hence my want to clarify some of the key issues such as the volunteer status and "informed consent" of the participant child of the original claim.
 

econ41

Senior Member
my guess is that health insurance should cover adverse effects. no?
Looks like it could in this instance. But generically it is still an issue of cost liability that should be clarified "up front" in any contractual relationship. Including "clinical trials".
 

deirdre

Senior Member.
But generically it is still an issue of cost liability that should be clarified "up front" in any contractual relationship. Including "clinical trials".
totally agree. but i'm going to assume clinical trials (esp this big) do cover that up front. the patient can release a copy of what they signed to us if this is not the case. now.. whether the patient actually understands what they are reading is another issue. but in U.S i bet the courts would side with the manufacturer in that case unless the language was excessively ambiguous.

now, for people in the UK.. with National Health, i dont know. my above link says
Article:
Federal law also does not require states to cover routine patient care costs in clinical trials through their Medicaid plans.


medicaid is like our "national health" for poor people.
 
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