Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults
"The excess risk of serious adverse events found in our study points to
the need for formal harm-benefit analyses, particularly those that are
stratified according to risk of serious COVID-19 outcomes. These
analyses will require public release of participant level datasets."
"Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI -0.4 to 20.6 and -3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI -23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI -3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39)."
What Happens If You Have a Bad Reaction to the COVID Vaccine
In the US vaccine manufacturers are exempt from liability if someone is harmed by a vaccine they produce. The US government established a program in the 1980s called the Vaccine Injury Compensation Program (VICP) that compensates some people who demonstrate that they (or their child) were injured or killed by a vaccine. This program is funded by a tax paid by consumers as part of the cost of the vaccine. In the case of vaccines for COVID 19 however, injured people are not allowed to file in the VICP and must file instead with the Countermeasures Injury Compensation Program (CICP). It has been explained that this is because COVID 19 vaccines were developed to address a pandemic. The CICP is a far less robust system- it gives you 1 year to file a claim compared to 3 years in the VICP, the CICP is not a legal system (the VICP is somewhat) so there is no right to counsel or appeal. In the case of the H1N1 vaccine only 29 claims out of 499 that were filed were compensated. A legal specialist from George Washington University who is involved in the VICP says that insisting that COVID 19 vaccines fall under the umbrella of the CICP rather than the VICP, as the Trump administration did, builds distrust with the public and fuels vaccine hesitancy because the CICP is such a weaker system and one that almost universally denies compensation for claims.
HRSA Countermeasures Injury Compensation Program (CICP) Data
The PREP Act and COVID-19: Limiting Liability for Medical Countermeasures
From the Congressional Research Service
The VAERS toll-free number is 1‐800‐822‐7967 or report online to
https://vaers.hhs.gov/reportevent.html
In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985
The VAERS Vaccine Adverse Events Reporting System with the CDC
How to file a report of a vaccine injury
What to do when vaccines go wrongVaccine damage schemes in the US and UK reappraised: making them fit for purpose in the light of Covid-19
"A longstanding problem of governments has been the extent to which they
should assume responsibility for the compensation of those injured by
vaccines. This paper reappraises the vaccine damage schemes currently
available in the US and UK in the light of the Covid-19 pandemic. It
argues that any improvements to both US and UK schemes should be
included in a revised national vaccine policy which takes into
consideration their respective long-term national vaccine strategies to
prepare for future pandemics."
“First Do No Harm”. No-Fault Compensation Program for COVID-19 Vaccines as Feasibility and Wisdom of a Policy Instrument to Mitigate Vaccine Hesitancy
"Vaccines are so far proven to be safe, although related adverse events
cannot be excluded. The urgency for COVID-19 vaccines determined a
dilution of the general expectations of safety and efficacy of
vaccination (from safe and effective to safe and effective enough). In
many countries, a no-fault program was established to compensate
individuals who experienced serious vaccine-related injuries. The
impressive number of administrations worldwide and the legal indemnity
afforded to manufacturers of approved vaccines that cannot be pursued
for compensation fed the debate about the availability of a compensation
model for COVID-19 vaccine-related injuries. Several European countries
have long introduced a system, Vaccine Injury Compensation Programs, to
compensate people who suffer physical harm because of vaccination."
No-fault compensation schemes for COVID-19 medical products
"No-fault compensation schemes for severe adverse events can help build confidence in vaccine safety after marketing. 25 of the 194 WHO member states have implemented such no-fault vaccine injury compensation programmes. Although the USA is covering COVID-19 vaccine-associated adverse events with the US Countermeasures Injury Compensation Program (CICP) for the duration of the public health emergency declaration, the country is having challenging issues as CICP does not have the ease of access to, and levels of compensation provided by the US National Vaccine Injury Compensation Program available at normal times, exacerbating long-standing inequities based on income, race, and ethnicity."
Covid-19 Vaccine Injuries — Preventing Inequities in Compensation
"Vaccine-related adverse events would especially burden low-income
people, who have limited financial resources to obtain medical care,
weather any resulting job loss, and pursue compensation and who are
disproportionately non-White."
"The United States has developed a robust system for vaccine-injury compensation to alleviate the burdens of adverse medical consequences of vaccines. But this system will be unavailable to people who receive Covid-19 vaccines during the declared public health emergency. All potential vaccine recipients, and especially people in high-risk communities, therefore face a dilemma: should they risk becoming infected or risk having a vaccine injury without sufficient access to compensation?"
"The declaration of a public health emergency by the Department of Health and Human Services in March 2020, however, resulted in exclusion of Covid-19 vaccine injuries from the VICP. This declaration triggered the Public Readiness and Emergency Preparedness (PREP) Act, a federal law that requires that all people injured by vaccines given as countermeasures during a declared emergency bring claims under only the Countermeasures Injury Compensation Program (CICP). The CICP is far less generous and less accessible than the VICP. It compensates people for only the most serious injuries, has a higher burden of proof than the VICP, has a 1-year statute of limitations after the date of vaccination, and limits awards for damages. For example, the CICP limits lost-income recovery to $50,000 for each year out of work and doesn’t include compensation for pain, suffering, or emotional distress."
"Congress could require that a 75-cent excise tax be applied to all vaccines for pandemic viruses in the United States — which is already done for childhood vaccines — to finance the Vaccine Injury Compensation Trust Fund. Allowing injured people, including members of vulnerable communities, to obtain compensation by means of the VICP will promote public health goals and enhanced equity while ensuring that anyone who has a vaccine-related injury receives adequate compensation."
Senator Johnson Expert Panel on COVID Vaccine Injuries and Federal Vaccine Mandates
"I suffered a life-altering reaction to my COVID vaccine on November 4, 2020, almost a year ago to the date. I suffered a cascade of neurological symptoms that persisted for months. And while my life has improved, I still feel I’m being electrocuted 24/7. For the first several months, I was totally alone. I kept my symptoms and my story completely to myself. I thought that this was an isolated incident. But in the spring, I started finding more and more like me, and before we knew it there were thousands of us. All of us unable to receive medical care, recognition… either from the drug companies, the CDC, the FDA. We all suffered the same constellation of symptoms, which is very strange… it’s a brand new disease, nobody knew anything about this."
Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials
"Pfizer and Moderna mRNA COVID-19 vaccines were associated with an
increased risk of serious adverse events of special interest, with an
absolute risk increase of 10.1 and 15.1 per 10,000 vaccinated over
placebo baselines of 17.6 and 42.2 (95% CI -0.4 to 20.6 and -3.6 to
33.8), respectively. Combined, the mRNA vaccines were associated with an
absolute risk increase of serious adverse events of special interest of
12.5 per 10,000 (95% CI 2.1 to 22.9). The excess risk of serious
adverse events of special interest surpassed the risk reduction for
COVID-19 hospitalization relative to the placebo group in both Pfizer
and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively)."
Latest risk figures from UK Health Security Agency (UKHSA) presentation to the Joint Committee on Vaccination and Immunisation (JCVI) on October 25, 2022
This report breaks down the numbers into "number needed to treat", which means how many people need to get vaccinated to prevent a single hospitalization. In this case they're talking about mRNA COVID 19 boosters in for autumn. For people aged 16 to 19, 73,500 people need to be vaccinated to prevent ONE hospitalization, and 185,100 needed to prevent ONE serious hospitalization (meaning ICU admission or requiring oxygen supplementation). A review of Pfizer's randomized controlled trial data showed a rate of serious adverse events of about 1 in 1,000 people vaccinated, which means that people in this age group are 73 times more likely to have a serious adverse event if they are boosted than to be hospitalized with COVID if they are not.
For people aged 20 to 29, 169,200 people without any risk factors would need to receive the autumn booster to prevent ONE hospitalization, and 706,500 to avoid ONE serious hospitalization. For those in this age group who do have risk factors the numbers drop such that 7,500 people need to be vaccinated to avoid ONE hospitalization and 59,500 from this group need to be vaccinated to avoid ONE serious hospitalization. Again, compare those numbers to the rate of serious adverse events from the Pfizer mRNA vaccine of about 1 in 1,000 and the rate for the Moderna vaccine of about 1 in 650. This makes the risk/benefit analysis very skewed.
How many more adverse effects have been covered up during the trials? - Maddie de Garay's story
Large German health insurer says up to 3 million people potentially suffered Covid-19 vaccine side effects
"One of Germany’s largest health insurance companies, BKK, analyzed the
records of 10.9 million insured individuals to determine the rate of
Covid-19 vaccine complications and has found alarming data, according to
a new report from one of Germany’s best-selling newspapers"
“If these figures are extrapolated to the year as a whole, 2.5 to 3
million people in Germany likely received medical treatment because of
the side effects of vaccination after the Covid-19 vaccination. We see
this as a significant alarm signal that must be taken into account when
the vaccines are used further. In our opinion, the figures can be
validated relatively simply and at short notice by asking the other
types of insurance (AOKen, substitute health insurance companies, etc.)
to evaluate the data available to them accordingly.” The original German article in Die Welt is here.
Data, we want it all (regarding vaccine trials)
Dr Campbell talks about how 2 years into the pandemic, even with vaccine mandates, the actual clinical trial data is being withheld. This goes against the basic premise of science and therefore is almost never seen. The last time this happened was around 2009 in the case of the anti-influenza drug Tamiflu. Academics who requested access to the clinical trial data to verify the results (standard practice in medicine) were denied. Most of the clinical trials had been sponsored by the manufacturer and it turned out that they had actually been ghostwritten by the manufacturer, but this didn't come out until after governments had spent billions stockpiling it. The drug has since fallen out of favor and seems not to be used much if at all (3 papers about this are listed at 4:13in the video).
As for the denial of access to the data from the clinical trials of the COVID 19 vaccines, the BMJ says "This is morally indefensible for all trials, but especially for those involving major public health interventions.” Pfizer has announced it will not “entertain” requests for its clinical trial data for external review before 2025. Moderna *may* allow access to their clinical trial data with the publication of their final study results, which is estimated to occur on October 27, 2022. AstraZeneca data was made available on December 31st 2021, but it may take up to one year to fulfill a request.
Clinical trial data is also being with held for some of the treatments for COVID 19 in addition to the vaccines. Regeneron, makers of the monoclonal antibody therapy Regen-Cov, will not be making the participant-level data from its phase 3 trial available while the product is under Emergency Use Authorization. Regeneron will consider sharing this data after (and if) the treatment is given full approval. In the case of Remdesivir, which was funded by the NIH (National Institutes of Health, an American governmental agency), "the longitudinal data set only contains a small subset of the protocol and statistical analysis plan objectives" (???).
We are left to wonder why access to all of this data is being restricted, when this is an extremely unusual thing to do. Again, from the BMJ "In our view, there is no dilemma. The anonymized individual participant data from clinical trials must be made available for independent scrutiny. US Food and Drug Administration, freedom of information request to the agency for Pfizer's vaccine data. The Medicines and Healthcare Products Regulatory Agency in the UK (their version of the FDA) is also not releasing clinical trial data. This lack of transparency, which is something the BMJ calls essential, has devastating effects on public trust, something that is essential during a pandemic.
Also from the BMJ "At least three of the many companies making COVID 19 vaccines have past criminal and civil settlements costing them billions of dollars." The BMJ further states that they support vaccination policy based on sound evidence, they are very clearly "pro-vaccine" as a medical technology. They say the same regarding COVID 19 treatments. Also from the BMJ:
"Data must be available when trial data are announced, published, or used to justify regulatory decisions."
"There is no place for wholesale exemptions from good practice during a pandemic"
"The public has paid for COVID 19 vaccines through vast public funding of research"
Self-Reported Real-World Safety and Reactogenicity of COVID-19 Vaccines: A Vaccine Recipient Survey
"An online survey was conducted to compare the safety, tolerability and
reactogenicity of available COVID-19 vaccines in different recipient
groups. This survey was launched in February 2021 and ran for 11 days.
Recipients of a first COVID-19 vaccine dose ≥7 days prior to survey
completion were eligible. The incidence and severity of vaccination side
effects were assessed. The survey was completed by 2002 respondents of
whom 26.6% had a prior COVID-19 infection. A prior COVID-19 infection
was associated with an increased risk of any side effect (risk ratio
1.08, 95% confidence intervals (1.05-1.11)), fever (2.24 (1.86-2.70)),
breathlessness (2.05 (1.28-3.29)), flu-like illness (1.78 (1.51-2.10)),
fatigue (1.34 (1.20-1.49)) and local reactions (1.10 (1.06-1.15)). It
was also associated with an increased risk of severe side effects
leading to hospital care (1.56 (1.14-2.12)). While mRNA vaccines were
associated with a higher incidence of any side effect (1.06 (1.01-1.11))
compared with viral vector-based vaccines, these were generally milder (p
< 0.001), mostly local reactions. Importantly, mRNA vaccine
recipients reported a considerably lower incidence of systemic reactions
(RR < 0.6) including anaphylaxis, swelling, flu-like illness,
breathlessness and fatigue and of side effects requiring hospital care
(0.42 (0.31-0.58)). Our study confirms the findings of recent randomised
controlled trials (RCTs) demonstrating that COVID-19 vaccines are
generally safe with limited severe side effects. For the first time, our
study links prior COVID-19 illness with an increased incidence of
vaccination side effects and demonstrates that mRNA vaccines cause
milder, less frequent systemic side effects but more local reactions."
Why People With PhD's Are More Hesitant To Take The Covid-19 Vaccine
Mistakes in Administration of COVID vaccines
Several Bay Area kids sick after receiving wrong dose of COVID vaccine
14 children were given the wrong dose of COVID vaccine at a pop-up clinic. They received 20mcg instead of 10mcg. Several children have been reported sick afterwards, including stomach pain and falling down.
100 Kids In Virginia Given Wrong Dose Of Covid Vaccine
Woman accidentally given Pfizer vaccine after receiving Moderna dose: daughter
In this video British doctor Dr Campbell
explains clearly the proper method of injecting a vaccine. Vaccines
are designed to be injected into the muscle (usually the deltoid muscle
in the upper arm) and NOT directly into the bloodstream, which would be
intravenous or IV administration. The contents of the vaccination would
have significantly different interactions with a person's body and
immune system if injected IV by accident. Evidence suggests that
injection into the bloodstream may be one of the factors leading to
certain adverse events including Myocarditis and Pericarditis,
Vaccine-Induced Thrombotic Thrombocytopenia, blood clotting leading to
other complications, and some neurological complications. This also
raises the question of whether vaccination administered IV provides the
same level of immune protection from the virus.
COVID-19 vaccine shoulder complication.
Sometimes
the vaccine is accidentally injected into the bursa in the shoulder
rather than into the deltoid muscle where it is intended to be given.
When this happens it can cause intense inflammation called bursitis
which is very painful.
Compensation for Vaccine Injuries and Adverse Events
No-Fault Compensation for Vaccine Injury — The Other Side of Equitable Access to Covid-19 Vaccines
"For a vaccine that will most likely be distributed worldwide, there is
an inevitable risk of serious adverse events, such as seizures and
allergic reactions, even with a very safe product. Such events might not
begin surfacing until a substantial number of people have been
vaccinated.... (F)or most countries, offering pharmaceutical companies indemnity or
complete immunity from lawsuits is constitutionally or financially
impossible. Some governments will refuse to make such offers because of
basic fairness principles: manufacturers should pay for the injuries
their products cause... Creating a comprehensive system for no-fault vaccine-injury compensation would be feasible and would promote justice... We believe that the global community that promotes immunization as a
collective interest, knowing that people will be injured, must share the
burden of these injuries’ costs."
Japan’s SUPERB vaccine ethics…USA, Europe, Oz Governments: please TAKE NOTE
The
government of Japan has approached COVID vaccination in a transparent
way, acknowledging the unavoidable reality that there will be people
harmed by vaccination and establishing a process to provide assistance
when that happens. They are also very clear that vaccination is only to
be given with informed consent, that no one should be pressured or
manipulated into being vaccinated. Additionally they state that people
who are not vaccinated must not be discriminated against.
In Australia, the government is creating a compensation program for people who are injured by a COVID 19 vaccination as part of negotiations to issue a vaccine mandate. Originally people could file a claim if the medical expenses and/or lost wages exceeded $5,000, but this threshold has been lowered to losses of at least $1,000.
General and Multisystem Adverse Reactions
Delayed Large Local Reactions to mRNA Covid-19 Vaccines in Blacks, Indigenous Persons, and People of Color
"Delayed large local reactions may be less commonly recognized or
reported in BIPOC vaccine recipients than in White recipients. Such
reactions may result in vaccine hesitancy or incomplete vaccination; as
such, proactive outreach is needed to increase education regarding these
reactions across diverse communities. We hope that this letter
encourages additional research and communication regarding cutaneous
vaccine reactions, including delayed large local reactions, in BIPOC
recipients."
Anti-idiotype Antibodies in SARS-CoV-2 Infection and Vaccination
Why did patients die in Norway after Pfizer vaccine administration?
Deaths
occurred in nursing home patients, most of whom were on hospice care
(shortened life expectancy). This doctor believes that the deaths were
due to per-existing disease or his belief that the patients were so sick
that they couldn't tolerate any side effects no matter how mild.
Receipt of mRNA Covid-19 Vaccines and Risk of Spontaneous Abortion
Herpes infection possibly linked to COVID-19 vaccine | New York Post
Six patients in Israel developed Shingles infections after vaccination with the Pfizer vaccine.
Moderna COVID-19 vaccine causes painful side effects in patients who have facial fillers
In
the Moderna trials, some participants who had had cosmetic facial
filler had a painful reaction to the vaccine that involved pain and
swelling at the site where the filler had been applied. The
participants recovered after treatment with steroids and anti-histamine
medications. Millions of Americans have cosmetic facial filler.
Covid-Arm: Moderna Vaccine Complication Experience Firsthand
A
doctor who teaches at a medical school (teaches dermatology)
experienced a reaction to the Moderna vaccine that appeared 13 days
after vaccination, at the vaccination site on his upper arm (typical
delayed hypersensitivity reactions normally take up to 48 hours to
happen). A dermatologist at Stanford told him she'd seen this before
and it was being called "COVID arm". His arm was itchy and had a red
rash. It is a type of allergy that almost never takes this long,
and no one seems to understand why it did in this case. It was
completely gone in about 5 days.
Boston Doctor Reports Serious Allergic Reaction After Getting Moderna’s Covid Vaccine
Myocarditis and Pericarditis
Myocarditis with COVID mRNA Vaccines - AHA Journals (Dr Mobeen lecture)
Dr Mark Gorelik, Pediatric Rheumatologist & Immunologist on Vaccine Induced Myocarditis
CDC confirms 226 cases of myocarditis after COVID-19 vaccination in people 30 and under
Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel
"The incidence of myocarditis, although low, increased after the receipt
of the BNT162b2 vaccine, particularly after the second dose among young
male recipients. The clinical presentation of myocarditis after
vaccination was usually mild."
Myocarditis after Covid-19 Vaccination in a Large Health Care Organization
"Among patients in a large Israeli health care system who had received at
least one dose of the BNT162b2 mRNA vaccine, the estimated incidence of
myocarditis was 2.13 cases per 100,000 persons; the highest incidence
was among male patients between the ages of 16 and 29 years. Most cases
of myocarditis were mild or moderate in severity."
13 year old boy dies 3 days after COVID Vaccine | Post Vaccine Deaths
This
video provides a lot of information about Myocarditis and Pericarditis
following vaccination as well as infection with the SARS Cov2 virus.
Orange County health care worker dies after receiving 2nd dose of COVID vaccine
(had adverse event within hours of getting vaccine including difficulty breathing and stomach problems, died within days)
CA person dies hours after receiving COVID-19 vaccine
(The
person in question had COVID 19 about a month before receiving the
vaccine, began having symptoms within an hour, admitted to ICU for
ventilator support, dies within 3 hours of vaccination)
Blood Clots
Clear link between AstraZeneca and rare blood clots | DW News
Germany
halted use of AstraZeneca vaccine in people under the age of 60 due to
the European Medicines Agency confirmed that there is a connection
between this vaccine and blood clots. Nine people have died due to rare
blood clotting following this vaccine. Young women seem to be at
highest risk for this, which is opposite to the risk of clots from the
disease itself, which is more likely to cause clotting in older men. A
virologist suggests that the clotting is the result of a
hypersensitivity reaction to the vaccine. In the U.K. the vaccine may
be limited to be used only in people older than 30, and in Scandinavian
countries and Canada the vaccine is being limited to use only in those
over 55.
New questions over safety of AstraZeneca vaccine for young adults raised by UK - BBC News
"Up
to the end of March, there have been 79 cases of rare clots with low
platelets following the first dose of the AstraZeneca vaccine. 19
people have died." This adverse reaction seems to occur at a rate of 1
in 250,000 vaccinations. Very few people under the age of 30 have died
from COVID 19 which also effects the risk/benefit calculation.
Oregon woman dies after receiving Johnson and Johnson vaccine
A 50 yo woman in Oregon died after developing a blood clot and very low levels of platelets after receiving the J and J vaccine.
Dekalb teacher hospitalized for blood clots after getting Johnson and Johnson vaccine
Woman
hospitalized with multiple blood clots in her lungs following the
Johnson and Johnson vaccine, requiring hospitalization. The woman had
developed a blood clot and had very low levels of platelets. Her death
was reported 2 days after the J and J vaccine was paused by the CDC.
Vaccine-Induced Thrombocytopenia (VITT)
Clinical Features of Vaccine-Induced Immune Thrombocytopenia and Thrombosis
"Vaccine-induced immune thrombocytopenia and thrombosis (VITT) is a new
syndrome associated with the ChAdOx1 nCoV-19 adenoviral vector vaccine
against severe acute respiratory syndrome coronavirus 2. Data are
lacking on the clinical features of and the prognostic criteria for this
disorder."
Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination
"Vaccination with ChAdOx1 nCov-19 can result in the rare development of
immune thrombotic thrombocytopenia mediated by platelet-activating
antibodies against PF4, which clinically mimics autoimmune
heparin-induced thrombocytopenia." (Funded by the German Research
Foundation.)
Thrombocytopenia and splenic platelet directed immune responses after intravenous ChAdOx1 nCov-19 administration
Vaccines
are intended to be injected into a muscle, usually the deltoid,
(intramuscular injection) but are sometimes accidentally injected into a
blood vessel (intravenous injection). This pre-print (a research paper
that has not yet been peer reviewed or published) demonstrates that in
the rare event that the adenovirus vaccine (the Oxford DNA vaccine) is
injected intravenously the virus particles trigger the platelets to form
blood clots. This can be avoided by simply pulling back on the syringe
when administering the vaccine (aspirating). If blood returns into the
syringe than the syringe has accidentally hit a blood vessel and the injection should NOT be given until a new needle is properly inserted. For a thorough
explanation of how this works this video by Dr Campbell is very helpful.
Pathologic Antibodies to Platelet Factor 4 after ChAdOx1 nCoV-19 Vaccination
"vaccination against SARS-CoV-2 remains critical for control of the
Covid-19 pandemic. A pathogenic PF4-dependent syndrome, unrelated to the
use of heparin therapy, can occur after the administration of the
ChAdOx1 nCoV-19 vaccine. Rapid identification of this rare syndrome is
important because of the therapeutic implications."
"VITT is a severe complication after ChAdOx1 nCoV-19 vaccination. Up-front treatment remains anticoagulation and IVIG. Although further validation is required, we suggest that therapeutic plasma exchange may be effective for the treatment of refractory VITT."
SARS-CoV-2 Vaccine–Induced Immune Thrombotic Thrombocytopenia
"The Journal has now highlighted three independent descriptions of 39 persons with a newly described syndrome characterized by thrombosis and thrombocytopenia that developed 5 to 24 days after initial vaccination with ChAdOx1 nCoV-19 (AstraZeneca), a recombinant chimpanzee adenoviral vector encoding the spike protein of SARS-CoV-2. These persons were healthy or in medically stable condition, and very few were known to have had previous thrombosis or a preexisting prothrombotic condition. Most of the patients included in these reports were women younger than 50 years of age, some of whom were receiving estrogen-replacement therapy or oral contraceptives. A remarkably high percentage of the patients had thromboses at unusual sites — specifically, cerebral venous sinus thrombosis or thrombosis in the portal, splanchnic, or hepatic veins. Other patients presented with deep venous thrombi, pulmonary emboli, or acute arterial thromboses. The median platelet counts at diagnosis were approximately 20,000 to 30,000 per cubic millimeter (range, approximately 10,000 to 110,000), but the rate of decline in platelet counts that preceded thrombosis is unknown. High levels of d-dimers and low levels of fibrinogen were common and suggest systemic activation of coagulation. Approximately 40% of the patients died, some from ischemic brain injury, superimposed hemorrhage, or both conditions, often after anticoagulation."
"Additional cases have now been reported to the European Medicines
Agency, including at least 169 possible cases of cerebral venous sinus
thrombosis and 53 possible cases of splanchnic vein thrombosis among 34
million recipients of the ChAdOx1 nCoV-19 vaccine, 35 possible cases of
central nervous system thrombosis among 54 million recipients of the
Pfizer–BioNTech mRNA vaccine, and 5 possible (but unvetted) cases of
cerebral venous sinus thrombosis among 4 million recipients of the
Moderna mRNA vaccine. Six possible cases of cerebral venous sinus
thrombosis (with or without splanchnic vein thrombosis) have been
reported among the more than 7 million recipients of the Johnson &
Johnson/Janssen Ad26.COV2.S adenoviral vector vaccine. It must be
emphasized that not all of these case reports have been subject to
rigorous central review, nor have results of tests for anti-PF4
antibodies been reported; however, these numbers may be underestimates,
since reporting is voluntary. Nevertheless, they clearly indicate the
need for maintaining a high level of concern when patients present with
central nervous system or abdominal symptoms after receiving any
SARS-CoV-2 vaccine."
Florida doctor's death after receiving COVID-19 vaccine sparks investigation
Dr Gregory Michael, a doctor in Florida, developed Immune Thrombocytopenia
(a rare disorder that limits clotting ability). He died of a
hemorrhagic stroke caused by this rare autoimmune disease. This disease
cam be triggered by several different viral infections.
Neurological Adverse Events
First Ever NIH/NIND Study on Vaccine Caused Neurological Injuries (Preprint)
Patient Interview - Neurological Issues After Vaccination
This
is an interview with a man who is a nurse practitioner and who has had
serious neurological side effects from taking a 2-dose mRNA vaccine
protocol. He developed parasthesias on his right side, mostly his right
arm, almost immediately after his first dose. As the symptoms
progressed he developed a very uncomfortable feeling in his right eye
and his ear became red and inflamed for several days. He received the
second shot, and after that developed severe tinnitus, POTS with very
pronounced tachycardia, and severe intractable insomnia. He says
basically his autonomic nervous system just didn't seem to work right.
He found that a low histamine diet helped as did a round of treatment
with a steroid. He later developed generalized neuropathies including
stinging and burning sensations. Testing of a skin biopsy showed signs
of Small Fiber Neuropathy developing.
The explanations that have been suggested include elevated cytokine levels (testing did show some for him), non-classical monocytes, C4D deposition at the blood barrier, MCAS (Mast Cell Activation Syndrome), glutamine storms,
A Chemist Describes His Wife's Major Adverse Reaction After Her COVID Vaccine | The Megyn Kelly Show
A
previously healthy 39yo woman took part in a vaccine trial for
AstraZeneca and experienced a number of significant adverse reactions
including neuropathy, sensitivity to light and sound, "drop foot" which
progressed to inability to walk, incontinence, sensory sensitivities
worsened to the point that she needed to wear ear muffs and dark glasses
when not in a quiet, dark room. She was seen at the "test clinic"
(vaccine trials, like many drug trials, are carried out through testing
sites hired for this purpose) but they offered no help. Her adverse
reaction was not included in the final results of the clinical trials.
She was eventually diagnosed at the NIH with a number of vaccine-induced
injuries. Because of her adverse neurological reactions to the first
dose of the vaccine, the group running the trial recommended that she
not receive the second dose. As in trials for other COVID 19 vaccines,
people enrolled in this study were given an app on their phone as the
only way to report adverse events. This app included only a list of
certain minor reactions such as pain at the injection site, fever,
muscle aches and pains, and a few more as options. There was no way for
trial participants to report other adverse reactions.
Unheard Concerns: Thousands blame COVID-19 vaccine for hearing problems
There
have been more than 10,000 reports of hearing problems, including
tinnitus and hearing loss, following vaccination for COVID 19. This is
recognized as real by many in the mainstream. The mechanism is not
known. Most affected people are getting better over time, sometimes
very slowly.
Eric Clapton's "Disastrous" Vaccine Experience
Mississippi man partially paralyzed, unable to talk after J&J vaccine | New York Post Paralyzed after 2nd COVID shot
Following
the second dose of Pfizer vaccine for a woman in Nashville with
epilepsy and who had already recovered from a previous COVID 19 infection.
Woman paralyzed 12 hours after first dose of Pfizer vaccine, doctors search for answers
Doctors: nervous system played a part, after being left paralyzed after first dose of Pfizer vaccine
(Appears to be same woman as in above report. Woman has no underlying medical conditions)
Woman's severe reaction to Pfizer COVID vaccine prompts investigation
Woman
in Louisiana with no underlying medical conditions develops convulsions
and seizure-like uncontrollable leg movements after receiving Pfizer
vaccine.
Woman describes reaction to Johnson & Johnson vaccine
Utah mom Kassidi Kurill dies four days after second dose of Moderna
Three more people die after receiving AstraZeneca vaccine in S. Korea