Side effect – Adverse event

Side effect, Adverse event

EudraVigilance – system for managing and analysing adverse reactions

Database links to the 4 main COVID-19 vaccinations

Moderna
Pfizer-BionTech
AstraZeneca
Janssen

https://www.adrreports.eu/en/eudravigilance.html

From 30 June 2022, it will be mandatory to report side effects to EudraVigilance using a data format based on international standards set by the International Organization for Standardization (ISO). This will help increase the data quality and analytical capabilities in EudraVigilance.

VAERS COVID Vaccine Myo/Pericarditis Reports

https://openvaers.com/covid-data/myo-pericarditis


The OpenVAERS Project:
VAERS is the Vaccine Adverse Event Reporting System put in place in 1990. It is a voluntary reporting system that has been estimated to account for only 1% ( see the Lazarus Report) of vaccine injuries. OpenVAERS is built from the HHS data available for download at vaers.hhs.gov.

The OpenVAERS Project allows browsing and searching of the reports without the need to compose an advanced search (more advanced searches can be done at medalerts.org or vaers.hhs.gov).

OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality. https://openvaers.com/openvaers

Pfizer BNT162b2 – Cumulative Analysis of Post-authorization Adverse Event Reports

https://i-do-not-consent.netlify.app/media/5.3.6-postmarketing-experience.pdf

https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf

Increased emergency cardiovascular events among under-40 population
Side effect – Adverse event

Published:  Increased emergency cardiovascular events among under-40 population in Israel during vaccine rollout and third COVID-19 wave.

More recently, several studies established probable causal relationship between the messenger RNA (mRNA) vaccines of BNT162b2 and mRNA-127311,14,15,16 as well as adenovirus (ChAdOx1) vaccines17 with myocarditis, primarily in children, young and middle-age adults.

The study by the Ministry of Health in Israel, a country with one of the highest vaccination rates in the world, assesses the risk of myocarditis after receiving the 2nd vaccine dose to be between 1 in 3000 to 1 in 6000 in men of age 16–24 and 1 in 120,000 in men under 3011,12,13.

A follow up study by the US Center of Disease Control (CDC) based on the VAERS and V-Safe self-reporting systems18 further confirms these findings19.

The CDC has recently posted a warning regarding a vaccine-related risk of myocarditis, but still maintained their recommendation to vaccinate young individuals and children over 127.

Similar concerns are reflected in the recent Food and Drug Administration approval to the Pfizer vaccine that requires several follow studies on the short and long terms effects of myocarditis in young individuals20.


1,000 scientific studies on serious adverse effects of anti-Covid vaccines.

Professor Luc Montagnier, a virologist who was awarded the Nobel Prize in Medicine for the discovery of AIDS, was invited to the Luxembourg Parliament on Wednesday 12 January 2022 to speak about the vaccine. Geneticist Alexandra Henrion Caude was also present.

The video of Montagnier’s speech to the Luxembourg Parliament was hosted on You Tube but was deleted in less than a minute. Now the social media giants are apparently acting anti-democratically and in cooperation with Big Pharma and the governments.

https://www-direktdemokratisch-jetzt.translate.goog/linksammlung/?_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=nl&_x_tr_pto=wapp

Decoding COVID-19 mRNA Vaccine Immunometabolism in Central Nervous System

Posted March 02, 2022. doi: https://doi.org/10.1101/2022.03.02.482639

Abstract
The paper presents the effect of COVID-19 mRNA (Pfizer/BioNT) vaccine on in vitro glial cells of the brain studied by means of Raman spectroscopy and imaging.. The results obtained for human brain normal and tumor glial cells of astrocytes, astrocytoma, glioblastoma incubated with the Covid-19 mRNA vaccine Pfizer/BioNT vaccine show alterations in the reduction-oxidation pathways associated with Cytochrome c.

We found that the Pfizer/BioNT vaccine down regulate the concentration of cytochrome c in mitochondria upon incubation with normal and tumorous glial cells.

Concentration of oxidized form of cytochrome c in brain cells has been shown to decrease upon incubation the mRNA vaccine. Lower concentration of oxidized cytochrome c results in lower effectiveness of oxidative phosphorylation (respiration), reduced apoptosis and lessened ATP production. Alteration of Amide I concentration, which may reflect the decrease of mRNA adenine nucleotide translocator. Moreover, mRNA vaccine leads to alterations in biochemical composition of lipids that suggest the increasing role of signaling.

mRNA vaccine produce statistically significant changes in cell nucleus due to histone alterations.
The results obtained for mitochondria, lipid droplets, cytoplasm may suggest that COVID-19 mRNA (Pfizer/BioNT) vaccine reprograms immune responses.

The observed alterations in biochemical profiles upon incubation with COVID-19 mRNA in the specific organelles of the glial cells are similar to those we observe for brain cancer vs grade of aggressiveness.

New-onset autoimmune phenomena post-COVID-19 vaccination

First published: 27 December 2021 https://doi.org/10.1111/imm.13443

Recently, new-onset autoimmune phenomena after COVID-19 vaccination have been reported increasingly (e.g. immune thrombotic thrombocytopenia, autoimmune liver diseases, Guillain–Barré syndrome, IgA nephropathy, rheumatoid arthritis and systemic lupus erythematosus). Molecular mimicry, the production of particular autoantibodies and the role of certain vaccine adjuvants seem to be substantial contributors to autoimmune phenomena.

However, whether the association between COVID-19 vaccine and autoimmune manifestations is coincidental or causal remains to be elucidated. Here, we summarize the emerging evidence about autoimmune manifestations occurring in response to certain COVID-19 vaccines. 

Dr Jessica Rose – FDA Public hearing Session

September 2021 – Vaccines and related Biological Products Advisory Committee

“There’s an over 1000% increase in the total number of adverse events just for 2021 and we are not done with 2021 … In my opinion [the risks] outweigh any potential benefits…with these products, especially in children.”

https://www.youtube.com/watch?v=WFph7-6t34M&t=14984s
Myocarditis Adverse Events in VAERS in Association with COVID-19 Injectable Biological Products

October 1, 2021 – Following the global rollout and administration of the Pfizer Inc./BioNTech BNT162b2 and Moderna mRNA-1273 vaccines on December 17, 2020, in the United States, and of the Janssen Ad26.COV2.S product on April 1st, 2021, in an unprecedented manner, hundreds of thousands of individuals have reported adverse events (AEs) using the Vaccine Adverse Events Reports System (VAERS). We used VAERS data to examine cardiac AEs, primarily myocarditis, reported following injection of the first or second dose of the COVID-19 injectable products.

Myocarditis rates reported in VAERS were significantly higher in youths between the ages of 13 to 23 (p<0.0001) with ∼80% occurring in males. Within 8 weeks of the public offering of COVID-19 products to the 12-15-year-old age group, we found 19 times the expected number of myocarditis cases in the vaccination volunteers over background myocarditis rates for this age group. 

As of May 18th, 2021, 600,000 children aged 12-15 had been injected with COVID-19 products3 .
The CDC estimated that 3,430,741 children aged 12-15 have received at least one dose of the COVID-19 products as of June 7th, 2021.

Since 1 per 100,000 children per year are affected by myocarditis then, statistically, we would expect ∼5 myocarditis cases if we calculate the expected number of cases using the June 7th CDC sample.

To date (up to and including July 2nd, 2021), 97 children aged 12-15 have had reports submitted to VAERS representing 17.4% of all myocarditis reports – and these are merely the cases that we are aware of. Thus, after 8 weeks of roll-out into the 12-15 years-old age group, we are at ∼19 times the expected number of cases within this sample.

Thus, the number of VAERS-reported cases far outnumber what would typically be expected to date. It is important to note that of the 559 myocarditis VAERS reports, 6 died (1.1%) and 33% of these deaths were in individuals under 20 years of age: 1 individual was 13 and one was 19 years of age. https://doi.org/10.1016/j.cpcardiol.2021.101011

Autopsy Histopathologic Cardiac Findings in Two Adolescents Following the Second COVID-19 Vaccine Dose

Feb 14, 2022

Context: – Myocarditis in adolescents has been diagnosed clinically following the administration of the second dose of an mRNA vaccine for coronavirus disease 2019 (COVID-19).

Objective: – To examine the autopsy microscopic cardiac findings in adolescent deaths that occurred shortly following administration of the second Pfizer-BioNTech COVID-19 dose to determine if the “myocarditis” described in these instances has the typical histopathology of myocarditis.

Design: – Clinical and autopsy investigation of two teenage boys who died shortly following administration of the second Pfizer-BioNTech COVID-19 dose.

Results: – The microscopic examination revealed features resembling a catecholamine-induced injury, not typical myocarditis pathology.

Conclusions: – The myocardial injury seen in these post-vaccine hearts is different from typical myocarditis and has an appearance most closely resembling a catecholamine-mediated stress (toxic) cardiomyopathy. Understanding that these instances are different from typical myocarditis and that cytokine storm has a known feedback loop with catecholamines may help guide screening and therapy.

https://pubmed.ncbi.nlm.nih.gov/35157759/

Severe Autoimmune Hemolytic Anemia Following Receipt of SARS-CoV-2 mRNA Vaccine

22 September 2021
Reports have emerged of autoimmune phenomena, including vaccine-associated myocarditis, immune thrombocytopenia, and immune thrombotic thrombocytopenia. 

Here we present a novel case of a young woman who developed life-threatening autoimmune hemolytic anemia (AIHA) after her first dose of a SARS-CoV-2 mRNA vaccine.

https://onlinelibrary.wiley.com/doi/10.1111/trf.16672

(COVID-19) mRNA Vaccine Can Induce Acute Myopericarditis in Mouse Model

Post-vaccination myopericarditis is reported after immunization with coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccines. The effect of accidental intravenous injection of this vaccine on the heart is unknown.

This study provided in vivo evidence that inadvertent intravenous injection of COVID-19 mRNA vaccines may induce myopericarditis. Brief withdrawal of syringe plunger to exclude blood aspiration may be one possible way to reduce such risk.

https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab707/6353927

Dr Malone, distribution of S-Protein throughout the body

Dr. Robert Malone, creator of mRNA vaccine technology:

The free Protein is a different story that comes out from Harvard and Brigham, and they did a a study of vaccinated nurses. So it’s pretty much an unimpeachable source! What that study showed, was that the vast majority had expression in circulation of free spike protein in their blood. They were all verified to not have been infected by SARS.-COV-2; it didn’t come from the virus. Infection came from vaccine !!

As somebody who spent a large fraction of their career trying to develop non viral gene therapy with both RNA and DNA. I was gobsmacked by the levels of protein, it appears that it’s a tip of the iceberg.

I’m sorry it didn’t work; we have a phenomena that we didn’t expect wasn’t predicted, but there it is. That’s the nature of science and evidence based medicine that we have to deal with it.

A dire warning from Dr. Charles Hoffe (blood clots)

A short summary of te video below:

We now know that only 25% of the injected mRNA actually stays in your arm and the other 75% is literally collected by your lymphatic system and fed into your circulation. So these little packages of messenger RNA, and by the way, in a single dose of a moderna vaccine, there are 40 trillion messenger RNA Molecules, 14 trillion that are injected into your arm. So 3/4 are taken by the lymphatics. Then go into your bloodstream. Obviously when something’s in circulation, the only cells that they’re going to get absorbed into is the cells around your blood vessels and the place where absorption happens is in the capillary networks.

The most alarming thing about this is that there are some parts of your body like your heart and your brain and your spinal cord and your lungs which cannot regenerate when those tissues are damaged, they are permanently damaged.

So on the basis of this D dimer test, which proves that the majority of people are clotting. These people, who now have reduced effort tolerance, literally what’s happened to them as they’ve plugged up thousands of tiny capillary’s in their lungs. The terrifying thing about this is not just that these people are now short of breath and can’t do what they used to be able to do, but once you block off a significant number of blood vessels through your lungs, your heart is now pumping up against a much greater resistance to try and get the blood through your lungs. And the problem that causes a condition called culinary artery hypertension. It’s like blood pressure, high blood pressure in your lungs because the blood can’t get through because so many of the vessels are blocked.

Like all these young people who are now getting myocarditis from these shots. They have permanently damaged hearts. It doesn’t matter how mild it is, they will not be able to do what they used to be able to do because heart muscle does not regenerate.
This is the terrifying concern and not only is the long term outlook very grim but with each successive shot, the damage will add and add. It’s going to be cumulative because you’re progressively getting more and more damaged.

Vaers reporting by the National Vaccine Information Center

Link to the Vaers reporting analysis

July 12, 2021 Janssen Biotech, Inc. letter to the FDA

Thrombosis with Thrombocytopenia
The reporting rate of thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine has been highest in females ages 18 through 49 years; some have been fatal.

Guillain-Barré Syndrome
Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.

OVERALL SAFETY SUMMARY
“Severe allergic reactions (including anaphylaxis), thrombosis with thrombocytopenia, Guillain-Barré syndrome, and capillary leak syndrome have been reported following administration of the Janssen COVID-19 Vaccine during mass vaccination outside of clinical trials.

Temporal relation between 2nd dose BNT162b2 mRNA Covid-19 vaccine and cardiac involvement

Although these vaccines can counteract the COVID-19 pandemic, there is apprehension for patients who experienced previous SARS-COV-2 infection, as these subjects have not been tested in the trials [5]. Systemic reactogenicity, leading to systemic adverse events often occurred after dose 2 and within 2 days after vaccination [5]. The present report describes a case of cardiac involvement in a patient with previous SARS-COV-2 infection within days of the second dose of BNT162b2 mRNA vaccine.

An otherwise healthy 56-year-old man presented to the emergency department complaining of acute onset of chest pain 3 days after the second dose of BNT162b2 mRNA COVID-19 vaccine. He did not report fever, systemic symptoms or cutaneous rash after the first and second dose of the vaccine. He had no history of allergy. Nine months earlier he experienced mild signs of COVID-19 infection with fever lasting for 3 days and cough for 1 week, but he did not complain of chest pain or dyspnea. He was not hospitalized, and he took only acetaminophen. Nasopharyngeal swabs by real-time reverse-transcriptase–polymerase-chain-reaction (rRT-PCR) assay, had been persistently positive for 1 month while he did not undergo any blood tests during that period. One month later, anti-SARS-COV-2 serology demonstrated presence of IgG anti S1 and S2 proteins (titer of 60 AU/mL with positive threshold above 15).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8011690/

COVID-19 vaccine AstraZeneca analysis print

All UK spontaneous reports received between 4/01/21 and /21 for COVID-19 vaccine Oxford University/AstraZeneca. 103 pages
Report Run Date: 13-May-2021
Data Lock Date: 12-May-2021 18:30:08

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/982499/S1208_CO-CIN_report_on_impact_of_vaccination_Apr_21.pdf
Side- and Adverse effects Articles December 2020

Dec 21: Suspicions grow that nanoparticles in Pfizer’s COVID-19 vaccine trigger rare allergic reactions
Severe allergy-like reactions in at least eight people who received the COVID-19 vaccine produced by Pfizer and BioNTech over the past 2 weeks may be due to a compound in the packaging of the messenger RNA (mRNA) that forms the vaccine’s main ingredient, scientists say. A similar mRNA vaccine developed by Moderna, which was authorized for emergency use in the United States on Friday, also contains the compound, polyethylene glycol (PEG). Full article online

Dec 20: CDC Issues New Guidelines, Launches Probe After 1000s Negatively-Affected Following COVID-19 Vaccination.
Thousands of people have been unable to work or perform daily activities, or required care from a healthcare professional, after getting the new COVID-19 vaccine, according to new data from the Centers for Disease Control and Prevention (CDC).
As of Dec. 18, 3,150 people reported what the agency terms “Health Impact Events” after getting vaccinated.
The definition of the term is: “unable to perform normal daily activities, unable to work, required care from doctor or health care professional.” Full article online.

Dec 19: FDA investigating five allergic reactions after Pfizer shot in U.S
Michael Erman NEW YORK (Reuters)
The U.S. Food and Drug Administration is investigating around five allergic reactions that happened after people were administered Pfizer Inc and BioNTech SE’s COVID-19 vaccine in the United States this week, a top FDA official said late on Friday.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at a press conference that the allergic reactions had been reported in more than one state, including in Alaska

Marks also said that a chemical called polyethylene glycol (PEG) that is an ingredient in the Pfizer vaccine – as well as the Moderna Inc vaccine authorized on Friday – “could be the culprit” causing the reactions.

Marks said that allergic reactions to PEG could be somewhat more common than previously understood. The cases in Alaska were similar to two cases reported last week in Britain.
Britain’s medical regulator has said that anyone with a history of anaphylaxis, or severe allergic reactions to a medicine or food, should not be given the Pfizer-BioNTech COVID-19 vaccine.

But the U.S. Food and Drug Administration has said that most Americans with allergies should be safe to receive the vaccine. It said only people who have previously had severe allergic reactions to vaccines or ingredients in this particular vaccine should avoid getting the shot.

On Friday, the FDA said the Moderna vaccine should not be given to individuals with a known history of a severe allergic reactions to any components of the shot.

The regulator is also requiring that appropriate medical treatments for immediate allergic reactions must be available when the shot is administered in case of an anaphylactic reaction.

Pfizer could not be immediately reached for comment.
Reporting by Michael Erman; Editing by Diane Craft and Daniel Wallis
https://www.reuters.com/article/us-health-coronavirus-vaccines-fda/fda-investigating-five-allergic-reactions-after-pfizer-shot-in-u-s-idUSKBN28T05J

Dec 16: Alaska healthcare worker with no history of drug allergies suffered serious ‘anaphylactic-like’ reaction
The worker allegedly had no history of allergies to any medication but it’s unknown if he or she had any other allergies.
The allergic reaction is believed to be similar to the anaphylactic-like reactions suffered by two healthcare workers in Great Britain, both whom have since recovered, after they were given the Pfizer-BioNTech SE vaccine.
https://www.dailymail.co.uk/health/article-9060697/Alaska-healthcare-worker-suffered-allergic-reaction-Pfizers-coronavirus-vaccine.html

Dec 12: French Expert Shocked By Number Of Adverse Reactions To COVID-19 Vaccine
“Not only is there a lack of information, but these injections based on genetic material (messenger RNA) have never passed the commercialization stage until now,” Caumes said. “Perhaps they are revolutionary, but I want proof of their reliability, otherwise it is tantamount to placing blind trust in industry.”
https://principia-scientific.com/french-expert-shocked-by-number-of-adverse-reactions-to-covid-19-vaccine/

Dec 10: As the United Kingdom started inoculating people with the coronavirus vaccine developed by Pfizer-BioNTech, four volunteers who were administered the vaccine in the trial stage developed Bell’s palsy, according to US Food and Drug Administration (FDA) regulators. Bell’s palsy is a form of temporary facial paralysis.
https://zeenews.india.com/world/covid-19-four-pfizer-vaccine-volunteers-develop-bells-palsy-read-details-here-2329924.html

UK Government officials are calling for calm after it emerged that several health workers have suffered an “anaphylactoid reaction” after receiving the Pfizer COVID-19 vaccine.British scientists attempted to quash public panic about the Pfizer/BioNTech following reports that two NHS staff suffered an adverse reaction just after being immunized this week.
https://neonnettle.com/news/13530-uk-health-workers-suffer-anaphylactoid-reaction-after-pfizer-s-covid-19-vaccine

Pfizer BioNtech Study: Vaccine has adverse event risks.
One cannot stress how untested this vaccine is. How the FDA would approve this against the known risks of COVID-19, which are very low (under 0.2%), but for a specific population with comorbidity issues that impact them for every flu season (approximately 5%). These people are, in totality, over 55, that have been most impacted (90%+ of U.S. Deaths).
https://dcfpress.com/pfizer-biontech-study-vaccine-has-adverse-events-risks/

Dec 9: Six people died in Pfizer’s late-stage trial of the COVID-19 vaccine, the US Food and Drug Administration has revealed just hours after Britain became the first country in the world to roll out the vaccine.
https://thenewdaily.com.au/news/coronavirus/2020/12/09/pfizer-oxford-astrazeneca-vaccines/

BOMBSHELL: More Death and Fever from Pfizer Vaccine than Covid
The FDA briefing document on the Pfizer-BioNTech COVID-19 vaccine contains some stunning information, including the revelation that most people are hundreds of times more likely to have an adverse reaction from their vaccine than they are to die from covid.
On Page 41 of the report, we can see a description of the Serious Adverse Events including 6 deaths and 12 cases of appendicitis. In total 0.6% of participants reported a Serious Adverse Events from the Covid Vaccine – 100 TIMES HIGHER THAN THE PROBABILITY OF DEATH FROM COVID (for under 60’s)
https://axisworldnews.com/2020/12/09/bombshell-more-die-from-vaccine-in-pfizer-trial-than-from-covid/

Dec 8: COVID-19 vaccine trial participants said they experienced intense symptoms and warned of possible “adverse effects” as novel coronavirus cases continue to surge across the U.S.
The U.S. Food and Drug Administration released a report Tuesday that said Pfizer and BioNTech’s COVID-19 vaccine candidate is safe and effective against the virus. The FDA also noted that while side effects were common, they have yet to identify the Pfizer vaccine’s safety concerns.
https://www.ibtimes.com/coronavirus-vaccine-side-effects-trial-participants-warn-intense-symptoms-possible-3097884