The document below is from Dr. Alexandra Henrion-Claude website https://www.pause2think.org/EN/lettercarcinogenicityprogress.html
Subject - Pressing need for mRNA vaccines' urgent carcinogenicity and genotoxicity studies
To whom it may concern,
Abstract
We doctors and scientists from different countries and different backgrounds, signatories of this letter, are making a call to anyone in a position to request, require, mandate, decide or conduct carcinogenicity studies that have become essential and urgent. We offer this letter to health agencies, judges, lawyers, laboratories, universities or anyone in a position to make such independent studies happen.
We understand this letter may be used in a court of law and are willing to provide explanations upon request.
We are guided by scientific findings and the desire for safety of our fellow citizens. Such studies would enlighten the medical and scientific community about the risks and their amplitude, and would guide us to organize eventual early screening, mitigation actions and possible anticipation of dangers and their solutions.
In this letter we explain why such SAFETY studies are needed, given ongoing massive vaccination campaigns. We also explain why new findings increase cause for concern. As such, it has become an absolute urgent necessity to conduct such studies.
We have found cause for concern and require these studies to anticipate how large and how serious the risks may be, since no scientist or wise person can claim to know the future. Thus we need this information to prepare eventual mitigation scenarios and minimize impacts on peoples' health; to provide screening and protection to the vaccinated.
Given the stakes, such studies are a very small price to pay, to mitigate eventual consequences.
1) Safety studies including carcinogenicity studies need to be conducted for a new intervention, using 2 new technologies (Lipidic Nano Particles and mRNA), for a new virus, on an immensely large population in a repetitive manner
In relation to the Covid pandemic, new vaccines have been created in a record time. Two such vaccines rely on a novel mRNA technology used for the first time in the area of vaccination. They are NEW technologies directed against a NEW virus. Urgency and high emotional stress has led to the application of NEW processes and NEW rules particularly in safety assessment. Rapid deployment has led to creation of NEW setups in manufacturing, conservation and delivery.
Such multiple NOVELTIES have led Pfizer and Moderna (manufacturers) to require and be granted immunity against legal action related to safety issues that may arise later. Urgency and high emotional stress may explain why governments have accepted these changes in usual safety processes and granted such immunity to manufacturers. We question strenuously the manufacturers’ insistence on being given medicolegal immunity from any and all proceedings that might arise from the delivery of such injections of unknown consequences in the next months or years.
Medical agencies 1 2, have relied on a document from the World Health Organization dated 2005 stating « Carcinogenicity studies are not required for vaccine antigens. However, they may be required for particular vaccine components such as novel adjuvants and additives »3 This WHO document refers to vaccination technologies that had been evaluated multiple times and
existed before novel mRNA vaccination and new associated unknown risks..
That same 2005 document defines adjuvants as being « Substances that are intended to enhance relevant immune response and subsequent clinical efficacy of the vaccine. »
Pfizer's website explains mRNA vaccination as follows « mRNA, delivered to your body's cells by lipid nanoparticles, instructs the cells to generate the spike protein found on the surface of the novel coronavirus that initiates infection.1,2 Instructing cells to generate the spike protein spurs an immune response, including generation of antibodies specific to the SARS-CoV-2 spike protein »4
For example the European Medicines Agency (EMA) recommendation states 5
"The objective of this guideline is to define the conditions under which carcinogenicity studies, should be conducted to avoid the unnecessary use of animals in testing..."
"The fundamental considerations in assessing the need for carcinogenicity studies are the maximum duration of patient treatment and any perceived cause for concern arising from other investigations. Other factors may also be considered such as the intended patient population, prior assessment of carcinogenic potential, the extent of systemic exposure, the (dis)similarity to endogenous substances, the appropriate study design, or the timing of study performance relative to clinical development."
"Certain classes of compounds may not be used continuously over a minimum of 6 months but may be expected to be used repeatedly in an intermittent manner." In this regard, the hypothesis emitted by the vaccine developers suggesting that there will be a need for ‘booster’ vaccinations on a yearly or even more frequent basis argues that carcinogenicity concerns, based on repeated exposure, are valid.
"For pharmaceuticals developed to treat certain serious diseases, carcinogenicity testing need not be conducted before market approval although these studies should be conducted post- approval. This speeds the availability of pharmaceuticals for life-threatening or severely debilitating diseases, especially where no satisfactory alternative therapy exists." Carcinogenicity studies must be conducted as an urgent matter. After carcinogenicity studies are properly conducted with the right animal models, with a reassuring outcome, post approval phase 4 may begin. It must also be considered that COVID 19 does not meet the definition of “ life-threatening or severely debilitating diseases” 6 7 8for vast portions of the population such as those already immune, young people, and middle age healthy people. As a sidenote, although agencies are hesitant, multiple(?) re- purposed drug therapy is being used de facto worldwide with documented success on vulnerable population.
Contrary to what was announced initially, biodistribution reports indicate systemic exposure as they show distribution in liver, adrenal glands, spleen, blood, bone marrow and ovaries for Pfizer9 as well as liver, adrenal glands, heart, eye, kidneys, testis, blood, bone marrow and brain for Moderna10 More elements have come to light confirming such wide distribution of nanoparticles into the body, their persistence with embedded mRNA and subsequent production of spike protein both from possibly leaked Japanese authorities and studies. 11
This was foreseeable, as the new lipid nanoparticles (LNP) were designed initially in medicine for mass bio-distribution. They are used in medicine to deliver/transport drugs to distant sites in the body for cancer treatment, as well as other treatments. Their core function is to reach distant tissues. As expected, Nanoparticles, embedded RNA, and subsequent production of spike protein spreads into multiple organs. These biodistribution findings differ from what has been known about
previous vaccines and substances staying at the injection site. This alone is sufficient to require at the very least immediate extensive carcinogencity studies.
Booster, repeated vaccination is being suggested after 6 months or a year repeatedly for populationsSuch repetition further strengthens the absolute necessity of such studies. 12
Use of recent technology and new mechanisms require more testing to better apprehend associated risks, and if necessary, to put in place actions to mitigate them.
Precautionary principle requires that such studies be fully performed, preferably by independent groups, so that results can be trusted by scientists and the public.
If full safety is confirmed, this would be reassuring for all, and if there are risks identified, particularly from the carcinogenicity studies, it would allow for early screening and treating those at risk.
In addition to necessity for public safety at a moderately low cost, out of precaution, such studies done concurrently to ongoing EUA would also provide additional scientific benefits related to future use of such technologies indicating which risks need further exploration.
These arguments in themselves justify for an urgent need to mandate [EMA] to perform or at least require such studies, particularly the carcinogenicity one.
As covid vaccination is progressing, in many countries, deployment of such vaccinations have been explained by urgency due to an ongoing epidemic. In that context, safety assessment procedures were altered with the promise that full extended safety studies would be carried out concurrently instead of linearly. EUA's were granted and people have been vaccinated, trusting that all safety procedures have been completed or are in progress.
Nothing can justify betraying such trust and skipping or delaying further safety studies altogether to avoid possible injurious outcome or responsibility allocation. Yet, medicines agencies have not required genotoxicity and carcinogenicity studies.13 14
Several findings raise cause for concern and indicate multiple emerging mechanisms by which these mRNA vaccines could cause, induce or lead to an increased risk of cancer.
As mentioned above, need for carcinogenicity studies has become all more pressing given that systemic exposure has been shown from pharmacokinetics and biodistribution studies. LNP with embedded mRNA reach multiple organs such as [liver, adrenal glands, spleen, ovaries, heart, eye, kidneys, testis, bone marrow and brain].
Scientific findings beg the implementation of safety studies to help reassure the public and scientific community and to potentially organize mitigation actions in such massive vaccination, based on the findings of such studies.
1. That spike protein has been shown to interact with p53 protein which has been shown to be involved in multiple cancers possibly up to 50% of cancers.15 16Much knowledge is still needed as to understanding how much spike protein is produced, for how long, and in which organs ? Differences in interactions need to be understood when the spike protein is present alone, as with mRNA, compared to when attached to a virus, as happens naturally or with adenovirus vaccines. Spike protein has been seen to freely circulate in the blood stream possibly up to 29 days after injection 17
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A preprint from the Radboud University Netherlands, the Hannover medical school Germany and the University of Bonn Germany finds that the Pfizer vaccine may result in changes to innate immunity.18 Innate immunity plays an important role in cancers 19 20
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The spike protein is a known toxin. 21 22 23 24And in relation to this, we know that following injection, the vehicles carrying the mRNA that encode for the spike protein are heterodispersed throughout the body as shown by the above-mentioned biodistribution studies shared by manufacturers with European and Japanese authorities. This leads to the production of free spike protein at levels that would never be seen in patients with natural SARS CoV-2 infection. Moreover, the toxic effects of the spike protein can now be produced, by passing the blood-brain barrier of the mRNA-containing nanolipid structures within the brain. However, in opposition to the claims made by the manufacturers, the spike protein encoded by vaccinal mRNA does not remain bound to the cell membranes, and can be found freely in the bloodstream, which exposes the vaccinated person to an even more protracted attack from spike protein. It has also been shown that nanoparticles containing mRNA seem to reach multiple organs, including the liver, testis, ovaries and bone marrow, possibly leading to spike protein production and causing cancers25 26.
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Human and viral reverse transcriptases are families of enzymes that allow the creation of segments of DNA from RNA so the DNA can be encoded within the human genome. We have evidence that RNA coding for SARS-CoV-2 major proteins could be reverse transcribed into human DNA in several different ways, some of which are known and some are to be discovered.27 28 29 30Given this evidence, that reverse transcription happens, and given the immense size of the healthy young population being vaccinated in a short period of time, downstream changes to the Human genome could have unwanted effects31 including oncogenic ones.32 We also note that if the DNA encoding for spike protein is taken up into the Human genome, and is incorporated downstream of an active promotor region, production of this toxic protein could increase the risk for several disorders, ranging from cancer to cardiovascular disease.
1) New LNP, 2) New mRNA vaccination, 3) Systemic exposure, 4) Immense intended population, 5) Repeated use. Any single one of these elements would alone suffice to require immediate safety carcinogenicity studies. 6) Spike protein interacting with P53, 7) Suspicion of altering innate immunity, 8) Free spike toxin reaching organs 9) Risks of integration. Each would be sufficient cause for concern for an immediate carcinogenicity study. Taken together, they lead us signatories of this letter to make this urgent, essential call for these safety studies to be conducted IMMEDIATELY, THOROUGHLY and INDEPENDENTLY to handle an unprecedented situation.
For all above-mentioned reasons, we call upon anyone who has the authority to request, mandate, order or undertake all steps to make sure all such studies, using the same substances as for humans, reproducing methods and frequency of administration, and ensuring these studies are performed as per best practices as indicated in attached guidelines33 preferably by independent bodies. Such studies should be conducted with the same substances injected in humans and reproduce booster doses on two appropriate animal models having similar ACE2 receptors as humans, such as ferrets, minks or golden hamsters. We understand that only humans can give safety on humans, but until that happens during phase 4 with proper scrutiny, carcinogenicity studies give us indications on risk amplitude and where to pay attention for early screening, mitigation and treatment actions. We also request that raw data be made available and public in a continuous transparent manner.
This is all the more essential ethically 34 35 36 37, as vaccination is being carried out on a very large scale, in healthy populations at negligible risk of severe disease or in covid recovered patients who were explicitly excluded from Moderna and Pfizer 38 39 trials and have no benefit. They could face
months or years of deadly or severely debilitating adverse events in addition to already known short-term inflammatory, circulatory, nervous, and allergic serious adverse events.
With much needed humility, and safety studies, we could collectively spare innumerable lives, and the health of many more individuals.
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1 https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s-1-need-carcinogenicity-studies- pharmaceuticals-step-5_en.pdf
Eurpoean Medicines Agency EMA July 1996 -
2 Public Assessment Report Authorisation for Temporary Supply COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA)
Medicines & Healthcare Regulatory Agency (MHRA) https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/944544/COVID- 19_mRNA_Vaccine_BNT162b2__UKPAR___PFIZER_BIONTECH__15Dec2020.pdf
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3 WHO guidelines on nonclinical evaluation of vaccines Annex 1
WHO Technical Report Series, No. 927, 2005 https://www.who.int/biologicals/publications/trs/areas/vaccines/nonclinical_evaluation/ANNEX %201Nonclinical.P31-63.pdf?ua=1 -
4 https://www.pfizer.com/news/hot-topics/the_facts_about_pfizer_and_biontech_s_covid_19_vaccine Accessed 14/06/2021
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5 https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s-1-need-carcinogenicity-studies- pharmaceuticals-step-5_en.pdf
Eurpoean Medicines Agency EMA July 1996 -
6 https://www.lawinsider.com/dictionary/life-threatening-condition Accessed June 22nd 2021
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7 https://medical-dictionary.thefreedictionary.com/severely+debilitating+illness Accessed June 22nd 2021
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8 https://www.lawinsider.com/dictionary/debilitating-medical-condition Accessed June 22nd 2021
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9 https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf
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10 https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-moderna-epar-public-assessment-
report_en.pdf
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11 Ogata AF et al.
Circulating SARS-CoV-2 Vaccine Antigen Detected in the Plasma of mRNA-1273 Vaccine Recipients Clinical Infectious Diseases May 2021
https://doi.org/10.1093/cid/ciab465 -
12 https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-study-part-broad- development
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13 EMA
https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf
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14 EU Risk management plan Moderna
EU Risk Management Plan for COVID-19 mRNA vaccinecovid-19-vaccine-moderna-epar-risk-management-plan_en.pdf (europa.eu)
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15 Nishant Singh et al.
S2 subunit of SARS-nCoV-2 interacts with tumor suppressor protein p53 and BRCA: an in silico study Translational Oncology Elsevier October 2020
https://doi.org/10.1016/j.tranon.2020.100814 -
16 Liz J. Hernández Borrero, Wafik S. El-Deiry,
Tumor suppressor p53: Biology, signaling pathways, and therapeutic targeting, Biochimica et Biophysica Acta (BBA) - Reviews on Cancer, 2021 https://doi.org/10.1016/j.bbcan.2021.188556 -
17 Ogata AF et al.
Circulating SARS-CoV-2 Vaccine Antigen Detected in the Plasma of mRNA-1273 Vaccine Recipients Clinical Infectious Diseases May 2021
https://doi.org/10.1093/cid/ciab465 -
18 Konstantin Fohse F et al.
The BNT162b2 mRNA vaccine against SARS-CoV-2 reprograms both adaptive and innate immune responses medRxiv May 2021
doi: https://doi.org/10.1101/2021.05.03.21256520 -
19 Jinushi M
OncoImmunology 2012
The role of innate immune signals in antitumor immunity https://doi.org/10.4161/onci.1.2.18495 -
20 Corrales L et al.
Innate immune signaling and regulation in cancer immunotherapy immunotherapy. Cell 2017
https://doi.org/10.1038/cr.2016.149
-
21 Tanmay S et al.
Is SARS-CoV-2 Spike glycoprotein impairing macrophage function via α7-nicotinic acetylcholine receptors? Food and Chemical Toxicology 2021
https://doi.org/10.1016/j.fct.2021.112184 -
22 Lei Y et al.
SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2 Circulation research March 2021
https://doi.org/10.1161/CIRCRESAHA.121.318902 -
23 Buzhdygan TP et al.
The SARS-CoV-2 spike protein alters barrier function in 2D static and 3D microfluidic in-vitro models of the human blood–brain barrier
Neurobiology of disease December 2020
https://doi.org/10.1016/j.nbd.2020.105131 -
24 Rhea EM et al.
The S1 protein of SARS-CoV-2 crosses the blood–brain barrier in mice Nature Neuroscience December 2020 https://doi.org/10.1038/s41593-020-00771-8 -
25 Singh N et al
Inflammation and cancer
Ann Afr Med [serial online] 2019 DOI: 10.4103/aam.aam_56_18 -
26 Coussens, L., Werb, Z. Inflammation and cancer.
Nature 420, 860–867 (2002). https://doi.org/10.1038/nature01322 -
27 Geuking M B et al
Recombination of Retrotransposon and Exogenous RNA Virus Results in Nonretroviral cDNA Integration Science Jan 2009
DOI: 10.1126/science.1167375 -
28 Belyi V et al.
Unexpected inheritance: multiple integrations of ancient bornavirus and ebolavirus/marburgvirus sequences in vertebrate genomes
PLOS PATHOG July 2010
DOI: 10.1371/journal.ppat.1001030 -
29 Chandramouly G et al.
Pol reverse transcribes RNA andpromotes RNA-templated DNA repair Science Advances Jun 2021:
DOI: 10.1126/sciadv.abf1771 -
30 Zhang L et al.
SARS-CoV-2 RNA reverse-transcribed and integrated into the human genome BioRxiv December 2020
https://doi.org/10.1101/2020.12.12.422516 -
31 Ming-Hsiang L M
Somatic APP gene recombination in Alzheimer’s disease and normal neurons Nature 2018
https://doi.org/10.1038/s41586-018-0718-6 -
32 Sigal A et al.
Oncogenic Mutations of the p53 Tumor Suppressor: The Demons of the Guardian of the Genome Cancer research December 2000
https://cancerres.aacrjournals.org/content/60/24/6788 -
33 OECD GUIDELINE FOR THE TESTING OF CHEMICALS: CARCINOGENICITY STUDIES June 25 2018
https://www.oecd-ilibrary.org/docserver/9789264071186-en.pdf?
expires=1623621149&id=id&accname=guest&checksum=4924859A984B8D84730C17CA9C4979D7
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34 https://www.ama-assn.org/delivering-care/ethics/code-medical-ethics-overview
Accessed 22/06/2021
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35 https://www.wma.net/policies-post/wma-international-code-of-medical-ethics/
Accessed 22/06/2021
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36 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3399321/
Accessed 22/06/2021
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37 https://www.conseil-national.medecin.fr/sites/default/files/external-
package/edition/168yke7/code_de_deontologie_version_anglaise.pdf
Accessed 22/06/2021
38 https://www.clinicaltrials.gov/ct2/show/NCT04470427 Clinicaltrials.gov June 2021
39 https://clinicaltrials.gov/ct2/show/NCT04368728?term=Pfizer&cond=covid&age=2&phase=12&draw=2&rank=3 Clinicaltrials.gov June 2021
COVID-19 vaccine clinical research
There are excellent reasons for not expanding this section, since the objective is to achieve near 100% vaccination, in order to be able to disprove the connexion of vaccination to a coming illness explosion.
In some areas, most of the dead turn out to have been vaccinated.
In Ireland, 76% have been fully vaccinated. Data from HPSC, as of the week ending November 20, 2021 shows that total deaths were 45 of whom 41 fully vaccinated, 4 partly, 0 unvaccinated.
Concerned medics note a tragic level of miscarriages in the first trimester of gestation, awakening of dormant viruses, and virulent return of cancers in remission.
Geneticists Alexandra Henrion-Caude has published her communications with the European Medicines Agency asking for information on their studies on any eventual cancerogenetic and mutagenic qualities of the COVID-19 vaccine components.
They answered that:
a. it would take time and money to do that;
b. vaccinations would be repeatable only twice;
c. they are not aware of biologically plausible mechanisms of concern. https://www.pause2think.org/EN/lettercarcinogenicityprogress.html
One less-frequent side effect (that generally occurs in less than 1 in 1,000 people) is hypersensitivity (allergy) to one or more of the vaccine's ingredients, which in some rare cases may cause anaphylaxis.[602][603][604][605]
Minor allergic reactions to vaccination are simply ignored. It could not be otherwise, if you consider the fact that, in the vaccine trials, they even managed to ignore paralysis, in the case of Maddy De Garay. For details, see under Johnson, Senator Ron of Wisconsin.
More serious side effects are very rare because a vaccine would not be approved even for emergency use if it had any known frequent serious adverse effects.
We have in front of our eyes a fine example of insolent pretended innocence. This Wikieditor is asking Americans, in the second year of the Plague, "Would the government deceive us about serious side effects of the vaccine?" Is this editor a starry-eyed migrant from Uzbekistan?
That's a place where they had a case of boiling a dissident, they were looking for information, but the patient died. So a migrant from Uz should be expected to be very partial to the government that allowed her to come here.
For example, the Janssen COVID-19 vaccine reported rare formation of blood clots in the blood vessels in combination with low levels of blood platelets known as thrombosis with thrombocytopenia syndrome (TTS) which occurred at a rate of about 7 per 1 million vaccinated women ages 18–49 years old; and even more rarely for other populations.[606]
So Wikipedia admits to very rare unpleasantries, 7 pretty bad blood clots/M, in the short term, over a few months.
According to the CDC, very rare cases of myocarditis and pericarditis have been reported in the United States, in about 13 per million young people (mostly in males and mostly over the age of 16), after vaccination with the Pfizer–BioNTech's or Moderna's vaccines.[607] According to reports, the recovery from these rare side effects is quick in most individuals, following adequate treatment and rest.[608]
"VERY RARE"
So it's 13 myocarditis cases/M, for young males.
That's nice, CDC was more watchful than European Medicines Agency, EMA, which said on May 28 2021, that they had received 107 reports of myocarditis following the Pfizer-BioNTech vaccine, or about one in 175,000 doses administered, or 5 cases/M. Few young men had been vaccinated, at the time. In that way, the problem remained hidden. https://www.science.org/news/2021/06/israel-reports-link-between-rare-cases-heart-inflammation-and-covid-19-vaccination
CDC, see charts under the voice Myocarditis/pericarditis, finds 66 such rare cases/million vaccinations.
VAERS-based study comes up with 94 to 162 rare cases/million vaccinations, depending on patient's age.
According to Science, The COVID-19 vaccine made by Pfizer and BioNTech appears to put young men at elevated risk of developing a heart muscle inflammation called myocarditis, researchers in Israel say. In a report submitted today to the Israeli Ministry of Health, they conclude that between one in 3000 and one in 6000 men ages 16 to 24 who received the vaccine developed the rare condition. [that's 3-600/M] https://www.science.org/news/2021/06/israel-reports-link-between-rare-cases-heart-inflammation-and-covid-19-vaccination
The CDC promises quick recovery from heart inflammation; however, the parents of young athletes who had bad vaccination experiences, say their sons are now disabled. Doctors tell us that heart muscle inflammation is always serious and debilitating.
Not downloaded from Wikipedia
Unsolicited Adverse Events
Reports of lymphadenopathy were imbalanced with 58 more cases in the vaccine group (64) than the placebo group (6); lymphadenopathy is plausibly related to the vaccine. Lymphadenopathy occurred in the arm and neck region and was reported within 2 to 4 days after vaccination. The average duration of lymphadenopathy was approximately 10 days. Bell’s palsy was reported by four vaccine recipients and none of the placebo recipients. The observed frequency of reported Bell’s palsy in the vaccine group is consistent with the background rate in the general population, and there is no basis upon which to conclude a causal relationship. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html
For other side effects, before consulting VAERS, let's try the vaccine trials reports, from the CDC--see them in the left column.
Lymphadenopathy appears at rates ten times higher than background. CDC agrees that there must be some undeterminate cause-and-effect connection, but they just can't tell why. Spike protein toxicity would explain it.
As for Bell's palsy, the observed frequency after vaccination is not at all consistent with expected background rate, without a bit of prestidigitation. Otherwise, the frequency is twenty times higher. For calculations and details of how the data were fixed, see under the https://www.covidr.org/en/85-three-cards-monte-to-hide-unpleasant-data-at-fda
The data below were Downloaded from CDC, not from Wikipedia
Serious Adverse Events--Over 18 of age
Serious adverse events were defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, or resulted in persistent disability/incapacity. The proportions of participants who reported at least 1 serious adverse event were 0.6% in the vaccine group and 0.5% in the placebo group. The most common serious adverse events in the vaccine group which were numerically higher than in the placebo group were appendicitis (7 in vaccine vs 2 in placebo), acute myocardial infarction (3 vs 0), and cerebrovascular accident (3 vs 1). Cardiovascular serious adverse events were balanced between vaccine and placebo groups. Two serious adverse events were considered by U.S. Food and Drug Administration (FDA) as possibly related to vaccine: shoulder injury possibly related to vaccine administration or to the vaccine itself, and lymphadenopathy involving the axilla contralateral to the vaccine injection site. Otherwise, occurrence of severe adverse events involving system organ classes and specific preferred terms were balanced between vaccine and placebo groups.
https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html
So, catastrophic trebling of appendicitis and circulatory system events is observed, among vaccinated people, but they advise us again that the events were quite consistent with expected rates. Should we believe that it was by coincidence that the control group had developed levels of health such as to mess up all calculations. It's possible, but most unlikely.
The hypothesis of fraud is more likely, since catastrophic events are frequently observed amongst the vaccinees.
So, we have six cases, between myocardial infarctions and cerebrovascular accidents, but not /M, not per million, because 36,901 received the vaccine. Six life-threatening unpleasantries/36,901 means 162 such cases per million. If everyone takes the vaccine in NYC, we should expect 1300 cases over the course of two months.
For the 36,901 size of the sample, see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7897359/