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Category: MRNA vaccines
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Creator of mRNA Vaccine Technology Tells Tucker Carlson: ‘Government Not Being Transparent’ About Vaccine Risks
By Children’s Health Defense Global Research, June 25, 2021
Children’s Health Defense 24 June 2021
All Global Research articles can be read in 51 languages by activating the “Translate Website” drop down menu on the top banner of our home page (Desktop version).
Visit and follow us on Instagram at @crg_globalresearch.
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Dr. Robert Malone told Tucker Carlson we know the vaccines pose risks, but it’s hard to assess them because the government isn’t capturing the data “rigorously enough,” so we don’t have the information we need to make a reasonable decision.
In the segment below on last night’s “Tucker Carlson Tonight,” Fox News commentator Tucker Carlson interviewed Dr. Robert Malone, creator of mRNA vaccine technology, about his opinion that COVID vaccines are unsafe for certain people, and how YouTube censored him for discussing vaccine safety.
YouTube took down an episode of the Dark Horse Podcast that featured an interview with Malone, despite Malone likely being “the single most qualified person on the planet” to discuss vaccine risks, Carlson explained. “He helped create the mRNA technology used in COVID vaccines.”
Malone told Carlson he’s concerned about vaccine safety in young people who are at low risk of becoming seriously ill or dying from COVID.
Malone’s comment followed news this week that within 24 hours of the World Health Organization (WHO) updating its guidance on who should get the COVID vaccine — with this statement: “Children should not be vaccinated for the moment” — the WHO removed the statement. The revised guidance now says the vaccines are “suitable for use” by children “over the age of 12.”
Malone told Carlson:
“One of my concerns is the government is not being transparent with us. I’m of the opinion that people have the right to decide whether to accept vaccines or not, especially since these are experimental vaccines. This is a fundamental right having to do with clinical research ethics.”
We know there are risks, but it’s hard to assess them because the government isn’t capturing the data “rigorously enough,” Malone said. “We don’t have the information we need to make a reasonable decision.”
Malone said the risk-benefit analysis has not been done.
“Normally, at this stage, Centers for Disease Control and Prevention’s Advisory Committee on Immunizations Practices would’ve performed those risk-benefit analyses,” said Malone. “They would be data-based and science-based. They’re not right now.”
Carlson also highlighted a Norwegian study linking the Pfizer vaccine to deaths in nursing home residents.
The study found that out of the first 100 reported deaths in nursing home residents who received the Pfizer vaccine, 10 were “likely” due to the vaccine. An additional 26 deaths were “possibly” caused by the vaccine, said the study authors.
Watch Tucker Carlson’s segment here:
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Featured image is a screenshot from the video
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15 June 2021The original source of this article is Children’s Health Defense
Copyright © Children’s Health Defense, Children’s Health Defense, 2021
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Video: Toxicologist Dr. Janci Chunn Lindsay to the CDC: Stop Vaccinations
By Dr. Janci Chunn Lindsay and Kristina Borjesson
Global Research, June 14, 2021
The Whistleblower Newsroom 11 June 2021
All Global Research articles can be read in 51 languages by activating the “Translate Website” drop down menu on the top banner of our home page (Desktop version).
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A veteran toxicologist and mechanistic biologist, Dr. Lindsay explains the science and troubling evidence behind her recent public plea before the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices to stop all covid gene therapy vaccine campaigns.
Dr. Lindsay is joined by dozens of other leading scientists and doctors calling for a halt to the use of these vaccines.
https://www.bitchute.com/embed/CqSa7hCYIcUH/
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Halt COVID Vaccine, Prominent Scientist Tells CDC
Video: Petition to Revoke the Covid-19 Vaccines: Dr. Meryl Nass
The CoVaxx-19 Scorecard: Bleeding, Blood-Clots and the Whole Nine Yards
11 May 2021The original source of this article is The Whistleblower Newsroom
Copyright © Dr. Janci Chunn Lindsay and Kristina Borjesson,
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C. Y. A. and “Fraudulent Marketing”: The Pfizer COVID-19 Vaccine Is an “Unapproved Product” which Is “Permitted for Use”
By Prof Michel Chossudovsky Global Research, March 03, 2021
All Global Research articles can be read in 27 languages by activating the “Translate Website” drop down menu on the top banner of our home page (Desktop version).
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Pfizer Inc, is currently involved in marketing its experimental mRNA vaccine with the relentless support of national governments. Amply documented, barely reported by the media, numerous cases of deaths and injury have occurred.
What is at stake is what you might call “C. Y. A.” namely,
“the bureaucratic technique of averting future accusations of policy error or wrongdoing by deflecting responsibility in advance” (William Safire, NYT,)
Extensive fraud and coverup prevail at the highest levels of government.
The “Green Light” to market the experimental mRNA vaccine was granted back in December 2020, despite the fact that according to the FDA, the vaccine is an “unapproved product”.
The FDA in its ambiguous (C. Y.A.) statement has provided a so-called Emergency Use Authorization (EUA) to the Pfizer-BioNTech vaccine, namely “to permit the emergency use of the unapproved product, … for active immunization…” (see below)
There is something fishy and “contradictory” in this statement. The experimental Pfizer mRNA vaccine is both “unapproved” and “permitted”.
I have checked this statement with a prominent lawyer. It is blatantly illegal to market an “unapproved product”.
The Pfizer-Moderna vaccine is categorized by the CDC as an “investigational drug”. “The emergency use” clause is there to justify the launching of what might be described as an “illegal drug”.
There is an ongoing fear campaign but there is no “Emergency” which justifies “Emergency Use”. Why?
- Both the WHO and the CDC have confirmed that Covid-19 is “similar to seasonal influenza”, It is not a killer virus.
- The PCR test used to estimate “confirmed positive cases” is flawed.
- Since March 2020, the Covid-19 “numbers” have been manipulated, hiked up.
- The validity of the test has been questioned (January 2021) by the WHO.
“Fraudulent Marketing”, “Health Care Fraud”
What is unfolding is the “fraudulent marketing” of an “unapproved” vaccine.
In a historic US Department of Justice decision in September 2009, Pfizer Inc. pleaded guilty to criminal charges. It was “The Largest Health Care Fraud Settlement in Its History” according to the DoD:
American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. … have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today. …
Pharmacia [Pfizer] & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act …. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion. (DoD emphasis added)
Pfizer “Largest Health Care Fraud” 2009
Déjà Vu: Flash Forward to 2020-2021
How on earth can you trust a Big Pharma vaccine conglomerate which pleaded guilty to criminal charges by the US Department of Justice including “fraudulent marketing” and “felony violation of the Food, Drug and Cosmetic Act”?
The 2020-2021 mRNA vaccine violations far surpass the health care fraud committed by Pfizer Inc in 2009.
“Fraudulent marketing” is an understatement: The mRNA vaccine announced by Pfizer and Moderna is based on an experimental gene editing mRNA technology which has a bearing on the human genome. The standard animal lab tests using mice or ferrets were not conducted. Pfizer “went straight to human “guinea pigs.”
Human tests began in late July and early August 2020. “Three months is unheard of for testing a new vaccine. Several years is the norm.”
Our thanks to Large and JIPÉM
This caricature by Large + JIPÉM explains our predicament:
Mouse No 1: “Are You Going to get Vaccinated”,
Mouse No. 2: Are You Crazy, They Haven’t finished the Tests on Humans”
“The plan to develop a vaccine is profit driven. It is supported by corrupt governments serving the interests of Big Pharma. The US government had already ordered 100 million doses back in July and the EU is to purchase 300 million doses. It’s Big Money for Big Pharma, generous payoffs to corrupt politicians, at the expense of tax payers.”
See Michel Chossudovsky, The 2020 Worldwide Corona Crisis: Destroying Civil Society, Engineered Economic Depression, Global Coup d’État and the “Great Reset” E-Book, February 26, 2021
So-called “emergency use” has been granted to Pfizer with a view to promoting a pharmaceutical product which is “experimental”, “unapproved” by the FDA and outright dangerous.
Legal Definitions are Turned Upside Down: The Transition from “Unapproved” to “Approved”
- “unapproved” by the FDA,
- “permitted” (under emergency use) by the FDA
- and then “approved” by the US government’s health authorities
- resulting in numerous deaths and injuries.
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Red Alert Warning About Pfizer and Moderna COVID Inoculations
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2 February 2021The original source of this article is Global Research
Copyright © Prof Michel Chossudovsky, Global Research, 2021
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Synthetic mRNA Covid vaccines: A Risk-Benefit Analysis/By Sadaf Gilani for OffGuardian
OffGuardian, February 22, 2021
With a “vaccine” based on untested technology, and safety trials still ongoing, is it safe to take the shot? And does it even work? And does a disease with an IFR of 0.2% even justify that risk?
Amidst the plethora of Covid-related issues, the Covid injections are the most imminent. Two formulations have received interim approval from the FDA, and Health Canada: Pfizer/BioNtech and Moderna.
Both these injections are employing the same technology, synthetic gene therapy (SGT), which is being dispensed to the populace for the first time in human history.
Medications are given to sick people to treat disease. Vaccines are given to healthy people to prevent an infection. Therefore consideration of risk-benefit analysis is paramount.
Covid is the umbrella label for PCR “positive” people regardless of clinical presentation. Most are “asymptomatic,”some have generic cold/flu symptoms, and a few present with moderate or severe respiratory distress. Unfortunately, the PCR assays being used for diagnosis, are not fit for purpose. Most PCR assays are constructed based on the German Drosten et al. protocol.
On November 27th 2020, 22 scientists submitted a request for retraction of this protocol which was published in the journal Eurosurveillance, citing a number of fatal design flaws.
It is also important to note, despite SarsCov2 virus and the syndrome labelled as Covid being used interchangeably, causation has not been proven as per Koch’s postulates.
The first metric which every medical doctor must convey to a person is how deadly Covid actually is. This is context for the legal and ethical practice of informed consent.
Incidentally, all Covid death stats are inflated: under direction of the WHO, deaths ‘from” and incidentally “with” Covid are not distinguished. Death coding has changed compared to Influenza/Pneumonia. According to one published analysis, this has resulted in over 16 times inflation of death stats, as supported by CDC data.
Furthermore, Infection Fatality Rate (IFR) stats based on seroprevalence antibody studies are also inflated since T-cell immunity, is not measured in these studies. This may result in a 3-5X lower IFR for Covid. Regardless, the general IFR is on order of the seasonal influenza, approx. 0.2%.
Covid mortality is a reflection of increased mortality with age, more so than influenza/pneumonia of previous years. The median age of Covid deaths (86) exceeds average life expectancy in Canada. Tragically, 70% of the deaths in the province of Ontario took place in care homes. The mortality rate from Covid in Canada under 59 years of age is 0.0017%.
According to the CDC, the survival from Covid (with inflated stats) is as follows: (under 20) 99.997%, (29-49) 99.98%, (50-69) 99.5% and (over 70), 94.6%.
The Covid synthetic gene therapy injections employ synthetic, thermostable nucleotide sequences which are wrapped in a PEG (polyethylene glycol)-lipid nanoparticles to protect from destruction in the bloodstream and facilitate entry into the cells. The claim is that the cellular machinery will engage with these synthetic sequences and produce segments which code for the SarsCov2 S1 spike protein. It is believed that the immune system will mount a sufficient antibody response.
Dr David Martin, emphasized that this technology does not meet the definition of a traditional vaccine as per the manufacturers’ claims. The trials do not test for reduction in transmission. These therapies do not prevent infection, merely reduction in one or more symptoms.
Interestingly, Moderna describes its technology as the “software of life,” not a vaccine.
Media outlets, politicians, and public health officials have blared the 95% efficacy for both formulations. To the casual observer, this would denote 95% reduction in hospitalizations or deaths. When in fact the 95% is calculated, based upon the “Primary Efficacy Endpoints.”
In the trial literature these endpoints are described by both companies as non-severe cold/flu SYMPTOMS coupled with a positive PCR.
Pfizer has reported:
For the primary efficacy endpoint, the case definition for a confirmed COVID-19 case was the presence of at least one of the following symptoms and a positive SARS-CoV-2 NAAT within 4 days of the symptomatic period: Fever; New or increased cough; New or increased shortness of breath; Chills; New or increased muscle pain; New loss of taste or smell; Sore throat; Diarrhea; Vomiting.”
Moderna reported in likeness:
For the primary efficacy endpoint, the case definition for a confirmed COVID-19 case was defined as: At least TWO of the following systemic symptoms: Fever (≥38ºC), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), OR At least ONE of the following respiratory signs/ symptoms: cough, shortness of breath or difficulty breathing, OR clinical or radiographical evidence of pneumonia; and NP swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by RT-PCR.”
To reiterate, in both trials, once one/two symptoms appeared in a participant, it was designated a “case” or “event” when coupled with a positive PCR “test”. Once 170 “cases” occurred in Pfizer/BioNtech trial, and 196 “cases” occurred in Moderna trial, this data was used to calculate efficacy. Shockingly, only under 200 cases for a novel therapy which is being deployed/subjected on millions of people around the world.
Furthermore, people are not being informed that “95%” or so efficacy, is calculated based on a useless metric of relative efficacy and is therefore very misleading.
Eg.Pfizer/BioNtech:
8 “cases” in vaccine group
162 “cases” in placebo group8/162 = 5%
100%-5%= 95%Therefore, they are claiming that the synthetic gene therapy injections are 95% efficacious. What they are not factoring in is the size of the denominator. If it is large, then with 8 vs 162, the difference becomes less significant. It matters how many people were in each group, for example, whether this be 200, 2,000, or 20,000.
This is the absolute risk reduction for Pfizer/BioNtech, each group had over 18,000 people!
Injection Group: 8/18,198 = 0.04%
Placebo Group: 162/18,325= 0.88%Therefore, the absolute risk reduction for Primary Efficacy Endpoint is 0.84%. (ie. 0.88-0.04)
This means, that someone who takes the Pfizer/BioNtech injection, has less than 1% chance of reducing at least one symptom of non-severe “Covid” for a period of 2 months. This means that someone who takes this injection has over 99% chance that it won’t work, regarding the efficacy. Over 100 people have to be injected for it to “work” in one person.
The actual efficacy of Pfizer/BioNtech Synthetic Gene Therapy
The actual efficacy of Moderna Synthetic Gene Therapy
There are many issues with the trial data, and design. It must be noted that PCR tests are not fit for purpose and without Sanger sequencing we have no idea how many of these people actually had “Covid” vs another respiratory virus or something else. This is a preeminent reason why Dr Yeadon and Dr Wodarg filed a Stay of Action on the vaccine trials.
As Dr Peter Doshi, Associate Editor of BMJ highlighted, access to the raw data is required to further elucidate the areas of concern:
With 20 times more suspected covid-19 than confirmed covid-19, and trials not designed to assess whether the vaccines can interrupt viral transmission, an analysis of severe disease irrespective of etiologic agent—namely, rates of hospitalizations, ICU cases, and deaths amongst trial participants—seems warranted, and is the only way to assess the vaccines’ real ability to take the edge off the pandemic.”
Approximately 5-6 symptoms listed as “side effects” are the same as Covid symptoms. Pfizer/BioNtech only started counting “cases” one week after the second dose, and Moderna, 2 weeks after the second dose. Therefore, if these side effects were labelled as “Covid” symptoms instead, even the paltry efficacy of about 1% would be relegated into the negative integers.
In others words, the injected group may have been sicker with “Covid” more than the placebo group.
There have been many critiques of the applicability of the limited data to the general populace, especially the vulnerable elderly. An important analysis of this was done by Dr James Lyons-Weiler who discovered the general population is dying at a rate 6.3 times the rate of participants in the Moderna trial (including placebo and injection groups).
If Moderna’s on-vaccine death rate is so far below the national death rate and also simultaneously more than five times greater than Pfizer’s on-vaccine death rate, then Pfizer’s study sample appears even less representative of the entire population. This, too, requires due consideration.”
An integral question as to whether Pfizer/BioNtech and Moderna recruited supermen and women for their trials, comes to mind. The incidence of “severe” Covid in Placebo groups which scrutinizing the details, wasn’t necessarily severe presentation, is so low that trials of 30,000-40,000 lacked statistical power to determine reductions in hospitalizations and deaths, according to Tal Zaks, CMO Moderna.
Zaks is correct, the incidence of severe “Covid” was only 0.04% in Pfizer/BioNtech and 0.22% in Moderna. Due to this very low attack rate of severe presentation in the population, the absolute risk reduction in severe presentation, even taking data at face value, is nominal.
Therefore, potential SGT recipients must be informed that to reduce “severe” presentation, chances are over 99.5% that these synthetic gene therapies will not work.
The British Medical Journal has reported:
Hospital admissions and deaths from covid-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30 000 people. The same is true of its ability to save lives or prevent transmission: the trials are not designed to find out.”
To convey informed consent, the side effect profile must also be considered. Up to 80% of injected trial recipients experienced side effects, in a setting for a nebulous syndrome where 80% of people are asymptomatic.
The incidences of immediate side effects in both trials were significant and dwarfed the absolute risk reduction in both the primary efficacy endpoints, as well as for “severe” Covid.
For example, for Moderna 81.9% experienced any systemic reaction. Grade 3 reactions (considered severe) were experienced by 17.4%. This is 79X more likely than the incidence of severe Covid in the Moderna group. (17.4/.22=79X) Based on preliminary reports of adverse events [emphasis added]:
This is an injury rate of 1 in every 40 jabs. This means that the 150 shots necessary to avert one mild case of COVID will cause serious injury to at least three people.“
The safety data for both companies is approximately only two months before receiving emergency use authorization status. Therefore, there is no data for mid-long term side effects, as the trials are ongoing.
The estimated completion date for Pfizer/BioNtech trials is Jan 31, 2023. The estimate completion date for Moderna trials is October 27, 2022.
According to the data, and elaborated by Tal Zaks (CMO of Moderna) the trials are not designed to demonstrate a reduction in transmission, due to “operational realities”. It is therefore baffling how medical doctors and public health officials are proclaiming these SGTs will promote herd immunity.
The manufacturers have also made it clear that efficacy beyond 2 months or so is unknown. Therefore, the 1% absolute risk reduction in mild/moderate, cold/flu symptoms may not last more than a few months.
Tragically, there is no pervasive data-centred discourse, only excessive fear-mongering. Without addressing the data people cannot make an informed choice about experimental SGTs.
Many are not aware any SGT recipient who participates in this therapy is now a part of an unprecedented experiment. When Health Canada shockingly agreed to interim authorization of the Pfizer/BioNtech injection, it came alongside a caveat: The company must submit 6 months of trial data when it is available.
To underscore: Health Canada approved this experimental SGT on the populace without even 6 months of trial data.
It is difficult to embark on a comprehensive risk-benefit analysis, as there is no safety data beyond a couple of months. New vaccines typically take about 7 to 20 years of research and trials before going to market. Pfizer/Moderna ran all of their trials simultaneously, including their animal trials, instead of sequentially. As retired Health Canada research scientist Dr Qureshi elaborated, it is during proper animal trials that meaningful toxicology data is obtained.
The anaphylactic reactions observed in some people is also worrisome, worthy of analysis. Children’s Health Defense submitted a request to the FDA to address PEG allergies, as up to 70% of the populace has antibodies to these compounds. PEG has never been a component in a vaccine before.
It must also be noted that according to an internal Health Human Services and Harvard study, less than 1% of vaccine side effects are reported. At this juncture, based on: paltry efficacy, issues with data transparency and trial design, high level of immediate side effects, and low IFR for Covid, there is already enough reason for concern.
Yet, the more disconcerting side effects are the potential mid-long term effects.
Many doctors and researchers around the world have promulgated concerns about the well-documented phenomena referred to as Antibody Dependent Enhancement (ADE) seen in some viruses such as coronaviruses.
In previous SARS, MERS, Dengue fever and RSV virus vaccine trials the exposure of wild viruses to vaccine recipients resulted in severe disease, cytokine storms, and deaths in some animal and human trials. The phenomenon of ADE did not present initially in vaccine recipients, rather it presented after vaccine recipients were exposed to wild viruses.
This is the reason we do not have a vaccine for the common cold, MERS and SARS which is 78% homologous with SarsCov2 (based on analysis of the digital genome). Immunology Professor Dolores Cahill warned that this disease enhancement may cause many vaccine recipients to die months or years down the road. Esteemed German infectious disease specialist, Dr Sucharit Bhakdi opined:
This vaccine will lead you to your doom.”
Researchers in The International Journal of Clinical Practice stated:
The absence of ADE evidence in COVID-19 vaccine data so far does not absolve investigators from disclosing the risk of enhanced disease to vaccine trial participants, and it remains a realistic, non-theoretical risk to the subjects. Unfortunately, no vaccines for any of the known human CoVs have been licensed, although several potential SARS-CoV and MERS-CoV vaccines have advanced into human clinical trials for years, suggesting the development of effective vaccines against human CoVs has always been challenging.”
Traditional vaccines involve injection of the pathogen/toxin in whole/part to elicit an immune reaction. For the first time in history, the recipients’ cells will manufacture the pathogen, the S1 spike protein of SarsCov2 virus.
In a presentation for Emergency Use Authorization to the FDA, Moderna reps explained that the mRNA stays in the cytoplasm of the cells, manufactures the S1 Spike Protein and then is destroyed. As Dr Sucharit Bhakdi and others have queried:
Where else do these packages go?”
Also, based on a couple of months of safety data, we do not know that these mRNAs last long enough to manufacture the protein but not long enough to exert deleterious effects. This nascent technology is risky.
Firstly, the RNA sequences are synthetic. Therefore, we do not know how long they will last in the cells. Dr Judy Mikovits has expressed concerns in that they may not be degraded immediately, and perhaps linger for days, months, years.
Moderna previously tried to use this same technology to treat Crigler-Najjar syndrome and was not able to strike the balance between therapeutic dose and toxic side effects.
It’s encased in nanolipid to prevent it from degrading too rapidly, but what happens if the mRNA degrades too slowly, or not at all? What happens when you turn your body into a “viral protein factory”, thus keeping antibody production activated on a continual basis with no ability to shut down?
So, taking a synthetic messenger RNA and making it thermostable — making it not break down — [is problematic]. We have lots of enzymes (RNAses and DNAses) that degrade free RNA and DNA because, again, those are danger signals to your immune system. They literally drive inflammatory diseases.
Moderna boldly claims that these synthetic mRNAs will not integrate with the host cell DNA. The discovery of epigenetics has revealed that DNA expression is in flux and constantly interacts with environmental signals. Dr Lanka explained that RNA-DNA is also a two-way process, dynamic.
There is the potential for this synthetic RNA to integrate into human DNA via the enzyme, reverse transcriptase. This may lead to mutagenesis, possibly cancer. It may lead to birth defects if it integrates into the germ cells of the injected. Reassurances cannot be made based on such limited safety data.
Therefore, it is important to clearly understand the potential risks of this type of mRNA-based vaccine, which include local and systemic inflammatory responses, the biodistribution and persistence of the induced immunogen expression, possible development of autoreactive antibodies and toxic effects of any non-native nucleotides and delivery system component”
It has been discovered that commonly transcribed mRNA sequences can integrate with DNA for form “R loop” patterns. Dysregulation of these sequences is implicated in different pathologies, including “oncogenic stress.”
This finding was referred to as:
unexpected interplay between RNA modifications (the epitranscriptome) and the maintenance of genome integrity.”
Clearly, we are in the nascent stages of understanding the complex field of epigenetics. The S1 SarsCov2 spike protein is highly homologous with HERV (human endogenous retrovirus) protein knowns as Syncytin-1. There is the potential for autoimmunity, as the Spike protein antibodies might attack Syncytin-1.
Whilst natural infections are benign and self-limiting for the vast majority of affected people, autoimmune diseases are mostly irreversible. This is even more terrifying with the mRNA treatment.
If the translation of SarsCov2 S1 spike protein persists there is potential to cause amplification of the expression of autoimmunity. As the SGT recipients’ cells are now producing the viral spike proteins, there is the potential for explosion of auto-immune diseases in coming years.
Syncytin-1’s primary function is in the placenta as well as sperm. Dr Wodarg and Yeadon’s Stay of Action, included concerns that the potential for antibodies against Syncytin-1 proteins (part of the placenta) may result in permanent infertility in women and possibly men as well. The manufacturers give the caveat:
It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility. And women of childbearing age are advised to avoid pregnancy for at least two months after their second dose.”
Pregnant women were not included in either of the trials. Trial recipients were instructed to use birth control.
The PEG-lipid nanoparticle is highly lipophilic, to cross cell membranes. Renowned aluminum and neurotoxicity expert Dr Chris Shaw, stated that these nanoparticles do cross the BBB (blood-brain barrier) and cited evidence from Moderna’s previous animal trials.
On social media, there have been many documented cases of bizarre neurologic symptoms in the SGT recipients. Could one mechanism be dysregulation of Syncytin-1 in the brain?
Except for the normal physiologic function of Syncytin-1 in the development of placenta, the activity and expression of Syncytin-1 increase in several diseases, such as neuropsychiatric disorders, autoimmune diseases, and cancer […] Syncytin-1 participates in human placental morphogenesis and can activate a pro-inflammatory and autoimmune cascade […] A growing number of studies indicate that Syncytin-1 plays an important role in MS.”
Bottom line: elevated levels of Syncytin-1 = brain inflammation.
We now have a therapy that uses the body’s own cells to produce unknown (perhaps continuous) levels of a protein that is almost identical to Syncytin-1. This is potential for disaster, as Dr Mikovits elaborated:
Syncytin is the endogenous gammaretrovirus envelope that’s encoded in the human genome…We know that if syncytin…is expressed aberrantly in the body, for instance in the brain, which these lipid nanoparticles will go into, then you’ve got multiple sclerosis […] The expression of that gene alone enrages microglia, literally inflames and dysregulates the communication between the brain microglia, which are critical for clearing toxins and pathogens in the brain and the communication with astrocytes that dysregulates not only the immune system but the endocannabinoid system…”
In the longer term, she suspects we’ll see a significant uptick in migraines, tics, Parkinson’s disease, microvascular disorders, different cancers, including prostate cancer, severe pain syndromes like fibromyalgia and rheumatoid arthritis, bladder problems, kidney disease, psychosis, neurodegenerative diseases such as Lou Gehrig’s disease (ALS) and sleep disorders, including narcolepsy. In young children, autism-like symptoms are likely to develop as well, she thinks.
Heart attacks are another documented side effect. Loved ones of the deceased have shared on social media that these deaths are not considered vaccine reactions and are therefore not recorded as such.
Cardiothoracic surgeon and researcher, Dr Hooman Noorchashm, wrote a letter of warning to the FDA. His concern, the spike protein will cause inflammation, clot formation and heart attacks in SGT recipients who previously were exposed to SarsCov2:
So if a person with a recent or active COVID-19 infection is vaccinated, the highly effective and antigen specific immune response incited by the vaccine will, very likely, attack the inner lining of the blood vessel and cause damage, leading to blood clot formation. This could result in major serious problems like strokes and heart attacks, at least in some people…Additionally, if the immunological risk I am prognosticating herein is in reality material, over the next months as millions more Americans are immunized, it will become quite visible to the public..Thromboembolic complications, 10–20 days following activation of a vaccine induced antigen specific immune response, in elderly frail vasculopaths, will not register as classical “vaccine related complications.”
Moderna and Pfizer reps have boasted that spike protein will result in reduction of symptoms without presenting with clinical disease, as only a portion of SarsCov2 is being produced. Dr Whelan expressed concern that the spike protein alone is sufficient to cause injury.
I am concerned about the possibility that the new vaccines aimed at creating immunity against the SARS-CoV-2 spike protein have the potential to cause microvascular injury to the brain, heart, liver and kidneys in a way that does not currently appear to be assessed in safety trials of these potential drugs.”
There are many avenues of potential harm and death, many are unknown as this experiment is only a few months old.
In contemplation of risk-benefit analysis, one must also consider low-risk efficacious treatments. It is well established that vitamin D deficiency is linked to presentation of severe respiratory distress, and cytokine storm sequelae, which also includes Covid.
This is a small study, but well supported in scientific literature. All the risk factors for Covid are also risk factors for vitamin D deficiency. We have a pandemic of vitamin D deficiency in many temperate climates. Over two hundred scientists urged consideration of vitamin D supplementation for prevention and treatment of Covid.
As Dr Raharusun expressed optimism after conducting his study, he felt this is a solution that is pennies on the dollar. Sadly, he met with an untimely death shortly after conducting his study.
Chinese health officials have recommended a moratorium on these SGT Covid injections, after the investigations of deaths in care homes in Norway. Daily, there are a barrage of reports detailing disconcerting side effects that result in death as this great experiment on humanity unfolds.
On Feb 5th, the UK Medical Freedom Alliance penned a letter to Boris Johnson, urging him to address the post-injection vaccine deaths in care homes:
We now call for an immediate and urgent audit of deaths that have occurred since the beginning of the Covid-19 vaccine rollout, to ascertain if Covid-19 vaccines (in general or any one brand in particular) are leading to an increased number of deaths (Covid-19 and non-Covid-19 related), Covid19 cases or increased risk of death in certain age groups or cohorts.”
There are now over 900 deaths in VAERS registry. As per Health and Human Services’ own analysis, these are likely a small percentage of actual deaths. Both companies wish to have the trials “unblinded” so that the placebo groups can acquire synthetic gene therapies. If this happens the placebo cohort will be lost which will further obfuscate deleterious side effects.
Worldwide, over 206 million doses have been dispensed. Pfizer has projected a profit of 15 billion for 2021. A very lucrative start for all companies benefitting from the Covid Industrial Complex.
Sadly, people are not being informed that Phase 3 trials are ongoing. The FDA and Health Canada have not approved these injections for licensure. The injections are highly experimental. These SGTs were designed and “assessed” at a record speed of less than a year and then given interim approval based on 2 months of safety data.
Recently, the Indian government declined the Pfizer SGT, which prompted America’s Front Line Doctors to call on Biden in addressing their concerns. Public Health Authorities are making claims about the SGTs that the manufacturers have not made.
ICAN recently wrote a letter to Cuomo urging retraction of fraudulent NY state advertisements that SGT injections are FDA approved and underwent rigorous safety trials.
Below is an example of the propaganda found in Government of Canada advertisement:
A family gathering for a meal is now tantamount to criminal behaviour.
Dr Peter Doshi, Associate Editor, BMJ stated:
Products can be marketed without access to the data, but doctors and professional societies should publicly state that, without complete data transparency, they will refuse to endorse covid-19 products as being based on science.”
Dr Michael Yeadon, former Vice-President of Pfizer has also stated [emphasis added]:
All vaccines against the SARS-CoV-2 virus are by definition novel. If any such vaccine is approved for use under any circumstances that are not EXPLICITLY experimental, I believe that recipients are being misled to a criminal extent.”
The American Frontline Doctor’s white paper reports,
An Experimental Vaccine Is Not Safer Than a Very Low IFR.”
To exercise informed consent, any recipient of this SGT must be made aware that they are now participating in a clinical trial. There is no claim about reduction of transmission. All risk-benefit analysis must be focused on the individual, as is treatment with a drug therapy.
Therefore, the potential trial recipient must understand IFR, the absolute risk reduction in symptoms, and potential side effects, including ADE as well as efficacious alternatives for treatment if the need arises.
If the potential trial subject is not relayed this information, or does not comprehend the information, it is a blatant violation of Nuremberg code.
The voluntary consent of the human subject is absolutely essential…This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.
This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.
There is a substantial body of experts around the world, warning about the potential disasters of this novel SGT. The sanctity of life is relegated to the proclamations of those substantiating and in command of the New Covid Religion.
The new normal breeds hysteria, “safe and effective” are the cacophonous mantras. Only a heretic dare analyze the actual data or initiate rational query. The unscrupulous message proclaimed from on high, Covid is extremely fatal, the injections are extremely safe and effective. Full stop.
Dr Vernon Coleman did not mince any words, in his emotional plea:
Legally all those people giving “vaccinations” are war criminals…There is no doubt in my mind, this is global genocide.”
Of course, Dr Coleman’s comments were flagged as False information by Facebook.
Meanwhile, Orwellian messages such as the following abound:
Sadaf Gilani MD is a Canadian entrepreneur and activist.
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Immunologist: Pfizer, Moderna Vaccines Could Cause Long-Term Chronic Illness
By Children’s Health Defense Global Research, February 10, 2021
Children’s Health Defense 9 February 2021
All Global Research articles can be read in 27 languages by activating the “Translate Website” drop down menu on the top banner of our home page (Desktop version).
***
In new research published in Microbiology & Infectious Diseases, immunologist J. Bart Classen warns the mRNA technology used in the Pfizer and Moderna COVID vaccines could create “new potential mechanisms” of adverse events that may take years to come to light.
Back in 1999, leading U.S. Food and Drug Administration (FDA) official Dr. Peter Patriarca contended that modern advances in vaccine technology were rapidly “outpacing researchers’ ability to predict potential vaccine-related adverse events.” Patriarca mused that this could lead to “a situation of unforeseen and unpredictable vaccine outcomes.”
In a new research article published in Microbiology & Infectious Diseases, veteran immunologist J. Bart Classen expresses similar concerns and writes that “RNA-based COVID vaccines have the potential to cause more disease than the epidemic of COVID-19.”
For decades, Classen has published papers exploring how vaccination can give rise to chronic conditions such as Type 1 and Type 2 diabetes — not right away, but three or four years down the road.
In this latest paper, Classen warns that the RNA-based vaccine technology could create “new potential mechanisms” of vaccine adverse events that may take years to come to light.
Classen’s study establishes the potential for the messenger RNA (mRNA) vaccines developed by Pfizer and Moderna to activate human proteins to take on “pathologic configurations” — configurations associated with chronic degenerative neurological diseases. Although his specific interest is in prion diseases (conditions associated with misfolded versions of normal proteins), Classen also outlines a handful of other mechanisms whereby RNA-based vaccines could give rise to “multiple other potential fatal adverse events.”
Ensuring that patients clearly understand risks — including known risks as well as potential unknown risks — is an important component of the informed consent process. This is all the more true when the intervention is experimental and lacks long-term safety data, as is the case with the Pfizer and Moderna vaccines against COVID-19. The FDA authorized the two vaccines for widespread emergency use based on just two months of clinical trial data.
Unfortunately, it is not unusual for researchers’ communication of risks to be perfunctory. In October, researchers at New York University and Tulane reported that the information communicated to participants in the coronavirus clinical trials about a worrisome problem known as pathogenic priming was “sufficiently obscured” as to make “adequate patient comprehension” of risks “unlikely.”
It would be interesting to know what those researchers would say about Classen’s blunt conclusion that “Approving a vaccine, utilizing novel RNA technology without extensive testing is extremely dangerous.”
Those contemplating COVID injections may be ignoring potential risks at their own peril.
*
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Featured image is from CHD
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17 January 2021The original source of this article is Children’s Health Defense
Copyright © Children’s Health Defense, Children’s Health Defense, 2021
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Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 31-Jan-2021
Data Lock Date: 28-Jan-2021 19:00:04
ALL UK spontaneous reports received between 9/12/20 and 24/01/21 for mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 31-Jan-2021
Data Lock Date: 28-Jan-2021 19:00:04
ALL UK spontaneous reports received between 9/12/20 and 24/01/21 for mRNA
Pfizer- BioNTech vaccine analysis print
Reaction Name Total Fatal Blood disorders Anaemias NEC Anaemia 2 0 Bleeding tendencies Increased tendency to bruise 1 0 Lymphatic system disorders NEC Lymph node pain 151 0 Lymphadenitis 18 0 Lymphadenopathy 969 0 Lymphatic disorder 1 0 Pseudolymphoma 1 0 Marrow depression and hypoplastic anaemias Pancytopenia 1 0 Neutropenias Neutropenia 2 0 Thrombocytopenias Immune thrombocytopenia 1 0 Thrombocytopenia 4 0 Thrombocytoses Thrombocytosis 1 0 Blood disorders SOC TOTAL 1152 0 Reaction Name Total Fatal Cardiac disorders Cardiac conduction disorders Bundle branch block right 2 0 Cardiac disorders NEC Cardiac disorder 1 0 Cardiac signs and symptoms NEC Palpitations 254 0 Heart failures NEC Cardiopulmonary failure 1 1 Ischaemic coronary artery disorders Acute myocardial infarction 4 0 Angina pectoris 4 0 Myocardial infarction 13 3 Left ventricular failures Left ventricular failure 1 0 Myocardial disorders NEC Right ventricular enlargement 1 0 Noninfectious myocarditis Myocarditis 5 0 Noninfectious pericarditis Pericarditis 2 0 Rate and rhythm disorders NEC Arrhythmia 7 0 Bradycardia 11 0 Cardiac flutter 8 0 Extrasystoles 7 0 Postural orthostatic tachycardia syndrome 1 0 Tachycardia 193 0 Supraventricular arrhythmias Arrhythmia supraventricular 2 0 Atrial fibrillation 24 1 Atrial tachycardia 1 0 Sinus bradycardia 1 0 Sinus tachycardia 18 0 Supraventricular tachycardia 7 0 Ventricular arrhythmias and cardiac arrest Cardiac arrest 16 7 Pulseless electrical activity 1 0 Ventricular extrasystoles 2 0 Ventricular fibrillation 2 0 Ventricular tachycardia 1 0 Cardiac disorders SOC TOTAL 590 12 Reaction Name Total Fatal Congenital disorders Neurological disorders congenital NEC Familial hemiplegic migraine 1 0 Congenital disorders SOC TOTAL 1 0 Reaction Name Total Fatal Ear disorders Ear disorders NEC Ear canal erythema 1 0 Ear congestion 2 0 Ear discomfort 9 0 Ear disorder 1 0 Ear pain 98 0 Ear pruritus 1 0 Ear swelling 1 0 Hearing losses Deafness 5 0 Hypoacusis 13 0 Sudden hearing loss 1 0 Hyperacusia Hyperacusis 5 0 Inner ear disorders NEC Acute vestibular syndrome 1 0 Inner ear disorder 1 0 Inner ear signs and symptoms Motion sickness 9 0 Tinnitus 72 0 Vertigo 105 0 Vertigo labyrinthine 2 0 Vertigo positional 6 0 Middle ear infections and inflammations Middle ear inflammation 1 0 Ear disorders SOC TOTAL 334 0 Reaction Name Total Fatal Endocrine disorders Endocrine abnormalities of puberty Premature menarche 1 0 Thyroid disorders NEC Goitre 1 0 Endocrine disorders SOC TOTAL 2 0 Reaction Name Total Fatal Eye disorders Amblyopic vision impairment Amblyopia 1 0 Choroid and vitreous structural change, deposit and degeneration Vitreous floaters 4 0 Conjunctival and corneal bleeding and vascular disorders Conjunctival haemorrhage 6 0 Corneal infections, oedemas and inflammations Ulcerative keratitis 1 0 Eyelid movement disorders Blepharospasm 8 0 Eyelid ptosis 1 0 Iris and uveal tract infections, irritations and inflammations Iridocyclitis 3 0 Uveitis 1 0 Lacrimation disorders Dry eye 10 0 Lacrimation increased 17 0 Lid, lash and lacrimal infections, irritations and inflammations Blepharitis 1 0 Erythema of eyelid 1 0 Eyelid irritation 1 0 Eyelid margin crusting 1 0 Eyelid rash 2 0 Swelling of eyelid 15 0 Lid, lash and lacrimal structural disorders Eyelid exfoliation 1 0 Ocular disorders NEC Eye disorder 9 0 Eye oedema 2 0 Eye pain 122 0 Eye swelling 56 0 Eye ulcer 1 0 Eyelid pain 1 0 Eyelids pruritus 1 0 Ocular discomfort 4 0 Periorbital oedema 3 0 Periorbital pain 1 0 Periorbital swelling 13 0 Ocular infections, inflammations and associated manifestations Eye allergy 1 0 Eye discharge 3 0 Eye inflammation 2 0 Eye irritation 13 0 Eye pruritus 32 0 Ocular hyperaemia 25 0 Ocular nerve and muscle disorders Binocular eye movement disorder 1 0 Eye movement disorder 4 0 Ophthalmoplegia 1 0 Ocular sensation disorders Abnormal sensation in eye 4 0 Asthenopia 22 0 Reaction Name Total Fatal Eye disorders Eye disorders cont’d Eye paraesthesia 1 0 Foreign body sensation in eyes 5 0 Hypoaesthesia eye 1 0 Photophobia 50 0 Optic disc abnormalities NEC Papilloedema 1 0 Pupil disorders Miosis 1 0 Mydriasis 2 0 Pupils unequal 2 0 Retinal structural change, deposit and degeneration Maculopathy 1 0 Scleral infections, irritations and inflammations Episcleritis 1 0 Visual disorders NEC Diplopia 12 0 Halo vision 2 0 Metamorphopsia 2 0 Oscillopsia 1 0 Photopsia 10 0 Vision blurred 106 0 Visual brightness 1 0 Visual impairment and blindness (excl colour blindness) Blindness 5 0 Blindness transient 2 0 Central vision loss 1 0 Visual acuity reduced 1 0 Visual impairment 31 0 Eye disorders SOC TOTAL 634 0 Reaction Name Total Fatal Gastrointestinal disorders Abdominal findings abnormal Gastrointestinal sounds abnormal 1 0 Anal and rectal disorders NEC Anal sphincter atony 1 0 Anal and rectal pains Proctalgia 2 0 Anal and rectal signs and symptoms Anorectal discomfort 1 0 Benign oral cavity neoplasms Mouth cyst 1 0 Colitis (excl infective) Colitis 1 0 Crohn’s disease 1 0 Dental disorders NEC Teething 1 0 Dental pain and sensation disorders Hyperaesthesia teeth 3 0 Toothache 8 0 Diarrhoea (excl infective) Diarrhoea 732 1 Diarrhoea haemorrhagic 2 0 Duodenal and small intestinal stenosis and obstruction Small intestinal obstruction 1 0 Dyspeptic signs and symptoms Dyspepsia 34 0 Epigastric discomfort 1 0 Eructation 7 0 Faecal abnormalities NEC Abnormal faeces 3 0 Faeces discoloured 6 0 Faeces pale 2 0 Flatulence, bloating and distension Abdominal distension 21 0 Aerophagia 2 0 Flatulence 20 0 Gastritis (excl infective) Gastritis 4 0 Reflux gastritis 2 0 Gastrointestinal and abdominal pains (excl oral and throat) Abdominal pain 156 0 Abdominal pain lower 8 0 Abdominal pain upper 214 0 Abdominal tenderness 2 0 Gastrointestinal pain 10 0 Gastrointestinal atonic and hypomotility disorders NEC Constipation 12 0 Duodenogastric reflux 1 0 Gastrooesophageal reflux disease 13 0 Gastrointestinal disorders NEC Functional gastrointestinal disorder 2 0 Gastric disorder 2 0 Gastrointestinal disorder 1 0 Reaction Name Total Fatal Gastrointestinal disordersGastrointestinal disorders cont’d Gastrointestinal dyskinetic disorders Dyschezia 1 0 Gastrointestinal motility disorder 1 0 Gastrointestinal inflammatory disorders NEC Enteritis 1 0 Gastrointestinal mucosal dystrophies and secretion disorders Hyperchlorhydria 1 0 Gastrointestinal signs and symptoms NEC Abdominal discomfort 66 0 Anal incontinence 2 0 Breath odour 5 0 Dysphagia 27 0 Gastrointestinal spastic and hypermotility disorders Defaecation urgency 2 0 Frequent bowel movements 8 0 Irritable bowel syndrome 6 0 Oesophageal spasm 1 0 Gingival disorders, signs and symptoms NEC Gingival blister 2 0 Gingival discomfort 1 0 Gingival pain 9 0 Gingival swelling 2 0 Gingivitis ulcerative 1 0 Noninfective gingivitis 1 0 Gingival haemorrhages Gingival bleeding 4 0 Haemorrhoids and gastrointestinal varices (excl oesophageal) Haemorrhoids 2 0 Intestinal haemorrhages Anal haemorrhage 1 0 Rectal haemorrhage 7 0 Malabsorption syndromes Steatorrhoea 1 0 Nausea and vomiting symptoms Discoloured vomit 2 0 Nausea 2365 0 Regurgitation 1 0 Retching 14 0 Vomiting 616 2 Vomiting projectile 10 0 Non-site specific gastrointestinal haemorrhages Gastrointestinal haemorrhage 2 0 Haematemesis 9 2 Haematochezia 2 0 Melaena 2 0 Upper gastrointestinal haemorrhage 2 0 Oesophagitis (excl infective) Oesophagitis 1 0 Oral dryness and saliva altered Aptyalism 1 0 Dry mouth 76 0 Lip dry 5 0 Reaction Name Total Fatal Gastrointestinal disordersGastrointestinal disorders cont’d Salivary hypersecretion 6 0 Oral soft tissue disorders NEC Chapped lips 3 0 Cheilitis 5 0 Enlarged uvula 2 0 Lip blister 5 0 Lip disorder 2 0 Oral disorder 3 0 Oral papule 1 0 Uvulitis 1 0 Oral soft tissue haemorrhages Mouth haemorrhage 1 0 Oral blood blister 3 0 Oral soft tissue signs and symptoms Hypoaesthesia oral 81 0 Lip discolouration 1 0 Lip erythema 1 0 Lip pain 8 0 Lip pruritus 2 0 Lip scab 1 0 Odynophagia 2 0 Oral discomfort 6 0 Oral mucosal blistering 6 0 Oral mucosal eruption 3 0 Oral mucosal exfoliation 2 0 Oral pain 18 0 Oral pruritus 4 0 Paraesthesia oral 255 0 Oral soft tissue swelling and oedema Lip oedema 1 0 Lip swelling 113 0 Mouth swelling 9 0 Oedema mouth 1 0 Peritoneal and retroperitoneal fibrosis and adhesions Abdominal adhesions 1 0 Rectal inflammations NEC Proctitis 1 0 Proctitis ulcerative 1 0 Salivary gland disorders NEC Salivary gland pain 2 0 Salivary gland enlargements Parotid gland enlargement 1 0 Submaxillary gland enlargement 3 0 Stomatitis and ulceration Aphthous ulcer 7 0 Lip ulceration 2 0 Mouth ulceration 46 0 Oral mucosa erosion 1 0 Stomatitis 6 0 Tongue disorders Glossitis 2 0 Plicated tongue 2 0 Reaction Name Total Fatal Gastrointestinal disordersGastrointestinal disorders cont’d Tongue disorder 4 0 Tongue haemorrhage 1 0 Tongue ulceration 7 0 Tongue signs and symptoms Glossodynia 31 0 Stiff tongue 1 0 Swollen tongue 88 0 Tongue blistering 2 0 Tongue coated 1 0 Tongue discolouration 1 0 Tongue discomfort 6 0 Tongue dry 4 0 Tongue eruption 3 0 Tongue erythema 1 0 Tongue movement disturbance 1 0 Tongue oedema 2 0 Tongue spasm 2 0 Gastrointestinal disorders SOC TOTAL 5314 5 Reaction Name Total Fatal General disorders Administration site reactions NEC Administration site bruise 1 0 Administration site erythema 1 0 Administration site pain 3 0 Administration site warmth 1 0 Puncture site bruise 3 0 Puncture site pain 3 0 Puncture site swelling 1 0 Vessel puncture site bruise 1 0 Adverse effect absent No adverse event 1 0 Application and instillation site reactions Application site bruise 1 0 Application site erythema 1 0 Application site pain 1 0 Instillation site warmth 1 0 Asthenic conditions Asthenia 223 0 Chronic fatigue syndrome 1 0 Fatigue 3230 0 Malaise 779 0 Sluggishness 2 0 Body temperature altered Hypothermia 8 0 Temperature regulation disorder 3 0 Complications associated with device NEC Medical device pain 1 0 Medical device site swelling 1 0 Death and sudden death Clinical death 1 1 Death 59 53 Sudden death 7 7 Febrile disorders Hyperpyrexia 2 0 Pyrexia 3173 0 Feelings and sensations NEC Chills 1994 0 Feeling abnormal 144 0 Feeling cold 191 0 Feeling drunk 10 0 Feeling hot 233 0 Feeling jittery 5 0 Feeling of body temperature change 66 0 Hangover 5 0 Hunger 3 0 Sensation of foreign body 10 0 Temperature intolerance 1 0 Thirst 37 0 Gait disturbances Gait disturbance 15 0 Gait inability 10 0 Loss of control of legs 1 0 Reaction Name Total Fatal General disorders General disorders cont’d General signs and symptoms NEC Condition aggravated 14 0 Crying 4 0 Disease recurrence 1 0 Exercise tolerance decreased 2 0 General physical health deterioration 1 0 Glassy eyes 2 0 Illness 203 0 Induration 2 0 Influenza like illness 412 0 Local reaction 25 0 Peripheral swelling 380 0 Pre-existing condition improved 1 0 Screaming 1 0 Secretion discharge 2 0 Swelling 328 0 Swelling face 102 0 Inflammations Inflammation 35 0 Systemic inflammatory response syndrome 1 0 Infusion site reactions Infusion site erythema 1 0 Infusion site joint pain 2 0 Infusion site pain 1 0 Injection site reactions Injected limb mobility decreased 7 0 Injection site bruising 10 0 Injection site discolouration 1 0 Injection site discomfort 2 0 Injection site erythema 96 0 Injection site haemorrhage 2 0 Injection site hypoaesthesia 4 0 Injection site induration 1 0 Injection site inflammation 6 0 Injection site joint pain 3 0 Injection site mass 63 0 Injection site oedema 4 0 Injection site pain 699 0 Injection site paraesthesia 2 0 Injection site pruritus 39 0 Injection site rash 13 0 Injection site reaction 5 0 Injection site scab 1 0 Injection site scar 2 0 Injection site swelling 85 0 Injection site urticaria 4 0 Injection site vesicles 2 0 Injection site warmth 29 0 Interactions Alcohol interaction 2 0 Drug interaction 2 0 Mass conditions NEC Reaction Name Total Fatal General disorders General disorders cont’d Cyst 1 0 Mass 3 0 Nodule 3 0 Oedema NEC Face oedema 4 0 Localised oedema 6 0 Oedema 5 0 Oedema peripheral 9 0 Pain and discomfort NEC Axillary pain 145 0 Chest discomfort 190 0 Chest pain 242 0 Discomfort 20 0 Facial discomfort 3 0 Facial pain 28 0 Non-cardiac chest pain 2 0 Pain 1176 0 Tenderness 93 0 Therapeutic and nontherapeutic responses Adverse drug reaction 599 0 Adverse event 5 0 Adverse reaction 4 0 Drug ineffective 58 0 Immediate post-injection reaction 1 0 No reaction on previous exposure to drug 4 0 Therapeutic product effect delayed 1 0 Therapeutic response unexpected 4 0 Treatment failure 1 0 Vaccination site reactions Extensive swelling of vaccinated limb 1 0 Shoulder injury related to vaccine administration 1 0 Vaccination site bruising 26 0 Vaccination site discolouration 4 0 Vaccination site discomfort 11 0 Vaccination site eczema 1 0 Vaccination site erythema 151 0 Vaccination site haemorrhage 4 0 Vaccination site hypoaesthesia 1 0 Vaccination site induration 23 0 Vaccination site inflammation 24 0 Vaccination site irritation 3 0 Vaccination site joint discomfort 2 0 Vaccination site joint erythema 3 0 Vaccination site joint movement impairment 8 0 Vaccination site joint pain 18 0 Vaccination site joint swelling 2 0 Vaccination site joint warmth 1 0 Vaccination site lymphadenopathy 1 0 Vaccination site mass 37 0 Vaccination site movement impairment 10 0 Vaccination site oedema 3 0 Vaccination site pain 624 0 Reaction Name Total Fatal General disorders General disorders cont’d Vaccination site paraesthesia 4 0 Vaccination site pruritus 43 0 Vaccination site rash 21 0 Vaccination site reaction 9 0 Vaccination site swelling 171 0 Vaccination site ulcer 1 0 Vaccination site urticaria 4 0 Vaccination site vesicles 1 0 Vaccination site warmth 91 0 General disorders SOC TOTAL 16749 61 Reaction Name Total Fatal Hepatic disorders Cholestasis and jaundice Jaundice 1 0 Hepatic vascular disorders Hepatic artery embolism 1 0 Hepatobiliary signs and symptoms Hepatic pain 4 0 Hepatocellular damage and hepatitis NEC Hepatitis 1 0 Liver injury 1 0 Hepatic disorders SOC TOTAL 8 0 Reaction Name Total Fatal Immune system disorders Allergic conditions NEC Allergic oedema 2 0 Hypersensitivity 121 0 Type IV hypersensitivity reaction 1 0 Allergies to foods, food additives, drugs and other chemicals Allergy to vaccine 12 0 Drug hypersensitivity 2 0 Reaction to preservatives 3 0 Anaphylactic and anaphylactoid responses Anaphylactic reaction 91 0 Anaphylactic shock 2 0 Anaphylactoid reaction 6 0 Anaphylactoid shock 2 0 Atopic disorders Seasonal allergy 1 0 Autoimmune disorders NEC Autoimmune disorder 1 0 Immune and associated conditions NEC Bacille Calmette-Guerin scar reactivation 2 0 Immune system disorder 1 0 Immune-mediated adverse reaction 1 0 Immune system disorders SOC TOTAL 248 0 Reaction Name Total Fatal Infections Abdominal and gastrointestinal infections Appendicitis 2 0 Gastroenteritis 3 0 Bacterial infections NEC Bacterial diarrhoea 1 0 Cellulitis 35 0 Injection site cellulitis 1 0 Tonsillitis bacterial 1 0 Vaccination site cellulitis 6 0 Breast infections Breast abscess 1 0 Mastitis 3 0 Candida infections Candida infection 2 0 Oral candidiasis 5 0 Vulvovaginal candidiasis 4 0 Central nervous system and spinal infections Myelitis 1 0 Clostridia infections Clostridium difficile infection 1 0 Coronavirus infections Asymptomatic COVID-19 4 0 COVID-19 217 10 COVID-19 pneumonia 2 1 Coronavirus infection 5 0 Severe acute respiratory syndrome 1 0 Suspected COVID-19 15 0 Coxiella infections Q fever 4 0 Dental and oral soft tissue infections Abscess oral 1 0 Gingivitis 1 0 Parotitis 4 0 Ear infections Ear infection 5 0 Labyrinthitis 9 0 Eye and eyelid infections Conjunctivitis 10 0 Eye abscess 1 0 Eye infection 1 0 Hordeolum 2 0 Female reproductive tract infections Vulval abscess 1 0 Hepatobiliary and spleen infections Biliary sepsis 1 0 Herpes viral infections Genital herpes 1 0 Herpes simplex 1 0 Herpes simplex reactivation 1 0 Herpes virus infection 3 0 Herpes zoster 70 0 Herpes zoster oticus 1 0 Reaction Name Total Fatal Infections Infections cont’d Oral herpes 30 0 Infections NEC Abscess 3 0 Infection 56 0 Injection site infection 1 0 Localised infection 2 0 Lymph gland infection 2 0 Vaccination site abscess 1 0 Vaccination site infection 6 0 Influenza viral infections Influenza 192 0 Lower respiratory tract and lung infections Bronchitis 1 0 Lower respiratory tract infection 14 4 Pneumonia 8 2 Sputum purulent 1 0 Male reproductive tract infections Orchitis 1 0 Muscle and soft tissue infections Soft tissue infection 1 0 Sepsis, bacteraemia, viraemia and fungaemia NEC Sepsis 3 0 Urosepsis 1 0 Skin structures and soft tissue infections Acne pustular 1 0 Folliculitis 2 0 Pustule 2 0 Rash pustular 1 0 Skin infection 1 0 Staphylococcal infections Furuncle 2 0 Staphylococcal abscess 1 0 Streptococcal infections Pharyngitis streptococcal 2 0 Trypanosomal infections African trypanosomiasis 1 0 Upper respiratory tract infections Nasopharyngitis 90 0 Pharyngitis 4 0 Rhinitis 10 0 Sinusitis 4 0 Tonsillitis 11 0 Tracheitis 1 0 Urinary tract infections Cystitis 4 0 Kidney infection 2 0 Pyelonephritis 1 0 Urinary tract infection 11 0 Vascular infections Haematoma infection 1 0 Viral infections NEC Conjunctivitis viral 1 0 Reaction Name Total Fatal Infections Infections cont’d Eye infection viral 1 0 Gastroenteritis viral 3 0 Post viral fatigue syndrome 4 0 Sweating fever 21 0 Vestibular neuronitis 3 0 Viral infection 1 0 Viral labyrinthitis 2 0 Viral pharyngitis 3 0 Viral rash 6 0 Viral tonsillitis 1 0 Infections SOC TOTAL 948 17 Reaction Name Total Fatal Injuries Abdominal and gastrointestinal injuries NEC Oral contusion 1 0 Anaesthetic and allied procedural complications Delayed recovery from anaesthesia 1 0 Conditions caused by cold Chillblains 4 0 Exposures associated with pregnancy, delivery and lactation Exposure during pregnancy 5 0 Maternal exposure during breast feeding 8 0 Maternal exposure during pregnancy 10 0 Eye injuries NEC Eye contusion 2 0 Eye injury 2 0 Injury corneal 1 0 Gastrointestinal and hepatobiliary procedural complications Post procedural constipation 1 0 Postoperative ileus 1 0 Procedural nausea 1 0 Heat injuries (excl thermal burns) Heat illness 1 0 Heat oedema 1 0 Heat stroke 1 0 Medication errors, product use errors and issues NEC Medication error 1 0 Muscle, tendon and ligament injuries Muscle strain 2 0 Nerve injuries NEC Nerve injury 2 0 Neurological and psychiatric procedural complications Procedural dizziness 2 0 Non-site specific injuries NEC Bite 1 0 Electric shock 2 0 Fall 18 0 Wound complication 1 0 Non-site specific procedural complications Incision site pain 1 0 Infusion related reaction 2 0 Injection related reaction 7 0 Off label uses Off label use 1 0 Overdoses NEC Overdose 6 0 Poisoning and toxicity Poisoning 1 0 Product administration errors and issues Accidental overdose 1 0 Contraindicated product administered 1 0 Inappropriate schedule of product administration 4 0 Product administered at inappropriate site 3 0 Product administered to patient of inappropriate age 1 0 Product administration error 1 0 Reaction Name Total Fatal Injuries Injuries cont’d Product dose omission issue 1 0 Product preparation errors and issues Product preparation issue 3 0 Radiation injuries Sunburn 1 0 Site specific injuries NEC Face crushing 1 0 Head injury 1 0 Limb injury 1 0 Skin injuries NEC Contusion 47 0 Scar 1 0 Skin abrasion 2 0 Stoma complications Gastrointestinal stoma complication 1 0 Stoma site discharge 1 0 Stoma site extravasation 1 0 Stoma site haemorrhage 1 0 Thermal burns Burns second degree 1 0 Thermal burn 2 0 Vaccination related complications Vaccination complication 9 0 Injuries SOC TOTAL 172 0 Reaction Name Total Fatal Investigations Adrenal cortex tests Cortisol decreased 1 0 Blood gas and acid base analyses Blood lactic acid increased 2 0 Blood pH increased 1 0 Oxygen consumption decreased 1 0 Oxygen saturation decreased 16 0 Carbohydrate tolerance analyses (incl diabetes) Blood glucose decreased 4 0 Blood glucose increased 13 0 Glycosylated haemoglobin increased 1 0 Cardiac function diagnostic procedures Central venous pressure 1 0 Chemistry analyses NEC Inflammatory marker increased 1 0 Coagulation and bleeding analyses Fibrin D dimer increased 1 0 International normalised ratio decreased 1 0 International normalised ratio increased 8 0 ECG investigations Electrocardiogram ST segment elevation 1 0 Haematological analyses NEC Red blood cell sedimentation rate increased 1 0 Heart rate and pulse investigations Heart rate 16 0 Heart rate abnormal 2 0 Heart rate decreased 5 0 Heart rate increased 98 0 Heart rate irregular 8 0 Pulse abnormal 5 0 Immunology analyses NEC Immunology test 1 0 Investigations NEC Blood test abnormal 2 0 Polymerase chain reaction positive 3 0 Liver function analyses Alanine aminotransferase increased 1 0 Gamma-glutamyltransferase increased 1 0 Hepatic enzyme increased 1 0 Liver function test increased 1 0 Transaminases increased 1 0 Metabolism tests NEC Blood ketone body increased 1 0 Microbiology and serology tests NEC Culture negative 1 0 Mineral and electrolyte analyses Blood potassium abnormal 1 0 Neurologic diagnostic procedures Coma scale abnormal 1 0 Ophthalmic function diagnostic procedures Intraocular pressure increased 1 0 Physical examination procedures and organ system status Reaction Name Total Fatal Investigations Investigations cont’d Body temperature 59 0 Body temperature abnormal 17 0 Body temperature decreased 6 0 Body temperature fluctuation 4 0 Body temperature increased 120 0 Body temperature normal 1 0 Breath sounds abnormal 1 0 Grip strength 1 0 Grip strength decreased 2 0 Lymph node palpable 3 0 Respiratory rate decreased 1 0 Respiratory rate increased 11 0 Skin temperature 4 0 Weight decreased 3 0 Pituitary analyses anterior Blood growth hormone 1 0 Protein analyses NEC C-reactive protein increased 2 0 Red blood cell analyses Haemoglobin decreased 3 0 Respiratory and pulmonary function diagnostic procedures Forced expiratory volume increased 1 0 Skeletal and cardiac muscle analyses Blood creatine phosphokinase increased 1 0 Troponin increased 2 0 Therapeutic drug monitoring analyses Anticoagulation drug level increased 1 0 Thyroid analyses Tri-iodothyronine 1 0 Tri-iodothyronine decreased 1 0 Urinalysis NEC Blood urine present 4 0 pH urine 1 0 Urinary tract function analyses NEC Urine output 2 0 Urine output decreased 3 0 Urine output increased 1 0 Vascular tests NEC (incl blood pressure) Blood pressure abnormal 2 0 Blood pressure decreased 9 0 Blood pressure increased 37 0 Blood pressure measurement 5 0 Blood pressure systolic decreased 1 0 Blood pressure systolic increased 1 0 Virus identification and serology SARS-CoV-2 test 1 0 SARS-CoV-2 test false positive 1 0 SARS-CoV-2 test positive 20 0 White blood cell analyses White blood cell count decreased 1 0 Investigations SOC TOTAL 538 0 Reaction Name Total Fatal Metabolic disorders Appetite disorders Appetite disorder 1 0 Decreased appetite 210 0 Eating disorder symptom 1 0 Food craving 1 0 Food refusal 1 0 Hypophagia 2 0 Increased appetite 1 0 Diabetes mellitus (incl subtypes) Diabetes mellitus inadequate control 2 1 Type 1 diabetes mellitus 1 0 Diabetic complications NEC Diabetic complication 1 0 Diabetic ketoacidosis 3 0 Disorders of purine metabolism Gout 4 0 Electrolyte imbalance NEC Fluid imbalance 1 0 Fluid intake decreased Fluid intake reduced 1 0 Fluid intake increased Polydipsia 1 0 General nutritional disorders NEC Abnormal weight gain 1 0 Feeding disorder 5 0 Hyperglycaemic conditions NEC Hyperglycaemia 11 0 Hypoglycaemic conditions NEC Hypoglycaemia 14 0 Lipid metabolism and deposit disorders NEC Body fat disorder 1 0 Metabolic acidoses (excl diabetic acidoses) Ketoacidosis 1 0 Mixed acid-base disorders Acidosis 2 0 Sodium imbalance Hyponatraemia 2 0 Total fluid volume decreased Dehydration 20 0 Total fluid volume increased Fluid retention 2 0 Metabolic disorders SOC TOTAL 290 1 Reaction Name Total Fatal Muscle & tissue disorders Arthropathies NEC Arthritis 18 0 Arthropathy 2 0 Sacroiliitis 1 0 Bone disorders NEC Medial tibial stress syndrome 1 0 Spinal disorder 1 0 Bone related signs and symptoms Bone pain 44 0 Bone swelling 2 0 Coccydynia 1 0 Pain in jaw 42 0 Spinal pain 6 0 Bursal disorders Bursitis 2 0 Cartilage disorders Costochondritis 2 0 Connective tissue disorders NEC Polymyalgia rheumatica 2 0 Extremity deformities Foot deformity 1 0 Joint related disorders NEC Joint lock 1 0 Periarthritis 4 0 Temporomandibular joint syndrome 1 0 Joint related signs and symptoms Arthralgia 1414 0 Jaw clicking 2 0 Joint effusion 3 0 Joint noise 2 0 Joint range of motion decreased 1 0 Joint stiffness 25 0 Joint swelling 31 0 Joint warmth 1 0 Lupus erythematosus (incl subtypes) Systemic lupus erythematosus 1 0 Muscle infections and inflammations Myositis 2 0 Muscle pains Fibromyalgia 6 0 Myalgia 2280 0 Myofascial pain syndrome 2 0 Muscle related signs and symptoms NEC Muscle discomfort 1 0 Muscle disorder 2 0 Muscle fatigue 47 0 Muscle spasms 87 0 Muscle swelling 5 0 Muscle tightness 6 0 Muscle twitching 28 0 Muscle tone abnormalities Muscle rigidity 5 0 Reaction Name Total Fatal Muscle & tissue disordersMuscle & tissue disorders cont’d Nuchal rigidity 2 0 Torticollis 1 0 Trismus 2 0 Muscle weakness conditions Muscular weakness 101 0 Musculoskeletal and connective tissue conditions NEC Limb mass 2 0 Mastication disorder 1 0 Mobility decreased 11 0 Musculoskeletal disorder 3 0 Musculoskeletal stiffness 149 0 Musculoskeletal and connective tissue infections and inflammations NEC Fasciitis 1 0 Plantar fasciitis 1 0 Musculoskeletal and connective tissue pain and discomfort Back pain 304 0 Flank pain 6 0 Limb discomfort 193 0 Musculoskeletal chest pain 16 0 Musculoskeletal discomfort 12 0 Musculoskeletal pain 10 0 Neck pain 260 0 Pain in extremity 1530 0 Myopathies Rhabdomyolysis 3 0 Osteoarthropathies Osteoarthritis 1 0 Psoriatic arthropathies Psoriatic arthropathy 1 0 Rheumatoid arthropathies Rheumatoid arthritis 5 0 Soft tissue disorders NEC Axillary mass 22 0 Groin pain 13 0 Neck mass 5 0 Spondyloarthropathies Ankylosing spondylitis 1 0 Arthritis reactive 3 0 Synovial disorders Synovial cyst 1 0 Synovitis 2 0 Tendon disorders Tendon pain 1 0 Tendonitis 1 0 Muscle & tissue disorders SOC TOTAL 6746 0 Reaction Name Total Fatal Neoplasms Lymphomas unspecified NEC Lymphoma 1 0 Metastases to specified sites Metastases to lymph nodes 1 0 Neoplasms SOC TOTAL 2 0 Reaction Name Total Fatal Nervous system disorders Abnormal reflexes Extensor plantar response 1 0 Hyperreflexia 1 0 Hyporeflexia 3 0 Absence seizures Petit mal epilepsy 3 0 Acute polyneuropathies Guillain-Barre syndrome 1 0 Autonomic nervous system disorders Anticholinergic syndrome 1 0 Central nervous system aneurysms and dissections Vertebral artery dissection 1 0 Central nervous system haemorrhages and cerebrovascular accidents Brain stem infarction 1 1 Cerebellar infarction 2 0 Cerebellar stroke 1 0 Cerebral artery occlusion 1 0 Cerebral haemorrhage 4 1 Cerebral infarction 4 0 Cerebrovascular accident 21 1 Haemorrhage intracranial 2 0 Ischaemic cerebral infarction 1 0 Ischaemic stroke 6 1 Lacunar infarction 2 0 Lacunar stroke 1 0 Subarachnoid haemorrhage 2 1 Central nervous system inflammatory disorders NEC Gliosis 1 0 Cerebrovascular venous and sinus thrombosis Cerebral venous sinus thrombosis 1 0 Coordination and balance disturbances Balance disorder 38 0 Coordination abnormal 7 0 Dysstasia 9 0 Cortical dysfunction NEC Aphasia 7 0 Cranial nerve disorders NEC Cranial nerve disorder 1 0 Dementia (excl Alzheimer’s type) Dementia 1 0 Disturbances in consciousness NEC Altered state of consciousness 3 0 Consciousness fluctuating 1 0 Depressed level of consciousness 4 0 Lethargy 390 0 Loss of consciousness 42 0 Sedation 2 0 Somnolence 105 0 Stupor 1 0 Syncope 151 0 Dyskinesias and movement disorders NEC Bradykinesia 2 0 Reaction Name Total Fatal Nervous system disordersNervous system disorders cont’d Dyskinesia 1 0 Fine motor skill dysfunction 1 0 Hypokinesia 2 0 Motor dysfunction 1 0 Movement disorder 5 0 Psychomotor hyperactivity 3 0 Dystonias Dystonia 5 0 Writer’s cramp 1 0 Encephalopathies NEC Posterior reversible encephalopathy syndrome 1 0 Eye movement disorders VIth nerve paralysis 1 0 Facial cranial nerve disorders Facial nerve disorder 1 0 Facial paralysis 58 0 Facial paresis 11 0 Facial spasm 6 0 Generalised tonic-clonic seizures Generalised tonic-clonic seizure 4 0 Headaches NEC Cervicogenic headache 1 0 Cluster headache 29 0 Cold-stimulus headache 1 0 Exertional headache 3 0 Headache 4570 0 Medication overuse headache 2 0 New daily persistent headache 1 0 Ophthalmoplegic migraine 1 0 Primary cough headache 1 0 Primary headache associated with sexual activity 1 0 Sinus headache 55 0 Tension headache 79 0 Thunderclap headache 1 0 Lumbar spinal cord and nerve root disorders Sciatica 7 0 Memory loss (excl dementia) Amnesia 7 0 Memory impairment 14 0 Mental impairment (excl dementia and memory loss) Cognitive disorder 6 0 Disturbance in attention 37 0 Mental impairment 5 0 Migraine headaches Migraine 308 0 Migraine with aura 21 0 Retinal migraine 2 0 Typical aura without headache 1 0 Vestibular migraine 1 0 Mononeuropathies Carpal tunnel syndrome 1 0 Mononeuropathy 1 0 Reaction Name Total Fatal Nervous system disordersNervous system disorders cont’d Nerve compression 2 0 Multiple sclerosis acute and progressive Multiple sclerosis 1 0 Multiple sclerosis relapse 2 0 Muscle tone abnormal Muscle tone disorder 1 0 Serotonin syndrome 1 0 Stiff leg syndrome 1 0 Myelitis (incl infective) Myelitis transverse 1 0 Narcolepsy and hypersomnia Hypersomnia 14 0 Narcolepsy 1 0 Nervous system disorders NEC Nervous system disorder 2 0 Neurologic visual problems NEC Tunnel vision 3 0 Visual field defect 1 0 Neurological signs and symptoms NEC Dizziness 1278 0 Dizziness exertional 3 0 Dizziness postural 117 0 Head discomfort 29 0 Hyporesponsive to stimuli 1 0 Myoclonus 1 0 Neurological symptom 2 0 Persistent postural-perceptual dizziness 1 0 Presyncope 95 0 Slow response to stimuli 1 0 Unresponsive to stimuli 12 0 Neuromuscular disorders NEC Muscle contractions involuntary 4 0 Neuromuscular junction dysfunction Myasthenia gravis 1 0 Olfactory nerve disorders Anosmia 38 0 Hyposmia 4 0 Parosmia 20 0 Optic nerve disorders NEC Optic neuritis 1 0 Paraesthesias and dysaesthesias Burning sensation 51 0 Dysaesthesia 1 0 Formication 3 0 Hemiparaesthesia 1 0 Hyperaesthesia 13 0 Hypoaesthesia 259 0 Paraesthesia 394 0 Paralysis and paresis (excl cranial nerve) Hemiparesis 10 0 Hemiplegia 1 0 Locked-in syndrome 1 0 Reaction Name Total Fatal Nervous system disordersNervous system disorders cont’d Monoparesis 4 0 Monoplegia 4 0 Paralysis 14 0 Parkinson’s disease and parkinsonism Freezing phenomenon 1 0 Parkinsonian gait 1 0 Parkinsonism 1 0 Partial complex seizures Dreamy state 1 0 Peripheral neuropathies NEC Neuropathy peripheral 8 0 Peripheral sensory neuropathy 2 0 Seizures and seizure disorders NEC Epilepsy 4 0 Febrile convulsion 1 0 Partial seizures 1 0 Seizure 34 0 Tonic convulsion 2 0 Sensory abnormalities NEC Ageusia 82 0 Allodynia 3 0 Aura 6 0 Dysgeusia 205 0 Neuralgia 31 0 Restless legs syndrome 13 0 Sensory disturbance 10 0 Sensory loss 3 0 Taste disorder 38 0 Sleep disturbances NEC Poor quality sleep 20 0 Speech and language abnormalities Dysarthria 14 0 Repetitive speech 1 0 Speech disorder 5 0 Spinal cord and nerve root disorders NEC Radiculopathy 1 0 Transient cerebrovascular events Transient ischaemic attack 11 0 Tremor (excl congenital) Essential tremor 1 0 Resting tremor 1 0 Tremor 221 0 Trigeminal disorders Facial neuralgia 2 0 Trigeminal nerve disorder 1 0 Trigeminal neuralgia 3 0 Nervous system disorders SOC TOTAL 9204 5 Reaction Name Total Fatal Pregnancy conditions Abortions spontaneous Abortion spontaneous 4 0 Maternal complications of pregnancy NEC Morning sickness 1 0 Normal pregnancy, labour and delivery Pregnancy 3 0 Pregnancy conditions SOC TOTAL 8 0 Reaction Name Total Fatal Device malfunction events NEC Device stimulation issue 1 0 Oversensing 4 0 Product contamination and sterility issues Product contamination physical 1 0 null SOC TOTAL 6 0 Reaction Name Total Fatal Psychiatric disorders Anxiety symptoms Agitation 18 0 Anxiety 55 0 Nervousness 30 0 Tension 12 0 Behaviour and socialisation disturbances Indifference 2 0 Paranoia 2 0 Social avoidant behaviour 2 0 Cognitive and attention disorders and disturbances NEC Mental fatigue 18 0 Communications disorders Communication disorder 1 0 Confusion and disorientation Confusional state 86 0 Disorientation 26 0 Deliria Delirium 21 0 Depressive disorders Depression 9 0 Dissociative states Depersonalisation/derealisation disorder 2 0 Dissociation 3 0 Dissociative amnesia 1 0 Disturbances in initiating and maintaining sleep Initial insomnia 3 0 Insomnia 129 0 Middle insomnia 3 0 Dyssomnias Dyssomnia 1 0 Eating disorders NEC Eating disorder 1 0 Emotional and mood disturbances NEC Anger 2 0 Emotional disorder 5 0 Emotional distress 2 0 Euphoric mood 3 0 Irritability 15 0 Mood altered 3 0 Fear symptoms and phobic disorders (incl social phobia) Phonophobia 1 0 Social fear 1 0 Fluctuating mood symptoms Mood swings 1 0 Hallucinations (excl sleep-related) Hallucination 31 0 Hallucination, auditory 2 0 Hallucination, olfactory 1 0 Hallucination, tactile 1 0 Hallucination, visual 4 0 Increased physical activity levels Restlessness 18 0 Reaction Name Total Fatal Psychiatric disordersPsychiatric disorders cont’d Mental disorders NEC Mental disorder 1 0 Mood alterations with depressive symptoms Decreased interest 2 0 Depressed mood 21 0 Negative thoughts 1 0 Tearfulness 2 0 Mood disorders NEC Apathy 1 0 Laziness 1 0 Listless 1 0 Narcolepsy and associated conditions Sleep attacks 2 0 Obsessive-compulsive disorders and symptoms Obsessive-compulsive symptom 1 0 Panic attacks and disorders Panic attack 11 0 Panic disorder 1 0 Panic reaction 3 0 Parasomnias Abnormal dreams 25 0 Nightmare 23 0 Sleep terror 1 0 Perception disturbances NEC Autoscopy 1 0 Derealisation 2 0 Illusion 1 0 Psychiatric elimination disorders Enuresis 4 0 Psychiatric symptoms NEC Trance 1 0 Psychotic disorder NEC Psychotic behaviour 1 0 Sleep disorders NEC Sleep disorder 23 0 Somatic symptom disorders Habit cough 2 0 Vomiting psychogenic 1 0 Speech and language usage disturbances Disorganised speech 2 0 Logorrhoea 1 0 Stereotypies and automatisms Head banging 2 0 Stereotypy 1 0 Suicidal and self-injurious behaviour Intentional self-injury 1 0 Thinking disturbances Bradyphrenia 7 0 Thinking abnormal 3 0 Psychiatric disorders SOC TOTAL 665 0 Reaction Name Total Fatal Renal & urinary disorders Bladder and urethral symptoms Bladder discomfort 1 0 Dysuria 6 0 Incontinence 4 0 Micturition disorder 1 0 Micturition urgency 1 0 Pollakiuria 6 0 Urinary incontinence 8 0 Urinary retention 8 0 Bladder disorders NEC Bladder disorder 3 0 Genital and urinary tract disorders NEC Urinary tract disorder 1 0 Myoneurogenic bladder disorders Hypertonic bladder 1 0 Loss of bladder sensation 1 0 Renal failure and impairment Acute kidney injury 3 0 Renal failure 2 0 Urinary abnormalities Chromaturia 11 0 Haematuria 3 0 Proteinuria 1 0 Urine abnormality 2 0 Urine odour abnormal 2 0 Urinary tract signs and symptoms NEC Costovertebral angle tenderness 1 0 Haemorrhage urinary tract 1 0 Nocturia 1 0 Polyuria 1 0 Renal pain 29 0 Renal & urinary disorders SOC TOTAL 98 0 Reaction Name Total Fatal Reproductive & breast disorders Benign and malignant breast neoplasms Breast cyst 1 0 Breast disorders NEC Breast mass 3 0 Breast signs and symptoms Breast discomfort 1 0 Breast pain 22 0 Breast swelling 8 0 Breast tenderness 2 0 Nipple pain 3 0 Nipple swelling 2 0 Erection and ejaculation conditions and disorders Erectile dysfunction 3 0 Menopausal effects NEC Menopausal symptoms 2 0 Menstruation and uterine bleeding NEC Dysmenorrhoea 9 0 Menstrual disorder 5 0 Menstruation irregular 7 0 Metrorrhagia 2 0 Menstruation with decreased bleeding Amenorrhoea 1 0 Hypomenorrhoea 2 0 Menstruation delayed 7 0 Menstruation with increased bleeding Menorrhagia 15 0 Polymenorrhoea 3 0 Ovarian and fallopian tube disorders NEC Ovulation pain 2 0 Pelvis and broad ligament disorders NEC Adnexa uteri pain 1 0 Penile disorders NEC (excl erection and ejaculation) Penile swelling 1 0 Prostatic signs, symptoms and disorders NEC Prostatomegaly 1 0 Reproductive tract signs and symptoms NEC Pelvic discomfort 1 0 Pelvic pain 2 0 Perineal pain 1 0 Scrotal disorders NEC Scrotal erythema 1 0 Scrotal exfoliation 1 0 Scrotal pain 2 0 Scrotal swelling 1 0 Testicular and epididymal disorders NEC Testicular pain 2 0 Testicular swelling 1 0 Uterine tone disorders Uterine spasm 1 0 Vulvovaginal disorders NEC Vaginal haemorrhage 16 0 Vulval ulceration 2 0 Reaction Name Total Fatal Reproductive & breast disordersReproductive & breast disorders cont’d Vulvovaginal signs and symptoms Vulvovaginal pruritus 1 0 Reproductive & breast disorders SOC TOTAL 135 0 Reaction Name Total Fatal Respiratory disorders Breathing abnormalities Dyspnoea 415 0 Dyspnoea exertional 6 1 Hyperventilation 5 0 Hypopnoea 6 0 Irregular breathing 1 0 Mouth breathing 1 0 Orthopnoea 2 0 Respiration abnormal 7 0 Respiratory arrest 2 0 Respiratory distress 1 0 Tachypnoea 11 0 Bronchial conditions NEC Bronchial secretion retention 1 0 Bronchospasm and obstruction Asthma 37 0 Bronchospasm 3 0 Obstructive airways disorder 1 0 Wheezing 55 0 Conditions associated with abnormal gas exchange Hypoxia 4 1 Coughing and associated symptoms Cough 325 0 Haemoptysis 5 0 Productive cough 18 0 Sputum discoloured 1 0 Laryngeal spasm, oedema and obstruction Epiglottic oedema 1 0 Stridor 1 0 Lower respiratory tract inflammatory and immunologic conditions Hypersensitivity pneumonitis 1 0 Pneumonia aspiration 2 2 Pneumonitis 3 0 Lower respiratory tract signs and symptoms Hiccups 2 0 Pleuritic pain 4 0 Pulmonary pain 9 0 Rales 1 0 Nasal congestion and inflammations Nasal congestion 27 0 Rhinitis allergic 2 0 Nasal disorders NEC Epistaxis 80 0 Intranasal hypoaesthesia 1 0 Intranasal paraesthesia 1 0 Nasal disorder 1 0 Nasal dryness 3 0 Nasal odour 1 0 Nasal oedema 1 0 Nasal pruritus 1 0 Paranasal sinus disorders (excl infections and neoplasms) Sinonasal obstruction 2 0 Reaction Name Total Fatal Respiratory disordersRespiratory disorders cont’d Sinus congestion 6 0 Sinus disorder 1 0 Sinusitis noninfective 1 0 Parenchymal lung disorders NEC Atelectasis 1 0 Pharyngeal disorders (excl infections and neoplasms) Pharyngeal erythema 3 0 Pharyngeal haemorrhage 1 0 Pharyngeal hypoaesthesia 7 0 Pharyngeal inflammation 1 0 Pharyngeal oedema 3 0 Pharyngeal paraesthesia 16 0 Pharyngeal swelling 37 0 Pharyngeal ulceration 2 0 Tonsillar hypertrophy 9 0 Tonsillar inflammation 1 0 Pleural infections and inflammations Pleurisy 1 0 Pneumothorax and pleural effusions NEC Pleural effusion 1 0 Pulmonary oedemas Pulmonary congestion 1 0 Pulmonary oedema 2 0 Pulmonary thrombotic and embolic conditions Pulmonary embolism 2 0 Pulmonary infarction 1 0 Respiratory failures (excl neonatal) Acute respiratory failure 1 1 Respiratory signs and symptoms NEC Painful respiration 2 0 Respiratory symptom 1 0 Respiratory tract disorders NEC Aspiration 1 0 Respiratory disorder 1 0 Respiratory tract irritation 1 0 Respiratory tract oedema 1 0 Upper respiratory tract neoplasms Tonsillar cyst 1 0 Upper respiratory tract signs and symptoms Aphonia 10 0 Catarrh 3 0 Choking 2 0 Dry throat 26 0 Dysphonia 21 0 Increased upper airway secretion 3 0 Increased viscosity of upper respiratory secretion 2 0 Nasal discharge discolouration 1 0 Nasal discomfort 5 0 Nasal obstruction 2 0 Oropharyngeal blistering 5 0 Oropharyngeal discomfort 10 0 Oropharyngeal pain 386 0 Reaction Name Total Fatal Respiratory disordersRespiratory disorders cont’d Paranasal sinus discomfort 4 0 Rhinalgia 4 0 Rhinorrhoea 77 0 Sinus pain 25 0 Sneezing 45 0 Snoring 2 0 Throat clearing 2 0 Throat irritation 37 0 Throat tightness 51 0 Respiratory disorders SOC TOTAL 1880 5 Reaction Name Total Fatal Skin disorders Acnes Acne 4 0 Alopecias Alopecia 4 0 Angioedemas Angioedema 27 0 Circumoral swelling 1 0 Apocrine and eccrine gland disorders Cold sweat 102 0 Hyperhidrosis 251 0 Miliaria 8 0 Night sweats 104 0 Bullous conditions Blister 26 0 Blood blister 1 0 Dermatitis bullous 3 0 Erythema multiforme 3 0 Stevens-Johnson syndrome 1 0 Toxic epidermal necrolysis 1 1 Dermal and epidermal conditions NEC Dermatosis 1 0 Dry skin 20 0 Macule 1 0 Pain of skin 45 0 Papule 11 0 Peau d’orange 2 0 Scar pain 3 0 Sensitive skin 27 0 Skin burning sensation 24 0 Skin discolouration 17 0 Skin disorder 1 0 Skin induration 1 0 Skin lesion 3 0 Skin odour abnormal 2 0 Skin reaction 17 0 Skin sensitisation 4 0 Skin swelling 10 0 Skin tightness 11 0 Skin warm 45 0 Sticky skin 1 0 Yellow skin 3 0 Dermatitis and eczema Dermatitis 15 0 Dermatitis allergic 29 0 Dyshidrotic eczema 1 0 Eczema 7 0 Skin irritation 11 0 Dermatitis ascribed to specific agent Drug eruption 2 0 Fixed eruption 1 0 Toxic skin eruption 1 0 Erythemas Reaction Name Total Fatal Skin disorders Skin disorders cont’d Erythema 371 0 Exfoliative conditions Skin exfoliation 9 0 Hyperpigmentation disorders Ephelides 1 0 Nail and nail bed conditions (excl infections and infestations) Nail discolouration 2 0 Nail disorder 1 0 Onychalgia 1 0 Panniculitides Erythema nodosum 1 0 Papulosquamous conditions Lichen planus 1 0 Pityriasis rosea 7 0 Photosensitivity and photodermatosis conditions Photosensitivity reaction 6 0 Pigmentation changes NEC Pigmentation disorder 1 0 Pilar disorders NEC Piloerection 3 0 Pruritus NEC Itching scar 3 0 Pruritus 612 0 Psoriatic conditions Psoriasis 4 0 Purpura and related conditions Petechiae 15 0 Purpura 6 0 Rashes, eruptions and exanthems NEC Rash 648 0 Rash erythematous 132 0 Rash macular 69 0 Rash maculo-papular 12 0 Rash morbilliform 4 0 Rash papular 42 0 Rash pruritic 102 0 Rash vesicular 4 0 Rosaceas Rosacea 1 0 Scaly conditions Pityriasis 3 0 Skin and subcutaneous conditions NEC Skin mass 3 0 Skin and subcutaneous tissue ulcerations Skin erosion 3 0 Skin ulcer 1 0 Skin cysts and polyps Dermal cyst 1 0 Skin haemorrhages Haemorrhage subcutaneous 1 0 Skin haemorrhage 1 0 Skin hyperplasias and hypertrophies Reaction Name Total Fatal Skin disorders Skin disorders cont’d Skin hypertrophy 1 0 Skin vasculitides Vasculitic rash 1 0 Skin vasomotor conditions Livedo reticularis 8 0 Urticarias Cold urticaria 1 0 Mechanical urticaria 1 0 Urticaria 217 0 Urticaria papular 1 0 Urticaria thermal 1 0 Skin disorders SOC TOTAL 3154 1 Reaction Name Total Fatal Social circumstances Disability issues Bedridden 5 0 Breast prosthesis user 1 0 Immobile 2 0 Impaired work ability 1 0 Social circumstances SOC TOTAL 9 0 Reaction Name Total Fatal Surgical & medical procedures Gastrointestinal therapeutic procedures NEC Prophylaxis of nausea and vomiting 4 0 Immunisations COVID-19 immunisation 3 0 Immunisation 1 0 Limb therapeutic procedures Limb immobilisation 1 0 Respiratory tract therapeutic procedures NEC Asthma prophylaxis 1 0 Skin and subcutaneous tissue therapeutic procedures NEC Dermal filler injection 1 0 Therapeutic procedures NEC Bed rest 1 0 Fatigue management 1 0 Hospitalisation 1 0 Injection 1 0 Surgical & medical procedures SOC TOTAL 15 0 Reaction Name Total Fatal Vascular disorders Blood pressure disorders NEC Blood pressure fluctuation 2 0 Circulatory collapse and shock Circulatory collapse 21 0 Neurogenic shock 6 0 Peripheral circulatory failure 2 0 Haemorrhages NEC Haematoma 3 0 Haemorrhage 5 0 Lymphoedemas Lymphoedema 17 0 Non-site specific embolism and thrombosis Thrombosis 6 0 Non-site specific vascular disorders NEC Superficial vein prominence 1 0 Vasodilatation 1 0 Vein discolouration 1 0 Vein disorder 2 0 Vein rupture 1 0 Peripheral embolism and thrombosis Blue toe syndrome 1 0 Deep vein thrombosis 5 0 Peripheral vascular disorders NEC Cyanosis 8 0 Flushing 106 0 Hot flush 152 0 Peripheral vasoconstriction, necrosis and vascular insufficiency Peripheral coldness 43 0 Peripheral ischaemia 1 0 Poor peripheral circulation 1 0 Raynaud’s phenomenon 3 0 Vasoconstriction 1 0 Site specific vascular disorders NEC Pallor 32 0 Vascular hypertensive disorders NEC Hypertension 78 0 Vascular hypotensive disorders Hypotension 62 0 Orthostatic hypotension 3 0 Vasculitides NEC Vasculitis 4 0 Vena caval embolism and thrombosis Vena cava embolism 1 0 Vena cava thrombosis 1 0 Vascular disorders SOC TOTAL 570 0 TOTAL REACTIONS FOR DRUG 49472 107 TOTAL REPORTS 16756 TOTAL FATAL OUTCOME REPORTS 107







