Category: MRNA vaccines

  • Creator of mRNA Vaccine Technology Tells Tucker Carlson: ‘Government Not Being Transparent’ About Vaccine Risks

    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.

    ***

    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:

    https://youtube.com/watch?v=KEoZh6YzsW8

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    Featured image is a screenshot from the video

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    Inventor of mRNA Technology: Vaccine Causes Lipid Nanoparticles to Accumulate in ‘High Concentrations’ in Ovaries

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    22 June 2021

    Did Pfizer Fail to Perform Industry Standard Animal Testing Prior to Initiation of mRNA Clinical Trials?

    15 June 2021The original source of this article is Children’s Health Defense

    Copyright © Children’s Health DefenseChildren’s Health Defense, 2021

  • Video: Toxicologist Dr. Janci Chunn Lindsay to the CDC: Stop Vaccinations

    Video: Toxicologist Dr. Janci Chunn Lindsay to the CDC: Stop Vaccinations

    Original Link Here

    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). 

    Visit and follow us on Instagram at @crg_globalresearch.

    ***

    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

    10 May 2021

    Video: Petition to Revoke the Covid-19 Vaccines: Dr. Meryl Nass

    30 May 2021

    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

    The Whistleblower Newsroom, 2021

  • Dr. Mike Yeadon

    Dr. Mike Yeadon

  • C. Y. A. and “Fraudulent Marketing”: The Pfizer COVID-19 Vaccine Is an “Unapproved Product” which Is “Permitted for Use”

    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).

    ***

    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 SafireNYT,)

    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?

    1. Both the WHO and the CDC have confirmed that Covid-19 is  “similar to seasonal influenza”, It is not a killer virus. 
    2. The PCR test used to estimate “confirmed positive cases” is flawed.
    3. Since March 2020, the Covid-19 “numbers” have been manipulated, hiked up.
    4. 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

    11 February 2021

    Unlike UK, U.S. FDA Allows Pregnant and Nursing Women to Receive Experimental Pfizer COVID Vaccine

    16 December 2020

    Dangerous mRNA Vaccine: Is Mandatory US Covid Vaxxing Coming?

    2 February 2021The original source of this article is Global Research

    Copyright © Prof Michel Chossudovsky, Global Research, 2021

  • Synthetic mRNA Covid vaccines: A Risk-Benefit Analysis/By Sadaf Gilani for OffGuardian

    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 group

    8/162 = 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.

    FILED UNDER: CORONAVIRUSFEATUREDLATESTSTATISTICS AND ANALYSISTAGGED WITH: ANTIBODY DEPENDENT ENHANCEMENTJUDY MIKOVITSMICHAEL YEADONMODERNAPFIZERSADAF GILANISUCHARIT BHAKDIVACCINESWOLFGANG WODARG

    can you spare $1.00 a month to support independent media

    Unlike the Guardian we are NOT funded by Bill & Melinda Gates, or any other NGO or government. So a few coins in our jar to help us keep going are always appreciated.

    Our Bitcoin JTR code is: 1JR1whUa3G24wXpDyqMKpieckMGGW2u2VX

  • Vaccination Deaths in a Berlin Care Home, February 8, 2021.

    Vaccination Deaths in a Berlin Care Home, February 8, 2021.

    https://vimeo.com/512937214?1&ref=fb-share&fbclid=IwAR0PxPXpBDtW6hAdv6ALz7a35vytz8Iyplg4HNmZEvKCfKI0Gb1gqCAa1ps
  • Immunologist: Pfizer, Moderna Vaccines Could Cause Long-Term Chronic Illness

    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.

    *

    Note to readers: please click the share buttons above or below. Forward this article to your email lists. Crosspost on your blog site, internet forums. etc.

    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 DefenseChildren’s Health Defense, 2021

  • Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print

    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 NameTotalFatal
    Blood disorders  
       Anaemias NEC  
          Anaemia20
       Bleeding tendencies  
          Increased tendency to bruise10
       Lymphatic system disorders NEC  
          Lymph node pain1510
          Lymphadenitis180
          Lymphadenopathy9690
          Lymphatic disorder10
          Pseudolymphoma10
       Marrow depression and hypoplastic anaemias  
          Pancytopenia10
       Neutropenias  
          Neutropenia20
       Thrombocytopenias  
          Immune thrombocytopenia10
          Thrombocytopenia40
       Thrombocytoses  
          Thrombocytosis10
    Blood disorders SOC TOTAL11520
    Reaction Name                                                                          Total    Fatal
    Cardiac disorders  
       Cardiac conduction disorders  
          Bundle branch block right20
       Cardiac disorders NEC  
          Cardiac disorder10
       Cardiac signs and symptoms NEC  
          Palpitations2540
       Heart failures NEC  
          Cardiopulmonary failure11
       Ischaemic coronary artery disorders  
          Acute myocardial infarction40
          Angina pectoris40
          Myocardial infarction133
       Left ventricular failures  
          Left ventricular failure10
       Myocardial disorders NEC  
          Right ventricular enlargement10
       Noninfectious myocarditis  
          Myocarditis50
       Noninfectious pericarditis  
          Pericarditis20
       Rate and rhythm disorders NEC  
          Arrhythmia70
          Bradycardia110
          Cardiac flutter80
          Extrasystoles70
          Postural orthostatic tachycardia syndrome10
          Tachycardia1930
       Supraventricular arrhythmias  
          Arrhythmia supraventricular20
          Atrial fibrillation241
          Atrial tachycardia10
          Sinus bradycardia10
          Sinus tachycardia180
          Supraventricular tachycardia70
       Ventricular arrhythmias and cardiac arrest  
          Cardiac arrest167
          Pulseless electrical activity10
          Ventricular extrasystoles20
          Ventricular fibrillation20
          Ventricular tachycardia10
    Cardiac disorders SOC TOTAL59012
    Reaction NameTotalFatal
    Congenital disorders  
       Neurological disorders congenital NEC  
          Familial hemiplegic migraine10
    Congenital disorders SOC TOTAL10
    Reaction Name                                                                          Total    Fatal
    Ear disorders  
       Ear disorders NEC  
          Ear canal erythema10
          Ear congestion20
          Ear discomfort90
          Ear disorder10
          Ear pain980
          Ear pruritus10
          Ear swelling10
       Hearing losses  
          Deafness50
          Hypoacusis130
          Sudden hearing loss10
       Hyperacusia  
          Hyperacusis50
       Inner ear disorders NEC  
          Acute vestibular syndrome10
          Inner ear disorder10
       Inner ear signs and symptoms  
          Motion sickness90
          Tinnitus720
          Vertigo1050
          Vertigo labyrinthine20
          Vertigo positional60
       Middle ear infections and inflammations  
          Middle ear inflammation10
    Ear disorders SOC TOTAL3340
    Reaction NameTotalFatal
    Endocrine disorders  
       Endocrine abnormalities of puberty  
          Premature menarche10
       Thyroid disorders NEC  
          Goitre10
    Endocrine disorders SOC TOTAL20
    Reaction Name                                                                          Total    Fatal
    Eye disorders  
       Amblyopic vision impairment  
          Amblyopia10
       Choroid and vitreous structural change, deposit and degeneration  
          Vitreous floaters40
       Conjunctival and corneal bleeding and vascular disorders  
          Conjunctival haemorrhage60
       Corneal infections, oedemas and inflammations  
          Ulcerative keratitis10
       Eyelid movement disorders  
          Blepharospasm80
          Eyelid ptosis10
       Iris and uveal tract infections, irritations and inflammations  
          Iridocyclitis30
          Uveitis10
       Lacrimation disorders  
          Dry eye100
          Lacrimation increased170
       Lid, lash and lacrimal infections, irritations and inflammations  
          Blepharitis10
          Erythema of eyelid10
          Eyelid irritation10
          Eyelid margin crusting10
          Eyelid rash20
          Swelling of eyelid150
       Lid, lash and lacrimal structural disorders  
          Eyelid exfoliation10
       Ocular disorders NEC  
          Eye disorder90
          Eye oedema20
          Eye pain1220
          Eye swelling560
          Eye ulcer10
          Eyelid pain10
          Eyelids pruritus10
          Ocular discomfort40
          Periorbital oedema30
          Periorbital pain10
          Periorbital swelling130
       Ocular infections, inflammations and associated manifestations  
          Eye allergy10
          Eye discharge30
          Eye inflammation20
          Eye irritation130
          Eye pruritus320
          Ocular hyperaemia250
       Ocular nerve and muscle disorders  
          Binocular eye movement disorder10
          Eye movement disorder40
          Ophthalmoplegia10
       Ocular sensation disorders  
          Abnormal sensation in eye40
          Asthenopia220
    Reaction Name                                                                          Total    Fatal
    Eye disorders          Eye disorders cont’d  
          Eye paraesthesia10
          Foreign body sensation in eyes50
          Hypoaesthesia eye10
          Photophobia500
       Optic disc abnormalities NEC  
          Papilloedema10
       Pupil disorders  
          Miosis10
          Mydriasis20
          Pupils unequal20
       Retinal structural change, deposit and degeneration  
          Maculopathy10
       Scleral infections, irritations and inflammations  
          Episcleritis10
       Visual disorders NEC  
          Diplopia120
          Halo vision20
          Metamorphopsia20
          Oscillopsia10
          Photopsia100
          Vision blurred1060
          Visual brightness10
       Visual impairment and blindness (excl colour blindness)  
          Blindness50
          Blindness transient20
          Central vision loss10
          Visual acuity reduced10
          Visual impairment310
    Eye disorders SOC TOTAL6340
    Reaction Name                                                                          Total    Fatal
    Gastrointestinal disorders  
       Abdominal findings abnormal  
          Gastrointestinal sounds abnormal10
       Anal and rectal disorders NEC  
          Anal sphincter atony10
       Anal and rectal pains  
          Proctalgia20
       Anal and rectal signs and symptoms  
          Anorectal discomfort10
       Benign oral cavity neoplasms  
          Mouth cyst10
       Colitis (excl infective)  
          Colitis10
          Crohn’s disease10
       Dental disorders NEC  
          Teething10
       Dental pain and sensation disorders  
          Hyperaesthesia teeth30
          Toothache80
       Diarrhoea (excl infective)  
          Diarrhoea7321
          Diarrhoea haemorrhagic20
       Duodenal and small intestinal stenosis and obstruction  
          Small intestinal obstruction10
       Dyspeptic signs and symptoms  
          Dyspepsia340
          Epigastric discomfort10
          Eructation70
       Faecal abnormalities NEC  
          Abnormal faeces30
          Faeces discoloured60
          Faeces pale20
       Flatulence, bloating and distension  
          Abdominal distension210
          Aerophagia20
          Flatulence200
       Gastritis (excl infective)  
          Gastritis40
          Reflux gastritis20
       Gastrointestinal and abdominal pains (excl oral and throat)  
          Abdominal pain1560
          Abdominal pain lower80
          Abdominal pain upper2140
          Abdominal tenderness20
          Gastrointestinal pain100
       Gastrointestinal atonic and hypomotility disorders NEC  
          Constipation120
          Duodenogastric reflux10
          Gastrooesophageal reflux disease130
       Gastrointestinal disorders NEC  
          Functional gastrointestinal disorder20
          Gastric disorder20
          Gastrointestinal disorder10
    Reaction Name                                                                          Total    Fatal
    Gastrointestinal disordersGastrointestinal disorders cont’d  
       Gastrointestinal dyskinetic disorders  
          Dyschezia10
          Gastrointestinal motility disorder10
       Gastrointestinal inflammatory disorders NEC  
          Enteritis10
       Gastrointestinal mucosal dystrophies and secretion disorders  
          Hyperchlorhydria10
       Gastrointestinal signs and symptoms NEC  
          Abdominal discomfort660
          Anal incontinence20
          Breath odour50
          Dysphagia270
       Gastrointestinal spastic and hypermotility disorders  
          Defaecation urgency20
          Frequent bowel movements80
          Irritable bowel syndrome60
          Oesophageal spasm10
       Gingival disorders, signs and symptoms NEC  
          Gingival blister20
          Gingival discomfort10
          Gingival pain90
          Gingival swelling20
          Gingivitis ulcerative10
          Noninfective gingivitis10
       Gingival haemorrhages  
          Gingival bleeding40
       Haemorrhoids and gastrointestinal varices (excl oesophageal)  
          Haemorrhoids20
       Intestinal haemorrhages  
          Anal haemorrhage10
          Rectal haemorrhage70
       Malabsorption syndromes  
          Steatorrhoea10
       Nausea and vomiting symptoms  
          Discoloured vomit20
          Nausea23650
          Regurgitation10
          Retching140
          Vomiting6162
          Vomiting projectile100
       Non-site specific gastrointestinal haemorrhages  
          Gastrointestinal haemorrhage20
          Haematemesis92
          Haematochezia20
          Melaena20
          Upper gastrointestinal haemorrhage20
       Oesophagitis (excl infective)  
          Oesophagitis10
       Oral dryness and saliva altered  
          Aptyalism10
          Dry mouth760
          Lip dry50
    Reaction Name                                                                          Total    Fatal
    Gastrointestinal disordersGastrointestinal disorders cont’d  
          Salivary hypersecretion60
       Oral soft tissue disorders NEC  
          Chapped lips30
          Cheilitis50
          Enlarged uvula20
          Lip blister50
          Lip disorder20
          Oral disorder30
          Oral papule10
          Uvulitis10
       Oral soft tissue haemorrhages  
          Mouth haemorrhage10
          Oral blood blister30
       Oral soft tissue signs and symptoms  
          Hypoaesthesia oral810
          Lip discolouration10
          Lip erythema10
          Lip pain80
          Lip pruritus20
          Lip scab10
          Odynophagia20
          Oral discomfort60
          Oral mucosal blistering60
          Oral mucosal eruption30
          Oral mucosal exfoliation20
          Oral pain180
          Oral pruritus40
          Paraesthesia oral2550
       Oral soft tissue swelling and oedema  
          Lip oedema10
          Lip swelling1130
          Mouth swelling90
          Oedema mouth10
       Peritoneal and retroperitoneal fibrosis and adhesions  
          Abdominal adhesions10
       Rectal inflammations NEC  
          Proctitis10
          Proctitis ulcerative10
       Salivary gland disorders NEC  
          Salivary gland pain20
       Salivary gland enlargements  
          Parotid gland enlargement10
          Submaxillary gland enlargement30
       Stomatitis and ulceration  
          Aphthous ulcer70
          Lip ulceration20
          Mouth ulceration460
          Oral mucosa erosion10
          Stomatitis60
       Tongue disorders  
          Glossitis20
          Plicated tongue20
    Reaction Name                                                                          Total    Fatal
    Gastrointestinal disordersGastrointestinal disorders cont’d  
          Tongue disorder40
          Tongue haemorrhage10
          Tongue ulceration70
       Tongue signs and symptoms  
          Glossodynia310
          Stiff tongue10
          Swollen tongue880
          Tongue blistering20
          Tongue coated10
          Tongue discolouration10
          Tongue discomfort60
          Tongue dry40
          Tongue eruption30
          Tongue erythema10
          Tongue movement disturbance10
          Tongue oedema20
          Tongue spasm20
    Gastrointestinal disorders SOC TOTAL53145
    Reaction Name                                                                          Total    Fatal
    General disorders  
       Administration site reactions NEC  
          Administration site bruise10
          Administration site erythema10
          Administration site pain30
          Administration site warmth10
          Puncture site bruise30
          Puncture site pain30
          Puncture site swelling10
          Vessel puncture site bruise10
       Adverse effect absent  
          No adverse event10
       Application and instillation site reactions  
          Application site bruise10
          Application site erythema10
          Application site pain10
          Instillation site warmth10
       Asthenic conditions  
          Asthenia2230
          Chronic fatigue syndrome10
          Fatigue32300
          Malaise7790
          Sluggishness20
       Body temperature altered  
          Hypothermia80
          Temperature regulation disorder30
       Complications associated with device NEC  
          Medical device pain10
          Medical device site swelling10
       Death and sudden death  
          Clinical death11
          Death5953
          Sudden death77
       Febrile disorders  
          Hyperpyrexia20
          Pyrexia31730
       Feelings and sensations NEC  
          Chills19940
          Feeling abnormal1440
          Feeling cold1910
          Feeling drunk100
          Feeling hot2330
          Feeling jittery50
          Feeling of body temperature change660
          Hangover50
          Hunger30
          Sensation of foreign body100
          Temperature intolerance10
          Thirst370
       Gait disturbances  
          Gait disturbance150
          Gait inability100
          Loss of control of legs10
    Reaction Name                                                                          Total    Fatal
    General disorders    General disorders cont’d  
       General signs and symptoms NEC  
          Condition aggravated140
          Crying40
          Disease recurrence10
          Exercise tolerance decreased20
          General physical health deterioration10
          Glassy eyes20
          Illness2030
          Induration20
          Influenza like illness4120
          Local reaction250
          Peripheral swelling3800
          Pre-existing condition improved10
          Screaming10
          Secretion discharge20
          Swelling3280
          Swelling face1020
       Inflammations  
          Inflammation350
          Systemic inflammatory response syndrome10
       Infusion site reactions  
          Infusion site erythema10
          Infusion site joint pain20
          Infusion site pain10
       Injection site reactions  
          Injected limb mobility decreased70
          Injection site bruising100
          Injection site discolouration10
          Injection site discomfort20
          Injection site erythema960
          Injection site haemorrhage20
          Injection site hypoaesthesia40
          Injection site induration10
          Injection site inflammation60
          Injection site joint pain30
          Injection site mass630
          Injection site oedema40
          Injection site pain6990
          Injection site paraesthesia20
          Injection site pruritus390
          Injection site rash130
          Injection site reaction50
          Injection site scab10
          Injection site scar20
          Injection site swelling850
          Injection site urticaria40
          Injection site vesicles20
          Injection site warmth290
       Interactions  
          Alcohol interaction20
          Drug interaction20
       Mass conditions NEC  
    Reaction Name                                                                          Total    Fatal
    General disorders    General disorders cont’d  
          Cyst10
          Mass30
          Nodule30
       Oedema NEC  
          Face oedema40
          Localised oedema60
          Oedema50
          Oedema peripheral90
       Pain and discomfort NEC  
          Axillary pain1450
          Chest discomfort1900
          Chest pain2420
          Discomfort200
          Facial discomfort30
          Facial pain280
          Non-cardiac chest pain20
          Pain11760
          Tenderness930
       Therapeutic and nontherapeutic responses  
          Adverse drug reaction5990
          Adverse event50
          Adverse reaction40
          Drug ineffective580
          Immediate post-injection reaction10
          No reaction on previous exposure to drug40
          Therapeutic product effect delayed10
          Therapeutic response unexpected40
          Treatment failure10
       Vaccination site reactions  
          Extensive swelling of vaccinated limb10
          Shoulder injury related to vaccine administration10
          Vaccination site bruising260
          Vaccination site discolouration40
          Vaccination site discomfort110
          Vaccination site eczema10
          Vaccination site erythema1510
          Vaccination site haemorrhage40
          Vaccination site hypoaesthesia10
          Vaccination site induration230
          Vaccination site inflammation240
          Vaccination site irritation30
          Vaccination site joint discomfort20
          Vaccination site joint erythema30
          Vaccination site joint movement impairment80
          Vaccination site joint pain180
          Vaccination site joint swelling20
          Vaccination site joint warmth10
          Vaccination site lymphadenopathy10
          Vaccination site mass370
          Vaccination site movement impairment100
          Vaccination site oedema30
          Vaccination site pain6240
    Reaction Name                                                                          Total    Fatal
    General disorders    General disorders cont’d  
          Vaccination site paraesthesia40
          Vaccination site pruritus430
          Vaccination site rash210
          Vaccination site reaction90
          Vaccination site swelling1710
          Vaccination site ulcer10
          Vaccination site urticaria40
          Vaccination site vesicles10
          Vaccination site warmth910
    General disorders SOC TOTAL1674961
    Reaction Name                                                                          Total    Fatal
    Hepatic disorders  
       Cholestasis and jaundice  
          Jaundice10
       Hepatic vascular disorders  
          Hepatic artery embolism10
       Hepatobiliary signs and symptoms  
          Hepatic pain40
       Hepatocellular damage and hepatitis NEC  
          Hepatitis10
          Liver injury10
    Hepatic disorders SOC TOTAL80
    Reaction Name                                                                          Total    Fatal
    Immune system disorders  
       Allergic conditions NEC  
          Allergic oedema20
          Hypersensitivity1210
          Type IV hypersensitivity reaction10
       Allergies to foods, food additives, drugs and other chemicals  
          Allergy to vaccine120
          Drug hypersensitivity20
          Reaction to preservatives30
       Anaphylactic and anaphylactoid responses  
          Anaphylactic reaction910
          Anaphylactic shock20
          Anaphylactoid reaction60
          Anaphylactoid shock20
       Atopic disorders  
          Seasonal allergy10
       Autoimmune disorders NEC  
          Autoimmune disorder10
       Immune and associated conditions NEC  
          Bacille Calmette-Guerin scar reactivation20
          Immune system disorder10
          Immune-mediated adverse reaction10
    Immune system disorders SOC TOTAL2480
    Reaction Name                                                                          Total    Fatal
    Infections  
       Abdominal and gastrointestinal infections  
          Appendicitis20
          Gastroenteritis30
       Bacterial infections NEC  
          Bacterial diarrhoea10
          Cellulitis350
          Injection site cellulitis10
          Tonsillitis bacterial10
          Vaccination site cellulitis60
       Breast infections  
          Breast abscess10
          Mastitis30
       Candida infections  
          Candida infection20
          Oral candidiasis50
          Vulvovaginal candidiasis40
       Central nervous system and spinal infections  
          Myelitis10
       Clostridia infections  
          Clostridium difficile infection10
       Coronavirus infections  
          Asymptomatic COVID-1940
          COVID-1921710
          COVID-19 pneumonia21
          Coronavirus infection50
          Severe acute respiratory syndrome10
          Suspected COVID-19150
       Coxiella infections  
          Q fever40
       Dental and oral soft tissue infections  
          Abscess oral10
          Gingivitis10
          Parotitis40
       Ear infections  
          Ear infection50
          Labyrinthitis90
       Eye and eyelid infections  
          Conjunctivitis100
          Eye abscess10
          Eye infection10
          Hordeolum20
       Female reproductive tract infections  
          Vulval abscess10
       Hepatobiliary and spleen infections  
          Biliary sepsis10
       Herpes viral infections  
          Genital herpes10
          Herpes simplex10
          Herpes simplex reactivation10
          Herpes virus infection30
          Herpes zoster700
          Herpes zoster oticus10
    Reaction Name                                                                          Total    Fatal
    Infections                Infections cont’d  
          Oral herpes300
       Infections NEC  
          Abscess30
          Infection560
          Injection site infection10
          Localised infection20
          Lymph gland infection20
          Vaccination site abscess10
          Vaccination site infection60
       Influenza viral infections  
          Influenza1920
       Lower respiratory tract and lung infections  
          Bronchitis10
          Lower respiratory tract infection144
          Pneumonia82
          Sputum purulent10
       Male reproductive tract infections  
          Orchitis10
       Muscle and soft tissue infections  
          Soft tissue infection10
       Sepsis, bacteraemia, viraemia and fungaemia NEC  
          Sepsis30
          Urosepsis10
       Skin structures and soft tissue infections  
          Acne pustular10
          Folliculitis20
          Pustule20
          Rash pustular10
          Skin infection10
       Staphylococcal infections  
          Furuncle20
          Staphylococcal abscess10
       Streptococcal infections  
          Pharyngitis streptococcal20
       Trypanosomal infections  
          African trypanosomiasis10
       Upper respiratory tract infections  
          Nasopharyngitis900
          Pharyngitis40
          Rhinitis100
          Sinusitis40
          Tonsillitis110
          Tracheitis10
       Urinary tract infections  
          Cystitis40
          Kidney infection20
          Pyelonephritis10
          Urinary tract infection110
       Vascular infections  
          Haematoma infection10
       Viral infections NEC  
          Conjunctivitis viral10
    Reaction Name                                                                          Total    Fatal
    Infections                Infections cont’d  
          Eye infection viral10
          Gastroenteritis viral30
          Post viral fatigue syndrome40
          Sweating fever210
          Vestibular neuronitis30
          Viral infection10
          Viral labyrinthitis20
          Viral pharyngitis30
          Viral rash60
          Viral tonsillitis10
    Infections SOC TOTAL94817
    Reaction Name                                                                          Total    Fatal
    Injuries  
       Abdominal and gastrointestinal injuries NEC  
          Oral contusion10
       Anaesthetic and allied procedural complications  
          Delayed recovery from anaesthesia10
       Conditions caused by cold  
          Chillblains40
       Exposures associated with pregnancy, delivery and lactation  
          Exposure during pregnancy50
          Maternal exposure during breast feeding80
          Maternal exposure during pregnancy100
       Eye injuries NEC  
          Eye contusion20
          Eye injury20
          Injury corneal10
       Gastrointestinal and hepatobiliary procedural complications  
          Post procedural constipation10
          Postoperative ileus10
          Procedural nausea10
       Heat injuries (excl thermal burns)  
          Heat illness10
          Heat oedema10
          Heat stroke10
       Medication errors, product use errors and issues NEC  
          Medication error10
       Muscle, tendon and ligament injuries  
          Muscle strain20
       Nerve injuries NEC  
          Nerve injury20
       Neurological and psychiatric procedural complications  
          Procedural dizziness20
       Non-site specific injuries NEC  
          Bite10
          Electric shock20
          Fall180
          Wound complication10
       Non-site specific procedural complications  
          Incision site pain10
          Infusion related reaction20
          Injection related reaction70
       Off label uses  
          Off label use10
       Overdoses NEC  
          Overdose60
       Poisoning and toxicity  
          Poisoning10
       Product administration errors and issues  
          Accidental overdose10
          Contraindicated product administered10
          Inappropriate schedule of product administration40
          Product administered at inappropriate site30
          Product administered to patient of inappropriate age10
          Product administration error10
    Reaction Name                                                                          Total    Fatal
    Injuries                    Injuries cont’d  
          Product dose omission issue10
       Product preparation errors and issues  
          Product preparation issue30
       Radiation injuries  
          Sunburn10
       Site specific injuries NEC  
          Face crushing10
          Head injury10
          Limb injury10
       Skin injuries NEC  
          Contusion470
          Scar10
          Skin abrasion20
       Stoma complications  
          Gastrointestinal stoma complication10
          Stoma site discharge10
          Stoma site extravasation10
          Stoma site haemorrhage10
       Thermal burns  
          Burns second degree10
          Thermal burn20
       Vaccination related complications  
          Vaccination complication90
    Injuries SOC TOTAL1720
    Reaction Name                                                                          Total    Fatal
    Investigations  
       Adrenal cortex tests  
          Cortisol decreased10
       Blood gas and acid base analyses  
          Blood lactic acid increased20
          Blood pH increased10
          Oxygen consumption decreased10
          Oxygen saturation decreased160
       Carbohydrate tolerance analyses (incl diabetes)  
          Blood glucose decreased40
          Blood glucose increased130
          Glycosylated haemoglobin increased10
       Cardiac function diagnostic procedures  
          Central venous pressure10
       Chemistry analyses NEC  
          Inflammatory marker increased10
       Coagulation and bleeding analyses  
          Fibrin D dimer increased10
          International normalised ratio decreased10
          International normalised ratio increased80
       ECG investigations  
          Electrocardiogram ST segment elevation10
       Haematological analyses NEC  
          Red blood cell sedimentation rate increased10
       Heart rate and pulse investigations  
          Heart rate160
          Heart rate abnormal20
          Heart rate decreased50
          Heart rate increased980
          Heart rate irregular80
          Pulse abnormal50
       Immunology analyses NEC  
          Immunology test10
       Investigations NEC  
          Blood test abnormal20
          Polymerase chain reaction positive30
       Liver function analyses  
          Alanine aminotransferase increased10
          Gamma-glutamyltransferase increased10
          Hepatic enzyme increased10
          Liver function test increased10
          Transaminases increased10
       Metabolism tests NEC  
          Blood ketone body increased10
       Microbiology and serology tests NEC  
          Culture negative10
       Mineral and electrolyte analyses  
          Blood potassium abnormal10
       Neurologic diagnostic procedures  
          Coma scale abnormal10
       Ophthalmic function diagnostic procedures  
          Intraocular pressure increased10
       Physical examination procedures and organ system status  
    Reaction Name                                                                          Total    Fatal
    Investigations          Investigations cont’d  
          Body temperature590
          Body temperature abnormal170
          Body temperature decreased60
          Body temperature fluctuation40
          Body temperature increased1200
          Body temperature normal10
          Breath sounds abnormal10
          Grip strength10
          Grip strength decreased20
          Lymph node palpable30
          Respiratory rate decreased10
          Respiratory rate increased110
          Skin temperature40
          Weight decreased30
       Pituitary analyses anterior  
          Blood growth hormone10
       Protein analyses NEC  
          C-reactive protein increased20
       Red blood cell analyses  
          Haemoglobin decreased30
       Respiratory and pulmonary function diagnostic procedures  
          Forced expiratory volume increased10
       Skeletal and cardiac muscle analyses  
          Blood creatine phosphokinase increased10
          Troponin increased20
       Therapeutic drug monitoring analyses  
          Anticoagulation drug level increased10
       Thyroid analyses  
          Tri-iodothyronine10
          Tri-iodothyronine decreased10
       Urinalysis NEC  
          Blood urine present40
          pH urine10
       Urinary tract function analyses NEC  
          Urine output20
          Urine output decreased30
          Urine output increased10
       Vascular tests NEC (incl blood pressure)  
          Blood pressure abnormal20
          Blood pressure decreased90
          Blood pressure increased370
          Blood pressure measurement50
          Blood pressure systolic decreased10
          Blood pressure systolic increased10
       Virus identification and serology  
          SARS-CoV-2 test10
          SARS-CoV-2 test false positive10
          SARS-CoV-2 test positive200
       White blood cell analyses  
          White blood cell count decreased10
    Investigations SOC TOTAL5380
    Reaction Name                                                                          Total    Fatal
    Metabolic disorders  
       Appetite disorders  
          Appetite disorder10
          Decreased appetite2100
          Eating disorder symptom10
          Food craving10
          Food refusal10
          Hypophagia20
          Increased appetite10
       Diabetes mellitus (incl subtypes)  
          Diabetes mellitus inadequate control21
          Type 1 diabetes mellitus10
       Diabetic complications NEC  
          Diabetic complication10
          Diabetic ketoacidosis30
       Disorders of purine metabolism  
          Gout40
       Electrolyte imbalance NEC  
          Fluid imbalance10
       Fluid intake decreased  
          Fluid intake reduced10
       Fluid intake increased  
          Polydipsia10
       General nutritional disorders NEC  
          Abnormal weight gain10
          Feeding disorder50
       Hyperglycaemic conditions NEC  
          Hyperglycaemia110
       Hypoglycaemic conditions NEC  
          Hypoglycaemia140
       Lipid metabolism and deposit disorders NEC  
          Body fat disorder10
       Metabolic acidoses (excl diabetic acidoses)  
          Ketoacidosis10
       Mixed acid-base disorders  
          Acidosis20
       Sodium imbalance  
          Hyponatraemia20
       Total fluid volume decreased  
          Dehydration200
       Total fluid volume increased  
          Fluid retention20
    Metabolic disorders SOC TOTAL2901
    Reaction Name                                                                          Total    Fatal
    Muscle & tissue disorders  
       Arthropathies NEC  
          Arthritis180
          Arthropathy20
          Sacroiliitis10
       Bone disorders NEC  
          Medial tibial stress syndrome10
          Spinal disorder10
       Bone related signs and symptoms  
          Bone pain440
          Bone swelling20
          Coccydynia10
          Pain in jaw420
          Spinal pain60
       Bursal disorders  
          Bursitis20
       Cartilage disorders  
          Costochondritis20
       Connective tissue disorders NEC  
          Polymyalgia rheumatica20
       Extremity deformities  
          Foot deformity10
       Joint related disorders NEC  
          Joint lock10
          Periarthritis40
          Temporomandibular joint syndrome10
       Joint related signs and symptoms  
          Arthralgia14140
          Jaw clicking20
          Joint effusion30
          Joint noise20
          Joint range of motion decreased10
          Joint stiffness250
          Joint swelling310
          Joint warmth10
       Lupus erythematosus (incl subtypes)  
          Systemic lupus erythematosus10
       Muscle infections and inflammations  
          Myositis20
       Muscle pains  
          Fibromyalgia60
          Myalgia22800
          Myofascial pain syndrome20
       Muscle related signs and symptoms NEC  
          Muscle discomfort10
          Muscle disorder20
          Muscle fatigue470
          Muscle spasms870
          Muscle swelling50
          Muscle tightness60
          Muscle twitching280
       Muscle tone abnormalities  
          Muscle rigidity50
    Reaction Name                                                                          Total    Fatal
    Muscle & tissue disordersMuscle & tissue disorders cont’d  
          Nuchal rigidity20
          Torticollis10
          Trismus20
       Muscle weakness conditions  
          Muscular weakness1010
       Musculoskeletal and connective tissue conditions NEC  
          Limb mass20
          Mastication disorder10
          Mobility decreased110
          Musculoskeletal disorder30
          Musculoskeletal stiffness1490
       Musculoskeletal and connective tissue infections and inflammations NEC  
          Fasciitis10
          Plantar fasciitis10
       Musculoskeletal and connective tissue pain and discomfort  
          Back pain3040
          Flank pain60
          Limb discomfort1930
          Musculoskeletal chest pain160
          Musculoskeletal discomfort120
          Musculoskeletal pain100
          Neck pain2600
          Pain in extremity15300
       Myopathies  
          Rhabdomyolysis30
       Osteoarthropathies  
          Osteoarthritis10
       Psoriatic arthropathies  
          Psoriatic arthropathy10
       Rheumatoid arthropathies  
          Rheumatoid arthritis50
       Soft tissue disorders NEC  
          Axillary mass220
          Groin pain130
          Neck mass50
       Spondyloarthropathies  
          Ankylosing spondylitis10
          Arthritis reactive30
       Synovial disorders  
          Synovial cyst10
          Synovitis20
       Tendon disorders  
          Tendon pain10
          Tendonitis10
    Muscle & tissue disorders SOC TOTAL67460
    Reaction NameTotalFatal
    Neoplasms  
       Lymphomas unspecified NEC  
          Lymphoma10
       Metastases to specified sites  
          Metastases to lymph nodes10
    Neoplasms SOC TOTAL20
    Reaction Name                                                                          Total    Fatal
    Nervous system disorders  
       Abnormal reflexes  
          Extensor plantar response10
          Hyperreflexia10
          Hyporeflexia30
       Absence seizures  
          Petit mal epilepsy30
       Acute polyneuropathies  
          Guillain-Barre syndrome10
       Autonomic nervous system disorders  
          Anticholinergic syndrome10
       Central nervous system aneurysms and dissections  
          Vertebral artery dissection10
       Central nervous system haemorrhages and cerebrovascular accidents  
          Brain stem infarction11
          Cerebellar infarction20
          Cerebellar stroke10
          Cerebral artery occlusion10
          Cerebral haemorrhage41
          Cerebral infarction40
          Cerebrovascular accident211
          Haemorrhage intracranial20
          Ischaemic cerebral infarction10
          Ischaemic stroke61
          Lacunar infarction20
          Lacunar stroke10
          Subarachnoid haemorrhage21
       Central nervous system inflammatory disorders NEC  
          Gliosis10
       Cerebrovascular venous and sinus thrombosis  
          Cerebral venous sinus thrombosis10
       Coordination and balance disturbances  
          Balance disorder380
          Coordination abnormal70
          Dysstasia90
       Cortical dysfunction NEC  
          Aphasia70
       Cranial nerve disorders NEC  
          Cranial nerve disorder10
       Dementia (excl Alzheimer’s type)  
          Dementia10
       Disturbances in consciousness NEC  
          Altered state of consciousness30
          Consciousness fluctuating10
          Depressed level of consciousness40
          Lethargy3900
          Loss of consciousness420
          Sedation20
          Somnolence1050
          Stupor10
          Syncope1510
       Dyskinesias and movement disorders NEC  
          Bradykinesia20
    Reaction Name                                                                          Total    Fatal
    Nervous system disordersNervous system disorders cont’d  
          Dyskinesia10
          Fine motor skill dysfunction10
          Hypokinesia20
          Motor dysfunction10
          Movement disorder50
          Psychomotor hyperactivity30
       Dystonias  
          Dystonia50
          Writer’s cramp10
       Encephalopathies NEC  
          Posterior reversible encephalopathy syndrome10
       Eye movement disorders  
          VIth nerve paralysis10
       Facial cranial nerve disorders  
          Facial nerve disorder10
          Facial paralysis580
          Facial paresis110
          Facial spasm60
       Generalised tonic-clonic seizures  
          Generalised tonic-clonic seizure40
       Headaches NEC  
          Cervicogenic headache10
          Cluster headache290
          Cold-stimulus headache10
          Exertional headache30
          Headache45700
          Medication overuse headache20
          New daily persistent headache10
          Ophthalmoplegic migraine10
          Primary cough headache10
          Primary headache associated with sexual activity10
          Sinus headache550
          Tension headache790
          Thunderclap headache10
       Lumbar spinal cord and nerve root disorders  
          Sciatica70
       Memory loss (excl dementia)  
          Amnesia70
          Memory impairment140
       Mental impairment (excl dementia and memory loss)  
          Cognitive disorder60
          Disturbance in attention370
          Mental impairment50
       Migraine headaches  
          Migraine3080
          Migraine with aura210
          Retinal migraine20
          Typical aura without headache10
          Vestibular migraine10
       Mononeuropathies  
          Carpal tunnel syndrome10
          Mononeuropathy10
    Reaction Name                                                                          Total    Fatal
    Nervous system disordersNervous system disorders cont’d  
          Nerve compression20
       Multiple sclerosis acute and progressive  
          Multiple sclerosis10
          Multiple sclerosis relapse20
       Muscle tone abnormal  
          Muscle tone disorder10
          Serotonin syndrome10
          Stiff leg syndrome10
       Myelitis (incl infective)  
          Myelitis transverse10
       Narcolepsy and hypersomnia  
          Hypersomnia140
          Narcolepsy10
       Nervous system disorders NEC  
          Nervous system disorder20
       Neurologic visual problems NEC  
          Tunnel vision30
          Visual field defect10
       Neurological signs and symptoms NEC  
          Dizziness12780
          Dizziness exertional30
          Dizziness postural1170
          Head discomfort290
          Hyporesponsive to stimuli10
          Myoclonus10
          Neurological symptom20
          Persistent postural-perceptual dizziness10
          Presyncope950
          Slow response to stimuli10
          Unresponsive to stimuli120
       Neuromuscular disorders NEC  
          Muscle contractions involuntary40
       Neuromuscular junction dysfunction  
          Myasthenia gravis10
       Olfactory nerve disorders  
          Anosmia380
          Hyposmia40
          Parosmia200
       Optic nerve disorders NEC  
          Optic neuritis10
       Paraesthesias and dysaesthesias  
          Burning sensation510
          Dysaesthesia10
          Formication30
          Hemiparaesthesia10
          Hyperaesthesia130
          Hypoaesthesia2590
          Paraesthesia3940
       Paralysis and paresis (excl cranial nerve)  
          Hemiparesis100
          Hemiplegia10
          Locked-in syndrome10
    Reaction Name                                                                          Total    Fatal
    Nervous system disordersNervous system disorders cont’d  
          Monoparesis40
          Monoplegia40
          Paralysis140
       Parkinson’s disease and parkinsonism  
          Freezing phenomenon10
          Parkinsonian gait10
          Parkinsonism10
       Partial complex seizures  
          Dreamy state10
       Peripheral neuropathies NEC  
          Neuropathy peripheral80
          Peripheral sensory neuropathy20
       Seizures and seizure disorders NEC  
          Epilepsy40
          Febrile convulsion10
          Partial seizures10
          Seizure340
          Tonic convulsion20
       Sensory abnormalities NEC  
          Ageusia820
          Allodynia30
          Aura60
          Dysgeusia2050
          Neuralgia310
          Restless legs syndrome130
          Sensory disturbance100
          Sensory loss30
          Taste disorder380
       Sleep disturbances NEC  
          Poor quality sleep200
       Speech and language abnormalities  
          Dysarthria140
          Repetitive speech10
          Speech disorder50
       Spinal cord and nerve root disorders NEC  
          Radiculopathy10
       Transient cerebrovascular events  
          Transient ischaemic attack110
       Tremor (excl congenital)  
          Essential tremor10
          Resting tremor10
          Tremor2210
       Trigeminal disorders  
          Facial neuralgia20
          Trigeminal nerve disorder10
          Trigeminal neuralgia30
    Nervous system disorders SOC TOTAL92045
    Reaction NameTotalFatal
    Pregnancy conditions  
       Abortions spontaneous  
          Abortion spontaneous40
       Maternal complications of pregnancy NEC  
          Morning sickness10
       Normal pregnancy, labour and delivery  
          Pregnancy30
    Pregnancy conditions SOC TOTAL80
    Reaction NameTotalFatal
       Device malfunction events NEC  
          Device stimulation issue10
          Oversensing40
       Product contamination and sterility issues  
          Product contamination physical10
    null SOC TOTAL60
    Reaction Name                                                                          Total    Fatal
    Psychiatric disorders  
       Anxiety symptoms  
          Agitation180
          Anxiety550
          Nervousness300
          Tension120
       Behaviour and socialisation disturbances  
          Indifference20
          Paranoia20
          Social avoidant behaviour20
       Cognitive and attention disorders and disturbances NEC  
          Mental fatigue180
       Communications disorders  
          Communication disorder10
       Confusion and disorientation  
          Confusional state860
          Disorientation260
       Deliria  
          Delirium210
       Depressive disorders  
          Depression90
       Dissociative states  
          Depersonalisation/derealisation disorder20
          Dissociation30
          Dissociative amnesia10
       Disturbances in initiating and maintaining sleep  
          Initial insomnia30
          Insomnia1290
          Middle insomnia30
       Dyssomnias  
          Dyssomnia10
       Eating disorders NEC  
          Eating disorder10
       Emotional and mood disturbances NEC  
          Anger20
          Emotional disorder50
          Emotional distress20
          Euphoric mood30
          Irritability150
          Mood altered30
       Fear symptoms and phobic disorders (incl social phobia)  
          Phonophobia10
          Social fear10
       Fluctuating mood symptoms  
          Mood swings10
       Hallucinations (excl sleep-related)  
          Hallucination310
          Hallucination, auditory20
          Hallucination, olfactory10
          Hallucination, tactile10
          Hallucination, visual40
       Increased physical activity levels  
          Restlessness180
    Reaction Name                                                                          Total    Fatal
    Psychiatric disordersPsychiatric disorders cont’d  
       Mental disorders NEC  
          Mental disorder10
       Mood alterations with depressive symptoms  
          Decreased interest20
          Depressed mood210
          Negative thoughts10
          Tearfulness20
       Mood disorders NEC  
          Apathy10
          Laziness10
          Listless10
       Narcolepsy and associated conditions  
          Sleep attacks20
       Obsessive-compulsive disorders and symptoms  
          Obsessive-compulsive symptom10
       Panic attacks and disorders  
          Panic attack110
          Panic disorder10
          Panic reaction30
       Parasomnias  
          Abnormal dreams250
          Nightmare230
          Sleep terror10
       Perception disturbances NEC  
          Autoscopy10
          Derealisation20
          Illusion10
       Psychiatric elimination disorders  
          Enuresis40
       Psychiatric symptoms NEC  
          Trance10
       Psychotic disorder NEC  
          Psychotic behaviour10
       Sleep disorders NEC  
          Sleep disorder230
       Somatic symptom disorders  
          Habit cough20
          Vomiting psychogenic10
       Speech and language usage disturbances  
          Disorganised speech20
          Logorrhoea10
       Stereotypies and automatisms  
          Head banging20
          Stereotypy10
       Suicidal and self-injurious behaviour  
          Intentional self-injury10
       Thinking disturbances  
          Bradyphrenia70
          Thinking abnormal30
    Psychiatric disorders SOC TOTAL6650
    Reaction Name                                                                          Total    Fatal
    Renal & urinary disorders  
       Bladder and urethral symptoms  
          Bladder discomfort10
          Dysuria60
          Incontinence40
          Micturition disorder10
          Micturition urgency10
          Pollakiuria60
          Urinary incontinence80
          Urinary retention80
       Bladder disorders NEC  
          Bladder disorder30
       Genital and urinary tract disorders NEC  
          Urinary tract disorder10
       Myoneurogenic bladder disorders  
          Hypertonic bladder10
          Loss of bladder sensation10
       Renal failure and impairment  
          Acute kidney injury30
          Renal failure20
       Urinary abnormalities  
          Chromaturia110
          Haematuria30
          Proteinuria10
          Urine abnormality20
          Urine odour abnormal20
       Urinary tract signs and symptoms NEC  
          Costovertebral angle tenderness10
          Haemorrhage urinary tract10
          Nocturia10
          Polyuria10
          Renal pain290
    Renal & urinary disorders SOC TOTAL980
    Reaction Name                                                                          Total    Fatal
    Reproductive & breast disorders  
       Benign and malignant breast neoplasms  
          Breast cyst10
       Breast disorders NEC  
          Breast mass30
       Breast signs and symptoms  
          Breast discomfort10
          Breast pain220
          Breast swelling80
          Breast tenderness20
          Nipple pain30
          Nipple swelling20
       Erection and ejaculation conditions and disorders  
          Erectile dysfunction30
       Menopausal effects NEC  
          Menopausal symptoms20
       Menstruation and uterine bleeding NEC  
          Dysmenorrhoea90
          Menstrual disorder50
          Menstruation irregular70
          Metrorrhagia20
       Menstruation with decreased bleeding  
          Amenorrhoea10
          Hypomenorrhoea20
          Menstruation delayed70
       Menstruation with increased bleeding  
          Menorrhagia150
          Polymenorrhoea30
       Ovarian and fallopian tube disorders NEC  
          Ovulation pain20
       Pelvis and broad ligament disorders NEC  
          Adnexa uteri pain10
       Penile disorders NEC (excl erection and ejaculation)  
          Penile swelling10
       Prostatic signs, symptoms and disorders NEC  
          Prostatomegaly10
       Reproductive tract signs and symptoms NEC  
          Pelvic discomfort10
          Pelvic pain20
          Perineal pain10
       Scrotal disorders NEC  
          Scrotal erythema10
          Scrotal exfoliation10
          Scrotal pain20
          Scrotal swelling10
       Testicular and epididymal disorders NEC  
          Testicular pain20
          Testicular swelling10
       Uterine tone disorders  
          Uterine spasm10
       Vulvovaginal disorders NEC  
          Vaginal haemorrhage160
          Vulval ulceration20
    Reaction NameTotalFatal
    Reproductive & breast disordersReproductive & breast disorders cont’d  
       Vulvovaginal signs and symptoms  
          Vulvovaginal pruritus10
    Reproductive & breast disorders SOC TOTAL1350
    Reaction Name                                                                          Total    Fatal
    Respiratory disorders  
       Breathing abnormalities  
          Dyspnoea4150
          Dyspnoea exertional61
          Hyperventilation50
          Hypopnoea60
          Irregular breathing10
          Mouth breathing10
          Orthopnoea20
          Respiration abnormal70
          Respiratory arrest20
          Respiratory distress10
          Tachypnoea110
       Bronchial conditions NEC  
          Bronchial secretion retention10
       Bronchospasm and obstruction  
          Asthma370
          Bronchospasm30
          Obstructive airways disorder10
          Wheezing550
       Conditions associated with abnormal gas exchange  
          Hypoxia41
       Coughing and associated symptoms  
          Cough3250
          Haemoptysis50
          Productive cough180
          Sputum discoloured10
       Laryngeal spasm, oedema and obstruction  
          Epiglottic oedema10
          Stridor10
       Lower respiratory tract inflammatory and immunologic conditions  
          Hypersensitivity pneumonitis10
          Pneumonia aspiration22
          Pneumonitis30
       Lower respiratory tract signs and symptoms  
          Hiccups20
          Pleuritic pain40
          Pulmonary pain90
          Rales10
       Nasal congestion and inflammations  
          Nasal congestion270
          Rhinitis allergic20
       Nasal disorders NEC  
          Epistaxis800
          Intranasal hypoaesthesia10
          Intranasal paraesthesia10
          Nasal disorder10
          Nasal dryness30
          Nasal odour10
          Nasal oedema10
          Nasal pruritus10
       Paranasal sinus disorders (excl infections and neoplasms)  
          Sinonasal obstruction20
    Reaction Name                                                                          Total    Fatal
    Respiratory disordersRespiratory disorders cont’d  
          Sinus congestion60
          Sinus disorder10
          Sinusitis noninfective10
       Parenchymal lung disorders NEC  
          Atelectasis10
       Pharyngeal disorders (excl infections and neoplasms)  
          Pharyngeal erythema30
          Pharyngeal haemorrhage10
          Pharyngeal hypoaesthesia70
          Pharyngeal inflammation10
          Pharyngeal oedema30
          Pharyngeal paraesthesia160
          Pharyngeal swelling370
          Pharyngeal ulceration20
          Tonsillar hypertrophy90
          Tonsillar inflammation10
       Pleural infections and inflammations  
          Pleurisy10
       Pneumothorax and pleural effusions NEC  
          Pleural effusion10
       Pulmonary oedemas  
          Pulmonary congestion10
          Pulmonary oedema20
       Pulmonary thrombotic and embolic conditions  
          Pulmonary embolism20
          Pulmonary infarction10
       Respiratory failures (excl neonatal)  
          Acute respiratory failure11
       Respiratory signs and symptoms NEC  
          Painful respiration20
          Respiratory symptom10
       Respiratory tract disorders NEC  
          Aspiration10
          Respiratory disorder10
          Respiratory tract irritation10
          Respiratory tract oedema10
       Upper respiratory tract neoplasms  
          Tonsillar cyst10
       Upper respiratory tract signs and symptoms  
          Aphonia100
          Catarrh30
          Choking20
          Dry throat260
          Dysphonia210
          Increased upper airway secretion30
          Increased viscosity of upper respiratory secretion20
          Nasal discharge discolouration10
          Nasal discomfort50
          Nasal obstruction20
          Oropharyngeal blistering50
          Oropharyngeal discomfort100
          Oropharyngeal pain3860
    Reaction Name                                                                          Total    Fatal
    Respiratory disordersRespiratory disorders cont’d  
          Paranasal sinus discomfort40
          Rhinalgia40
          Rhinorrhoea770
          Sinus pain250
          Sneezing450
          Snoring20
          Throat clearing20
          Throat irritation370
          Throat tightness510
    Respiratory disorders SOC TOTAL18805
    Reaction Name                                                                          Total    Fatal
    Skin disorders  
       Acnes  
          Acne40
       Alopecias  
          Alopecia40
       Angioedemas  
          Angioedema270
          Circumoral swelling10
       Apocrine and eccrine gland disorders  
          Cold sweat1020
          Hyperhidrosis2510
          Miliaria80
          Night sweats1040
       Bullous conditions  
          Blister260
          Blood blister10
          Dermatitis bullous30
          Erythema multiforme30
          Stevens-Johnson syndrome10
          Toxic epidermal necrolysis11
       Dermal and epidermal conditions NEC  
          Dermatosis10
          Dry skin200
          Macule10
          Pain of skin450
          Papule110
          Peau d’orange20
          Scar pain30
          Sensitive skin270
          Skin burning sensation240
          Skin discolouration170
          Skin disorder10
          Skin induration10
          Skin lesion30
          Skin odour abnormal20
          Skin reaction170
          Skin sensitisation40
          Skin swelling100
          Skin tightness110
          Skin warm450
          Sticky skin10
          Yellow skin30
       Dermatitis and eczema  
          Dermatitis150
          Dermatitis allergic290
          Dyshidrotic eczema10
          Eczema70
          Skin irritation110
       Dermatitis ascribed to specific agent  
          Drug eruption20
          Fixed eruption10
          Toxic skin eruption10
       Erythemas  
    Reaction Name                                                                          Total    Fatal
    Skin disorders          Skin disorders cont’d  
          Erythema3710
       Exfoliative conditions  
          Skin exfoliation90
       Hyperpigmentation disorders  
          Ephelides10
       Nail and nail bed conditions (excl infections and infestations)  
          Nail discolouration20
          Nail disorder10
          Onychalgia10
       Panniculitides  
          Erythema nodosum10
       Papulosquamous conditions  
          Lichen planus10
          Pityriasis rosea70
       Photosensitivity and photodermatosis conditions  
          Photosensitivity reaction60
       Pigmentation changes NEC  
          Pigmentation disorder10
       Pilar disorders NEC  
          Piloerection30
       Pruritus NEC  
          Itching scar30
          Pruritus6120
       Psoriatic conditions  
          Psoriasis40
       Purpura and related conditions  
          Petechiae150
          Purpura60
       Rashes, eruptions and exanthems NEC  
          Rash6480
          Rash erythematous1320
          Rash macular690
          Rash maculo-papular120
          Rash morbilliform40
          Rash papular420
          Rash pruritic1020
          Rash vesicular40
       Rosaceas  
          Rosacea10
       Scaly conditions  
          Pityriasis30
       Skin and subcutaneous conditions NEC  
          Skin mass30
       Skin and subcutaneous tissue ulcerations  
          Skin erosion30
          Skin ulcer10
       Skin cysts and polyps  
          Dermal cyst10
       Skin haemorrhages  
          Haemorrhage subcutaneous10
          Skin haemorrhage10
       Skin hyperplasias and hypertrophies  
    Reaction Name                                                                          Total    Fatal
    Skin disorders          Skin disorders cont’d  
          Skin hypertrophy10
       Skin vasculitides  
          Vasculitic rash10
       Skin vasomotor conditions  
          Livedo reticularis80
       Urticarias  
          Cold urticaria10
          Mechanical urticaria10
          Urticaria2170
          Urticaria papular10
          Urticaria thermal10
    Skin disorders SOC TOTAL31541
    Reaction NameTotalFatal
    Social circumstances  
       Disability issues  
          Bedridden50
          Breast prosthesis user10
          Immobile20
          Impaired work ability10
    Social circumstances SOC TOTAL90
    Reaction Name                                                                          Total    Fatal
    Surgical & medical procedures  
       Gastrointestinal therapeutic procedures NEC  
          Prophylaxis of nausea and vomiting40
       Immunisations  
          COVID-19 immunisation30
          Immunisation10
       Limb therapeutic procedures  
          Limb immobilisation10
       Respiratory tract therapeutic procedures NEC  
          Asthma prophylaxis10
       Skin and subcutaneous tissue therapeutic procedures NEC  
          Dermal filler injection10
       Therapeutic procedures NEC  
          Bed rest10
          Fatigue management10
          Hospitalisation10
          Injection10
    Surgical & medical procedures SOC TOTAL150
    Reaction Name                                                                          Total    Fatal
    Vascular disorders  
       Blood pressure disorders NEC  
          Blood pressure fluctuation20
       Circulatory collapse and shock  
          Circulatory collapse210
          Neurogenic shock60
          Peripheral circulatory failure20
       Haemorrhages NEC  
          Haematoma30
          Haemorrhage50
       Lymphoedemas  
          Lymphoedema170
       Non-site specific embolism and thrombosis  
          Thrombosis60
       Non-site specific vascular disorders NEC  
          Superficial vein prominence10
          Vasodilatation10
          Vein discolouration10
          Vein disorder20
          Vein rupture10
       Peripheral embolism and thrombosis  
          Blue toe syndrome10
          Deep vein thrombosis50
       Peripheral vascular disorders NEC  
          Cyanosis80
          Flushing1060
          Hot flush1520
       Peripheral vasoconstriction, necrosis and vascular insufficiency  
          Peripheral coldness430
          Peripheral ischaemia10
          Poor peripheral circulation10
          Raynaud’s phenomenon30
          Vasoconstriction10
       Site specific vascular disorders NEC  
          Pallor320
       Vascular hypertensive disorders NEC  
          Hypertension780
       Vascular hypotensive disorders  
          Hypotension620
          Orthostatic hypotension30
       Vasculitides NEC  
          Vasculitis40
       Vena caval embolism and thrombosis  
          Vena cava embolism10
          Vena cava thrombosis10
    Vascular disorders SOC TOTAL5700
    TOTAL REACTIONS FOR DRUG49472107
       
    TOTAL REPORTS16756 
    TOTAL FATAL OUTCOME REPORTS 107