The nine injured children in Denmark likely represent only the tip of the iceberg.
- jearungby
- 3 days ago
- 28 min read
Updated: 21 hours ago
By Jeanne A. Rungby, specialist.
This article may be freely used by lawyers representing patients injured by COVID-19 mRNA vaccines as part of their evidence.
Recently, nine children in Denmark were awarded compensation for injuries following COVID19 vaccines. This was reported in several media outlets including Berlingske Tidende. The screenshot below is from Berlingske Tidende.
Part of the text in thescreenshot says, that this doesn't change that it was the right thing to vaccinate according to the Government.
Many have sought compensation for injuries following COVID19 vaccines. Most of these have been denied.
I have had occasion to read a decision, in this case a rejection of compensation, from the Patient Complaints Board. The injured party has given me permission to use the content of this rejection to debate the Patient Complaints Board's decisions.
This concerns a person who received several injections from the Pfizer/BioNTechs Comirnaty against COVID19 in 2021. Immediately afterwards, the person (hereinafter referred to as the patient) developed debilitating symptoms and subsequently became permanently unable to work and thus unable to support his family in the future.
A quite serious situation.
The rejection
The patient experienced many symptoms, including dizziness, muscle and joint pain, fatigue, diarrhea, and headache.
The Patient Complaints Board admits that some of the patient's symptoms are perceived as very common after COVID19 vaccines.
There is thus an obvious connection between the onset of the symptoms and the injections. More than 1 in 10 had the symptoms mentioned. The screen clip below is taken from the Patient Complaints Board's background note for the aforementioned rejection, see the source list.
The absurdity of the rejection arises from the Patient Complaints Board's claim that these symptoms may only occur temporarily (up to 4 weeks) .
In other words, because the symptoms have lasted more than 4 weeks, they cannot be due to side effects after Comirnaty, according to their definition.
The rejection is therefore based on a definition of the duration of symptoms!
Where does this definition come from?
It probably comes from the WHO . We will return to that.
The pathophysiological causes of these symptoms are not explained, nor are data presented to support why these symptoms cannot occur for longer than 4 weeks.
The Patient Complaints Board has probably not read the scientific studies attached to the list of subjects for this article. Studies that refute their claim about the duration of a large number of serious side effects after Comirnaty.
The background note.
The Patient Complaints Board substantiates its rejection in a so-called "background note".
This background note is general information about the COVID19 vaccines, which will probably be attached and reused in every rejection from the Patient Complaints Board. The background note is attached as a document at the end of the article. The red markings are mine.
This background note contains several debatable claims and questionable assumptions, which I will point out in the following points.
1. In Quote no. 1, the Patient Complaints Board has based its decision on the following:
Quote from the background material for the decision:
“Before release, the vaccines were evaluated in multiple systematic and rigid testing steps , and in the final phase, they were tested on tens of thousands of people in clinical trials specifically designed to capture side effects and ensure that the vaccines are effective .”
These claims contained in the quote are, in my opinion, incorrect , which I will justify in the following:
The clinical trials that the Patient Complaints Board refers to in the quote (multiple systematic and rigid test steps) were based on a manufacturing method called process 1 , which is Pfizer's own designation of the phase 3 trial that was used to declare the vaccine safe and effective.
However, Pfizer/BioNTech changed their manufacturing method after the conditional approval of their mRNA COVID-19 vaccine.
The manufacturing method, process 2, used for large-scale (commercial) production of these vaccines, which were given to billions of people, was completely different from the process on which the approval was based, as referred to in the background note.
It is also not correct that the mentioned clinical studies (process 1) were “specifically designed to capture side effects and ensure that the vaccines are effective”.
Within two months of the start of the trial, Pfizer had given the same vaccine to the comparison group (placebo group) that the test group had received in process 1. The trial was therefore unblinded. Such a maneuver makes the study worthless in terms of assessing all side effects that occurred thereafter (long-term side effects). The same applies to assessing effectiveness, i.e. the risk of getting COVID19.
In addition, the definition of COVID19 infection was based on varying criteria. This is not done in a randomized trial. All data collected was random and unsystematic.
In Pfizer's own words , the study was changed from randomized to observational. More on this later.
Pfizer thus amputated their own huge clinical study.
Why did they do that?
It is a fact that material from process 2 was not reviewed in clinical phase 3 trials in humans.
Thus, the basis for declaring this product safe and effective did not exist.
It thus appears that the Patient Complaints Board is distorting the truth in the quote.
To facilitate understanding, a brief description of the two manufacturing methods is given below.
Process 1 is a PCR-based method where a piece of modified RNA encoding the spike protein is amplified a number of times and then injected. It is a clean process that does not involve the same risks of impurities as is known from process 2.
Process 2 is based on fecal bacteria (E-coli bacteria) which are grown on a specially prepared medium (something resembling digested food). These coli bacteria have a genetically engineered genetic material, the so-called Plasmid DNA itself . This is a much longer piece of DNA, which in addition to both the DNA code and the RNA code for spike protein also contains the bacterium's own DNA, antibiotic resistance genes (Kanamycin and Neomycin) and a number of other undefined DNA sequences, including the SV40 promoter sequence.
SV40 (Simian virus) has previously been linked to cancer in rodents . And in a recent article, the SV40 promoter has been detected in up to 25.6% of all human tissue , presumably injected through vaccines over the years.
Not all of the DNA sequences in the vaccine were disclosed in Pfizer's application for approval to the European Medicines Agency (EMA). In particular, several national drug regulatory authorities, including the Danish Medicines Agency, have admitted that the SV40 partial sequence was not reported in Pfizer's application . These DNA impurities were discovered by chance by an independent genetic researcher (Kevin McKernan) in 2023 and have since been documented in a peer-reviewed scientific article by Speicher et al. , who found that the amount of DNA impurities greatly exceeded the permitted amounts of naked DNA.
The EMA also accepted an unusually high level of impurities in these products.
Risks of process 2 - unlike process 1 - are that impurities with larger or smaller DNA sequences, including the SV40 subsequence and bacterial membrane parts (endotoxins), may be contained in the vaccine and thus reach the bloodstream when injected into the shoulder. These can cause a number of side effects that are not seen with process 1.
Endotoxins from the bacterial membrane can, for example, trigger (well-studied) anaphylactic shock (often fatal).
Purification and separation of RNA and DNA is very difficult and RNA is usually much more fragile than DNA, which is why DNA impurities cannot be completely avoided. In addition, there are risks from the positively charged lipid nanoparticles (LNPs), which protect (surround) mRNA, DNA and DNA-RNA hybrids during transport via the bloodstream to the target cells, the dendritic cells (circulating immune cells).
It is therefore obvious that clinical trials should be based on process 2 and not on process 1.
The undersigned has received the following response from the Danish Medicines Agency in a request for access to documents:
"Dear Jeanne Rungby,
In your latest inquiry, you ask us to inform you of the placebo-controlled randomized clinical trials in humans (phase 3) where process 2 has been used in the manufacture of the vaccine on which the conditional or final approval is based. This applies to both Pfizer and Moderna's vaccines.
The Danish Medicines Agency maintains that thorough clinical studies, including phase III trials, are the basis for the approvals of both mRNA COVID-19 vaccines.
Here, the Danish Medicines Agency refers to process 1, as far as Pfizer's mRNA vaccine is concerned.
The Danish Medicines Agency's next sentence:
No placebo-controlled studies have been conducted specifically for Comirnaty. randomized clinical trials in humans with material from process 2.
It is not unusual for a pharmaceutical company to make changes to its manufacturing process during the development of a drug/vaccine, and it was assessed at the time of approval by Comirnaty that the changes to the manufacturing process were acceptable and had no impact on the safety and/or efficacy of the vaccine .
Excuse me. When I, as a doctor, read that it is normal for manufacturers to change the manufacturing process after approval, I lose all confidence in the Health Authorities. How much of the medicine I have prescribed to my patients over the years has been changed after approval? Why have the authorities allowed this?
The devil is in the detail here. The difference between process 1 and process 2 is neglected.
However, the Danish Medicines Agency also writes:
The assessment of this is based on data from physical and biological analyses (so-called comparability studies ).
This is described as follows in the public report for Comirnaty's approval:
This link states the following:
"Two active substance processes have been used during the development history; Process 1 (clinical trial material) and Process 2 (commercial process). Details about process differences, justification for making changes, and results from a comparability study are provided. The major changes between active substance process versions were described in the dossier.
Batch analysis results showing comparability between non-clinical and clinical batches are provided. Additional characterization of product-related species and their relation to final product specifications will be provided as a specific obligation".
The quote says that the results of this comparability study “will be provided.” Another untruth, as the results were never made available.
The Danish Medicines Agency continues:
“We therefore do not share the concerns you have raised regarding the quality, safety and effectiveness of COVID-19 vaccines.”
I didn't feel reassured.
It is interesting that the Danish Medicines Agency admits that process 1 and process 2 are not the same as comparability studies were planned.
It thus appears that all safety data is based on this "comparability" study .
It is therefore important to understand the results of this study, which the Danish Medicines Agency mentions - but otherwise fails to refer to directly - in their response.
Repeated requests for access to documents from the EMA (European Medicines Agency) have also not yielded satisfactory responses.
It is normal for vaccines (not necessarily acceptable) that manufacturers do not compare with placebo (saline/inactive substance), but with previous similar products, as in this case a comparison between the product from the two described processes. If no significant differences in side effects and deaths are found between the two processes, the two products are assumed to be comparable.
It is then assumed that the safety and efficacy of the clinical trials based on process 1 are representative of the risks of process 2.
However, the alleged comparability study between the commercial product, Comirnaty, produced by process 2 and the test substance produced by process 1 was never conducted.
Therefore, the Danish Medicines Agency cannot of course refer directly to the results of this comparability study, as it does not exist.
Their reference to the EMA documents is therefore probably a diversionary tactic.
The following appears from Pfizer's own report of Sept. 15, 2022. See section 6.1.1 on page 95:
Protocol amendment 20 will also remove the objective to describe the safety and immunogenicity of prophylactic BNT162b2 in individuals 16 to 55 years of age vaccinated with study intervention produced by manufacturing “Process 1” or “Process 2.” As of 03 July 2022, more than 3.6 billion doses of BNT162b2 have been distributed, with over 620 million doses of BNT162b2 administered worldwide, which were manufactured via “Process 2.” Given the number of doses now administered globally, the originally planned manufacturing process comparison is no longer warranted .
Pfizer's own words!
This comparability study was thus never carried out! This is documented in several places in the document.
Why?
Because now 3.6 billion doses had already been given!
In my opinion, this makes this vaccine experimental, with healthy people as unknowing test subjects.
I am surprised that the Danish Medicines Agency needs to camouflage the fact that the comparability study was never conducted.
I wonder why they do that!
Regarding process 1 itself, the clinical study to which the summary of product characteristics refers.
As mentioned, Pfizer chose to make the original randomized study unblinded (after approximately 2 months) and it therefore no longer fell under the definition of a randomized study, but instead became an observational study.
That decision was contrary to the study protocol.
This destroyed the possibility of follow-up safety evaluation, including recording of long-term side effects, as planned.
This was in practice a deviation from GMP (Good Manufacturing Practice) and the approval was therefore an omission of GRP (Good Regulatory Practice).
This made it impossible to draw any conclusions about safety and efficacy, including long-term side effects and mortality in a randomized material.
The clinical comparability study was therefore neither conducted nor completed.
The trials were fully completed on February 10, 2023. contrary to the original plan, as mentioned.
2. Quote no. 2 in the background material of the decision:
The background material states:
“When the COVID vaccine activates the immune system, approximately 50% will experience flu-like symptoms consisting of fatigue, headache, malaise, joint and muscle pain, and a slight increase in temperature. This is completely common and a sign that the body's immune system is responding to the vaccine. The reactions can be seen with all COVID vaccines (and all other vaccines) and typically last 1-2 days. A few people may experience a tail of milder, diminishing symptoms for another 5-6 days, and a much smaller number of people may have mild, transient symptoms for up to 4 weeks.
Based on information from the European Medicines Agency, product summaries, updated safety information and the pathophysiological knowledge about the COVID vaccines, it is assessed that the vaccines do not cause persistent, non-specific side effects (longer than 4 weeks).”
According to their wording, these statements contain, among other things, three central claims:
• that there is a known and studied connection between the vaccine and its serious and non-specific side effects, which can only last a maximum of 4 weeks.
• that existing monitoring and registration are sufficient to identify new side effects
• that updated safety information and pathophysiological knowledge document that the vaccine is safe and is not associated with persistent, non-specific disease states.
Especially when the experimental design has the limitations described above, such statements require a clear, identifiable and verifiable documentation basis.
Studies based on post-marketing registry data can contribute to important population-level surveillance, but they cannot in themselves document the absence of risk. or replace clinical safety data with systematic long-term follow-up, which should have taken place in proper randomized trials with the correct manufacturing process.
It was therefore, after all, sensible to inform the medical profession that this product was under stricter monitoring, including stricter reporting requirements.
The Patient Complaints Board has not documented the following in their response :
· That side effects only last 4 weeks.
· The pathophysiological knowledge referred to.
· The information provided by the EMA.
The Patient Complaints Board claims that the mRNA vaccines are comparable to other traditional vaccines in the quote "and all other vaccines" and that long-term side effects cannot be caused by the COVID19 vaccine, even though it was well known that these vaccines were based on a new technology, mRNA technology.
No previous vaccines in Denmark had been based on this technology.
The chart below shows the difference between mRNA vaccines and traditional vaccines.
It appears from the Ministry of Health's letter of January 26, 2021 (Folketingstidende supplement E, document 150) that
“The European Medicines Agency (EMA) has provisionally granted conditional marketing approval to two newly developed vaccines against COVID-19 , the BioNTech/Pfizer vaccine and the Moderna vaccine…. Knowledge about the effect of the different vaccines with regard to, among other things, the degree of immunity and time horizon however, immunity is limited …. The long-term effect of the vaccines is not known …. Several of the new vaccines are based on new technologies”
One may wonder about the choice of a duration of up to 4 weeks for recognized side effects when it is acknowledged in the Danish Parliament that long-term side effects are not known.
The Danish Medicines Agency also informs in a recent request for access to documents about an executive order of 3 February 2021, issued by the then Minister of Health Magnus Heunicke, which provides for the possibility of a forensic autopsy if the death occurred within 7 days of vaccination against COVID19 . This executive order was extended in 2022, until 15 March 2023 .
This is a clear (political) signal to the police and the medical profession about expectations regarding ordering autopsies in connection with deaths following vaccines.
In my young days as a hospital doctor, it was my duty to report all suspicious deaths to the police for a forensic autopsy.
Thus, a political decision was made to limit the time period for routine forensic autopsy to 7 days for an experimental product - based on a new technology - where the final clinical trials (process 1 only) had not yet been completed? This prevented the collection of important knowledge about serious long-term side effects that could cause fatal outcomes.
Since then, the Danish Medicines Agency - under the guidance of the WHO - has continued to assess/perceive serious adverse reactions to this new product as something that can only occur for a short time (apparently 4 weeks), despite numerous scientific studies showing that both non-serious and serious, disabling long-term adverse reactions, including cancer, are associated with these products. More on this in the topic-based source list below.
The Danish Medicines Agency informs that in the period of almost 5 weeks from the last week of December 2020 up to and including February 2, 2021, 19 reports of deaths were received following vaccination with Comirnaty alone.
19 died in 5 weeks after just one of the COVID19 vaccines!
It is highly debatable whether due care and conscientious conduct were exercised by the authorities in connection with the safety assessment of these products.
It was thus known to both the Danish Medicines Agency and the Danish Parliament that:
· long-term side effects were unknown with this new technology , which had not previously been approved for use in humans,
· the marketing authorisation was conditional.
· no phase 3 clinical trials had been conducted on Pfizer's Comirnaty based on material from process 2, see response from Jakob Lundsteen, Danish Medicines Agency (case number 2024024182).
· the planned comparability studies were never completed by Pfizer.
· 19 people were reported to have died after using these products just 5 weeks into the vaccination campaign.
Why were reports of serious adverse reactions, including fatal ones, registered with a time limit (1-4 weeks) without follow-up (or autopsy after 7 days), when reporting obligations had been tightened for these new products?
When real-world data show an increased mortality rate temporally associated with a medicinal product that has been granted conditional approval due to exemptions from product control, authorities should ensure that investigations into the association between the medicinal product and the death are carried out in connection with autopsies of sudden, unexpected deaths.
It does not appear that the authorities have shown sufficient care and conscientiousness in connection with these mRNA vaccines, as the order, on the contrary, limited autopsies to 7 days according to the said order, which was also extended in 2022, despite the never-conducted comparability study.
It looks like something that should be swept under the carpet.
To my knowledge, the vaccine-specific 2-proline spike protein or the vaccine-specific modified RNA is not measured in the blood, nor by immunohistochemical staining of tissue samples in Denmark, although it has long been possible. These examinations of, for example, a skin biopsy or biopsies from the heart and arteries of the deceased are apparently not done, not even at forensic autopsies (the ones I have read). This prevents those injured by vaccines or relatives of the deceased from being able to provide evidence that their suffering is due to the vaccines.
Example: A recent case study of a patient with multiple genes after 3 Pfizer COVID-19 mRNA injections showed circulating vaccine-specific modified RNA in the bloodstream 3.5 years after the last injection. This is evidence that the vaccine elements are present in and affect the body long after vaccination, possibly due to integration of plasmid DNA (contamination from process 2) into the body's cells.
The Patient Complaints Board does not seem to be up to date on the knowledge provided above.
1. Quote no. 3 in the background material.
The importance of the Summary of Product Characteristics and Informed Consent.
It appears from the Patient Complaints Board's background note that the summary of product characteristics is largely relied on in cases of doubt.
Quote:
Notes regarding Comirnaty:
Guillain Barré (acute nerve inflammation), myelitis (spinal cord inflammation) and ADEM (acute disseminated encephalomyelitis) do not appear in the summary of product characteristics for Comirnaty, but are considered, based on the literature, to be a vaccination side effect after a specific assessment.
Healthcare professionals who perform vaccinations in Denmark must, by law, obtain informed consent.
In a document access to the Danish Regions regarding what information material/guidance was given to healthcare professionals who vaccinate, it appeared that the summary of product characteristics for Comirnaty was the actual instructions.
We are talking about 405 pages, written in a difficult to understand language with countless repetitions, no dates, and very little readability in a busy everyday life.
Based on the above statement, review of the summary of product characteristics , it is my assessment that it has not been possible to obtain legally informed consent for these mRNA COVID19 vaccines from Pfizer/BioNTech, as informed consent requires that the vaccinator is correctly informed and is thus able to pass on this information to the person being vaccinated.
The product summary refers broadly to material from process 1. It has not been clearly explained in the product summary that Pfizer changed the manufacturing process after approval and that the new manufacturing process (process 2) had not been studied.
Since both the healthcare professionals who vaccinate and the Patient Complaints Board use the summary of product characteristics as basic information and in decisions, respectively, it is important that the information in the summary of product characteristics is complete and up-to-date.
The product summary did not contain clear and unambiguous information about a wide range of data, listed below:
· The overall risk of COVID19 was very low.
An experimental emergency vaccine cannot be assumed to be safer than a virus with a very high survival rate, like COVID. The average survival rate for untreated COVID was 99.85%. This risk assessment from January 2021 came from Dr. John Ioannidis , one of the most cited scientists in the world. The risk assessment was conducted at the request of the WHO.
· The vaccines did not prevent infection (transmission). This should have been clearly stated in the instructions to the vaccinator. The Danish Health Authority explained in their invitation letters that vaccination against COVID-19 helped to protect against infection, which was not correct . This desire not to infect others was, for many people, precisely the most important motivation for getting vaccinated.
Screenshot of invitation for vaccination below.
On May 20, 2021, Søren Brostrøm told Politiken :
"Young and healthy people should think about their own protection, but also get vaccinated to protect their grandparents . Vaccines also don't work as well in everyone, for example cancer patients and people with an immune disease. They need the indirect protection that the young and healthy help to ensure for them. The 16-year-old should therefore have good reason to get vaccinated to protect their grandparents' generation."
It later turned out that it was not true that the vaccine provided high protection against infection.
A response from the EMA to MEP Graaff and statements from former US-FDA Commissioner (US Food and Drug Administration), Margaret Hamburg, MD, indicated that it was not known whether the vaccine could prevent infection. It also indicated that the clinical trials were not designed to investigate whether the vaccines prevented infection.
Quote: "We don't know if people can become infected and thus also transmit even with vaccination."
The same source quotes Larry Corey, MD, lead investigator on the clinical trials for COVID-19 vaccines:
" It may take a year or more to get the studies to answer the transmission question"
Were Søren Brostrøm and the authorities honest about the ability of vaccines to prevent infection in their letters of invitation?
· vaccines seem to damage the immune system in the long term - worse the more vaccines are given.
Several scientific studies have documented that the immune system's ability to fight both COVID-19 and other infections weakens over time and, furthermore, with repeated injections.
The first study on the negative effect of the vaccine was published in December 2021, among others, by the Serum Institute. This study showed that the vaccines had a negative effect after about 4 months. A negative effect means an increased risk of infection.
Even then, alarm bells should have rung and the vaccine should have been stopped in December 2021 - before the booster vaccine was offered.
Of particular note is a recent study from Korea based on 51 million people - the entire population of Korea. The study showed that the risk of respiratory infections and colds increased with the number of COVID-19 vaccine doses received. The authors explain that several biological mechanisms may underlie the observed associations between COVID-19 vaccination status and the risk of respiratory infections. Although COVID-19 vaccination appears to provide some protection against certain infections, such as influenza-like illnesses and whooping cough, a paradoxical increase in the risk of upper respiratory infections and common cold was observed with higher vaccine doses, especially in children and adolescents.
This study - and several of the following studies - confirm that there are non-specific long-term effects in connection with these mRNA vaccines, which contrasts with the Patient Complaints Board's claim no. 2.
Dr. Robert Malone, former chair of the American ACIP committee, has recently provided an updated review of the scientific studies to date that document how COVID19 mRNA vaccines negatively affect the immune system.
· The risk of getting Covid increases with each injection given ; a not unimportant detail when assessing Comirnaty's effectiveness.
A study from Cleveland was a game changer. This large and well-conducted study of approximately 52,000 healthcare workers clearly showed that the risk of getting Covid increased with each injection given. The unvaccinated had the lowest risk.
· The risk of permanent damage to the heart is so great that it does not match the severity of the disease .
· Other antiviral agents were available to treat COVID-19
· The risk of serious side effects, Alzheimer's, disability and fatal outcomes for children and adults with the vaccine was greater than the risk of them becoming seriously ill from COVID-19 , which the authorities already knew in January 2021, when the risk of dying from Covid-19 for those under 70 years of age was 0.15% in a study commissioned by the WHO.
· Four studies should be mentioned in particular:
1. In a large study from Korea, the health data of 519,330 people who received two doses of the COVID-19 vaccine were analyzed, and these vaccinated people were compared to about 38,687 people who did not receive the vaccine . First, the study showed that the incidence of mild cognitive impairment (MCI), an early stage of dementia, more than doubled among vaccinated individuals compared to unvaccinated individuals ( +140% increase ). The number of vaccinated individuals who developed dementia, including Alzheimer’s disease (AD), increased by 23% compared to unvaccinated individuals within three months of vaccination. The differences were significant P < 0.001 for MCI and P = 0.026 for AD. Thus, preliminary evidence suggests a non-random association between COVID-19 vaccination, particularly mRNA vaccines, and increased incidence of Alzheimer’s disease and mild cognitive impairment .
2. Another study from Seoul, South Korea, analyzed the psychiatric adverse events following COVID-19 vaccination in a large population-based cohort of almost 2.5 million people compared to unvaccinated individuals. The researchers assessed the cumulative incidence of psychiatric adverse events per 10,000 at one week, two weeks, one month, and three months after COVID-19 vaccination. The results showed that the cumulative incidence of depression, anxiety, dissociative, stress-related, and somatoform disorders, sleep disorders, and sexual disorders three months after COVID-19 vaccination was higher in the vaccinated group than in the unvaccinated group.
Depression +68%
Anxiety, dissociative, stress, somatoform disorders +44%
Sleep disorders +93%
The figure below provides a schematic representation of the study's results regarding sleep disorders.
3. A systematic review of the scientific literature on case reports of new-onset psychosis after COVID-19 vaccination showed the following:
54% were women, the average age was 34 years, and the average time from vaccination to symptom onset was 6 days.
The duration of psychotic symptoms varied between 1 and 2 months with an average of 52.48 days.
Abnormal blood test results were noted in 50% of cases, mainly mild to moderate elevations in white blood cells and elevated C-reactive protein (signs of inflammation).
MRI scan results were abnormal in only 20.8% of cases.
Overall, 50% of patients achieved full recovery (50% did not).
These data thus suggest a likely association between young age, mRNA vaccines, and new-onset psychosis after vaccination.
4. This study in adolescents in Norway showed that the second dose of the COVID-19 vaccine was associated with a significantly increased risk of anaphylaxis , lymph node swelling, myocarditis and pericarditis, and acute appendicitis.
· There is a risk that allergies may be aggravated . It is well known in the scientific literature that endotoxins from the coliform membrane can cause allergic shock in guinea pigs, which have many physiological similarities to humans. It is also documented that these endotoxins can exacerbate existing allergies or asthma by acting as adjuvants (additives to vaccines and medicines).
· Several studies suggest that the incidence and severity of cancer increases with each injection. A new review article by Kuperwasser and El-Diery brings together the scientific studies that support the risk. In this regard, the presence of DNA impurities, SV40 subsequences, persistent exposure to the spike protein, inflammatory effects from lipid nanoparticles (LNPs), and immune suppression are important contributors to the risk of cancer. The amount of residual DNA reported in several independent studies exceeds the accepted limits for free DNA, and the size distribution of DNA fragments, combined with LNPs, increases the risk of gene alterations. Furthermore, since SV40 regulatory elements are present in the impurities in Pfizer's COVID-19 mRNA vaccine, this DNA, when inserted into the genome, may alter cellular functions and/or normal gene regulation, thereby increasing the cancer-causing potential.
· SV40 subsequences were found in Comirnaty, which was not declared by Pfizer.
It was not part of the informed consent.
" It is correct that it was not specified in the application that the DNA plasmid contains small pieces of SV40 sequence . This has subsequently been clarified in connection with follow-up questions from EMA to Pfizer. The small pieces of SV40 sequence included in the vaccine do not pose a safety risk."
My comments in the second letter to the Minister of Health :
"The Minister confirms that a "segment" of SV40 has been found in the vaccines (Pfizer) - after the EMA has asked clarifying questions to Pfizer. This must be interpreted as meaning that the Danish Medicines Agency was not aware of the partial sequence of SV40 in the vaccines, as they was given to the population. The subsequences, or the consequence of this, could therefore not be part of the informed consent either.”
· The clinical trials used to approve the COVID-19 vaccines excluded pregnant women.
The Danish Medicines Agency has stated in a document access that the study that was the basis for giving Pfizer's mRNA vaccines to pregnant and fertile women was based on a study by Bowman et al on 44 rats. In this study - with material process 1 - no studies were conducted on the future fertility of the rat pups, germ cells nor DNA integration studies.
The rats were quickly killed so that long-term effects were not studied. The authors were employed by Pfizer. Despite the article's headline, which concluded that there was no risk to fertility, it turned out that hidden in the material was actually a significant risk that fertilized eggs could not implant in the uterus , and therefore be rejected, which can also be described as early miscarriage.
Since then , estimates of pregnancy complications, miscarriages and stillbirths have been made , which show an unacceptable risk. See also the topic-based source list below.
· The very high incidence of menstrual disorders after the vaccine could indicate that the vaccine had a negative impact on fertility . See the topic-based source list below.
· Sperm quality decreased with each injection . See topic-based source list below.
· Multiple population studies have shown a significant (non-random) association between these vaccines and excess mortality . See the subject-based source list below.
Last but not least:
· The manufacturers changed the production method after the conditional approval and that no randomized clinical trials based on this production process 2 have been conducted , as already documented.
Conclusion:
It is clear from the above review that many important information and updates appear to be missing from the Comirnaty summary of product characteristics , which prevented vaccinators from providing the correct information prior to the informed consent required by law.
Vaccination invitation letters from the Danish Health Authority are also considered essential information for the population that forms the basis for consent.
That the vaccines protected against infection was untrue and was apparently given against one's better judgment.
It is my opinion that the patient was unable to give informed consent on a properly informed basis based on the above points. In particular, they were not informed about the difference between process 1 and process 2 and the risks this process change entailed.
The product summary cannot therefore be considered as documentation that risks have been investigated or excluded.
In other words:
Pfizer's COVID19 modRNA vaccines were apparently given on an experimental basis , which was not apparent from the product summary on which the informed consent is based.
That the COVID-19 vaccines were experimental was subsequently confirmed at the highest level; documented in testimony by US Secretary of Defense Pete Hegseth in April 2025. He issued a formal apology to the US military for the COVID vaccine mandate — calling it
“illegal” and the product “experimental”.
He ordered the reinstatement of over 8,700 military personnel who were discharged for refusing the vaccination, with retroactive pay and the expungement of their records.
The US Department of Defense—under its new leadership—has effectively admitted that the military mandate was illegal and that the product was experimental.
I have justified above that the Patient Complaints Board's claim
“Before release, the vaccines were evaluated in multiple systematic and rigid testing steps , and in the final phase, they were tested on tens of thousands of people in clinical trials specifically designed to capture side effects and ensure that the vaccines are effective .”
is contradicted by the Danish Medicines Agency's own response to access to documents, Pfizer's own reports and the statements of the US Secretary of Defense.
It is my general assessment that no Comirnaty vaccine recipient has been properly informed prior to vaccination.
Comirnaty was the COVID19 vaccine that most Danes received.
The 9 injured children
The fact that the 9 injured children most likely represent the tip of the iceberg should be seen in light of the above-mentioned
time limit for recognition,
lack of registration and
inadequate investigation of injuries (correct paraclinical and histological examinations as well as
lack of adequate investigation of deaths (autopsy).
In addition, the reporting system itself is passive. When an adverse event or death suspected of being caused by a vaccine or medicinal product is reported in a country, it is important to understand that the reporting is passive and voluntary.
A wide range of data such as social security number, batch number, diagnosis codes, medication list and much more must be ready at hand for the reporter. Such a report is most often made after a busy working day and the average time spent is 30 - 45 minutes (own experience). It is predictable that this last heavy step in a busy working day is not achieved.
A US report by Lazarus based on 1.4 million doses (of 45 different vaccines) concluded that less than 1% of identified adverse reactions to vaccines were reported during the given period. The low reporting rate prevents or delays the identification of “problematic” vaccines that pose a risk to public health.
There is clearly a need for new monitoring methods for adverse reactions to drugs and vaccines.
Barriers to reporting include:
· lack of or late information about possible side effects from authorities,
· lack of awareness among clinicians,
· missing diagnosis codes for adverse reactions after immunization with mRNA vaccines against COVID19 in the ICD system, which is managed by the WHO.
· uncertainty about when, where and what to report,
· and the burden of reporting. Reporting is not part of the clinicians' normal workflow, takes time and is duplicative.
Proactive, spontaneous and automated reporting of adverse reactions integrated into electronic patient records and other information systems has the potential to speed up the identification of problems with new drugs and a more careful quantification of adverse reactions. Unfortunately, this does not happen in the record systems used in Denmark. Although automatic data capture has been taking place at many levels in patients' medical records for decades, reporting of adverse reactions after vaccines does not seem to be part of this system.
One might well wonder about that.
Reported adverse reactions are forwarded to Eudravigilance under EMA via a database system. At EMA level, considerable processing takes place, as manufacturers, such as Pfizer/BioNTech, are allowed to assess whether reports are valid or “invalid” . If they are invalid, they are stored.
The final processing of the reports takes place at the WHO Collaborating Centre in Uppsala, an independent, self-financed, non-profit foundation that runs the WHO's programme for international pharmacovigilance, which is not under democratic control.
WHO-UMC cannot be subject to access to documents, despite the fact that they handle the adverse reaction database, VigiBase, from approximately 160 countries in the world.
It is therefore not possible to gain insight into the data management regarding, for example, side effects after COVID-19 vaccines, as WHO-UMC is not obliged to follow the Freedom of Information Act.
According to the WHO-UMC (website), they investigate adverse events (AEFI) by looking at the clinical phase 3 trials based on process 1 and at the summary of product characteristics, which is also based on process 1. If the UMC's "experts" find adverse events in these, they are accepted as adverse events .
Reports received after marketing, i.e. after a change in manufacturing method, are apparently not given sufficient consideration.
In other words, if the reports from the regional authorities via VigiBase contain adverse reactions/safety signals that do not fall under the definitions of AEFI, such as serious adverse reactions that cannot persist for more than days, or are not found in the summary of product characteristics, then they cannot be considered to be "biologically plausible", i.e. they are classified as having no causal relationship.
This is therefore most likely a case of rough sorting, where an unknown, probably significant number of reported side effects that are not already in the summary of product characteristics appear to be sorted out.
Thus, frequent adverse effects can become “very rare”.
Lack of conscience and care on the part of the authorities:
The COVID19 modRNA vaccines have not been evaluated for their potential ability to cause changes to the human genome, cancer, fertility, death, and long-term organ disease prior to approval.
Neither have any dose-response studies been conducted (or published) with regard to spike proteins, anti-RNA, DNA impurities, and lipid nanoparticles.
No complete biodistribution studies have been conducted, except in rats in 2015 with a similar product encapsulated in lipid nanoparticles. The study showed that only 33% and 7% of the dose remained in the muscle after injection. 67% and 93% have thus leaked directly into the bloodstream with access to the body's organs.
A review of Pfizer's limited distribution studies , which were interrupted after 48 hours before maximum distribution was achieved, showed that predominantly the liver but also the spleen, intestine, adrenal glands, ovaries and lungs received significant portions of the vaccine until the study was stopped.
The fact that non-specific side effects cannot occur in the long term is thus an undocumented claim, since it has not been studied properly.
When a medical intervention is used on a large scale in healthy people, it is crucial that the basis for the safety assessment can be presented and assessed on a fully informed basis. This is not believed to be the case for Comirnaty.
Background note from the Patient Complaints Board:
Topic-based source list:
The list of topics is far from complete. A much more comprehensive review with sources can be found in a letter from the German non-profit organization MWGFD to Emer Cooke, head of EMA. The letter elaborates and explains many of the topics I have touched on in this article. It is well suited for use by lawyers conducting cases.
A brief overview of the letter's content and background can be found here:
Access to documents and letters to the Danish health authorities, Minister of Health Sophie Løhde and statements from the US Secretary of Defense: https://www.wch-scandinavia.org/post/lægemiddelstyrelsens-svar-på-forespørgsel-ved-proces-2-comirnaty
Response from the Danish Medicines Agency of 3 Nov. 2023 and 13 March 2024:
Later access to documents for the Danish Medicines Agency, the Regions and the Summary of Product Characteristics for Pfizer's C19 vaccine can be found as a PDF here
The general risk of COVID19
Document 150, Folketinget . Long-term effects were not known. https://www.ft.dk/samling/20201/aktstykke/Aktstk.150/2325034.pdf
Document access to EMA: The vaccines did not prevent infection (transmission):
Questions and Answers to MEP Marcel-de-Graaff https://www.dropbox.com/scl/fi/0tmz0c3ui0te9jq7qwt37/2023-10-18-Letter-to-MEP-Marcel-de-Graaff-Request-for-the-dire.pdf?rlkey=8hgl56ykrxoq7i4y2t11as9ub&dl=0
Timeline and events surrounding the rollout of C19 vaccines in Denmark:
DNA impurities in mRNA vaccines: https://www.tandfonline.com/doi/full/10.1080/08916934.2025.2551517#abstract
Biodistribution of mRNA genetic vaccines:
Pfizer's discontinued biodistribution studies : https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M4_4223_185350.pdf
Pfizer's other protocols and reports :
The underreporting factor in passive reporting of vaccine adverse reactions in the United States. https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf
Post-marketing independent quality control studies in Denmark, the Czech Republic, Sweden, the USA and Germany have all shown that the variability of vaccine batches varied to an extreme degree .
https://www.preprints.org/manuscript/202603.0688 https://onlinelibrary.wiley.com/doi/10.1111/eci.13998
Excess mortality in temporal relation to mRNA COVID-19 vaccines .
Existing treatment for COVID19:
Diseases and symptoms:
Documentation of lack of efficacy , long-term weakening of the immune system, increased risk of COVID19, allergic reactions and other infections associated with COVID19 mRNA vaccines:
https://www.ijidonline.com/article/S1201-9712(25)00416-3/fulltext https://www.malone.news/p/igg4-class-switching-immune-tolerance?utm_source=post-email-title&publication_id=583200&post_id=191771141&utm_campaign=email-post-title&isFreemail=true&r=b8pf1&triedRedirect=true&utm_medium=email
Vaccine-induced heart inflammation (myocarditis) and autopsy findings:
Brain damage/Alzheimer's caused by COVID19 mRNA vaccines compared to unvaccinated: https://academic.oup.com/qjmed/advance-article-abstract/doi/10.1093/qjmed/hcae103/7684274
Increased incidence of psychiatric disorders, depression and sleep disorders https:// www.nature.com/articles/s41380-024-02627-0
Demyelinating disorders: https://pubmed.ncbi.nlm.nih.gov/38534984/?utm_source=substack&utm_medium=email
Increased risk of anaphylaxis, lymphatic disease and appendicitis. https://www.medrxiv.org/content/10.1101/2023.12.13.23299926v1.full.pdf
Blood clots and cerebral venous thrombosis .
Joint and muscle pain . https://www.medrxiv.org/content/10.1101/2023.11.14.23298544v1.full.pdf
Dizziness, ear stones .
Autoimmune skin disorders. https://www.sciencedirect.com/science/article/pii/S0091674924001295
Blood disorders after COVID19 vaccination . https://www.medrxiv.org/content/10.1101/2023.11.15.23298565v1
Skin reactions after COVID-19 mRNA vaccines:
Fertility and COVID-19 mRNA vaccines .
Part II: https://www.preprints.org/manuscript/202407.0069/v1 Comparison of anti- https://www.sciencedirect.com/science/article/pii/S2590136224001128
Menstrual disorders after administration of COVID-19 mRNA vaccines.
Sperm count and motility are reduced by COVID-19 mRNA vaccines.
Increased risk of cancer:
A review article on cancer risk after COVID-1 vaccines. https://www.oncotarget.com/article/28824/text/
This analysis was prepared by
specialist Jeanne A. Rungby, MD. for free use by lawyers who handle cases for patients with injuries or deaths after vaccines.
Specialties: Otorhinolaryngology including oto-neurology including dizziness and allergology.
Email info@rungbyclinic.com