Meeting with the Danish Health Authority – 1/11 2023

Location: Islands Brygge 57, 2300 Copenhagen S

1. Participants:

The association:
Anette Lindberg Friedrichsen (ALF)
Anne Bove Nielsen (ABN)
Jon-Anders Evensen (JAE)

SDU:
Christine Stabell Benn (CSB)

Danish Health Authority:
Tanja Popp (meeting chair)
Line Riddersholm
Kirstine Moll Harboe
Stine Ulendorf Jacobsen
Amalie Grue Valentin

2. Agenda:

Point 1 – Presentation round
Point 2 – Background and Framework by the Danish Health Authority
Item 3 – Presentation of the Association for Adverse Reactions – Covid19 vaccination: Presentation of the association and the association's purpose
Point 4 – Meeting with the healthcare system: Focus on the members' progress, including condition/symptoms and how it affects their everyday life, whether the meeting with healthcare and the challenges they experience
Item 5 – Closing of the meeting

Point 1

The participants are introduced.

Tanja Popp, Head of Unit Primary Health Care. The unit handles tasks related to health services provided by municipalities and the practice sector, rehabilitation, rehabilita- tion and the cancer and heart areas. Responsible for coordinating the recommendations of the SST for patients with late consequences after Covid.

Kirstine Moll Harboe, acting unit head of the unit for preparedness and infectious diseases, including Covid and various vaccination programs. Health preparedness and the role of the authorities in preparedness.

Line Riddersholm, Section Manager in the Primary Health Care Section.

Amalie Valentin, Physician in the Primary Health Care Unit.

Stine Ulendorf Jacobsen, chief consultant in emergency preparedness and infectious diseases.

Christine Stabell Benn, Professor of Global Health. Invited by the Association for Adverse Reactions due to contact from many vaccine victims, as she was public and visible in the vaccine debate. Has therefore accumulated knowledge about health problems and the limitations of the health system. Interested in research in the field of vaccine reactions.

Anette Lindberg Friedrichsen, Chairwoman of the Association for Adverse Reactions – Covid19 Vaccination and Vaccine Injury.

Jon-Anders Evensen, general practitioner.

Anne Bove Nielsen, organizational psychology consultant, communications advisor.

Point 2

Review of issues and challenges for those invited and SST's desire for knowledge in the area. Emphasis will be placed on point 4 during the meeting, so that SST receives information about what patients with vaccine injuries are struggling with and what needs to be raised about.

Point 3

Brief presentation of the association. The association was formed due to the great need for help among vaccine-injured citizens who have late effects after Covid vaccination. Online groups for vaccine-injured people on Facebook are large and the patients' experiences in the healthcare system are similar. The purpose of the association is assessment, treatment and recognition. Patients with vaccine-injured people experience being sent around the healthcare system without getting help. Previously healthy people are now so sick that they cannot resume their lives as they were before. The association was formed to raise awareness of patients with vaccine injuries and their cry for help. The association hopes that by cooperating with authorities, a good solution can be found for vaccine-injured citizens.

The association's website is under construction.

Only the chairman speaks on behalf of the association. This is because vaccination injuries have become a politically sensitive issue and the association is apolitical. For example, vaccine injured people are called anti-vaxxers and the rhetoric is harsh towards vaccine injured people. Anti-vaxxers have played a large role in the public debate and vaccine injured people are invisible. The association would like to change that. It does not want to be compared to anti-vaxxers. The association does not want to discuss the handling of Covid-19 or vaccination in general. When asked by SST, the chairman of the association stated that there is an international organization for vaccine injured people, React19, which brings together the many associations around the world. The associations are in contact with each other and share knowledge that can benefit patients. In addition, hotlines are organized to prevent suicide among vaccine injured people. In other countries such as Germany, they are further advanced than Denmark in terms of researching and seeing patterns in vaccine injuries. Censorship all over the world makes it difficult for vaccine injured people to find each other and the associations.

Point 4

The association: Had sent 114 patient stories prior to the meeting.
SST: SST states that it has read these patient stories. The stories depict the different patient processes and very different encounters with the healthcare system. SST requests a description of what causes problems for the patients and challenges in the encounter with the healthcare system.

The association: Explains that many of the patients suffer from complex disorders involving many different organ systems. It is clear that it depends on the general practitioner where the patients are referred, what diagnoses and what treatments the patients have received. There are common features in the disease courses identical to what is now called Post-Acute Covid-19 Vaccine Syndrome (PACVS). The focus of the meeting is not on the short-term, transient side effects, but on the group of patients with complex disorders.

The association: Has spoken to the patients, looked at the reports and patient inquiries and made a small list of the most frequently occurring side effects patients experience:

– Heart problems (with and without inflammation), persistent cannot be treated – Nerve damage, loss of strength and muscle spasms
– Hormonal problems, sudden menopause, bleeding disorders, metabolic problems – Autoimmune diseases
– Lung problems, persistent and untreatable
– Chest pain and shortness of breath, cause unknown
– Dizziness around the clock, memory loss, difficulty concentrating – often with sensory disturbances and decreased strength
– Change in blood pressure for unexplained reasons
– Pain 24 hours a day and trembling in arms and legs, headache
– Lost vision, hearing and tinnitus
– SFN Small Fiber Neuropathy
– ME
– Cancer
– Blood clots
– BMS Burning Mouth Syndrome
– Severe hair loss

None of the patients have been cured. A few have experienced improvement over time, but not due to treatment. Patients rarely experience relief of their symptoms with treatment and the cause is not treated.

Personal accounts from the three participants from the Association:

1: Tried to diagnose due to Myocarditis and Pericarditis, which are recognized vaccine side effects, but the doctors don't know what to do. Just finished from the pulmonary department because they don't know why lung function and oxygen uptake are decreasing. In the cardiology department they don't know what to do, as you can't really handle the large diagnostic packages. The doctors' only suggestion is to lower the pulse to spare the heart, but they don't know why the heart is beating faster than normal. But the condition is dangerous because the oxygen uptake is poor. So still not diagnosed and still getting no help. The damage is getting worse, lung function is decreasing and there is now scar tissue on the heart because no treatment has been offered.

2: Internationally, the two patient groups are equated as “sick with the virus” and “vaccination” and are called Long-Covid. The symptoms are similar in both groups. The meeting with the health service has been disappointing and the patients feel let down and abandoned. Assume that SST has also followed what is happening internationally in the area, including Germany. The German Minister of Health Lauterbach was on live TV in March 2023 and said there were side effects after Covid vaccination and promised help and investigation of these patients. In Germany, they are establishing regional centers, they are researching and trying to treat the most severely affected. There is currently no optimal treatment. It is a sad signal to send to the population when the Danish Minister of Health does not respond to inquiries from patients suffering from vaccine injuries. One should intercept and collect the dangerous signals that indicate that some people are becoming seriously ill from the vaccine and gather these patients in centers. The reporting client, as it works today, is difficult to work with and does not capture complex disease patterns. A better way must be found to collect data on side effects from vaccination. Since this was a trial, a better system should have been set up to capture these serious danger signals and side effects. This could ensure that patients were recognized and had access to help, assessment and, in the long term, treatment. That is the hope of the patients.

3: Description of medical history with complex course. Has previously reacted to another type of vaccination with late effects after this. Rigshospitalet was therefore consulted about whether it was safe to get the Covid vaccine. They thought that was the case. After the 2nd and especially the 3rd vaccination, there was a dramatic change in health and functional level. The day before vaccination, I ran 45 minutes on a treadmill, cycled 10km in time and pulled 80 kg in my arms. Immediately after the 3rd vaccination, it was no longer possible to stand upright and had to grab furniture and walls at home. I could not get up and paralysis had occurred from the waist down and the reflexes in my legs disappeared. All other diseases were investigated. Then individual referrals after individual referrals and back to the general practitioner who is powerless due to lack of progress. It is not possible to refer to a comprehensive course. The meeting with the health service has sometimes been positive. An example is from the same department at the hospital staff say they will probably find out what is wrong and they have seen others with similar vaccine injuries. Biopsies and nerve examinations were performed. At the second consultation in the same department, the doctor is incomprehensible to her that she has come there and the doctor asks questions that show that she has not read the medical record. The doctor wanted to discharge the patient. When asked by the patient what could be wrong, the doctor says that it was not vaccine injuries at all because there was none. This took place in the same hospital, same department. The patient was discharged and sent back to the neurological department that had referred her there. This gives an insight into the lack of knowledge, lack of curiosity and a lack of empathy in the encounter with patients who are so sick with late effects after vaccination. The patient has lost his mobility, large parts of his business and his turnover. The injuries and the development of these are existentially threatening.

The doctors have also tried to refer to the Covid late-effects clinics, as it was most relevant, but the clinics have refused to take patients with vaccination injuries. This has happened twice for the same patient. Has also been sent to the Center for Functional Disorders. However, they did not think the patient belonged there, with the physical injuries. If the patient had not actively sought help, he would have been paralyzed and a vegetable today. Hopefully this can provide SST with knowledge of where the healthcare system is failing these patients.

The Association: The three depictions illustrate some of the Association's main complaints: The Association believes that there is a lack of empathy and recognition of the patients. The therapists signal fear of dealing with something that should not be possible. It is surprising that doctors cannot help the patients. Many of the frontline staff were among the first to be vaccinated when they were asked to do so. It is striking that no one writes cases about the healthy and fit people who are in good shape and do sports and suddenly after vaccination cannot stand upright for many months or years. There is not a single article in Danish time shifts. But in Germany and Science, they started publishing articles a few years ago. It is difficult to get these articles included in time shifts, as there is a taboo, due to the communication from the health authorities that the vaccines are safe and effective. The vaccines were not safe for the Association's members and continuing that rhetoric is a mockery of the citizens who were affected by late effects after vaccination. The rhetoric from the authorities has created a shame associated with suffering from vaccine side effects. Patients are shamed. Patients must now fight a year-long battle to be recognized as vaccine-injured. The rhetoric of the health authorities in this process is harsh and subject to all criticism and should be reconsidered for the next vaccination effort.

SST: I can certainly recognize that. There are many other groups of patients with persistent symptoms that the health system has difficulty explaining and treating. SST mentions the treatment options for these patients, for example the Center for Functional Disorders or other organizations where there may be a broader effort. SST is aware that with long-term processes with difficult investigations, the concept of "star patients" sometimes arises (where patients are sent around the health system). There, patients may lack the feeling of a leader. This may be the same thing that vaccine-injured people see as the challenge.

The association: I partly agree, but what vaccine-injured people are exposed to that other patient groups do not is stigmatization. Example: A patient had waited 6 months to come to a hospital after a referral had been sent. When the patient arrives, the doctor tells her that there are no long-term reactions after vaccination, that women cannot have heart problems after vaccination (the patient was a woman) and then he laughs at her. This despite several scans and examinations confirming vaccine injury and heart inflammation. This is how vaccine-injured people are treated. There is not only a lack of treatment options, but also a disgust that has become personal for the doctors. But since no one gets sick from vaccination on purpose, this stigmatization must end. There is a lack of information for doctors that vaccine injuries exist. We must agree that this is not a group of patients who have been made sick on purpose by a vaccine. Claiming that there are no vaccine injuries does not cure the patients and it creates a stigmatization of this entire group of patients. This behavior rubs off on colleagues, nurses and all the way down through the system. So patients are not only met with a lack of professional capacity, they are also met with a lack of will. It has become personal for some in the health service to reject vaccine-injured patients. So the motto "Safe and Effective" thought the association should stop. For those who were injured by vaccines, these vaccines were not safe. When you don't know why the vaccine-injured people got sick, you can't say the vaccines are safe. It is a mockery of the people who are so sick from vaccination. You owe it to the patients who have taken a stab at showing civic-mindedness to have a safety net for those who get sick from vaccination. This safety net does not exist and the patients experience that you are not willing to watch someone get sick from vaccines. There is a pattern in which patients who get sick from vaccination have accelerating damage that does not stop on its own. So if you do not intervene and stop the damage, no one can say about the risk of early death, cancer or future functional level. No one can tell patients whether they will recover or not get worse.

SST: If you hear mention of the personal meeting and the lack of empathy and ridicule. Regardless of the cause of illness, no one in the Danish healthcare system should meet in that way and there must be a respectful dialogue between doctor and patient. Regardless of whether there are currently no treatment options, SST cannot promise that they can provide this. SST offers follow-up and there must be a respectful and proper conversation with the individual patient.

The association: I believe that since symptoms from late effects after a virus are very similar to late effects after vaccination, it is obvious to have both patient groups together for treatment purposes. However, doctors at hospitals refuse to accept patients with vaccine late effects as it has been decided from a political point of view that this patient group may not be accepted at late effects clinics.

CSB: There is a prevailing opinion in the regions and among doctors that the SST has told the regions and general practitioners that patients with vaccine injuries should not be referred to the late-effects clinics. I would like to ask what the Danish Health Authority's position is on this.

SST: Recommendations have been made aimed at Covid late effects. A working group has made the recommendations. In some cases, the clinics are being phased out. Recommendations are being made on coordination to meet the demands of vaccine-injured patients. However, the working group did not believe that vaccine-injured patients should be included. Since SST has not been tasked with making recommendations for patients with injuries after Covid vaccination, it would be recommended that local regions look at whether the offers for late effects patients can also benefit vaccine-injured patients. Therefore, SST has not specifically addressed long-term vaccine injuries but believes that it should be considered locally.

CSB: believes that there is an understanding locally that one may not refer vaccine-injured patients to the late-effects clinics. There is a perception that SST has said this. Asks whether SST will announce nationally that one may refer vaccine-injured patients to the late-effects clinics. This could provide important recognition of that patient group. So far, they have only announced what patients with vaccine injuries are not allowed to do.

The association: Informs that on April 4, 2022, a letter was sent to general practitioners, with the following wording: "Patients with symptoms attributed to Covid-19 vaccination cannot be referred to the late-consequence clinic for Covid, as the Danish Health Authority has not taken a position on handling any symptoms from vaccination against Covid-19."

SST: Will follow up on this and believe it is based on a misunderstanding locally in the Regions. SST is not familiar with the letter. It is assumed that it is the Regions that have sent the letter to the general practitioners and not SST. SST points out that reference is probably made to an interpretation of a version of recommendations from SST that has since been updated.

CSB: Believes that SST has an important task in terms of overcoming stigmatization of the patient group. Doctors need a professional helping hand. For example, information that PACVS is a recognized phenomenon and instructions on where patients can be referred.

SST: Will follow up on the issue. Have tried to get information from GPs about their experiences with vaccine-injured patients. The feedback is that doctors receive very few inquiries. But SST has needed to get the patients' experiences in order to see it through the patients' eyes. In relation to Germany, SST is in contact with colleagues there to gain insight into their organizational set-up.

The association: Suggested solutions:
– There is a need for SST to communicate about vaccine injuries so that everyone receives uniform and proper treatment.
– Patients must be properly received in the healthcare system regardless of what has made them ill.
– One should look to Germany for solutions that can benefit vaccine-injured patients.
– In the event of a new illness after vaccination, the patient should be given the benefit of the doubt. The patient should not prove themselves to be harmed by the vaccine. The health service must prove that the patient is not sick from the vaccine by means of an investigation. If there is no other explanation, it must be considered a side effect of the vaccine. Vaccine harm must be recognized.
– Statement from SST about vaccine injuries exists, so that stigmatization of this patient group is stopped.
– Proposal to establish centers for vaccine-injured people, possibly one in the east and one in the west.
– Establishing research to find out what is a vaccine injury and can it be diagnosed using tests.

CSB: Have discussed research and initiatives for vaccine injuries with Allan Randrup Thomsen and Lennart Friis-Hansen and are in the process of writing a status article for Ugeskriftet. They would all like to come to SST and talk about how to create a joint research and investigation program for vaccine and virus late effects, as the two things overlap. It is possible that in connection with the shutdown, there may have been a peak in vaccine late effects, due to an overreaction in the immune system. It is important to bring the patients together and create a joint investigation program. The three have prepared a long list of tests that can be performed in connection with the investigation of both groups of patients. It will benefit vaccine confidence if the health authorities follow up on these vaccination injuries, as it has been three years since vaccination began. Time is of the essence now. Something needs to happen. At this time, there are probably no doctors who maintain that vaccines cannot in rare cases cause PACVS.

CSB: states that since mRNA vaccines will be dominant in the future, there is a need to find out what these vaccines can do, and especially how they can cause harm in rare cases. There are three groups of vaccine-injured people: the first are pure vaccine injuries, the second are those with already underlying vulnerabilities that are triggered by vaccines, and then there is a third group that has been allowed to play a large role in the public debate, namely those who believe that the vaccine is the reason they have become ill, but where no connection can be found. The first two groups are real patients who have been harmed by the vaccines (The third group must of course also have relevant treatment). It is important to find out whether there are any who may be predisposed to illness and harm from mRNA vaccines.

CSB: further states that research in the area is required, also in light of future vaccines being rolled out. At a minimum, there should be two centers in the east and west, where you can have interdisciplinary teams that can examine patients and research their disease and underlying mechanisms. In the existing late-stage clinics, there is also not the capacity that patients need in connection with the examination and treatment of their disease. Interdisciplinary teams can consist of immunologists, cardiologists, rheumatologists, psychologists and researchers. This can alleviate the stigmatization of patients. This can also make it more attractive to enter research in the area. Because today, no doctors want to work in this area because it is so politicized and polarized. It is not beneficial for one's career to work with vaccine injuries. Overall, the polarized access to vaccines damages trust in vaccines. This is an international problem.

The association: I believe destigmatization is important. Just empathy and recognition can provide a better quality of life for some, even in the midst of serious illness. SST rhetoric so far has helped stigmatize those injured by vaccines. Patients have to tell doctors when consulting them that they are not against vaccines, as this is necessary to get them to take you seriously. It's crazy that you have to say that to be greeted by the doctor.

The association has contacted The Danish Medicines Agency (LMST) and was told that they only use the reports of side effects to register when an injury may have the character of a side effect. But there is no follow-up on the reports. The association calls for a signal that a side effect has occurred to result in measures with treatment and not just registration. CSB proposes a joint meeting with SST, SSI and LMST, to discuss strengths and limitations in relation to capturing complex disorders such as those suffered by patients, in the Danish systems and registry studies.

SST: LMST uses the reports to detect a signal. A signal about possible side effects is not used to create targeted treatment for these, as it is expected that it can be treated in the established healthcare system. Signals are looked at more closely and, for example, whether side effects should be added to the product summaries of the medicines.

The association: I believe that since patients share information about reports, there are clear signs that many are making the same mistake. This should also give rise to investigation, treatment offers and recognition.

SST: The reports to LMST have no direct connection with the establishment of practical measures to benefit patients in the form of treatment. There is currently no treatment specifically targeted at people whose illness is due to vaccine side effects.

The association: Hope SST will establish assessment and treatment for vaccine-injured patients so that the damage can be stopped.

SST: Minutes are taken from the SST and forwarded for review. There are many different actions that may be relevant based on the information they have received, e.g. communication, organization and financing. In addition, it requires contact with others who are decision-makers in areas where those present are not. Thank you for your attendance and information. SST will follow up on the information they have received.

The association: I think the last thing patients need is for all this information and knowledge to be given to SST and then nothing happens. The association has promised to write a report to the patients about what was discussed. The report will be sent to all meeting participants for approval.

SST/Association: Agree to share minutes with each other for transparency.

Point 5

End of the meeting and SST thanks the association and CSB for their participation.