Vaccination damage: That’s why it’s so difficult to prove

Anyone who fell ill after a corona vaccination quickly suspected the injection against Covid-19. Such a suspicion was dismissed for a long time. In the meantime, possible vaccination damage is taken seriously, even by Health Minister Karl Lauterbach (SPD). A post-Covid ambulance set up a post-vac consultation, and the vaccine manufacturers are being sued for damages and pain and suffering. In detail, however, the subject is complex: there are misunderstandings, vagueness, deliberate misleading and legal pitfalls. The crux of the matter is: causality. The most important questions and answers:

What are the processes about?

The presumed first civil trial was initially scheduled for the end of April in Frankfurt. In the meantime, however, the start of this process has been postponed to July 7th. It’s about damages and compensation. The lawsuit is directed against the manufacturer Biontech. The plaintiff claims to have suffered heart damage as a result of the Covid 19 vaccination. The woman, who, according to her lawyer, works in a medical profession herself, wants to remain unknown.

According to their own statements, two large law firms represent a three-digit number of people in court. Manufacturers of various vaccines used in Germany are complaining.

In principle, the same liability rules apply to Covid-19 vaccines as to other drugs, for example under drug law or the Product Liability Act. The manufacturer can be held responsible if there is a production error. For example, if the drug is administered incorrectly, the person vaccinating is liable. The crux of the matter is the causality: is the damage caused by the vaccination?

What do the manufacturers say?

The Mainz-based vaccine manufacturer Biontech emphasizes with regard to the pending processes “that in none of the cases examined by Biontech has a causal connection between the described health impairments and the vaccination with Comirnaty been proven”.

“We take our responsibility as a vaccine manufacturer very seriously,” said a spokeswoman. Biontech carefully examines each case in which claims are asserted against Biontech. The prerequisite, however, is that the lawyers submit sufficient documents. In evaluating the case, we can rely solely on the medical facts to evaluate whether there is a causal relationship or not. Unfortunately, that’s exactly what’s missing very often.”

What are vaccine damages anyway?

The terms are often confused. First, there is the “vaccination reaction”. These are typical symptoms such as redness, swelling or pain at the puncture site. Fever, headaches and body aches are also considered normal, they are an expression of the immune system’s desired confrontation with the vaccine.

The Paul-Ehrlich-Institut (PEI), which is responsible for the safety of vaccines, sees an undesirable reaction occurring after the vaccination as a “vaccination complication”, which firstly could be causally related to the vaccination and secondly goes beyond a vaccination reaction. In the narrower sense, “vaccination damage” means “the health and economic consequences” of this complication.

“Serious side effects” are defined in Section 4 of the Medicines Act – as vaccination consequences “that are fatal or life-threatening, require hospitalization or prolongation of hospitalization, lead to permanent or serious disability, disability, congenital anomalies or birth defects”.

What damages are known?

The PEI regularly publishes “safety reports”. It lists the following serious vaccination complications: heart disease myo-/pericarditis, sinus vein thrombosis occurring in the brain and other blood clots, facial paralysis, a muscle weakness called Guillain-Barré syndrome and hearing impairment tinnitus. They are all according to the PEI data

• “rarely” (one case per 10,000 to 1,000 vaccinations) or
• “very rare” (less than one case per 10,000 vaccinations).

According to the latest full safety report – which includes data up to the end of June 2022 – there have been 120 cases in which a “probable or possible causal link” has been recognized between a death and the corona vaccination. According to the PEI, the number of deaths 30 days after a corona vaccination is no more frequent than would be expected on the statistical average.

How many suspected cases were reported?

The PEI also counts the reported suspected cases. These statistics do not show whether the suspicion is confirmed later. By the middle of last year, 323,684 suspected cases of side effects and vaccination complications had been reported to the Institute.

According to the Robert Koch Institute, a total of 183 million individual vaccinations have been administered to protect against Covid-19 since vaccination began. The reporting rate for all vaccines together was 1.8 reports per 1000 vaccine doses, for suspected cases of serious side effects and vaccination complications 0.3 reports per 1000 vaccine doses. The number is therefore in the per thousand range.

How are dramatic individual fates to be classified?

The media keep reporting on dramatic individual fates. The “heute-journal” showed, for example, in an article a young former competitive athlete who had to fight for her life after the second dose of the corona vaccination and is now in a wheelchair.

“But according to the current data, cases like the one in the article are so rare that they are not recorded as a statistical accumulation,” said Leif Erik Sander, vaccine researcher and head of the Infectious Diseases Clinic at the Charité in Berlin, after the “Zeit”. Such extreme consequences could occur in individual cases after a corona vaccination. If there were an accumulation of such serious complications, said Sander, this would have been noticed in the PEI data and – with more than 13 billion doses vaccinated worldwide – even more so in international data. And that is not the case.

Is something being swept under the rug?

Opponents of the corona vaccinations claim that. In 2022, for example, citing the National Association of Statutory Health Insurance Physicians, it was claimed that doctors in private practice had coded vaccination side effects 2.5 million times in their statements. This would have caused problems in 1.5 percent of all corona vaccinations. With conventional vaccinations before the mRMA technique, this value was 0.3 percent.

Fact checkers came to the conclusion that different things were being equated here and incorrect conclusions drawn from them. For example, harmless vaccine reactions, which are common, and real vaccine damage, which are very rare, have been lumped together. The catchphrase of the 2.5 million victims of the corona vaccinations nevertheless stuck. During a visit to the constituency, Chancellor Olaf Scholz (SPD) was thrown this number at his head.

Have people been awarded money before?

Claims for benefits were granted for a few hundred people. This is not about compensation for pain and suffering, but about pension benefits. The pension offices of the federal states are responsible. If they reject the application, you can appeal the decision to the social court. Here, too, the question is whether the damage happened by chance close to the vaccination or was caused by the vaccination.

According to research by the “Frankfurter Allgemeine Zeitung” (FAZ), by mid-March 2023, 6,600 applications for benefits due to corona vaccination damage had been received in 13 of the 16 federal states. According to the research, the number of corona vaccination damages recognized by the pension offices was 284. “In the 13 countries, there is recognized corona vaccination damage for almost 214,000 vaccinated citizens,” according to the FAZ.

When is vaccination a risk?

Like a mantra, the PEI emphasizes “that undesirable reactions are often related in time, but not necessarily causally, to a vaccination”. It is one thing to prove or disprove this in a specific individual case. The other is to quantify the risk to the general public.

Statistics on how often certain diseases occur in a certain population group in a certain time frame help with this. They are the benchmark for reported adverse events after vaccination. If there is a significantly higher number of suspected case reports for an event after a vaccination than would be statistically expected in a comparable population, the PEI speaks of a “risk signal”. So there could be danger lurking here.

What is Post Vac?

Analogous to Long- or Post-Covid, the term Post Vac has established itself for complaints after a vaccination. The clinical picture is not medically defined. In general, this means complaints that can also occur after a Covid infection.

The University Hospital Marburg has launched a post-vac consultation as part of its Covid outpatient clinic. “We have hundreds of inquiries about post-vac syndrome every day,” said the head of the outpatient clinic, Prof. Bernhard Schieffer. ” When you first contact us, you can’t say that many suspected cases will come true in the end.”

If the ambulance takes care of a suspected post-vac, it not only has to be checked whether there is actually a causal connection. It is also important to distinguish whether the patient is only vaccinated or was also infected. According to Schieffer, a test is used for this that can distinguish between the antibodies against the virus and the antibodies against the spike protein of the vaccine.

How are politicians reacting?

Health Minister Karl Lauterbach (SPD) has promised help for people with long-term damage from a corona infection or vaccination. Lauterbach announced in March on the ZDF “heute journal” that his ministry would launch a program in which the consequences of Long Covid and Post Vac – i.e. vaccination damage – would be examined and the care of those affected would be improved. The long-term consequences of a corona vaccination should be recognized more quickly. Commentators saw this as a 180-degree turn by the minister, who had previously emphasized the harmlessness of the corona vaccines.