In the first of potentially hundreds of cases in the nation, BioNTech will appear in court on Monday to defend itself against a claim made by a German lady seeking damages for purported adverse effects of its COVID-19 vaccine.

The woman is suing the German vaccine manufacturer for at least 150,000 euros ($161,500) in damages for bodily harm as well as compensation for unspecified material damage, according to the regional court in Hamburg that is hearing the case and law firm Rogert & Ulbrich, which is representing her, as reported by Reuters. The woman is exercising her right under German privacy law for her name not to be made public.

BioNTech Concludes the Claim Lacks Merit

The complainant alleges that the vaccine caused upper-body pain, swelling limbs, exhaustion, and sleep disturbance. Monday is the first hearing.

Tobias Ulbrich, an attorney at Rogert & Ulbrich, said that he intended to contest in court the conclusion reached by German vaccine review authorities and European Union regulators that the BioNTech shot has a favorable risk-benefit profile.

According to German pharmaceutical legislation, manufacturers of medications or vaccines are only responsible for paying damages for side effects if "medical science" demonstrates that their goods cause excessive harm compared to their advantages or if the label information is inaccurate.

Following careful study, BioNTech, which owns the marketing authorization in Germany for the shot it co-developed with Pfizer, said it had concluded that the claim lacked merit.

It was mentioned that around 64 million people in Germany were among the approximately 1.5 billion people worldwide who had received the shot. The most widely used drug in the West, Comirnaty from BioNTech, is safe to use, according to the European Medicines Agency (EMA).

In a media briefing last week, the EMA reiterated the value of every COVID shot it had previously approved, including BioNTech's, noting that vaccines were thought to have prevented nearly 20 million deaths worldwide in the first year of the pandemic.

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Who Would Cover Accuser's Winnings?

Myocarditis and pericarditis, two forms of heart inflammation, have been reported to occur very rarely after receiving the Comirnaty vaccine, mostly in young males.

Rarely do side effects emerge after medicine has received regulatory approval. Due to the unprecedentedly quick pace at which COVID vaccines were created during the pandemic, rare adverse effects were not as quickly identified as they may have been in conventionally longer studies.

According to EMA, safety monitoring was maintained during the expedited review. By May, the EMA had received about 1.7 million spontaneous reports of potential side effects, or around 0.2 for every 100 doses.

It is unclear who would be responsible for covering the plaintiff's winnings regarding compensation or court fees. According to sources, several bulk purchase contracts the EU has with vaccine manufacturers, such as BioNTech-Pfizer, include complete or partial liability waivers for legal fees and potential compensation, which could require EU governments to shoulder some of the costs.

Germany has a public sector financial assistance program known as a no-fault compensation program for those who experience irreversible injury from vaccines. However, membership in the program does not exclude someone from suing individually for damages.

In the US, makers of vaccines against COVID that have regulatory approval are immune from responsibility. According to Rogert & Ulbrich, it has filed roughly 250 cases for individuals seeking compensation for purported COVID-19 vaccination side effects.

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