Glossary
The Paul-Ehrlich-Institut has developed the definitions in this glossary to help users understand regulatory and biomedical terminology. Definitions may differ from those given in German and European Union legislation and medicine. Many definitions correspond to the glossary entries on the pages of the European Medicines Agency (EMA).
Vaccination Complication
According to section 6 paragraph 1 no. 3 of the Infection Protection Act (Infektionsschutzgesetz, IfSG), medical professionals are required to report any suspicion of damage to health beyond the usual extent of a vaccination reaction. This means symptoms occurring after vaccination that could be causally related to the vaccination and go beyond the usual vaccination reactions (vaccination complication). Common vaccination reactions include short-term, transient local and general reactions or similar symptoms of a 'vaccine disease' (example: non-infectious measles-like rash).
Vaccination Damage
According to section 24 of the Social Code (Sozialgesetzbuch, SGB) XIV, vaccination damage is understood to mean damage to one's health that exceeds the usual extent of a vaccination reaction. Section 5 of the SGB XIV regulates the degrees of damage and stipulates that temporary health conditions lasting up to six months are not to be considered as damage.
If a vaccinated person or their relatives suspect that they have suffered vaccination damage after a publicly recommended vaccination, they can submit an application for relief under the Federal War Victims Relief Act (Bundesversorgungsgesetz) in accordance with section 24 of the Social Code (SGB) XIV in conjunction with section 4 of the Social Code XIV.
Pursuant to section 4 subsection 4 of the SGB XIV, a determination of the existence of a probable causal relationship is sufficient for the recognition of a health condition as a result of damage.
The application for compensation must be submitted to the Social Welfare Office in the federal state in whose territory the vaccination was carried out in accordance with section 113 subsection 5 of the SGB XIV. The Paul-Ehrlich-Institut is not responsible for processing recognition procedures for vaccination damages.
Further Information
Vaccination Reactions
Vaccination reactions are understood to be short-term, temporary, local, and general reactions to a vaccine that do not exceed the usual extent of a reaction and are to be regarded as an expression of the organism's confrontation with the vaccine, such as redness, swelling and pain at the injection site, increased temperature, fever, fatigue, headache, or other flu-like symptoms. Vaccination reactions are a type of side effect.
Variation
A change to the terms of a marketing authorisation of a medicine.