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 German Social Code XIV (Sozialgesetzbuch, SGB XIV), vaccination damage is defined as a damage to health that goes beyond the usual extent of a reaction to a vaccination.
Section 5 SGB XIV regulates the degree of damage and stipulates that temporary health impairments of up to six months are not to be taken into account.
If vaccinated persons or their relatives suspect that they have suffered a vaccination damage following a publicly recommended vaccination, it is possible to submit an application for care under the German Federal Pension Act in accordance with Section 24 of the German Social Code (SGB) XIV in conjunction with Section 4 SGB XIV.
According to Section 113 (5) SGB XIV, the application for compensation must be submitted to the state pension office of the federal state in whose territory the vaccination was carried out. The Paul–Ehrlich-Institut is not responsible for processing applications for recognition of vaccination damage.
According to Section 4 (4) SGB XIV, the probability of a causal connection is sufficient for the recognition of a health disorder as a consequence of injury.
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.
