If you suspect that a medicine or vaccine has caused side effects or damage to health, you can report this directly to the competent authorities. Adverse reactions are, for example, harmful effects of a medicinal product, vaccination complications or damage to health.

Every suspected case of an adverse reaction reported in Europe is forwarded to the common European adverse reaction database EudraVigilance. The national authorities responsible for drug safety in Europe and the European Medicines Agency (EMA) jointly and systematically assess the safety of medicines based on these reports and other scientific information:

• Medicinal products;
• vaccines;
• Tissue preparations, for example heart valves or corneas;
• advanced therapy medicinal products (ATMPs).

Notifications from private individuals
As a private individual, you can report a suspected adverse reaction for yourself. You can also report on behalf of someone you care for, for example your child or other relatives.

Doctors and pharmacists can help you fill in the form or report suspected cases directly. You should always contact a doctor to diagnose your symptoms and treat your complaints.

As a patient, you can remain anonymous: Providing your name or personal contact details is voluntary. However, by providing a contact for queries, you will help the authorities to follow up on suspected cases, which is important for drug safety.

Reports from healthcare professionals
As a healthcare professional - such as a doctor or pharmacist - you are legally obliged to report vaccination complications to the relevant authorities. The obligation to report suspected adverse drug reactions is regulated by the respective professional code of conduct. Adverse drug reactions can also be reported to the relevant competent authority.

Reports from manufacturers and other healthcare professionals
As a pharmaceutical company or commercial sponsor of a clinical trial, you report adverse drug reaction cases exclusively electronically to the relevant European (EMA) or national authority using the EudraVigilance infrastructure in accordance with the legal regulations and guidelines. As a non-commercial sponsor of clinical trials, you report suspected cases directly to the national authorities, preferably also electronically using the EudraVigilance infrastructure.

As a marketing authorization holder of medicinal products, you are also obliged to pass on safety-relevant information immediately to doctors and pharmacies in consultation with the competent higher federal authority via so-called red hand letters.

Information for reporting suspected cases
If possible, please provide the following information for tracking the suspected case:

• Information about the person who experienced the adverse reaction or vaccination complication, in particular age and gender;
• a description of the adverse reaction or vaccination complication;
• the dose and name of the medicinal product/vaccine (trade name and name of the active substance) suspected of having caused the adverse reaction or vaccination complication, including the timing of the adverse reaction or vaccination complication;
• the batch number of the medicinal product or vaccine indicated on the packaging
• any other medicines or vaccines taken or injected around the same time; this includes non-prescription medicines, herbal medicines and contraceptives;
• any other health problems of the person experiencing the side effect, such as pre-existing medical conditions, but also health risk factors such as obesity or smoking.