The safety of the vaccine and any related adverse effects are usually among the most important issues to be investigated in a study. Information about adverse events occurring during the study is collected in accordance with legislation and the study-specific protocol.
Participants in vaccine studies are instructed to report all significant health-related events, especially any hospitalizations, in line with the study-specific instructions. Possible adverse effects are often reported using regularly completed electronic diaries. Information is also collected during regular study visits and through remote contacts.
You can always contact your study clinic if you have questions about the study, suspect a vaccine-related adverse effect, or have been hospitalized.
Suspected adverse effects and sudden illness – what to do
If you suspect an adverse effect related to the investigational product, please report it to the study staff according to the instructions you have been given. If you are unsure about how to report or have questions regarding adverse events, contact your study clinic.
If you become suddenly ill, contact the emergency healthcare unit in your area. In urgent emergencies, call the emergency number 112.
If you are hospitalized during your participation in the vaccine study, we ask that you inform your vaccine study clinic staff as soon as possible.