An Adverse Event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An adverse event can be any unfavorable or unintended abnormality, symptom or illness associated with the intake/use of the drug. Thus, the suspicion that an observed physical or psychological reaction is due to prior medication use is sufficient for reporting.
Reporting Adverse Events is helpful because pharmaceutical companies and regulatory authorities learn from it how to make the use of drugs even safer.
For BioNTech, patient and drug safety is paramount. By reporting Adverse Events regarding use of BioNTech drugs, you help us ensure the safety of our drugs as well as our patients. Your information also enables us to meet our reporting obligations to regulatory authorities.
Adverse Events that occur as part of a clinical trial must be reported to the appropriate coordinating study center.
If you or the person on whose behalf you are reporting is currently suffering from a serious Adverse Event, you should contact your doctor or other healthcare professional before reporting the Adverse Event.
You can use this website to report Adverse Events on our COVID-19 mRNA vaccine (COMIRNATY®).
You may report an Adverse Event by completing the following web-form: