What is an Adverse Event?

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.

Why report Adverse Events?

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.

You can use this website to report Adverse Events on our COVID-19 mRNA vaccine (COMIRNATY®).

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 may report an Adverse Event by telephone at +49 6131 9084 0, or alternatively complete the following web form:

Personal Information

Context Information

Suspect Drug Information

Name of the Suspect Product * Batch/Lot no. Expiry date Indication Administration date Route of administration Booster vaccination

Please add at least one suspect drug.

Patient Information

Please fill in at least one patient identifier: patient initials, date of birth, age group or gender.

Adverse Event(s)

Country of occurrence * Adverse Event * Onset date/time Event end date/time Did the Adverse Event/s result in any of the following? Event Outcome: Additional information about the Adverse Event

Please fill in the field "Adverse event(s)".

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