Report Adverse Events

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.

Adverse Events that occur as part of a clinical trial must be reported to the appropriate coordinating study site.

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:

Reporter's Personal Information

Are you a healthcare professional?

Nothing found

Type of healthcare professional

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Institution

Are you the patient?

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First Name

Surname

Phone

Street Address

Zip Code

City

Country

Nothing found

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

Gender

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Age Group

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Date of birth

Patient Initials

Pregnant at the time of administration

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Breastfeeding at the time of administration

Nothing found

Please fill in at least one patient identifier: patient initials, date of birth 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)".

Our Privacy Notice outlines how we process your personal information when dealing with your adverse event report, including the information about your rights and how to exercise them. Our collaboration partner Pfizer will contact you for adverse event follow up questions or missing information that are necessary to assess your report for drug safety purposes.