Report an Adverse Event (AE)
This page is intended for residents of Ireland.
This form is NOT intended to request Medical Information and/or report Product Quality Complaints. You can access these two forms from the bottom of this page.
It is also NOT intended to report adverse events that occur while you are participating in a clinical trial. If you are participating in a clinical trial, please report your adverse event to your study site.
If you are an individual receiving a Novavax medicinal product, please contact your doctor, nurse or healthcare provider for medical support before making any changes to your treatment.
An adverse event is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes Special Reporting Situations such as:
- Overdose, abuse, or misuse of the product;
- An adverse event occurring from the withdrawal of the product;
- Lack of product effect/efficacy;
- Accidental or occupational exposure to the product;
- Medication error (suspected or actual, including “near-miss” reports);
- Pregnancy or exposure to the product during breastfeeding;
- Suspected transmission of infectious agent via product;
- An unexpected therapeutic or clinical benefit;
- Suspected or actual report of counterfeit product;
- Off-label use.