What is a side effect or an adverse event?
A side effect or an adverse event is any unwanted medical occurrence in a patient who has been given a pharmaceutical product or vaccine that may or may not have been caused by treatment with the product. A side effect can therefore be any unfavourable and unintended sign, symptom, or disease associated with the use of the product.
Why report side effects and adverse events?
By reporting side effects and adverse events for Seqirus products you help us to ensure the safety of our products and our patients. Your information will also enable Seqirus to fulfill its reporting responsibilities to health authorities, which requires that we provide information on side effects with our products - even in cases where a relationship between the product and the effect is not established.
If you or the person you are reporting on behalf of are currently suffering from severe side effects, you should contact your local doctor or other medical health professional before reporting the side effect.
When reporting side effects please provide the following information in your email to ensure it is handled in a manner consistent with the applicable local laws:
- Name of the vaccine or medication: description of when the patient was receiving the vaccination or the medication. Any action taken with the product, and impact of that action on the side effect.
- The side effect associated with the drug: symptom evolution over time. Description of any treatment needed for the side effect. Name of healthcare provider who provided treatment and contact information.
- Information about the person who experienced the side effect: any other medical conditions currently ongoing. Medications currently taken (name, dosing strength, frequency, and when medication was started). Gender and age of the person taking medication (optional).
When you report an undesirable effect, we will collect certain personal information about you. If you make a report to one of the countries listed below, which is in the EU, you can find out more about how we handle your personal information here Europe and GDPR applicable suspected adverse event reporting privacy notice
If you make a report to one of the countries outside of the EU you can find out more about how we handle your personal information here US, Australia and rest of the world website privacy notice.
For the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) can be contacted through its Yellow Card reporting system.