Patient's safety and public health are key priorities of Novartis Vaccines. Therefore, Pharmacovigilance is a major company objective and the maintenance of a comprehensive Pharmacovigilance system with adequate processes and procedures is mandatory.

According to legal requirements a pharmaceutical company must ensure that it has an appropriate system of pharmacovigilance in place in order to assure responsibility and liability for its marketed products, and products in development, to ensure that appropriate action can be taken, when necessary.

Novartis Vaccines has therefore established a system which ensures that information about all suspected adverse events/reactions from any source is collected, collated and assessed in order to comply with current national and international guidelines and Novartis Vaccines procedures.

Forms are available in various languages - please select the relevant country TAB above.

For recording an adverse event following the administration of a Novartis swine-flu vaccine please use our English Only AE report form.

Particular attention should be focused on recording the following items:

• Name and address of the source
• Details on the patient (initials, date of birth or age, sex)
• Product/Vaccine (brand name, batch number, dates of vaccination)
• Adverse event(s) including date of onset and outcome

For further advice on how to fill in the AE report form click here.

Healthcare Professionals

Information for health-care professionals:

In accordance with the guidance from the EMEA, Novartis would like to stress the importance of reporting the following adverse events after administration of a Novartis pandemic flu vaccine

• All adverse events with fatal outcome
• All adverse events resulting in a life-threatening situation
• All serious and unexpected adverse events
• All adverse events of special interest (AESI), which are: neuritis, convulsions, anaphylaxis, encephalitis, vasculitis, Guillain-Barré syndrome, Bell's palsy, demyelinating disorders, laboratory-confirmed vaccination failure (of swine-flu pandemic vaccine).

Forms available

Instructions for completing the form

Adverse Event Web Form