Get the free Report of Adverse Event Following Immunization (AEFI) Requisition. Public Health Ont...

Report of Adverse Event Following Immunization (AEF) When completed, please send the form to your local Public Health Unit by a secure means. For more information about AEF reporting in Ontario visit

How to fill out report of adverse event

How to fill out report of adverse event

1. Begin by obtaining the necessary reporting forms from your organization or regulatory agency.
2. Gather all relevant information and documentation related to the adverse event, such as patient records, lab reports, and any available medical notes.
3. Start filling out the reporting form by providing the required details about the adverse event, including date and time of occurrence, description of the event, and any contributing factors or suspected causes.
4. Include information about the affected patient, such as their age, gender, medical history, and any known allergies or pre-existing conditions.
5. Describe the severity and outcome of the adverse event, whether it resulted in hospitalization, disability, or death.
6. Provide your contact information and any additional comments or observations that could help in understanding the event better.
7. Once completed, review the report for accuracy and completeness. Make sure all necessary signatures and dates are included.
8. Submit the filled-out report to the designated authority or department within your organization or regulatory agency.

Who needs report of adverse event?

1. Healthcare professionals
2. Pharmaceutical companies
3. Regulatory agencies
4. Researchers
5. Public health organizations

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What is report of adverse event?

A report of adverse event is a document that provides information about an unfavorable or unintended occurrence related to the use of a medical product or intervention, such as a drug or device.

Who is required to file report of adverse event?

Healthcare professionals, manufacturers, and sponsors of clinical trials are typically required to file reports of adverse events.

How to fill out report of adverse event?

To fill out a report of adverse event, gather relevant information about the patient, the event, the medical product involved, and any other pertinent details, and complete the designated form provided by regulatory authorities.

What is the purpose of report of adverse event?

The purpose of a report of adverse event is to monitor the safety of medical products, identify potential risks, and implement necessary actions to ensure patient safety.

What information must be reported on report of adverse event?

Information that must be reported includes the patient’s demographic details, description of the adverse event, the medical product involved, the outcome of the event, and any relevant medical history.