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This user guide provides detailed instructions on how to complete and submit reports of adverse events following immunization (AEFI) in Canada, developed by the Vaccine Vigilance Working Group and
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How to fill out Reporting Adverse Events Following Immunization (AEFI) in Canada

01
Begin by obtaining a copy of the Reporting Adverse Events Following Immunization (AEFI) form from your local health authority or relevant health department website.
02
Fill in the patient’s personal information, including name, date of birth, and contact details.
03
Provide the date of vaccination and specify the vaccine received.
04
Describe the adverse event experienced by the individual, including symptoms and their onset dates.
05
Include any relevant medical history that may assist in understanding the event.
06
Indicate whether the individual sought medical treatment for the adverse event and provide details if applicable.
07
Complete all sections of the form accurately and thoroughly.
08
Submit the completed form to the designated health authority or agency as indicated on the form.

Who needs Reporting Adverse Events Following Immunization (AEFI) in Canada?

01
Healthcare professionals who administer vaccines.
02
Parents or guardians of individuals experiencing adverse events post-vaccination.
03
Public health officials monitoring vaccine safety.
04
Researchers studying vaccine-related adverse events.
05
Regulatory agencies involved in vaccine evaluation and safety monitoring.
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Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) Provides a national monitoring system for reporting adverse events and suspected adverse events following immunization. Formerly Vaccine Associated Adverse Events Surveillance System (VAAESS).
Examples: pain, swelling at injection site, fever, irritability, malaise etc. Examples of severe reactions include non-hospitalized cases of anaphylaxis that has recovered, high fever (>102-degree F), etc.
Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) Provides a national monitoring system for reporting adverse events and suspected adverse events following immunization. Formerly Vaccine Associated Adverse Events Surveillance System (VAAESS).
Many vaccine injections can cause soreness, redness, itching, swelling or burning at the injection site for 1–2 days. Paracetamol might be needed to ease the discomfort. Sometimes a small, hard lump (nodule) at the injection site may persist for some weeks or months.
Meet one or more of the seriousness criteria: An adverse event that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, or is a congenital anomaly/birth defect should be considered serious.
Events that must be reported include: serious events (life-threatening or resulting in death, requiring hospitalization, resulting in a residual disability, associated with congenital malformation) events requiring urgent medical attention.
The FDA Adverse Event Reporting System (FAERS) database contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to FDA.
How to report an AEFI ACT: ACT Health 02 6205 2300. NSW: NSW Health 1300 066 055 (to connect to your local public health unit) NT: NT Health 08 8922 8044. QLD: Queensland Health 07 3328 9888, or complete an AEFI initial report form on the Queensland Health website. SA: SA Health 1300 232 272 (Immunisation section)

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Reporting Adverse Events Following Immunization (AEFI) in Canada refers to the process of monitoring and documenting any adverse events or reactions that occur after the administration of vaccines. This system is crucial for assessing vaccine safety and effectiveness.
Healthcare providers, including physicians, nurses, and pharmacists, are required to file reports of AEFIs. In addition, vaccine recipients or their caregivers can also report adverse events.
To fill out an AEFI report, the reporter must collect relevant information about the event, including the patient's details, the vaccine received, the nature of the adverse event, and the timeline of the event. The completed report should then be submitted to the appropriate health authority.
The purpose of AEFI reporting is to ensure vaccine safety by identifying potential adverse reactions and evaluating their impact on public health. This data helps health authorities to monitor vaccine performance and take necessary actions if required.
The information that must be reported includes the patient's demographic details, vaccination history, details of the adverse event, the time frame of the event relative to vaccination, any medical interventions required, and any prior history of similar adverse events.
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