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Adverse Events Following Immunization (AEFI)

 
An adverse event following immunization (AEFI) is any untoward medical occurrence in a vaccinee that follows immunization. It does not necessarily have a causal relationship with the vaccine or the immunization process.

For the criteria for the reporting of adverse events, and for help with the interpretation of adverse events following immunization and their implications for subsequent immunization, see the BC Immunization Manual, Part 5 - Adverse Events Following Immunization.

‎As of January 1, 2019, a health professional who is aware of an adverse event following immunization must report the event to the medical health officer as per the Reporting Information Affecting Public Health Regulation, Part 2, Division 1, Section 5 of the Public Health Act.


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
  • unusual or unexpected events (for example, an event that has not been identified previously or has been identified before but is occurring with greater frequency in the population)
  • clusters of events: known or new events that occur in a geographic or temporal cluster (for example, 6 in a week or 6 in a single Health Service Delivery Area)

Events that should not be reported:

  • local injection site reactions and non-specific systemic reactions (for example, headache, myalgia) that are known to occur with the vaccine(s), unless these are more frequent or severe than expected based on clinical trial findings (However, always counsel clients about expected reactions following immunization and how to manage these reactions.)
  • events that have another obvious cause (for example, co-existing conditions)

‎If your patient experiences an adverse event

Instructions for Clinicians and Pharmacists:

Health care providers including physicians and pharmacists are required by law to report Adverse Events Following Immunization (AEFI) to monitor vaccine safety. Please complete the form Report of Adverse Event Following Immunization (for non-public health professionals reporting AEFI) and send it to the local health unit (see Where to submit an AEFI report).


Instructions for Public Health:

Public Health to complete the Adverse Event Following Immunization Case Report Form (for public health) and enter into Panorama or PARIS. Additional information collection may be required for public health reporting. Criteria for reporting and management of adverse events are found in the BC Communicable Disease Control Manual, Chapter 2: Immunization,  Part 5 - Adverse Events Following Immunization.


To report an AEFI follow these steps:

  1. Download the Adverse Event Following Immunization case report form  (for public health) or the Report of Adverse Event Following Immunization (for non-public health professionals reporting AEFI).
  2. Refer to the AEFI user guide for instructions on how to complete the AEFI case report form.
  3. Complete the form and submit it to your local health unit by fax or email. Please click on map of where to report adverse event following immunization to find your Regional Health Authority contact information.
  4. Additional Resource: Educational video on reporting Adverse Events Following Immunization.

If you observe or treat an anaphylactic episode

Anaphylaxis is an adverse event, a very rare but potentially life-threatening reaction to immunization. Healthcare providers who observe or treat an anaphylactic episode are asked to complete a worksheet in addition to the AEFI form. The information in the worksheet can be used to help complete the AEFI form. 


  1. Download the Worksheet for Events Managed as Anaphylaxis Following Immunization.  
  2. Print and complete the form. 
  3. Use the worksheet to complete the AEFI form and report the AEFI to the local health unit as outlined under 'How to report an AEFI'.
For a decision tool, with immunization-specific information, including background information and reporting regulations, see the BC Immunization Manual: Part 3 - Management of Anaphylaxis in a Non-Hospital Setting.

After filling and printing the form, please submit the form to the appropriate Medical Health Officer (MHO) for review. Please also complete a Panorama report on this adverse event.

‎It is very rare for a vaccine to result in a permanent injury. Canada's Vaccine Injury Support Program (VISP) is a federal program that provides financial suport if it is determined that an individual has experienced a serious and permanent injury after receiving a Health Canada-approved vaccine, administered in Canada on or after December 8, 2020. This includes all vaccines approved by Health Canada and emergency use authorization vaccines such as COVID-19. Financial support is also available to dependents of an individual who has died after vaccination. Learn more at vaccineinjurysupport.ca


Physicians and other health professionals are encouraged to inform patients who may be eligible for compensation by VISP about this program. If you support a patient in submission of a claim to the Vaccine Injury Support Program, please also report their adverse events to public health as outlined above.



SOURCE: Adverse Events Following Immunization (AEFI) ( )
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