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Adverse events following immunization must be reported

February 3, 2021
An important reminder about pharmacists’ responsibilities to report AEFIs.

As COVID-19 immunization has begun in Alberta and the province plans to involve community pharmacists in those efforts, ACP reminds pharmacists about the requirement to report adverse events following immunization (AEFI).

An AEFI is defined as any unexpected and unwanted medical occurrence in a vaccinee which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. The adverse event may be any unfavourable and/or unintended sign, abnormal laboratory finding, symptom, or disease.

Pharmacists administering vaccines for immunization are required under the Immunization Regulation to report AEFIs to Alberta Health Services (AHS). This part of the regulations came into force on December 17, 2018, and standardizes immunization practices for all vaccines, regardless of whether a vaccine is provincially funded or privately purchased.

For more information about AEFIs and reporting requirements in the Immunization Regulation, please refer to the AHS Adverse Event Following Immunization (AEFI) Reporting for All Health Care Practitioners in Alberta website and Alberta Health’s instructional video.

How and by when to report AEFIs

An online reporting form can be found on the AHS website. If unable to complete the form, call 1-855-444-2324. While some provinces use a Health Canada reporting form, AHS uses its own unique online form to document AEFIs. Alberta pharmacists must not use or submit the Health Canada reporting form to AHS.

Please note that pharmacists are not required to report directly to Health Canada; the reports they submit to AHS are provided to Alberta Health who then submit data to the Public Health Agency of Canada.

Pharmacists must ensure any AEFIs are reported to AHS within three days of determining or being informed that a patient has experienced an event which has not previously been reported.

What type of events should be reported?

Reports should be submitted for any adverse event that

  • follows immunization;
  • cannot be attributed to a pre-existing condition; and
  • meets one or more of the following criteria:
    • the health occurrence is life threatening, could result in permanent disability, requires hospitalization or urgent medical attention, or for any other reason is considered to be of a serious nature;
    • unusual or unexpected, including, without limitation, an occurrence that
      • has not previously been identified; or
      • has previously been identified but is being reported at increased frequency; or
    • cannot be explained by anything in the patient’s medical history, including, without limitation, a recent disease or illness, or consumption of medication.

Examples of events that should be reported include allergic reactions, anaphylaxis, convulsions, paralysis, rash or severe diarrhea, and/or vomiting.

Events that should NOT be reported to AHS include, but are not limited to

  • adverse events following administration of medications other than immunizations, such as psychotropic medications and vitamins; and
  • fever only, excessive somnolence, or irritability.

For a detailed list of reportable and non-reportable events, please refer to the Adverse Events Following Immunization (AEFI) policy for Alberta immunization providers.

Reporting AEFIs during COVID-19

During the current pandemic, pharmacists play a critical role in monitoring the safety of immunizations that are provided to patients. AEFI reporting is critical to identify previously unknown concerns about a product. With the introduction of COVID-19 vaccines, AH will continue to monitor AEFIs reported through the passive surveillance system to ensure information on AEFIs are collected rapidly and safety signals are detected and responded to early.

In addition to the general list of reportable AEFIs, Alberta Health has included a list of adverse events of special interest (AESI) for COVID-19 immunizations. AESIs are pre-identified and pre-defined events that have the potential to be causally associated with a vaccine product that needs to be carefully monitored and confirmed by further studies. A list of reportable AESIs can be found on COVID-19 vaccine: active surveillance and reporting of adverse events following immunization (AEFI).