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Section 9: Reporting Adverse Events Following Immunization (AEFI) in Canada – AEFI details

Section 9.
AEFI Details

Indicate the details of the AEFI being reported by checking all that apply. All additional pertinent details (e.g., results of medical investigations, laboratory test, treatment, etc.) should be provided in section 10. For convenience and consistency, high level definitions have been provided for most events listed in section 9. However, if an asterisk (*) is present beside an AEFI term, this specific event should be diagnosed by a physician. If not, sufficient information should be provided (in section 10) to support the selection(s). For all AEFIs, indicate the time to onset or interval (time from immunization to onset of first symptom/sign), and the duration (time from onset of first symptom/sign to resolution of all of signs and symptoms). For each AEFI where a Brighton Collaboration Case Definition (BCCD) exists, the most current published version of the case definition has been cited.

Section 9A) Local Reaction at or Near Vaccination Site

Any description of morphological or physiological change at or near the vaccination site.
(BCCD: Vaccine 26 (2008) 6800-6813).

Indicate, by choosing all that apply any local reactions at or near the vaccination site, as described below:

For all local reactions at or near the vaccination site, describe the signs and symptoms by checking all that apply from the list below. Provide any additional details in section 10:

Section 9B) Allergic and Allergic-like events

Choose one of the following events below:

For a chosen event, describe the signs and symptoms by checking all that apply from the list below. Provide all additional details in section 10.

Skin/Mucosal

Choose all that apply from the list provided below, and indicate the site of reaction:

Urticaria (‘hives’): Localized redness of superficial layers of skin that is itchy, raised, sharply demarcated and transient (that is skin changes at any location are usually present for less than 12 hours). Specify site of reaction. (BCCD: Vaccine 28 (2010) 4487-4498)

Erythema: Abnormal redness of the skin without any raised skin lesions. Specify site of reaction. (BCCD: Vaccine 28 (2010) 4487-4498)

Pruritus: An unpleasant cutaneous sensation that provokes a desire to rub and/or scratch to obtain relief. Specify site of reaction.

Prickle sensation: Tingling or smarting (stinging) sensation. Specify site of reaction.

Rash: A morphologically described change in the appearance of the skin or mucosa that occurs in the context of and in conjunction with an emerging allergic event that consists of one or more clearly identified primary lesion(s) (macule, papule, vesicle, nodule, bulla, cyst, plaque, pustule) and/or secondary skin change(s) (scaling, atrophy, ulcer, fissure, excoriation). (BCCD: Vaccine, 25 (2007) 5697-5706)

Angioedema: Areas of deeper swelling of the skin and/or mucosal tissues in either single or multiple sites which may not be well circumscribed and is usually not itchy (Reported symptoms of “swelling of the lip” or “swelling of the tongue or throat” should not be documented as angioedema unless there is visible skin or mucosal swelling. Check all of the locations where angioedema is seen on the AEFI report form and if “other” is checked, provide details. (BCCD: Vaccine 28 (2010) 4487-4498)

Red eyes (bilateral or unilateral): Redness of the white(s) of the eye(s) (sclera). (BCCD: Vaccine 28 (2010) 4487-44498)

Itchy eyes: A sensation that provokes the desire to rub and/or scratch to obtain relief. (BCCD: Vaccine 28 (2010) 4487-4498)

Cardio-Vascular

Choose all that apply from the list provided below:

Respiratory

Choose all that apply by choosing from the list provided below:

Gastrointestinal:

Choose all that apply from the list provided below:

Section 9C) Neurologic Events

Indicate, by choosing all that apply from the list provided all neurologic events. Provide all additional details in section 10.

Indicate all signs, symptoms and test results relating to the reported neurologic event by choosing all that apply from the list below and provide a detailed description in section 10.

Section 9D) Other Events

For a selected event, describe the signs and symptoms by checking all that apply. Provide all additional details in section 10.

Section 10.
Supplementary Information

Section 10 should be used to capture information that is pertinent to the AEFI but that has not been fully captured elsewhere or that needs further explanation. Document all known details of any investigations or treatments for the recorded AEFI. Indicate the section of the AEFI report that the information applies to, if applicable, when recording information in section 10.

Section 11.
Recommendations for Further Immunization

This section is to be completed by the health professional. In some P/Ts, only the MOH or MD can provide recommendations for future immunizations. In others, RNs have been trained to provide the recommendations as well.

Indicate, by choosing all that apply in section 11, your recommendations for the patient with regard to future vaccinations and specify additional information when requested. A comments section has been added for your convenience; however, should you require additional space for your recommendation(s), please capture this information in section 10.

Complete the reporter information section in full providing your full name and professional status (MOH/MHO: Medical Officer of Health/Medical Health Officer; MD: Medical Doctor; RN: Registered Nurse). If your professional status is not listed, describe under other. In addition, indicate a phone number where you can be reached and sign and date the AEFI form in the space provided.

Section 12.
Follow up Information for a Subsequent Dose of Same Vaccine(s)

Note: The information in this section is not collected by all provinces/territories.

Complete section 12 when an individual who has previously experienced an AEFI following administration of a vaccine receives a subsequent dose of the same vaccine.

Choose one of the responses as described below to describe the outcome following the administration of the subsequent dose of vaccine and provide all pertinent details in section 10.

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2017-06-20