Section 1: Reporting Adverse Events Following Immunization (AEFI) in Canada – Provincial and regional identifying information

Section 1.
Provincial and Regional Identifying Information

Section 1A) Unique Episode Number

A unique episode number is to be assigned to each AEFI report.  In provinces/territories that use electronic reporting systems, this number may be automatically generated by the system.  In provinces/territories that do no use electronic reporting systems, this number should only be filled in by those persons who are authorized to assign the number at provincial/territorial health authorities (e.g., provincial/territorial health professionals and/or officials). The unique episode number should be marked on the top of the first three (3) pages of the AEFI form as an identifier to link the pages together.  If you are not authorized to assign this number, please leave this field blank.

Section 1B) Region Number

A region number that corresponds to a given health unit should be entered for those regions that have one. The region number (the number that corresponds to a given health unit) should be marked on the top of the first three (3) pages of the AEFI form as an identifier to link the pages together. This number should only be filled in by those persons who are authorized to assign it and should be left blank if it does not apply to your locale.

Section 2.
IMPACT LIN (Local Inventory Number)

IMPACT is a paediatric, hospital-based, national active surveillance network for adverse events following immunization, vaccine failures and selected infectious diseases in children. IMPACT is administered by the Canadian Paediatric Society with funding from the Public Health Agency of Canada. IMPACT reports the more serious hospitalized cases and selected outpatient visits for adverse events and vaccine-preventable diseases.

An IMPACT Local Inventory Number (LIN) is to be assigned by the IMPACT Nurse monitor when an AEFI report is generated from an IMPACT centre. The IMPACT LIN should be marked on the top of the first three (3) pages of the AEFI form. Please leave this section blank if it does not apply to you (e.g., if you are not an IMPACT hospital/centre).

The IMPACT LIN is used to link the initial provincial/territorial AEFI report to the IMPACT report. Once both reports have been received, the data contained on the AEFI form and the IMPACT forms are merged in the CAEFISS database.

Section 3.
Patient Identification

This section is intended to capture patient information for use by regional and/or provincial/territorial health officials. This information is kept confidential and should not be forwarded to PHAC.

This section should be completed in keeping with provincial/territorial guidelines.

• Patient Identification Information: Provide the patient’s first and last name, health number (if applicable), address of usual residence including postal code (with the understanding that this address might be in a different province/territory than where the vaccine(s) was administered or where the AEFI is being reported) and a telephone number (either residential or business or both), where the patient can be reached.
• Information Source: If the source of the information for the AEFI report is a parent, or another care provider, provide their name, relation to the patient and contact information (including their full mailing address and phone number where they can be reached) if it is different from the patient’s.

Section 4.
Information at Time of Immunization and AEFI Onset

Section 4A) At Time of Immunization

Provide all information, as described below, in the space provided on the form:

• Province/Territory of immunization: Indicate the province or territory where the immunization was received. This may be different from the patient’s province or territory of residence and/or where the AEFI is being reported.
• If the vaccine was administered outside of Canada, indicate the country in which the vaccine(s) was/were administered in the space to capture province/territory and also comment if it was received at a Canadian operated clinic in that country.
• Date and time vaccine administered: Indicate the date and time of vaccine administration remembering to specify if the vaccine was administrated in the “am” or “pm” by circling the appropriate descriptor. If complete information is unknown, provide as much detail as is available (e.g. month and/or year).
• Date of Birth: Indicate the patient’s date of birth in the space provided. If the complete date is unknown, please provide as much information as is available (e.g. month and/or year).
• Age: Indicate the patient’s age at the time of immunization. Use days for infant’s aged less than 1 week; weeks for infants aged less than 1 month; months for infants aged less than 1 year; and years thereafter. Fractions should be used as appropriate (e.g., 6 weeks should be captured as 1.5 months; 15 months should be captured as 1.25 years). If the patient’s exact age is unknown, please estimate patient’s age.
• Sex: Indicate the patient’s gender (e.g., male or female). If the gender is unknown or ambiguous, please choose “other”.

Section 4B) Medical History (up to the time of AEFI onset)

Indicate the patient’s medical history prior to the time of AEFI onset by choosing all that apply from the list provided below. Provide all additional details, when available, in section 10.

• Concomitant medication(s): Provide the name of all medications, including prescription, over the counter and herbal supplements, which the patient had been taking immediately prior to the time of AEFI onset, including those taken only as needed in section 10. When available, provide the dose, frequency, route of administration and reason for taking each concomitant medication.
• Known medical conditions/allergies: Indicate all known medical conditions and/or allergies that the patient experienced prior to the time of immunization with a corresponding date of onset in section 10. If an exact date of onset is unknown, please provide the greatest amount of detail that is available (e.g., year of onset).  Include any conditions for which the patient is taking a concomitant medication including chronic conditions with intermittent symptoms such as migraine headaches. Also, specify in this section if the subject was pregnant at the time of immunization.
• Acute illness/injury: Indicate if the patient had an acute illness and/or injury immediately prior to the time of immunization and specify a corresponding date of onset in section 10 if known. If an exact date of onset is unknown, provide the greatest amount of detail that is available (e.g., month and/or year of onset).

Section 4C) Immunizing Agent

Provide all information pertaining to the immunizing agent(s) administered just prior to the onset of the reported AEFI(s). There is space to record five (5) immunizing agents in section 4c; however, if more than five (5) were administered simultaneously, record the additional vaccines in section 10.

Note that PHAC collects AEFI reports following the administration of active immunizing agents (vaccines). In comparison, Health Canada (HC) collects case reports of adverse events following the administration of therapeutic (passive) and diagnostic agents. When an adverse event follows the administration of an active immunizing agent (e.g., vaccine) that is administered simultaneously with a passive immunizing agent (e.g., immune globulin) and/or a diagnostic agent (e.g., tuberculin skin test), complete the AEFI Report form. Provide the name of the active immunizing agent, in addition to the passive immunizing agent and/or diagnostic agent, in section 4c, and follow the established procedures for reporting an AEFI in your province. This information will subsequently be forwarded to PHAC and to HC. Alternatively, if no active immunizing agent (vaccine) has been administered, an AEFI Report form should not be completed. Instead, please follow the established procedures in your province for reporting an adverse drug reaction to HC (e.g., completion of the Canada Vigilance Reporting Form).

When completing section 4C, provide all information as outlined below:

• Immunizing agent(s): Please record the proper name or accepted abbreviation as outlined in Appendix II for all immunizing agent(s).
• Trade name: Indicate the trade name of all vaccine(s) received.
• Manufacturer: Specify the name of the manufacturer as indicated on the product label and as referenced in Appendix II.
• Lot number: Document the complete lot number including all letters and numbers. This information is essential for conducting future risk assessments.
• Dose number: Provide the number in series (1, 2, 3, 4, or 5) or indicate if known. For the Influenza vaccine, unless a patient receives two doses in one season, the “dose #” should be recorded as one.
• Dosage/unit: Indicate the dose (e.g., 0.5) and unit (e.g., ml) for each vaccine.
• Route: Specify the route of administration for each vaccine received. Abbreviations (as described below) are acceptable:

• Intradermal: ID
• Intramuscular: IM
• Subcutaneous: SC
• Intranasal: IN
• Oral: PO
• Other: please specify (no abbreviations)

Site: Indicate the site of injection for each vaccine administered. Abbreviations (as described below) are acceptable:

• Left arm: LA
• Right arm: RA
• Arm: Arm
• Left leg: LL
• Right leg: RL
• Leg: Leg
• Left gluteal: LG
• Right gluteal: RG
• Gluteal: Glut
• Mouth: Mo
• Nose: Nose
• Multiple sites: MS
• Other: please specify (no abbreviations)