Section 5: Reporting Adverse Events Following Immunization (AEFI) in Canada – Immunization errors

Section 5.
Immunization Errors

Indicate whether the AEFI has followed an incorrect immunization (an immunization error, program error, etc.) by choosing “no”, “unknown” or “yes”. If “yes”, please indicate all that apply in section 5 by checking the box next to the situation that most closely reflects the error (as described below) and provide all known details in section 10.

• Given outside the recommended age limits: The vaccine was administered to an individual who was not within the recommended age limits for a specific vaccine.
• Product expired: The vaccine was administered after the expiry date as indicated on the vaccine label by the manufacturer and/or after the recommended amount of time elapsed between the first use of a multi-dose vial and the last use (e.g., as indicated in the product monograph for Fluviral, once entered, the multi-dose vial should be discarded after 28 days).
• Incorrect route: The vaccine was administered via a route not recommended for its administration (e.g., subcutaneous vs. intramuscular).
• Dose exceeded that recommended for age: A larger dose of vaccine was administered than is recommended for the patient’s age group.
• Other: If an error has occurred that is not accurately reflected in the list of provided errors, please choose “other” and provide all details.

Section 6.
Previous AEFI

Indicate whether the patient had ever experienced an AEFI following a previous dose of any of the immunizing agents as listed in response to question 4c. Choose only one of the answers provided in section 6, as described below:

• No: The patient had previously received immunization with one or more of the immunizing agents listed in section 4C and had not experienced a subsequent AEFI.
• Yes: The patient had previously received immunization with at least one of the immunizing agents listed in section 4C and had subsequently experienced an AEFI.
• Unknown: It is unknown if the patient had previously received immunization with any of the immunizing agents listed in section 4C and/or, if an AEFI followed.
• Not applicable: The patient had never previously received immunization with any of the immunizing agents listed section 4C.

If the answer is “yes”, the patient had previously experienced an AEFI following a previous dose of one or more of the immunizing agent(s) listed in section 4C, provide all details of the previous AEFI in section 10, including the corresponding time to onset and duration, when known. Also, when possible, provide information regarding the severity of the AEFI and if the previous AEFI was less or more severe than the currently reported AEFI.

If there is uncertainty regarding which option to choose, or if there is additional information to provide (e.g., multiple vaccines were administered and not all of the information regarding the patient’s past AEFI experience can be captured in section 6), please provide additional details in section 10.

Section 7.
Impact of AEFI, Outcome, and Level of Care Obtained

Section 7A) Highest Impact of AEFI

Indicate the highest perceived impact of the AEFI by choosing one of the provided responses in section 7a based on the patient’s assessment of the impact on their daily activities:

• Did not interfere with daily activities: No change, or only minimal change is reported by the patient in relation to their daily activities (e.g., work, exercise, social commitments, etc.).
• Interfered with but did not prevent daily activities: Moderate change is reported by the patient in relation to their daily activities (e.g., interfered with work, exercise and/or social commitments).
• Prevented daily activities: Significant change is reported by the patient in relation to their daily activities (e.g., prevented work, exercise and/or social commitments).

For young children (e.g., infants and toddlers), indicate the highest perceived impact of the AEFI on their daily activities as assessed by the child’s parent/caregiver according to the following:

• Did not interfere with daily activities: No change or only minimal change is observed in the child’s daily patterns and/or habits (e.g., eating, sleeping, playing, etc.).
• Interfered with but did not prevent daily activities: Moderate change is observed in the child’s daily patterns and/or habits (e.g., reduced appetite, disrupted sleep, disrupted play, etc.).
• Prevented daily activities: Significant change is observed in the child’s daily patterns and/or habits (e.g., not eating, not sleeping, not playing, etc.).

Section 7B) Outcome at Time of Report

Indicate the outcome of the AEFI at the time of completion of the report by choosing one of the provided responses in section 7b. If the patient is not yet recovered, provide all available details in section 10 and provide updates as they become available. Similarly, should the event result in permanent disability and/or incapacity or death, provide all available details in section 10.

When completing section 7B, provide the information as outlined below:

• Death: Patient died (record the corresponding date of death in the space provided).
• Permanent disability/incapacity: An injury which impairs the physical and/or mental ability of a person to perform his/her normal work or non-occupational activities supposedly for the remainder of his/her life.
• Not yet recovered: Residual signs and/or symptoms remain (at the time of the report).
• Fully recovered: All signs and symptoms have resolved.
• Unknown: The outcome of the AEFI is unknown or unclear.

Section 7C) Highest Level of Care Obtained

Indicate the highest level of care obtained for the reported AEFI by choosing one of the provided options in section 7C, described in detail below.

• Unknown: It is unknown if the patient received care for the reported AEFI.
• None: No care was received for the reported AEFI.
• Telephone advice from a health professional: The patient received telephone advice from a health care professional (e.g., nurse, nurse practitioner, physician, etc.) regarding the reported AEFI.
• Non-urgent visit: The patient was seen by a health care professional (e.g., at a physician’s office or walk in clinic) for the assessment and/or treatment of the reported AEFI. Document all investigations conducted in section 10.
• Emergency visit: The patient was seen by a health care professional for an emergency visit for the assessment and/or treatment of the reported AEFI. Please note that emergency visits are not considered admission to hospital and therefore, admission and discharge dates are not required. Document all investigations conducted in section 10.
• Required hospitalization: The patient was hospitalized for the assessment and/or treatment of the reported AEFI. Indicate the number of days the patient was hospitalized, the date of admission and the date of discharge. Document all investigations conducted in section 10.
• Resulted in prolongation of existing hospitalization: If a patient was already in hospital at the time of immunization and the AEFI resulted in a longer hospital stay, please check: “Resulted in prolongation of existing hospitalization” and indicate the number of additional days stayed in hospital as a result of the AEFI. Also indicate the date of hospital admission and discharge for the entire period of hospitalization (if known). Document all investigations conducted in section 10.

Section 7D) Treatment Received

Indicate whether the patient received any treatment, including self treatment, for the reported AEFI by choosing yes, no or unknown. Provide details of all treatments received, following the onset of the AEFI in section 10 when applicable.

Section 8.
Reporter Information

Complete the reporter information section in full including the reporter’s first and last names, a phone and fax contact number (including extensions when applicable) and the full mailing address of the institution/setting/centre. Indicate the setting in which the reporter is located (e.g., physician office, public health clinic, hospital) or specify if other. Sign and date the AEFI form in the space provided and specify your professional status (e.g., MD: Medical Doctor; RN: Registered Nurse) or your affiliation (e.g., IMPACT) by choosing one of the options provided. If your professional status or affiliation is not listed, specify beside other.