MEMO: Updates to Adverse Events Following Immunization Reporting and Case DefinitionsTO: Health Care Professionals in the Niagara region FROM: Vaccine Preventable Disease Program, Niagara Region Public Health REFERENCE: Updates to Adverse Events Following
Immunization Reporting and Case Definitions DATE: June 14, 2021
In follow-up to the MEMO shared on Friday, April 9, please see key updates below to help support reporting of adverse events following immunization (AEFIs). Due to the massive immunization efforts underway for COVID-19, there is an increased caseload for the AEFI team. If an AEFI Reporting Form has been submitted to the Vaccine Preventable Disease (VPD) program, please note an investigation is underway, but may be pending recommendations. Until the AEFI investigation is complete and the Associate/Medical Officer of Health makes recommendations, your client should not receive their second dose of the
COVID-19 vaccine. Key Updates Include: - On May 10, 2021, Public Health Ontario (PHO) updated the Report of Adverse Event Following Immunization (AEFI) Form to better capture reportable Adverse Events of Special Interest (AESIs)
- Updates to the following COVID-19 AESI case definitions include:
- Coagulation disorders now capture thrombotic events
- Addition of Thrombosis with Thrombocytopenia Syndrome / Vaccine -Induced Immune Thrombotic Thrombocytopenia (TTS/VITT)
- Addition of the following sections to the AEFI Reporting Form:
- COVID-19 AESI (section 4)
- Updated to align with revised AESI case definitions linked above
- Medical History (section 5)
- Please include a detailed description of client’s medical history (e.g. immunocompromised, chronic illness / underlying medical conditions, concomitant medications, history of allergies)
- Separate indicator for those pregnant at time of immunization
- Comments Further Describing the Adverse Event (section 6)
- Please provide a detailed description of the event including all signs and symptoms, investigation, treatment, hospitalization details, and description of previous history of AEFI or immunization error
Tips for Completing Section 3 of the AEFI Reporting Form - “Other severe OR unusual events”
- Reserved for reports of adverse events that are either severe, results in death, is life-threatening, requires hospitalization, results in residual disability or congenital malformation, OR unusual (e.g., not previously identified) and which are not covered under categories in section 3 or 4
- “Severe vomiting / diarrhea”
- Defined as 3 or more episodes in a 24 hour period and severe enough to interfere with daily routine (e.g., projectile vomiting or explosive diarrhea)
- “Fever greater than 38°C”
- Only reportable in conjunction with another reportable adverse event as fever is an expected common side effect
- “Convulsions / seizure”
- Refers to an episode of unconsciousness accompanied by generalized motor manifestations that may be tonic, clonic, tonic-clonic or atonic. Fainting is sometimes accompanied by brief rhythmic jerking of the limbs: this is not reportable unless it results in injury.
- “Syncope (fainting) with Injury”
- Reportable when fainting results in injury to the vaccine recipient that requires EMS assessment or health care professional (HCP) follow-up
- “Pain or redness or swelling” at the injection site
- Only reportable if it lasts 4 days or longer or extends past the nearest joint
- “Anaesthesia / paraesthesia”
- Reportable when it continuously lasts 24 hours or more and is physician-diagnosed
- “Rash”
- Needs to accompany applicable details such as morphology, size, demarcation, colour, distribution, etc.
- “Allergic reaction – skin”
- Includes any one of the following: urticaria (hives), erythema, pruritus, prickle (or tingling) sensation, localized or generalized edema (in the
deeper layers of the skin, subcutaneous tissues or mucosa lining the throat, airways and gut)
- “Local reaction at the injection site”
- Select if skin changes occur only at (or near) the injection site
- Onset and duration must be completed
- If client has not yet recovered, indicate “ongoing” as duration. Do not leave blank.
Important Considerations for HCPs HCPs should report AEFIs using the Report of Adverse Event Following Immunization (AEFI) Form and fax it to 905-688-8225. - Comprehensive completion of the AEFI Reporting Form is required even if you did not administer the vaccine
- HCPs are
asked to fully complete sections 1–7 of the AEFI Reporting Form
- Section 8 is only to be completed by Public Health
- Document any additional plan for follow-up in section 6
- A thorough physician assessment and diagnosis is required prior to reporting
- Public Health refers to HCP’s physical assessment of the patient and the documentation of confirmed diagnoses within the comments section of the AEFI Reporting Form. This helps ensure accurate recommendations on future immunizations.
- Selecting a reportable adverse event alone on the AEFI Reporting Form does not always allow enough context to conclude recommendations
- Priority reporting is required for the following:
- TTS/VITT
- Myocarditis, endocarditis, pericarditis, and/or chest pain
- Allergic reactions
- Neurologic events
- There may be a delay in review and recommendations
by Niagara Region Public Health (NRPH) if the most current AEFI Reporting Form is not used or is submitted incomplete
Additional Information
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