Immunization Program
Policy & Practice Standards Manual
Population and Public Health – Disease Control Department
Adverse Event Following Immunization (AEFI)
Approved:
Number: 70-15
Date: February 2009; R 06/11; R 01/13; R-01-16; R-07-16
Page: 1 of 4
Policy:
PHNs are responsible for obtaining and maintaining the immunization competencies,
proficiencies and education outlined in the Nursing Protocols for Administration of
Biological Products and Anaphylaxis Management in a Clinic or Community Setting.
Clients are instructed, as part of informed consent, to report an Adverse Event Following
Immunization (AEFI) to health care provider.
AEFIs, within Saskatoon Health Region (SHR) are documented and processed in a timely
manner.
AEFIs are reviewed by the Medical Health Officer (MHO) who makes recommendations
regarding future immunization.
AEFI’s are scanned and saved electronically.
AEFI recommendations from MHO are documented in the electronic provincial
immunization registry database, Panorama, by a public health nurse.
Recommendations from MHO are shared with client.
AEFI’s, sent from external health care providers, are mailed back to the provider after
client has been notified of MHO recommendations.
If reporting is not complete the immunization clinician reviews AEFI process with
practitioner involved to identify and address factors.
Purpose:
To identify, report and follow up local AEFI’s prior to forwarding to the Ministry.
Immunization Program
Adverse Event Following Immunization (AEFI)
Number 70-15
Page 2 of 4
Procedure:
Public Health Nurse/ Primary Care Provider / Physician /Pharmacist:
1. Informs client of importance of reporting an AEFI to health care provider as part of
informed consent prior to immunization.
2. Determines if reported reaction is an AEFI according to Saskatchewan Immunization
Manual (SIM) Chapter 11, Appendix 11.1 ‘Summary of AEFI Reporting Criteria’.
a) Reaction does not fit AEFI criteria:
i.
Advises client of treatment options for reaction and/or refers to physician
ii.
Documents phone consult on one or more of the following:
 Panorama ‘Client Warning’ if information needed by future immunizer“ see ‘comments’ under _______ vaccine”
 Panorama ‘Imms Details/update/comments’ to make information
available to future immunizer.
 Hard copy record (HF-15)
 PPH Daily Telephone Journal (CATS 41)
 School Consultation Log (CATS-68)
 Other documentation as available (Example: electronic medical
record).
b) Reaction fits AEFI criteria:
i.
Completes a “Report of Adverse Event Following Immunization”
http://www.phac-aspc.gc.ca/im/pdf/raefi-dmcisi-eng.pdf referring to
‘User Guide to completion and submission of the AEFI reports’
http://www.phac-aspc.gc.ca/im/aefi-essi_guide/index-eng.php
ii.
Back enters vaccine involved in AEFI into Panorama if not already
entered.
iii.
Documents a summary of the reaction - Panorama Bulletin 24
http://www.ehealthsask.ca/services/panorama/immun/Pages/Bulletins.as
px
iv.
Attaches Panorama Profile Report to the AEFI Report.
v.
Forwards the completed AEFI report, with attachments, to Immunization
Clinician within 2 working days.
vi.
Reports an anaphylactic reaction as per Immunization Program Policy 5020, Emergency Preparation and Response in PPH Locations.
vii.
Submits a follow-up report if additional information is obtained at a later
date.
viii.
Receives the original AEFI hard copy back from the Executive Assistant to
the Medical Health Officer with DMHO recommendations.
 Discusses DMHO recommendations with client/parent.
 Updates Client Warning on Panorama according to Bulletins 0024 and
0028.
 Shreds the AEFI
Immunization Program
Adverse Event Following Immunization (AEFI)
Number 70-15
Page 3 of 4
Immunization Clinician:
1.
Receives the completed AEFI from the PHNs, other SHR nurse immunizers,
physicians and Pharmacists in Saskatoon Health Region. Forwards AEFI directly to
MHO if anaphylactic event.
2.
Assess the completeness and appropriateness of form:
a) Returns incomplete forms to Health Professionals for completion.
b) Notifies and returns AEFI to reporter if reaction does not meet AEFI criteria
3.
Forwards AEFI to Executive Assistant of MHO in charge of immunization.
4.
Documents reaction and recommendations in Panorama, notifies client of MHO
recommendations and mails AEFI to reporter of adverse event, if reporter does
not have Panorama access.
5.
Reviews the original AEFI reports saved electronically by the Executive Assistant
to the MHO and creates annual summary/analysis to include in immunization
program highlights document.
Executive Coordinator to the Chief MHO:
1.
Receives AEFI form and date stamps.
2.
Assigns AEFI form a Unique Episode number (year-000) and Region (SktnHR).
3.
Records Unique Episode number, clients name and date received in excel
spread sheet.
4.
Scans AEFI forms and saves to I:\DC\Immunization Programs\AEFI
5.
Gives AEFI to DMHO responsible for immunization program for his/her review and
recommendations.
6.
Receives completed AEFI from DMHO and “scans and resaves” under
I:\DC\Immunization Programs\AEFI
7.
Records date processed in excel spread sheet.
8.
Sends confidential fax of AEFI form to Saskatchewan Ministry of Health – CDC
AEFI fax number 306-787-9576.
Immunization Program
Adverse Event Following Immunization (AEFI)
Number 70-15
Page 4 of 4
DMHO determines reaction does not meet AEFI criteria;
a)
AEFI is not forwarded to Ministry,
b)
Scans and saves in SHR electronic AEFI file only
c)
Records Not Forwarded to Ministry (NF) beside name on excel
spreadsheet
9.
Sends original AEFI form back to reporter of AEFI who has Panorama access
(Public Health nurses and Positive Living nurses) with a note advising what action
is needed:
Note to Reporter (with Panorama access)
This AEFI is returned to: _________________________________________

Inform client of MHO recommendations found in section 11.

Document recommendations in Panorama: (bulletin 24 and 28)




o
Click administration date beside vaccine(s) involved
o
In ‘Immunization Detail’ click update
o
In ‘comment’ section quote MHO recommendations starting with Unique
Episode number
o
Click add and save
Enter a ‘Special Consideration’ if MHO recommendations warrant
Update ‘Client Warning’
If not an AEFI end date warning
Shred the AEFI
If you have any questions, please call Population and Public Health Immunization
Clinician at (306) 655-4139.
10.
If reporter does not have Panorama access, sends original AEFI forms to
Immunization Clinician to document and contact the client and completes a
note to Reporter advising what action has been taken. Includes addressed
envelope for Clinician to mail AEFI once documentation complete.
MHO responsible for immunization:
1.
Reviews the urgent AEFI forms within 14 days of receiving.
2.
Review non-urgent AEFI forms within 28 days of receiving.
3.
Contacts client if more health information is required.
4.
Requests health records through Executive Coordinator to MHO if required.
5.
Makes recommendations re: further immunizations or treatment required on AEFI
form section 11 and forwards to Executive Coordinator to Chief Medical Health
Officer (CMHO).
6.
Indicates whether AEFI form needs to be forwarded to the Ministry.