Fall Refresher: Adverse Events Following …...Fall Refresher: Adverse Events Following Immunization...
Transcript of Fall Refresher: Adverse Events Following …...Fall Refresher: Adverse Events Following Immunization...
Fall Refresher:
Adverse Events Following Immunization
December 7, 2018
Teri Cole
Communicable Disease Prevention and Control Consultant
Office of the Chief Medical Officer of Health
Nova Scotia Department of Health and Wellness
Disclosure2
No disclosures to declare
Objectives 3
To define Adverse Events Following Immunization (AEFI)
To understand the importance of AEFI reporting
To identify what and how to report an AEFI
AEFI Definition 4
“An AEFI is any untoward medical occurrence which
follows immunization, and which does not necessarily
have a causal relationship with the administration of the
vaccine.
The adverse event may be any unfavourable and/or
unintended sign, abnormal laboratory finding, symptom
or disease.”
http://www.phac-aspc.gc.ca/im/pdf/AEFI-ug-gu-eng.pdf
5Do you have to report AEFI’s to
Public Health
AEFI Reporting 6
Nova Scotia Health Protection Act, Regulations under the Act
Purpose of AEFI Reporting 7
To minimize the risk of immunizations
To maximize the benefit of immunizations
What to Report 8
AEFI’s should be reported when the event:
Has a temporal association with a vaccine
Has no other clear cause at the time of reporting
Meets one or more of the seriousness criteria
Life threatening
Causes or prolongs hospitalization ≥ 24 hours
Results in permanent disability or congenital malformation
Is fatal
Is unusual or unexpected regardless of seriousness
Occurs as a cluster
Reporting an AEFI 9
Health care providers: Initial contact, assessment and report
Public Health: Review, investigation, individual public health
action
Department of Health and Wellness: Review, analyze and report
to the Public Health Agency of Canada
National/Provincial: Review, identify signals, changes could be
implemented if necessary
When to Report 10
CAEFISS 11
Canadian Adverse Event Following Immunization Surveillance
System
Federal/Provincial/Territorial public health post market vaccine
safety monitoring system
CAEFISS Objectives 12
Continuously monitor the safety of marketed vaccines in Canada
Identify increases in frequency or severity of previously identified
vaccine-related reactions
Identify previously unknown AEFI that could be related to vaccine
(unexpected AEFI)
Provide timely information on AEFI reporting profiles to help
inform immunization related decisions
CAEFISS Reporting Pathway 13
Types of AEFI’s (Brighton Collaboration) 14
The Brighton Collaboration: Creating a Global Standard for Case Definitions (and
Guidelines) for Adverse Events Following Immunization
Katrin S. Kohl, Jan Bonhoeffer, M. Miles Braun, Robert T. Chen, Philippe Duclos, Harald Heijbel, Ulrich
Heininger, Elisabeth Loupi, S. Michael Marcy; The Brighton Collaboration. 2005
https://www.ncbi.nlm.nih.gov/books/NBK20507/
Local reaction at the injection site
Abscess
Cellulitis
Nodule
Pain or Redness or Swelling
Types of AEFI’s (Brighton Collaboration) 15
Systemic Reactions
Adenopathy/Lymphadenopathy
Fever
Hypotonic-Hyporesponsive Episode (HHE)
Parotitis
Orchitis
Rash
Screaming/Persistent Crying
Severe Vomiting/Diarrhea
Types of AEFI’s (Brighton Collaboration) 16
Allergic Reactions
Anaphylaxis
Oculo-respiratory Syndrome (ORS)
Other Allergic Reactions
Types of AEFI’s (Brighton Collaboration) 17
Neurological Events
Anaesthesia/Paresthesia
Bell’s palsy
Convulsion/Seizure
Encephalopathy/Encephalitis
Acute Disseminated Encephalomyelitis (ADEM)
Myelitis/Transverse Myelitis
Subacute Sclerosing Panencephalitis (SSPE)
Guillian-Barre Syndrome (GBS)
Meningitis
Vaccine Associated Paralytic Poliomyelitis
Types of AEFI’s (Brighton Collaboration) 18
Other Events of Interest
Arthritis
Intussusception or Hematochezia
Syncope with Injury
Thrombocytopenia
Other Severe or Unusual Events
How to Report AEFI’s 19
National AEFI Report Form
https://www.canada.ca/en/public-health/services/immunization/reporting-adverse-events-
following-immunization.html
User Guide to Completion and Submission of the AEFI Reports
https://www.canada.ca/en/public-health/services/immunization/reporting-adverse-events-
following-immunization/user-guide-completion-submission-aefi-reports.html
Send to Local Public Health Office
http://www.nshealth.ca/public-health-offices
20
Why Report AEFI’s 21
Health Protection Act, Regulations under the Act
Meet legislative requirement for mandatory reporting of AEFI’s
Ensure vaccines in Canada are safe
Identify risk factors for AEFI’s
Identify problems requiring quick epidemiologic investigation
Carry out lot-by-lot monitoring of unusually high rates of AEFI’s
Maintain public confidence in Canada’s immunization programs
22
https://www.canada.ca/en
/public-
health/services/publications
/pseudonode/summary-
reports-submitted-
canadian-adverse-events-
surveillance-system.html
23PRIMARY ADVERSE EVENT FOLLOWING IMMUNIZATION CATEGORY
BY SERIOUSNESS, 2013-2016https://www.canada.ca/en/public-health/services/publications/pseudonode/summary-reports-submitted-
canadian-adverse-events-surveillance-system.html
24Total Nova Scotia, Adverse Events
Following Immunization (AEFIs), by
year, 2013 to 2017
2013 2014 2015 2016 2017
# of AEFIs 28 52 67 43 68
0
10
20
30
40
50
60
70
80
Num
ber
of A
EFIs
25Total Nova Scotia, Influenza Vaccine
Adverse Events Following Immunization
(AEFIs), by year, 2013 to 2017
2013/2014 2014/2015 2015/2016 2016/2017 2017/2018
# of AEFIs 25 17 27 10 23
0
5
10
15
20
25
30
26Questions and Discussion