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