Adverse Events

Following Immunization
(AEFI)
ANSDC 1
Objectives
At the end of the session participants will be
able to:
1. Know the principles of immunization
2. Define AEFI
3. Enumerate the different types of AEFI
4. Know the management of some AEFI events
5. Discuss the AEFI reporting system

ANSDC 2
 Principle of Immunization
• No vaccine is completely safe nor effective
• Benefits range from partial to complete
protection
• Goal of vaccine development
– Achieve highest degree of protection with
lowest rate of untoward effects
• Process of immunization is a potential
source of adverse events
– Should not deviate from recommended routes to
avoid unnecessary local or systemic effect
– Ensure optimal efficacy
ANSDC 3
What is an AEFI?
• Adverse Event Following Immunization
(AEFI) is any serious event or condition that
follows after immunization and is believed to
be caused by immunization

ANSDC 4
 Classification of Adverse Events
Following Immunization
1. Vaccine reactions - caused by the inherent
properties of the vaccine
2. Program error - some error in the immunization
process
3. Coincidental - event that happens after
immunization but not caused by the vaccine - a
chance association
4. Injection reaction - anxiety-related reaction from
fear or pain of injection rather than the vaccine
5. Unknown - event’s cause cannot be determined

ANSDC 5
1. Vaccine Reactions

Common minor events How to manage

Pain and redness at Avoid touching or hitting

injection site the swollen area; may
(most common) give Paracetamol until
fever is gone.

Fever (5 – 15%) Give Paracetamol until

fever is gone.

Rash - occurs in 5% None

ANSDC 6
Dosage of Paracetamol

Age Tablet Syrup

(500mg/tablet) (120 mg/5ml)

9 months up to 3
years (4 – 14 kg) 1/4 5 ml (1 tsp)

3 years up to 7 years
old (14 – 25 kg) 1/2 10 ml (2 tsp)

ANSDC 7
Anaphylaxis

• Involves multiple body systems

• Unconsciousness is rare sole manifestation
– Occurs as late event in severe cases
• Severe reaction of rapid onset
• Circulatory collapse

ANSDC 8
Early Signs of Anaphylaxis

• Generalized erythema and urticaria

• Upper and/or lower respiratory tract
obstruction
• Limpness, pallor, loss of consciousness,
hypotension

ANSDC 9
Anaphylaxis VS Faint
Faint Anaphylaxis
Onset Usually at the time or soon Within the first few
after the injection minutes after injection
Skin Pale, sweaty, cold and clammy Red, raised and itchy
rash; swollen eyes, face;
generalized rash
Respira-tory Normal to deep breaths Noisy breathing from
airways obstruction
(wheeze or stridor)
Cardio-
vascular Bradycardia Tachycardia
Transient hypotension Hypotension
Gastro-
intestinal Nausea/vomiting Abdominal cramps
Neuro-
logical Transient loss of consciousness, Loss of consciousness,
good response once in prone little response once in
position prone position
ANSDC 10
Management of Anaphylaxis

• Give epinephrine by deep intramuscular injection at

the deltoid area according to the following doses:

Dose of Epinephrine
Age (in years)
(1:1000)
Less than 1 year old 0.05 ml
1 year old 0.1 ml
2 years old 0.2 ml
3 – 4 years old 0.3 ml
5 – 7 years old 0.4 ml

ANSDC 11
2. Program Errors

• Due to errors and accidents in vaccine

preparation, handling and administration
• Preventable
• Detract from benefits of immunization
program

ANSDC 12
 Program Errors Leading to Adverse Events
Programme Errors
Non-sterile injection
• reuse of disposable syringe or
needle
• Improperly sterilized syringe
or needle
• Contaminated vaccine or
diluent
• Reuse of reconstituted
vaccine at subsequent session
Vaccine prepared incorrectly
• Vaccine reconstituted with
incorrect diluent
• Drugs substituted for vaccine
or diluent
ANSDC
Adverse Events
Infection
(e.g. local suppuration at injection
site, abscess, cellulitis, systemic
infection, sepsis, toxic shock
syndrome, transmission of blood
borne virus (HIV, hepatitis B or
hepatitis C).
Local reaction or abscess from
inadequate shaking
Effect of drug (e.g. muscle
relaxant, insulin)
13
 Program Errors Leading to Adverse Events
Programme Errors Adverse Events

Immunization injected in
wrong site
• Subcutaneous instead of Local reaction or injection site
intradermal for BCG abscess
• Too superficial for toxoid
vaccine (DPT, DT, TT)
• Buttocks Sciatic nerve damage (+ ineffective
vaccine-hepatitis B)

Vaccine transported/stored Increased local reaction from

incorrectly frozen vaccine (and ineffective
vaccine)
Contraindications ignored Avoidable severe vaccine reaction

ANSDC 14
How to Avoid Program Errors

• Follow recommended route of administration

• Follow recommended storage, handling and
transport
• Mishandled vaccine cannot be distinguished
from potent vaccine
– When in doubt DO NOT USE

15
3. Coincidental Events

• May occur with immunization

• Falsely attributed to vaccine
• Temporal association
• Inevitable in mass campaigns
• Vaccines given early in life when infections
and other illnesses common
– Events falsely attributed through chance
association
Ex. SIDS
ANSDC 16
4. Injection Reactions
• Fainting:
– Common in  5 years
– No management required
• Hyperventilation
• Vomiting
– Young children
• Breath-holding
• Scream, run away
Not related to vaccine but to injection.
ANSDC 17
Events That Should be Reported
• Acute hypersensitivity reaction: exaggerated acute allergic
reaction, occurring within 2 hours after immunization,
characterized by one or more of the following:
– wheezing and shortness of breath
– laryngospasm/laryngeal edema
– one or more skin manifestations, e.g. hives, facial edema
or generalized edema
• Abscess: fluctuant or draining fluid-filled lesion at the site of
injection
• Seizures: occurrence of generalized convulsions that are not
accompanied by focal neurological signs or symptoms (maybe
febrile or afebrile)
• Any death, hospitalization or severe and unusual events
thought to be related to immunization
ANSDC 18
Events That Should be Reported
• Anaphylaxis: severe immediate allergic reaction leading to
circulatory failure with or without bronchospasm and/or
laryngospasm/laryngeal edema
• Encephalopathy: acute onset of major illness characterized
by any of two of the following conditions:
– Seizures
– Alteration in level of consciousness
– distinct change in behavior
• Sepsis: acute onset of severe generalized illness due to
bacterial infection and confirmed (if possible) by positive
blood culture
• Toxic Shock Syndrome: abrupt onset of fever, vomiting and
watery diarrhea within a few hours after immunization
ANSDC 19
Who Should Report AEFI

• Health Worker
• Concerned Citizen
• Parent
• Teacher

ANSDC 20
ANSDC 21
ANSDC 22