Adverse Events Following Immunization (AEFI)

Learning Objectives
At the end of the unit, you should be able to answer:
 What is an Adverse Event following
Immunization (AEFI)?

 What are the Types of AEFIs

 List the responsibilities of Mos & HW in

managing AEFIs.

 Recognise & treat cases of Anaphylaxis.

What is an AEFI ?
A medical incident that

 Takes place after an immunization

 Causes concern

 Is believed to be caused by immunization

Ranges from mild side effects to life-threatening,

but rare, illnesses
 AEFI
• Adverse event following immunization (AEFI) is
defined as any untoward medical occurrence
which follows immunization and which does not
necessarily have a causal relationship with the
usage of the vaccine.

• AEFI are not due to the vaccine or immunization

process, but are temporally associated with
immunization.
Types of AEFIs (Old classification)

1. Vaccine reaction

2. Programme error

3. Coincidental

4. Injection reaction

5. Unknown
 Cause-specific categorization of AEFIs
Sr. Cause-specific type of AEFI Definition

An AEFI that is caused or precipitated by a

1 Vaccine product-related reaction vaccine due to one or more of the inherent
properties of the vaccine product

An AEFI that is caused or precipitated by a

Vaccine quality defect-related vaccine that is due to one or more quality
2 reaction defects of the vaccine product, including its
(Vaccine Reaction) administration device as provided by the
manufacturer

An AEFI that is caused by inappropriate

3
Immunization error-related reaction vaccine handling, prescribing or
( “programme error”) administration and thus by its nature is
preventable

4
Immunization anxiety-related reaction An AEFI arising from anxiety about the
(“injection reaction”) immunization

An AEFI that is caused by something other

5 Coincidental event than the vaccine product, immunization
error or immunization anxiety
 Vaccine reactions
• First –
 vaccine product-related reaction
 reaction (an individual’s response) to the inherent
properties of the vaccine
 even when the vaccine has been prepared, handled
and administered correctly.

• Second
 vaccine quality defect-related reaction
 defect in a vaccine that occurred during the
manufacturing process
 Classification of Vaccine Reaction
Common, minor vaccine reactions
vaccine Local adverse Fever Irritability, malaise Treatment
Events (pain, swelling, (> 38°C) and systemic
redness) symptoms

BCG 90-95% - -
OPV None Less Less than 1%
than 1%
•Paracetamol
15mg/kg every
6–8 hours with
a maximum of
four doses in
Hepatitis B Adults: up to 15% 1-6% - 24 hours
Children: up to 5%
•Tepid sponge
Hib 5-15% 2-10% - or bath
Pertussis (DwPT) up to 50% up to up to 55%
(whole cell DPT) 50% •Extra fluids

Measles/MR/MMR ~10% 5-15% 5% (Rash)

JE live-attenuated <1% - -
 Serious and severe vaccine reactions

• Serious Reaction:-
 Death
 Hospitalization
 Persistent or significant disability/incapacity
 Cluster (two or more cases)
 Serious and severe vaccine reactions
• Severe Reaction :-
 Non-hospitalized cases of seizures
 Hypotonic hyporesponsive episodes (HHEs)
 Persistent screaming
 Anaphylaxis
 Severe local reaction
 Injection site abscesses
 Intussusceptions, etc.
Immunization error-related reactions
(Programmatic error)
Event caused by error in vaccine
selection, storage, preparation,
handling, or administration
(95% and Preventable)
 Wrong vaccine
 Vaccine reconstituted incorrectly
 Needle left in vial
 Wrong technique
 Expired vaccine
 Reconstituted vaccine not
discarded after 4 hours. BCG injection given sub-cutaneously
instead of Intradermally: local
 Freezing of freeze-sensitive
vaccines (DPT, DT, TT) lymphadenitis and abcess
•Use of AD syringes

•Use of reconstituted vaccine beyond the recommended period

• Inadequate shaking of the vaccine before use

• Superficial injection

• use of frozen vaccine increases

•Local reactions from aluminium containing vaccines, especially

dpt.

• Contamination of vaccine or injection equipment can also lead

to a bacterial abscess.

•Bcg vaccine:- injection abscess can arise from improper injection

(subcutaneous rather than intradermal injection).
 Immunization anxiety-related reactions
(Injection reaction)

• Event is caused by pain from

(or fear about) the injection
itself.
• Common in children over 5
years of age

Child screams and faints at

the sight of the needle.
 Immunization anxiety-related reactions
(Injection reaction)
• In mass vaccination campaigns.
• Fainting, lightheadedness, and dizziness, tingling
around the mouth and in the hands.
• Younger children - vomiting, breath-holding, sometimes
a brief period of unconsciousness and convulsions.

•Minimize over-crowding by proper planning of the

immunization sessions to reduce waiting time.
• Prepare vaccine out of recipient’s view
• Ensure privacy during the procedure to prevent anxiety.
Coincidence

Event that happens after

immunization but not
caused by the vaccine.
(a chance association)

Child shows signs of measles a

few days/ weeks after DPT
vaccine is given.
 Responsibilities of health service providers in
preventing, managing and reporting AEFIs

 Community level
Anganwadi\andASHA/volunteers/frontlineworkers.
o Follow up after the vaccination session.
o Inform by telephone to concerned ANM, MO, etc
o Assist in referral of any suspected cases
o Assist the team investigating the event
o Support in building community confidence.
• Sub Centre level
ANM
ANM must note down in diary
o Manufacturer’s name
o Expiry date
o Batch number
o VVM status (for new and partially used vaccines)
o Date on the label of partially used vaccine (in case
of OVP)
o In case of reconstituted vaccines, date and time of
opening on the label.
o Treat minor/non-serious AEFIs (mild symptoms like
fever, pain,etc.) symptomatically.

o For serious/severe, provide immediate first aid and

refer AEFI to MO(PHC) or to appropriate health
facility.

o Inform the MO(PHC) immediately.

o Share details of all AEFIs with the MOIC.

o Assist in investigation of AEFIs and take corrective

action.
• Health supervisors (HSs)
o Supervise and provide hands-on training to the
ANMs/vaccinators in the field.
o Monitor the AEFI during supervisory visits.
o Encourage the HWs to report AEFIs.
o Analyze the reported AEFIs.
o Assist the investigation team in conducting the
investigation.
• MO In-Charge
 Detection of AEFIs.
 Training of all staff.
 Clinical case management of AEFIs and referral to the next
level if required.
 Ensure availability of emergency drugs and medical
equipment.
 Timely reporting of AEFI cases.
 Inform to the DIO.
 Take corrective action.
 Completely fill up CRF and submit to the DIO within 24 hours.
 Ensure weekly submission of information of the number of
serious/severe AEFI cases to the district in the VPD H-002
form.
 Ensure adequate supervision and monitoring in the field.
 Distinguish anaphylaxis from fainting (vasovagal reaction)
Fainting Anaphylaxis
Onset Usually at the time or soon after the Usually some delay, between
injection 5 to 30 mins, after
injection

Systemic

Skin Pale, sweaty, cold and clammy Red, raised and itchy rash;
swollen eyes, face, generalized
rash

Respiratory Normal to deep breaths Noisy breathing from airways

obstruction (wheeze
or stridor)

Cardiovascular Bradycardia, transient hypotension Tachycardia, hypotension

Gastrointestinal Nausea, vomiting Abdominal cramps

Neurological Transient loss of consciousness, relieved Loss of consciousness, not
by supine posture relieved by supine posture
 Signs and symptoms of anaphylaxis
Clinical progression Progression of signs and symptoms
of anaphylaxis
Mild, early warning Signs Itching of the skin, rash and swelling
around injection site.
Dizziness, general feeling of
warmth.
Painless swellings in parts of the
body e.g. face or mouth.
Flushed, itching skin, nasal
Late, life-threatening congestion, sneezing, tears.
symptoms Hoarseness, nausea, vomiting
Swelling in the throat, difficult
breathing, abdominal pain.
Wheezing, noisy and difficult
breathing, collapse, low blood
pressure, irregular weak pulse.
 Treatment of anaphylaxis
• Steps in initial management
If unconscious, place the patient in the recovery
position (prone) and ensure that the airway is clear.
Assess heart rate and respiratory rate.
Begin cardiopulmonary resuscitation (CPR).
Give adrenaline 1:1000 by deep intramuscular
injection into the opposite limb to that in which the
vaccine was given.
If the patient is conscious after the adrenaline is given,
place his/her head lower than the feet and keep the
patient warm.
 Give Inj. Hydrocortisone IM or slow IV as per dosage
 Give oxygen by facemask, if available.
 Call an ambulance.
 If there is no improvement in the patient’s condition
within 10–20 mins of the first injection, repeat the
dose of adrenaline up to a maximum of three doses
in total.
 If not Responding to the treatment urgent refer to
higher centre.
 Report the occurrence of anaphylaxis to the DIO.
 Adrenaline dosage
• 1:1000 adrenaline (epinephrine) at a dose of
0.01ml/kg up to a maximum of 0.5 ml injected
intramuscularly (or subcutaneously in very
mild cases)

• If the weight of the patient is unknown an

approximate guide is given in Table.
 Injection adrenaline (1:1000 solution)
dosage chart IM

Age group Dosage (in units)

(in One inch Dosage (in mL) using 1 using 40
years) needle gauge mL tuberculin syringe units insulin
syringe

0-1 24G/ 25G 0.05 2

1-6 24G/ 25G 0.1 4

6-12 24G/ 25G 0.2 8

12-18 24G/ 25G 0.3 12

Adults 24G/ 25G 0.5 20

Injection hydrocortisone (IM or slow IV):
dosage chart
Age Dosage

Less than 6 months 25 mg

6months to 6 years 50 mg

6–12 years 100 mg

>12 years 200 mg

Contents of AEFI kit
1. Injection adrenalin (1:1000) solution – 8. IV fluids (5% dextrose): 1 unit in plastic
2 ampoules Bottle

2. Injection hydrocortisone (100 mg) – 1 9. IV drip set: 1 set

Vial
10. Cotton wool, adhesive tape – 1 each
3. Disposable syringe - Tuberculin
syringes (1mL) OR insulin syringe 11. AEFI Case Reporting Form (CRF)
(without fixed needle of 40 units) 3
Nos 12. Label showing date of inspection,
expiry date of Inj. adrenaline and
4. Disposable syringe (5 ml) and 24/25G shortest expiry date of any of the
IM needle – 2 sets Components

5. Scalp vein set – 2 sets 13. Drug dosage tables for Inj.adrenaline
and hydrocortisone
6. Tab paracetamol (500 mg) – 10 tabs
14. In hospital settings, oxygen support
7. IV fluids (Ringer lactate/normal and airway intubation facility should
saline): 1 unit in plastic bottle be available
 Anaphylaxis kit for ANM
1. Dose chart for adrenaline as
per age

2. 1 ml ampoule of adrenaline (1:1000

aqueous solution) - 3 nos.
(adrenaline ampoules may also labeled as
epinephrine)

3. Tuberculin syringes (1ml) or insulin syringe

(without fixed needle of 40 units)-3 nos.

4. 24G/25G needles (1 inch) - 3 Nos.

5. Swabs - 3 nos.

6. Updated contact information of DIO,

Medical Officer(s) of PHC/CHC, referral centre
and local ambulance services.

7. Adrenaline administration record slips.

 Difference between AEFI kit and Anaphylaxis kit
AEFI kit Anaphylaxis
kit

Location At health Outreach

facilities with session
Medical Officer

For use by Medical Officer ANM

Contents
Equipment for intubation and resuscitation Yes No

Ringer lactate, normal saline, 5% dextrose, IV drip Yes No

set, scalp vein sets(2)
Inj. Hydrocortisone and Tab. Hydrocortisone Yes No

Cotton wool Yes Yes

Inj. Adrenaline ampoules Yes Yes
24G/25G needles 1 inch length Yes Yes
Tuberculin syringes (1ml) or Insulin syringes (40 Yes Yes
units, without fixed needles)
 How to minimize AEFIs?
1. Use separate site for Vit A (oral)
Oral POLIO
each vaccine. RVV
IPV (intradermal
JE (subcutaneous)
Measles
(subcutaneous)
BCG
(intradermal)

Pentavelent
(intramuscular)
How to minimize AEFIs?
4. Reconstitute
vaccines only with
diluents supplied by
the manufacturer for
that vaccine.
How to minimize AEFIs?
4. Reconstitute
vaccines only with
diluents supplied by
the manufacturer for
that vaccine.
How to minimize AEFIs?

5. Use Measles and BCG

vaccine within 4 hours of
reconstitution.

6. Keep diluents of BCG and

measles vaccine separate
from other potentially
harmful liquids.
How to minimize AEFIs?

7. Do not keep needles in the

rubber cap (stopper) of
vaccine vials. This can
cause toxic shock
syndrome, a deadly and
completely avoidable
adverse event.
 How to minimize AEFIs?
8. Do not store other drugs or
substances in the ice-lined
refrigerator or deep freezer.

These refrigerators are only

meant for vaccines.
What to Report?

• All abscesses

• Serious events
requiring
hospitalizations

• Deaths
What not to Report?
Minor Reactions due to vaccines
Mild vaccine Treatment When to report
reactions
Local reaction (pain, • Cold cloth at  In case of an abscess
swelling, redness) injection site
• Give Paracetamol
Fever > 38.50C • Give extra fluids  When accompanied by
• Wear cool clothing other symptoms
• Give tepid sponging
• Give Paracetamol
Irritability, malaise and • Give extra fluids  When severe or
systemic Symptoms • Give Paracetamol unusual
 AEFI REPORTING FORMATS

CRF (Case Reporting Form)

PCIF (Preliminary Case Investigation Form)

FCIF (Final Case Investigation Form)

Lab investigation form

State Causality Assessment Form

Verbal autopsy form (in selected cases)

 AEFI reporting timelines
Causality Assessment
Day 100
Final investigation –district
reports to state (FCIF) Day 70

Preliminary investigation –
district reports to state (PCIF) Day 10

District decision on
investigation and informs state
48 hrs

Medical officer decision

on case, visits and
reports to district (CRF)
24 hrs

Notification
Day 0

Onset
THANK YOU