Immunization in practice (IIP)

Vaccine safety and Adverse Events

Following Immunization (AEFI)
For HWs
June 2021
 Objectives
Remind the familiar steps of
improving injection safety
Introduce to the concept of AEFI
Describe the types of AEFIs
AEFI Surveillance
 Purpose of the system
 Formats Used

Anaphylaxis
 Immunization Safety
 Immunization safety is the process of ensuring and
monitoring the safety of all aspects of immunization,
including the detection and investigation of adverse
events

 Vaccine quality

 Vaccine storage and handling

 Vaccine administration

 disposal of sharps and management of waste products

 Safe injection and disposal

Definition: Reuse of equipment

Any injection is considered safe

when it is not a health threat to:
• Recipient; Mother and child
• Vaccinator; Health workers
• Community; pollution and injuries Unsafe
• Environment; pollution disposal

Unsafe collection
Why is Vaccine Safety increasing in Importance
 As disease risks decrease, attention on vaccine risks
increase
 Public confidence in vaccine safety is critical
 Higher than ever standard of safety for vaccines
 Vaccines generally healthy vs. consumers of other
pharmaceuticals
 Vaccinations universally recommended and
mandated
Incorrect immunization practices
1. Non sterile injections

2. Reconstitution errors (wrong diluents & vaccines)

3. Injection at incorrect site and routes

4. Incorrect vaccine transportation/storage (Absence of proper use of

cold chain)

5. Contraindications ignored

6. Improper immunization set-up (work place)

7. Improper disposal (Unsafe waste disposal)

Simple ways to improve injection safety

1.Prepare injections in a clean designated area. Prepare each

dose immediately before administering

2. Never leave the needle in the top of the vaccine vial

3. Follow product-specific recommendations for use, storage

and handling of vaccines
 Disposing of used syringes and needles

• Injection equipment should be discarded immediately

after use
Importance of handling waste properly

- Dangers to health

- Dangers to the community

Use of safety box:

- all used sharp injection equipment should be placed in safety

boxes immediately after use

 Use of safety box
 Fill the box ¾, close the hole and carry safely to
incinerator or dug pit

Procedures for disposing of sharps waste and injection

equipment

- Used syringes and needles must never be dumped in

open areas

- Should never be disposed of along with other kinds of

waste
 Five methods of disposal

1. Incinerator
2. Burning in a metal drum
3. Open burning in a pit
4. Encapsulation
5. Buried in a disposal pit
 Adverse Events Following
Immunization(AEFI)

 Definition:

 An adverse event following immunization (AEFI)

is any untoward medical occurrence which follows
immunization and which does not necessarily have
a causal relationship with the usage of the vaccine

 can be established after effective investigation

and causality assessment
 Classification of AEFI
Types Description

Vaccine product- An AEFI that is caused or precipitated by a vaccine due to one

related reaction: or more of the inherent properties of the vaccine product.

Vaccine quality An AEFI that is caused or precipitated by a vaccine that is due to

one or more quality defects of the vaccine product including its
defect-related administration device as provided by the manufacturer.
reaction:

Immunization error- An AEFI that is caused by Inappropriate vaccine handling,

related reaction: prescribing or administration and thus by its nature is
preventable
Immunization An AEFI arising from anxiety about the immunization.
anxiety-related
reaction:
Coincidental event An AEFI that is caused by something other than the vaccine
product, immunization error or immunization anxiety
Unknown Undetermined cause
 Vaccine Reactions

 Classified as common- (rare), and minor- serious

 Common reactions are minor and settle on their own

• Most common
 Local reactions (pain, swelling, redness of inj. site), systemic
reactions (fever, irritability, malaise, loss of appetite)

 Serious reactions – very rare and generally do not result in long-

term problems
 Seizures, low platelet count, hypotonic hypo responsive
episodes, persistent inconsolable screaming, anaphylaxis
 AEFI Presentations…
 Common minor reactions following
immunization include:
oLocal reactions
oRedness at injection sites
oPain
oSwelling
oFever <38 degree centigrade
oIrritability
oMalaise
oGeneral apathy
 AEFI Presentations
 The rare, more serious vaccine reactions include:
oConvulsion
oAnaphylactic shock
oSevere allergic reactions e.g. generalized
urticaria and angioedema
oAdenopathy
oEncephalopathy

 Advice the girl and parents on management of

minor AEFI

 Advice the girl and parent on when to return to

HFs
 Common Events in Campaigns

Campaigns are characterized with large number of AEFI’s since large number
of doses are given over a short period of time – leading to more vaccine
reactions and coincidental events.

 A real increase in program errors:

 Staff who are unfamiliar with new vaccines

 Under pressure situation

 Involve all age groups (not familiar with adverse events esp. in older group)

 It is important to monitor AEFIs and ensure that appropriate actions

are taken; especially appropriate and adequate communication activities to
address community fear.
 AEFI surveillance goals
 A system for ensuring immunization safety through
detecting, reporting, investigating, and responding to
AEFIs.

 Primary goal: early detection with appropriate and quick

response to adverse events

 Secondary Goal:
– lessen the negative impact on the health of the
individuals and on the immunization program
– Enhance program credibility and can provide country-
specific data on vaccine risks.
 AEFI surveillance

 Reporting: AEFIs observed at or reported to the

vaccination post must be recorded on the daily tally
sheet and line listed in the AEFI line-listing form

 Investigation: All incidents of AEFI must be followed

up and investigated by the surveillance focal person
in the Woreda with regards to person, time, place
and severity of event, as part of AEFI surveillance
 What is Expected of Health Workers

 Practice safe immunization techniques

 Know how to diagnose and treat serious AEFIs, and

report a serious AEFI

 Report at least the following “trigger events”

 All injection site abscesses
 All cases of BCG lymphadenitis
 All deaths suspected to be related to immunization
 All hospitalisation suspected to be related to immunization
 AEFIs- Investigation and Reporting

Which reports should be investigated?

 May have been caused by program error

 Listed events defined for AEFI surveillance

 Serious event of unexplained cause

 Causing significant parental or community concern

 Investigation is by regional or zonal team

 Analysis of findings should lead to clear report

 Recommendations regarding identified gaps in the system

 Report shared with health center, woreda, zone (if applicable), region
and federal level
Name _____________________________________ sex __________Date of birth ____/___/___
Region _______________ zone ___________ wereda ___________kebele___________gott___
Health facility _________________________ health worker reported _____________
Vaccine(s) Route Site number Manufacture Expiry date
given r

Date vaccine given Date AEFI started Onset interval Date AEFI reported

Tick box(es) and describe event: Past medical history (including history of
similar reaction or other allergies) and any
 Toxic shock syndrome other relevant information (e.g. other cases):

 Sepsis
 Abscess: sterile  bacterial 
 Lymphadenities: > 1.5 cm  or draining sinus 
 Severe local reaction: > 3 days  beyond nearest joint 
or hospitalized 
 Vaccine reaction on list (state):
 Other AEFI(state):
Recovered ? Yes / No ?
Hospitalized Yes / No?
Died: Yes /No?

Zonal level office to complete

Date report received: Checked by:
Investigation needed: If yes, date started
Investigator AEFI investigation ID
Causality assessment: Certainty:
No.
Patient's Name

Sex (M/F)
Date of Birth
Address /district/

Vaccine Used

Batch/ #

Expiry date

Date of onset

Date vaccine given

Vaccine given by*:

Type of AEFI**

Outcome***

Investigated?
(if Yes, date of
investigation)

Comment
 Anaphylaxis
 Anaphylaxis is a severe reaction of rapid onset characterized
by circulatory collapse
– (usually 5-30 minutes after the injection)

 The early signs of anaphylaxis are generalized erythema and

urticaria with upper and/or lower respiratory tract obstruction.

 In more severe cases, limpness, pallor, loss of consciousness

and hypotension become evident in addition.

 The more severe the reaction, the more rapid the onset.
– Most life threatening reactions begin within 10 minutes of immunization.
Progression of Anaphylaxis
 Recognition of Anaphylaxis

 There is a high risk that health workers who lack training

will misdiagnose faints (vasovagal syncope) and dizziness
following immunization for the onset on anaphylaxis.

 Most episodes of feeling ill or faint, or actual fainting that

occur immediately after immunization, are not due to the
onset of anaphylaxis.
– The administration of adrenaline in faints is contraindicated and very
dangerous

 Other symptoms almost always precede unconsciousness

 Recognition of Anaphylaxis
Syncope Anxiety attack Breath holding Anaphylaxis
episode
(Faint)

Good central pulses May appear fearful Mainly in young Poor central pulses, usually sinus
but may be Usually tachycardic children tachycardia
bradycardic Generally distressed/ Possible apnoea, especially in children
Hyperventilation
Respiration continues crying prior to Upper airway oedema, sneezing
Pallor episode
Pallor
Complain of Bronchospasm, may be audible
Facial flushing and
Warm skin expiratory wheeze or stridor
tingling of face and perioral cynosis
Unusual in pre-school extremities Urticarial lesions , Itching
Can briefly become
children
Complain of feeling unconscious during Sense of impending, doom
No upper airway light-headed, dizzy which breathing Flushing/sweating, Cold skin
oedema or numb returns
Patient does not revive when lying
No itching down
Patient regains
consciousness when
lying down
Case #1

• A three year old child comes to the vaccination post

with no history of previous problems with measles
vaccination
• Immediately after the child is vaccinated, he
collapsed
• What do you do next?
Case #1- Response

• Lie child down

• Check pulse
• Pulse is strong
• This is NOT anaphylaxis (strong pulse)
• Giving adrenalin would hurt the child
Case #2

• A 10 months old boy comes to site for measles

About 5 minutes after receiving measles vaccine
the child begins to start itching his arms
• After a few more minutes his lips start to swell and
you hear a stridor/wheeze
• what do you do ?
Case #2- Response

• Give oxygen if available

• Check heart rate
• Start CPR if necessary
• Give deep intramuscular injection of adrenalin (0.1
ml of 1:1000 adrenalin)
• If unconscious, place head lower than feet
• If no improvement in 10-20 min after injection give
second injection
Treatment of Anaphylaxis
• Assess clinical situation
• If unconscious patients: institute standard procedures
for basic life support (airway, breathing, circulation)
• Administer adrenaline: in all patients, as the
condition can deteriorate rapidly
• Intramuscularly 10mcg/kg (0.01 ml/kg of adrenaline
1:1,000)
• Around injection site: half dose may be given to delay
antigen absorption
• Repeated administration may be needed
Adrenalin Dose- Unknown Weight

Age Dose of Adrenalin

0-6 months 0.05 ml
7-23 months 0.1 ml
2 years 0.2 ml
3 years 0.3 ml
4 years 0.4 ml
>5 years 0.5 ml
Communication with caretakers in case of
an AEFI

• Reassure the caretaker

• Admit uncertainty
• Convey that the AEFI will be reported
and investigated fully
• Keep the community informed with
follow-up information
 Determining cause of AEFI

Causality
Is the relationship between two events (the cause and
the effect), where the second event is a consequence of
the first
Causality assessment
Determining if such a relationship exists and if so to
what extent
Who should do the causality assessment
 Prevention of AEFIs

•Logistics: to improve Basic rules to follow:

• availability of vaccines and • Ensure adherence to
safe injection syringes MDVP (Multi-Dose Vial
• cold chain management Policy)
•Training: To improve • Ensure proper labelling of
skills and knowledge of medicines (vaccines and
health workers other drugs)
•Supervision: site visit • Do not keep other drugs
conducted and feedback in the vaccine fridge???
given • Ensure practice of one
•Communication: respond needle one syringe policy
quickly to enquiries or • Investigate fully AEFI
prevent rumours. and correct errors
 SUMMARY
• AEFI are adverse events associated with immunization
• Types: Vaccine Reaction, Program Error, Injection
Reaction, Coincidental Events, Unknown
• Report AEFIs immediately
• Treat patient
• Gather initial data and report to higher level
• If severe a full investigation will be completed
• AEFI Reporting/Investigation
• Identification of AEFIs can stop additional
morbidity/mortality
• Improves program quality
 Thank you
!for your attention