AEFI reporting & management

during MR campaigns
 Outline of the Presentation
• Basics of AEFI Surveillance
– Definition
– Types (for reporting) - Minor, Severe and Serious
– WHO cause specific definition of AEFIs

• Adverse events and MR campaign

– Safety Profile for MR vaccine
– Adverse events reported in MR campaigns
– Preventable adverse events (anxiety reactions, immunization errors)
– Managing session sites to reduce chances of AEFIs

• AEFI surveillance during MR campaign

– District and Block level activities

• Management of AEFIs (including anaphylaxis) during MR campaign

 Adverse Event Following Immunization (AEFI)

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.

The adverse event may be any unfavorable or unintended sign (e.g.

abscess following vaccination), abnormal laboratory finding (e.g.
thrombocytopenia following measles vaccination), symptom or disease
(e.g. disseminated BCG infection following BCG vaccination).
 death
• Requires
inpatient
hospitalizatio Serio
n
•• Results in
Can be
us
disabling
persistentand,or AEFI
significant
rarely, life
threatening,
disability do
• not
AEFIlead to
cluster
• long-term
Evokes
problems
significant
• Examples of
parental/com Seve
severe
munity
reactions re
concern
include- non-
hospitalized AEFI
cases of:
• anaphylaxis
that has
recovered,
high
• • Common,
fever(
Self >102
limiting
degree F),
Mino
• reactions
hypotonic r
• E.g. Pain,
hyporesponsi
swelling at
ve episodes,
AEFI
• the
sepsis, Site,
inj.etc.
fever,
irritability,
malaise etc.
Categorization of AEFI cases based on severity
 WHO cause specific definition of AEFIs

An AEFI that is
1 2 or
caused 4 5
3 An AEFI that is
AnVaccine
AEFI that is Vaccine by
precipitated Immunization
Immunization
caused by
product-
caused or quality
a vaccine that is An AEFI that is anxiety-
precipitated error-related An AEFI arising something
Coincidental
related by due to one or
defect-related caused by related other than the
a vaccine due to more quality reaction
Inappropriate from anxiety event
reaction
one or more of reaction
defects of the vaccine reaction
about the vaccine
immunization. product,
the inherent vaccine product handling,
immunization
properties of including its prescribing or
error or
the vaccine administration administration.
immunization
product. device as
anxiety
provided by the
manufacturer.
 Safety of MR vaccine
• Measles Rubella vaccine – Live attenuated vaccine, safe and
effective.

• 194 countries have MCV/MR vaccine in routine immunization

programmes

• MR campaign in states
– Phase 1- Five
– Phase 2- Eight
– Phase 3- Seven (ongoing campaign activity)

• No. of doses administered- 8.82 crore doses (as on 27 May 2018)

 Adverse events and MR vaccination
• Adverse reactions are generally mild and transient
– Slight pain, tenderness at injection site may occur within 24 hours
– Fever (>39.4°C for 1–2 days) may occur 7–12 days after
vaccination in 5% of recipients.
– Febrile seizures may occur in 1 in 3000 vaccine recipients
– Transient rash may occur in about 2% of recipients.
– Thrombocytopenic purpura occurs in approximately 1 in 30,000
vaccinated individuals.
– Arthralgia / joint pain can also occur when given in adolescent or
adults

• Risk of anaphylaxis due to measles vaccine is as low as 1 in 1 million

children vaccinated.
 AEFI Cases reported –MR campaign
Phase of MR State Target (in lakh) Achievement (in Number of AEFI
Campaign lakh) reported (campaign)

1 Karnataka 160.33 158.45 48

1 Tamil Nadu 176.05 169.53 64
1 Goa 3.20 3.12 0
1 Puducherry 3.04 2.66 4
1 Lakshadweep 0.16 0.12 0
2 Andhra Pradesh 118.54 114.58 24
2 Chandigarh 3.10 3.01 0
2 Daman & Diu 0.58 0.62 0
2 Dadra & Nagar Haveli 1.13 1.15 0
2 Telangana 90.01 91.48 1
2 Himachal Pradesh 17.74 18.08 11
2 Uttarakhand 28.36 28.76 0
2 Kerala 76.55 64.76 122
Total (phase 1 & 2) 678.79 656.32 274
 Valid diagnosis of causally approved 30 cases following MR vaccination
(including co-administered)

CAMPAIGN
No. of
VALID DIAGNOSIS
cases ROUTINE (WITH OTHER VACCINES)
PYOGENIC MENINGITIS/ MENINGOENCEPHALITIS 2
No. of
VALID DIAGNOSIS
SSPE 1 cases
ACUTE GASTRITIS 1 FEBRILE SEIZURE 4
PNEUMONIA / ARI 2 ARI 1
HEMOLYTIC UREMIC SYNDROME 1
ACUTE GASTROENTRITIS 1
ABDOMINAL PAIN WITH VOMITING 1
SEIZURE 1
FEVER WITH RASH WITH MULTIPLE LYMPHADENOPATHY,INGUINAL ABSCESS 1
Grand Total 7
ALLERGIC REACTION/ URTICARIA 3
PAIN & SWELLING AT INJECTION SITE 1
ANAPHYLAXIS 1
SEIZURE 3
GIDDINESS 1
FEBRILE SEIZURE 1
FEVER/ ACUTE FEBRILE ILLNESS/ VIRAL FEVER 3
DRY COUGH 1
Grand Total 23

*Data as on 17-May-2018
 Steps to prevent immunization anxiety reactions

– Ensure IEC activities are implemented before campaign

– Orient school staff on safety of MR vaccine

– Ensure children are not receiving vaccine on empty

stomach

– Proper management of session sites at school

• Well ventilated session site
• No overcrowding, recipients enter the room one by one
• Post vaccination observation room should be separate from
room in which potential vaccine recipients are waiting for their
turn
Steps to prevent immunization error during campaign

– Maintain cold chain for MR vaccine & diluents at CCP.

– During monitoring and supervision activities, check ILRs/DFs

for presence of drugs other than vaccines

– Health workers to check expiry date, VVM and name of the

diluent and vaccine before loading vaccine carriers and
before administration

– Ensure safe injection practices by health worker (ANM)

– Ensure adequate supply of reconstitution syringes to prevent

re-use

– Ensure reconstituted vaccines are used within 4 hours and

are not carried to another session
AEFI surveillance in MR campaign – preparations
At district level
– To conduct ½ day training on AEFI surveillance & case
management for MOs.
– To update the status of District AEFI committee and conduct its
meeting prior to launch of campaign
• To create awareness among committee members & also to
support the DIO in investigating serious AEFIs.
• To help in managing media during times of crises as secondary
spokesperson

At Block level
All ANMs/ASHAs/AWWs and MOs must:
• be sensitized to recognize and notify/report AEFI promptly.
• know what to do when an AEFI occurs and be aware of location of
the nearest AEFI management centre.
AEFI surveillance in MR campaign – preparations
• Prepare AEFI Management Plan as part of micro plan
– AEFI Management Centres
• Designate all government health facilities, with at least one medical
officer as an AEFI management centre
• Private clinics / hospitals may also be designated as an AEFI
management centre with arrangements for reimbursement of
treatment costs on case-to-case basis
• Ensure AEFI kits are available with contents within expiry dates,
especially adrenaline at all AEFI Management Centres
• Train all MOs in AEFI management and reporting procedures

• Session tally-sheets should have address & contact details of

nearest AEFI management centre

• All medical officers acting as supervisors will carry an

emergency AEFI treatment kit.
 Activities during Immunization session
At start of session site ensure- After vaccination-
• A safe and comfortable environment • Beneficiary to wait for 30 minutes
for beneficiaries • Actively observe for any signs of
• List of emergency contact numbers discomfort/reactions
(ambulance, supervisor, MO, AEFI • ASHAs, AWWs and other volunteers
mgmt. centre, DIO) are available should be involved in post
• AEFI Management kit is available & vaccination management of
all drugs are within expiry beneficiaries
• Do not leave session site before the
scheduled time of ending the session

Post campaign -
• Ensure school teachers/ volunteers have the contact details of the nearest AEFI
management centre
• Volunteers should follow up children for any adverse events and should have contact
numbers of the team to inform about the adverse event
• Any serious / severe AEFI should be managed clinically, reported and completely
investigated as per AEFI guidelines
 AEFI treatment kit - contents
1. Drugs
a. Injection adrenaline (1:1000) solution- Two ampoules
b. Injection hydrocortisone (100 mg) – One vial
c. Tab. Paracetamol (500 mg) – 10 tabs
d. IV fluids – Ringer lactate/normal saline – 1 unit
e. IV fluids – 5% dextrose – 1 unit
2. Syringes and drip sets
a. Disposable syringe – insulin type with 0.01 ml
graduations and 26G IM needle – 2 sets
b. Disposable syringe – 5 ml with 24 / 26G IM needle -2
sets
c. Scalp vein – 2 sets
d. IV drip set – 1 set
e. Cotton wool, adhesive tape – 1 each
3. Forms and job aids
a. AEFI Case Reporting Form (CRF)
b. Label with date of inspection, date of expiry of inj.
Adrenaline, date of shortest expiry of any content
c. Drug dosage tables for inj. adrenaline and inj.
hydrocortisone
ANAPHYLAXIS AND ITS
MANAGEMENT
 Anaphylaxis as an AEFI
• Risk of Anaphylaxis following vaccination is very rare (1 case
per 1 million doses)
• The onset of anaphylaxis occurs usually between few minutes
and upto one hour following vaccination.

A case of anaphylaxis is suspected if the following criteria are

met:
• Sudden onset and rapid progression
• At least one sign/symptom related to at least two of the
three systems - respiratory, cardiovascular and
dermatological/mucosal
 Signs and symptoms of Anaphylaxis
Respiratory:
• Swelling of tongue, lip, throat
• Difficulty in breathing
• Harsh vibrating sounds during breathing from chest -
stridor
• Breathing with whistling or rattling sound in chest -
wheezing
• Bluish discoloration of arms and legs, tongue, ears, lips,
Picture 1:
etc.)- cyanosis
Angioedema
• Noisy breathing - grunting
Cardiovascular:
• Fainting, dizziness - Decreased level /loss of consciousness
• Low blood pressure (measured hypotension)
Picture2 : • Increased heart rate, palpitation- tachycardia
Cyanosis
Dermatological or mucosal:
• Raised red skin lesion, rash with itching over body –
generalized urticaria
• Redness of skin - generalized erythema
Picture 3: Urticaria • Itchy/ painful swelling of subcutaneous tissues such as
upper eyelids, lips, tongue, face etc.
• Itching of skin – generalized pruritus
 Differentiating anaphylaxis from fainting/syncope

Fainting/syncope Anaphylaxis
Immediate - At the time or soon
Onset Within few minutes of injection
after injection

Urticaria, swollen eyes, face;

Skin Pale, sweaty, cold and clammy
generalized rash.
Noisy breathing from airways
Respiratory Normal to deep breaths
obstruction

Bradycardia Tachycardia
Cardiovascular Strong carotid pulse Weak carotids

Transient hypotension Hypotension

Gastrointestinal Nausea/Vomiting Abdominal cramps

Transient loss of consciousness, Loss of consciousness, little response

Neurological
good response once prone once prone
One time use of injection adrenaline by ANM

One-time use of Injection

Adrenaline by ANM for
management
ANMs are now allowedof suspected
to administer a single
intramuscular dose of adrenaline for initial
anaphylaxis inoffield
management of a case settings
suspected anaphylaxis
following vaccination.
 Immediate management of Anaphylaxis

• Reassure patient, parents/ relatives

• Immediately administer single and age-
appropriate dose of injection Adrenaline by deep
IM route on anterolateral aspect of thigh
• Seek help to immediately arrange for
ambulance/vehicle to transport the patient to the
nearest referral centre - PHC/CHC/District
Hospital/Civil Hospital, etc.
• Do not leave patient alone
• If patient is conscious, keep in supine position
with lower limbs raised higher than head Adrenaline is also supplied in
ampoules labelled as Epinephrine
• If patient is unconscious, keep in left lateral
position
 Content of Anaphylaxis kit for ANM
1. Job aid for recognizing anaphylaxis;
dose chart for adrenaline as per age
2. 1 mL ampoule of adrenaline (1:1000
aqueous solution) – 3 nos.
(adrenaline ampoules may also be
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. Certification by medical officer for
expiry dates of contents
Age group-wise doses of adrenaline in mL and units
 Immediate Referral
• With the help of people around, call an ambulance and in case
of its unavailability or delay in arrival, arrange a vehicle
immediately for transportation of the case to nearest referral
centre/health facility

• Note time and dosage of adrenaline administered

• Inform the Medical officer about the case for timely

management.

• If Anaphylaxis is confirmed following vaccination, it should be

written on the immunization card in block letters so that the
same vaccine is not administered again.
 Role of Medical Officer

• Encourage staff to insist on caregivers waiting for at least half hour

Detection of following vaccination
AEFIs • Train staff in suspecting, detecting and reporting of AEFIs.
• Encourage staff to report AEFIs

• AEFI management centres in health facilities to be identified in

microplans
• Ensure availability of emergency drugs and medical equipment to
Management deal with an adverse event.
of AEFI • Regularly check the emergency tray (functional status of equipment
and expiry of drugs) and AEFI kits
• Provide appropriate treatment to AEFI cases and refer if needed
 Summary
• Measles-Rubella vaccine is safe and effective
• Manage serious/severe AEFIs (e.g. anaphylaxis) promptly
• Immunization errors and anxiety reactions are preventable
• Designate AEFI management centres with trained medical officers,
AEFI treatment kits and protocols
• District AEFI Committee should be functional with current
membership and oriented to support in AEFI investigation and
media management
• Reporting and investigation of AEFIs following MR should be as per
national AEFI surveillance guidelines - 2015
 Thank You
Report AEFIs in India : [email protected]