COVID-19 vaccination
training for health workers
Module 4:
AEFI monitoring for COVID-19
vaccination
© WHO/Blink Media – Giliane Soupe
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At the end of this module, you should be
Learning objectives able to:
o identify an adverse event following
immunization (AEFI);
o describe how to identify and respond
to AEFI; and
o explain how to report AEFI following
COVID-19 vaccination.
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What is an AEFI?
An ADVERSE EVENT FOLLOWING IMMUNIZATION (AEFI) is any
untoward medical occurrence which:
• follows immunization;
• does not necessarily have a causal relationship with vaccine usage;
• may be an unfavourable symptom about which a vaccine recipient
complains; and
• may be abnormal laboratory finding, sign or disease found by medical staff.
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01 Vaccine product-related reaction:
What can be the caused or precipitated by a vaccine due to one
cause of an AEFI? or more of the inherent properties of the
vaccine product
02 Vaccine quality defect-related reaction:
caused or precipitated by a vaccine that is due
to one or more quality defects of the vaccine
product, including its administration device as
provided by the manufacturer
03 Immunization error-related reaction:
caused by inappropriate vaccine handling,
prescribing or administration
04 Immunization anxiety-related reaction:
arising from anxiety about the immunization
and fear of injection
05 Coincidental event:
event that happens after vaccination but is not
https://www.who.int/vaccine_safety/publications/aefi_surveillance/en/ caused by vaccine or vaccination process
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01 Vaccine product-related reaction:
How can vaccine caused or precipitated by a vaccine due to one or
more of the inherent properties of the vaccine
reactions be product
classified? 02 Vaccine quality defect-related reaction:
caused or precipitated by a vaccine that is due to
one or more quality defects of the vaccine product,
including its administration device as provided by
the manufacturer
o Vaccine reaction is an individual’s response to the
inherent properties of the vaccine, even when
vaccine has been prepared, handled and
administered correctly.
o By intensity, vaccine reactions can be classified into:
• minor reactions
• severe reactions – can be serious and non-serious.
https://www.who.int/vaccine_safety/publications/aefi_surveillance/en/
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03 Immunization error-related reaction:
What are caused by inappropriate vaccine handling or
administration
immunization error-
related reactions? o May occur due to human error:
• reconstitution error (e.g. use of incorrect
diluent, diluent mistakenly substituted with a
drug vial)
• contamination of vaccine and/or syringe
(e.g. touching the needle or the rubber cap
of the vial with hand or other object, using
the reconstituted vaccine after the maximum
recommended time)
• administration error (e.g. incorrect
vaccination technique).
o They can cause severe reactions, and may
also lead to serious AEFI and result in death.
https://www.who.int/vaccine_safety/publications/aefi_surveillance/en/
o These errors are PREVENTABLE.
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04 Immunization anxiety-related reaction:
What are arising from anxiety about the immunization and fear
of injection
immunization
anxiety-related
reactions? o Different factors can contribute to anxiety-
related reactions such as different vaccination
environment, novelty of the vaccine, fear of
injection.
o To help prevent fainting and injures that could
occur from a fall, vaccinated individuals
should stay seated for about 15 minutes after
vaccination.
https://www.who.int/vaccine_safety/publications/aefi_surveillance/en/
https://www.who.int/publications/i/item/978-92-4-151594-8
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05 Coincidental event:
What are event that happens after vaccination but is not
caused by vaccine or vaccination process
coincidental
events?
o Adult and elderly populations with chronic
diseases may develop conditions irrespective
of vaccination that may be attributed to
vaccine.
o Similar events may occur in healthy
individuals where higher frequency of a
specific condition, including any
communicable disease, can be expected
based on age, sex, geographic location or
ethnic background.
https://www.who.int/vaccine_safety/publications/aefi_surveillance/en/
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Other important terms and definitions
o AEFI can be classified by o Cluster – two or more cases of the
seriousness as: same or similar events related in time,
• serious AEFI – results in death, place/geography, and/or vaccine
is life-threatening, requires administered.
hospitalization or prolongation of o Coincidental events can occur as
existing hospitalization, results in clusters.
persistent or significant disability, or is o Immunization stress-related responses
a congenital anomaly/birth defect (ISRR) can occur in clusters.
• non-serious AEFI – does not pose a o Clusters should be reported.
potential risk to the health of the
recipient.
o Both serious and non-serious events
should be carefully monitored.
How can you prevent immunization error-related AEFI? | 10
o Do not store and/or pack other diluents o Do not touch the rubber cap of the
or medications together with the vaccine vial.
COVID-19 vaccine. o If reconstituted, never carry
o Always check the labels of vaccines vaccines from one place to another.
and diluents before reconstitution – o Do not cover the vaccine carrier with
vaccines and diluents should be from the lid while the reconstituted
the same manufacturer. vaccine vial is in the foam pad.
o Follow manufacturer’s o Discard the vaccine if it was
recommendations on storage, vaccine reconstituted before the maximum
preparation, route and technique of recommended time or at the end of
administration, and contraindications the session, whichever comes first.
and precautions. o When in doubt, contact your
o Draw the auto-disable (AD) syringe just supervisor for clarification. Do not
before vaccination. hesitate to report issues or concerns
o Do not touch the needle. when identified.
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AEFI monitoring AEFI committee
National/ sub-national programme manager
Health worker / vaccine recipient or parent
cycle, key players
and roles Causality
assessment Feedback
Analysis AEFI detection
National/
subnational
programme
manager
Investigation Notification Caregiver
Reporting
Subnational
or national
team
https://www.who.int/vaccine_safety/publications/aefi_surveillance/en/ Health
worker
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What AEFI should Report all AEFI that are brought to your notice.
you report and how? o Complete the reporting forms and send them
to your supervisor.
o Use the COVID-19 reporting form.
o Include all available information as accurately
as possible.
Report all non-serious AEFI according to your
country’s policy.
In case of serious AEFI, inform your supervisor
and/or AEFI focal person immediately (over
telephone) and complete the reporting form
within 24 hours.
COVID-19 AEFI reporting form | 13
o Important:
• The changes from the WHO standard
AEFI reporting form in red font
includes specifying the COVID-19
vaccine brand, the name of the
manufacturer and the age of the
recipient.
• All AEFI (minor and severe) should be
reported in this form if the case has
been notified.
• The reporting form should be
completed and the case should be
line-listed.
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o When completing the COVID-19 AEFI
What should you be reporting form, ensure the following:
aware of for quality • Information on the type (brand) of
reporting? vaccine, name of the manufacturer,
dose number, diluents used (if
applicable), the batch numbers, expiry
date MUST be accurate.
• Details pertaining to the identifier,
address of the vaccine recipient as well
as the contact details as well the
reporters’ own details SHOULD be
correct.
• When entering data on the event and
clinical features, include all information
to the best of your knowledge.
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o Known minor AEFI from COVID-19
AEFI after vaccines are similar to other injectable
COVID-19 vaccines vaccines and include injection site
from clinical trials pain, headache, fatigue, muscle pain.
o Other minor AEFI include fever, chills,
nausea, arthralgia (pain in a joint).
o No serious safety concerns have been
reported to date.
o General precaution/contraindication
for any vaccine is possible allergic
reaction, including anaphylaxis, to a
vaccine component.
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What are o Anaphylaxis
• In general anaphylaxis is a very rare
extremely rare (estimated as <1/1 000 000) but severe
safety events and potentially fatal reaction. Proper
diagnosis and urgent treatment and
the health management are essential.
worker should • When sudden loss of consciousness
occurs >5–10 minutes after immunization,
be prepared anaphylaxis should be considered as a
for? possible diagnosis,
in addition to fainting (vasovagal syncope).
• More on differences between anaphylaxis,
general acute stress response and fainting
is available at:
https://www.who.int/publications/i/item/978-92-4-151594-8
Distinguishing acute stress response and anaphylaxis | 17
Acute stress response Anaphylaxis
(vasovagal syncope – VVS)
At onset VVS and general: occurs suddenly, before, at Seconds to minutes after exposure, almost
time of or soon after injection all cases within 1 hour
Skin VVS and general: Red, raised itchy rash, swollen eyes and
pale, cold, sweaty/clammy face, generalized rash
Respiratory VVS: normal to deep breaths Noisy breathing, wheeze or stridor,
General: rapid deep breathing persistent cough
Heart VVS: slow pulse, transient hypotension Fast pulse, hypotension
General: normal or fast pulse or hypertension
Gastro– VVS: nausea, vomiting Abdominal cramps, vomiting, nausea
intestinal General: nausea
Neurologic VVS: transient loss of consciousness May develop loss of consciousness not
reversed by supine position relieved by supine position
General: fearfulness, dizziness, numbness,
weakness, tingling around lips, spasms in
hands and feet
https://www.who.int/publications/i/item/978-92-4-151594-8
Treatment of anaphylaxis (WHO recommended) | 18
Drug, site and route Frequency of administration Dose
of administration
Adrenaline (epinephrine) Repeat every 5–15 minutes as According to age
1:1000, immediate needed until there is resolution of
the anaphylaxis. Children: 0.01mg/kg
intramuscular injection to
Adults: 0.2 mL to maximum of
the midpoint of Note: Persisting or worsening 0.5 mL
anterolateral aspect of the cough associated with pulmonary
middle third of the thigh oedema is an important sign of
adrenaline overdose and toxicity.
https://www.who.int/immunization/diseases/measles/SIA-Field-Guide.pdf
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1. The known safety profile of COVID-19
Summary of vaccines is similar to the existing injectable
key points vaccines.
2. Report all AEFI brought to your notice and
ensure adequate medical intervention/
referral as needed.
3. Fill in the COVID-19 reporting form in a
complete, accurate and timely manner,
and forward to your supervisor.
4. Because this is a new vaccine, it is
essential to notify any safety concern and
provide support during any investigations.
Resources | 20
o Global manual on surveillance of AEFI
https://www.who.int/vaccine_safety/publications/aefi_surveillance/en/
o AEFI causality assessment manual
https://www.who.int/vaccine_safety/publications/gvs_aefi/en/
o Aide memoir on AEFI investigation
https://www.who.int/vaccine_safety/initiative/investigation/New_aide-memoire_AEFI.pdf
o AEFI investigation software
https://www.who.int/vaccine_safety/software-assistance-guiding-hq-AEFI-investigations/en/
o For COVID-19 vaccine AEFI reporting and COVID-19 AEFI investigation form, refer to
the COVID-19 Vaccine Safety Guidance Manual
