Adverse event following immunization (AEFI)

What is 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.
The adverse event may be any unfavorable or unintended sign, abnormal laboratory finding, symptom or disease.
Reported adverse events can either be true adverse events, i.e. actually a result of the vaccine or immunization process, or coincidental events that are not due to the vaccine or immunization process, but are temporally associated with immunization.

What are the categories of AEFIs?
1. Vaccine product-related reaction: inherent property of the vaccine formulation
2. Vaccine quality defect-related reaction: deficient quality of the vaccine, diluent and/or delivery equipment from the manufacturer’s side
3. Immunization error-related reaction: due to inappropriate handling or administration of the vaccine, thus preventable
4. Immunization anxiety-related reaction: arising from anxiety about immunization
5. Coincidental event: is caused by something other than the vaccine product, immunization error or immunization anxiety

When a vaccine reaction is considered serious and severe?
An AEFI will be considered serious if it
• Results in death,
• Requires hospitalization,
• Results in persistent or significant disability/incapacity or
• A cluster (two or more cases) of AEFIs occur in a geographical area

AEFIs that are not minor but do not result in death, hospitalization or disability, are categorized as severe. Examples include non-hospitalized cases of seizures, hypotonic hypo-responsive episodes (HHEs), persistent screaming, anaphylaxis, severe local reaction, injection site abscesses, intussusception, etc.

Mention the contents of an AEFI treatment kit.
1. Injection adrenalin (1:1000) solution – 2 ampoules
2. Injection hydrocortisone (100 mg) – 1 vial
3. Disposable syringe (insulin type) having 0.01 ml graduations and 26G IM needle – 2 sets
4. Disposable syringe (5 ml) and 24/26G IM needle – 2 sets
5. Scalp vein set – 2 sets
6. Tab paracetamol (500 mg) – 10 tabs
7. IV fluids (Ringer lactate/normal saline): 1 unit in plastic bottle
8. IV fluids (5% dextrose): 1 unit in plastic bottle
9. IV drip set: 1 set
10. Cotton wool, adhesive tape – 1 each
11. AEFI Case Reporting Form (CRF)
12. Label showing date of inspection, expiry date of Inj. adrenaline and shortest expiry date of any of the components
13. Drug dosage tables for Inj. Adrenaline and hydrocortisone
14. In hospital settings, oxygen support and airway intubation facility should be available

Reference:
GOI. Immunization Handbook for Medical Officers. New Delhi: Department of Health and Family Welfare; 2016.

National Immunization Schedule in India; 2017: http://www.ihatepsm.com/blog/national-immunization-schedule-india-2017

Rotavirus vaccine: http://www.ihatepsm.com/blog/rotavirus-vaccine

Pentavalent vaccine: http://www.ihatepsm.com/blog/pentavalent-vaccine

BACILLE CALMETTE GUERIN (BCG) VACCINE: http://www.ihatepsm.com/blog/bacille-calmette-guerin-bcg-vaccine

IPV (INACTIVATED POLIOVIRUS VACCINE): http://www.ihatepsm.com/blog/ipv-inactivated-poliovirus-vaccine

DT & TT Vaccines: http://www.ihatepsm.com/blog/dpt-and-tt-vaccines

Oral Polio Vaccines (OPV): http://www.ihatepsm.com/blog/oral-polio-vaccines-opv

Measles Containing Vaccines (MCV): http://www.ihatepsm.com/blog/measles-containing-vaccines-mcv

HEPATITIS B VACCINE: http://www.ihatepsm.com/blog/hepatitis-b-vaccine

JAPANESE ENCEPHALITIS (JE) VACCINE: http://www.ihatepsm.com/blog/japanese-encephalitis-je-vaccine

Pneumococcal Conjugate Vaccine (PCV): http://www.ihatepsm.com/blog/pneumococcal-conjugate-vaccine-pcv