1. Module 6 Rotavirus vaccine AEFI monitoring
Training for rotavirus vaccine introduction
Module 6
Rotavirus vaccine AEFI monitoring

2. Learning objectives
At the end of the module, the participants will be able to:
Identify adverse events following immunization (AEFIs), including intussusception (IS)
Explain how to report AEFIs
Duration
15’

3. Key issues 1 2 3 What is an AEFI? What is intussusception (IS)?
How to report an AEFI? 3
To the facilitator:
Explain to the participants the key issues raised in this module.
It is important to monitor and report AEFIs so that the community continues to have confidence in the immunization programme.
We will provide you with answers to the following questions:
What are the AEFIs of rotavirus vaccine?
What is Intussusception (IS)?
How to report an AEFI?

4. What is an AEFI? AEFI = Adverse event following immunization
A medical incident
Takes place after an immunization
Causes concern
Is believed to be caused by immunization
AEFI can be categorized into
Vaccine reaction
Programme error
Coincidental
Injection reaction
Unknown
To the facilitator:
Explain to the participants the adverse event following immunization of rotavirus vaccine.
An adverse event following immunization (AEFI) is a medical incident that takes place after an immunization, causes concern, and is believed to be caused by the immunization. The safety profile of the rotavirus vaccines currently available is good. Most infants who get the rotavirus vaccine do not experience any side effects.
Intussusception has been associated with Rotavirus vaccine and can result in severe illness or death.

5. What about Intussusception (IS)?
In the past, the first rotavirus vaccines (RotashieldTM) caused IS, a serious but very rare bowel obstruction
With the new rotavirus vaccines, there seems to be a very small increased risk of IS in infants following rotavirus vaccination
The increased risk appears to occur mainly in the first days following the first dose of rotavirus vaccine
To the facilitator:
Explain to the participants what intussusception (IS) is, its symptoms, and link with rotavirus vaccine.
IS is a rare type of bowel obstruction that occurs when one portion of the bowel slides into an immediately adjacent segment (also known as telescoping or prolapse).
Symptoms of IS include stomach pain with severe crying (which may be brief); several episodes of vomiting; blood in the stool; weakness, or irritability.
With the old Rotavirus vaccine called the RotashieldTM vaccine, studies suggested that the Rotavirus vaccine may be associated with a slight increased risk of IS in infants after they receive the vaccine, during the first week, especially.
Studies in the new rotavirus vaccines show that there is a very small increased risk of IS in infants. 5

6. Risk of IS against risk of rotavirus infection 2/2
Whether the new rotavirus vaccine (RotaSiilTM) affects the overall incidence of IS has not yet been established
The risk of IS after rotavirus vaccination is much lower than the risk of severe rotavirus disease in unvaccinated infants and young children!
To the facilitator:
Explain to the participants what intussusception (IS) is, its symptoms, and link to rotavirus vaccine.
Whether the new rotavirus vaccine (RotaSiilTM) affects the overall incidence of IS has not yet been established.
The rotavirus vaccine (RotaSiilTM) offers tremendous benefits by protecting infants and children from rotavirus disease. Rotavirus is the most common cause of severe diarrhoea among infants and young children. According to the U.S. Centers for Disease Control and Prevention, the risk of IS after rotavirus vaccination is much lower than the risk of severe rotavirus disease in unvaccinated children. Hence, rotavirus vaccine is strongly recommended to prevent rotavirus disease in infants and young children.

7. How to report an AEFI? (1/2)
Report the identified AEFI through existing AEFI reporting systems established by national immunization programmes
Suspected signs or symptoms
Community, district, and regional levels
National
authorities
To the facilitator:
Explain to the participants what should be done for adverse events following immunization (AEFIs).
Similar to all other vaccines, rotavirus vaccine needs to be monitored for safety and adverse events following immunization.
Health workers should ask parents to immediately report any reaction that may be related to the vaccine. Report the AEFI through the existing AEFI reporting systems established by national immunization programmes. Health workers should report AEFI to the upper level of the health system. The National Authorities will then decide if further investigation is required. 7

8. How to report an AEFI? (2/2)
AEFI report should contain
Client information
Immunization event(s) description
Adverse event(s) description
Relevant medical and treatment
history
Associated event(s)
Reporter details
To the facilitator:
Explain to the participants what information should be included in an AEFI report.
An AEFI report should contain:
Client – unique identifier, date of birth and gender
Immunization event(s) – province where given, date, all vaccines given including name, manufacturer, lot number, administration site and route, as well as the number in series of vaccine doses if relevant
Adverse event(s) – description, including time of first onset following immunization, duration, health care utilization, treatment and outcome
Relevant medical and treatment history – underlying disease, known allergies, prior AEFI, concomitant medication
Associated event(s) – acute illness, injury, exposure to environmental toxins
Reporter details

9. Key messages The current safety profile of rotavirus vaccines is good
Many infants who get the rotavirus vaccine (RotaSiilTM) do not experience any side effects
The risk of IS after rotavirus vaccination is much lower than the risk of severe rotavirus disease in unvaccinated infants and young children
AEFIs should be reported through the existing AEFI reporting systems/forms
Reassure the caretaker- admit uncertainty, investigate fully, and keep the community informed
To the facilitator:
Explain to the participants that this is the main information to keep in mind.

10. End of module for your attention! Thank you To the facilitator:
This is the end of the module.
You have been introduced to “Rotavirus vaccine AEFI monitoring” module. The following module is titled “Rotavirus vaccine communication with caretakers”.
Thank you for your attention!