1. Module 5 Recording and monitoring of HPV vaccine GardasilTM
Essential Training Package for HPV Vaccine Introduction
Module 5
Recording and monitoring of HPV vaccine
GardasilTM

2. Learning objectives
At the end of the module, you will have learned to:
Define process of monitoring HPV vaccine coverage data
Describe the 4 main monitoring tools at service delivery level
Describe the procedure to monitor AEFIs
Duration
25’

3. Key issues 1
What is the process for HPV vaccine coverage monitoring? 2
How to use the monitoring tools?
What is the process for AEFI monitoring and reporting? 3
Explain to the participants the key issues raised in this module.
We will provide you with answers to the following questions:
What is the process for HPV vaccine coverage monitoring?
How to use the tools of HPV vaccine coverage monitoring?
How to monitor and report AEFI related to HPV vaccine?

4. Flowchart of HPV vaccine coverage monitoring process and tools
1 - Service delivery/site level (i.e. point of vaccine delivery)
Data collection & reporting tools
Record each vaccinated girl by year of age and by dose number
(fill out one tally sheet/vaccination day)
1- Immunization cards
2- Immunization register
Sum up tally sheets
3-Tally sheet
Report numbers of doses given by year of age and by dose number to district
4- Monthly report
Let’s start with HPV vaccine coverage monitoring
This diagram describes generic instructions on how to monitor HPV vaccine coverage by year of age and by vaccine dose number from the site of vaccine delivery up to the national level. For demonstrative purpose, only 3 levels of reporting are shown
There are mainly 3 key activities for monitoring HPV vaccine at site level:
Activity 1: Record each vaccinated girl by year of age and by dose number filling one tally sheet per vaccination day
Activity 2: Sum up tally sheets monthly
Activity 3: Report monthly number of doses given per dose number and per age of girls
There are 4 key data collection and reporting tools to be used for HPV vaccine coverage monitoring at site level: 1) the personal immunization cards of the girl, 2) the logbook or register of the site, 3) the tally sheet used for one single vaccination day, and 4) the monthly record sheet
In the next slides, we will discuss the procedures and tools for HPV vaccine coverage monitoring and reporting.
2 - District level
3 - Country level

5. HPV vaccine coverage data collection procedure
Key steps
Tools 1
Register each eligible girl
Immunization register 2
Complete the girl’s immunization card
Immunization card
Tally the number of dose given, by dose number & by year of age (per vaccination) 3
Tally Sheet
Calculate sub-totals of HPV doses given, by dose number & by year of age (at the end of each vaccination session) 4
At health centre level, a specific HPV vaccine data collection procedure is recommended. This diagram recaps 5 steps of the procedure:
Use one logbook (register) per delivery site
Register each girl by collecting the following information
Name
Address
Date of birth and reported year of age (Note: if neither is known, vaccinator should document an age based on educated guess)
Date of vaccination
HPV dose number (1,2,or3)
Date of previous doses if applicable
Age at previous doses if applicable
Ask girl to present her vaccination card. Check the logbook (register) to verify which dose is being given. If she doesn’t have her card, check the register using information she provides
Register each administered dose on the tally sheet (based on year of age and dose number)
At the end of the vaccination day, tally number of HPV doses given, by dose number and by year of age
Count and record the number of strike-throughs on the tally form for each dose number and age category 5
Report the sub-totals to service delivery site
Monthly record sheet

6. Monitoring tool 1: Immunization card
HPV vaccination should always be recorded in the appropriate immunization card
Girls and Health Workers need to understand the importance of the card and how to handle it
Explain to the participants the main uses of the immunization card:
The immunization card is an important tool to check and to register:
the date of birth of the girl
The vaccines already received and those needed in the future
The next appointment for vaccination
Immunization card can also be used during coverage survey to validate vaccination status
Explain to the girls how to use her immunization card:
The girl should keep the immunization card in a safe place at home
Then she needs to remember to bring the immunization card for the next vaccination
The health worker must check the card to determine eligibility, and add details after the girl’s vaccination, providing information of vaccines given and the date for the next visit
Then, the girl should take the immunization card back home and keep in a safe place
NOTE for facilitator: change scenario according to your country process (e.g. card maybe kept safe in the school)

7. What should you do in this scenario?
The girl does not bring her HPV immunization card
How should you record the vaccination given?
Read the situation and question to the participants.
This question will test if participants understand what to do in the event that the Immunization card is not presented.
Response: If the girl does not bring the HPV immunization card, document the given dose on piece of paper, and ask her to bring the regular card next time for updating. 7

8. Monitoring tool 2: Immunization register
Use one register per service delivery site
Record the details of each girl in the register
When a girl returns for HPV2 or HPV3 use her card to locate her entry in the register
Use register to follow up with girls that did not return for 2nd or 3rd dose of HPV vaccine
Explain to the participants how to use the HPV register
Use only one register per service delivery site
The register should include both date of birth or reported age at each vaccine dose given, in case one DOB is not available
Register each girl by recording her name, address, date of birth, date of HPV1, HPV2 or HPV3, and age when each dose is given:
Enter the age as reported by the girl or her mother
When a girl returns for HPV2 or HPV3, her personal immunization card should be used to locate her place in the log book and to verify the need for HPV2 or HPV3

9. Monitoring tool 3: Tally sheet Record the number (No
Monitoring tool 3: Tally sheet Record the number (No.) of HPV doses given on a single vaccination day
Date of vaccination (DD/MM/YYYY): 01/01/2010
District: _____________________________________________________________________
Town/Village: _________________________________________________________________
Service delivery site: __________________________________________________________
Age (years)
No. of HPV1 doses given
No. of HPV2 doses given
No. of HPV3 doses given
OPTIONAL CHECK COLUMN
(sum up rows) 9
9yrHPV1= 8
9yrHPV2=
 10
9yrHPV3= 3 = 10
10yrHPV1=
10yrHPV2=
 15
10yrHPV3=  4 11
11yrHPV1=
11yrHPV2=
11yrHPV3= 12
12yrHPV1=
12yrHPV2=
12yrHPV3= 13
13yrHPV1=
13yrHPV2=
13yrHPV3=
14 
14yrHPV1=
14yrHPV2=
14yrHPV3=
≥15
15yrHPV1=
15yrHPV2=
15yrHPV3=
Unknown
UknHPV1=
UknHPV2=
UknHPV3=
OPTIONAL CHECK ROW
(sum up columns)
Grand total =
Explain to the participants how to record the number (No.) of HPV doses given on a single vaccination day:
Tally sheets are used each vaccination day to record the number of HPV vaccine doses given in a single vaccination day
Circle 1: Fill out one Tally Sheet per vaccination day
Circle 2: When registering each girl, strike one zero on the Tally Sheet according to the HPV dose number given and her age
At the end of each vaccination day, calculate the sub-totals of HPV doses given, by dose number and by age:
Count and record the number of strike-throughs made in each HPV dose number /age category
For sub-totals of 0, do not leave blank but clearly record the number 0 with a strike-through
Transfer the sub-totals to the Service Delivery Site - Monthly Record Sheet of Vaccination Days'

10. Monitoring tool 4: Monthly Record Sheet
Month/Year of report:
01/2010
District: ________________________________
Town/Village:____________________________
Service delivery site: _____________________
Age (years)
No. of HPV1 doses given
No. of HPV2 doses given
No. of HPV3 doses given
9 year old
9yrHPV1:
9yrHPV2:
9yrHPV3: 1. 2. 3. 4. 5.
Total 8 10 3
10 year old
10yrHPV1:
10yrHPV2:
10yrHPV3: 15 4
11 year old
11yrHPV1:
11yrHPV2:
11yrHPV3:
12 year old
12yrHPV1:
12yrHPV2:
12yrHPV3:
13 year old
13yrHPV1:
13yrHPV2:
13yrHPV3:
14 year old
14yrHPV1:
14yrHPV2:
14yrHPV3:
≥15 year olds
15yrHPV1:
15yrHPV2:
15yrHPV3:
Unknown
UknHPV1:
UknHPV2:
UknHPV3:
Explain to the participants how to record monthly the HPV doses given during the vaccination days:
This form should be updated monthly to report to the upper level
Boxes marked 1. refer to the number of HPV doses given, by dose number and by age, on the 1st HPV vaccination day
Boxes marked 2. refer to the number of HPV doses given, by dose number and by age, on the 2nd HPV vaccination day
so on and so forth

11. Using data to improve HPV vaccine coverage
Compare doses given to the target population by year (e.g. no. of 9 year old girls that received HPV1 dose versus no. of 9 year old girls in the catchment area) and consider:
Are there groups of girls that are not reached?
Are girls in the right age group being vaccinated?
Compare number of HPV1 doses administered with number of HPV2 and HPV3 doses administered and consider
Are there problems with communication, vaccine availability, etc. causing drop-outs?
Identify and vaccinate defaulters
Data collected on the monitoring tools should be used to improve HPV vaccine uptake.
On a regular basis, HPV1 doses administered by age group should be compared with number of girls in that age group. Ideally all girls in the target age group should be vaccinated with HPV vaccine. If there are huge differences, you need to identify and address the reasons for these.
Similarly, compare number of HPV1 doses administered with number of HPV2 and HPV3 doses administered, if HPV1 doses administered are much more than HPV2/HPV3 doses administered, then there is a problem of utilization, the girls are not returning back for vaccination. This problem needs to be addressed.

12. Considerations of AEFI related to HPV vaccine
HPV vaccine is a safe vaccine but mild adverse events can occur after administering the vaccine
Redness, pain or swelling at the injection site
Syncope (fainting)
In extremely rare instances it can cause anaphylaxis
One per 1.7 million doses
Girls should be observed carefully for 15 minutes after administration of vaccine
Manage and document any adverse reaction accordingly to the national reporting procedures
HPV vaccine is a safe vaccine. Results from clinical trials suggest that HPV vaccine is well tolerated with no major safety concerns.
The most common mild adverse events reported in vaccinated girls included redness, pain or swelling at the infection site. Syncope (fainting) may follow any vaccination, especially in adolescents and young adults
In extremely rare instances it can cause anaphylaxis (one per 1.7 million doses). Although vaccine associated anaphylaxis is rare, health workers should be prepared to provide medical treatment should it occur. Each vaccinator must have an AEFI kit with adrenaline and be familiar with its dosage and administration
Carefully observe the girls for 15 minutes after administration of vaccine
Should an adverse event occur, manage and document any adverse reaction
Reference:

13. Procedure for AEFI reporting
Report AEFIs through existing AEFI reporting systems established by national immunization programs
Suspected signs or symptoms 1
Health worker should immediately report to a local public health authority 2
National
Authorities will then decide if futher investigation is required 3
Explain to the participants the procedure for reporting on adverse events following immunization (AEFIs):
After dealing with vaccine coverage monitoring process and tools, we are now moving to the procedure for reporting on AEFI related to HPV vaccine.
Report AEFIs through the existing AEFI reporting systems established by national immunization programs
Animated picture 1: You should inform girl on the needs to immediately report any reaction that may be related to the vaccine. If suspected signs or symptoms, you should immediately report AEFI to reporting authority which is, in general, a local public health authority
Animated picture 2: The local public authority will move up to intermediate level, then to the national level and to the central immunization programme or national regulatory authority (NRA)
Animated picture 3: The National Authorities will then decide if further investigation is required 13

14. AEFI reporting form Details of Patient Reporter details
AEFI report should contain
Reporter details
Details of Vaccine
Details of the event
Explain to the participants what information should be included in an AEFI report.
An AEFI report should contain:
Animation 1: Client – unique identifier, date of birth and gender
Animation 2:Immunization event(s) – province where given, date, all vaccines given including name, manufacturer, lot number, administration site and route, as well as expiry date of vaccines
Animation 3: Adverse event(s) – description, including date vaccinated, date AEFI started, onset interval, date of report, and description of AEFIs
Animation 4:Reporter details

15. Key messages (1/2)
Monitoring vaccine coverage
Monitoring and reporting HPV vaccine coverage is crucial for evaluating the performance of the immunization programme and its impact on the vaccinated girls
HPV vaccine coverage should be monitored by year of age and by dose number
Vaccine coverage should be monitored with a set of tools including immunization card, register, tally sheet, and monthly report form.
The process for monitoring vaccine coverage data includes 5 steps
Explain to the participants that this is the main information to keep in mind.
1.Registering girls details
2. Using immunization
card
3. registering given dose per age
4. Calculate sub-totals of HPV dose given
5. Report Sub-totals
to service delivery site

16. Key messages (2/2)
Monitoring AEFI related to HPV vaccine
Monitoring and reporting AEFI related to HPV vaccine is essential for dispelling rumors and monitoring continued safety of HPV vaccines
AEFI should be reported using the existing system established by the national immunization program
Suspected AEFI related to HPV vaccines should be reported immediately to reporting authorities
The AEFI reporting form should contain details of patient, event, vaccine and reporter details
Explain to the participants that this is the main information to keep in mind.

17. End of module for your attention! Thank you
This is the end of the module, thank you for your attention!

18. References
Comprehensive Cervical Cancer Control. A guide to essential practice (C4 GEP). WHO 2013
HPV vaccine introduction into national immunization programmes: Information for programme managers and health workers. WHO 2013
Draft Human Papillomavirus (HPV) Vaccine Coverage Monitoring Tool. WHO 2012