PATH's Cervical Cancer Prevention Action Planner

Records, data collection, and reports

When HPV immunization is added to a country program, the eventual goal is to integrate the vaccination records into existing EPI program records at all levels, from local health facilities to the national level. This integration may take time because of the need to update forms, so in the meantime, it may be necessary to keep separate records. The reporting systems should be designed to minimize health worker burden and confusion.

Good basic recording tools are available in WHO guides such as Immunization in Practice Module 7: Monitoring and Using Your Data, as well as in country EPI manuals. Another excellent resource is USAID’s Immunization Essentials, which includes information on using forms such as patient registers, maps, vaccination cards, tickler files, tally sheets, and immunization monitoring charts.

After immunization data are collected on various forms, they should be consolidated into summaries for transmission from the health facility to the district and higher levels. When data are summarized, the information can be used not only for official recordkeeping purposes, but also for identifying problems and taking corrective actions.

Examples of forms from PATH HPV vaccine demonstration project countries are available in sample vaccination cards and registers, while Annex 3 in the Bridging Phase for the Delivery of Human Papillomavirus (HPV) Vaccine to Prevent Cervical Cancer: A Field Guide for Health Managers and Service Providers includes examples of health unit, sub-county, and district monthly vaccination summary sheets for the three doses of HPV vaccine.

Adverse events following immunization

There are no live or attenuated biological components in HPV vaccines, thus reducing the potential for serious adverse events. It is not possible for anyone to become infected with HPV because of vaccination.

AEFIs are events or reactions that are observed sometime after immunization—they may occur immediately, or weeks or months later. Some of these may be caused by the vaccine or by error in administering the vaccine, while others may have causes that are not vaccine-related but occurred coincidently following vaccination.
The WHO publication Immunization Safety Surveillance presents a review of the five categories of AEFIs and strategies that health workers can employ to prevent or manage them. The manual includes definitions of AEFIs that must be reported and their treatments, with a separate annex that deals with recognizing and treating anaphylaxis. Keeping an emergency kit in the vaccination area will ensure that health workers can respond to an AEFI; the WHO manual reminds managers that emergency kits must contain adrenalin in case of an anaphylactic reaction. Health workers who participate in HPV vaccination and emergency teams at district hospitals should be trained on monitoring and management of AEFIs.

The WHO document Adverse Events Following Immunization (AEFI): Causality Assessment is also available, and country EPI materials offer further information. A general AEFI reporting form can be adapted for HPV vaccinations.

As noted in the section on basic information about cervical cancer and HPV vaccines, reports from clinical trials for the two currently available HPV vaccines showed that the most common side effect was discomfort at the injection site (pain, swelling), and that other common side effects were headache, fever, nausea, dizziness, vomiting, and fainting. Most side effects were of short duration (from several hours up to a few days).

No deaths that occurred during the clinical trials or that were reported after licensing were shown to be causally linked to HPV vaccines. For summaries of adverse events reported during the clinical trials of the HPV vaccines, see the vaccine package inserts for Cervarix® and for Gardasil®.

Despite the excellent safety record of the HPV vaccines to date, people are often suspicious of new vaccines, and reports of adverse events are more common with these. Identifying and managing adverse events promptly and effectively is critical to maintaining public confidence in immunization, so it is important to include this in training for health workers and education for community leaders.

Photo: PATH/Jessica Fleming

Man with paperwork

Additional resources

Print version: Implementing HPV Vaccination Programs (RHO Cervical Cancer website)

Watch videoHPV vaccination video and transcript

Case study: HPV vaccination in Africa

Case study: HPV vaccination in Latin America

Shaping Strategies to Introduce HPV Vaccines: Formative Research Results from India, Peru, Uganda, and Vietnam (RHO Cervical Cancer website)

Conducting Formative Research for HPV Vaccination Program Planning (RHO Cervical Cancer website)

Evaluating HPV Vaccination Pilots (RHO Cervical Cancer website)

HPV delivery strategies that achieved high coverage in low- and middle-income countries (PDF)

Vaccination (RHO Cervical Cancer website)

World Health Organization position paper on human papillomavirus vaccines (PDF)

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