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Adverse event reporting in all its forms

Your national pharmacovigilance system is only as strong as your data. With our digital reporting forms, you can make it easier for patients and health workers to give you the information you need.

An immunisation worker enters child vaccination data into a mobile app. Hyderabad district, Sindh Province, Pakistan. Photo: WHO/Asad Zaidi
An immunisation worker enters child vaccination data into a mobile app. Hyderabad district, Sindh Province, Pakistan. Photo: WHO/Asad Zaidi

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support@who-umc.org

After a medicine or vaccine is approved, there is a risk that new side effects could come to light – the sooner we know about them, the faster we can act. But getting the data we want, how we want it, where we want it, isn’t as simple as it sounds.

Paper forms can be difficult and time-consuming to process for all sorts of reasons. They may be hard to read, incomplete, or include the wrong information. They can also get lost or be misplaced.

Digital reporting systems make reporting easier, but they can be costly to develop or maintain. Not all of them work offline either, which can be an issue in places with weak internet.

Available as a free of charge add-on module to VigiFlow, VigiMobile is a customisable app that both health workers and members of the public can use on any device – even when they are offline – to report suspected adverse effects of medicines and vaccines. Reports can be submitted later when they are connected again.

Based on the WHO standard reporting forms for collecting information on potential adverse effects of medicines and vaccines, VigiMobile forms capture the core variables recommended by WHO for evaluating adverse event data. The forms can be customised with your logo and colour scheme, so they are instantly recognisable as coming from you. You can also decide which languages you want to use.

VigiMobile for national immunisation programmes

Vaccine safety surveillance is essential to the success of immunisation programmes. But that data is not always easy to come by – especially in parts of the world with limited internet access. VigiMobile makes it easier for reporters to gather structured information out in the field and share it with immunisation databases for further investigation.

  • Reporters can install the app on their smartphone, laptop or tablet.
  • Structured reporting saves time and effort to convert unstructured information into a format compatible with national and state immunisation databases.
  • Structured geographic data capture makes it possible to locate and investigate clusters of adverse events at district level.
  • The AEFI reporting form features drop-down menus containing prequalified vaccine lists and recognised adverse events for more efficient, reliable, and accurate information gathering.
  • Reporters’ information is stored in the app, so they only need to fill it in once. 

VigiFlow for AEFI

 

Immunisation workers in Tanzania head for the remote hills of Monduli Juu. Photo: WHO/Ethnovision/Billy Miaron
Filling out forms on your phone or computer makes it much easier to report the right information. VigiMobile has now replaced paper reporting completely in my district.

Abdillah Mnenge
City Council Pharmacist and AEFI Reporter, Tanga, Tanzania

Get the data you want, how you want it, where you want it

Unlike paper forms, where missing or unclear information can be problematic, digital forms give you more control over the type and amount of data you receive.

Required fields and drop-down menus make data entry more efficient, reliable, and accurate, reducing the need for data cleaning.

Structured reporting also solves the challenge of converting unstructured information into a format compatible with VigiFlow, speeding up the analysis process. This saves time and reduces your administrative burden by removing the need for manual data entry and verification. 

VigiMobile is included free of charge with VigiFlow. Depending on how your national safety surveillance system is set up, you can configure workflows to automatically route reports to regional or district authorities. With just one click, authorised users can easily share reports with VigiBase, the WHO global database of adverse event reports for medicines and vaccines. 

Key benefits
 

  • Available free of charge to VigiFlow and VigiFlow for AEFI subscribers, VigiMobile forms can be installed on any device and on any operating system. Each form has its own URL, which you can distribute via a direct link, button on your website, or QR code. They appear on screen as a separate icon when they are downloaded.
  • Forms can be made available in your own language and customised with your logo and colour scheme on request.
  • Based on the WHO standard forms for reporting potential adverse effects of medicines and vaccines, VigiMobile forms capture the recommended core variables for analysing adverse event data.
  • VigiMobile can be easily configured to route reports directly to districts or provinces for follow-up.
  • Digital forms simplify data collection, making it easier for reporters to give you the information you need.
  • Forms can be accessed even without an internet connection.
  • All data sent over the internet is encrypted, preventing unauthorised access.
Last modified on: August 30, 2024