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VigiMobile

Customizable mobile forms for structured adverse event and vaccine safety reporting by healthcare workers and the public, with offline capability.

Overview

VigiMobile is a customisable web application for structured adverse event reporting, designed for use by healthcare workers and the general public. It is a free add-on to VigiFlow, available to all WHO Programme for International Drug Monitoring (PIDM) members, and works on any device and operating system. The tool is intended to support national pharmacovigilance and immunisation safety surveillance systems by making it easier to collect accurate, structured data in the field.

Reporting form templates in VigiMobile capture the core variables recommended by WHO for adverse event data collection. Forms can be customised with an organisation's logo, colour scheme, and preferred language, and can be distributed via direct links, website buttons, or QR codes.

Key Benefits

  • Included free of charge in VigiFlow for all WHO PIDM members.
  • Installable on any device and operating system; reporting form templates have unique URLs and appear as separate icons when downloaded.
  • Available in the user's preferred language and customisable with a logo and colour scheme.
  • Forms can be completed without an internet connection, with data saved and submitted once a connection is available.
  • All data transmitted over the internet is encrypted to prevent unauthorised access.
  • Digital forms reduce issues associated with paper reporting, such as missing or unclear information.

Key Features

  • Installable on smartphones, laptops, and tablets.
  • Reporter information is stored in VigiMobile so it only needs to be entered once.
  • Drop-down menus include prequalified vaccine lists and recognised adverse events to support efficient and accurate data entry.
  • Structured reporting organises information into a format compatible with immunisation databases, reducing the time and effort needed to convert unstructured data.
  • Patient and vaccination location is captured at the time of reporting, helping investigators identify clusters of adverse events at district level.
  • Required fields and drop-down menus reduce the need for data cleaning after submission.

Support for National Immunisation Programmes

  • VigiMobile is designed to assist vaccine safety surveillance, particularly in areas with limited internet access.
  • Reporters can collect structured information in the field and share it with immunisation databases for further investigation.
  • Structured reporting speeds up analysis and reduces administrative burden by organising data into a VigiFlow-compatible format.
  • Workflows can be configured to automatically route reports to provincial or district authorities, depending on the national safety surveillance system setup.
  • Authorised users can share reports with VigiBase, the WHO global database of adverse event reports for medicines and vaccines, with a single click.

VigiMobile is included at no additional cost with VigiFlow and integrates with related tools including VigiFlow eReporting for Industry. It has been deployed in national pharmacovigilance programmes in countries including Oman, Malawi, and Tanzania, where it has supported a shift away from paper-based reporting and strengthened cooperation between regulatory authorities and immunisation programmes.

Meta

Domain
Regulatory & Safety Documentation
Subdomain
Pharmacovigilance & Drug Safety
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechAcademic / Research
Development stage(s)
Post-Market & RWE
Target user(s)
QA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
ICH