OpenVigil 1 and 2 are software packages
to analyse pharmacovigilance data. There are several national and
international databases of so called spontaneous adverse event
reports, e.g., the U.S. american FDA Adverse Event Reporting
System (AERS, mostly domestic data) or the WHO Uppsala Monitoring Centre (international).
Currently, analyses of FDA AERS (LAERS & FAERS)
pharmacovigilance data are available. In addition to U.S. american data, we are currently importing German data. Data mining features include highly configurable search criteria filters and output filters. Analyses include
disproportionality analyses for signal detection like Proportional Reporting Ratio (PRR) calculations. Results can be viewed,
sorted and filtered in the webbrowser or saved for further
analyses in statistical software packages. Both projects aim at
integrating these and other pharmacolovigilance sources to
pharmacoepidemiological data like prescription data.
OpenVigilFDA is a fron-end to the openFDA-interface which is being developed by the FDA since 2014. It allows you to extract the latest reports. Due to technical limitations, the beta-version status and the ongoing changes to the API of openFDA, OpenVigil 2 is more stable and superior for analyses of disproportionality.
There are live installations with U.S. american FDA pharmacovigilance data of both versions of OpenVigil with FDA AERS data and OpenVigilFDA freely
available at Christian Albrecht University (CAU) of Kiel, Germany:
OpenVigil 2.1 (data 2004Q1-2014Q2): http://www.is.informatik.uni-kiel.de/pvt/OpenVigil2.1/search/
OpenVigil 2.0 (data 2004Q1-2012Q2): http://www.is.informatik.uni-kiel.de/pvt/OpenVigil/search/
OpenVigil FDA: http://openvigil.pharmacology.uni-kiel.de/openvigilfda.php
OpenVigil 1: http://openvigil.pharmacology.uni-kiel.de/openvigil.php
(development version at: http://openvigil.pharmacology.uni-kiel.de/openvigil-current.php)
OpenVigil 2 and OpenVigilFDA are the successors of OpenVigil 1 and use cleansed FDA AERS data. For scientific research on U.S. american data, do not use OpenVigil 1 but only version 2 or OpenVigilFDA!
There is also a development version of OpenVigil 1 with German pharmacovigilance data available for preview:
OpenVigil 1 German: http://openvigil.pharmacology.uni-kiel.de/openvigil-current-bfarm.php)
We are also working on a development version of OpenVigil 1 with Canadian pharmacovigilance data (database is currently sill empty):
OpenVigil 1 Canadian: http://openvigil.pharmacology.uni-kiel.de/openvigil-current-hc.php)
The German and Canadian pharmacovigilance data are of sufficient quality and do not need further drugname-mapping prior to mining or analysing them.
You can download the PHP-sources/executables of OpenVigil 1 and OpenVigilFDA and a WAR-file of OpenVigil 2.1 at
Source code of OpenVigil 2 will be made available soon, too, after some more improvement on code readability and documentation has been done.
The project is maintained by Dr. Ruwen Böhm, specialist for clinical pharmacology, Institute of
Experimental and Clinical Pharmacology, UKSH Kiel, <firstname.lastname@example.org>
and Prof. Dr. Hans-Joachim Klein, computer scientist, Institut für Informatik, Christian Albrechts
University, Kiel, <email@example.com>
The OpenVigil project follows the HONcode and was certified in november 2015. The annual re-certification was made possible by private funding and the kind help of the HON foundation for projects without dedicated budget.
All software uses browser cookies. Cookies are used for the captchas and to store previous queries as convenience for the user (OpenVigilFDA only). Users are not tracked.
Emails sent to the projects members are treated confidentially and are neither systematically saved nor used for statistics.
Cf. the installation overview pages for date of last changes to programs or databases and version numbers and the cave-at documents for general pitfalls.
All software uses brand names which are not specifically identified (e.g., by using ®). Cf. the documentation to understand the difference between drug name and brand name and to learn which output does contain brand names. The authors declare no conflicts of interested as they have no financial or other relation to any of the producers.
Responsible for this website (Impressum / Betreiber der Website): Dr. med. Ruwen Böhm, Institut für Experimentelle und Klinisch Pharmakologie, UKSH Kiel, Hospitalstr. 4, 24105 Kiel, Germany. Tel. +49 431 500 30414, <firstname.lastname@example.org>.
The project is funded by public funding via the Christian Albrechts University (CAU) of Kiel, Germany. There is no funding via advertisements.
The OpenVigil project does not produce or gather any of the pharmacovigilance data itself but is dependent on external data sources.
Our software is being developed for physicians, pharmacists and scientists. Due to the origin and nature of the data and the ongoing work on our programs, all results should be considered unvalidated. Especially, any findings must not uncritically be used for therapy changes or legal proceedings. However, these data are well usable for hypothesis generation.
This page was last changed on 2016-11-25.