Coding adverse event information

Coding adverse event information with MedDRA enables users to find reports in searches and queries and allows for computer processing of cases (such as calculations of disproportionality).

Method 1

In the “Reaction” section, search for suitable terms in the field Reaction/event (MedDRA).

Method 2

If you don’t find the term when searching, click the list symbol on the right to browse the MedDRA hierarchy. Clicking the arrows expands levels of the dictionary, eventually leading to a list of LLTs.

If you are unsure and cannot find an adequate MedDRA term, you can use the free text field Reaction/event as reported by initial reporter. However, since free text reactions cannot be searched in VigiFlow or VigiLyze, it is preferable to code them using the methods described above. The two fields can also be used in combination to reflect both the original report and its corresponding MedDRA term.