Replication Data for: Consensus clustering for case series identification and adverse event profiles in pharmacovigilance

Replication Data for: Consensus clustering for case series identification and adverse event profiles in pharmacovigilance This data was extracted from VigiBase, the WHO global database of individual case safety reports. Its reports are collected by national pharmacovigilance centres such as the US FDA, which are members of the WHO Programme for International Drug Monitoring. This study included data available in VigiBase on 27 December 2018, a total of 18.4 million reports, not counting suspected duplicates. This dataset includes data for three drugs, sumatriptan, ambroxol and tacrolimus (on reports in VigiBase drugs are encoded using the WHODrug dictionary for medicinal information). Data is provided in CSV files with header rows. Reports are encoded as sparse indices, where InstanceID[row_i] and AdverseEventID[row_i] mean that the Adverse Event ID given in row_i is present on the report with Instance ID given in row_i. Instance IDs and Adverse Event IDs are unique numbers and differ between the three drugs. On reports in VigiBase, adverse events are encoded in MedDRA®. In this dataset, 991 commonly reported MedDRA Preferred Terms are presented in full (in line with the Statement on MedDRA Data Sharing) whereas the rest are coded with the unique IDs, which differ between the drugs. MedDRA®, the Medical Dictionary for Regulatory Activities terminology, is the international medical terminology developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). MedDRA® trademark is registered by IFPMA on behalf of ICH.