New drug safety concerns described in patient reports can be identified in a global database.

Case narratives from patient reports provide detailed clinical stories that describe the experiences and the impact of adverse drug reactions on the patient’s quality of life.

To benefit from the unique information available in patient reports to pharmacovigilance, signal detection practice that focuses on the review of case narratives, such as case-by-case assessments, is preferable. When this is not possible, we recommend considering tailoring statistical signal detection to capture patient concerns.