Individual Case Safety Reports

Individual Case Safety Reports (ICSRs) are detailed documents healthcare professionals or patients submit to medication regulators when they experience or observe a side effect or adverse event from a drug or vaccine. These reports help monitor the safety of medicines by providing information about potential risks. They include details about the patient, the medication involved, and the nature of the adverse event. Collecting ICSRs allows authorities to detect patterns, evaluate safety concerns, and take actions to protect public health. Essentially, they are vital tools for ensuring medicines remain safe for everyone.