Spontaneous Reporting

Spontaneous Reporting is the process of healthcare professionals and pharmaceutical companies voluntarily submitting Adverse Event (AE) cases without any prompt or solicitation. These reports are not a result of a formal study or organized data collection scheme but instead arise from the initiative of individuals or organizations to report potential adverse effects associated with a medical product. Spontaneous reporting is a critical component of pharmacovigilance and aids in the ongoing surveillance of medication safety.