spontaneous reporting

Spontaneous reporting is a process where healthcare professionals and patients voluntarily report any suspected adverse reactions or side effects they experience from medications or vaccines. These reports are submitted to regulatory agencies to help monitor safety in real-world use. Although the reports don’t confirm a cause-and-effect relationship, they are valuable for detecting potential safety issues that may not have been identified during clinical trials. This ongoing surveillance helps regulatory authorities assess risks, update safety information, and take appropriate actions to protect public health.