spontaneous reporting

What are the Key Elements of a Spontaneous Report?

A well-documented spontaneous report typically includes the following elements:
Reporter Information: Contact details of the person reporting the event.
Patient Information: Age, sex, and other relevant demographic data.
Event Description: Detailed account of the adverse event, including onset, duration, and severity.
Suspected Substance: Name and dosage of the drug or chemical implicated.
Outcome: Any medical interventions required and the outcome of the event.

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