form – ARAC Healthcare

Adverse Event Reporting form

Patient Information

Patient Name

Age

Age Group

Gender

Suspected Product Information

Trade Name / Generic Name & Strength

Indication

Dose

Route

Frequency

Duration

Date

Batch Number

Adverse Event Information

Event onset Date

Event end Date

Outcome

Causality

Treatment Medication, Diagnostic and Lab Values (associated with adverse event(s))

Action Taken: What happened after adverse reaction?

Seriousness

Concomitant Drugs

Were any concomitant drugs taken?

Reporter information

Reporter name

Profession (Specialty)

Address

Phone / Mobile

Fax

Country

Date