Healthcare Pharmacovigilance Document

HEALTHCARE PHARMACOVIGILANCE REPORT

This form documents an adverse event, medication error, product quality complaint, or other safety information related to a medicinal product. Complete all applicable sections with factual, objective information. Submission of this report authorizes collection and processing of the information for pharmacovigilance and public safety purposes in accordance with applicable privacy protections.

Patient Information

Date of birth:    Gender: Male Female Other Unknown

Reporter Information

Reporter name:    Relationship to patient:

Reporter type: Patient Healthcare professional Manufacturer/Distributor Other

Suspected Product(s)

Active ingredient(s):    Manufacturer:

Batch/Lot number:    Expiry date:

Route of administration:    Dose and regimen:

Adverse Event Details

Date/time of onset:    Time to onset after exposure:

Seriousness (check all that apply): Death Life-threatening Hospitalization Persistent disability/incapacity Congenital anomaly Other

Outcome of event: Resolved Recovering Not resolved Fatal Unknown

Action taken with suspected product: Discontinued Dose reduced No change Unknown

Medical History and Investigations

Follow-up and Additional Information

Is follow-up required?    If yes, planned follow-up date:

Consent, Authorization and Certification

By submitting this report I certify that I am authorized to provide the information contained herein. I authorize collection, use and disclosure of the information for pharmacovigilance activities, including follow-up contact by clinicians or safety personnel to obtain additional clinical information. Information will be handled in accordance with applicable privacy requirements; personal identifiers will be used only as necessary for case assessment and follow-up.

I acknowledge that I may withdraw consent to further follow-up at any time by notifying the reporter contact provided above; withdrawal does not affect the processing of information already collected. I understand that accurate and complete information is necessary for appropriate safety assessment and public health action.

Authorization expiration date:

Patient/Reporter attestation: I attest that the information provided is accurate and complete to the best of my knowledge.

HIPAA/Privacy acknowledgment: I acknowledge receipt of the privacy information related to this report.    Initials:

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