Reporter Name or Initials (Required)

Email Address or Phone Number (Required)

PATIENT INFORMATION - Please answer at least 1 of 4 of the following PATIENT INFORMATION - Please answer at least 1 of 4 of the following Name Age Date of Birth Gender (assigned at birth)

Patient Name or Initials

Patient Age (in years)

Patient Date of Birth

Patient Gender (assigned at birth) Patient Gender (assigned at birth) Male Female

PRODUCT INFORMATION - Please answer at least 1 of 5 of the following PRODUCT INFORMATION - Please answer at least 1 of 5 of the following Product Name Lot Number NDC Number Start Date / Stop Date Dosage

Product Name

Lot Number

NDC Number

Start Date / Stop Date

Dosage

ADVERSE EVENT INFORMATION (Required)

Start Date of Adverse Event

Adverse Event Outcome Adverse Event Outcome Hospitilization Prolongation of existing hospitalization Life threatening illness (immediate risk of fatal event) Disability or permanent damage Patient death Congenital anomaly or birth defect None of the above

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