Voluntary Adverse Event Reporting via the SRP (other than RFR reports)

Signs, Symptoms, or
Diagnoses

Food Allergies

was associated with

that were not thought to be involved in the event?

food allergies?

Outcomes attributed to this adverse event
Death
A life-threatening experience
Hospitalization—Initial or Prolonged
Other Serious (Important Medical Events)
Congenital Anomaly / Birth Defects
Persistent or Significant Disability or Incapacity
Date adverse event began
associated with

SIGNS, SYMPTOMS, OR DIAGNOSES

XX/XX/20XX

Signs, Symptoms, or
Diagnoses
Product Problem
Description

Food Allergies

was associated with

that were not thought to be involved in the event?

food allergies?

Outcomes attributed to this adverse event
Death
A life-threatening experience
Hospitalization—Initial or Prolonged
Other Serious (Important Medical Events)
Congenital Anomaly / Birth Defects
Persistent or Significant Disability or Incapacity
Date adverse event began
associated with
ate

SIGNS, SYMPTOMS, OR DIAGNOSES

XX/XX/20XX

Food Allergies

Signs, Symptoms, or
Diagnoses

was associated with

Reason for Use

that were not thought to be involved in the event?

food allergies?

FOOD ALLERGIES
Allergen Category: Allergen:

Outcomes attributed to this adverse event
Death
A life-threatening experience
Hospitalization—Initial or Prolonged
Other Serious (Important Medical Events)
Congenital Anomaly / Birth Defects
Persistent or Significant Disability or Incapacity
Date adverse event began
associated with

SIGNS, SYMPTOMS, OR DIAGNOSES

XX/XX/20XX

Signs, Symptoms, or
Diagnoses

Food Allergies

was associated with

that were not thought to be involved in the event?

food allergies?

Outcomes attributed to this
Death
A life-threatening experience
Hospitalization—Initial or Prolonged
Other Serious (Important Medical Events)
Congenital Anomaly / Birth Defects
Persistent or Significant Disability or Incapacity
Date adverse event began
associated with

SIGNS, SYMPTOMS, OR DIAGNOSES

XX/XX/20XX

Riley Reporter

Signs, Symptoms, or
Diagnoses

food allergies?

What condition was this medication treating?

Death
A life-threatening experience
Hospitalization—Initial or Prolonged
Other Serious (Important Medical Events)
Congenital Anomaly / Birth Defects
Persistent or Significant Disability or Incapacity
Date adverse event began
Please provide any additional details about the adverse event *

SIGNS, SYMPTOMS, OR DIAGNOSES

XX/XX/20xx