According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it 

displays a valid OMB control number. The valid OMB control number for this information collection is 0579-0013. The time required to complete this information collection is 

estimated to average .33 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and 

completing and reviewing the collection of information.

OMB Approved

0579-0013

EXP. 02/2022

UNITED STATES DEPARTMENT OF AGRICULTURE 

ANIMAL AND PLANT HEALTH INSPECTION SERVICE 

VETERINARY SERVICES

CENTER FOR VETERINARY BIOLOGICS 

1920 DAYTON AVENUE 

AMES, IOWA 50010 

ADVERSE EVENT REPORT 

1. Information Reported By

 Attending Veterinarian Clinical Pathology Laboratory Distributer Human Patient 

 Medical Physician Owner/Producer/Employee Other 

2. First Name 3. Last Name 4. Contact Number 5. Submitter’s Case Number

6. Date First Received

(MM/DD/YYYY)

 Initial Follow-up 

8. Submitted to Manufacturer

Yes No 

9. Country of Occurrence

10. Case Type

 Animal Complaint Human Exposure Product Problem Only 

11. Problem Type

 Adverse Reaction Eco-toxicity Extra Label Use Human Exposure -

Asymptomatic

Human Exposure -

Symptomatic Lack of Efficacy Product Problem

PRODUCT INFORMATION

Product 

Number Brand Name/Trade Name Generic Name/Active Ingredient(s)

1 

2 

3 

4 

Product 1 Product 2 Product 3 Product 4

Manufacturer 

Serial/Lot Number 

Expiration Date 

Was product used as per 

label instructions?

Yes No Not Applicable Yes No Not Applicable Yes No Not Applicable Yes No Not Applicable 

Unknown to Reporter Unknown to Reporter Unknown to Reporter Unknown to Reporter

Off-label use type 

Has patient received this 

product before

Yes No Not Applicable Yes No Not Applicable Yes No Not Applicable Yes No Not Applicable 

Unknown to Reporter Unknown to Reporter Unknown to Reporter Unknown to Reporter

Has patient experienced

AEs from this product 

before?

Yes No Not Applicable Yes No Not Applicable Yes No Not Applicable Yes No Not Applicable 

Unknown to Reporter Unknown to Reporter Unknown to Reporter Unknown to Reporter

Route of Administration

Site of Administration 

Duration of 

Treatment/Exposure 

Start Date End Date Start Date End Date Start Date End Date Start Date End Date

Dose Amount

Who administered the 

product?

Attending veterinarian’s 

level of suspicion

APHIS Form 2080

APR 2020 
DETAILED DESCRIPTION OF EVENT (narrative)

Event Category

 Anaphylaxis - Hypersensitivity Autoimmune Birth Defect Lack of Expected Efficacy 

 Local Neoplasia Reproductive Other 

What was the final outcome?

 Alive with Sequelae Death (All Causes) Euthanasia Natural Death 

 Recovered Remains Under Treatment Not Applicable Unknown 

Enter case narrative (if necessary, use continuation sheet on page 3):

SUSPECTED ADVERSE EVENT DATE(S)

1. Date of Onset of AE (MM/DD/YYYY) 2. Duration of Suspected Adverse Event 3. Time Between Administration and Event

ANIMAL INFORMATION

1. Number of Animals Exposed 2. Number of Animals Reacted 3. Number of Dead Animals

4. Animal Condition Prior to Treatment

 Critical Fair Good Poor Not Applicable Unknown 

5. Animal Name 6. Gender

Female Male Mixed Not Applicable Unknown 

7. Species

 Cat Cattle Chicken Dog Goat Horse Human Other

8. Mixed Breed Mixed with 9. Status

Intact Neutered Not Applicable Unknown 

10. Age From 11. Age To 12. Weight From 13. Weight To

REPORTER INFORMATION

Primary Report

1. Sender

Attending 

Veterinarian

Clinical Pathology

Laboratory Distributor Human Patient Medical Physician

Owner/Producer/ 

Employee Other 

2. First Name 3. Last Name

4. Address (include ZIP Code and country)

5. Phone Number 6. Fax Number 7.Email

Additional Information

Save and submit via email to: Print form and mail to: Print and fax it to:

CVB@usda.gov

Pharmacovigilance, USDA, 

Center for Veterinary Biologics, 

1920 Dayton Avenue, 

Ames, IA 50010 

515-337-6120

APHIS Form 2080 Page 2 
CONTINUATION SHEET

(use this page to continue any item on this form)

APHIS Form 2080 Page 3