APHIS Form 2080 Adverse Event Report

Clear Form
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 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.

UNITED STATES DEPARTMENT OF AGRICULTURE
ANIMAL AND PLANT HEALTH INSPECTION SERVICE
VETERINARY SERVICES

OMB Approved
0579-0013
EXP. 02/2022

ADVERSE EVENT REPORT

CENTER FOR VETERINARY BIOLOGICS
1920 DAYTON AVENUE
AMES, IOWA 50010

See reverse side for Privacy Act notice
1. Information Reported By
Attending Veterinarian

Clinical Pathology Laboratory

Distributer

Human Patient

Medical Physician
2. First Name

Owner/Producer/Employee
3. Last Name

Other
4. Contact Number

5. Submitter’s Case Number

6. Date First Received

7. Report

8. Submitted to Manufacturer

9. Country of Occurrence

(MM/DD/YYYY)

Initial

Follow-up

Yes

No

10. Case Type
Animal Complaint

Human Exposure

Product Problem Only

11. Problem Type
Adverse Reaction

Eco-toxicity

Extra Label Use

Human Exposure Symptomatic

Lack of Efficacy

Product Problem

Human Exposure Asymptomatic

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

Yes

Yes

Yes

Yes

Off-label use type
Has patient received this
product before
Has patient experienced
AEs from this product
before?

No

Not Applicable

No

Not Applicable

No

Not Applicable

No

Not Applicable

Unknown to Reporter

Unknown to Reporter

Unknown to Reporter

Unknown to Reporter

Yes

Yes

Yes

Yes

No

Not Applicable

Unknown to Reporter

No

Not Applicable

Unknown to Reporter

No

Not Applicable

Unknown to Reporter

No

Not Applicable

Unknown to Reporter

Route of Administration
Site of Administration
Duration of
Treatment/Exposure
Dose Amount
Who administered the
product?
Attending veterinarian’s
level of suspicion
APHIS Form 2080
MAR 2019

Start Date

End Date

Start Date

End Date

Start Date

End Date

Start Date

End Date

Event Category
Anaphylaxis - Hypersensitivity
Local
What was the final outcome?
Alive with Sequelae

DETAILED DESCRIPTION OF EVENT (narrative)
Autoimmune

Birth Defect

Lack of Expected Efficacy

Neoplasia

Reproductive

Other

Death (All Causes)

Euthanasia

Natural Death

Not Applicable

Unknown

Recovered
Remains Under Treatment
Enter case narrative (if necessary, continue 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
5. Animal Name

Fair

Good

Poor

Female
7. Species
Cat
8. Mixed Breed

Not Applicable

Unknown

6. Gender

Cattle
Mixed with

Male

Chicken

Mixed

Dog
9. Status

Goat

Intact
10. Age From

Unknown

Human

Other

Horse

Neutered

11. Age To

Not Applicable

Not Applicable

12. Weight From

Unknown

13. Weight To

REPORTER INFORMATION

Primary Report
1. Sender
Attending
Veterinarian
2. First Name

Clinical Pathology
Laboratory

Distributor

Human Patient
3. Last Name

Medical
Physician

Owner/Producer/
Employee

Other

4. Address (include ZIP Code and country)
5. Phone Number

6. Fax Number

7.Email

Additional Information

Save and submit via email to:
[email protected]

Print form and mail to:
Pharmacovigilance, USDA,
Center for Veterinary Biologics,
1920 Dayton Avenue,
Ames, IA 50010

Print and fax it to:
515-337-6120

PRIVACY ACT NOTICE
The information requested on this form will not be retrieved from our files by using your name or personal identifier and is therefore, in the
opinion of this agency, not subject to provisions of the Privacy Act of 1974. However, in keeping with the spirit and intent of the Privacy Act we
are informing you of the following:
Authority:

9 CFR Section 114.7.

Purpose:

That compliance with the Act and applicable regulations be under supervision of person(s) competent in the preparation of
biological products.

Routine uses:

To determine that the responsible person(s) producing biological products are qualified by training and experience and have
demonstrated fitness to produce such products in compliance with the Act.

APHIS Form 2080

Page 2

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

APHIS Form 2080

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