Form APHIS Form 2080 APHIS Form 2080 Adverse Event Report

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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 0579-0209. The time required to complete this information collection is estimated
to average 2 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
0579-0209
EXP. XX/XXXX

ADVERSE EVENT REPORT

CENTER FOR VETERINARY BIOLOGICS
1920 DAYTON AVENUE
AMES, IOWA 50010
1. Information Reported By
Attending Veterinarian

Clin Path Laboratory

Distributer

Human Patient

Licensed Partner
2. First Name

Medical Physician
3. Last Name

NOS Other
4. Contract Number

Owner/Producer/Employee
5. Submitter’s Case Number

6. Date First Received
(MM/DD/YYYY)

7. Report

8. Submitted to Manufacturer

9. Country of Occurrence

Initial

Follow-up

Yes

No

10. Case Type
Animal Complaint

Field Safety Study

Human Exposure

Inquiry

Product Problem Only

11. Problem Type
Adverse Reaction

Eco-toxicity

Extra Label Use

Human Exposure Asymptomatic

Human Exposure Symptomatic

Inquiry

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

Unknown to
Company

Not Applicable
Unknown to
Reporter

Yes

No

Unknown to
Company

Not Applicable
Unknown to
Reporter

Yes

No

Unknown to
Company

Not Applicable
Unknown to
Reporter

No

Not Applicable

Unknown to
Company

Yes

Unknown to
Reporter

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

Yes

No

Unknown to
Company
Yes

No

Unknown to
Company

Not Applicable
Unknown to
Reporter
Not Applicable
Unknown to
Reporter

Yes

No

Not Applicable

Unknown to
Company

Unknown to
Reporter

Yes

No

Not Applicable

Unknown to
Company

Unknown to
Reporter

Yes

No

Unknown to
Company
Yes

No

Unknown to
Company

Not Applicable
Unknown to
Reporter
Not Applicable
Unknown to
Reporter

No

Not Applicable

Unknown to
Company

Yes

Unknown to
Reporter

No

Not Applicable

Unknown to
Company

Yes

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
SEP 2015

Start Date

End Date

Start Date

End Date

Start Date

End Date

Start Date

End Date

DETAILED DESCRIPTION OF EVENT (narrative):
Event Category
Anaphylaxis - Hypersensitivity

Autoimmune

Birth Defect

Lack of Expected Efficacy

Local
What was the final outcome?
Alive with Sequelae

Neoplasia

Other

Reproductive

Death (All Causes)

Euthanasia

Natural Death

Not Applicable
Enter case narrative:

Recovered

Remains Under Treatment

Unknown

SUSPECTED ADVERSE EVENT DATE(S):
1. Date of Onset of AE

APX

2. Duration of Suspected Adverse Event

3. Time Between Administration and Event

(MM/DD/YYYY)

ANIMAL INFORMATION
1. Number of Animals Exposed

2. Number of Animals Reacted

3. Number of Dead Animals

Estate
4. Animal Condition Prior to Treatment
Critical
5. Animal Name

Estate

Fair

Good

Estate

Not Applicable

Poor

Unknown

6. Gender
Female

Male

Mixed

Not Applicable

Unknown

7. Species
Cat

Cattle

8. Mixed Breed

Chicken

Dog

Mixed with

Goat

Other

9. Status
Intact

10. Age From

Human

Horse

Neutered

11. Age To

12. Weight From

Not Applicable

Unknown

13. Weight To

REPORTER INFORMATION
Primary Report
1. Sender
Attending
Veterinarian
2. First Name

Clin Path
Laboratory

Human
Patient

Distributor

Licensed
Medical
Partner
Physician
3. Last Name

NOS
Other

Owner/Producer/
Employee

NOS
Other

Owner/Producer/
Employee

4. Address(include ZIP Code and country)

5. Phone Number
Other Report
1. Sender
Attending
Veterinarian
2. First Name

6. Fax Number

Clin Path
Laboratory

7.Email

Human
Patient

Distributor

Licensed
Medical
Partner
Physician
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:
[email protected]

APHIS Form 2080 (Reverse)
SEP 2015

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