#188 
 
Data Elements for Submission of 
Veterinary Adverse Event Reports to 
the Center for Veterinary Medicine 
 
Guidance for Industry 
 
This guidance replaces the version dated April 2021.  The document has been revised to update 
information and harmonize with the March 2023 revision of VICH GL42 to the extent consistent 
with FDA regulations. 
Submit comments on this guidance at any time.  Submit electronic comments to 
https://www.regulations.gov.  Submit written comments to the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD  
20852.  All comments should be identified with the docket number FDA-2010-D-0241. 
For further information regarding this document, contact AskCVM@fda.hhs.gov. 
Additional copies of this guidance document may be requested from the Policy and Regulations 
Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish 
Place, Rockville MD 20855, and may be viewed on the Internet at https://www.fda.gov/animal-
veterinary, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
http://www.regulations.gov. 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine (CVM) 
January 2024
    Contains Nonbinding Recommendations 
 
Table of Contents 
 
I.  Purpose .................................................................................................................................. 1 
II.  Background ........................................................................................................................... 2 
III.  Guidance and Instructions ................................................................................................... 3 
1.  Guidance for Completing Form FDA 1932 ................................................................. 3 
2.  Instructions for Completing Form FDA 1932 ............................................................. 4 
PART A  ADMINISTRATIVE AND IDENTIFICATION INFORMATION ...................... 4 
A.1 Regulatory Authority (RA) (Open Ended Text) ..................................................... 4 
A.2 Marketing Authorization Holder (MAH) ................................................................ 5 
A.3 Person(s) Involved in the AER .................................................................................. 5 
A.4 AER Information ....................................................................................................... 6 
PART B  DESCRIPTION OF THE AE .................................................................................. 10 
B.1 Animal Data .............................................................................................................. 10 
B.2 VMP(s) Data and Usage ........................................................................................... 16 
B.3 Adverse Event Data .................................................................................................. 29 
B.4 Dechallenge-Rechallenge Information ................................................................... 34 
B.5 Assessment of AE ..................................................................................................... 35 
B.6 Report Number(s) of Linked Report(s) .................................................................. 35 
B.7 Supplemental Documents ........................................................................................ 36 
B.8 HL7 ICSR Wrapper Data Elements ....................................................................... 36 
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Data Elements for Submission of Veterinary Adverse Event Reports 
to the Center for Veterinary Medicine1 
 
Guidance for Industry 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA 
or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page. 
 
I.  Purpose 
The purpose of this guidance is to assist applicants (referred to as Marketing Authorization 
Holder (MAH) in this guidance) and nonapplicants with filling out Form FDA 1932, Veterinary 
Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.  As required by Food 
and Drug Administration (FDA) regulations at 21 CFR 514.80, an applicant must report adverse 
drug experiences2 (ADEs) and product/manufacturing defects on Form FDA 1932.  Firms named 
on the label as a manufacturer, packer, or distributor may also use this form. 
As part of FDAs ongoing effort to harmonize the Agencys adverse event (AE) regulatory 
reporting data elements with those of other nations as well as streamline reporting for product 
and manufacturing defects, FDA revised Form FDA 1932.3  The changes to Form FDA 1932 are 
the product of discussions undertaken between the United States, Japan, and the European Union 
as part of the International Cooperation on Harmonisation of Technical Requirements for 
Registration of Veterinary Medicinal Products (VICH).  FDA revised Form FDA 1932 to bring 
the AE reporting data elements on the form more in line with the data elements developed as a 
result of the VICH discussions.4  In addition, the Agency has included new data elements to 
gather information specific only to the FDA.  This information will enable FDA to process and 
review electronic and paper reports. 
This document is intended to provide guidance on how to complete Form FDA 1932.  Form FDA 
 
1 This title harmonizes this guidance, to the extent consistent with FDA regulations, with the International 
Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products 
(VICH) guideline, Pharmacovigilance of Veterinary Medicinal Products Data Elements for Submission of Adverse 
Event Reports (VICH GL42) but identifies it as having some FDA-specific application.  Certain terms, such as 
Marketing Authorization Holder (MAH) and Veterinary Medicinal Product (VMP) originate from this 
harmonization. 
2 The terms adverse drug event and adverse drug experience may be used interchangeably. 
3 On November 20, 2009, FDA published a notice in the Federal Register (74 FR 60265) announcing its intention to 
revise Form FDA 1932, among other things.  The notice gave the public an opportunity to comment on proposed 
data elements to be included on a revised version of Form FDA 1932.  Form FDA 1932 was revised January 2010 
(OMB Control No. 0910-0645) and again in January 2013 (OMB Control No. 0910-0645).  
4 This guideline (VICH GL42) is available at http://www.vichsec.org/ (accessed September 26, 2023). 
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1932 can be completed as follows: 
  by filling out the paper form as described in 21 CFR 514.80(d); 
  through the Rational Questionnaire5; or 
  through the FDA Electronic Submissions Gateway (ESG) for gateway-to-gateway 
reporting.6 
This guidance document is not intended to provide guidance on how to electronically transmit the 
Form FDA 1932 to FDA.  FDA intends to provide additional guidance on the electronic 
transmission of the information in a separate document.  If you need additional information for 
appropriate transmission of the information based on the FDA electronic transmission standard, 
please refer to Guidance for Industry #108, How to Register with the CVM Electronic 
Submission System to Submit Information in Electronic Format using the FDA Electronic 
Submissions Gateway.  Furthermore, this guidance does not address voluntary reporting on 
Form FDA 1932a. 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required. 
II.  Background 
Section 512(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(l)) 
requires applicants to establish and maintain records and make such reports of data relating to 
experience with uses and other data or information received or obtained by the applicant with 
respect to such drug as required by regulation or order.  Section 514.80(b) (21 CFR 514.80(b)) of 
FDA regulations requires applicants of approved new animal drug applications (NADAs) and 
approved abbreviated new animal drug applications (ANADAs) to report ADEs and product and 
manufacturing defects.  In addition, nonapplicants, defined at 21 CFR 514.3 as any person other 
than the applicant whose name appears on the label and who is engaged in manufacturing, packing, 
distribution, or labeling of the product, must report ADEs to the applicant but may also report 
them to the FDA (see section 21 CFR 514.80(b)(3)).  This continuous monitoring of approved 
NADAs and ANADAs affords the primary means by which FDAs Center for Veterinary 
Medicine (CVM) obtains information regarding potential problems with the safety and 
effectiveness of marketed approved new animal drugs as well as potential product/manufacturing 
problems. 
 
5 The Rational Questionnaire is a user-friendly, web-based questionnaire that displays a series of questions to be 
answered by the person submitting the report.  These questions are intended to ensure proper collection of the 
information that is needed by FDA to appropriately evaluate the reported incident.  The Rational Questionnaire is 
part of the FDA-National Institutes of Health Safety Reporting Portal (the Safety Reporting Portal). 
6 The third option for submission, gateway-to-gateway electronic transmission, collects the same information as in 
Form FDA 1932 and is an acceptable method for electronic report submission. 
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CVM relies on adverse event reports (AERs) to facilitate a determination under section 512(e) of 
the FD&C Act (21 U.S.C. 360b(e)) as to whether there may be grounds for suspending or 
withdrawing approval of the NADA or ANADA (21 CFR 514.80(a)(3)).  In addition, the 
information contained in veterinary AERs assists CVM in working with firms to minimize ADEs 
due to manufacturing problems; previously unidentified or uncommon side effects; and off-label 
(also known as extralabel) use of animal drugs. 
  Manufacturing/product defect cases must be reported as a Three-day NADA/ANADA 
Field Alert Report if they may result in serious adverse drug events (see 21 CFR 
514.80(b)(1)). 
  Adverse drug event cases must be reported as a Fifteen-day NADA/ANADA Alert Report 
if they are serious and unexpected (see 21 CFR 514.80 (b)(2)).   
  If the manufacturing/product defect is associated with a serious and unexpected adverse 
drug event, the applicant must submit a Fifteen-day NADA/ANADA Alert. 
  All other adverse drug events and manufacturing/product defects should be submitted in a 
periodic report as described in 21 CFR 514.80 (b)(4)(iv).  
   If a nonapplicant elects to report directly to FDA (after forwarding reports of ADEs to 
the applicant within 3 days after receiving information about the event), the nonapplicant 
should submit the report on Form FDA 1932, pursuant to 21 CFR 514.80(b)(3).  
III.  Guidance and Instructions 
1.  Guidance for Completing Form FDA 1932 
Under FDA regulations, Form FDA 1932 must be used for the reporting of ADEs and 
product/manufacturing defect(s) (see 21 CFR 514.80(d)).  The paper and electronic versions of 
Form FDA 1932 contain data elements necessary for us to process and access the report.  
However, not every data element will be applicable for every report.  For example, if the ADE 
only involved a human, there may not be a data entry for data elements asking about the animal 
involved (i.e., breed, production class, reproductive status of the animal, etc.). 
Complete all applicable data elements if the information is available.  The data elements that are 
required to be filled out by everyone are marked on Form FDA 1932 with a single asterisk.  
Although there are data elements that are not marked with an asterisk, we strongly encourage 
you to submit that information, because it will help FDA process and review the report.  It is 
expected that all available information supplied by the reporter will be provided to CVM.  FDA 
has indicated which data elements are minimum requirements for acceptance of the ADE report 
as follows: 
  The required elements for the paper form are indicated on the paper form itself; 
  The required data elements for the gateway-to-gateway electronic transmissions are 
indicated in the technical specification documents; and   
  The required data elements for the web-based Rationale Questionnaire are indicated on 
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the screen during data entry and also through software functionality (e.g., upon 
submission of the report, the system will notify the reporter if a required field is 
empty). 
According to 21 CFR 514.80(b)(1), the applicant must submit a three-day NADA/ANADA field 
alert report providing information pertaining to product and manufacturing defects that may 
result in serious ADEs.  The three-day NADA/ANADA field reports must be sent to the 
appropriate FDA District Office or local FDA resident post.  The information may be provided 
by telephone or other telecommunication means, with prompt written followup.  The requirement 
to provide written followup can be satisfied by: 
  submitting the three-day NADA/NADA field alert report directly to the appropriate FDA 
District Office or local resident post using the paper version of Form FDA 1932;  
OR  
  submitting the three-day NADA/NADA field alert report directly to FDA CVM using the 
web-based Rational Questionnaire or gateway-to-gateway electronic submission and 
entering the appropriate FDA District Office or local resident post on the form in B.2.6.5, 
Office of Regulatory Affairs (ORA) District Field Office.  FDA automatically shares 
reports submitted through the web-based Rational Questionnaire or gateway-to gateway 
electronic submission with the FDA District Office or local resident post listed in the 
report. 
2.  Instructions for Completing Form FDA 1932  
Type or print all entries in a font no smaller than 8 point. 
Complete all fields if the information is available. 
The values and codes for the lists of categories will be specified in FDA technical specification 
for electronic transmission and can be obtained from the CVM Veterinary Adverse Event 
Reporting for Manufacturers webpage. 
The values for U.S. state codes and country code can be found under Supporting Documents in 
the FDA CVM Vocabularies for HL7 GL42.  
Electronic submissions require a compliant .xml format to avoid rejection of the submission.  Do 
not use any special symbols, such as single or double quotation marks and ampersands, in the 
free text fields.  Do not include any accent marks, such as o, n, e, e, a, C and so on in the free text 
fields. 
PART A  ADMINISTRATIVE AND IDENTIFICATION INFORMATION 
A.1 Regulatory Authority (RA) (Open Ended Text) 
The RA is the government agency or authority to which this AER is to be submitted initially 
based on which RA has the authority to regulate the product. 
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Enter the RA name, street address, city, state/county, mail/zip code, and country (3-character 
country code).  The RA for Veterinary Medicinal Products (VMPs) in the United States is the 
FDA, Center for Veterinary Medicine, entered as follows: 
RA Name:   Food and Drug Administration, Center for Veterinary Medicine 
Street Address:  7500 Standish Place (HFV-199), Room 403 
City:    Rockville 
State/County:  MD 
Mail/Zip Code:  20855 
Country:    USA 
 
A.2 Marketing Authorization Holder (MAH) 
The MAH is the applicant (sometimes referred to as the company or the firm) or the 
nonapplicant (such as the firms distributor).  The MAH is responsible for reporting the AE 
information to the RA who is responsible for regulating the veterinary medicinal product (VMP).  
For purposes of this guidance document, the term veterinary medicinal product has the same 
meaning as new animal drug, as defined in section 201(v) of the FD&C Act, 21 U.S.C. 321(v). 
A.2.1 MAH Information (Open Ended Text) 
Provide the business name, street address, city, state/county, mail/zip code, and country (3-
character country code) of the MAH. 
A.2.2 Person Acting on Behalf of the MAH (Open Ended Text) 
Enter the title, first name, last name, telephone number, fax number, and e-mail address of the 
person acting on behalf of the MAH. 
A.3 Person(s) Involved in the AER 
Enter the name of the veterinarian involved in this AER as one of the reporters, if a veterinarian 
is involved in the AE. 
A.3.1 Primary Reporter (Open Ended Text) 
The primary reporter is the person or organization, as determined by the MAH, who holds or 
provides the most pertinent information related to this AER.   
Provide the last name, first name, telephone number, fax number, e-mail address, business name, 
street address, city, state/county, mail/zip code, and 3-character country code of the individual or 
organization reporting the primary information for this AER. 
If the telephone number, fax number, or e-mail address is not available, leave these fields blank. 
If the reporter requests his/her name not be provided to the FDA, enter Withheld in the Last 
Name field. 
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A.3.1.1 Primary Reporter Category (Code List)   
This field is a list of values regarding the role or involvement of the primary reporter.  For an 
agent acting on behalf of the owner (e.g., horse trainer or pet sitter), choose Animal Owner.  
Choose Patient only when the affected species in the AE is a human.  Only use Physician 
when the affected species in the AE is a human, unless a physician is reporting on an animal. 
Enter a choice from the List of Reporter Categories. 
A.3.2 Other Reporter (Open Ended Text) 
The other reporter, as determined by the MAH, is the person or organization who also possesses 
pertinent information related to this AER.  For example, if the primary reporter is the 
veterinarian, the other reporter may be the animal owner.   
Provide the last name, first name, telephone number, fax number, e-mail address, business name, 
street address, city, state/county, mail/zip code, and 3-character country code of the other 
reporter. 
If the telephone number, fax number, or e-mail address is not available, leave these fields blank. 
If the reporter requests his/her name not be provided to the FDA, enter Withheld in the Last 
Name field. 
A.3.2.1 Other Reporter Category (Code List) 
This field is a list of values regarding the role or involvement of the other reporter.  For an agent 
acting on behalf of the owner (e.g., horse trainer or pet sitter), choose Animal Owner.  Choose 
Patient only when the affected species in the AE is a human.  Choose Physician only when 
the affected species in the AE is a human, unless a physician is reporting on an animal. 
Enter a choice from the List of Reporter Categories. 
A.4 AER Information 
A.4.1 Unique Adverse Event Report Identification Number (Open Ended Text) 
This globally unique AER identification number is designated by the MAH.  It consists of a 3-
character country code, 8-character MAH identifier code, and a unique number assigned by the 
MAH.  If the report originally was sent by an RA, this number may include the RA identifier 
code in place of the MAH identifier code. 
  The country code specifies the country where the AE occurred. 
  MAH identifier code:  This is an 8-character code assigned by each MAH to identify 
itself. 
  Unique number:  This is a number, such as a case number, assigned by the MAH which 
would always allow retrieval of that report, including all of its follow-ups, in all future 
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correspondence regarding the case. 
Enter the unique AER identification number (e.g., USA-GAPINDUS-000001).  If the case has a 
hospital case number or other nonapplicant case number, provide these numbers in the narrative 
B.3.1, Narrative of AE. 
A.4.2 Original Receive Date (Date Field  Day, Month, Year) 
For AERs submitted in accordance with 21 CFR 514.80 (b)(2)(i), (b)(3), and (b)(4)(iv)(A), the 
original receive date is the date of first receipt of information by the MAH responsible for 
reporting the AER to the FDA. 
We interpret receipt of information to include the following factors: 
  An identifiable reporter 
  An identifiable animal(s) or human(s) 
  An identifiable VMP 
  One or more adverse events 
For reports submitted in accordance with 21 CFR 514.80 (b)(1) and (b)(4)(iv)(A), the original 
receive date is the date that the MAH first became aware of the manufacturing/product defect.  
Enter the date that the AER was received by your company.  This date remains the same for 
follow-up or future submissions concerning this AER. 
A.4.3 Date of Current Submission (Date Field  Day, Month, Year) 
Enter the date of the submission of this AER to the RA. 
A.4.4 Type of Report 
A.4.4.1 Type of Submission (Code List) 
This field is a list of values regarding the type of report being submitted to the RA.  Choose the 
values represented by this AER from the List of Type of Submission. 
The Expedited (fifteen-day NADA/ANADA alert report) report provides information on each 
serious, unexpected adverse drug event.  These reports should be submitted on Form FDA 1932 
in accordance with 21 CFR 514.80 (b)(2)(i). 
The Three-Day NADA/ANADA Field Alert Report contains information pertaining to the VMP 
that is the subject of the manufacturing/product defect(s) that may result in serious adverse 
events.  These reports should be submitted on Form FDA 1932 in accordance with 21 CFR 
514.80 (b)(1). 
A Followup adverse event report provides additional information to a previously submitted 
initial AER.  These reports should be submitted on Form FDA 1932 in accordance with 21 CFR 
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514.80 (b)(2)(ii). 
Nullification is a specific type of followup report that describes why the initially submitted 
AER needs to be nullified. 
A Periodic is an adverse event or manufacturing/product defect report included in the Drug 
Experience Report.  These reports should be submitted on Form FDA 1932 in accordance with 
21 CFR 514.80(b)(4). 
A.4.4.2 Reason for Nullification Report (Text) 
If Nullification was chosen in A.4.4.1, Type of Submission, provide a reason for the 
nullification of the report.  The use of Nullification should be reserved for circumstances of 
inappropriate submission, such as mistaken submission to the wrong application.  CVM will 
determine prior to nullifying the report if the reason provided is valid.  CVM may notify the 
MAH if CVM does not agree with the reason for nullification. 
A.4.4.3 Type of Information in Report (Code List) 
This field is a list of values regarding the type of information in the AER.  Choose the value 
represented by this AER from the List of Type of Information. 
SPONTANEOUS REPORTS 
For purposes of this document, a spontaneous report is an AER that is voluntarily reported to the 
MAH for the identification of possible AEs following the use of a marketed VMP(s).  The 
following terms and descriptions can be used for spontaneous reports. 
Safety Issue is a spontaneous report that involves a perceived illness or other injury.  This may 
refer to both animal and human AEs. 
Lack of Expected Effectiveness is a spontaneous report that involves a lack of expected 
effectiveness (LOEE). 
Both Safety Issue and Lack of Expected Effectiveness is a spontaneous report that represents 
both a safety issue and LOEE occurring in the same case. 
NON-SPONTANEOUS REPORTS 
For purposes of this document, a non-spontaneous report is an AER that is reported to the MAH 
for the identification of possible AEs following the use of a marketed VMP(s) in planned studies 
(such as clinical or marketing studies).  The following terms and descriptions can be used for 
non-spontaneous reports. 
Safety Issue (Clinical Studies) is a non-spontaneous report that involves a perceived illness or 
other injury that occurred in a planned study using an approved VMP, regardless of how or why 
the VMP is used. 
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Lack of Expected Effectiveness (Clinical Studies) is a non-spontaneous report that involves a 
lack of expected effectiveness (LOEE) that occurred during a planned study using an approved 
VMP, regardless of how or why the VMP is used. 
Both Safety Issue and Lack of Expected Effectiveness (Clinical Studies) is a non-spontaneous 
report that represents both a safety issue and LOEE that occurred during a planned study using 
an approved VMP, regardless of how or why the VMP is used. 
If the AER is associated with a planned study utilizing an approved VMP, provide the approved 
VMP name in B.2.1, Registered or Brand Name, and the NADA/ANADA number as part of the 
B.2.1.2, Registration Identifier. 
MANUFACTURING/PRODUCT DEFECTS 
The following terms describe an AER where either humans or animals were exposed to the VMP 
that had a manufacturing/product defect and an AE occurred:  
  MANUFACTURING/PRODUCT DEFECT (SAFETY) 
  MANUFACTURING/PRODUCT DEFECT (LOEE) 
  MANUFACTURING/PRODUCT DEFECT (BOTH SAFETY AND LOEE) 
These terms apply to both spontaneous and non-spontaneous reports. 
MEDICATION ERRORS 
Medication errors are defined by the National Coordinating Council for Medication Error 
Reporting and Prevention (NCCMERP) as any preventable event that may cause or lead to 
inappropriate medication use or patient harm while the medication is in the control of the health 
care professional, patient, or consumer.  Such events may be related to professional practice, 
health care products, procedures, and systems, including prescribing; order communication; 
product labeling, packaging, and nomenclature; compounding; dispensing; distribution; 
administration; education; monitoring; and use.7  FDA focuses on medication errors related to 
drug names, labeling and/or packaging of the product. 
There is no CVM regulatory reporting requirement for medication errors.  However, medication 
error reports are of great value to CVM because they can lead to label/package design 
improvements and may point to considerations about the product name and other potential 
sources of error.  Evaluation of these reports is essential in CVM's efforts to protect animal and 
human health. Although there is no specific category for medication errors, such reports may be 
submitted for your convenience under the category of Manufacturing/Product Defect. 
A medication error might be identified without any animal exposure, such as when an error 
almost occurred but was identified and exposure was prevented.  Sometimes animal exposure 
occurs but without an adverse event, and the reporter wishes to alert the MAH to the potential of 
an adverse event.  
 
7 http://www.nccmerp.org (accessed September 26, 2023) 
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Should you voluntarily choose to report a medication error, enter Type of Information as 
follows: 
  If no animals were exposed, or if no adverse event occurred, designate the Type of 
Information as MANUFACTURING/PRODUCT DEFECT WITH NO ADVERSE EVENTS. 
  If an adverse event occurred, designate the Type of Information as 
MANUFACTURING/PRODUCT DEFECT (SAFETY) 
LACK OF EXPECTED EFFECTIVENESS (LOEE) 
A LOEE is considered to be an AE.  Complete Form FDA 1932 in the same manner as a safety 
report.  Include the number of animals treated and affected. 
The Expedited (fifteen-day NADA/ANADA alert report) report provides information on each 
serious, unexpected ADE.  An unexpected ADE is an adverse event that is not listed in the 
current labeling (21 CFR 514.3).  Based on this definition, all LOEE events would be 
unexpected.  Because all LOEE events are considered unexpected, the determination of whether 
it is an expedited or periodic report depends on the seriousness of the AE.  Off-label use for 
indication or species should be reported, as such use often reflects common clinical practice or 
pending supplemental application. 
PART B  DESCRIPTION OF THE AE 
B.1 Animal Data 
Except for B.1.1, Number of Animals Treated, data in Part B relates to the affected animals only.  
In the case of human exposure, conform the descriptive information to patient privacy laws as 
pertinent to the country of occurrence (e.g., Health Insurance Portability and Accountability Act 
Privacy Rule in the United States). 
If the AE concerns a group of animals of the same species, where the variability among the 
animals is reasonably close so that a meaningful assessment of the AE can be made, you can use 
a single Form FDA 1932 to report the information for the group.  A medically appropriate group 
exhibiting similar clinical signs can be included in a single report.  Describe information 
concerning the group in the narrative in B.3.1, Narrative of AE. 
If there is too much variability among animals in the group to allow reasonable assessment of the 
AE, then complete a separate Form FDA 1932 for each animal that does not conform to a group.  
Use a separate Unique AER Identification Number for each of these case reports and provide a 
cross-reference for each by entering the Unique AER Identification Number in the narrative in B.3.1, 
Narrative of AE. 
B.1.1 Number of Animals Treated (Integer Field; 12 Characters) 
This is the number of animals being directly treated by the VMP(s).  This does not include 
animals being indirectly exposed to the use of the VMP(s).  This number represents all animals 
treated, not just those affected by the treatment (as reported in B.1.2, Number of Animals 
Affected). 
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If the actual number is unknown, estimate the number of animals treated.  Report a number 
greater than zero, rather than a percentage, for the number of animals treated. 
When separate reports for each animal are being submitted for an AE involving multiple 
animals, the Number of Animals Treated is the number of animals referred to in the specific 
AER, rather than for the overall AE. 
Provide the number of animals being directly treated by the VMP(s). 
B.1.2 Number of Animals Affected (Integer Field; 12 Characters) 
This is the total number of animals affected by the AE, whether through direct or indirect 
exposure (e.g., treated during pregnancy or lactation, commingled, infectious spread, etc.).  If the 
actual number of affected animals is unknown, estimate the number of animals affected.  Use a 
number greater than zero, rather than a percentage of the number of animals treated.  If the AE 
involved a lack of expected effectiveness, the number of animals affected is greater than zero. 
When separate reports for each animal or animal group are being submitted for an AE involving 
multiple animals, the Number of Animals Affected is the number of animals referred to in the 
specific AER, rather than for the overall AE. 
Since the number of animals affected in the AE represents the total number of animals affected, 
whether by direct or indirect exposure, the number of animals affected may be greater than the 
number of animals treated.  The following are examples: 
1.  A pregnant dog is treated with a VMP.  She has no clinical signs.  Two of her puppies 
have adverse clinical signs.  The number entered in B.1.1, Number of Animals Treated, 
would be 1.  The number entered in B.1.2 would be 2. 
2.  Two cows are treated with a pour-on VMP.  These 2 cows and 7 more cows corralled 
with them experience an adverse clinical sign of a rash.  The number entered in B.1.1, 
Number of Animals Treated, would be 2.  The number entered in B.1.2 would be 9. 
Provide the number of animals adversely affected by the VMP(s).  
 
B.1.2.1 Attending Veterinarians Assessment of Animal Health Status Prior to VMP (Code 
List) 
This field is a list of values regarding the attending veterinarians assessment of the health status 
of the animal(s) involved in the AE prior to their exposure to the VMP.  The definitions of these 
values will be left to the veterinarians medical opinion.  Unknown may be chosen if the 
attending veterinarian does not provide the information, or if there is no attending veterinarian. 
In the case of human exposure, this would be the assessment by the attending physician. 
Choose the value for health status of the animal(s) from the List of Veterinarians Health Status 
Assessment. 
B.1.3 Species (Code List) 
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This field is a list of values regarding the species of animal affected.  Select one species per 
AER.  Choose the value for animal species represented in B.1.2, Number of Animals Affected, 
from the List of Species.  
For AEs involving multiple species, make a separate report for each species and provide a 
description and a cross-reference for each case using the Unique AER Identification Number in 
the narrative in B.3.1, Narrative of AE.  
The species list is not intended to be all-inclusive.  If the species list does not contain a value for 
your animal, choose Other and describe the species in the narrative in B.3.1, Narrative of AE. 
In the case(s) where the affected species in the AE is human, choose human as the species. 
In the case of a hybrid, choose the appropriate Other category from the species list.   
Examples: 
  Wolf/Dog Hybrid, choose Other Canids as the species and Wolf Hybrid as the breed 
  Zebra/Horse Hybrid, choose Other Equids as the species and Equine Hybrid as the 
breed 
B.1.4 Breed (Code List) 
This field is a list of values regarding the breed(s) of animal(s) affected. 
Choose the value for the breed of the animal(s) associated with the species chosen in B.3.1, 
Narrative of AE from the List of Breeds.  
Breed values have not been provided for every species listed in B.3.1, Narrative of AE.  If the 
breed list does not contain a value for your animal, choose Other and describe the breed in the 
narrative in B.3.1, Narrative of AE.  In the case of a human exposure, the breed is not applicable. 
The term (Unspecified) allows identification of breed if the general breed could be identified 
but not the specific one, e.g., Poodle (Unspecified) because it is not known if this is a standard, 
miniature, or toy poodle. 
B.1.4.1 Purebred Information 
The Purebred Information identifies an animal made up of only one breed.  For reports of 
herds with multiple purebred animals of different breeds, report the breed for each animal.  The 
field is repeatable to allow the capture of several breeds in a herd.  
Enter information in the Purebred Information field to identify an animal made up of only one 
breed and choose the correct breed from the Type of Breed list of values. 
B.1.4.2 Crossbred Information 
The Crossbred Information identifies an animal made up of more than one breed. 
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  Contains Nonbinding Recommendations 
 
Enter information in the Crossbred Information and up to three breeds from the Type of Breed 
list of values to describe a crossbred animal. 
Following are examples of how to populate these fields for specific animals of different species 
and breeds: 
  Tennessee Walking Horse: Use B.1.4.1.1 to enter Tennessee Walking Horse (This animal 
is a purebred Tennessee Walking Horse.) 
  Horse of undetermined breeds:  Use B.1.4.2.1 to enter Crossbred Equine/Horse (This 
animal is a crossbred animal but the breed makeup is not known.) 
  Labrador Retriever:  Use B.1.4.1.1 to enter Labrador Retriever (This animal is a purebred 
Labrador Retriever.) 
  Heinz 57 Dog:  Use B.1.4.2.1 to enter Crossbred Canine/Dog (This animal is a 
crossbred animal but the breed makeup is not known.) 
  Labrador Retriever Mix:  Use B.1.4.2.1 to enter Labrador Retriever (This animal is a 
crossbred animal with Labrador Retriever being a known breed but the remainder of the 
breed makeup is not known.)  
  Labrador Retriever/German Shepherd Mix:  Use two fields in B.1.4.2.1 to enter Labrador 
Retriever; German Shepherd (This animal is a crossbred animal composed of at least 2 
breeds with Labrador Retriever and German Shepherd being the known breeds.)  
  Poland China/Tamworth/Landrace:  Use three fields in B.1.4.2.1 to enter Poland China; 
Tamworth; Landrace (This animal is composed of 3 breeds with Poland China, 
Tamworth, and Landrace being the known breeds.) 
  Heinz 57 Cats are identified as Domestic Shorthair, Domestic Mediumhair, or 
Domestic Longhair according to the length of their hair coat.  If the cat has short hair:  
Use B.1.4.2.1 to enter Domestic Shorthair 
  Siamese/Domestic Shorthair Mix:  Use two fields in B.1.4.2.1 to enter Siamese; 
Domestic Shorthair (This animal is a crossbred animal with Siamese and Domestic 
Shorthair being the known breeds.) 
  Persian Mix:  Use B.1.4.2.1 to enter Persian (This animal is a crossbred animal with 
Persian being the known breed but the remainder of the breed makeup is not known.) 
Examples for herds: 
  The herd consists of purebred Angus, Angus/Shorthorn mixes, and 
Charolais/Angus/Shorthorn mixes: 
  Use B.1.4.1.1 to enter Angus; 
o
  Use three fields in B.1.4.2.1 to enter Angus; Shorthorn; Charolais 
o
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  Contains Nonbinding Recommendations 
 
  The herd consists of various types of purebreds but the individual breeds are not known:  
Use B.1.4.1.1 to enter Mixed 
  The herd consists of various types of crossbreds, but their makeup is not known or there 
are a great many different contributing breeds:  Use B.1.4.2.1 to enter Mixed 
B.1.5 Gender (Code List) 
This field is a list of values that describes whether the affected animal(s) is male or female.  
Choose the value for the gender of the animal(s) reported in B.1.2, Number of Animals Affected, 
from the List of Gender. 
Choose Mixed where a group is reported, and the group represents both male and female 
animals.  If Mixed is chosen, describe the gender of the animals involved in the narrative in 
B.3.1, Narrative of AE.  Choose Unknown when the gender is not known for the single animal 
affected or when the gender is not known for all animals in the group.  If Unknown is chosen, 
describe the known gender of any of the animals in the group in the narrative in B.3.1, Narrative 
of AE. 
B.1.6 Reproductive Status (Code List) 
This field is a list of values that describes whether the affected animal(s) is intact or neutered.  
Choose the value for the reproductive status of the animal(s) reported in B.1.2, Number of 
Animals Affected, from the List of Reproductive Status. 
Choose Mixed where group information is reported, and the group represents both intact and 
neutered animals.  If Mixed is chosen, describe the reproductive status of the group in the 
narrative in B.3.1, Narrative of AE.  Choose Unknown when the reproductive status is not 
known for the single animal affected or when the reproductive status is not known for all animals 
in the group.  If Unknown is chosen, describe the known reproductive status of any of the 
animals in the group in the narrative B.3.1, Narrative of AE. 
B.1.7 Female Physiological Status (Code List) 
This field is a list of values that describes the pregnancy and lactation status of the affected 
female animal(s).  Choose the value for the female physiological status of the animal(s) reported 
in B.1.2, Number of Animals Affected, from the List of Female Physiological Status. 
Choose Not Applicable if there are only male animals and/or neutered female animals.  For a 
mixed group of male and female animals, choose the physiological status appropriate for the 
female animals.  If the group has multiple different physiological statuses, choose Mixed and 
describe the physiological status of the group in the narrative in B.3.1, Narrative of AE.  If only 
one of the physiological factors is known, provide the physiological status of the animal in the 
narrative in B.3.1, Narrative of AE.  Choose Unknown if the pregnancy and/or lactating status 
of the animal(s) is not known. 
B.1.8 Weight 
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  Contains Nonbinding Recommendations 
 
This field describes the weight of the animal(s) involved in the AE.  Enter the weight in 
kilograms (kg). 
B.1.8.1 Measured, Estimated, Unknown Weights (Code List) 
This list describes how the weight of the affected animal(s) was determined. 
  Measured  the animal was weighed.  
  Estimated  the animal was not weighed but an estimation of its weight can be made. 
  Unknown  the animals weight is not known. 
If the weight is Unknown, then B.1.8.2, Minimum Weight, and B.1.8.3, Maximum Weight, 
cannot contain a numeric value. 
Choose the value from the List of Precision Categories. 
B.1.8.2  Minimum Weight (Numeric Field) 
This is the minimum weight of the affected animals, or the weight of a single affected animal.  If 
only a single animal is affected, enter its numerical weight in the minimum weight field.  If a 
group of animals is affected, enter the numerical weight of the smallest individual animal or an 
average weight of a subgroup of the smallest animals within the group. 
The field allows no more than 3 places to the right of the decimal and a total of 12 characters 
(which includes the decimal point). 
B.1.8.3 Maximum Weight (Numeric Field) 
This is the maximum weight of the affected animals.  Enter the numerical weight of the largest 
individual animal or an average weight of a subgroup of the largest animals within the group.  
Do not use this field if the case involves only a single animal. 
The field allows no more than 3 places to the right of the decimal and a total of 12 characters 
(which includes the decimal point). 
B.1.9 Age 
B.1.9.1 Measured, Estimated, Unknown Age (Code List) 
This list describes the method used to determine the age of the affected animal(s). 
  Measured  the age of the animal(s) is known. 
  Estimated  the age of the animal(s) is not known, but an estimation of the age can be 
made. 
  Unknown  the age of the animal(s) is not known. 
If the age is Unknown, then B.1.9.2, Minimum Age, and B.1.9.3, Maximum Age, cannot 
  15 
  Contains Nonbinding Recommendations 
 
contain numeric values. 
Choose the value from the List of Precision Categories. 
B.1.9.2 Minimum Age (Numeric Field) 
This is the age of the youngest of the affected animals, or the age of a single affected animal.  If 
only a single animal is affected, enter its numerical age in the minimum age field.  If a group of 
animals is affected, enter the age of the youngest individual animal or an average age of a 
subgroup of the youngest animals within the group to represent the minimum age of the group. 
Enter the numerical minimum age for the animal(s) reported in B.1.2, Number of Animals 
Affected. 
The field allows no more than 2 places to the right of the decimal and a total of 12 characters 
(which includes the decimal point). 
B.1.9.2.1 Minimum Age Units (Code List) 
Choose the time units from the List of Units of Measurement associated with the numerical 
minimum age reported in B.1.9.2, Minimum Age. 
B.1.9.3 Maximum Age (Numeric Field) 
This is the age of the oldest of the affected animals.  For groups of animals, either use the 
numerical age of the oldest individual animal or an average age of a subgroup of the oldest 
animals within the group.  Do not use this field if the case involves only a single animal. 
Enter the numerical maximum age for the animal(s) reported in B.1.2, Number of Animals 
Affected. 
The field allows no more than 2 places to the right of the decimal and a total of 12 characters 
(which includes the decimal point). 
B.1.9.3.1 Maximum Age Units (Code List) 
Choose the time units from the List of Units of Measurement associated with the numerical 
maximum age reported in B.1.9.3, Maximum Age. 
B.2 VMP(s) Data and Usage 
Fields B.2.1, Registered or Brand Name  B.2.5.1, Explanation for Off-Label Use are repeatable 
for each VMP involved in the AE.  Do not combine different VMPs within the same data fields.  
Use the repeatable function to describe each VMP separately. 
Use fields B.2.6.1, Manufacturing Site Identifier Number  B.2.6.5, Office of Regulatory Affairs 
(ORA) District Field Office for AER involving product/manufacturing defects.  
B.2.1 Registered or Brand Name (Open Ended Text) 
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  Contains Nonbinding Recommendations 
 
Specifically, this is the name by which the product is presented by the MAH.  This is known in 
various countries as the Registered, Brand, Proprietary, or Trade Name of the product. 
If the reporting MAH does not own or is not responsible for the VMP, and if the registered or 
brand name(s) is not available, enter Unknown in this field and enter the active ingredient(s) in 
B.2.2.1, Active Ingredient(s). 
For AEs related to more than one VMP held by the reporting MAH, if the primary reporter 
suspects that each may have contributed to the AE, submit separate reports under the 
Registration Identifier for each VMP.  If the primary reporter does not believe the other VMPs 
contributed to the AE, additional reports need not be submitted. 
Provide the complete/entire registered or brand name for the VMP(s) involved in the AE.  
B.2.1.1 Product Code (Open Ended Text) 
The product code is the National Drug Code (NDC) number for U.S. FDA-regulated products.  
This code is a combination of the labeler and product code components of the NDC number.  
The labeler code of the NDC number is a number containing up to 6 digits.  The product code of 
the NDC number is either a 4- or 3-digit number.  Separate the labeler code and product code of 
the NDC number by a dash (-) (e.g., 0123-1234, 0001-1234, 12345-123, or 12367-1234).  
Provide the product code for the VMP(s) involved in the AE. 
B.2.1.2 Registration Identifier (Open Ended Text) 
The registration identifier is a combination of the 3-character country code for the country where 
the VMP is approved, the 8-character RA Identifier Code, and the registration number of the 
VMP involved in the AE.  
  Registration Number:  For FDA-regulated VMPs, the registration number is the 1-
character application/file identifier followed by the 6 numbers assigned by FDA for that 
application/file (e.g., A200999, N199999, I999999). 
The following table lists the 1-character application/file identifiers. 
 
1-CharacterApplication/File 
Application/File Type 
Identifier 
Abbreviated New Animal Drug Application  A 
Generic Investigational New Animal Drug File  J 
Investigational New Animal Drug File  I 
New Animal Drug Application  N 
MUMS Index File  Z 
Unapproved Animal Drug Products  D 
 
Provide the registration identifier (application number) for your VMP(s).  Choose the appropriate 
  17 
  Contains Nonbinding Recommendations 
 
3-character Country Code and the RA Identifier code from the List of 3-Digit Country Codes and 
List of Identifier Codes for Regulatory Authorities, respectively. 
For the VMP(s) for which you are not responsible, provide the registration identifier, if known. 
If the registration identifier cannot be determined due to insufficient information from the 
reporter, enter Cannot Be Determined. 
Domestic Reports (Approved U.S. FDA Products) 
Domestic reports are those AERs that involve an FDA-regulated VMP, regardless of the country 
in which the AE occurs.  
For FDA-approved VMP(s), the registration identifier is the 3-character country code, 8-
character RA Identifier Code, and FDA Application/File Number (e.g., USA-USFDACVM-
N199999, USA-USFDACVM-I999999, USA-USFDACVM-A200999).  Following are some 
examples of domestic reports:  
  An AE occurring in the United States with an FDA-approved VMP. 
  An AE occurring in Germany with an FDA-approved VMP (e.g., U.S. military personnel 
bought the VMP on a military base in Frankfurt). 
  An AE occurring in Japan with an FDA-approved VMP (e.g., Japanese visitor bought 
VMP in Hawaii and used product in Tokyo). 
Unapproved Animal Drug Products 
These are veterinary products that are not FDA-approved but that are marketed in the U.S. and 
that are commonly used in veterinary practice.  Some examples include: oral health care 
products, subcutaneous fluids, chemotherapeutic agents, injectable vitamins, and heparin.  If the 
MAH chooses to submit a report for a VMP that is not FDA-approved, we recommend Form 
FDA 1932 be used to submit the report. 
Contact the Pharmacovigilance Liaison in CVMs Division of Veterinary Product Safety at 
CVMAESupport@fda.hhs.gov for a D Number for use as part of the registration identifier to 
which this product would be submitted. 
Foreign Reports  
Foreign reports are those AERs that involve a VMP that is the same as or similar to an FDA-
regulated VMP but that is not the FDA-approved product (i.e., may have different labeling, 
different brand name, etc.).  If the MAH submits a report for a VMP that is the same as or similar 
to an FDA-approved product, we recommend Form FDA 1932 be used to submit the report. 
  Same pharmaceutical VMP:  The VMP originates from the same MAH with the same 
active ingredient(s) and formulation as the product approved in the United States.  For 
example, the product has a different name, or the label is in a different language, or the 
product has different indications than the FDA-regulated VMP. 
  18 
  Contains Nonbinding Recommendations 
 
  Example: the FDA-approved VMP named Newcomer is registered with the European 
Medicines Agency as Forthright.  The registration identifier is NLD-EUEMEA00-
xxxxxxxx. 
  Similar pharmaceutical VMP:  The VMP is from the same MAH, containing the same 
active ingredient(s), major excipients with the same or similar pharmaceutical function, 
and at least one common registered species as the product approved in the United States.  
For example, the product has a different strength, formulation, or is a product not 
approved in the U.S. 
Example: the FDA-approved VMP contains the active ingredient at 50 milligrams 
(mg)/milliliter (ml).  The Canadian-approved VMP contains the active ingredient at 70 
mg/ml.  The registration identifier is CAN-CANHCVDD-xxxxx. 
If the registration identifier cannot be determined due to insufficient information from the 
reporter, enter Cannot Be Determined. 
B.2.1.3 Anatomical Therapeutic Chemical Vet (ATCvet) Code (Open Ended Text) 
The ATCvet code is an Anatomic Therapeutic Chemical system for the classification of 
substances intended for therapeutic use and can serve as a tool for the classification of VMPs.  
More information about the ATCvet code is available at http://www.whocc.no/atcvet/.  
If your VMP does not have an ATCvet code, you can request it through the website given above.  
Use the free text Unknown in this ATCvet Code text field until your ATCvet code is supplied.  
Please notify CVM of your ATCvet code when it is supplied to you. 
B.2.1.4 Company or MAH (Open Ended Text) 
Provide the name(s) of the company or MAH that owns the VMP(s) involved in the AE.  
B.2.1.5 MAH Assessment (Open Ended Text) 
This is the assessment by the MAH of the association between the use of the VMP and the AE.  
Each VICH region may have its own requirements for this assessment. 
B.2.1.6 RA Assessment  
B.2.1.6.1 RA Assessment Term (Code List) 
This is the assessment by the RA of the association between the use of the VMP and the AE.  
Each RA may have its own requirements for this assessment. 
Choose a value from the List of RA Assessment Categories. 
B.2.1.6.1.1 Explanation Relating to Assessment (Open Ended Text) 
This is the explanation of the assessment provided by the MAH or the RA about the association 
between the use of the VMP and the AE. 
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  Contains Nonbinding Recommendations 
 
Enter the explanation of the assessment provided by the MAH or the RA.  
B.2.1.7 Route of Exposure (Code List) 
This is the route by which the VMP was administered.  Field B.2.1.7, Route of Exposure, and 
subfields are repeatable for each route of exposure for any given VMP. 
Choose from the List of Route of Exposure the route of exposure for the VMP(s). 
B.2.1.7.1 Dose per Administration 
This is the actual dose administered to the animal involved in the AE.  Field B.2.1.7.1, Dose per 
Administration, and subfields are repeatable if different doses of the VMP are given over time. 
The denominator field allows description of the dose recipient on the basis of an individual 
animal or enclosure in a herd situation, rather than requiring complicated calculation of an 
average dose based on the weight of the animals. 
Complex situations, such as premixes for multiple animals, should be described in the narrative. 
B.2.1.7.1.1 Numeric Value for Dose (Numerator) (Numeric Field) 
This is the quantity/volume of the actual dose given, e.g., number of tablets, number of boluses, 
amount of feed, quantity of solution, etc.  For example, the veterinarian gives the animal 10 ml of 
the VMP, which has strength of 13 milligrams (mg)/ml (as reported in B.2.2.1.1, Numeric Value 
for Strength (Numerator)  B.2.2.1.1.1, Units for Numeric Value for Strength (Numerator)).  The 
numeric value reported in this field would be 10. 
Enter the numeric value for the dose administered. 
(The field allows no more than 4 places to the right of the decimal and a total of 12 characters 
(which includes the decimal point). 
B.2.1.7.1.1.1 Units of Value for Dose (Numerator) (Code List) 
These are the units that qualify the numeric value for dose. 
Choose from the list of values for List of Units of Measurement or List of Units of Presentation 
the unit associated with the numeric value for dose entered in B.2.1.7.1.1, Numeric Value for 
Dose (Numerator). 
B.2.1.7.1.2 Numeric Value for Dose (Denominator) (Numeric Field) 
This describes the recipient of the dose by individual animal, weight, volume, etc.  
The field allows no more than 4 places to the right of the decimal and a total of 12 characters 
(which includes the decimal point)). 
B.2.1.7.1.2.1 Units of Value for Dose (Denominator) (Code List) 
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  Contains Nonbinding Recommendations 
 
These are the units that qualify the numeric value for dose. 
Choose from the list of values for List of Units of Measurement or List of Units of Presentation, 
or Dose Denominator Qualifiers the unit associated with the numeric value for dose entered in 
B.2.1.7.1.2, Numeric Value for Dose (Denominator). 
Examples of how to enter information for Dose and Dose Unit: 
1.  The owners give 3 tablets to their dog. 
Numeric value for dose (numerator)      3 
Units of value for dose (numerator)      tablets 
Numeric value for dose (denominator)      1 
Units of value for dose (denominator)      animal 
2.  The veterinarian gives each animal in the herd 10 ml of the VMP per kg of body 
weight. 
Numeric value for dose (numerator)      10 
Units of value for dose (numerator)      ml 
Numeric value for dose (denominator)      1 
Units of value for dose (denominator)      kg 
3.  The pond of 100,000 fish is administered a 1-liter container of a 100 mg/L 
strength liquid tetracycline at a dose of 100 mg/1000 L. 
Numeric value for dose (numerator)      1 
Units of value for dose (numerator)      container 
Numeric value for dose (denominator)      1000 
Units of value for dose (denominator)      L 
Or 
Numeric value for dose (numerator)      1 
Units of value for dose (numerator)      L 
Numeric value for dose (denominator)      100,000 
Units of value for dose (denominator)      animals 
4.  A cow is infused with 1 tube of VMP in her right front quarter. 
Numeric value for dose (numerator)      1 
Units of value for dose (numerator)      tube 
Numeric value for dose (denominator)      1 
Units of value for dose (denominator)      quarter 
5.  A goat is infused with 1 tube of VMP in her left mammary gland. 
Numeric value for dose (numerator)      1 
Units of value for dose (numerator)      tube 
Numeric value for dose (denominator)      1 
Units of value for dose (denominator)      teat 
  21 
  Contains Nonbinding Recommendations 
 
B.2.1.7.1.3 Interval of Administration 
This is the frequency of administration of the VMP(s) involved in the AE.  Field B.2.1.7.1.3, 
Interval of Administration, and subfields are repeatable if there are multiple frequencies of 
administration for the same given dose per administration. 
B.2.1.7.1.3.1 Numeric Value for Interval of Administration (Integer Field) 
This is a number that characterizes the frequency of administration of the VMP(s).  Enter the 
numeric value for the interval of administration. 
  Enter the number 1 in B.2.1.7.1.3.1, Numeric Value for Interval of Administration, to 
represent once. 
B.2.1.7.1.3.1.1 Units of Value for Interval of Administration (Code List) 
These are the units that qualify the numeric value of the interval of administration.  Do not use 
this field unless a value is provided in B.2.1.7.1.3.1, Numeric Value for Interval of 
Administration. 
Use the time unit from the List of Units of Measurement) for interval of administration 
associated with the numeric value provided in B.2.1.7.1.3.1, Numeric Value for Interval of 
Administration. 
  If a value is entered for the Numeric Value for Interval of Administration, choose 
Years to represent the situation where the VMP was given only once. 
B.2.1.7.1.3.2 Date of First Exposure (Date Field  Day, Month, Year) 
This field request information regarding the date on which the animal was first treated with the 
VMP.  Enter the Day, Month, and Year for the date of first exposure for each VMP, if 
multiple VMPs are involved in the AE. 
Enter the date on which the animal was first exposed to the VMP.  If the actual day of first 
exposure cannot be supplied, just enter the Month and the Year.  If the month of first 
exposure cannot be supplied, just enter the Year. 
B.2.1.7.1.3.3 Date of Last Exposure (Date Field  Day, Month, Year) 
This is the date on which the animal was last treated with the VMP.  Enter the Day, Month, 
and Year for the date of last exposure for each VMP, if multiple VMPs are involved in the AE.  
If the treatment with the VMP is still ongoing, enter the date the report was received by the 
MAH.  
Enter the date on which the animal was last exposed to the VMP.  If the actual day of last 
exposure cannot be supplied, just enter the Month and the Year.  If the month of last 
exposure cannot be supplied, just enter the Year. 
  22 
  Contains Nonbinding Recommendations 
 
Examples of how to enter information for Interval of Administration Fields and Exposure 
Dates: 
1.  A tablet given once on August 1, 2006, is entered as follows: 
  Enter the number 1 in B.2.1.7.1.3.1, Numeric Value for Interval of Administration, 
to represent once.  Choose the unit years for B.2.1.7.1.3.1.1, Units of Value for 
Interval of Administration.  The per is understood and does not need to be entered.   
  Enter the day 01 in the day field of B.2.1.7.1.3.2, Date of First Exposure. 
  Enter the month 08 in the month field of B.2.1.7.1.3.2, Date of First Exposure. 
  Enter the year 2006 in the year field of B.2.1.7.1.3.2, Date of First Exposure. 
2.  A tablet given once per day from August 1, 2006, to February 10, 2007, is entered as 
follows: 
  Enter the number 1 in B.2.1.7.1.3.1, Numeric Value for Interval of Administration, 
to represent once.  Choose the unit day for B.2.1.7.1.3.1.1, Units of Value for 
Interval of Administration.  The per is understood and does not need to be entered.   
  Enter the day 01 in the day field of B.2.1.7.1.3.2, Date of First Exposure. 
  Enter the month 08 in the month field of B.2.1.7.1.3.2, Date of First Exposure. 
  Enter the year 2006 in the year field of B.2.1.7.1.3.2, Date of First Exposure. 
  Enter the day 10 in the day field of B.2.1.7.1.3.3, Date of Last Exposure. 
  Enter the month 02 in the month field of B.2.1.7.1.3.3, Date of Last Exposure. 
  Enter the year 2007 in the year field of B.2.1.7.1.3.3, Date of Last Exposure. 
3.  A tablet given once per day from August 2006 to February 2007, but with unknown 
actual start and end dates, is entered as follows: 
  Enter the number 1 in B.2.1.7.1.3.1, Numeric Value for Interval of Administration, 
to represent once.  Choose the unit day for B.2.1.7.1.3.1.1, Units of Value for 
Interval of Administration.  The per is understood and does not need to be entered.   
  Leave blank the day field of B.2.1.7.1.3.2, Date of First Exposure. 
  Enter the month 08 in the month field of B.2.1.7.1.3.2, Date of First Exposure. 
  Enter the year 2006 in the year field of B.2.1.7.1.3.2, Date of First Exposure. 
  Leave blank the day field of B.2.1.7.1.3.3, Date of Last Exposure. 
  Enter the month 02 in the month field of B.2.1.7.1.3.3, Date of Last Exposure. 
B.2.2 Active Ingredient(s)  
Provide the active ingredient(s) for your VMP(s). 
Fields B.2.2.1, Active Ingredient(s)  B.2.2.1.2, Numeric Value for Strength (Denominator) are 
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  Contains Nonbinding Recommendations 
 
repeatable for each VMP involved in the AE.  In cases where the user has altered the physical 
characteristics of the VMP prior to administration (e.g., mixing VMPs together, diluting the 
VMP, etc.), this field and its subfields are to be entered with the characteristics of the VMP as 
labeled.  In such cases, leave B.2.1.7.1, Dose per Administration blank and describe the dose 
administered in the narrative in B.3.1, Narrative of AE. 
B.2.2.1 Active Ingredient(s) (Open Ended Text) 
For VMP(s) where the reporting MAH does not own or is not responsible for the VMP(s), 
provide brand name(s) in B.2.1, Registered or Brand Name, or active ingredient(s) in B.2.2.1, 
Active Ingredient(s). 
Provide the active ingredient(s) for your VMP(s). 
B.2.2.1.1 Numeric Value for Strength (Numerator) (Numeric Field) and 
B.2.2.1.2 Numeric Value for Strength (Denominator) (Numeric Field) 
Strength is the concentration of the active pharmaceutical ingredient of the VMP(s) involved in 
the AE and is a ratio of the active pharmaceutical ingredient (numerator) to the units of the 
product (denominator) and is reported as a ratio of the 2 quantities.  Complete the information 
for both the numerator and denominator. 
Provide the numeric strength of the active ingredients for the VMP(s) for which the reporting 
MAH is responsible based on the labeled, approved strength.  Report the strength and its 
associated strength unit for each active ingredient in the VMP.  If the strength administered was 
not the concentration as labeled on the product, provide a description of the strength of the active 
ingredient(s) in the narrative in B.3.1, Narrative of AE. 
For VMP(s) for which the MAH is not responsible, provide the labeled, approved strength, if 
known.  If the strength is not known, enter 1 Unknown for the Strength and Strength Unit of 
both the Numerator and the Denominator. 
Report terms typically used to describe premixes, such as parts per million (ppm) or grams 
(g)/ton, as g/kg, for example, 100 g/10 kg Type A Medicated Article. 
The field allows no more than 4 places to the right of the decimal and a total of 12 characters 
(which includes the decimal point). 
B.2.2.1.1.1 Units for Numeric Value for Strength (Numerator) (Code List) 
For the numeric value of strength (numerator), choose the strength unit from the List of Units of 
Measurement. 
B.2.2.1.2.1 Units for Numeric Value for Strength (Denominator) (Code List) 
For the numeric value of strength (denominator), choose the strength unit from the List of Units 
of Measurement or List of Units of Presentation. 
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Examples of how to enter information for Strength and Strength Unit: 
1.  100 mg active ingredient to 1 kg of product = 100 mg/1 kg 
Numeric value for strength (numerator)    100 
Units of value for strength (numerator)    mg 
Numeric value for strength (denominator)  1 
Units of value for strength (denominator)  kg 
2.  100 mg active ingredient in each tablet = 100 mg/1 tablet 
Numeric value for strength (numerator)    100 
Units of value for strength (numerator)    mg 
Numeric value for strength (denominator)  1 
Units of value for strength (denominator)  Tablet 
3.  The Strength is not known 
Numeric value for strength (numerator)    1 
Units of value for strength (numerator)    Unknown 
Numeric value for strength (denominator)  1 
Units of value for strength (denominator)  Unknown 
B.2.2.1.3 Active Ingredient Code (Code List) 
This is a list of values of the active ingredient substance associated with the unique ingredient 
identifier (UNII) codes.  The UNII code is a non-proprietary, free, unique, unambiguous, non-
semantic, alphanumeric identifier based on a substances molecular structure and/or descriptive 
information.  The UNII code is generated by the joint FDA/United States Pharmacopeia (USP) 
Substance Registration System (SRS). 
Click on the following link for the list of the codes: 
https://www.fda.gov/industry/fda-resources-data-standards/structured-product-labeling-resources 
  Scroll down to SPL Terminology Files for Validation and choose Active Ingredient-
Active Moiety Relationship/Basis of Strength (Excel)  
Provide the AM UNII for your VMP(s) from the list of values. 
If there are multiple UNII codes for the same active ingredient moiety, choose the same code 
used for your product in Structured Product Labeling.8 
B.2.2.2 Dosage Form (Code List) 
This is a list of values of the labeled dosage form of the VMP(s) involved in the AE.  
 
8 Structured Product Labeling (SPL) is the electronic format used by manufacturers to submit content of labeling to 
the FDA for drug establishment registration and drug product listing.  You can find information on SPL at the 
following link:  https://www.fda.gov/industry/fda-resources-data-standards/structured-product-labeling-resources. 
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Choose a value for the labeled dosage form of the VMP(s) involved in the AE from the List of 
Dosage Forms. 
B.2.3 Lot Number (Open Ended Text) 
Enter the lot number of the VMP(s) involved in the AE. 
Use a separate field for each lot number.  Fields B.2.3, Lot Number  B.2.3.1, Expiration Date 
are repeatable if there are multiple lot numbers involved in the AE. 
B.2.3.1 Expiration Date (Date Field  Day, Month, Year) 
Enter the expiration date of the VMP(s) involved in the AE.  If the actual day of expiration 
cannot be supplied, just enter the Month and the Year.  If the month of expiration cannot be 
supplied, just enter the Year. 
B.2.4 Who Administered the VMP(s) (Code List) 
This field is a list of values describing the individual who administered the VMP(s) to the animal 
involved in the AE. 
Choose from the List of Administrators of VMP the role of the person(s) who administered the 
VMP(s).  For an agent acting on behalf of the animal owner, choose Animal Owner.  For an 
agent acting on behalf of the veterinarian, choose Other Health Professional.  In cases where 
multiple people administered the VMP(s) (e.g., the veterinarian administered the VMP at their 
place of business and the animal owner continued the treatment at home), choose Multiple 
Administrators and provide a detailed explanation of each persons role in the narrative in 
B.3.1, Narrative of AE.  Choose Patient for when the affected species in the AE is human and 
for cases where an animal inadvertently exposed itself to the VMP. 
B.2.5 Use According to Label (Code List) 
This is a list of values (Yes, No, or Unknown) describing whether the VMP(s) was used 
according to its labeled recommendations/directions of use. 
Choose Yes if the VMP(s) was used according to its labeled recommendations/directions of 
use.  Choose No if the VMP was used in an off-label use manner.  Choose Unknown if the 
information is not available.  If the VMP was used according to the label, and an AE involving 
human exposure results, choose Yes. 
NOTE CONCERNING SUBMISSION: Choose From This List: Yes, No, Unknown.  
(Boolean/Unknown is a Null Flavor) 
Examples: 
  Human applied topical medication to cat according to label directions and now has a 
headache.  Choose Yes. 
  Human applied topical medication to cat according to label directions but accidentally 
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splashed some on self and now has a skin rash.  Choose Yes. 
  Human accidentally ingested anti-anxiety medication prescribed for dog and now has a 
nervous twitch.  Choose No. 
B.2.5.1 Explanation for Off-Label Use  
Provide information for this field if No was chosen in B.2.5, Use According to Label. 
This field is a series of nine questions used to describe how the VMP was used in an off-label 
manner.  Answer Yes to as many questions as applicable to characterize the manner of off-
label use and provide a description of the off-label use in the narrative. 
NOTE CONCERNING SUBMISSION: Answer options include Yes (Boolean) or NI (No 
Information is a Null Flavor) 
B.2.5.1.1 Was the target species Off-Label 
B.2.5.1.2 Was the route of administration Off-Label  
B.2.5.1.3 Was the animal overdosed 
B.2.5.1.4 Was the animal underdosed 
B.2.5.1.5 Was the treatment regime Off-Label 
B.2.5.1.6 Was the indication Off-Label 
B.2.5.1.7 Was the storage condition Off-Label 
B.2.5.1.8 Was the product expired 
B.2.5.1.9 Was there any other Off-Label issue 
B.2.6 Product/Manufacturing Defect Information 
The fields within this subsection (B.2.6.1, Manufacturing Site Identifier Number  B.2.6.5, 
Office of Regulatory Affairs (ORA) District Field Office) need only be completed for 
product/manufacturing defect AERs.  Fields B.2.6.1B.2.6.5 are repeatable if there are multiple 
manufacturers involved in the AE. 
B.2.6.1 Manufacturing Site Identifier Number (Open Ended Text) 
The manufacturing site identifier number identifies the site where the product/manufacturing 
defect issue occurred. 
Enter the manufacturers 7- to 10-digit FDA Establishment Identifier (FEI Number) or 9-digit 
Data Universal Numbering System (D-U-N-S) Number. 
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B.2.6.1.1 Manufacturers Identifier Type (Code List) 
Identify the Manufacturing Site Identifier Number Type, i.e., whether it is an FEI or D-U-N-S 
Number.  Choose a code from the List of Manufacturer Site Identifiers (US Only). 
B.2.6.2 Manufacturing Date (Date Field  Day, Month, Year) 
The Manufacturing Date is typically set by each individual companys processes and 
documented internally. 
Provide the date the VMP was manufactured. 
B.2.6.3 Number of Defective Items (Numeric Field) 
Provide the number of defective items of the VMP described in the AE, based on the applicable 
retail unit.  For example, if a product is sold as 20 syringes per carton, enter the number of 
defective syringes. 
The field allows no more than 4 places to the right of the decimal and a total of 12 characters 
(which includes the decimal point). 
B.2.6.3.1 Defective Item Units (Code List) 
Choose the unit from the List of Package Types (US Only) associated with the defective items 
from B.2.6.3, Number of Defective Items. 
Examples of how to enter information for Number of Defective Items and Defective Item 
Units: 
1.  The product is sold in bottles.  Twelve bottles in the shipped carton were leaking. 
Number of Defective Items = 12 
Defective Item Units = Bottles 
2.  The product is sold as 100 syringes per carton.  Three cartons were shipped.  
Twenty of the syringes in the shipped cartons arrived crushed. 
Number of Defective Items = 20 
Defective Item Units = Syringes 
B.2.6.4 Number of Items Returned (Numeric Field) 
Provide the number of VMP items returned as described in the AE. For example, if a product is 
sold as 20 syringes per carton, enter the number of syringes returned. 
The field allows no more than 4 places to the right of the decimal and a total of 12 characters 
(which includes the decimal point). 
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B.2.6.4.1 Returned Item Units (Code List) 
For the items reported in B.2.6.4, Number of Items Returned elect the unit type from the List of 
Package Types (US Only). 
Examples of how to enter information for fields, Number of Items Returned, and Returned 
Item Units: 
1.  The product is sold in bottles.  Twelve bottles in the shipped carton were leaking. 
One of the leaking bottles was returned. 
Number of Returned Items = 1 
Returned Item Units = Bottles 
2.  The product is sold as 100 syringes per carton.  Three cartons were shipped.  
Twenty of the syringes in the shipped cartons arrived crushed. All twenty of them 
were returned. 
Number of Returned Items = 20 
Defective Item Units = Syringes 
B.2.6.5 Office of Regulatory Affairs (ORA) District Field Office (Code List) 
This field is a list of values for selecting the ORA District Field Office or local FDA resident 
post to which the product/manufacturing defect information is being submitted for three-day 
NADA/ANADA field alert reports. 
Use the List of ORA District Field Offices (US Only) to provide the office to which the AE is 
being sent. 
B.3 Adverse Event Data 
B.3.1 Narrative of AE (Open Ended Text) 
Provide a detailed narrative description of the AE, including a chronological history that clearly 
identifies relevant information, such as: 
  relevant medical history  
  reason for using the VMP(s) 
  possible contributing factors 
  sites of response 
  severity of response 
  pertinent laboratory and other diagnostic test results 
  treatment of the AE 
  date of death (if applicable) 
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  necropsy results, including accurate description of gross pathology and accurate 
description of histopathologic findings including a pathologists assessment 
  comments on assessments from veterinarian or MAH 
  other significant information pertaining to the adverse event  
If multiple laboratory tests were performed, the results for each relevant test date can be provided 
as an attachment.  Provide a description of all attached documents at the end of the narrative. 
If the AER was generated by a poison control center or other contract organization, provide the 
case number (if available).  If the AER relates to an animal in a clinical or pilot study, provide 
the study number (i.e., approved animal study protocol number). 
For VMP product/manufacturing defect reports, enter a detailed description of:  1) the defect and 
the investigation results; 2) actions taken by the MAH/manufacturer/distributor to address the 
problem, including any corrective actions taken; and 3) any notifications that have been issued to 
alert the vendor/manufacturer to the defect issues. 
B.3.2 Adverse Clinical Manifestations (Code List) 
These fields are lists of values for the clinical signs that occurred during the AE. There are three 
vocabulary lists for use in describing adverse clinical manifestations.  You may choose terms 
from one or more of these lists to most completely and accurately describe the adverse event: 
  VeDDRA Terms 
  FDA CVM Internal Adverse Events Terms (US Only) 
  FDA CVM Internal Product Problem/Medication Error Terms (US Only) 
VeDDRA Terms 
The VeDDRA Vocabulary is the VICH-harmonized list for submission of AE terms.  Refer to 
the VeDDRA9 medical terminology to describe the adverse clinical manifestations.  VeDDRA 
terminology for animal and human AEs is the clinical dictionary used to describe adverse clinical 
manifestations.  
The most current list, as well as the full explanation and Guidance Notes on the Use of VeDDRA 
Terminology for Reporting Adverse Events in Animals, can be downloaded from the European 
Medicines Agency Website.10  
Choose the lowest level term as used in VeDDRA for each adverse clinical manifestation 
observed in the AE.  In the case of human AEs, choose terms designated as H (Exclusively 
Human) or C (Common).  For animal adverse events, choose terms designated as A 
(Exclusively Animal) or C (Common). 
 
9 Veterinary Dictionary for Drug Regulatory Activities 
10 https://www.ema.europa.eu/en/veterinary-regulatory/post-authorisation/pharmacovigilance/eudravigilance-
veterinary (accessed September 26, 2023) 
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FDA CVM Internal Adverse Event Terms (US Only) 
CVM has a list of additional terms used internally to capture adverse clinical manifestations for 
which no term exists in VeDDRA.  Examples include laboratory and pathology terms, as well as 
more specific types of reported lack of expected efficacy (LOEE).  These terms are now 
available for use in AER submission to CVM, should you choose to use them. 
If you prefer not to use the FDA CVM Internal AE Terms when reporting a LOEE, choose Lack 
of Efficacy from the VeDDRA vocabulary and describe the nature of the LOEE in the narrative 
in B.3.1, Narrative of AE. 
FDA CVM Internal Product Problem/Medication Error Terms (US Only) 
CVM has a list of additional terms used internally to describe product problems, as such terms 
do not exist in VeDDRA.  Examples include problems related to manufacturing and shipping, as 
well as terms used to describe medication errors.  These terms are now available for use in AER 
submission to CVM, should you choose to use them. 
If you prefer not to use the FDA CVM Internal Product Problem/Medication Error Terms when 
reporting a VMP product/manufacturing defect, choose Product problem and describe the 
nature of the defect in the narrative in B.3.1, Narrative of AE. 
B.3.2.1 Number of Animals (Integer Field) 
Please make a reasonable attempt to provide the number of animals affected per clinical sign.  
When only percentages have been made available, convert this percentage into an integer and 
insert this value into B.3.2.1.  The way in which the MAH arrives at the integer should be 
provided in the narrative in B.3.1, Narrative of AE.  If the reporting party cannot or will not 
provide an integer value or a percentage estimate, please describe in the narrative. 
B.3.2.1.1 Accuracy of the Number of Animals (Code List) 
If a value is entered in B.3.2.1, Number of Animals, please indicate whether the integer provided 
under B.3.2.1 is an actual or estimated number.  Choose a value from the List of Accuracy of the 
Number of Animals. 
B.3.3 Date of Onset of AE (Date Field  Day, Month, Year) 
Enter the date of onset of the AE.  If the actual date is unknown, enter the approximate date 
information using the reporters description in the B.3.4, Length of Time Between Exposure to 
VMP and Onset of AE and B.2.1.7.1.3.2, Date of First Exposure.  If the actual day of onset 
cannot be supplied, just enter the Month and the Year.  If the month of onset cannot be 
supplied, just enter the Year. 
B.3.4 Length of Time Between Exposure to VMP(s) and Onset of AE (Code List) 
This field is a list of values for the length of time between the first exposure to the VMP and the 
onset of the AE.  For cases where there is a clear time relationship between the administration of 
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the VMP(s) and the onset of AE(s), choose a value from the List of Exposure and Onset Time.  
When a clear time relationship is difficult to determine, such as for a lack of expected 
effectiveness, choose Unknown from the List of Exposure and Onset Time. 
B.3.5 Duration of the AE 
This section describes the actual or approximate length of time the AE lasted. 
B.3.5.1 Duration (Numeric Field) 
This is the numeric value for the duration of the AE.  For example, if the AE lasted 3 days, enter 
3 in this field.  If the AE is ongoing, enter the number based on the onset date entered in B.3.3, 
Date of Onset of AE, and the date entered in A.4.2, Original Receive Date.  In the case of the 
animals death, this field is not applicable. 
Enter the numeric value for the duration of the AE. 
The field allows no more than 4 places to the right of the decimal and a total of 12 characters 
(which includes the decimal point). 
B.3.5.1.1 Duration Time Units (Code List) 
This is a list of values for the unit associated with the numeric value for duration specified in 
B.3.5.1, Duration.  For example, if the AE lasted 3 days, choose Days. 
Choose the time units from the List of Units of Measurement associated with the numeric value 
for duration specified in B.3.5.1, Duration. 
B.3.6 Serious AE (Code List) 
This is a list of values (Yes or No) characterizing the seriousness of the AE. 
Serious, as used in this document, means the AE was serious according to the following 
definition in FDA regulations at 21 CFR 514.3: 
Serious adverse drug experience is an adverse event that is fatal, or life-threatening, or requires 
professional intervention, or causes an abortion, or stillbirth, or infertility, or congenital anomaly, 
or prolonged or permanent disability, or disfigurement. 
Choose Yes or No to answer whether or not the AE was serious. 
NOTE CONCERNING SUBMISSION: Choose From This List: Yes, No (Boolean) 
B.3.7 Treatment of AE (Code List) 
This is a list of values (Yes, No, or Unknown) describing whether or not the human or animal 
affected received treatment in response to the AE (e.g., pharmacological, physical rehabilitation, 
diet, etc.). 
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NOTE CONCERNING SUBMISSION: Choose From This List: Yes, No, Unknown.  
(Boolean/Unknown is a Null Flavor) 
Select whether there was treatment for the AE.  If the human or animal involved in the AE was 
treated, describe the treatment and the outcome from such treatment in the narrative in B.3.1, 
Narrative of AE. 
B.3.8 Outcome to Date (Integer Field - B.3.8.1  B.3.8.6) 
This is the medical status of the animal(s) affected in the AER at the time the AE is 
reported to the RA.  Fields B.3.8.1, Ongoing  B.3.8.6, Unkown list the possible 
outcomes experienced by animals affected by the AER.  In each field, enter the number 
of animals that experienced the listed outcome.  The total number of animals entered in 
fields B.3.8.1  B.3.8.6 should equal the number entered in B.1.2, Number of Animals 
Affected.  We recommend that you do not enter percentages in these fields for group 
reports.  
Determine and enter the number of animals for each of the categories below.  If there are 
no animals represented by a given category, enter 0. 
B.3.8.1 Ongoing 
Enter the number of animals described in the AER with ongoing clinical manifestations. 
B.3.8.2  Recovered/Normal 
Enter the number of animals described in the AER that have recovered or returned to normal 
health. 
B.3.8.3  Recovered with Sequela  
Enter the number of animals described in the AER that have recovered but are left with an 
altered health status. 
B.3.8.4 Died  
Enter the number of animals described in the AER that died (not including those that have been 
euthanized). 
B.3.8.5 Euthanized 
Enter the number of animals described in the AER that were euthanized. 
B.3.8.6  Unknown 
Enter the number of animals with an unknown outcome. 
B.3.9 Previous Exposure to the VMP (Code List) 
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This is a list of values (Yes, No, or Unknown) describing whether or not the affected 
animal(s) had been exposed to the VMP on a date previous to this AER.  This field 
applies only to exposures outside the dates mentioned in B.2.1.7.1.3.2, Date of First 
Exposure, and B.2.1.7.1.3.3, Date of Last Exposure.  
Select whether there was previous exposure to the VMP.  If there was a previous 
exposure to the VMP, choose Yes and provide the dates of the previous exposure in the 
narrative in B.3.1, Narrative of AE.  Choose No if there was no previous exposure.  
Choose Unknown if the information was not available from the reporter. 
NOTE CONCERNING SUBMISSION: Choose From This List: Yes, No, Unknown.  
(Boolean/Unknown is a Null Flavor) 
B.3.10 Previous AE to the VMP (Code List) 
This is a list of values (Yes, No, Unknown, or Not Applicable) describing whether or not 
the affected animal(s) experienced an AE when exposed to the VMP on a date previous 
to this AER.  
This field refers only to clinical manifestations identified during a previous exposure to 
the VMP. 
Select whether there was a previous AE to the VMP.  Choose Yes if there was a 
previous AE and No if there was not a previous AE to the VMP.  If Yes is chosen, 
describe the clinical signs of the previous AE in the narrative in B.3.1, Narrative of AE.  
Choose Unknown if the information was not available from the reporter.  Choose Not 
Applicable if there was no previous exposure, i.e., if No was selected in B.3.9, 
Previous Exposure to the VMP. 
NOTE CONCERNING SUBMISSION: Choose From This List: Yes, No, Unknown. 
(Boolean/Unknown is a Null Flavor) 
B.4 Dechallenge-Rechallenge Information 
This section addresses dechallenges or rechallenges related to AEs involving a single 
VMP.  Dechallenge is the removal, withdrawal, or discontinuance of a VMP from the 
animals therapeutic regimen.  Dechallenge also includes a substantial dosage reduction.  
Rechallenge is the reintroduction of a VMP after the occurrence of a positive 
dechallenge.  It also includes a substantial increase in dosage following a previous 
reduction which produced improvement in the clinical manifestations. 
Use the narrative in B.3.1, Narrative of AE to describe dechallenge-rechallenge 
information for multiple VMP AEs. 
B.4.1 Did AE Abate After Stopping the VMP (Code List) 
This is a list of values (Yes, No, Unknown, or Not Applicable) for whether the AE abated 
after stopping the VMP.  Choose a value for whether the AE abated after stopping the 
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VMP.  If the VMP is neither stopped nor re-introduced, choose Not Applicable.  
Choose Unknown if the information was not available from the reporter. 
NOTE CONCERNING SUBMISSION: Choose From This List: Yes, No, Not 
Applicable, Unknown. (Boolean/Not Applicable and Unknown are Null Flavors) 
 B.4.2 Did AE Reappear After Reintroduction of the VMP (Code List) 
This is a list of values (Yes, No, Unknown, or Not Applicable) for whether the AE 
reappeared after re-introduction of the VMP.  Choose a value for whether the AE 
reappeared after reintroduction of the VMP.  If the VMP is neither stopped nor re-
introduced, choose Not Applicable.  Choose Unknown if the information was not 
available from the reporter.  
NOTE CONCERNING SUBMISSION: Choose From This List: Yes, No, Not 
Applicable, Unknown. (Boolean/Not Applicable and Unknown are Null Flavors) 
B.5 Assessment of AE 
B.5.1 Attending Veterinarians Assessment (Code List) 
This is a list that describes the assessment of the attending veterinarian regarding the 
association between the VMP(s) and the AE (where the species affected is not human). 
Choose from the List of Vet Causality Assessment the value that best describes the 
attending veterinarians assessment (if applicable).  Choose No Assessment if a 
veterinarian has not been consulted about the AE.  If the AE was evaluated by a 
physician, the value for the physicians assessment may be entered here and details given 
in the narrative in B.3.1, Narrative of AE. 
B.6 Report Number(s) of Linked Report(s) 
This section should be used to identify reports that warrant being evaluated together, such 
as those for several animals in the same household, a cluster of events in one locality, or 
both a human and an animal adverse event after exposure to the same product. 
B.6.1 Unique Adverse Event Report Identification Number (Open Ended Text) 
Provide the Unique AER Identification Number of linked reports.  Be sure to use the 
format specified in A.4.1, Unique Adverse Event Report Identification Number of this 
Guidance. 
B.6.1.1 Explanation for Linkage (Code List) 
This is a list that describes possible reasons for the linked reports.  Choose from the List 
of Explanation of Linkage the value that best describes the reason these reports should be 
evaluated together. 
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B.7 Supplemental Documents 
The fields in this section can be voluntarily used by the MAH or used by the MAH upon 
request from the RA for additional information on a specific AER.  This section provides 
for the attachment of additional documents containing information relevant to the AE, 
such as medical record, radiology, clinical chemistry reports, newspaper articles, and 
letters. 
If submitting by regular mail in hard copy, affix attachments to the paper form of Form 
FDA 1932.  If submitting a CD, label the CD with the FDA CVM Application/File Type 
Number, the Unique Adverse Event Report Identification Number, and the date (see 
A.4.3) the AER was submitted to the FDAs CVM. 
B.7.1 Attached Document Name(s) (Filename(s) if Electronic) (Open Ended Text) 
Specify the filename of the attached document, including the 3-character document type 
extension, such as:   
  .pdf  Portable document format  
  .jpg, .jpeg  Image file format 
  .tiff  Tagged image file format  
  .wpd  Word processing document format.  
Examples of filenames: 
  Documents for Princess.pdf. 
  Spreadsheet of Princess lab results.pdf 
  Photographs of Princess before and after treatment.jpg 
  Newspaper article about the product.pdf 
Refer to the List of Attached Document Kind for a list of files that are acceptable for 
electronic submission. 
B.7.1.1 Attached Document Type(s) (Code List) 
This is a list of values that describes the type of document that is attached, e.g., medical 
record.  Choose from the List of Document Type(s).  
B.8 HL7 ICSR Wrapper Data Elements 
The following are the data elements to be included in the submission of an electronic report. 
Only sections B.8.2.2.3, Title  B.8.2.2.8, Email; B.8.2.5, Report Identifier; and B.8.2.6, 
Domestic vs. Foreign Report Category are relevant for submission of the paper form. 
 B.8.1 Batch Wrapper 
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B.8.1.1 Batch Number/Identifier 
The Batch Number/Identifier information identifies the collection of reports in this batch as a 
complete submission.  The concatenation of Batch Number/Identifier Root and Extension 
uniquely identifies each batch of reports.  This is comparable to a cover letter identifying a paper 
submission.  It is the senders responsibility to define and assign this identifier, as each batch 
submission should have a unique identifier.  A Batch Number/Identifier should be supplied even 
if only one AER or PPR is within the batch. 
B.8.1.1.1 Batch Number/Identifier  Root (Open Ended Text) 
This is the submitting organizations unique sender identifier.  This data element identifies the 
sender of the AER or PPR message, e.g., the MAH unique ID.  
B.8.1.1.2 Batch Number/Identifier  Extension (Open Ended Text) 
The Batch Number/Identifier Extension is a unique tracking number assigned to a specific batch 
file transmitted by the sender.  The form and format of this element is designated by the creator 
of the batch submission. 
B.8.1.2 Batch Sender 
This information identifies the sender who is responsible for any technical communications 
between FDA CVM and sender regarding the batch submission of the AER or PPR report(s). 
B.8.1.2.1 Batch Sender  Root (Open Ended Text) 
This is the submitting organizations unique sender identifier.  This data element identifies the 
sender of the AER or PPR report. 
B.8.1.2.2 Batch Sender  Extension (Open Ended Text) 
The Batch Sender Extension is a field that contains the senders organization name. 
B.8.1.2.3 Batch Sender  Title (Open Ended Text) 
The Batch Sender Title is a field that contains the title of the sender who is responsible for any 
corresponding communications regarding the submission. 
B.8.1.2.4 Batch Sender  Last name (Open Ended Text) 
The Batch Sender Last name is a field that contains the last name of the sender who is 
responsible for any corresponding communications regarding the submission. 
B.8.1.2.5 Batch Sender  First name (Open Ended Text) 
The Batch Sender First name is a field that contains the first name of the sender who is 
responsible for any corresponding communications regarding the submission. 
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B.8.1.2.6 Batch Sender  Telephone (Open Ended Text) 
The Batch Sender Telephone is a field that contains the telephone of the sender who is 
responsible for any corresponding communications regarding the submission. 
B.8.1.2.7 Batch Sender  Fax (Open Ended Text) 
The Batch Sender Fax is a field that contains the fax of the sender who is responsible for any 
corresponding communications regarding the submission. 
B.8.1.2.8 Batch Sender  e-mail (Open Ended Text) 
The Batch Sender e-mail is a field that contains the e-mail of the sender (or an equally functional 
group e-mail address) who is responsible for any corresponding communications regarding the 
submission. 
B.8.1.3 Batch Receiver (Open Ended Text) 
The Batch Receiver information identifies the receiver of the batch report.  The Batch 
Receiver of the report will be USFDA. 
B.8.1.3.1 Batch Receiver  Root (Open Ended Text) 
This is the submitting organizations unique receiver identifier.  This data element identifies 
the receiver of the AER or PPR report.  This will be the USFDA. 
B.8.1.3.2 Batch Receiver  Extension (Open Ended Text) 
The Batch Receiver Extension is a field that contains the organization name.  This will be the 
US Food and Drug Administration. 
B.8.1.4 Date of Batch Creation (Date Field) 
The Date of Batch Creation indicates the date the batch report is created. 
B.8.1.5 VICH AER Version Number (Open Ended Text) 
The VICH AER Version Number indicates the AER Message Version and Release Number on 
which this batch is based, currently VICHAER1.0.0. 
B.8.2 Transmission Wrapper 
B.8.2.1 Message Number (Open Ended Text) 
The Message Number information identifies each individual report from any other report that the 
sender submits.  The concatenation of Message Number Root and Extension uniquely identifies 
each report.  The message creator should ensure that this uniquely assigned identifier will never 
be used in another report.  It is the senders responsibility to define and assign this number, as 
each report should have a unique number. 
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B.8.2.1.1 Message Number  Root (Open Ended Text) 
The Message Number Root is the submitting organizations unique sender identifier.  This data 
element identifies the sender of the AER or PPR report, e.g., the MAH unique ID. 
B.8.2.1.2 Message Number  Extension (Open Ended Text) 
This data element is a field that contains the uniquely assigned identifier for the specified report 
(this is not the Unique Adverse Event Report Identification Number).  Each submitted message 
should have a unique identifier assigned regardless of the Type of Submission.  This field format 
is up to the creator of the report. 
B.8.2.2 Pharmacovigilance Contact Person for the MAH (Message Sender) 
This section includes fields to enter information about the person within the United States 
who is acting on behalf of the MAH and is the contact person for the FDA for any 
Pharmacovigilance issues about the report. 
B.8.2.2.1 Message Sender  Root (Open Ended Text) 
This is the submitting organizations unique sender identifier.  This data element identifies the 
sender of the AER or PPR report, e.g., the MAH unique ID.  However, this sender identifier can 
be different from the responsible MAH if the Pharmacovigilance Contact Person is a contractor 
of the MAH.  If so, the sender identifier should be the contractors unique sender identifier. 
B.8.2.2.2 Message Sender  Extension (Open Ended Text) 
The Message Sender Extension is a field that contains the organization name of the message 
sender who is defined as the Pharmacovigilance Contact Person in charge of the AER or PPR 
report. 
B.8.2.2.3 Title (Message Sender  Title) (Open Ended Text) 
The Message Sender Title is a field that contains the title of the message sender who is defined 
as the Pharmacovigilance Contact Person in charge of the AER or PPR report. 
B.8.2.2.4 Last Name (Message Sender  Last name) (Open Ended Text) 
The Message Sender Last name is a field that contains the last name of the message sender who 
is defined as the Pharmacovigilance Contact Person in charge of the AER or PPR report. 
B.8.2.2.5 First Name (Message Sender  First name) (Open Ended Text) 
The Message Sender First name is a field that contains the first name of the message sender who 
is defined as the Pharmacovigilance Contact Person in charge of the AER or PPR report. 
B.8.2.2.6 Telephone (Message Sender  Telephone) (Open Ended Text) 
The Message Sender Telephone is a field that contains the telephone of the message sender who 
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is defined as the Pharmacovigilance Contact Person in charge of the AER or PPR report. 
B.8.2.2.7 Fax (Message Sender  Fax) (Open Ended Text) 
The Message Sender Fax is a field that contains the fax of the message sender who is defined as 
the Pharmacovigilance Contact Person in charge of the AER or PPR report. 
B.8.2.2.8 Email (Message Sender  e-mail) (Open Ended Text) 
The Message Sender e-mail is a field that contains the e-mail of the message sender (or an 
equally functional group e-mail address) who is defined as the Pharmacovigilance Contact 
Person in charge of the AER or PPR report. 
B.8.2.3 Message Receiver 
B.8.2.3.1 Message Receiver  Root (Open Ended Text) 
The Message Receiver Root is a field that contains the receiver of the AER or PPR report, e.g., 
the RA unique ID.  This will be the USFDACVM. 
B.8.2.4 Date of Message Creation (Date Field) 
This is the date on which each report inside the batch was created.  This date can be the same as 
the date of batch creation for electronic transmission. 
B.8.2.5 Report Identifier (Open Ended Text) 
The format for the report identifier is the 1-character application/file identifier followed 
by the 6-number identifier assigned by FDA for that application/file (e.g., A200999).  
The application/file number is the NADA or ANADA number to which the report is 
being sent.  
The following table represents the 1-character application/file identifiers. 
 
1-Character Application/File 
Application/File Type 
Identifier 
Abbreviated New Animal Drug Application  A 
New Animal Drug Application  N 
MUMS Index File  Z 
Unapproved Animal Drug Products  D 
 
The report identifier is the same as the registration number segment in the B.2.1.2, 
Registration Identifier. 
  Registration Number  For FDA-regulated VMPs, the registration number is the 
1-character application/file identifier followed by the 6 numbers assigned by FDA 
for that application/file (e.g., A200999, N199999, I999999). 
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Enter the Report Identifier. 
B.8.2.6 Domestic vs. Foreign Report Category (Code List) 
This field is a list of values for reporting either a U.S.-approved or a non-U.S.-approved 
product that is the same as or similar to a U.S.-approved VMP(s). 
Choose a value from the List of Domestic and Foreign Report Categories. 
Domestic Reports 
Domestic reports are those AERs that involve an FDA-regulated VMP, regardless of the 
country in which the AE occurs. 
Foreign Reports 
Foreign reports are those AERs that involve a VMP that is the same as or similar to an 
FDA-regulated VMP. 
  Foreign  Same [category]:  The VMP originates from the same MAH with the same 
active ingredient(s) and formulation as the product approved in the United States.  For 
example, the product has a different name, or the label is in a different language, or the 
product has different indications than the FDA-regulated VMP. 
  Foreign  Similar [category]:  The VMP is from the same MAH, containing the same 
active ingredient(s), major excipients with the same or similar pharmaceutical function, 
and at least one common registered species as the product approved in the United States.  
For example, the product has a different strength, formulation, or is a product not 
approved in the U.S. 
The following are examples of the different domestic and foreign report categories: 
  Domestic: 
1.  U.S.-approved VMP and AE occurred in the United States 
Report is sent to the FDA 
Report Category = Domestic 
2.  U.S.-approved VMP and AE occurred in Germany (e.g., U.S. military personnel 
purchased product on a military base in Frankfurt) 
Report is sent to the FDA 
Report Category = Domestic 
3.  U.S.-approved VMP and AE occurred in Japan (e.g., Japanese visitor purchased 
product in Hawaii, used in Tokyo) 
Report is sent to the FDA 
Report Category = Domestic 
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  Foreign  Same [category]: 
1.  Germany-approved product and AE occurs in Germany 
Report is sent to the FDA because the MAH has a same VMP approved by 
FDA 
Report Category = Foreign  Same 
  Foreign  Similar [category]: 
1.  Canada-approved product and AE occurs in Canada 
Report is sent to the FDA because the MAH has a similar VMP approved by 
FDA 
Report Category = Foreign  Similar 
B.8.2.7 Profile Identifier (Open Ended Text) 
The Profile Identifier (Profile ID) Code categorizes the details of the report as Adverse Event 
only; Adverse Event and Product Problem; or Product Problem only. 
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