Guidance for Industry
 
How to Complete the Vaccine 
Adverse Event Reporting System 
Form (VAERS-1) 
Comments and suggestions regarding this document may be submitted at anytime to Astrid L. 
Szeto, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 
1401 Rockville Pike, Rockville, MD 20852-1448.  For questions regarding this document, 
contact Dr. Marcel Salive, CBER, Division of Biostatistics and Epidemiology (HFM-220),  (301) 
827-3974. 
Additional copies are available from the Office of Communication, Training and Manufacturers 
Assistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1448, or by calling 
1-800-835-4709 or 301-827-1800, or from the Internet at 
http://www.fda.gov/cber/guidelines.htm 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Biologics Evaluation and Research (CBER) 
September 1998  TABLE OF CONTENTS 
Note: Page numbering may vary for documents distributed electronically. 
I.  INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
 
II.  GENERAL INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
 
III.  SPECIFIC INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
 
IV.  HOW TO OBTAIN FORM VAERS-1 AND INSTRUCTIONS . . . . . . . . . . . . . . . . . . . 9
 
V.  QUESTIONS ABOUT REPORTING?  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
 
VI.  WHERE TO SEND COMPLETED VAERS-1 FORMS  . . . . . . . . . . . . . . . . . . . . . . . 10
 
APPENDIX A:  VAERS ABBREVIATIONS FOR VACCINE TYPE  . . . . . . . . . . . . . . . . . . 11
 
APPENDIX B:  ROUTES OF ADMINISTRATION LIST AND NUMERIC CODES  . . . . . .  13
 
APPENDIX C: FORM VAERS-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
  GUIDANCE FOR INDUSTRY1 
How to Complete the Vaccine Adverse Event Reporting System 

Form (VAERS-1) 

I.  INTRODUCTION 
This guidance for industry has been developed to clarify what information should be obtained 
before an individual case of an adverse experience after immunization should be submitted to the 
Vaccine Adverse Event Reporting System (VAERS).  The Food and Drug Administration (FDA) 
believes that the recommendations in this guidance document will improve the quality of 
postmarketing safety reports and clarify the industry's current safety reporting responsibility to 
assure public health. 
This guidance document should be used in conjunction with the Center For Biologics Evaluation 
and Research (CBER's) Guideline for Adverse Experience Reporting for Licensed Biological 
Products (October 1993) and, ultimately, with any future guidance that supersedes the October 
1993 guideline.  Hard copies of the guidances are available from CBER's Office of 
Communication, Training and Manufacturers Assistance (address above).  Electronic versions of 
these guidances are also available on the Internet at 
http://www.fda.gov/medwatch/report/mfg.htm. 
II.  GENERAL INSTRUCTIONS 
Licensed manufacturers2 of approved vaccines are required to report adverse experiences to the 
FDA under 21 CFR 600.80.  These instructions for completing form VAERS-1 are for use by 
manufacturers for mandatory reporting of  adverse events as designated in the applicable statutes 
and FDA regulations.
   All entries should be typed or printed in a font no smaller than 10 point
   All boxes should be completed 
1This guidance has been prepared by the Epidemiology Branch in the Center for Biologics Evaluation and 
Research (CBER) at the Food and Drug Administration. This guidance represents the Agencys current thinking 
on reporting of certain postmarketing adverse experiences for licensed vaccines. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if 
such approach satisfies the requirement of the applicable statute, regulations, or both. 
2  For purposes of this guidance, the term licensed manufacturer includes manufacturers, packers, 
distributors, shared manufacturers, joint manufacturers, or any other participant involved in divided 
manufacturing.   	  To complete an item when information is not available, use: 
  NA for not applicable 
  NI for no information at this time (but may become available later) 
  UNK for unknown 
	  Dates should be entered as month, day, and year, formatted as MM/DD/YYYY (e.g., 
June 3, 1997 = 06/03/1997).  If exact dates are unknown, provide the best estimate.  If 
day is unknown, month and year is acceptable.  If day and month are unknown, year is 
acceptable. 
	  Times should be reported as hour: minute (hh:mm) with AM or PM specified.  If exact 
time is unknown, estimate AM or PM, if possible. 
	  For narrative entries, if the fields do not provide adequate space, attach an additional 
page(s). 
The following specific information is to be incorporated: 
	  Identify all attached pages as Page __ of __ using the page number and total 
	  Indicate the appropriate  box number and field name next to the narrative 
continuation 
	  Include the phrase continued at the end of each field that has additional 
information continued onto another page 
	  Display the Manufacturer report number (see box 24) in the upper right corner of 
each page, with the VAERS identification number, if known, for follow-up 
reports. 
	  Include the firm's name in the upper right corner, if the report is from a distributor 
or manufacturer 
	  A computer-generated facsimile of the form may be submitted in lieu of the preprinted 
form dependent upon written preapproval by the Division of Biostatistics and 
Epidemiology, Center for Biologics Evaluation and Research, FDA.  It is not necessary 
for this form to be generated front and back like the preprinted form.  Submission of the 
front of the form only is acceptable. 
2
 III. 	 SPECIFIC INSTRUCTIONS 
Patient Name - Provide the patients full name (last name, first name, middle initial).  Information 
identifying the person who received the vaccine or that person's legal representative is required by 
the National Childhood Vaccine Injury Act and will not be made available to the public. 
	  Complete a separate form for each patient 
N.B.: 	 When a newborn baby is found to have a congenital anomaly that the initial reporter 
considers possibly associated with a vaccine administered to the mother during pregnancy, 
the patient is the newborn baby. 
Parent-child/fetus report(s) are those cases in which either a fetus/suckling infant or the mother, 
or both, sustain an adverse event that the initial reporter considers possibly associated with a 
vaccine administered to the mother during pregnancy.  Several general principles are used for 
filing these reports: 
  If there has been NO event affecting the child/fetus, report ONLY on the parent 
  For those cases describing fetal demise or early spontaneous abortion, ONLY a parent 
report is applicable 
  When ONLY the child/fetus has an adverse reaction/event (other than early 
spontaneous abortion/fetal demise), the information in boxes 3, 4, 5, 11, 22 and 23 
applies to the child/fetus, and characteristics concerning the parent who was the source of 
exposure to the vaccine is to be provided in boxes 10, 13, 14, 17, and 18.  
  If BOTH the parent and the child/fetus sustain adverse events, two reports should be 
provided and linked using the narrative (refer to the manufacturer control #s in  box 24) 
N.B.:  Submitted VAERS-1 report forms can be obtained under the Freedom of Information 
(FOI) Act, with patient and reporter identifying information redacted. 
  Thus, when a patient or parent is the reporter, the patient name should be provided in case 
follow-up might be needed, since such information is NOT releasable under FOI. 
However, a company can use the term Consumer-Confidential, provided that should 
FDA request to contact that patient, the information would be made available to FDA. 
Address - Provide the patients current address and telephone number. 
Vaccine Administered by - Provide the name of the health care provider who administered the 
vaccination (not prescribing health care provider, unless it is the same person). 
3
  Responsible physician - Name of prescribing or responsible physician in the health care setting 
where the vaccine was given 
Form completed by - Provide the name, mailing address and phone number of the initial reporter 
(the person who initially reported the adverse event to the manufacturer) who can be contacted to 
provide information on the event if follow up is necessary.  If a report is provided anonymously, 
so indicate. 
1:  State - Provide two-letter postal abbreviation for state where vaccine was administered. 
Use patients home state if state where administered is not known.  Use FR if vaccine 
was not administered in the United States. 
2:  County where administered - Provide full name of county where vaccine was 
administered, if known. 
3:  Date of birth - Enter the patient's birth date, if known; otherwise enter the patient's age at 
the time of vaccination in Box 4. 
4:  Patient age - Provide patients age at time of vaccination.  Identify units as years, months, 
or days. 
  if the patient is 3 years or older, use years (e.g., 4 years). 
  if the patient is less than 3 years old, use months (e.g., 24 months). 
  if the patient is less than 1 month old, use days (e.g., 5 days). 
Provide the best estimate if exact age is unknown.  For example, if age can be estimated as 
18 years or older, code AD for adult; if under 18 years, code PD for pediatric. 
5:  Sex - Check box for the patients gender. 
6:  Date form completed - Enter the date the report is filled out. 
7:  Describe adverse event(s) - Describe the event in detail using the reporter's own words, 
including a description of what happened and a summary of all relevant clinical 
information (signs and/or symptoms; differential diagnosis for the event in question; 
clinical course; treatment; outcome, etc.).  If relevant and  available, include synopses of 
any office visit notes or the hospital discharge summary.  To save time (and if permitted by 
the institution), attach copies of these records. 
  Include a list of adverse event terms that most accurately characterizes the adverse event 
described in this narrative.  List the most important terms first.  The terminology should be 
an accepted standard (e.g., Medical Dictionary for Drug Regulatory Affairs (MedDRA) or 
FDA's Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART)). 
4
  	  The adverse event should at a minimum consist of signs, symptoms, and/or disease 
diagnosis.  If it is initially known only that a patient experienced unspecified injury, 
active investigation should be conducted to obtain more specific information about the 
adverse event before it is submitted.  The only exception occurs with a fatal outcome, 
where the FDA expects manufacturers to submit all reports of patient deaths (outcome) 
even if the causal adverse event is unknown. 
	  Results of relevant tests and laboratory data should be entered in box 12.  Previous and 
concurrent treatments, pre-existing medical conditions and other relevant history belong 
in boxes 14, 17, 18, 19.  (See instructions for those specific boxes). 
8:	  Check all appropriate - Check all boxes that apply. 
Patient Died - Check only if the death was an outcome of the adverse event and include 
the date of death, if known. 
Do NOT check if 
	  the patient happened to die but there was no suspected association between the 
death and vaccine; 
	  a fetus is aborted because of a congenital anomaly, or is miscarried. 
Life-threatening  illness - Check if the patient was at substantial risk of dying at the time 
of the adverse event. 
Required emergency room/doctor visit - Check if an emergency room or physician was 
visited as a result of the adverse event. 
Hospitalization (initial or prolonged) - Check if the adverse event resulted in admission 
to the hospital or prolongation of hospitalization.  Note number of days hospitalized. 
DO NOT check if: 
	  A patient in the hospital received a vaccine and subsequently developed an 
otherwise nonserious adverse event, UNLESS the adverse event prolonged the 
hospital stay 
Resulted in permanent disability - Check if the adverse event resulted in a substantial 
disruption of the persons ability to conduct normal life functions. Such would be the case 
if the adverse event resulted in a significant, persistent or permanent change, impairment, 
damage or disruption in the patients body function/structure, physical activities and/or 
quality of life. 
None of the above - Check only if the other categories are not applicable to the report. 
5
  9:	  Patient recovered - Check status of patient at time form was completed.  Check yes if 
the patients health condition is the same as it was prior to the vaccination, no if the 
patient has not returned to the pre-vaccination state of health. 
10:	  Date of vaccination - Provide date of last vaccination before event. 
11:	  Adverse event onset - Provide date and time of onset of event symptoms following 
vaccination.  If more than one adverse event occurred, provide information for the most 
serious event. 
	  When a newborn baby is found to have a congenital anomaly, the event onset date 
is the date of birth of the child. 
 
	  When a fetus is aborted because of a congenital anomaly, or is miscarried, the 
event onset date is the date pregnancy is terminated. 
If information is available as to time during pregnancy when exposure occurred, 
indicate that information in narrative box 7. 
12:	  Relevant diagnostic tests/laboratory data - Provide all appropriate information, 
including relevant negative test and laboratory findings, in order to convey most 
completely how the medical work-up and assessment led to consideration of vaccine as a 
possible etiology for clinical status, as other differential diagnostic considerations were 
being eliminated.  In addition to providing the laboratory values, identify normal results 
with NL, abnormal results with ABNL or provide the normal range for the 
laboratory.  Standard, unambiguous medical abbreviations should be used; otherwise 
terms should be spelled out. 
Include relevant laboratory data: 
	  Providing baseline prior to the vaccine administration 
	  Used in diagnosing the event 
	  Providing information on the course of the event. 
Also include: 
	  Synopses of any relevant autopsy, pathology, or lab reports 
	  Pre- and post-event levels of concomitant medication and dates (if applicable, such 
as for suspected interactions) 
6
  If preferred, copies of any reports may be submitted as attachments (put a note in this 
box), with all confidential information deleted. 
13:	  Enter all vaccines given on date listed in item 10 - Enter all known vaccines 
administered on that date, regardless of presumption of causal relationship to event. 
Vaccine (type) - Use the abbreviations provided in Appendix A of this guidance.  If 
unknown or if no trade name, use the generic name (with the manufacturers name if 
known).  For foreign reports, use the foreign trade name and the U.S. generic name. 
Lot number - Include the lot number(s) for all vaccines. 
Route/site - Describe how the vaccine was administered to the patient (e.g., IM/rt. leg). 
No. Previous  doses  - Indicate the number of previous doses of each vaccine.  If event 
occurred after a series of several vaccinations (e.g., 3 doses of hepatitis B vaccine), give 
details of prior immunizations in box 14. 
Route of Administration  Code 
Intramuscular  IM 
Oral  PO 
Subcutaneous  SC 
Other  See Appendix B 
14:	  Any other vaccinations within 4 weeks prior to the date listed in item 10 - See 
instructions for box 13.  Also include information regarding any previous injections of a 
vaccine listed in box 13 that were given to an adult patient in a series (e.g., 2 prior doses 
of hepatitis B vaccine). 
15:	  Vaccinated at - Check appropriate box. 
16:	  Vaccine purchased with - Check appropriate box based on how the facility or person 
who administered the vaccine purchased it, not to payment by the patients health 
insurance. 
  Private funds - purchased by the administering facility with private funds 
  Public funds - purchased by state or local health department or the 
Centers for Disease Control and Prevention (CDC) 
  Military funds - purchased by US military. 
17:	  Other medications - List and provide therapy dates for any other medical products 
(drugs, biologics, and medical devices) that a patient was using at the time of the event. 
Include routine medications, prophylactic medications such as over-the-counter (OTC) 
7
  antipyretics, and medications given before the onset of symptoms.  Include tuberculin skin 
test if given on the date of vaccination.  Do NOT include products used to treat the event, 
which should be reported in Box  7. 
18:	  Illness at time of vaccination - Provide information on any short-term illness, condition 
or symptom present at or about the time of vaccination (e.g., cold, fever, ear infection). 
19:	  Pre-existing physician-diagnosed allergies, birth defects, medical conditions - If 
available, provide information on other known physician-diagnosed medical conditions in 
the patient (e.g., asthma, seizure disorder, immunosuppression, etc.) and significant 
historical information (allergies, birth defects, etc.). 
20:	  Have you reported this adverse event previously? - Indicate if the initial reporter has 
also notified the patients physician or health department.  Check To manufacturer if 
another manufacturer has been notified by initial reporter or by reporting manufacturer. 
Otherwise leave blank. 
21:	  Adverse event following prior vaccination - List any suspected adverse events the 
patient, or the patient's brothers or sisters, may have had to previous vaccinations, 
specifying the implicated vaccine, if possible.  If more than one brother or sister, or if the 
patient has reacted to more than one prior vaccine, use additional pages to explain. 
22:	  Birth weight - Provide the patient's birth weight (in pounds and ounces) for children 5 
years of age or younger.  Current weight, if relevant, should be noted in the narrative (Box 
7). 
23:	  No. of brothers and sisters - Provide the number of patient's brothers and sisters, as of 
the date of vaccination, if the patient is 5 years of age or younger. 
24:	  Mfr/imm. proj. report no. - Provide manufacturers name and unique identification 
number for this event.  All follow-up reports should have the same number as the initial 
report. 
25:	  Date received by mfr./imm. proj - Provide the date when the manufacturer received 
adequate information to determine that the adverse event was reportable; namely that a 
patient, vaccine, adverse event, and reporter can be identified.  For follow-up reports, use 
the date that the follow-up information was received. 
26:	  15 Day report? - Check yes if this report meets criteria specified in the biologic 
regulations for reports of serious and unexpected adverse events (21 CFR section 600.80). 
If original report did not meet criteria for an expedited report, indicate date that such 
information was received in narrative summary (Box 7) and/or in cover letter. 
8
  27:	  Report type - Check applicable box. 
Initial - check if the report is the first submission of a report. 
Follow-up - Check if the report is a follow-up to a previously submitted report. 
Follow-up reports should contain information that was submitted in 
the original report if the information is still correct. 
If a follow-up report, make sure that the manufacturer report 
number for the previously submitted initial report has been recorded 
in box 24. 
IV.  HOW TO OBTAIN FORM VAERS-1 AND INSTRUCTIONS 
Copies of Form VAERS-1 can be obtained from: 
VAERS 
P.O. Box 1100
 
Rockville, MD 20849-1100 

Copies of Form VAERS-1 and Instructions may also be obtained by: 
  Mail or fax: Call 1-800-822-7967 
  If no access to 800 number, call (301) 217-9660 
  Internet: http://www.fda.gov/cber/vaers.html 
Copies of blank Form VAERS-1 may also be duplicated by the manufacturer. 
V.  QUESTIONS ABOUT REPORTING? 
Epidemiology Branch (HFM-220),  Attention: VAERS 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

1401 Rockville Pike 

Rockville, MD  20852-1448 

Phone 301-827-3974; fax 301-827-3529. 

9
  VI.  WHERE TO SEND COMPLETED VAERS-1 FORMS 

VAERS 
P.O. Box 1100
 
Rockville, MD 20849-1100 

10
  APPENDIX A:  VAERS ABBREVIATIONS FOR VACCINE TYPE 

N.B.  In addition to vaccines licensed in the U.S., this list includes abbreviations for some 
vaccines not licensed in the U.S., but which have been the subject of VAERS reports 
ADEN  Adenovirus Vaccine Live Oral Type 7 
ANTH  Anthrax Vaccine 
BCG  BCG Vaccine 
CHOL  Cholera Vaccine 
DT  Diphtheria and Tetanus Toxoids Adsorbed Pediatric 
DTAP  Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine 
Adsorbed Pediatric 
DTAPH  Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine 
Adsorbed Pediatric and Hemophilus B Conjugate Vaccine 
DTIPV  Diphtheria and Tetanus Toxoids and Inactivated Polio Virus Vaccine 
DTOX  Diphtheria Toxoid Adsorbed 
DTP  Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed Pediatric 
DTPH  Diphtheria and Tetanus Toxoids and Pertussis and Hemophilus B 
Conjugate Vaccine Adsorbed Pediatric 
DTPIPV  Diphtheria and Tetanus Toxoids and Pertussis Adsorbed Pediatric and 
Inactivated Polio Virus Vaccine 
FLU  Influenza Virus Vaccine 
HBHEPB  Hemophilus B Conjugate Vaccine and Hepatitis B Vaccine 
HEPA  Hepatitis A Vaccine 
HEPB  Hepatitis B Vaccine 
HIBV  Hemophilus B Vaccine 
IPV  Inactivated Polio Virus Vaccine 
JEV  Japanese Encephalitis virus Vaccine Inactivated 
M  Measles Virus Vaccine Live 
MEN  Meningococcal Polysaccharide Vaccine 
MM  Measles and Mumps Virus Vaccine Live 
MMR  Measles, Mumps, and Rubella Virus Vaccine Live 
MR  Measles and Rubella Virus Vaccine Live 
MU  Mumps Virus Vaccine Live 
MUR  Rubella and Mumps Virus Vaccine Live 
OPV    Polio Virus Vaccine Live Oral Trivalent 
P  Pertussis Vaccine 
PLAGUE  Plague Vaccine 
PPV  Pneumococcal Vaccine Polyvalent 
R  Rubella Virus Vaccine Live 
RAB  Rabies Vaccine 
RSV  Respiratory Syncytial Virus Vaccine 
SMALL  Smallpox Vaccine 
11
  TD  Tetanus and Diphtheria Toxoids Adsorbed Adults 
TTOX  Tetanus Toxoid 
TYP  Typhoid Vaccine 
VARCEL  Varicella Vaccine Live 
YF  Yellow Fever Vaccine 
12
  APPENDIX B:  ROUTES OF ADMINISTRATION LIST AND NUMERIC CODES 
Description  ICH-M2 Numeric Codes 
Auricular (otic)  001
Buccal  002
Cutaneous  003
Dental  004
Endocervical  005
Endosinusial  006
Endotracheal  007
Epidural  008
Extra-amniotic  009
Hemodialysis  010
Intra corpus cavernosum  011
Intra-amniotic  012
Intra-arterial  013
Intra-articular  014
Intra-uterine  015
Intracardiac  016
Intracavernous  017
Intracerebral  018
Intracervical  019
Intracisternal  020
Intracorneal  021
Intracoronary  022
Intradermal  023
Intradiscal (intraspinal)  024
Intrahepatic  025
Intralesional  026
Intralymphatic  027
Intramedullar (bone marrow)  028
Intrameningeal  029
Intramuscular  030
Intraocular  031
Intrapericardial  032
Intraperitoneal  033
Intrapleural  034
Intrasynovial  035
Intratumor  036
Intrathecal  037
Intrathoracic  038
Intratracheal  039
Intravenous bolus  040
13
  Description  ICH-M2 Numeric Codes 
Intravenous drip  041
 
Intravenous(not otherwise specified)  042 

Intravesical  043 
Iontophoresis  044 
Occlusive dressing technique  045 
Ophthalmic  046 
Oral  047 
Oropharingeal  048 
Other  049 
Parenteral  050 
Periarticular  051 
Perineural  052 
Rectal  053 
Respiratory (inhalation)  054 
Retrobulbar  055 
Subconjunctival  056 
Subcutaneous  057 
Subdermal  058 
Sublingual  059 
Topical  060 
Transdermal  061 
Transmammary  062 
Transplacental  063 
Unknown  064 
Urethral  065 
Vaginal  066 
14
  APPENDIX C: FORM VAERS-1 

15  VACCINE ADVERSE EVENT REPORTING SYSTEM  For CDC/FDA Use Only 
24 Hour Toll Free Information 1-800-822-7967 
VAERS Number 
P.O. Box 1100, Rockville, MD 20849-1100 
VAERS  PATIENT IDENTITY KEPT CONFIDENTIAL  Date Received 
Patient Name:  Vaccine administered by (Name):  Form completed by (Name): 
Last  First  M.I.  Responsible 	 Relation  Vaccine Provider  Patient/Parent 
Physician  to Patient  Manufacturer  Other 
Address  Facility Name/Address  Address (if different from patient or provider) 
City  State  Zip  City  State  Zip
  City  State  Zip
Telephone no. (____) ______________________ Telephone no. (____) ______________________ Telephone no. (____) ______________________

1. State  2. County where administered  3.  Date of birth  4.  Patient age  5. Sex  6. Date form completed 
M  F 
mm  dd  yy  mm  dd  yy 
7.  Describe adverse events(s) (symptoms, signs, time course) and treatment, if any  8.  Check all appropriate: 
Patient died  (date  ) 
mm  dd  yy 
Life threatening illness 
Required emergency room/doctor visit 
Required hospitalization (________days) 
Resulted in prolongation of hospitalization 
Resulted in permanent disability 
None of the above 
9. Patient recovered  YES  NO  UNKNOWN  10.  Date of vaccination 11. Adverse event onset 
12. Relevant diagnostic tests/laboratory data  mm  dd  yy  mm  dd  yy 
AM  AM 
Time ____________ PM Time ____________ PM 
13. Enter all vaccines given on date listed in no. 10 
No. Previous
Vaccine (type)  Manufacturer  Lot number  Route/Site   Doses 
a. 
b. 
c. 
d. 
14. Any other vaccinations within 4 weeks prior to the date listed in no. 10 
No. Previous Date 
Vaccine (type)  Manufacturer  Lot number  Route/Site  doses  given 
a. 
b. 
15. Vaccinated at:  16. Vaccine purchased with:  17. Other medications 
Private doctors office/hospital  Military clinic/hospital  Private funds  Military funds 
Public health clinic/hospital  Other/unknown  Public funds  Other/unknown 
18. Illness at time of vaccination (specify)  19. Pre-existing physician-diagnosed allergies, birth defects, medial conditions(specify) 
20. Have you reported No To health department	  Only for children 5 and under 
this adverse event 22. Birth weight  23. No. of brother and sisters 
previously?  To doctor  To manufacturer __________ lb. _________ oz. 
21. Adverse event following prior vaccination (check all applicable, specify)	  Only for reports submitted by manufacturer/Immunization project 
Adverse  Onset  Type  Dose no.  24.Mfr./imm. proj. report no.  25. Date received by mfr./imm.proj. 
Event	  Age  Vaccine  in series 
In patient 
In brother
  26.15 day report?  27. Report type
or sister
  Yes  No  Initial Follow-Up
Health care providers and manufacturers are required by law (42 USC 300aa-25) to report reactions to vaccines listed in the Table of Reportable Events Following Immunization
 Reports for reactions to other vaccines are voluntary except when required as a condition of immunization grant awards. 
Form VAERS-1(FDA)  Fold in thirds, tape & mail - DO NOT STAPLE FORM
 NO POSTAGE

 NECESSARY

 IF MAILED 

IN THE 
UNITED STATES
 OR APO/FPO 
BUSINESS REPLY MAIL 
FIRST-CLASS MAIL   PERMIT NO. 1895   ROCKVILLE, MD 
POSTAGE WILL BE PAID BY ADDRESSEE 
VAERS 
P.O. Box 1100 
Rockville MD 20849-1100 
DIRECTIONS FOR COMPLETING FORM 
(Additional pages may be attached if more space is needed) 
GENERAL 
    Use a separate form for each patient. Complete the form to the best of your abilities. Items 3, 4, 7, 8, 10, 11, and 13 are considered
 essential and should be completed whenever possible. Parents/Guardians may need to consult the facility where the vaccine was
 administered for some of the information (such as manufacturer, lot number or laboratory data.)
 Refer to the Reportable Events Table (RET) for events mandated for reporting by law. Reporting for other serious events felt to be
 related but not on the RET is encouraged.
 Health care providers other than the vaccine administrator (VA) treating a patient for a suspected adverse event should notify the
 VA and provide the information about the adverse event to allow the VA to complete the form to meet the VA's legal responsibility.
 These data will be used to increase understanding of adverse events following vaccination and will become part of CDC Privacy
 Act System 09-20-0136, "Epidemiologic Studies and Surveillance of Disease Problems". Information identifying the person who
 received the vaccine orthat person's legal representativewill not be made available tothe public, but may be available to the vaccinee
 or legal representative.
 Postage will be paid by addressee. Forms may be photocopied (must be front & back on same sheet). 
 SPECIFIC INSTRUCTIONS 
 Form Completed By: To be used by parents/guardians, vaccine manufacturers/distributors, vaccine administrators, and/or the person
 completing the form on behalf of the patient or the health professional who administered the vaccine.
 Item 7:      Describe the suspected adverse event. Such things as temperature, local and general signs and symptoms, time course,
 duration of symptoms diagnosis, treatment and recovery should be noted.
 Item 9:      Check "YES" if the patient's health condition is the same as it was prior to the vaccine, "NO" if the patient has not returned
 to the pre-vaccination state of health, or "UNKNOWN" if the patient's condition is not known.

 Item 10:    Give dates and times as specifically as you can remember. If you do not know the exact time, please

 Item 11:    indicate "AM" or "PM" when possible if this information is known. If more than one adverse event, give the onset date and

 time for the most serious event.
 Item 12:    Include "negative" or "normal" results of any relevant tests performed as well as abnormal findings.
 Item 13:    List ONLY those vaccines given on the day listed in Item 10.
 Item 14:    List any other vaccines that the patient received within 4 weeks prior to the date listed in Item 10.
 Item 16:    This section refers to how the person who gave the vaccine purchased it, not to the patient's insurance.
 Item 17:    List any prescription or non-prescription medications the patient was taking when the vaccine(s) was given.
 Item 18:    List any short term illnesses the patient had on the date the vaccine(s) was given (i.e., cold, flu, ear infection).
 Item 19:    List any pre-existing physician-diagnosed allergies, birth defects, medical conditions (including developmental and/or
 neurologic disorders) for the patient.
 Item 21: 	  L ist any suspected adverse events the patient, or the patient's brothers or sisters, may have had to previous vaccinations.

 If more than one brother or sister, or if the patient has reacted to more than one priorvaccine, use additional pages to 

explain completely. For the onset age of a patient, provide the age in months if less than two years old.

 Item 26: 	  T his space is for manufacturers' use only.