TAILIEUCHUNG - Guidance for Industry - How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)

Use these options from the very beginning and you could save money: cost-saving, sustainable options such as serving tap water instead of bottled water balances out more expensive choices like ordering sustainably-sourced fish; using electronic communication will save on paper, energy use and postage. Thinking sustainably will also help you achieve value for money, by taking into account total production costs and quality. See the boxes below for tips and ideas. Remember that it may not be possible to do everything suggested in the guide, so think about the overall approach and how the options you choose can make your event more sustainable | 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 cber . 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. II. GENERAL III. SPECIFIC IV. HOW TO OBTAIN FORM VAERS-1 AND 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 .

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