C FDA C54447 FDA Individual Case Safety Report Terminology C102430 Vaccine Provider C FDA C54447 FDA Individual Case Safety Report Terminology C102431 Funding Source for Product C FDA C54447 FDA Individual Case Safety Report Terminology C102432 Private Funds C FDA C54447 FDA Individual Case Safety Report Terminology C102433 Military Funds C FDA C54447 FDA Individual Case Safety Report Terminology C102434 Public Funds C FDA C54447 FDA Individual Case Safety Report Terminology C102443 Number of Hospitalization Days C FDA C54447 FDA Individual Case Safety Report Terminology C102450 Resulted in prolongation of hospitalization C FDA C54447 FDA Individual Case Safety Report Terminology C102451 Resulted in permanent disability C FDA C54447 FDA Individual Case Safety Report Terminology C102467 Other vaccinations given within 4 weeks C FDA C54447 FDA Individual Case Safety Report Terminology C102468 Illness at time of vaccination C FDA C54447 FDA Individual Case Safety Report Terminology C102469 Number of Siblings C FDA C54447 FDA Individual Case Safety Report Terminology C102470 Adverse event following prior vaccination C FDA C54447 FDA Individual Case Safety Report Terminology C103173 Age at the Time of Vaccination C FDA C54447 FDA Individual Case Safety Report Terminology C103982 Voluntary C FDA C54447 FDA Individual Case Safety Report Terminology C103983 Product Use Error C FDA C54447 FDA Individual Case Safety Report Terminology C105632 Left Thigh C FDA C54447 FDA Individual Case Safety Report Terminology C105633 Left Arm C FDA C54447 FDA Individual Case Safety Report Terminology C105634 Left Deltoid C FDA C54447 FDA Individual Case Safety Report Terminology C105635 Right Deltoid C FDA C54447 FDA Individual Case Safety Report Terminology C105636 Right Arm C FDA C54447 FDA Individual Case Safety Report Terminology C105637 Right Thigh C FDA C54447 FDA Individual Case Safety Report Terminology C105638 Left Gluteus Medius C FDA C54447 FDA Individual Case Safety Report Terminology C105639 Right Gluteus Medius C FDA C54447 FDA Individual Case Safety Report Terminology C105640 Left Vastus Lateralis C FDA C54447 FDA Individual Case Safety Report Terminology C105641 Right Vastus Lateralis C FDA C54447 FDA Individual Case Safety Report Terminology C105642 Left Lower Forearm C FDA C54447 FDA Individual Case Safety Report Terminology C105643 Right Lower Forearm C FDA C54447 FDA Individual Case Safety Report Terminology C111737 ER C FDA C54447 FDA Individual Case Safety Report Terminology C111738 Doctor Visit C FDA C54447 FDA Individual Case Safety Report Terminology C114854 Active Duty C FDA C54447 FDA Individual Case Safety Report Terminology C114857 Reserve C FDA C54447 FDA Individual Case Safety Report Terminology C114858 National Guard C FDA C54447 FDA Individual Case Safety Report Terminology C114859 TRICARE Beneficiary C FDA C54447 FDA Individual Case Safety Report Terminology C114860 Public Health Department Facility C FDA C54447 FDA Individual Case Safety Report Terminology C114862 School Student Health Clinic C FDA C54447 FDA Individual Case Safety Report Terminology C114863 Pharmacy/Drug Store C FDA C54447 FDA Individual Case Safety Report Terminology C114865 Military Site C FDA C54447 FDA Individual Case Safety Report Terminology C14182 ANIMAL C FDA C54447 FDA Individual Case Safety Report Terminology C15206 CLINICAL STUDY C FDA C54447 FDA Individual Case Safety Report Terminology C16281 AMBULATORY CARE FACILITY C FDA C54447 FDA Individual Case Safety Report Terminology C16576 F C FDA C54447 FDA Individual Case Safety Report Terminology C16696 HOSPITAL C FDA C54447 FDA Individual Case Safety Report Terminology C16960 PATIENT LAY USER/PATIENT C FDA C54447 FDA Individual Case Safety Report Terminology C17049 RACE C FDA C54447 FDA Individual Case Safety Report Terminology C17118 SCHOOL C FDA C54447 FDA Individual Case Safety Report Terminology C17237 Food and Drug Administration C FDA C54447 FDA Individual Case Safety Report Terminology C17649 OTHER Other C FDA C54447 FDA Individual Case Safety Report Terminology C17998 UNKNOWN Unknown C FDA C54447 FDA Individual Case Safety Report Terminology C18002 HOME C FDA C54447 FDA Individual Case Safety Report Terminology C19177 SPEECH THERAPIST C FDA C54447 FDA Individual Case Safety Report Terminology C20197 M C FDA C54447 FDA Individual Case Safety Report Terminology C20821 NURSE C FDA C54447 FDA Individual Case Safety Report Terminology C21007 DISABILITY C FDA C54447 FDA Individual Case Safety Report Terminology C25150 AGE C FDA C54447 FDA Individual Case Safety Report Terminology C25179 HOSPITALIZATION C FDA C54447 FDA Individual Case Safety Report Terminology C25193 OCCUPATION C FDA C54447 FDA Individual Case Safety Report Terminology C25208 WEIGHT C FDA C54447 FDA Individual Case Safety Report Terminology C25274 ACTUAL C FDA C54447 FDA Individual Case Safety Report Terminology C25297 NOTIFICATION C FDA C54447 FDA Individual Case Safety Report Terminology C25392 MANUFACTURER C FDA C54447 FDA Individual Case Safety Report Terminology C25464 COUNTRY C FDA C54447 FDA Individual Case Safety Report Terminology C25498 ESTIMATED C FDA C54447 FDA Individual Case Safety Report Terminology C25512 FOREIGN C FDA C54447 FDA Individual Case Safety Report Terminology C25690 STREET C FDA C54447 FDA Individual Case Safety Report Terminology C25741 PHYSICIAN C FDA C54447 FDA Individual Case Safety Report Terminology C25745 FAILURE C FDA C54447 FDA Individual Case Safety Report Terminology C28174 OCCUPATIONAL THERAPIST C FDA C54447 FDA Individual Case Safety Report Terminology C28248 DIETICIAN C FDA C54447 FDA Individual Case Safety Report Terminology C28421 SEX C FDA C54447 FDA Individual Case Safety Report Terminology C2849 CONGENITAL DEFECT/DEFORMITY DEFECT/DEFORMITY, CONGENITAL C FDA C54447 FDA Individual Case Safety Report Terminology C28554 DIED EXPIRED/DEATH C FDA C54447 FDA Individual Case Safety Report Terminology C36292 TEST RESULT C FDA C54447 FDA Individual Case Safety Report Terminology C37984 LABORATORY C FDA C54447 FDA Individual Case Safety Report Terminology C38046 UNSPECIFIED C FDA C54447 FDA Individual Case Safety Report Terminology C41331 ADVERSE EVENT C FDA C54447 FDA Individual Case Safety Report Terminology C41337 LIFE THREATENING Life Threatening Adverse Event C FDA C54447 FDA Individual Case Safety Report Terminology C42709 Parent C FDA C54447 FDA Individual Case Safety Report Terminology C48289 DISTRIBUTOR C FDA C54447 FDA Individual Case Safety Report Terminology C48471 LITERATURE C FDA C54447 FDA Individual Case Safety Report Terminology C48660 NOT APPLICABLE C FDA C54447 FDA Individual Case Safety Report Terminology C49487 NO C FDA C54447 FDA Individual Case Safety Report Terminology C49488 YES C FDA C54447 FDA Individual Case Safety Report Terminology C49489 ADVERSE EVENT OUTCOME OUTCOME ATTRIBUTED TO ADVERSE EVENT C FDA C54447 FDA Individual Case Safety Report Terminology C49498 Patient recovered C FDA C54447 FDA Individual Case Safety Report Terminology C50414 Required hospitalization C FDA C54447 FDA Individual Case Safety Report Terminology C50913 INVALID DATA C FDA C54447 FDA Individual Case Safety Report Terminology C51282 CLINIC - WALK IN, OTHER C FDA C54447 FDA Individual Case Safety Report Terminology C51804 AUDIOLOGIST C FDA C54447 FDA Individual Case Safety Report Terminology C51840 PHARMACIST C FDA C54447 FDA Individual Case Safety Report Terminology C51945 AMBULATORY SURGICAL FACILITY OUTPATIENT CLINIC/SURGERY C FDA C54447 FDA Individual Case Safety Report Terminology C51957 AMBULATORY SURGICAL CENTER C FDA C54447 FDA Individual Case Safety Report Terminology C51959 ATTORNEY C FDA C54447 FDA Individual Case Safety Report Terminology C51960 BIOMEDICAL ENGINEER C FDA C54447 FDA Individual Case Safety Report Terminology C51963 BLOOD BANK C FDA C54447 FDA Individual Case Safety Report Terminology C51964 BLOODMOBILE C FDA C54447 FDA Individual Case Safety Report Terminology C51966 FREE-STANDING CARDIAC CATHETERIZATION LABORATORY C FDA C54447 FDA Individual Case Safety Report Terminology C51967 CHEMOTHERAPY CENTER C FDA C54447 FDA Individual Case Safety Report Terminology C51968 COMPANY REPRESENTATIVE C FDA C54447 FDA Individual Case Safety Report Terminology C52654 DENTIST C FDA C54447 FDA Individual Case Safety Report Terminology C52668 INTERVENTION REQUIRED C FDA C54447 FDA Individual Case Safety Report Terminology C53053 TYPE OF EVENT TYPE OF REPORTABLE EVENT C FDA C54447 FDA Individual Case Safety Report Terminology C53054 PRODUCT PROBLEM C FDA C54447 FDA Individual Case Safety Report Terminology C53263 OTHER PERSONAL MEDICAL HISTORY C FDA C54447 FDA Individual Case Safety Report Terminology C53265 TYPE OF DEVICE C FDA C54447 FDA Individual Case Safety Report Terminology C53269 NO INFORMATION NO ANSWER PROVIDED C FDA C54447 FDA Individual Case Safety Report Terminology C53272 OPERATOR OF MEDICAL DEVICE C FDA C54447 FDA Individual Case Safety Report Terminology C53273 SERVICE PERSONNEL C FDA C54447 FDA Individual Case Safety Report Terminology C53274 DEVICE UNATTENDED C FDA C54447 FDA Individual Case Safety Report Terminology C53287 HEALTH CARE PROFESSIONAL C FDA C54447 FDA Individual Case Safety Report Terminology C53289 OTHER HEALTH CARE PROFESSIONAL C FDA C54447 FDA Individual Case Safety Report Terminology C53293 DENTAL HYGIENIST C FDA C54447 FDA Individual Case Safety Report Terminology C53417 EMERGENCY MEDICAL TECHNICIAN C FDA C54447 FDA Individual Case Safety Report Terminology C53418 MEDICAL TECHNOLOGIST C FDA C54447 FDA Individual Case Safety Report Terminology C53419 NUCLEAR MEDICINE TECHNOLOGIST C FDA C54447 FDA Individual Case Safety Report Terminology C53420 PARAMEDIC C FDA C54447 FDA Individual Case Safety Report Terminology C53421 PHLEBOTOMIST C FDA C54447 FDA Individual Case Safety Report Terminology C53422 PHYSICAL THERAPIST C FDA C54447 FDA Individual Case Safety Report Terminology C53423 PHYSICIAN ASSISTANT C FDA C54447 FDA Individual Case Safety Report Terminology C53424 RADIOLOGIC TECHNOLOGIST C FDA C54447 FDA Individual Case Safety Report Terminology C53425 RESPIRATORY THERAPIST C FDA C54447 FDA Individual Case Safety Report Terminology C53427 OTHER CAREGIVER C FDA C54447 FDA Individual Case Safety Report Terminology C53428 DENTAL ASSISTANT C FDA C54447 FDA Individual Case Safety Report Terminology C53429 HOME HEALTH AID C FDA C54447 FDA Individual Case Safety Report Terminology C53430 MEDICAL ASSISTANT C FDA C54447 FDA Individual Case Safety Report Terminology C53431 NURSING ASSISTANT C FDA C54447 FDA Individual Case Safety Report Terminology C53432 PATIENT FAMILY MEMBER OR FRIEND C FDA C54447 FDA Individual Case Safety Report Terminology C53433 HOSPITAL SERVICE TECHNICIAN C FDA C54447 FDA Individual Case Safety Report Terminology C53441 SERVICE AND TESTING PERSONNEL C FDA C54447 FDA Individual Case Safety Report Terminology C53442 MEDICAL EQUIPMENT COMPANY TECHNICIAN OR REPRESENTATIVE C FDA C54447 FDA Individual Case Safety Report Terminology C53446 PHYSICIST C FDA C54447 FDA Individual Case Safety Report Terminology C53448 RISK MANAGER C FDA C54447 FDA Individual Case Safety Report Terminology C53449 DEVICE AVAILABLE FOR EVALUATION C FDA C54447 FDA Individual Case Safety Report Terminology C53451 APPROXIMATE AGE OF DEVICE C FDA C54447 FDA Individual Case Safety Report Terminology C53481 DATE OF DEVICE RETURN TO MANUFACTURER C FDA C54447 FDA Individual Case Safety Report Terminology C53486 DATE OF CONCOMITANT THERAPY C FDA C54447 FDA Individual Case Safety Report Terminology C53509 LOCATION WHERE EVENT OCCURRED C FDA C54447 FDA Individual Case Safety Report Terminology C53510 CARDIAC CATHETERIZATION SUITE CATHETERIZATION SUITE C FDA C54447 FDA Individual Case Safety Report Terminology C53511 INTENSIVE CARE UNIT CRITICAL CARE UNIT C FDA C54447 FDA Individual Case Safety Report Terminology C53512 DIALYSIS UNIT C FDA C54447 FDA Individual Case Safety Report Terminology C53513 EMERGENCY ROOM C FDA C54447 FDA Individual Case Safety Report Terminology C53514 EXAMINATION ROOM C FDA C54447 FDA Individual Case Safety Report Terminology C53515 MATERNITY WARD - NURSERY C FDA C54447 FDA Individual Case Safety Report Terminology C53516 OPERATING ROOM C FDA C54447 FDA Individual Case Safety Report Terminology C53517 RADIOLOGY DEPARTMENT C FDA C54447 FDA Individual Case Safety Report Terminology C53518 DIALYSIS CENTER C FDA C54447 FDA Individual Case Safety Report Terminology C53519 DRUG CLINIC C FDA C54447 FDA Individual Case Safety Report Terminology C53521 IMAGING CENTER - MOBILE C FDA C54447 FDA Individual Case Safety Report Terminology C53523 MOBILE HEALTH UNIT C FDA C54447 FDA Individual Case Safety Report Terminology C53524 MRI CENTER MRI CENTERS C FDA C54447 FDA Individual Case Safety Report Terminology C53525 TUBERCULOSIS CLINIC C FDA C54447 FDA Individual Case Safety Report Terminology C53528 URGENT CARE CENTER C FDA C54447 FDA Individual Case Safety Report Terminology C53530 LONG-TERM CARE FACILITY C FDA C54447 FDA Individual Case Safety Report Terminology C53532 HOSPICE C FDA C54447 FDA Individual Case Safety Report Terminology C53533 NURSING HOME C FDA C54447 FDA Individual Case Safety Report Terminology C53535 REHABILITATION CENTER C FDA C54447 FDA Individual Case Safety Report Terminology C53536 PSYCHIATRIC FACILITY C FDA C54447 FDA Individual Case Safety Report Terminology C53537 RETIREMENT HOME C FDA C54447 FDA Individual Case Safety Report Terminology C53538 IN TRANSIT TO USER/MEDICAL FACILITY C FDA C54447 FDA Individual Case Safety Report Terminology C53541 OUTDOORS C FDA C54447 FDA Individual Case Safety Report Terminology C53542 PARK C FDA C54447 FDA Individual Case Safety Report Terminology C53546 PUBLIC BUILDING C FDA C54447 FDA Individual Case Safety Report Terminology C53548 OUTPATIENT DIAGNOSTIC FACILITY C FDA C54447 FDA Individual Case Safety Report Terminology C53549 OUTPATIENT TREATMENT FACILITY C FDA C54447 FDA Individual Case Safety Report Terminology C53551 LABORATORY OR PATHOLOGY DEPARTMENT C FDA C54447 FDA Individual Case Safety Report Terminology C53552 WARD OR PATIENT ROOM C FDA C54447 FDA Individual Case Safety Report Terminology C53563 SINGLE USE AND REUSED C FDA C54447 FDA Individual Case Safety Report Terminology C53564 PSYCHIATRIC CENTER-WALK IN, OTHER C FDA C54447 FDA Individual Case Safety Report Terminology C53566 REPORT SOURCE C FDA C54447 FDA Individual Case Safety Report Terminology C53567 USER FACILITY C FDA C54447 FDA Individual Case Safety Report Terminology C53568 CONSUMER/CONCERNED CITIZEN C FDA C54447 FDA Individual Case Safety Report Terminology C53569 SERIOUS INJURY C FDA C54447 FDA Individual Case Safety Report Terminology C53571 TYPE OF REPORT REPORT TYPE C FDA C54447 FDA Individual Case Safety Report Terminology C53573 FIVE-DAY C FDA C54447 FDA Individual Case Safety Report Terminology C53574 SEVEN-DAY C FDA C54447 FDA Individual Case Safety Report Terminology C53575 TEN-DAY C FDA C54447 FDA Individual Case Safety Report Terminology C53576 FIFTEEN-DAY C FDA C54447 FDA Individual Case Safety Report Terminology C53577 THIRTY-DAY C FDA C54447 FDA Individual Case Safety Report Terminology C53578 PERIODIC C FDA C54447 FDA Individual Case Safety Report Terminology C53579 FOLLOW-UP C FDA C54447 FDA Individual Case Safety Report Terminology C53580 FDA REQUESTED C FDA C54447 FDA Individual Case Safety Report Terminology C53581 MANUFACTURER RESPONSE TO VOLUNTARY REPORT C FDA C54447 FDA Individual Case Safety Report Terminology C53584 TYPE OF FOLLOW-UP C FDA C54447 FDA Individual Case Safety Report Terminology C53585 CORRECTION C FDA C54447 FDA Individual Case Safety Report Terminology C53586 ADDITIONAL INFORMATION C FDA C54447 FDA Individual Case Safety Report Terminology C53587 RESPONSE TO FDA REQUEST C FDA C54447 FDA Individual Case Safety Report Terminology C53588 DEVICE EVALUATION C FDA C54447 FDA Individual Case Safety Report Terminology C53591 DEVICE RETURNED TO MANUFACTURER FOR EVALUATION C FDA C54447 FDA Individual Case Safety Report Terminology C53592 EVALUATION SUMMARY STATUS C FDA C54447 FDA Individual Case Safety Report Terminology C53593 REASON FOR NON-EVALUATION C FDA C54447 FDA Individual Case Safety Report Terminology C53598 DEVICE RECEIVED IN CONDITION WHICH MADE ANALYSIS IMPOSSIBLE C FDA C54447 FDA Individual Case Safety Report Terminology C53599 DEVICE NOT MADE BY COMPANY C FDA C54447 FDA Individual Case Safety Report Terminology C53600 DEVICE PROBLEM ALREADY KNOWN NO EVALUATION NECESSARY C FDA C54447 FDA Individual Case Safety Report Terminology C53601 DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN C FDA C54447 FDA Individual Case Safety Report Terminology C53602 DEVICE LABELED FOR SINGLE USE C FDA C54447 FDA Individual Case Safety Report Terminology C53603 TYPE OF REMEDIAL ACTION C FDA C54447 FDA Individual Case Safety Report Terminology C53604 INSPECTION C FDA C54447 FDA Individual Case Safety Report Terminology C53606 MODIFICATION OR ADJUSTMENT C FDA C54447 FDA Individual Case Safety Report Terminology C53607 PATIENT MONITORING C FDA C54447 FDA Individual Case Safety Report Terminology C53609 RECALL C FDA C54447 FDA Individual Case Safety Report Terminology C53610 REPLACEMENT C FDA C54447 FDA Individual Case Safety Report Terminology C53611 REPAIR C FDA C54447 FDA Individual Case Safety Report Terminology C53612 INITIAL C FDA C54447 FDA Individual Case Safety Report Terminology C53613 REUSE C FDA C54447 FDA Individual Case Safety Report Terminology C53614 REPROCESSOR C FDA C54447 FDA Individual Case Safety Report Terminology C53615 TYPE OF REPORTER REPORTER TYPE C FDA C54447 FDA Individual Case Safety Report Terminology C53617 IMPORTER C FDA C54447 FDA Individual Case Safety Report Terminology C53618 ORIGINAL EQUIPMENT MANUFACTURER C FDA C54447 FDA Individual Case Safety Report Terminology C53619 CORRECTIVE ACTION NUMBER C FDA C54447 FDA Individual Case Safety Report Terminology C53620 INITIAL C FDA C54447 FDA Individual Case Safety Report Terminology C53628 Report Receiver C FDA C54447 FDA Individual Case Safety Report Terminology C53629 Device Evaluated by Manufacturer C FDA C54447 FDA Individual Case Safety Report Terminology C53630 Concomitant Therapy C FDA C54447 FDA Individual Case Safety Report Terminology C53645 USAGE OF DEVICE C FDA C54447 FDA Individual Case Safety Report Terminology C53687 STATIONARY IMAGING CENTER C FDA C54447 FDA Individual Case Safety Report Terminology C53688 PUBLIC VENUE C FDA C54447 FDA Individual Case Safety Report Terminology C53689 PLAYGROUND C FDA C54447 FDA Individual Case Safety Report Terminology C53692 BREED C FDA C54447 FDA Individual Case Safety Report Terminology C54026 DEVICE PROBLEM C FDA C54447 FDA Individual Case Safety Report Terminology C54027 PATIENT PROBLEM PATIENT PROBLEM CODE C FDA C54447 FDA Individual Case Safety Report Terminology C54028 EVALUATION METHOD C FDA C54447 FDA Individual Case Safety Report Terminology C54029 EVALUATION RESULT C FDA C54447 FDA Individual Case Safety Report Terminology C54030 EVALUATION CONCLUSION C FDA C54447 FDA Individual Case Safety Report Terminology C54068 Over-the-Counter Product C FDA C54447 FDA Individual Case Safety Report Terminology C54597 TYPE OF MANUFACTURER C FDA C54447 FDA Individual Case Safety Report Terminology C54696 Combination Product C FDA C54447 FDA Individual Case Safety Report Terminology C60811 PEDIATRIC DEATH C FDA C54447 FDA Individual Case Safety Report Terminology C60812 MULTIPLE DEATHS AND SERIOUS INJURIES C FDA C54447 FDA Individual Case Safety Report Terminology C73607 RELABELING C FDA C54447 FDA Individual Case Safety Report Terminology C77664 TEAT C FDA C54447 FDA Individual Case Safety Report Terminology C84266 Life-threatening adverse experience C FDA C54447 FDA Individual Case Safety Report Terminology C88065 AGE AT TIME OF ADVERSE EVENT C FDA C54447 FDA Individual Case Safety Report Terminology C88066 CROSSBREED INDICATOR C FDA C54447 FDA Individual Case Safety Report Terminology C88067 HEALTH ASSESSMENT PRIOR TO EXPOSURE C FDA C54447 FDA Individual Case Safety Report Terminology C88068 VETERINARY ANATOMIC THERAPEUTIC CHEMICAL CLASSIFICATION SYSTEM CODE C FDA C54447 FDA Individual Case Safety Report Terminology C88069 POSITIVE DECHALLENGE REACTION INDICATOR C FDA C54447 FDA Individual Case Safety Report Terminology C88070 POSITIVE RECHALLENGE INDICATOR C FDA C54447 FDA Individual Case Safety Report Terminology C88071 NEGATIVE RECHALLENGE INDICATOR C FDA C54447 FDA Individual Case Safety Report Terminology C88072 GESTATIONAL AGE AT TIME OF ADVERSE EVENT C FDA C54447 FDA Individual Case Safety Report Terminology C88073 ADVERSE EVENT EXPOSURE CODE C FDA C54447 FDA Individual Case Safety Report Terminology C88074 MARKETING AUTHORIZATION HOLDER C FDA C54447 FDA Individual Case Safety Report Terminology C88075 NUMBER OF ANIMALS AFFECTED C FDA C54447 FDA Individual Case Safety Report Terminology C88076 NUMBER OF DEFECTIVE UNITS C FDA C54447 FDA Individual Case Safety Report Terminology C88077 NUMBER OF UNITS RETURNED C FDA C54447 FDA Individual Case Safety Report Terminology C88078 FOOD AND DRUG ADMINISTRATION OFFICE OF REGULATORY AFFAIRS DISTRICT FIELD OFFICE C FDA C54447 FDA Individual Case Safety Report Terminology C88079 PREVIOUS ADVERSE EVENT INDICATOR C FDA C54447 FDA Individual Case Safety Report Terminology C88080 PREVIOUS EXPOSURE INDICATOR C FDA C54447 FDA Individual Case Safety Report Terminology C88081 REGULATORY AUTHORITY C FDA C54447 FDA Individual Case Safety Report Terminology C88082 ADVERSE EVENT TREATMENT C FDA C54447 FDA Individual Case Safety Report Terminology C88083 TYPE OF REPORT INFORMATION C FDA C54447 FDA Individual Case Safety Report Terminology C88084 USED ACCORDING TO LABEL INDICATOR C FDA C54447 FDA Individual Case Safety Report Terminology C88085 ICSR ASSIGNED ENTITY PERSON ROLE CODE C FDA C54447 FDA Individual Case Safety Report Terminology C88086 ICSR ASSIGNED ENTITY ORGANIZATION ROLE CODE C FDA C54447 FDA Individual Case Safety Report Terminology C88087 PRIMARY SOURCE REPORTER C FDA C54447 FDA Individual Case Safety Report Terminology C92487 EXPLANATION OF OFF LABEL USE C FDA C54447 FDA Individual Case Safety Report Terminology C92489 LENGTH OF TIME BETWEEN PRODUCT EXPOSURE AND ONSET OF ADVERSE EVENT SYMPTOM C FDA C54447 FDA Individual Case Safety Report Terminology C93539 Reporter Confidentiality Disclosure Indicator C FDA C54447 FDA Individual Case Safety Report Terminology C94848 QUANTITY EXACTNESS C FDA C54447 FDA Individual Case Safety Report Terminology C94850 ENCLOSURE C FDA C54447 FDA Individual Case Safety Report Terminology C94851 QUARTER C FDA C54447 FDA Individual Case Safety Report Terminology C95017 FEMALE PHYSIOLOGICAL STATUS C FDA C54447 FDA Individual Case Safety Report Terminology C99176 Pre-1938 Product