Source Subset Code Subset Name Concept Code Source PT Source Definition Source Synonym(s) FDA C54583 Adverse Event Outcome ICSR Terminology C49489 ADVERSE EVENT OUTCOME OUTCOME ATTRIBUTED TO ADVERSE EVENT FDA C54583 Adverse Event Outcome ICSR Terminology C2849 CONGENITAL DEFECT/DEFORMITY DEFECT/DEFORMITY, CONGENITAL FDA C54583 Adverse Event Outcome ICSR Terminology C28554 DIED EXPIRED/DEATH FDA C54583 Adverse Event Outcome ICSR Terminology C21007 DISABILITY FDA C54583 Adverse Event Outcome ICSR Terminology C25179 HOSPITALIZATION FDA C54583 Adverse Event Outcome ICSR Terminology C52668 INTERVENTION REQUIRED FDA C54583 Adverse Event Outcome ICSR Terminology C50913 INVALID DATA FDA C54583 Adverse Event Outcome ICSR Terminology C41337 LIFE THREATENING Life Threatening Adverse Event FDA C54583 Adverse Event Outcome ICSR Terminology C84266 Life-threatening adverse experience FDA C54583 Adverse Event Outcome ICSR Terminology C60812 MULTIPLE DEATHS AND SERIOUS INJURIES FDA C54583 Adverse Event Outcome ICSR Terminology C53269 NO INFORMATION NO ANSWER PROVIDED FDA C54583 Adverse Event Outcome ICSR Terminology C48660 NOT APPLICABLE FDA C54583 Adverse Event Outcome ICSR Terminology C102443 Number of Hospitalization Days FDA C54583 Adverse Event Outcome ICSR Terminology C17649 OTHER Other FDA C54583 Adverse Event Outcome ICSR Terminology C49498 Patient recovered FDA C54583 Adverse Event Outcome ICSR Terminology C60811 PEDIATRIC DEATH FDA C54583 Adverse Event Outcome ICSR Terminology C102436 Required emergency room/doctor visit FDA C54583 Adverse Event Outcome ICSR Terminology C50414 Required hospitalization FDA C54583 Adverse Event Outcome ICSR Terminology C102451 Resulted in permanent disability FDA C54583 Adverse Event Outcome ICSR Terminology C102450 Resulted in prolongation of hospitalization FDA C54583 Adverse Event Outcome ICSR Terminology C17998 UNKNOWN Unknown FDA C54583 Adverse Event Outcome ICSR Terminology C103982 Voluntary FDA C99173 Device Evaluation ICSR Terminology C54030 EVALUATION CONCLUSION FDA C99173 Device Evaluation ICSR Terminology C54028 EVALUATION METHOD FDA C99173 Device Evaluation ICSR Terminology C54029 EVALUATION RESULT FDA C54595 Device Usage ICSR Terminology C53612 INITIAL FDA C54595 Device Usage ICSR Terminology C53613 REUSE FDA C54595 Device Usage ICSR Terminology C17998 UNKNOWN Unknown FDA C54595 Device Usage ICSR Terminology C38046 UNSPECIFIED FDA C54595 Device Usage ICSR Terminology C53645 USAGE OF DEVICE FDA C94849 Dose Denominator Qualifier ICSR Terminology C14182 ANIMAL FDA C94849 Dose Denominator Qualifier ICSR Terminology C94850 ENCLOSURE FDA C94849 Dose Denominator Qualifier ICSR Terminology C94851 QUARTER FDA C94849 Dose Denominator Qualifier ICSR Terminology C77664 TEAT FDA C54447 Individual Case Safety Report Terminology C25274 ACTUAL FDA C54447 Individual Case Safety Report Terminology C53586 ADDITIONAL INFORMATION FDA C54447 Individual Case Safety Report Terminology C41331 ADVERSE EVENT FDA C54447 Individual Case Safety Report Terminology C88073 ADVERSE EVENT EXPOSURE CODE FDA C54447 Individual Case Safety Report Terminology C102470 Adverse event following prior vaccination FDA C54447 Individual Case Safety Report Terminology C49489 ADVERSE EVENT OUTCOME OUTCOME ATTRIBUTED TO ADVERSE EVENT FDA C54447 Individual Case Safety Report Terminology C88082 ADVERSE EVENT TREATMENT FDA C54447 Individual Case Safety Report Terminology C25150 AGE FDA C54447 Individual Case Safety Report Terminology C103173 Age at the Time of Vaccination FDA C54447 Individual Case Safety Report Terminology C88065 AGE AT TIME OF ADVERSE EVENT FDA C54447 Individual Case Safety Report Terminology C16281 AMBULATORY CARE FACILITY FDA C54447 Individual Case Safety Report Terminology C51957 AMBULATORY SURGICAL CENTER FDA C54447 Individual Case Safety Report Terminology C51945 AMBULATORY SURGICAL FACILITY OUTPATIENT CLINIC/SURGERY FDA C54447 Individual Case Safety Report Terminology C14182 ANIMAL FDA C54447 Individual Case Safety Report Terminology C53451 APPROXIMATE AGE OF DEVICE FDA C54447 Individual Case Safety Report Terminology C51959 ATTORNEY FDA C54447 Individual Case Safety Report Terminology C51804 AUDIOLOGIST FDA C54447 Individual Case Safety Report Terminology C51960 BIOMEDICAL ENGINEER FDA C54447 Individual Case Safety Report Terminology C51963 BLOOD BANK FDA C54447 Individual Case Safety Report Terminology C51964 BLOODMOBILE FDA C54447 Individual Case Safety Report Terminology C53692 BREED FDA C54447 Individual Case Safety Report Terminology C53510 CARDIAC CATHETERIZATION SUITE CATHETERIZATION SUITE FDA C54447 Individual Case Safety Report Terminology C51967 CHEMOTHERAPY CENTER FDA C54447 Individual Case Safety Report Terminology C51282 CLINIC - WALK IN, OTHER FDA C54447 Individual Case Safety Report Terminology C15206 CLINICAL STUDY FDA C54447 Individual Case Safety Report Terminology C54696 Combination Product FDA C54447 Individual Case Safety Report Terminology C51968 COMPANY REPRESENTATIVE FDA C54447 Individual Case Safety Report Terminology C53630 Concomitant Therapy FDA C54447 Individual Case Safety Report Terminology C2849 CONGENITAL DEFECT/DEFORMITY DEFECT/DEFORMITY, CONGENITAL FDA C54447 Individual Case Safety Report Terminology C53568 CONSUMER/CONCERNED CITIZEN FDA C54447 Individual Case Safety Report Terminology C53585 CORRECTION FDA C54447 Individual Case Safety Report Terminology C53619 CORRECTIVE ACTION NUMBER FDA C54447 Individual Case Safety Report Terminology C25464 COUNTRY FDA C54447 Individual Case Safety Report Terminology C88066 CROSSBREED INDICATOR FDA C54447 Individual Case Safety Report Terminology C53486 DATE OF CONCOMITANT THERAPY FDA C54447 Individual Case Safety Report Terminology C53481 DATE OF DEVICE RETURN TO MANUFACTURER FDA C54447 Individual Case Safety Report Terminology C53428 DENTAL ASSISTANT FDA C54447 Individual Case Safety Report Terminology C53293 DENTAL HYGIENIST FDA C54447 Individual Case Safety Report Terminology C52654 DENTIST FDA C54447 Individual Case Safety Report Terminology C53449 DEVICE AVAILABLE FOR EVALUATION FDA C54447 Individual Case Safety Report Terminology C53629 Device Evaluated by Manufacturer FDA C54447 Individual Case Safety Report Terminology C53588 DEVICE EVALUATION FDA C54447 Individual Case Safety Report Terminology C53601 DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN FDA C54447 Individual Case Safety Report Terminology C53602 DEVICE LABELED FOR SINGLE USE FDA C54447 Individual Case Safety Report Terminology C53599 DEVICE NOT MADE BY COMPANY FDA C54447 Individual Case Safety Report Terminology C54026 DEVICE PROBLEM FDA C54447 Individual Case Safety Report Terminology C53600 DEVICE PROBLEM ALREADY KNOWN NO EVALUATION NECESSARY FDA C54447 Individual Case Safety Report Terminology C53598 DEVICE RECEIVED IN CONDITION WHICH MADE ANALYSIS IMPOSSIBLE FDA C54447 Individual Case Safety Report Terminology C53591 DEVICE RETURNED TO MANUFACTURER FOR EVALUATION FDA C54447 Individual Case Safety Report Terminology C53274 DEVICE UNATTENDED FDA C54447 Individual Case Safety Report Terminology C53518 DIALYSIS CENTER FDA C54447 Individual Case Safety Report Terminology C53512 DIALYSIS UNIT FDA C54447 Individual Case Safety Report Terminology C28554 DIED EXPIRED/DEATH FDA C54447 Individual Case Safety Report Terminology C28248 DIETICIAN FDA C54447 Individual Case Safety Report Terminology C21007 DISABILITY FDA C54447 Individual Case Safety Report Terminology C48289 DISTRIBUTOR FDA C54447 Individual Case Safety Report Terminology C53519 DRUG CLINIC FDA C54447 Individual Case Safety Report Terminology C53417 EMERGENCY MEDICAL TECHNICIAN FDA C54447 Individual Case Safety Report Terminology C53513 EMERGENCY ROOM FDA C54447 Individual Case Safety Report Terminology C94850 ENCLOSURE FDA C54447 Individual Case Safety Report Terminology C25498 ESTIMATED FDA C54447 Individual Case Safety Report Terminology C54030 EVALUATION CONCLUSION FDA C54447 Individual Case Safety Report Terminology C54028 EVALUATION METHOD FDA C54447 Individual Case Safety Report Terminology C54029 EVALUATION RESULT FDA C54447 Individual Case Safety Report Terminology C53592 EVALUATION SUMMARY STATUS FDA C54447 Individual Case Safety Report Terminology C53514 EXAMINATION ROOM FDA C54447 Individual Case Safety Report Terminology C92487 EXPLANATION OF OFF LABEL USE FDA C54447 Individual Case Safety Report Terminology C16576 F FDA C54447 Individual Case Safety Report Terminology C25745 FAILURE FDA C54447 Individual Case Safety Report Terminology C53580 FDA REQUESTED FDA C54447 Individual Case Safety Report Terminology C95017 FEMALE PHYSIOLOGICAL STATUS FDA C54447 Individual Case Safety Report Terminology C53576 FIFTEEN-DAY FDA C54447 Individual Case Safety Report Terminology C53573 FIVE-DAY FDA C54447 Individual Case Safety Report Terminology C53579 FOLLOW-UP FDA C54447 Individual Case Safety Report Terminology C17237 Food and Drug Administration FDA C54447 Individual Case Safety Report Terminology C88078 FOOD AND DRUG ADMINISTRATION OFFICE OF REGULATORY AFFAIRS DISTRICT FIELD OFFICE FDA C54447 Individual Case Safety Report Terminology C25512 FOREIGN FDA C54447 Individual Case Safety Report Terminology C51966 FREE-STANDING CARDIAC CATHETERIZATION LABORATORY FDA C54447 Individual Case Safety Report Terminology C102431 Funding Source for Product FDA C54447 Individual Case Safety Report Terminology C88072 GESTATIONAL AGE AT TIME OF ADVERSE EVENT FDA C54447 Individual Case Safety Report Terminology C88067 HEALTH ASSESSMENT PRIOR TO EXPOSURE FDA C54447 Individual Case Safety Report Terminology C53287 HEALTH CARE PROFESSIONAL FDA C54447 Individual Case Safety Report Terminology C18002 HOME FDA C54447 Individual Case Safety Report Terminology C53429 HOME HEALTH AID FDA C54447 Individual Case Safety Report Terminology C53532 HOSPICE FDA C54447 Individual Case Safety Report Terminology C16696 HOSPITAL FDA C54447 Individual Case Safety Report Terminology C53433 HOSPITAL SERVICE TECHNICIAN FDA C54447 Individual Case Safety Report Terminology C25179 HOSPITALIZATION FDA C54447 Individual Case Safety Report Terminology C88086 ICSR ASSIGNED ENTITY ORGANIZATION ROLE CODE FDA C54447 Individual Case Safety Report Terminology C88085 ICSR ASSIGNED ENTITY PERSON ROLE CODE FDA C54447 Individual Case Safety Report Terminology C102468 Illness at time of vaccination FDA C54447 Individual Case Safety Report Terminology C53521 IMAGING CENTER - MOBILE FDA C54447 Individual Case Safety Report Terminology C53617 IMPORTER FDA C54447 Individual Case Safety Report Terminology C53538 IN TRANSIT TO USER/MEDICAL FACILITY FDA C54447 Individual Case Safety Report Terminology C53612 INITIAL FDA C54447 Individual Case Safety Report Terminology C53620 INITIAL FDA C54447 Individual Case Safety Report Terminology C53604 INSPECTION FDA C54447 Individual Case Safety Report Terminology C53511 INTENSIVE CARE UNIT CRITICAL CARE UNIT FDA C54447 Individual Case Safety Report Terminology C52668 INTERVENTION REQUIRED FDA C54447 Individual Case Safety Report Terminology C50913 INVALID DATA FDA C54447 Individual Case Safety Report Terminology C37984 LABORATORY FDA C54447 Individual Case Safety Report Terminology C53551 LABORATORY OR PATHOLOGY DEPARTMENT FDA C54447 Individual Case Safety Report Terminology C105633 Left Arm FDA C54447 Individual Case Safety Report Terminology C105634 Left Deltoid FDA C54447 Individual Case Safety Report Terminology C105638 Left Gluteus Medius FDA C54447 Individual Case Safety Report Terminology C105642 Left Lower Forearm FDA C54447 Individual Case Safety Report Terminology C105632 Left Thigh FDA C54447 Individual Case Safety Report Terminology C105640 Left Vastus Lateralis FDA C54447 Individual Case Safety Report Terminology C92489 LENGTH OF TIME BETWEEN PRODUCT EXPOSURE AND ONSET OF ADVERSE EVENT SYMPTOM FDA C54447 Individual Case Safety Report Terminology C41337 LIFE THREATENING Life Threatening Adverse Event FDA C54447 Individual Case Safety Report Terminology C84266 Life-threatening adverse experience FDA C54447 Individual Case Safety Report Terminology C48471 LITERATURE FDA C54447 Individual Case Safety Report Terminology C53509 LOCATION WHERE EVENT OCCURRED FDA C54447 Individual Case Safety Report Terminology C53530 LONG-TERM CARE FACILITY FDA C54447 Individual Case Safety Report Terminology C20197 M FDA C54447 Individual Case Safety Report Terminology C25392 MANUFACTURER FDA C54447 Individual Case Safety Report Terminology C53581 MANUFACTURER RESPONSE TO VOLUNTARY REPORT FDA C54447 Individual Case Safety Report Terminology C88074 MARKETING AUTHORIZATION HOLDER FDA C54447 Individual Case Safety Report Terminology C53515 MATERNITY WARD - NURSERY FDA C54447 Individual Case Safety Report Terminology C53430 MEDICAL ASSISTANT FDA C54447 Individual Case Safety Report Terminology C53442 MEDICAL EQUIPMENT COMPANY TECHNICIAN OR REPRESENTATIVE FDA C54447 Individual Case Safety Report Terminology C53418 MEDICAL TECHNOLOGIST FDA C54447 Individual Case Safety Report Terminology C102433 Military Funds FDA C54447 Individual Case Safety Report Terminology C53523 MOBILE HEALTH UNIT FDA C54447 Individual Case Safety Report Terminology C53606 MODIFICATION OR ADJUSTMENT FDA C54447 Individual Case Safety Report Terminology C53524 MRI CENTER MRI CENTERS FDA C54447 Individual Case Safety Report Terminology C60812 MULTIPLE DEATHS AND SERIOUS INJURIES FDA C54447 Individual Case Safety Report Terminology C88071 NEGATIVE RECHALLENGE INDICATOR FDA C54447 Individual Case Safety Report Terminology C49487 NO FDA C54447 Individual Case Safety Report Terminology C53269 NO INFORMATION NO ANSWER PROVIDED FDA C54447 Individual Case Safety Report Terminology C48660 NOT APPLICABLE FDA C54447 Individual Case Safety Report Terminology C25297 NOTIFICATION FDA C54447 Individual Case Safety Report Terminology C53419 NUCLEAR MEDICINE TECHNOLOGIST FDA C54447 Individual Case Safety Report Terminology C88075 NUMBER OF ANIMALS AFFECTED FDA C54447 Individual Case Safety Report Terminology C88076 NUMBER OF DEFECTIVE UNITS FDA C54447 Individual Case Safety Report Terminology C102443 Number of Hospitalization Days FDA C54447 Individual Case Safety Report Terminology C102469 Number of Siblings FDA C54447 Individual Case Safety Report Terminology C88077 NUMBER OF UNITS RETURNED FDA C54447 Individual Case Safety Report Terminology C20821 NURSE FDA C54447 Individual Case Safety Report Terminology C53431 NURSING ASSISTANT FDA C54447 Individual Case Safety Report Terminology C53533 NURSING HOME FDA C54447 Individual Case Safety Report Terminology C25193 OCCUPATION FDA C54447 Individual Case Safety Report Terminology C28174 OCCUPATIONAL THERAPIST FDA C54447 Individual Case Safety Report Terminology C53516 OPERATING ROOM FDA C54447 Individual Case Safety Report Terminology C53272 OPERATOR OF MEDICAL DEVICE FDA C54447 Individual Case Safety Report Terminology C53618 ORIGINAL EQUIPMENT MANUFACTURER FDA C54447 Individual Case Safety Report Terminology C17649 OTHER Other FDA C54447 Individual Case Safety Report Terminology C53427 OTHER CAREGIVER FDA C54447 Individual Case Safety Report Terminology C53289 OTHER HEALTH CARE PROFESSIONAL FDA C54447 Individual Case Safety Report Terminology C53263 OTHER PERSONAL MEDICAL HISTORY FDA C54447 Individual Case Safety Report Terminology C102467 Other vaccinations given within 4 weeks FDA C54447 Individual Case Safety Report Terminology C53541 OUTDOORS FDA C54447 Individual Case Safety Report Terminology C53548 OUTPATIENT DIAGNOSTIC FACILITY FDA C54447 Individual Case Safety Report Terminology C53549 OUTPATIENT TREATMENT FACILITY FDA C54447 Individual Case Safety Report Terminology C54068 Over-the-Counter Product FDA C54447 Individual Case Safety Report Terminology C53420 PARAMEDIC FDA C54447 Individual Case Safety Report Terminology C42709 Parent FDA C54447 Individual Case Safety Report Terminology C53542 PARK FDA C54447 Individual Case Safety Report Terminology C16960 PATIENT LAY USER/PATIENT FDA C54447 Individual Case Safety Report Terminology C53432 PATIENT FAMILY MEMBER OR FRIEND FDA C54447 Individual Case Safety Report Terminology C53607 PATIENT MONITORING FDA C54447 Individual Case Safety Report Terminology C54027 PATIENT PROBLEM PATIENT PROBLEM CODE FDA C54447 Individual Case Safety Report Terminology C49498 Patient recovered FDA C54447 Individual Case Safety Report Terminology C60811 PEDIATRIC DEATH FDA C54447 Individual Case Safety Report Terminology C53578 PERIODIC FDA C54447 Individual Case Safety Report Terminology C51840 PHARMACIST FDA C54447 Individual Case Safety Report Terminology C53421 PHLEBOTOMIST FDA C54447 Individual Case Safety Report Terminology C53422 PHYSICAL THERAPIST FDA C54447 Individual Case Safety Report Terminology C25741 PHYSICIAN FDA C54447 Individual Case Safety Report Terminology C53423 PHYSICIAN ASSISTANT FDA C54447 Individual Case Safety Report Terminology C53446 PHYSICIST FDA C54447 Individual Case Safety Report Terminology C53689 PLAYGROUND FDA C54447 Individual Case Safety Report Terminology C88069 POSITIVE DECHALLENGE REACTION INDICATOR FDA C54447 Individual Case Safety Report Terminology C88070 POSITIVE RECHALLENGE INDICATOR FDA C54447 Individual Case Safety Report Terminology C99176 Pre-1938 Product FDA C54447 Individual Case Safety Report Terminology C88079 PREVIOUS ADVERSE EVENT INDICATOR FDA C54447 Individual Case Safety Report Terminology C88080 PREVIOUS EXPOSURE INDICATOR FDA C54447 Individual Case Safety Report Terminology C88087 PRIMARY SOURCE REPORTER FDA C54447 Individual Case Safety Report Terminology C102432 Private Funds FDA C54447 Individual Case Safety Report Terminology C53054 PRODUCT PROBLEM FDA C54447 Individual Case Safety Report Terminology C103983 Product Use Error FDA C54447 Individual Case Safety Report Terminology C53564 PSYCHIATRIC CENTER-WALK IN, OTHER FDA C54447 Individual Case Safety Report Terminology C53536 PSYCHIATRIC FACILITY FDA C54447 Individual Case Safety Report Terminology C53546 PUBLIC BUILDING FDA C54447 Individual Case Safety Report Terminology C102434 Public Funds FDA C54447 Individual Case Safety Report Terminology C53688 PUBLIC VENUE FDA C54447 Individual Case Safety Report Terminology C94848 QUANTITY EXACTNESS FDA C54447 Individual Case Safety Report Terminology C94851 QUARTER FDA C54447 Individual Case Safety Report Terminology C17049 RACE FDA C54447 Individual Case Safety Report Terminology C53424 RADIOLOGIC TECHNOLOGIST FDA C54447 Individual Case Safety Report Terminology C53517 RADIOLOGY DEPARTMENT FDA C54447 Individual Case Safety Report Terminology C53593 REASON FOR NON-EVALUATION FDA C54447 Individual Case Safety Report Terminology C53609 RECALL FDA C54447 Individual Case Safety Report Terminology C88081 REGULATORY AUTHORITY FDA C54447 Individual Case Safety Report Terminology C53535 REHABILITATION CENTER FDA C54447 Individual Case Safety Report Terminology C73607 RELABELING FDA C54447 Individual Case Safety Report Terminology C53611 REPAIR FDA C54447 Individual Case Safety Report Terminology C53610 REPLACEMENT FDA C54447 Individual Case Safety Report Terminology C53628 Report Receiver FDA C54447 Individual Case Safety Report Terminology C53566 REPORT SOURCE FDA C54447 Individual Case Safety Report Terminology C93539 Reporter Confidentiality Disclosure Indicator FDA C54447 Individual Case Safety Report Terminology C53614 REPROCESSOR FDA C54447 Individual Case Safety Report Terminology C102436 Required emergency room/doctor visit FDA C54447 Individual Case Safety Report Terminology C50414 Required hospitalization FDA C54447 Individual Case Safety Report Terminology C53425 RESPIRATORY THERAPIST FDA C54447 Individual Case Safety Report Terminology C53587 RESPONSE TO FDA REQUEST FDA C54447 Individual Case Safety Report Terminology C102451 Resulted in permanent disability FDA C54447 Individual Case Safety Report Terminology C102450 Resulted in prolongation of hospitalization FDA C54447 Individual Case Safety Report Terminology C53537 RETIREMENT HOME FDA C54447 Individual Case Safety Report Terminology C53613 REUSE FDA C54447 Individual Case Safety Report Terminology C105636 Right Arm FDA C54447 Individual Case Safety Report Terminology C105635 Right Deltoid FDA C54447 Individual Case Safety Report Terminology C105639 Right Gluteus Medius FDA C54447 Individual Case Safety Report Terminology C105643 Right Lower Forearm FDA C54447 Individual Case Safety Report Terminology C105637 Right Thigh FDA C54447 Individual Case Safety Report Terminology C105641 Right Vastus Lateralis FDA C54447 Individual Case Safety Report Terminology C53448 RISK MANAGER FDA C54447 Individual Case Safety Report Terminology C17118 SCHOOL FDA C54447 Individual Case Safety Report Terminology C53569 SERIOUS INJURY FDA C54447 Individual Case Safety Report Terminology C53441 SERVICE AND TESTING PERSONNEL FDA C54447 Individual Case Safety Report Terminology C53273 SERVICE PERSONNEL FDA C54447 Individual Case Safety Report Terminology C53574 SEVEN-DAY FDA C54447 Individual Case Safety Report Terminology C28421 SEX FDA C54447 Individual Case Safety Report Terminology C53563 SINGLE USE AND REUSED FDA C54447 Individual Case Safety Report Terminology C19177 SPEECH THERAPIST FDA C54447 Individual Case Safety Report Terminology C53687 STATIONARY IMAGING CENTER FDA C54447 Individual Case Safety Report Terminology C25690 STREET FDA C54447 Individual Case Safety Report Terminology C77664 TEAT FDA C54447 Individual Case Safety Report Terminology C53575 TEN-DAY FDA C54447 Individual Case Safety Report Terminology C36292 TEST RESULT FDA C54447 Individual Case Safety Report Terminology C53577 THIRTY-DAY FDA C54447 Individual Case Safety Report Terminology C53525 TUBERCULOSIS CLINIC FDA C54447 Individual Case Safety Report Terminology C53265 TYPE OF DEVICE FDA C54447 Individual Case Safety Report Terminology C53053 TYPE OF EVENT TYPE OF REPORTABLE EVENT FDA C54447 Individual Case Safety Report Terminology C53584 TYPE OF FOLLOW-UP FDA C54447 Individual Case Safety Report Terminology C54597 TYPE OF MANUFACTURER FDA C54447 Individual Case Safety Report Terminology C53603 TYPE OF REMEDIAL ACTION FDA C54447 Individual Case Safety Report Terminology C53571 TYPE OF REPORT REPORT TYPE FDA C54447 Individual Case Safety Report Terminology C88083 TYPE OF REPORT INFORMATION FDA C54447 Individual Case Safety Report Terminology C53615 TYPE OF REPORTER REPORTER TYPE FDA C54447 Individual Case Safety Report Terminology C17998 UNKNOWN Unknown FDA C54447 Individual Case Safety Report Terminology C38046 UNSPECIFIED FDA C54447 Individual Case Safety Report Terminology C53528 URGENT CARE CENTER FDA C54447 Individual Case Safety Report Terminology C53645 USAGE OF DEVICE FDA C54447 Individual Case Safety Report Terminology C88084 USED ACCORDING TO LABEL INDICATOR FDA C54447 Individual Case Safety Report Terminology C53567 USER FACILITY FDA C54447 Individual Case Safety Report Terminology C102430 Vaccine Provider FDA C54447 Individual Case Safety Report Terminology C88068 VETERINARY ANATOMIC THERAPEUTIC CHEMICAL CLASSIFICATION SYSTEM CODE FDA C54447 Individual Case Safety Report Terminology C103982 Voluntary FDA C54447 Individual Case Safety Report Terminology C53552 WARD OR PATIENT ROOM FDA C54447 Individual Case Safety Report Terminology C25208 WEIGHT FDA C54447 Individual Case Safety Report Terminology C49488 YES FDA C54590 Location of Event Occurrence ICSR Terminology C16281 AMBULATORY CARE FACILITY FDA C54590 Location of Event Occurrence ICSR Terminology C51957 AMBULATORY SURGICAL CENTER FDA C54590 Location of Event Occurrence ICSR Terminology C51945 AMBULATORY SURGICAL FACILITY OUTPATIENT CLINIC/SURGERY FDA C54590 Location of Event Occurrence ICSR Terminology C51963 BLOOD BANK FDA C54590 Location of Event Occurrence ICSR Terminology C51964 BLOODMOBILE FDA C54590 Location of Event Occurrence ICSR Terminology C53510 CARDIAC CATHETERIZATION SUITE CATHETERIZATION SUITE FDA C54590 Location of Event Occurrence ICSR Terminology C51967 CHEMOTHERAPY CENTER FDA C54590 Location of Event Occurrence ICSR Terminology C51282 CLINIC - WALK IN, OTHER FDA C54590 Location of Event Occurrence ICSR Terminology C53518 DIALYSIS CENTER FDA C54590 Location of Event Occurrence ICSR Terminology C53512 DIALYSIS UNIT FDA C54590 Location of Event Occurrence ICSR Terminology C53519 DRUG CLINIC FDA C54590 Location of Event Occurrence ICSR Terminology C53513 EMERGENCY ROOM FDA C54590 Location of Event Occurrence ICSR Terminology C53514 EXAMINATION ROOM FDA C54590 Location of Event Occurrence ICSR Terminology C51966 FREE-STANDING CARDIAC CATHETERIZATION LABORATORY FDA C54590 Location of Event Occurrence ICSR Terminology C18002 HOME FDA C54590 Location of Event Occurrence ICSR Terminology C53532 HOSPICE FDA C54590 Location of Event Occurrence ICSR Terminology C16696 HOSPITAL FDA C54590 Location of Event Occurrence ICSR Terminology C53521 IMAGING CENTER - MOBILE FDA C54590 Location of Event Occurrence ICSR Terminology C53538 IN TRANSIT TO USER/MEDICAL FACILITY FDA C54590 Location of Event Occurrence ICSR Terminology C53511 INTENSIVE CARE UNIT CRITICAL CARE UNIT FDA C54590 Location of Event Occurrence ICSR Terminology C50913 INVALID DATA FDA C54590 Location of Event Occurrence ICSR Terminology C37984 LABORATORY FDA C54590 Location of Event Occurrence ICSR Terminology C53551 LABORATORY OR PATHOLOGY DEPARTMENT FDA C54590 Location of Event Occurrence ICSR Terminology C53509 LOCATION WHERE EVENT OCCURRED FDA C54590 Location of Event Occurrence ICSR Terminology C53530 LONG-TERM CARE FACILITY FDA C54590 Location of Event Occurrence ICSR Terminology C53515 MATERNITY WARD - NURSERY FDA C54590 Location of Event Occurrence ICSR Terminology C53523 MOBILE HEALTH UNIT FDA C54590 Location of Event Occurrence ICSR Terminology C53524 MRI CENTER MRI CENTERS FDA C54590 Location of Event Occurrence ICSR Terminology C53269 NO INFORMATION NO ANSWER PROVIDED FDA C54590 Location of Event Occurrence ICSR Terminology C48660 NOT APPLICABLE FDA C54590 Location of Event Occurrence ICSR Terminology C53533 NURSING HOME FDA C54590 Location of Event Occurrence ICSR Terminology C53516 OPERATING ROOM FDA C54590 Location of Event Occurrence ICSR Terminology C17649 OTHER Other FDA C54590 Location of Event Occurrence ICSR Terminology C53541 OUTDOORS FDA C54590 Location of Event Occurrence ICSR Terminology C53548 OUTPATIENT DIAGNOSTIC FACILITY FDA C54590 Location of Event Occurrence ICSR Terminology C53549 OUTPATIENT TREATMENT FACILITY FDA C54590 Location of Event Occurrence ICSR Terminology C53542 PARK FDA C54590 Location of Event Occurrence ICSR Terminology C53689 PLAYGROUND FDA C54590 Location of Event Occurrence ICSR Terminology C53564 PSYCHIATRIC CENTER-WALK IN, OTHER FDA C54590 Location of Event Occurrence ICSR Terminology C53536 PSYCHIATRIC FACILITY FDA C54590 Location of Event Occurrence ICSR Terminology C53546 PUBLIC BUILDING FDA C54590 Location of Event Occurrence ICSR Terminology C53688 PUBLIC VENUE FDA C54590 Location of Event Occurrence ICSR Terminology C53517 RADIOLOGY DEPARTMENT FDA C54590 Location of Event Occurrence ICSR Terminology C53535 REHABILITATION CENTER FDA C54590 Location of Event Occurrence ICSR Terminology C53537 RETIREMENT HOME FDA C54590 Location of Event Occurrence ICSR Terminology C17118 SCHOOL FDA C54590 Location of Event Occurrence ICSR Terminology C53687 STATIONARY IMAGING CENTER FDA C54590 Location of Event Occurrence ICSR Terminology C25690 STREET FDA C54590 Location of Event Occurrence ICSR Terminology C53525 TUBERCULOSIS CLINIC FDA C54590 Location of Event Occurrence ICSR Terminology C17998 UNKNOWN Unknown FDA C54590 Location of Event Occurrence ICSR Terminology C53528 URGENT CARE CENTER FDA C54590 Location of Event Occurrence ICSR Terminology C53552 WARD OR PATIENT ROOM FDA C88088 Observation ICSR Terminology C25274 ACTUAL FDA C88088 Observation ICSR Terminology C88073 ADVERSE EVENT EXPOSURE CODE FDA C88088 Observation ICSR Terminology C102470 Adverse event following prior vaccination FDA C88088 Observation ICSR Terminology C88082 ADVERSE EVENT TREATMENT FDA C88088 Observation ICSR Terminology C103173 Age at the Time of Vaccination FDA C88088 Observation ICSR Terminology C88065 AGE AT TIME OF ADVERSE EVENT FDA C88088 Observation ICSR Terminology C53692 BREED FDA C88088 Observation ICSR Terminology C53619 CORRECTIVE ACTION NUMBER FDA C88088 Observation ICSR Terminology C88066 CROSSBREED INDICATOR FDA C88088 Observation ICSR Terminology C25498 ESTIMATED FDA C88088 Observation ICSR Terminology C92487 EXPLANATION OF OFF LABEL USE FDA C88088 Observation ICSR Terminology C16576 F FDA C88088 Observation ICSR Terminology C95017 FEMALE PHYSIOLOGICAL STATUS FDA C88088 Observation ICSR Terminology C17237 Food and Drug Administration FDA C88088 Observation ICSR Terminology C88078 FOOD AND DRUG ADMINISTRATION OFFICE OF REGULATORY AFFAIRS DISTRICT FIELD OFFICE FDA C88088 Observation ICSR Terminology C102431 Funding Source for Product FDA C88088 Observation ICSR Terminology C88072 GESTATIONAL AGE AT TIME OF ADVERSE EVENT FDA C88088 Observation ICSR Terminology C88067 HEALTH ASSESSMENT PRIOR TO EXPOSURE FDA C88088 Observation ICSR Terminology C88086 ICSR ASSIGNED ENTITY ORGANIZATION ROLE CODE FDA C88088 Observation ICSR Terminology C88085 ICSR ASSIGNED ENTITY PERSON ROLE CODE FDA C88088 Observation ICSR Terminology C102468 Illness at time of vaccination FDA C88088 Observation ICSR Terminology C92489 LENGTH OF TIME BETWEEN PRODUCT EXPOSURE AND ONSET OF ADVERSE EVENT SYMPTOM FDA C88088 Observation ICSR Terminology C20197 M FDA C88088 Observation ICSR Terminology C88074 MARKETING AUTHORIZATION HOLDER FDA C88088 Observation ICSR Terminology C102433 Military Funds FDA C88088 Observation ICSR Terminology C88071 NEGATIVE RECHALLENGE INDICATOR FDA C88088 Observation ICSR Terminology C88075 NUMBER OF ANIMALS AFFECTED FDA C88088 Observation ICSR Terminology C88076 NUMBER OF DEFECTIVE UNITS FDA C88088 Observation ICSR Terminology C102469 Number of Siblings FDA C88088 Observation ICSR Terminology C88077 NUMBER OF UNITS RETURNED FDA C88088 Observation ICSR Terminology C17649 OTHER Other FDA C88088 Observation ICSR Terminology C102467 Other vaccinations given within 4 weeks FDA C88088 Observation ICSR Terminology C88069 POSITIVE DECHALLENGE REACTION INDICATOR FDA C88088 Observation ICSR Terminology C88070 POSITIVE RECHALLENGE INDICATOR FDA C88088 Observation ICSR Terminology C88079 PREVIOUS ADVERSE EVENT INDICATOR FDA C88088 Observation ICSR Terminology C88080 PREVIOUS EXPOSURE INDICATOR FDA C88088 Observation ICSR Terminology C88087 PRIMARY SOURCE REPORTER FDA C88088 Observation ICSR Terminology C102432 Private Funds FDA C88088 Observation ICSR Terminology C102434 Public Funds FDA C88088 Observation ICSR Terminology C94848 QUANTITY EXACTNESS FDA C88088 Observation ICSR Terminology C88081 REGULATORY AUTHORITY FDA C88088 Observation ICSR Terminology C93539 Reporter Confidentiality Disclosure Indicator FDA C88088 Observation ICSR Terminology C28421 SEX FDA C88088 Observation ICSR Terminology C88083 TYPE OF REPORT INFORMATION FDA C88088 Observation ICSR Terminology C17998 UNKNOWN Unknown FDA C88088 Observation ICSR Terminology C88084 USED ACCORDING TO LABEL INDICATOR FDA C88088 Observation ICSR Terminology C88068 VETERINARY ANATOMIC THERAPEUTIC CHEMICAL CLASSIFICATION SYSTEM CODE FDA C54585 Occupation ICSR Terminology C51959 ATTORNEY FDA C54585 Occupation ICSR Terminology C51804 AUDIOLOGIST FDA C54585 Occupation ICSR Terminology C51960 BIOMEDICAL ENGINEER FDA C54585 Occupation ICSR Terminology C53428 DENTAL ASSISTANT FDA C54585 Occupation ICSR Terminology C53293 DENTAL HYGIENIST FDA C54585 Occupation ICSR Terminology C52654 DENTIST FDA C54585 Occupation ICSR Terminology C28248 DIETICIAN FDA C54585 Occupation ICSR Terminology C53417 EMERGENCY MEDICAL TECHNICIAN FDA C54585 Occupation ICSR Terminology C53287 HEALTH CARE PROFESSIONAL FDA C54585 Occupation ICSR Terminology C53429 HOME HEALTH AID FDA C54585 Occupation ICSR Terminology C53433 HOSPITAL SERVICE TECHNICIAN FDA C54585 Occupation ICSR Terminology C50913 INVALID DATA FDA C54585 Occupation ICSR Terminology C53430 MEDICAL ASSISTANT FDA C54585 Occupation ICSR Terminology C53442 MEDICAL EQUIPMENT COMPANY TECHNICIAN OR REPRESENTATIVE FDA C54585 Occupation ICSR Terminology C53418 MEDICAL TECHNOLOGIST FDA C54585 Occupation ICSR Terminology C53269 NO INFORMATION NO ANSWER PROVIDED FDA C54585 Occupation ICSR Terminology C48660 NOT APPLICABLE FDA C54585 Occupation ICSR Terminology C53419 NUCLEAR MEDICINE TECHNOLOGIST FDA C54585 Occupation ICSR Terminology C20821 NURSE FDA C54585 Occupation ICSR Terminology C53431 NURSING ASSISTANT FDA C54585 Occupation ICSR Terminology C25193 OCCUPATION FDA C54585 Occupation ICSR Terminology C28174 OCCUPATIONAL THERAPIST FDA C54585 Occupation ICSR Terminology C17649 OTHER Other FDA C54585 Occupation ICSR Terminology C53427 OTHER CAREGIVER FDA C54585 Occupation ICSR Terminology C53289 OTHER HEALTH CARE PROFESSIONAL FDA C54585 Occupation ICSR Terminology C53420 PARAMEDIC FDA C54585 Occupation ICSR Terminology C51840 PHARMACIST FDA C54585 Occupation ICSR Terminology C53421 PHLEBOTOMIST FDA C54585 Occupation ICSR Terminology C53422 PHYSICAL THERAPIST FDA C54585 Occupation ICSR Terminology C25741 PHYSICIAN FDA C54585 Occupation ICSR Terminology C53423 PHYSICIAN ASSISTANT FDA C54585 Occupation ICSR Terminology C53446 PHYSICIST FDA C54585 Occupation ICSR Terminology C53424 RADIOLOGIC TECHNOLOGIST FDA C54585 Occupation ICSR Terminology C53425 RESPIRATORY THERAPIST FDA C54585 Occupation ICSR Terminology C53448 RISK MANAGER FDA C54585 Occupation ICSR Terminology C53441 SERVICE AND TESTING PERSONNEL FDA C54585 Occupation ICSR Terminology C53273 SERVICE PERSONNEL FDA C54585 Occupation ICSR Terminology C19177 SPEECH THERAPIST FDA C54585 Occupation ICSR Terminology C17998 UNKNOWN Unknown FDA C54584 Operator of Medical Device ICSR Terminology C51804 AUDIOLOGIST FDA C54584 Operator of Medical Device ICSR Terminology C51960 BIOMEDICAL ENGINEER FDA C54584 Operator of Medical Device ICSR Terminology C53428 DENTAL ASSISTANT FDA C54584 Operator of Medical Device ICSR Terminology C53293 DENTAL HYGIENIST FDA C54584 Operator of Medical Device ICSR Terminology C52654 DENTIST FDA C54584 Operator of Medical Device ICSR Terminology C53274 DEVICE UNATTENDED FDA C54584 Operator of Medical Device ICSR Terminology C28248 DIETICIAN FDA C54584 Operator of Medical Device ICSR Terminology C53417 EMERGENCY MEDICAL TECHNICIAN FDA C54584 Operator of Medical Device ICSR Terminology C53287 HEALTH CARE PROFESSIONAL FDA C54584 Operator of Medical Device ICSR Terminology C53429 HOME HEALTH AID FDA C54584 Operator of Medical Device ICSR Terminology C53433 HOSPITAL SERVICE TECHNICIAN FDA C54584 Operator of Medical Device ICSR Terminology C50913 INVALID DATA FDA C54584 Operator of Medical Device ICSR Terminology C53430 MEDICAL ASSISTANT FDA C54584 Operator of Medical Device ICSR Terminology C53442 MEDICAL EQUIPMENT COMPANY TECHNICIAN OR REPRESENTATIVE FDA C54584 Operator of Medical Device ICSR Terminology C53418 MEDICAL TECHNOLOGIST FDA C54584 Operator of Medical Device ICSR Terminology C53269 NO INFORMATION NO ANSWER PROVIDED FDA C54584 Operator of Medical Device ICSR Terminology C48660 NOT APPLICABLE FDA C54584 Operator of Medical Device ICSR Terminology C53419 NUCLEAR MEDICINE TECHNOLOGIST FDA C54584 Operator of Medical Device ICSR Terminology C20821 NURSE FDA C54584 Operator of Medical Device ICSR Terminology C53431 NURSING ASSISTANT FDA C54584 Operator of Medical Device ICSR Terminology C28174 OCCUPATIONAL THERAPIST FDA C54584 Operator of Medical Device ICSR Terminology C53272 OPERATOR OF MEDICAL DEVICE FDA C54584 Operator of Medical Device ICSR Terminology C17649 OTHER Other FDA C54584 Operator of Medical Device ICSR Terminology C53427 OTHER CAREGIVER FDA C54584 Operator of Medical Device ICSR Terminology C53289 OTHER HEALTH CARE PROFESSIONAL FDA C54584 Operator of Medical Device ICSR Terminology C53420 PARAMEDIC FDA C54584 Operator of Medical Device ICSR Terminology C16960 PATIENT LAY USER/PATIENT FDA C54584 Operator of Medical Device ICSR Terminology C53432 PATIENT FAMILY MEMBER OR FRIEND FDA C54584 Operator of Medical Device ICSR Terminology C51840 PHARMACIST FDA C54584 Operator of Medical Device ICSR Terminology C53421 PHLEBOTOMIST FDA C54584 Operator of Medical Device ICSR Terminology C53422 PHYSICAL THERAPIST FDA C54584 Operator of Medical Device ICSR Terminology C25741 PHYSICIAN FDA C54584 Operator of Medical Device ICSR Terminology C53423 PHYSICIAN ASSISTANT FDA C54584 Operator of Medical Device ICSR Terminology C53446 PHYSICIST FDA C54584 Operator of Medical Device ICSR Terminology C53424 RADIOLOGIC TECHNOLOGIST FDA C54584 Operator of Medical Device ICSR Terminology C53425 RESPIRATORY THERAPIST FDA C54584 Operator of Medical Device ICSR Terminology C53448 RISK MANAGER FDA C54584 Operator of Medical Device ICSR Terminology C53441 SERVICE AND TESTING PERSONNEL FDA C54584 Operator of Medical Device ICSR Terminology C53273 SERVICE PERSONNEL FDA C54584 Operator of Medical Device ICSR Terminology C19177 SPEECH THERAPIST FDA C54584 Operator of Medical Device ICSR Terminology C17998 UNKNOWN Unknown FDA C99174 Product Characteristic ICSR Terminology C54696 Combination Product FDA C99174 Product Characteristic ICSR Terminology C53629 Device Evaluated by Manufacturer FDA C99174 Product Characteristic ICSR Terminology C54068 Over-the-Counter Product FDA C99174 Product Characteristic ICSR Terminology C99176 Pre-1938 Product FDA C54593 Reason for Non-Evaluation ICSR Terminology C53601 DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN FDA C54593 Reason for Non-Evaluation ICSR Terminology C53599 DEVICE NOT MADE BY COMPANY FDA C54593 Reason for Non-Evaluation ICSR Terminology C53600 DEVICE PROBLEM ALREADY KNOWN NO EVALUATION NECESSARY FDA C54593 Reason for Non-Evaluation ICSR Terminology C53598 DEVICE RECEIVED IN CONDITION WHICH MADE ANALYSIS IMPOSSIBLE FDA C54593 Reason for Non-Evaluation ICSR Terminology C17649 OTHER Other FDA C54593 Reason for Non-Evaluation ICSR Terminology C53593 REASON FOR NON-EVALUATION FDA C54587 Report Source ICSR Terminology C15206 CLINICAL STUDY FDA C54587 Report Source ICSR Terminology C51968 COMPANY REPRESENTATIVE FDA C54587 Report Source ICSR Terminology C53568 CONSUMER/CONCERNED CITIZEN FDA C54587 Report Source ICSR Terminology C48289 DISTRIBUTOR FDA C54587 Report Source ICSR Terminology C25512 FOREIGN FDA C54587 Report Source ICSR Terminology C53287 HEALTH CARE PROFESSIONAL FDA C54587 Report Source ICSR Terminology C50913 INVALID DATA FDA C54587 Report Source ICSR Terminology C48471 LITERATURE FDA C54587 Report Source ICSR Terminology C17649 OTHER Other FDA C54587 Report Source ICSR Terminology C53566 REPORT SOURCE FDA C54587 Report Source ICSR Terminology C17998 UNKNOWN Unknown FDA C54587 Report Source ICSR Terminology C53567 USER FACILITY FDA C99175 Substance Administration ICSR Terminology C53630 Concomitant Therapy FDA C54580 Type of Event ICSR Terminology C41331 ADVERSE EVENT FDA C54580 Type of Event ICSR Terminology C53054 PRODUCT PROBLEM FDA C54580 Type of Event ICSR Terminology C103983 Product Use Error FDA C54580 Type of Event ICSR Terminology C53053 TYPE OF EVENT TYPE OF REPORTABLE EVENT FDA C54592 Type of Follow-Up ICSR Terminology C53586 ADDITIONAL INFORMATION FDA C54592 Type of Follow-Up ICSR Terminology C53585 CORRECTION FDA C54592 Type of Follow-Up ICSR Terminology C53588 DEVICE EVALUATION FDA C54592 Type of Follow-Up ICSR Terminology C53587 RESPONSE TO FDA REQUEST FDA C54592 Type of Follow-Up ICSR Terminology C53584 TYPE OF FOLLOW-UP FDA C54598 Type of Manufacturer ICSR Terminology C53618 ORIGINAL EQUIPMENT MANUFACTURER FDA C54598 Type of Manufacturer ICSR Terminology C53614 REPROCESSOR FDA C54598 Type of Manufacturer ICSR Terminology C54597 TYPE OF MANUFACTURER FDA C54594 Type of Remedial Action ICSR Terminology C53604 INSPECTION FDA C54594 Type of Remedial Action ICSR Terminology C50913 INVALID DATA FDA C54594 Type of Remedial Action ICSR Terminology C53606 MODIFICATION OR ADJUSTMENT FDA C54594 Type of Remedial Action ICSR Terminology C53269 NO INFORMATION NO ANSWER PROVIDED FDA C54594 Type of Remedial Action ICSR Terminology C25297 NOTIFICATION FDA C54594 Type of Remedial Action ICSR Terminology C17649 OTHER Other FDA C54594 Type of Remedial Action ICSR Terminology C53607 PATIENT MONITORING FDA C54594 Type of Remedial Action ICSR Terminology C53609 RECALL FDA C54594 Type of Remedial Action ICSR Terminology C73607 RELABELING FDA C54594 Type of Remedial Action ICSR Terminology C53611 REPAIR FDA C54594 Type of Remedial Action ICSR Terminology C53610 REPLACEMENT FDA C54594 Type of Remedial Action ICSR Terminology C53603 TYPE OF REMEDIAL ACTION FDA C54588 Type of Report ICSR Terminology C53580 FDA REQUESTED FDA C54588 Type of Report ICSR Terminology C53576 FIFTEEN-DAY FDA C54588 Type of Report ICSR Terminology C53573 FIVE-DAY FDA C54588 Type of Report ICSR Terminology C53579 FOLLOW-UP FDA C54588 Type of Report ICSR Terminology C53620 INITIAL FDA C54588 Type of Report ICSR Terminology C53581 MANUFACTURER RESPONSE TO VOLUNTARY REPORT FDA C54588 Type of Report ICSR Terminology C53578 PERIODIC FDA C54588 Type of Report ICSR Terminology C53574 SEVEN-DAY FDA C54588 Type of Report ICSR Terminology C53575 TEN-DAY FDA C54588 Type of Report ICSR Terminology C53577 THIRTY-DAY FDA C54588 Type of Report ICSR Terminology C53571 TYPE OF REPORT REPORT TYPE FDA C54591 Type of Reportable Event ICSR Terminology C28554 DIED EXPIRED/DEATH FDA C54591 Type of Reportable Event ICSR Terminology C25745 FAILURE FDA C54591 Type of Reportable Event ICSR Terminology C60812 MULTIPLE DEATHS AND SERIOUS INJURIES FDA C54591 Type of Reportable Event ICSR Terminology C17649 OTHER Other FDA C54591 Type of Reportable Event ICSR Terminology C60811 PEDIATRIC DEATH FDA C54591 Type of Reportable Event ICSR Terminology C53569 SERIOUS INJURY FDA C54591 Type of Reportable Event ICSR Terminology C53053 TYPE OF EVENT TYPE OF REPORTABLE EVENT FDA C54596 Type of Reporter ICSR Terminology C53617 IMPORTER FDA C54596 Type of Reporter ICSR Terminology C25392 MANUFACTURER FDA C54596 Type of Reporter ICSR Terminology C17649 OTHER Other FDA C54596 Type of Reporter ICSR Terminology C42709 Parent FDA C54596 Type of Reporter ICSR Terminology C16960 PATIENT LAY USER/PATIENT FDA C54596 Type of Reporter ICSR Terminology C53615 TYPE OF REPORTER REPORTER TYPE FDA C54596 Type of Reporter ICSR Terminology C53567 USER FACILITY FDA C54596 Type of Reporter ICSR Terminology C102430 Vaccine Provider FDA C105691 Vaccination Site on Body ICSR Terminology C105633 Left Arm FDA C105691 Vaccination Site on Body ICSR Terminology C105634 Left Deltoid FDA C105691 Vaccination Site on Body ICSR Terminology C105638 Left Gluteus Medius FDA C105691 Vaccination Site on Body ICSR Terminology C105642 Left Lower Forearm FDA C105691 Vaccination Site on Body ICSR Terminology C105632 Left Thigh FDA C105691 Vaccination Site on Body ICSR Terminology C105640 Left Vastus Lateralis FDA C105691 Vaccination Site on Body ICSR Terminology C105636 Right Arm FDA C105691 Vaccination Site on Body ICSR Terminology C105635 Right Deltoid FDA C105691 Vaccination Site on Body ICSR Terminology C105639 Right Gluteus Medius FDA C105691 Vaccination Site on Body ICSR Terminology C105643 Right Lower Forearm FDA C105691 Vaccination Site on Body ICSR Terminology C105637 Right Thigh FDA C105691 Vaccination Site on Body ICSR Terminology C105641 Right Vastus Lateralis