| # | Name | Location | Type | Details | Index | Description |
|---|---|---|---|---|---|---|
| .01 | date/time of event(+) | 0;1 | DATE-TIME | B | The date/time that this observed reaction occurred. | |
| .02 | patient(+) | 0;2 | POINTER | 2 | D | This field is the patient to whom this observed reaction occurred. This field is a pointer to the Patient file. |
| .03 | related reaction(+) | 0;15 | POINTER | 120.8 | C | This is the related reaction in the Patient Allergies (120.8) file for this event. |
| .5 | observer | 0;13 | POINTER | 200 | This field is the person who witnessed this reaction. | |
| 1.1 | date reported | 0;18 | DATE-TIME | ARDT | This field is to track when a report is entered into this file. | |
| 1.2 | reporting user | 0;19 | POINTER | 200 | This field is used to track the user who entered the reaction. It is a pointer to File 200. | |
| 2 | reactions | 2;0 | MULTIPLE | 120.8502 | A list of signs/symptoms observed for this reaction. | |
| 3 | suspected agent | 3;0 | MULTIPLE | 120.8503 | A list of suspected agents for this observed reaction. | |
| 4 | relevant test/lab data | 4;0 | MULTIPLE | 120.8504 | A list of all the relevant test/lab data for this observed reaction. | |
| 5 | question #1 | 0;3 | BOOLEAN | y:YES n:NO | This field indicates whether or not a patient has died from this reaction. | |
| 6 | question #2 | 0;4 | BOOLEAN | y:YES n:NO | This field indicates whether or not a patient was treated with a RX drug for this reaction. | |
| 7 | question #3 | 0;5 | BOOLEAN | y:YES n:NO | This field indicates whether or not the reaction caused a life threatening illness. | |
| 8 | question #4 | 0;6 | BOOLEAN | y:YES n:NO | This field indicates whether or not the patient had to visit a doctor or an ER because of this reaction. | |
| 9 | question #5 | 0;7 | BOOLEAN | y:YES n:NO | This field indicates whether this reaction required hospitalization. | |
| 9.1 | no. day hospitalized | 0;8 | NUMERIC | This field shows the number of days the patient was hospitalized because of the reaction. | ||
| 10 | question #6 | 0;9 | BOOLEAN | y:YES n:NO | This field indicates if the patient had a prolonged hospitalization because of the reaction. | |
| 11 | question #7 | 0;10 | BOOLEAN | y:YES n:NO | This field indicates whether or not the patient had some sort of permanent disability as a result of this reaction. | |
| 12 | question #8 | 0;11 | BOOLEAN | y:YES n:NO | This field indicates whether the patient recovered from any illness that may have resulted from the reaction. | |
| 12.1 | question #9 | 0;16 | BOOLEAN | y:YES n:NO | This field is to find out if the observed reaction was a Congenital Anomaly. | |
| 12.2 | question #10 | 0;17 | BOOLEAN | y:YES n:NO | This field is to find out if this event required any intervention. | |
| 13 | concomitant drugs | 13;0 | MULTIPLE | 120.8513 | A list of all drugs that may have been taken at the time of the reaction. | |
| 14 | other related history | 14;0 | WORD-PROCESSING | This field contains any other related event history for this reaction. | ||
| 14.5 | severity | 0;14 | SET OF CODES | 1:MILD 2:MODERATE 3:SEVERE | This field indicates the severity of this reaction. | |
| 22 | date md notified | 0;12 | DATE-TIME | This field contains the date the doctor was notified of this reaction. | ||
| 23 | fda question #1 | PTC1;1 | BOOLEAN | y:YES n:NO | This field determines if the reaction is considered serious. | |
| 24 | fda question #2 | PTC1;2 | BOOLEAN | y:YES n:NO | This question determines whether this reaction is related to a new drug. | |
| 25 | fda question #3 | PTC1;3 | BOOLEAN | y:YES n:NO | This question determines whether this reaction was an unexpected reaction for this drug. | |
| 26 | fda question #4 | PTC1;4 | BOOLEAN | y:YES n:NO | This question determines whether this reaction is related to a therapeutic failure of the drug. | |
| 26.1 | fda question #5 | PTC1;13 | BOOLEAN | y:YES n:NO | This field is to track if the reaction was a dose related reaction. | |
| 27 | date reported to fda | PTC1;5 | DATE-TIME | This field contains the date on which the FDA was sent the ADR report. | ||
| 28 | date of patient consent to mfr | PTC1;6 | DATE-TIME | This field is the date the patient had given his consent to have the reaction reported to the manufacturer. | ||
| 29 | date sent to mfr | PTC1;7 | DATE-TIME | This is the date when the report was sent to the manufacturer. | ||
| 30 | *date sent to rcpm | PTC1;8 | DATE-TIME | This is the date when the report was sent to the regional offices. | ||
| 31 | date sent to vaers | PTC1;9 | DATE-TIME | This field is the date when the report was sent to the VAERS. | ||
| 31.1 | p&t action fda report | PTC1;10 | BOOLEAN | y:YES n:NO | This field indicates if the P&T committee determined whether to send the report to FDA. | |
| 31.2 | p&t action mfr report | PTC1;11 | BOOLEAN | y:YES n:NO | This field tells if the P&T committee determined whether to send the report to the manufacturer. | |
| 31.3 | *p&t action rcpm report | PTC1;12 | BOOLEAN | y:YES n:NO | This field determines whether or not the P&T committee will send the report to the regional offices. | |
| 31.5 | p&t addendum | PTC2;0 | MULTIPLE | 120.85315 | List of comments made by the P&T committee. | |
| 43 | reporter name | RPT;1 | FREE TEXT | This field contains the name of the person filling out the reports. | ||
| 44 | reporter address1 | RPT;2 | FREE TEXT | Line one of the address of the person filling out the report. | ||
| 45 | reporter address2 | RPT;3 | FREE TEXT | Line two of the address of the person filling out the report. | ||
| 46 | reporter address3 | RPT;4 | FREE TEXT | Line three of the address of the person filling out the report. | ||
| 47 | reporter city | RPT;5 | FREE TEXT | The city where the person lives who is filling out the report. | ||
| 48 | reporter state | RPT;6 | POINTER | 5 | The state where the reporter resides. | |
| 49 | reporter zip | RPT;7 | FREE TEXT | This is the zip code of the person filling out the report. | ||
| 50 | reporter phone | RPT;8 | FREE TEXT | This is the phone number of the person who is filling out the report. | ||
| 51 | rpt question #1 | RPT;9 | BOOLEAN | y:YES n:NO | This field determines if the reporter is a health care provider. | |
| 52 | rpt question #2 | RPT;10 | BOOLEAN | y:YES n:NO | This field determines if the reporter wants to permit the FDA to inform the manufacturer of his identity. | |
| 52.1 | occupation | RPT;11 | FREE TEXT | This field contains the reporter's current occupation. | ||
| 53 | manufacturer name | MFR1;1 | FREE TEXT | This field is the name of the manufacturer of the reactant. | ||
| 54 | mfr address #1 | MFR1;2 | FREE TEXT | This is address line one for the manufacturer. | ||
| 55 | mfr address #2 | MFR1;3 | FREE TEXT | This is address line two for the manufacturer. | ||
| 56 | mfr address #3 | MFR1;4 | FREE TEXT | This is address line three for the manufacturer. | ||
| 57 | mfr city | MFR1;5 | FREE TEXT | This is the city of the manufacturer. | ||
| 58 | mfr state | MFR1;6 | POINTER | 5 | This is the state where the manufacturer is located. | |
| 59 | mfr zip | MFR1;7 | FREE TEXT | This is the Zip Code of the manufacturer. | ||
| 60 | ind/nda # for support drug | MFR2;1 | FREE TEXT | This is the IND/NDA # for support drug for the manufacturer. | ||
| 61 | mfr control # | MFR2;2 | FREE TEXT | This is the control number used by the manufacturer. | ||
| 62 | date received by mfr | MFR2;3 | DATE-TIME | This is the date the report was received by the manufacturer. | ||
| 63 | report source | 63;0 | MULTIPLE | 120.8563 | This is the source of the report. | |
| 64 | 15 day report | MFR2;4 | BOOLEAN | y:YES n:NO | This field is to determine if the 15 Day Report has been completed. | |
| 65 | report type | MFR2;5 | SET OF CODES | i:INITIAL f:FOLLOWUP | This is the type of report issued. |
Not Referenced