turer (blank for manufacturer reports).
identity should not be disclosed to the product manufac-
Whether or not (Y/N) voluntary reporter stated that his
Date FDA received report. (YYYYMMDD)
Date FDA received report. (YYYYMMDD format)
Rockville, MD, 20857, USA. Website: www.fda.gov/foi
Freedom of Information Staff (HFI-35), 5600 Fishers Lane (Rm 12A-16),
of reports through the FOIA. Address: Food and Drug Administration,
number that should be used by anyone requesting sanitized hard copies
3 IMAGE (Demographic file). The Image number is the identifying
notes image : (ex: 3123456-X) See End Note 3.
notes image : the ISR number, a dash, and a check digit or letter.
notes image : Identifier for an AERS report image. Character field consisting of
FOLL_SEQ number.
considers linked reports. For initial reports, there will be no
based on the AERS system's independent determination of what it
as given by the manufacture; in contrast, the case number is
The I_F_COD code and the FOLL_SEQ number are basically verbatim data
agree with how a manufacturer shows follow-up status on a report.
of what is a follow-up will usually, but not always,
different ISR number). It should be kept in mind that the AERS system's determination
report will have the same CASE number as the initial report (but a
consists of one or more reports (ISRs). If correctly linked, a followup
2 CASE, I_F_COD, and FOLL_SEQ (Demographic file). In AERS, a "case"
(See End Note 2.)
for this number, such as alphabetic or special characters.)
this field. (A small number of reports may have "bad" data
manufacturer. For initial reports, there will be no data for
The sequence number of a followup report, as reported by
CN Consumer
LW Lawyer
OT Other health-professional
PH Pharmacist
MD Physician
---- ------------
CODE MEANING_TEXT
Abbreviation for the reporter's type of occupation in the latest version of a case.
Whether (Y/N) voluntary reporter also notified manufacturer (blank for manufacturer reports).
See the NOTE on dates at the end of this section.
If a complete date is not available, a partial date is provided.
Date report was sent (YYYYMMDD format).
GMS Grams
LBS Pounds
KG Kilograms
Unit abbreviation for patient's weight. (See table below.)
Numeric value of patient's weight.
Whether (Y/N) this report was submitted under the electronic submissions procedure for manufacturers.
NS Not Specified
F Female
M Male
UNK Unknown
Code for patient's sex. (See table below.)
HR HOUR
DY DAY
WK WEEK
MON MONTH
YR YEAR
DEC DECADE
Unit abbreviation for patient's age. (See table below.)
Numeric value of patient's age at event.
if not found, then verbatim name of organization sending report.
Coded name of manufacturer sending report;
Manufacturer's unique report identifier.
"Direct" reports are voluntarily submitted to the FDA by non-manufacturers.
Expedited (15-day) and Periodic reports are from manufacturers;
DIR Direct
PER Periodic
EXP Expedited (15-Day)
---- ---------------
Also, see Section E, End Note 1, below.
Code for the type of report submitted. (See table below.)
YYYYMM-onlys are converted to midpoint of month: YYYYMM15
YYYY-onlys are converted to midpoint of year: YYYY0702
Date manufacturer first received initial information.
If a complete date is not available, a partial date will be provided.
In subsequent versions of a case, the latest manufacturer received date will be provided (YYYYMMDD format).
Date the adverse event occurred or began. (YYYYMMDD format)
F Follow-up
I Initial
Code for initial or follow-up status of report, as reported by manufacturer.
will have the same CASE number as the initial/oldest version.
A follow-up version (that is, the newest/latest version received by FDA)
A case consists of one or more versions.
Number for identifying a FAERS case (example. 3123456).
It is the Identifier for the case sequence (version) number as reported by the manufacturer.
This is a concatenated key of Case ID and Case Version Number.
This is the primary link field (primary key) between data files (example: 31234561).
Unique number for identifying a FAERS report.
DEMOyyQq.TXT contains patient demographic and administrative information, a single record for each event report.
by Jean Roth , jroth@nber.org , 26 Mar 2015