type: object properties: authoritynumb: format: is_exact: true type: string pattern: description: "Populated with the Regulatory Authority’s case report number, when available." possible_values: companynumb: format: is_exact: true type: string pattern: description: "Identifier for the company providing the report. This is self-assigned." possible_values: duplicate: format: is_exact: false type: string pattern: description: "This value is `1` if earlier versions of this report were submitted to FDA. openFDA only shows the most recent version." possible_values: fulfillexpeditecriteria: format: int32 is_exact: false type: string pattern: description: "Identifies expedited reports (those that were processed within 15 days)." possible_values: type: one_of value: '1': Yes '2': No occurcountry: format: is_exact: true type: string pattern: ^[A-Z]{2}$ description: "The name of the country where the event occurred." possible_values: type: reference value: name: "Country codes" link: "http://data.okfn.org/data/core/country-list" patient: type: object properties: drug: type: array items: properties: actiondrug: format: int64 is_exact: false type: string pattern: description: "Actions taken with the drug." possible_values: type: one_of value: '1': "Drug withdrawn" '2': "Dose reduced" '3': "Dose increased" '4': "Dose not changed" '5': "Unknown" '6': "Not applicable" activesubstance: type: object properties: activesubstancename: format: is_exact: true type: string pattern: description: "Product active ingredient, which may be different than other drug identifiers (when provided)." possible_values: drugadditional: format: int64 is_exact: false type: string pattern: description: "Dechallenge outcome information—whether the event abated after product use stopped or the dose was reduced. Only present when this was attempted and the data was provided." possible_values: type: one_of value: '1': 'Yes' '2': 'No' '3': 'Does not apply' drugadministrationroute: format: is_exact: true type: string pattern: description: "The drug’s route of administration." possible_values: type: one_of value: '001': "Auricular (otic)" '002': "Buccal" '003': "Cutaneous" '004': "Dental" '005': "Endocervical" '006': "Endosinusial" '007': "Endotracheal" '008': "Epidural" '009': "Extra-amniotic" '010': "Hemodialysis" '011': "Intra corpus cavernosum" '012': "Intra-amniotic" '013': "Intra-arterial" '014': "Intra-articular" '015': "Intra-uterine" '016': "Intracardiac" '017': "Intracavernous" '018': "Intracerebral" '019': "Intracervical" '020': "Intracisternal" '021': "Intracorneal" '022': "Intracoronary" '023': "Intradermal" '024': "Intradiscal (intraspinal)" '025': "Intrahepatic" '026': "Intralesional" '027': "Intralymphatic" '028': "Intramedullar (bone marrow)" '029': "Intrameningeal" '030': "Intramuscular" '031': "Intraocular" '032': "Intrapericardial" '033': "Intraperitoneal" '034': "Intrapleural" '035': "Intrasynovial" '036': "Intratumor" '037': "Intrathecal" '038': "Intrathoracic" '039': "Intratracheal" '040': "Intravenous bolus" '041': "Intravenous drip" '042': "Intravenous (not otherwise specified)" '043': "Intravesical" '044': "Iontophoresis" '045': "Nasal" '046': "Occlusive dressing technique" '047': "Ophthalmic" '048': "Oral" '049': "Oropharingeal" '050': "Other" '051': "Parenteral" '052': "Periarticular" '053': "Perineural" '054': "Rectal" '055': "Respiratory (inhalation)" '056': "Retrobulbar" '057': "Sunconjunctival" '058': "Subcutaneous" '059': "Subdermal" '060': "Sublingual" '061': "Topical" '062': "Transdermal" '063': "Transmammary" '064': "Transplacental" '065': "Unknown" '066': "Urethral" '067': "Vaginal" drugauthorizationnumb: format: is_exact: true type: string pattern: ^[0-9]{6}$ description: "Drug authorization or application number (NDA or ANDA), if provided." possible_values: drugbatchnumb: format: is_exact: true type: string pattern: description: "Drug product lot number, if provided." possible_values: drugcharacterization: format: int32 is_exact: false type: string pattern: description: "Reported role of the drug in the adverse event report. These values are not validated by FDA." possible_values: type: one_of value: '1': "Suspect (the drug was considered by the reporter to be the cause)" '2': "Concomitant (the drug was reported as being taken along with the suspect drug)" '3': "Interacting (the drug was considered by the reporter to have interacted with the suspect drug)" drugcumulativedosagenumb: format: float is_exact: false type: string pattern: description: "The cumulative dose taken until the first reaction was experienced, if provided." possible_values: drugcumulativedosageunit: format: is_exact: false type: string pattern: description: "The unit for `drugcumulativedosagenumb`." possible_values: type: one_of value: "001": "kg (kilograms)" "002": "g (grams)" "003": "mg (milligrams)" "004": "µg (micrograms)" drugdosageform: format: is_exact: true type: string pattern: description: "The drug’s dosage form. There is no standard, but values may include terms like `tablet` or `solution for injection`." possible_values: drugdosagetext: format: is_exact: true type: string pattern: description: "Additional detail about the dosage taken. Frequently unknown, but occasionally including information like a brief textual description of the schedule of administration." possible_values: drugenddate: format: date is_exact: false type: string pattern: description: "Date the patient stopped taking the drug." possible_values: drugenddateformat: format: is_exact: false type: string pattern: description: "Encoding format of the field `drugenddateformat`. Always set to `102` (YYYYMMDD)." possible_values: drugindication: format: is_exact: true type: string pattern: description: "Indication for the drug’s use." possible_values: drugintervaldosagedefinition: format: int32 is_exact: false type: string pattern: description: "The unit for the interval in the field `drugintervaldosageunitnumb.`" possible_values: type: one_of value: '801': "Year" '802': "Month" '803': "Week" '804': "Day" '805': "Hour" '806': "Minute" '807': "Trimester" '810': "Cyclical" '811': "Trimester" '812': "As necessary" '813': "Total" drugintervaldosageunitnumb: format: int32 is_exact: false type: string pattern: description: "Number of units in the field `drugintervaldosagedefinition`." possible_values: drugrecurreadministration: format: int32 is_exact: false type: string pattern: description: "Whether the reaction occured after readministration of the drug." possible_values: type: one_of value: '1': "Yes" '2': "No" '3': "Unknown" drugrecurrence: properties: drugrecuraction: format: is_exact: true type: string pattern: description: "Populated with the Reaction/Event information if/when `drugrecurreadministration` equals `1`." possible_values: drugseparatedosagenumb: format: int32 is_exact: false type: string pattern: description: "The number of separate doses that were administered." possible_values: drugstartdate: format: date is_exact: false type: string pattern: description: "Date the patient began taking the drug." possible_values: drugstartdateformat: format: is_exact: false type: string pattern: description: "Encoding format of the field `drugstartdate`. Always set to `102` (YYYYMMDD)." possible_values: drugstructuredosagenumb: format: is_exact: true type: string pattern: description: "The number portion of a dosage; when combined with `drugstructuredosageunit` the complete dosage information is represented. For example, *300* in `300 mg`." possible_values: drugstructuredosageunit: format: is_exact: false type: string pattern: description: "The unit for the field `drugstructuredosagenumb`. For example, *mg* in `300 mg`." possible_values: type: one_of value: '001': "kg (kilograms)" '002': "g (grams)" '003': "mg (milligrams)" '004': "µg (micrograms)" drugtreatmentduration: format: is_exact: true type: string pattern: description: "The interval of the field `drugtreatmentdurationunit` for which the patient was taking the drug." possible_values: drugtreatmentdurationunit: format: is_exact: false type: string pattern: description: possible_values: type: one_of value: '801': "Year" '802': "Month" '803': "Week" '804': "Day" '805': "Hour" '806': "Minute" medicinalproduct: format: type: string pattern: is_exact: true description: "Drug name. This may be the valid trade name of the product (such as `ADVIL` or `ALEVE`) or the generic name (such as `IBUPROFEN`). This field is not systematically normalized. It may contain misspellings or idiosyncratic descriptions of drugs, such as combination products such as those used for birth control." possible_values: openfda: type: object properties: application_number: type: array items: format: is_exact: true type: string pattern: ^[BLA|ANDA|NDA]{3,4}[0-9]{6}$ description: "This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null." possible_values: brand_name: type: array items: format: is_exact: true type: string pattern: description: "Brand or trade name of the drug product." possible_values: generic_name: type: array items: format: is_exact: true type: string pattern: description: "Generic name(s) of the drug product." possible_values: manufacturer_name: type: array items: format: is_exact: true type: string pattern: description: "Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC." possible_values: nui: type: array items: format: is_exact: true type: string pattern: ^[N][0-9]{10}$ description: "Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT)." possible_values: type: reference value: name: "NDF-RT" link: "https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/NDFRT/" package_ndc: type: array items: format: is_exact: true type: string pattern: ^[0-9]{5,4}-[0-9]{4,3}-[0-9]{1,2}$ description: "This number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug." possible_values: pharm_class_cs: type: array items: format: is_exact: true type: string pattern: description: "Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]." possible_values: pharm_class_epc: type: array items: format: is_exact: true type: string pattern: description: "Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`." possible_values: pharm_class_pe: type: array items: format: is_exact: true type: string pattern: description: "Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`." possible_values: pharm_class_moa: type: array items: format: is_exact: true type: string pattern: description: "Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`." possible_values: product_ndc: type: array items: format: is_exact: true type: string pattern: ^[0-9]{5,4}-[0-9]{4,3}$ description: "The labeler manufacturer code and product code segments of the NDC number, separated by a hyphen." possible_values: product_type: type: array items: format: is_exact: true type: string pattern: description: possible_values: type: reference value: name: "Type of drug product" link: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162063.htm route: type: array items: format: is_exact: true type: string pattern: description: "The route of administation of the drug product." possible_values: type: reference value: name: "Route of administration" link: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162034.htm rxcui: type: array items: format: is_exact: true type: string pattern: ^[0-9]{6}$ description: "The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms." possible_values: type: reference value: name: "RxNorm and RxCUI documentation" link: "https://www.nlm.nih.gov/research/umls/rxnorm/docs/2012/rxnorm_doco_full_2012-3.html" spl_id: type: array items: format: is_exact: true type: string pattern: ^[a-fA-F0-9]{8}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{12}$ description: "Unique identifier for a particular version of a Structured Product Label for a product. Also referred to as the document ID." possible_values: spl_set_id: type: array items: format: is_exact: true type: string pattern: ^[a-fA-F0-9]{8}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{12}$ description: "Unique identifier for the Structured Product Label for a product, which is stable across versions of the label. Also referred to as the set ID." possible_values: substance_name: type: array items: format: is_exact: true type: string pattern: description: "The list of active ingredients of a drug product." possible_values: unii: type: array items: format: is_exact: true type: string pattern: ^[A-Z0-9]{10}$ description: "Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information." possible_values: type: reference value: name: "Unique Ingredient Identifiers" link: "http://fdasis.nlm.nih.gov/srs/srs.jsp" patientagegroup: format: int32 is_exact: false type: string pattern: description: "Populated with Patient Age Group code." possible_values: type: one_of value: '1': "Neonate" '2': "Infant" '3': "Child" '4': "Adolescent" '5': "Adult" '6': "Elderly" patientdeath: type: object properties: patientdeathdate: format: date is_exact: false type: string pattern: description: "If the patient died, the date that the patient died." possible_values: patientdeathdateformat: format: is_exact: false type: string pattern: description: "Encoding format of the field `patientdeathdate`. Always set to `102` (YYYYMMDD)." possible_values: patientonsetage: format: float is_exact: false type: string pattern: description: "Age of the patient when the event first occured." possible_values: patientonsetageunit: format: is_exact: false type: string pattern: description: "The unit for the interval in the field `patientonsetage.`" possible_values: type: one_of value: '800': "Decade" '801': "Year" '802': "Month" '803': "Week" '804': "Day" '805': "Hour" patientsex: format: int32 is_exact: false type: string pattern: description: "The sex of the patient." possible_values: type: one_of value: '0': "Unknown" '1': "Male" '2': "Female" patientweight: format: float is_exact: false type: string pattern: description: "The patient weight, in kg (kilograms)." possible_values: reaction: type: array items: type: object properties: reactionmeddrapt: format: is_exact: true type: string pattern: description: "Patient reaction, as a MedDRA term. Note that these terms are encoded in British English. For instance, diarrhea is spelled `diarrohea`. MedDRA is a standardized medical terminology." possible_values: type: reference value: name: "MedDRA" link: "http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162038.htm" reactionmeddraversionpt: format: is_exact: false type: string pattern: description: "The version of MedDRA from which the term in `reactionmeddrapt` is drawn." possible_values: reactionoutcome: format: int32 is_exact: false type: string pattern: description: "Outcome of the reaction in `reactionmeddrapt` at the time of last observation." possible_values: type: one_of value: '1': "Recovered/resolved" '2': "Recovering/resolving" '3': "Not recovered/not resolved" '4': "Recovered/resolved with sequelae (consequent health issues)" '5': "Fatal" '6': "Unknown" summary: type: object properties: narrativeincludeclinical: format: is_exact: false type: string pattern: description: "Populated with Case Event Date, when available; does `NOT` include Case Narrative." possible_values: primarysource: type: object properties: literaturereference: format: is_exact: false type: string pattern: description: "Populated with the Literature Reference information, when available." possible_values: qualification: format: is_exact: false type: string pattern: description: "Category of individual who submitted the report." possible_values: type: one_of value: '1': "Physician" '2': "Pharmacist" '3': "Other health professional" '4': "Lawyer" '5': "Consumer or non-health professional" reportercountry: format: is_exact: true type: string pattern: description: "Country from which the report was submitted." possible_values: primarysourcecountry: format: is_exact: true type: string pattern: description: "Country of the reporter of the event." possible_values: type: reference value: name: "Country codes" link: "http://data.okfn.org/data/core/country-list" receiptdate: format: date is_exact: false type: string pattern: description: "Date that the _most recent_ information in the report was received by FDA." possible_values: receiptdateformat: format: is_exact: false type: string pattern: description: "Encoding format of the `transmissiondate` field. Always set to 102 (YYYYMMDD)." possible_values: receivedate: format: date is_exact: false type: string pattern: description: "Date that the report was _first_ received by FDA. If this report has multiple versions, this will be the date the first version was received by FDA." possible_values: receivedateformat: format: is_exact: false type: string pattern: description: "Encoding format of the `transmissiondate` field. Always set to 102 (YYYYMMDD)." possible_values: receiver: type: object description: "Information on the organization receiving the report." properties: receiverorganization: format: is_exact: true type: string pattern: description: "Name of the organization receiving the report. Because FDA received the report, the value is always `FDA`." possible_values: receivertype: format: int32 is_exact: false type: string pattern: description: "The type of organization receiving the report. The value,`6`, is only specified if it is `other`, otherwise it is left blank." possible_values: type: one_of value: '6': "Other" reportduplicate: type: object description: "If a report is a duplicate or more recent version than a previously submitted report, this field will provide additional details on source provider." properties: duplicatenumb: format: is_exact: true type: string pattern: description: "The case identifier for the duplicate." possible_values: duplicatesource: format: is_exact: true type: string pattern: description: "The name of the organization providing the duplicate." possible_values: reporttype: format: int32 is_exact: false type: string pattern: description: "Code indicating the circumstances under which the report was generated." possible_values: type: one_of value: '1': "Spontaneous" '2': "Report from study" '3': "Other" '4': "Not available to sender (unknown)" safetyreportid: format: is_exact: true type: string pattern: ^[0-9]{7}-[0-9]{1,2}$ description: "The 8-digit Safety Report ID number, also known as the case report number or case ID. The first 7 digits (before the hyphen) identify an individual report and the last digit (after the hyphen) is a checksum. This field can be used to identify or find a specific adverse event report." possible_values: safetyreportversion: format: int32 is_exact: false type: string pattern: description: "The version number of the `safetyreportid`. Multiple versions of the same report may exist, it is generally best to only count the latest report and disregard others. openFDA will only return the latest version of a report." possible_values: sender: type: object properties: senderorganization: format: is_exact: true type: string pattern: description: "Name of the organization sending the report. Because FDA is providing these reports to you, the value is always `FDA-Public Use.`" possible_values: sendertype: format: int32 is_exact: false type: string pattern: description: "The name of the organization sending the report. Because FDA is providing these reports to you, the value is always `2`." possible_values: type: one_of value: '2': "Regulatory authority" serious: format: int32 is_exact: false type: string pattern: description: "Seriousness of the adverse event." possible_values: type: one_of value: '1': "The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition" '2': "The adverse event did not result in any of the above" seriousnesscongenitalanomali: format: int32 is_exact: false type: string pattern: description: "This value is `1` if the adverse event resulted in a congenital anomaly, and absent otherwise." possible_values: seriousnessdeath: format: int32 is_exact: false type: string pattern: description: "This value is `1` if the adverse event resulted in death, and absent otherwise." possible_values: seriousnessdisabling: format: int32 is_exact: false type: string pattern: description: "This value is `1` if the adverse event resulted in disability, and absent otherwise." possible_values: seriousnesshospitalization: format: int32 is_exact: false type: string pattern: description: "This value is `1` if the adverse event resulted in a hospitalization, and absent otherwise." possible_values: seriousnesslifethreatening: format: int32 is_exact: false type: string pattern: description: "This value is `1` if the adverse event resulted in a life threatening condition, and absent otherwise." possible_values: seriousnessother: format: int32 is_exact: false type: string pattern: description: "This value is `1` if the adverse event resulted in some other serious condition, and absent otherwise." possible_values: transmissiondate: format: date is_exact: false type: string pattern: description: "Date that the record was created. This may be earlier than the date the record was received by the FDA." possible_values: transmissiondateformat: format: int32 is_exact: false type: string pattern: description: "Encoding format of the `transmissiondate` field. Always set to 102 (YYYYMMDD)." possible_values: