FDA FAERS Adverse Event Reports

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{ "_id": "69d435793b3830196fa5458e", "safetyreportid": "25949510", "authoritynumb": "783116", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 54.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 84.3, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Acute myocardial infarction", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anaphylactic reaction", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CEFTRIAXONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "OTHER FREQUENCY : 1 TIME;?", "drugdosageform": null, "drugadministrationroute": "040", "drugindication": "Pneumonia", "drugstartdateformat": "102", "drugstartdate": "2025-10-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-10T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": null, "activesubstance": { "activesubstancename": "CEFTRIAXONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251010" }, "primarysource": { "reportercountry": "US", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435793b3830196fa5458d", "safetyreportid": "25949509", "authoritynumb": null, "companynumb": "CA-TEVA-VS-3383325", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": 72.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Arteriosclerosis coronary artery", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mite allergy", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Haemoptysis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypoxia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Spirometry abnormal", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Conjunctivitis allergic", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Sleep disorder due to a general medical condition", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pulmonary vasculitis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Arteriosclerosis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Respiratory symptom", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Full blood count abnormal", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mycotic allergy", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Normochromic normocytic anaemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pulmonary fibrosis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dust allergy", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Loss of personal independence in daily activities", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neuritis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Wheezing", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Asthma", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Therapeutic product effect incomplete", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Thrombosis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain in extremity", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Skin exfoliation", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypothyroidism", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lung disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anxiety", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Productive cough", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Obstructive airways disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neurological symptom", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nodule", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Condition aggravated", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pulmonary embolism", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pulmonary alveolar haemorrhage", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Eosinophilic granulomatosis with polyangiitis", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DILTIAZEM", "drugauthorizationnumb": "074079", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 12.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Capsule", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DILTIAZEM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DILTIAZEM", "drugauthorizationnumb": "074079", "drugbatchnumb": "UNKNOWN", 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"activesubstance": { "activesubstancename": "MAGNESIUM OXIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE", "drugauthorizationnumb": "208799", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FLUTICASONE PROPIONATE/SALMETEROL XINAFOATE", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE" }, 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{ "_id": "69d435793b3830196fa54581", "safetyreportid": "25949497", "authoritynumb": null, "companynumb": "US-AstraZeneca-CH-00971267AP", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oxygen saturation abnormal", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Incorrect dose administered", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Wrong technique in product usage process", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device defective", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BREZTRI", "drugauthorizationnumb": "212122", "drugbatchnumb": "6102494C00", "drugstructuredosagenumb": 160.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "160 MICROGRAM", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "BUDESONIDE\\FORMOTEROL\\GLYCOPYRROLATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ALBUTEROL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALBUTEROL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ALEXION PHARMACEUTICALS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }