Datasets:

PrashantRGore
/

synthetic-faers-1m-v2

Error code:   DatasetGenerationCastError
Exception:    DatasetGenerationCastError
Message:      An error occurred while generating the dataset

All the data files must have the same columns, but at some point there are 25 new columns ({'event_soc', 'event_pt', 'concomitant_medications', 'bun_mg_dl', 'bilirubin_mg_dl', 'ast_u_l', 'receive_date', 'creatinine_mg_dl', 'action_taken', 'event_hlgt', 'event_duration_days', 'route', 'treatment_duration_days', 'event_hlt', 'weight_kg', 'dose_frequency', 'indication', 'suspect_drug', 'causality_assessment', 'time_to_onset_days', 'event_llt', 'report_type', 'reporter_type', 'seriousness', 'alt_u_l'}) and 25 missing columns ({'dose_freq', 'event_duration', 'reporter_qualification', 'drug_indication', 'drug_name', 'alt', 'serious', 'pt', 'weight', 'route_of_admin', 'causality', 'creatinine', 'ast', 'concomitant_drugs', 'therapy_duration', 'soc', 'action_drug', 'bilirubin', 'fda_dt', 'report_source', 'llt', 'bun', 'ttp_days', 'hlgt', 'hlt'}).

This happened while the csv dataset builder was generating data using

hf://datasets/PrashantRGore/synthetic-faers-1m-v2/synthetic_faers_1m_v2.csv (at revision b57df3af2c006f15ca7ba8ee68746c2ba356bf22)

Please either edit the data files to have matching columns, or separate them into different configurations (see docs at https://hf.co/docs/hub/datasets-manual-configuration#multiple-configurations)
Traceback:    Traceback (most recent call last):
                File "/usr/local/lib/python3.12/site-packages/datasets/builder.py", line 1831, in _prepare_split_single
                  writer.write_table(table)
                File "/usr/local/lib/python3.12/site-packages/datasets/arrow_writer.py", line 714, in write_table
                  pa_table = table_cast(pa_table, self._schema)
                             ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
                File "/usr/local/lib/python3.12/site-packages/datasets/table.py", line 2272, in table_cast
                  return cast_table_to_schema(table, schema)
                         ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
                File "/usr/local/lib/python3.12/site-packages/datasets/table.py", line 2218, in cast_table_to_schema
                  raise CastError(
              datasets.table.CastError: Couldn't cast
              case_id: string
              receive_date: string
              country: string
              age: int64
              age_group: string
              sex: string
              weight_kg: double
              suspect_drug: string
              indication: string
              route: string
              dose: int64
              dose_unit: string
              dose_frequency: string
              treatment_duration_days: double
              event_llt: string
              event_pt: string
              event_hlt: string
              event_hlgt: string
              event_soc: string
              time_to_onset_days: int64
              event_duration_days: double
              seriousness: string
              outcome: string
              action_taken: string
              dechallenge: string
              rechallenge: string
              concomitant_medications: string
              medical_history: string
              reporter_type: string
              report_type: string
              causality_assessment: string
              alt_u_l: double
              ast_u_l: double
              bilirubin_mg_dl: double
              creatinine_mg_dl: double
              bun_mg_dl: double
              -- schema metadata --
              pandas: '{"index_columns": [{"kind": "range", "name": null, "start": 0, "' + 4656
              to
              {'case_id': Value('string'), 'fda_dt': Value('string'), 'country': Value('string'), 'age': Value('int64'), 'age_group': Value('string'), 'sex': Value('string'), 'weight': Value('float64'), 'drug_name': Value('string'), 'drug_indication': Value('string'), 'route_of_admin': Value('string'), 'dose': Value('int64'), 'dose_unit': Value('string'), 'dose_freq': Value('string'), 'therapy_duration': Value('float64'), 'llt': Value('string'), 'pt': Value('string'), 'hlt': Value('string'), 'hlgt': Value('string'), 'soc': Value('string'), 'ttp_days': Value('int64'), 'event_duration': Value('float64'), 'serious': Value('string'), 'outcome': Value('string'), 'action_drug': Value('string'), 'dechallenge': Value('string'), 'rechallenge': Value('string'), 'concomitant_drugs': Value('string'), 'medical_history': Value('string'), 'reporter_qualification': Value('string'), 'report_source': Value('string'), 'causality': Value('string'), 'alt': Value('float64'), 'ast': Value('float64'), 'bilirubin': Value('float64'), 'creatinine': Value('float64'), 'bun': Value('float64')}
              because column names don't match
              
              During handling of the above exception, another exception occurred:
              
              Traceback (most recent call last):
                File "/src/services/worker/src/worker/job_runners/config/parquet_and_info.py", line 1339, in compute_config_parquet_and_info_response
                  parquet_operations = convert_to_parquet(builder)
                                       ^^^^^^^^^^^^^^^^^^^^^^^^^^^
                File "/src/services/worker/src/worker/job_runners/config/parquet_and_info.py", line 972, in convert_to_parquet
                  builder.download_and_prepare(
                File "/usr/local/lib/python3.12/site-packages/datasets/builder.py", line 894, in download_and_prepare
                  self._download_and_prepare(
                File "/usr/local/lib/python3.12/site-packages/datasets/builder.py", line 970, in _download_and_prepare
                  self._prepare_split(split_generator, **prepare_split_kwargs)
                File "/usr/local/lib/python3.12/site-packages/datasets/builder.py", line 1702, in _prepare_split
                  for job_id, done, content in self._prepare_split_single(
                                               ^^^^^^^^^^^^^^^^^^^^^^^^^^^
                File "/usr/local/lib/python3.12/site-packages/datasets/builder.py", line 1833, in _prepare_split_single
                  raise DatasetGenerationCastError.from_cast_error(
              datasets.exceptions.DatasetGenerationCastError: An error occurred while generating the dataset
              
              All the data files must have the same columns, but at some point there are 25 new columns ({'event_soc', 'event_pt', 'concomitant_medications', 'bun_mg_dl', 'bilirubin_mg_dl', 'ast_u_l', 'receive_date', 'creatinine_mg_dl', 'action_taken', 'event_hlgt', 'event_duration_days', 'route', 'treatment_duration_days', 'event_hlt', 'weight_kg', 'dose_frequency', 'indication', 'suspect_drug', 'causality_assessment', 'time_to_onset_days', 'event_llt', 'report_type', 'reporter_type', 'seriousness', 'alt_u_l'}) and 25 missing columns ({'dose_freq', 'event_duration', 'reporter_qualification', 'drug_indication', 'drug_name', 'alt', 'serious', 'pt', 'weight', 'route_of_admin', 'causality', 'creatinine', 'ast', 'concomitant_drugs', 'therapy_duration', 'soc', 'action_drug', 'bilirubin', 'fda_dt', 'report_source', 'llt', 'bun', 'ttp_days', 'hlgt', 'hlt'}).
              
              This happened while the csv dataset builder was generating data using
              
              hf://datasets/PrashantRGore/synthetic-faers-1m-v2/synthetic_faers_1m_v2.csv (at revision b57df3af2c006f15ca7ba8ee68746c2ba356bf22)
              
              Please either edit the data files to have matching columns, or separate them into different configurations (see docs at https://hf.co/docs/hub/datasets-manual-configuration#multiple-configurations)

Need help to make the dataset viewer work? Make sure to review how to configure the dataset viewer, and open a discussion for direct support.

case_id string	fda_dt string	country string	age int64	age_group string	sex string	weight float64	drug_name string	drug_indication string	route_of_admin string	dose int64	dose_unit string	dose_freq string	therapy_duration float64	llt string	pt string	hlt string	hlgt string	soc string	ttp_days int64	event_duration float64	serious string	outcome string	action_drug string	dechallenge string	rechallenge string	concomitant_drugs string	medical_history string	reporter_qualification string	report_source string	causality string	alt float64	ast float64	bilirubin float64	creatinine float64	bun float64
E787C9A1FC17D940	2023-04-19	CHN	52	adult	Unknown	null	Hematocare	Hypothyroidism	Subcutaneous	5	mg	Four times daily	688	High blood pressure	Deep vein thrombosis	Hypertension	Vascular hypertensive disorders	Vascular disorders	29	null	Non-serious	Recovered/Resolved	Drug withdrawn	Positive	Not applicable	Aspirin	null	Physician	Spontaneous	Probable/Likely	12	12	0.4	1	16
A29236736650CAB3	2021-10-30	POL	45	adult	Male	110.5	Osteostrong	Bipolar disorder	Intravenous	50	mg	Four times daily	348	AKI	Acute kidney injury	Acute renal failures	Renal failures and impairments	Renal and urinary disorders	7	69	Non-serious	Recovered/Resolved	Drug withdrawn	Positive	Not applicable	Hydrochlorothiazide	null	Consumer	Clinical trial	Probable/Likely	15	null	0.5	7.1	46
837A1C25D1B0ED72	2021-09-12	ITA	92	elderly	Female	null	Hematocare	COPD	Subcutaneous	1	mg	As needed	556	Hepatic injury	Hepatotoxicity	Liver failures and associated disorders	Liver disorders	Hepatobiliary disorders	45	null	Non-serious	Recovering/Resolving	Not applicable	Not applicable	Not applicable	null	Hyperlipidemia; Alcohol use disorder; Chronic kidney disease; Previous myocardial infarction	Physician	Spontaneous	Possible	340	null	9.5	0.9	15
BF1523DD99667C0D	2021-10-03	USA	47	adult	Male	115	Vasodilate	Schizophrenia	Ophthalmic	1	mg	Once daily	null	Erythema multiforme	Toxic epidermal necrolysis	Rashes, eruptions and exanthems NEC	Epidermal and dermal conditions	Skin and subcutaneous tissue disorders	5	45	Non-serious	Recovered with sequelae	Dose reduced	Not applicable	Not applicable	null	Peripheral vascular disease; Hypothyroidism; Previous myocardial infarction	Consumer	Spontaneous	Possible	45	null	1.1	1.2	9
F470F722F96A2FF7	2021-03-08	GBR	19	adult	Female	94.4	Cardiomax	Rheumatoid arthritis	Intramuscular	5	mg	Twice daily	453	Hyperthyroidism	Diabetes mellitus	Hyperglycaemic conditions NEC	Glucose metabolism disorders	Endocrine disorders	174	null	Other medically important condition	Recovered with sequelae	Dose increased	Not applicable	Not applicable	Pantoprazole; Hydrochlorothiazide	null	Pharmacist	Spontaneous	Unlikely	33	35	0.1	1.1	12
785B2438894CDCFA	2025-08-05	ESP	89	elderly	Male	111.7	Eyeprotect	Rheumatoid arthritis	Topical	2	mg	Three times daily	null	AKI	Acute kidney injury	Acute renal failures	Renal failures and impairments	Renal and urinary disorders	2	61	Disability	Recovered/Resolved	Not applicable	Not applicable	Not applicable	Warfarin; Aspirin	Osteoarthritis; Depression	Other health professional	Literature	Possible	27	26	1.2	null	null
5A0796C50364BAA5	2023-04-29	CAN	58	adult	Unknown	58.1	Immunoshield	Type 2 diabetes	Topical	1	mg	As needed	null	Blood clot in leg	Hypertension	Hypertension	Vascular hypertensive disorders	Vascular disorders	14	9	Non-serious	Recovered with sequelae	Dose not changed	Not applicable	Not applicable	Atorvastatin; Ciprofloxacin	Chronic pain; Hypothyroidism; Heart failure	Lawyer	Spontaneous	Possible	28	16	1.1	1.2	11
BEA3CC1D4F66B39B	2022-04-26	NLD	47	adult	Unknown	null	Eyeprotect	Anxiety	Intravenous	250	mg	As needed	680	New malignancy	Carcinoma	Leukaemias NEC	Malignant neoplasms	Neoplasms benign, malignant and unspecified	54	null	Non-serious	Recovered/Resolved	Drug withdrawn	Positive	Not applicable	Lisinopril	Hepatitis B	Consumer	Spontaneous	Possible	34	null	0.9	1.2	19
A3B710F35B3DBE9E	2022-04-13	BEL	78	elderly	Unknown	null	Thyroregul	Schizophrenia	Inhalation	10	mg	As needed	517	Blood clot in lung	Pulmonary embolism	Dyspnoea and related conditions	Respiratory disorders NEC	Respiratory, thoracic and mediastinal disorders	171	null	Non-serious	Not recovered/Not resolved	Dose reduced	Not applicable	Not applicable	Warfarin	Gastroesophageal reflux disease; Occupational radiation exposure; Chronic pain	Lawyer	Spontaneous	Unlikely	27	32	0.4	null	10
73BDA39A3B797270	2021-10-29	AUT	9	child	Unknown	46.2	Cardiomax	Infection	Ophthalmic	10	mg	Four times daily	null	Low WBC	Agranulocytosis	Neutropenias	White blood cell disorders	Blood and lymphatic system disorders	13	7	Non-serious	Not recovered/Not resolved	Dose increased	Not applicable	Not applicable	Acetaminophen; Warfarin	Gastroesophageal reflux disease	Lawyer	Spontaneous	Possible	34	31	0.9	1.2	null
4EF830077EAB9CC6	2023-11-19	RUS	21	adult	Male	76.5	Diabecontrol	Rheumatoid arthritis	Topical	5	mg	Four times daily	259	Hepatocellular injury	Hepatotoxicity	Liver failures and associated disorders	Liver disorders	Hepatobiliary disorders	24	70	Hospitalization - initial or prolonged	Recovered/Resolved	Drug withdrawn	Unknown	Not applicable	null	null	Pharmacist	Spontaneous	Possible	120	null	10.5	0.8	19
57C98C2AA1EA87E7	2024-11-12	POL	53	adult	Unknown	null	Psychostabil	Migraine prophylaxis	Subcutaneous	1	mg	As needed	708	Acute leukemia	Acute myeloid leukaemia	Leukaemias NEC	Malignant neoplasms	Neoplasms benign, malignant and unspecified	23	39	Non-serious	Recovering/Resolving	Drug withdrawn	Unknown	Not applicable	Albuterol; Hydrochlorothiazide	Anxiety disorder	Physician	Spontaneous	Possible	null	23	0.2	1	null
FBC0C579BD045CEF	2024-03-06	JPN	80	elderly	Unknown	null	Diabecontrol	GERD	Intravenous	250	mg	Four times daily	250	Cannot sleep	Anxiety	Depressive disorders	Mental disorders NEC	Psychiatric disorders	22	null	Disability	Recovered with sequelae	Drug withdrawn	Positive	Not applicable	Acetaminophen	Gastroesophageal reflux disease; Migraine	Physician	Spontaneous	Probable/Likely	null	33	null	0.9	14
A5BDDF88AE65A095	2024-01-13	SWE	51	adult	Unknown	79.8	Diabecontrol	Osteoarthritis	Rectal	5	mg	Three times daily	258	Convulsion	Headache	Headaches	Neurological disorders NEC	Nervous system disorders	7	null	Congenital anomaly	Unknown	Dose not changed	Not applicable	Not applicable	null	Gastroesophageal reflux disease; Benign prostatic hyperplasia	Consumer	Regulatory authority	Possible	43	13	0.4	0.8	9
6C88310FB016B892	2021-05-07	RUS	20	adult	Female	69.9	Diabecontrol	Anxiety	Oral	50	mg	Four times daily	null	DILI	Jaundice	Liver failures and associated disorders	Liver disorders	Hepatobiliary disorders	3	null	Non-serious	Recovered/Resolved	Drug withdrawn	Positive	Not applicable	Atorvastatin; Hydrochlorothiazide; Prednisone	Occupational chemical exposure; Previous myocardial infarction	Pharmacist	Clinical trial	Probable/Likely	489	543	9.4	null	null
772C929AC2342465	2021-08-20	DNK	26	adult	Unknown	78.6	Painaway	COPD	Oral	25	mg	Three times daily	724	Vomiting symptom	Gastrointestinal haemorrhage	Nausea and vomiting symptoms	Gastrointestinal signs and symptoms	Gastrointestinal disorders	147	10	Non-serious	Recovered with sequelae	Dose not changed	Not applicable	Not applicable	Amoxicillin; Metoprolol	Migraine	Pharmacist	Spontaneous	Unlikely	27	null	1	1.2	null
409F47B4A2E65357	2024-03-11	JPN	13	adolescent	Unknown	73.1	Cardiomax	Hyperlipidemia	Subcutaneous	25	mg	As needed	22	CVA	Stroke	Hypertension	Vascular hypertensive disorders	Vascular disorders	178	null	Non-serious	Recovered/Resolved	Dose increased	Not applicable	Not applicable	Furosemide	Osteoporosis	Lawyer	Spontaneous	Unlikely	41	25	0.5	1.2	18
19C30D76AA6B6C45	2024-01-23	POL	26	adult	Male	null	Thyroregul	Coronary artery disease	Topical	1	mg	Twice daily	null	Low hemoglobin	Anemia	Neutropenias	White blood cell disorders	Blood and lymphatic system disorders	158	81	Non-serious	Recovered/Resolved	Drug withdrawn	Positive	Not applicable	Simvastatin; Atorvastatin	null	Consumer	Clinical trial	Possible	20	10	0.2	1.2	8
A72FAEBA9BD08C38	2023-03-25	MEX	47	adult	Male	82	Hematocare	Schizophrenia	Sublingual	2	mg	Once daily	283	Wheezing	Dyspnoea	Dyspnoea and related conditions	Respiratory disorders NEC	Respiratory, thoracic and mediastinal disorders	26	null	Death	Fatal	Drug withdrawn	Positive	Not applicable	Simvastatin; Omeprazole; Losartan	Anxiety disorder; Depression	Consumer	Clinical trial	Probable/Likely	34	20	null	0.9	null
44F4DA6CA2153492	2021-07-25	BEL	70	elderly	Male	117.5	Lipidlow	Rheumatoid arthritis	Intravenous	500	mg	Once daily	539	Generalized anxiety	Insomnia	Depressive disorders	Mental disorders NEC	Psychiatric disorders	5	53	Non-serious	Unknown	Drug withdrawn	Not applicable	Not applicable	Acetaminophen	Previous stroke; Hyperlipidemia	Other health professional	Literature	Possible	44	20	1.1	1	10
ABAB4B3427295CC2	2023-01-15	ZAF	25	adult	Female	61.6	Cardiomax	Type 2 diabetes	Inhalation	1	mg	Three times daily	null	Decreased blood cells	Pancytopenia	Neutropenias	White blood cell disorders	Blood and lymphatic system disorders	8	68	Non-serious	Recovering/Resolving	Drug withdrawn	Positive	Not applicable	Amoxicillin	Hepatitis C	Consumer	Spontaneous	Probable/Likely	39	24	0.1	1.2	null
27FD1578D123F555	2025-09-11	FRA	36	adult	Female	120	Pulmofix	Migraine prophylaxis	Ophthalmic	5	mg	As needed	303	Loose stools	Diarrhoea	Nausea and vomiting symptoms	Gastrointestinal signs and symptoms	Gastrointestinal disorders	27	null	Non-serious	Recovered/Resolved	Not applicable	Not applicable	Not applicable	Metformin; Acetaminophen	Smoking history; Hepatitis B	Other health professional	Clinical trial	Possible	24	null	0.3	1.1	17
6F3EB8ACAB09E582	2021-06-07	IND	63	adult	Female	56.3	Eyeprotect	Atrial fibrillation	Intramuscular	2	mg	null	553	Decreased RBC	Thrombocytopenia	Neutropenias	White blood cell disorders	Blood and lymphatic system disorders	30	35	Non-serious	Recovered/Resolved	Not applicable	Not applicable	Not applicable	Insulin	Depression; Occupational chemical exposure	Physician	Spontaneous	Possible	null	null	0.8	0.9	15
BDE02EA4D5241E3D	2023-08-23	FRA	56	adult	Female	107.6	Dermafix	GERD	Rectal	1	mg	null	575	Blood in stool	Nausea	Nausea and vomiting symptoms	Gastrointestinal signs and symptoms	Gastrointestinal disorders	407	null	Disability	Recovered with sequelae	Dose reduced	Not applicable	Not applicable	Omeprazole	null	Physician	Spontaneous	Unlikely	null	17	0.2	1.1	15
E1FCEEC20570540D	2025-10-13	RUS	33	adult	Male	98.3	Vasodilate	GERD	Inhalation	1	mg	Three times daily	null	Basal cell carcinoma	Lymphoma	Leukaemias NEC	Malignant neoplasms	Neoplasms benign, malignant and unspecified	13	36	Death	Fatal	Unknown	Not applicable	Not applicable	Lisinopril; Amoxicillin	Previous stroke	Consumer	Regulatory authority	Possible	13	17	null	1.2	null
11927E0309C1CBAC	2025-03-16	FRA	68	elderly	Male	87.8	Dermafix	Hypertension	Intramuscular	1	mg	null	244	Eosinophilia	Drug reaction with eosinophilia	Hypersensitivity conditions NEC	Allergic conditions	Immune system disorders	6	34	Other medically important condition	Recovered/Resolved	Drug withdrawn	Positive	Not applicable	Pantoprazole	null	Consumer	Spontaneous	Probable/Likely	12	39	0.7	null	14
FA8D3B8951A3D545	2024-11-10	FIN	25	adult	Unknown	58.8	Lipidlow	Hypothyroidism	Inhalation	10	mg	null	null	Loose stools	Diarrhoea	Nausea and vomiting symptoms	Gastrointestinal signs and symptoms	Gastrointestinal disorders	20	56	Other medically important condition	Recovered/Resolved	Dose not changed	Not applicable	Not applicable	Hydrochlorothiazide; Ciprofloxacin	Rheumatoid arthritis; Obesity; Hepatitis B	Pharmacist	Spontaneous	Possible	39	null	0.6	null	null
6DCE6F0EAA6CFE42	2025-09-25	FRA	57	adult	Unknown	null	Infectoban	Osteoarthritis	Topical	1	mg	Three times daily	615	Cramping	Diarrhoea	Nausea and vomiting symptoms	Gastrointestinal signs and symptoms	Gastrointestinal disorders	19	65	Other medically important condition	Recovered/Resolved	Not applicable	Not applicable	Not applicable	Hydrochlorothiazide	Occupational radiation exposure	Other health professional	Spontaneous	Possible	37	34	0.8	0.6	20
353ED98700262A43	2024-08-08	ITA	29	adult	Male	null	Eyeprotect	Bipolar disorder	Oral	10	mg	As needed	221	Cytopenia	Leukopenia	Neutropenias	White blood cell disorders	Blood and lymphatic system disorders	11	21	Non-serious	Not recovered/Not resolved	Dose not changed	Not applicable	Not applicable	Lisinopril	Atrial fibrillation; Chronic kidney disease; Occupational radiation exposure	Consumer	Spontaneous	Possible	15	31	0.8	0.8	12
03786152A65949A9	2022-10-28	CAN	54	adult	Female	null	Sleepwell	Depression	Transdermal	5	mg	Three times daily	123	CHF	Cardiac failure	Heart failures NEC	Heart failures	Cardiac disorders	14	23	Congenital anomaly	Not recovered/Not resolved	Dose increased	Not applicable	Not applicable	Albuterol; Lisinopril	Benign prostatic hyperplasia	Physician	Spontaneous	Possible	39	37	0.6	1	null
D52AF8B08D66FB20	2025-02-26	MEX	16	adolescent	Unknown	50.9	Anticoag-XR	Hyperlipidemia	Topical	5	mg	Three times daily	227	Low neutrophils	Pancytopenia	Neutropenias	White blood cell disorders	Blood and lymphatic system disorders	50	66	Non-serious	Recovering/Resolving	Drug withdrawn	Not applicable	Not applicable	Ibuprofen	COPD; Coronary artery disease; Atrial fibrillation	Other health professional	Spontaneous	Unlikely	19	null	1.1	0.9	16
3E7BD717FF124F0E	2021-11-21	FIN	28	adult	Female	54.8	Oncotreat	Asthma	Ophthalmic	1	mg	Three times daily	null	Hepatic dysfunction	Hepatic failure	Liver failures and associated disorders	Liver disorders	Hepatobiliary disorders	15	5	Hospitalization - initial or prolonged	Recovered/Resolved	Not applicable	Not applicable	Not applicable	Acetaminophen; Clopidogrel	Osteoporosis	Consumer	Regulatory authority	Possible	142	675	5.8	null	8
5E515EA76957E281	2024-07-19	BRA	48	adult	Male	86.6	Arthrorelief	COPD	Topical	10	mg	Three times daily	null	Septic shock	Sepsis	Bacterial infections NEC	Infections NEC	Infections and infestations	21	83	Hospitalization - initial or prolonged	Recovered/Resolved	Dose not changed	Not applicable	Not applicable	Ciprofloxacin	Hepatitis C; Previous myocardial infarction; Alcohol use disorder	Pharmacist	Spontaneous	Possible	19	19	0.9	1	11
668DE02B9761605D	2024-12-09	CHN	95	elderly	Unknown	56.5	Anticoag-XR	Osteoarthritis	Oral	100	mg	Three times daily	185	Erythema multiforme	Toxic epidermal necrolysis	Rashes, eruptions and exanthems NEC	Epidermal and dermal conditions	Skin and subcutaneous tissue disorders	25	63	Life-threatening	Recovered/Resolved	Drug withdrawn	Not applicable	Not applicable	Hydrochlorothiazide	Hepatitis B; Chronic pain; Diabetes mellitus type 2	Other health professional	Literature	Possible	18	null	1	null	null
F8A93FECC5A98328	2021-01-20	ZAF	74	elderly	Female	66.7	Hematocare	Osteoarthritis	Ophthalmic	10	mg	Four times daily	289	Shortness of breath	Respiratory failure	Dyspnoea and related conditions	Respiratory disorders NEC	Respiratory, thoracic and mediastinal disorders	14	null	Non-serious	Not recovered/Not resolved	Drug withdrawn	Positive	Not applicable	Hydrochlorothiazide; Atorvastatin	Chronic pain; Alcohol use disorder	Physician	Spontaneous	Probable/Likely	20	38	null	1.2	12
B16C43B9E05EE8CC	2025-07-11	IND	36	adult	Unknown	108.7	Neurobalance	Depression	Oral	50	mg	Four times daily	null	Oliguria	Acute kidney injury	Acute renal failures	Renal failures and impairments	Renal and urinary disorders	151	null	Non-serious	Recovered with sequelae	Drug withdrawn	Positive	Unknown	Prednisone; Atorvastatin	COPD; Hypothyroidism	Physician	Spontaneous	Possible	36	29	0.2	null	90
ED35BFC66A9EF391	2023-11-07	DEU	58	adult	Female	null	Anticoag-XR	Hypothyroidism	Sublingual	25	mg	null	21	SOB	Pneumonitis	Dyspnoea and related conditions	Respiratory disorders NEC	Respiratory, thoracic and mediastinal disorders	42	21	Non-serious	Recovered/Resolved	Dose not changed	Not applicable	Not applicable	Lisinopril	Benign prostatic hyperplasia	Physician	Clinical trial	Unlikely	null	21	null	1.1	18
7F22EE40E9747174	2024-10-25	BEL	28	adult	Female	null	Psychostabil	Hypothyroidism	Rectal	5	mg	Once daily	663	Hives	Urticaria	Rashes, eruptions and exanthems NEC	Epidermal and dermal conditions	Skin and subcutaneous tissue disorders	28	7	Non-serious	Recovered/Resolved	Drug withdrawn	Positive	Not applicable	Gabapentin; Levothyroxine	Sleep apnea; Peripheral vascular disease; Anxiety disorder; Hepatitis C	Consumer	Spontaneous	Probable/Likely	15	12	null	null	12
937A3483B70E66A1	2023-03-14	FIN	9	child	Female	null	Hepatosan	Hyperlipidemia	Topical	5	mg	As needed	696	Skin rash	Toxic epidermal necrolysis	Rashes, eruptions and exanthems NEC	Epidermal and dermal conditions	Skin and subcutaneous tissue disorders	327	null	Non-serious	Recovered/Resolved	Drug withdrawn	Positive	Not applicable	Pantoprazole	null	Pharmacist	Spontaneous	Possible	33	null	0.3	0.8	null
1E76B4CE76D8D58A	2025-04-11	CAN	33	adult	Female	70	Dermatopin	Depression	Intravenous	500	mg	Twice daily	null	Mixed hepatic injury	Hepatitis acute	Liver failures and associated disorders	Liver disorders	Hepatobiliary disorders	112	null	Death	Fatal	Dose increased	Not applicable	Not applicable	Insulin	Peripheral vascular disease; Hepatitis C; Previous stroke	Pharmacist	Clinical trial	Unlikely	null	295	4.7	0.9	14
AADDD20E42CBAAFD	2023-07-01	DEU	52	adult	Unknown	null	Neurobalance	Rheumatoid arthritis	Intravenous	500	mg	Four times daily	697	Muscle fatigue	Rhabdomyolysis	Myopathies	Muscle disorders	Musculoskeletal and connective tissue disorders	29	null	Non-serious	Recovered/Resolved	Unknown	Not applicable	Not applicable	Metformin	Chronic pain; Atrial fibrillation; Hypothyroidism	Pharmacist	Spontaneous	Possible	24	40	null	0.7	null
A5EFF1ED7A43BCE5	2022-08-25	IND	62	adult	Unknown	100.4	Lipidlow	Type 2 diabetes	Oral	10	mg	Once daily	657	Facial swelling	Angioedema	Hypersensitivity conditions NEC	Allergic conditions	Immune system disorders	7	74	Non-serious	Recovering/Resolving	Dose reduced	Not applicable	Not applicable	Insulin; Ibuprofen	Sleep apnea; COPD; Occupational chemical exposure; Heart failure	Lawyer	Spontaneous	Possible	14	15	null	1	18
7D63D54087253868	2025-07-18	AUS	14	adolescent	Female	45.5	Neurobalance	Pain management	Oral	50	mg	Four times daily	631	Bronchial constriction	Respiratory failure	Dyspnoea and related conditions	Respiratory disorders NEC	Respiratory, thoracic and mediastinal disorders	28	null	Non-serious	Recovered with sequelae	Dose not changed	Not applicable	Not applicable	null	Chronic pain	Lawyer	Spontaneous	Possible	29	12	0.7	0.8	7
4469ED65369AF93A	2020-12-17	BRA	13	adolescent	Female	72.7	Hepatosan	Migraine prophylaxis	Oral	1,000	mg	Twice daily	null	Hyperthyroidism	Diabetes mellitus	Hyperglycaemic conditions NEC	Glucose metabolism disorders	Endocrine disorders	13	65	Non-serious	Recovering/Resolving	Not applicable	Not applicable	Not applicable	Acetaminophen; Atorvastatin	null	Physician	Spontaneous	Possible	31	21	0.3	null	9
CEADD96423260391	2021-11-28	CHE	74	elderly	Unknown	null	Oncotreat	Seizure disorder	Inhalation	25	mg	As needed	null	Elevated CPK	Back pain	Myopathies	Muscle disorders	Musculoskeletal and connective tissue disorders	107	null	Non-serious	Recovered/Resolved	Dose not changed	Not applicable	Not applicable	Pantoprazole; Insulin; Ciprofloxacin	Previous stroke; Hypertension; Previous myocardial infarction	Lawyer	Spontaneous	Unlikely	24	28	0.7	1.1	20
FB7454AF6380AF6B	2023-07-29	NZL	61	adult	Unknown	78.7	Painaway	Stroke prevention	Oral	20	mg	As needed	213	Anaphylactic shock	Anaphylactic reaction	Hypersensitivity conditions NEC	Allergic conditions	Immune system disorders	22	62	Non-serious	Recovered/Resolved	Drug withdrawn	Unknown	Not applicable	Albuterol	Alcohol use disorder; Benign prostatic hyperplasia	Other health professional	Spontaneous	Possible	22	18	0.3	0.8	10
30000BCEFBB1E0D9	2025-10-13	TUR	56	adult	Female	null	Arthrorelief	Infection	Intramuscular	5	mg	Once daily	295	Hepatocellular injury	Hepatotoxicity	Liver failures and associated disorders	Liver disorders	Hepatobiliary disorders	15	84	Disability	Recovered/Resolved	Not applicable	Not applicable	Not applicable	Hydrochlorothiazide	Atrial fibrillation; Coronary artery disease	Consumer	Clinical trial	Possible	null	null	null	0.8	17
9AEB86F5B864388B	2025-02-02	IND	79	elderly	Female	null	Oncotreat	Bipolar disorder	Oral	10	mg	As needed	null	Low blood sugar	Thyroid disorder	Hyperglycaemic conditions NEC	Glucose metabolism disorders	Endocrine disorders	40	23	Non-serious	Not recovered/Not resolved	Unknown	Not applicable	Not applicable	null	Occupational chemical exposure; Sleep apnea; Chronic kidney disease	Other health professional	Literature	Possible	10	null	1.2	1.3	14
B3BD1928E414F658	2025-06-28	CHE	59	adult	Male	100.3	Diabecontrol	COPD	Ophthalmic	2	mg	Twice daily	626	Non-Hodgkin lymphoma	Acute myeloid leukaemia	Leukaemias NEC	Malignant neoplasms	Neoplasms benign, malignant and unspecified	140	66	Disability	Recovering/Resolving	Drug withdrawn	Positive	Not applicable	Furosemide	Obesity	Other health professional	Regulatory authority	Possible	29	null	0.8	null	null
2B89D9B20E213E3A	2024-12-31	ITA	36	adult	Male	null	Painaway	Depression	Rectal	25	mg	Three times daily	null	Hypothyroidism	Thyroid disorder	Hyperglycaemic conditions NEC	Glucose metabolism disorders	Endocrine disorders	956	69	Non-serious	Not recovered/Not resolved	Dose not changed	Not applicable	Not applicable	Acetaminophen; Lisinopril	Chronic pain; Peripheral vascular disease	Other health professional	Spontaneous	Unlikely	null	27	0.3	0.7	null
5333134178EA57DC	2025-06-12	SWE	51	adult	Male	82	Vasodilate	Cancer	Transdermal	1	mg	Four times daily	261	Heart failure	Cardiac failure	Heart failures NEC	Heart failures	Cardiac disorders	179	10	Hospitalization - initial or prolonged	Not recovered/Not resolved	Dose increased	Not applicable	Not applicable	null	Hepatitis C; Sleep apnea; Diabetes mellitus type 2	Other health professional	Spontaneous	Possible	18	33	0.6	0.9	13
957326EA46B40FB4	2022-10-05	AUS	53	adult	Unknown	null	Cardiomax	Infection	Oral	50	mg	Four times daily	null	Thyroid dysfunction	Thyroid disorder	Hyperglycaemic conditions NEC	Glucose metabolism disorders	Endocrine disorders	13	30	Hospitalization - initial or prolonged	Recovered/Resolved	Drug withdrawn	Not applicable	Not applicable	Metformin; Amoxicillin	Occupational radiation exposure	Physician	Spontaneous	Possible	null	11	0.8	null	null
3EF675D049109158	2022-09-01	PRT	90	elderly	Unknown	null	Dermafix	Rheumatoid arthritis	Subcutaneous	5	mg	Twice daily	null	Weakness	Rhabdomyolysis	Myopathies	Muscle disorders	Musculoskeletal and connective tissue disorders	10	36	Congenital anomaly	Recovered with sequelae	Unknown	Not applicable	Not applicable	Prednisone; Hydrochlorothiazide	Anxiety disorder	Lawyer	Clinical trial	Possible	30	null	0.5	0.9	11
FD9A5886A483DFC5	2024-02-19	FIN	41	adult	Female	67.8	Nephroguard	Coronary artery disease	Inhalation	1	mg	As needed	196	Bradycardia	Cardiac failure	Heart failures NEC	Heart failures	Cardiac disorders	22	null	Non-serious	Recovered with sequelae	Drug withdrawn	Not applicable	Not applicable	Hydrochlorothiazide; Metoprolol	Alcohol use disorder	Other health professional	Spontaneous	Possible	null	16	0.2	null	16
89EC5E64989D1E01	2021-12-26	RUS	37	adult	Female	75.2	Dermatopin	Stroke prevention	Rectal	5	mg	null	380	Hard stools	Gastrointestinal haemorrhage	Nausea and vomiting symptoms	Gastrointestinal signs and symptoms	Gastrointestinal disorders	19	null	Non-serious	Recovered/Resolved	Dose not changed	Not applicable	Not applicable	Ciprofloxacin	Atrial fibrillation	Pharmacist	Spontaneous	Possible	34	17	0.8	0.8	18
50F637EECF1F3D2B	2021-02-19	TUR	50	adult	Male	null	Dermafix	Type 2 diabetes	Oral	200	mg	null	null	Convulsion	Headache	Headaches	Neurological disorders NEC	Nervous system disorders	5	2	Disability	Recovered/Resolved	Dose not changed	Not applicable	Not applicable	Acetaminophen; Simvastatin	Hypertension; Migraine	Consumer	Spontaneous	Possible	11	18	0.4	1.1	null
70A636595BCAFC00	2022-10-31	RUS	41	adult	Female	76.1	Lipidlow	GERD	Subcutaneous	5	mg	null	670	High blood pressure	Deep vein thrombosis	Hypertension	Vascular hypertensive disorders	Vascular disorders	54	null	Non-serious	Recovering/Resolving	Drug withdrawn	Positive	Positive	Levothyroxine	Alcohol use disorder; Coronary artery disease	Consumer	Literature	Certain	null	37	0.7	1.2	11
14F99AE4E4B593CC	2021-06-16	ESP	64	adult	Female	115	Lipidlow	GERD	Ophthalmic	10	mg	As needed	null	Breathing difficulty	Pulmonary embolism	Dyspnoea and related conditions	Respiratory disorders NEC	Respiratory, thoracic and mediastinal disorders	66	89	Non-serious	Recovering/Resolving	Unknown	Not applicable	Not applicable	null	Smoking history	Physician	Spontaneous	Possible	35	null	0.4	0.9	13
91C416DEA5553E44	2023-10-08	GRC	23	adult	Unknown	60.8	Osteostrong	Depression	Topical	5	mg	Three times daily	null	Elevated transaminases	Hepatotoxicity	Liver failures and associated disorders	Liver disorders	Hepatobiliary disorders	10	null	Non-serious	Recovered/Resolved	Drug withdrawn	Positive	Not applicable	Prednisone	null	Physician	Spontaneous	Probable/Likely	195	422	1.7	1.1	15
DDB6705FBDFE7BD6	2025-02-01	JPN	48	adult	Female	54.4	Infectoban	COPD	Rectal	1	mg	Three times daily	258	Light-headedness	Seizure	Headaches	Neurological disorders NEC	Nervous system disorders	157	null	Non-serious	Recovered/Resolved	Drug withdrawn	Positive	Not applicable	Gabapentin; Levothyroxine	Rheumatoid arthritis	Consumer	Spontaneous	Possible	30	null	0.4	1.3	18
9CA35463ED5A8CFE	2025-10-25	ESP	53	adult	Unknown	91.5	Dermafix	Infection	Sublingual	1	mg	Four times daily	726	Skin peeling	Pruritus	Rashes, eruptions and exanthems NEC	Epidermal and dermal conditions	Skin and subcutaneous tissue disorders	10	null	Disability	Recovering/Resolving	Drug withdrawn	Positive	Not applicable	null	Osteoarthritis	Physician	Spontaneous	Probable/Likely	40	27	1.1	1	12
9DF41A45AEFCAB99	2024-12-24	POL	30	adult	Unknown	null	Osteostrong	Migraine prophylaxis	Inhalation	10	mg	null	11	Yellow skin	Jaundice	Liver failures and associated disorders	Liver disorders	Hepatobiliary disorders	17	9	Non-serious	Recovering/Resolving	Drug withdrawn	Positive	Not applicable	Azithromycin; Clopidogrel	Hypertension	Lawyer	Spontaneous	Probable/Likely	525	null	null	0.8	10
DE41841676D12418	2021-10-13	FRA	1	child	Unknown	null	Dermafix	Anxiety	Subcutaneous	25	mg	Twice daily	null	Skin rash	Toxic epidermal necrolysis	Rashes, eruptions and exanthems NEC	Epidermal and dermal conditions	Skin and subcutaneous tissue disorders	14	60	Disability	Recovering/Resolving	Drug withdrawn	Negative	Not applicable	Ciprofloxacin	Asthma; Obesity	Consumer	Spontaneous	Unlikely	10	16	0.9	1	null
6F5AD8AF068AD6F2	2024-06-15	FRA	57	adult	Unknown	null	Arthrorelief	Osteoarthritis	Rectal	25	mg	Twice daily	null	Watery stools	Diarrhoea	Nausea and vomiting symptoms	Gastrointestinal signs and symptoms	Gastrointestinal disorders	785	null	Non-serious	Recovered/Resolved	Drug withdrawn	Positive	Not applicable	null	Previous myocardial infarction	Pharmacist	Spontaneous	Possible	null	30	1.1	null	null
201BEA405C92AAF7	2021-10-17	FIN	19	adolescent	Unknown	117.5	Painaway	Atrial fibrillation	Rectal	10	mg	Four times daily	null	SJS	Toxic epidermal necrolysis	Rashes, eruptions and exanthems NEC	Epidermal and dermal conditions	Skin and subcutaneous tissue disorders	1	29	Hospitalization - initial or prolonged	Recovered/Resolved	Drug withdrawn	Not applicable	Not applicable	Simvastatin	Coronary artery disease; Osteoporosis	Physician	Spontaneous	Possible	44	21	0.9	null	null
A2BDEA67E37F41F5	2021-11-20	PRT	24	adult	Male	110.6	Pulmofix	Insomnia	Ophthalmic	5	mg	null	648	Blood clot in lung	Pulmonary embolism	Dyspnoea and related conditions	Respiratory disorders NEC	Respiratory, thoracic and mediastinal disorders	5	null	Non-serious	Not recovered/Not resolved	Dose not changed	Not applicable	Not applicable	Acetaminophen	Depression; Peripheral vascular disease	Other health professional	Spontaneous	Possible	27	26	null	1.3	7
F5B347856E8CCB0E	2024-10-09	FIN	90	elderly	Unknown	null	Immunoshield	Bipolar disorder	Topical	10	mg	Four times daily	78	New malignancy	Carcinoma	Leukaemias NEC	Malignant neoplasms	Neoplasms benign, malignant and unspecified	54	null	Non-serious	Recovered/Resolved	Unknown	Not applicable	Not applicable	Simvastatin	Hypertension	Physician	Clinical trial	Unlikely	39	32	0.2	0.8	10
627200A91C8E661A	2024-11-22	GRC	91	elderly	Unknown	null	Vasodilate	Hypertension	Intravenous	100	mg	Four times daily	null	Heart failure	Cardiac failure	Heart failures NEC	Heart failures	Cardiac disorders	619	26	Non-serious	Recovered with sequelae	Not applicable	Not applicable	Not applicable	Furosemide	null	Other health professional	Spontaneous	Unlikely	33	null	0.5	null	null
F70365BF2ACAF087	2024-09-22	AUT	18	adult	Female	107.2	Neurobalance	Heart failure	Intravenous	100	mg	Four times daily	92	Jaundice symptom	Drug-induced liver injury	Liver failures and associated disorders	Liver disorders	Hepatobiliary disorders	12	null	Life-threatening	Recovering/Resolving	Dose not changed	Not applicable	Not applicable	null	Previous myocardial infarction; Previous stroke	Pharmacist	Spontaneous	Possible	318	245	9.8	0.8	9
D3E7D7BC23D3B753	2021-10-16	CHE	22	adult	Unknown	null	Glucobalance	COPD	Oral	50	mg	Twice daily	531	UTI	Urinary tract infection	Bacterial infections NEC	Infections NEC	Infections and infestations	24	null	Death	Fatal	Dose not changed	Not applicable	Not applicable	Warfarin; Simvastatin	COPD	Lawyer	Spontaneous	Possible	14	10	null	1.2	12
AC0D5C4253EC96BD	2021-01-30	GRC	1	infant	Male	null	Psychostabil	Chronic kidney disease	Transdermal	25	mg	Four times daily	434	Lung inflammation	Dyspnoea	Dyspnoea and related conditions	Respiratory disorders NEC	Respiratory, thoracic and mediastinal disorders	18	null	Non-serious	Recovered/Resolved	Dose reduced	Not applicable	Not applicable	Metoprolol	Atrial fibrillation; Migraine; Depression; Osteoarthritis	Consumer	Spontaneous	Possible	14	23	null	0.7	14
26B0B99A09EAA0CC	2022-12-20	BEL	11	adolescent	Female	29.9	Anticoag-XR	Stroke prevention	Transdermal	2	mg	Three times daily	130	Fainting	Headache	Headaches	Neurological disorders NEC	Nervous system disorders	61	null	Disability	Recovered/Resolved	Drug withdrawn	Negative	Not applicable	Lisinopril	Chronic pain	Other health professional	Spontaneous	Unlikely	20	18	1.1	0.7	null
A7B6846198108FAC	2022-10-11	CHE	90	elderly	Unknown	88.7	Osteostrong	Atrial fibrillation	Subcutaneous	5	mg	Twice daily	427	Difficulty defecating	Gastrointestinal haemorrhage	Nausea and vomiting symptoms	Gastrointestinal signs and symptoms	Gastrointestinal disorders	3	null	Non-serious	Recovering/Resolving	Unknown	Not applicable	Not applicable	null	Diabetes mellitus type 2; Osteoarthritis; Hyperlipidemia	Lawyer	Literature	Possible	29	27	0.5	1.1	10
3BF5D05671C2815E	2022-05-11	USA	71	elderly	Female	50.4	Pulmofix	Hypothyroidism	Inhalation	1	mg	null	2	Low blood pressure	Hypertension	Hypertension	Vascular hypertensive disorders	Vascular disorders	24	null	Congenital anomaly	Unknown	Dose reduced	Not applicable	Not applicable	Omeprazole; Azithromycin; Furosemide	null	Pharmacist	Literature	Possible	43	38	null	null	20
6C26F26EAB47642A	2023-03-19	IND	95	elderly	Unknown	null	Diabecontrol	Coronary artery disease	Transdermal	2	mg	null	null	Elevated creatinine	Renal impairment	Acute renal failures	Renal failures and impairments	Renal and urinary disorders	180	null	Life-threatening	Recovered/Resolved	Dose reduced	Not applicable	Not applicable	null	Occupational radiation exposure	Pharmacist	Spontaneous	Possible	39	null	1	6.1	52
0AA9692ECFF9B273	2023-05-21	ISR	33	adult	Female	52.2	Vasodilate	Hypothyroidism	Sublingual	2	mg	Once daily	474	Jaundice symptom	Drug-induced liver injury	Liver failures and associated disorders	Liver disorders	Hepatobiliary disorders	66	16	Life-threatening	Recovered/Resolved	Not applicable	Not applicable	Not applicable	Ibuprofen	Hyperlipidemia; Osteoporosis; Gastroesophageal reflux disease	Physician	Spontaneous	Unlikely	null	544	2.7	null	null
62BE3BD015D18472	2025-09-07	JPN	39	adult	Female	null	Vasodilate	Depression	Oral	25	mg	Three times daily	511	Productive cough	Pneumonitis	Dyspnoea and related conditions	Respiratory disorders NEC	Respiratory, thoracic and mediastinal disorders	153	8	Disability	Recovered/Resolved	Drug withdrawn	Not applicable	Not applicable	Ibuprofen	Migraine; Occupational chemical exposure; Hypertension; Osteoarthritis	Other health professional	Spontaneous	Unlikely	41	28	null	null	19
A40510A9EEF7513B	2022-07-28	SWE	67	elderly	Female	96	Eyeprotect	Type 2 diabetes	Subcutaneous	25	mg	Four times daily	364	Erythematous rash	Dermatitis	Rashes, eruptions and exanthems NEC	Epidermal and dermal conditions	Skin and subcutaneous tissue disorders	19	null	Non-serious	Recovering/Resolving	Unknown	Not applicable	Not applicable	null	Osteoporosis; Atrial fibrillation	Consumer	Regulatory authority	Possible	41	15	null	0.8	7
CAA451D756274CD1	2025-11-19	NZL	64	elderly	Unknown	60.3	Neurobalance	Infection	Intravenous	1,000	mg	Three times daily	75	Decreased blood cells	Pancytopenia	Neutropenias	White blood cell disorders	Blood and lymphatic system disorders	132	13	Hospitalization - initial or prolonged	Recovered/Resolved	Drug withdrawn	Unknown	Not applicable	Simvastatin; Ibuprofen	Peripheral vascular disease	Consumer	Spontaneous	Unlikely	null	28	0.5	null	7
8E9BD130EC55CCD8	2023-08-17	NZL	56	adult	Male	94.8	Painaway	Depression	Inhalation	1	mg	Twice daily	356	Difficulty defecating	Gastrointestinal haemorrhage	Nausea and vomiting symptoms	Gastrointestinal signs and symptoms	Gastrointestinal disorders	29	12	Non-serious	Recovering/Resolving	Dose not changed	Not applicable	Not applicable	Aspirin	COPD	Physician	Spontaneous	Possible	16	11	0.9	1.2	13
88E417428472EAE3	2025-03-27	KOR	44	adult	Male	null	Cardiomax	Rheumatoid arthritis	Transdermal	1	mg	Once daily	null	TEN	Rash	Rashes, eruptions and exanthems NEC	Epidermal and dermal conditions	Skin and subcutaneous tissue disorders	72	10	Non-serious	Recovered with sequelae	Drug withdrawn	Positive	Not applicable	Aspirin	Previous stroke	Pharmacist	Spontaneous	Possible	null	13	1.2	1	15
662A831726332AA5	2021-06-10	TUR	39	adult	Female	79.9	Dermafix	Bipolar disorder	Ophthalmic	10	mg	Twice daily	null	Myocardial infarction	Cardiac failure	Heart failures NEC	Heart failures	Cardiac disorders	21	null	Non-serious	Recovered/Resolved	Drug withdrawn	Not applicable	Not applicable	Amoxicillin	Previous stroke	Consumer	Spontaneous	Possible	33	null	0.1	0.8	null
74268041C9F7CF42	2022-07-16	TUR	82	elderly	Female	88.8	Anticoag-XR	Atrial fibrillation	Sublingual	10	mg	As needed	242	Suicidal thoughts	Insomnia	Depressive disorders	Mental disorders NEC	Psychiatric disorders	13	5	Non-serious	Recovered with sequelae	Not applicable	Not applicable	Not applicable	Acetaminophen; Omeprazole	null	Lawyer	Spontaneous	Possible	20	null	null	null	20
5E225B62E71609D9	2022-12-16	BEL	45	adult	Female	72.8	Vasodilate	Hypertension	Ophthalmic	25	mg	As needed	null	Acute renal failure	Renal failure acute	Acute renal failures	Renal failures and impairments	Renal and urinary disorders	5	73	Non-serious	Not recovered/Not resolved	Unknown	Not applicable	Not applicable	Pantoprazole; Atorvastatin; Insulin	Hepatitis B; Anxiety disorder; Rheumatoid arthritis	Other health professional	Spontaneous	Possible	41	null	null	5.5	29
4C07091CDA18813C	2025-10-20	ISR	39	adult	Female	null	Urocare	Cancer	Intravenous	100	mg	null	null	Clinical depression	Hallucination	Depressive disorders	Mental disorders NEC	Psychiatric disorders	113	null	Non-serious	Recovering/Resolving	Drug withdrawn	Positive	Not applicable	Simvastatin	Alcohol use disorder; Anxiety disorder	Physician	Spontaneous	Possible	null	32	0.2	null	10
99A0575903ABA10A	2021-08-27	NZL	42	adult	Unknown	85.4	Dermatopin	Cancer	Oral	25	mg	null	null	Bacterial pneumonia	Urinary tract infection	Bacterial infections NEC	Infections NEC	Infections and infestations	28	61	Non-serious	Recovered/Resolved	Drug withdrawn	Not applicable	Not applicable	Azithromycin; Lisinopril	Osteoarthritis	Physician	Spontaneous	Possible	23	null	0.3	1	19
49EC66E68ACB2777	2025-05-28	ISR	37	adult	Female	79.7	Arthrorelief	Coronary artery disease	Transdermal	2	mg	Four times daily	310	Cerebrovascular accident	Hypertension	Hypertension	Vascular hypertensive disorders	Vascular disorders	20	51	Non-serious	Recovered/Resolved	Unknown	Not applicable	Not applicable	Albuterol; Hydrochlorothiazide; Ibuprofen	Hypothyroidism; Heart failure	Physician	Spontaneous	Possible	31	30	0.4	1.3	null
593CCA96BA6C46F5	2023-08-19	NLD	60	adult	Unknown	null	Oncotreat	Asthma	Topical	10	mg	Four times daily	37	DRESS syndrome	Hypersensitivity	Hypersensitivity conditions NEC	Allergic conditions	Immune system disorders	177	13	Other medically important condition	Recovered/Resolved	Dose increased	Not applicable	Not applicable	Amoxicillin; Albuterol	Alcohol use disorder; Chronic kidney disease	Consumer	Spontaneous	Unlikely	16	33	1	0.7	12
26093CE7ACCAE7D2	2023-07-06	NLD	55	adult	Male	82.5	Hepatosan	Bipolar disorder	Ophthalmic	25	mg	As needed	73	Auditory hallucinations	Suicidal ideation	Depressive disorders	Mental disorders NEC	Psychiatric disorders	159	16	Non-serious	Recovered/Resolved	Drug withdrawn	Positive	Not applicable	null	Rheumatoid arthritis	Consumer	Literature	Probable/Likely	null	37	1	null	null
C0B7FD60ABE1ACFF	2021-07-29	FIN	87	elderly	Female	59.1	Infectoban	Migraine prophylaxis	Topical	10	mg	Four times daily	5	Right ventricular failure	Arrhythmia	Heart failures NEC	Heart failures	Cardiac disorders	24	3	Non-serious	Recovered with sequelae	Dose not changed	Not applicable	Not applicable	Aspirin	Previous stroke; Benign prostatic hyperplasia	Pharmacist	Spontaneous	Possible	32	13	null	1.2	11
27D3BDF733D6D5B8	2025-09-30	NZL	80	elderly	Male	null	Psychostabil	Hypertension	Subcutaneous	2	mg	Twice daily	null	Cardiac arrest	Cardiac failure acute	Heart failures NEC	Heart failures	Cardiac disorders	6	16	Non-serious	Recovering/Resolving	Drug withdrawn	Not applicable	Not applicable	Hydrochlorothiazide	Previous myocardial infarction; Diabetes mellitus type 2	Physician	Spontaneous	Possible	null	13	0.5	null	18
B00D32B56922FBCF	2022-10-09	FRA	42	adult	Unknown	null	Oncotreat	Pain management	Intravenous	500	mg	Twice daily	null	Contact dermatitis	Toxic epidermal necrolysis	Rashes, eruptions and exanthems NEC	Epidermal and dermal conditions	Skin and subcutaneous tissue disorders	164	null	Non-serious	Recovered/Resolved	Drug withdrawn	Positive	Not applicable	Simvastatin; Levothyroxine	Hypertension	Physician	Literature	Possible	null	12	0.2	1.2	14
F3B5517E735AFF5E	2023-12-05	FRA	61	adult	Male	79.8	Sleepwell	Type 2 diabetes	Oral	20	mg	Twice daily	337	Decreased WBC	Anemia	Neutropenias	White blood cell disorders	Blood and lymphatic system disorders	99	12	Non-serious	Recovered/Resolved	Drug withdrawn	Positive	Not applicable	Azithromycin; Simvastatin	Previous stroke; Hepatitis B	Pharmacist	Spontaneous	Possible	13	null	0.6	1.2	9
7B7475EC570AEF49	2024-02-07	RUS	81	elderly	Female	57.9	Hepatosan	Hyperlipidemia	Transdermal	5	mg	null	722	Cerebrovascular accident	Hypertension	Hypertension	Vascular hypertensive disorders	Vascular disorders	24	null	Non-serious	Recovered/Resolved	Unknown	Not applicable	Not applicable	Clopidogrel; Azithromycin	Coronary artery disease; Rheumatoid arthritis	Pharmacist	Spontaneous	Possible	null	36	null	null	20
AB29505FFE1ED1A8	2025-07-30	MEX	49	adult	Female	88.5	Pulmofix	Hyperlipidemia	Rectal	10	mg	As needed	459	Mixed hepatic injury	Hepatitis acute	Liver failures and associated disorders	Liver disorders	Hepatobiliary disorders	145	null	Disability	Not recovered/Not resolved	Drug withdrawn	Positive	Positive	Acetaminophen; Ibuprofen	Chronic pain	Consumer	Spontaneous	Certain	787	439	null	0.9	16
DF79D294304A19A0	2025-06-16	SWE	1	neonate	Female	43.2	Anticoag-XR	Osteoarthritis	Intravenous	50	mg	Twice daily	null	Oliguria	Acute kidney injury	Acute renal failures	Renal failures and impairments	Renal and urinary disorders	135	14	Life-threatening	Recovered/Resolved	Unknown	Not applicable	Not applicable	Losartan	Asthma; Peripheral vascular disease; Depression	Physician	Clinical trial	Unlikely	12	36	0.2	4.5	null
9E688451BE8B18B8	2023-07-04	CHE	49	adult	Male	98.4	Neurobalance	Pain management	Topical	25	mg	As needed	330	Arthritis pain	Muscle weakness	Myopathies	Muscle disorders	Musculoskeletal and connective tissue disorders	138	78	Non-serious	Not recovered/Not resolved	Drug withdrawn	Unknown	Not applicable	Losartan; Omeprazole; Prednisone	Hepatitis B; Benign prostatic hyperplasia	Consumer	Spontaneous	Unlikely	45	32	null	0.7	17
13D042D55DAC3022	2022-02-06	NLD	36	adult	Unknown	103.3	Lipidlow	Seizure disorder	Topical	25	mg	Three times daily	433	Acute heart failure	Cardiac failure acute	Heart failures NEC	Heart failures	Cardiac disorders	1	49	Other medically important condition	Recovered/Resolved	Drug withdrawn	Not applicable	Not applicable	Amoxicillin; Furosemide; Omeprazole	Peripheral vascular disease; Occupational chemical exposure; Hypothyroidism	Pharmacist	Clinical trial	Possible	12	null	1.1	1.2	15
8E265E7053ED510E	2025-08-30	USA	44	adult	Male	117.6	Eyeprotect	Asthma	Subcutaneous	25	mg	Four times daily	231	New malignancy	Carcinoma	Leukaemias NEC	Malignant neoplasms	Neoplasms benign, malignant and unspecified	125	76	Non-serious	Recovering/Resolving	Dose not changed	Not applicable	Not applicable	Insulin; Losartan; Amlodipine	Hyperlipidemia; Chronic kidney disease; Benign prostatic hyperplasia; Chronic pain	Physician	Spontaneous	Unlikely	37	null	0.7	0.8	null
59701888752D54BD	2022-10-01	IND	56	adult	Unknown	null	Anticoag-XR	GERD	Intramuscular	25	mg	Once daily	518	Skin rash	Toxic epidermal necrolysis	Rashes, eruptions and exanthems NEC	Epidermal and dermal conditions	Skin and subcutaneous tissue disorders	18	52	Life-threatening	Recovered with sequelae	Dose not changed	Not applicable	Not applicable	Insulin	Occupational radiation exposure	Consumer	Spontaneous	Possible	45	null	0.8	1.2	null

End of preview.

Synthetic FAERS-Style Pharmacovigilance Dataset (1M Records)

Dataset Description

This is a fully synthetic dataset designed for pharmacovigilance signal detection and ML model training. Contains 1,000,000 synthetic Individual Case Safety Reports (ICSRs).

Features

100% Synthetic: No real patient data - GDPR/HIPAA compliant
1M Records: Large-scale dataset for ML training
35 Features: Causality, temporal, lab values, demographics
700+ Drug-Event Signals: Realistic signal patterns

Files

synthetic_faers_1m_pv_signal_ml.csv - PV Signal ML compatible (recommended)
synthetic_faers_1m_v2.csv - Original column names

Quick Start

from datasets import load_dataset

Load the dataset dataset = load_dataset("koreo/synthetic-faers-1m-v2", data_files="synthetic_faers_1m_pv_signal_ml.csv", split="train")

Convert to pandas df = dataset.to_pandas() print(f"Loaded {len(df):,} records")

Schema

Drug Information:

drug_name, dose, route, therapy_duration

Event Information (MedDRA):

llt, pt, hlt, hlgt, soc

Causality Features:

dechallenge, rechallenge, causality, action_drug

Temporal:

ttp_days (time to onset), event_duration

Demographics:

age, sex, weight, country

Lab Values:

alt, ast, bilirubin, creatinine, bun

Other:

concomitant_drugs, medical_history, serious, outcome

Privacy

✅ GDPR Compliant
✅ HIPAA Compliant
✅ 100% Synthetic
✅ No PII/PHI

License

CC0-1.0 (Public Domain)

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