Datasets:
codigo stringclasses 35
values | sent_idx int32 0 135 | tokens listlengths 1 142 | ner_tags listlengths 1 142 |
|---|---|---|---|
89413 | 0 | [
"El",
"medicamento",
"SOTALOL",
"SANDOZ",
"80",
"MG",
"COMPRIMIDOS",
"EFG",
"con",
"los",
"principios",
"activos",
"SOTALOL",
"HIDROCLORURO",
"tiene",
"la",
"siguiente",
"información",
"en",
"la",
"sección",
"4.8"
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
3,
4,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 1 | [
"La",
"mayoría",
"de",
"las",
"personas",
"toleran",
"bien",
"sotalol",
",",
"y",
"las",
"reacciones",
"adversas",
"más",
"frecuentes",
"son",
"las",
"asociadas",
"a",
"sus",
"propiedades",
"betabloqueantes",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 2 | [
"Suelen",
"ser",
"transitorias",
",",
"y",
"raramente",
"se",
"precisa",
"la",
"interrupción",
"retirada",
"del",
"tratamiento",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 3 | [
"Incluyen",
"disnea",
",",
"fatiga",
",",
"mareos",
",",
"cefalea",
",",
"fiebre",
"y",
"bradicardia",
"o",
"hipotensión",
"excesivas",
"."
] | [
0,
1,
0,
1,
0,
0,
0,
0,
0,
0,
0,
1,
0,
1,
0,
0
] |
89413 | 4 | [
"Si",
"se",
"detectan",
",",
"generalmente",
"desaparecen",
"al",
"reducir",
"la",
"dosis",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 5 | [
"Las",
"reacciones",
"adversas",
"más",
"significativas",
"son",
"aquellas",
"debidas",
"a",
"la",
"proarritmia",
",",
"incluyendo",
"la",
"«",
"torsade",
"de",
"pointes",
"»",
"(",
"ver",
"sección",
"4.4",
")",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
1,
2,
2,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 6 | [
"La",
"frecuencia",
"se",
"define",
"según",
"las",
"categorías",
"siguientes",
":",
"muy",
"frecuentes",
"(",
"≥",
"1/10",
")",
",",
"frecuentes",
"(",
"≥",
"1/100",
",",
"<",
"1/10",
")",
",",
"poco",
"frecuentes",
"(",
"≥",
"1/1.000",
",",
"<",
"1/1... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0... |
89413 | 7 | [
"Las",
"siguientes",
"reacciones",
"adversas",
"se",
"consideran",
"relacionadas",
"con",
"el",
"tratamiento",
"con",
"sotalol",
":"
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 8 | [
"Trastornos",
"de",
"la",
"sangre",
"y",
"del",
"sistema",
"linfático"
] | [
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 9 | [
"Frecuencia",
"no",
"conocida",
":",
"trombocitopenia",
"."
] | [
0,
0,
0,
0,
1,
0
] |
89413 | 10 | [
"Trastornos",
"psiquiátricos"
] | [
7,
8
] |
89413 | 11 | [
"Frecuentes",
":",
"depresión",
",",
"confusión",
",",
"trastornos",
"del",
"sueño",
",",
"cambios",
"del",
"estado",
"de",
"ánimo",
",",
"ansiedad",
"."
] | [
0,
0,
1,
0,
0,
0,
1,
2,
2,
0,
1,
2,
2,
2,
2,
0,
1,
0
] |
89413 | 12 | [
"Frecuencia",
"no",
"conocida",
":",
"alucinaciones",
",",
"sueños",
"inusuales",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 13 | [
"Trastornos",
"del",
"sistema",
"nervioso"
] | [
7,
8,
8,
8
] |
89413 | 14 | [
"Frecuentes",
":",
"mareos",
",",
"vahídos",
",",
"cefalea",
",",
"parestesia",
",",
"disgeusia",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
1,
0,
1,
0
] |
89413 | 15 | [
"Trastornos",
"oculares"
] | [
0,
0
] |
89413 | 16 | [
"Frecuentes",
":",
"trastornos",
"visuales",
"."
] | [
0,
0,
0,
0,
0
] |
89413 | 17 | [
"Frecuencia",
"no",
"conocida",
":",
"visión",
"borrosa",
",",
"conjuntivitis",
",",
"queratoconjuntivitis",
",",
"sequedad",
"ocular",
"(",
"particularmente",
"en",
"personas",
"que",
"usan",
"lentes",
"de",
"contacto",
")",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 18 | [
"Trastornos",
"del",
"oído",
"y",
"del",
"laberinto"
] | [
0,
0,
0,
0,
0,
0
] |
89413 | 19 | [
"Frecuentes",
":",
"trastornos",
"de",
"la",
"audición",
"."
] | [
0,
0,
0,
0,
0,
0,
0
] |
89413 | 20 | [
"Trastornos",
"cardiacos"
] | [
0,
0
] |
89413 | 21 | [
"Frecuentes",
":",
"bradicardia",
",",
"disnea",
",",
"dolor",
"de",
"pecho",
",",
"palpitaciones",
",",
"edema",
",",
"anomalías",
"en",
"el",
"ECG",
",",
"torsade",
"de",
"pointes",
",",
"prolongación",
"del",
"intervalo",
"QT",
",",
"trastornos",
"de",
... | [
0,
0,
1,
0,
1,
0,
0,
0,
0,
0,
1,
0,
1,
0,
0,
0,
0,
0,
0,
1,
2,
2,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
1,
2,
2,
0,
1,
0,
1,
0,
1,
2,
0,
1,
0
] |
89413 | 22 | [
"Frecuencia",
"no",
"conocida",
":",
"parada",
"cardiaca",
"."
] | [
0,
0,
0,
0,
0,
0,
0
] |
89413 | 23 | [
"Trastornos",
"vasculares"
] | [
0,
0
] |
89413 | 24 | [
"Frecuentes",
":",
"hipotensión",
",",
"agravamiento",
"de",
"la",
"vasculopatía",
"periférica",
"oclusiva",
",",
"extremidades",
"frías",
"."
] | [
0,
0,
1,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 25 | [
"Trastornos",
"gastrointestinales"
] | [
0,
0
] |
89413 | 26 | [
"Frecuentes",
":",
"náuseas",
",",
"vómitos",
",",
"diarrea",
",",
"dolor",
"abdominal",
",",
"flatulencia",
",",
"dispepsia",
"."
] | [
0,
0,
1,
0,
1,
0,
1,
0,
1,
2,
0,
1,
0,
1,
0
] |
89413 | 27 | [
"Frecuencia",
"no",
"conocida",
":",
"sequedad",
"de",
"boca",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 28 | [
"Trastornos",
"de",
"la",
"piel",
"y",
"del",
"tejido",
"subcutáneo"
] | [
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 29 | [
"Frecuentes",
":",
"erupción",
"cutánea",
",",
"reacciones",
"en",
"la",
"piel",
"."
] | [
0,
0,
1,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 30 | [
"Frecuencia",
"no",
"conocida",
":",
"los",
"medicamentos",
"con",
"acción",
"betabloqueante",
"pueden",
"desencadenar",
"psoriasis",
",",
"agravarla",
"o",
"producir",
"exantema",
"psoriásico",
",",
"alopecia",
"o",
"hiperhidrosis",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
1,
0,
1,
0
] |
89413 | 31 | [
"Trastornos",
"musculoesqueléticos",
"y",
"del",
"tejido",
"conjuntivo"
] | [
0,
0,
0,
0,
0,
0
] |
89413 | 32 | [
"Frecuentes",
":",
"espasmos",
"musculares",
"."
] | [
0,
0,
1,
2,
0
] |
89413 | 33 | [
"Trastornos",
"del",
"aparato",
"reproductor",
"y",
"de",
"la",
"mama"
] | [
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 34 | [
"Frecuentes",
":",
"disfunción",
"sexual",
",",
"impotencia",
"."
] | [
0,
0,
1,
2,
0,
0,
0
] |
89413 | 35 | [
"Trastornos",
"generales",
"y",
"alteraciones",
"en",
"el",
"lugar",
"de",
"administración"
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 36 | [
"Frecuentes",
":",
"pirexia",
",",
"fatiga",
",",
"astenia",
"."
] | [
0,
0,
1,
0,
1,
0,
1,
0
] |
89413 | 37 | [
"Trastornos",
"del",
"metabolismo",
"y",
"de",
"la",
"nutrición"
] | [
0,
0,
0,
0,
0,
0,
0
] |
89413 | 38 | [
"Frecuencia",
"no",
"conocida",
":",
"aumento",
"de",
"los",
"niveles",
"de",
"colesterol",
"total",
"y",
"triglicéridos",
",",
"disminución",
"del",
"colesterol",
"HDL",
",",
"hipoglucemia",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
1,
0
] |
89413 | 39 | [
"En",
"ensayos",
"clínicos",
"se",
"administró",
"sotalol",
"oral",
"a",
"3.257",
"pacientes",
"con",
"arritmias",
"cardiacas",
"(",
"1.363",
"con",
"pronóstico",
"de",
"taquicardia",
"ventricular",
")",
",",
"de",
"los",
"cuales",
"2.451",
"tomaron",
"el",
"m... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 40 | [
"Las",
"reacciones",
"adversas",
"más",
"significativas",
"fueron",
"torsade",
"de",
"pointes",
"y",
"otras",
"arritmias",
"ventriculares",
"graves",
"nuevas",
"(",
"ver",
"sección",
"4.4",
")",
",",
"con",
"las",
"siguientes",
"cifras",
"de",
"incidencia",
":"
... | [
0,
0,
0,
0,
0,
0,
1,
2,
2,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 41 | [
"*",
"*",
"Grupo",
"de",
"pacientes",
"*",
"*",
"(",
"n",
"=",
"3257)\\",
"*"
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 42 | [
"*",
"*",
"TV",
"/",
"FV",
"*",
"*"
] | [
0,
0,
0,
0,
0,
0,
0
] |
89413 | 43 | [
"(",
"n",
"=",
"1,363",
")",
"*",
"*",
"TVNS",
"/",
"ESV",
"*",
"*"
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 44 | [
"(",
"n",
"=",
"946",
")",
"*",
"*",
"ASV",
"*",
"*"
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 45 | [
"(",
"n",
"=",
"947",
")"
] | [
0,
0,
0,
0,
0
] |
89413 | 46 | [
"Torsade",
"de",
"pointes",
"4,1%",
"1,0%",
"1,4%"
] | [
1,
2,
2,
0,
0,
0
] |
89413 | 47 | [
"TV",
"/",
"FV",
"prevista",
"1,2%",
"0,7%",
"0,3%"
] | [
0,
0,
0,
0,
0,
0,
0
] |
89413 | 48 | [
"\\",
"*",
"1",
"paciente",
"padecía",
"taquicardia",
"sinusal",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 49 | [
"TV=",
"taquicardia",
"ventricular",
";",
"FV=",
"fibrilación",
"ventricular",
";",
"TVNS=",
"taquicardia",
"ventricular",
"no",
"sostenida",
";",
"ESV=",
"extrasístole",
"ventricular",
";",
"ASV=",
"arritmias",
"supraventriculares",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 50 | [
"En",
"resumen",
",",
"en",
"estudios",
"realizados",
"en",
"pacientes",
"con",
"arritmias",
"cardíacas",
",",
"fue",
"necesario",
"interrumpir",
"el",
"tratamiento",
"a",
"causa",
"de",
"los",
"eventos",
"adversos",
"en",
"el",
"18%",
"de",
"los",
"pacientes"... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 51 | [
"Las",
"reacciones",
"adversas",
"más",
"frecuentes",
"que",
"ocasionaron",
"la",
"interrupción",
"del",
"tratamiento",
"con",
"sotalol",
"se",
"muestran",
"en",
"el",
"siguiente",
"cuadro",
":"
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 52 | [
"Fatiga",
"4%"
] | [
1,
0
] |
89413 | 53 | [
"Bradicardia",
"(",
"<",
"50",
"lpm",
")",
"3%"
] | [
1,
0,
0,
0,
0,
0,
0
] |
89413 | 54 | [
"Disnea",
"3%"
] | [
1,
0
] |
89413 | 55 | [
"Proarritmia",
"2%"
] | [
0,
0
] |
89413 | 56 | [
"Astenia",
"2%"
] | [
1,
0
] |
89413 | 57 | [
"Mareos",
"2%"
] | [
0,
0
] |
89413 | 58 | [
"En",
"combinación",
"con",
"otros",
"betabloqueantes",
"se",
"observaron",
"extremidades",
"frías",
"y",
"cianóticas",
",",
"el",
"fenómeno",
"de",
"Raynaud",
",",
"aumentos",
"de",
"la",
"claudicación",
"intermitente",
"existente",
"y",
"sequedad",
"ocular",
"."... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 59 | [
"Notificación",
"de",
"sospechas",
"de",
"reacciones",
"adversas"
] | [
0,
0,
0,
0,
0,
0
] |
89413 | 60 | [
"Es",
"importante",
"notificar",
"las",
"sospechas",
"de",
"reacciones",
"adversas",
"al",
"medicamento",
"tras",
"su",
"autorización",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 61 | [
"Ello",
"permite",
"una",
"supervisión",
"continuada",
"de",
"la",
"relación",
"beneficio",
"/",
"riesgo",
"del",
"medicamento",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
89413 | 62 | [
"Se",
"invita",
"a",
"los",
"profesionales",
"sanitarios",
"a",
"notificar",
"las",
"sospechas",
"de",
"reacciones",
"adversas",
"a",
"través",
"del",
"Sistema",
"Español",
"de",
"Farmacovigilancia",
"de",
"Medicamentos",
"de",
"Uso",
"Humano",
":",
"www.notificar... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
75887 | 0 | [
"El",
"medicamento",
"LAMIVUDINA",
"NORMON",
"100",
"mg",
"COMPRIMIDOS",
"RECUBIERTOS",
"CON",
"PELICULA",
"EFG",
"con",
"los",
"principios",
"activos",
"LAMIVUDINA",
"tiene",
"la",
"siguiente",
"información",
"en",
"la",
"sección",
"4.8"
] | [
0,
0,
3,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
3,
0,
0,
0,
0,
0,
0,
0,
0
] |
75887 | 1 | [
"La",
"incidencia",
"de",
"reacciones",
"adversas",
"y",
"anormalidades",
"de",
"laboratorio",
"(",
"a",
"excepción",
"de",
"los",
"incrementos",
"de",
"ALT",
"y",
"CPK",
",",
"ver",
"a",
"continuación",
")",
"fue",
"similar",
"entre",
"los",
"pacientes",
"t... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
3,
0
] |
75887 | 2 | [
"Las",
"reacciones",
"adversas",
"comunicadas",
"con",
"más",
"frecuencia",
"fueron",
"malestar",
"y",
"fatiga",
",",
"infecciones",
"del",
"tracto",
"respiratorio",
",",
"molestias",
"en",
"la",
"garganta",
"y",
"amígdalas",
",",
"cefalea",
",",
"dolor",
"y",
... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
75887 | 3 | [
"A",
"continuación",
"se",
"presentan",
"las",
"reacciones",
"adversas",
"clasificadas",
"por",
"órganos",
",",
"sistemas",
"y",
"frecuencias",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
75887 | 4 | [
"Las",
"categorías",
"de",
"frecuencia",
"se",
"asignan",
"únicamente",
"a",
"aquellas",
"reacciones",
"adversas",
"consideradas",
"al",
"menos",
"posiblemente",
"relacionadas",
"con",
"lamivudina",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
3,
0
] |
75887 | 5 | [
"Las",
"frecuencias",
"se",
"definen",
"como",
":",
"muy",
"frecuentes",
"(",
"≥",
"1/10",
")",
",",
"frecuentes",
"(",
"≥",
"1/100",
"a",
"<",
"1/10",
")",
",",
"poco",
"frecuentes",
"(",
"≥",
"1/1000",
"a",
"<",
"1/100",
")",
",",
"raras",
"(",
"... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
75887 | 6 | [
"Las",
"categorías",
"de",
"frecuencias",
"asignadas",
"a",
"las",
"reacciones",
"adversas",
"se",
"basan",
"principalmente",
"en",
"la",
"experiencia",
"de",
"los",
"ensayos",
"clínicos",
"que",
"incluyeron",
"un",
"total",
"de",
"1.171",
"pacientes",
"con",
"h... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
3
] |
75887 | 7 | [
"*",
"*",
"Trastornos",
"de",
"la",
"sangre",
"y",
"del",
"sistema",
"linfático",
"*",
"*"
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
75887 | 8 | [
"Desconocida",
"Trombocitopenia"
] | [
0,
1
] |
75887 | 9 | [
"*",
"*",
"Trastornos",
"del",
"sistema",
"inmunológico",
"*",
"*"
] | [
0,
0,
7,
8,
8,
8,
0,
0
] |
75887 | 10 | [
"Raras",
"Angioedema"
] | [
0,
1
] |
75887 | 11 | [
"*",
"*",
"Trastornos",
"hepatobiliares",
"*",
"*"
] | [
0,
0,
0,
0,
0,
0
] |
75887 | 12 | [
"Muy",
"frecuentes",
"Incrementos",
"de",
"ALT",
"(",
"ver",
"sección",
"4.4",
")"
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
75887 | 13 | [
"Durante",
"el",
"tratamiento",
"y",
"tras",
"la",
"retirada",
"de",
"lamivudina",
"se",
"han",
"notificado",
"exacerbaciones",
"de",
"la",
"hepatitis",
",",
"detectadas",
"principalmente",
"por",
"aumento",
"en",
"las",
"concentraciones",
"de",
"ALT",
"en",
"su... | [
0,
0,
0,
0,
0,
0,
0,
0,
3,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
75887 | 14 | [
"La",
"mayoría",
"han",
"remitido",
",",
"aunque",
"muy",
"raramente",
"se",
"han",
"observado",
"muertes",
"(",
"ver",
"sección",
"4.4",
")",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
75887 | 15 | [
"*",
"*",
"Trastornos",
"de",
"la",
"piel",
"y",
"del",
"tejido",
"subcutáneo",
"*",
"*"
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
75887 | 16 | [
"Frecuentes",
"Erupción",
",",
"prurito"
] | [
0,
1,
0,
1
] |
75887 | 17 | [
"*",
"*",
"Trastornos",
"musculoesqueléticos",
"y",
"del",
"tejido",
"conjuntivo",
"*",
"*"
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
75887 | 18 | [
"Frecuentes",
"Incrementos",
"de",
"CPK"
] | [
0,
0,
0,
0
] |
75887 | 19 | [
"Trastornos",
"musculares",
",",
"incluyendo",
"mialgias",
"y",
"calambres\\",
"*",
"."
] | [
0,
0,
0,
0,
1,
0,
1,
0,
0
] |
75887 | 20 | [
"Desconocida",
"Rabdomiolisis"
] | [
0,
1
] |
75887 | 21 | [
"\\",
"*",
"En",
"los",
"ensayos",
"de",
"fase",
"III",
"la",
"frecuencia",
"observada",
"en",
"el",
"grupo",
"tratado",
"con",
"lamivudina",
"no",
"fue",
"mayor",
"que",
"la",
"observada",
"en",
"el",
"grupo",
"placebo",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
3,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
75887 | 22 | [
"En",
"pacientes",
"con",
"infección",
"por",
"VIH",
",",
"se",
"han",
"comunicado",
"casos",
"de",
"pancreatitis",
"y",
"neuropatía",
"periférica",
"(",
"o",
"parestesia",
")",
"En",
"pacientes",
"con",
"hepatitis",
"B",
"crónica",
"no",
"se",
"observaron",
... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
3,
0
] |
75887 | 23 | [
"Se",
"han",
"comunicado",
"casos",
"de",
"acidosis",
"láctica",
",",
"a",
"veces",
"mortales",
",",
"normalmente",
"asociados",
"con",
"hepatomegalia",
"grave",
"y",
"esteatosis",
"hepática",
",",
"con",
"el",
"uso",
"de",
"terapia",
"de",
"combinación",
"de"... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
75887 | 24 | [
"Raramente",
"se",
"han",
"comunicado",
"casos",
"de",
"acidosis",
"láctica",
"en",
"pacientes",
"que",
"recibían",
"lamivudina",
"para",
"el",
"tratamiento",
"de",
"hepatitis",
"B."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
3,
0,
0,
0,
0,
0,
0
] |
75887 | 25 | [
"En",
"pacientes",
"infectados",
"por",
"el",
"VIH",
"que",
"presentan",
"inmunodeficiencia",
"grave",
"en",
"el",
"momento",
"de",
"iniciar",
"el",
"TARC",
",",
"puede",
"aparecer",
"una",
"reacción",
"inflamatoria",
"frente",
"a",
"infecciones",
"oportunistas",
... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
75887 | 26 | [
"También",
"se",
"han",
"notificado",
"trastornos",
"autoinmunes",
"(",
"como",
"la",
"enfermedad",
"de",
"Graves",
"y",
"la",
"hepatitis",
"autoinmune",
")",
";",
"sin",
"embargo",
",",
"el",
"tiempo",
"notificado",
"hasta",
"la",
"aparición",
"es",
"más",
... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
69589 | 0 | [
"El",
"medicamento",
"SPIRIVA",
"RESPIMAT",
"2,5",
"microgramos",
"SOLUCION",
"PARA",
"INHALACION",
"con",
"los",
"principios",
"activos",
"TIOTROPIO",
"BROMURO",
"tiene",
"la",
"siguiente",
"información",
"en",
"la",
"sección",
"4.8"
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
3,
4,
0,
0,
0,
0,
0,
0,
0,
0
] |
69589 | 1 | [
"Resumen",
"del",
"perfil",
"de",
"seguridad"
] | [
0,
0,
0,
0,
0
] |
69589 | 2 | [
"Muchas",
"de",
"las",
"reacciones",
"adversas",
"listadas",
"pueden",
"atribuirse",
"a",
"las",
"propiedades",
"anticolinérgicas",
"del",
"bromuro",
"de",
"tiotropio",
"."
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
69589 | 3 | [
"Resumen",
"tabulado",
"de",
"reacciones",
"adversas"
] | [
0,
0,
0,
0,
0
] |
69589 | 4 | [
"Las",
"frecuencias",
"asignadas",
"a",
"las",
"reacciones",
"adversas",
"listadas",
"a",
"continuación",
"se",
"basan",
"en",
"porcentajes",
"de",
"incidencia",
"bruta",
"de",
"reacciones",
"adversas",
"al",
"fármaco",
"(",
"es",
"decir",
",",
"acontecimientos",
... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0... |
69589 | 5 | [
"Las",
"reacciones",
"adversas",
"han",
"sido",
"ordenadas",
"según",
"sus",
"frecuencias",
"utilizando",
"la",
"siguiente",
"clasificación",
":",
"muy",
"frecuentes",
"(",
"≥1/10",
")",
";",
"frecuentes",
"(",
"≥1/100",
"a",
"<",
"1/10",
")",
";",
"poco",
"... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0... |
69589 | 6 | [
"*",
"*",
"C",
"*",
"*",
"*",
"*",
"lasificación",
"por",
"órganos",
"y",
"sistemas",
"/",
"Término",
"preferente",
"MedDRA",
"*",
"*",
"*",
"*",
"Frecuencia",
"*",
"*"
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
69589 | 7 | [
"*",
"*",
"EPOC",
"*",
"*",
"*",
"*",
"Frecuencia",
"*",
"*"
] | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
69589 | 8 | [
"*",
"*",
"Asma",
"*",
"*"
] | [
0,
0,
0,
0,
0
] |
69589 | 9 | [
"Trastornos",
"del",
"metabolismo",
"y",
"de",
"la",
"nutrición"
] | [
0,
0,
0,
0,
0,
0,
0
] |
CIMA Sección 4.8 NER
Dataset de reconocimiento de entidades nombradas (NER) en español sobre la sección 4.8 ("Reacciones adversas") de las fichas técnicas publicadas por la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) en el Centro de Información Online de Medicamentos (CIMA).
Cada documento es la sección 4.8 completa de un medicamento, tokenizada con
spaCy (es_core_news_sm) y etiquetada en formato CoNLL BIO (IOB2) con
hasta cuatro tipos de entidad:
| Tag | Significado | Origen (columna CSV) |
|---|---|---|
REACT |
Reacción adversa (p. ej. cefalea, náuseas, trombocitopenia) | REACADV |
ACTIVE |
Principio activo (p. ej. SOTALOL HIDROCLORURO) | PACTIVO |
FREQ |
Frecuencia de la reacción (p. ej. MUY FRECUENTE, POCO FRECUENTE) | FRECUENCIA |
SYS |
Sistema u órgano afectado (p. ej. TRASTORNOS DEL SISTEMA NERVIOSO) | SISTEMA |
El dataset se publica como parte del Proyecto Fin de Grado (PFG) de la UNED sobre extracción automática de información de pacto de seguridad de medicamentos.
Autoría
Dataset elaborado en el marco del Trabajo Fin de Grado (PFG) del Grado en Ingeniería Informática de la Universidad Nacional de Educación a Distancia (UNED), curso 2025/2026.
- Autor: Luis Miguel Guerrero Guirado (@guerrerotook).
- Director del PFG: Salvador Ros Muñoz, UNED.
Configuraciones
Se publican cinco configuraciones (config_name), una por cada combinación
de tags entrenada en el trabajo original. Todas comparten exactamente los
mismos documentos, sentencias y tokens; sólo cambia el vocabulario de
etiquetas y, en consecuencia, qué spans están marcados como B-/I- y
cuáles caen a O.
config_name |
Tags incluidos | Labels (orden de IDs) |
|---|---|---|
react |
REACT | O, B-REACT, I-REACT |
active |
ACTIVE | O, B-ACTIVE, I-ACTIVE |
freq |
FREQ | O, B-FREQ, I-FREQ |
sys |
SYS | O, B-SYS, I-SYS |
react-active-freq-sys |
REACT + ACTIVE + FREQ + SYS (default) | O, B-REACT, I-REACT, B-ACTIVE, I-ACTIVE, B-FREQ, I-FREQ, B-SYS, I-SYS |
La configuración react-active-freq-sys es la multi-tag y la marcada
como default — es la más útil porque cualquier consumidor puede derivar
las versiones single-tag por filtrado local sin perder información.
Estadísticas
Mismos documentos y tokens para todas las configuraciones; sólo cambia la
proporción de etiquetas no-O:
| Split | Fármacos | Sentencias | Tokens |
|---|---|---|---|
| train | 35 | 2 180 | 34 886 |
| test | 15 | 941 | 17 316 |
Proporción de tokens etiquetados (no-O) por configuración:
| Config | non-O train | non-O test |
|---|---|---|
react |
10,00 % | 12,76 % |
active |
0,53 % | 0,32 % |
freq |
0,28 % | 0,25 % |
sys |
0,87 % | 0,79 % |
react-active-freq-sys |
11,64 % | 14,12 % |
Distribución detallada por etiqueta para react-active-freq-sys:
| Label | Train | Test |
|---|---|---|
O |
30 826 | 14 871 |
B-REACT |
1 856 | 1 120 |
I-REACT |
1 632 | 1 090 |
B-ACTIVE |
163 | 50 |
I-ACTIVE |
21 | 5 |
B-FREQ |
63 | 32 |
I-FREQ |
35 | 11 |
B-SYS |
88 | 40 |
I-SYS |
202 | 97 |
Cada stats/{config}.json del repositorio contiene el detalle completo.
Esquema del dataset
Cada ejemplo es una sentencia (no un documento completo) con cuatro campos:
| Campo | Tipo | Descripción |
|---|---|---|
codigo |
string |
Código nacional CIMA del medicamento al que pertenece la frase |
sent_idx |
int32 |
Índice de la sentencia dentro del documento (0-indexado) |
tokens |
Sequence(string) |
Tokens spaCy de la sentencia |
ner_tags |
Sequence(ClassLabel(names=[...])) |
IDs de etiqueta BIO alineados 1:1 con tokens |
Para recuperar las etiquetas en texto:
from datasets import load_dataset
ds = load_dataset("guerrerotook/cima-section48-ner", "react-active-freq-sys")
label_names = ds["train"].features["ner_tags"].feature.names
print(label_names)
# ['O', 'B-REACT', 'I-REACT', 'B-ACTIVE', 'I-ACTIVE', 'B-FREQ', 'I-FREQ', 'B-SYS', 'I-SYS']
example = ds["train"][5]
for tok, tag_id in zip(example["tokens"], example["ner_tags"]):
print(f"{tok}\t{label_names[tag_id]}")
Cómo se construyó
Pipeline determinista en cuatro pasos:
- Lectura del CSV de menciones:
train.csv/test.csvcon columnasCODIGO, MEDICAMENTO, PACTIVO, REACADV, FRECUENCIA, SISTEMA(una fila por reacción adversa de cada fármaco). - Tokenización word-level con spaCy (
es_core_news_sm) del texto bruto de la sección 4.8 de cada fármaco, con segmentación porsentencizer+ corte adicional por saltos de línea. - Etiquetado BIO mediante matching word-boundary insensible a
acentos/case sobre el texto normalizado (
unicodedata+ lower). Si dos menciones solapan, gana la más larga (longest-first ordering). Se aplica promoción IOB2 (I-Xhuérfano →B-X). - Serialización a Parquet (
Sequence(ClassLabel)) y, en paralelo, atoken<TAB>labelBIO plano (formato CoNLL clásico, blank line entre sentencias y# {codigo}como cabecera de documento).
Todo el código del builder está en src/conll_ner_builder.py
del repositorio original. El export se reproduce con
python tools/export_hf_dataset.py.
Formatos disponibles
El mismo dataset se distribuye dos veces para máxima compatibilidad:
data/<config>/train.parquet ← canónico, recomendado para HF Datasets
data/<config>/test.parquet
conll/<config>/train.conll ← BIO plano, recomendado para seqeval/flair/spaCy
conll/<config>/test.conll
stats/<config>.json ← estadísticas por split (label counts, etc.)
Los .conll siguen exactamente el contrato token<TAB>label con líneas en
blanco entre sentencias y # {codigo} como cabecera de documento. Son
compatibles directamente con el parse_conll de la mayoría de baselines NER
en español.
Uso
Opción 1 — Fine-tuning con transformers (recomendado)
import numpy as np
from datasets import load_dataset
from transformers import (
AutoTokenizer,
AutoModelForTokenClassification,
DataCollatorForTokenClassification,
Trainer,
TrainingArguments,
)
from seqeval.metrics import classification_report, f1_score
ds = load_dataset("guerrerotook/cima-section48-ner", "react-active-freq-sys")
label_names = ds["train"].features["ner_tags"].feature.names
num_labels = len(label_names)
model_name = "PlanTL-GOB-ES/roberta-base-biomedical-es"
tokenizer = AutoTokenizer.from_pretrained(model_name, add_prefix_space=True)
def tokenize_and_align(batch):
enc = tokenizer(
batch["tokens"],
is_split_into_words=True,
truncation=True,
max_length=256,
)
labels = []
for i, tag_seq in enumerate(batch["ner_tags"]):
word_ids = enc.word_ids(batch_index=i)
prev = None
seq = []
for w in word_ids:
if w is None:
seq.append(-100)
elif w != prev:
seq.append(tag_seq[w])
else:
seq.append(-100)
prev = w
labels.append(seq)
enc["labels"] = labels
return enc
tok_ds = ds.map(tokenize_and_align, batched=True, remove_columns=ds["train"].column_names)
model = AutoModelForTokenClassification.from_pretrained(
model_name,
num_labels=num_labels,
id2label={i: n for i, n in enumerate(label_names)},
label2id={n: i for i, n in enumerate(label_names)},
)
def compute_metrics(p):
preds = np.argmax(p.predictions, axis=2)
true_labels = [
[label_names[l] for l in lab if l != -100]
for lab in p.label_ids
]
pred_labels = [
[label_names[pr] for pr, l in zip(pre, lab) if l != -100]
for pre, lab in zip(preds, p.label_ids)
]
return {"f1": f1_score(true_labels, pred_labels)}
args = TrainingArguments(
output_dir="./cima-ner-ft",
eval_strategy="epoch",
per_device_train_batch_size=16,
num_train_epochs=10,
learning_rate=2e-5,
)
trainer = Trainer(
model=model,
args=args,
train_dataset=tok_ds["train"],
eval_dataset=tok_ds["test"],
tokenizer=tokenizer,
data_collator=DataCollatorForTokenClassification(tokenizer),
compute_metrics=compute_metrics,
)
trainer.train()
Opción 2 — Descarga directa del CoNLL plano
Útil si trabajas con seqeval, flair, spaCy o un pipeline propio que ya sabe
parsear el formato token<TAB>label:
from huggingface_hub import hf_hub_download
path = hf_hub_download(
repo_id="guerrerotook/cima-section48-ner",
filename="conll/react-active-freq-sys/train.conll",
repo_type="dataset",
)
def parse_conll(path):
sentences, current_tokens, current_tags = [], [], []
with open(path, encoding="utf-8") as f:
for line in f:
line = line.rstrip("\n")
if line.startswith("#") or not line:
if current_tokens:
sentences.append((current_tokens, current_tags))
current_tokens, current_tags = [], []
continue
tok, tag = line.split("\t")
current_tokens.append(tok)
current_tags.append(tag)
if current_tokens:
sentences.append((current_tokens, current_tags))
return sentences
sentences = parse_conll(path)
print(f"{len(sentences):,} sentencias")
Opción 3 — Inferencia con un modelo ya entrenado
Si publicas tu modelo NER en HF (por ejemplo
guerrerotook/cima-roberta-ner-react-active-freq-sys):
from transformers import pipeline
ner = pipeline(
"token-classification",
model="guerrerotook/cima-roberta-ner-react-active-freq-sys",
aggregation_strategy="simple",
)
text = (
"El medicamento puede producir cefalea, mareo y, con menos frecuencia, "
"trombocitopenia. La hipertensión es POCO FRECUENTE."
)
for ent in ner(text):
print(f"{ent['entity_group']:<8s} {ent['score']:.3f} {ent['word']}")
Filtrar a una entidad concreta sobre la config multi-tag
from datasets import load_dataset, ClassLabel, Sequence
ds = load_dataset("guerrerotook/cima-section48-ner", "react-active-freq-sys")
src = ds["train"].features["ner_tags"].feature.names # ['O', 'B-REACT', ...]
KEEP = {"O", "B-REACT", "I-REACT"}
remap = {i: (src.index(t) if t in KEEP else 0) for i, t in enumerate(src)}
def to_react_only(example):
example["ner_tags"] = [remap[t] if src[t] in KEEP else 0 for t in example["ner_tags"]]
return example
ds_react = ds.map(to_react_only)
Limitaciones y sesgos
- Tamaño reducido: 50 fármacos en total (35 train / 15 test). Apto para fine-tuning de modelos pre-entrenados, no para entrenar desde cero.
- Anotación silver-standard: las menciones provienen de las tablas estructuradas de la sección 4.8 (no de una anotación span-level manual); el etiquetado BIO se obtiene por matching exacto insensible a acentos/case con word boundaries.
- Dominio cerrado: vocabulario biomédico español, registro de ficha técnica. El rendimiento fuera de dominio (literatura clínica, foros de pacientes, etc.) no está caracterizado.
- Multi-tag desbalanceado: REACT representa >80 % de las menciones positivas. Las clases ACTIVE/FREQ/SYS son minoritarias y conviene evaluarlas con métricas por entidad (no sólo micro-F1).
Citación
@thesis{guerreroros2026cima,
author = {Guerrero Guirado, Luis Miguel y Ros Munoz, Salvador},
title = {Detección de reacciones adversas de medicamentos en textos clínicos: Un estudio comparativo de los modelos basados en BERT y modelos LLMs},
school = {Universidad Nacional de Educación a Distancia (UNED)},
year = {2026},
type = {Trabajo Fin de Grado},
}
Licencia y atribución
Dataset publicado bajo CC BY 4.0.
El texto bruto de la sección 4.8 procede de las fichas técnicas oficiales publicadas por la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) en su Centro de Información Online de Medicamentos (CIMA). Al reutilizar este dataset cita tanto el dataset original como la fuente AEMPS-CIMA.
- Downloads last month
- 57