checkpoints/ner_phase7_cohort_study/cls_val.jsonl

{"id": "954aa74eadbf", "text": "The temporal assessment of an ADR is illustrated by a quote: “The way I was before I visited the hospital, it has become over (after taking the medicine).” [Participant 11: female, no education].Only one participant assessed an ADR with the help of a family member.", "label": 1, "source_type": "qualitative_interview"}
{"id": "a145da3c7c61", "text": "A 38-year old health worker had this to say on the issue:“Well, some patients vomit and there is dizziness as well, but it is the dizziness and the vomiting that I have heard a lot of people complained about.", "label": 1, "source_type": "qualitative_interview"}
{"id": "31334088b6d7", "text": "In this study however, views expressed are slightly different because most patients attributed all the side effects to the use of artesunate-amodiaquine compared to other combinations.According to Asante et al., side effects such as headache, inability for some patients to control the neck and tongue were reported by patients who used ACT [5].", "label": 1, "source_type": "qualitative_interview"}
{"id": "3bfce90f3beb", "text": "This will encourage patients who experience side effects to report them.", "label": 0, "source_type": "qualitative_interview"}
{"id": "85737ddb20cb", "text": "Patients perceived such side effects as normal and reporting them held no relevance to them.", "label": 0, "source_type": "qualitative_interview"}
{"id": "590bfb302940", "text": "They added that poly-pharmacy was common within the health system and that drug interaction was more likely to cause some of the side effects that the patients complain about.", "label": 0, "source_type": "qualitative_interview"}
{"id": "719820e3cdff", "text": "They were particularly concerned about overdosing of medications, including ACT, by some patients as a contributor to these side effects.“The other reason is that they think that when they take overdose it will help to cure the illness fast and this makes them get the side effect.", "label": 0, "source_type": "qualitative_interview"}
{"id": "6518fc1325ac", "text": "We got this experience from our father who died of malaria” (IDI: 32-year old female patient).Similar views were shared by health professionals and chemical shop owners on the side effects patients with malaria experience from using ACT.", "label": 0, "source_type": "qualitative_interview"}
{"id": "9c15791b5ed2", "text": "They were particularly concerned about overdosing by some patients.In Ghana, the policy is that all patients are supposed to be well informed by prescribers and pharmacists on the possible side effect they are likely to experience from the use of ACT and the need for them to report.", "label": 0, "source_type": "qualitative_interview"}
{"id": "1b83bb52b148", "text": "These side effects have not been reported in this study.", "label": 0, "source_type": "qualitative_interview"}
{"id": "5f5cf273de2a", "text": "It is possible that these differences in views on the side effects on the use of ACT could be as a result of differences in individual human system.Patients are supposed to eat very well before using these medications.", "label": 0, "source_type": "qualitative_interview"}
{"id": "3e0bbeefe10e", "text": "ConclusionThe key factors responsible for the inability of patients to report side effects from using ACT are lack of health education, attitude of some patients and the unpleasant behaviour of some health workers towards patients at the health facilities.", "label": 0, "source_type": "qualitative_interview"}
{"id": "a0b0cc7b5c67", "text": "The management of drug-induced oculogyric crisis includes discontinuation or, if not possible, reducing the dose of the opposing agent.", "label": 0, "source_type": "case_report"}
{"id": "b57fb2e1f129", "text": "The mainstay treatment for oculogyric crisis is anticholinergics [6].", "label": 0, "source_type": "case_report"}
{"id": "55d69c97098a", "text": "His urine output for the first 24 hours was 100mls but he was not in pulmonary oedema.On day 2 of admission, his daily IV fluid input was increased to 3.5L in 24 hours.", "label": 0, "source_type": "case_report"}
{"id": "92526e3c1933", "text": "Therefore, the aim of this case report is bring to fore the association of AL as a cause of drug-induced oculogyric crisis.", "label": 1, "source_type": "case_report"}
{"id": "ba30728895eb", "text": "The symptoms of oculogyric crisis significantly improved 1 h after the IM injection.", "label": 1, "source_type": "case_report"}
{"id": "e1f79cf2556d", "text": "Common side effects include muscle and joint pain, fever, loss of appetite, and headache.", "label": 1, "source_type": "case_report"}
{"id": "a1b02f8dec2f", "text": "Two days prior to presentation at our facility, he visited a pharmacy with complaints of fever measuring 37.9 °C, general body pains, and weakness.", "label": 1, "source_type": "case_report"}
{"id": "06ff19b3c0aa", "text": "V, 2333 CN Leiden, The Netherlands 2°C - 8°C Moderna’s Dispersion for Injection [COVID-19 mRNA Vaccine (nucleoside modified)] Moderna Biotech Spain, S.L. -25°C - 15°C Comirnaty Concentrate for Dispersion for Injection [COVID-19 mRNA Vaccine (nucleoside modified)] BioNTech Manufacturing GmbH, Germany -80°C - 60°C (6months) and 2°C to 8°C up to 5days COVID-19 Vaccine AstraZeneca Suspension for Injection (ChAdOx1 S [recombinant]) AstraZeneca, United Kingdom 2°C - 8°C The FDA has granted Emergency Use Authorization (EUA) to six COVID-19 vaccines on the dates indicated below at the time of publication of this newsletter.", "label": 0, "source_type": "fda_newsletter"}
{"id": "53453fa9be8a", "text": "DrugLens Issue 7 NO MAH NAME OF DRUG ACTIVE INGREDIENT INDICATION 6 7 GSK GSK Nepine SR 20mg tablets Ventolin Rotacaps 200mcg Nifedipine SR 20mg Ventolin Rotacaps 200mcg Treatment of hypertension (high blood pressure) and angina (chest pain).", "label": 0, "source_type": "fda_newsletter"}
{"id": "2785b98ef517", "text": "The MHRA recommended that patients with underlying cardiac conditions who are administered Hyoscine butylbromide injection should be monitored.", "label": 0, "source_type": "fda_newsletter"}
{"id": "a19cece34324", "text": "DrugLens Issue 7 NO MAH NAME OF DRUG ACTIVE INGREDIENT INDICATION 18 GSK Seretide Evohaler 25/125mcg and 25/50mcg Inhaler Fluticasone propionate/ Salmeterol Treatment of asthma where use of a combination product (longacting β2 agonist and inhaled corticosteroid) is appropriate and for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy 19 GSK Xylal 5mg Tablets Levocetirizine Hydrochloride Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria in adults and children aged 6 years and above GHANA Your Well-being, Our Priority. 15", "label": 0, "source_type": "fda_newsletter"}
{"id": "27f23912e574", "text": "New safety information or signals identified by FDA through the adverse reaction reporting system in 2021 SAFETY COMMUNICATIONS PUBLISHED BETWEEN JANUARY 2021 TO JUNE 2022 Contamination of Losartan Active Substance with Mutagenic Azido Impurities This publication sought to bring to the attention of the general public information from European health authorities about detection of previously unknown Azido impurity, 4-chlorazidomethyltetrazole in some sartan medicines.", "label": 0, "source_type": "fda_newsletter"}
{"id": "9ab528caff6c", "text": "From March to August 2021, three vaccines namely, Oxford/AstraZeneca (Covishield/Vaxzevria), Sputnik V and COVID-19 Vaccine Janssen (Johnson and Johnson vaccine) had been deployed in Ghana.", "label": 0, "source_type": "fda_newsletter"}
{"id": "c6448f35e9e3", "text": "She had to travel on a number of occasions from Peki to the FDA Regional Office in Ho to pick up adverse reaction reporting forms when none was available in her institution.", "label": 0, "source_type": "fda_newsletter"}
{"id": "2a738f5c7200", "text": "7 DRUGLENS ISSUE 5 Hyoscine butylbromide (Buscopan) is indicated for acute muscular spasm including renal or biliary colic, in radiology for differential diagnosis of obstruction and to reduce spasm and pain in pyelography, and in other diagnostic procedures where spasm may be a problem.", "label": 0, "source_type": "fda_newsletter"}
{"id": "e1f27d315b6c", "text": "DrugLens Newsletter 11 Figure 10: Outcome of causality assessment of RTS,S serious AEFI reports, Ghana, 1st May 2019 – 31st May 2022 Ghana has been deploying COVID-19 vaccines since March 2021 and as of 31st May 2022, approximately 15,496,852 doses of the five vaccine types (AstraZeneca COVID-19 Vaccine, COVID-19 vaccine Janssen, Moderna COVID-19 vaccine, Pfizer BioNTech COVID-19 vaccine and Sputnik V) have been administered to various segments of the target population.", "label": 0, "source_type": "fda_newsletter"}
{"id": "bc00a72f6869", "text": "There were 3,365 AEFI reports submitted for Oxford/AstraZeneca (Covishield/Vaxzevria), 1,993 for Sputnik V and 93 for COVID-19 Vaccine Janssen.", "label": 0, "source_type": "fda_newsletter"}
{"id": "e4e52541f0b4", "text": "Hydrochlorothiazide-containing medicines are used to treat hypertension, as well as cardiac and hepatic oedema, or chronic heart insufficiency.", "label": 0, "source_type": "fda_newsletter"}
{"id": "1e9dcdf14f51", "text": "Studies have suggested that anaphylaxis is more likely to be fatal in patients with underlying coronary heart disease compared with those without.", "label": 1, "source_type": "fda_newsletter"}
{"id": "694cb9a8ccf6", "text": "Tis publication sought to update healthcare professionals on a publication in the 2017 edition of the Druglens on the safety information relating to reports published by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of acute myocardial infarction or cardiac arrest with fatal outcomes associated with the use of hyoscine butylbromide injection.", "label": 1, "source_type": "fda_newsletter"}
{"id": "f6deaf7276dd", "text": "Cardiac symptoms reported include restlessness, sudden collapse with hypovolemic shock and sweating with cold peripheries.", "label": 1, "source_type": "fda_newsletter"}
{"id": "e90188e5ec35", "text": "Newly reported ADRs of interest were one report each of tremor for doxycycline; scrotal pain, dyspnoea, gait disturbances and dysgeusia for chloroquine; and dry throat, hyperhidrosis, restlessness and micturition frequency increased for hydroxychloroquine.", "label": 1, "source_type": "fda_newsletter"}
{"id": "8e5cbb21f74f", "text": "Guideline on Reporting Adverse Drug Reactions FDA/SMD/GDL - 01/05 Page 8 of 28 Drug abuse is a persistent or sporadic, intentional excessive use of medicines, which is accompanied by a harmful physical or psychological effect. “Expedited Reporting” This is the immediate reporting and in not more than 7 calendar days of a serious adverse reaction to the Authority. “Food supplements” Concentrated sources of nutrients or other substances produced in a pharmaceutical dosage form such as tablets, gelatin capsules (soft or hard), sachets, syrups and powders.", "label": 0, "source_type": "fda_guideline"}
{"id": "cbde4b926718", "text": "The original words/description (verbatim) used by the initial reporter to describe the adverse reaction should be provided.", "label": 0, "source_type": "fda_guideline"}
{"id": "987bca8d6fb9", "text": "Guideline on Reporting Adverse Drug Reactions FDA/SMD/GDL - 01/05 Page 23 of 28 4.4 Feedback on Reports Received 4.4.1 Adverse Reaction Reports The FDA shall acknowledge receipt of the adverse reaction report within 14 days of receipt.", "label": 0, "source_type": "fda_guideline"}
{"id": "33dea22e8346", "text": "Internet or Digital media under the management of MAH should be screened regularly for adverse reaction reports and report to the Authority within the specified timelines.", "label": 0, "source_type": "fda_guideline"}
{"id": "1233426000c5", "text": "It is very important that follow up reports are identified and linked to the original report. 3.1.7 Reporting During Clinical Trials For safety reporting in clinical trials, please refer to the Food and Drugs Authority’s Guidelines for Authorization of Clinical Trials of Medicines, Food Supplements, Vaccines and Medical Devices in Ghana (FDA/SMC/CTD/GL-ACT/2013/01). 3.1.8 Duplication of Report If the Local Representative Marketing Authorization Holder is aware that a person has reported a reaction of one of its products directly to the Food and Drugs Authority: The Local Representative or Manufacturer/ Marketing Authorization Holder should still report the adverse reaction informing the Authority that the report is a duplicate of a previous report.", "label": 1, "source_type": "fda_guideline"}
{"id": "d3576317b790", "text": "Five potential safety concerns were identified under the period under review: anaemia (5 reports), jaundice (4 reports), aggression (2 reports), difficulty breathing (2 reports), and thigh pain (1 report).", "label": 1, "source_type": "fda_annual_report"}
{"id": "5b5212f9be76", "text": "Healthcare professionals were informed about various issues, including the risk of anesthesia in individuals exposed to Pholcodine within 12 months before using neuromuscular blocking agents, the recall of Lupin's Quinapril Hydrochloride Tablets, enhanced risk management for Sodium valproate requiring changes to product information, and the detection of falsified Meronem IV in the Ghanaian market. 10,214 5,191 1,172 2,821 4,264 1,601 1,642 2,807 1,098 -42% -34% -31% ICSRs RECEIVED ICSRs ENTERED IN THE SWS ICSRs with CAUSALITY ASSESSMENT TRIAGED- TAC 2021 2022 2023 % DIFF BETWEEN 2023 & 2022", "label": 0, "source_type": "fda_annual_report"}
{"id": "bad884bce3fd", "text": "The Minister of Health, Ghana, eventually issued an instruction through Executive Instrument 167 for the restriction of importation, manufacturer and registration of codeine-containing cough syrups [27].", "label": 0, "source_type": "surveillance_evaluation"}
{"id": "81d68b77c1b6", "text": "Patients report to healthcare professionals (primary reporters) of any untoward experience after taking a medicine; the details of the experience are verified and recorded on the reporting form (BlueForm®) as suspected ADR.", "label": 0, "source_type": "surveillance_evaluation"}
{"id": "be5f547e9f25", "text": "The 1,188 reports came from Public Health Programs (PHPs) such as School Deworming Program, the Girls Iron-Folate Tablet Supplementation (GIFTS) Programme and Ivermectin Mass Drug Administration.10.1371/journal.pone.0291482.g002Fig 2ADRs reported to NPC per year vs those not reported to NPC.Fig 3 shows the ADR reporting rate per million population for both Ho Municipal and the national data for the period of evaluation.", "label": 0, "source_type": "surveillance_evaluation"}
{"id": "50aedb88ba9b", "text": "Sensitivity was also assessed by looking at the number of signals detected by the surveillance system.Predictive value positive was assessed using the number of case investigations completed and the proportion of confirmed ADRs (classified as “certain”) after causality assessment.", "label": 0, "source_type": "surveillance_evaluation"}
{"id": "8621f5e1ee52", "text": "Major side effects of codeine use such as bloating, blurred vision, chills, confusion, darkened urine, shortness of breath, difficulty in breathing, weak pulse, the feeling of warmth, fever, indigestion, and loss of appetite had been reported.", "label": 1, "source_type": "surveillance_evaluation"}