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+{"id": "5ca17c31a09a", "text": "Some participants said they experienced an unusual heart beat and their health deteriorated after taking artesunate-amodiaquine.“….When I took the artesunate-amodiaquine, I had chest pains and I vomited” (IDI: 32-year old female patient).Other uncommon side effects of ACT were also reported by one of the participants.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "4908fb42d3ae", "text": "For me, immediately I put it into my mouth, I become very weak… when I took it the first time, I lost appetite and I was also very weak” (IDI-26 year old Mother).Shivering and poor vision “Some people complain of poor vision and difficulty to hear or they hear some noise in their ears” (IDI-36 year old health worker)Consultation content during out-patient visitsThe consultation content between clinician and client in the Out-Patient Department (OPD) focused mainly on drug administration to the neglect of drug efficacy and side effects.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "5d7510510656", "text": "Majority of the patients who took artesunate-amodiaquine and artemether-lumefantrine, respectively, reported to have experienced side effects such as body weakness, dizziness, itching and abdominal pain [5–14].", "label": 1, "source_type": "qualitative_interview"}
+{"id": "7d5a32abf2dd", "text": "However, swollen testes was reported in this study as one of the side effects of ACT.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "76cd3a824efd", "text": "Opinions from patients who use artesunate-amodiaquine in this study suggested that the components are still high and that could be the reason why they are still experiencing these side effects.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "10cf568d694e", "text": "Some people complain of poor vision and difficulty to hear or they experience some noise in their ears”(IDI: 38-year old health worker).The health workers explained that some malaria patients only initiate treatment when the condition is severe and that this was responsible for some of the side effects and not necessarily ACT.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "6a858f082579", "text": "Body weakness and dizziness are the most frequent side effects many of the patients reported.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "c20e7da61ee6", "text": "When the artesunate-amodiaquine was first introduced in Ghana, many patients who used it had several side effects because the components of the drug were very high [7].", "label": 1, "source_type": "qualitative_interview"}
+{"id": "f29b4b315333", "text": "Experience of side-effects of ACTThe findings revealed that participants who took artesunate-amodiaqiune to treat malaria reported most side effects.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "f172a686d2bb", "text": "The most commonly reported side effects were general body weakness and dizziness.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "94d48abf79be", "text": "For me, immediately I put it into my mouth, I become very weak… when I took it the first time, I lost appetite and I was also very weak” (IDI-26 year old Mother).Shivering and poor vision “Some people complain of poor vision and difficulty to hear or they hear some noise in their ears” (IDI-36 year old health worker)", "label": 1, "source_type": "qualitative_interview"}
+{"id": "87aeb0631c5d", "text": "Others however thought that the components of artesunate-amodiaqiune were too high for them and, therefore, the side effects.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "9d6e1608c526", "text": "It is possible that swollen testes may not be as a result of the use of ACT as reported by participants.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "2183591be115", "text": "Some people complain of poor vision and difficulty to hear or they experience some noise in their ears” (IDI-38 year old health worker)Chest pains “…When I took the artesunate-amodiaquine, I had chest pains and I vomited” (IDI-32 year old female patient)Swollen testicles “…others especially the men have their testes and body swollen.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "7dcfb568b4eb", "text": "When it starts unless he takes akpetashie (type of wine prepared locally) (type of wine prepared locally) it will always be serious” (IDI-32 year old female patient)Loss of appetite “When my child took the artesunate-amodiaquine, he was weak and could not open his eyes.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "f1bce2d9160c", "text": "Consequently, research studies that evaluated the performance of the new anti-malarials reported widespread severe side effects such as severe headache, body weakness, dizziness and vomiting [4, 5].", "label": 1, "source_type": "qualitative_interview"}
+{"id": "526199857826", "text": "Some patients shared their experiences in the excerpts below.“I was given artesunate-amodiaquine and when I started taking the drug I could not do anything because my whole body was weak” (IDI: 29-year old male patient).The other side effects reported were vomiting, chest pains, itching, loss of appetite, poor vision and shivering.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "c885c7340dec", "text": "However, people are not being encouraged to report when they experience these side effects.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "f9bce99c9651", "text": "The participants reported that this was common with patients who suffered side effects due to non-adherence to the dosing regimen because they were likely to be verbally abused by the health workers.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "1ca1af282bf4", "text": "The health professionals were selected to share their experiences on the side effects of ACT and the factors affecting side effects reporting.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "91ce1bfbe699", "text": "Purchasing medicines from unlicensed and itinerant sellers makes it difficult for patients to report ADRs because sometimes they are reluctant to mention or cannot trace where or whom they bought their medicines from as the interviews revealed.Table 3Identified obstacles experienced in ADR-reporting by Ghanaian patients and possible solutions to itObstaclePotential solutionsPoor dispensing practices of medicinesImprove the regulation of medicine dispensing practices.Urging pharmaceutical companies to produce smaller medicine boxesEducate HCWs on good dispensary practices of medicines in their education program and by in-service training.Substandard recognition of ADRs by patientsHCWs and primary schools should focus on educating (lower educated) patients on ADRs and how to recognize and assess ADRs.An easy tool can be developed to assist patients in the recognition and assessment of ADRs.Skipping the first line of healthcare in reporting ADRsThe authorities concerned need to make patients more aware of avenues to report and particularly urge patients to report ADRs to their first line of care which is the pharmacy attendants and then other HCWs.Pharmacists or attendants in turn need to improve their participation in ADR-reporting by improving their patient engagement with the hope of establishing a lasting trust-based relationship.Lacking awareness to report ADRs to HCWsBetter information provision practices from HCWs by including ADR reporting/patient education in the curriculum of healthcare disciplinesTargeted campaigns by the Ghana-FDA.Socio-economic differences between patients and HCWsPoint out alternative options for patient reporting of ADRs such as their first line of care (pharmacist) and/or the PRS.Lacking awareness of the PRS and willingness to use itCampaigns to make patients aware of the PRSCreating a patient-friendly version of the PRSThe second identified obstacle is substandard recognition of ADRs.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "4e795e092314", "text": "DiscussionThe study presents reported side effects as are experienced from using ACT to treat uncomplicated malaria using qualitative approach.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "75bb3305483c", "text": "For example, one participant described an ADR as: “If you should take the drug and should become plenty, it gives you a side effect.” [Participant 7: male, finished primary school].", "label": 0, "source_type": "qualitative_interview"}
+{"id": "496a76f8d88a", "text": "They should tell the people to feel free and come back to the health facility anything they take these drugs and get side effects….” (IDI: 25-year old female patient).“…The doctors should make it such that when you take the drugs and get side effects you should walk straight to the doctor and complain to him, it should not look like you are coming for the first time where you would go and follow line for long before you see the doctor to give your complain about the side effects you got from using the drugs they gave you” (IDI: 39-year old female patient).", "label": 0, "source_type": "qualitative_interview"}
+{"id": "c4ca791e4fc6", "text": "Of 439 participants that received medicines from the dispensary, 6% received information about possible side effects of medicines from their HCW.Table 2Persons or institutions to whom the participants reported or would report an adverse drug reaction (ADR).", "label": 0, "source_type": "qualitative_interview"}
+{"id": "c6202105654a", "text": "Older participants were significantly more likely to be familiar with the words “side effect”, “ADR” or their local translation (p = 0.004) compared to younger participants.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "a7160f7ff54d", "text": "This is my second time of going there (health facility) and they have not told me anything on the side effects I will get when I use the drug”(IDI: 25-year old female patient).The providers confirmed that in addition to giving instructions on the dosing regimen, they are required to provide information on side effects to patients and to explain to them why it was important for them to report any side effects they experience with the drug to the nearest health facility.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "b78cb8a22a5a", "text": "Patients preferred to endure such side effects at home rather than report them to the health facility with the reason that every drug has a side effect and therefore it was normal to experience them.“The reason is that I know the way it works and that made me not to go back and I was waiting to see what would happen after the third day….So because I know how the drug works is the reason why I did not go back to tell them” (IDI: 30-year old female patient).Participants also identified long queues at the OPD that led to long waiting-time before receiving care as a critical factor that affect the reporting of adverse events.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "f5524806320b", "text": "And others will say that if I am strong enough to go to the facility why don’t I just go to the market and manage my business, so mostly that is the reason why they don’t come” (IDI: 29-year old health worker).Other patients said that previous reports of side effects yielded no benefits to them.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "a5656106f8c0", "text": "Earlier study reported that because of lack of knowledge, seventy-five percent (75) % of those who experienced side effects did not report to health workers [4].Based on the views shared by participants, health workers are not educating patients on the possible side effects they are likely to experience and the need to report them.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "f308a9a04cb3", "text": "N = 491 Yes45 (9,2%)p = 0.162p = 0.238T = 0.159p = < 0.001*T = < 0.001*p = 0.047*No446 (90,8%)Information about ADRs provided by pharmacists N = 439 Yes25 (5,7%)No414 (94,3%) *indicates statistical significance Participants with higher education were significantly more likely to be familiar with the words “side effect”, “ADR” or their local translation (p < 0.001).", "label": 0, "source_type": "qualitative_interview"}
+{"id": "f2fc36d10989", "text": "Artemether-lumefantrine and dihydroartemisinin-piperaquine were subsequently added as first-line anti-malarial treatment for uncomplicated malaria to cater for those who could not tolerate the artesunate-amodiaqiune [7].These different artemisinin-based combinations have been used to treat uncomplicated malaria in Ghana for about a decade now.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "b0deef8077ae", "text": "Two participants indicated they did not know the medicine that caused the ADR, because they took multiple drugs: “If I was taking one particular medicine, I would say ‘okay when I take this medicine, this is the side effect’.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "adc8f7ef8559", "text": "The health professionals were selected to share their experiences on the side effects of ACT and the factors affecting side effects reporting.Data collectionThe in-depth interviews were conducted by trained university graduates with experience in qualitative research technique.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "e1bf040441bb", "text": "Other participants mentioned every effect after taking a medicine (n = 4), an unexpected effect after taking a medicine (n = 3), the effect after taking an overdose of a medicine (n = 2) or the medicine is not working (n = 1) as definitions of an ADR.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "c07ffd95d794", "text": "FDA = Ghana Food and Drug Authority, MoH = Ministry of HealthResponsesGenderAgeEducationArea of livingAre you familiar with the word side effect or ADR?", "label": 0, "source_type": "qualitative_interview"}
+{"id": "37cb945d14f6", "text": "Patients were of the opinion that there should be a policy whereby people who took ACT and got side effects should not be made to join long queues at the hospital during review visits.“The nurses should have patience when dealing with people at the health facility.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "4cc93eff6a83", "text": "Although most of the causes of the side effects were drug-related, some were due to the introduction of generics that were poorly formulated and poor compliance to drug regimens [4].Ghana changed her first-line anti-malarial drug policy in 2004, from chloroquine to the use of artesunate-amodiaquine as the first-line drug for the treatment of uncomplicated malaria [7].", "label": 0, "source_type": "qualitative_interview"}
+{"id": "4835553e0798", "text": "Consultation content during out-patient visitsThe consultation content between clinician and client in the Out-Patient Department (OPD) focused mainly on drug administration to the neglect of drug efficacy and side effects.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "0082195ab134", "text": "The problem is that when they take the drugs wrongly and get problems (side effects) at home, they are afraid to go and tell the doctor because they do not know what the doctor would say and sometime, they could be insulted by these health workers.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "8c7989eb92a9", "text": "According to the study participants, patients’ inability to eat food before using the drugs made them to experience these side effects.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "f1f269598316", "text": "Most of the patients were of the view that health education should be given to patients in order to encourage them to report these side effects.“…drug store attendants and the health workers at the hospitals should often inform patients of the possible side effects and also tell them to come back if they experience serious side effects after taking the drugs so that they can test you and see what the problem is”(IDI: 38-year old female patient).The health workers said that most people were ignorance and at such did not know that they were supposed to come back and report and if patients were reminded continuously each time they were given ACT, it would have a positive impact on adverse event reporting in the study area.“…we (health workers) should have patience towards our clients and try to educate them about the side effects and also encourage them to report when they get these side effects at home….” (IDI: 41-year old health worker).Most of the patients said that it was important for health workers to have patience and behave nicely toward their clients in a manner that would encourage them to always feel free to visit the health facility anytime they have health problems.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "dc994a3f6384", "text": "JSS = Junior Secondary School, JHS = Junior High School, SSS = Senior Secondary School, SHS = Senior High SchoolSurveyIn-depth interviewsFigures GhanaVariableN%N%%GenderFemale29351,3%1342%52,8%Male27848,7%1858%47,2%Age18–247012,3%13%24,7%*25-3412722,2%826%27,3%35–4411720,5%619%19,1%45–5410818,9%723%13,0%55–647613,3%619%7,3%65–74549,5%310%4,7%75 ≤193,3%00%3,8%Education**None569,8%310%28,5%Primary/JSS/JHS19133,5%826%34,1%Secondary/SHS/SSS17330,3%1032%27,3%Tertiary14926,1%1032%10,2%Unknown20,3%–––Area of livingRural area14024,5%826%49,1%Urban area43175,5%2374%50,9% *age group 15–19 was used, corrected to age range 18–19 and added to age group 20–24 **The figures from the educational attainment in Ghana and the four regions are from people 15 ≤ years old In this study, 14% of participants (n = 80) indicated they had never heard of the words “side effect”, “adverse drug reaction” or their local equivalents.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "6b8bc3594012", "text": "They should tell the people to feel free and come back to the health facility anything they take these drugs and get side effects….” (IDI: 25-year old female patient).“…The doctors should make it such that when you take the drugs and get side effects you should walk straight to the doctor and complain to him, it should not look like you are coming for the first time where you would go and follow line for long before you see the doctor to give your complain about the side effects you got from using the drugs they gave you” (IDI: 39-year old female patient).LimitationsThough, this study provides information on factors affecting adverse events reporting of ACT, some limitation however must be considered.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "7e7ec92d38f3", "text": "ResultsExperience of side-effects of ACTThe findings revealed that participants who took artesunate-amodiaqiune to treat malaria reported most side effects.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "979c1a5b0e93", "text": "Participants associated poor eating before taking their medications as the main cause of the side effects.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "808ff96d0d13", "text": "These facilities reported using feedback from the FDA, to observe patients who suffered particular side effects during subsequent treatments, Most of the community health compounds had never documented any side effect and they did not have the appropriate forms to capture adverse events.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "be6830eb7dbe", "text": "So we have to monitor the person and make sure that he/she takes the drug correctly and if the same side effects are presented then you have to change treatment for the person and see” (IDI: 46-year old pharmacist).Factors affecting adverse events reportingProvider and patient-related factors were the two broad factors identified to be responsible for the low reports of adverse drug reactions in the study area.Provider-related factorsThe providers reported that, doctors, pharmacists and dispensary technicians who are required to educate patients on adverse drug events are few and the pressure of work leaves them no time to discharge such duties.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "a9731f593e54", "text": "Those who are insured, when they collect these drugs they go and share them with those who are not insured at home and such people will not be able to educate them the way they will take the drug hence they can use the drug the way they want and when they get these side effects, they turn to put the blame on the drug” (IDI: 32-year old health worker).", "label": 0, "source_type": "qualitative_interview"}
+{"id": "0b8a120dbaa0", "text": "ADR = adverse drug reaction, HCW = health care workerThe way patients discover ADRs (Discovery) and reasons why they act when experiencing an ADR (Action) were two themes within the conceptual framework based on earlier studies [17, 18, 21, 23].", "label": 0, "source_type": "qualitative_interview"}
+{"id": "2e093b8ba60b", "text": "Now that they said it is as a result of the drug and nothing else why then would you waste your time going if you take the drug again and get these side effects.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "2df3dddb42fd", "text": "This is the one other reason why such people who get these side effects do not report”(IDI: 26-year old female patient).", "label": 0, "source_type": "qualitative_interview"}
+{"id": "23d44f4fc405", "text": "Most participants (n = 21) described an ADR as a negative reaction after taking a medicine.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "d2f4bec877ba", "text": "Only a few patients reported receiving information on side effects of the ACT that was given but none reported being told to report back to the health facility if they experienced any side effects.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "fcab7b793605", "text": "Patients who experienced side effects were required to report to the nearest health facility, but compliance was low due to poor adverse events reporting systems [4].", "label": 0, "source_type": "qualitative_interview"}
+{"id": "255aa024efe1", "text": "This is the one other reason why such people who get these side effects do not report”(IDI: 26-year old female patient).Patient-related factorsPatients are usually not motivated to come back and report adverse events especially if the side effects are those already known to be associated with the drug.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "5edd1e1ba1d0", "text": "The health workers reported non-adherence to the dosing regimen as a significant contributor to side effects.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "5fdbbc32789e", "text": "Patient-related factorsPatients are usually not motivated to come back and report adverse events especially if the side effects are those already known to be associated with the drug.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "6cc7bd9848be", "text": "Instead of them to tell you that when you take the drug and get side effects, you should come back to complain they don’t do that.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "fd3d11df49fd", "text": "So we have to monitor the person and make sure that he/she takes the drug correctly and if the same side effects are presented then you have to change treatment for the person and see” (IDI: 46-year old pharmacist).", "label": 0, "source_type": "qualitative_interview"}
+{"id": "97d2bdd4d7af", "text": "It is demonstrated that poor noncompliance to guidelines to the use of medications accounted for drug side effects [15].", "label": 0, "source_type": "qualitative_interview"}
+{"id": "f1698bc5c842", "text": "Despite the fact that some level of health education has been given to patients by health workers on the use of ACT and how to prevent malaria, there is a need for health workers to specifically educate patients on the side effects of ACT.It is, therefore, recommended that intensive and continued education should be incorporated into the routine health care activities.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "5631079bc24a", "text": "These were also mentioned as factors affecting effective side effects reporting in this study.The fact that patients who previously reported side effects at the health facility and could not get any help from health workers has been reported to have negative effect on adverse events reporting.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "f8a3f43705e2", "text": "Also, patients who experience side effects should be properly taken care of at the health facility during review visits.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "c7f2fa273f3f", "text": "A 46-year old pharmacist shared his views this way on the issue:“Yes there is a procedure and what usually happens is that there is an institutional contact person that is the pharmacist, who is supposed to compile all the side effects people come to complain about.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "1e517fd4e359", "text": "The health professionals explained that some malaria patients only initiate treatment when the condition is severe and that this was responsible for some of the side effects and not necessarily the ACT.", "label": 0, "source_type": "qualitative_interview"}
+{"id": "112f315e1812", "text": "Since Plasmodium falciparum became resistant to chloroquine, AL has been used to treat malaria.", "label": 0, "source_type": "case_report"}
+{"id": "31b2c31505bd", "text": "BackgroundArtemether/lumefantrine (AL), sold under the brand name Coartem, is the most common artemisinin-based combination therapy recommended by the World Health Organization.", "label": 0, "source_type": "case_report"}
+{"id": "574dcfdbef6c", "text": "He was started on IV 0.9% Normal saline fluids of 3L over 24hours with strict urine output monitoring, IV ciprofloxacin 400mg two times daily, tablet doxycycline 100mg twice daily was prescribed to treat the urethritis and urinary tract infection empirically as cultures were negative.", "label": 0, "source_type": "case_report"}
+{"id": "00a121a6e027", "text": "This case brings to light the dangers of treatment of simple conditions with complementary medicines and the need for thorough investigations for all cases of acute kidney injury (AKI) and the valuable use of urine microscopy in the management of kidney disease in low resource countries like Ghana.", "label": 0, "source_type": "case_report"}
+{"id": "9e93bc49c6b2", "text": "Serology for Hepatitis B, Hepatitis C and retroviral infection were also negative.", "label": 0, "source_type": "case_report"}
+{"id": "1d23490f06db", "text": "ADRs can also be a side effect of other medications, such as antiemetic, antipsychotic, antidepressant, antiepileptic, and antimalarial medications, which produce ADRs due to dopaminergic-cholinergic imbalance in the basal ganglia [3].", "label": 0, "source_type": "case_report"}
+{"id": "16d2295082d0", "text": "Our patient presented with hypotension which increased his risk of AKI.", "label": 0, "source_type": "case_report"}
+{"id": "b2efd0327c0d", "text": "Wyllie et al. reported that versive seizures can mimic oculogyric crisis, but they are associated with an alteration of consciousness and should be excluded with an electroencephalogram [9].", "label": 0, "source_type": "case_report"}
+{"id": "c0f606d3c970", "text": "The presence of granular cast suggests ATN which could be due to the use of the NSAID diclofenac and or the presence of infection.", "label": 0, "source_type": "case_report"}
+{"id": "898b08457f7b", "text": "The patient without symptoms following treatment (b)Upon the examination of the eyes, the pupils were isocoric and reactive to light.", "label": 0, "source_type": "case_report"}
+{"id": "c516ec6bba67", "text": "He arrived at the Emergency Department fully conscious but looked pale, temperature 36.80C, blood pressure 83/60mmHg, pulse rate was 111 beats per minute, respiratory rate was 16 cycle per minute, random blood glucose was 13.6mmol/L, oxygen saturation of 98% in room air, his chest was clinically clear and had no peripheral oedema.", "label": 0, "source_type": "case_report"}
+{"id": "3db9986fe5fa", "text": "Acute kidney injury occurs in 19% of patient with moderate infections and up to 51% of patients with severe sepsis with septic shock [7].", "label": 0, "source_type": "case_report"}
+{"id": "5179eedff5e8", "text": "Oculogyric crisis must be excluded from versive seizures, eye movement tics, paroxysmal tonic upgaze syndrome, and retinal disease.", "label": 0, "source_type": "case_report"}
+{"id": "1532e73edd25", "text": "One serious side effect is prolongation of the QT interval.", "label": 0, "source_type": "case_report"}
+{"id": "29f9a2208bd8", "text": "When a patient exhibits the symptoms of a neurological disorder, such as oculogyric crisis, with conscious state and normal vital signs, special attention should be given to recently administered medications.", "label": 0, "source_type": "case_report"}
+{"id": "5dfbabf634aa", "text": "Versive seizures are phenomenologically similar to oculogyric crisis, yet they are fundamentally different [3, 9].", "label": 0, "source_type": "case_report"}
+{"id": "3cb53a140237", "text": "He was put on Intravenous (IV) artesunate, IV ceftriazone 2g, Intramuscular (IM) diclofenac 75mg and tablet acetamenophen 1g three times a day then referred to KATH for haemotransfusion and possible haemodialysis when he was noted to have reduced urine output with rising serum creatinine up to 2315umol/L.", "label": 1, "source_type": "case_report"}
+{"id": "c4ba1c49cd3f", "text": "Paroxysmal tonic upward gaze is characterized by episodes of sustained conjugate upward deviation of the eyes and can be differentiated from oculogyric crisis by the presence of neck flexion and concomitant episodic ataxia [10].Considering the important key points including the medication history and the clinical findings of the patient, a diagnosis of AL (Coartem)-induced oculogyric crisis was made.", "label": 1, "source_type": "case_report"}
+{"id": "4aae36616ffc", "text": "The spasms may be followed by emotional lability, such as restlessness, compulsive thinking, anxiety, and sensations of increased brightness or visual distortions [6].", "label": 1, "source_type": "case_report"}
+{"id": "f8690793da3d", "text": "On discharge after 3 weeks, his urine output was 2700mls and his renal function had normalized with a urea of 6.50mmol/L, creatinine 96umol/L, serum sodium concentration of 139mmol/L, potassium of 4.7mmol/L, Chloride of 103 mmol/L and normocytic anaemia of 9.2g/dl.", "label": 1, "source_type": "case_report"}
+{"id": "430d91c7e352", "text": "When a patient exhibits a neurological disorder, such as oculogyric crisis, with normal conscious state and normal vital signs, special attention should be given to obtaining a history of recently administered medications.", "label": 1, "source_type": "case_report"}
+{"id": "c4fc23447cab", "text": "He was commenced on acute intermittent haemodialysis on account of refractory hyperkalaemia and pulmonary oedema.", "label": 1, "source_type": "case_report"}
+{"id": "119eb1c0efe4", "text": "Aluminium toxicity has been well described in literature as a cause of encephalopathy, osteomalacia and microcytic anaemia especially in patients who have been on chronic dialysis.", "label": 1, "source_type": "case_report"}
+{"id": "342c37290033", "text": "Both eyes exhibited conjugate upward deviation, and the patient was unable to fully close both eyes (oculogyric crisis).", "label": 1, "source_type": "case_report"}
+{"id": "d0fd14509c04", "text": "An initial diagnosis of: 1) Acute Kidney injury secondary to toxic acute tubular necrosis; 2) Naphthalene induced intravascular haemolytic anaemia; 3) Urethritis/Urinary tract infection were made.", "label": 1, "source_type": "case_report"}
+{"id": "2b523168311f", "text": "Based on the above-mentioned findings, the patient was diagnosed with Coartem-induced oculogyric crisis.", "label": 1, "source_type": "case_report"}
+{"id": "46d0a4a195a0", "text": "NSAID have been described as a risk for acute kidney injury through via mechanisms such as ischemic ATN, glomerulopathies, acute interstitial nephritis, and fluid overload [6].", "label": 1, "source_type": "case_report"}
+{"id": "a254c06672ce", "text": "Patient and observationA 26 year old African male university student with no known medical condition presented to the Emergency Department of the Komfo Anokye Teaching Hospital (KATH) with a 4-day history of jaundice, cola like urine and reduced urine volume associated with palpitation, dizziness and easy fatigability.", "label": 1, "source_type": "case_report"}
+{"id": "38e20e0ca98d", "text": "It is still not entirely clear what the cause of the suspected glomerulonephritis was as evidenced by the red cell cast on urine microscopy as there is no clear association with naphthalene, alum or diclofenac in literature.", "label": 1, "source_type": "case_report"}
+{"id": "9587ecf2481a", "text": "He was admitted at a peripheral hospital at the onset of his symptoms for three days and was managed as a case of severe anaemia secondary to intravascular haemolysis from naphthalene containing herbal preparation.", "label": 1, "source_type": "case_report"}
+{"id": "38f9e3011206", "text": "It binds to the proximal tubular cells via the megalin-cubilin receptors where it leads to direct cytotoxicity of the tubular cells, associated with renal vasoconstriction and also leads to formation of intratubular cast with interaction with Tamm-Horsfall's protein which obstructs the tubules leading to the formation of muddy brown granular cast as seen in our patient [5].Our patient was also given a non-steroidal anti-inflammatory drug (NSAID) diclofenac at the peripheral hospital which has various effects on the kidney.", "label": 1, "source_type": "case_report"}
+{"id": "6f1aa3760968", "text": "Although oculogyric crisis is mostly drug-induced, it can be seen in hereditary and sporadic movement disorders and disorders related to focal brain lesions.", "label": 1, "source_type": "case_report"}
+{"id": "906af5619fd9", "text": "Patient however then developed pulmonary oedema which was managed with IV furosemide (80mg twice daily which was increased to 80mg three times daily).", "label": 1, "source_type": "case_report"}
+{"id": "c64d3fbd3570", "text": "The incidence of Coartem-induced oculogyric crisis has not been reported in the literature, whereas other antimalarial drugs such as artesunate/amodiaquine were reported to cause ADRs in children [3].AL is thought to be highly effective in treating uncomplicated malaria in children and the frequency of associated side effects is not higher that other available artemisinin-based combination therapies [5].", "label": 1, "source_type": "case_report"}
+{"id": "9d2d66e5a908", "text": "Therefore, the patient received antimalarial therapy artemether/lumefantrine, Coartem® (Novartis Pharma AG, Basel, Switzerland), at a dose of 80/480 mg and to be taken after 8 h on day one and twice daily thereafter for 2 days.Just after initiation of treatment, the patient complained of double vision, involuntary upward eye deviation, and inability to close both eyes (Fig. 1a).", "label": 1, "source_type": "case_report"}
+{"id": "af5ad0d53d68", "text": "C46H58Cl3NO6 for Lumefantrine (b)Oculogyric crisis is defined as rare nonlife-threatening neurological manifestation that causes spasmodic movements of the eyeballs into a fixed position that may last from seconds to hours [3, 8].", "label": 1, "source_type": "case_report"}
+{"id": "1a1848ff560b", "text": "ConclusionsA literature search demonstrated no published articles on Coartem-induced oculogyric crisis in Ghana, where malaria is endemic.", "label": 1, "source_type": "case_report"}
+{"id": "5025b45cdc57", "text": "All suspected ADRs whether known or not which causes concern in the caregiver/the patient Lack of efficacy/therapeutic failure Suspected pharmaceutical defect Counterfeit pharmaceuticals Mediation errors Consumers, patients and healthcare professionals are encouraged to use the Med Safety App because it is a quick and easy way to report adverse reactions to the Food and Drugs Authority.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "a8f4e89e1a27", "text": "The Technical Advisory Committee of the FDA arrived at this decision based on the following reasons: • Codeine has no greater antitussive (cough suppres sant) activity compared with dextromethorphan. • Dextromethorphan, the alternative ingredient listed in the Standard Treatment Guidelines of Ghana (7th Edition, 2017), exhibits similar antitussive (cough suppressant) activity compared with codeine but has a lower addictive potential. • Codeine has a much greater side effect profile compared to dextromethorphan. • There are a number of products both locally manu factured and imported containing dextrometho rphan registered by the FDA which could be used in place of CCS.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "6ed213f575e4", "text": "The higher reporting rate for Sputnik V was because the AEFI reports were mainly through the active safety surveillance system.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "969aa1e3e089", "text": "The FDA component of the consortium, Work Package 4, seeks to promote pharmacovigilance and is currently undertaking an IR around the deployment of the Med Safety App as an adverse reaction reporting tool.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "a4d3ab96be48", "text": "Torrent Pharmaceutical Limited Dopcor 80mg and 160mg tablets Valsartan 80mg and 160mg Treatment of high blood pressure (hypertension) in adults and children who are at least 6 years old.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "4781b8f7fe9e", "text": "The UK medicines regulation agency, Medicines and Healthcare products Regulatory Agency (MHRA) in their Drug Safety Update newsletter, volume 10 issue 7, published in February 2017, provided updates to guide the prescribing and administration on Hyoscine butylbromide injection.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "7ec0d7ffdcac", "text": "14 DrugLens Newsletter Product Name Indication Safety Concern Additional Risk Minimization Measure Xarelto (Rivarobaxan) Adults Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "66fffda841e8", "text": "Strengthening Haemovigilance in Ghana New safety information or signals identified by FDA through the adverse reaction reporting system in 2020 Product Name: Brand (Active Ingredient) Bupivacaine Hydrochloride Injection Paraconica (Paracetamol 10mg/ml) Solution Crystallization and Discoloration of Paracetamol 1000mg IV Healthcare professionals were advised about the proper storage condition of the product.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "506043309524", "text": "Community pharmacies that volunteered to support this initiative were branded by the FDA as “Patient Safety Centres” with the responsibility to educate patients on how to identify side effects of medicine and vaccines and to report these to the FDA.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "9a6365d54f7f", "text": "Hyoscine butylbromide injection is contraindicated in patients with tachycardia.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "f2052bb94030", "text": "MARKET WITHDRAWALS FOR SAFETY REASONS NO NAME OF DRUG REASON FOR THE WITHDRAWAL 1 2 Codeine Containing Cough Syrups (CCS) Oral Ketoconazole products This decision was arrived at following reports of widespread abuse of CCS.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "089b27063f62", "text": "Just submit a completed adverse reaction report and take a 5 minute online test at https://www.az-engage.com/login/ to obtain your 2 points Figure 7: A man ready to receive yellow fever (YF) vaccine in the Akatsi South District in the Volta Region Increasingly more patients through the Community Pharmacies are becoming active participants in the Patient Engagement in Medicine Safety initiative since it was launched in June 2016.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "22265cb7ba99", "text": "These should therefore be reported to the FDA using the Adverse Reaction Reporting Form.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "1c25b9a3737b", "text": "Objective: Objective of this study is to describe the pattern of stimulated spontaneous adverse drug reaction (ADR) reports received from healthcare professionals for SARS-CoV-2 positive patients in Ghana and lessons learnt particularly for lowand middle-income countries.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "d9de51f92bcf", "text": "Consequently, causality assessment was done by the FDA’s Joint COVID-19 Vaccine Safety Review Committee (JCVSRC) using the WHO's AEFI Causality Assessment procedure.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "912deb56a60f", "text": "Adverse reactions (side effects) of medicines reduce the quality of life of clients.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "c0953aa054df", "text": "Omeprazole may also be given together with antibiotics to treat gastric ulcer caused by infection with Helicobacter pylori (H. pylori) Treatment of some types of breast cancer in men and women.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "bcd4ad238706", "text": "The outcome of Causality Assessment per antigen for 82 SAEFIs by the Technical Advisory Committee on Safety of Vaccines and Biological Products (TAC-VBP) using the process outlined in the WHO User Manual on Revised Classification of AEFI is shown in Figure 8.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "fb45464a42d9", "text": "MAHs Brand Name Active Ingredient(s) Indication MSD Peg-Intron Injection 50mcg, 80mcg, 100mcg, 120mcg, 150mcg and 250mcg Peginterferon alfa-2b Chronic Hepatitis C (CHC) in patients with compensated liver disease Quadriderm Cream Bethamethasone + Tolnaftate g + Clioquinol + Gentamycin Relief of the inflammatory manifestations of corticosteroid responsive dermatoses complicated by secondary infection caused by organisms sensitive to the components.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "094d81e53d99", "text": "Hyoscine butylbromide injection remains contraindi cated in patients with tachycardia.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "a85424bc7f30", "text": "Hyoscine butylbromide injection should be used with caution in patients with cardiac disease. 4.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "ce0eb84924bb", "text": "Secondly, improved stakeholder collaboration has been found most effective, as the recent opioid epidemic - abuse of codeine, tramadol and other prescription medicines continues to be one of the major challenges facing the youth in our country.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "2b57e604fed5", "text": "Strategies put in place include increased public education and awareness creation on the dangers of these products, withdrawal of the marketing authorization and ban on the importation of codeine-containing cough syrups, reclassification of tramadol as a controlled narcotic medicine, intensification of market surveillance particularly at the ports of entry and collaboration with relevant stakeholders like Pharmacy Council, Mental Health Authority, the security agencies and the media to execute measures aimed at reducing the incidence of abuse.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "e257bc2e9b4c", "text": "The lower number of adverse reaction reports received in 2020 compared to the previous years’ is likely due to COVID-19 pandemic resulting in reduced hospital visits. 11 13 14 14 16 16 17 18 24 25 27 38 41 49 72 0 10 20 30 40 50 60 70 80 Methyldopa Chloroquine phospate Artemether Lumefantrine Pregabalin Meƞormin Sacubitril Valsartan Amoxicillin Diclofenac Hydroxychloroquine Hydroxycarbamide Ciprofloxacin Praziquantel Tenofovir/Lamivudine/Dolutegavir Lisinopril Nifedipine Fig. 5: Outcome of reported adverse reactions 1274 1687 1542 2236 1325 0 500 1000 1500 2000 2500 2016 2017 2018 2019 2020 33.7 61.6 4.7 Males Females Unknown", "label": 0, "source_type": "fda_newsletter"}
+{"id": "8f08d8bd29a4", "text": "Clozapine is used to treat schizophrenia when other antipsychotic medicines either have not worked or have caused severe side effects.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "a6856126e5db", "text": "Darko The FDA encourages the reporting of all suspected adverse reaction to medicines, including vaccine, Over-the-Counter medicine and herbal, traditional or alternative remedies.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "330d806bedb4", "text": "Three hundred (300) AEFI reports were received from the passive (spontaneous) reporting system, 744 from the Phase 2B Yellow Fever Preventive Mass vaccination campaign and 997 from the Malaria Vaccine Implementation Program (MVIP).", "label": 0, "source_type": "fda_newsletter"}
+{"id": "e0b2adbc7eb4", "text": "We particularly request reports of: • All suspected ADR’s whether known or not which cause concern in the caregiver/the patient. • Lack of efficacy/therapeutic failure • Suspected pharmaceutical defect • Counterfeit pharmaceuticals. • Mediation errors Report maybe submitted using the FDA “BlueForm” available at hospitals and pharmacies and also available at the FDA website https://fdaghana.gov.gh/ or the Med Safety app available from the Google play store on android or App store for IOS.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "54ae4cff430f", "text": "GHANA Your Well-being, Our Priority. 13 8 GSK Actavis Limited Ventolin Rotacaps 200mcg Salbutamol Sulphate 200mcg Treatment or prevention of bronchospasm in people with reversible obstructive airway disease. 9 10 11 Treatment of high blood pressure (hypertension) in adults and children who are at least 6 years old.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "852bfa9f6fc2", "text": "The FDA encourages the reporting of all suspected adverse reaction to medicines, including vaccine, Over-the-Counter medicine and herbal, traditional or alternative remedies.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "dec8c2408e07", "text": "This publication was to alert healthcare professionals on reports of pharmaceutical defects presenting in the form of crystallization and discoloration with Paraconica (Paracetamol 10mg/ml) Solution for Infusion when stored under refrigerated conditions (2°C-8°C).", "label": 0, "source_type": "fda_newsletter"}
+{"id": "f614b569df77", "text": "SPONTANEOUS REPORTING FOR 2021 Figure 1: Number of reports received from 2016-2021 Figure 2: Gender distribution of patients who had adverse reactions An analysis of the 1,333 adverse reaction reports showed that 768(57.6%) of those who had the reaction were females and 476 (35.7%) were males, the gender for the remaining 89 (6.7%) was not stated (refer to figure 2).", "label": 0, "source_type": "fda_newsletter"}
+{"id": "22fc929a9bc7", "text": "Te App offers the underlisted benefits to users: • Submit reports of adverse reactions whiles offline • View and submit updates to previously submitted reports • View previous ADR reports submitted through the app • Receive immediate acknowledgement of their reports • Create a watchlist of medications on which to receive personalized news and alerts You will need the following information to submit a report using the Med Safety App: • Your Personal Details: Name and email address; this will help us acknowledge receipt of the report submitted. • Patient Details: Gender, date of birth or age, initials, weight or height. • Te Name(s) of the Suspected Medicine(s) or Product(s): Te name of the suspected medicine(s) and other medi cine(s) taken in addition, if any. • Reason(s) for taking the Medicine: What the medi cine is being used for and the dosage. • Te Reaction: Details of the adverse reaction, when it started, when it ended and the outcome.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "b9188793ce3c", "text": "SGLT2 containing-medicines registered for use in Ghana are Forxiga (Dapagliflozin) tablets, Invokana (Canagli flozin) tablets and Vokanamet (Canagliflozin and Metformin hydrochloride) tablets.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "97828d404a05", "text": "GHANA Your Well-being, Our Priority. 7 Fever", "label": 0, "source_type": "fda_newsletter"}
+{"id": "a38aae17fd7e", "text": "The conclusion was based on the fact that FDA has not received any adverse reaction report to gentian violet use in humans and there is no evidence from the literature that gentian violet can cause cancer in humans.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "4e3eec89a476", "text": "After causality assessment, one AEFI was assessed to be related to the vaccine product, two were coincidental and the causality of one case could not be assessed due to insufficient information.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "20dafa3da842", "text": "5 Fig. 7: Regional distribution of AEFI reports received in 2020 Fig. 8: Causality assessment of serious AEFI cases per vaccine received from the passive reporting system Fig 9: Outcome of causality assessment for 12 serious cases received during the YF campaign Fig 10: Top 5 commonly reported events with their System Organ Class during the YF campaign Fig 11: Regional distribution of reports received per 100,000 vaccinated during the YF campaign The top 5 commonly reported events with their System Organ Classification are as shown below: The regional distribution of AEFI reports received through the Spontaneous Reporting System is as shown below: The Food and Drugs Authority in collaboration with the Expanded Programme on Immunisation employed enhanced passive surveillance system during the 2020 sub-national Phase 2B Yellow Fever Preventive Mass vaccination campaign.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "7e6e0d45994a", "text": "Causality assessment by the TAC-VBP classified nine of the eleven serious AEFI cases as coincidental and the remaining two as unclassifiable.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "4861a6b6e4c6", "text": "In 2021, the FDA granted Emergency Use Authorization (EUA) to six COVID-19 to vaccines listed below: • Sputnik V (Gam-COVID-Vac) • Covishield (ChAdOX1Ncov-19 Corona Virus Vaccine (Recombinant) • COVID-19 Vaccine Janssen Suspension for Injection (Ad26.COV2-S [recombinant]) • Moderna’s Dispersion for Injection [COVID-19 mRNA Vaccine (nucleoside modified)] • Comirnaty Concentrate for Dispersion for Injection [COVID-19 mRNA Vaccine (nucleoside modified)] • COVID-19 Vaccine AstraZeneca Suspension for Injection (ChAdOx1 S [recombinant]) The FDA employed a robust safety monitoring strategy including spontaneous and active monitoring during the deployment of these vaccines.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "d25f6940d8be", "text": "GHANA Your Well-being, Our Priority. 2 14 NO MAH NAME OF DRUG ACTIVE INGREDIENT INDICATION 12 14 15 GSK GSK Bayer Clavulin 457mg/5ml suspension Flixonase Nasal Spray 0.05% w/w Magnevist Injection Fluticasone propionate/ Salmeterol Gadopentetic acid Amoxicillin trihydrate/ potassium clavunate Used in adults and children to treat middle ear and sinus, respiratory tract, urinary tract, skin and soft tissue, including dental, bone and joint infections.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "9411d8b083c8", "text": "Healthcare professionals are therefore advised not to refrigerate or freeze Paracetamol IV Solution containing mannitol Storage of the product under refrigerated condition because of ambiguous storage conditions on the primary package which indicated “Do not store above 30°C” Advice to Healthcare Professionals:", "label": 0, "source_type": "fda_newsletter"}
+{"id": "4786f103d978", "text": "The FDA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines and herbal, traditional or alternative remedies.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "7f80591f3d62", "text": "Manufacturer Sputnik V (Gam-COVID-Vac) 1. 2. 3. 4. 5. 6.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "7405af3add16", "text": "The total doses of the three vaccines administered is 1,404,463 consisting of 1,232,876 doses of Covishield, 107,766 doses of COVID-19 Vaccine Janssen and 63,821 doses of Sputnik V.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "b67b2daff391", "text": "The Upper West and Upper East regions submitted the highest number of reports per 1,000,000 inhabitants in 2016; this is largely due to the Seasonal Malaria Chemoprevention (SMC) programme in these two regions. 0 20 40 60 80 100 120 140 160 Amoxicillin clavulanic Artemether/ Lumefantrine Iron Dextran Metformin Artesunate/ Amodiaquine Lisinopril/ Hydrochlorthiazide Lisinopril Ciprofloxacin Nifedipine Sulfadoxine/ Pyrimethamine Amlodipine Diclofenac Ivermectin Praziquantel Albendazole", "label": 0, "source_type": "fda_newsletter"}
+{"id": "ae25f70f3ff0", "text": "The FDA has since informed the manufacturer of Paraconica IV Solution and other Paracetamol IV Solutions containing mannitol as an inactive ingredient to revise the storage conditions on the product labels to include the instruction “Do not refrigerate or freeze” and also list all excipients on the product labels.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "36492f391583", "text": "Used with magnetic resonance imaging (MRI) in adults and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. 16 GSK Protedex 1000mg, 2000mg and 5000mg Injection Ceftriaxone Treatment of chest and sexually transmitted infections,Lyme disease, bacterial infection in patients with neutropenia and prevention of infections during surgery.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "e0ad87a20fe8", "text": "Te Food and Drugs Authority in collaboration with the Expanded Programme on Immunization (EPI) also employed enhanced (stimulated) passive surveillance for adverse events following immunization (AEFI) during the 2018 sub-national yellow fever and nationwide measles-rubella vaccination campaigns.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "53208a55cedf", "text": "GSK Augmentin ES 642.9mg/5ml suspension Amoxicillin trihydrate /potassium clavunate Used in adults and children to treat middle ear and sinus, respiratory tract, urinary tract, skin and soft tissue, including dental, bone and joint infections.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "f5aa3c583765", "text": "Astra Zeneca 5 Astra Zeneca Losec Mumps 20mg tablets Nolvadex 20mg tablets Tamoxifen 20mg Omeprazole 20mg Treatment of symptoms of gastroesophageal reflux disease (GERD) and other conditions caused by excess stomach acid.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "34607c044bbb", "text": "3 Figure 6 is the contribution of all regions to spontaneous adverse reaction reports received per 1,000,000 population of the region.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "1f76fe0f3be6", "text": "The FDA received 48 adverse reaction reports to blood and blood between 2018 and 2020.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "b2b6a6e755a8", "text": "All the reports were classified as nonserious reports and did not lead to any major reviews in policy. 8 Below is the list of signals identified by the FDA in 2020 through the spontaneous adverse reaction reporting system and actions taken to protect patients.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "71a7ed3f399c", "text": "We particularly request reports of:  All suspected ADRs whether known or not which causes concern in the caregiver/the patient.  Lack of efficacy/therapeutic failure  Suspected pharmaceutical defect  Counterfeit Pharmaceuticals  Blood and Blood Products Reports may be submitted using the FDA ‘’blue form’’ available at all hospitals and some pharmacies and also available at the FDA website at http://www.fdaghana.gov.gh.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "b65c4fbf1a99", "text": "11 Crystallization and Discoloration of Paracetamol 100mg IV Public Statement on the Withdrawal of Johnson and Johnson Brand of Baby Talcum Powder from North American Market Rigorous Quality Control Laboratory analysis to verify that indeed the talc-containing powders submitted do not contain asbestos.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "910bf9c899db", "text": "EPI Code FDA Code Causality 1 ASH-SEK-18-001 1218AEFIAR0013 Coincidental 2 ASH-SKC-18-001 1218AEFIAR0012 Coincidental 3 BAR-SUW-18-009 1218AEFIBA0047 Coincidental 4 BAR-TAS-18-002 1218AEFIBA0046 Coincidental 5 BAR-TAS-18-003 1218AEFIBA0045 Coincidental 6 CEN KEA-18-006 1218AEFICR0088 Coincidental 7 EAS-AKS-18-003 1218AEFIER0010 Unclassifiable 8 EAS-EAK-18-006 1218AEFIER0011 Coincidental 9 EAS-EAK-18-008 1218AEFIER0013 Coincidental 10 EAS-KAP-18-002 1218AEFIER0012 Coincidental 11 VOL-HOH-18-001 1218AEFIVR0020 Unclassifiable Te EPI also carried out a sub-national yellow fever (YF) preventive mass vaccination campaign from 28th November to 4th December 2018 in nine regions excluding the Upper West Region.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "648f1787ba9e", "text": "DrugLens Issue 7 Table 4: Causality assessment of serious AEFI, MR vaccination campaign AEFI surveillance, 17th Oct – 19th Dec 2018 No.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "327b3ec51272", "text": "Tese reactions were reported with a minimum frequency of three and all these reactions are listed for Nifedipine.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "006ceeb54655", "text": "Testosterone replacement for men Sanofi Aventis Quinimax 125mg Tablets 18’s Quinine hydrochloride + Quinidine hydrochloride + Cinchonidine hydrochloride + Cinchonodine Hydrochloride Plasmodium Falciparum Malaria Quinimax 500mg Tablets 9’s Quinine hydrochloride + Quinidine hydrochloride + Cinchonidine hydrochloride + Cinchonodine Hydrochloride Plasmodium Falciparum Malaria Flagyl 500mg Pessaries Metronidazole Topical treatment of Trichomonas vaginitis and nonspecific vaginitis Nospa Forte Tablets (80mg) Drotavarine Smooth Muscle Spasms Connected with Diseases of Biliary Origin e.g. cholecystolithiasis Smooth Muscle Spasms of the Urinary Tract e.g. nephrolithiasis As an adjunct in treatment of: Smooth Muscle Spasms of Gastrointestinal Origin e.g. gastric and duodenal ulcer Headaches of Vascular Origin Gynecological Diseases e.g Dysmenorrhoea, Insuman Basal 100IU/ml suspension for injection in a vial 5ml Human insulin Diabetes mellitus where treatment with insulin is required Insuman Rapid 100 IU/ml suspension for injection in vial 5ml Human Insulin F Hoffman La Roche Limited Pegasys Vial 180 mcg/1ml Peginterferon alfa-2a Chronic Hepatitis B and C with compensated liver disease Glaxo- SmithKline Augmentin Infant Drops Amoxicillin+Clavulanic Acid 62.5mg/1ml Short-term treatment of susceptible bacteria infections Continued from page 6", "label": 0, "source_type": "fda_newsletter"}
+{"id": "6a51a35d70ec", "text": "I. 168 to prohibit the importation and sale of codeine–containing cough syrups and control the importation, manufacture and sale of tramadol respectively.", "label": 0, "source_type": "fda_newsletter"}
+{"id": "d19c655f30a0", "text": "Rare Events of Thrombosis and Thrombocytopenia Following Vaccination with Covid-19 Vaccine AstraZeneca", "label": 1, "source_type": "fda_newsletter"}
+{"id": "57d080123031", "text": "These rare reports consisted of blood clots associated with thrombocytopenia, with or without bleeding, including rare cases of cerebral venous sinus thrombosis (CVST) i.e. clots in the vessels draining blood from the brain.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "3a08bac0d4b1", "text": "Te remaining 1,132 were AEFI reports from stimulated spontaneous reporting during the nationwide yellow fever and measles rubella campaigns.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "75cf25aeccf5", "text": "Whilst no causal link has been found between the reported thrombotic events and the AstraZeneca Covid-19 vaccine, the FDA advised healthcare professionals to closely monitor persons vaccinated and ask them to seek immediate medical attention if they develop any of the underlisted after vaccination: Shortness of breath, chest pain, leg swelling, persistent abdominal pain Neurological symptoms including severe or persistent headaches or blurred vision, headache for more than 4 days after vaccination, or experiences skin bruising (petechia) beyond the site of vaccination after a few days.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "0fcbbf4189fb", "text": "Hyoscine butylbromide given intravenously or intramuscularly is indicated in acute muscular spasm, as in 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 (eg, gastroduodenal endoscopy).Hyoscine butylbromide injection can cause adverse effects including tachycardia, hypotension, and anaphylaxis.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "409407be1e30", "text": "No Indicator Example 1 Staff and Infrastructure Institutional Contact Person (ICP) available and trained 2 Tools for Pharmacovigilance Availability of Adverse Reaction and Adverse Event Following Immunization forms 3 Systems and Structures Drug and Therapeutics Committees exists and has the mandate to carry out pharmacovigilance activities 4 Training and skills Pharmacovigilance training for healthcare professionals within the past 12 months 5 Safety issues Knowledge of safety issues to report DRUGLENS ISSUE 5 Hyoscine butylbromide (Buscopan) injection and risk of serious adverse effects in patients with underlying cardiac disease 6 FDA Organized Continuous Professional Development Training Course for Pharmacists The FDA on 10th April, 2017 organized a one-day Continuous Professional Development (CPD) training workshop for ninety-nine Pharmacists on Drug Regulation and Life Cycle of Pharmaceutical Products at the FDA Offices in Accra.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "5cb56eab8756", "text": "Te highest number of adverse reactions was for Nifedipine tablets, with the most commonly reported reactions being sleepless nights, general body discomfort, cough, dizziness, headache and palpitation.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "3d6d6a92545d", "text": "The outcome of the causality assessment of the 180 serious cases reviewed by the Joint Malaria Vaccine Committee (JMVC) is shown below: Table 3: Number of serious AEFI reports by source 6 AEFI Reports from the Malaria Vaccine Implementation Programme reports from MVIP Fig 12: Outcome of causality assessment of serious AEFIs received through the MVIP Out of the 997 AEFI reports received from the MVIP in 2020, 965 (96.8%) were received from the phase 4 study, titled A prospective study to evaluate the safety, effectiveness and impact of the RTS,S/AS01E vaccine in young children in sub-Saharan Africa (EPI-MAL-003) at Navrongo Health Research Centre and Kintampo Health Research Centre in the Upper East and Bono East regions respectively.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "19f454e5d635", "text": "Advice to patients and healthcare professionals: Patients • Seek medical attention immediately if you experience any symptoms of tenderness, redness, or swellng of the genitals or the area from the genitals back to therectum, and have a fever above 38oC or a general feeling of being unwell.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "05220f92a9ba", "text": "Cardiovascular disease and anaphylaxis.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "f157a947b307", "text": "Hyoscine butylbromide injection can cause adverse effects including tachycardia, hypotension, and anaphylaxis.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "232bbecc0080", "text": "Cord infection has not been stated as an adverse reaction in the product information of chlorhexidine digluconate gel, however, review of literature showed that cord infection could occur whilst using the product.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "0ee3e23d7b2e", "text": "The most commonly reported AEFIs for the three vaccines were headache, fever, chills, pain at injection site and body pains which resolved within a day or two.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "9df34d08a0f7", "text": "The outcome of the causality assessment of the 12 serious cases by the TAC-VBP is shown below: AEFI reports from 2020 sub-national Phase 2B Yellow Fever Preventive Mass vaccination campaign Out of the 300 AEFI reports received from the passive reporting system, sixty (60) were classified as serious and the results of the Causality Assessment per antigen by the Technical Advisory Committee on Safety of Vaccines and Biological Products (TAC-VBP) using the process outlined in the WHO User Manual on Revised Classification of AEFI is shown in Figure 8. 1 1 5 6 7 10 11 13 14 14 16 1 1 1 1 2 1 1 1 1 4 2 2 3 1 4 5 0 5 10 15 20 25 30 HepaƟƟs B BCG YF Men A IPV Rota mOPV MR PCV OPV Penta No. of Cases per Causality AnƟgen Coincidental Ineligible for causality Vaccine product ImmunizaƟon error 7 4 1 0 1 2 3 4 5 6 7 8 Coincidental Vaccine product related ImmunizaƟon error related 23 50 57 60 79 0 10 20 30 40 50 60 70 80 90 Muscle pain (Musculoskeletal and connecƟve Ɵssue disorders) Fever (General disorders and administraƟon site condiƟons) Severe local reacƟon (General disorders and administraƟon site condiƟons) Malaise (General disorders and administraƟon site condiƟons) Headache (Nervous System Disorders) 18 16 14 13 12 11 10 9 7 6 3 3 2 0 2 4 6 8 10 12 14 16 18 20 Bono East Volta Savanna Ahafo Central Greater Accra Eastern Bono Upper West Upper East OƟ AshanƟ Northern 64 64 41 27 23 21 18 9 8 7 7 5 4 2 0 0 0 10 20 30 40 50 60 70 Bono East Bono Central Ahafo Eastern Northern Upper East Volta Upper West OƟ Region AshanƟ Greater Accra Western Savannah North East Western North No. of Cases Series1", "label": 1, "source_type": "fda_newsletter"}
+{"id": "29d79410b28a", "text": "Hyoscine butylbromide injection can cause serious adverse effects including tachycardia, hypotension, and anaphylaxis. 2.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "26d38ef1e131", "text": "Tese adverse effects can result in a fatal outcome in patients with underlying cardiac disease, such as those with heart failure, coronary heart disease, cardiac arrhythmia or hypertension. 3.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "4bbc0c1ecc68", "text": "Tese effects can be more serious in patients with underlying cardiac DrugLens Issue 7 GHANA Your Well-being, Our Priority. 2 10 4 5 6 disease (eg, heart failure, coronary heart disease, cardiac arrhythmia, or hypertension).", "label": 1, "source_type": "fda_newsletter"}
+{"id": "3f1e35a46a7b", "text": "Safety Advisory - Constipation: a Potentially Serious Side Effect Product Information (PI) and Consumer Medicine Information (CMI) for clozapine have been updated to strengthen warnings about potential severe gastrointestinal side effects, including constipation.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "cd58b5979c17", "text": "12 DrugLens Newsletter Table 3: AEFI reporting per vaccine Name of Vaccine Cumulative Dose Administered Method of Detection No. of AEFIs AstraZeneca COVID-19 Vaccine 9,471,006 Active Spontaneous 4,093 Sputnik V 17,982 Active 2458 COVID-19 Vaccine Janssen 1,755,751 Active Spontaneous 1668 Moderna COVID-19 Vaccine 1,065,357 Active Passive 826 Pfizer-BioNTech COVID-19 Vaccine 3,186,756 Active Passive 379 The JCVSRC has performed causality assessment for 49 serious AEFIs as at its 16th Meeting held on 22nd June 2022 as shown in figure 10 below Figure 11: Causality assessment for COVID-19 vaccines Following the extension of vaccination to persons 15 years and above and pregnant women, in addition to booster doses, the FDA has been monitoring the safety of the vaccines in these categories of persons.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "c1eaca6730e6", "text": "The AEFIs were similar to those reported by non-pregnant vaccinees including headache, chills and dizziness.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "f20e9d7ba51f", "text": "The National Pharmacovigilance Centre reviewed the SafetyWatch System (FDA’s national safety database) as part of its routine signal management processes and identified 8 adverse reaction reports of cord infection (including laceration and haemorrhage) associated with the use of chlorhexidine gel between July 2019 to December 2021.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "0251f727f3d0", "text": "This publication was targeted towards healthcare professionals to provide information on the safety signal of rare events of thrombosis and thrombocytopenia following vaccination with COVID-19 Vaccine AstraZeneca (Covishield) in Ghana.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "d4a6cf89876b", "text": "Study Suggests Risk of Birth Defects in Babies Born to Women on HIV Medicine Dolutegravir (Tivicay) Hyoscine Butylbromide Injection: Risk of Serious Adverse Effects in Patients with Underlying Cardiac Disease Tere are increased cases of lower limb amputation (mostly affecting the toes) observed in patients taking the Type 2 diabetes medicine Canagliflozin compared with those taking placebo in two clinical trials, CANVAS (Canagli- flozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus) studies.", "label": 1, "source_type": "fda_newsletter"}
+{"id": "cf60739f02ab", "text": "Additional information, not available at the time of the initial report, should be provided in the form of follow-up reports. 3.1.4 How to Report To report a suspected ADR for products marketed in Ghana, Health care Professionals should complete a copy of the Adverse Reaction Reporting Form (Appendix I).", "label": 0, "source_type": "fda_guideline"}
+{"id": "2e1d5b1b4946", "text": "The Local Representative or Marketing Authorization Holder is required to submit the name or initials, address and telephone number and qualification of the initial reporter on the adverse drug reaction report form.", "label": 0, "source_type": "fda_guideline"}
+{"id": "fa590ff03426", "text": "Overdosage ........................................................................................................ 22 4.4 Feedback on Reports Received ............................................................................... 23 4.4.1 Adverse Reaction Reports ................................................................................. 23 4.4.2 Risk Management Plans, PSURs (or PBRERs) ................................................. 23 5.0 SANCTIONS ......................................................................................................... 24 6.0.", "label": 0, "source_type": "fda_guideline"}
+{"id": "83ac33f50630", "text": "Lack of Efficacy Every case of lack of efficacy should be reported to the Authority using the Adverse Reaction reporting form or the Consumer Reporting form (BlueForm) or the Consumer Complaint Forms that are available at the Food and Drugs Authority Offices.", "label": 0, "source_type": "fda_guideline"}
+{"id": "200078e653c6", "text": "If the article describes identifiable patients, adverse reaction report(s) should be completed for each patient and the publication authors considered as the primary source.", "label": 0, "source_type": "fda_guideline"}
+{"id": "c1ade4ffdef9", "text": "Causality assessment of Adverse Drug Reaction (ADR) reports presented to the TAC by the Authority. d.", "label": 0, "source_type": "fda_guideline"}
+{"id": "50851c380676", "text": "Guideline on Reporting Adverse Drug Reactions FDA/SMD/GDL - 01/05 Page 7 of 28 2.0 Definitions and Abbreviations In these guidelines, unless the context otherwise states: “Adverse Drug Reaction Report” An adverse drug reaction report is a detailed record of all relevant data associated with the use of a medicine in a subject or patient. “Adverse Drug Reaction (ADR) / Adverse Reaction” A response to a medicinal product which is noxious and unintended including lack of efficacy and which occurs at any dosage and can arise from: • The use of product within the terms of the marketing authorization • The use of product outside the terms of the marketing authorization, including overdose, off-label use, misuse, abuse and medication errors; • Occupational exposure A reaction, contrary to an event is characterized by the occurrence of a suspected causal relationship between the drug and the reaction, as determined by the reporter or a reviewing health care professional.", "label": 0, "source_type": "fda_guideline"}
+{"id": "dfde3f184948", "text": "For Adverse Events Following Immunization, refer to the Guidelines for Surveillance on Adverse Events Following Immunization (www.fdaghana.gov.gh/img/vacine/Guidelines for Surveillance on Adverse Events Following Immunization In Ghana.pdf). 4.2 Reporting by the Local Representatives or Marketing Authorization Holder Serious adverse reaction reports received by the Local Representative or the Marketing Authorization Holder shall be submitted to the Authority within 7 calendar days.", "label": 0, "source_type": "fda_guideline"}
+{"id": "7edbdc177f8c", "text": "If Local Representative or Manufacturer/ Marketing Authorization Holder receives an adverse reaction from consumer, the consumer should be advised to seek treatment, when necessary, from a healthcare provider.", "label": 0, "source_type": "fda_guideline"}
+{"id": "290c60949728", "text": "Guideline on Reporting Adverse Drug Reactions FDA/SMD/GDL - 01/05 Page 11 of 28 medicines and which is not derived from a study or any organized data collection systems where adverse event reporting is actively sought. “Unexpected Adverse Reaction” An unexpected adverse reaction is one in which the nature, specificity, severity and outcome is not consistent with the applicable product information (i.e., with the approved package inserts for registered medicines, or the investigator’s brochure or other product information for unregistered medicines.", "label": 0, "source_type": "fda_guideline"}
+{"id": "90c8e8ee7ee1", "text": "Treatment provided for the adverse reaction (if any). 12.", "label": 0, "source_type": "fda_guideline"}
+{"id": "a887f8cbde8f", "text": "All spontaneous reports are, therefore, suspected adverse drug reactions. “Adverse Event (or adverse experience)” “Adverse event/experience” is any untoward medical occurrence in a patient or clinical trial subject administered a product that may present during treatment with a medicine but which does not necessarily have a causal relationship with this treatment. “Adverse Events Following Immunization (AEFI)” An Adverse Event Following Immunization is any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine.", "label": 0, "source_type": "fda_guideline"}
+{"id": "f63628b3b435", "text": "Which has been marketed in Ghana for a period of not less than ten (10) years or any other period to be determined by the Authority from time to time, for public health reasons “Overdose” Accidental or intentional use of drug or medicine in an amount that is higher than is normally used. “Periodic Benefit Risk Evaluation Report (PBRER)” An update of the world-wide marketing experience of a product at defined times with focus on formal evaluation of benefit in special population at defined times during postregistration period. “Periodic Safety Update Report (PSUR)” A regular update of the world-wide safety experience of a product at defined times during post-registration period. “Pharmacovigilance” The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.", "label": 0, "source_type": "fda_guideline"}
+{"id": "67648e3c3776", "text": "Guideline on Reporting Adverse Drug Reactions FDA/SMD/GDL - 01/05 Page 19 of 28 Reporting can be done using the adverse reaction reporting form which can be obtained from the Food and Drugs Authority’s office (Appendix 1), or applicants may use their inhouse reporting forms, provided all the necessary data elements are included on the forms in a readable format and the form also complies with the CIOMS 1 format. 3.4 Reporting by MAH or Local Representative A Serious Adverse Event / Reaction (SAE) reporting form designed by the investigator / sponsor with the necessary data elements (CIOMS I format) should be used for reporting of preregistration clinical trial adverse events / reaction reports.", "label": 0, "source_type": "fda_guideline"}
+{"id": "6b27263a35b5", "text": "This is not the same as “serious,” which is based on patient/event outcome or action criteria. “Spontaneous Report or Spontaneous Notification” Unsolicited communication by a patient, a consumer or healthcare professional to the Authority, marketing authorization holder or local representative or an organization that describes a suspected adverse reaction in a patient, a consumer who is given one or more", "label": 0, "source_type": "fda_guideline"}
+{"id": "cae04594fb27", "text": "Guideline on Reporting Adverse Drug Reactions FDA/SMD/GDL - 01/05 Page 26 of 28 APPENDIX APPENDIX I- Adverse Reaction Reporting Form APPENDIX II-Patient Reporting Form", "label": 0, "source_type": "fda_guideline"}
+{"id": "f4de6e57b566", "text": "Local Representative or Marketing Authorization Holder shall submit all relevant information available at the time of initial notification of an adverse drug reaction report.", "label": 0, "source_type": "fda_guideline"}
+{"id": "ec3ec8b6eda8", "text": "The feedback of evaluation of the adverse reaction reports shall be communicated to the reporter within one month of such evaluation by the Authority. 4.4.2 Risk Management Plans, PSURs (or PBRERs) The FDA shall acknowledge receipt of the report and preliminary evaluation comments communicated to the Local Representative or the Marketing Authorization Holder within 28 days of receipt of the report.", "label": 0, "source_type": "fda_guideline"}
+{"id": "0df4d0c7fe0a", "text": "A detailed description of the suspected adverse drug reaction. 9.", "label": 0, "source_type": "fda_guideline"}
+{"id": "3884b03b8c98", "text": "The scope of this guideline outlines the type of report to be submitted to the FDA, the required details, the reporting process, the confidentiality of adverse reaction reports, the procedure for submitting follow up information on previously submitted reports, steps to avoid duplicate reporting and timelines for submitting reports.", "label": 0, "source_type": "fda_guideline"}
+{"id": "86a77a055320", "text": "The guideline also outlines the roles and responsibilities of the Authority, the Local Representative, Healthcare Professionals Marketing Authorization Holders, and the Consumer with respect to adverse reaction reporting.", "label": 0, "source_type": "fda_guideline"}
+{"id": "95a1602cdf2b", "text": "Guideline on Reporting Adverse Drug Reactions FDA/SMD/GDL - 01/05 Page 10 of 28 “Risk Management Plan” A systematic approach and set of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks relating to medical products, and the assessment of effectiveness of those interventions and how these risks will be communicated to the Authority and the general population. “Serious Adverse Drug Reaction or Adverse Event” A serious adverse event or reaction is any untoward medical occurrence that at any dose: • Results in death • Is life threatening • Requires inpatient hospitalisation or results in prolongation of existing hospitalisation; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Is a medically important event or reaction. (NOTE: The term \"life-threatening\" in the definition of \"serious\" refers to an event/reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/ reaction which hypothetically might have caused death if it were more severe); Medical and scientific judgment should be exercised in deciding whether other situations should be considered serious such as important medical events that might not be immediately life-threatening or result in death or hospitalisation but might jeopardise the patient or might require intervention to prevent one of the other outcomes listed in the definition above.", "label": 0, "source_type": "fda_guideline"}
+{"id": "4579e056bf0e", "text": "During the new oral polio vaccination campaign (nOPV2), five potential safety concerns were identified, including cases of 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": "c6d8c5e0f989", "text": "For product quality monitoring exercise in 2023, the FDA tested various products, resulting in a 53% pass rate for bleach products in Q1; a 63% pass rate for anti-diabetics, anti-hypertensive drugs, chlorpromazine 50mg injection, lithium carbonate 300mg, clozapine 100mg, benztropine 2mg from Rock Chemist, haloperidol injection from Max Health Pharmaceuticals Limited, amodiaquine 150mg + sulphadoxine/pyrimethamine 500/25mg tablets (batch 23001) supplied by Kina Pharma, and some anti-malarials in Q2; a 33% pass rate for bleach, paracetamol/vitamin C fixed dose combinations, haloperidol, and fluphenazine injection in Q3; and a 69% pass rate for vaccines, psychotropics, antihypertensives, antidiabetics, and antimalarials in Q4. 5427 89.6% 3932 92.5% 5555 93.2% 41% 1% NUMBER OF SAMPLES RECEIVED % TESTED 2021 2022 2023 % DIFF BETWEEN 2023 & 2022", "label": 0, "source_type": "fda_annual_report"}
+{"id": "da78045de65d", "text": "At the level of the MHD, there was no existing committee for causality assessment.10.1371/journal.pone.0291482.g005Fig 5Ho Municipality ADR reporting trend, 2015–2019.There were 36 reports sent to the NPC; 35 were ADR reports and 1 product quality.", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "4fd4a2fc7b88", "text": "A similar study among community pharmacists reported that only 16% of those who had seen a patient with a suspected ADR in 2015 reported it [14].In Ghana, the Food Drugs Authority (FDA) acts as the National Pharmacovigilance Centre (NPC) and is responsible for ensuring the safety of pharmaceuticals on the market, collecting and managing ADR reports, as well as communicating safety concerns to healthcare professionals, patients, and other stakeholders.", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "eda76fb6defd", "text": "Reporting of ADRsUp to 97.2% (1,192/1,227) of suspected ADRs that occurred between 2015 and 2019 were not reported to the NPC.", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "2b7ae6c39be4", "text": "Up to 88.9% (32/36) were drug-related, covering a wide range of groups of medications.", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "411dd9bfe52a", "text": "The WHO-UMC causality assessment method considers clinical-pharmacological aspects and quality of documentation in assessing case reports for adverse drug reactions.", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "28991a0ea539", "text": "Feedback on causality assessment is sent through the same channel of reporting to the primary reporter and the patient or general public.", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "fa2cc2dc54ae", "text": "All the 35 ADR reports were assessed for causality as indicated in Fig 6 with the majority (54.3%) graded as ‘Possible’.10.1371/journal.pone.0291482.g006Fig 6Causality assessment of ADR reports from the Ho Municipality, 2015–2019.While the reports from the Ho Municipality did not have a direct influence on the risk of ADR concerns that were discovered throughout the reporting period, when combined with other information, a signal was formed about the widespread abuse of cough syrups containing codeine.", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "a1c3611226b2", "text": "A suspected ADR that was documented by the healthcare provider or patient and sent to the MHD but did not end up in NPC is not considered reported.", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "2b2a7e2442f1", "text": "The FDA withdrew marketing authorization for Codeine-containing cough syrups and oral ketoconazole products [15].", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "1faf679e4a8b", "text": "Timeliness of report submission, timeliness of investigation and causality assessment as well as timeliness of feedback was assessed.Stability was assessed by considering the backlog of data not entered into the database, the sustainability of the system when Institutional Contact Persons (ICPs) were changed, unscheduled outages and downtimes for the system’s computer and electronic resources, back-up of data, and the actual amount of time required for the system to release meaningful data.", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "0415c6d26dc8", "text": "Codeine-containing cough syrup was added to the essential medicines list when the national standard treatment guidelines were reviewed [26].", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "fa9c40f4aefb", "text": "The causality assessment scale was recorded.Representativeness was assessed using the characteristics of the population under surveillance–age, sex, geographic location, healthcare facility reporting.", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "fa4157156391", "text": "Timeliness of report submission, timeliness of investigation and causality assessment as well as timeliness of feedback was assessed.Stability was assessed by considering the backlog of data not entered into the database, the sustainability of the system when Institutional Contact Persons (ICPs) were changed, unscheduled outages and downtimes for the system’s computer and electronic resources, back-up of data, and the actual amount of time required for the system to release meaningful data.Assessing the usefulness of the ADRSSThe usefulness was assessed by reviewing the objectives of the system and its effect on public health interventions–policy decisions that have been implemented to promote the safe use of drugs.", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "9ce66411e7f4", "text": "To improve the safety and effectiveness of medications, it is recommended to involve a variety of professionals in the causality assessment and management process [33].", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "cce99b2087ec", "text": "The reports are subsequently processed for causality assessment (whether the suspected ADR was linked to the drug or not) by a group of experts in varying medical fields called the Technical Advisory Committee (TAC) [18, 25].", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "75ff6c61932f", "text": "Fig 1 indicates the Data and Information Flow Chart of the ADR Surveillance System in the Ho Municipality.10.1371/journal.pone.0291482.g001Fig 1National data and information flow chart of the ADR Surveillance System used by Ho Municipality.Reporting of ADRsUp to 97.2% (1,192/1,227) of suspected ADRs that occurred between 2015 and 2019 were not reported to the NPC.", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "4e4e5035174f", "text": "An ADR was considered missing if it was detected in a health facility or MHD but not reported to the NPC within the calendar year These were suspected ADR reports captured by a healthcare professional for onward submission to the NPC for causality assessment.For the purpose of this study, a suspected ADR is considered reported when the ADR form reaches the NPC.", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "b6a3e66a42e1", "text": "Reports that were sent to the NPC were compared to the WHO target.Causality assessments for the reports were done by an independent group of experts at the national level using WHO-UMC System for Standardized Case Causality Assessment Scale [29].", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "d0a357971fb5", "text": "This indicated a lack of understanding of the surveillance system and how it operated, which is a significant factor linked to poor reporting of ADRs by health professionals, according to Khan et al., 2013 [31].All suspected ADRs received were subjected to causality assessments using the WHO-UMC scale [29], and reporters were given feedback.", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "342db23bc31f", "text": "Although this suggests a high rate of false positives, it is important to acknowledge the significant impact of ADRs on healthcare costs and hospital admissions [1–6] Therefore, it is crucial to continually evaluate and enhance the system’s performance to accurately identify ADRs and reduce false positives.Causality assessments for the reports were done by an independent group of experts at the national level using WHO-UMC System for Standardized Case Causality Assessment Scale [29].", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "a343ba81cfd0", "text": "It is noteworthy that all suspected ADRs, regardless of causality assessment classification, are stored in an electronic database for future data mining and signal generation.", "label": 0, "source_type": "surveillance_evaluation"}
+{"id": "87aeb0631c5d_aug_arte", "text": "Others however thought that the components of artemether-lumefantrine were too high for them and, therefore, the side effects.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "87aeb0631c5d_aug_dihy", "text": "Others however thought that the components of dihydroartemisinin-piperaquine were too high for them and, therefore, the side effects.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "87aeb0631c5d_aug_chlo", "text": "Others however thought that the components of chloroquine were too high for them and, therefore, the side effects.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "526199857826_aug_arte", "text": "Some patients shared their experiences in the excerpts below.“I was given artemether-lumefantrine and when I started taking the drug I could not do anything because my whole body was weak” (IDI: 29-year old male patient).The other side effects reported were vomiting, chest pains, itching, loss of appetite, poor vision and shivering.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "526199857826_aug_dihy", "text": "Some patients shared their experiences in the excerpts below.“I was given dihydroartemisinin-piperaquine and when I started taking the drug I could not do anything because my whole body was weak” (IDI: 29-year old male patient).The other side effects reported were vomiting, chest pains, itching, loss of appetite, poor vision and shivering.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "526199857826_aug_chlo", "text": "Some patients shared their experiences in the excerpts below.“I was given chloroquine and when I started taking the drug I could not do anything because my whole body was weak” (IDI: 29-year old male patient).The other side effects reported were vomiting, chest pains, itching, loss of appetite, poor vision and shivering.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "5ca17c31a09a_aug_arte", "text": "Some participants said they experienced an unusual heart beat and their health deteriorated after taking artemether-lumefantrine“….When I took the artesunate-amodiaquine, I had chest pains and I vomited” (IDI: 32-year old female patient).Other uncommon side effects of ACT were also reported by one of the participants.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "5ca17c31a09a_aug_dihy", "text": "Some participants said they experienced an unusual heart beat and their health deteriorated after taking dihydroartemisinin-piperaquine“….When I took the artesunate-amodiaquine, I had chest pains and I vomited” (IDI: 32-year old female patient).Other uncommon side effects of ACT were also reported by one of the participants.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "5ca17c31a09a_aug_chlo", "text": "Some participants said they experienced an unusual heart beat and their health deteriorated after taking chloroquine“….When I took the artesunate-amodiaquine, I had chest pains and I vomited” (IDI: 32-year old female patient).Other uncommon side effects of ACT were also reported by one of the participants.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "2183591be115_aug_arte", "text": "Some people complain of poor vision and difficulty to hear or they experience some noise in their ears” (IDI-38 year old health worker)Chest pains “…When I took the artemether-lumefantrine, I had chest pains and I vomited” (IDI-32 year old female patient)Swollen testicles “…others especially the men have their testes and body swollen.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "2183591be115_aug_dihy", "text": "Some people complain of poor vision and difficulty to hear or they experience some noise in their ears” (IDI-38 year old health worker)Chest pains “…When I took the dihydroartemisinin-piperaquine, I had chest pains and I vomited” (IDI-32 year old female patient)Swollen testicles “…others especially the men have their testes and body swollen.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "2183591be115_aug_chlo", "text": "Some people complain of poor vision and difficulty to hear or they experience some noise in their ears” (IDI-38 year old health worker)Chest pains “…When I took the chloroquine, I had chest pains and I vomited” (IDI-32 year old female patient)Swollen testicles “…others especially the men have their testes and body swollen.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "f29b4b315333_aug_arte", "text": "Experience of side-effects of ACTThe findings revealed that participants who took artemether-lumefantrine to treat malaria reported most side effects.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "f29b4b315333_aug_dihy", "text": "Experience of side-effects of ACTThe findings revealed that participants who took dihydroartemisinin-piperaquine to treat malaria reported most side effects.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "f29b4b315333_aug_chlo", "text": "Experience of side-effects of ACTThe findings revealed that participants who took chloroquine to treat malaria reported most side effects.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "5d7510510656_aug_arte", "text": "Majority of the patients who took artemether-lumefantrine and artemether-lumefantrine, respectively, reported to have experienced side effects such as body weakness, dizziness, itching and abdominal pain [5–14].", "label": 1, "source_type": "qualitative_interview"}
+{"id": "5d7510510656_aug_dihy", "text": "Majority of the patients who took dihydroartemisinin-piperaquine and artemether-lumefantrine, respectively, reported to have experienced side effects such as body weakness, dizziness, itching and abdominal pain [5–14].", "label": 1, "source_type": "qualitative_interview"}
+{"id": "5d7510510656_aug_chlo", "text": "Majority of the patients who took chloroquine and artemether-lumefantrine, respectively, reported to have experienced side effects such as body weakness, dizziness, itching and abdominal pain [5–14].", "label": 1, "source_type": "qualitative_interview"}
+{"id": "31334088b6d7_aug_arte", "text": "In this study however, views expressed are slightly different because most patients attributed all the side effects to the use of artemether-lumefantrine 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": "31334088b6d7_aug_dihy", "text": "In this study however, views expressed are slightly different because most patients attributed all the side effects to the use of dihydroartemisinin-piperaquine 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": "31334088b6d7_aug_chlo", "text": "In this study however, views expressed are slightly different because most patients attributed all the side effects to the use of chloroquine 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": "c20e7da61ee6_aug_arte", "text": "When the artemether-lumefantrine was first introduced in Ghana, many patients who used it had several side effects because the components of the drug were very high [7].", "label": 1, "source_type": "qualitative_interview"}
+{"id": "c20e7da61ee6_aug_dihy", "text": "When the dihydroartemisinin-piperaquine was first introduced in Ghana, many patients who used it had several side effects because the components of the drug were very high [7].", "label": 1, "source_type": "qualitative_interview"}
+{"id": "c20e7da61ee6_aug_chlo", "text": "When the chloroquine was first introduced in Ghana, many patients who used it had several side effects because the components of the drug were very high [7].", "label": 1, "source_type": "qualitative_interview"}
+{"id": "76cd3a824efd_aug_arte", "text": "Opinions from patients who use artemether-lumefantrine in this study suggested that the components are still high and that could be the reason why they are still experiencing these side effects.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "76cd3a824efd_aug_dihy", "text": "Opinions from patients who use dihydroartemisinin-piperaquine in this study suggested that the components are still high and that could be the reason why they are still experiencing these side effects.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "76cd3a824efd_aug_chlo", "text": "Opinions from patients who use chloroquine in this study suggested that the components are still high and that could be the reason why they are still experiencing these side effects.", "label": 1, "source_type": "qualitative_interview"}
+{"id": "synthetic_phase7_p2_temporal_001", "text": "Since I start efavirenz, skin rash dey disturb me plenty all over my body.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_002", "text": "The rash started before I began efavirenz — it was already there when the doctor put me on the drug.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_003", "text": "After starting nevirapine the rash developed on my chest and arms within the first two weeks.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_004", "text": "I had that rash even before they put me on nevirapine; the doctor confirmed it was not related.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_005", "text": "Patient reports persistent nausea that began shortly after initiating isoniazid therapy.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_006", "text": "My mother get the nausea before dem start her on isoniazid — the doctors say na the ulcer cause am.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_007", "text": "Since I begin metformin I dey vomit every morning — the nausea is too much.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_008", "text": "The nausea was already there before I started metformin; my stomach has been troubling me for years.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_009", "text": "After starting efavirenz, I have been feeling dizzy every morning when I wake up.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_010", "text": "I had dizziness before I was put on efavirenz — it started when I had malaria last year.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_011", "text": "Since I started amlodipine I feel light-headed every time I stand up quickly.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_012", "text": "The dizziness started before I was given amlodipine; the doctor says it is low blood pressure that was there already.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_013", "text": "Since starting pyrazinamide my joints dey pain me badly — I no fit walk well at all.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_014", "text": "I had joint pain long before they started me on pyrazinamide — it is my old arthritis.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_015", "text": "Since starting artesunate-amodiaquine my joints dey pain me badly — e dey hurt plenty.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_016", "text": "The joint pain was there before I even took artesunate-amodiaquine; I have had it since childhood.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_017", "text": "Since I started co-trimoxazole I have been running to the toilet every hour with watery stool.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_018", "text": "The co-trimoxazole don cause diarrhea before — my child's stool was loose before dem even start the drug.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_019", "text": "After starting amoxicillin the diarrhea started and has not stopped for three days now.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_020", "text": "I had the loose stool before I was given amoxicillin; it began after I ate bad food at the chop bar.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_021", "text": "Since starting tenofovir, I feel so tired I cannot do any work at all.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_022", "text": "The fatigue was already there before I started tenofovir — I had been anaemic for months.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_023", "text": "After initiating rifampicin the patient developed extreme fatigue and weakness.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_024", "text": "Patient's fatigue predates rifampicin therapy — it was documented at the initial clinic visit before treatment began.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_025", "text": "Since I started mefloquine I get terrible headaches every day; it is disturbing me too much.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_026", "text": "I had the headache even before they gave me mefloquine — it has been my problem since secondary school.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_027", "text": "After taking doxycycline the headache started and has been persistent since then.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_028", "text": "The headache started before I began doxycycline; it was brought on by the stress at work.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_029", "text": "Since I started ethambutol I have noticed my vision is blurring, especially when I read.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_030", "text": "My father had vision problems before ethambutol was started — he has had cataracts for a long time.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_031", "text": "After starting efavirenz I am seeing strange colours at night and my vision is not clear.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_032", "text": "The vision changes were there before efavirenz — the optician found it when I went for glasses.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_033", "text": "Since starting artesunate-amodiaquine my child says sounds are muffled and she cannot hear properly.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_034", "text": "My child had the hearing problem before we gave her artesunate-amodiaquine — the ENT doctor saw it two months ago.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_035", "text": "After starting lisinopril I have been coughing every night — a dry cough that will not stop.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_036", "text": "I had the cough before I started lisinopril; I am an asthmatic and it is my usual cough.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_037", "text": "Since I started amlodipine my feet have been swelling — the ankles are very big by evening.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_038", "text": "The swelling in my legs started before amlodipine — it is because of my kidney problem that was there before.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_039", "text": "After starting isoniazid I feel tingling in my hands and feet — like pins and needles all the time.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_040", "text": "I had the tingling sensations in my feet before isoniazid was started; I have diabetic neuropathy already.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_041", "text": "I dey get bad dreams and I no fit sleep since I start efavirenz last month — e dey disturb me every night.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_042", "text": "I had nightmares two years ago during a very stressful period but they went away on their own before I started efavirenz.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_043", "text": "Since starting nevirapine last month the itching all over my body has been constant.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_044", "text": "I had that itching problem years ago — it resolved before I ever started nevirapine and has nothing to do with my current medication.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_045", "text": "My child has been getting a rash every week since we started co-trimoxazole three weeks ago.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_046", "text": "My child had a similar rash two years ago — it cleared up long before co-trimoxazole was even started; the doctors said it was eczema.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_047", "text": "I dey feel dizzy and I dey vomit since I start artemether-lumefantrine for this malaria — e still dey happen.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_048", "text": "The dizziness was something I had years ago — it stopped long before they gave me artemether-lumefantrine this time.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_049", "text": "Since I start metformin last month I dey get loose stool every morning — the problem still dey there.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_050", "text": "I had diarrhea two years ago because of a stomach infection, but it cleared on its own well before metformin was introduced.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_051", "text": "I am currently experiencing numbness in my toes and fingers since starting isoniazid six weeks ago.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_052", "text": "Patient experienced numbness in the extremities three years ago following a road traffic accident — this resolved before isoniazid was initiated.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_053", "text": "Since starting rifampicin my urine has been orange-red — it is happening every day.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_054", "text": "Patient reported orange discolouration of urine historically, two years ago, attributed to a dietary supplement — this was before rifampicin was started and is unrelated.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_055", "text": "I have been getting heartburn and acid feeling in my chest since I started doxycycline last week.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_056", "text": "I had heartburn badly several years ago but it went away on its own before doxycycline was started; my stomach has been fine until now.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_057", "text": "My joints have been swollen and painful since I started pyrazinamide — the pain is there every day.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_058", "text": "The joint swelling happened once before, years ago, and resolved completely before pyrazinamide was ever prescribed.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_059", "text": "I have had a persistent dry cough every single night since starting lisinopril four weeks ago.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_060", "text": "I had a cough like this years ago when I had TB — that was fully treated and gone before I started lisinopril.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_061", "text": "Since starting abacavir I have been feeling feverish, tired, and getting a rash — all within the past month.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_062", "text": "She had fever and rash two years ago during a malaria episode — this fully resolved before abacavir was started and the doctors say it is different.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_063", "text": "I dey get headache almost every day since I start lamivudine last month — e no go away.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_064", "text": "Patient experienced chronic daily headaches three years ago which resolved spontaneously well before lamivudine was initiated.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_065", "text": "Since starting mefloquine I have been anxious and unable to sleep — it is happening every night.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_066", "text": "The sleep difficulties were a problem years ago during a bereavement but they resolved before I was put on mefloquine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_067", "text": "My vision has been blurring progressively since I started ethambutol six weeks ago.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_068", "text": "Patient had blurring of vision years ago due to a refractive error — corrected with glasses before ethambutol was started.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_069", "text": "I have been having tinnitus — a ringing in my ears — since I started taking aspirin daily.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_070", "text": "I had ringing in my ears years ago after a loud concert but it resolved well before I started aspirin and is not related.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_071", "text": "Since I started ibuprofen for my back pain my stomach has been very painful every time I eat.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_072", "text": "I had stomach ulcer pains years ago — treated and healed long before I started ibuprofen this time.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_073", "text": "Since starting amoxicillin my child has been vomiting and having stomach pain every day.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_074", "text": "The child had vomiting episodes two years ago from a rotavirus infection — resolved fully before amoxicillin was ever given.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_075", "text": "I have been feeling my muscles are weak and my legs ache since I started tenofovir last month.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_076", "text": "The muscle weakness occurred years ago when I had a bad flu — it resolved before tenofovir was started.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_077", "text": "Since starting artesunate-amodiaquine I have been feeling very weak and cannot eat well.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_078", "text": "Patient was very weak and anorexic two years ago during a typhoid episode — this resolved before artesunate-amodiaquine was prescribed.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_079", "text": "Since I started taking high-dose paracetamol for my pain I have been feeling nauseated constantly.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_080", "text": "I had nausea and vomiting years ago during pregnancy — that ended before I started paracetamol and is completely unrelated.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_081", "text": "I stop the nevirapine and within three days the rash just disappear completely — e comot.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_082", "text": "I stopped the nevirapine but the rash did not change at all — it is still there just as it was before.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_083", "text": "When we discontinued efavirenz, the nightmares and dizziness resolved completely within one week.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_084", "text": "Even after stopping efavirenz the dizziness and bad dreams continued just the same — no change at all.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_085", "text": "I stopped lisinopril and the cough disappeared after just a few days — I can sleep well now.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_086", "text": "I stopped lisinopril as the doctor advised but the cough has not improved at all — it is still the same.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_087", "text": "When the doctor stopped amlodipine the ankle swelling went down within a week.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_088", "text": "Even after stopping amlodipine the swelling in my ankles continued and did not reduce.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_089", "text": "We stopped isoniazid and the tingling in his hands resolved completely over the following two weeks.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_090", "text": "We stopped isoniazid but the numbness and tingling in his hands did not get better at all.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_091", "text": "After we stopped co-trimoxazole the rash faded completely within four days.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_092", "text": "After stopping co-trimoxazole the rash remained unchanged — no sign of fading at all.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_093", "text": "I stopped metformin and the diarrhea resolved within two days — my stomach is normal again.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_094", "text": "I stopped metformin as the doctor said but the loose stool continued just the same.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_095", "text": "When we discontinued pyrazinamide, the joint pain resolved and the patient could walk normally again.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_096", "text": "Pyrazinamide was discontinued but the joint pain persisted without any improvement.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_097", "text": "I stopped artemether-lumefantrine and the nausea and vomiting stopped completely within two days.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_098", "text": "Even after stopping artemether-lumefantrine the nausea continued and I was still vomiting.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_099", "text": "When doxycycline was stopped, the heartburn and chest discomfort resolved within three days.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_100", "text": "Even after dem stop doxycycline the heartburn continue — no change at all.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_101", "text": "We stopped rifampicin temporarily and the patient's itching resolved within five days.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_102", "text": "Rifampicin was stopped but the itching did not reduce at all — the patient was still scratching.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_103", "text": "When I stopped mefloquine, the anxiety and sleep problems resolved within one week.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_104", "text": "I stopped mefloquine but the anxiety and insomnia continued — no change was noticed.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_105", "text": "After stopping ethambutol, the patient's vision improved noticeably over two weeks.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_106", "text": "Ethambutol was stopped but the patient's vision did not improve — it remained blurred as before.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_107", "text": "I stopped ibuprofen and the stomach pain went away immediately — I feel fine now.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_108", "text": "Even after I stopped ibuprofen the stomach pain continued — it did not improve at all.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_109", "text": "When abacavir was discontinued the fever, rash, and fatigue resolved completely within a week.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_110", "text": "Abacavir was discontinued but the fever and rash continued without any improvement.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_111", "text": "I stopped the aspirin and the ringing in my ears stopped within a few days.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_112", "text": "I stopped aspirin but the tinnitus continued just as loudly as before — no improvement.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_113", "text": "When we stop amoxicillin my child's vomiting and stomach pain just comot within two days — she fine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_114", "text": "We stopped amoxicillin but the child's vomiting and stomach pain continued unchanged.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_115", "text": "After stopping tenofovir the patient's fatigue and muscle weakness improved significantly over two weeks.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_116", "text": "Tenofovir was stopped but the fatigue and weakness did not improve — the patient remained the same.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_117", "text": "I stopped lamivudine and my headaches went away within a few days.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_118", "text": "I stopped lamivudine as instructed but the headaches continued every day — no improvement.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_119", "text": "When artesunate-amodiaquine was discontinued, the patient's weakness and poor appetite resolved within a week.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_120", "text": "We stop artesunate-amodiaquine but the weakness and poor appetite no change — patient still dey suffer.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_121", "text": "When I restarted nevirapine the rash came back immediately — within two days it was all over my body.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_122", "text": "I took nevirapine again and had no rash at all this time — no reaction, nothing.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_123", "text": "We rechallenged with efavirenz and the same dizziness and nightmares occurred again within three days.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_124", "text": "Patient was rechallenged with efavirenz and had no dizziness or nightmares — completely tolerating the drug.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_125", "text": "When isoniazid was restarted the tingling in his hands returned within one week.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_126", "text": "Isoniazid was restarted and the patient had no tingling or numbness — no adverse reaction.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_127", "text": "We rechallenged with co-trimoxazole and the rash appeared again on the second day.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_128", "text": "Co-trimoxazole was restarted and no rash developed — the patient tolerated it without any problem.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_129", "text": "When I started lisinopril again the cough came back within four days.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_130", "text": "I started lisinopril again and this time I had no cough at all — the doctor says I am tolerating it fine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_131", "text": "When dem restart amlodipine the ankle swelling come back — the feet big again within two weeks.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_132", "text": "Amlodipine was reintroduced and there was no swelling — the patient had no discomfort at all.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_133", "text": "I started metformin again and the diarrhea returned immediately — worse than before.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_134", "text": "I took metformin again and had no diarrhea this time — my stomach was fine throughout.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_135", "text": "When doxycycline was restarted the heartburn returned on the very first day.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_136", "text": "We rechallenged with doxycycline and the patient reported no heartburn or discomfort.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_137", "text": "When I took artemether-lumefantrine again the nausea and vomiting returned just as before.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_138", "text": "I took artemether-lumefantrine again for a new malaria episode — no nausea, no vomiting, I was fine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_139", "text": "We rechallenged with abacavir and the same hypersensitivity reaction — fever, rash, and fatigue — occurred again.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_140", "text": "Abacavir was rechallenged with careful monitoring and the patient had no fever, no rash, no reaction.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_141", "text": "When mefloquine was restarted the anxiety and bad dreams came back the very first week.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_142", "text": "She get mefloquine again and no anxiety, no bad dream — she dey tolerate am fine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_143", "text": "When rifampicin was reintroduced the patient developed itching again within five days.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_144", "text": "Rifampicin was reintroduced and the patient had no itching — she tolerated it without any complaint.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_145", "text": "We rechallenged with pyrazinamide and the joint pain recurred just as severely as before.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_146", "text": "Pyrazinamide was rechallenged and no joint pain occurred — the patient is tolerating it well.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_147", "text": "When ethambutol was restarted the blurred vision returned within two weeks.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_148", "text": "Ethambutol was restarted and the patient reported no vision problems — tolerating the drug without issue.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_149", "text": "When I took ibuprofen again the stomach pain came back immediately — I had to stop again.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_150", "text": "I took ibuprofen again and my stomach was completely fine — no pain, no discomfort.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_151", "text": "When I restarted aspirin the tinnitus came back within a few days.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_152", "text": "Aspirin was restarted and the ringing in the ears did not return — no reaction was noticed.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_153", "text": "When we gave the child amoxicillin again the vomiting and stomach pain returned on the second day.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_154", "text": "We rechallenged the child with amoxicillin and she had no vomiting or stomach pain — she tolerated it fine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_155", "text": "When tenofovir was reintroduced the patient's fatigue and muscle weakness returned within two weeks.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_156", "text": "We restart tenofovir and the patient dey fine — no fatigue, no muscle ache at all.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_157", "text": "When I restarted lamivudine the headaches came back within a few days.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_158", "text": "I restarted lamivudine and had no headaches at all this time — I am fine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_159", "text": "We rechallenged with artesunate-amodiaquine and the same weakness and anorexia occurred again.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p2_temporal_160", "text": "Artesunate-amodiaquine was rechallenged and the patient had no weakness or anorexia — no reaction.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_001", "text": "I am still getting dizziness every morning since I started efavirenz — it has not improved at all.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_002", "text": "The dizziness I had from efavirenz cleared up completely after the second week. I am fine now.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_003", "text": "The vivid dreams from efavirenz are ongoing and disrupting my sleep every single night.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_004", "text": "Those vivid dreams from efavirenz settled down on their own — I sleep without any problem now.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_005", "text": "A rash appeared on my chest and arms after I began nevirapine and it is still spreading.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_006", "text": "The rash I had when I started nevirapine has completely resolved. No more skin problem.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_007", "text": "I keep having nausea every time I take nevirapine — it will not go away no matter what I eat.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_008", "text": "I had some nausea at first on nevirapine but it settled after the first week and I feel better now.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_009", "text": "My joint pain has been persistent since I started isoniazid; both knees ache daily.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_010", "text": "The joint pain from isoniazid has gone — it passed about three weeks into treatment.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_011", "text": "I am experiencing tingling in my hands continuously since beginning isoniazid treatment.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_012", "text": "The tingling in my hands that started with isoniazid has resolved completely with the vitamin B6 supplement.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_013", "text": "Stomach upset is ongoing since I started rifampicin — I feel sick after every dose.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_014", "text": "The stomach upset I had on rifampicin has cleared up. I take it with food now and I am fine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_015", "text": "I feel extreme fatigue every day and it has not lifted since beginning rifampicin.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_016", "text": "That fatigue from rifampicin passed after about ten days. I have my energy back now.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_017", "text": "The headache started when I took artemether-lumefantrine and it is still with me three days on.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_018", "text": "The headache from artemether-lumefantrine went away by the next morning — no longer bothering me.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_019", "text": "I am still feeling dizzy after finishing the artemether-lumefantrine course; it won't stop.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_020", "text": "The rash don clear — dizziness from the artemether-lumefantrine left after I completed the course. I dey fine now.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_021", "text": "Diarrhea is persisting since I started metformin — I am going to the toilet many times a day.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_022", "text": "The diarrhea I had when metformin was first started has resolved. Stool is now normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_023", "text": "Nausea after each metformin dose is still a problem — I cannot eat properly.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_024", "text": "I had nausea from metformin initially but it has settled down. No more problem now.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_025", "text": "My ankles have been swelling continuously since the doctor put me on amlodipine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_026", "text": "The swelling in my ankles from amlodipine has completely gone — the doctor adjusted the dose and it resolved.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_027", "text": "I am having a headache every day since starting amlodipine; it is getting worse, not better.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_028", "text": "The headache that came with amlodipine cleared up after the first few days. I no longer have that issue.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_029", "text": "I have been itching all over my body since I started co-trimoxazole and I cannot sleep from it.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_030", "text": "The itching from co-trimoxazole passed once the course ended. It has not returned.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_031", "text": "A rash appeared on my back after starting co-trimoxazole and is still present and spreading.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_032", "text": "That rash from co-trimoxazole has cleared up — the doctor applied some cream and it is better now.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_033", "text": "Every time I swallow the doxycycline tablet I get nausea that lasts for hours — still happening.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_034", "text": "I had nausea with doxycycline at first but it has completely gone. I take it with a full glass of water now.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_035", "text": "Stomach upset from doxycycline is still ongoing — sharp pain in my upper abdomen after each dose.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_036", "text": "The stomach upset from doxycycline settled down by day four. No more issue with it.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_037", "text": "I developed a rash all over after starting amoxicillin and it is still worsening.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_038", "text": "The rash I got from amoxicillin has resolved — it faded within days of stopping the medication.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_039", "text": "Diarrhea is still ongoing since the amoxicillin was started — very loose stools multiple times daily.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_040", "text": "Diarrhea from amoxicillin has cleared. Stool returned to normal consistency three days after finishing the course.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_041", "text": "I am feeling fatigued every day since being switched to tenofovir — I can barely walk to the clinic.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_042", "text": "The fatigue that started when I was put on tenofovir has since resolved. I feel stronger now.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_043", "text": "Muscle pain is ongoing and has not improved since I started tenofovir three weeks ago.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_044", "text": "The muscle pain from tenofovir has gone away on its own — I had it for about a week then it stopped.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_045", "text": "Joint pain in my shoulders and hips is still ongoing since pyrazinamide was added to my regimen.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_046", "text": "The joint pain from pyrazinamide has resolved after uric acid treatment was added. I dey fine now.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_047", "text": "Nausea and vomiting persist — every dose of pyrazinamide makes me feel sick and it is still happening.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_048", "text": "That nausea from pyrazinamide settled after the first ten days. Patient reports no further discomfort.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_049", "text": "I have been dizzy and unsteady on my feet since taking mefloquine — still the same today.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_050", "text": "The dizziness from mefloquine passed two days after the dose. I am no longer experiencing it.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_051", "text": "A pounding headache has been with me since I took mefloquine for prophylaxis and won't go away.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_052", "text": "The headache that came after mefloquine cleared up by day three. No longer a problem.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_053", "text": "I still have a rash on my arms and face three weeks after starting efavirenz — it is not going away.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_054", "text": "The rash from efavirenz cleared up completely. Skin is back to normal and no longer any itching.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_055", "text": "Fatigue is still severe — every day since starting isoniazid I feel too weak to do anything.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_056", "text": "I had fatigue from isoniazid at first but it has now resolved. I am managing fine on the treatment.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_057", "text": "I have been itching all over since starting rifampicin — it is still there every day after I take it.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_058", "text": "The itching from rifampicin cleared after the first two weeks. It has not returned since.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_059", "text": "Nausea from co-trimoxazole is an ongoing issue — I feel queasy for hours after every dose.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_060", "text": "I had nausea from co-trimoxazole at the start but it has settled down. No more nausea at all.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_061", "text": "I believe the stomach cramps I am having are from the metformin — they started the very day I began taking it.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_062", "text": "The stomach cramps are not from metformin — the doctor confirmed they are due to a GI infection, unrelated to my medication.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_063", "text": "The cough started right after I was put on amlodipine and the doctor thinks the amlodipine is likely causing it.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_064", "text": "The cough is not from amlodipine — tests confirmed it is a respiratory infection and has nothing to do with my blood pressure medication.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_065", "text": "I have been feeling low and depressed since starting efavirenz — the counsellor suspects the drug is the cause.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_066", "text": "The depression is not from efavirenz — psychiatric review confirmed it is unrelated to the antiretroviral and has a separate cause.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_067", "text": "I am having pain in my right side and the doctor suspects the isoniazid is affecting my liver.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_068", "text": "The liver pain is not caused by isoniazid — liver biopsy showed another aetiology, not drug-induced.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_069", "text": "The fever started right after I began co-trimoxazole — I think the drug is the one causing it.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_070", "text": "The fever is not from co-trimoxazole — the doctor confirmed it is a separate opportunistic infection, not a drug reaction.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_071", "text": "The rash appeared within 24 hours of starting doxycycline. The doctor believes doxycycline is responsible.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_072", "text": "Tests showed the rash was not caused by doxycycline — it was an existing allergic reaction to another substance.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_073", "text": "My vision has been blurring since rifampicin was started — I believe the medication is affecting my eyesight.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_074", "text": "The vision changes are not from rifampicin — the ophthalmologist confirmed the cause is diabetic retinopathy, not the TB drug.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_075", "text": "I am having pain in my lower back and the nephrologist suspects tenofovir nephrotoxicity is the cause.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_076", "text": "The kidney pain is not from tenofovir — urology review found a kidney stone that is the real cause, not the medication.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_077", "text": "The vomiting started immediately after the first artemether-lumefantrine dose — the nurse thinks the drug caused it.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_078", "text": "The vomiting is not from artemether-lumefantrine — the doctor confirmed it is from gastroenteritis that started before the drug was given.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_079", "text": "My face swelled up after the first amoxicillin tablet — the doctor says it is an allergic reaction to the drug.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p3_negation_080", "text": "The swelling of the face is not from amoxicillin — allergy testing confirmed the trigger was a food allergen taken at the same time, not the antibiotic.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_001", "text": "I am not sure if it is the efavirenz, but since I started taking it I have been having very vivid nightmares and I wake up feeling completely disoriented.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_002", "text": "I am not sure if it is the isoniazid, but since I started taking it my joints have been aching terribly, especially in the mornings when I try to get up.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_003", "text": "Patient uncertain whether rash is related to rifampicin, but temporal association noted — rash appeared within four days of treatment initiation and has persisted.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_004", "text": "I am not sure if it is the metformin, but ever since I began the tablets I have had constant stomach pain and loose stools that make it hard to go to work.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_005", "text": "I am not sure if it is the artemether-lumefantrine, but since my daughter started the course she has been vomiting after every dose and she is too weak to eat.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_006", "text": "I no sure if na the amlodipine, but since I start take am my feet dey swell plenty and I dey feel dizzy when I stand up fast.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_007", "text": "I am not sure if it is the nevirapine, but since starting the regimen two weeks ago I have had a rash on my chest that is spreading and itching without stopping.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_008", "text": "Patient uncertain whether fatigue is attributable to tenofovir, but reports onset coincides with initiation of regimen and has worsened progressively over three weeks.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_009", "text": "I am not sure if it is the doxycycline, but since I started the tablets I have been getting severe headaches every day that do not go away even with paracetamol.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_010", "text": "I am not sure if it is the co-trimoxazole, but since we started giving my son the syrup he has been breaking out in a rash all over his body and crying from the itching.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_011", "text": "I think it might be from the pyrazinamide — I have been having severe joint pain in both knees every day and it only started after we added that tablet to my treatment.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_012", "text": "Patient thinks the persistent dry cough might be from lisinopril. Cough has been present daily since antihypertensive was started six weeks ago.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_013", "text": "I think it might be the efavirenz — I have been having strange mood changes and feeling very low almost every afternoon, and it only began after I started the ARVs.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_014", "text": "I think it might be the amoxicillin — my child has been having diarrhoea every single day since we started the course and the stool is sometimes mixed with mucus.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_015", "text": "I think maybe the isoniazid be the thing giving me this problem. Since I start take am, I dey feel like the ground dey spin and I fall small-small sometimes.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_016", "text": "Patient suspects metformin may be causing nausea. Reports daily nausea with each dose since initiating therapy; no prior gastrointestinal history.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_017", "text": "I think it might be from the rifampicin — I have been having orange-coloured urine and my skin feels itchy all over, and it has been like this since the first week of treatment.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_018", "text": "I think the amlodipine might be causing my severe headaches — I get them almost every morning now and they were not there before I started the blood pressure medicine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_019", "text": "Could the nevirapine be causing this rash? It started exactly when I began the treatment and it keeps getting worse no matter what cream I apply.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_020", "text": "Could tenofovir be responsible for the muscle pain? Patient reports bilateral leg weakness and pain beginning within one week of starting the regimen.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_021", "text": "Could the co-trimoxazole be causing my nausea? It started right when I began the prophylaxis and I feel like vomiting every time I swallow the tablet.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_022", "text": "Could the artemether-lumefantrine be causing my child to have such bad dizziness? He keeps falling and says everything looks like it is spinning, and it started on the first day of the treatment.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_023", "text": "Could doxycycline be causing my vision to blur? It started right when I began the course and I am struggling to read texts on my phone at night.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_024", "text": "Is it possible the lisinopril is giving me this dry cough? The cough started immediately after I started taking the tablet and it has not gone since then.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_025", "text": "Could the amoxicillin be causing my daughter's rash? The bumps appeared on her second day of the course and they are still spreading across her stomach and back.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_026", "text": "Could the pyrazinamide be what is making my stomach hurt so badly? The pain started right after they added it to my TB treatment and it is there every single day.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_027", "text": "I thought it was just stress from work, but every single time I take the efavirenz at night I have nightmares and wake up in a cold sweat — it happens without fail.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_028", "text": "Patient initially attributed tingling in the hands to heavy lifting at work. However, the temporal pattern is consistent with isoniazid-induced peripheral neuropathy following six weeks of treatment.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_029", "text": "I thought the nausea was from something I ate, but every time I take the rifampicin in the morning I feel sick for the next two or three hours — it happens every day.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_030", "text": "I thought my son was just weak from the malaria itself, but every time he takes the artemether-lumefantrine tablet he vomits within thirty minutes and then becomes very sleepy.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_031", "text": "I think say e be the food I chop, but every time I take the metformin my belly dey pain me well well and I go toilet plenty. E happen every time.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_032", "text": "I thought the swelling in my ankles was from being on my feet all day, but it has been there every morning since I started the amlodipine — even when I rest.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_033", "text": "I thought the headache was from the sun, but I get a pounding headache every day after taking the doxycycline and it lasts for hours — it never happened before the antibiotics.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_034", "text": "I assumed my baby was just teething, but every time I give the co-trimoxazole drops she develops a rash around her mouth within the hour and it fades overnight.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_035", "text": "It might be nothing, but since the nevirapine was added to my regimen I have had a rash on my arms and chest that will not go away no matter what I do.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_036", "text": "Patient minimises symptoms but has had persistent fatigue and bone pain since tenofovir was added to the antiretroviral regimen eight weeks ago.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_037", "text": "It may be nothing serious, but since pyrazinamide was added to my treatment I have had joint pain in my fingers and wrists every morning that makes it hard to grip things.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_038", "text": "It might not be a big problem, but since my child started the amoxicillin she has had loose stools three or four times a day that will not stop, and she is losing weight.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_039", "text": "Maybe I am just overthinking it, but since they put me on lisinopril for my pressure I have this dry cough that has not stopped for even one day since I started.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_040", "text": "It might be nothing, but since the metformin was added to my diabetes treatment I have had constant nausea and stomach cramps after every meal that were not there before.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_041", "text": "It might not be related, but since I started the doxycycline I have been having severe sun sensitivity — my skin burns and blisters even after a short time outside.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_042", "text": "Patient dismisses itching as minor but reports it has been present daily since rifampicin was initiated and is now disturbing sleep; no prior dermatological history.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_043", "text": "I am on three medications — I do not know which one is causing it, but I have been having severe dizziness and strange dreams every night since they started efavirenz last month.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_044", "text": "Patient on multiple TB drugs and uncertain which agent is responsible, but developed peripheral tingling and numbness shortly after isoniazid was added to the regimen.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_045", "text": "I take four different tablets and I do not know which one is making me feel so tired all the time, but the fatigue got much worse after they introduced tenofovir to my regimen.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_046", "text": "My daughter is on multiple medicines and I cannot tell which is causing the rash, but it appeared the same week they added co-trimoxazole and it has been spreading every day.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_047", "text": "I dey take plenty medicine so I no know which one dey cause am, but since dem add the amlodipine my legs dey swell and I dey feel pain for my chest small-small.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_048", "text": "They have me on several medications and I honestly do not know which one is responsible, but I have been having nausea and stomach cramps since they started rifampicin three weeks ago.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_049", "text": "My husband is on multiple TB tablets and we are not sure which one is causing the joint pain, but it started when they added pyrazinamide to his treatment and he can barely walk now.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p9_hedging_050", "text": "Patient unable to identify causative agent given polypharmacy, but hepatotoxicity markers elevated and temporal association with nevirapine introduction is clinically significant.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_001", "text": "ALT 156 U/L (3.2× ULN) noted on day 28 of isoniazid therapy — drug-induced liver injury suspected, isoniazid held pending review.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_002", "text": "Liver function check shows ALT 42 U/L (1.1× ULN) at week 4 of isoniazid — mildly elevated but sub-threshold, continue current regimen with monthly monitoring.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_003", "text": "Transaminase markedly raised: ALT 320 U/L (8.0× ULN) after 6 weeks on rifampicin-containing regimen — hepatotoxicity confirmed, regimen suspended.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_004", "text": "ALT 58 U/L (1.5× ULN) on routine LFT while on rifampicin — transaminase elevation present but not clinically significant; monitoring continued.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_005", "text": "Patient on pyrazinamide reports right upper quadrant discomfort; ALT 210 U/L (5.4× ULN) — drug-induced hepatitis, pyrazinamide withdrawn immediately.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_006", "text": "Liver enzymes checked at 8-week visit: ALT 72 U/L (1.9× ULN) while on pyrazinamide — mild elevation below 3× ULN threshold, no dose adjustment at this time.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_007", "text": "ALT 185 U/L (4.7× ULN) detected on week 6 of nevirapine-based ART — hepatotoxicity reaction, nevirapine discontinued and substitution initiated.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_008", "text": "Routine LFT on nevirapine shows ALT 88 U/L (2.3× ULN) — transaminase 2.3 times upper limit of normal; sub-threshold, patient counselled and follow-up in 2 weeks.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_009", "text": "ALT 148 U/L (3.8× ULN) recorded at month 3 on efavirenz — clinically significant liver enzyme elevation meeting DILI criteria, regimen review initiated.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_010", "text": "LFT results: ALT 65 U/L (1.7× ULN) on efavirenz at 12-week check — mild transaminase rise, below the 3× ULN action threshold, continue with monitoring.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_011", "text": "Follow-up LFT shows ALT 245 U/L (6.3× ULN) after 16 weeks of methotrexate — hepatotoxicity suspected, drug held and gastroenterology referral placed.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_012", "text": "ALT 95 U/L (2.4× ULN) on monthly monitoring during methotrexate therapy — elevation noted but does not reach 3× ULN threshold; liver biopsy deferred, close follow-up arranged.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_013", "text": "Week 12 LFT: ALT 162 U/L (4.2× ULN) in patient on isoniazid and pyridoxine — values exceed 3× ULN, drug-induced liver injury protocol activated.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_014", "text": "ALT 50 U/L (1.3× ULN) at routine hepatic monitoring while on rifampicin — transaminase at 1.3 times upper limit; within acceptable watch-and-wait range, continue therapy.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_015", "text": "Severe hepatotoxicity on nevirapine: ALT 510 U/L (13.1× ULN), patient jaundiced — treatment immediately stopped, supportive care commenced.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_016", "text": "ALT measured at 80 U/L (2.1× ULN) during efavirenz monitoring at month 2 — physician notes sub-threshold elevation, no clinical action warranted at present.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_017", "text": "Liver panel shows ALT 118 U/L (3.0× ULN) exactly at the threshold after 10 weeks of pyrazinamide — classified as clinically significant DILI; drug withheld.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_018", "text": "ALT 78 U/L (2.0× ULN) on methotrexate 15 mg weekly — not yet at action threshold; folic acid supplementation confirmed and monitoring frequency increased.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_019", "text": "Patient on isoniazid presents with fatigue and nausea; ALT 290 U/L (7.4× ULN) — hepatotoxicity adverse event confirmed, drug stopped and notified to pharmacovigilance unit.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_020", "text": "LFT at 4-week mark on rifampicin: ALT 110 U/L (2.8× ULN) — elevated but remains below 3× ULN clinical action threshold; intensify monitoring to biweekly.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_021", "text": "Serum creatinine doubled from baseline 98 μmol/L to 202 μmol/L (2.1× baseline) after 8 weeks on tenofovir — nephrotoxicity confirmed, drug substituted with abacavir.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_022", "text": "Creatinine increased to 128 μmol/L from baseline 105 μmol/L (1.2× baseline) on tenofovir — mildly elevated within acceptable range, no dose adjustment required at this point.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_023", "text": "Day 7 of gentamicin therapy: creatinine 260 μmol/L, up from baseline 118 μmol/L (2.2× baseline) — acute kidney injury attributed to aminoglycoside nephrotoxicity, drug discontinued.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_024", "text": "Renal function check on day 4 of gentamicin: creatinine 155 μmol/L from baseline 120 μmol/L (1.3× baseline) — sub-threshold rise, ensure adequate hydration and continue monitoring.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_025", "text": "Creatinine rose to 310 μmol/L from pre-treatment baseline of 90 μmol/L (3.4× baseline) after amphotericin B infusions — severe nephrotoxicity, liposomal formulation substituted.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_026", "text": "Renal profile after 5 days of amphotericin B: creatinine 148 μmol/L vs baseline 110 μmol/L (1.35× baseline) — mild creatinine rise not exceeding 2× baseline, saline pre-hydration reinforced.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_027", "text": "Post-cycle creatinine 240 μmol/L compared to pre-cisplatin baseline of 88 μmol/L (2.7× baseline) — nephrotoxicity event documented, dose reduction and nephrology review requested.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_028", "text": "Creatinine 132 μmol/L from baseline 95 μmol/L (1.4× baseline) on day 10 post-cisplatin — kidney function mildly impacted but below 2× baseline action threshold, aggressive hydration maintained.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_029", "text": "eGFR declined to 52 mL/min/1.73m² (below 60 threshold) and creatinine 218 μmol/L on tenofovir at 6-month review — tenofovir nephrotoxicity, regimen switched.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_030", "text": "Creatinine 170 μmol/L from baseline 125 μmol/L (1.36× baseline) after 6 days gentamicin — renal function mildly affected; sub-threshold, trough levels checked and dose interval extended.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_031", "text": "Acute kidney injury on amphotericin B: serum creatinine 350 μmol/L from baseline 100 μmol/L (3.5× baseline), eGFR 18 mL/min — drug held, urgent nephrology consulted.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_032", "text": "Creatinine 140 μmol/L vs pre-treatment 102 μmol/L (1.37× baseline) on day 7 post-cisplatin cycle — within acceptable range (below 2× baseline), continue current hydration protocol.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_033", "text": "Creatinine doubled to 198 μmol/L from baseline 99 μmol/L (2.0× baseline) — nephrotoxicity threshold reached on tenofovir; regimen change to abacavir-based ART initiated.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_034", "text": "Day 5 renal monitoring on gentamicin: creatinine 158 μmol/L from baseline 118 μmol/L (1.34× baseline) — sub-threshold elevation, no adjustment yet; recheck in 48 hours.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_035", "text": "Post-chemotherapy review: creatinine 226 μmol/L from cisplatin pre-treatment baseline of 92 μmol/L (2.5× baseline) — significant nephrotoxicity, oncology team alerted and hydration escalated.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_036", "text": "Creatinine 138 μmol/L from baseline 102 μmol/L (1.35× baseline) after 3 days amphotericin B — minor renal stress below nephrotoxicity threshold, oral hydration reinforced.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_037", "text": "Platelet count dropped to 68,000/μL during co-trimoxazole therapy — thrombocytopenia adverse drug reaction, drug held and haematology notified.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_038", "text": "Full blood count: platelets 125,000/μL on co-trimoxazole — borderline low but above the 100,000/μL clinical action threshold; weekly monitoring instituted.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_039", "text": "Platelet count 45,000/μL in patient on quinine for malaria — severe thrombocytopenia attributed to quinine, drug discontinued and platelet transfusion considered.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_040", "text": "Repeat CBC shows platelets 138,000/μL on day 5 of quinine — above the 100,000/μL threshold; platelets trending toward low-normal, continue quinine and recheck in 48 hours.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_041", "text": "Week-3 CBC on linezolid: platelet count 72,000/μL — thrombocytopenia below critical threshold, linezolid-induced myelosuppression suspected, dose held.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_042", "text": "Platelet count 112,000/μL at week 2 of linezolid — borderline low but above the 100,000/μL action threshold; haematological monitoring intensified to twice weekly.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_043", "text": "CBC on valproate shows platelet count of 88,000/μL — clinically significant thrombocytopenia, dose reduction initiated and neurologist informed.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_044", "text": "Routine blood count: platelets 143,000/μL while on valproate sodium — below normal range but above clinical action threshold of 100,000/μL; no dose change, monitor monthly.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_045", "text": "Platelet count fell to 55,000/μL on day 14 of co-trimoxazole prophylaxis — meets thrombocytopenia criteria, drug withheld and dapsone substitution considered.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_046", "text": "Platelets 130,000/μL at week-4 monitoring on linezolid — above the 100,000/μL threshold but trending down from 165,000/μL at baseline; close haematological follow-up maintained.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_047", "text": "Platelet count 22,000/μL on day 7 of quinine — acute immune thrombocytopenia consistent with quinine-induced reaction, immediately discontinued.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_048", "text": "Haematology panel: platelets 119,000/μL after 6 weeks on valproate — low-normal, currently above the 100,000/μL action threshold; repeat CBC in 4 weeks.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_049", "text": "ECG performed after chloroquine loading dose shows QTc interval of 530ms — clinically significant QT prolongation exceeding 500ms threshold, chloroquine withheld.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_050", "text": "ECG review on chloroquine: QTc 472ms — borderline prolongation noted, below the 500ms action threshold; cardiology advised and telemetry monitoring initiated.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_051", "text": "Post-dose ECG on azithromycin shows QTc 518ms — QT interval prolongation above 500ms threshold, drug substituted with doxycycline after senior review.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_052", "text": "Cardiac monitor: QTc 462ms during azithromycin course — prolonged relative to baseline 430ms but below the 500ms safety cutoff; continue with daily ECG surveillance.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_053", "text": "ECG on haloperidol decanoate: QTc interval 508ms — exceeds the 500ms clinical threshold for significant QTc prolongation, psychiatry and cardiology consulted for dose review.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_054", "text": "Routine ECG shows QTc 488ms on haloperidol 5 mg daily — borderline prolongation within watchful range (below 500ms), electrolytes corrected and ECG repeated in one week.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_055", "text": "ECG performed during methadone maintenance: QTc 545ms — dangerous QT prolongation far exceeding 500ms, dose immediately reduced and cardiology review arranged.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_056", "text": "Cardiac assessment on methadone 60 mg: QTc 490ms — QTc borderline elevated, within watchful range below 500ms threshold; continue methadone with bi-weekly ECG and electrolyte checks.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_057", "text": "ECG check after 3 months on hydroxychloroquine: QTc interval 522ms — significant QTc prolongation exceeding 500ms, drug paused and alternative antimalarial prophylaxis considered.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_058", "text": "ECG on hydroxychloroquine at 6-week visit: QTc 455ms — mildly prolonged from baseline 420ms but well below the 500ms action threshold; continue with monitoring.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_059", "text": "Patient on chloroquine for malaria prophylaxis: repeat ECG shows QTc 560ms — critically prolonged QT interval, risk of torsades de pointes, chloroquine stopped immediately.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p12_lab_060", "text": "Follow-up ECG on day 3 of azithromycin: QTc 478ms — borderline prolongation, below the 500ms critical threshold; no action taken, patient reminded to avoid co-administration of other QT-prolonging agents.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_001", "text": "I am on medication for my condition — I prefer not to say what it is in front of people — but since starting the new tablet, I have been hearing strange sounds and seeing things at night that are not there. It is very frightening and I cannot sleep properly.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_002", "text": "My family does not know about my treatment and I take my tablets in private. But since I started them three weeks ago, I have been losing weight very fast and my hair is falling out in clumps. My clothes no longer fit me properly.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_003", "text": "I do not discuss my treatment with anyone, not even my husband. Since I started the tablets my doctor gave me for my condition, I have been having very vivid and frightening dreams every night. I wake up sweating and confused about what is real.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_004", "text": "I take it privately because people in my community will talk if they know. But since starting this medication, a very bad rash has appeared all over my chest and back and it is spreading. The itching is unbearable and keeps me awake.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_005", "text": "I prefer not to say what I am being treated for — my neighbours must not know. Since they added this new tablet to my regimen, I have been feeling pins and needles in both feet that do not go away, even when I am resting. Walking has become very painful.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_006", "text": "I am on medication for my condition but I cannot say what condition in front of my family. Since I began the treatment, I have been experiencing a constant dull pain in my right side below my ribs. The pain is worse after I take the tablet each evening.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_007", "text": "My relatives do not know I am on treatment and I intend to keep it that way. But since starting this medicine, both my legs have been feeling very weak and I have numbness in my toes that travels up to my ankles. It is difficult to stand for long.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_008", "text": "I take this treatment privately and I will not tell you the name of my condition. But since I started the new tablet about a month ago, I keep hearing voices calling my name at night when no one is there. My doctor said it is a known side effect but it is very disturbing.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_009", "text": "People in my church do not know about my treatment and I am ashamed for them to find out. Since I began taking the tablets, my skin has been turning yellow and I feel very tired all the time. Even simple tasks at home leave me exhausted.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_010", "text": "I keep my medication hidden in my room because my children must not know. Since I started this treatment, I have been having bad nightmares almost every night and I wake up very anxious. My mood has also changed — I feel very low and cry without reason.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_011", "text": "I do not want my coworkers to know what I am being treated for, so I take my tablet alone at home at night. Since starting it, my dreams have become so vivid and strange — I see people and places that are frightening and very real. I am afraid to sleep now.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_012", "text": "I prefer not to name my treatment here because my family is present. But since they changed my tablet three months ago, I have noticed my hair thinning badly and a rash on my neck that has not cleared. I have also lost about five kilograms without trying.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_013", "text": "I was ashamed to tell my family I am on tablets for my mind, so I have kept this secret for two years. But since I started the white tablet, I have been having uncontrollable shaking in my hands and my mouth moves by itself. It is very embarrassing in public.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_014", "text": "I do not want people to know I am on treatment for my nerves. Since starting the new medication, I cannot sleep at all and my heart is racing all the time even when I am just sitting quietly. I have also gained a lot of weight since I started.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_015", "text": "I take these tablets quietly and I have not told my husband what they are for. Since I began them, my legs will not stay still — I feel compelled to keep moving and pacing, even at night. The restlessness is worse than the problem the medication is supposed to treat.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_016", "text": "My family does not know I am receiving treatment for a mental condition and I prefer to keep it that way. Since they added this new tablet last month, my whole body has become very stiff and I move very slowly. I also feel like I am floating and not fully awake.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_017", "text": "I am on tablets for my mind but I do not discuss this openly even with close friends. Since I began the treatment, I have been sleeping almost fourteen hours a day and I cannot function properly at work. My boss thinks I am lazy but it is the medication making me so drowsy.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_018", "text": "I prefer not to say what I am treated for because people do not understand these conditions. But since I began the new tablet, my hands tremble constantly and I feel very thirsty all the time, drinking water all day. My urine has also increased greatly.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_019", "text": "I take this privately — I am embarrassed for my community to know I am on psychiatric medication. Since starting it, I have gained almost ten kilograms in two months and my blood sugar was found to be high at my last check. These changes worry me very much.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_020", "text": "I do not want my in-laws to know I am being treated for a condition of the mind. Since they started me on this new tablet, I have been losing a lot of hair and my weight has increased even though I have not changed what I eat. My hands also shake in the mornings.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_021", "text": "I am on a program but I do not want to tell you what for — please understand. Since they started me on the new medication in the program, my stomach has been very bad every morning and I vomit before I can eat anything. This has been going on for three weeks now.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_022", "text": "I attend a clinic for a personal matter I prefer not to discuss here. Since they changed my tablet last month, I have been severely constipated for days at a time and I sweat very heavily at night even though the room is not hot. My sleep is very poor.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_023", "text": "My family does not know I am on treatment and I take my medication very privately. But since starting the program medication, I have been feeling very dizzy when I stand up quickly and twice I have nearly fallen. I also feel my heart beating strangely sometimes.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_024", "text": "I do not discuss what I am being treated for — it is a private matter. Since I began taking the tablet I was prescribed, I have been having bad nausea every morning and I feel very tired throughout the day. I also get sudden headaches that come without warning.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_025", "text": "I prefer not to say what my treatment is for, even to the nurse. Since they started me on the new tablet at the clinic, I sweat a lot even in cool conditions and my heart races in the afternoons. Some days I feel very anxious and shaky for no reason I can explain.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_026", "text": "I am on hormone treatment but I do not discuss this openly with my family or community. Since starting, I have been having very bad headaches almost every day and my blood pressure was found to be high at the clinic. The doctor asked me to monitor it at home.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_027", "text": "I take hormone medication privately and I do not want others to know about my treatment. Since I began, I have noticed swelling and pain in my left calf that has not gone away and the leg feels warm to touch. I am worried because it came on suddenly.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_028", "text": "My treatment is a private matter and I prefer not to disclose it here. Since starting the hormone tablets, my mood has been changing very rapidly — I cry easily, then I feel angry, then very sad again within the same day. This did not happen before I started the medication.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_029", "text": "I do not discuss my hormone treatment openly because people in Ghana do not understand. But since I started injections, I have been getting severe headaches that last for hours and my skin has broken out very badly on my face and back. This has not happened to me before.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p13_stigma_030", "text": "I keep my hormone treatment private — even my closest relatives do not know. Since I began taking the tablets, I have been feeling tightness in my chest when I climb stairs and I get short of breath more easily than before. I also feel my heart pounding at times when I am resting.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_001", "text": "We discontinued efavirenz and within three days the dizziness resolved completely. The patient had no further neurological complaints after stopping the drug.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_002", "text": "The patient stopped taking co-trimoxazole and the rash disappeared within three days — positive dechallenge. This confirms the drug was responsible for the cutaneous reaction.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_003", "text": "Since stopping isoniazid, the nausea has completely gone. This confirms drug-induced causation and the patient will not be rechallenged.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_004", "text": "I stopped the nevirapine and within a week, the severe itching was fully gone. My skin is back to normal now.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_005", "text": "Amoxicillin was discontinued and the urticarial rash resolved within 48 hours. Dechallenge was positive, confirming drug-induced urticaria.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_006", "text": "We held rifampicin for ten days and the patient's liver pain resolved. Positive dechallenge strongly implicates rifampicin in the hepatotoxic reaction.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_007", "text": "After I stopped taking doxycycline, the stomach cramps disappeared completely within two days. I am sure it was the tablets causing my pain.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_008", "text": "Pyrazinamide was withdrawn and within one week the joint pain fully resolved — a clear positive dechallenge. The patient was then managed on a pyrazinamide-free regimen.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_009", "text": "My doctor told me to stop the metformin and within three days my diarrhea was completely gone. I had been suffering for weeks and it was the drug all along.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_010", "text": "Following discontinuation of artemether-lumefantrine, the patient reported complete resolution of headache and vomiting within 48 hours. This positive dechallenge response supports drug causality.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_011", "text": "Since we stopped tenofovir, the fatigue has improved dramatically. The dechallenge is positive and the case is being reported to the national pharmacovigilance centre.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_012", "text": "I stopped the chloroquine tablets and my dizziness went away after about four days. My mother also noticed I was walking better once I quit the medicine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_013", "text": "Amlodipine was discontinued and the patient's peripheral oedema and headache resolved within ten days. Positive dechallenge confirmed amlodipine-induced adverse effects.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_014", "text": "We stopped co-trimoxazole prophylaxis and the nausea resolved within two days. Positive dechallenge; alternative prophylaxis was initiated.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_015", "text": "The patient discontinued isoniazid on day 14 of treatment due to peripheral neuropathy. Within ten days of stopping, the tingling in the hands and feet resolved — dechallenge positive.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_016", "text": "My wife stopped her efavirenz and within one week she stopped having those bad dreams and her dizziness was gone. The doctor said this was a positive dechallenge.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_017", "text": "Drug withdrawn: nevirapine. Outcome: rash resolved within 5 days of discontinuation. Assessment: positive dechallenge; probable drug-induced Stevens-Johnson precursor reaction.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_018", "text": "After stopping rifampicin, the patient's vomiting ceased within three days and liver enzymes began normalising. The positive dechallenge response confirms rifampicin hepatotoxicity.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_019", "text": "I had a bad rash and my pharmacist told me to stop the amoxicillin immediately. In two days it was completely cleared up — it was definitely the amoxicillin.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_020", "text": "Doxycycline was ceased and within 48 hours the patient reported complete resolution of nausea and epigastric pain. Dechallenge positive; alternative antibiotic prescribed.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_021", "text": "We stopped co-trimoxazole but the rash did not improve at all — dechallenge was negative. The drug is not the cause and further investigation for an alternative aetiology is warranted.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_022", "text": "Despite discontinuing metformin, the diarrhea persisted unchanged for over two weeks. Negative dechallenge suggests the gastrointestinal symptoms are not drug-related.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_023", "text": "I stopped the amlodipine tablets but the headache continued just the same for another ten days — it was not from the drug. My doctor is now looking for another cause.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_024", "text": "Even after stopping efavirenz for two weeks, the patient's dizziness remained unchanged, suggesting an alternative aetiology such as vestibular disorder. Dechallenge negative.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_025", "text": "Isoniazid was held for ten days but the patient continued to experience joint pain without any improvement. Negative dechallenge; arthralgia likely attributable to underlying disease.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_026", "text": "We discontinued artemether-lumefantrine but the patient's headache and fatigue persisted for another week. The dechallenge was negative, indicating an alternative explanation for the symptoms.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_027", "text": "My mother stopped the chloroquine but her nausea did not get better at all. The nurses said the drug probably was not the cause of her sickness.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_028", "text": "Nevirapine was discontinued on suspicion of drug-induced rash; however, the rash progressed and worsened despite withdrawal. Negative dechallenge; viral exanthem suspected instead.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_029", "text": "I stopped the tenofovir for three weeks on my own but the fatigue was still there every day. My doctor confirmed the medicine was not causing my tiredness.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_030", "text": "Drug held: pyrazinamide. Dechallenge outcome: joint pain persisted without improvement over 14-day observation. Assessment: negative dechallenge; gout from other causes considered.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_031", "text": "Despite holding rifampicin for one week, liver enzyme levels remained markedly elevated and the patient continued to complain of liver pain. Dechallenge was negative for rifampicin.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_032", "text": "Even after stopping amoxicillin, the patient's stomach cramps persisted daily without relief for two weeks, suggesting an alternative gastrointestinal aetiology. Dechallenge was negative.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_033", "text": "I quit the doxycycline completely but the vomiting carried on for another week, just as bad as before. It was not the tablets causing the problem.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_034", "text": "Metformin was withheld for two weeks but the patient's nausea did not resolve, remaining at the same severity. Negative dechallenge; gastroparesis from diabetes suspected.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_035", "text": "We stopped co-trimoxazole for ten days but the fatigue and headache were completely unchanged. Dechallenge was negative and the drug has been restarted for HIV prophylaxis.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_036", "text": "When efavirenz was reintroduced, the dizziness and vivid nightmares recurred within 48 hours — positive rechallenge confirms drug causality. The patient was switched to dolutegravir.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_037", "text": "She was rechallenged with co-trimoxazole and the same maculopapular rash appeared again within three days — confirmed ADR. Rechallenge positive; drug permanently discontinued.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_038", "text": "I started taking isoniazid again and the nausea came back immediately, just like before. My stomach was hurting the same way it did the first time.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_039", "text": "On restarting nevirapine, the patient again developed an extensive rash within 72 hours — rechallenge positive. This confirms nevirapine as the definitive cause of the cutaneous reaction.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_040", "text": "Rechallenge with rifampicin was performed cautiously at low dose and liver pain recurred with rising transaminases within one week. Positive rechallenge; definite hepatotoxicity.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_041", "text": "When my doctor gave me amoxicillin again to test it, the itching and rash came back within two days, just as bad as the first time. He confirmed it was the drug.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_042", "text": "Pyrazinamide was reintroduced at a lower dose for rechallenge purposes; within five days the patient again developed severe joint pain — rechallenge positive, confirming drug-induced arthralgia.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_043", "text": "The patient was rechallenged with doxycycline and experienced the same epigastric pain and nausea within 24 hours of resumption. Positive rechallenge confirmed the causal relationship.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_044", "text": "I tried taking the metformin again after a month without it and the diarrhea came right back within two days. I am certain now that metformin was causing it all along.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_045", "text": "Drug rechallenge: artemether-lumefantrine restarted for a second malaria episode. Outcome: patient developed vomiting and dizziness again within 48 hours. Rechallenge positive; ADR confirmed.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_046", "text": "After switching back to tenofovir, the patient's fatigue returned within one week and renal function began to decline again. Positive rechallenge strongly implicates tenofovir nephrotoxicity.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_047", "text": "My husband started chloroquine again for a new infection and the same dizziness and headache came back within three days. We know now that it is from the chloroquine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_048", "text": "Amlodipine was reintroduced and within ten days the patient again developed lower limb oedema and headache — positive rechallenge. This establishes a definite drug-adverse effect relationship.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_049", "text": "When isoniazid was restarted as part of sequential rechallenge, the patient developed peripheral neuropathy symptoms again within two weeks. Rechallenge was positive; pyridoxine supplementation intensified.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_050", "text": "She was placed back on efavirenz after a brief trial off and the neuropsychiatric symptoms reappeared within 48 hours — dizziness, confusion and disturbing dreams. Positive rechallenge confirmed.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_051", "text": "Patient was rechallenged with co-trimoxazole — no rash, no discomfort. The previous episode of skin reaction was coincidental and not drug-related.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_052", "text": "I took the amoxicillin again and had absolutely no reaction this time. My doctor confirmed that it was not the drug that caused my rash the first time.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_053", "text": "Rechallenge with metformin was performed and the patient tolerated it well with no adverse gastrointestinal effects. Negative rechallenge; previous diarrhea was attributed to concurrent gastroenteritis.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_054", "text": "Doxycycline was reintroduced and the patient had no nausea or stomach pain on this occasion. Negative rechallenge confirmed that the earlier gastrointestinal symptoms had an alternative cause.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_055", "text": "My doctor restarted the amlodipine and this time I had no headache, no swelling — nothing. He said the swelling I had before was from another reason, not the blood pressure pill.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_056", "text": "Rechallenge with chloroquine was conducted for a new malaria episode — the patient experienced no dizziness, no vomiting, and no adverse effects whatsoever. Negative rechallenge; prior symptoms were malaria itself.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_057", "text": "Drug rechallenge: isoniazid reintroduced at full dose. Outcome: no nausea, no liver pain, and liver function tests remained within normal limits throughout. Negative rechallenge.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_058", "text": "Rifampicin was cautiously reintroduced and liver enzymes remained stable over three weeks of monitoring with no symptoms. Negative rechallenge indicates the earlier hepatitis was not rifampicin-induced.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_059", "text": "When I went back on tenofovir, I felt completely fine. The tiredness I had before must have been from my illness, not from the medicine, because I had no problems this time.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p14_dechallenge_060", "text": "Rechallenge with nevirapine at reduced dose showed no recurrence of rash or other adverse events over a four-week observation period. Negative rechallenge; original reaction attributed to concurrent infection.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_001", "text": "Since dem start give me the streptomycin injection every morning, my ear dey ring and I no fit hear well again.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_002", "text": "After I begin take the gentamicin injection, my two ears dey make noise all the time and I no fit hear what people dey say.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_003", "text": "I dey take streptomycin for three weeks now and my ear dey do me somehow — the ringing no stop and my hearing don reduce plenty.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_004", "text": "Since I start the quinine injection for severe malaria, my head dey ring and my hearing don go down small small.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_005", "text": "My ear dey pain me and I no fit hear well since dem give me the gentamicin. The doctor say na the injection cause am.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_006", "text": "Since I begin use furosemide every morning, I no fit hear as before — everything dey sound far away and my ear dey ring.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_007", "text": "I dey take my diabetes drug and I also dey drink the herbal tea my grandmother prepare. Since then my sugar dey go too low and I dey dizzy all the time.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_008", "text": "I dey use the white sugar tablet and also dey boil the bitter leaf for drink. Since then I dey shake plenty and I faint one time — doctor say my sugar go down too low.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_009", "text": "I mix the metformin with the herbal root my neighbour give me. After that, my head dey swim and I dey sweat cold sweat — hospital say blood sugar low.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_010", "text": "I take the diabetes medicine with the herbal tonic from the market. My body start shake and I no fit stand well — sugar drop too low.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_011", "text": "Since I start efavirenz I start walk around my house in the night and I no know what I dey do. My wife tell me I dey talk plenty in my sleep.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_012", "text": "After dem give me the haloperidol injection, I no fit sit down — my legs dey move by themselves and I dey pace up and down. Na the injection cause am.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_013", "text": "Since I start take the diazepam tablet, I dey feel like say something dey move inside my head and my thoughts dey mix up all the time.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_014", "text": "Since efavirenz start, I dey see strange things when I close my eyes for sleep — like bad dream but I still dey wake. The nurse say na the drug.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_015", "text": "After I take the chlorpromazine, my whole body don stiffen and my mouth open and no fit close. I go hospital emergency and dem say na the drug reaction.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_016", "text": "Since I begin take artesunate-amodiaquine my body dey hot inside but outside cold and I dey shake — na drug fever the nurse say.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_017", "text": "My body dey do me anyhow since I start the TB tablet — system scatter and I no fit work well at all.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_018", "text": "Medicine enter my head since I start the lopinavir tablet — I no dey think straight and everything dey confuse me.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_019", "text": "Since I start co-trimoxazole my pikin dey shake after I give am the tablet. The whole body dey vibrate and the eyes go up — doctor say na reaction.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_020", "text": "Since I begin tenofovir my body dey do me somehow — I no fit explain but nothing dey normal. Nurse say na the ARV tablet.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_021", "text": "I dey pass water too much since I start the blood pressure tablet — every thirty minutes I run to toilet. Doctor say na the amlodipine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_022", "text": "My pikin eyes yellow small after I give am co-trimoxazole for two weeks. Doctor say na the tablet cause am — jaundice from the drug.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_023", "text": "Tummy run dey worry me plenty since I start the TB injection — I go toilet more than five times per day. Nurse say na the isoniazid.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_024", "text": "Since dem give me the injection, my body no dey rest — I dey pace up and down, legs no fit keep still. Na akathisia from the drug.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_025", "text": "Blood dey run cold and body dey shake since I start the pyrazinamide tablet — shivers plenty and temperature go up. Doctor say na drug fever.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_026", "text": "The metformin tablet dey help my sugar but my stomach dey pain me every morning oo — I dey vomit after I take am.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_027", "text": "Efavirenz dey keep my viral load down but my head dey confuse me every night — I dey see things and no fit sleep well at all.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_028", "text": "The TB tablet dey work for my chest but since I start am my legs and hands dey pain me — doctor say na nerve damage from the isoniazid.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_029", "text": "The amlodipine tablet dey bring my pressure down but my two legs dey swell since I start am — I no fit wear my shoe well again.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_adr_030", "text": "Co-trimoxazole dey protect me from infection but since I start am my skin don come out with plenty rash all over my body.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_031", "text": "My ear was ringing before dem even give me the streptomycin injection — the doctor say na wax inside my ear cause am, not the drug.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_032", "text": "The hearing problem dey before I start gentamicin — I don have problem with my ear since I was small. The doctor confirm say na my old condition.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_033", "text": "I stop the streptomycin one week ago and my ear ringing no change at all — still the same. Doctor say na ear infection, not the drug.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_034", "text": "I had ear noise before they give me quinine injection — it started when I had that fever two months ago. The doctor say the quinine never cause am.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_035", "text": "My hearing was already going down before I start the gentamicin. Doctor check and say na age — I don be old man and my ear dey do am since.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_036", "text": "I dey take metformin and also dey use herbal tea but my sugar dey normal — doctor check and say both together no cause any problem for me.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_037", "text": "I try the herbal together with my diabetes tablet but dem no affect me — blood sugar check fine and doctor say my body tolerate am well.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_038", "text": "I walk in my sleep before I even start efavirenz — I been do am since secondary school. My family confirm say na old habit.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_039", "text": "My legs were restless before dem give me the haloperidol injection. Doctor check and say na the anxiety cause am, not the injection.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_040", "text": "The confusion I dey have was already there before I start the diazepam — it started after I fall and hit my head. Doctor say no be the tablet.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_041", "text": "I was shaking before I even take the artesunate — the malaria itself give me the chills. After I finish the drug the shaking stop — na the disease, not the drug.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_042", "text": "My body dey do me somehow before I start the TB tablet — the disease itself was making me weak. After I start treatment I start feel better.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_043", "text": "My pikin was yellow before I give am co-trimoxazole — doctor say na malaria cause the jaundice, not the tablet. Drug was innocent.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_044", "text": "I don dey feel somehow for months before I even start tenofovir — the HIV itself was making me weak. Drug no cause am.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_045", "text": "I no dey pass water more than normal. My doctor check and say my kidney fine and the amlodipine no cause any problem with my water.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_046", "text": "The metformin dey help my sugar and I feel fine — no stomach pain, no vomiting. I dey take am well well and no problem at all.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_047", "text": "Efavirenz dey work for my viral load and I no have problem with my sleep — no strange dreams, no confusion. I dey tolerate am well.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_048", "text": "The TB tablet dey treat my chest well and I no feel any nerve pain in my hands or legs. I dey take am without any problem.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_049", "text": "Amlodipine dey bring my pressure down and my legs no dey swell — doctor check and say everything fine with the drug.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_050", "text": "Co-trimoxazole dey protect me and I no develop any rash or reaction. I dey take am every day without any side effect.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_051", "text": "I no have any stiffness or movement problem since I start the chlorpromazine tablet. Nurse say I dey tolerate am well.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_052", "text": "I take efavirenz for three months now and no strange thing happen — no bad dream, no confusion. My body accept the drug well.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_053", "text": "I was already having rigors from the TB infection before I start pyrazinamide. After I start the drug, the shaking reduce — na the treatment working.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_054", "text": "I dey sit still fine since I start the haloperidol — no restless legs, no pacing. The injection agree with me.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p5_pidgin_nonadr_055", "text": "My tummy was upset before I start metformin — I been have that problem for years. Doctor confirm the metformin no cause any stomach issue for me.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_001", "text": "She was a little unsettled the evening after BCG but fed well and slept normally tonight. No fever. She was fine by morning.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_002", "text": "The baby cried more than usual the first evening after BCG vaccination. She settled overnight and was completely normal by the next day.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_003", "text": "Small redness at the BCG injection site — the nurse said this is normal and expected. It went away on its own within a week.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_004", "text": "The BCG site was slightly raised and red. Our health worker said it was the expected response. It passed and healed normally over two weeks.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_005", "text": "After the pentavalent injection my baby had a mild fever of 37.8°C. I gave paracetamol and she was fine by the next morning. No other problems.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_006", "text": "Baby was fussy and cried a lot after the pentavalent shot. She slept it off and was completely normal the next day. Nothing serious.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_007", "text": "A bit of redness and swelling at the injection site after pentavalent. It was sore for about two days and then nothing serious. Normal I think.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_008", "text": "No vomiting, no diarrhoea, no unusual crying after the hexavalent vaccine. Routine check — all normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_009", "text": "Baby was slightly irritable after the hexavalent injection but she fed well and slept normally. Fine the next morning.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_010", "text": "Mild fever for one day after hexavalent. Took paracetamol and was fine by the second day. The nurse confirmed it was an expected reaction.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_011", "text": "A mild rash appeared 8 days after measles-rubella vaccination. The doctor said it was a common mild vaccine reaction and it went away on its own.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_012", "text": "Low-grade fever five days after measles-rubella shot. It lasted one day and passed quickly. The midwife told me it was normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_013", "text": "My daughter had a mild rash after the measles vaccine. The health worker confirmed it was expected and it cleared within three days.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_014", "text": "My baby had loose stool for one day after the rotavirus drops. The nurse said this is expected and it settled by the next day.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_015", "text": "Mild diarrhoea for 24 hours after rotavirus vaccine. All checks were normal and it went away on its own. Health worker said it was fine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_016", "text": "Sore arm for two days after COVID vaccination. I felt a bit off on day one — tired and mild headache. Fine the next morning.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_017", "text": "Arm was painful and I was feverish the night after the COVID jab. I took paracetamol and was fine by the second day. Nothing serious.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_018", "text": "I felt tired for one day after the COVID vaccine and had a mild headache. It went away on its own by the following morning. Fine after that.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_019", "text": "Slightly sore arm and mild body aches after COVID vaccination. I felt a bit off for the first day. Fine the next morning.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_020", "text": "Low-grade fever on the evening after my second COVID dose. I took paracetamol and was fine by the next morning. No other issues.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_021", "text": "Mild headache and low-grade fever for two days after yellow fever vaccination. It went away on its own. The doctor confirmed it was a normal vaccine response.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_022", "text": "I felt tired and had a sore arm after the yellow fever jab. Took paracetamol and was fine the next day. Nothing unusual beyond mild expected effects.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_023", "text": "Soreness at the meningococcal injection site for about two days. Nothing serious — the nurse said it was normal and it passed quickly.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_024", "text": "Mild fever after the meningococcal vaccine. Took paracetamol and was fine by the second day. All readings were normal at follow-up.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_025", "text": "My daughter had a sore arm and felt tired after her first HPV vaccine dose. She was fine the next morning. The nurse said it was expected.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_026", "text": "Mild headache and slight dizziness after HPV vaccination. She sat down and it passed within twenty minutes. Nurse said it was fine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_027", "text": "Baby was slightly fussy after OPV drops. He fed well and settled within a few hours. No fever, no unusual crying. All normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_028", "text": "My son cried briefly after the oral polio vaccine but settled quickly. No fever, no rash. The nurse confirmed it was nothing to worry about.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_029", "text": "My son had a cough and runny nose after the pentavalent vaccination. The doctor said the whole family had been sick with the same thing — coincidental URTI, not from the vaccine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_030", "text": "My child developed a rash all over her body after the measles vaccine. The doctor examined her and said it looks like actual measles from a coincidental exposure — the vaccine cannot cause measles rash this quickly.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_031", "text": "I developed a cough and fever two days after my COVID vaccine. My husband and two colleagues had the exact same illness that week — we all had flu. Not from the vaccine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_032", "text": "Baby had diarrhoea after the vaccination visit. The health worker checked and found that three other children in the compound had the same — it was a community gastroenteritis.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_033", "text": "I felt fine after the BCG vaccination. Just a small pain where the needle went. The nurse said everything was completely normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_034", "text": "No vomiting, no diarrhoea, no unusual crying after the vaccination. The nurse checked the baby thoroughly. Routine follow-up — all normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_035", "text": "I felt completely fine after the COVID vaccine. Just a small pain where the needle went. Nothing else at all. The nurse said my response was excellent.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_036", "text": "No rash, no fever, no unusual crying after the hexavalent shot. The nurse checked the baby and said all was well. Normal expected follow-up.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_037", "text": "I felt fine. Just a small pain where the needle went for one day. The health worker confirmed it was a normal mild reaction below the AEFI reporting threshold.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_038", "text": "The child was unsettled for a few hours after the artesunate injection. She settled and was fine by the next morning. Nurse said it was expected.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_039", "text": "Minor fever for one day after the artesunate injection for malaria. Took paracetamol and was fine by the second day. Health worker said all was normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_040", "text": "Baby felt warm but not feverish after the pentavalent injection. She fed normally and slept well. Nothing serious — it passed on its own.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_041", "text": "Tiny lump at BCG injection site after two weeks — health worker said it was expected BCG response and it resolved on its own over four weeks.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_042", "text": "Mild chills and body aches the evening after COVID vaccination. Took paracetamol and felt fine by the next morning. No serious symptoms.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_043", "text": "I felt a bit off on day two after yellow fever vaccination — mild headache and tiredness. It went away on its own by day three.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_044", "text": "Sore arm and mild headache after second HPV dose. It was fine the next morning. The nurse confirmed it was within the normal expected range.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_045", "text": "Mild redness and warmth at the injection site after meningococcal vaccine. It went away on its own within three days. All normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_046", "text": "Baby passed one loose stool after rotavirus drops. No fever, no other symptoms. The nurse said it was an expected minor response. All normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_047", "text": "Slight fever of 37.6°C after MR vaccine. Took paracetamol and was fine by the next morning. Midwife told me it was normal and expected.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_048", "text": "My daughter cried after the injection but was consolable. She slept normally and woke up fine. Nothing concerning. All checks normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_049", "text": "Mild swelling at the hexavalent injection site. It was sore for two days then nothing serious. All readings were normal at follow-up.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_050", "text": "Fatigue and mild muscle aches on day one after COVID vaccination. I rested and was completely fine by day two. Normal vaccine response.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_051", "text": "Small scab forming at BCG injection site at two weeks — health worker confirmed this is the expected BCG response and not an adverse event.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_052", "text": "Low-grade fever of 37.9°C after pentavalent vaccine. Gave paracetamol syrup and baby was fine by the next morning. Nurse confirmed it was expected.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_053", "text": "Mild injection site pain after yellow fever vaccine. It was fine the next morning. Health worker said it was completely normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_054", "text": "Swollen lymph node under my arm after COVID vaccine on that side. Doctor said this is a known expected reaction that resolves on its own within weeks.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_055", "text": "My daughter fainted briefly immediately after the HPV vaccination. She recovered in two minutes. Nurse said vasovagal syncope is expected — she was observed and discharged normally.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_056", "text": "Headache for one day after meningococcal vaccine. I took paracetamol and was fine the next day. The nurse said it was within expected effects.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_057", "text": "Baby was unsettled for one evening after the vaccination. She slept normally and was fine by morning. Nothing serious and all checks normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_058", "text": "I had a slightly sore arm for two days after my COVID booster. Nothing else. The pharmacist said it was completely within the expected response range.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_059", "text": "The baby was slightly warm but not feverish after BCG. She fed well and slept through. Fine the next morning. Nurse told us it was normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_060", "text": "Minor fussiness after hexavalent vaccination. Baby settled when held and was normal by the next morning. No fever, no rash, no vomiting. All normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_061", "text": "Mild shivering after the artesunate injection — the nurse said it was expected and it passed within fifteen minutes. No further problems.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_062", "text": "Baby had very soft stool once after the rotavirus drops. No other symptoms. Health worker said this is expected. All fine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_063", "text": "Baby cried briefly after the oral polio drops but was consoled quickly. No fever, no rash. All normal at follow-up. Nothing concerning.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_064", "text": "Low-grade fever after MR vaccination — temperature 37.7°C. Took paracetamol and was fine by the next morning. Nurse confirmed it was a normal vaccine response.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_065", "text": "The injection site was red and slightly swollen for one day after pentavalent vaccine. It was nothing serious and went away on its own. Nurse confirmed normal reaction.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_066", "text": "Second COVID dose caused mild fatigue and chills that evening. Paracetamol helped and I was fully normal by morning. Health worker said it was expected.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_067", "text": "My daughter had a mild headache for one day after her HPV booster. She took paracetamol and was fine by the next morning. All normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_068", "text": "Slight redness at injection site after meningococcal vaccine. It resolved on its own within two days. Nothing else — all checks were normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_069", "text": "BCG reaction at six weeks — small pustule forming at the site. Health worker confirmed this is the expected BCG response and should not be reported as an adverse event.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_nonadr_070", "text": "After the pentavalent shot, my baby had mild fever and was fussy. I gave paracetamol syrup and she was fine by the next morning. Nurse said it was normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_001", "text": "After the pentavalent vaccination my baby went limp — completely floppy and not responding normally. Temperature was 40.1°C. We rushed to hospital. Doctor said it was a hypotonic hyporesponsive episode from the vaccine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_002", "text": "The baby had convulsions within three hours of the pentavalent vaccine — full tonic-clonic seizure lasting five minutes. Admitted to hospital. Serious AEFI confirmed.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_003", "text": "Extensive swelling and pus at the BCG injection site spreading beyond 3 cm — the health worker said this was an extensive local reaction requiring medical review. Not the normal BCG response.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_004", "text": "The BCG injection site became a large abscess after two months. The baby was brought to the clinic and the doctor confirmed it was a serious BCG injection site reaction requiring incision and drainage.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_005", "text": "My sister's eyes became yellow two days after the yellow fever vaccination and she developed severe liver pain and high fever. Doctor said it was yellow fever vaccine-associated viscerotropic disease — a very serious reaction.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_006", "text": "My son developed severe encephalitis one week after the measles-rubella vaccination — high fever, seizures, and altered consciousness. Admitted to neurological ward. Serious AEFI.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_007", "text": "The baby received pentavalent vaccine then three hours later the arm became massively swollen from shoulder to wrist and she was screaming in pain. Brought to emergency — serious local reaction.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_008", "text": "I developed sudden difficulty breathing and my face swelled within thirty minutes of the COVID vaccine. The nurse gave me adrenaline injection immediately. Confirmed anaphylaxis from the vaccine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_009", "text": "I collapsed on the way out of the vaccination centre after my COVID shot. I woke up on the floor with nurses around me. They said it was a vasovagal syncope with loss of consciousness — I was observed for one hour before discharge.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_010", "text": "My baby passed red jelly-like material in his nappy two days after the rotavirus vaccine and cried non-stop with his legs drawn up. Doctor diagnosed intussusception — emergency surgery performed.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_011", "text": "My child developed weakness in one leg six weeks after the oral polio drops. The weakness got worse over two weeks and she cannot walk now. Doctors said it may be vaccine-derived poliovirus paralysis.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_012", "text": "Baby was inconsolably crying for more than three hours after the pentavalent injection — high-pitched cry that we could not settle. She was admitted overnight. Persistent crying AEFI confirmed.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_013", "text": "Within minutes of the COVID vaccine I developed hives all over my body, throat tightening, and my blood pressure dropped. Treated with adrenaline in clinic — anaphylactic reaction to vaccine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_014", "text": "Three hours after the hexavalent vaccine my baby became very pale, floppy, and unresponsive with a weak pulse. Emergency admission — doctor diagnosed hypotonic hyporesponsive episode. Serious AEFI report filed.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_015", "text": "The patient developed progressive liver failure with jaundice and coagulopathy ten days after yellow fever vaccination. ICU admission required. Yellow fever vaccine-associated viscerotropic disease confirmed.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_016", "text": "The baby developed generalised BCG disease with widespread lymph node swelling and fever. The immunologist confirmed BCG dissemination due to underlying immune deficiency. Serious AEFI.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_017", "text": "High fever of 40.5°C and a generalised seizure eight days after measles vaccine. Child admitted to paediatric ward. Doctor confirmed febrile seizure as serious AEFI.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_018", "text": "The baby's arm swelled to twice its size within an hour of the pentavalent injection with red streaks going up the arm. Emergency admission — doctor treated serious injection site infection.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_019", "text": "I developed chest pain and shortness of breath three days after my COVID-19 booster. ECG and troponin confirmed myocarditis. Cardiologist confirmed vaccine-associated myocarditis — serious AEFI.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p6_aefi_adr_020", "text": "My daughter collapsed immediately after the HPV vaccine — not vasovagal, she had a tonic-clonic seizure lasting two minutes. Admitted for observation. Neurologist assessed as serious AEFI.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_001", "text": "08:45 Oxytocin infusion started per protocol. 09:30 — hyperstimulation noted: more than five contractions in ten minutes. FHR decelerations on CTG — late decelerations. Infusion stopped immediately. Paediatrician alerted. Assessed as oxytocin-induced hyperstimulation.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_002", "text": "Uterine tachysystole following oxytocin: six contractions in ten minutes with fetal bradycardia on trace. CTG Category III. Oxytocin ceased, repositioned left lateral, oxygen given. Obstetric registrar called. ADR — uterine hyperstimulation.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_003", "text": "16:00 — Misoprostol 25mcg administered per cervical ripening protocol. 18:30 — tetanic contraction lasting 3 minutes with severe fetal bradycardia to 80 bpm. Emergency LSCS performed for fetal distress. Misoprostol-induced uterine hyperstimulation confirmed.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_004", "text": "Patient received misoprostol for induction of labour. Subsequently developed uterine rupture with sudden loss of FHR on CTG and severe abdominal pain. Laparotomy performed. Causality assessment: probable misoprostol ADR.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_005", "text": "MgSO4 infusion for eclampsia prophylaxis. Urinary output fell to 15 ml/hour and respiratory rate 8/min with loss of patellar reflexes — signs of magnesium toxicity. Infusion stopped, calcium gluconate administered. Confirmed MgSO4 overdose reaction.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_006", "text": "Midwife note 14:20: uterine hyperstimulation with prolonged contraction five minutes duration. FHR showing variable decelerations with poor recovery. Oxytocin rate reduced and tocolysis requested. Reaction to oxytocin — documented as intrapartum ADR.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_007", "text": "She was having fits after the traditional birth attendant gave her something to speed up the labour. Her blood pressure was very high and she lost consciousness. She was rushed to the health centre — they said the traditional medicine caused the problem.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_008", "text": "TBA gave the woman herbal medicine to hasten delivery. Contractions became continuous and the baby's heartbeat became very weak. The TBA brought her in. Doctor said the traditional medicine caused uterine hyperstimulation.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_009", "text": "The traditional medicine man gave her something to drink for the delivery. After that she had very strong non-stop pain and the baby could not come. Health worker said it was an abnormal contraction from the traditional drug.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_010", "text": "Patient administered pethidine for postpartum pain. Developed marked dysphoria and depersonalisation — reported feeling she was watching herself from outside. 'I am not in my own body' — she was terrified. Opioid-induced dysphoric reaction confirmed.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_011", "text": "Two weeks postpartum on methyldopa for chronic hypertension. Presenting with persistent low mood, psychomotor slowing, flat affect and inability to bond with baby. Psychiatry reviewed — methyldopa-induced depressive syndrome.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_012", "text": "Patient post-caesarean on morphine PCA. At 36 hours she became acutely confused and reported seeing people in the room who were not there. Opioid-induced delirium confirmed — morphine dose reduced and haloperidol administered.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_013", "text": "Postpartum patient — thought the baby had been replaced by another baby. Confused, agitated and suspicious. After pethidine injection for pain. Opioid-induced psychosis assessed and antipsychotic medication started.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_014", "text": "Week three postpartum. Patient on methyldopa for pre-eclampsia. Presenting with severe postpartum depression and suicidal ideation. Psychiatrist consulted and confirmed methyldopa as contributing factor. Drug switched.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_015", "text": "My belle dey pain me too much — like fire inside — since dem put the drip for my hand for speed up the delivery. The pain no stop at all, it continuous.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_016", "text": "After dem put the misoprostol tablet for ripen my womb, pain dey come one after another without stopping — no rest between. Midwife say contraction too too much from the tablet.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_017", "text": "Since dem start the injection to bring the labour, my womb never rest at all — pain constant. Midwife check baby heartbeat and run call doctor — she say na the drip cause problem for baby.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_018", "text": "After I drink the something the TBA give me, my belly start pain like I go burst. Baby heartbeat go down and dem take me hospital emergency — doctor say na the local medicine cause am.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_019", "text": "After the MgSO4 drip start, I no fit breathe well and my legs go heavy — reflex check show nothing. Nurse say magnesium too high in blood — drip stop and dem give me injection to reverse.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_adr_020", "text": "After the pethidine injection everything feel unreal — like say I watching myself from far away, I no dey in my body. This na not normal feeling from pain medicine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_001", "text": "Oxytocin infusion commenced at 08:00 for augmentation of labour. Contractions three in ten minutes, well-tolerated. FHR baseline 140 bpm, reactive. Progress normal. No adverse event noted. Delivery at 15:30 — good outcome.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_002", "text": "Labour augmented with oxytocin — contractions established at four in ten minutes with good FHR variability throughout. Patient tolerated the infusion well with no adverse effects. Normal vaginal delivery achieved.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_003", "text": "Misoprostol 25 mcg administered for cervical ripening. Mild cervical cramping for twenty minutes — midwife informed patient this was expected. Contractions established normally thereafter. Uncomplicated progress.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_004", "text": "I felt cold briefly after the misoprostol tablet but it passed quickly. The midwife told me it was expected. Baby moving normally after. Everything went fine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_005", "text": "MgSO4 infusion for eclampsia prophylaxis. Reflexes were checked every hour as instructed. Urinary output satisfactory at 50 ml/hour. Respiratory rate 16/min. No signs of toxicity throughout infusion.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_006", "text": "Patient on MgSO4 — 4g loading dose then 1g/hour maintenance. Hourly monitoring of reflexes, urine output and respiratory rate all within normal parameters. Uneventful antenatal monitoring. No adverse event.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_007", "text": "Post-delivery oxytocin 10 units IM administered. Patient was cold and shaky for ten minutes — the midwife told her it was normal and it passed within ten minutes. Uterus well-contracted. Observation complete, discharged.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_008", "text": "Routine post-partum Syntocinon injection. Mild shivering noted — midwife confirmed this is expected and it resolved spontaneously within fifteen minutes. Post-partum check satisfactory.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_009", "text": "I have been taking my iron every day in pregnancy. I feel well and my energy is better than before. Doctor checked and everything is fine with me and the baby.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_010", "text": "Pregnant patient on ferrous sulphate and folic acid. Mild constipation on day two — health worker advised high fibre diet and it resolved. No ADR, drug continued. Baby scan normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_011", "text": "I had some nausea in the first two days of malaria treatment but it settled after I took the tablet with food. Baby has been moving normally throughout. No adverse event.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_012", "text": "Maternal treatment with artemether-lumefantrine for uncomplicated malaria in second trimester. Nausea mild and resolved by day three. Fetal movements normal throughout. Outcome: healthy delivery.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_013", "text": "Patient on methyldopa 250mg TDS for gestational hypertension. Blood pressure well-controlled. No symptoms of depression or slowing noted at follow-up. Patient coping well. Drug continued.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_014", "text": "Inpatient blood pressure management with labetalol IV. BP responded well. Patient reported mild tiredness which is expected from the drug. No chest pain, no dyspnoea. Normal fetal monitoring. Discharged stable.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_015", "text": "I took the antibiotic for the infection in pregnancy and I had no side effect at all. Baby moving well and scan showed normal development.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_016", "text": "Patient on co-trimoxazole prophylaxis in pregnancy — no allergic reaction, no rash. Full blood count normal. Baby at twenty weeks scan — normal anatomy. Drug continued without issue.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_017", "text": "The traditional birth attendant said the mother had a normal delivery at home with no complications. She did not give any traditional medicine. Both mother and baby are well.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_018", "text": "Community midwife report: uncomplicated home delivery. No uterotonics administered by TBA. Mother and baby healthy. No adverse event to report.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_019", "text": "Two weeks postpartum on ferrous sulphate for anaemia. Patient reports feeling well and bonding with the baby normally. No mood changes. Iron levels improving on repeat blood test.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p7_obstetric_nonadr_020", "text": "Postpartum iron supplementation — patient tolerating well, energy improving, no gastrointestinal side effects. Baby breastfeeding normally. No adverse event.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_adr_001", "text": "The scan shows the baby has not developed normally since I started taking the drug at twelve weeks pregnant. The doctor thinks it is from the artemisinin I took in the first trimester.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_adr_002", "text": "The ultrasound found that the baby had not developed normally and the doctor said it may be from the artemisinin medication I was given before I knew I was pregnant.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_adr_003", "text": "My baby was born with bone problems — the doctor said it was because I was taking methotrexate before we knew about the pregnancy. The drug affected the baby's development.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_adr_004", "text": "My child has a cleft lip and learning problems. The neurologist said it is fetal phenytoin syndrome from the epilepsy drug I was on throughout pregnancy before they switched me.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_adr_005", "text": "The baby was born with the warfarin embryopathy — the rheumatologist confirmed that the nose bone and bone development problems are from the blood thinner I took in the first trimester.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_adr_006", "text": "My baby's skin turned yellow in the first week — the doctor said it is because of the co-trimoxazole I was taking during pregnancy. The drug caused the baby's jaundice.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_adr_007", "text": "The baby has jaundice and the neonatologist told me it is from the medicine I was on during pregnancy — the co-trimoxazole. My baby has a G6PD deficiency and the drug triggered the jaundice.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_adr_008", "text": "My baby was born and started shaking on day two. The doctor said it is neonatal withdrawal from the isoniazid — the anti-TB drug I was on throughout pregnancy. The baby needed treatment.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_adr_009", "text": "My newborn was very floppy and could not suck well. The neonatal team said it was because of the diazepam I was given before delivery — the baby had neonatal sedation syndrome.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_adr_010", "text": "My baby was born not breathing well — very slow breathing and could not cry. The midwife said it was because I had pethidine for pain before delivery and it crossed to the baby. They gave the baby an antidote injection.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_nonadr_001", "text": "I have been on ferrous sulphate and folic acid throughout the pregnancy. The scan at twenty weeks showed completely normal baby development. No concerns.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_nonadr_002", "text": "Patient on methyldopa for gestational hypertension throughout pregnancy. Anatomy scan at twenty weeks — all structures normal. No evidence of drug effect on fetal development.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_nonadr_003", "text": "I was on labetalol for blood pressure in pregnancy. All my baby scans were normal and my baby was born healthy with good APGAR scores. No problems at all.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_nonadr_004", "text": "I took amoxicillin for a urine infection in the second trimester. Baby scan was normal and delivery was uncomplicated. Baby is fine and developing normally.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_nonadr_005", "text": "My baby has jaundice but the paediatrician confirmed it is normal physiological jaundice — nothing to do with the iron tablets I was taking. The bilirubin is coming down with phototherapy.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_nonadr_006", "text": "The baby has mild jaundice but the neonatologist tested for G6PD and it was normal. The jaundice is physiological — not related to the co-trimoxazole I took. Baby is fine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_nonadr_007", "text": "My baby was born with Down syndrome. The geneticist confirmed it is a chromosomal condition — completely unrelated to any medication I took during pregnancy.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_nonadr_008", "text": "The baby has a heart defect that was found on the antenatal scan. The cardiologist explained it is a structural defect that developed before eight weeks and is unrelated to any drug I took.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_nonadr_009", "text": "My newborn had some breathing difficulty in the first minutes after birth. The neonatologist said it was normal transitional breathing and confirmed no drug exposure caused it. Baby is now well.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p8_fetal_nonadr_010", "text": "Baby was born healthy with APGAR 9 at 1 minute and 10 at 5 minutes. No jaundice, no feeding problems. I was only on folic acid and iron throughout — no adverse effect on the baby.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_001", "text": "My tummy hurts a lot since I started taking the medicine. I feel like vomiting after every tablet. Mummy says I have to take it but it makes me feel yucky.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_002", "text": "My tummy hurts and I feel sick every time I take the white tablet. I told my mummy and she said I should tell the nurse.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_003", "text": "The malaria medicine makes me feel bad inside my tummy. I want to vomit after I take it and my head hurts a lot.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_004", "text": "After I take the antibiotic tablet my tummy hurts so much I cannot sleep. Mummy had to rub my tummy and I still felt sick. I don't want to take it anymore.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_005", "text": "I am having a bad rash all over my body since I started the white tablet. It is itchy and I am scratching all the time. Mummy took me to the clinic.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_006", "text": "Since they gave me the injection for malaria I feel dizzy and my head is paining me plenty. I cannot go to school.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_007", "text": "I feel like there is something turning in my tummy after I take the malaria tablet. I vomited two times. My teacher sent me home.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_008", "text": "My skin got spots all over since I started taking the tablet. I showed teacher and she said I should go to the nurse. It is itchy everywhere.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_009", "text": "I have been drinking a lot of water since I started the diabetes tablet. I thought maybe it was because I was not drinking enough water before. But I am drinking plenty now and still thirsty.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_010", "text": "My hair is falling out since I started the new epilepsy tablet. I told my mum but she said maybe it's just stress from school. But it's a lot of hair and it started exactly when I started the medicine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_011", "text": "Since I started the acne tablet my lips are very dry and cracked and my skin peels all the time. I thought it was the dry harmattan weather but it started when I started the drug.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_012", "text": "I have been passing urine so many times since I started the diabetes medicine — even at night. My friend said maybe I am drinking too much water. But I am not — the medicine is making me pass too much water.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_013", "text": "I am sensitive to the sun since I started the antibiotic. I got a bad sunburn reaction on my face even from a short walk outside. It started with the drug.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_014", "text": "Since my doctor started me on this new blood pressure tablet last month, my ankles have been swelling badly. I can no longer wear my church shoes. My daughter says it is the new medicine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_015", "text": "Since I started the cholesterol tablet I have terrible muscle pain in my thighs and calves. I cannot climb the stairs properly anymore. My children say it started with the new tablet.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_016", "text": "I am having bad loose stool multiple times a day since I started the diabetes medicine. I am eighty years old and this has never happened to me before. It is the tablet causing it.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_017", "text": "My legs are very heavy and swollen since the new blood pressure medicine was started. I had to buy bigger shoes. At my age this is embarrassing and I know it is the tablet.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_018", "text": "Since they gave me the new heart tablet my head feels heavy and I am slow — I cannot think clearly. My children say I am not myself since the new medicine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_019", "text": "After tablet. My head. Pain too much. I no fit work. I go toilet plenty. Since I start the medicine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_020", "text": "Start tablet. Three days. Legs. Hands. Dey pain me. Numbness. I go hospital. Doctor say na the TB medicine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_021", "text": "After. Antibiotic. My belly. Too much. Run toilet many times. Vomit also. Since start drug.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_022", "text": "I start the HIV tablet. Night. Bad dreams. No fit sleep. Wake up plenty. Na the efavirenz. Doctor say.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_023", "text": "Sugar tablet. Start it. Now stomach. Pain. Plenty. Loose stool. Every morning. Since tablet start.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_adr_024", "text": "Take the white tablet. Two days. Skin come out. Rash everywhere. Itching plenty. Na the tablet.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_001", "text": "My daughter had a tummy ache before I started giving her the antibiotic — it was there from the stomach infection. The doctor said the drug is fine and the pain is from the illness, not the medicine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_002", "text": "The child had a rash before we started the co-trimoxazole — the nurse confirmed it was from the food allergy that was already there. The medicine did not cause it.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_003", "text": "My son said his tummy hurt but the doctor checked and said it was from the malaria itself. The medicine is fine — no side effect.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_004", "text": "My daughter felt a bit nauseous but the doctor said it was from the throat infection, not the antibiotic. She finished the course and is now fine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_005", "text": "My child was dizzy but the doctor confirmed it was from the fever itself, not from the injection. After the fever came down the dizziness stopped.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_006", "text": "My daughter has been well on the diabetes tablet. No excessive thirst, no unusual urination. She plays sports normally and says she has no complaints from the medicine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_007", "text": "My son started the epilepsy tablet three months ago. No hair loss, no side effects. He is doing well at school and his seizures are controlled.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_008", "text": "I have been on the antibiotic for two weeks with no sun sensitivity or skin reaction. I go outside normally and have no complaints from the drug.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_009", "text": "My daughter has been on the acne treatment for one month. No severe dryness, no mood changes. She is tolerating it well and the acne is improving.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_010", "text": "I am taking the diabetes medicine and passing urine normally — not more than before. Doctor checked my kidneys and they are fine. No problem from the tablet.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_011", "text": "I have been on the new blood pressure tablet for three months. No new problems with the medication. My ankles are fine and I sleep well. My daughter says I am back to my old self.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_012", "text": "I started the cholesterol tablet six weeks ago. No muscle pain, no weakness. I walk to the market normally and have no complaints from the new medicine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_013", "text": "The diabetes tablet has not caused me any problems. No diarrhoea, no nausea. I am eighty and I am tolerating it well. Doctor says my sugar is well-controlled.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_014", "text": "I have been on the heart tablet for six months. No dizziness, no slowing of my thinking. My family says I am sharp as ever. No new problems with this medicine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_015", "text": "My legs are not swelling since I started the blood pressure tablet. I can still wear my normal shoes. No new problems — the medicine is agreeing with me.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_016", "text": "Take tablet. Feel fine. No problem. Finish treatment. All good.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_017", "text": "TB medicine. Take every day. No pain. Legs fine. Hands fine. All normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_018", "text": "Antibiotic. Take it. No problem. Belly fine. No vomiting. All fine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_019", "text": "HIV tablet. Take it. Sleep normal. No bad dream. Fine. Three months. No problem.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_020", "text": "Sugar tablet. Take every day. Stomach fine. No loose stool. All normal.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_021", "text": "My child took the full course of co-trimoxazole and had no reaction at all. No rash, no fever. Doctor confirmed the drug was well tolerated.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_022", "text": "My son finished the full antibiotic course without any side effect. He said his tummy was fine the whole time. No problems at all.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_023", "text": "My daughter completed malaria treatment with no side effects. No vomiting, no dizziness. She was back at school within three days.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_024", "text": "I am a sixteen-year-old girl taking iron tablets for anaemia. I have no side effects — no constipation, no nausea. My haemoglobin is improving.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p10_age_nonadr_025", "text": "I am a teenage girl on valproate for epilepsy. I have no hair loss, no weight gain. Periods are regular. I am tolerating the drug well.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_001", "text": "Discharge Summary. Diagnosis: Acute allergic reaction secondary to co-trimoxazole. Presentation: urticaria, angioedema, and stridor. Management: adrenaline IM, antihistamine, steroids. Drug permanently discontinued.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_002", "text": "Discharge Summary. Principal diagnosis: gentamicin-induced acute kidney injury. Creatinine on admission 95 μmol/L; peak creatinine on day 4: 380 μmol/L. Gentamicin held. Renal function recovering at discharge.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_003", "text": "Discharge Summary — Impression: Drug-induced lupus syndrome most likely attributable to hydralazine. ANA positive, anti-histone antibodies positive. Hydralazine ceased. Commenced hydroxychloroquine. Rheumatology review arranged.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_004", "text": "Discharge Summary. Principal diagnosis: isoniazid-induced peripheral neuropathy. Patient on TB therapy for four months. Tingling and numbness in both feet. Pyridoxine 50mg added; isoniazid dose reduced. Neurology follow-up.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_005", "text": "Discharge Summary — Diagnosis: methotrexate-induced hepatotoxicity. LFTs on admission: ALT 480 U/L (12× ULN). Methotrexate held. LFTs improving at discharge: ALT 95 U/L. Gastroenterology review for further management.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_006", "text": "Discharge Summary. Diagnosis: efavirenz-induced neuropsychiatric syndrome. Patient presented with acute psychosis, hallucinations, and aggression. Efavirenz substituted to dolutegravir. Psychiatry inpatient review completed. Improved on discharge.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_007", "text": "D/C Summary — Allergic reaction secondary to co-trimoxazole: drug withdrawn D1. Urticaria and angioedema resolved after two days antihistamine. Discharged with drug allergy alert documented. Co-trimoxazole contraindicated.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_008", "text": "Discharge Summary. Principal diagnosis: Drug-induced cholestatic hepatitis secondary to rifampicin. Jaundice on D7 of TB therapy. Bili 180 μmol/L. Rifampicin withheld. LFTs normalising. Sequential reintroduction planned.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_009", "text": "DAR 09:45 — Patient on metronidazole 400mg TDS. Reported nausea at 14:30 and vomiting x2 at 15:10. Observations: T37.2, BP 110/70. Dr [initials] notified 15:15. Metronidazole dose reviewed; anti-emetic prescribed. 18:00 — patient settled.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_010", "text": "Nursing note 06:00: Patient reports tingling and burning pain in both hands and feet. Started on isoniazid four weeks ago. New complaint — not present on previous shift. Reported to medical team. Pyridoxine prescribed 06:30.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_011", "text": "DAR 11:30: IV quinine infusion running. Patient developed tinnitus and reported visual blurring at 12:00. Quinine rate reduced per protocol. Medical team notified. 14:00: symptoms improved. Cinchonism documented.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_012", "text": "22:15 — Patient developed generalised urticaria within 30 minutes of first ampicillin IV dose. Infusion stopped immediately. Adrenaline 0.5mg IM given. Antihistamine IV. Dr called stat. Drug allergy confirmed.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_013", "text": "Ward round — Day 3. Patient on haloperidol 5mg IM. Overnight: involuntary jaw movements and lip smacking since 0600 hours. Nurse reported rhythmic facial movements. Extrapyramidal reaction. Haloperidol dose reduced, procyclidine added.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_014", "text": "Ward round — D2 chlorpromazine. Patient holding head fixed upward, unable to look down, neck extended. Eyes deviated upward. Diagnosed oculogyric crisis. Biperiden given IM with resolution. Drug dose adjusted.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_015", "text": "Ward round. Patient five weeks post TB treatment commencement. New complaint: numbness hands and feet since one week. Examination: stocking-glove sensory loss. Impression: isoniazid-induced peripheral neuropathy. Pyridoxine added.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_016", "text": "Ward round D5. Gentamicin continued for sepsis. Creatinine today 290 μmol/L (was 95 μmol/L on admission). Drug nephrotoxicity suspected. Drug level sent. Nephrology review requested. Gentamicin held pending result.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_017", "text": "Impression: clinical picture consistent with drug-induced systemic lupus erythematosus. Most likely attributable to hydralazine commenced eight months ago. ANA 1:320, anti-histone antibody positive. Causality: probable.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_018", "text": "Impression: Drug-induced hepatotoxicity most likely secondary to isoniazid. ALT 420 U/L at week six of TB treatment. Patient symptomatic with nausea and right upper quadrant pain. Drug held pending liver biopsy result.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_019", "text": "Impression: Efavirenz-induced neuropsychiatric toxicity. Patient commenced efavirenz eight weeks ago and presenting with vivid nightmares, disorientation, and aggression. Causality: probable. Switch to dolutegravir recommended.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_adr_020", "text": "Impression: Adverse drug reaction secondary to co-trimoxazole. Presentation: Stevens-Johnson syndrome, target lesions on trunk and oral mucosal involvement. SCORTEN score calculated. Dermatology review requested. Drug permanently contraindicated.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_001", "text": "Discharge Summary. Diagnosis: community-acquired pneumonia. Treatment: amoxicillin-clavulanate. Patient completed seven-day course without any adverse drug reaction. Discharged well. No drug allergy documented.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_002", "text": "Discharge Summary. Patient completed initial two months of TB therapy (HRZE). No drug reaction recorded. LFTs monitored — within normal limits throughout. Discharged to outpatient follow-up. Continuing treatment.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_003", "text": "Discharge Summary. Type 2 diabetes mellitus. Metformin commenced during admission. Well tolerated. No hypoglycaemia, no lactic acidosis risk factors. Patient educated on drug. Discharged on metformin 500mg BD.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_004", "text": "Discharge Summary. HIV — started co-trimoxazole prophylaxis during admission. No allergic reaction. No rash. Discharge with prophylaxis confirmed. Patient counselled.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_005", "text": "Discharge Summary. Hypertension. New antihypertensive started — amlodipine 5mg OD. BP well controlled. No ankle oedema, no headache. Patient tolerating drug well. Discharged.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_006", "text": "DAR 08:00 — Patient on ferrous sulphate. Reports mild constipation. Health worker advised high fibre diet and fluids. No nausea, no pain. Normal bowel motion expected. Drug continued.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_007", "text": "Nursing note: Day 3 oral amoxicillin for wound infection. No signs of allergic reaction. Wound healing well. Patient afebrile. No adverse effects documented. Continue as prescribed.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_008", "text": "Nursing note 09:00: Patient on TB therapy, month four. No new complaints. LFTs checked this week — normal. Patient reports no tingling or numbness. Continue current regimen.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_009", "text": "DAR 10:30 — Patient received IV metronidazole for abdominal infection. No nausea, no vomiting. Patient comfortable. Obs stable: T37.1, BP 120/78. Infusion completed without incident. Continue as charted.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_010", "text": "Nursing note 14:00: Patient on co-trimoxazole day 5. No rash observed. Patient feels well. No itching, no fever. Drug tolerated without adverse effect. Continue as prescribed.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_011", "text": "Ward round D30 of TB therapy. Patient well. No peripheral neuropathy symptoms. LFTs reviewed — within normal range. Compliance confirmed. No side effects reported. Continue first-line TB treatment.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_012", "text": "Ward round. Diabetes management review. Metformin 1g BD — well tolerated. No diarrhoea, no nausea. HbA1c improving. Renal function normal. Continue current regimen.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_013", "text": "Ward round. Patient on amlodipine for six months. BP at target. No ankle oedema, no headache. Heart rate normal. Drug well tolerated. Continue.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_014", "text": "Ward round. HIV review — patient on efavirenz-based regimen. Viral load suppressed. No neuropsychiatric symptoms reported. Sleep normal. Patient happy with regimen. Continue.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_015", "text": "Ward round. Day 3 co-trimoxazole for Pneumocystis prophylaxis. No rash, no fever, no nausea. FBC normal. G6PD normal. Drug well tolerated. Continue as planned.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_016", "text": "Impression: uncomplicated community pneumonia responding well to amoxicillin. No drug adverse effects. Patient improving clinically. Continue antibiotic for full seven-day course.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_017", "text": "Impression: type 2 diabetes mellitus with good glycaemic control on metformin. No evidence of lactic acidosis risk. Renal function normal. Continue metformin.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_018", "text": "Impression: TB treatment progressing well. No drug-induced hepatotoxicity or peripheral neuropathy. Patient compliant and tolerating all four drugs without adverse effect.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_019", "text": "Impression: essential hypertension, well controlled on amlodipine monotherapy. No adverse drug effects. Continue current management.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p11_clinical_nonadr_020", "text": "Impression: HIV — co-trimoxazole prophylaxis well tolerated. No allergic reaction documented after three months. Continue prophylaxis per guidelines.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_adr_001", "text": "Since I started the blood pressure medicine I am having problems with my manhood. I cannot perform as a man should and my wife is not happy. I know it is the tablet causing it.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_adr_002", "text": "Since the doctor gave me this blood pressure tablet my man-power has gone down. I struggle to satisfy my wife. I did not have this problem before the medicine.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_adr_003", "text": "Since starting spironolactone my breasts are growing and I feel shame in front of my colleagues. I am a man and this is not right. It started exactly when the drug was started.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_adr_004", "text": "The stomach tablet has caused me problems in the bedroom. I cannot function as a man since I started it. My wife has noticed and I am embarrassed. It is the drug.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_adr_005", "text": "Since they gave me the injection for nausea, my breasts are tender and swollen. As a man this is very embarrassing. The doctor said it is from the injection.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_adr_006", "text": "Since starting the psychiatric tablet I have no interest in my wife at all. My manhood does not work. I told the doctor and he confirmed it is from the haloperidol.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_adr_007", "text": "The heart tablet has affected my ability to perform in the bedroom. I have problems with erection since I started metoprolol. This never happened before.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_adr_008", "text": "Since I started the prostate tablet my interest in my wife has gone completely. I cannot perform and I told my doctor — he said it is a known side effect of the drug.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_adr_009", "text": "I am ashamed to say it but since spironolactone, my chest is swollen and I cannot have relations with my wife. As a man in Ghana this is very difficult to live with.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_adr_010", "text": "I told my pharmacist that since the blood pressure tablet, I have been unable to be a man for my wife. He said this is a side effect and I should discuss with my doctor about changing the drug.", "label": 1, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_nonadr_001", "text": "I have been on the blood pressure tablet for six months and I have no problems in the bedroom. My manhood is working normally and my wife is satisfied. No side effect.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_nonadr_002", "text": "I discussed concerns about the heart tablet with my doctor. He checked and confirmed that my problems in the bedroom are from my age and diabetes — not from the atenolol. The drug is fine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_nonadr_003", "text": "I have been on spironolactone for three months. No breast swelling, no changes in my manhood. I am tolerating the drug well and my wife says I am fine.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_nonadr_004", "text": "My doctor told me that the problem with my manhood started before I was put on the heart tablet. My blood sugar has been high for years and that is the cause — not the metoprolol.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_nonadr_005", "text": "I told the doctor about my concerns but he examined me and said my problem in the bedroom is from the depression itself, not from the haloperidol tablet. The drug is not the cause.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_nonadr_006", "text": "I have had problems with my manhood since long before the blood pressure medicine. I was checked by the urologist and he confirmed it is vascular — the amlodipine is not the cause.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_nonadr_007", "text": "I am on atenolol for my heart and I have no problems at all in the bedroom. I perform normally as a man. The drug has not affected me in that way.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_nonadr_008", "text": "I finished the stomach treatment and my manhood is functioning normally. I had no problems in the bedroom during or after the cimetidine course.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_nonadr_009", "text": "My doctor explained that the problem I described started two years before the heart tablet was prescribed. The cause is my long-standing diabetes — not the metoprolol.", "label": 0, "source_type": "synthetic_phase7"}
+{"id": "synthetic_phase7_p15_male_repro_nonadr_010", "text": "I discussed the prostate tablet with my doctor and he confirmed that my libido issues started before the finasteride — they are from stress and my age, not from the drug.", "label": 0, "source_type": "synthetic_phase7"}