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<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-103
Date of Submission: 2024-10-27
This report was submitted by a Patient from Lloyd, Wells and Palmer Medical Center concerning patient ANON-PX-8629. The subject is a 32-year-old male with a significant medical history including hypertension, atrial fibrillation, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin administered via the Topical route at a dosage of 245mg, initiated on 2024-07-31 for Bacterial infection with the course ongoing.
On approximately 2024-09-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Hepatotoxicity, Pruritus, Somnolence. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed range and advised end. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed agree and advised wear. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed hair and advised happen. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-103
report_date: '2024-10-27'
patient_details:
patient_id: ANON-PX-8629
gender: Male
relevant_history:
- hypertension
- atrial fibrillation
- migraines
age_at_reaction: 32
suspected_drugs:
- drug_name: Amoxicillin
dosage: 245mg
route_of_administration: Topical
start_date: '2024-07-31'
indication_for_use: Bacterial infection
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-09-17'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed range and advised end.
- symptom_name: Hepatotoxicity
onset_date: '2024-09-17'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed agree and advised wear.
- symptom_name: Pruritus
onset_date: '2024-09-17'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed hair and advised happen.
- symptom_name: Somnolence
onset_date: '2024-09-17'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 7
reporting_facility: Lloyd, Wells and Palmer Medical Center
reporter_type: Patient
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-811
Date of Submission: 2025-06-23
This report was submitted by a Nurse from Johnson LLC Medical Center concerning patient ANON-PX-9816. The subject is an adult other with a significant medical history including hypertension, anxiety, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine administered via the Intravenous route at a dosage of 43mg, initiated on 2025-03-27 for Hypothyroidism and discontinued on 2025-05-21; Sertraline (SSRI) administered via the Topical route at a dosage of 414mg, initiated on 2025-03-27 for Major depressive disorder and discontinued on 2025-05-21.
On approximately 2025-04-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Vomiting. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Particular social down believe order evening road. Media avoid region dream beautiful time main.</data>
|
report_id: ADR-2025-811
report_date: '2025-06-23'
patient_details:
patient_id: ANON-PX-9816
gender: Other
relevant_history:
- hypertension
- anxiety
- type 2 diabetes
suspected_drugs:
- drug_name: Levothyroxine
dosage: 43mg
route_of_administration: Intravenous
start_date: '2025-03-27'
indication_for_use: Hypothyroidism
end_date: '2025-05-21'
- drug_name: Sertraline
dosage: 414mg
route_of_administration: Topical
start_date: '2025-03-27'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-05-21'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-04-15'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-04-15'
severity: Mild
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Johnson LLC Medical Center
reporter_type: Nurse
notes: Particular social down believe order evening road. Media avoid region dream
beautiful time main.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-118
Date of Submission: 2025-03-15
This report was submitted by a Nurse from Lowe-Le Medical Center concerning patient ANON-PX-5489. The subject is an adult other with a significant medical history including osteoarthritis, migraines, seasonal allergies, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin administered via the Oral route at a dosage of 293mg, initiated on 2025-01-08 for Thromboembolism prevention and discontinued on 2025-02-22; Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 86mg, initiated on 2025-01-08 for Bacterial infection and discontinued on 2025-02-22.
On approximately 2025-01-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Maculopapular Rash, Pruritus, Headache, Somnolence. The Nausea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Our book dinner sport ball knowledge keep actually. Current morning exist other crime raise call.</data>
|
report_id: ADR-2025-118
report_date: '2025-03-15'
patient_details:
patient_id: ANON-PX-5489
gender: Other
relevant_history:
- osteoarthritis
- migraines
- seasonal allergies
- coronary artery disease
suspected_drugs:
- drug_name: Warfarin
dosage: 293mg
route_of_administration: Oral
start_date: '2025-01-08'
indication_for_use: Thromboembolism prevention
end_date: '2025-02-22'
- drug_name: Amoxicillin
dosage: 86mg
route_of_administration: Intramuscular
start_date: '2025-01-08'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-02-22'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-01-12'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-01-12'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-01-12'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Headache
onset_date: '2025-01-12'
severity: Severe
outcome: Recovering
intervention_required: true
- symptom_name: Somnolence
onset_date: '2025-01-12'
severity: Life-threatening
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 6
reporting_facility: Lowe-Le Medical Center
reporter_type: Nurse
notes: Our book dinner sport ball knowledge keep actually. Current morning exist other
crime raise call.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-696
Date of Submission: 2025-01-08
This report was submitted by a Physician from Young-Carson Medical Center concerning patient ANON-PX-5975. The subject is an adult male with a significant medical history including chronic kidney disease, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin administered via the Intramuscular route at a dosage of 369mg, initiated on 2024-12-30 for Hypercholesterolemia with the course ongoing.
On approximately 2025-01-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Angioedema, Dizziness. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed mother and advised activity. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Art high school card case pull. Pull toward threat direction science early. Break down south perform east.</data>
|
report_id: ADR-2025-696
report_date: '2025-01-08'
patient_details:
patient_id: ANON-PX-5975
gender: Male
relevant_history:
- chronic kidney disease
- anxiety
suspected_drugs:
- drug_name: Atorvastatin
dosage: 369mg
route_of_administration: Intramuscular
start_date: '2024-12-30'
indication_for_use: Hypercholesterolemia
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-01-05'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed mother and advised activity.
- symptom_name: Angioedema
onset_date: '2025-01-05'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Dizziness
onset_date: '2025-01-05'
severity: Severe
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 8
reporting_facility: Young-Carson Medical Center
reporter_type: Physician
notes: Art high school card case pull. Pull toward threat direction science early.
Break down south perform east.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-511
Date of Submission: 2024-12-01
This report was submitted by a Other Healthcare Professional from Sanchez LLC Medical Center concerning patient ANON-PX-1208. The subject is a 22-year-old other with a significant medical history including seasonal allergies, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 294mg, initiated on 2024-11-16 for Pain and inflammation and discontinued on 2024-11-25.
On approximately 2024-11-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Hepatotoxicity, Angioedema. The Nausea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Kitchen court behind show own play. Adult data magazine specific.</data>
|
report_id: ADR-2024-511
report_date: '2024-12-01'
patient_details:
patient_id: ANON-PX-1208
gender: Other
relevant_history:
- seasonal allergies
- asthma
age_at_reaction: 22
suspected_drugs:
- drug_name: Ibuprofen
dosage: 294mg
route_of_administration: Subcutaneous
start_date: '2024-11-16'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-11-25'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-11-18'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-11-18'
severity: Mild
outcome: Not Recovered
intervention_required: true
- symptom_name: Angioedema
onset_date: '2024-11-18'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 3
reporting_facility: Sanchez LLC Medical Center
reporter_type: Other Healthcare Professional
notes: Kitchen court behind show own play. Adult data magazine specific.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-339
Date of Submission: 2025-05-22
This report was submitted by a Other Healthcare Professional from Mclean LLC Medical Center concerning patient ANON-PX-2956. The subject is a 71-year-old other with a significant medical history including asthma, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Intramuscular route at a dosage of 241mg, initiated on 2025-03-10 for Type 2 diabetes and discontinued on 2025-05-01; Omeprazole administered via the Intravenous route at a dosage of 398mg, initiated on 2025-03-10 for Gastroesophageal reflux disease and discontinued on 2025-05-01.
On approximately 2025-03-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Anaphylaxis, Somnolence, Vomiting. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed move and advised impact. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed indicate and advised discover. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed win and advised analysis. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-339
report_date: '2025-05-22'
patient_details:
patient_id: ANON-PX-2956
gender: Other
relevant_history:
- asthma
- anxiety
age_at_reaction: 71
suspected_drugs:
- drug_name: Metformin
dosage: 241mg
route_of_administration: Intramuscular
start_date: '2025-03-10'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-05-01'
- drug_name: Omeprazole
dosage: 398mg
route_of_administration: Intravenous
start_date: '2025-03-10'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-05-01'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-03-23'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed move and advised impact.
- symptom_name: Anaphylaxis
onset_date: '2025-03-23'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-03-23'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed indicate and advised discover.
- symptom_name: Vomiting
onset_date: '2025-03-23'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed win and advised analysis.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 8
reporting_facility: Mclean LLC Medical Center
reporter_type: Other Healthcare Professional
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-886
Date of Submission: 2024-09-02
This report was submitted by a Pharmacist from Goodwin, Garner and Brewer Medical Center concerning patient ANON-PX-6337. The subject is a 33-year-old other with a significant medical history including anxiety, migraines, coronary artery disease, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Intramuscular route at a dosage of 147mg, initiated on 2024-07-06 for Major depressive disorder and discontinued on 2024-08-27.
On approximately 2024-07-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Headache, Pruritus. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Guy myself family why card. Year place future any much majority.</data>
|
report_id: ADR-2024-886
report_date: '2024-09-02'
patient_details:
patient_id: ANON-PX-6337
gender: Other
relevant_history:
- anxiety
- migraines
- coronary artery disease
- hypertension
age_at_reaction: 33
suspected_drugs:
- drug_name: Sertraline
dosage: 147mg
route_of_administration: Intramuscular
start_date: '2024-07-06'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-08-27'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-07-23'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Headache
onset_date: '2024-07-23'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-07-23'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 2
reporting_facility: Goodwin, Garner and Brewer Medical Center
reporter_type: Pharmacist
notes: Guy myself family why card. Year place future any much majority.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-120
Date of Submission: 2024-09-26
This report was submitted by a Other Healthcare Professional from Harmon-Galvan Medical Center concerning patient ANON-PX-2662. The subject is an adult female with a significant medical history including chronic kidney disease, anxiety, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Intramuscular route at a dosage of 111mg, initiated on 2024-07-07 for Hypercholesterolemia with the course ongoing; Warfarin (Anticoagulant) administered via the Topical route at a dosage of 462mg, initiated on 2024-07-07 for Thromboembolism prevention with the course ongoing.
On approximately 2024-09-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Anaphylaxis, Dizziness, Nausea, Headache. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed look and advised expert. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed over and advised right. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed administration and advised onto. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Finally own must beyond. Range worker manager.</data>
|
report_id: ADR-2024-120
report_date: '2024-09-26'
patient_details:
patient_id: ANON-PX-2662
gender: Female
relevant_history:
- chronic kidney disease
- anxiety
- asthma
suspected_drugs:
- drug_name: Atorvastatin
dosage: 111mg
route_of_administration: Intramuscular
start_date: '2024-07-07'
indication_for_use: Hypercholesterolemia
drug_class: Statin
- drug_name: Warfarin
dosage: 462mg
route_of_administration: Topical
start_date: '2024-07-07'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-09-21'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed look and advised expert.
- symptom_name: Anaphylaxis
onset_date: '2024-09-21'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-09-21'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed over and advised right.
- symptom_name: Nausea
onset_date: '2024-09-21'
severity: Moderate
outcome: Recovered
intervention_required: true
- symptom_name: Headache
onset_date: '2024-09-21'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed administration and advised onto.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Harmon-Galvan Medical Center
reporter_type: Other Healthcare Professional
notes: Finally own must beyond. Range worker manager.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-514
Date of Submission: 2025-05-28
This report was submitted by a Physician from Davis-Thomas Medical Center concerning patient ANON-PX-8987. The subject is a 71-year-old male with a significant medical history including anxiety, coronary artery disease, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Topical route at a dosage of 88mg, initiated on 2025-05-05 for Pain and inflammation and discontinued on 2025-05-25.
On approximately 2025-05-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Dizziness, Anaphylaxis, Nausea. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed benefit and advised subject. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: State best he health claim kind stock space. Writer responsibility realize thing evening. Pull instead per unit science attention pull.</data>
|
report_id: ADR-2025-514
report_date: '2025-05-28'
patient_details:
patient_id: ANON-PX-8987
gender: Male
relevant_history:
- anxiety
- coronary artery disease
- osteoarthritis
age_at_reaction: 71
suspected_drugs:
- drug_name: Ibuprofen
dosage: 88mg
route_of_administration: Topical
start_date: '2025-05-05'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-05-25'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-05-24'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed benefit and advised subject.
- symptom_name: Dizziness
onset_date: '2025-05-24'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-05-24'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-05-24'
severity: Mild
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Davis-Thomas Medical Center
reporter_type: Physician
notes: State best he health claim kind stock space. Writer responsibility realize
thing evening. Pull instead per unit science attention pull.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-283
Date of Submission: 2025-03-01
This report was submitted by a Other Healthcare Professional from Perez Ltd Medical Center concerning patient ANON-PX-8040. The subject is an adult male with a significant medical history including seasonal allergies, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Oral route at a dosage of 376mg, initiated on 2024-12-09 for Major depressive disorder and discontinued on 2025-02-26.
On approximately 2024-12-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Pruritus, Nausea. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-283
report_date: '2025-03-01'
patient_details:
patient_id: ANON-PX-8040
gender: Male
relevant_history:
- seasonal allergies
- osteoarthritis
suspected_drugs:
- drug_name: Sertraline
dosage: 376mg
route_of_administration: Oral
start_date: '2024-12-09'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-02-26'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-12-10'
severity: Mild
outcome: Unknown
intervention_required: true
- symptom_name: Pruritus
onset_date: '2024-12-10'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-12-10'
severity: Life-threatening
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 4
reporting_facility: Perez Ltd Medical Center
reporter_type: Other Healthcare Professional
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-763
Date of Submission: 2025-02-19
This report was submitted by a Pharmacist from Watts LLC Medical Center concerning patient ANON-PX-1937. The subject is an adult female with a significant medical history including chronic kidney disease, coronary artery disease, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin administered via the Subcutaneous route at a dosage of 235mg, initiated on 2024-12-25 for Hypercholesterolemia and discontinued on 2025-01-03.
On approximately 2024-12-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Hepatotoxicity. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed well and advised wait. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Six but trade yeah though. First per skill. Record speak away share ready answer report. Yes officer especially myself statement evidence.</data>
|
report_id: ADR-2025-763
report_date: '2025-02-19'
patient_details:
patient_id: ANON-PX-1937
gender: Female
relevant_history:
- chronic kidney disease
- coronary artery disease
- atrial fibrillation
suspected_drugs:
- drug_name: Atorvastatin
dosage: 235mg
route_of_administration: Subcutaneous
start_date: '2024-12-25'
indication_for_use: Hypercholesterolemia
end_date: '2025-01-03'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-12-28'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed well and advised wait.
- symptom_name: Hepatotoxicity
onset_date: '2024-12-28'
severity: Life-threatening
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 5
reporting_facility: Watts LLC Medical Center
reporter_type: Pharmacist
notes: Six but trade yeah though. First per skill. Record speak away share ready answer
report. Yes officer especially myself statement evidence.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-611
Date of Submission: 2025-01-28
This report was submitted by a Nurse from Patterson, Smith and Parker Medical Center concerning patient ANON-PX-5496. The subject is a 81-year-old female with a significant medical history including seasonal allergies, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine administered via the Topical route at a dosage of 310mg, initiated on 2024-12-15 for Hypothyroidism and discontinued on 2025-01-22; Omeprazole administered via the Intravenous route at a dosage of 215mg, initiated on 2024-12-15 for Gastroesophageal reflux disease and discontinued on 2025-01-22.
On approximately 2024-12-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Headache, Stevens-Johnson syndrome. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed they and advised school. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-611
report_date: '2025-01-28'
patient_details:
patient_id: ANON-PX-5496
gender: Female
relevant_history:
- seasonal allergies
- coronary artery disease
age_at_reaction: 81
suspected_drugs:
- drug_name: Levothyroxine
dosage: 310mg
route_of_administration: Topical
start_date: '2024-12-15'
indication_for_use: Hypothyroidism
end_date: '2025-01-22'
- drug_name: Omeprazole
dosage: 215mg
route_of_administration: Intravenous
start_date: '2024-12-15'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-01-22'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-12-23'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Headache
onset_date: '2024-12-23'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed they and advised school.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-12-23'
severity: Life-threatening
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 8
reporting_facility: Patterson, Smith and Parker Medical Center
reporter_type: Nurse
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-818
Date of Submission: 2024-12-03
This report was submitted by a Physician from Bradley-Marsh Medical Center concerning patient ANON-PX-1974. The subject is a 84-year-old female with a significant medical history including osteoarthritis, hypertension, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline administered via the Intravenous route at a dosage of 136mg, initiated on 2024-10-16 for Major depressive disorder and discontinued on 2024-11-05; Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 481mg, initiated on 2024-10-16 for Pain and inflammation and discontinued on 2024-11-05.
On approximately 2024-10-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Pruritus, Headache. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed worker and advised charge. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed artist and advised another. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed never and advised maybe. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-818
report_date: '2024-12-03'
patient_details:
patient_id: ANON-PX-1974
gender: Female
relevant_history:
- osteoarthritis
- hypertension
- atrial fibrillation
age_at_reaction: 84
suspected_drugs:
- drug_name: Sertraline
dosage: 136mg
route_of_administration: Intravenous
start_date: '2024-10-16'
indication_for_use: Major depressive disorder
end_date: '2024-11-05'
- drug_name: Ibuprofen
dosage: 481mg
route_of_administration: Intramuscular
start_date: '2024-10-16'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-11-05'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-21'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed worker and advised charge.
- symptom_name: Pruritus
onset_date: '2024-10-21'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed artist and advised another.
- symptom_name: Headache
onset_date: '2024-10-21'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed never and advised maybe.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 1
reporting_facility: Bradley-Marsh Medical Center
reporter_type: Physician
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-244
Date of Submission: 2025-04-14
This report was submitted by a Nurse from Jackson and Sons Medical Center concerning patient ANON-PX-8206. The subject is a 40-year-old male with a significant medical history including osteoarthritis, chronic kidney disease, type 2 diabetes, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen administered via the Intramuscular route at a dosage of 228mg, initiated on 2025-02-05 for Pain and inflammation with the course ongoing; Lisinopril administered via the Topical route at a dosage of 220mg, initiated on 2025-02-05 for Hypertension with the course ongoing.
On approximately 2025-02-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Somnolence, Diarrhea, Hepatotoxicity, Anaphylaxis. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed black and advised staff. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Wind vote city score water good.</data>
|
report_id: ADR-2025-244
report_date: '2025-04-14'
patient_details:
patient_id: ANON-PX-8206
gender: Male
relevant_history:
- osteoarthritis
- chronic kidney disease
- type 2 diabetes
- asthma
age_at_reaction: 40
suspected_drugs:
- drug_name: Ibuprofen
dosage: 228mg
route_of_administration: Intramuscular
start_date: '2025-02-05'
indication_for_use: Pain and inflammation
- drug_name: Lisinopril
dosage: 220mg
route_of_administration: Topical
start_date: '2025-02-05'
indication_for_use: Hypertension
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-02-27'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-02-27'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-02-27'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-02-27'
severity: Life-threatening
outcome: Fatal
intervention_required: true
- symptom_name: Anaphylaxis
onset_date: '2025-02-27'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed black and advised staff.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 5
reporting_facility: Jackson and Sons Medical Center
reporter_type: Nurse
notes: Wind vote city score water good.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-477
Date of Submission: 2024-12-09
This report was submitted by a Nurse from Moon PLC Medical Center concerning patient ANON-PX-8748. The subject is a 51-year-old other with a significant medical history including hypertension, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin (Anticoagulant) administered via the Topical route at a dosage of 363mg, initiated on 2024-11-28 for Thromboembolism prevention and discontinued on 2024-12-08; Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 176mg, initiated on 2024-11-28 for Bacterial infection and discontinued on 2024-12-08.
On approximately 2024-12-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Diarrhea, Dizziness. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed democratic and advised one. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Civil huge another leader effort. Audience media such way next bed.</data>
|
report_id: ADR-2024-477
report_date: '2024-12-09'
patient_details:
patient_id: ANON-PX-8748
gender: Other
relevant_history:
- hypertension
- type 2 diabetes
age_at_reaction: 51
suspected_drugs:
- drug_name: Warfarin
dosage: 363mg
route_of_administration: Topical
start_date: '2024-11-28'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-12-08'
- drug_name: Amoxicillin
dosage: 176mg
route_of_administration: Intramuscular
start_date: '2024-11-28'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-12-08'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-12-07'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed democratic and advised one.
- symptom_name: Diarrhea
onset_date: '2024-12-07'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-12-07'
severity: Severe
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 9
reporting_facility: Moon PLC Medical Center
reporter_type: Nurse
notes: Civil huge another leader effort. Audience media such way next bed.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-662
Date of Submission: 2025-06-19
This report was submitted by a Physician from Sims Group Medical Center concerning patient ANON-PX-6801. The subject is an adult male with a significant medical history including seasonal allergies, coronary artery disease, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin (Anticoagulant) administered via the Subcutaneous route at a dosage of 438mg, initiated on 2025-05-23 for Thromboembolism prevention with the course ongoing.
On approximately 2025-06-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Somnolence, Angioedema, Maculopapular Rash, Anaphylaxis. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed where and advised education. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: About successful remain dark. Late of story. Half success state mouth.</data>
|
report_id: ADR-2025-662
report_date: '2025-06-19'
patient_details:
patient_id: ANON-PX-6801
gender: Male
relevant_history:
- seasonal allergies
- coronary artery disease
- osteoarthritis
suspected_drugs:
- drug_name: Warfarin
dosage: 438mg
route_of_administration: Subcutaneous
start_date: '2025-05-23'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-06-17'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-06-17'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-06-17'
severity: Severe
outcome: Fatal
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2025-06-17'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed where and advised education.
- symptom_name: Anaphylaxis
onset_date: '2025-06-17'
severity: Mild
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 2
reporting_facility: Sims Group Medical Center
reporter_type: Physician
notes: About successful remain dark. Late of story. Half success state mouth.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-206
Date of Submission: 2025-06-30
This report was submitted by a Patient from Klein Inc Medical Center concerning patient ANON-PX-3180. The subject is a 69-year-old male with a significant medical history including coronary artery disease, asthma, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 373mg, initiated on 2025-05-14 for Hypertension and discontinued on 2025-06-28; Warfarin (Anticoagulant) administered via the Intravenous route at a dosage of 436mg, initiated on 2025-05-14 for Thromboembolism prevention and discontinued on 2025-06-28.
On approximately 2025-06-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Stevens-Johnson syndrome, Dizziness. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Visit trip customer three body structure. Consider suffer trouble result wait want if at. While against popular often television good.</data>
|
report_id: ADR-2025-206
report_date: '2025-06-30'
patient_details:
patient_id: ANON-PX-3180
gender: Male
relevant_history:
- coronary artery disease
- asthma
- hypertension
age_at_reaction: 69
suspected_drugs:
- drug_name: Lisinopril
dosage: 373mg
route_of_administration: Subcutaneous
start_date: '2025-05-14'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-06-28'
- drug_name: Warfarin
dosage: 436mg
route_of_administration: Intravenous
start_date: '2025-05-14'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-06-28'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-06-02'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-02'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-06-02'
severity: Severe
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 2
reporting_facility: Klein Inc Medical Center
reporter_type: Patient
notes: Visit trip customer three body structure. Consider suffer trouble result wait
want if at. While against popular often television good.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-388
Date of Submission: 2024-08-24
This report was submitted by a Physician from Madden, Garcia and Carpenter Medical Center concerning patient ANON-PX-6494. The subject is a 29-year-old female with a significant medical history including type 2 diabetes, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Subcutaneous route at a dosage of 273mg, initiated on 2024-07-12 for Type 2 diabetes with the course ongoing.
On approximately 2024-07-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Maculopapular Rash, Diarrhea. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed I and advised need. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed after and advised born. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Phone study either still product throughout. Agency fish her remain ten nation along.</data>
|
report_id: ADR-2024-388
report_date: '2024-08-24'
patient_details:
patient_id: ANON-PX-6494
gender: Female
relevant_history:
- type 2 diabetes
- osteoarthritis
age_at_reaction: 29
suspected_drugs:
- drug_name: Metformin
dosage: 273mg
route_of_administration: Subcutaneous
start_date: '2024-07-12'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-07-27'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-07-27'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed I and advised need.
- symptom_name: Diarrhea
onset_date: '2024-07-27'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed after and advised born.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 8
reporting_facility: Madden, Garcia and Carpenter Medical Center
reporter_type: Physician
notes: Phone study either still product throughout. Agency fish her remain ten nation
along.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-836
Date of Submission: 2025-05-24
This report was submitted by a Nurse from Wallace, Freeman and Johnson Medical Center concerning patient ANON-PX-9378. The subject is a 30-year-old male with a significant medical history including seasonal allergies, chronic kidney disease, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 70mg, initiated on 2025-04-26 for Hypertension with the course ongoing; Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 312mg, initiated on 2025-04-26 for Pain and inflammation with the course ongoing.
On approximately 2025-05-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Anaphylaxis, Headache. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed himself and advised smile. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed Mr and advised off. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed professor and advised treatment. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Image fight between. Detail agree have how movement. Across government boy poor maintain rate statement population.</data>
|
report_id: ADR-2025-836
report_date: '2025-05-24'
patient_details:
patient_id: ANON-PX-9378
gender: Male
relevant_history:
- seasonal allergies
- chronic kidney disease
- osteoarthritis
age_at_reaction: 30
suspected_drugs:
- drug_name: Lisinopril
dosage: 70mg
route_of_administration: Oral
start_date: '2025-04-26'
indication_for_use: Hypertension
drug_class: ACE inhibitor
- drug_name: Ibuprofen
dosage: 312mg
route_of_administration: Subcutaneous
start_date: '2025-04-26'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-05-16'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed himself and advised smile.
- symptom_name: Anaphylaxis
onset_date: '2025-05-16'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed Mr and advised off.
- symptom_name: Headache
onset_date: '2025-05-16'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed professor and advised treatment.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 3
reporting_facility: Wallace, Freeman and Johnson Medical Center
reporter_type: Nurse
notes: Image fight between. Detail agree have how movement. Across government boy
poor maintain rate statement population.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-899
Date of Submission: 2024-09-20
This report was submitted by a Other Healthcare Professional from Novak-Molina Medical Center concerning patient ANON-PX-5164. The subject is a 27-year-old male with a significant medical history including asthma, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine administered via the Intravenous route at a dosage of 499mg, initiated on 2024-07-11 for Hypothyroidism and discontinued on 2024-07-29; Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 142mg, initiated on 2024-07-11 for Neuropathic pain and discontinued on 2024-07-29.
On approximately 2024-07-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Headache, Dizziness, Angioedema. The Nausea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed benefit and advised thought. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Meeting skill explain during candidate never it. Owner bad cup century feel language teacher. Join station tonight once data.</data>
|
report_id: ADR-2024-899
report_date: '2024-09-20'
patient_details:
patient_id: ANON-PX-5164
gender: Male
relevant_history:
- asthma
- hypertension
age_at_reaction: 27
suspected_drugs:
- drug_name: Levothyroxine
dosage: 499mg
route_of_administration: Intravenous
start_date: '2024-07-11'
indication_for_use: Hypothyroidism
end_date: '2024-07-29'
- drug_name: Gabapentin
dosage: 142mg
route_of_administration: Intravenous
start_date: '2024-07-11'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2024-07-29'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-07-18'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Headache
onset_date: '2024-07-18'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed benefit and advised thought.
- symptom_name: Dizziness
onset_date: '2024-07-18'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-07-18'
severity: Mild
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 7
reporting_facility: Novak-Molina Medical Center
reporter_type: Other Healthcare Professional
notes: Meeting skill explain during candidate never it. Owner bad cup century feel
language teacher. Join station tonight once data.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-319
Date of Submission: 2025-03-03
This report was submitted by a Physician from Black-Hicks Medical Center concerning patient ANON-PX-6644. The subject is a 31-year-old female with a significant medical history including anxiety, atrial fibrillation, hypertension, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 457mg, initiated on 2025-01-27 for Pain and inflammation with the course ongoing; Omeprazole administered via the Oral route at a dosage of 288mg, initiated on 2025-01-27 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2025-01-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Somnolence, Stevens-Johnson syndrome, Pruritus. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Bed where either need anyone energy stop. Why family western election color.</data>
|
report_id: ADR-2025-319
report_date: '2025-03-03'
patient_details:
patient_id: ANON-PX-6644
gender: Female
relevant_history:
- anxiety
- atrial fibrillation
- hypertension
- asthma
age_at_reaction: 31
suspected_drugs:
- drug_name: Ibuprofen
dosage: 457mg
route_of_administration: Intramuscular
start_date: '2025-01-27'
indication_for_use: Pain and inflammation
drug_class: NSAID
- drug_name: Omeprazole
dosage: 288mg
route_of_administration: Oral
start_date: '2025-01-27'
indication_for_use: Gastroesophageal reflux disease
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-01-30'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-01-30'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-01-30'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-01-30'
severity: Moderate
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 5
reporting_facility: Black-Hicks Medical Center
reporter_type: Physician
notes: Bed where either need anyone energy stop. Why family western election color.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-271
Date of Submission: 2025-08-05
This report was submitted by a Nurse from Johnson, Frederick and Patel Medical Center concerning patient ANON-PX-1543. The subject is a 35-year-old male with a significant medical history including anxiety, chronic kidney disease, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 455mg, initiated on 2025-07-14 for Neuropathic pain and discontinued on 2025-07-31; Warfarin administered via the Intramuscular route at a dosage of 337mg, initiated on 2025-07-14 for Thromboembolism prevention and discontinued on 2025-07-31.
On approximately 2025-07-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Nausea, Stevens-Johnson syndrome, Headache. The Pruritus was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed summer and advised our. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed though and advised computer. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed list and advised within. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-271
report_date: '2025-08-05'
patient_details:
patient_id: ANON-PX-1543
gender: Male
relevant_history:
- anxiety
- chronic kidney disease
- hypertension
age_at_reaction: 35
suspected_drugs:
- drug_name: Gabapentin
dosage: 455mg
route_of_administration: Intravenous
start_date: '2025-07-14'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-07-31'
- drug_name: Warfarin
dosage: 337mg
route_of_administration: Intramuscular
start_date: '2025-07-14'
indication_for_use: Thromboembolism prevention
end_date: '2025-07-31'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-07-29'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-07-29'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed summer and advised our.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-07-29'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed though and advised computer.
- symptom_name: Headache
onset_date: '2025-07-29'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed list and advised within.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 6
reporting_facility: Johnson, Frederick and Patel Medical Center
reporter_type: Nurse
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-514
Date of Submission: 2025-08-05
This report was submitted by a Physician from Bartlett-Wallace Medical Center concerning patient ANON-PX-7546. The subject is a 22-year-old other with a significant medical history including osteoarthritis, seasonal allergies, anxiety, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril administered via the Intravenous route at a dosage of 488mg, initiated on 2025-06-10 for Hypertension with the course ongoing; Metformin administered via the Intravenous route at a dosage of 251mg, initiated on 2025-06-10 for Type 2 diabetes with the course ongoing.
On approximately 2025-07-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Nausea, Stevens-Johnson syndrome. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Necessary any win push citizen reflect. Statement service born soldier enough up firm so.</data>
|
report_id: ADR-2025-514
report_date: '2025-08-05'
patient_details:
patient_id: ANON-PX-7546
gender: Other
relevant_history:
- osteoarthritis
- seasonal allergies
- anxiety
- type 2 diabetes
age_at_reaction: 22
suspected_drugs:
- drug_name: Lisinopril
dosage: 488mg
route_of_administration: Intravenous
start_date: '2025-06-10'
indication_for_use: Hypertension
- drug_name: Metformin
dosage: 251mg
route_of_administration: Intravenous
start_date: '2025-06-10'
indication_for_use: Type 2 diabetes
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-07-20'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-07-20'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-07-20'
severity: Mild
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 6
reporting_facility: Bartlett-Wallace Medical Center
reporter_type: Physician
notes: Necessary any win push citizen reflect. Statement service born soldier enough
up firm so.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-481
Date of Submission: 2025-07-03
This report was submitted by a Physician from Moore, Wilson and Mosley Medical Center concerning patient ANON-PX-6617. The subject is an adult female with a significant medical history including chronic kidney disease, type 2 diabetes, seasonal allergies, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine (Thyroid hormone) administered via the Subcutaneous route at a dosage of 97mg, initiated on 2025-04-08 for Hypothyroidism and discontinued on 2025-06-22.
On approximately 2025-06-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Stevens-Johnson syndrome. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-481
report_date: '2025-07-03'
patient_details:
patient_id: ANON-PX-6617
gender: Female
relevant_history:
- chronic kidney disease
- type 2 diabetes
- seasonal allergies
- atrial fibrillation
suspected_drugs:
- drug_name: Levothyroxine
dosage: 97mg
route_of_administration: Subcutaneous
start_date: '2025-04-08'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2025-06-22'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-06-22'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-22'
severity: Mild
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Moore, Wilson and Mosley Medical Center
reporter_type: Physician
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-269
Date of Submission: 2024-10-22
This report was submitted by a Pharmacist from Dickson, Wilson and Sharp Medical Center concerning patient ANON-PX-6359. The subject is a 84-year-old male with a significant medical history including hypertension, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin (Anticonvulsant) administered via the Intramuscular route at a dosage of 220mg, initiated on 2024-10-13 for Neuropathic pain with the course ongoing; Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 163mg, initiated on 2024-10-13 for Bacterial infection with the course ongoing.
On approximately 2024-10-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Somnolence, Diarrhea. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed key and advised everybody. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed color and advised role. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Again test single require and. From often deep color score. Yeah government expect several black evidence police.</data>
|
report_id: ADR-2024-269
report_date: '2024-10-22'
patient_details:
patient_id: ANON-PX-6359
gender: Male
relevant_history:
- hypertension
- coronary artery disease
age_at_reaction: 84
suspected_drugs:
- drug_name: Gabapentin
dosage: 220mg
route_of_administration: Intramuscular
start_date: '2024-10-13'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
- drug_name: Amoxicillin
dosage: 163mg
route_of_administration: Subcutaneous
start_date: '2024-10-13'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-10-16'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed key and advised everybody.
- symptom_name: Somnolence
onset_date: '2024-10-16'
severity: Life-threatening
outcome: Recovered
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2024-10-16'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed color and advised role.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 1
reporting_facility: Dickson, Wilson and Sharp Medical Center
reporter_type: Pharmacist
notes: Again test single require and. From often deep color score. Yeah government
expect several black evidence police.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-150
Date of Submission: 2024-11-15
This report was submitted by a Patient from Kelly, Pena and Williams Medical Center concerning patient ANON-PX-1935. The subject is a 67-year-old female with a significant medical history including asthma, migraines, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Topical route at a dosage of 455mg, initiated on 2024-09-15 for Major depressive disorder and discontinued on 2024-10-11; Atorvastatin (Statin) administered via the Oral route at a dosage of 24mg, initiated on 2024-09-15 for Hypercholesterolemia and discontinued on 2024-10-11.
On approximately 2024-09-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Dizziness, Hepatotoxicity. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed deal and advised production. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Right sit mother security offer assume letter. Summer art game late low option. Mrs rule sea somebody show conference.</data>
|
report_id: ADR-2024-150
report_date: '2024-11-15'
patient_details:
patient_id: ANON-PX-1935
gender: Female
relevant_history:
- asthma
- migraines
- atrial fibrillation
age_at_reaction: 67
suspected_drugs:
- drug_name: Sertraline
dosage: 455mg
route_of_administration: Topical
start_date: '2024-09-15'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-10-11'
- drug_name: Atorvastatin
dosage: 24mg
route_of_administration: Oral
start_date: '2024-09-15'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-10-11'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-09-27'
severity: Severe
outcome: Not Recovered
intervention_required: true
- symptom_name: Dizziness
onset_date: '2024-09-27'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-09-27'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed deal and advised production.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 7
reporting_facility: Kelly, Pena and Williams Medical Center
reporter_type: Patient
notes: Right sit mother security offer assume letter. Summer art game late low option.
Mrs rule sea somebody show conference.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-181
Date of Submission: 2025-07-04
This report was submitted by a Pharmacist from Williams, Davidson and Martin Medical Center concerning patient ANON-PX-9439. The subject is a 72-year-old other with a significant medical history including migraines, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin (Anticonvulsant) administered via the Intramuscular route at a dosage of 103mg, initiated on 2025-04-11 for Neuropathic pain and discontinued on 2025-06-30; Warfarin (Anticoagulant) administered via the Intravenous route at a dosage of 24mg, initiated on 2025-04-11 for Thromboembolism prevention and discontinued on 2025-06-30.
On approximately 2025-06-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Vomiting, Pruritus, Maculopapular Rash, Stevens-Johnson syndrome. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed again and advised back. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed player and advised care. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-181
report_date: '2025-07-04'
patient_details:
patient_id: ANON-PX-9439
gender: Other
relevant_history:
- migraines
- type 2 diabetes
age_at_reaction: 72
suspected_drugs:
- drug_name: Gabapentin
dosage: 103mg
route_of_administration: Intramuscular
start_date: '2025-04-11'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-06-30'
- drug_name: Warfarin
dosage: 24mg
route_of_administration: Intravenous
start_date: '2025-04-11'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-06-30'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-06-24'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed again and advised back.
- symptom_name: Vomiting
onset_date: '2025-06-24'
severity: Severe
outcome: Recovered
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-06-24'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-06-24'
severity: Severe
outcome: Fatal
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-24'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed player and advised care.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 6
reporting_facility: Williams, Davidson and Martin Medical Center
reporter_type: Pharmacist
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-955
Date of Submission: 2025-01-01
This report was submitted by a Other Healthcare Professional from Garcia-Hart Medical Center concerning patient ANON-PX-5820. The subject is an adult female with a significant medical history including coronary artery disease, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Intravenous route at a dosage of 199mg, initiated on 2024-10-31 for Major depressive disorder with the course ongoing; Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 40mg, initiated on 2024-10-31 for Pain and inflammation with the course ongoing.
On approximately 2024-11-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Anaphylaxis, Hepatotoxicity. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed bar and advised business. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Hotel central value. Name somebody attention all job keep act. Name executive tonight focus edge toward discover.</data>
|
report_id: ADR-2025-955
report_date: '2025-01-01'
patient_details:
patient_id: ANON-PX-5820
gender: Female
relevant_history:
- coronary artery disease
- hypertension
suspected_drugs:
- drug_name: Sertraline
dosage: 199mg
route_of_administration: Intravenous
start_date: '2024-10-31'
indication_for_use: Major depressive disorder
drug_class: SSRI
- drug_name: Ibuprofen
dosage: 40mg
route_of_administration: Intramuscular
start_date: '2024-10-31'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-11-30'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed bar and advised business.
- symptom_name: Anaphylaxis
onset_date: '2024-11-30'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-11-30'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 9
reporting_facility: Garcia-Hart Medical Center
reporter_type: Other Healthcare Professional
notes: Hotel central value. Name somebody attention all job keep act. Name executive
tonight focus edge toward discover.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-744
Date of Submission: 2025-05-09
This report was submitted by a Nurse from Atkinson and Sons Medical Center concerning patient ANON-PX-5874. The subject is a 26-year-old female with a significant medical history including migraines, chronic kidney disease, hypertension, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 118mg, initiated on 2025-04-30 for Bacterial infection and discontinued on 2025-05-07.
On approximately 2025-05-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Nausea, Maculopapular Rash, Hepatotoxicity. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed agent and advised stop. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-744
report_date: '2025-05-09'
patient_details:
patient_id: ANON-PX-5874
gender: Female
relevant_history:
- migraines
- chronic kidney disease
- hypertension
- osteoarthritis
age_at_reaction: 26
suspected_drugs:
- drug_name: Amoxicillin
dosage: 118mg
route_of_administration: Oral
start_date: '2025-04-30'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-05-07'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-05-01'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-05-01'
severity: Moderate
outcome: Not Recovered
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2025-05-01'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed agent and advised stop.
- symptom_name: Hepatotoxicity
onset_date: '2025-05-01'
severity: Moderate
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Atkinson and Sons Medical Center
reporter_type: Nurse
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-588
Date of Submission: 2025-03-01
This report was submitted by a Other Healthcare Professional from Carey, Thomas and Mccullough Medical Center concerning patient ANON-PX-4989. The subject is a 52-year-old other with a significant medical history including asthma, hypertension, atrial fibrillation, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Topical route at a dosage of 242mg, initiated on 2025-01-18 for Pain and inflammation with the course ongoing; Levothyroxine (Thyroid hormone) administered via the Intramuscular route at a dosage of 153mg, initiated on 2025-01-18 for Hypothyroidism with the course ongoing.
On approximately 2025-02-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Pruritus, Hepatotoxicity. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed memory and advised prevent. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Thousand rich war design medical. Democrat coach day its person point size sure.</data>
|
report_id: ADR-2025-588
report_date: '2025-03-01'
patient_details:
patient_id: ANON-PX-4989
gender: Other
relevant_history:
- asthma
- hypertension
- atrial fibrillation
- seasonal allergies
age_at_reaction: 52
suspected_drugs:
- drug_name: Ibuprofen
dosage: 242mg
route_of_administration: Topical
start_date: '2025-01-18'
indication_for_use: Pain and inflammation
drug_class: NSAID
- drug_name: Levothyroxine
dosage: 153mg
route_of_administration: Intramuscular
start_date: '2025-01-18'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-02-19'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-02-19'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed memory and advised prevent.
- symptom_name: Hepatotoxicity
onset_date: '2025-02-19'
severity: Mild
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Carey, Thomas and Mccullough Medical Center
reporter_type: Other Healthcare Professional
notes: Thousand rich war design medical. Democrat coach day its person point size
sure.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-704
Date of Submission: 2025-07-26
This report was submitted by a Physician from Morgan-Clark Medical Center concerning patient ANON-PX-3617. The subject is an adult male with a significant medical history including asthma, seasonal allergies, chronic kidney disease, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen administered via the Topical route at a dosage of 82mg, initiated on 2025-06-04 for Pain and inflammation and discontinued on 2025-07-05.
On approximately 2025-06-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Angioedema, Vomiting. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed own and advised ask. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: New bad medical more ability south treat piece.</data>
|
report_id: ADR-2025-704
report_date: '2025-07-26'
patient_details:
patient_id: ANON-PX-3617
gender: Male
relevant_history:
- asthma
- seasonal allergies
- chronic kidney disease
- migraines
suspected_drugs:
- drug_name: Ibuprofen
dosage: 82mg
route_of_administration: Topical
start_date: '2025-06-04'
indication_for_use: Pain and inflammation
end_date: '2025-07-05'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-07'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-06-07'
severity: Moderate
outcome: Recovering
intervention_required: true
- symptom_name: Vomiting
onset_date: '2025-06-07'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed own and advised ask.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 9
reporting_facility: Morgan-Clark Medical Center
reporter_type: Physician
notes: New bad medical more ability south treat piece.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-903
Date of Submission: 2024-10-27
This report was submitted by a Other Healthcare Professional from Hill PLC Medical Center concerning patient ANON-PX-4035. The subject is a 70-year-old male with a significant medical history including anxiety, osteoarthritis, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Intramuscular route at a dosage of 283mg, initiated on 2024-09-03 for Hypertension and discontinued on 2024-09-26.
On approximately 2024-09-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Pruritus, Maculopapular Rash, Dizziness, Headache. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed foreign and advised thousand. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Full Mr after myself under. His hand be state. Democrat worry relationship.</data>
|
report_id: ADR-2024-903
report_date: '2024-10-27'
patient_details:
patient_id: ANON-PX-4035
gender: Male
relevant_history:
- anxiety
- osteoarthritis
- seasonal allergies
age_at_reaction: 70
suspected_drugs:
- drug_name: Lisinopril
dosage: 283mg
route_of_administration: Intramuscular
start_date: '2024-09-03'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-09-26'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-09-13'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-09-13'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed foreign and advised thousand.
- symptom_name: Maculopapular Rash
onset_date: '2024-09-13'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-09-13'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2024-09-13'
severity: Life-threatening
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 2
reporting_facility: Hill PLC Medical Center
reporter_type: Other Healthcare Professional
notes: Full Mr after myself under. His hand be state. Democrat worry relationship.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-239
Date of Submission: 2025-05-02
This report was submitted by a Nurse from Martinez-Knight Medical Center concerning patient ANON-PX-7000. The subject is a 47-year-old male with a significant medical history including osteoarthritis, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen administered via the Topical route at a dosage of 333mg, initiated on 2025-03-17 for Pain and inflammation and discontinued on 2025-04-27; Sertraline (SSRI) administered via the Oral route at a dosage of 330mg, initiated on 2025-03-17 for Major depressive disorder and discontinued on 2025-04-27.
On approximately 2025-04-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Maculopapular Rash, Hepatotoxicity, Stevens-Johnson syndrome, Anaphylaxis. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed along and advised care. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed artist and advised off. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Call style government ten action above clear. Than certain yard school certain society theory own.</data>
|
report_id: ADR-2025-239
report_date: '2025-05-02'
patient_details:
patient_id: ANON-PX-7000
gender: Male
relevant_history:
- osteoarthritis
- seasonal allergies
age_at_reaction: 47
suspected_drugs:
- drug_name: Ibuprofen
dosage: 333mg
route_of_administration: Topical
start_date: '2025-03-17'
indication_for_use: Pain and inflammation
end_date: '2025-04-27'
- drug_name: Sertraline
dosage: 330mg
route_of_administration: Oral
start_date: '2025-03-17'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-04-27'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-04-24'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-04-24'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-04-24'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed along and advised care.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-24'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-04-24'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed artist and advised off.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 6
reporting_facility: Martinez-Knight Medical Center
reporter_type: Nurse
notes: Call style government ten action above clear. Than certain yard school certain
society theory own.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-234
Date of Submission: 2024-10-27
This report was submitted by a Other Healthcare Professional from Allison, Rice and Haley Medical Center concerning patient ANON-PX-9133. The subject is a 18-year-old female with a significant medical history including type 2 diabetes, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin administered via the Oral route at a dosage of 362mg, initiated on 2024-09-16 for Bacterial infection and discontinued on 2024-10-08; Warfarin administered via the Subcutaneous route at a dosage of 14mg, initiated on 2024-09-16 for Thromboembolism prevention and discontinued on 2024-10-08.
On approximately 2024-09-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Diarrhea, Nausea, Headache, Pruritus. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed stuff and advised technology. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed identify and advised leader. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed woman and advised foot. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed much and advised force. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed paper and advised item. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Baby crime despite cup election suffer. Sometimes mother message interest several best affect.</data>
|
report_id: ADR-2024-234
report_date: '2024-10-27'
patient_details:
patient_id: ANON-PX-9133
gender: Female
relevant_history:
- type 2 diabetes
- asthma
age_at_reaction: 18
suspected_drugs:
- drug_name: Amoxicillin
dosage: 362mg
route_of_administration: Oral
start_date: '2024-09-16'
indication_for_use: Bacterial infection
end_date: '2024-10-08'
- drug_name: Warfarin
dosage: 14mg
route_of_administration: Subcutaneous
start_date: '2024-09-16'
indication_for_use: Thromboembolism prevention
end_date: '2024-10-08'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-09-29'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed stuff and advised technology.
- symptom_name: Diarrhea
onset_date: '2024-09-29'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed identify and advised leader.
- symptom_name: Nausea
onset_date: '2024-09-29'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed woman and advised foot.
- symptom_name: Headache
onset_date: '2024-09-29'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed much and advised force.
- symptom_name: Pruritus
onset_date: '2024-09-29'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed paper and advised item.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Allison, Rice and Haley Medical Center
reporter_type: Other Healthcare Professional
notes: Baby crime despite cup election suffer. Sometimes mother message interest several
best affect.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-760
Date of Submission: 2025-06-06
This report was submitted by a Physician from Snyder, Rivera and Rogers Medical Center concerning patient ANON-PX-6095. The subject is an adult other with a significant medical history including osteoarthritis, anxiety, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin (Anticonvulsant) administered via the Oral route at a dosage of 166mg, initiated on 2025-05-05 for Neuropathic pain and discontinued on 2025-05-23; Atorvastatin (Statin) administered via the Subcutaneous route at a dosage of 192mg, initiated on 2025-05-05 for Hypercholesterolemia and discontinued on 2025-05-23.
On approximately 2025-05-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Angioedema. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed though and advised method. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-760
report_date: '2025-06-06'
patient_details:
patient_id: ANON-PX-6095
gender: Other
relevant_history:
- osteoarthritis
- anxiety
- coronary artery disease
suspected_drugs:
- drug_name: Gabapentin
dosage: 166mg
route_of_administration: Oral
start_date: '2025-05-05'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-05-23'
- drug_name: Atorvastatin
dosage: 192mg
route_of_administration: Subcutaneous
start_date: '2025-05-05'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-05-23'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-05-22'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed though and advised method.
- symptom_name: Angioedema
onset_date: '2025-05-22'
severity: Moderate
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 6
reporting_facility: Snyder, Rivera and Rogers Medical Center
reporter_type: Physician
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-541
Date of Submission: 2025-02-24
This report was submitted by a Nurse from Oneill Inc Medical Center concerning patient ANON-PX-7580. The subject is a 84-year-old other with a significant medical history including migraines, osteoarthritis, atrial fibrillation, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Oral route at a dosage of 51mg, initiated on 2024-12-17 for Pain and inflammation and discontinued on 2025-02-02; Omeprazole administered via the Intramuscular route at a dosage of 403mg, initiated on 2024-12-17 for Gastroesophageal reflux disease and discontinued on 2025-02-02.
On approximately 2025-01-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Hepatotoxicity. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Impact see near use. Report hard present system brother.</data>
|
report_id: ADR-2025-541
report_date: '2025-02-24'
patient_details:
patient_id: ANON-PX-7580
gender: Other
relevant_history:
- migraines
- osteoarthritis
- atrial fibrillation
- type 2 diabetes
age_at_reaction: 84
suspected_drugs:
- drug_name: Ibuprofen
dosage: 51mg
route_of_administration: Oral
start_date: '2024-12-17'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-02-02'
- drug_name: Omeprazole
dosage: 403mg
route_of_administration: Intramuscular
start_date: '2024-12-17'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-02-02'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-01-02'
severity: Life-threatening
outcome: Recovered
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2025-01-02'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Oneill Inc Medical Center
reporter_type: Nurse
notes: Impact see near use. Report hard present system brother.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-306
Date of Submission: 2025-01-29
This report was submitted by a Nurse from Leblanc, Duffy and Thompson Medical Center concerning patient ANON-PX-2485. The subject is a 30-year-old other with a significant medical history including type 2 diabetes, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 361mg, initiated on 2024-11-03 for Neuropathic pain with the course ongoing.
On approximately 2025-01-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Angioedema, Anaphylaxis, Stevens-Johnson syndrome. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed save and advised short. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed series and advised Mr. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-306
report_date: '2025-01-29'
patient_details:
patient_id: ANON-PX-2485
gender: Other
relevant_history:
- type 2 diabetes
- atrial fibrillation
age_at_reaction: 30
suspected_drugs:
- drug_name: Gabapentin
dosage: 361mg
route_of_administration: Subcutaneous
start_date: '2024-11-03'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-01-22'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed save and advised short.
- symptom_name: Angioedema
onset_date: '2025-01-22'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-01-22'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed series and advised Mr.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-01-22'
severity: Severe
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Leblanc, Duffy and Thompson Medical Center
reporter_type: Nurse
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-756
Date of Submission: 2025-03-08
This report was submitted by a Pharmacist from Turner, Parker and Myers Medical Center concerning patient ANON-PX-8075. The subject is a 22-year-old female with a significant medical history including osteoarthritis, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Intramuscular route at a dosage of 223mg, initiated on 2025-02-23 for Type 2 diabetes and discontinued on 2025-03-03; Omeprazole administered via the Oral route at a dosage of 268mg, initiated on 2025-02-23 for Gastroesophageal reflux disease and discontinued on 2025-03-03.
On approximately 2025-02-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Dizziness, Diarrhea, Nausea, Anaphylaxis. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed someone and advised challenge. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed each and advised up. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Return goal turn allow they. Guy open for movie other.</data>
|
report_id: ADR-2025-756
report_date: '2025-03-08'
patient_details:
patient_id: ANON-PX-8075
gender: Female
relevant_history:
- osteoarthritis
- migraines
age_at_reaction: 22
suspected_drugs:
- drug_name: Metformin
dosage: 223mg
route_of_administration: Intramuscular
start_date: '2025-02-23'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-03-03'
- drug_name: Omeprazole
dosage: 268mg
route_of_administration: Oral
start_date: '2025-02-23'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-03-03'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-02-25'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed someone and advised challenge.
- symptom_name: Dizziness
onset_date: '2025-02-25'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-02-25'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-02-25'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed each and advised up.
- symptom_name: Anaphylaxis
onset_date: '2025-02-25'
severity: Severe
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 5
reporting_facility: Turner, Parker and Myers Medical Center
reporter_type: Pharmacist
notes: Return goal turn allow they. Guy open for movie other.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-527
Date of Submission: 2025-01-06
This report was submitted by a Pharmacist from David Inc Medical Center concerning patient ANON-PX-7864. The subject is an adult male with a significant medical history including osteoarthritis, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 212mg, initiated on 2024-12-29 for Hypothyroidism with the course ongoing; Sertraline (SSRI) administered via the Topical route at a dosage of 140mg, initiated on 2024-12-29 for Major depressive disorder with the course ongoing.
On approximately 2025-01-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Headache. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed do and advised few. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-527
report_date: '2025-01-06'
patient_details:
patient_id: ANON-PX-7864
gender: Male
relevant_history:
- osteoarthritis
- type 2 diabetes
suspected_drugs:
- drug_name: Levothyroxine
dosage: 212mg
route_of_administration: Topical
start_date: '2024-12-29'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
- drug_name: Sertraline
dosage: 140mg
route_of_administration: Topical
start_date: '2024-12-29'
indication_for_use: Major depressive disorder
drug_class: SSRI
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-01-04'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed do and advised few.
- symptom_name: Headache
onset_date: '2025-01-04'
severity: Severe
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 3
reporting_facility: David Inc Medical Center
reporter_type: Pharmacist
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-396
Date of Submission: 2024-11-25
This report was submitted by a Patient from Rodriguez Inc Medical Center concerning patient ANON-PX-4543. The subject is an adult female with a significant medical history including hypertension, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 431mg, initiated on 2024-09-06 for Hypothyroidism and discontinued on 2024-11-10.
On approximately 2024-11-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Somnolence, Pruritus, Maculopapular Rash. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed what and advised firm. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed information and advised information. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-396
report_date: '2024-11-25'
patient_details:
patient_id: ANON-PX-4543
gender: Female
relevant_history:
- hypertension
- migraines
suspected_drugs:
- drug_name: Levothyroxine
dosage: 431mg
route_of_administration: Topical
start_date: '2024-09-06'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-11-10'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-11-01'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed what and advised firm.
- symptom_name: Somnolence
onset_date: '2024-11-01'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-11-01'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-11-01'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed information and advised information.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 10
reporting_facility: Rodriguez Inc Medical Center
reporter_type: Patient
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-178
Date of Submission: 2025-04-15
This report was submitted by a Patient from Lopez, Kelly and Thompson Medical Center concerning patient ANON-PX-5239. The subject is a 47-year-old female with a significant medical history including hypertension, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Intramuscular route at a dosage of 362mg, initiated on 2025-02-18 for Type 2 diabetes with the course ongoing; Warfarin (Anticoagulant) administered via the Oral route at a dosage of 104mg, initiated on 2025-02-18 for Thromboembolism prevention with the course ongoing.
On approximately 2025-02-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Diarrhea, Nausea, Pruritus. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed start and advised cup. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed beyond and advised listen. The current patient status regarding this symptom is 'Recovering'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Oil property call indicate get past benefit. Continue hospital participant. Head race another Mrs.</data>
|
report_id: ADR-2025-178
report_date: '2025-04-15'
patient_details:
patient_id: ANON-PX-5239
gender: Female
relevant_history:
- hypertension
- migraines
age_at_reaction: 47
suspected_drugs:
- drug_name: Metformin
dosage: 362mg
route_of_administration: Intramuscular
start_date: '2025-02-18'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
- drug_name: Warfarin
dosage: 104mg
route_of_administration: Oral
start_date: '2025-02-18'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-02-28'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2025-02-28'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed start and advised cup.
- symptom_name: Nausea
onset_date: '2025-02-28'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed beyond and advised listen.
- symptom_name: Pruritus
onset_date: '2025-02-28'
severity: Life-threatening
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 4
reporting_facility: Lopez, Kelly and Thompson Medical Center
reporter_type: Patient
notes: Oil property call indicate get past benefit. Continue hospital participant.
Head race another Mrs.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-386
Date of Submission: 2025-01-11
This report was submitted by a Pharmacist from Booker-Patel Medical Center concerning patient ANON-PX-5507. The subject is a 65-year-old male with a significant medical history including hypertension, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 73mg, initiated on 2024-11-26 for Gastroesophageal reflux disease and discontinued on 2025-01-02; Warfarin (Anticoagulant) administered via the Subcutaneous route at a dosage of 174mg, initiated on 2024-11-26 for Thromboembolism prevention and discontinued on 2025-01-02.
On approximately 2025-01-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Nausea, Diarrhea, Angioedema. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed finally and advised contain. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed management and advised say. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed force and advised born. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-386
report_date: '2025-01-11'
patient_details:
patient_id: ANON-PX-5507
gender: Male
relevant_history:
- hypertension
- atrial fibrillation
age_at_reaction: 65
suspected_drugs:
- drug_name: Omeprazole
dosage: 73mg
route_of_administration: Subcutaneous
start_date: '2024-11-26'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-01-02'
- drug_name: Warfarin
dosage: 174mg
route_of_administration: Subcutaneous
start_date: '2024-11-26'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-01-02'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-01-01'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-01-01'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed finally and advised contain.
- symptom_name: Diarrhea
onset_date: '2025-01-01'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed management and advised say.
- symptom_name: Angioedema
onset_date: '2025-01-01'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed force and advised born.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 8
reporting_facility: Booker-Patel Medical Center
reporter_type: Pharmacist
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-554
Date of Submission: 2024-10-31
This report was submitted by a Pharmacist from Brown LLC Medical Center concerning patient ANON-PX-7991. The subject is an adult male with a significant medical history including chronic kidney disease, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole administered via the Intramuscular route at a dosage of 46mg, initiated on 2024-10-15 for Gastroesophageal reflux disease and discontinued on 2024-10-29.
On approximately 2024-10-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Hepatotoxicity. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Away blue challenge source when. Choice husband ahead fast choose physical.</data>
|
report_id: ADR-2024-554
report_date: '2024-10-31'
patient_details:
patient_id: ANON-PX-7991
gender: Male
relevant_history:
- chronic kidney disease
- hypertension
suspected_drugs:
- drug_name: Omeprazole
dosage: 46mg
route_of_administration: Intramuscular
start_date: '2024-10-15'
indication_for_use: Gastroesophageal reflux disease
end_date: '2024-10-29'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-10-29'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-10-29'
severity: Moderate
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Brown LLC Medical Center
reporter_type: Pharmacist
notes: Away blue challenge source when. Choice husband ahead fast choose physical.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-714
Date of Submission: 2025-08-03
This report was submitted by a Physician from Cox-Williams Medical Center concerning patient ANON-PX-2347. The subject is a 79-year-old other with a significant medical history including anxiety, type 2 diabetes, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 373mg, initiated on 2025-06-27 for Hypertension and discontinued on 2025-07-31.
On approximately 2025-07-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Dizziness. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Fish back drop firm. Design third five education collection professor cold.</data>
|
report_id: ADR-2025-714
report_date: '2025-08-03'
patient_details:
patient_id: ANON-PX-2347
gender: Other
relevant_history:
- anxiety
- type 2 diabetes
- migraines
age_at_reaction: 79
suspected_drugs:
- drug_name: Lisinopril
dosage: 373mg
route_of_administration: Oral
start_date: '2025-06-27'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-07-31'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-07-19'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-07-19'
severity: Mild
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 8
reporting_facility: Cox-Williams Medical Center
reporter_type: Physician
notes: Fish back drop firm. Design third five education collection professor cold.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-131
Date of Submission: 2024-12-14
This report was submitted by a Pharmacist from Brooks PLC Medical Center concerning patient ANON-PX-9888. The subject is a 58-year-old other with a significant medical history including coronary artery disease, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 400mg, initiated on 2024-09-17 for Hypertension and discontinued on 2024-10-31; Metformin administered via the Subcutaneous route at a dosage of 422mg, initiated on 2024-09-17 for Type 2 diabetes and discontinued on 2024-10-31.
On approximately 2024-10-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Maculopapular Rash. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Thousand color look several.</data>
|
report_id: ADR-2024-131
report_date: '2024-12-14'
patient_details:
patient_id: ANON-PX-9888
gender: Other
relevant_history:
- coronary artery disease
- migraines
age_at_reaction: 58
suspected_drugs:
- drug_name: Lisinopril
dosage: 400mg
route_of_administration: Oral
start_date: '2024-09-17'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-10-31'
- drug_name: Metformin
dosage: 422mg
route_of_administration: Subcutaneous
start_date: '2024-09-17'
indication_for_use: Type 2 diabetes
end_date: '2024-10-31'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-10-05'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-10-05'
severity: Severe
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 6
reporting_facility: Brooks PLC Medical Center
reporter_type: Pharmacist
notes: Thousand color look several.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-153
Date of Submission: 2025-06-12
This report was submitted by a Nurse from Andersen, Walker and West Medical Center concerning patient ANON-PX-6334. The subject is a 88-year-old female with a significant medical history including migraines, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin (Anticoagulant) administered via the Subcutaneous route at a dosage of 22mg, initiated on 2025-05-17 for Thromboembolism prevention with the course ongoing.
On approximately 2025-05-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Somnolence, Angioedema, Vomiting. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Wish thus production quality. Since social blood pressure difference.</data>
|
report_id: ADR-2025-153
report_date: '2025-06-12'
patient_details:
patient_id: ANON-PX-6334
gender: Female
relevant_history:
- migraines
- anxiety
age_at_reaction: 88
suspected_drugs:
- drug_name: Warfarin
dosage: 22mg
route_of_administration: Subcutaneous
start_date: '2025-05-17'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-05-25'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-05-25'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-05-25'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-05-25'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 9
reporting_facility: Andersen, Walker and West Medical Center
reporter_type: Nurse
notes: Wish thus production quality. Since social blood pressure difference.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-554
Date of Submission: 2024-12-22
This report was submitted by a Patient from Anderson Group Medical Center concerning patient ANON-PX-7957. The subject is an adult other with a significant medical history including chronic kidney disease, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin administered via the Intravenous route at a dosage of 166mg, initiated on 2024-10-20 for Neuropathic pain with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 151mg, initiated on 2024-10-20 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2024-12-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Dizziness. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed least and advised born. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-554
report_date: '2024-12-22'
patient_details:
patient_id: ANON-PX-7957
gender: Other
relevant_history:
- chronic kidney disease
- migraines
suspected_drugs:
- drug_name: Gabapentin
dosage: 166mg
route_of_administration: Intravenous
start_date: '2024-10-20'
indication_for_use: Neuropathic pain
- drug_name: Omeprazole
dosage: 151mg
route_of_administration: Intramuscular
start_date: '2024-10-20'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-12-02'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-12-02'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed least and advised born.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Anderson Group Medical Center
reporter_type: Patient
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-616
Date of Submission: 2025-02-28
This report was submitted by a Other Healthcare Professional from Campbell Ltd Medical Center concerning patient ANON-PX-4829. The subject is an adult other with a significant medical history including chronic kidney disease, asthma, seasonal allergies, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Oral route at a dosage of 112mg, initiated on 2025-02-12 for Pain and inflammation with the course ongoing; Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 114mg, initiated on 2025-02-12 for Bacterial infection with the course ongoing.
On approximately 2025-02-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Dizziness. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-616
report_date: '2025-02-28'
patient_details:
patient_id: ANON-PX-4829
gender: Other
relevant_history:
- chronic kidney disease
- asthma
- seasonal allergies
- type 2 diabetes
suspected_drugs:
- drug_name: Ibuprofen
dosage: 112mg
route_of_administration: Oral
start_date: '2025-02-12'
indication_for_use: Pain and inflammation
drug_class: NSAID
- drug_name: Amoxicillin
dosage: 114mg
route_of_administration: Oral
start_date: '2025-02-12'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-02-24'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-02-24'
severity: Mild
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Campbell Ltd Medical Center
reporter_type: Other Healthcare Professional
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-887
Date of Submission: 2024-08-26
This report was submitted by a Physician from Shepherd and Sons Medical Center concerning patient ANON-PX-7286. The subject is a 80-year-old male with a significant medical history including type 2 diabetes, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 391mg, initiated on 2024-05-30 for Bacterial infection and discontinued on 2024-07-24.
On approximately 2024-06-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Dizziness, Stevens-Johnson syndrome, Headache. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed summer and advised ball. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed current and advised send. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed scene and advised movement. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed time and advised less. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Billion which how just middle speech. Week gun eye hear second. Power top article material need look figure student.</data>
|
report_id: ADR-2024-887
report_date: '2024-08-26'
patient_details:
patient_id: ANON-PX-7286
gender: Male
relevant_history:
- type 2 diabetes
- migraines
age_at_reaction: 80
suspected_drugs:
- drug_name: Amoxicillin
dosage: 391mg
route_of_administration: Subcutaneous
start_date: '2024-05-30'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-07-24'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-06-07'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed summer and advised ball.
- symptom_name: Dizziness
onset_date: '2024-06-07'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed current and advised send.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-06-07'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed scene and advised movement.
- symptom_name: Headache
onset_date: '2024-06-07'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed time and advised less.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 8
reporting_facility: Shepherd and Sons Medical Center
reporter_type: Physician
notes: Billion which how just middle speech. Week gun eye hear second. Power top article
material need look figure student.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-842
Date of Submission: 2025-02-13
This report was submitted by a Patient from Ponce-Frost Medical Center concerning patient ANON-PX-2930. The subject is an adult male with a significant medical history including migraines, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin administered via the Subcutaneous route at a dosage of 61mg, initiated on 2024-12-20 for Type 2 diabetes and discontinued on 2024-12-30.
On approximately 2024-12-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Vomiting, Headache, Hepatotoxicity, Anaphylaxis. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed behind and advised kind. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed fall and advised fine. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-842
report_date: '2025-02-13'
patient_details:
patient_id: ANON-PX-2930
gender: Male
relevant_history:
- migraines
- coronary artery disease
suspected_drugs:
- drug_name: Metformin
dosage: 61mg
route_of_administration: Subcutaneous
start_date: '2024-12-20'
indication_for_use: Type 2 diabetes
end_date: '2024-12-30'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-12-29'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed behind and advised kind.
- symptom_name: Vomiting
onset_date: '2024-12-29'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Headache
onset_date: '2024-12-29'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-12-29'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed fall and advised fine.
- symptom_name: Anaphylaxis
onset_date: '2024-12-29'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 9
reporting_facility: Ponce-Frost Medical Center
reporter_type: Patient
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-117
Date of Submission: 2024-08-31
This report was submitted by a Nurse from Juarez PLC Medical Center concerning patient ANON-PX-7112. The subject is a 83-year-old male with a significant medical history including osteoarthritis, coronary artery disease, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin administered via the Topical route at a dosage of 204mg, initiated on 2024-06-08 for Hypercholesterolemia and discontinued on 2024-08-26; Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 51mg, initiated on 2024-06-08 for Major depressive disorder and discontinued on 2024-08-26.
On approximately 2024-08-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Angioedema. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Ok public state way. Accept hotel reach deal go. Election toward receive decide month former think.</data>
|
report_id: ADR-2024-117
report_date: '2024-08-31'
patient_details:
patient_id: ANON-PX-7112
gender: Male
relevant_history:
- osteoarthritis
- coronary artery disease
- atrial fibrillation
age_at_reaction: 83
suspected_drugs:
- drug_name: Atorvastatin
dosage: 204mg
route_of_administration: Topical
start_date: '2024-06-08'
indication_for_use: Hypercholesterolemia
end_date: '2024-08-26'
- drug_name: Sertraline
dosage: 51mg
route_of_administration: Subcutaneous
start_date: '2024-06-08'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-08-26'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-08-13'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-08-13'
severity: Mild
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 8
reporting_facility: Juarez PLC Medical Center
reporter_type: Nurse
notes: Ok public state way. Accept hotel reach deal go. Election toward receive decide
month former think.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-374
Date of Submission: 2024-08-23
This report was submitted by a Other Healthcare Professional from Washington-Berry Medical Center concerning patient ANON-PX-8761. The subject is a 50-year-old other with a significant medical history including type 2 diabetes, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Intramuscular route at a dosage of 108mg, initiated on 2024-07-27 for Hypertension and discontinued on 2024-08-18; Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 395mg, initiated on 2024-07-27 for Bacterial infection and discontinued on 2024-08-18.
On approximately 2024-08-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Hepatotoxicity, Maculopapular Rash, Somnolence. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed many and advised back. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Heart major maintain level someone between west provide. Enter rock effect weight little than into. Subject part clearly expect employee them.</data>
|
report_id: ADR-2024-374
report_date: '2024-08-23'
patient_details:
patient_id: ANON-PX-8761
gender: Other
relevant_history:
- type 2 diabetes
- seasonal allergies
age_at_reaction: 50
suspected_drugs:
- drug_name: Lisinopril
dosage: 108mg
route_of_administration: Intramuscular
start_date: '2024-07-27'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-08-18'
- drug_name: Amoxicillin
dosage: 395mg
route_of_administration: Intramuscular
start_date: '2024-07-27'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-08-18'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-12'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-08-12'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-08-12'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-08-12'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed many and advised back.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 3
reporting_facility: Washington-Berry Medical Center
reporter_type: Other Healthcare Professional
notes: Heart major maintain level someone between west provide. Enter rock effect
weight little than into. Subject part clearly expect employee them.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-322
Date of Submission: 2025-04-10
This report was submitted by a Physician from Kim PLC Medical Center concerning patient ANON-PX-2611. The subject is a 52-year-old female with a significant medical history including chronic kidney disease, seasonal allergies, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 467mg, initiated on 2025-04-01 for Neuropathic pain and discontinued on 2025-04-09.
On approximately 2025-04-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Stevens-Johnson syndrome, Hepatotoxicity, Headache. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed school and advised owner. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Deal fly necessary into capital. Gun artist material professional until. Issue thank street also.</data>
|
report_id: ADR-2025-322
report_date: '2025-04-10'
patient_details:
patient_id: ANON-PX-2611
gender: Female
relevant_history:
- chronic kidney disease
- seasonal allergies
- migraines
age_at_reaction: 52
suspected_drugs:
- drug_name: Gabapentin
dosage: 467mg
route_of_administration: Subcutaneous
start_date: '2025-04-01'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-04-09'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-04-05'
severity: Moderate
outcome: Recovering
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-05'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed school and advised owner.
- symptom_name: Hepatotoxicity
onset_date: '2025-04-05'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Headache
onset_date: '2025-04-05'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 2
reporting_facility: Kim PLC Medical Center
reporter_type: Physician
notes: Deal fly necessary into capital. Gun artist material professional until. Issue
thank street also.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-598
Date of Submission: 2024-08-14
This report was submitted by a Physician from Moore Ltd Medical Center concerning patient ANON-PX-6116. The subject is an adult other with a significant medical history including type 2 diabetes, atrial fibrillation, migraines, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 310mg, initiated on 2024-07-09 for Hypertension with the course ongoing; Gabapentin administered via the Topical route at a dosage of 119mg, initiated on 2024-07-09 for Neuropathic pain with the course ongoing.
On approximately 2024-08-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Anaphylaxis, Maculopapular Rash, Hepatotoxicity. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed simply and advised traditional. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed social and advised attorney. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Nor as machine Congress audience make know. Hope card middle quite may lead. Because nearly throughout he alone.</data>
|
report_id: ADR-2024-598
report_date: '2024-08-14'
patient_details:
patient_id: ANON-PX-6116
gender: Other
relevant_history:
- type 2 diabetes
- atrial fibrillation
- migraines
- seasonal allergies
suspected_drugs:
- drug_name: Lisinopril
dosage: 310mg
route_of_administration: Intravenous
start_date: '2024-07-09'
indication_for_use: Hypertension
drug_class: ACE inhibitor
- drug_name: Gabapentin
dosage: 119mg
route_of_administration: Topical
start_date: '2024-07-09'
indication_for_use: Neuropathic pain
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-08-03'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed simply and advised traditional.
- symptom_name: Anaphylaxis
onset_date: '2024-08-03'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-08-03'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-08-03'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed social and advised attorney.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 1
reporting_facility: Moore Ltd Medical Center
reporter_type: Physician
notes: Nor as machine Congress audience make know. Hope card middle quite may lead.
Because nearly throughout he alone.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-520
Date of Submission: 2024-11-20
This report was submitted by a Physician from Ramirez and Sons Medical Center concerning patient ANON-PX-9650. The subject is an adult other with a significant medical history including type 2 diabetes, osteoarthritis, hypertension, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Intramuscular route at a dosage of 163mg, initiated on 2024-10-12 for Hypertension with the course ongoing.
On approximately 2024-11-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Nausea. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed huge and advised our. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: West six represent. Particularly later drug model difficult executive. Operation show week catch.</data>
|
report_id: ADR-2024-520
report_date: '2024-11-20'
patient_details:
patient_id: ANON-PX-9650
gender: Other
relevant_history:
- type 2 diabetes
- osteoarthritis
- hypertension
- atrial fibrillation
suspected_drugs:
- drug_name: Lisinopril
dosage: 163mg
route_of_administration: Intramuscular
start_date: '2024-10-12'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-11-05'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-11-05'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed huge and advised our.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 3
reporting_facility: Ramirez and Sons Medical Center
reporter_type: Physician
notes: West six represent. Particularly later drug model difficult executive. Operation
show week catch.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-791
Date of Submission: 2024-11-24
This report was submitted by a Other Healthcare Professional from Murphy LLC Medical Center concerning patient ANON-PX-7559. The subject is a 22-year-old female with a significant medical history including osteoarthritis, atrial fibrillation, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine (Thyroid hormone) administered via the Intravenous route at a dosage of 6mg, initiated on 2024-10-08 for Hypothyroidism with the course ongoing.
On approximately 2024-11-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Hepatotoxicity, Headache, Anaphylaxis. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed step and advised list. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-791
report_date: '2024-11-24'
patient_details:
patient_id: ANON-PX-7559
gender: Female
relevant_history:
- osteoarthritis
- atrial fibrillation
- seasonal allergies
age_at_reaction: 22
suspected_drugs:
- drug_name: Levothyroxine
dosage: 6mg
route_of_administration: Intravenous
start_date: '2024-10-08'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-22'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-11-22'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Headache
onset_date: '2024-11-22'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-11-22'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed step and advised list.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Murphy LLC Medical Center
reporter_type: Other Healthcare Professional
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-854
Date of Submission: 2024-11-24
This report was submitted by a Nurse from Hubbard-Holder Medical Center concerning patient ANON-PX-2638. The subject is a 29-year-old female with a significant medical history including coronary artery disease, asthma, type 2 diabetes, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Subcutaneous route at a dosage of 424mg, initiated on 2024-11-09 for Type 2 diabetes and discontinued on 2024-11-22; Levothyroxine (Thyroid hormone) administered via the Subcutaneous route at a dosage of 208mg, initiated on 2024-11-09 for Hypothyroidism and discontinued on 2024-11-22.
On approximately 2024-11-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Anaphylaxis. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Short far newspaper rich southern director. Magazine southern state notice. Theory cause road tree provide stage. Newspaper her weight economic benefit benefit.</data>
|
report_id: ADR-2024-854
report_date: '2024-11-24'
patient_details:
patient_id: ANON-PX-2638
gender: Female
relevant_history:
- coronary artery disease
- asthma
- type 2 diabetes
- hypertension
age_at_reaction: 29
suspected_drugs:
- drug_name: Metformin
dosage: 424mg
route_of_administration: Subcutaneous
start_date: '2024-11-09'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-11-22'
- drug_name: Levothyroxine
dosage: 208mg
route_of_administration: Subcutaneous
start_date: '2024-11-09'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-11-22'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-11-19'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-11-19'
severity: Severe
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 5
reporting_facility: Hubbard-Holder Medical Center
reporter_type: Nurse
notes: Short far newspaper rich southern director. Magazine southern state notice.
Theory cause road tree provide stage. Newspaper her weight economic benefit benefit.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-868
Date of Submission: 2024-08-23
This report was submitted by a Nurse from Caldwell-Kelly Medical Center concerning patient ANON-PX-7494. The subject is a 70-year-old male with a significant medical history including atrial fibrillation, migraines, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 466mg, initiated on 2024-07-10 for Gastroesophageal reflux disease with the course ongoing; Atorvastatin administered via the Intramuscular route at a dosage of 127mg, initiated on 2024-07-10 for Hypercholesterolemia with the course ongoing.
On approximately 2024-07-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed modern and advised speech. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-868
report_date: '2024-08-23'
patient_details:
patient_id: ANON-PX-7494
gender: Male
relevant_history:
- atrial fibrillation
- migraines
- anxiety
age_at_reaction: 70
suspected_drugs:
- drug_name: Omeprazole
dosage: 466mg
route_of_administration: Subcutaneous
start_date: '2024-07-10'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Atorvastatin
dosage: 127mg
route_of_administration: Intramuscular
start_date: '2024-07-10'
indication_for_use: Hypercholesterolemia
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-07-19'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-07-19'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed modern and advised speech.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 7
reporting_facility: Caldwell-Kelly Medical Center
reporter_type: Nurse
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-689
Date of Submission: 2025-01-27
This report was submitted by a Other Healthcare Professional from Brewer and Sons Medical Center concerning patient ANON-PX-2391. The subject is a 65-year-old male with a significant medical history including asthma, chronic kidney disease, atrial fibrillation, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen administered via the Intravenous route at a dosage of 168mg, initiated on 2024-12-15 for Pain and inflammation with the course ongoing; Atorvastatin administered via the Intramuscular route at a dosage of 389mg, initiated on 2024-12-15 for Hypercholesterolemia with the course ongoing.
On approximately 2025-01-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Headache, Stevens-Johnson syndrome, Hepatotoxicity. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Financial house question support. Capital full sometimes where seven recognize thousand decide.</data>
|
report_id: ADR-2025-689
report_date: '2025-01-27'
patient_details:
patient_id: ANON-PX-2391
gender: Male
relevant_history:
- asthma
- chronic kidney disease
- atrial fibrillation
- type 2 diabetes
age_at_reaction: 65
suspected_drugs:
- drug_name: Ibuprofen
dosage: 168mg
route_of_administration: Intravenous
start_date: '2024-12-15'
indication_for_use: Pain and inflammation
- drug_name: Atorvastatin
dosage: 389mg
route_of_administration: Intramuscular
start_date: '2024-12-15'
indication_for_use: Hypercholesterolemia
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-01-13'
severity: Moderate
outcome: Not Recovered
intervention_required: true
- symptom_name: Headache
onset_date: '2025-01-13'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-01-13'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-01-13'
severity: Life-threatening
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 8
reporting_facility: Brewer and Sons Medical Center
reporter_type: Other Healthcare Professional
notes: Financial house question support. Capital full sometimes where seven recognize
thousand decide.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-722
Date of Submission: 2024-10-21
This report was submitted by a Other Healthcare Professional from Smith, Tanner and White Medical Center concerning patient ANON-PX-6225. The subject is a 63-year-old male with a significant medical history including hypertension, migraines, coronary artery disease, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 102mg, initiated on 2024-08-22 for Bacterial infection with the course ongoing; Gabapentin administered via the Intramuscular route at a dosage of 363mg, initiated on 2024-08-22 for Neuropathic pain with the course ongoing.
On approximately 2024-10-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Stevens-Johnson syndrome, Dizziness, Diarrhea. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-722
report_date: '2024-10-21'
patient_details:
patient_id: ANON-PX-6225
gender: Male
relevant_history:
- hypertension
- migraines
- coronary artery disease
- seasonal allergies
age_at_reaction: 63
suspected_drugs:
- drug_name: Amoxicillin
dosage: 102mg
route_of_administration: Oral
start_date: '2024-08-22'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
- drug_name: Gabapentin
dosage: 363mg
route_of_administration: Intramuscular
start_date: '2024-08-22'
indication_for_use: Neuropathic pain
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-10-05'
severity: Moderate
outcome: Not Recovered
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-05'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-10-05'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-10-05'
severity: Mild
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 10
reporting_facility: Smith, Tanner and White Medical Center
reporter_type: Other Healthcare Professional
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-389
Date of Submission: 2025-04-24
This report was submitted by a Physician from Huff LLC Medical Center concerning patient ANON-PX-3453. The subject is a 29-year-old male with a significant medical history including coronary artery disease, hypertension, atrial fibrillation, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin (Anticoagulant) administered via the Oral route at a dosage of 160mg, initiated on 2025-01-30 for Thromboembolism prevention and discontinued on 2025-04-16; Metformin (Biguanide) administered via the Intramuscular route at a dosage of 296mg, initiated on 2025-01-30 for Type 2 diabetes and discontinued on 2025-04-16.
On approximately 2025-04-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Pruritus, Hepatotoxicity. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed benefit and advised minute. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed phone and advised economic. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Effect street receive suddenly give worry her. Land can avoid attorney become story.</data>
|
report_id: ADR-2025-389
report_date: '2025-04-24'
patient_details:
patient_id: ANON-PX-3453
gender: Male
relevant_history:
- coronary artery disease
- hypertension
- atrial fibrillation
- asthma
age_at_reaction: 29
suspected_drugs:
- drug_name: Warfarin
dosage: 160mg
route_of_administration: Oral
start_date: '2025-01-30'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-04-16'
- drug_name: Metformin
dosage: 296mg
route_of_administration: Intramuscular
start_date: '2025-01-30'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-04-16'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-04-16'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed benefit and advised minute.
- symptom_name: Pruritus
onset_date: '2025-04-16'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed phone and advised economic.
- symptom_name: Hepatotoxicity
onset_date: '2025-04-16'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 5
reporting_facility: Huff LLC Medical Center
reporter_type: Physician
notes: Effect street receive suddenly give worry her. Land can avoid attorney become
story.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-874
Date of Submission: 2024-11-15
This report was submitted by a Physician from Beltran PLC Medical Center concerning patient ANON-PX-1098. The subject is an adult male with a significant medical history including migraines, coronary artery disease, chronic kidney disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine administered via the Topical route at a dosage of 383mg, initiated on 2024-08-26 for Hypothyroidism with the course ongoing.
On approximately 2024-10-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Nausea. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Full enter hand. Left think green might ability rest leg.</data>
|
report_id: ADR-2024-874
report_date: '2024-11-15'
patient_details:
patient_id: ANON-PX-1098
gender: Male
relevant_history:
- migraines
- coronary artery disease
- chronic kidney disease
suspected_drugs:
- drug_name: Levothyroxine
dosage: 383mg
route_of_administration: Topical
start_date: '2024-08-26'
indication_for_use: Hypothyroidism
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-10-01'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-10-01'
severity: Severe
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 6
reporting_facility: Beltran PLC Medical Center
reporter_type: Physician
notes: Full enter hand. Left think green might ability rest leg.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-229
Date of Submission: 2024-12-14
This report was submitted by a Nurse from Brown, Moreno and Barber Medical Center concerning patient ANON-PX-4686. The subject is a 21-year-old female with a significant medical history including atrial fibrillation, asthma, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Intramuscular route at a dosage of 74mg, initiated on 2024-10-09 for Hypercholesterolemia and discontinued on 2024-12-11; Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 159mg, initiated on 2024-10-09 for Gastroesophageal reflux disease and discontinued on 2024-12-11.
On approximately 2024-11-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Dizziness, Pruritus, Anaphylaxis, Maculopapular Rash. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed point and advised decade. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Card learn woman kitchen soldier human.</data>
|
report_id: ADR-2024-229
report_date: '2024-12-14'
patient_details:
patient_id: ANON-PX-4686
gender: Female
relevant_history:
- atrial fibrillation
- asthma
- seasonal allergies
age_at_reaction: 21
suspected_drugs:
- drug_name: Atorvastatin
dosage: 74mg
route_of_administration: Intramuscular
start_date: '2024-10-09'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-12-11'
- drug_name: Omeprazole
dosage: 159mg
route_of_administration: Oral
start_date: '2024-10-09'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-12-11'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-11-24'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-11-24'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed point and advised decade.
- symptom_name: Pruritus
onset_date: '2024-11-24'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-11-24'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-11-24'
severity: Moderate
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 9
reporting_facility: Brown, Moreno and Barber Medical Center
reporter_type: Nurse
notes: Card learn woman kitchen soldier human.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-667
Date of Submission: 2025-08-09
This report was submitted by a Pharmacist from Jones, Daniel and Dudley Medical Center concerning patient ANON-PX-5208. The subject is an adult female with a significant medical history including seasonal allergies, chronic kidney disease, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 8mg, initiated on 2025-05-21 for Bacterial infection with the course ongoing; Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 477mg, initiated on 2025-05-21 for Hypertension with the course ongoing.
On approximately 2025-05-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Angioedema, Pruritus, Dizziness. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed sing and advised next. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed painting and advised answer. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Trip many thus capital side. Design west billion share skill door growth.</data>
|
report_id: ADR-2025-667
report_date: '2025-08-09'
patient_details:
patient_id: ANON-PX-5208
gender: Female
relevant_history:
- seasonal allergies
- chronic kidney disease
- coronary artery disease
suspected_drugs:
- drug_name: Amoxicillin
dosage: 8mg
route_of_administration: Topical
start_date: '2025-05-21'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
- drug_name: Lisinopril
dosage: 477mg
route_of_administration: Subcutaneous
start_date: '2025-05-21'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-05-30'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed sing and advised next.
- symptom_name: Angioedema
onset_date: '2025-05-30'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-05-30'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed painting and advised answer.
- symptom_name: Dizziness
onset_date: '2025-05-30'
severity: Mild
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 9
reporting_facility: Jones, Daniel and Dudley Medical Center
reporter_type: Pharmacist
notes: Trip many thus capital side. Design west billion share skill door growth.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-108
Date of Submission: 2024-09-20
This report was submitted by a Pharmacist from Lee-Rodriguez Medical Center concerning patient ANON-PX-5302. The subject is a 29-year-old female with a significant medical history including asthma, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin administered via the Oral route at a dosage of 65mg, initiated on 2024-07-03 for Thromboembolism prevention with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 451mg, initiated on 2024-07-03 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2024-09-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Stevens-Johnson syndrome. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed stuff and advised level. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-108
report_date: '2024-09-20'
patient_details:
patient_id: ANON-PX-5302
gender: Female
relevant_history:
- asthma
- anxiety
age_at_reaction: 29
suspected_drugs:
- drug_name: Warfarin
dosage: 65mg
route_of_administration: Oral
start_date: '2024-07-03'
indication_for_use: Thromboembolism prevention
- drug_name: Omeprazole
dosage: 451mg
route_of_administration: Intramuscular
start_date: '2024-07-03'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-09-10'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-09-10'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed stuff and advised level.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 10
reporting_facility: Lee-Rodriguez Medical Center
reporter_type: Pharmacist
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-134
Date of Submission: 2025-07-27
This report was submitted by a Physician from Morgan, Zamora and Torres Medical Center concerning patient ANON-PX-1890. The subject is an adult female with a significant medical history including anxiety, type 2 diabetes, hypertension, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 440mg, initiated on 2025-05-08 for Neuropathic pain and discontinued on 2025-07-18; Metformin (Biguanide) administered via the Intravenous route at a dosage of 105mg, initiated on 2025-05-08 for Type 2 diabetes and discontinued on 2025-07-18.
On approximately 2025-05-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Vomiting, Maculopapular Rash, Angioedema. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed foreign and advised economic. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-134
report_date: '2025-07-27'
patient_details:
patient_id: ANON-PX-1890
gender: Female
relevant_history:
- anxiety
- type 2 diabetes
- hypertension
- migraines
suspected_drugs:
- drug_name: Gabapentin
dosage: 440mg
route_of_administration: Topical
start_date: '2025-05-08'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-07-18'
- drug_name: Metformin
dosage: 105mg
route_of_administration: Intravenous
start_date: '2025-05-08'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-07-18'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-05-15'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-05-15'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-05-15'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-05-15'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed foreign and advised economic.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 5
reporting_facility: Morgan, Zamora and Torres Medical Center
reporter_type: Physician
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-253
Date of Submission: 2024-10-07
This report was submitted by a Physician from Davis-Johnson Medical Center concerning patient ANON-PX-5706. The subject is a 60-year-old male with a significant medical history including seasonal allergies, anxiety, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole administered via the Oral route at a dosage of 145mg, initiated on 2024-07-11 for Gastroesophageal reflux disease and discontinued on 2024-08-16; Atorvastatin (Statin) administered via the Intravenous route at a dosage of 150mg, initiated on 2024-07-11 for Hypercholesterolemia and discontinued on 2024-08-16.
On approximately 2024-08-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Stevens-Johnson syndrome, Angioedema, Dizziness. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed capital and advised physical. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed pick and advised machine. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Wrong for star south. Property knowledge tax debate property keep throw fund. Popular arrive number standard water.</data>
|
report_id: ADR-2024-253
report_date: '2024-10-07'
patient_details:
patient_id: ANON-PX-5706
gender: Male
relevant_history:
- seasonal allergies
- anxiety
- migraines
age_at_reaction: 60
suspected_drugs:
- drug_name: Omeprazole
dosage: 145mg
route_of_administration: Oral
start_date: '2024-07-11'
indication_for_use: Gastroesophageal reflux disease
end_date: '2024-08-16'
- drug_name: Atorvastatin
dosage: 150mg
route_of_administration: Intravenous
start_date: '2024-07-11'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-08-16'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-08-15'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-15'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed capital and advised physical.
- symptom_name: Angioedema
onset_date: '2024-08-15'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed pick and advised machine.
- symptom_name: Dizziness
onset_date: '2024-08-15'
severity: Mild
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 8
reporting_facility: Davis-Johnson Medical Center
reporter_type: Physician
notes: Wrong for star south. Property knowledge tax debate property keep throw fund.
Popular arrive number standard water.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-319
Date of Submission: 2025-01-07
This report was submitted by a Other Healthcare Professional from Williams PLC Medical Center concerning patient ANON-PX-9449. The subject is a 60-year-old female with a significant medical history including migraines, asthma, chronic kidney disease, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Intravenous route at a dosage of 168mg, initiated on 2024-10-14 for Pain and inflammation with the course ongoing; Levothyroxine (Thyroid hormone) administered via the Subcutaneous route at a dosage of 493mg, initiated on 2024-10-14 for Hypothyroidism with the course ongoing.
On approximately 2024-11-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Hepatotoxicity, Nausea, Diarrhea. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed me and advised sport. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Once where interesting think assume buy. Even rather table. Eye but enjoy cost way.</data>
|
report_id: ADR-2025-319
report_date: '2025-01-07'
patient_details:
patient_id: ANON-PX-9449
gender: Female
relevant_history:
- migraines
- asthma
- chronic kidney disease
- atrial fibrillation
age_at_reaction: 60
suspected_drugs:
- drug_name: Ibuprofen
dosage: 168mg
route_of_administration: Intravenous
start_date: '2024-10-14'
indication_for_use: Pain and inflammation
drug_class: NSAID
- drug_name: Levothyroxine
dosage: 493mg
route_of_administration: Subcutaneous
start_date: '2024-10-14'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-11-11'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-11-11'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed me and advised sport.
- symptom_name: Nausea
onset_date: '2024-11-11'
severity: Mild
outcome: Fatal
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2024-11-11'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 2
reporting_facility: Williams PLC Medical Center
reporter_type: Other Healthcare Professional
notes: Once where interesting think assume buy. Even rather table. Eye but enjoy cost
way.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-439
Date of Submission: 2025-02-27
This report was submitted by a Physician from Romero-Stein Medical Center concerning patient ANON-PX-8334. The subject is an adult other with a significant medical history including atrial fibrillation, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin administered via the Subcutaneous route at a dosage of 211mg, initiated on 2025-01-18 for Neuropathic pain with the course ongoing.
On approximately 2025-02-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Headache, Somnolence. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed number and advised finish. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed board and advised agency. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Place partner road. Produce threat item manage rest watch. Executive we there out.</data>
|
report_id: ADR-2025-439
report_date: '2025-02-27'
patient_details:
patient_id: ANON-PX-8334
gender: Other
relevant_history:
- atrial fibrillation
- migraines
suspected_drugs:
- drug_name: Gabapentin
dosage: 211mg
route_of_administration: Subcutaneous
start_date: '2025-01-18'
indication_for_use: Neuropathic pain
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-02-13'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed number and advised finish.
- symptom_name: Headache
onset_date: '2025-02-13'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
- symptom_name: Somnolence
onset_date: '2025-02-13'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed board and advised agency.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 8
reporting_facility: Romero-Stein Medical Center
reporter_type: Physician
notes: Place partner road. Produce threat item manage rest watch. Executive we there
out.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-360
Date of Submission: 2025-03-30
This report was submitted by a Physician from Robertson Inc Medical Center concerning patient ANON-PX-3911. The subject is a 56-year-old male with a significant medical history including anxiety, migraines, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin administered via the Topical route at a dosage of 127mg, initiated on 2025-01-23 for Type 2 diabetes and discontinued on 2025-02-27.
On approximately 2025-02-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Stevens-Johnson syndrome, Angioedema. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed local and advised here. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: New strategy his month girl think. Effect step institution drop woman night relate participant. Race level site cause.</data>
|
report_id: ADR-2025-360
report_date: '2025-03-30'
patient_details:
patient_id: ANON-PX-3911
gender: Male
relevant_history:
- anxiety
- migraines
- asthma
age_at_reaction: 56
suspected_drugs:
- drug_name: Metformin
dosage: 127mg
route_of_administration: Topical
start_date: '2025-01-23'
indication_for_use: Type 2 diabetes
end_date: '2025-02-27'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-02-23'
severity: Severe
outcome: Not Recovered
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-02-23'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-02-23'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed local and advised here.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 8
reporting_facility: Robertson Inc Medical Center
reporter_type: Physician
notes: New strategy his month girl think. Effect step institution drop woman night
relate participant. Race level site cause.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-963
Date of Submission: 2025-08-06
This report was submitted by a Other Healthcare Professional from Mendoza Inc Medical Center concerning patient ANON-PX-6909. The subject is an adult other with a significant medical history including osteoarthritis, asthma, type 2 diabetes, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Topical route at a dosage of 22mg, initiated on 2025-05-30 for Pain and inflammation and discontinued on 2025-08-05; Gabapentin administered via the Intravenous route at a dosage of 245mg, initiated on 2025-05-30 for Neuropathic pain and discontinued on 2025-08-05.
On approximately 2025-07-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Somnolence, Hepatotoxicity, Nausea. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed many and advised forget. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Once approach dog care. Floor audience light.</data>
|
report_id: ADR-2025-963
report_date: '2025-08-06'
patient_details:
patient_id: ANON-PX-6909
gender: Other
relevant_history:
- osteoarthritis
- asthma
- type 2 diabetes
- hypertension
suspected_drugs:
- drug_name: Ibuprofen
dosage: 22mg
route_of_administration: Topical
start_date: '2025-05-30'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-08-05'
- drug_name: Gabapentin
dosage: 245mg
route_of_administration: Intravenous
start_date: '2025-05-30'
indication_for_use: Neuropathic pain
end_date: '2025-08-05'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-07-11'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-07-11'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-07-11'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed many and advised forget.
- symptom_name: Nausea
onset_date: '2025-07-11'
severity: Severe
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Mendoza Inc Medical Center
reporter_type: Other Healthcare Professional
notes: Once approach dog care. Floor audience light.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-581
Date of Submission: 2025-03-23
This report was submitted by a Physician from Ford Group Medical Center concerning patient ANON-PX-2620. The subject is an adult male with a significant medical history including migraines, osteoarthritis, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 165mg, initiated on 2024-12-31 for Hypertension with the course ongoing; Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 485mg, initiated on 2024-12-31 for Pain and inflammation with the course ongoing.
On approximately 2025-01-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Dizziness, Vomiting, Diarrhea, Pruritus. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Size hotel state sea involve create office. Eat bag child standard career old woman bag. Someone board unit agreement the similar.</data>
|
report_id: ADR-2025-581
report_date: '2025-03-23'
patient_details:
patient_id: ANON-PX-2620
gender: Male
relevant_history:
- migraines
- osteoarthritis
- seasonal allergies
suspected_drugs:
- drug_name: Lisinopril
dosage: 165mg
route_of_administration: Oral
start_date: '2024-12-31'
indication_for_use: Hypertension
drug_class: ACE inhibitor
- drug_name: Ibuprofen
dosage: 485mg
route_of_administration: Intramuscular
start_date: '2024-12-31'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-01-18'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-01-18'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-01-18'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-01-18'
severity: Moderate
outcome: Recovered
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-01-18'
severity: Life-threatening
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 3
reporting_facility: Ford Group Medical Center
reporter_type: Physician
notes: Size hotel state sea involve create office. Eat bag child standard career old
woman bag. Someone board unit agreement the similar.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-709
Date of Submission: 2025-01-08
This report was submitted by a Patient from Davis-Medina Medical Center concerning patient ANON-PX-2339. The subject is a 37-year-old male with a significant medical history including asthma, hypertension, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin (Anticoagulant) administered via the Intramuscular route at a dosage of 426mg, initiated on 2024-11-17 for Thromboembolism prevention and discontinued on 2025-01-01; Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 492mg, initiated on 2024-11-17 for Bacterial infection and discontinued on 2025-01-01.
On approximately 2024-12-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Headache, Anaphylaxis, Pruritus, Angioedema. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed tell and advised week. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Investment their area price. Break manage best occur. Impact research write.</data>
|
report_id: ADR-2025-709
report_date: '2025-01-08'
patient_details:
patient_id: ANON-PX-2339
gender: Male
relevant_history:
- asthma
- hypertension
- coronary artery disease
age_at_reaction: 37
suspected_drugs:
- drug_name: Warfarin
dosage: 426mg
route_of_administration: Intramuscular
start_date: '2024-11-17'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-01-01'
- drug_name: Amoxicillin
dosage: 492mg
route_of_administration: Subcutaneous
start_date: '2024-11-17'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-01-01'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-12-13'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Headache
onset_date: '2024-12-13'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-12-13'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed tell and advised week.
- symptom_name: Pruritus
onset_date: '2024-12-13'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-12-13'
severity: Life-threatening
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 7
reporting_facility: Davis-Medina Medical Center
reporter_type: Patient
notes: Investment their area price. Break manage best occur. Impact research write.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-876
Date of Submission: 2025-02-16
This report was submitted by a Physician from Kelley, Kim and Soto Medical Center concerning patient ANON-PX-9862. The subject is a 59-year-old female with a significant medical history including seasonal allergies, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 397mg, initiated on 2025-01-20 for Hypothyroidism and discontinued on 2025-02-12; Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 398mg, initiated on 2025-01-20 for Neuropathic pain and discontinued on 2025-02-12.
On approximately 2025-01-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Stevens-Johnson syndrome. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed modern and advised officer. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-876
report_date: '2025-02-16'
patient_details:
patient_id: ANON-PX-9862
gender: Female
relevant_history:
- seasonal allergies
- osteoarthritis
age_at_reaction: 59
suspected_drugs:
- drug_name: Levothyroxine
dosage: 397mg
route_of_administration: Topical
start_date: '2025-01-20'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2025-02-12'
- drug_name: Gabapentin
dosage: 398mg
route_of_administration: Intravenous
start_date: '2025-01-20'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-02-12'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-01-28'
severity: Severe
outcome: Recovered
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-01-28'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed modern and advised officer.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Kelley, Kim and Soto Medical Center
reporter_type: Physician
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-523
Date of Submission: 2025-02-20
This report was submitted by a Pharmacist from Avila-Chavez Medical Center concerning patient ANON-PX-2646. The subject is a 87-year-old male with a significant medical history including osteoarthritis, atrial fibrillation, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Topical route at a dosage of 20mg, initiated on 2025-01-13 for Major depressive disorder with the course ongoing; Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 120mg, initiated on 2025-01-13 for Neuropathic pain with the course ongoing.
On approximately 2025-02-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Anaphylaxis, Diarrhea, Somnolence, Nausea. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed few and advised point. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-523
report_date: '2025-02-20'
patient_details:
patient_id: ANON-PX-2646
gender: Male
relevant_history:
- osteoarthritis
- atrial fibrillation
- coronary artery disease
age_at_reaction: 87
suspected_drugs:
- drug_name: Sertraline
dosage: 20mg
route_of_administration: Topical
start_date: '2025-01-13'
indication_for_use: Major depressive disorder
drug_class: SSRI
- drug_name: Gabapentin
dosage: 120mg
route_of_administration: Intravenous
start_date: '2025-01-13'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-02-03'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-02-03'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-02-03'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-02-03'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed few and advised point.
- symptom_name: Nausea
onset_date: '2025-02-03'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 8
reporting_facility: Avila-Chavez Medical Center
reporter_type: Pharmacist
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-295
Date of Submission: 2025-05-28
This report was submitted by a Nurse from Lee-Clements Medical Center concerning patient ANON-PX-9107. The subject is a 34-year-old female with a significant medical history including atrial fibrillation, hypertension, coronary artery disease, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin (Anticoagulant) administered via the Oral route at a dosage of 379mg, initiated on 2025-03-18 for Thromboembolism prevention and discontinued on 2025-05-20.
On approximately 2025-05-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Vomiting. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed half and advised structure. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Group kid discuss yet article more stuff church. Own property concern according stage cell. Scientist wait personal week situation. Between from source subject however remain.</data>
|
report_id: ADR-2025-295
report_date: '2025-05-28'
patient_details:
patient_id: ANON-PX-9107
gender: Female
relevant_history:
- atrial fibrillation
- hypertension
- coronary artery disease
- seasonal allergies
age_at_reaction: 34
suspected_drugs:
- drug_name: Warfarin
dosage: 379mg
route_of_administration: Oral
start_date: '2025-03-18'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-05-20'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-05-13'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed half and advised structure.
- symptom_name: Vomiting
onset_date: '2025-05-13'
severity: Severe
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Lee-Clements Medical Center
reporter_type: Nurse
notes: Group kid discuss yet article more stuff church. Own property concern according
stage cell. Scientist wait personal week situation. Between from source subject
however remain.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-193
Date of Submission: 2025-01-17
This report was submitted by a Pharmacist from Hughes, Hubbard and Alvarez Medical Center concerning patient ANON-PX-1718. The subject is a 82-year-old male with a significant medical history including osteoarthritis, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 214mg, initiated on 2024-12-28 for Hypertension and discontinued on 2024-12-30.
On approximately 2024-12-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Somnolence. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Garden data thousand strong smile name in. Cover option natural step begin.</data>
|
report_id: ADR-2025-193
report_date: '2025-01-17'
patient_details:
patient_id: ANON-PX-1718
gender: Male
relevant_history:
- osteoarthritis
- anxiety
age_at_reaction: 82
suspected_drugs:
- drug_name: Lisinopril
dosage: 214mg
route_of_administration: Subcutaneous
start_date: '2024-12-28'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-12-30'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-12-29'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-12-29'
severity: Life-threatening
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 1
reporting_facility: Hughes, Hubbard and Alvarez Medical Center
reporter_type: Pharmacist
notes: Garden data thousand strong smile name in. Cover option natural step begin.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-440
Date of Submission: 2025-01-14
This report was submitted by a Patient from Bass Ltd Medical Center concerning patient ANON-PX-1421. The subject is a 80-year-old other with a significant medical history including chronic kidney disease, anxiety, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Topical route at a dosage of 267mg, initiated on 2024-10-25 for Hypercholesterolemia and discontinued on 2024-12-26.
On approximately 2024-11-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Diarrhea. The Headache was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed strategy and advised better. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-440
report_date: '2025-01-14'
patient_details:
patient_id: ANON-PX-1421
gender: Other
relevant_history:
- chronic kidney disease
- anxiety
- atrial fibrillation
age_at_reaction: 80
suspected_drugs:
- drug_name: Atorvastatin
dosage: 267mg
route_of_administration: Topical
start_date: '2024-10-25'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-12-26'
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-11-13'
severity: Mild
outcome: Not Recovered
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2024-11-13'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed strategy and advised better.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 3
reporting_facility: Bass Ltd Medical Center
reporter_type: Patient
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-326
Date of Submission: 2025-01-09
This report was submitted by a Pharmacist from Kirby, Garcia and Hart Medical Center concerning patient ANON-PX-2906. The subject is a 42-year-old female with a significant medical history including migraines, atrial fibrillation, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Topical route at a dosage of 9mg, initiated on 2024-12-05 for Type 2 diabetes and discontinued on 2024-12-29; Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 406mg, initiated on 2024-12-05 for Hypertension and discontinued on 2024-12-29.
On approximately 2024-12-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Nausea, Anaphylaxis. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed name and advised family. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed voice and advised type. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Market old gun everybody task yourself service. Magazine president history style picture treat course. Toward develop teacher art water.</data>
|
report_id: ADR-2025-326
report_date: '2025-01-09'
patient_details:
patient_id: ANON-PX-2906
gender: Female
relevant_history:
- migraines
- atrial fibrillation
- hypertension
age_at_reaction: 42
suspected_drugs:
- drug_name: Metformin
dosage: 9mg
route_of_administration: Topical
start_date: '2024-12-05'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-12-29'
- drug_name: Lisinopril
dosage: 406mg
route_of_administration: Oral
start_date: '2024-12-05'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-12-29'
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-12-13'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed name and advised family.
- symptom_name: Nausea
onset_date: '2024-12-13'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-12-13'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed voice and advised type.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Kirby, Garcia and Hart Medical Center
reporter_type: Pharmacist
notes: Market old gun everybody task yourself service. Magazine president history
style picture treat course. Toward develop teacher art water.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-124
Date of Submission: 2024-12-01
This report was submitted by a Pharmacist from Cortez Group Medical Center concerning patient ANON-PX-9706. The subject is an adult other with a significant medical history including migraines, hypertension, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline administered via the Topical route at a dosage of 124mg, initiated on 2024-11-11 for Major depressive disorder and discontinued on 2024-11-30; Warfarin (Anticoagulant) administered via the Topical route at a dosage of 160mg, initiated on 2024-11-11 for Thromboembolism prevention and discontinued on 2024-11-30.
On approximately 2024-11-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Nausea, Stevens-Johnson syndrome, Diarrhea, Maculopapular Rash. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: First than what may research clearly. Piece while writer herself something free store.</data>
|
report_id: ADR-2024-124
report_date: '2024-12-01'
patient_details:
patient_id: ANON-PX-9706
gender: Other
relevant_history:
- migraines
- hypertension
- asthma
suspected_drugs:
- drug_name: Sertraline
dosage: 124mg
route_of_administration: Topical
start_date: '2024-11-11'
indication_for_use: Major depressive disorder
end_date: '2024-11-30'
- drug_name: Warfarin
dosage: 160mg
route_of_administration: Topical
start_date: '2024-11-11'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-11-30'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-11-27'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-11-27'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-27'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-11-27'
severity: Severe
outcome: Recovering
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2024-11-27'
severity: Severe
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Cortez Group Medical Center
reporter_type: Pharmacist
notes: First than what may research clearly. Piece while writer herself something
free store.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-962
Date of Submission: 2024-12-03
This report was submitted by a Pharmacist from Shannon LLC Medical Center concerning patient ANON-PX-5397. The subject is a 82-year-old other with a significant medical history including seasonal allergies, osteoarthritis, type 2 diabetes, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Oral route at a dosage of 291mg, initiated on 2024-10-29 for Hypercholesterolemia with the course ongoing.
On approximately 2024-11-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Somnolence, Vomiting, Dizziness. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed the and advised recently. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed wind and advised tonight. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed into and advised marriage. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-962
report_date: '2024-12-03'
patient_details:
patient_id: ANON-PX-5397
gender: Other
relevant_history:
- seasonal allergies
- osteoarthritis
- type 2 diabetes
- atrial fibrillation
age_at_reaction: 82
suspected_drugs:
- drug_name: Atorvastatin
dosage: 291mg
route_of_administration: Oral
start_date: '2024-10-29'
indication_for_use: Hypercholesterolemia
drug_class: Statin
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-11-01'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed the and advised recently.
- symptom_name: Somnolence
onset_date: '2024-11-01'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Vomiting
onset_date: '2024-11-01'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed wind and advised tonight.
- symptom_name: Dizziness
onset_date: '2024-11-01'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed into and advised marriage.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 1
reporting_facility: Shannon LLC Medical Center
reporter_type: Pharmacist
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-966
Date of Submission: 2024-08-16
This report was submitted by a Pharmacist from Oliver PLC Medical Center concerning patient ANON-PX-8761. The subject is a 77-year-old female with a significant medical history including osteoarthritis, chronic kidney disease, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Intramuscular route at a dosage of 414mg, initiated on 2024-07-04 for Hypercholesterolemia with the course ongoing; Lisinopril (ACE inhibitor) administered via the Intramuscular route at a dosage of 350mg, initiated on 2024-07-04 for Hypertension with the course ongoing.
On approximately 2024-08-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Hepatotoxicity. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Those ago condition set particularly wrong coach eight. Relationship his car even. Consumer wish capital standard human degree. While list happy memory evening two.</data>
|
report_id: ADR-2024-966
report_date: '2024-08-16'
patient_details:
patient_id: ANON-PX-8761
gender: Female
relevant_history:
- osteoarthritis
- chronic kidney disease
- seasonal allergies
age_at_reaction: 77
suspected_drugs:
- drug_name: Atorvastatin
dosage: 414mg
route_of_administration: Intramuscular
start_date: '2024-07-04'
indication_for_use: Hypercholesterolemia
drug_class: Statin
- drug_name: Lisinopril
dosage: 350mg
route_of_administration: Intramuscular
start_date: '2024-07-04'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-08-09'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-08-09'
severity: Severe
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Oliver PLC Medical Center
reporter_type: Pharmacist
notes: Those ago condition set particularly wrong coach eight. Relationship his car
even. Consumer wish capital standard human degree. While list happy memory evening
two.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-783
Date of Submission: 2024-09-08
This report was submitted by a Patient from Larsen-Davis Medical Center concerning patient ANON-PX-5182. The subject is an adult female with a significant medical history including migraines, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Subcutaneous route at a dosage of 425mg, initiated on 2024-06-12 for Hypercholesterolemia with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Intravenous route at a dosage of 10mg, initiated on 2024-06-12 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2024-06-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Nausea, Dizziness. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed source and advised see. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Effect energy management most experience.</data>
|
report_id: ADR-2024-783
report_date: '2024-09-08'
patient_details:
patient_id: ANON-PX-5182
gender: Female
relevant_history:
- migraines
- hypertension
suspected_drugs:
- drug_name: Atorvastatin
dosage: 425mg
route_of_administration: Subcutaneous
start_date: '2024-06-12'
indication_for_use: Hypercholesterolemia
drug_class: Statin
- drug_name: Omeprazole
dosage: 10mg
route_of_administration: Intravenous
start_date: '2024-06-12'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-06-30'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed source and advised see.
- symptom_name: Nausea
onset_date: '2024-06-30'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-06-30'
severity: Moderate
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Larsen-Davis Medical Center
reporter_type: Patient
notes: Effect energy management most experience.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-444
Date of Submission: 2025-05-23
This report was submitted by a Nurse from Marshall, Noble and Gonzalez Medical Center concerning patient ANON-PX-4363. The subject is a 55-year-old male with a significant medical history including type 2 diabetes, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 15mg, initiated on 2025-03-13 for Gastroesophageal reflux disease with the course ongoing; Metformin administered via the Intramuscular route at a dosage of 245mg, initiated on 2025-03-13 for Type 2 diabetes with the course ongoing.
On approximately 2025-04-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Dizziness, Nausea. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-444
report_date: '2025-05-23'
patient_details:
patient_id: ANON-PX-4363
gender: Male
relevant_history:
- type 2 diabetes
- seasonal allergies
age_at_reaction: 55
suspected_drugs:
- drug_name: Omeprazole
dosage: 15mg
route_of_administration: Topical
start_date: '2025-03-13'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Metformin
dosage: 245mg
route_of_administration: Intramuscular
start_date: '2025-03-13'
indication_for_use: Type 2 diabetes
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-04-10'
severity: Moderate
outcome: Fatal
intervention_required: true
- symptom_name: Dizziness
onset_date: '2025-04-10'
severity: Moderate
outcome: Recovering
intervention_required: true
- symptom_name: Nausea
onset_date: '2025-04-10'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 7
reporting_facility: Marshall, Noble and Gonzalez Medical Center
reporter_type: Nurse
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-552
Date of Submission: 2024-12-01
This report was submitted by a Other Healthcare Professional from Sims-Luna Medical Center concerning patient ANON-PX-6307. The subject is a 79-year-old male with a significant medical history including asthma, anxiety, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 348mg, initiated on 2024-10-01 for Bacterial infection and discontinued on 2024-11-30; Atorvastatin (Statin) administered via the Subcutaneous route at a dosage of 146mg, initiated on 2024-10-01 for Hypercholesterolemia and discontinued on 2024-11-30.
On approximately 2024-11-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Dizziness, Angioedema. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Public usually example describe direction. Police opportunity themselves close black exist peace doctor. Often list also there focus event bad.</data>
|
report_id: ADR-2024-552
report_date: '2024-12-01'
patient_details:
patient_id: ANON-PX-6307
gender: Male
relevant_history:
- asthma
- anxiety
- atrial fibrillation
age_at_reaction: 79
suspected_drugs:
- drug_name: Amoxicillin
dosage: 348mg
route_of_administration: Topical
start_date: '2024-10-01'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-11-30'
- drug_name: Atorvastatin
dosage: 146mg
route_of_administration: Subcutaneous
start_date: '2024-10-01'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-11-30'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-28'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-11-28'
severity: Mild
outcome: Fatal
intervention_required: true
- symptom_name: Angioedema
onset_date: '2024-11-28'
severity: Severe
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 2
reporting_facility: Sims-Luna Medical Center
reporter_type: Other Healthcare Professional
notes: Public usually example describe direction. Police opportunity themselves close
black exist peace doctor. Often list also there focus event bad.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-247
Date of Submission: 2025-06-25
This report was submitted by a Patient from Phillips, Garcia and Campbell Medical Center concerning patient ANON-PX-1096. The subject is a 63-year-old female with a significant medical history including chronic kidney disease, asthma, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Topical route at a dosage of 403mg, initiated on 2025-05-25 for Major depressive disorder with the course ongoing; Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 175mg, initiated on 2025-05-25 for Hypothyroidism with the course ongoing.
On approximately 2025-06-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Headache. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed significant and advised west. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Option seat college lead. Condition sit court. Help radio describe.</data>
|
report_id: ADR-2025-247
report_date: '2025-06-25'
patient_details:
patient_id: ANON-PX-1096
gender: Female
relevant_history:
- chronic kidney disease
- asthma
- atrial fibrillation
age_at_reaction: 63
suspected_drugs:
- drug_name: Sertraline
dosage: 403mg
route_of_administration: Topical
start_date: '2025-05-25'
indication_for_use: Major depressive disorder
drug_class: SSRI
- drug_name: Levothyroxine
dosage: 175mg
route_of_administration: Topical
start_date: '2025-05-25'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-06-07'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Headache
onset_date: '2025-06-07'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed significant and advised west.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 1
reporting_facility: Phillips, Garcia and Campbell Medical Center
reporter_type: Patient
notes: Option seat college lead. Condition sit court. Help radio describe.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-619
Date of Submission: 2025-06-12
This report was submitted by a Patient from Hall-Castillo Medical Center concerning patient ANON-PX-9104. The subject is a 90-year-old male with a significant medical history including anxiety, atrial fibrillation, migraines, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 187mg, initiated on 2025-03-29 for Gastroesophageal reflux disease and discontinued on 2025-05-01.
On approximately 2025-04-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Pruritus, Hepatotoxicity, Headache. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Baby short class bank strategy interview carry. Team turn TV weight manager sometimes thank. Accept need detail enough according.</data>
|
report_id: ADR-2025-619
report_date: '2025-06-12'
patient_details:
patient_id: ANON-PX-9104
gender: Male
relevant_history:
- anxiety
- atrial fibrillation
- migraines
- coronary artery disease
age_at_reaction: 90
suspected_drugs:
- drug_name: Omeprazole
dosage: 187mg
route_of_administration: Subcutaneous
start_date: '2025-03-29'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-05-01'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-04-27'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-04-27'
severity: Moderate
outcome: Recovered
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2025-04-27'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Headache
onset_date: '2025-04-27'
severity: Severe
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 3
reporting_facility: Hall-Castillo Medical Center
reporter_type: Patient
notes: Baby short class bank strategy interview carry. Team turn TV weight manager
sometimes thank. Accept need detail enough according.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-808
Date of Submission: 2024-09-29
This report was submitted by a Other Healthcare Professional from Duarte, Warren and Davis Medical Center concerning patient ANON-PX-1115. The subject is a 19-year-old female with a significant medical history including chronic kidney disease, anxiety, type 2 diabetes, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin administered via the Intramuscular route at a dosage of 197mg, initiated on 2024-07-13 for Bacterial infection with the course ongoing.
On approximately 2024-09-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Maculopapular Rash, Diarrhea, Angioedema, Dizziness. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed everybody and advised law. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed reflect and advised imagine. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Part item speak something sound test simply hand. Product price anything near federal computer.</data>
|
report_id: ADR-2024-808
report_date: '2024-09-29'
patient_details:
patient_id: ANON-PX-1115
gender: Female
relevant_history:
- chronic kidney disease
- anxiety
- type 2 diabetes
- hypertension
age_at_reaction: 19
suspected_drugs:
- drug_name: Amoxicillin
dosage: 197mg
route_of_administration: Intramuscular
start_date: '2024-07-13'
indication_for_use: Bacterial infection
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-09-20'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-09-20'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-09-20'
severity: Severe
outcome: Unknown
intervention_required: true
- symptom_name: Angioedema
onset_date: '2024-09-20'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed everybody and advised law.
- symptom_name: Dizziness
onset_date: '2024-09-20'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed reflect and advised imagine.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 2
reporting_facility: Duarte, Warren and Davis Medical Center
reporter_type: Other Healthcare Professional
notes: Part item speak something sound test simply hand. Product price anything near
federal computer.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-921
Date of Submission: 2024-09-22
This report was submitted by a Other Healthcare Professional from Vasquez and Sons Medical Center concerning patient ANON-PX-4742. The subject is an adult female with a significant medical history including osteoarthritis, chronic kidney disease, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 172mg, initiated on 2024-07-01 for Gastroesophageal reflux disease and discontinued on 2024-09-08; Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 36mg, initiated on 2024-07-01 for Bacterial infection and discontinued on 2024-09-08.
On approximately 2024-08-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Headache, Pruritus, Hepatotoxicity. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Listen sound gas room. Deep just room song.</data>
|
report_id: ADR-2024-921
report_date: '2024-09-22'
patient_details:
patient_id: ANON-PX-4742
gender: Female
relevant_history:
- osteoarthritis
- chronic kidney disease
- seasonal allergies
suspected_drugs:
- drug_name: Omeprazole
dosage: 172mg
route_of_administration: Topical
start_date: '2024-07-01'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-09-08'
- drug_name: Amoxicillin
dosage: 36mg
route_of_administration: Oral
start_date: '2024-07-01'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-09-08'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-26'
severity: Severe
outcome: Fatal
intervention_required: true
- symptom_name: Headache
onset_date: '2024-08-26'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-08-26'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2024-08-26'
severity: Moderate
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Vasquez and Sons Medical Center
reporter_type: Other Healthcare Professional
notes: Listen sound gas room. Deep just room song.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-945
Date of Submission: 2025-03-10
This report was submitted by a Pharmacist from Fernandez, Holder and Rivera Medical Center concerning patient ANON-PX-1820. The subject is a 58-year-old other with a significant medical history including osteoarthritis, migraines, coronary artery disease, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Topical route at a dosage of 433mg, initiated on 2025-01-28 for Hypertension and discontinued on 2025-02-19.
On approximately 2025-02-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Pruritus, Vomiting, Headache, Nausea. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed over and advised else. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed dream and advised few. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed paper and advised may. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Civil throw suddenly forget education financial event. Call citizen any few. Ago sea so shake.</data>
|
report_id: ADR-2025-945
report_date: '2025-03-10'
patient_details:
patient_id: ANON-PX-1820
gender: Other
relevant_history:
- osteoarthritis
- migraines
- coronary artery disease
- seasonal allergies
age_at_reaction: 58
suspected_drugs:
- drug_name: Lisinopril
dosage: 433mg
route_of_administration: Topical
start_date: '2025-01-28'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-02-19'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-02-13'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed over and advised else.
- symptom_name: Pruritus
onset_date: '2025-02-13'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed dream and advised few.
- symptom_name: Vomiting
onset_date: '2025-02-13'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2025-02-13'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed paper and advised may.
- symptom_name: Nausea
onset_date: '2025-02-13'
severity: Moderate
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 7
reporting_facility: Fernandez, Holder and Rivera Medical Center
reporter_type: Pharmacist
notes: Civil throw suddenly forget education financial event. Call citizen any few.
Ago sea so shake.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-712
Date of Submission: 2025-02-10
This report was submitted by a Patient from Ayers-Palmer Medical Center concerning patient ANON-PX-5580. The subject is an adult male with a significant medical history including seasonal allergies, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine (Thyroid hormone) administered via the Intravenous route at a dosage of 306mg, initiated on 2024-11-24 for Hypothyroidism with the course ongoing.
On approximately 2024-12-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Angioedema. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Week agency know maintain put call edge. Increase door here today. Trip new relationship create notice agreement.</data>
|
report_id: ADR-2025-712
report_date: '2025-02-10'
patient_details:
patient_id: ANON-PX-5580
gender: Male
relevant_history:
- seasonal allergies
- migraines
suspected_drugs:
- drug_name: Levothyroxine
dosage: 306mg
route_of_administration: Intravenous
start_date: '2024-11-24'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-12-17'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Angioedema
onset_date: '2024-12-17'
severity: Severe
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 1
reporting_facility: Ayers-Palmer Medical Center
reporter_type: Patient
notes: Week agency know maintain put call edge. Increase door here today. Trip new
relationship create notice agreement.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-739
Date of Submission: 2025-06-01
This report was submitted by a Nurse from Williams, Davis and Hansen Medical Center concerning patient ANON-PX-7756. The subject is a 44-year-old male with a significant medical history including asthma, type 2 diabetes, hypertension, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin (Anticoagulant) administered via the Topical route at a dosage of 407mg, initiated on 2025-04-14 for Thromboembolism prevention and discontinued on 2025-05-11.
On approximately 2025-04-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Hepatotoxicity, Somnolence. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed money and advised follow. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-739
report_date: '2025-06-01'
patient_details:
patient_id: ANON-PX-7756
gender: Male
relevant_history:
- asthma
- type 2 diabetes
- hypertension
- coronary artery disease
age_at_reaction: 44
suspected_drugs:
- drug_name: Warfarin
dosage: 407mg
route_of_administration: Topical
start_date: '2025-04-14'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-05-11'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-25'
severity: Mild
outcome: Fatal
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2025-04-25'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-04-25'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed money and advised follow.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 1
reporting_facility: Williams, Davis and Hansen Medical Center
reporter_type: Nurse
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-184
Date of Submission: 2025-07-05
This report was submitted by a Other Healthcare Professional from Richardson LLC Medical Center concerning patient ANON-PX-8000. The subject is a 39-year-old female with a significant medical history including anxiety, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Intravenous route at a dosage of 306mg, initiated on 2025-05-25 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2025-06-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Maculopapular Rash, Vomiting. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed serious and advised clearly. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-184
report_date: '2025-07-05'
patient_details:
patient_id: ANON-PX-8000
gender: Female
relevant_history:
- anxiety
- atrial fibrillation
age_at_reaction: 39
suspected_drugs:
- drug_name: Omeprazole
dosage: 306mg
route_of_administration: Intravenous
start_date: '2025-05-25'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-06-02'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-06-02'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed serious and advised clearly.
- symptom_name: Vomiting
onset_date: '2025-06-02'
severity: Severe
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 10
reporting_facility: Richardson LLC Medical Center
reporter_type: Other Healthcare Professional
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-209
Date of Submission: 2024-12-25
This report was submitted by a Other Healthcare Professional from Gray and Sons Medical Center concerning patient ANON-PX-8294. The subject is an adult male with a significant medical history including hypertension, anxiety, coronary artery disease, chronic kidney disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Intravenous route at a dosage of 422mg, initiated on 2024-11-22 for Type 2 diabetes with the course ongoing.
On approximately 2024-11-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Diarrhea, Hepatotoxicity. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed age and advised left. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed check and advised report. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Create us kind quality example until. Professional among level truth large determine which.</data>
|
report_id: ADR-2024-209
report_date: '2024-12-25'
patient_details:
patient_id: ANON-PX-8294
gender: Male
relevant_history:
- hypertension
- anxiety
- coronary artery disease
- chronic kidney disease
suspected_drugs:
- drug_name: Metformin
dosage: 422mg
route_of_administration: Intravenous
start_date: '2024-11-22'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-11-24'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-11-24'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed age and advised left.
- symptom_name: Hepatotoxicity
onset_date: '2024-11-24'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed check and advised report.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 2
reporting_facility: Gray and Sons Medical Center
reporter_type: Other Healthcare Professional
notes: Create us kind quality example until. Professional among level truth large
determine which.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-286
Date of Submission: 2024-11-16
This report was submitted by a Pharmacist from Taylor-Bruce Medical Center concerning patient ANON-PX-5914. The subject is an adult other with a significant medical history including migraines, osteoarthritis, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin administered via the Topical route at a dosage of 75mg, initiated on 2024-08-31 for Neuropathic pain and discontinued on 2024-10-30; Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 318mg, initiated on 2024-08-31 for Pain and inflammation and discontinued on 2024-10-30.
On approximately 2024-09-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Headache, Pruritus, Nausea. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed person and advised policy. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed his and advised language. The current patient status regarding this symptom is 'Recovering'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed store and advised maintain. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Or morning half lose play beat radio. Hear ready though admit.</data>
|
report_id: ADR-2024-286
report_date: '2024-11-16'
patient_details:
patient_id: ANON-PX-5914
gender: Other
relevant_history:
- migraines
- osteoarthritis
- asthma
suspected_drugs:
- drug_name: Gabapentin
dosage: 75mg
route_of_administration: Topical
start_date: '2024-08-31'
indication_for_use: Neuropathic pain
end_date: '2024-10-30'
- drug_name: Ibuprofen
dosage: 318mg
route_of_administration: Intramuscular
start_date: '2024-08-31'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-10-30'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-09-17'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed person and advised policy.
- symptom_name: Headache
onset_date: '2024-09-17'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed his and advised language.
- symptom_name: Pruritus
onset_date: '2024-09-17'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed store and advised maintain.
- symptom_name: Nausea
onset_date: '2024-09-17'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 10
reporting_facility: Taylor-Bruce Medical Center
reporter_type: Pharmacist
notes: Or morning half lose play beat radio. Hear ready though admit.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-559
Date of Submission: 2024-10-05
This report was submitted by a Patient from Peterson, Mooney and Cervantes Medical Center concerning patient ANON-PX-2809. The subject is a 63-year-old male with a significant medical history including chronic kidney disease, hypertension, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin administered via the Intramuscular route at a dosage of 187mg, initiated on 2024-07-21 for Hypercholesterolemia and discontinued on 2024-09-26; Warfarin (Anticoagulant) administered via the Intravenous route at a dosage of 76mg, initiated on 2024-07-21 for Thromboembolism prevention and discontinued on 2024-09-26.
On approximately 2024-08-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Anaphylaxis. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Total social listen east. Network speech toward also fight unit.</data>
|
report_id: ADR-2024-559
report_date: '2024-10-05'
patient_details:
patient_id: ANON-PX-2809
gender: Male
relevant_history:
- chronic kidney disease
- hypertension
- coronary artery disease
age_at_reaction: 63
suspected_drugs:
- drug_name: Atorvastatin
dosage: 187mg
route_of_administration: Intramuscular
start_date: '2024-07-21'
indication_for_use: Hypercholesterolemia
end_date: '2024-09-26'
- drug_name: Warfarin
dosage: 76mg
route_of_administration: Intravenous
start_date: '2024-07-21'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-09-26'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-08-01'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-08-01'
severity: Life-threatening
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 1
reporting_facility: Peterson, Mooney and Cervantes Medical Center
reporter_type: Patient
notes: Total social listen east. Network speech toward also fight unit.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-878
Date of Submission: 2025-06-08
This report was submitted by a Nurse from Anderson, Rivas and Holmes Medical Center concerning patient ANON-PX-5423. The subject is an adult male with a significant medical history including seasonal allergies, chronic kidney disease, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine administered via the Topical route at a dosage of 159mg, initiated on 2025-05-22 for Hypothyroidism and discontinued on 2025-06-06.
On approximately 2025-06-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Headache, Stevens-Johnson syndrome, Vomiting, Hepatotoxicity. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed media and advised summer. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed size and advised only. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-878
report_date: '2025-06-08'
patient_details:
patient_id: ANON-PX-5423
gender: Male
relevant_history:
- seasonal allergies
- chronic kidney disease
- type 2 diabetes
suspected_drugs:
- drug_name: Levothyroxine
dosage: 159mg
route_of_administration: Topical
start_date: '2025-05-22'
indication_for_use: Hypothyroidism
end_date: '2025-06-06'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-06-05'
severity: Mild
outcome: Recovered
intervention_required: true
- symptom_name: Headache
onset_date: '2025-06-05'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-05'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed media and advised summer.
- symptom_name: Vomiting
onset_date: '2025-06-05'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-06-05'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed size and advised only.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 6
reporting_facility: Anderson, Rivas and Holmes Medical Center
reporter_type: Nurse
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-878
Date of Submission: 2024-08-24
This report was submitted by a Pharmacist from Paul, Berry and Terrell Medical Center concerning patient ANON-PX-8849. The subject is an adult female with a significant medical history including type 2 diabetes, migraines, chronic kidney disease, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Topical route at a dosage of 459mg, initiated on 2024-07-24 for Pain and inflammation and discontinued on 2024-08-23; Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 380mg, initiated on 2024-07-24 for Bacterial infection and discontinued on 2024-08-23.
On approximately 2024-08-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Stevens-Johnson syndrome, Somnolence, Maculopapular Rash, Diarrhea. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed water and advised story. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Side they American always.</data>
|
report_id: ADR-2024-878
report_date: '2024-08-24'
patient_details:
patient_id: ANON-PX-8849
gender: Female
relevant_history:
- type 2 diabetes
- migraines
- chronic kidney disease
- asthma
suspected_drugs:
- drug_name: Ibuprofen
dosage: 459mg
route_of_administration: Topical
start_date: '2024-07-24'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-08-23'
- drug_name: Amoxicillin
dosage: 380mg
route_of_administration: Oral
start_date: '2024-07-24'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-08-23'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-08-05'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-05'
severity: Severe
outcome: Recovering
intervention_required: true
- symptom_name: Somnolence
onset_date: '2024-08-05'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-08-05'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-08-05'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed water and advised story.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 9
reporting_facility: Paul, Berry and Terrell Medical Center
reporter_type: Pharmacist
notes: Side they American always.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-214
Date of Submission: 2025-06-21
This report was submitted by a Patient from Floyd PLC Medical Center concerning patient ANON-PX-8034. The subject is a 41-year-old female with a significant medical history including coronary artery disease, anxiety, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Intravenous route at a dosage of 389mg, initiated on 2025-05-17 for Type 2 diabetes with the course ongoing.
On approximately 2025-06-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Nausea, Diarrhea, Maculopapular Rash. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-214
report_date: '2025-06-21'
patient_details:
patient_id: ANON-PX-8034
gender: Female
relevant_history:
- coronary artery disease
- anxiety
- migraines
age_at_reaction: 41
suspected_drugs:
- drug_name: Metformin
dosage: 389mg
route_of_administration: Intravenous
start_date: '2025-05-17'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-06-07'
severity: Moderate
outcome: Recovered
intervention_required: true
- symptom_name: Nausea
onset_date: '2025-06-07'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-06-07'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-06-07'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Floyd PLC Medical Center
reporter_type: Patient
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-397
Date of Submission: 2025-01-04
This report was submitted by a Nurse from Morton-Cole Medical Center concerning patient ANON-PX-6855. The subject is a 60-year-old female with a significant medical history including coronary artery disease, anxiety, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin administered via the Subcutaneous route at a dosage of 268mg, initiated on 2024-12-04 for Thromboembolism prevention with the course ongoing.
On approximately 2024-12-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Vomiting, Somnolence. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed play and advised look. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed training and advised war. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Free be chair exactly. Understand reason lay plant hair.</data>
|
report_id: ADR-2025-397
report_date: '2025-01-04'
patient_details:
patient_id: ANON-PX-6855
gender: Female
relevant_history:
- coronary artery disease
- anxiety
- seasonal allergies
age_at_reaction: 60
suspected_drugs:
- drug_name: Warfarin
dosage: 268mg
route_of_administration: Subcutaneous
start_date: '2024-12-04'
indication_for_use: Thromboembolism prevention
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-12-29'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed play and advised look.
- symptom_name: Vomiting
onset_date: '2024-12-29'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed training and advised war.
- symptom_name: Somnolence
onset_date: '2024-12-29'
severity: Mild
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 8
reporting_facility: Morton-Cole Medical Center
reporter_type: Nurse
notes: Free be chair exactly. Understand reason lay plant hair.
|
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