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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-2025-111
Date of Submission: 2025-01-01
This report was submitted by a Pharmacist from Mason LLC Medical Center concerning patient ANON-PX-5449. The subject is a 74-year-old female with a significant medical history including hypertension, migraines, 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): Atorvastatin (Statin) administered via the Topical route at a dosage of 432mg, initiated on 2024-10-22 for Hypercholesterolemia and discontinued on 2024-12-16.
On approximately 2024-10-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Nausea, Angioedema, Anaphylaxis, Pruritus. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Moderate 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. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis 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 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 5 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: Base participant door carry wind so certainly. Energy modern both too whose positive.</data>
|
report_id: ADR-2025-111
report_date: '2025-01-01'
patient_details:
patient_id: ANON-PX-5449
gender: Female
relevant_history:
- hypertension
- migraines
- seasonal allergies
- atrial fibrillation
age_at_reaction: 74
suspected_drugs:
- drug_name: Atorvastatin
dosage: 432mg
route_of_administration: Topical
start_date: '2024-10-22'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-12-16'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-10-23'
severity: Moderate
outcome: Not Recovered
intervention_required: true
- symptom_name: Nausea
onset_date: '2024-10-23'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-10-23'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-10-23'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-10-23'
severity: Mild
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 5
reporting_facility: Mason LLC Medical Center
reporter_type: Pharmacist
notes: Base participant door carry wind so certainly. Energy modern both too whose
positive.
|
<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-2025-631
Date of Submission: 2025-04-07
This report was submitted by a Nurse from Williams, Collins and Ryan Medical Center concerning patient ANON-PX-5983. The subject is an adult male with a significant medical history including migraines, seasonal allergies, anxiety, 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 Topical route at a dosage of 286mg, initiated on 2025-01-26 for Hypertension and discontinued on 2025-02-25.
On approximately 2025-02-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Diarrhea, Maculopapular Rash, Vomiting, Nausea. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. 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 mean and advised everybody. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Vomiting 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 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 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: Area article community PM want since law often. Relate staff live yeah expert with. Hit treat design themselves resource particularly.</data>
|
report_id: ADR-2025-631
report_date: '2025-04-07'
patient_details:
patient_id: ANON-PX-5983
gender: Male
relevant_history:
- migraines
- seasonal allergies
- anxiety
- hypertension
suspected_drugs:
- drug_name: Lisinopril
dosage: 286mg
route_of_administration: Topical
start_date: '2025-01-26'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-02-25'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-02-04'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-02-04'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed mean and advised everybody.
- symptom_name: Maculopapular Rash
onset_date: '2025-02-04'
severity: Mild
outcome: Recovering
intervention_required: true
- symptom_name: Vomiting
onset_date: '2025-02-04'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-02-04'
severity: Moderate
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 7
reporting_facility: Williams, Collins and Ryan Medical Center
reporter_type: Nurse
notes: Area article community PM want since law often. Relate staff live yeah expert
with. Hit treat design themselves resource particularly.
|
<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-2024-189
Date of Submission: 2024-10-29
This report was submitted by a Physician from Ward-Smith Medical Center concerning patient ANON-PX-1438. The subject is a 18-year-old female with a significant medical history including 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): Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 250mg, initiated on 2024-09-24 for Bacterial infection and discontinued on 2024-10-26; Metformin (Biguanide) administered via the Subcutaneous route at a dosage of 21mg, initiated on 2024-09-24 for Type 2 diabetes and discontinued on 2024-10-26.
On approximately 2024-10-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Stevens-Johnson syndrome. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed join and advised foot. 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.
</data>
|
report_id: ADR-2024-189
report_date: '2024-10-29'
patient_details:
patient_id: ANON-PX-1438
gender: Female
relevant_history:
- chronic kidney disease
- asthma
age_at_reaction: 18
suspected_drugs:
- drug_name: Amoxicillin
dosage: 250mg
route_of_administration: Subcutaneous
start_date: '2024-09-24'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-10-26'
- drug_name: Metformin
dosage: 21mg
route_of_administration: Subcutaneous
start_date: '2024-09-24'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-10-26'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-10-17'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-17'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed join and advised foot.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 8
reporting_facility: Ward-Smith 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-2024-769
Date of Submission: 2024-09-23
This report was submitted by a Nurse from Sawyer, Watts and Simpson Medical Center concerning patient ANON-PX-6574. The subject is a 23-year-old other with a significant medical history including chronic kidney disease, 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 23mg, initiated on 2024-09-04 for Gastroesophageal reflux disease and discontinued on 2024-09-20; Gabapentin (Anticonvulsant) administered via the Oral route at a dosage of 261mg, initiated on 2024-09-04 for Neuropathic pain and discontinued on 2024-09-20.
On approximately 2024-09-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Anaphylaxis, Headache, Somnolence, Dizziness. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. 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 'Fatal'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed technology and advised class. 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 rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Gas model environment hear push. Draw much fund institution. Second simple certain school.</data>
|
report_id: ADR-2024-769
report_date: '2024-09-23'
patient_details:
patient_id: ANON-PX-6574
gender: Other
relevant_history:
- chronic kidney disease
- hypertension
- atrial fibrillation
age_at_reaction: 23
suspected_drugs:
- drug_name: Omeprazole
dosage: 23mg
route_of_administration: Subcutaneous
start_date: '2024-09-04'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-09-20'
- drug_name: Gabapentin
dosage: 261mg
route_of_administration: Oral
start_date: '2024-09-04'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2024-09-20'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-09-19'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-09-19'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Headache
onset_date: '2024-09-19'
severity: Mild
outcome: Not Recovered
intervention_required: true
- symptom_name: Somnolence
onset_date: '2024-09-19'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-09-19'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed technology and advised class.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 5
reporting_facility: Sawyer, Watts and Simpson Medical Center
reporter_type: Nurse
notes: Gas model environment hear push. Draw much fund institution. Second simple
certain school.
|
<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-2025-954
Date of Submission: 2025-07-11
This report was submitted by a Patient from Olson-Young Medical Center concerning patient ANON-PX-9605. The subject is a 71-year-old female with a significant medical history including coronary artery 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): Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 280mg, initiated on 2025-06-14 for Bacterial infection with the course ongoing; Ibuprofen administered via the Intramuscular route at a dosage of 68mg, initiated on 2025-06-14 for Pain and inflammation with the course ongoing.
On approximately 2025-06-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Somnolence, Diarrhea. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed star and advised night. 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 growth and advised become. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed election and advised blue. 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-954
report_date: '2025-07-11'
patient_details:
patient_id: ANON-PX-9605
gender: Female
relevant_history:
- coronary artery disease
- asthma
age_at_reaction: 71
suspected_drugs:
- drug_name: Amoxicillin
dosage: 280mg
route_of_administration: Intramuscular
start_date: '2025-06-14'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
- drug_name: Ibuprofen
dosage: 68mg
route_of_administration: Intramuscular
start_date: '2025-06-14'
indication_for_use: Pain and inflammation
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-06-28'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed star and advised night.
- symptom_name: Somnolence
onset_date: '2025-06-28'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed growth and advised become.
- symptom_name: Diarrhea
onset_date: '2025-06-28'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed election and advised blue.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 6
reporting_facility: Olson-Young 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-2025-504
Date of Submission: 2025-02-10
This report was submitted by a Other Healthcare Professional from Morales Inc Medical Center concerning patient ANON-PX-2307. The subject is a 87-year-old female with a significant medical history including 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 administered via the Intramuscular route at a dosage of 361mg, initiated on 2025-01-10 for Pain and inflammation and discontinued on 2025-02-07.
On approximately 2025-02-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Maculopapular Rash, Pruritus, Anaphylaxis. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Moderate 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 5 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: Son new line sea technology. Grow nothing trial weight including.</data>
|
report_id: ADR-2025-504
report_date: '2025-02-10'
patient_details:
patient_id: ANON-PX-2307
gender: Female
relevant_history:
- type 2 diabetes
- hypertension
age_at_reaction: 87
suspected_drugs:
- drug_name: Ibuprofen
dosage: 361mg
route_of_administration: Intramuscular
start_date: '2025-01-10'
indication_for_use: Pain and inflammation
end_date: '2025-02-07'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-02-06'
severity: Moderate
outcome: Fatal
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2025-02-06'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-02-06'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-02-06'
severity: Moderate
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 5
reporting_facility: Morales Inc Medical Center
reporter_type: Other Healthcare Professional
notes: Son new line sea technology. Grow nothing trial weight including.
|
<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-2024-158
Date of Submission: 2024-12-25
This report was submitted by a Patient from Hurley-Walter Medical Center concerning patient ANON-PX-4435. The subject is an adult female with a significant medical history including migraines, atrial fibrillation, 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): Omeprazole (Proton-pump inhibitor) administered via the Intravenous route at a dosage of 486mg, initiated on 2024-11-30 for Gastroesophageal reflux disease and discontinued on 2024-12-17.
On approximately 2024-12-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Nausea, Stevens-Johnson syndrome, Diarrhea, Anaphylaxis. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed company and advised executive. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed drug and advised smile. 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 listen and advised trip. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed beautiful and advised nature. The current patient status regarding this symptom is 'Fatal'.
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: Billion move go quite PM draw analysis. Point sister protect be billion food.</data>
|
report_id: ADR-2024-158
report_date: '2024-12-25'
patient_details:
patient_id: ANON-PX-4435
gender: Female
relevant_history:
- migraines
- atrial fibrillation
- seasonal allergies
- type 2 diabetes
suspected_drugs:
- drug_name: Omeprazole
dosage: 486mg
route_of_administration: Intravenous
start_date: '2024-11-30'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-12-17'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-12-16'
severity: Severe
outcome: Not Recovered
intervention_required: true
- symptom_name: Nausea
onset_date: '2024-12-16'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed company and advised executive.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-12-16'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed drug and advised smile.
- symptom_name: Diarrhea
onset_date: '2024-12-16'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed listen and advised trip.
- symptom_name: Anaphylaxis
onset_date: '2024-12-16'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed beautiful and advised nature.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 2
reporting_facility: Hurley-Walter Medical Center
reporter_type: Patient
notes: Billion move go quite PM draw analysis. Point sister protect be billion food.
|
<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-2025-699
Date of Submission: 2025-05-07
This report was submitted by a Patient from Moreno, Ross and Ramos Medical Center concerning patient ANON-PX-6289. The subject is a 77-year-old other with a significant medical history including atrial fibrillation, migraines, 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): Levothyroxine administered via the Intramuscular route at a dosage of 274mg, initiated on 2025-02-24 for Hypothyroidism and discontinued on 2025-03-14; Ibuprofen (NSAID) administered via the Oral route at a dosage of 142mg, initiated on 2025-02-24 for Pain and inflammation and discontinued on 2025-03-14.
On approximately 2025-02-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Somnolence, Diarrhea, Anaphylaxis. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed voice and advised song. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Life-threatening 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 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.
</data>
|
report_id: ADR-2025-699
report_date: '2025-05-07'
patient_details:
patient_id: ANON-PX-6289
gender: Other
relevant_history:
- atrial fibrillation
- migraines
- asthma
- anxiety
age_at_reaction: 77
suspected_drugs:
- drug_name: Levothyroxine
dosage: 274mg
route_of_administration: Intramuscular
start_date: '2025-02-24'
indication_for_use: Hypothyroidism
end_date: '2025-03-14'
- drug_name: Ibuprofen
dosage: 142mg
route_of_administration: Oral
start_date: '2025-02-24'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-03-14'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-02-28'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed voice and advised song.
- symptom_name: Somnolence
onset_date: '2025-02-28'
severity: Severe
outcome: Unknown
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2025-02-28'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-02-28'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 3
reporting_facility: Moreno, Ross and Ramos 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-2025-209
Date of Submission: 2025-04-23
This report was submitted by a Pharmacist from Jimenez-Wilson Medical Center concerning patient ANON-PX-4847. The subject is a 76-year-old female with a significant medical history including atrial fibrillation, 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): Atorvastatin administered via the Oral route at a dosage of 362mg, initiated on 2025-01-31 for Hypercholesterolemia and discontinued on 2025-04-20.
On approximately 2025-03-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Angioedema, Anaphylaxis. The Headache 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 Moderate 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. 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-209
report_date: '2025-04-23'
patient_details:
patient_id: ANON-PX-4847
gender: Female
relevant_history:
- atrial fibrillation
- chronic kidney disease
age_at_reaction: 76
suspected_drugs:
- drug_name: Atorvastatin
dosage: 362mg
route_of_administration: Oral
start_date: '2025-01-31'
indication_for_use: Hypercholesterolemia
end_date: '2025-04-20'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-03-18'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Angioedema
onset_date: '2025-03-18'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-03-18'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Jimenez-Wilson 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-2024-686
Date of Submission: 2024-09-10
This report was submitted by a Pharmacist from Moore and Sons Medical Center concerning patient ANON-PX-8978. The subject is an adult other 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): Sertraline (SSRI) administered via the Intravenous route at a dosage of 187mg, initiated on 2024-08-03 for Major depressive disorder and discontinued on 2024-08-29; Levothyroxine (Thyroid hormone) administered via the Intravenous route at a dosage of 408mg, initiated on 2024-08-03 for Hypothyroidism and discontinued on 2024-08-29.
On approximately 2024-08-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Anaphylaxis. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed standard and advised everyone. 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 play and advised have. The current patient status regarding this symptom is 'Recovering'.
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: Enough truth she leg. Newspaper be prevent school style. Again south world herself six could.</data>
|
report_id: ADR-2024-686
report_date: '2024-09-10'
patient_details:
patient_id: ANON-PX-8978
gender: Other
relevant_history:
- chronic kidney disease
- hypertension
suspected_drugs:
- drug_name: Sertraline
dosage: 187mg
route_of_administration: Intravenous
start_date: '2024-08-03'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-08-29'
- drug_name: Levothyroxine
dosage: 408mg
route_of_administration: Intravenous
start_date: '2024-08-03'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-08-29'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-08-24'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed standard and advised everyone.
- symptom_name: Anaphylaxis
onset_date: '2024-08-24'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed play and advised have.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 4
reporting_facility: Moore and Sons Medical Center
reporter_type: Pharmacist
notes: Enough truth she leg. Newspaper be prevent school style. Again south world
herself six could.
|
<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-2025-977
Date of Submission: 2025-02-18
This report was submitted by a Other Healthcare Professional from Mendoza-Mccormick Medical Center concerning patient ANON-PX-9127. The subject is a 36-year-old other with a significant medical history including seasonal allergies, 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): Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 158mg, initiated on 2024-12-24 for Bacterial infection and discontinued on 2025-02-04.
On approximately 2025-02-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Hepatotoxicity, Diarrhea, Nausea, Vomiting. The Dizziness was classified as Severe 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. No specific therapeutic intervention was required. 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 anything and advised six. 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 prevent and advised performance. 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'.
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-2025-977
report_date: '2025-02-18'
patient_details:
patient_id: ANON-PX-9127
gender: Other
relevant_history:
- seasonal allergies
- hypertension
- atrial fibrillation
age_at_reaction: 36
suspected_drugs:
- drug_name: Amoxicillin
dosage: 158mg
route_of_administration: Intramuscular
start_date: '2024-12-24'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-02-04'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-02-04'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-02-04'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-02-04'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed anything and advised six.
- symptom_name: Nausea
onset_date: '2025-02-04'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed prevent and advised performance.
- symptom_name: Vomiting
onset_date: '2025-02-04'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Mendoza-Mccormick 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-2025-394
Date of Submission: 2025-07-11
This report was submitted by a Physician from Ferguson Inc Medical Center concerning patient ANON-PX-7559. The subject is a 44-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): Metformin (Biguanide) administered via the Oral route at a dosage of 73mg, initiated on 2025-04-24 for Type 2 diabetes with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Intravenous route at a dosage of 53mg, initiated on 2025-04-24 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2025-05-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Maculopapular Rash, Nausea. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed left and advised deep. The current patient status regarding this symptom is 'Fatal'. The Nausea 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Pressure improve power data somebody watch measure matter. Building party push box.</data>
|
report_id: ADR-2025-394
report_date: '2025-07-11'
patient_details:
patient_id: ANON-PX-7559
gender: Male
relevant_history:
- seasonal allergies
- chronic kidney disease
- osteoarthritis
age_at_reaction: 44
suspected_drugs:
- drug_name: Metformin
dosage: 73mg
route_of_administration: Oral
start_date: '2025-04-24'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
- drug_name: Omeprazole
dosage: 53mg
route_of_administration: Intravenous
start_date: '2025-04-24'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-05-05'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-05-05'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed left and advised deep.
- symptom_name: Nausea
onset_date: '2025-05-05'
severity: Moderate
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Ferguson Inc Medical Center
reporter_type: Physician
notes: Pressure improve power data somebody watch measure matter. Building party push
box.
|
<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-2024-130
Date of Submission: 2024-10-04
This report was submitted by a Nurse from Smith, Smith and Mclaughlin Medical Center concerning patient ANON-PX-5745. The subject is an adult other 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): Lisinopril administered via the Intravenous route at a dosage of 298mg, initiated on 2024-07-08 for Hypertension and discontinued on 2024-09-02.
On approximately 2024-08-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Diarrhea, Stevens-Johnson syndrome, Hepatotoxicity, Dizziness. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. 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 contain and advised place. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Dizziness 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 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: Huge individual sound can be. Relationship discover more cup power message.</data>
|
report_id: ADR-2024-130
report_date: '2024-10-04'
patient_details:
patient_id: ANON-PX-5745
gender: Other
relevant_history:
- migraines
- hypertension
suspected_drugs:
- drug_name: Lisinopril
dosage: 298mg
route_of_administration: Intravenous
start_date: '2024-07-08'
indication_for_use: Hypertension
end_date: '2024-09-02'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-08-30'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-08-30'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-30'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed contain and advised place.
- symptom_name: Hepatotoxicity
onset_date: '2024-08-30'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-08-30'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 3
reporting_facility: Smith, Smith and Mclaughlin Medical Center
reporter_type: Nurse
notes: Huge individual sound can be. Relationship discover more cup power message.
|
<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-2025-828
Date of Submission: 2025-05-28
This report was submitted by a Nurse from Brewer and Sons Medical Center concerning patient ANON-PX-8238. The subject is a 78-year-old male with a significant medical history including asthma, 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): Sertraline administered via the Oral route at a dosage of 141mg, initiated on 2025-03-30 for Major depressive disorder and discontinued on 2025-05-09.
On approximately 2025-05-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Vomiting, Nausea. The Pruritus was classified as Severe 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. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Life-threatening 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 5 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-2025-828
report_date: '2025-05-28'
patient_details:
patient_id: ANON-PX-8238
gender: Male
relevant_history:
- asthma
- seasonal allergies
- migraines
age_at_reaction: 78
suspected_drugs:
- drug_name: Sertraline
dosage: 141mg
route_of_administration: Oral
start_date: '2025-03-30'
indication_for_use: Major depressive disorder
end_date: '2025-05-09'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-05-08'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-05-08'
severity: Mild
outcome: Fatal
intervention_required: true
- symptom_name: Nausea
onset_date: '2025-05-08'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 5
reporting_facility: Brewer 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-2025-755
Date of Submission: 2025-07-15
This report was submitted by a Pharmacist from Smith-Swanson Medical Center concerning patient ANON-PX-9326. The subject is a 47-year-old other with a significant medical history including 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): Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 52mg, initiated on 2025-06-28 for Pain and inflammation and discontinued on 2025-07-09.
On approximately 2025-06-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Stevens-Johnson syndrome, Dizziness, Hepatotoxicity, Anaphylaxis. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed leader and advised task. 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 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 'Unknown'. The Hepatotoxicity 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 Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed hundred and advised attack. The current patient status regarding this symptom is 'Recovering'.
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.
</data>
|
report_id: ADR-2025-755
report_date: '2025-07-15'
patient_details:
patient_id: ANON-PX-9326
gender: Other
relevant_history:
- hypertension
- coronary artery disease
- seasonal allergies
age_at_reaction: 47
suspected_drugs:
- drug_name: Ibuprofen
dosage: 52mg
route_of_administration: Intramuscular
start_date: '2025-06-28'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-07-09'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-06-29'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed leader and advised task.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-29'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Dizziness
onset_date: '2025-06-29'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-06-29'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-06-29'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed hundred and advised attack.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 9
reporting_facility: Smith-Swanson 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-2025-883
Date of Submission: 2025-04-05
This report was submitted by a Physician from Parks LLC Medical Center concerning patient ANON-PX-7208. The subject is a 36-year-old male with a significant medical history including 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): Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 86mg, initiated on 2025-02-09 for Hypertension with the course ongoing.
On approximately 2025-03-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Diarrhea, Headache, Pruritus, Vomiting. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. 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 Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed future and advised civil. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed east and advised I. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed policy and advised visit. The current patient status regarding this symptom is 'Unknown'.
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.
Reporter's Narrative Summary: Treatment only across stuff responsibility. Body recognize few together mean unit material.</data>
|
report_id: ADR-2025-883
report_date: '2025-04-05'
patient_details:
patient_id: ANON-PX-7208
gender: Male
relevant_history:
- coronary artery disease
- chronic kidney disease
age_at_reaction: 36
suspected_drugs:
- drug_name: Lisinopril
dosage: 86mg
route_of_administration: Oral
start_date: '2025-02-09'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-03-24'
severity: Moderate
outcome: Fatal
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2025-03-24'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2025-03-24'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed future and advised civil.
- symptom_name: Pruritus
onset_date: '2025-03-24'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed east and advised I.
- symptom_name: Vomiting
onset_date: '2025-03-24'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed policy and advised visit.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 7
reporting_facility: Parks LLC Medical Center
reporter_type: Physician
notes: Treatment only across stuff responsibility. Body recognize few together mean
unit material.
|
<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: 2025-02-19
This report was submitted by a Nurse from Ramirez, Hubbard and Preston Medical Center concerning patient ANON-PX-4283. The subject is a 48-year-old other with a significant medical history including 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): Levothyroxine administered via the Topical route at a dosage of 500mg, initiated on 2024-12-16 for Hypothyroidism with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 261mg, initiated on 2024-12-16 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2025-02-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Vomiting, Pruritus. The Diarrhea 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 Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Other remember set arm security. Need deep yourself color.</data>
|
report_id: ADR-2025-667
report_date: '2025-02-19'
patient_details:
patient_id: ANON-PX-4283
gender: Other
relevant_history:
- coronary artery disease
- seasonal allergies
age_at_reaction: 48
suspected_drugs:
- drug_name: Levothyroxine
dosage: 500mg
route_of_administration: Topical
start_date: '2024-12-16'
indication_for_use: Hypothyroidism
- drug_name: Omeprazole
dosage: 261mg
route_of_administration: Oral
start_date: '2024-12-16'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-02-04'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-02-04'
severity: Severe
outcome: Unknown
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-02-04'
severity: Life-threatening
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 5
reporting_facility: Ramirez, Hubbard and Preston Medical Center
reporter_type: Nurse
notes: Other remember set arm security. Need deep yourself 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-2025-633
Date of Submission: 2025-02-09
This report was submitted by a Nurse from Lozano, Weber and Weber Medical Center concerning patient ANON-PX-8255. The subject is an adult other with a significant medical history including hypertension, asthma, 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): Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 50mg, initiated on 2024-12-03 for Gastroesophageal reflux disease and discontinued on 2025-01-20; Levothyroxine administered via the Topical route at a dosage of 10mg, initiated on 2024-12-03 for Hypothyroidism and discontinued on 2025-01-20.
On approximately 2024-12-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Diarrhea, Angioedema, Hepatotoxicity. The Pruritus was classified as Severe 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 'Unknown'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed age and advised couple. 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'.
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: Pull likely its go yard. Play certainly read after PM. Training knowledge sign action.</data>
|
report_id: ADR-2025-633
report_date: '2025-02-09'
patient_details:
patient_id: ANON-PX-8255
gender: Other
relevant_history:
- hypertension
- asthma
- type 2 diabetes
suspected_drugs:
- drug_name: Omeprazole
dosage: 50mg
route_of_administration: Intramuscular
start_date: '2024-12-03'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-01-20'
- drug_name: Levothyroxine
dosage: 10mg
route_of_administration: Topical
start_date: '2024-12-03'
indication_for_use: Hypothyroidism
end_date: '2025-01-20'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-12-30'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-12-30'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Angioedema
onset_date: '2024-12-30'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed age and advised couple.
- symptom_name: Hepatotoxicity
onset_date: '2024-12-30'
severity: Severe
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 2
reporting_facility: Lozano, Weber and Weber Medical Center
reporter_type: Nurse
notes: Pull likely its go yard. Play certainly read after PM. Training knowledge sign
action.
|
<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-2025-451
Date of Submission: 2025-05-17
This report was submitted by a Nurse from Harris, Kent and Wilcox Medical Center concerning patient ANON-PX-4500. The subject is a 18-year-old female 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): Levothyroxine administered via the Intravenous route at a dosage of 196mg, initiated on 2025-04-09 for Hypothyroidism and discontinued on 2025-05-10.
On approximately 2025-05-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Headache, Diarrhea, Dizziness. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. 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 force and advised believe. 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 'Unknown'. The Dizziness was classified as Moderate 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 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: Act time upon car. Hair after full room much Mrs perform.</data>
|
report_id: ADR-2025-451
report_date: '2025-05-17'
patient_details:
patient_id: ANON-PX-4500
gender: Female
relevant_history:
- type 2 diabetes
- seasonal allergies
age_at_reaction: 18
suspected_drugs:
- drug_name: Levothyroxine
dosage: 196mg
route_of_administration: Intravenous
start_date: '2025-04-09'
indication_for_use: Hypothyroidism
end_date: '2025-05-10'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-05-09'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Headache
onset_date: '2025-05-09'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed force and advised believe.
- symptom_name: Diarrhea
onset_date: '2025-05-09'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-05-09'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 10
reporting_facility: Harris, Kent and Wilcox Medical Center
reporter_type: Nurse
notes: Act time upon car. Hair after full room much Mrs perform.
|
<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-2025-589
Date of Submission: 2025-01-09
This report was submitted by a Pharmacist from Allen-Reed Medical Center concerning patient ANON-PX-5630. The subject is a 58-year-old female with a significant medical history including chronic kidney disease, seasonal allergies, 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): Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 486mg, initiated on 2024-10-31 for Neuropathic pain and discontinued on 2024-12-30; Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 393mg, initiated on 2024-10-31 for Gastroesophageal reflux disease and discontinued on 2024-12-30.
On approximately 2024-12-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Stevens-Johnson syndrome, Diarrhea, Maculopapular Rash. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. 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 organization and advised idea. 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 'Recovered'. The Maculopapular Rash 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-589
report_date: '2025-01-09'
patient_details:
patient_id: ANON-PX-5630
gender: Female
relevant_history:
- chronic kidney disease
- seasonal allergies
- anxiety
age_at_reaction: 58
suspected_drugs:
- drug_name: Gabapentin
dosage: 486mg
route_of_administration: Topical
start_date: '2024-10-31'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2024-12-30'
- drug_name: Omeprazole
dosage: 393mg
route_of_administration: Subcutaneous
start_date: '2024-10-31'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-12-30'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-12-16'
severity: Severe
outcome: Unknown
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-12-16'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed organization and advised idea.
- symptom_name: Diarrhea
onset_date: '2024-12-16'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-12-16'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 10
reporting_facility: Allen-Reed 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-2025-943
Date of Submission: 2025-07-04
This report was submitted by a Other Healthcare Professional from Newman-Alvarado Medical Center concerning patient ANON-PX-9601. The subject is a 38-year-old male with a significant medical history including type 2 diabetes, 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): Levothyroxine administered via the Intravenous route at a dosage of 355mg, initiated on 2025-04-26 for Hypothyroidism and discontinued on 2025-06-23; Sertraline administered via the Intravenous route at a dosage of 111mg, initiated on 2025-04-26 for Major depressive disorder and discontinued on 2025-06-23.
On approximately 2025-04-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Angioedema. The Stevens-Johnson syndrome 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 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. 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: Could word myself. Area they require customer son offer statement country.</data>
|
report_id: ADR-2025-943
report_date: '2025-07-04'
patient_details:
patient_id: ANON-PX-9601
gender: Male
relevant_history:
- type 2 diabetes
- seasonal allergies
- coronary artery disease
- osteoarthritis
age_at_reaction: 38
suspected_drugs:
- drug_name: Levothyroxine
dosage: 355mg
route_of_administration: Intravenous
start_date: '2025-04-26'
indication_for_use: Hypothyroidism
end_date: '2025-06-23'
- drug_name: Sertraline
dosage: 111mg
route_of_administration: Intravenous
start_date: '2025-04-26'
indication_for_use: Major depressive disorder
end_date: '2025-06-23'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-29'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-04-29'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Newman-Alvarado Medical Center
reporter_type: Other Healthcare Professional
notes: Could word myself. Area they require customer son offer statement country.
|
<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-2025-116
Date of Submission: 2025-03-04
This report was submitted by a Patient from King, Edwards and Murphy Medical Center concerning patient ANON-PX-2297. The subject is an adult female 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): Warfarin administered via the Intramuscular route at a dosage of 41mg, initiated on 2025-01-21 for Thromboembolism prevention and discontinued on 2025-03-02.
On approximately 2025-03-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Stevens-Johnson syndrome. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. 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 when and advised road. 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-2025-116
report_date: '2025-03-04'
patient_details:
patient_id: ANON-PX-2297
gender: Female
relevant_history:
- chronic kidney disease
- hypertension
suspected_drugs:
- drug_name: Warfarin
dosage: 41mg
route_of_administration: Intramuscular
start_date: '2025-01-21'
indication_for_use: Thromboembolism prevention
end_date: '2025-03-02'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-03-01'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-01'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed when and advised road.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: King, Edwards and Murphy 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-2025-856
Date of Submission: 2025-01-28
This report was submitted by a Patient from Alvarez, Hamilton and Martin Medical Center concerning patient ANON-PX-7050. The subject is an adult male with a significant medical history including atrial fibrillation, 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): Omeprazole administered via the Intramuscular route at a dosage of 9mg, initiated on 2024-12-28 for Gastroesophageal reflux disease with the course ongoing; Levothyroxine administered via the Intramuscular route at a dosage of 419mg, initiated on 2024-12-28 for Hypothyroidism 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 Diarrhea, Stevens-Johnson syndrome, Somnolence. The Diarrhea was classified as Moderate 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. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence 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 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: Cost benefit reality decide involve. Message enough PM most PM responsibility option sell. Shoulder film market course knowledge with.</data>
|
report_id: ADR-2025-856
report_date: '2025-01-28'
patient_details:
patient_id: ANON-PX-7050
gender: Male
relevant_history:
- atrial fibrillation
- type 2 diabetes
- migraines
suspected_drugs:
- drug_name: Omeprazole
dosage: 9mg
route_of_administration: Intramuscular
start_date: '2024-12-28'
indication_for_use: Gastroesophageal reflux disease
- drug_name: Levothyroxine
dosage: 419mg
route_of_administration: Intramuscular
start_date: '2024-12-28'
indication_for_use: Hypothyroidism
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-01-13'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-01-13'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-01-13'
severity: Severe
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 2
reporting_facility: Alvarez, Hamilton and Martin Medical Center
reporter_type: Patient
notes: Cost benefit reality decide involve. Message enough PM most PM responsibility
option sell. Shoulder film market course knowledge with.
|
<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-2025-126
Date of Submission: 2025-03-31
This report was submitted by a Pharmacist from Woodward, Molina and Butler Medical Center concerning patient ANON-PX-7118. The subject is a 39-year-old female with a significant medical history including anxiety, migraines, 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): Ibuprofen administered via the Intramuscular route at a dosage of 30mg, initiated on 2025-01-28 for Pain and inflammation and discontinued on 2025-03-21.
On approximately 2025-03-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Diarrhea, Maculopapular Rash, Angioedema. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed because and advised exactly. 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 high and advised direction. 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 'Unknown'. The Angioedema 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 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.
</data>
|
report_id: ADR-2025-126
report_date: '2025-03-31'
patient_details:
patient_id: ANON-PX-7118
gender: Female
relevant_history:
- anxiety
- migraines
- chronic kidney disease
- coronary artery disease
age_at_reaction: 39
suspected_drugs:
- drug_name: Ibuprofen
dosage: 30mg
route_of_administration: Intramuscular
start_date: '2025-01-28'
indication_for_use: Pain and inflammation
end_date: '2025-03-21'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-03-21'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed because and advised exactly.
- symptom_name: Diarrhea
onset_date: '2025-03-21'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed high and advised direction.
- symptom_name: Maculopapular Rash
onset_date: '2025-03-21'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-03-21'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 1
reporting_facility: Woodward, Molina and Butler 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-2025-599
Date of Submission: 2025-01-30
This report was submitted by a Nurse from Smith-Wheeler Medical Center concerning patient ANON-PX-2332. The subject is a 37-year-old other with a significant medical history including atrial fibrillation, 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): Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 279mg, initiated on 2025-01-17 for Neuropathic pain with the course ongoing.
On approximately 2025-01-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Anaphylaxis, Vomiting, Somnolence. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis 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. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Life-threatening 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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Move public artist study. Sound ground study especially coach government. Way oil assume improve approach party.</data>
|
report_id: ADR-2025-599
report_date: '2025-01-30'
patient_details:
patient_id: ANON-PX-2332
gender: Other
relevant_history:
- atrial fibrillation
- chronic kidney disease
age_at_reaction: 37
suspected_drugs:
- drug_name: Gabapentin
dosage: 279mg
route_of_administration: Intravenous
start_date: '2025-01-17'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-01-24'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-01-24'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Vomiting
onset_date: '2025-01-24'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-01-24'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 2
reporting_facility: Smith-Wheeler Medical Center
reporter_type: Nurse
notes: Move public artist study. Sound ground study especially coach government. Way
oil assume improve approach party.
|
<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-2025-196
Date of Submission: 2025-03-13
This report was submitted by a Physician from Hogan Ltd Medical Center concerning patient ANON-PX-2374. The subject is a 61-year-old male with a significant medical history including type 2 diabetes, 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 Oral route at a dosage of 466mg, initiated on 2025-02-07 for Bacterial infection and discontinued on 2025-02-25; Sertraline administered via the Subcutaneous route at a dosage of 291mg, initiated on 2025-02-07 for Major depressive disorder and discontinued on 2025-02-25.
On approximately 2025-02-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Anaphylaxis, Vomiting, Angioedema. The Somnolence 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 Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed resource and advised event. 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Chair far lose eye mention interesting some. Several low laugh piece production thing test.</data>
|
report_id: ADR-2025-196
report_date: '2025-03-13'
patient_details:
patient_id: ANON-PX-2374
gender: Male
relevant_history:
- type 2 diabetes
- anxiety
- atrial fibrillation
age_at_reaction: 61
suspected_drugs:
- drug_name: Amoxicillin
dosage: 466mg
route_of_administration: Oral
start_date: '2025-02-07'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-02-25'
- drug_name: Sertraline
dosage: 291mg
route_of_administration: Subcutaneous
start_date: '2025-02-07'
indication_for_use: Major depressive disorder
end_date: '2025-02-25'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-02-09'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-02-09'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-02-09'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-02-09'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed resource and advised event.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 2
reporting_facility: Hogan Ltd Medical Center
reporter_type: Physician
notes: Chair far lose eye mention interesting some. Several low laugh piece production
thing test.
|
<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-2025-912
Date of Submission: 2025-06-04
This report was submitted by a Pharmacist from Sanchez LLC Medical Center concerning patient ANON-PX-9489. The subject is a 81-year-old male with a significant medical history including anxiety, osteoarthritis, 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): Sertraline (SSRI) administered via the Topical route at a dosage of 481mg, initiated on 2025-03-16 for Major depressive disorder and discontinued on 2025-04-29; Warfarin administered via the Intravenous route at a dosage of 148mg, initiated on 2025-03-16 for Thromboembolism prevention and discontinued on 2025-04-29.
On approximately 2025-04-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Dizziness. 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 Dizziness 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-912
report_date: '2025-06-04'
patient_details:
patient_id: ANON-PX-9489
gender: Male
relevant_history:
- anxiety
- osteoarthritis
- coronary artery disease
- chronic kidney disease
age_at_reaction: 81
suspected_drugs:
- drug_name: Sertraline
dosage: 481mg
route_of_administration: Topical
start_date: '2025-03-16'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-04-29'
- drug_name: Warfarin
dosage: 148mg
route_of_administration: Intravenous
start_date: '2025-03-16'
indication_for_use: Thromboembolism prevention
end_date: '2025-04-29'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-08'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-04-08'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 7
reporting_facility: Sanchez 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-2024-930
Date of Submission: 2024-08-25
This report was submitted by a Pharmacist from Warren Group Medical Center concerning patient ANON-PX-2658. The subject is a 47-year-old female with a significant medical history including osteoarthritis, coronary artery disease, 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): Atorvastatin (Statin) administered via the Intravenous route at a dosage of 60mg, initiated on 2024-08-11 for Hypercholesterolemia with the course ongoing.
On approximately 2024-08-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Stevens-Johnson syndrome, Maculopapular Rash, Diarrhea. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. 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 'Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed sell and advised eye. The current patient status regarding this symptom is 'Recovering'. The Diarrhea 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 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: Scene audience hear power military ok.</data>
|
report_id: ADR-2024-930
report_date: '2024-08-25'
patient_details:
patient_id: ANON-PX-2658
gender: Female
relevant_history:
- osteoarthritis
- coronary artery disease
- chronic kidney disease
- asthma
age_at_reaction: 47
suspected_drugs:
- drug_name: Atorvastatin
dosage: 60mg
route_of_administration: Intravenous
start_date: '2024-08-11'
indication_for_use: Hypercholesterolemia
drug_class: Statin
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-08-15'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-15'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-08-15'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed sell and advised eye.
- symptom_name: Diarrhea
onset_date: '2024-08-15'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 9
reporting_facility: Warren Group Medical Center
reporter_type: Pharmacist
notes: Scene audience hear power military ok.
|
<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-2025-858
Date of Submission: 2025-06-11
This report was submitted by a Patient from Durham-Flores Medical Center concerning patient ANON-PX-2206. The subject is a 31-year-old female with a significant medical history including asthma, 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): Lisinopril administered via the Topical route at a dosage of 446mg, initiated on 2025-04-01 for Hypertension with the course ongoing.
On approximately 2025-04-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Nausea. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. 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 '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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-858
report_date: '2025-06-11'
patient_details:
patient_id: ANON-PX-2206
gender: Female
relevant_history:
- asthma
- migraines
- coronary artery disease
- hypertension
age_at_reaction: 31
suspected_drugs:
- drug_name: Lisinopril
dosage: 446mg
route_of_administration: Topical
start_date: '2025-04-01'
indication_for_use: Hypertension
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-04-24'
severity: Severe
outcome: Recovering
intervention_required: true
- symptom_name: Nausea
onset_date: '2025-04-24'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 4
reporting_facility: Durham-Flores 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-2024-945
Date of Submission: 2024-11-23
This report was submitted by a Other Healthcare Professional from Mendez-Warren Medical Center concerning patient ANON-PX-2268. The subject is a 42-year-old male with a significant medical history including 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): Gabapentin administered via the Intramuscular route at a dosage of 448mg, initiated on 2024-10-22 for Neuropathic pain and discontinued on 2024-11-09.
On approximately 2024-11-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Dizziness, 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 Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed need and advised itself. 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 'Not Recovered'. The Pruritus 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-945
report_date: '2024-11-23'
patient_details:
patient_id: ANON-PX-2268
gender: Male
relevant_history:
- atrial fibrillation
- hypertension
age_at_reaction: 42
suspected_drugs:
- drug_name: Gabapentin
dosage: 448mg
route_of_administration: Intramuscular
start_date: '2024-10-22'
indication_for_use: Neuropathic pain
end_date: '2024-11-09'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-11-09'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-11-09'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed need and advised itself.
- symptom_name: Headache
onset_date: '2024-11-09'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-11-09'
severity: Moderate
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Mendez-Warren 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-2025-862
Date of Submission: 2025-03-03
This report was submitted by a Patient from Ali Group Medical Center concerning patient ANON-PX-6790. The subject is a 69-year-old male with a significant medical history including coronary artery disease, osteoarthritis, seasonal allergies, 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 Intramuscular route at a dosage of 471mg, initiated on 2024-12-08 for Neuropathic pain and discontinued on 2025-03-02.
On approximately 2025-02-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Diarrhea, Headache, Dizziness, Hepatotoxicity. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Diarrhea 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 Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 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 Hepatotoxicity was classified as Life-threatening 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 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-2025-862
report_date: '2025-03-03'
patient_details:
patient_id: ANON-PX-6790
gender: Male
relevant_history:
- coronary artery disease
- osteoarthritis
- seasonal allergies
- hypertension
age_at_reaction: 69
suspected_drugs:
- drug_name: Gabapentin
dosage: 471mg
route_of_administration: Intramuscular
start_date: '2024-12-08'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-03-02'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-02-27'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2025-02-27'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Headache
onset_date: '2025-02-27'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-02-27'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-02-27'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 5
reporting_facility: Ali 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-2024-681
Date of Submission: 2024-11-03
This report was submitted by a Physician from Gallagher Group Medical Center concerning patient ANON-PX-2400. The subject is a 90-year-old male with a significant medical history including atrial fibrillation, asthma, migraines, 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): Atorvastatin (Statin) administered via the Topical route at a dosage of 81mg, initiated on 2024-10-23 for Hypercholesterolemia and discontinued on 2024-10-30; Omeprazole administered via the Topical route at a dosage of 23mg, initiated on 2024-10-23 for Gastroesophageal reflux disease and discontinued on 2024-10-30.
On approximately 2024-10-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Stevens-Johnson syndrome, Angioedema. The Diarrhea 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 Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed pull and advised want. 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 dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-681
report_date: '2024-11-03'
patient_details:
patient_id: ANON-PX-2400
gender: Male
relevant_history:
- atrial fibrillation
- asthma
- migraines
- chronic kidney disease
age_at_reaction: 90
suspected_drugs:
- drug_name: Atorvastatin
dosage: 81mg
route_of_administration: Topical
start_date: '2024-10-23'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-10-30'
- drug_name: Omeprazole
dosage: 23mg
route_of_administration: Topical
start_date: '2024-10-23'
indication_for_use: Gastroesophageal reflux disease
end_date: '2024-10-30'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-10-28'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-28'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-10-28'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed pull and advised want.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 8
reporting_facility: Gallagher Group 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-2025-900
Date of Submission: 2025-02-14
This report was submitted by a Patient from Smith-Allen Medical Center concerning patient ANON-PX-8724. The subject is a 18-year-old other with a significant medical history including atrial fibrillation, hypertension, 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): Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 162mg, initiated on 2024-11-30 for Neuropathic pain and discontinued on 2025-01-24.
On approximately 2024-12-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Dizziness, Stevens-Johnson syndrome, Nausea, Somnolence. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed attention and advised understand. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed quickly and advised affect. 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 'Recovered'. The Somnolence 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: Safe we rise institution commercial find sort. Popular since indicate catch painting field note.</data>
|
report_id: ADR-2025-900
report_date: '2025-02-14'
patient_details:
patient_id: ANON-PX-8724
gender: Other
relevant_history:
- atrial fibrillation
- hypertension
- chronic kidney disease
age_at_reaction: 18
suspected_drugs:
- drug_name: Gabapentin
dosage: 162mg
route_of_administration: Subcutaneous
start_date: '2024-11-30'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-01-24'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-12-26'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed attention and advised understand.
- symptom_name: Dizziness
onset_date: '2024-12-26'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-12-26'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed quickly and advised affect.
- symptom_name: Nausea
onset_date: '2024-12-26'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-12-26'
severity: Severe
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Smith-Allen Medical Center
reporter_type: Patient
notes: Safe we rise institution commercial find sort. Popular since indicate catch
painting field note.
|
<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-2025-269
Date of Submission: 2025-06-01
This report was submitted by a Pharmacist from Baker, Collins and Cabrera Medical Center concerning patient ANON-PX-1910. The subject is a 52-year-old female with a significant medical history including anxiety, 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): Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 394mg, initiated on 2025-03-12 for Neuropathic pain and discontinued on 2025-05-25; Levothyroxine administered via the Intravenous route at a dosage of 201mg, initiated on 2025-03-12 for Hypothyroidism and discontinued on 2025-05-25.
On approximately 2025-04-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Hepatotoxicity, Headache, Vomiting. The Angioedema 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 Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed deep and advised machine. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed line and advised agency. 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: Way late ability. Girl here summer television war.</data>
|
report_id: ADR-2025-269
report_date: '2025-06-01'
patient_details:
patient_id: ANON-PX-1910
gender: Female
relevant_history:
- anxiety
- seasonal allergies
- atrial fibrillation
age_at_reaction: 52
suspected_drugs:
- drug_name: Gabapentin
dosage: 394mg
route_of_administration: Topical
start_date: '2025-03-12'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-05-25'
- drug_name: Levothyroxine
dosage: 201mg
route_of_administration: Intravenous
start_date: '2025-03-12'
indication_for_use: Hypothyroidism
end_date: '2025-05-25'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-04-18'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-04-18'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed deep and advised machine.
- symptom_name: Headache
onset_date: '2025-04-18'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-04-18'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed line and advised agency.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Baker, Collins and Cabrera Medical Center
reporter_type: Pharmacist
notes: Way late ability. Girl here summer television war.
|
<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-2024-798
Date of Submission: 2024-09-08
This report was submitted by a Pharmacist from Anderson and Sons Medical Center concerning patient ANON-PX-7460. The subject is a 76-year-old female with a significant medical history including seasonal allergies, atrial fibrillation, 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): Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 131mg, initiated on 2024-07-16 for Bacterial infection with the course ongoing; Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 399mg, initiated on 2024-07-16 for Hypertension with the course ongoing.
On approximately 2024-08-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Headache, Stevens-Johnson syndrome. The Hepatotoxicity was classified as Moderate 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 'Fatal'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed purpose and advised gas. 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 dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Boy realize try truth although yes various rich. Condition fall player mission key.</data>
|
report_id: ADR-2024-798
report_date: '2024-09-08'
patient_details:
patient_id: ANON-PX-7460
gender: Female
relevant_history:
- seasonal allergies
- atrial fibrillation
- migraines
- hypertension
age_at_reaction: 76
suspected_drugs:
- drug_name: Amoxicillin
dosage: 131mg
route_of_administration: Topical
start_date: '2024-07-16'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
- drug_name: Lisinopril
dosage: 399mg
route_of_administration: Intravenous
start_date: '2024-07-16'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-08-27'
severity: Moderate
outcome: Fatal
intervention_required: true
- symptom_name: Headache
onset_date: '2024-08-27'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-27'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed purpose and advised gas.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Anderson and Sons Medical Center
reporter_type: Pharmacist
notes: Boy realize try truth although yes various rich. Condition fall player mission
key.
|
<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-2024-950
Date of Submission: 2024-09-25
This report was submitted by a Nurse from Ramirez, Scott and Hall Medical Center concerning patient ANON-PX-3652. The subject is a 26-year-old female with a significant medical history including migraines, asthma, 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): Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 303mg, initiated on 2024-09-04 for Neuropathic pain and discontinued on 2024-09-24.
On approximately 2024-09-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Dizziness. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed say and advised work. 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. 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-2024-950
report_date: '2024-09-25'
patient_details:
patient_id: ANON-PX-3652
gender: Female
relevant_history:
- migraines
- asthma
- coronary artery disease
- hypertension
age_at_reaction: 26
suspected_drugs:
- drug_name: Gabapentin
dosage: 303mg
route_of_administration: Topical
start_date: '2024-09-04'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2024-09-24'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-09-20'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed say and advised work.
- symptom_name: Dizziness
onset_date: '2024-09-20'
severity: Mild
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Ramirez, Scott and Hall 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-2024-640
Date of Submission: 2024-12-26
This report was submitted by a Physician from Hernandez Inc Medical Center concerning patient ANON-PX-2138. The subject is a 83-year-old male with a significant medical history including osteoarthritis, 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): Omeprazole administered via the Topical route at a dosage of 243mg, initiated on 2024-11-07 for Gastroesophageal reflux disease and discontinued on 2024-12-14.
On approximately 2024-12-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Dizziness, Stevens-Johnson syndrome. 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 Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed state and advised others. The current patient status regarding this symptom is 'Unknown'. 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. 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: Tax too home information. Crime difference away create explain might president.</data>
|
report_id: ADR-2024-640
report_date: '2024-12-26'
patient_details:
patient_id: ANON-PX-2138
gender: Male
relevant_history:
- osteoarthritis
- hypertension
- coronary artery disease
age_at_reaction: 83
suspected_drugs:
- drug_name: Omeprazole
dosage: 243mg
route_of_administration: Topical
start_date: '2024-11-07'
indication_for_use: Gastroesophageal reflux disease
end_date: '2024-12-14'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-12-09'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-12-09'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed state and advised others.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-12-09'
severity: Life-threatening
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Hernandez Inc Medical Center
reporter_type: Physician
notes: Tax too home information. Crime difference away create explain might president.
|
<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-2025-332
Date of Submission: 2025-07-15
This report was submitted by a Other Healthcare Professional from Johnson, Price and Perez Medical Center concerning patient ANON-PX-4595. The subject is a 35-year-old male with a significant medical history including hypertension, 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): Gabapentin administered via the Topical route at a dosage of 58mg, initiated on 2025-07-04 for Neuropathic pain and discontinued on 2025-07-13.
On approximately 2025-07-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Dizziness. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed want and advised push. The current patient status regarding this symptom is 'Recovered'. 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'.
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-2025-332
report_date: '2025-07-15'
patient_details:
patient_id: ANON-PX-4595
gender: Male
relevant_history:
- hypertension
- type 2 diabetes
- asthma
age_at_reaction: 35
suspected_drugs:
- drug_name: Gabapentin
dosage: 58mg
route_of_administration: Topical
start_date: '2025-07-04'
indication_for_use: Neuropathic pain
end_date: '2025-07-13'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-07-12'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed want and advised push.
- symptom_name: Dizziness
onset_date: '2025-07-12'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 8
reporting_facility: Johnson, Price and Perez 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-2024-951
Date of Submission: 2024-09-19
This report was submitted by a Pharmacist from Ellis, White and Hernandez Medical Center concerning patient ANON-PX-3679. The subject is a 85-year-old other with a significant medical history including 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): Sertraline administered via the Intravenous route at a dosage of 431mg, initiated on 2024-08-19 for Major depressive disorder and discontinued on 2024-09-16; Levothyroxine (Thyroid hormone) administered via the Intramuscular route at a dosage of 278mg, initiated on 2024-08-19 for Hypothyroidism and discontinued on 2024-09-16.
On approximately 2024-08-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Headache. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed myself and advised wind. The current patient status regarding this symptom is 'Not Recovered'. The Headache 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: You where get few each herself imagine. News country agency mouth watch. Candidate system think radio life drug floor.</data>
|
report_id: ADR-2024-951
report_date: '2024-09-19'
patient_details:
patient_id: ANON-PX-3679
gender: Other
relevant_history:
- chronic kidney disease
- type 2 diabetes
age_at_reaction: 85
suspected_drugs:
- drug_name: Sertraline
dosage: 431mg
route_of_administration: Intravenous
start_date: '2024-08-19'
indication_for_use: Major depressive disorder
end_date: '2024-09-16'
- drug_name: Levothyroxine
dosage: 278mg
route_of_administration: Intramuscular
start_date: '2024-08-19'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-09-16'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-08-28'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed myself and advised wind.
- symptom_name: Headache
onset_date: '2024-08-28'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 7
reporting_facility: Ellis, White and Hernandez Medical Center
reporter_type: Pharmacist
notes: You where get few each herself imagine. News country agency mouth watch. Candidate
system think radio life drug floor.
|
<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-2025-166
Date of Submission: 2025-04-01
This report was submitted by a Other Healthcare Professional from Mays PLC Medical Center concerning patient ANON-PX-2344. The subject is a 48-year-old female with a significant medical history including 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 Intravenous route at a dosage of 114mg, initiated on 2025-03-23 for Neuropathic pain with the course ongoing.
On approximately 2025-03-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Maculopapular Rash. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. 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 must and advised glass. The current patient status regarding this symptom is 'Recovering'.
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-2025-166
report_date: '2025-04-01'
patient_details:
patient_id: ANON-PX-2344
gender: Female
relevant_history:
- osteoarthritis
- asthma
age_at_reaction: 48
suspected_drugs:
- drug_name: Gabapentin
dosage: 114mg
route_of_administration: Intravenous
start_date: '2025-03-23'
indication_for_use: Neuropathic pain
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-03-27'
severity: Mild
outcome: Unknown
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2025-03-27'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed must and advised glass.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 4
reporting_facility: Mays PLC 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-2025-473
Date of Submission: 2025-01-22
This report was submitted by a Patient from Baker, Morris and Dodson Medical Center concerning patient ANON-PX-6879. The subject is a 77-year-old female 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): Warfarin administered via the Subcutaneous route at a dosage of 55mg, initiated on 2024-11-18 for Thromboembolism prevention and discontinued on 2024-12-25; Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 58mg, initiated on 2024-11-18 for Gastroesophageal reflux disease and discontinued on 2024-12-25.
On approximately 2024-11-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Diarrhea, Pruritus, Angioedema, Nausea. 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 'Unknown'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed month and advised husband. The current patient status regarding this symptom is '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 Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed those and advised level. The current patient status regarding this symptom is 'Recovering'. The Nausea 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-2025-473
report_date: '2025-01-22'
patient_details:
patient_id: ANON-PX-6879
gender: Female
relevant_history:
- migraines
- coronary artery disease
age_at_reaction: 77
suspected_drugs:
- drug_name: Warfarin
dosage: 55mg
route_of_administration: Subcutaneous
start_date: '2024-11-18'
indication_for_use: Thromboembolism prevention
end_date: '2024-12-25'
- drug_name: Omeprazole
dosage: 58mg
route_of_administration: Oral
start_date: '2024-11-18'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-12-25'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-25'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-11-25'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed month and advised husband.
- symptom_name: Pruritus
onset_date: '2024-11-25'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-11-25'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed those and advised level.
- symptom_name: Nausea
onset_date: '2024-11-25'
severity: Mild
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Baker, Morris and Dodson 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-2024-887
Date of Submission: 2024-09-14
This report was submitted by a Other Healthcare Professional from Lewis, Arroyo and Wheeler Medical Center concerning patient ANON-PX-5524. The subject is a 18-year-old other with a significant medical history including type 2 diabetes, 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): Amoxicillin administered via the Intravenous route at a dosage of 39mg, initiated on 2024-07-29 for Bacterial infection and discontinued on 2024-09-07; Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 477mg, initiated on 2024-07-29 for Pain and inflammation and discontinued on 2024-09-07.
On approximately 2024-08-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Pruritus, Maculopapular Rash, Somnolence, Dizziness. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Pruritus 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 Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed common and advised million. 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 'Unknown'. The Dizziness 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 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: Light plant black different month left. Game wear pass against poor among believe. Cell television opportunity baby doctor pay hour.</data>
|
report_id: ADR-2024-887
report_date: '2024-09-14'
patient_details:
patient_id: ANON-PX-5524
gender: Other
relevant_history:
- type 2 diabetes
- atrial fibrillation
- asthma
age_at_reaction: 18
suspected_drugs:
- drug_name: Amoxicillin
dosage: 39mg
route_of_administration: Intravenous
start_date: '2024-07-29'
indication_for_use: Bacterial infection
end_date: '2024-09-07'
- drug_name: Ibuprofen
dosage: 477mg
route_of_administration: Intramuscular
start_date: '2024-07-29'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-09-07'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-08-06'
severity: Moderate
outcome: Fatal
intervention_required: true
- symptom_name: Pruritus
onset_date: '2024-08-06'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-08-06'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed common and advised million.
- symptom_name: Somnolence
onset_date: '2024-08-06'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-08-06'
severity: Mild
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 10
reporting_facility: Lewis, Arroyo and Wheeler Medical Center
reporter_type: Other Healthcare Professional
notes: Light plant black different month left. Game wear pass against poor among believe.
Cell television opportunity baby doctor pay hour.
|
<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-2024-776
Date of Submission: 2024-11-28
This report was submitted by a Other Healthcare Professional from Carpenter-Ryan Medical Center concerning patient ANON-PX-6925. The subject is a 37-year-old other with a significant medical history including type 2 diabetes, migraines, 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): Ibuprofen administered via the Intravenous route at a dosage of 75mg, initiated on 2024-09-16 for Pain and inflammation with the course ongoing.
On approximately 2024-11-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Nausea, Diarrhea, Pruritus. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed understand and advised affect. 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 'Not Recovered'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Life-threatening 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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Mouth college she movement structure sister between. Front radio laugh beyond than surface relationship drop.</data>
|
report_id: ADR-2024-776
report_date: '2024-11-28'
patient_details:
patient_id: ANON-PX-6925
gender: Other
relevant_history:
- type 2 diabetes
- migraines
- chronic kidney disease
age_at_reaction: 37
suspected_drugs:
- drug_name: Ibuprofen
dosage: 75mg
route_of_administration: Intravenous
start_date: '2024-09-16'
indication_for_use: Pain and inflammation
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-11-17'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed understand and advised affect.
- symptom_name: Nausea
onset_date: '2024-11-17'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-11-17'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-11-17'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Carpenter-Ryan Medical Center
reporter_type: Other Healthcare Professional
notes: Mouth college she movement structure sister between. Front radio laugh beyond
than surface relationship drop.
|
<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-2025-649
Date of Submission: 2025-07-12
This report was submitted by a Physician from Moore, Serrano and Monroe Medical Center concerning patient ANON-PX-6643. The subject is a 30-year-old female with a significant medical history including chronic kidney disease, 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 321mg, initiated on 2025-05-21 for Major depressive disorder and discontinued on 2025-07-02.
On approximately 2025-06-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Hepatotoxicity, Nausea. The Stevens-Johnson syndrome 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 example and advised attack. 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 '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: Agreement paper kid discuss do small. Environment themselves should case south analysis past positive. Yes so away want material discuss standard.</data>
|
report_id: ADR-2025-649
report_date: '2025-07-12'
patient_details:
patient_id: ANON-PX-6643
gender: Female
relevant_history:
- chronic kidney disease
- migraines
- atrial fibrillation
age_at_reaction: 30
suspected_drugs:
- drug_name: Sertraline
dosage: 321mg
route_of_administration: Topical
start_date: '2025-05-21'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-07-02'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-30'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-06-30'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed example and advised attack.
- symptom_name: Nausea
onset_date: '2025-06-30'
severity: Severe
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 3
reporting_facility: Moore, Serrano and Monroe Medical Center
reporter_type: Physician
notes: Agreement paper kid discuss do small. Environment themselves should case south
analysis past positive. Yes so away want material discuss standard.
|
<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: 2025-01-10
This report was submitted by a Patient from Shah, Davis and Robinson Medical Center concerning patient ANON-PX-9877. The subject is a 40-year-old other with a significant medical history including hypertension, 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 administered via the Subcutaneous route at a dosage of 186mg, initiated on 2024-12-14 for Gastroesophageal reflux disease and discontinued on 2025-01-08; Levothyroxine (Thyroid hormone) administered via the Oral route at a dosage of 493mg, initiated on 2024-12-14 for Hypothyroidism and discontinued on 2025-01-08.
On approximately 2025-01-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Angioedema, Vomiting, Headache, Stevens-Johnson syndrome. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed cut and advised Mrs. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed federal and advised whom. 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 set and advised suffer. 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Bring again box bar. Practice ago expect financial wear. Expect lot success.</data>
|
report_id: ADR-2025-439
report_date: '2025-01-10'
patient_details:
patient_id: ANON-PX-9877
gender: Other
relevant_history:
- hypertension
- seasonal allergies
age_at_reaction: 40
suspected_drugs:
- drug_name: Omeprazole
dosage: 186mg
route_of_administration: Subcutaneous
start_date: '2024-12-14'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-01-08'
- drug_name: Levothyroxine
dosage: 493mg
route_of_administration: Oral
start_date: '2024-12-14'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2025-01-08'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-01-06'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-01-06'
severity: Severe
outcome: Recovered
intervention_required: true
- symptom_name: Vomiting
onset_date: '2025-01-06'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed cut and advised Mrs.
- symptom_name: Headache
onset_date: '2025-01-06'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed federal and advised whom.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-01-06'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed set and advised suffer.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 5
reporting_facility: Shah, Davis and Robinson Medical Center
reporter_type: Patient
notes: Bring again box bar. Practice ago expect financial wear. Expect lot success.
|
<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-2025-944
Date of Submission: 2025-01-12
This report was submitted by a Nurse from Smith and Sons Medical Center concerning patient ANON-PX-7700. The subject is a 88-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): Sertraline (SSRI) administered via the Topical route at a dosage of 10mg, initiated on 2024-10-28 for Major depressive disorder with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 315mg, initiated on 2024-10-28 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2024-12-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Anaphylaxis, Nausea. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed job and advised admit. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed else and advised name. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed stage and advised more. 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Else thus water student science. Yourself cover individual note work decide successful research.</data>
|
report_id: ADR-2025-944
report_date: '2025-01-12'
patient_details:
patient_id: ANON-PX-7700
gender: Female
relevant_history:
- hypertension
- migraines
age_at_reaction: 88
suspected_drugs:
- drug_name: Sertraline
dosage: 10mg
route_of_administration: Topical
start_date: '2024-10-28'
indication_for_use: Major depressive disorder
drug_class: SSRI
- drug_name: Omeprazole
dosage: 315mg
route_of_administration: Oral
start_date: '2024-10-28'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-12-22'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed job and advised admit.
- symptom_name: Anaphylaxis
onset_date: '2024-12-22'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed else and advised name.
- symptom_name: Nausea
onset_date: '2024-12-22'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed stage and advised more.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 7
reporting_facility: Smith and Sons Medical Center
reporter_type: Nurse
notes: Else thus water student science. Yourself cover individual note work decide
successful research.
|
<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-2024-542
Date of Submission: 2024-09-15
This report was submitted by a Other Healthcare Professional from Harris, Hodges and Green Medical Center concerning patient ANON-PX-7046. The subject is an adult male with a significant medical history including asthma, coronary artery disease, 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 administered via the Topical route at a dosage of 287mg, initiated on 2024-06-20 for Type 2 diabetes and discontinued on 2024-09-12.
On approximately 2024-09-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Angioedema, Stevens-Johnson syndrome. 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 Angioedema 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 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-542
report_date: '2024-09-15'
patient_details:
patient_id: ANON-PX-7046
gender: Male
relevant_history:
- asthma
- coronary artery disease
- hypertension
- migraines
suspected_drugs:
- drug_name: Metformin
dosage: 287mg
route_of_administration: Topical
start_date: '2024-06-20'
indication_for_use: Type 2 diabetes
end_date: '2024-09-12'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-09-01'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-09-01'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-09-01'
severity: Mild
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 8
reporting_facility: Harris, Hodges and Green 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-2025-570
Date of Submission: 2025-07-13
This report was submitted by a Physician from Fuller, Davis and Avila Medical Center concerning patient ANON-PX-3154. The subject is a 79-year-old female with a significant medical history including coronary artery disease, type 2 diabetes, osteoarthritis, 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): Warfarin (Anticoagulant) administered via the Topical route at a dosage of 38mg, initiated on 2025-05-08 for Thromboembolism prevention with the course ongoing; Lisinopril administered via the Topical route at a dosage of 368mg, initiated on 2025-05-08 for Hypertension with the course ongoing.
On approximately 2025-06-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Vomiting, Anaphylaxis. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed guy and advised black. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis 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. 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: House game approach picture kind. Manager some side address service.</data>
|
report_id: ADR-2025-570
report_date: '2025-07-13'
patient_details:
patient_id: ANON-PX-3154
gender: Female
relevant_history:
- coronary artery disease
- type 2 diabetes
- osteoarthritis
- hypertension
age_at_reaction: 79
suspected_drugs:
- drug_name: Warfarin
dosage: 38mg
route_of_administration: Topical
start_date: '2025-05-08'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
- drug_name: Lisinopril
dosage: 368mg
route_of_administration: Topical
start_date: '2025-05-08'
indication_for_use: Hypertension
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-06-24'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed guy and advised black.
- symptom_name: Vomiting
onset_date: '2025-06-24'
severity: Mild
outcome: Not Recovered
intervention_required: true
- symptom_name: Anaphylaxis
onset_date: '2025-06-24'
severity: Mild
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 9
reporting_facility: Fuller, Davis and Avila Medical Center
reporter_type: Physician
notes: House game approach picture kind. Manager some side address service.
|
<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-2024-259
Date of Submission: 2024-11-13
This report was submitted by a Pharmacist from Perry and Sons Medical Center concerning patient ANON-PX-8503. The subject is a 35-year-old female 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 (Proton-pump inhibitor) administered via the Topical route at a dosage of 386mg, initiated on 2024-10-13 for Gastroesophageal reflux disease and discontinued on 2024-11-06; Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 408mg, initiated on 2024-10-13 for Pain and inflammation and discontinued on 2024-11-06.
On approximately 2024-11-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Somnolence, Diarrhea. The Dizziness was classified as Life-threatening 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 brother and advised brother. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Moderate 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 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: Lot system contain final response mention customer. Life decision spend check voice. Shake source fly skill course.</data>
|
report_id: ADR-2024-259
report_date: '2024-11-13'
patient_details:
patient_id: ANON-PX-8503
gender: Female
relevant_history:
- chronic kidney disease
- hypertension
age_at_reaction: 35
suspected_drugs:
- drug_name: Omeprazole
dosage: 386mg
route_of_administration: Topical
start_date: '2024-10-13'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-11-06'
- drug_name: Ibuprofen
dosage: 408mg
route_of_administration: Subcutaneous
start_date: '2024-10-13'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-11-06'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-11-06'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-11-06'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed brother and advised brother.
- symptom_name: Diarrhea
onset_date: '2024-11-06'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 5
reporting_facility: Perry and Sons Medical Center
reporter_type: Pharmacist
notes: Lot system contain final response mention customer. Life decision spend check
voice. Shake source fly skill course.
|
<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-2025-170
Date of Submission: 2025-02-02
This report was submitted by a Nurse from Barnes LLC Medical Center concerning patient ANON-PX-1681. The subject is a 31-year-old other with a significant medical history including migraines, anxiety, 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): Metformin administered via the Intravenous route at a dosage of 306mg, initiated on 2024-12-09 for Type 2 diabetes and discontinued on 2025-01-20; Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 138mg, initiated on 2024-12-09 for Neuropathic pain and discontinued on 2025-01-20.
On approximately 2025-01-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Hepatotoxicity. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed news and advised hour. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed environmental and advised talk. 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-2025-170
report_date: '2025-02-02'
patient_details:
patient_id: ANON-PX-1681
gender: Other
relevant_history:
- migraines
- anxiety
- atrial fibrillation
- type 2 diabetes
age_at_reaction: 31
suspected_drugs:
- drug_name: Metformin
dosage: 306mg
route_of_administration: Intravenous
start_date: '2024-12-09'
indication_for_use: Type 2 diabetes
end_date: '2025-01-20'
- drug_name: Gabapentin
dosage: 138mg
route_of_administration: Subcutaneous
start_date: '2024-12-09'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-01-20'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-01-16'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed news and advised hour.
- symptom_name: Hepatotoxicity
onset_date: '2025-01-16'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed environmental and advised talk.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 6
reporting_facility: Barnes LLC 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-2025-650
Date of Submission: 2025-07-20
This report was submitted by a Nurse from Snyder, Hayden and Ray Medical Center concerning patient ANON-PX-1249. The subject is a 67-year-old male with a significant medical history including seasonal allergies, anxiety, 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): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 420mg, initiated on 2025-05-16 for Gastroesophageal reflux disease with the course ongoing; Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 375mg, initiated on 2025-05-16 for Major depressive disorder with the course ongoing.
On approximately 2025-06-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Nausea. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed new and advised rather. 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'.
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.
Reporter's Narrative Summary: Throughout value beyond significant happen study. Structure memory year bank always per PM agreement.</data>
|
report_id: ADR-2025-650
report_date: '2025-07-20'
patient_details:
patient_id: ANON-PX-1249
gender: Male
relevant_history:
- seasonal allergies
- anxiety
- osteoarthritis
age_at_reaction: 67
suspected_drugs:
- drug_name: Omeprazole
dosage: 420mg
route_of_administration: Subcutaneous
start_date: '2025-05-16'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Sertraline
dosage: 375mg
route_of_administration: Subcutaneous
start_date: '2025-05-16'
indication_for_use: Major depressive disorder
drug_class: SSRI
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-06-28'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed new and advised rather.
- symptom_name: Nausea
onset_date: '2025-06-28'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 3
reporting_facility: Snyder, Hayden and Ray Medical Center
reporter_type: Nurse
notes: Throughout value beyond significant happen study. Structure memory year bank
always per PM 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-2025-640
Date of Submission: 2025-01-24
This report was submitted by a Patient from Moran PLC Medical Center concerning patient ANON-PX-7028. The subject is a 58-year-old 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): Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 83mg, initiated on 2024-11-29 for Neuropathic pain and discontinued on 2025-01-13; Atorvastatin administered via the Topical route at a dosage of 375mg, initiated on 2024-11-29 for Hypercholesterolemia and discontinued on 2025-01-13.
On approximately 2025-01-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Headache, Hepatotoxicity, Somnolence, Pruritus. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. 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 'Not Recovered'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed three and advised conference. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed cut and advised right. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed green and advised tax. 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-640
report_date: '2025-01-24'
patient_details:
patient_id: ANON-PX-7028
gender: Male
relevant_history:
- osteoarthritis
- type 2 diabetes
age_at_reaction: 58
suspected_drugs:
- drug_name: Gabapentin
dosage: 83mg
route_of_administration: Subcutaneous
start_date: '2024-11-29'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-01-13'
- drug_name: Atorvastatin
dosage: 375mg
route_of_administration: Topical
start_date: '2024-11-29'
indication_for_use: Hypercholesterolemia
end_date: '2025-01-13'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-01-02'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Headache
onset_date: '2025-01-02'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-01-02'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed three and advised conference.
- symptom_name: Somnolence
onset_date: '2025-01-02'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed cut and advised right.
- symptom_name: Pruritus
onset_date: '2025-01-02'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed green and advised tax.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 9
reporting_facility: Moran 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-2025-894
Date of Submission: 2025-02-01
This report was submitted by a Pharmacist from Skinner and Sons Medical Center concerning patient ANON-PX-3021. The subject is an adult female with a significant medical history including seasonal allergies, anxiety, asthma, 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): Gabapentin (Anticonvulsant) administered via the Intramuscular route at a dosage of 274mg, initiated on 2024-11-10 for Neuropathic pain and discontinued on 2025-01-30.
On approximately 2024-12-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Somnolence, Anaphylaxis, Stevens-Johnson syndrome, Headache. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed area and advised act. 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 'Not Recovered'. The Anaphylaxis was classified as Severe 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. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Headache 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 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.
Reporter's Narrative Summary: Debate per use issue person item. Government will grow style behind late. All fill line responsibility.</data>
|
report_id: ADR-2025-894
report_date: '2025-02-01'
patient_details:
patient_id: ANON-PX-3021
gender: Female
relevant_history:
- seasonal allergies
- anxiety
- asthma
- chronic kidney disease
suspected_drugs:
- drug_name: Gabapentin
dosage: 274mg
route_of_administration: Intramuscular
start_date: '2024-11-10'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-01-30'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-12-31'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed area and advised act.
- symptom_name: Somnolence
onset_date: '2024-12-31'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-12-31'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-12-31'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2024-12-31'
severity: Mild
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 7
reporting_facility: Skinner and Sons Medical Center
reporter_type: Pharmacist
notes: Debate per use issue person item. Government will grow style behind late. All
fill line responsibility.
|
<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-2025-591
Date of Submission: 2025-04-13
This report was submitted by a Patient from Smith Ltd Medical Center concerning patient ANON-PX-4945. The subject is a 38-year-old other with a significant medical history including osteoarthritis, anxiety, 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 Subcutaneous route at a dosage of 256mg, initiated on 2025-04-04 for Type 2 diabetes with the course ongoing.
On approximately 2025-04-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Nausea, Hepatotoxicity. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed nearly and advised quite. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed drive and advised book. The current patient status regarding this symptom is 'Recovered'. 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. 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: Where like few natural property. Too capital audience rather. Civil citizen same idea four if.</data>
|
report_id: ADR-2025-591
report_date: '2025-04-13'
patient_details:
patient_id: ANON-PX-4945
gender: Other
relevant_history:
- osteoarthritis
- anxiety
- hypertension
- migraines
age_at_reaction: 38
suspected_drugs:
- drug_name: Metformin
dosage: 256mg
route_of_administration: Subcutaneous
start_date: '2025-04-04'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-04-09'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed nearly and advised quite.
- symptom_name: Nausea
onset_date: '2025-04-09'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed drive and advised book.
- symptom_name: Hepatotoxicity
onset_date: '2025-04-09'
severity: Life-threatening
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Smith Ltd Medical Center
reporter_type: Patient
notes: Where like few natural property. Too capital audience rather. Civil citizen
same idea four if.
|
<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: 2024-08-18
This report was submitted by a Other Healthcare Professional from Miller-Rojas Medical Center concerning patient ANON-PX-1421. The subject is an adult other 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): Sertraline administered via the Intravenous route at a dosage of 371mg, initiated on 2024-07-06 for Major depressive disorder with the course ongoing.
On approximately 2024-07-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Somnolence. 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 Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed middle and advised draw. 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 dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Performance beautiful per white brother quite simply though.</data>
|
report_id: ADR-2024-878
report_date: '2024-08-18'
patient_details:
patient_id: ANON-PX-1421
gender: Other
relevant_history:
- hypertension
- coronary artery disease
suspected_drugs:
- drug_name: Sertraline
dosage: 371mg
route_of_administration: Intravenous
start_date: '2024-07-06'
indication_for_use: Major depressive disorder
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-07-21'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-07-21'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed middle and advised draw.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Miller-Rojas Medical Center
reporter_type: Other Healthcare Professional
notes: Performance beautiful per white brother quite simply though.
|
<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-2024-487
Date of Submission: 2024-10-30
This report was submitted by a Patient from Gonzalez, Kerr and Miller Medical Center concerning patient ANON-PX-5039. The subject is a 53-year-old female with a significant medical history including atrial fibrillation, anxiety, 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): Warfarin (Anticoagulant) administered via the Oral route at a dosage of 300mg, initiated on 2024-09-28 for Thromboembolism prevention and discontinued on 2024-10-29.
On approximately 2024-10-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Vomiting. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 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. 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: Explain agreement dinner media Mr control building show. Site low laugh national popular myself foot. Whether pay but create pretty see.</data>
|
report_id: ADR-2024-487
report_date: '2024-10-30'
patient_details:
patient_id: ANON-PX-5039
gender: Female
relevant_history:
- atrial fibrillation
- anxiety
- chronic kidney disease
age_at_reaction: 53
suspected_drugs:
- drug_name: Warfarin
dosage: 300mg
route_of_administration: Oral
start_date: '2024-09-28'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-10-29'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-10-28'
severity: Mild
outcome: Unknown
intervention_required: true
- symptom_name: Vomiting
onset_date: '2024-10-28'
severity: Severe
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Gonzalez, Kerr and Miller Medical Center
reporter_type: Patient
notes: Explain agreement dinner media Mr control building show. Site low laugh national
popular myself foot. Whether pay but create pretty see.
|
<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-2025-919
Date of Submission: 2025-02-22
This report was submitted by a Other Healthcare Professional from Richard-Brock Medical Center concerning patient ANON-PX-3649. The subject is an adult female with a significant medical history including seasonal allergies, migraines, 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): Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 377mg, initiated on 2025-01-26 for Neuropathic pain and discontinued on 2025-01-31; Atorvastatin (Statin) administered via the Intravenous route at a dosage of 400mg, initiated on 2025-01-26 for Hypercholesterolemia and discontinued on 2025-01-31.
On approximately 2025-01-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Pruritus, Nausea, Stevens-Johnson syndrome. 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 documented action was: Prescribed too and advised either. The current patient status regarding this symptom is 'Fatal'. 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 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. 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.
</data>
|
report_id: ADR-2025-919
report_date: '2025-02-22'
patient_details:
patient_id: ANON-PX-3649
gender: Female
relevant_history:
- seasonal allergies
- migraines
- osteoarthritis
suspected_drugs:
- drug_name: Gabapentin
dosage: 377mg
route_of_administration: Topical
start_date: '2025-01-26'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-01-31'
- drug_name: Atorvastatin
dosage: 400mg
route_of_administration: Intravenous
start_date: '2025-01-26'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-01-31'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-01-29'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-01-29'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed too and advised either.
- symptom_name: Nausea
onset_date: '2025-01-29'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-01-29'
severity: Mild
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 4
reporting_facility: Richard-Brock 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-2025-192
Date of Submission: 2025-05-02
This report was submitted by a Pharmacist from Garcia, Clayton and Torres Medical Center concerning patient ANON-PX-4934. The subject is an adult other 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): Sertraline (SSRI) administered via the Topical route at a dosage of 269mg, initiated on 2025-03-23 for Major depressive disorder and discontinued on 2025-04-21; Lisinopril (ACE inhibitor) administered via the Topical route at a dosage of 132mg, initiated on 2025-03-23 for Hypertension and discontinued on 2025-04-21.
On approximately 2025-03-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Stevens-Johnson syndrome. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed live and advised me. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed exist and advised environment. 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 dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-192
report_date: '2025-05-02'
patient_details:
patient_id: ANON-PX-4934
gender: Other
relevant_history:
- migraines
- anxiety
suspected_drugs:
- drug_name: Sertraline
dosage: 269mg
route_of_administration: Topical
start_date: '2025-03-23'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-04-21'
- drug_name: Lisinopril
dosage: 132mg
route_of_administration: Topical
start_date: '2025-03-23'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-04-21'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-03-31'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed live and advised me.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-31'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed exist and advised environment.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 6
reporting_facility: Garcia, Clayton and Torres 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-2024-593
Date of Submission: 2024-09-09
This report was submitted by a Pharmacist from Evans-Lopez Medical Center concerning patient ANON-PX-6002. The subject is a 68-year-old male with a significant medical history including osteoarthritis, 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): Atorvastatin (Statin) administered via the Topical route at a dosage of 162mg, initiated on 2024-06-13 for Hypercholesterolemia and discontinued on 2024-08-15.
On approximately 2024-07-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Diarrhea, Dizziness, Somnolence, Headache. The Stevens-Johnson syndrome 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 Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed sense and advised product. 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 them and advised its. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. 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 '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: Art popular speech same when health data. Continue drop ten thing whether modern attack. Produce hundred whom exist appear mention rock.</data>
|
report_id: ADR-2024-593
report_date: '2024-09-09'
patient_details:
patient_id: ANON-PX-6002
gender: Male
relevant_history:
- osteoarthritis
- migraines
- coronary artery disease
age_at_reaction: 68
suspected_drugs:
- drug_name: Atorvastatin
dosage: 162mg
route_of_administration: Topical
start_date: '2024-06-13'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-08-15'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-07-03'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2024-07-03'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed sense and advised product.
- symptom_name: Dizziness
onset_date: '2024-07-03'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed them and advised its.
- symptom_name: Somnolence
onset_date: '2024-07-03'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2024-07-03'
severity: Life-threatening
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Evans-Lopez Medical Center
reporter_type: Pharmacist
notes: Art popular speech same when health data. Continue drop ten thing whether modern
attack. Produce hundred whom exist appear mention rock.
|
<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-2025-133
Date of Submission: 2025-05-04
This report was submitted by a Other Healthcare Professional from Lee, Miller and Carter Medical Center concerning patient ANON-PX-9086. The subject is a 71-year-old other with a significant medical history including atrial fibrillation, 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): Lisinopril administered via the Oral route at a dosage of 175mg, initiated on 2025-03-10 for Hypertension and discontinued on 2025-05-02.
On approximately 2025-05-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Hepatotoxicity, Headache, Vomiting, Somnolence. The Anaphylaxis 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 Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed night and advised customer. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 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 Somnolence 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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-133
report_date: '2025-05-04'
patient_details:
patient_id: ANON-PX-9086
gender: Other
relevant_history:
- atrial fibrillation
- seasonal allergies
- osteoarthritis
age_at_reaction: 71
suspected_drugs:
- drug_name: Lisinopril
dosage: 175mg
route_of_administration: Oral
start_date: '2025-03-10'
indication_for_use: Hypertension
end_date: '2025-05-02'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-05-02'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-05-02'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed night and advised customer.
- symptom_name: Headache
onset_date: '2025-05-02'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-05-02'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-05-02'
severity: Severe
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 6
reporting_facility: Lee, Miller and Carter 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-2024-463
Date of Submission: 2024-12-17
This report was submitted by a Patient from Anderson, Brown and Johnson Medical Center concerning patient ANON-PX-4075. The subject is a 77-year-old other with a significant medical history including migraines, chronic kidney disease, osteoarthritis, 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): Warfarin (Anticoagulant) administered via the Subcutaneous route at a dosage of 322mg, initiated on 2024-12-09 for Thromboembolism prevention and discontinued on 2024-12-15; Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 225mg, initiated on 2024-12-09 for Pain and inflammation and discontinued on 2024-12-15.
On approximately 2024-12-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Anaphylaxis, Somnolence, Stevens-Johnson syndrome, Headache. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed board and advised act. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed man and advised simple. 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 item and advised thing. The current patient status regarding this symptom is 'Recovered'. The Headache 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. 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-2024-463
report_date: '2024-12-17'
patient_details:
patient_id: ANON-PX-4075
gender: Other
relevant_history:
- migraines
- chronic kidney disease
- osteoarthritis
- hypertension
age_at_reaction: 77
suspected_drugs:
- drug_name: Warfarin
dosage: 322mg
route_of_administration: Subcutaneous
start_date: '2024-12-09'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-12-15'
- drug_name: Ibuprofen
dosage: 225mg
route_of_administration: Subcutaneous
start_date: '2024-12-09'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-12-15'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-12-13'
severity: Life-threatening
outcome: Unknown
intervention_required: true
- symptom_name: Anaphylaxis
onset_date: '2024-12-13'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed board and advised act.
- symptom_name: Somnolence
onset_date: '2024-12-13'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed man and advised simple.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-12-13'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed item and advised thing.
- symptom_name: Headache
onset_date: '2024-12-13'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Anderson, Brown and Johnson 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-2025-752
Date of Submission: 2025-08-07
This report was submitted by a Patient from Sandoval PLC Medical Center concerning patient ANON-PX-1149. The subject is a 24-year-old male with a significant medical history including osteoarthritis, chronic kidney disease, coronary artery 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): Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 157mg, initiated on 2025-06-30 for Pain and inflammation with the course ongoing.
On approximately 2025-07-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Vomiting. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed how and advised food. The current patient status regarding this symptom is 'Recovering'. The Vomiting 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-752
report_date: '2025-08-07'
patient_details:
patient_id: ANON-PX-1149
gender: Male
relevant_history:
- osteoarthritis
- chronic kidney disease
- coronary artery disease
- anxiety
age_at_reaction: 24
suspected_drugs:
- drug_name: Ibuprofen
dosage: 157mg
route_of_administration: Subcutaneous
start_date: '2025-06-30'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-07-12'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed how and advised food.
- symptom_name: Vomiting
onset_date: '2025-07-12'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Sandoval 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-2024-114
Date of Submission: 2024-08-17
This report was submitted by a Other Healthcare Professional from Foster, Cook and Patton Medical Center concerning patient ANON-PX-9246. The subject is a 25-year-old male 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): Warfarin (Anticoagulant) administered via the Intramuscular route at a dosage of 41mg, initiated on 2024-05-30 for Thromboembolism prevention with the course ongoing; Ibuprofen (NSAID) administered via the Intravenous route at a dosage of 50mg, initiated on 2024-05-30 for Pain and inflammation with the course ongoing.
On approximately 2024-06-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Diarrhea. The Stevens-Johnson syndrome 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 Moderate 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Administration opportunity air. Politics consumer simply white serve most history. Their task method collection.</data>
|
report_id: ADR-2024-114
report_date: '2024-08-17'
patient_details:
patient_id: ANON-PX-9246
gender: Male
relevant_history:
- anxiety
- type 2 diabetes
- hypertension
- migraines
age_at_reaction: 25
suspected_drugs:
- drug_name: Warfarin
dosage: 41mg
route_of_administration: Intramuscular
start_date: '2024-05-30'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
- drug_name: Ibuprofen
dosage: 50mg
route_of_administration: Intravenous
start_date: '2024-05-30'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-06-15'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2024-06-15'
severity: Moderate
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 8
reporting_facility: Foster, Cook and Patton Medical Center
reporter_type: Other Healthcare Professional
notes: Administration opportunity air. Politics consumer simply white serve most history.
Their task method collection.
|
<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-2025-188
Date of Submission: 2025-06-15
This report was submitted by a Other Healthcare Professional from Mcguire Inc Medical Center concerning patient ANON-PX-5262. The subject is an adult female with a significant medical history including osteoarthritis, 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 338mg, initiated on 2025-04-26 for Type 2 diabetes with the course ongoing; Amoxicillin administered via the Subcutaneous route at a dosage of 490mg, initiated on 2025-04-26 for Bacterial infection with the course ongoing.
On approximately 2025-05-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Dizziness, Stevens-Johnson syndrome, Angioedema. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed language and advised send. 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 'Recovered'. The Stevens-Johnson syndrome 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 Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed audience and advised eye. 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Far project name matter despite hit begin. Movement system radio pretty morning.</data>
|
report_id: ADR-2025-188
report_date: '2025-06-15'
patient_details:
patient_id: ANON-PX-5262
gender: Female
relevant_history:
- osteoarthritis
- atrial fibrillation
- hypertension
suspected_drugs:
- drug_name: Metformin
dosage: 338mg
route_of_administration: Topical
start_date: '2025-04-26'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
- drug_name: Amoxicillin
dosage: 490mg
route_of_administration: Subcutaneous
start_date: '2025-04-26'
indication_for_use: Bacterial infection
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-05-10'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed language and advised send.
- symptom_name: Dizziness
onset_date: '2025-05-10'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-05-10'
severity: Mild
outcome: Not Recovered
intervention_required: true
- symptom_name: Angioedema
onset_date: '2025-05-10'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed audience and advised eye.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 1
reporting_facility: Mcguire Inc Medical Center
reporter_type: Other Healthcare Professional
notes: Far project name matter despite hit begin. Movement system radio pretty morning.
|
<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-2025-889
Date of Submission: 2025-04-16
This report was submitted by a Pharmacist from Flores-Chandler Medical Center concerning patient ANON-PX-7365. The subject is an adult female with a significant medical history including type 2 diabetes, 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): Sertraline (SSRI) administered via the Topical route at a dosage of 139mg, initiated on 2025-01-23 for Major depressive disorder with the course ongoing; Warfarin (Anticoagulant) administered via the Topical route at a dosage of 145mg, initiated on 2025-01-23 for Thromboembolism prevention with the course ongoing.
On approximately 2025-01-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Angioedema. The Diarrhea 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. 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: Field magazine now role. Edge other this. Specific reveal way capital.</data>
|
report_id: ADR-2025-889
report_date: '2025-04-16'
patient_details:
patient_id: ANON-PX-7365
gender: Female
relevant_history:
- type 2 diabetes
- atrial fibrillation
- asthma
suspected_drugs:
- drug_name: Sertraline
dosage: 139mg
route_of_administration: Topical
start_date: '2025-01-23'
indication_for_use: Major depressive disorder
drug_class: SSRI
- drug_name: Warfarin
dosage: 145mg
route_of_administration: Topical
start_date: '2025-01-23'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-01-25'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-01-25'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 8
reporting_facility: Flores-Chandler Medical Center
reporter_type: Pharmacist
notes: Field magazine now role. Edge other this. Specific reveal way capital.
|
<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-2024-183
Date of Submission: 2024-09-27
This report was submitted by a Pharmacist from Gray, Kelly and Franco Medical Center concerning patient ANON-PX-1815. The subject is a 51-year-old other with a significant medical history including atrial fibrillation, chronic kidney disease, anxiety, 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 Subcutaneous route at a dosage of 172mg, initiated on 2024-08-06 for Hypothyroidism and discontinued on 2024-09-20; Lisinopril administered via the Topical route at a dosage of 67mg, initiated on 2024-08-06 for Hypertension and discontinued on 2024-09-20.
On approximately 2024-08-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Nausea, Headache, Stevens-Johnson syndrome, Anaphylaxis. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed get and advised now. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed white and advised indeed. The current patient status regarding this symptom is 'Fatal'. The Headache 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 Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed floor and advised car. 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.
Reporter's Narrative Summary: Later work past young car energy guy. Loss visit recent former as. Possible dinner next defense economy.</data>
|
report_id: ADR-2024-183
report_date: '2024-09-27'
patient_details:
patient_id: ANON-PX-1815
gender: Other
relevant_history:
- atrial fibrillation
- chronic kidney disease
- anxiety
- osteoarthritis
age_at_reaction: 51
suspected_drugs:
- drug_name: Levothyroxine
dosage: 172mg
route_of_administration: Subcutaneous
start_date: '2024-08-06'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-09-20'
- drug_name: Lisinopril
dosage: 67mg
route_of_administration: Topical
start_date: '2024-08-06'
indication_for_use: Hypertension
end_date: '2024-09-20'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-08-31'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed get and advised now.
- symptom_name: Nausea
onset_date: '2024-08-31'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed white and advised indeed.
- symptom_name: Headache
onset_date: '2024-08-31'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-31'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-08-31'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed floor and advised car.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 6
reporting_facility: Gray, Kelly and Franco Medical Center
reporter_type: Pharmacist
notes: Later work past young car energy guy. Loss visit recent former as. Possible
dinner next defense economy.
|
<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-2025-225
Date of Submission: 2025-02-16
This report was submitted by a Other Healthcare Professional from Guzman, Shepherd and Brooks Medical Center concerning patient ANON-PX-2698. The subject is a 62-year-old male with a significant medical history including 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): Atorvastatin (Statin) administered via the Oral route at a dosage of 104mg, initiated on 2025-01-10 for Hypercholesterolemia with the course ongoing.
On approximately 2025-02-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Vomiting, Anaphylaxis. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed environment and advised during. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed must and advised PM. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-225
report_date: '2025-02-16'
patient_details:
patient_id: ANON-PX-2698
gender: Male
relevant_history:
- coronary artery disease
- chronic kidney disease
age_at_reaction: 62
suspected_drugs:
- drug_name: Atorvastatin
dosage: 104mg
route_of_administration: Oral
start_date: '2025-01-10'
indication_for_use: Hypercholesterolemia
drug_class: Statin
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-02-08'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed environment and advised during.
- symptom_name: Vomiting
onset_date: '2025-02-08'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed must and advised PM.
- symptom_name: Anaphylaxis
onset_date: '2025-02-08'
severity: Life-threatening
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 6
reporting_facility: Guzman, Shepherd and Brooks 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-2024-753
Date of Submission: 2024-09-27
This report was submitted by a Pharmacist from Crane and Sons Medical Center concerning patient ANON-PX-7647. The subject is a 22-year-old female with a significant medical history including hypertension, 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): Atorvastatin (Statin) administered via the Intravenous route at a dosage of 40mg, initiated on 2024-08-23 for Hypercholesterolemia and discontinued on 2024-09-22.
On approximately 2024-09-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Pruritus, Dizziness, Hepatotoxicity. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed deep and advised audience. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed toward and advised relate. The current patient status regarding this symptom is 'Recovered'. The Dizziness 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. 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.
Reporter's Narrative Summary: Thank chair theory scientist civil. Write report toward receive center size decision next. According bar area direction into.</data>
|
report_id: ADR-2024-753
report_date: '2024-09-27'
patient_details:
patient_id: ANON-PX-7647
gender: Female
relevant_history:
- hypertension
- migraines
- atrial fibrillation
age_at_reaction: 22
suspected_drugs:
- drug_name: Atorvastatin
dosage: 40mg
route_of_administration: Intravenous
start_date: '2024-08-23'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-09-22'
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-09-08'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed deep and advised audience.
- symptom_name: Pruritus
onset_date: '2024-09-08'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed toward and advised relate.
- symptom_name: Dizziness
onset_date: '2024-09-08'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-09-08'
severity: Mild
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Crane and Sons Medical Center
reporter_type: Pharmacist
notes: Thank chair theory scientist civil. Write report toward receive center size
decision next. According bar area direction into.
|
<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-2025-988
Date of Submission: 2025-06-03
This report was submitted by a Pharmacist from Villa-Mcdonald Medical Center concerning patient ANON-PX-7163. The subject is a 23-year-old male with a significant medical history including asthma, coronary artery disease, seasonal allergies, 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 Intramuscular route at a dosage of 320mg, initiated on 2025-03-14 for Thromboembolism prevention and discontinued on 2025-05-21; Sertraline administered via the Topical route at a dosage of 362mg, initiated on 2025-03-14 for Major depressive disorder and discontinued on 2025-05-21.
On approximately 2025-04-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Anaphylaxis, Stevens-Johnson syndrome. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed compare and advised there. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed cell and advised water. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed product and advised time. 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Receive consider exist main them reason some nearly. Bill how mention ahead compare fire.</data>
|
report_id: ADR-2025-988
report_date: '2025-06-03'
patient_details:
patient_id: ANON-PX-7163
gender: Male
relevant_history:
- asthma
- coronary artery disease
- seasonal allergies
- anxiety
age_at_reaction: 23
suspected_drugs:
- drug_name: Warfarin
dosage: 320mg
route_of_administration: Intramuscular
start_date: '2025-03-14'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-05-21'
- drug_name: Sertraline
dosage: 362mg
route_of_administration: Topical
start_date: '2025-03-14'
indication_for_use: Major depressive disorder
end_date: '2025-05-21'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-04-30'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed compare and advised there.
- symptom_name: Anaphylaxis
onset_date: '2025-04-30'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed cell and advised water.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-30'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed product and advised time.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 3
reporting_facility: Villa-Mcdonald Medical Center
reporter_type: Pharmacist
notes: Receive consider exist main them reason some nearly. Bill how mention ahead
compare fire.
|
<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-2025-977
Date of Submission: 2025-08-06
This report was submitted by a Other Healthcare Professional from Brown-Mitchell Medical Center concerning patient ANON-PX-7097. The subject is an adult other with a significant medical history including migraines, 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): Sertraline (SSRI) administered via the Topical route at a dosage of 325mg, initiated on 2025-07-29 for Major depressive disorder and discontinued on 2025-08-04; Atorvastatin (Statin) administered via the Subcutaneous route at a dosage of 374mg, initiated on 2025-07-29 for Hypercholesterolemia and discontinued on 2025-08-04.
On approximately 2025-08-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Maculopapular Rash, Anaphylaxis, Vomiting. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed community and advised foreign. 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 contain and advised world. 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 'Recovering'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed instead and advised whom. 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-977
report_date: '2025-08-06'
patient_details:
patient_id: ANON-PX-7097
gender: Other
relevant_history:
- migraines
- chronic kidney disease
suspected_drugs:
- drug_name: Sertraline
dosage: 325mg
route_of_administration: Topical
start_date: '2025-07-29'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-08-04'
- drug_name: Atorvastatin
dosage: 374mg
route_of_administration: Subcutaneous
start_date: '2025-07-29'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-08-04'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-08-01'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed community and advised foreign.
- symptom_name: Maculopapular Rash
onset_date: '2025-08-01'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed contain and advised world.
- symptom_name: Anaphylaxis
onset_date: '2025-08-01'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-08-01'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed instead and advised whom.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 5
reporting_facility: Brown-Mitchell 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-2025-270
Date of Submission: 2025-04-29
This report was submitted by a Patient from Gross-Myers Medical Center concerning patient ANON-PX-1357. The subject is an adult female with a significant medical history including atrial fibrillation, osteoarthritis, 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): Ibuprofen administered via the Intravenous route at a dosage of 262mg, initiated on 2025-04-01 for Pain and inflammation and discontinued on 2025-04-22; Levothyroxine administered via the Intramuscular route at a dosage of 370mg, initiated on 2025-04-01 for Hypothyroidism and discontinued on 2025-04-22.
On approximately 2025-04-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Angioedema, Nausea, Pruritus. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed but and advised brother. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed manage and advised live. 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 'Fatal'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed weight and advised idea. 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: Left American discover hold development character. Successful president next quickly life.</data>
|
report_id: ADR-2025-270
report_date: '2025-04-29'
patient_details:
patient_id: ANON-PX-1357
gender: Female
relevant_history:
- atrial fibrillation
- osteoarthritis
- coronary artery disease
- chronic kidney disease
suspected_drugs:
- drug_name: Ibuprofen
dosage: 262mg
route_of_administration: Intravenous
start_date: '2025-04-01'
indication_for_use: Pain and inflammation
end_date: '2025-04-22'
- drug_name: Levothyroxine
dosage: 370mg
route_of_administration: Intramuscular
start_date: '2025-04-01'
indication_for_use: Hypothyroidism
end_date: '2025-04-22'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-04-06'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed but and advised brother.
- symptom_name: Angioedema
onset_date: '2025-04-06'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed manage and advised live.
- symptom_name: Nausea
onset_date: '2025-04-06'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-04-06'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed weight and advised idea.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 2
reporting_facility: Gross-Myers Medical Center
reporter_type: Patient
notes: Left American discover hold development character. Successful president next
quickly life.
|
<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-2024-305
Date of Submission: 2024-11-12
This report was submitted by a Physician from Norris, Dennis and Johnson Medical Center concerning patient ANON-PX-7711. The subject is a 45-year-old other with a significant medical history including anxiety, asthma, 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 Intramuscular route at a dosage of 465mg, initiated on 2024-10-04 for Type 2 diabetes and discontinued on 2024-10-20; Levothyroxine (Thyroid hormone) administered via the Intramuscular route at a dosage of 461mg, initiated on 2024-10-04 for Hypothyroidism and discontinued on 2024-10-20.
On approximately 2024-10-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Headache, Maculopapular Rash, Nausea. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed finish and advised choose. 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'. The Maculopapular Rash 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 eye and advised mission. 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: Including director fly debate. Land amount what military.</data>
|
report_id: ADR-2024-305
report_date: '2024-11-12'
patient_details:
patient_id: ANON-PX-7711
gender: Other
relevant_history:
- anxiety
- asthma
- coronary artery disease
- chronic kidney disease
age_at_reaction: 45
suspected_drugs:
- drug_name: Metformin
dosage: 465mg
route_of_administration: Intramuscular
start_date: '2024-10-04'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-10-20'
- drug_name: Levothyroxine
dosage: 461mg
route_of_administration: Intramuscular
start_date: '2024-10-04'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-10-20'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-18'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed finish and advised choose.
- symptom_name: Headache
onset_date: '2024-10-18'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-10-18'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-10-18'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed eye and advised mission.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 3
reporting_facility: Norris, Dennis and Johnson Medical Center
reporter_type: Physician
notes: Including director fly debate. Land amount what military.
|
<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-2025-505
Date of Submission: 2025-04-08
This report was submitted by a Nurse from Hill-Meyer Medical Center concerning patient ANON-PX-6590. The subject is a 52-year-old other 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): Ibuprofen (NSAID) administered via the Topical route at a dosage of 423mg, initiated on 2025-02-26 for Pain and inflammation and discontinued on 2025-03-25; Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 320mg, initiated on 2025-02-26 for Gastroesophageal reflux disease and discontinued on 2025-03-25.
On approximately 2025-03-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Vomiting. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed work and advised professional. 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: Community visit person individual owner how situation example. Remain trip remain difference movie above popular particular. Tend wish scene image.</data>
|
report_id: ADR-2025-505
report_date: '2025-04-08'
patient_details:
patient_id: ANON-PX-6590
gender: Other
relevant_history:
- anxiety
- atrial fibrillation
age_at_reaction: 52
suspected_drugs:
- drug_name: Ibuprofen
dosage: 423mg
route_of_administration: Topical
start_date: '2025-02-26'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-03-25'
- drug_name: Omeprazole
dosage: 320mg
route_of_administration: Subcutaneous
start_date: '2025-02-26'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-03-25'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-03-20'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-03-20'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed work and advised professional.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 5
reporting_facility: Hill-Meyer Medical Center
reporter_type: Nurse
notes: Community visit person individual owner how situation example. Remain trip
remain difference movie above popular particular. Tend wish scene image.
|
<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-2024-944
Date of Submission: 2024-10-25
This report was submitted by a Patient from Kirk-Rangel Medical Center concerning patient ANON-PX-2802. The subject is a 79-year-old male with a significant medical history including chronic kidney disease, 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 Intravenous route at a dosage of 150mg, initiated on 2024-07-27 for Major depressive disorder and discontinued on 2024-10-21; Lisinopril (ACE inhibitor) administered via the Topical route at a dosage of 16mg, initiated on 2024-07-27 for Hypertension and discontinued on 2024-10-21.
On approximately 2024-10-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Pruritus. 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 Pruritus 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Land he option sing manage night charge. Try store skill speak decade another.</data>
|
report_id: ADR-2024-944
report_date: '2024-10-25'
patient_details:
patient_id: ANON-PX-2802
gender: Male
relevant_history:
- chronic kidney disease
- atrial fibrillation
- coronary artery disease
age_at_reaction: 79
suspected_drugs:
- drug_name: Sertraline
dosage: 150mg
route_of_administration: Intravenous
start_date: '2024-07-27'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-10-21'
- drug_name: Lisinopril
dosage: 16mg
route_of_administration: Topical
start_date: '2024-07-27'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-10-21'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-10-16'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-10-16'
severity: Severe
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 1
reporting_facility: Kirk-Rangel Medical Center
reporter_type: Patient
notes: Land he option sing manage night charge. Try store skill speak decade another.
|
<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-2024-502
Date of Submission: 2024-09-03
This report was submitted by a Patient from Cochran LLC Medical Center concerning patient ANON-PX-3943. The subject is an adult male with a significant medical history including 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): Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 182mg, initiated on 2024-07-18 for Bacterial infection and discontinued on 2024-08-20.
On approximately 2024-08-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Maculopapular Rash, Headache, Anaphylaxis, Angioedema. 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 Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed service and advised different. 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 young and advised certain. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed choice and advised particularly. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Life-threatening 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Dinner smile firm mouth. Around account stand late can such appear. My leave fish.</data>
|
report_id: ADR-2024-502
report_date: '2024-09-03'
patient_details:
patient_id: ANON-PX-3943
gender: Male
relevant_history:
- coronary artery disease
- atrial fibrillation
suspected_drugs:
- drug_name: Amoxicillin
dosage: 182mg
route_of_administration: Topical
start_date: '2024-07-18'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-08-20'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-08-14'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-08-14'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed service and advised different.
- symptom_name: Headache
onset_date: '2024-08-14'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed young and advised certain.
- symptom_name: Anaphylaxis
onset_date: '2024-08-14'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed choice and advised particularly.
- symptom_name: Angioedema
onset_date: '2024-08-14'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 3
reporting_facility: Cochran LLC Medical Center
reporter_type: Patient
notes: Dinner smile firm mouth. Around account stand late can such appear. My leave
fish.
|
<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-2024-633
Date of Submission: 2024-12-28
This report was submitted by a Other Healthcare Professional from Rhodes, Deleon and Blanchard Medical Center concerning patient ANON-PX-9079. The subject is a 42-year-old male with a significant medical history including hypertension, 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 222mg, initiated on 2024-12-17 for Hypertension and discontinued on 2024-12-21.
On approximately 2024-12-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Dizziness, Stevens-Johnson syndrome. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed edge and advised focus. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed player and advised service. 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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Lead effect debate. Although author commercial share whether laugh. It use five defense.</data>
|
report_id: ADR-2024-633
report_date: '2024-12-28'
patient_details:
patient_id: ANON-PX-9079
gender: Male
relevant_history:
- hypertension
- seasonal allergies
age_at_reaction: 42
suspected_drugs:
- drug_name: Lisinopril
dosage: 222mg
route_of_administration: Oral
start_date: '2024-12-17'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-12-21'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-12-21'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed edge and advised focus.
- symptom_name: Dizziness
onset_date: '2024-12-21'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-12-21'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed player and advised service.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Rhodes, Deleon and Blanchard Medical Center
reporter_type: Other Healthcare Professional
notes: Lead effect debate. Although author commercial share whether laugh. It use
five defense.
|
<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-2024-635
Date of Submission: 2024-11-29
This report was submitted by a Other Healthcare Professional from Hamilton, Johnson and Kelly Medical Center concerning patient ANON-PX-1460. The subject is a 31-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 Intravenous route at a dosage of 365mg, initiated on 2024-10-28 for Hypertension with the course ongoing; Atorvastatin (Statin) administered via the Intravenous route at a dosage of 238mg, initiated on 2024-10-28 for Hypercholesterolemia with the course ongoing.
On approximately 2024-10-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Headache, Diarrhea. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Diarrhea 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 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: Fast clearly really east include. Military social cost two international prevent.</data>
|
report_id: ADR-2024-635
report_date: '2024-11-29'
patient_details:
patient_id: ANON-PX-1460
gender: Male
relevant_history:
- osteoarthritis
- anxiety
age_at_reaction: 31
suspected_drugs:
- drug_name: Lisinopril
dosage: 365mg
route_of_administration: Intravenous
start_date: '2024-10-28'
indication_for_use: Hypertension
drug_class: ACE inhibitor
- drug_name: Atorvastatin
dosage: 238mg
route_of_administration: Intravenous
start_date: '2024-10-28'
indication_for_use: Hypercholesterolemia
drug_class: Statin
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-10-29'
severity: Life-threatening
outcome: Unknown
intervention_required: true
- symptom_name: Headache
onset_date: '2024-10-29'
severity: Mild
outcome: Recovering
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2024-10-29'
severity: Moderate
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 2
reporting_facility: Hamilton, Johnson and Kelly Medical Center
reporter_type: Other Healthcare Professional
notes: Fast clearly really east include. Military social cost two international prevent.
|
<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-2024-823
Date of Submission: 2024-10-21
This report was submitted by a Physician from Hall Inc Medical Center concerning patient ANON-PX-3351. The subject is a 47-year-old male with a significant medical history including 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): Levothyroxine (Thyroid hormone) administered via the Intramuscular route at a dosage of 18mg, initiated on 2024-09-18 for Hypothyroidism and discontinued on 2024-10-05.
On approximately 2024-09-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Anaphylaxis, Hepatotoxicity. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. 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 song and advised movie. 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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-823
report_date: '2024-10-21'
patient_details:
patient_id: ANON-PX-3351
gender: Male
relevant_history:
- migraines
- chronic kidney disease
- asthma
age_at_reaction: 47
suspected_drugs:
- drug_name: Levothyroxine
dosage: 18mg
route_of_administration: Intramuscular
start_date: '2024-09-18'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-10-05'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-09-23'
severity: Mild
outcome: Not Recovered
intervention_required: true
- symptom_name: Anaphylaxis
onset_date: '2024-09-23'
severity: Severe
outcome: Recovering
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2024-09-23'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed song and advised movie.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 6
reporting_facility: Hall Inc 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-2024-730
Date of Submission: 2024-10-05
This report was submitted by a Nurse from Osborne-Russell Medical Center concerning patient ANON-PX-5922. The subject is a 48-year-old other with a significant medical history including type 2 diabetes, hypertension, 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): Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 228mg, initiated on 2024-09-18 for Hypertension with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 136mg, initiated on 2024-09-18 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2024-09-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Diarrhea, Stevens-Johnson syndrome, Hepatotoxicity, Vomiting. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed much and advised whom. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Life-threatening 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 current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed network and advised law. The current patient status regarding this symptom is 'Recovering'.
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.
</data>
|
report_id: ADR-2024-730
report_date: '2024-10-05'
patient_details:
patient_id: ANON-PX-5922
gender: Other
relevant_history:
- type 2 diabetes
- hypertension
- chronic kidney disease
- asthma
age_at_reaction: 48
suspected_drugs:
- drug_name: Lisinopril
dosage: 228mg
route_of_administration: Subcutaneous
start_date: '2024-09-18'
indication_for_use: Hypertension
drug_class: ACE inhibitor
- drug_name: Omeprazole
dosage: 136mg
route_of_administration: Topical
start_date: '2024-09-18'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-09-30'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed much and advised whom.
- symptom_name: Diarrhea
onset_date: '2024-09-30'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-09-30'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2024-09-30'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-09-30'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed network and advised law.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 1
reporting_facility: Osborne-Russell 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-2024-509
Date of Submission: 2024-08-14
This report was submitted by a Nurse from Stevens Ltd Medical Center concerning patient ANON-PX-5653. The subject is a 81-year-old female with a significant medical history including anxiety, chronic kidney disease, asthma, 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 Topical route at a dosage of 107mg, initiated on 2024-08-06 for Type 2 diabetes with the course ongoing.
On approximately 2024-08-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Nausea, Pruritus, Vomiting. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed them and advised deep. 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 election and advised sometimes. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed north and advised never. 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 treatment and advised suddenly. 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: Look product improve father law him partner. Economic staff ability respond bad environment work value. Candidate garden defense dinner pay certainly.</data>
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report_id: ADR-2024-509
report_date: '2024-08-14'
patient_details:
patient_id: ANON-PX-5653
gender: Female
relevant_history:
- anxiety
- chronic kidney disease
- asthma
- osteoarthritis
age_at_reaction: 81
suspected_drugs:
- drug_name: Metformin
dosage: 107mg
route_of_administration: Topical
start_date: '2024-08-06'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-08-12'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed them and advised deep.
- symptom_name: Nausea
onset_date: '2024-08-12'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed election and advised sometimes.
- symptom_name: Pruritus
onset_date: '2024-08-12'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed north and advised never.
- symptom_name: Vomiting
onset_date: '2024-08-12'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed treatment and advised suddenly.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Stevens Ltd Medical Center
reporter_type: Nurse
notes: Look product improve father law him partner. Economic staff ability respond
bad environment work value. Candidate garden defense dinner pay certainly.
|
<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-2025-490
Date of Submission: 2025-07-21
This report was submitted by a Pharmacist from Bowers and Sons Medical Center concerning patient ANON-PX-6408. The subject is a 80-year-old other with a significant medical history including atrial fibrillation, 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): Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 285mg, initiated on 2025-06-21 for Bacterial infection and discontinued on 2025-07-08; Sertraline administered via the Subcutaneous route at a dosage of 163mg, initiated on 2025-06-21 for Major depressive disorder and discontinued on 2025-07-08.
On approximately 2025-06-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Stevens-Johnson syndrome, Diarrhea, Hepatotoxicity, Vomiting. The Pruritus 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 Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed professional and advised friend. 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 'Not Recovered'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed modern and advised painting. 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 '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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Arrive big because. Race page source. Of I themselves require government.</data>
|
report_id: ADR-2025-490
report_date: '2025-07-21'
patient_details:
patient_id: ANON-PX-6408
gender: Other
relevant_history:
- atrial fibrillation
- anxiety
- type 2 diabetes
age_at_reaction: 80
suspected_drugs:
- drug_name: Amoxicillin
dosage: 285mg
route_of_administration: Subcutaneous
start_date: '2025-06-21'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-07-08'
- drug_name: Sertraline
dosage: 163mg
route_of_administration: Subcutaneous
start_date: '2025-06-21'
indication_for_use: Major depressive disorder
end_date: '2025-07-08'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-06-23'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-23'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed professional and advised friend.
- symptom_name: Diarrhea
onset_date: '2025-06-23'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-06-23'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed modern and advised painting.
- symptom_name: Vomiting
onset_date: '2025-06-23'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 3
reporting_facility: Bowers and Sons Medical Center
reporter_type: Pharmacist
notes: Arrive big because. Race page source. Of I themselves require government.
|
<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-2024-116
Date of Submission: 2024-08-24
This report was submitted by a Nurse from Lawson, Miller and Wilson Medical Center concerning patient ANON-PX-8101. 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): Lisinopril administered via the Oral route at a dosage of 455mg, initiated on 2024-07-19 for Hypertension and discontinued on 2024-07-29.
On approximately 2024-07-27, 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 Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed contain and advised significant. 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 '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.
Reporter's Narrative Summary: Develop away third happy nearly. Yeah teacher situation part especially audience relationship. Hot might each dark.</data>
|
report_id: ADR-2024-116
report_date: '2024-08-24'
patient_details:
patient_id: ANON-PX-8101
gender: Male
relevant_history:
- seasonal allergies
- chronic kidney disease
- type 2 diabetes
suspected_drugs:
- drug_name: Lisinopril
dosage: 455mg
route_of_administration: Oral
start_date: '2024-07-19'
indication_for_use: Hypertension
end_date: '2024-07-29'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-07-27'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed contain and advised significant.
- symptom_name: Hepatotoxicity
onset_date: '2024-07-27'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Lawson, Miller and Wilson Medical Center
reporter_type: Nurse
notes: Develop away third happy nearly. Yeah teacher situation part especially audience
relationship. Hot might each dark.
|
<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-2024-386
Date of Submission: 2024-08-29
This report was submitted by a Patient from Moran, Pratt and Long Medical Center concerning patient ANON-PX-8094. The subject is a 64-year-old male with a significant medical history including 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): Lisinopril administered via the Subcutaneous route at a dosage of 6mg, initiated on 2024-08-20 for Hypertension with the course ongoing.
On approximately 2024-08-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Nausea. The Pruritus 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 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 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: Article word race picture increase institution story picture. Someone pretty begin thousand recent.</data>
|
report_id: ADR-2024-386
report_date: '2024-08-29'
patient_details:
patient_id: ANON-PX-8094
gender: Male
relevant_history:
- migraines
- atrial fibrillation
age_at_reaction: 64
suspected_drugs:
- drug_name: Lisinopril
dosage: 6mg
route_of_administration: Subcutaneous
start_date: '2024-08-20'
indication_for_use: Hypertension
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-08-21'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-08-21'
severity: Life-threatening
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 1
reporting_facility: Moran, Pratt and Long Medical Center
reporter_type: Patient
notes: Article word race picture increase institution story picture. Someone pretty
begin thousand recent.
|
<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-2025-164
Date of Submission: 2025-08-06
This report was submitted by a Nurse from Davis Ltd Medical Center concerning patient ANON-PX-3560. The subject is a 63-year-old male with a significant medical history including asthma, coronary artery 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): Lisinopril administered via the Intramuscular route at a dosage of 289mg, initiated on 2025-07-22 for Hypertension and discontinued on 2025-07-28; Gabapentin (Anticonvulsant) administered via the Oral route at a dosage of 81mg, initiated on 2025-07-22 for Neuropathic pain and discontinued on 2025-07-28.
On approximately 2025-07-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Anaphylaxis, Maculopapular Rash. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed successful and advised allow. 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 'Recovered'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed land and advised meeting. 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: Skin growth majority cost trade amount market common. Management administration partner party after. Treat view design never individual customer.</data>
|
report_id: ADR-2025-164
report_date: '2025-08-06'
patient_details:
patient_id: ANON-PX-3560
gender: Male
relevant_history:
- asthma
- coronary artery disease
- type 2 diabetes
age_at_reaction: 63
suspected_drugs:
- drug_name: Lisinopril
dosage: 289mg
route_of_administration: Intramuscular
start_date: '2025-07-22'
indication_for_use: Hypertension
end_date: '2025-07-28'
- drug_name: Gabapentin
dosage: 81mg
route_of_administration: Oral
start_date: '2025-07-22'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-07-28'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-07-28'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed successful and advised allow.
- symptom_name: Anaphylaxis
onset_date: '2025-07-28'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-07-28'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed land and advised meeting.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 3
reporting_facility: Davis Ltd Medical Center
reporter_type: Nurse
notes: Skin growth majority cost trade amount market common. Management administration
partner party after. Treat view design never individual customer.
|
<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-2025-998
Date of Submission: 2025-05-18
This report was submitted by a Other Healthcare Professional from Smith, Larson and Ferrell Medical Center concerning patient ANON-PX-2833. The subject is a 45-year-old other with a significant medical history including 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): Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 236mg, initiated on 2025-03-28 for Neuropathic pain and discontinued on 2025-04-29.
On approximately 2025-04-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Vomiting, Anaphylaxis, Nausea, Pruritus. The Somnolence 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 Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed question and advised look. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed bit and advised account. The current patient status regarding this symptom is 'Unknown'. The Pruritus 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Measure too door. Animal current seem by specific matter.</data>
|
report_id: ADR-2025-998
report_date: '2025-05-18'
patient_details:
patient_id: ANON-PX-2833
gender: Other
relevant_history:
- migraines
- seasonal allergies
age_at_reaction: 45
suspected_drugs:
- drug_name: Gabapentin
dosage: 236mg
route_of_administration: Topical
start_date: '2025-03-28'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-04-29'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-04-20'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-04-20'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-04-20'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed question and advised look.
- symptom_name: Nausea
onset_date: '2025-04-20'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed bit and advised account.
- symptom_name: Pruritus
onset_date: '2025-04-20'
severity: Moderate
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Smith, Larson and Ferrell Medical Center
reporter_type: Other Healthcare Professional
notes: Measure too door. Animal current seem by specific matter.
|
<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-2025-197
Date of Submission: 2025-08-06
This report was submitted by a Pharmacist from Harris-Maynard Medical Center concerning patient ANON-PX-9923. The subject is a 61-year-old other with a significant medical history including seasonal allergies, 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): Gabapentin administered via the Intravenous route at a dosage of 384mg, initiated on 2025-06-23 for Neuropathic pain and discontinued on 2025-07-12; Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 271mg, initiated on 2025-06-23 for Gastroesophageal reflux disease and discontinued on 2025-07-12.
On approximately 2025-06-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Nausea, Stevens-Johnson syndrome. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed minute and advised might. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome 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 6 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-2025-197
report_date: '2025-08-06'
patient_details:
patient_id: ANON-PX-9923
gender: Other
relevant_history:
- seasonal allergies
- atrial fibrillation
- asthma
age_at_reaction: 61
suspected_drugs:
- drug_name: Gabapentin
dosage: 384mg
route_of_administration: Intravenous
start_date: '2025-06-23'
indication_for_use: Neuropathic pain
end_date: '2025-07-12'
- drug_name: Omeprazole
dosage: 271mg
route_of_administration: Subcutaneous
start_date: '2025-06-23'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-07-12'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-06-28'
severity: Mild
outcome: Recovered
intervention_required: true
- symptom_name: Nausea
onset_date: '2025-06-28'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed minute and advised might.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-28'
severity: Mild
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 6
reporting_facility: Harris-Maynard 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-2025-375
Date of Submission: 2025-07-30
This report was submitted by a Patient from Hood, Thompson and Goodwin Medical Center concerning patient ANON-PX-2134. The subject is a 37-year-old other 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): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 166mg, initiated on 2025-06-30 for Gastroesophageal reflux disease and discontinued on 2025-07-21; Atorvastatin (Statin) administered via the Subcutaneous route at a dosage of 375mg, initiated on 2025-06-30 for Hypercholesterolemia and discontinued on 2025-07-21.
On approximately 2025-07-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Nausea, Anaphylaxis, Diarrhea. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed author and advised look. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea 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 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: Song too likely play dog. News themselves artist. Technology social standard family indicate church.</data>
|
report_id: ADR-2025-375
report_date: '2025-07-30'
patient_details:
patient_id: ANON-PX-2134
gender: Other
relevant_history:
- osteoarthritis
- anxiety
age_at_reaction: 37
suspected_drugs:
- drug_name: Omeprazole
dosage: 166mg
route_of_administration: Subcutaneous
start_date: '2025-06-30'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-07-21'
- drug_name: Atorvastatin
dosage: 375mg
route_of_administration: Subcutaneous
start_date: '2025-06-30'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-07-21'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-07-01'
severity: Moderate
outcome: Recovering
intervention_required: true
- symptom_name: Nausea
onset_date: '2025-07-01'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-07-01'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed author and advised look.
- symptom_name: Diarrhea
onset_date: '2025-07-01'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 1
reporting_facility: Hood, Thompson and Goodwin Medical Center
reporter_type: Patient
notes: Song too likely play dog. News themselves artist. Technology social standard
family indicate church.
|
<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-2025-215
Date of Submission: 2025-06-17
This report was submitted by a Other Healthcare Professional from Mcintyre, Preston and Mendoza Medical Center concerning patient ANON-PX-4980. The subject is a 85-year-old female with a significant medical history including atrial fibrillation, osteoarthritis, 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 Subcutaneous route at a dosage of 136mg, initiated on 2025-05-17 for Neuropathic pain and discontinued on 2025-06-15; Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 84mg, initiated on 2025-05-17 for Pain and inflammation and discontinued on 2025-06-15.
On approximately 2025-06-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Headache. The Dizziness 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 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 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.
Reporter's Narrative Summary: Experience yourself budget them short fine for. Trip tax evidence out plant pick. Whose keep nearly.</data>
|
report_id: ADR-2025-215
report_date: '2025-06-17'
patient_details:
patient_id: ANON-PX-4980
gender: Female
relevant_history:
- atrial fibrillation
- osteoarthritis
- hypertension
age_at_reaction: 85
suspected_drugs:
- drug_name: Gabapentin
dosage: 136mg
route_of_administration: Subcutaneous
start_date: '2025-05-17'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-06-15'
- drug_name: Ibuprofen
dosage: 84mg
route_of_administration: Intramuscular
start_date: '2025-05-17'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-06-15'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-06-15'
severity: Moderate
outcome: Not Recovered
intervention_required: true
- symptom_name: Headache
onset_date: '2025-06-15'
severity: Moderate
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 1
reporting_facility: Mcintyre, Preston and Mendoza Medical Center
reporter_type: Other Healthcare Professional
notes: Experience yourself budget them short fine for. Trip tax evidence out plant
pick. Whose keep nearly.
|
<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-2024-950
Date of Submission: 2024-11-24
This report was submitted by a Pharmacist from Mcclure and Sons Medical Center concerning patient ANON-PX-6659. The subject is an adult male with a significant medical history including atrial fibrillation, 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): Warfarin (Anticoagulant) administered via the Topical route at a dosage of 97mg, initiated on 2024-11-09 for Thromboembolism prevention and discontinued on 2024-11-16.
On approximately 2024-11-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Headache, Diarrhea. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. 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 'Unknown'. The Diarrhea 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 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.
</data>
|
report_id: ADR-2024-950
report_date: '2024-11-24'
patient_details:
patient_id: ANON-PX-6659
gender: Male
relevant_history:
- atrial fibrillation
- chronic kidney disease
- asthma
suspected_drugs:
- drug_name: Warfarin
dosage: 97mg
route_of_administration: Topical
start_date: '2024-11-09'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-11-16'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-15'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Headache
onset_date: '2024-11-15'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-11-15'
severity: Severe
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 6
reporting_facility: Mcclure and Sons 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-2025-115
Date of Submission: 2025-04-28
This report was submitted by a Pharmacist from Cameron-Green Medical Center concerning patient ANON-PX-9173. The subject is an adult male with a significant medical history including coronary artery disease, 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): Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 410mg, initiated on 2025-02-23 for Neuropathic pain and discontinued on 2025-04-18; Atorvastatin (Statin) administered via the Intramuscular route at a dosage of 76mg, initiated on 2025-02-23 for Hypercholesterolemia and discontinued on 2025-04-18.
On approximately 2025-04-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Somnolence, Pruritus, Dizziness, Angioedema. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed most and advised road. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Pruritus 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. This necessitated clinical intervention. The documented action was: Prescribed scientist and advised bank. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed once and advised way. The current patient status regarding this symptom is 'Recovering'.
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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Worker morning bar truth fly raise. Day public worry guess exist camera. Here marriage television seven. Whole ok expect live authority.</data>
|
report_id: ADR-2025-115
report_date: '2025-04-28'
patient_details:
patient_id: ANON-PX-9173
gender: Male
relevant_history:
- coronary artery disease
- atrial fibrillation
- asthma
suspected_drugs:
- drug_name: Gabapentin
dosage: 410mg
route_of_administration: Topical
start_date: '2025-02-23'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-04-18'
- drug_name: Atorvastatin
dosage: 76mg
route_of_administration: Intramuscular
start_date: '2025-02-23'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-04-18'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-04-18'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed most and advised road.
- symptom_name: Somnolence
onset_date: '2025-04-18'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-04-18'
severity: Severe
outcome: Not Recovered
intervention_required: true
- symptom_name: Dizziness
onset_date: '2025-04-18'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed scientist and advised bank.
- symptom_name: Angioedema
onset_date: '2025-04-18'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed once and advised way.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 4
reporting_facility: Cameron-Green Medical Center
reporter_type: Pharmacist
notes: Worker morning bar truth fly raise. Day public worry guess exist camera. Here
marriage television seven. Whole ok expect live authority.
|
<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-2024-843
Date of Submission: 2024-11-17
This report was submitted by a Nurse from Watts-Mclaughlin Medical Center concerning patient ANON-PX-4040. The subject is a 43-year-old female with a significant medical history including osteoarthritis, 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): Amoxicillin administered via the Topical route at a dosage of 229mg, initiated on 2024-10-30 for Bacterial infection and discontinued on 2024-11-15.
On approximately 2024-11-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Nausea, Vomiting, Somnolence, Maculopapular Rash. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed approach and advised happy. The current patient status regarding this symptom is 'Unknown'. The Vomiting 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 'Recovered'. The Maculopapular Rash was classified as Moderate 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 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: We business choose behind recent. Discover thousand media challenge. World none keep couple fact.</data>
|
report_id: ADR-2024-843
report_date: '2024-11-17'
patient_details:
patient_id: ANON-PX-4040
gender: Female
relevant_history:
- osteoarthritis
- chronic kidney disease
- hypertension
age_at_reaction: 43
suspected_drugs:
- drug_name: Amoxicillin
dosage: 229mg
route_of_administration: Topical
start_date: '2024-10-30'
indication_for_use: Bacterial infection
end_date: '2024-11-15'
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-11-08'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-11-08'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed approach and advised happy.
- symptom_name: Vomiting
onset_date: '2024-11-08'
severity: Severe
outcome: Recovering
intervention_required: true
- symptom_name: Somnolence
onset_date: '2024-11-08'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-11-08'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 5
reporting_facility: Watts-Mclaughlin Medical Center
reporter_type: Nurse
notes: We business choose behind recent. Discover thousand media challenge. World
none keep couple fact.
|
<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-2025-188
Date of Submission: 2025-01-19
This report was submitted by a Physician from Golden-Garcia Medical Center concerning patient ANON-PX-9333. The subject is an adult male with a significant medical history including osteoarthritis, 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 (Biguanide) administered via the Topical route at a dosage of 17mg, initiated on 2024-11-07 for Type 2 diabetes and discontinued on 2025-01-15.
On approximately 2024-11-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Diarrhea. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Mild 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: National current try difficult shake. Say couple forget skin get where produce.</data>
|
report_id: ADR-2025-188
report_date: '2025-01-19'
patient_details:
patient_id: ANON-PX-9333
gender: Male
relevant_history:
- osteoarthritis
- coronary artery disease
suspected_drugs:
- drug_name: Metformin
dosage: 17mg
route_of_administration: Topical
start_date: '2024-11-07'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-01-15'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-11-29'
severity: Life-threatening
outcome: Fatal
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2024-11-29'
severity: Mild
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Golden-Garcia Medical Center
reporter_type: Physician
notes: National current try difficult shake. Say couple forget skin get where produce.
|
<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-2024-169
Date of Submission: 2024-12-09
This report was submitted by a Other Healthcare Professional from Lopez, Gonzalez and Stewart Medical Center concerning patient ANON-PX-9488. The subject is a 88-year-old other with a significant medical history including migraines, anxiety, 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): Omeprazole administered via the Intramuscular route at a dosage of 196mg, initiated on 2024-10-20 for Gastroesophageal reflux disease with the course ongoing; Ibuprofen (NSAID) administered via the Intravenous route at a dosage of 366mg, initiated on 2024-10-20 for Pain and inflammation with the course ongoing.
On approximately 2024-11-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Headache, Dizziness, Angioedema. 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 Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed race and advised really. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed work and advised edge. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed recognize and advised leave. 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Happen than safe land again common feeling foot. Technology society assume crime. Instead particular culture yeah.</data>
|
report_id: ADR-2024-169
report_date: '2024-12-09'
patient_details:
patient_id: ANON-PX-9488
gender: Other
relevant_history:
- migraines
- anxiety
- atrial fibrillation
- asthma
age_at_reaction: 88
suspected_drugs:
- drug_name: Omeprazole
dosage: 196mg
route_of_administration: Intramuscular
start_date: '2024-10-20'
indication_for_use: Gastroesophageal reflux disease
- drug_name: Ibuprofen
dosage: 366mg
route_of_administration: Intravenous
start_date: '2024-10-20'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-11-06'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Headache
onset_date: '2024-11-06'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed race and advised really.
- symptom_name: Dizziness
onset_date: '2024-11-06'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed work and advised edge.
- symptom_name: Angioedema
onset_date: '2024-11-06'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed recognize and advised leave.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 8
reporting_facility: Lopez, Gonzalez and Stewart Medical Center
reporter_type: Other Healthcare Professional
notes: Happen than safe land again common feeling foot. Technology society assume
crime. Instead particular culture yeah.
|
<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-2025-849
Date of Submission: 2025-03-07
This report was submitted by a Patient from Hurley-Hernandez Medical Center concerning patient ANON-PX-2631. The subject is an adult male with a significant medical history including osteoarthritis, 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): Omeprazole administered via the Subcutaneous route at a dosage of 188mg, initiated on 2025-01-30 for Gastroesophageal reflux disease and discontinued on 2025-02-15; Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 417mg, initiated on 2025-01-30 for Hypertension and discontinued on 2025-02-15.
On approximately 2025-02-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Hepatotoxicity. The Pruritus 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 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 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: Ago full senior notice would newspaper. Unit popular know design.</data>
|
report_id: ADR-2025-849
report_date: '2025-03-07'
patient_details:
patient_id: ANON-PX-2631
gender: Male
relevant_history:
- osteoarthritis
- seasonal allergies
- coronary artery disease
suspected_drugs:
- drug_name: Omeprazole
dosage: 188mg
route_of_administration: Subcutaneous
start_date: '2025-01-30'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-02-15'
- drug_name: Lisinopril
dosage: 417mg
route_of_administration: Subcutaneous
start_date: '2025-01-30'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-02-15'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-02-14'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-02-14'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 6
reporting_facility: Hurley-Hernandez Medical Center
reporter_type: Patient
notes: Ago full senior notice would newspaper. Unit popular know design.
|
<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-2025-720
Date of Submission: 2025-01-07
This report was submitted by a Patient from Young, Wilson and Dickerson Medical Center concerning patient ANON-PX-3730. The subject is a 49-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): Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 257mg, initiated on 2024-11-01 for Gastroesophageal reflux disease with the course ongoing; Gabapentin administered via the Intramuscular route at a dosage of 333mg, initiated on 2024-11-01 for Neuropathic pain with the course ongoing.
On approximately 2024-12-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Maculopapular Rash. The Somnolence was classified as Moderate 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. 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 5 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: Cup visit machine power bed move baby skill. Matter throughout industry.</data>
|
report_id: ADR-2025-720
report_date: '2025-01-07'
patient_details:
patient_id: ANON-PX-3730
gender: Female
relevant_history:
- osteoarthritis
- hypertension
- atrial fibrillation
age_at_reaction: 49
suspected_drugs:
- drug_name: Omeprazole
dosage: 257mg
route_of_administration: Intramuscular
start_date: '2024-11-01'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Gabapentin
dosage: 333mg
route_of_administration: Intramuscular
start_date: '2024-11-01'
indication_for_use: Neuropathic pain
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-12-05'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-12-05'
severity: Mild
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 5
reporting_facility: Young, Wilson and Dickerson Medical Center
reporter_type: Patient
notes: Cup visit machine power bed move baby skill. Matter throughout industry.
|
<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-2025-925
Date of Submission: 2025-06-11
This report was submitted by a Patient from Johnston-Nelson Medical Center concerning patient ANON-PX-9273. The subject is a 61-year-old other with a significant medical history including anxiety, 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): Levothyroxine (Thyroid hormone) administered via the Intramuscular route at a dosage of 175mg, initiated on 2025-04-04 for Hypothyroidism with the course ongoing; Sertraline administered via the Intramuscular route at a dosage of 86mg, initiated on 2025-04-04 for Major depressive disorder with the course ongoing.
On approximately 2025-05-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Pruritus, Maculopapular Rash. The Nausea 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 Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed loss and advised data. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-925
report_date: '2025-06-11'
patient_details:
patient_id: ANON-PX-9273
gender: Other
relevant_history:
- anxiety
- asthma
- migraines
- atrial fibrillation
age_at_reaction: 61
suspected_drugs:
- drug_name: Levothyroxine
dosage: 175mg
route_of_administration: Intramuscular
start_date: '2025-04-04'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
- drug_name: Sertraline
dosage: 86mg
route_of_administration: Intramuscular
start_date: '2025-04-04'
indication_for_use: Major depressive disorder
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-05-29'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-05-29'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed loss and advised data.
- symptom_name: Maculopapular Rash
onset_date: '2025-05-29'
severity: Moderate
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Johnston-Nelson 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-2025-704
Date of Submission: 2025-05-26
This report was submitted by a Pharmacist from Grant Group Medical Center concerning patient ANON-PX-5825. The subject is an adult other with a significant medical history including 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 Intravenous route at a dosage of 366mg, initiated on 2025-05-17 for Hypercholesterolemia and discontinued on 2025-05-24.
On approximately 2025-05-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Anaphylaxis, Dizziness, Hepatotoxicity, Pruritus. The Vomiting 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 Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. 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 Hepatotoxicity was classified as Mild in severity. No specific therapeutic intervention was required. 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 '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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Thousand week adult hold everybody mission some. Cover yet stock red change ever remember news.</data>
|
report_id: ADR-2025-704
report_date: '2025-05-26'
patient_details:
patient_id: ANON-PX-5825
gender: Other
relevant_history:
- anxiety
- asthma
suspected_drugs:
- drug_name: Atorvastatin
dosage: 366mg
route_of_administration: Intravenous
start_date: '2025-05-17'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-05-24'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-05-24'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-05-24'
severity: Severe
outcome: Recovering
intervention_required: true
- symptom_name: Dizziness
onset_date: '2025-05-24'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-05-24'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-05-24'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 9
reporting_facility: Grant Group Medical Center
reporter_type: Pharmacist
notes: Thousand week adult hold everybody mission some. Cover yet stock red change
ever remember news.
|
<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-2025-361
Date of Submission: 2025-01-03
This report was submitted by a Other Healthcare Professional from Nunez Group Medical Center concerning patient ANON-PX-5875. The subject is a 33-year-old male with a significant medical history including hypertension, asthma, 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): Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 204mg, initiated on 2024-12-25 for Major depressive disorder and discontinued on 2024-12-28; Metformin (Biguanide) administered via the Subcutaneous route at a dosage of 417mg, initiated on 2024-12-25 for Type 2 diabetes and discontinued on 2024-12-28.
On approximately 2024-12-28, 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 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 Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed nice and advised way. 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: Off lead skill piece a eight. Card should campaign. Not street race position. Free behind accept movie beat international imagine city.</data>
|
report_id: ADR-2025-361
report_date: '2025-01-03'
patient_details:
patient_id: ANON-PX-5875
gender: Male
relevant_history:
- hypertension
- asthma
- seasonal allergies
- coronary artery disease
age_at_reaction: 33
suspected_drugs:
- drug_name: Sertraline
dosage: 204mg
route_of_administration: Subcutaneous
start_date: '2024-12-25'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-12-28'
- drug_name: Metformin
dosage: 417mg
route_of_administration: Subcutaneous
start_date: '2024-12-25'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-12-28'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-12-28'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-12-28'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed nice and advised way.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 6
reporting_facility: Nunez Group Medical Center
reporter_type: Other Healthcare Professional
notes: Off lead skill piece a eight. Card should campaign. Not street race position.
Free behind accept movie beat international imagine city.
|
<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-2024-479
Date of Submission: 2024-09-03
This report was submitted by a Pharmacist from Obrien PLC Medical Center concerning patient ANON-PX-6693. The subject is a 81-year-old male with a significant medical history including coronary artery disease, anxiety, 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): Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 206mg, initiated on 2024-08-24 for Hypothyroidism and discontinued on 2024-09-01.
On approximately 2024-08-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Somnolence, Hepatotoxicity. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed alone and advised reveal. The current patient status regarding this symptom is 'Recovered'. The Somnolence 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'.
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: Until need at go attack development. Present say old throw work. Group its protect strong born like.</data>
|
report_id: ADR-2024-479
report_date: '2024-09-03'
patient_details:
patient_id: ANON-PX-6693
gender: Male
relevant_history:
- coronary artery disease
- anxiety
- chronic kidney disease
- seasonal allergies
age_at_reaction: 81
suspected_drugs:
- drug_name: Levothyroxine
dosage: 206mg
route_of_administration: Topical
start_date: '2024-08-24'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-09-01'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-08-28'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed alone and advised reveal.
- symptom_name: Somnolence
onset_date: '2024-08-28'
severity: Moderate
outcome: Recovered
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2024-08-28'
severity: Severe
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Obrien PLC Medical Center
reporter_type: Pharmacist
notes: Until need at go attack development. Present say old throw work. Group its
protect strong born like.
|
<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-2024-427
Date of Submission: 2024-08-25
This report was submitted by a Nurse from Adams-Hall Medical Center concerning patient ANON-PX-1716. The subject is a 21-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): Gabapentin (Anticonvulsant) administered via the Oral route at a dosage of 37mg, initiated on 2024-07-12 for Neuropathic pain and discontinued on 2024-08-06.
On approximately 2024-07-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Vomiting, Dizziness. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness 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 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.
</data>
|
report_id: ADR-2024-427
report_date: '2024-08-25'
patient_details:
patient_id: ANON-PX-1716
gender: Female
relevant_history:
- migraines
- anxiety
age_at_reaction: 21
suspected_drugs:
- drug_name: Gabapentin
dosage: 37mg
route_of_administration: Oral
start_date: '2024-07-12'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2024-08-06'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-07-18'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-07-18'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-07-18'
severity: Severe
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 2
reporting_facility: Adams-Hall Medical Center
reporter_type: Nurse
|
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