prompt
stringlengths 1.92k
9.98k
| response
stringlengths 714
11k
|
|---|---|
<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-2025-344
Date of Submission: 2025-05-22
This report was submitted by a Physician from Kim PLC Medical Center concerning patient ANON-PX-4821. The subject is a 82-year-old female with a significant medical history including hypertension, anxiety, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen administered via the Oral route at a dosage of 353mg, initiated on 2025-03-08 for Pain and inflammation with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Intravenous route at a dosage of 316mg, initiated on 2025-03-08 for Gastroesophageal reflux disease 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 Somnolence, Dizziness, Maculopapular Rash. 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 Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed eat and advised it. 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Tv sort begin picture. Simply professor institution painting believe bill way PM. Order on into officer key.</data>
|
report_id: ADR-2025-344
report_date: '2025-05-22'
patient_details:
patient_id: ANON-PX-4821
gender: Female
relevant_history:
- hypertension
- anxiety
- type 2 diabetes
age_at_reaction: 82
suspected_drugs:
- drug_name: Ibuprofen
dosage: 353mg
route_of_administration: Oral
start_date: '2025-03-08'
indication_for_use: Pain and inflammation
- drug_name: Omeprazole
dosage: 316mg
route_of_administration: Intravenous
start_date: '2025-03-08'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-05-10'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-05-10'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-05-10'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed eat and advised it.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 9
reporting_facility: Kim PLC Medical Center
reporter_type: Physician
notes: Tv sort begin picture. Simply professor institution painting believe bill way
PM. Order on into officer 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-2025-986
Date of Submission: 2025-05-19
This report was submitted by a Physician from Fisher-Quinn Medical Center concerning patient ANON-PX-5548. The subject is a 24-year-old female with a significant medical history including chronic kidney disease, osteoarthritis, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril administered via the Topical route at a dosage of 455mg, initiated on 2025-03-02 for Hypertension with the course ongoing; Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 333mg, initiated on 2025-03-02 for Pain and inflammation with the course ongoing.
On approximately 2025-05-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Somnolence, Vomiting, Dizziness. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed heart and advised ten. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. 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 information and advised television. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Center order a support center. Group strong animal cover until task owner. Development ask think goal especially. Month thus management administration serious.</data>
|
report_id: ADR-2025-986
report_date: '2025-05-19'
patient_details:
patient_id: ANON-PX-5548
gender: Female
relevant_history:
- chronic kidney disease
- osteoarthritis
- seasonal allergies
age_at_reaction: 24
suspected_drugs:
- drug_name: Lisinopril
dosage: 455mg
route_of_administration: Topical
start_date: '2025-03-02'
indication_for_use: Hypertension
- drug_name: Ibuprofen
dosage: 333mg
route_of_administration: Subcutaneous
start_date: '2025-03-02'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-05-12'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed heart and advised ten.
- symptom_name: Somnolence
onset_date: '2025-05-12'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-05-12'
severity: Life-threatening
outcome: Unknown
intervention_required: true
- symptom_name: Dizziness
onset_date: '2025-05-12'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed information and advised television.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Fisher-Quinn Medical Center
reporter_type: Physician
notes: Center order a support center. Group strong animal cover until task owner.
Development ask think goal especially. Month thus management administration serious.
|
<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-2025-494
Date of Submission: 2025-01-15
This report was submitted by a Patient from Allen, Shaw and Savage Medical Center concerning patient ANON-PX-8817. The subject is a 35-year-old female with a significant medical history including osteoarthritis, 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 171mg, initiated on 2024-12-19 for Major depressive disorder and discontinued on 2025-01-04; Ibuprofen administered via the Topical route at a dosage of 371mg, initiated on 2024-12-19 for Pain and inflammation and discontinued on 2025-01-04.
On approximately 2024-12-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Nausea. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed particularly and advised recently. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed on and advised use. 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-2025-494
report_date: '2025-01-15'
patient_details:
patient_id: ANON-PX-8817
gender: Female
relevant_history:
- osteoarthritis
- chronic kidney disease
age_at_reaction: 35
suspected_drugs:
- drug_name: Sertraline
dosage: 171mg
route_of_administration: Topical
start_date: '2024-12-19'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-01-04'
- drug_name: Ibuprofen
dosage: 371mg
route_of_administration: Topical
start_date: '2024-12-19'
indication_for_use: Pain and inflammation
end_date: '2025-01-04'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-12-23'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed particularly and advised recently.
- symptom_name: Nausea
onset_date: '2024-12-23'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed on and advised use.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 3
reporting_facility: Allen, Shaw and Savage 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-2025-840
Date of Submission: 2025-03-30
This report was submitted by a Pharmacist from Torres, Horton and Freeman Medical Center concerning patient ANON-PX-2338. The subject is an adult other with a significant medical history including hypertension, type 2 diabetes, 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 131mg, initiated on 2025-01-09 for Major depressive disorder with the course ongoing; Amoxicillin administered via the Oral route at a dosage of 388mg, initiated on 2025-01-09 for Bacterial infection with the course ongoing.
On approximately 2025-03-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Angioedema, Vomiting, Stevens-Johnson syndrome, Anaphylaxis. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. 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 response and advised key. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed really and advised best. 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 '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: Purpose sure road item treatment. Certain spring when order matter.</data>
|
report_id: ADR-2025-840
report_date: '2025-03-30'
patient_details:
patient_id: ANON-PX-2338
gender: Other
relevant_history:
- hypertension
- type 2 diabetes
- coronary artery disease
suspected_drugs:
- drug_name: Sertraline
dosage: 131mg
route_of_administration: Intravenous
start_date: '2025-01-09'
indication_for_use: Major depressive disorder
- drug_name: Amoxicillin
dosage: 388mg
route_of_administration: Oral
start_date: '2025-01-09'
indication_for_use: Bacterial infection
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-03-17'
severity: Severe
outcome: Fatal
intervention_required: true
- symptom_name: Angioedema
onset_date: '2025-03-17'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed response and advised key.
- symptom_name: Vomiting
onset_date: '2025-03-17'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-17'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed really and advised best.
- symptom_name: Anaphylaxis
onset_date: '2025-03-17'
severity: Severe
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Torres, Horton and Freeman Medical Center
reporter_type: Pharmacist
notes: Purpose sure road item treatment. Certain spring when order 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-2025-867
Date of Submission: 2025-03-14
This report was submitted by a Pharmacist from Collins, Walker and Boyd Medical Center concerning patient ANON-PX-5170. The subject is an adult female with a significant medical history including osteoarthritis, migraines, 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): Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 407mg, initiated on 2025-02-06 for Bacterial infection with the course ongoing.
On approximately 2025-03-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Pruritus, Anaphylaxis. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Remain debate customer indicate relationship husband state. Beat bank share could rock top. Black leader man win role.</data>
|
report_id: ADR-2025-867
report_date: '2025-03-14'
patient_details:
patient_id: ANON-PX-5170
gender: Female
relevant_history:
- osteoarthritis
- migraines
- atrial fibrillation
- chronic kidney disease
suspected_drugs:
- drug_name: Amoxicillin
dosage: 407mg
route_of_administration: Oral
start_date: '2025-02-06'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-02'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-03-02'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-03-02'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 1
reporting_facility: Collins, Walker and Boyd Medical Center
reporter_type: Pharmacist
notes: Remain debate customer indicate relationship husband state. Beat bank share
could rock top. Black leader man win role.
|
<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-2025-442
Date of Submission: 2025-03-07
This report was submitted by a Patient from Moore-Anderson Medical Center concerning patient ANON-PX-6944. The subject is a 18-year-old male with a significant medical history including 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): Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 133mg, initiated on 2025-02-25 for Bacterial infection and discontinued on 2025-03-04; Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 294mg, initiated on 2025-02-25 for Gastroesophageal reflux disease and discontinued on 2025-03-04.
On approximately 2025-03-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Angioedema, Diarrhea, Anaphylaxis, Stevens-Johnson syndrome. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The 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: One admit board my thousand wonder. Whole eat down teacher yes that from. Kind despite similar section return.</data>
|
report_id: ADR-2025-442
report_date: '2025-03-07'
patient_details:
patient_id: ANON-PX-6944
gender: Male
relevant_history:
- chronic kidney disease
- seasonal allergies
age_at_reaction: 18
suspected_drugs:
- drug_name: Amoxicillin
dosage: 133mg
route_of_administration: Topical
start_date: '2025-02-25'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-03-04'
- drug_name: Omeprazole
dosage: 294mg
route_of_administration: Subcutaneous
start_date: '2025-02-25'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-03-04'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-03-03'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-03-03'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-03-03'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-03-03'
severity: Moderate
outcome: Recovering
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-03'
severity: Life-threatening
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Moore-Anderson Medical Center
reporter_type: Patient
notes: One admit board my thousand wonder. Whole eat down teacher yes that from. Kind
despite similar section return.
|
<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-2024-998
Date of Submission: 2024-08-22
This report was submitted by a Other Healthcare Professional from Smith-Johnson Medical Center concerning patient ANON-PX-2076. The subject is an adult female with a significant medical history including type 2 diabetes, seasonal allergies, osteoarthritis, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine (Thyroid hormone) administered via the Intravenous route at a dosage of 142mg, initiated on 2024-06-15 for Hypothyroidism and discontinued on 2024-08-18; Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 260mg, initiated on 2024-06-15 for Gastroesophageal reflux disease and discontinued on 2024-08-18.
On approximately 2024-07-11, 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 Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Life-threatening in severity. 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 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Tax past large force such. Soon cost child show. Impact director really small morning sense.</data>
|
report_id: ADR-2024-998
report_date: '2024-08-22'
patient_details:
patient_id: ANON-PX-2076
gender: Female
relevant_history:
- type 2 diabetes
- seasonal allergies
- osteoarthritis
- migraines
suspected_drugs:
- drug_name: Levothyroxine
dosage: 142mg
route_of_administration: Intravenous
start_date: '2024-06-15'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-08-18'
- drug_name: Omeprazole
dosage: 260mg
route_of_administration: Subcutaneous
start_date: '2024-06-15'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-08-18'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-07-11'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-07-11'
severity: Life-threatening
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 5
reporting_facility: Smith-Johnson Medical Center
reporter_type: Other Healthcare Professional
notes: Tax past large force such. Soon cost child show. Impact director really small
morning sense.
|
<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-2024-701
Date of Submission: 2024-09-23
This report was submitted by a Physician from Miller-Wagner Medical Center concerning patient ANON-PX-2954. The subject is a 71-year-old male with a significant medical history including 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 Oral route at a dosage of 270mg, initiated on 2024-06-30 for Neuropathic pain with the course ongoing; Sertraline (SSRI) administered via the Topical route at a dosage of 319mg, initiated on 2024-06-30 for Major depressive disorder with the course ongoing.
On approximately 2024-09-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Headache, Somnolence, Maculopapular Rash, Stevens-Johnson syndrome. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed reduce and advised room. 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 hundred and advised environmental. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Grow true number kitchen could real which. Gas human product including Democrat.</data>
|
report_id: ADR-2024-701
report_date: '2024-09-23'
patient_details:
patient_id: ANON-PX-2954
gender: Male
relevant_history:
- migraines
- osteoarthritis
age_at_reaction: 71
suspected_drugs:
- drug_name: Gabapentin
dosage: 270mg
route_of_administration: Oral
start_date: '2024-06-30'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
- drug_name: Sertraline
dosage: 319mg
route_of_administration: Topical
start_date: '2024-06-30'
indication_for_use: Major depressive disorder
drug_class: SSRI
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-09-17'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed reduce and advised room.
- symptom_name: Headache
onset_date: '2024-09-17'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed hundred and advised environmental.
- symptom_name: Somnolence
onset_date: '2024-09-17'
severity: Severe
outcome: Recovering
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2024-09-17'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-09-17'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 1
reporting_facility: Miller-Wagner Medical Center
reporter_type: Physician
notes: Grow true number kitchen could real which. Gas human product including Democrat.
|
<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-2025-859
Date of Submission: 2025-05-10
This report was submitted by a Other Healthcare Professional from Lewis-Campbell Medical Center concerning patient ANON-PX-2302. The subject is a 30-year-old male with a significant medical history including atrial fibrillation, seasonal allergies, hypertension, 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 Intramuscular route at a dosage of 271mg, initiated on 2025-02-15 for Gastroesophageal reflux disease and discontinued on 2025-05-08; Ibuprofen administered via the Intramuscular route at a dosage of 55mg, initiated on 2025-02-15 for Pain and inflammation and discontinued on 2025-05-08.
On approximately 2025-03-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Dizziness. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed garden and advised society. The current patient status regarding this symptom is 'Unknown'. 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 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: Top age central without place. I probably outside watch yard think.</data>
|
report_id: ADR-2025-859
report_date: '2025-05-10'
patient_details:
patient_id: ANON-PX-2302
gender: Male
relevant_history:
- atrial fibrillation
- seasonal allergies
- hypertension
- anxiety
age_at_reaction: 30
suspected_drugs:
- drug_name: Omeprazole
dosage: 271mg
route_of_administration: Intramuscular
start_date: '2025-02-15'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-05-08'
- drug_name: Ibuprofen
dosage: 55mg
route_of_administration: Intramuscular
start_date: '2025-02-15'
indication_for_use: Pain and inflammation
end_date: '2025-05-08'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-03-18'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed garden and advised society.
- symptom_name: Dizziness
onset_date: '2025-03-18'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 9
reporting_facility: Lewis-Campbell Medical Center
reporter_type: Other Healthcare Professional
notes: Top age central without place. I probably outside watch yard think.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-598
Date of Submission: 2024-10-22
This report was submitted by a Physician from Morgan, Flores and Henry Medical Center concerning patient ANON-PX-4071. The subject is a 29-year-old other with a significant medical history including type 2 diabetes, seasonal allergies, asthma, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Intravenous route at a dosage of 142mg, initiated on 2024-09-18 for Pain and inflammation and discontinued on 2024-10-18; Levothyroxine (Thyroid hormone) administered via the Oral route at a dosage of 478mg, initiated on 2024-09-18 for Hypothyroidism and discontinued on 2024-10-18.
On approximately 2024-10-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Diarrhea. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed many and advised drive. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed yet and advised produce. 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.
</data>
|
report_id: ADR-2024-598
report_date: '2024-10-22'
patient_details:
patient_id: ANON-PX-4071
gender: Other
relevant_history:
- type 2 diabetes
- seasonal allergies
- asthma
- migraines
age_at_reaction: 29
suspected_drugs:
- drug_name: Ibuprofen
dosage: 142mg
route_of_administration: Intravenous
start_date: '2024-09-18'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-10-18'
- drug_name: Levothyroxine
dosage: 478mg
route_of_administration: Oral
start_date: '2024-09-18'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-10-18'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-10-10'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed many and advised drive.
- symptom_name: Diarrhea
onset_date: '2024-10-10'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed yet and advised produce.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 9
reporting_facility: Morgan, Flores and Henry 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-2025-770
Date of Submission: 2025-07-15
This report was submitted by a Physician from Weaver Ltd Medical Center concerning patient ANON-PX-4219. The subject is a 30-year-old male with a significant medical history including type 2 diabetes, 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 administered via the Oral route at a dosage of 402mg, initiated on 2025-04-23 for Major depressive disorder and discontinued on 2025-06-15; Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 314mg, initiated on 2025-04-23 for Bacterial infection and discontinued on 2025-06-15.
On approximately 2025-05-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Stevens-Johnson syndrome, Pruritus, Dizziness. The Anaphylaxis 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 Life-threatening 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. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed catch and advised media. The current patient status regarding this symptom is 'Not Recovered'.
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: Discussion room tell college page perhaps their. Amount seek compare up.</data>
|
report_id: ADR-2025-770
report_date: '2025-07-15'
patient_details:
patient_id: ANON-PX-4219
gender: Male
relevant_history:
- type 2 diabetes
- anxiety
age_at_reaction: 30
suspected_drugs:
- drug_name: Sertraline
dosage: 402mg
route_of_administration: Oral
start_date: '2025-04-23'
indication_for_use: Major depressive disorder
end_date: '2025-06-15'
- drug_name: Amoxicillin
dosage: 314mg
route_of_administration: Oral
start_date: '2025-04-23'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-06-15'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-05-08'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-05-08'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-05-08'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-05-08'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed catch and advised media.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 4
reporting_facility: Weaver Ltd Medical Center
reporter_type: Physician
notes: Discussion room tell college page perhaps their. Amount seek compare up.
|
<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-2025-312
Date of Submission: 2025-07-01
This report was submitted by a Physician from Murphy-Hernandez Medical Center concerning patient ANON-PX-1741. The subject is a 36-year-old other with a significant medical history including type 2 diabetes, osteoarthritis, 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): Warfarin administered via the Subcutaneous route at a dosage of 194mg, initiated on 2025-06-17 for Thromboembolism prevention and discontinued on 2025-06-28; Gabapentin administered via the Subcutaneous route at a dosage of 125mg, initiated on 2025-06-17 for Neuropathic pain and discontinued on 2025-06-28.
On approximately 2025-06-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Stevens-Johnson syndrome. The Maculopapular Rash 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. This necessitated clinical intervention. The documented action was: Prescribed beautiful and advised moment. 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 rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Important base yet star oil bad involve blood. Reality see college not military age try.</data>
|
report_id: ADR-2025-312
report_date: '2025-07-01'
patient_details:
patient_id: ANON-PX-1741
gender: Other
relevant_history:
- type 2 diabetes
- osteoarthritis
- migraines
- chronic kidney disease
age_at_reaction: 36
suspected_drugs:
- drug_name: Warfarin
dosage: 194mg
route_of_administration: Subcutaneous
start_date: '2025-06-17'
indication_for_use: Thromboembolism prevention
end_date: '2025-06-28'
- drug_name: Gabapentin
dosage: 125mg
route_of_administration: Subcutaneous
start_date: '2025-06-17'
indication_for_use: Neuropathic pain
end_date: '2025-06-28'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-06-27'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-27'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed beautiful and advised moment.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 2
reporting_facility: Murphy-Hernandez Medical Center
reporter_type: Physician
notes: Important base yet star oil bad involve blood. Reality see college not military
age try.
|
<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-2025-383
Date of Submission: 2025-08-12
This report was submitted by a Pharmacist from Obrien Group Medical Center concerning patient ANON-PX-9376. The subject is a 59-year-old other with a significant medical history including atrial fibrillation, 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 (Thyroid hormone) administered via the Intravenous route at a dosage of 42mg, initiated on 2025-07-29 for Hypothyroidism with the course ongoing; Omeprazole administered via the Topical route at a dosage of 315mg, initiated on 2025-07-29 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2025-07-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Headache, Nausea. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed government and advised chance. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is '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'.
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: Picture herself available window might. Congress career baby.</data>
|
report_id: ADR-2025-383
report_date: '2025-08-12'
patient_details:
patient_id: ANON-PX-9376
gender: Other
relevant_history:
- atrial fibrillation
- anxiety
age_at_reaction: 59
suspected_drugs:
- drug_name: Levothyroxine
dosage: 42mg
route_of_administration: Intravenous
start_date: '2025-07-29'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
- drug_name: Omeprazole
dosage: 315mg
route_of_administration: Topical
start_date: '2025-07-29'
indication_for_use: Gastroesophageal reflux disease
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-07-31'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed government and advised chance.
- symptom_name: Headache
onset_date: '2025-07-31'
severity: Life-threatening
outcome: Unknown
intervention_required: true
- symptom_name: Nausea
onset_date: '2025-07-31'
severity: Moderate
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 5
reporting_facility: Obrien Group Medical Center
reporter_type: Pharmacist
notes: Picture herself available window might. Congress career baby.
|
<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-2025-458
Date of Submission: 2025-02-21
This report was submitted by a Pharmacist from Wilkerson and Sons Medical Center concerning patient ANON-PX-5990. The subject is an adult female with a significant medical history including asthma, 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): Warfarin (Anticoagulant) administered via the Intravenous route at a dosage of 496mg, initiated on 2025-01-03 for Thromboembolism prevention and discontinued on 2025-02-20.
On approximately 2025-02-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Nausea, Pruritus, Maculopapular Rash. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed control and advised hundred. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed pattern and advised everybody. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed well and advised personal. The current patient status regarding this symptom is 'Not Recovered'.
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.
</data>
|
report_id: ADR-2025-458
report_date: '2025-02-21'
patient_details:
patient_id: ANON-PX-5990
gender: Female
relevant_history:
- asthma
- osteoarthritis
- seasonal allergies
- hypertension
suspected_drugs:
- drug_name: Warfarin
dosage: 496mg
route_of_administration: Intravenous
start_date: '2025-01-03'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-02-20'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-02-15'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed control and advised hundred.
- symptom_name: Nausea
onset_date: '2025-02-15'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed pattern and advised everybody.
- symptom_name: Pruritus
onset_date: '2025-02-15'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-02-15'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed well and advised personal.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 4
reporting_facility: Wilkerson 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-2025-485
Date of Submission: 2025-02-24
This report was submitted by a Other Healthcare Professional from Brown, Walker and Mcconnell Medical Center concerning patient ANON-PX-2349. The subject is a 34-year-old male with a significant medical history including 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): Atorvastatin (Statin) administered via the Oral route at a dosage of 416mg, initiated on 2024-12-20 for Hypercholesterolemia and discontinued on 2025-02-19; Sertraline administered via the Oral route at a dosage of 229mg, initiated on 2024-12-20 for Major depressive disorder and discontinued on 2025-02-19.
On approximately 2025-02-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Stevens-Johnson syndrome, Nausea, Dizziness. The Angioedema 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. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. 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 '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: Tough speech player field. Center role professional strong despite international eight.</data>
|
report_id: ADR-2025-485
report_date: '2025-02-24'
patient_details:
patient_id: ANON-PX-2349
gender: Male
relevant_history:
- asthma
- osteoarthritis
age_at_reaction: 34
suspected_drugs:
- drug_name: Atorvastatin
dosage: 416mg
route_of_administration: Oral
start_date: '2024-12-20'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-02-19'
- drug_name: Sertraline
dosage: 229mg
route_of_administration: Oral
start_date: '2024-12-20'
indication_for_use: Major depressive disorder
end_date: '2025-02-19'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-02-15'
severity: Severe
outcome: Unknown
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-02-15'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-02-15'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Dizziness
onset_date: '2025-02-15'
severity: Life-threatening
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 1
reporting_facility: Brown, Walker and Mcconnell Medical Center
reporter_type: Other Healthcare Professional
notes: Tough speech player field. Center role professional strong despite international
eight.
|
<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: 2025-06-23
This report was submitted by a Pharmacist from Knight-Ellison Medical Center concerning patient ANON-PX-3031. The subject is a 31-year-old male with a significant medical history including migraines, osteoarthritis, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline administered via the Topical route at a dosage of 70mg, initiated on 2025-05-11 for Major depressive disorder with the course ongoing; Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 291mg, initiated on 2025-05-11 for Hypothyroidism with the course ongoing.
On approximately 2025-05-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Vomiting, Angioedema, Dizziness, Anaphylaxis. The Headache was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed paper and advised family. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed raise and advised somebody. 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 Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed Mr and advised million. 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Truth boy pay job. Girl rather school accept response education well. News material itself against.</data>
|
report_id: ADR-2025-599
report_date: '2025-06-23'
patient_details:
patient_id: ANON-PX-3031
gender: Male
relevant_history:
- migraines
- osteoarthritis
- atrial fibrillation
age_at_reaction: 31
suspected_drugs:
- drug_name: Sertraline
dosage: 70mg
route_of_administration: Topical
start_date: '2025-05-11'
indication_for_use: Major depressive disorder
- drug_name: Levothyroxine
dosage: 291mg
route_of_administration: Topical
start_date: '2025-05-11'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-05-22'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-05-22'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed paper and advised family.
- symptom_name: Angioedema
onset_date: '2025-05-22'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed raise and advised somebody.
- symptom_name: Dizziness
onset_date: '2025-05-22'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-05-22'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed Mr and advised million.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 6
reporting_facility: Knight-Ellison Medical Center
reporter_type: Pharmacist
notes: Truth boy pay job. Girl rather school accept response education well. News
material itself against.
|
<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: 2025-07-31
This report was submitted by a Patient from Brown, Lee and Gardner Medical Center concerning patient ANON-PX-9083. The subject is an adult other 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): Warfarin (Anticoagulant) administered via the Oral route at a dosage of 115mg, initiated on 2025-06-29 for Thromboembolism prevention and discontinued on 2025-07-20; Lisinopril administered via the Intravenous route at a dosage of 243mg, initiated on 2025-06-29 for Hypertension and discontinued on 2025-07-20.
On approximately 2025-07-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Anaphylaxis, Angioedema. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed important and advised exactly. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed four and advised staff. 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-505
report_date: '2025-07-31'
patient_details:
patient_id: ANON-PX-9083
gender: Other
relevant_history:
- type 2 diabetes
- hypertension
suspected_drugs:
- drug_name: Warfarin
dosage: 115mg
route_of_administration: Oral
start_date: '2025-06-29'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-07-20'
- drug_name: Lisinopril
dosage: 243mg
route_of_administration: Intravenous
start_date: '2025-06-29'
indication_for_use: Hypertension
end_date: '2025-07-20'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-07-11'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-07-11'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed important and advised exactly.
- symptom_name: Angioedema
onset_date: '2025-07-11'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed four and advised staff.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 2
reporting_facility: Brown, Lee and Gardner 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-2025-976
Date of Submission: 2025-08-07
This report was submitted by a Pharmacist from Perez Inc Medical Center concerning patient ANON-PX-7468. The subject is a 70-year-old other with a significant medical history including anxiety, 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): Lisinopril administered via the Subcutaneous route at a dosage of 479mg, initiated on 2025-07-16 for Hypertension and discontinued on 2025-08-02; Levothyroxine administered via the Topical route at a dosage of 95mg, initiated on 2025-07-16 for Hypothyroidism and discontinued on 2025-08-02.
On approximately 2025-07-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Nausea. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. 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 sort and advised yet. The current patient status regarding this symptom is 'Recovering'.
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: Lay beyond size set past take we water. Admit seem so experience size. Role capital although there increase community.</data>
|
report_id: ADR-2025-976
report_date: '2025-08-07'
patient_details:
patient_id: ANON-PX-7468
gender: Other
relevant_history:
- anxiety
- osteoarthritis
- asthma
age_at_reaction: 70
suspected_drugs:
- drug_name: Lisinopril
dosage: 479mg
route_of_administration: Subcutaneous
start_date: '2025-07-16'
indication_for_use: Hypertension
end_date: '2025-08-02'
- drug_name: Levothyroxine
dosage: 95mg
route_of_administration: Topical
start_date: '2025-07-16'
indication_for_use: Hypothyroidism
end_date: '2025-08-02'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-07-27'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Nausea
onset_date: '2025-07-27'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed sort and advised yet.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 7
reporting_facility: Perez Inc Medical Center
reporter_type: Pharmacist
notes: Lay beyond size set past take we water. Admit seem so experience size. Role
capital although there increase community.
|
<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-2025-717
Date of Submission: 2025-05-08
This report was submitted by a Nurse from Lamb, Garcia and Bartlett Medical Center concerning patient ANON-PX-6682. The subject is a 21-year-old male 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): Warfarin (Anticoagulant) administered via the Topical route at a dosage of 433mg, initiated on 2025-02-15 for Thromboembolism prevention and discontinued on 2025-04-29.
On approximately 2025-04-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Maculopapular Rash. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed each and advised program. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed decision and advised capital. 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: Air language staff major. Discuss modern player method that.</data>
|
report_id: ADR-2025-717
report_date: '2025-05-08'
patient_details:
patient_id: ANON-PX-6682
gender: Male
relevant_history:
- anxiety
- asthma
- migraines
- atrial fibrillation
age_at_reaction: 21
suspected_drugs:
- drug_name: Warfarin
dosage: 433mg
route_of_administration: Topical
start_date: '2025-02-15'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-04-29'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-04-01'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed each and advised program.
- symptom_name: Maculopapular Rash
onset_date: '2025-04-01'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed decision and advised capital.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Lamb, Garcia and Bartlett Medical Center
reporter_type: Nurse
notes: Air language staff major. Discuss modern player method that.
|
<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-2025-904
Date of Submission: 2025-06-09
This report was submitted by a Nurse from Harrington, Frost and Jones Medical Center concerning patient ANON-PX-8021. The subject is an adult male with a significant medical history including anxiety, asthma, 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 Topical route at a dosage of 284mg, initiated on 2025-04-29 for Major depressive disorder and discontinued on 2025-05-26.
On approximately 2025-05-11, 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 Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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: Sign show only church wrong certain. Because almost different young fish process second. Hot grow night chair western anyone issue Democrat.</data>
|
report_id: ADR-2025-904
report_date: '2025-06-09'
patient_details:
patient_id: ANON-PX-8021
gender: Male
relevant_history:
- anxiety
- asthma
- migraines
suspected_drugs:
- drug_name: Sertraline
dosage: 284mg
route_of_administration: Topical
start_date: '2025-04-29'
indication_for_use: Major depressive disorder
end_date: '2025-05-26'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-05-11'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-05-11'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-05-11'
severity: Mild
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Harrington, Frost and Jones Medical Center
reporter_type: Nurse
notes: Sign show only church wrong certain. Because almost different young fish process
second. Hot grow night chair western anyone issue Democrat.
|
<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-2024-958
Date of Submission: 2024-12-26
This report was submitted by a Physician from Mclaughlin PLC Medical Center concerning patient ANON-PX-5527. The subject is a 76-year-old other with a significant medical history including osteoarthritis, type 2 diabetes, 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): Ibuprofen administered via the Topical route at a dosage of 237mg, initiated on 2024-12-14 for Pain and inflammation and discontinued on 2024-12-23; Sertraline (SSRI) administered via the Intramuscular route at a dosage of 192mg, initiated on 2024-12-14 for Major depressive disorder and discontinued on 2024-12-23.
On approximately 2024-12-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Maculopapular Rash, Nausea. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed wish and advised between. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-958
report_date: '2024-12-26'
patient_details:
patient_id: ANON-PX-5527
gender: Other
relevant_history:
- osteoarthritis
- type 2 diabetes
- seasonal allergies
- hypertension
age_at_reaction: 76
suspected_drugs:
- drug_name: Ibuprofen
dosage: 237mg
route_of_administration: Topical
start_date: '2024-12-14'
indication_for_use: Pain and inflammation
end_date: '2024-12-23'
- drug_name: Sertraline
dosage: 192mg
route_of_administration: Intramuscular
start_date: '2024-12-14'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-12-23'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-12-21'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-12-21'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-12-21'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed wish and advised between.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 5
reporting_facility: Mclaughlin PLC 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-2025-531
Date of Submission: 2025-02-22
This report was submitted by a Pharmacist from Yang, Casey and Gill Medical Center concerning patient ANON-PX-6125. The subject is an adult female with a significant medical history including coronary artery disease, 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): Atorvastatin (Statin) administered via the Intramuscular route at a dosage of 105mg, initiated on 2025-01-23 for Hypercholesterolemia and discontinued on 2025-02-13; Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 162mg, initiated on 2025-01-23 for Neuropathic pain and discontinued on 2025-02-13.
On approximately 2025-01-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Stevens-Johnson syndrome. The Hepatotoxicity 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 Mild 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 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: Ball thing commercial attack investment. Summer add report old. Ten listen need health kind choose.</data>
|
report_id: ADR-2025-531
report_date: '2025-02-22'
patient_details:
patient_id: ANON-PX-6125
gender: Female
relevant_history:
- coronary artery disease
- chronic kidney disease
- anxiety
- osteoarthritis
suspected_drugs:
- drug_name: Atorvastatin
dosage: 105mg
route_of_administration: Intramuscular
start_date: '2025-01-23'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-02-13'
- drug_name: Gabapentin
dosage: 162mg
route_of_administration: Subcutaneous
start_date: '2025-01-23'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-02-13'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-01-25'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-01-25'
severity: Mild
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 1
reporting_facility: Yang, Casey and Gill Medical Center
reporter_type: Pharmacist
notes: Ball thing commercial attack investment. Summer add report old. Ten listen
need health kind choose.
|
<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-2025-814
Date of Submission: 2025-04-30
This report was submitted by a Other Healthcare Professional from Munoz-Martin Medical Center concerning patient ANON-PX-4929. The subject is a 68-year-old female with a significant medical history including 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 administered via the Oral route at a dosage of 172mg, initiated on 2025-03-10 for Hypercholesterolemia and discontinued on 2025-04-12; Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 271mg, initiated on 2025-03-10 for Hypertension and discontinued on 2025-04-12.
On approximately 2025-03-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Dizziness. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed people and advised score. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed Congress and advised us. 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: East dark wide. Wear exactly myself company each. Pick rise space develop artist.</data>
|
report_id: ADR-2025-814
report_date: '2025-04-30'
patient_details:
patient_id: ANON-PX-4929
gender: Female
relevant_history:
- seasonal allergies
- atrial fibrillation
age_at_reaction: 68
suspected_drugs:
- drug_name: Atorvastatin
dosage: 172mg
route_of_administration: Oral
start_date: '2025-03-10'
indication_for_use: Hypercholesterolemia
end_date: '2025-04-12'
- drug_name: Lisinopril
dosage: 271mg
route_of_administration: Intravenous
start_date: '2025-03-10'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-04-12'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-03-21'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed people and advised score.
- symptom_name: Dizziness
onset_date: '2025-03-21'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed Congress and advised us.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Munoz-Martin Medical Center
reporter_type: Other Healthcare Professional
notes: East dark wide. Wear exactly myself company each. Pick rise space develop artist.
|
<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-2025-205
Date of Submission: 2025-01-13
This report was submitted by a Nurse from Cook-Brown Medical Center concerning patient ANON-PX-8345. The subject is an adult female with a significant medical history including chronic kidney disease, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Intravenous route at a dosage of 337mg, initiated on 2024-12-14 for Major depressive disorder with the course ongoing.
On approximately 2025-01-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Headache, Pruritus. The Angioedema was classified as Moderate 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 current patient status regarding this symptom is 'Recovering'. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is '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.
Reporter's Narrative Summary: According around base western president hundred money. Direction often phone cost young bed middle. Wife allow real story economic.</data>
|
report_id: ADR-2025-205
report_date: '2025-01-13'
patient_details:
patient_id: ANON-PX-8345
gender: Female
relevant_history:
- chronic kidney disease
- anxiety
suspected_drugs:
- drug_name: Sertraline
dosage: 337mg
route_of_administration: Intravenous
start_date: '2024-12-14'
indication_for_use: Major depressive disorder
drug_class: SSRI
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-01-09'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2025-01-09'
severity: Severe
outcome: Recovering
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-01-09'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 9
reporting_facility: Cook-Brown Medical Center
reporter_type: Nurse
notes: According around base western president hundred money. Direction often phone
cost young bed middle. Wife allow real story economic.
|
<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-2025-455
Date of Submission: 2025-05-11
This report was submitted by a Nurse from Sanders, Castro and Miller Medical Center concerning patient ANON-PX-5141. The subject is a 40-year-old male with a significant medical history including seasonal allergies, hypertension, osteoarthritis, 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 Intravenous route at a dosage of 141mg, initiated on 2025-02-22 for Bacterial infection with the course ongoing; Gabapentin (Anticonvulsant) administered via the Oral route at a dosage of 147mg, initiated on 2025-02-22 for Neuropathic pain with the course ongoing.
On approximately 2025-03-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Vomiting. The Dizziness 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 beyond and advised time. 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.
Reporter's Narrative Summary: Agreement Mrs fast best truth fear. Out continue clear. Current unit sure also watch everything.</data>
|
report_id: ADR-2025-455
report_date: '2025-05-11'
patient_details:
patient_id: ANON-PX-5141
gender: Male
relevant_history:
- seasonal allergies
- hypertension
- osteoarthritis
- atrial fibrillation
age_at_reaction: 40
suspected_drugs:
- drug_name: Amoxicillin
dosage: 141mg
route_of_administration: Intravenous
start_date: '2025-02-22'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
- drug_name: Gabapentin
dosage: 147mg
route_of_administration: Oral
start_date: '2025-02-22'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-03-18'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-03-18'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed beyond and advised time.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 6
reporting_facility: Sanders, Castro and Miller Medical Center
reporter_type: Nurse
notes: Agreement Mrs fast best truth fear. Out continue clear. Current unit sure also
watch everything.
|
<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-2024-375
Date of Submission: 2024-10-27
This report was submitted by a Nurse from Gillespie PLC Medical Center concerning patient ANON-PX-3288. The subject is a 53-year-old female 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): Ibuprofen (NSAID) administered via the Topical route at a dosage of 347mg, initiated on 2024-09-11 for Pain and inflammation with the course ongoing; Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 32mg, initiated on 2024-09-11 for Major depressive disorder with the course ongoing.
On approximately 2024-09-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Headache, Anaphylaxis, Pruritus. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. 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 '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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-375
report_date: '2024-10-27'
patient_details:
patient_id: ANON-PX-3288
gender: Female
relevant_history:
- osteoarthritis
- type 2 diabetes
age_at_reaction: 53
suspected_drugs:
- drug_name: Ibuprofen
dosage: 347mg
route_of_administration: Topical
start_date: '2024-09-11'
indication_for_use: Pain and inflammation
drug_class: NSAID
- drug_name: Sertraline
dosage: 32mg
route_of_administration: Subcutaneous
start_date: '2024-09-11'
indication_for_use: Major depressive disorder
drug_class: SSRI
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-09-18'
severity: Severe
outcome: Not Recovered
intervention_required: true
- symptom_name: Headache
onset_date: '2024-09-18'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-09-18'
severity: Severe
outcome: Unknown
intervention_required: true
- symptom_name: Pruritus
onset_date: '2024-09-18'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 1
reporting_facility: Gillespie PLC 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-2025-885
Date of Submission: 2025-02-27
This report was submitted by a Nurse from Espinoza, Burnett and Butler Medical Center concerning patient ANON-PX-6402. The subject is a 56-year-old other with a significant medical history including asthma, osteoarthritis, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin administered via the Topical route at a dosage of 98mg, initiated on 2024-12-06 for Thromboembolism prevention and discontinued on 2025-02-19.
On approximately 2025-01-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Stevens-Johnson syndrome. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-885
report_date: '2025-02-27'
patient_details:
patient_id: ANON-PX-6402
gender: Other
relevant_history:
- asthma
- osteoarthritis
- seasonal allergies
age_at_reaction: 56
suspected_drugs:
- drug_name: Warfarin
dosage: 98mg
route_of_administration: Topical
start_date: '2024-12-06'
indication_for_use: Thromboembolism prevention
end_date: '2025-02-19'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-01-13'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-01-13'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 4
reporting_facility: Espinoza, Burnett and Butler 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-2025-570
Date of Submission: 2025-02-23
This report was submitted by a Other Healthcare Professional from Davis PLC Medical Center concerning patient ANON-PX-3543. The subject is a 85-year-old female with a significant medical history including anxiety, coronary artery disease, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole administered via the Topical route at a dosage of 162mg, initiated on 2025-01-31 for Gastroesophageal reflux disease and discontinued on 2025-02-14; Ibuprofen (NSAID) administered via the Oral route at a dosage of 196mg, initiated on 2025-01-31 for Pain and inflammation and discontinued on 2025-02-14.
On approximately 2025-02-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed author and advised rule. 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.
Reporter's Narrative Summary: Truth edge scene reflect education anything. Question student air nearly sell.</data>
|
report_id: ADR-2025-570
report_date: '2025-02-23'
patient_details:
patient_id: ANON-PX-3543
gender: Female
relevant_history:
- anxiety
- coronary artery disease
- migraines
age_at_reaction: 85
suspected_drugs:
- drug_name: Omeprazole
dosage: 162mg
route_of_administration: Topical
start_date: '2025-01-31'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-02-14'
- drug_name: Ibuprofen
dosage: 196mg
route_of_administration: Oral
start_date: '2025-01-31'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-02-14'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-02-13'
severity: Moderate
outcome: Recovering
intervention_required: true
- symptom_name: Vomiting
onset_date: '2025-02-13'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed author and advised rule.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 4
reporting_facility: Davis PLC Medical Center
reporter_type: Other Healthcare Professional
notes: Truth edge scene reflect education anything. Question student air nearly sell.
|
<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-2025-646
Date of Submission: 2025-03-21
This report was submitted by a Nurse from Murillo-Ferguson Medical Center concerning patient ANON-PX-8371. The subject is a 43-year-old female with a significant medical history including 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): Ibuprofen (NSAID) administered via the Oral route at a dosage of 459mg, initiated on 2025-01-03 for Pain and inflammation and discontinued on 2025-02-07; Sertraline (SSRI) administered via the Oral route at a dosage of 324mg, initiated on 2025-01-03 for Major depressive disorder and discontinued on 2025-02-07.
On approximately 2025-02-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Nausea. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed teacher and advised this. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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-2025-646
report_date: '2025-03-21'
patient_details:
patient_id: ANON-PX-8371
gender: Female
relevant_history:
- asthma
- osteoarthritis
age_at_reaction: 43
suspected_drugs:
- drug_name: Ibuprofen
dosage: 459mg
route_of_administration: Oral
start_date: '2025-01-03'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-02-07'
- drug_name: Sertraline
dosage: 324mg
route_of_administration: Oral
start_date: '2025-01-03'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-02-07'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-02-01'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed teacher and advised this.
- symptom_name: Nausea
onset_date: '2025-02-01'
severity: Moderate
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Murillo-Ferguson 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-2025-857
Date of Submission: 2025-02-07
This report was submitted by a Physician from Lee PLC Medical Center concerning patient ANON-PX-2813. The subject is an adult male with a significant medical history including hypertension, 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): Lisinopril administered via the Oral route at a dosage of 460mg, initiated on 2025-01-23 for Hypertension and discontinued on 2025-02-05.
On approximately 2025-02-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Maculopapular Rash, Headache, Dizziness, Diarrhea. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed of and advised author. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. 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 whatever and advised say. 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 drug and advised be. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed upon and advised your. 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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-857
report_date: '2025-02-07'
patient_details:
patient_id: ANON-PX-2813
gender: Male
relevant_history:
- hypertension
- coronary artery disease
- osteoarthritis
suspected_drugs:
- drug_name: Lisinopril
dosage: 460mg
route_of_administration: Oral
start_date: '2025-01-23'
indication_for_use: Hypertension
end_date: '2025-02-05'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-02-01'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed of and advised author.
- symptom_name: Maculopapular Rash
onset_date: '2025-02-01'
severity: Mild
outcome: Not Recovered
intervention_required: true
- symptom_name: Headache
onset_date: '2025-02-01'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed whatever and advised say.
- symptom_name: Dizziness
onset_date: '2025-02-01'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed drug and advised be.
- symptom_name: Diarrhea
onset_date: '2025-02-01'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed upon and advised your.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 7
reporting_facility: Lee PLC 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-2025-123
Date of Submission: 2025-05-18
This report was submitted by a Nurse from Hancock and Sons Medical Center concerning patient ANON-PX-4322. The subject is a 72-year-old other with a significant medical history including chronic kidney disease, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril administered via the Intramuscular route at a dosage of 355mg, initiated on 2025-04-13 for Hypertension with the course ongoing; Sertraline administered via the Oral route at a dosage of 36mg, initiated on 2025-04-13 for Major depressive disorder with the course ongoing.
On approximately 2025-04-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Dizziness, Somnolence, Diarrhea, Vomiting. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed end and advised weight. 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 'Fatal'. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. 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 '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-2025-123
report_date: '2025-05-18'
patient_details:
patient_id: ANON-PX-4322
gender: Other
relevant_history:
- chronic kidney disease
- osteoarthritis
age_at_reaction: 72
suspected_drugs:
- drug_name: Lisinopril
dosage: 355mg
route_of_administration: Intramuscular
start_date: '2025-04-13'
indication_for_use: Hypertension
- drug_name: Sertraline
dosage: 36mg
route_of_administration: Oral
start_date: '2025-04-13'
indication_for_use: Major depressive disorder
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-04-16'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-04-16'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed end and advised weight.
- symptom_name: Somnolence
onset_date: '2025-04-16'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-04-16'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-04-16'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 6
reporting_facility: Hancock 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-2024-761
Date of Submission: 2024-09-27
This report was submitted by a Physician from Huffman-Medina Medical Center concerning patient ANON-PX-8747. The subject is a 77-year-old female with a significant medical history including type 2 diabetes, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Topical route at a dosage of 273mg, initiated on 2024-07-14 for Major depressive disorder and discontinued on 2024-08-30.
On approximately 2024-07-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Dizziness, Diarrhea, Headache. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed help and advised build. 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'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed nothing and advised business. 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 '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 rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Election guy hear rather enough. Only image onto past.</data>
|
report_id: ADR-2024-761
report_date: '2024-09-27'
patient_details:
patient_id: ANON-PX-8747
gender: Female
relevant_history:
- type 2 diabetes
- coronary artery disease
age_at_reaction: 77
suspected_drugs:
- drug_name: Sertraline
dosage: 273mg
route_of_administration: Topical
start_date: '2024-07-14'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-08-30'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-07-18'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed help and advised build.
- symptom_name: Dizziness
onset_date: '2024-07-18'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-07-18'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed nothing and advised business.
- symptom_name: Headache
onset_date: '2024-07-18'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 2
reporting_facility: Huffman-Medina Medical Center
reporter_type: Physician
notes: Election guy hear rather enough. Only image onto past.
|
<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-2025-251
Date of Submission: 2025-05-31
This report was submitted by a Patient from Brown LLC Medical Center concerning patient ANON-PX-6286. The subject is an adult female with a significant medical history including type 2 diabetes, 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 Subcutaneous route at a dosage of 355mg, initiated on 2025-04-07 for Thromboembolism prevention with the course ongoing; Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 68mg, initiated on 2025-04-07 for Bacterial infection with the course ongoing.
On approximately 2025-05-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Dizziness. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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-2025-251
report_date: '2025-05-31'
patient_details:
patient_id: ANON-PX-6286
gender: Female
relevant_history:
- type 2 diabetes
- chronic kidney disease
suspected_drugs:
- drug_name: Warfarin
dosage: 355mg
route_of_administration: Subcutaneous
start_date: '2025-04-07'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
- drug_name: Amoxicillin
dosage: 68mg
route_of_administration: Subcutaneous
start_date: '2025-04-07'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-05-19'
severity: Severe
outcome: Not Recovered
intervention_required: true
- symptom_name: Dizziness
onset_date: '2025-05-19'
severity: Life-threatening
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Brown LLC 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-2025-571
Date of Submission: 2025-04-09
This report was submitted by a Physician from Massey Group Medical Center concerning patient ANON-PX-3747. The subject is a 88-year-old other with a significant medical history including 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): Metformin administered via the Topical route at a dosage of 42mg, initiated on 2025-02-24 for Type 2 diabetes with the course ongoing.
On approximately 2025-03-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Stevens-Johnson syndrome. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed population and advised become. 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 thing and advised mother. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-571
report_date: '2025-04-09'
patient_details:
patient_id: ANON-PX-3747
gender: Other
relevant_history:
- seasonal allergies
- type 2 diabetes
age_at_reaction: 88
suspected_drugs:
- drug_name: Metformin
dosage: 42mg
route_of_administration: Topical
start_date: '2025-02-24'
indication_for_use: Type 2 diabetes
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-03-31'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed population and advised become.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-31'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed thing and advised mother.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 5
reporting_facility: Massey 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-2025-994
Date of Submission: 2025-04-02
This report was submitted by a Other Healthcare Professional from Simpson and Sons Medical Center concerning patient ANON-PX-5592. The subject is a 33-year-old other with a significant medical history including osteoarthritis, type 2 diabetes, chronic kidney disease, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 203mg, initiated on 2025-01-23 for Gastroesophageal reflux disease and discontinued on 2025-03-28; Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 294mg, initiated on 2025-01-23 for Bacterial infection and discontinued on 2025-03-28.
On approximately 2025-02-22, 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 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 be and advised man. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed should and advised will. The current patient status regarding this symptom is 'Recovering'.
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: Home whatever loss person agreement you. Republican explain decide traditional option Democrat plan.</data>
|
report_id: ADR-2025-994
report_date: '2025-04-02'
patient_details:
patient_id: ANON-PX-5592
gender: Other
relevant_history:
- osteoarthritis
- type 2 diabetes
- chronic kidney disease
- atrial fibrillation
age_at_reaction: 33
suspected_drugs:
- drug_name: Omeprazole
dosage: 203mg
route_of_administration: Subcutaneous
start_date: '2025-01-23'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-03-28'
- drug_name: Amoxicillin
dosage: 294mg
route_of_administration: Subcutaneous
start_date: '2025-01-23'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-03-28'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-02-22'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Angioedema
onset_date: '2025-02-22'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed be and advised man.
- symptom_name: Anaphylaxis
onset_date: '2025-02-22'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed should and advised will.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 7
reporting_facility: Simpson and Sons Medical Center
reporter_type: Other Healthcare Professional
notes: Home whatever loss person agreement you. Republican explain decide traditional
option Democrat plan.
|
<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-2024-360
Date of Submission: 2024-11-16
This report was submitted by a Physician from Sutton, Mora and Johnson Medical Center concerning patient ANON-PX-1049. The subject is a 35-year-old female with a significant medical history including asthma, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen administered via the Topical route at a dosage of 346mg, initiated on 2024-11-02 for Pain and inflammation with the course ongoing.
On approximately 2024-11-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Hepatotoxicity, Somnolence, Diarrhea. The Angioedema was classified as Mild 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 body and advised nothing. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Diarrhea 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. 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-2024-360
report_date: '2024-11-16'
patient_details:
patient_id: ANON-PX-1049
gender: Female
relevant_history:
- asthma
- atrial fibrillation
age_at_reaction: 35
suspected_drugs:
- drug_name: Ibuprofen
dosage: 346mg
route_of_administration: Topical
start_date: '2024-11-02'
indication_for_use: Pain and inflammation
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-11-12'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-11-12'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed body and advised nothing.
- symptom_name: Somnolence
onset_date: '2024-11-12'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-11-12'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Sutton, Mora and Johnson 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-2024-845
Date of Submission: 2024-09-21
This report was submitted by a Other Healthcare Professional from Griffith Inc Medical Center concerning patient ANON-PX-5750. The subject is a 70-year-old other with a significant medical history including seasonal allergies, type 2 diabetes, 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 Oral route at a dosage of 158mg, initiated on 2024-07-11 for Type 2 diabetes with the course ongoing.
On approximately 2024-08-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Dizziness, Nausea, Stevens-Johnson syndrome, Maculopapular Rash. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed church and advised manager. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Among meet threat. Never into how include.</data>
|
report_id: ADR-2024-845
report_date: '2024-09-21'
patient_details:
patient_id: ANON-PX-5750
gender: Other
relevant_history:
- seasonal allergies
- type 2 diabetes
- coronary artery disease
age_at_reaction: 70
suspected_drugs:
- drug_name: Metformin
dosage: 158mg
route_of_administration: Oral
start_date: '2024-07-11'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-08-16'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-08-16'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed church and advised manager.
- symptom_name: Nausea
onset_date: '2024-08-16'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-16'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-08-16'
severity: Mild
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Griffith Inc Medical Center
reporter_type: Other Healthcare Professional
notes: Among meet threat. Never into how include.
|
<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-2025-614
Date of Submission: 2025-01-27
This report was submitted by a Other Healthcare Professional from Warren, Chavez and Sparks Medical Center concerning patient ANON-PX-8975. 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): Lisinopril administered via the Intramuscular route at a dosage of 410mg, initiated on 2025-01-10 for Hypertension and discontinued on 2025-01-20.
On approximately 2025-01-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Hepatotoxicity, Somnolence. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed key and advised sign. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The 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 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: Sea worry recent positive. Relationship peace stop.</data>
|
report_id: ADR-2025-614
report_date: '2025-01-27'
patient_details:
patient_id: ANON-PX-8975
gender: Other
relevant_history:
- migraines
- anxiety
suspected_drugs:
- drug_name: Lisinopril
dosage: 410mg
route_of_administration: Intramuscular
start_date: '2025-01-10'
indication_for_use: Hypertension
end_date: '2025-01-20'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-01-18'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed key and advised sign.
- symptom_name: Hepatotoxicity
onset_date: '2025-01-18'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-01-18'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 1
reporting_facility: Warren, Chavez and Sparks Medical Center
reporter_type: Other Healthcare Professional
notes: Sea worry recent positive. Relationship peace stop.
|
<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-2024-458
Date of Submission: 2024-12-28
This report was submitted by a Pharmacist from Freeman-Clements Medical Center concerning patient ANON-PX-1797. The subject is a 34-year-old female with a significant medical history including anxiety, atrial fibrillation, 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): Lisinopril (ACE inhibitor) administered via the Topical route at a dosage of 402mg, initiated on 2024-10-07 for Hypertension and discontinued on 2024-12-12; Sertraline (SSRI) administered via the Intravenous route at a dosage of 268mg, initiated on 2024-10-07 for Major depressive disorder and discontinued on 2024-12-12.
On approximately 2024-11-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Hepatotoxicity, Vomiting, Nausea. The Diarrhea 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 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 'Not Recovered'. 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. 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-2024-458
report_date: '2024-12-28'
patient_details:
patient_id: ANON-PX-1797
gender: Female
relevant_history:
- anxiety
- atrial fibrillation
- osteoarthritis
- asthma
age_at_reaction: 34
suspected_drugs:
- drug_name: Lisinopril
dosage: 402mg
route_of_administration: Topical
start_date: '2024-10-07'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-12-12'
- drug_name: Sertraline
dosage: 268mg
route_of_administration: Intravenous
start_date: '2024-10-07'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-12-12'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-11-27'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-11-27'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-11-27'
severity: Mild
outcome: Not Recovered
intervention_required: true
- symptom_name: Nausea
onset_date: '2024-11-27'
severity: Severe
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Freeman-Clements 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-2025-434
Date of Submission: 2025-04-15
This report was submitted by a Patient from Lewis, Long and Carter Medical Center concerning patient ANON-PX-6365. The subject is a 66-year-old other 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): Warfarin (Anticoagulant) administered via the Intravenous route at a dosage of 93mg, initiated on 2025-01-26 for Thromboembolism prevention and discontinued on 2025-02-03; Sertraline (SSRI) administered via the Topical route at a dosage of 128mg, initiated on 2025-01-26 for Major depressive disorder and discontinued on 2025-02-03.
On approximately 2025-01-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Angioedema, Nausea, Vomiting. The Dizziness 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 Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-434
report_date: '2025-04-15'
patient_details:
patient_id: ANON-PX-6365
gender: Other
relevant_history:
- osteoarthritis
- hypertension
- atrial fibrillation
age_at_reaction: 66
suspected_drugs:
- drug_name: Warfarin
dosage: 93mg
route_of_administration: Intravenous
start_date: '2025-01-26'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-02-03'
- drug_name: Sertraline
dosage: 128mg
route_of_administration: Topical
start_date: '2025-01-26'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-02-03'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-01-28'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-01-28'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-01-28'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-01-28'
severity: Mild
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 10
reporting_facility: Lewis, Long and Carter 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-2024-443
Date of Submission: 2024-09-16
This report was submitted by a Physician from Clark and Sons Medical Center concerning patient ANON-PX-4432. The subject is a 43-year-old female with a significant medical history including osteoarthritis, 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 administered via the Oral route at a dosage of 443mg, initiated on 2024-07-12 for Hypothyroidism and discontinued on 2024-08-21; Atorvastatin (Statin) administered via the Topical route at a dosage of 115mg, initiated on 2024-07-12 for Hypercholesterolemia and discontinued on 2024-08-21.
On approximately 2024-07-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Maculopapular Rash, Hepatotoxicity. 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 Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed western and advised scientist. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity 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. 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: Full power reveal born safe. Behavior throw between book.</data>
|
report_id: ADR-2024-443
report_date: '2024-09-16'
patient_details:
patient_id: ANON-PX-4432
gender: Female
relevant_history:
- osteoarthritis
- atrial fibrillation
age_at_reaction: 43
suspected_drugs:
- drug_name: Levothyroxine
dosage: 443mg
route_of_administration: Oral
start_date: '2024-07-12'
indication_for_use: Hypothyroidism
end_date: '2024-08-21'
- drug_name: Atorvastatin
dosage: 115mg
route_of_administration: Topical
start_date: '2024-07-12'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-08-21'
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-07-15'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-07-15'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed western and advised scientist.
- symptom_name: Hepatotoxicity
onset_date: '2024-07-15'
severity: Severe
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Clark and Sons Medical Center
reporter_type: Physician
notes: Full power reveal born safe. Behavior throw between book.
|
<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-2024-147
Date of Submission: 2024-08-13
This report was submitted by a Pharmacist from Lewis and Sons Medical Center concerning patient ANON-PX-9062. The subject is an adult other with a significant medical history including type 2 diabetes, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin administered via the Intramuscular route at a dosage of 474mg, initiated on 2024-05-23 for Neuropathic pain and discontinued on 2024-07-21; Atorvastatin (Statin) administered via the Topical route at a dosage of 389mg, initiated on 2024-05-23 for Hypercholesterolemia and discontinued on 2024-07-21.
On approximately 2024-07-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Nausea, Pruritus. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed identify and advised party. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Story ten town decision lawyer light. Couple since hit through. Rest television power prepare.</data>
|
report_id: ADR-2024-147
report_date: '2024-08-13'
patient_details:
patient_id: ANON-PX-9062
gender: Other
relevant_history:
- type 2 diabetes
- asthma
suspected_drugs:
- drug_name: Gabapentin
dosage: 474mg
route_of_administration: Intramuscular
start_date: '2024-05-23'
indication_for_use: Neuropathic pain
end_date: '2024-07-21'
- drug_name: Atorvastatin
dosage: 389mg
route_of_administration: Topical
start_date: '2024-05-23'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-07-21'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-07-19'
severity: Life-threatening
outcome: Unknown
intervention_required: true
- symptom_name: Nausea
onset_date: '2024-07-19'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-07-19'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed identify and advised party.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 4
reporting_facility: Lewis and Sons Medical Center
reporter_type: Pharmacist
notes: Story ten town decision lawyer light. Couple since hit through. Rest television
power prepare.
|
<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-2024-994
Date of Submission: 2024-10-02
This report was submitted by a Nurse from Miller-Hebert Medical Center concerning patient ANON-PX-2779. The subject is an adult other with a significant medical history including chronic kidney disease, 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): Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 273mg, initiated on 2024-09-24 for Pain and inflammation and discontinued on 2024-09-29.
On approximately 2024-09-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Dizziness, Hepatotoxicity. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed future and advised trial. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed force and advised while. 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-994
report_date: '2024-10-02'
patient_details:
patient_id: ANON-PX-2779
gender: Other
relevant_history:
- chronic kidney disease
- coronary artery disease
- hypertension
suspected_drugs:
- drug_name: Ibuprofen
dosage: 273mg
route_of_administration: Intramuscular
start_date: '2024-09-24'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-09-29'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-09-25'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-09-25'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed future and advised trial.
- symptom_name: Hepatotoxicity
onset_date: '2024-09-25'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed force and advised while.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 1
reporting_facility: Miller-Hebert 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-2025-599
Date of Submission: 2025-07-15
This report was submitted by a Nurse from Myers Inc Medical Center concerning patient ANON-PX-1502. The subject is a 71-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): Atorvastatin (Statin) administered via the Topical route at a dosage of 191mg, initiated on 2025-05-29 for Hypercholesterolemia and discontinued on 2025-06-12; Omeprazole administered via the Intravenous route at a dosage of 57mg, initiated on 2025-05-29 for Gastroesophageal reflux disease and discontinued on 2025-06-12.
On approximately 2025-06-11, 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 Life-threatening 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 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: Force third identify economic return information thing. Five a investment against attention.</data>
|
report_id: ADR-2025-599
report_date: '2025-07-15'
patient_details:
patient_id: ANON-PX-1502
gender: Other
relevant_history:
- hypertension
- seasonal allergies
age_at_reaction: 71
suspected_drugs:
- drug_name: Atorvastatin
dosage: 191mg
route_of_administration: Topical
start_date: '2025-05-29'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-06-12'
- drug_name: Omeprazole
dosage: 57mg
route_of_administration: Intravenous
start_date: '2025-05-29'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-06-12'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-06-11'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-11'
severity: Severe
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Myers Inc Medical Center
reporter_type: Nurse
notes: Force third identify economic return information thing. Five a investment against
attention.
|
<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-2024-715
Date of Submission: 2024-09-26
This report was submitted by a Nurse from Johnson-Simmons Medical Center concerning patient ANON-PX-8858. The subject is a 60-year-old female with a significant medical history including seasonal allergies, chronic kidney disease, atrial fibrillation, 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): Atorvastatin (Statin) administered via the Intravenous route at a dosage of 385mg, initiated on 2024-08-26 for Hypercholesterolemia with the course ongoing; Amoxicillin administered via the Subcutaneous route at a dosage of 38mg, initiated on 2024-08-26 for Bacterial infection with the course ongoing.
On approximately 2024-09-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Somnolence. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed them and advised car. 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: List single top which yourself third move. Ground always recently wish. To personal so very.</data>
|
report_id: ADR-2024-715
report_date: '2024-09-26'
patient_details:
patient_id: ANON-PX-8858
gender: Female
relevant_history:
- seasonal allergies
- chronic kidney disease
- atrial fibrillation
- osteoarthritis
age_at_reaction: 60
suspected_drugs:
- drug_name: Atorvastatin
dosage: 385mg
route_of_administration: Intravenous
start_date: '2024-08-26'
indication_for_use: Hypercholesterolemia
drug_class: Statin
- drug_name: Amoxicillin
dosage: 38mg
route_of_administration: Subcutaneous
start_date: '2024-08-26'
indication_for_use: Bacterial infection
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-09-04'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-09-04'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed them and advised car.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Johnson-Simmons Medical Center
reporter_type: Nurse
notes: List single top which yourself third move. Ground always recently wish. To
personal so very.
|
<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-2025-359
Date of Submission: 2025-07-22
This report was submitted by a Nurse from Bradley PLC Medical Center concerning patient ANON-PX-5507. The subject is a 64-year-old male with a significant medical history including asthma, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Intramuscular route at a dosage of 444mg, initiated on 2025-05-10 for Hypercholesterolemia and discontinued on 2025-07-20.
On approximately 2025-07-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting, Anaphylaxis, Somnolence, Pruritus. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed high and advised air. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Moderate 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. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Pruritus 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 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-359
report_date: '2025-07-22'
patient_details:
patient_id: ANON-PX-5507
gender: Male
relevant_history:
- asthma
- hypertension
age_at_reaction: 64
suspected_drugs:
- drug_name: Atorvastatin
dosage: 444mg
route_of_administration: Intramuscular
start_date: '2025-05-10'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-07-20'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-07-19'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-07-19'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed high and advised air.
- symptom_name: Anaphylaxis
onset_date: '2025-07-19'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-07-19'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-07-19'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 6
reporting_facility: Bradley PLC 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-2025-218
Date of Submission: 2025-05-18
This report was submitted by a Patient from Mccormick-Myers Medical Center concerning patient ANON-PX-9437. The subject is a 53-year-old other 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): Warfarin (Anticoagulant) administered via the Subcutaneous route at a dosage of 158mg, initiated on 2025-04-22 for Thromboembolism prevention with the course ongoing.
On approximately 2025-05-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Hepatotoxicity, Pruritus, Headache. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. 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 'Not Recovered'. The Headache 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. 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: Serious already order bed. Charge surface late maybe mention. Particular someone use culture.</data>
|
report_id: ADR-2025-218
report_date: '2025-05-18'
patient_details:
patient_id: ANON-PX-9437
gender: Other
relevant_history:
- coronary artery disease
- asthma
age_at_reaction: 53
suspected_drugs:
- drug_name: Warfarin
dosage: 158mg
route_of_administration: Subcutaneous
start_date: '2025-04-22'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-05-04'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-05-04'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-05-04'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2025-05-04'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Mccormick-Myers Medical Center
reporter_type: Patient
notes: Serious already order bed. Charge surface late maybe mention. Particular someone
use culture.
|
<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-2025-809
Date of Submission: 2025-07-21
This report was submitted by a Physician from Myers-Alvarez Medical Center concerning patient ANON-PX-5784. The subject is a 78-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): Atorvastatin (Statin) administered via the Topical route at a dosage of 496mg, initiated on 2025-05-18 for Hypercholesterolemia and discontinued on 2025-07-07.
On approximately 2025-05-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Pruritus, Nausea. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed watch and advised rather. 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 partner and advised father. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed investment and advised think. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Production partner boy method total. Most be generation soon. It go truth.</data>
|
report_id: ADR-2025-809
report_date: '2025-07-21'
patient_details:
patient_id: ANON-PX-5784
gender: Female
relevant_history:
- chronic kidney disease
- asthma
age_at_reaction: 78
suspected_drugs:
- drug_name: Atorvastatin
dosage: 496mg
route_of_administration: Topical
start_date: '2025-05-18'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-07-07'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-05-25'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed watch and advised rather.
- symptom_name: Pruritus
onset_date: '2025-05-25'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed partner and advised father.
- symptom_name: Nausea
onset_date: '2025-05-25'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed investment and advised think.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Myers-Alvarez Medical Center
reporter_type: Physician
notes: Production partner boy method total. Most be generation soon. It go truth.
|
<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-2025-320
Date of Submission: 2025-03-08
This report was submitted by a Physician from Rodriguez LLC Medical Center concerning patient ANON-PX-2940. The subject is a 84-year-old female with a significant medical history including coronary artery disease, 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): Sertraline (SSRI) administered via the Topical route at a dosage of 104mg, initiated on 2024-12-28 for Major depressive disorder with the course ongoing.
On approximately 2025-02-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Headache, Vomiting, Nausea, Stevens-Johnson syndrome. 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 Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed skin and advised beat. 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 'Recovering'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed form and advised weight. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed memory and advised high. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Happen news government measure himself home. Admit figure participant. Throw case five cell physical.</data>
|
report_id: ADR-2025-320
report_date: '2025-03-08'
patient_details:
patient_id: ANON-PX-2940
gender: Female
relevant_history:
- coronary artery disease
- migraines
- seasonal allergies
age_at_reaction: 84
suspected_drugs:
- drug_name: Sertraline
dosage: 104mg
route_of_administration: Topical
start_date: '2024-12-28'
indication_for_use: Major depressive disorder
drug_class: SSRI
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-02-18'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2025-02-18'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed skin and advised beat.
- symptom_name: Vomiting
onset_date: '2025-02-18'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-02-18'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed form and advised weight.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-02-18'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed memory and advised high.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 10
reporting_facility: Rodriguez LLC Medical Center
reporter_type: Physician
notes: Happen news government measure himself home. Admit figure participant. Throw
case five cell physical.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-119
Date of Submission: 2025-02-26
This report was submitted by a Patient from Bradshaw PLC Medical Center concerning patient ANON-PX-8386. The subject is a 61-year-old female with a significant medical history including anxiety, type 2 diabetes, seasonal allergies, 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): Amoxicillin administered via the Subcutaneous route at a dosage of 420mg, initiated on 2025-02-02 for Bacterial infection and discontinued on 2025-02-16.
On approximately 2025-02-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Stevens-Johnson syndrome, Vomiting. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed also and advised laugh. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The 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 '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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Fact occur heavy research number. Avoid good painting who house. Age ball space.</data>
|
report_id: ADR-2025-119
report_date: '2025-02-26'
patient_details:
patient_id: ANON-PX-8386
gender: Female
relevant_history:
- anxiety
- type 2 diabetes
- seasonal allergies
- chronic kidney disease
age_at_reaction: 61
suspected_drugs:
- drug_name: Amoxicillin
dosage: 420mg
route_of_administration: Subcutaneous
start_date: '2025-02-02'
indication_for_use: Bacterial infection
end_date: '2025-02-16'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-02-08'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed also and advised laugh.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-02-08'
severity: Severe
outcome: Not Recovered
intervention_required: true
- symptom_name: Vomiting
onset_date: '2025-02-08'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 7
reporting_facility: Bradshaw PLC Medical Center
reporter_type: Patient
notes: Fact occur heavy research number. Avoid good painting who house. Age ball space.
|
<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-2025-398
Date of Submission: 2025-06-26
This report was submitted by a Patient from Smith, Gonzalez and Ruiz Medical Center concerning patient ANON-PX-3618. The subject is an adult female with a significant medical history including hypertension, type 2 diabetes, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin administered via the Intravenous route at a dosage of 328mg, initiated on 2025-04-05 for Neuropathic pain with the course ongoing; Metformin (Biguanide) administered via the Intravenous route at a dosage of 208mg, initiated on 2025-04-05 for Type 2 diabetes with the course ongoing.
On approximately 2025-05-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Pruritus, Diarrhea. 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 'Fatal'. The Pruritus 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 '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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: West kid friend draw home their. Woman free customer detail. Question evening account doctor.</data>
|
report_id: ADR-2025-398
report_date: '2025-06-26'
patient_details:
patient_id: ANON-PX-3618
gender: Female
relevant_history:
- hypertension
- type 2 diabetes
- osteoarthritis
suspected_drugs:
- drug_name: Gabapentin
dosage: 328mg
route_of_administration: Intravenous
start_date: '2025-04-05'
indication_for_use: Neuropathic pain
- drug_name: Metformin
dosage: 208mg
route_of_administration: Intravenous
start_date: '2025-04-05'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-05-03'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-05-03'
severity: Moderate
outcome: Fatal
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2025-05-03'
severity: Mild
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 10
reporting_facility: Smith, Gonzalez and Ruiz Medical Center
reporter_type: Patient
notes: West kid friend draw home their. Woman free customer detail. Question evening
account doctor.
|
<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-2025-143
Date of Submission: 2025-06-11
This report was submitted by a Pharmacist from Dixon, Jones and Hurley Medical Center concerning patient ANON-PX-3319. The subject is a 57-year-old female 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): Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 5mg, initiated on 2025-03-25 for Neuropathic pain and discontinued on 2025-04-17.
On approximately 2025-04-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Vomiting, Hepatotoxicity. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Station door service have though music everyone. May necessary why strategy.</data>
|
report_id: ADR-2025-143
report_date: '2025-06-11'
patient_details:
patient_id: ANON-PX-3319
gender: Female
relevant_history:
- migraines
- atrial fibrillation
age_at_reaction: 57
suspected_drugs:
- drug_name: Gabapentin
dosage: 5mg
route_of_administration: Subcutaneous
start_date: '2025-03-25'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-04-17'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-04-17'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-04-17'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-04-17'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 8
reporting_facility: Dixon, Jones and Hurley Medical Center
reporter_type: Pharmacist
notes: Station door service have though music everyone. May necessary why strategy.
|
<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-2025-536
Date of Submission: 2025-04-09
This report was submitted by a Pharmacist from Brown, Dunlap and Huber Medical Center concerning patient ANON-PX-8338. The subject is a 81-year-old male with a significant medical history including type 2 diabetes, seasonal allergies, hypertension, 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 administered via the Topical route at a dosage of 327mg, initiated on 2025-02-28 for Pain and inflammation and discontinued on 2025-03-20; Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 404mg, initiated on 2025-02-28 for Gastroesophageal reflux disease and discontinued on 2025-03-20.
On approximately 2025-03-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Headache. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed him and advised drug. 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 east and advised money. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Either now picture drop big end. Seat chance finally help drive fall. National air job know perhaps situation mission.</data>
|
report_id: ADR-2025-536
report_date: '2025-04-09'
patient_details:
patient_id: ANON-PX-8338
gender: Male
relevant_history:
- type 2 diabetes
- seasonal allergies
- hypertension
- anxiety
age_at_reaction: 81
suspected_drugs:
- drug_name: Ibuprofen
dosage: 327mg
route_of_administration: Topical
start_date: '2025-02-28'
indication_for_use: Pain and inflammation
end_date: '2025-03-20'
- drug_name: Omeprazole
dosage: 404mg
route_of_administration: Topical
start_date: '2025-02-28'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-03-20'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-03-15'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed him and advised drug.
- symptom_name: Headache
onset_date: '2025-03-15'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed east and advised money.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Brown, Dunlap and Huber Medical Center
reporter_type: Pharmacist
notes: Either now picture drop big end. Seat chance finally help drive fall. National
air job know perhaps situation mission.
|
<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-2024-459
Date of Submission: 2024-09-04
This report was submitted by a Pharmacist from Taylor-Patterson Medical Center concerning patient ANON-PX-4503. The subject is a 48-year-old female with a significant medical history including seasonal allergies, hypertension, 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): Omeprazole administered via the Topical route at a dosage of 433mg, initiated on 2024-07-18 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2024-08-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Nausea. The Headache was classified as Severe 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. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Discover food she international knowledge source down. Since follow skill. Argue gun campaign.</data>
|
report_id: ADR-2024-459
report_date: '2024-09-04'
patient_details:
patient_id: ANON-PX-4503
gender: Female
relevant_history:
- seasonal allergies
- hypertension
- asthma
- osteoarthritis
age_at_reaction: 48
suspected_drugs:
- drug_name: Omeprazole
dosage: 433mg
route_of_administration: Topical
start_date: '2024-07-18'
indication_for_use: Gastroesophageal reflux disease
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-08-14'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-08-14'
severity: Mild
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 10
reporting_facility: Taylor-Patterson Medical Center
reporter_type: Pharmacist
notes: Discover food she international knowledge source down. Since follow skill.
Argue gun campaign.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-616
Date of Submission: 2025-06-11
This report was submitted by a Nurse from Knight-Barnes Medical Center concerning patient ANON-PX-2981. The subject is a 25-year-old female with a significant medical history including chronic kidney disease, 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): Warfarin administered via the Oral route at a dosage of 378mg, initiated on 2025-04-18 for Thromboembolism prevention with the course ongoing.
On approximately 2025-04-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Diarrhea, Pruritus, Headache. The Somnolence 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 Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed thousand and advised experience. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 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: Huge tough keep example drop require. Onto member build think. Price blood middle discover bar practice.</data>
|
report_id: ADR-2025-616
report_date: '2025-06-11'
patient_details:
patient_id: ANON-PX-2981
gender: Female
relevant_history:
- chronic kidney disease
- hypertension
- seasonal allergies
age_at_reaction: 25
suspected_drugs:
- drug_name: Warfarin
dosage: 378mg
route_of_administration: Oral
start_date: '2025-04-18'
indication_for_use: Thromboembolism prevention
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-04-26'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-04-26'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-04-26'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed thousand and advised experience.
- symptom_name: Headache
onset_date: '2025-04-26'
severity: Severe
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 4
reporting_facility: Knight-Barnes Medical Center
reporter_type: Nurse
notes: Huge tough keep example drop require. Onto member build think. Price blood
middle discover bar practice.
|
<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-2025-219
Date of Submission: 2025-04-01
This report was submitted by a Nurse from Wright LLC Medical Center concerning patient ANON-PX-6495. The subject is a 33-year-old female with a significant medical history including anxiety, atrial fibrillation, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 355mg, initiated on 2025-02-02 for Major depressive disorder and discontinued on 2025-03-19.
On approximately 2025-02-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Somnolence, Headache, Stevens-Johnson syndrome, Dizziness. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed leg and advised executive. The current patient status regarding this symptom is 'Recovered'. The Dizziness 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-219
report_date: '2025-04-01'
patient_details:
patient_id: ANON-PX-6495
gender: Female
relevant_history:
- anxiety
- atrial fibrillation
- migraines
age_at_reaction: 33
suspected_drugs:
- drug_name: Sertraline
dosage: 355mg
route_of_administration: Subcutaneous
start_date: '2025-02-02'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-03-19'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-02-25'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-02-25'
severity: Moderate
outcome: Recovered
intervention_required: true
- symptom_name: Headache
onset_date: '2025-02-25'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-02-25'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed leg and advised executive.
- symptom_name: Dizziness
onset_date: '2025-02-25'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Wright 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-2025-838
Date of Submission: 2025-02-02
This report was submitted by a Nurse from Walker Group Medical Center concerning patient ANON-PX-3884. The subject is a 88-year-old other with a significant medical history including seasonal allergies, 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): Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 346mg, initiated on 2024-11-22 for Gastroesophageal reflux disease with the course ongoing; Lisinopril administered via the Topical route at a dosage of 431mg, initiated on 2024-11-22 for Hypertension with the course ongoing.
On approximately 2025-01-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Angioedema, Dizziness, Pruritus, Diarrhea. The Anaphylaxis was classified as Mild 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 later and advised activity. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as 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 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.
Reporter's Narrative Summary: While side order soldier generation forget blue. Example board generation want wall.</data>
|
report_id: ADR-2025-838
report_date: '2025-02-02'
patient_details:
patient_id: ANON-PX-3884
gender: Other
relevant_history:
- seasonal allergies
- type 2 diabetes
- asthma
age_at_reaction: 88
suspected_drugs:
- drug_name: Omeprazole
dosage: 346mg
route_of_administration: Oral
start_date: '2024-11-22'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Lisinopril
dosage: 431mg
route_of_administration: Topical
start_date: '2024-11-22'
indication_for_use: Hypertension
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-01-22'
severity: Mild
outcome: Unknown
intervention_required: true
- symptom_name: Angioedema
onset_date: '2025-01-22'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed later and advised activity.
- symptom_name: Dizziness
onset_date: '2025-01-22'
severity: Severe
outcome: Unknown
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-01-22'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-01-22'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 6
reporting_facility: Walker Group Medical Center
reporter_type: Nurse
notes: While side order soldier generation forget blue. Example board generation want
wall.
|
<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-2024-987
Date of Submission: 2024-08-31
This report was submitted by a Other Healthcare Professional from Cox, Edwards and Watson Medical Center concerning patient ANON-PX-3810. The subject is a 63-year-old female with a significant medical history including hypertension, seasonal allergies, 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 administered via the Intravenous route at a dosage of 439mg, initiated on 2024-07-08 for Major depressive disorder with the course ongoing.
On approximately 2024-08-11, 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 Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed market and advised measure. 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 '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: Successful ahead already current. Population represent front back decide right man. Audience expect kind seem not.</data>
|
report_id: ADR-2024-987
report_date: '2024-08-31'
patient_details:
patient_id: ANON-PX-3810
gender: Female
relevant_history:
- hypertension
- seasonal allergies
- chronic kidney disease
age_at_reaction: 63
suspected_drugs:
- drug_name: Sertraline
dosage: 439mg
route_of_administration: Intravenous
start_date: '2024-07-08'
indication_for_use: Major depressive disorder
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-08-11'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed market and advised measure.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-11'
severity: Mild
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Cox, Edwards and Watson Medical Center
reporter_type: Other Healthcare Professional
notes: Successful ahead already current. Population represent front back decide right
man. Audience expect kind seem not.
|
<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-2025-653
Date of Submission: 2025-06-18
This report was submitted by a Pharmacist from King Inc Medical Center concerning patient ANON-PX-9513. The subject is a 90-year-old female with a significant medical history including chronic kidney disease, coronary artery disease, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Intramuscular route at a dosage of 115mg, initiated on 2025-05-10 for Hypertension and discontinued on 2025-06-10; Warfarin administered via the Subcutaneous route at a dosage of 48mg, initiated on 2025-05-10 for Thromboembolism prevention and discontinued on 2025-06-10.
On approximately 2025-05-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Stevens-Johnson syndrome, Angioedema, Headache. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed data and advised my. 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 'Unknown'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed audience and advised democratic. 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 good and advised test. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Health four on. Situation assume kid reveal. Recognize debate our agree.</data>
|
report_id: ADR-2025-653
report_date: '2025-06-18'
patient_details:
patient_id: ANON-PX-9513
gender: Female
relevant_history:
- chronic kidney disease
- coronary artery disease
- seasonal allergies
age_at_reaction: 90
suspected_drugs:
- drug_name: Lisinopril
dosage: 115mg
route_of_administration: Intramuscular
start_date: '2025-05-10'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-06-10'
- drug_name: Warfarin
dosage: 48mg
route_of_administration: Subcutaneous
start_date: '2025-05-10'
indication_for_use: Thromboembolism prevention
end_date: '2025-06-10'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-05-31'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed data and advised my.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-05-31'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-05-31'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed audience and advised democratic.
- symptom_name: Headache
onset_date: '2025-05-31'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed good and advised test.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: King Inc Medical Center
reporter_type: Pharmacist
notes: Health four on. Situation assume kid reveal. Recognize debate our agree.
|
<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-2025-521
Date of Submission: 2025-08-01
This report was submitted by a Other Healthcare Professional from Davis-Aguirre Medical Center concerning patient ANON-PX-5859. The subject is a 59-year-old female with a significant medical history including atrial fibrillation, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin (Anticoagulant) administered via the Intramuscular route at a dosage of 298mg, initiated on 2025-07-06 for Thromboembolism prevention with the course ongoing; Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 398mg, initiated on 2025-07-06 for Hypertension with the course ongoing.
On approximately 2025-07-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Angioedema, Somnolence, 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 Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Diarrhea 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Next history clear theory practice. Why with push argue democratic store most. Building hotel carry anything.</data>
|
report_id: ADR-2025-521
report_date: '2025-08-01'
patient_details:
patient_id: ANON-PX-5859
gender: Female
relevant_history:
- atrial fibrillation
- asthma
age_at_reaction: 59
suspected_drugs:
- drug_name: Warfarin
dosage: 298mg
route_of_administration: Intramuscular
start_date: '2025-07-06'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
- drug_name: Lisinopril
dosage: 398mg
route_of_administration: Intravenous
start_date: '2025-07-06'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-07-11'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
- symptom_name: Angioedema
onset_date: '2025-07-11'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-07-11'
severity: Severe
outcome: Unknown
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2025-07-11'
severity: Life-threatening
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Davis-Aguirre Medical Center
reporter_type: Other Healthcare Professional
notes: Next history clear theory practice. Why with push argue democratic store most.
Building hotel carry anything.
|
<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: 2025-02-20
This report was submitted by a Patient from Beck-Harris Medical Center concerning patient ANON-PX-4229. The subject is an adult other with a significant medical history including seasonal allergies, 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): Ibuprofen (NSAID) administered via the Topical route at a dosage of 133mg, initiated on 2025-02-06 for Pain and inflammation and discontinued on 2025-02-14; Metformin (Biguanide) administered via the Intramuscular route at a dosage of 169mg, initiated on 2025-02-06 for Type 2 diabetes and discontinued on 2025-02-14.
On approximately 2025-02-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Anaphylaxis. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed shoulder and advised away. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Mild 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-943
report_date: '2025-02-20'
patient_details:
patient_id: ANON-PX-4229
gender: Other
relevant_history:
- seasonal allergies
- coronary artery disease
- asthma
suspected_drugs:
- drug_name: Ibuprofen
dosage: 133mg
route_of_administration: Topical
start_date: '2025-02-06'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-02-14'
- drug_name: Metformin
dosage: 169mg
route_of_administration: Intramuscular
start_date: '2025-02-06'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-02-14'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-02-10'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed shoulder and advised away.
- symptom_name: Anaphylaxis
onset_date: '2025-02-10'
severity: Mild
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 6
reporting_facility: Beck-Harris 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-2025-161
Date of Submission: 2025-02-23
This report was submitted by a Physician from Lopez-Sanchez Medical Center concerning patient ANON-PX-4176. The subject is a 84-year-old other 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): Omeprazole administered via the Subcutaneous route at a dosage of 134mg, initiated on 2024-12-12 for Gastroesophageal reflux disease and discontinued on 2025-02-12; Sertraline (SSRI) administered via the Intramuscular route at a dosage of 110mg, initiated on 2024-12-12 for Major depressive disorder and discontinued on 2025-02-12.
On approximately 2025-02-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Vomiting, Nausea, Stevens-Johnson syndrome, Maculopapular Rash. The Anaphylaxis was classified as Mild 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 'Recovering'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash 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 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-161
report_date: '2025-02-23'
patient_details:
patient_id: ANON-PX-4176
gender: Other
relevant_history:
- coronary artery disease
- chronic kidney disease
age_at_reaction: 84
suspected_drugs:
- drug_name: Omeprazole
dosage: 134mg
route_of_administration: Subcutaneous
start_date: '2024-12-12'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-02-12'
- drug_name: Sertraline
dosage: 110mg
route_of_administration: Intramuscular
start_date: '2024-12-12'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-02-12'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-02-11'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-02-11'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-02-11'
severity: Moderate
outcome: Fatal
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-02-11'
severity: Moderate
outcome: Recovered
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2025-02-11'
severity: Moderate
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 10
reporting_facility: Lopez-Sanchez 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-2025-979
Date of Submission: 2025-07-15
This report was submitted by a Other Healthcare Professional from White, Daniel and Wang Medical Center concerning patient ANON-PX-6101. 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): Lisinopril (ACE inhibitor) administered via the Topical route at a dosage of 34mg, initiated on 2025-04-22 for Hypertension with the course ongoing; Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 458mg, initiated on 2025-04-22 for Pain and inflammation with the course ongoing.
On approximately 2025-06-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Anaphylaxis. The Angioedema 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 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Fire reflect cold many under democratic. Factor size owner along. Near nice short upon situation so reveal. Everyone until indeed almost sign herself quite.</data>
|
report_id: ADR-2025-979
report_date: '2025-07-15'
patient_details:
patient_id: ANON-PX-6101
gender: Other
relevant_history:
- anxiety
- asthma
suspected_drugs:
- drug_name: Lisinopril
dosage: 34mg
route_of_administration: Topical
start_date: '2025-04-22'
indication_for_use: Hypertension
drug_class: ACE inhibitor
- drug_name: Ibuprofen
dosage: 458mg
route_of_administration: Subcutaneous
start_date: '2025-04-22'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-06-07'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-06-07'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 10
reporting_facility: White, Daniel and Wang Medical Center
reporter_type: Other Healthcare Professional
notes: Fire reflect cold many under democratic. Factor size owner along. Near nice
short upon situation so reveal. Everyone until indeed almost sign herself quite.
|
<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-2025-513
Date of Submission: 2025-07-26
This report was submitted by a Physician from Booth-Bailey Medical Center concerning patient ANON-PX-2382. The subject is an adult other with a significant medical history including atrial fibrillation, 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 65mg, initiated on 2025-06-18 for Gastroesophageal reflux disease with the course ongoing; Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 328mg, initiated on 2025-06-18 for Hypothyroidism with the course ongoing.
On approximately 2025-06-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Somnolence, Nausea, Pruritus. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed about and advised environment. 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 'Recovered'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed something and advised toward. 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: Hour they beyond court answer woman card. Drug bar skill thank.</data>
|
report_id: ADR-2025-513
report_date: '2025-07-26'
patient_details:
patient_id: ANON-PX-2382
gender: Other
relevant_history:
- atrial fibrillation
- chronic kidney disease
- hypertension
suspected_drugs:
- drug_name: Omeprazole
dosage: 65mg
route_of_administration: Topical
start_date: '2025-06-18'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Levothyroxine
dosage: 328mg
route_of_administration: Topical
start_date: '2025-06-18'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-06-19'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed about and advised environment.
- symptom_name: Somnolence
onset_date: '2025-06-19'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-06-19'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-06-19'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed something and advised toward.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 2
reporting_facility: Booth-Bailey Medical Center
reporter_type: Physician
notes: Hour they beyond court answer woman card. Drug bar skill thank.
|
<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-2025-486
Date of Submission: 2025-05-01
This report was submitted by a Physician from Douglas, Terry and Mcconnell Medical Center concerning patient ANON-PX-8104. The subject is a 29-year-old male with a significant medical history including osteoarthritis, coronary artery disease, 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): Omeprazole administered via the Oral route at a dosage of 154mg, initiated on 2025-02-04 for Gastroesophageal reflux disease and discontinued on 2025-03-24.
On approximately 2025-03-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Headache. 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 Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Others month act year. Agency listen difficult quite goal draw three. Science under ago kind important set.</data>
|
report_id: ADR-2025-486
report_date: '2025-05-01'
patient_details:
patient_id: ANON-PX-8104
gender: Male
relevant_history:
- osteoarthritis
- coronary artery disease
- hypertension
- chronic kidney disease
age_at_reaction: 29
suspected_drugs:
- drug_name: Omeprazole
dosage: 154mg
route_of_administration: Oral
start_date: '2025-02-04'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-03-24'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-22'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Headache
onset_date: '2025-03-22'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 2
reporting_facility: Douglas, Terry and Mcconnell Medical Center
reporter_type: Physician
notes: Others month act year. Agency listen difficult quite goal draw three. Science
under ago kind important set.
|
<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-2025-400
Date of Submission: 2025-02-14
This report was submitted by a Pharmacist from Clay, Nichols and Christensen Medical Center concerning patient ANON-PX-2369. The subject is a 73-year-old male with a significant medical history including chronic kidney disease, type 2 diabetes, 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 Intramuscular route at a dosage of 388mg, initiated on 2025-01-21 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2025-01-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Headache, Maculopapular Rash, Nausea, Stevens-Johnson syndrome. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed since and advised hold. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 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: Continue current prove. Single see small positive little happy. Late stop everybody cell item.</data>
|
report_id: ADR-2025-400
report_date: '2025-02-14'
patient_details:
patient_id: ANON-PX-2369
gender: Male
relevant_history:
- chronic kidney disease
- type 2 diabetes
- anxiety
- osteoarthritis
age_at_reaction: 73
suspected_drugs:
- drug_name: Omeprazole
dosage: 388mg
route_of_administration: Intramuscular
start_date: '2025-01-21'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-01-23'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2025-01-23'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-01-23'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed since and advised hold.
- symptom_name: Nausea
onset_date: '2025-01-23'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-01-23'
severity: Mild
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 6
reporting_facility: Clay, Nichols and Christensen Medical Center
reporter_type: Pharmacist
notes: Continue current prove. Single see small positive little happy. Late stop everybody
cell item.
|
<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-2025-447
Date of Submission: 2025-03-05
This report was submitted by a Other Healthcare Professional from Brown, Barrera and Freeman Medical Center concerning patient ANON-PX-7271. The subject is an adult female with a significant medical history including migraines, osteoarthritis, 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 administered via the Intravenous route at a dosage of 141mg, initiated on 2025-01-17 for Hypothyroidism with the course ongoing; Warfarin (Anticoagulant) administered via the Oral route at a dosage of 17mg, initiated on 2025-01-17 for Thromboembolism prevention with the course ongoing.
On approximately 2025-02-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Diarrhea, Vomiting. 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 Diarrhea 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 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 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-2025-447
report_date: '2025-03-05'
patient_details:
patient_id: ANON-PX-7271
gender: Female
relevant_history:
- migraines
- osteoarthritis
- atrial fibrillation
suspected_drugs:
- drug_name: Levothyroxine
dosage: 141mg
route_of_administration: Intravenous
start_date: '2025-01-17'
indication_for_use: Hypothyroidism
- drug_name: Warfarin
dosage: 17mg
route_of_administration: Oral
start_date: '2025-01-17'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-02-15'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-02-15'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-02-15'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 8
reporting_facility: Brown, Barrera and Freeman 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-2025-735
Date of Submission: 2025-04-30
This report was submitted by a Other Healthcare Professional from Mcmahon Group Medical Center concerning patient ANON-PX-1644. The subject is a 71-year-old female with a significant medical history including type 2 diabetes, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Intramuscular route at a dosage of 319mg, initiated on 2025-03-13 for Type 2 diabetes with the course ongoing.
On approximately 2025-04-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Somnolence, Stevens-Johnson syndrome, Dizziness, Pruritus. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed remember and advised left. 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 'Recovered'. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Leg consider imagine type. Race nation meet its. Nice line down where grow.</data>
|
report_id: ADR-2025-735
report_date: '2025-04-30'
patient_details:
patient_id: ANON-PX-1644
gender: Female
relevant_history:
- type 2 diabetes
- atrial fibrillation
age_at_reaction: 71
suspected_drugs:
- drug_name: Metformin
dosage: 319mg
route_of_administration: Intramuscular
start_date: '2025-03-13'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-04-16'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed remember and advised left.
- symptom_name: Somnolence
onset_date: '2025-04-16'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-16'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-04-16'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-04-16'
severity: Mild
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Mcmahon Group Medical Center
reporter_type: Other Healthcare Professional
notes: Leg consider imagine type. Race nation meet its. Nice line down where grow.
|
<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-2025-729
Date of Submission: 2025-05-01
This report was submitted by a Pharmacist from Bell-Miller Medical Center concerning patient ANON-PX-4764. The subject is a 47-year-old other with a significant medical history including migraines, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 368mg, initiated on 2025-04-08 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2025-04-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Headache, Angioedema, Dizziness, Vomiting. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. 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 'Fatal'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Last remember sport require popular yard week. End feeling sense each involve race. Court create peace lawyer health.</data>
|
report_id: ADR-2025-729
report_date: '2025-05-01'
patient_details:
patient_id: ANON-PX-4764
gender: Other
relevant_history:
- migraines
- asthma
age_at_reaction: 47
suspected_drugs:
- drug_name: Omeprazole
dosage: 368mg
route_of_administration: Oral
start_date: '2025-04-08'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-18'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2025-04-18'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-04-18'
severity: Severe
outcome: Unknown
intervention_required: true
- symptom_name: Dizziness
onset_date: '2025-04-18'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-04-18'
severity: Severe
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 8
reporting_facility: Bell-Miller Medical Center
reporter_type: Pharmacist
notes: Last remember sport require popular yard week. End feeling sense each involve
race. Court create peace lawyer health.
|
<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-2025-442
Date of Submission: 2025-06-29
This report was submitted by a Nurse from Sandoval, Lawson and Reed Medical Center concerning patient ANON-PX-3747. The subject is a 80-year-old female with a significant medical history including osteoarthritis, 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 Intravenous route at a dosage of 115mg, initiated on 2025-06-01 for Hypothyroidism and discontinued on 2025-06-28.
On approximately 2025-06-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Nausea, Angioedema. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed policy and advised resource. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 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.
Reporter's Narrative Summary: Turn glass interesting. There message into ready bag arm listen.</data>
|
report_id: ADR-2025-442
report_date: '2025-06-29'
patient_details:
patient_id: ANON-PX-3747
gender: Female
relevant_history:
- osteoarthritis
- asthma
- anxiety
age_at_reaction: 80
suspected_drugs:
- drug_name: Levothyroxine
dosage: 115mg
route_of_administration: Intravenous
start_date: '2025-06-01'
indication_for_use: Hypothyroidism
end_date: '2025-06-28'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-06-21'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed policy and advised resource.
- symptom_name: Nausea
onset_date: '2025-06-21'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-06-21'
severity: Severe
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 4
reporting_facility: Sandoval, Lawson and Reed Medical Center
reporter_type: Nurse
notes: Turn glass interesting. There message into ready bag arm listen.
|
<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-2025-569
Date of Submission: 2025-08-02
This report was submitted by a Other Healthcare Professional from Brewer LLC Medical Center concerning patient ANON-PX-9626. The subject is a 76-year-old male 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): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 414mg, initiated on 2025-07-12 for Gastroesophageal reflux disease and discontinued on 2025-07-26; Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 310mg, initiated on 2025-07-12 for Bacterial infection and discontinued on 2025-07-26.
On approximately 2025-07-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Maculopapular Rash. The Vomiting 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 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 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: Base suggest center might idea. Admit him back per seem always purpose.</data>
|
report_id: ADR-2025-569
report_date: '2025-08-02'
patient_details:
patient_id: ANON-PX-9626
gender: Male
relevant_history:
- coronary artery disease
- seasonal allergies
age_at_reaction: 76
suspected_drugs:
- drug_name: Omeprazole
dosage: 414mg
route_of_administration: Subcutaneous
start_date: '2025-07-12'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-07-26'
- drug_name: Amoxicillin
dosage: 310mg
route_of_administration: Topical
start_date: '2025-07-12'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-07-26'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-07-22'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-07-22'
severity: Mild
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 4
reporting_facility: Brewer LLC Medical Center
reporter_type: Other Healthcare Professional
notes: Base suggest center might idea. Admit him back per seem always purpose.
|
<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-2025-799
Date of Submission: 2025-08-05
This report was submitted by a Physician from Compton-Johnson Medical Center concerning patient ANON-PX-9854. The subject is an adult male with a significant medical history including type 2 diabetes, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin administered via the Intravenous route at a dosage of 446mg, initiated on 2025-06-20 for Thromboembolism prevention and discontinued on 2025-07-29; Omeprazole administered via the Subcutaneous route at a dosage of 380mg, initiated on 2025-06-20 for Gastroesophageal reflux disease and discontinued on 2025-07-29.
On approximately 2025-07-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Stevens-Johnson syndrome, Nausea. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. 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'.
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-2025-799
report_date: '2025-08-05'
patient_details:
patient_id: ANON-PX-9854
gender: Male
relevant_history:
- type 2 diabetes
- osteoarthritis
suspected_drugs:
- drug_name: Warfarin
dosage: 446mg
route_of_administration: Intravenous
start_date: '2025-06-20'
indication_for_use: Thromboembolism prevention
end_date: '2025-07-29'
- drug_name: Omeprazole
dosage: 380mg
route_of_administration: Subcutaneous
start_date: '2025-06-20'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-07-29'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-07-06'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-07-06'
severity: Life-threatening
outcome: Unknown
intervention_required: true
- symptom_name: Nausea
onset_date: '2025-07-06'
severity: Moderate
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 7
reporting_facility: Compton-Johnson 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-2025-518
Date of Submission: 2025-04-26
This report was submitted by a Physician from Watson, Kennedy and Shaw Medical Center concerning patient ANON-PX-5179. The subject is a 53-year-old male with a significant medical history including migraines, 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): Warfarin (Anticoagulant) administered via the Topical route at a dosage of 433mg, initiated on 2025-04-08 for Thromboembolism prevention and discontinued on 2025-04-24; Lisinopril (ACE inhibitor) administered via the Intramuscular route at a dosage of 486mg, initiated on 2025-04-08 for Hypertension and discontinued on 2025-04-24.
On approximately 2025-04-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Diarrhea, Pruritus. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed maintain and advised general. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed military and advised national. 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 dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Debate scientist pressure common carry. Then watch security past others dream dog road.</data>
|
report_id: ADR-2025-518
report_date: '2025-04-26'
patient_details:
patient_id: ANON-PX-5179
gender: Male
relevant_history:
- migraines
- osteoarthritis
- type 2 diabetes
age_at_reaction: 53
suspected_drugs:
- drug_name: Warfarin
dosage: 433mg
route_of_administration: Topical
start_date: '2025-04-08'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-04-24'
- drug_name: Lisinopril
dosage: 486mg
route_of_administration: Intramuscular
start_date: '2025-04-08'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-04-24'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-04-17'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed maintain and advised general.
- symptom_name: Diarrhea
onset_date: '2025-04-17'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-04-17'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed military and advised national.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 7
reporting_facility: Watson, Kennedy and Shaw Medical Center
reporter_type: Physician
notes: Debate scientist pressure common carry. Then watch security past others dream
dog road.
|
<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-2025-647
Date of Submission: 2025-07-14
This report was submitted by a Physician from Parker-Juarez Medical Center concerning patient ANON-PX-5114. The subject is a 80-year-old female 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): Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 462mg, initiated on 2025-07-04 for Major depressive disorder and discontinued on 2025-07-13; Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 147mg, initiated on 2025-07-04 for Gastroesophageal reflux disease and discontinued on 2025-07-13.
On approximately 2025-07-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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.
Reporter's Narrative Summary: Player fire just indeed south whole. Age yes project take it by general.</data>
|
report_id: ADR-2025-647
report_date: '2025-07-14'
patient_details:
patient_id: ANON-PX-5114
gender: Female
relevant_history:
- migraines
- atrial fibrillation
age_at_reaction: 80
suspected_drugs:
- drug_name: Sertraline
dosage: 462mg
route_of_administration: Subcutaneous
start_date: '2025-07-04'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-07-13'
- drug_name: Omeprazole
dosage: 147mg
route_of_administration: Subcutaneous
start_date: '2025-07-04'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-07-13'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-07-07'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-07-07'
severity: Severe
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 4
reporting_facility: Parker-Juarez Medical Center
reporter_type: Physician
notes: Player fire just indeed south whole. Age yes project take it by general.
|
<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-2024-431
Date of Submission: 2024-10-25
This report was submitted by a Physician from Haas PLC Medical Center concerning patient ANON-PX-2451. The subject is an adult female with a significant medical history including 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): Metformin (Biguanide) administered via the Intravenous route at a dosage of 413mg, initiated on 2024-08-07 for Type 2 diabetes and discontinued on 2024-10-11.
On approximately 2024-09-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Somnolence, Maculopapular Rash, Diarrhea. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-431
report_date: '2024-10-25'
patient_details:
patient_id: ANON-PX-2451
gender: Female
relevant_history:
- coronary artery disease
- osteoarthritis
suspected_drugs:
- drug_name: Metformin
dosage: 413mg
route_of_administration: Intravenous
start_date: '2024-08-07'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-10-11'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-09-20'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-09-20'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-09-20'
severity: Severe
outcome: Fatal
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2024-09-20'
severity: Life-threatening
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 5
reporting_facility: Haas PLC 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-2024-891
Date of Submission: 2024-11-17
This report was submitted by a Other Healthcare Professional from Davis-Nelson Medical Center concerning patient ANON-PX-1998. The subject is an adult other with a significant medical history including seasonal allergies, 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 Intramuscular route at a dosage of 23mg, initiated on 2024-09-29 for Neuropathic pain with the course ongoing; Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 266mg, initiated on 2024-09-29 for Hypothyroidism with the course ongoing.
On approximately 2024-10-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Diarrhea, Vomiting, Headache, Hepatotoxicity. 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 Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed class and advised show. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Mild in severity. This necessitated clinical intervention. 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 stock and advised almost. The current patient status regarding this symptom is '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: I knowledge free this matter land.</data>
|
report_id: ADR-2024-891
report_date: '2024-11-17'
patient_details:
patient_id: ANON-PX-1998
gender: Other
relevant_history:
- seasonal allergies
- atrial fibrillation
- chronic kidney disease
suspected_drugs:
- drug_name: Gabapentin
dosage: 23mg
route_of_administration: Intramuscular
start_date: '2024-09-29'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
- drug_name: Levothyroxine
dosage: 266mg
route_of_administration: Topical
start_date: '2024-09-29'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-10-12'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-10-12'
severity: Mild
outcome: Recovering
intervention_required: true
- symptom_name: Vomiting
onset_date: '2024-10-12'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed class and advised show.
- symptom_name: Headache
onset_date: '2024-10-12'
severity: Mild
outcome: Not Recovered
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2024-10-12'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed stock and advised almost.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 5
reporting_facility: Davis-Nelson Medical Center
reporter_type: Other Healthcare Professional
notes: I knowledge free this matter land.
|
<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-2024-230
Date of Submission: 2024-09-14
This report was submitted by a Patient from Wyatt Group Medical Center concerning patient ANON-PX-2437. The subject is a 89-year-old male with a significant medical history including asthma, osteoarthritis, 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): Amoxicillin administered via the Subcutaneous route at a dosage of 495mg, initiated on 2024-07-27 for Bacterial infection and discontinued on 2024-08-26; Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 349mg, initiated on 2024-07-27 for Neuropathic pain and discontinued on 2024-08-26.
On approximately 2024-08-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Maculopapular Rash, Dizziness, Somnolence, Diarrhea. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed compare and advised by. 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 'Recovered'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. 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 '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'.
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: Tough only realize. Let church attorney. Store race process structure.</data>
|
report_id: ADR-2024-230
report_date: '2024-09-14'
patient_details:
patient_id: ANON-PX-2437
gender: Male
relevant_history:
- asthma
- osteoarthritis
- seasonal allergies
- anxiety
age_at_reaction: 89
suspected_drugs:
- drug_name: Amoxicillin
dosage: 495mg
route_of_administration: Subcutaneous
start_date: '2024-07-27'
indication_for_use: Bacterial infection
end_date: '2024-08-26'
- drug_name: Gabapentin
dosage: 349mg
route_of_administration: Topical
start_date: '2024-07-27'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2024-08-26'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-08-23'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed compare and advised by.
- symptom_name: Maculopapular Rash
onset_date: '2024-08-23'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-08-23'
severity: Severe
outcome: Recovered
intervention_required: true
- symptom_name: Somnolence
onset_date: '2024-08-23'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-08-23'
severity: Mild
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Wyatt Group Medical Center
reporter_type: Patient
notes: Tough only realize. Let church attorney. Store race process structure.
|
<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-2025-309
Date of Submission: 2025-06-17
This report was submitted by a Nurse from Garrison, Mccarthy and Nash Medical Center concerning patient ANON-PX-4059. The subject is an adult male with a significant medical history including migraines, coronary artery disease, asthma, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 456mg, initiated on 2025-04-18 for Bacterial infection and discontinued on 2025-05-14.
On approximately 2025-04-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Hepatotoxicity, Stevens-Johnson syndrome, Pruritus, Diarrhea. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed leader and advised truth. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Moderate 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. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed tax and advised behavior. The current patient status regarding this symptom is 'Not Recovered'.
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: Student whether like pull among. Play suddenly once question. Someone herself job respond single officer door center.</data>
|
report_id: ADR-2025-309
report_date: '2025-06-17'
patient_details:
patient_id: ANON-PX-4059
gender: Male
relevant_history:
- migraines
- coronary artery disease
- asthma
- atrial fibrillation
suspected_drugs:
- drug_name: Amoxicillin
dosage: 456mg
route_of_administration: Subcutaneous
start_date: '2025-04-18'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-05-14'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-04-27'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed leader and advised truth.
- symptom_name: Hepatotoxicity
onset_date: '2025-04-27'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-27'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-04-27'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2025-04-27'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed tax and advised behavior.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 4
reporting_facility: Garrison, Mccarthy and Nash Medical Center
reporter_type: Nurse
notes: Student whether like pull among. Play suddenly once question. Someone herself
job respond single officer door center.
|
<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-2024-322
Date of Submission: 2024-09-17
This report was submitted by a Physician from Gonzalez, Gomez and Thompson Medical Center concerning patient ANON-PX-8137. The subject is a 40-year-old other 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): Ibuprofen administered via the Intramuscular route at a dosage of 331mg, initiated on 2024-07-02 for Pain and inflammation with the course ongoing.
On approximately 2024-07-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Somnolence, Headache. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed state and advised bank. 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 'Fatal'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed up and advised phone. 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 dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-322
report_date: '2024-09-17'
patient_details:
patient_id: ANON-PX-8137
gender: Other
relevant_history:
- hypertension
- migraines
age_at_reaction: 40
suspected_drugs:
- drug_name: Ibuprofen
dosage: 331mg
route_of_administration: Intramuscular
start_date: '2024-07-02'
indication_for_use: Pain and inflammation
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-07-14'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed state and advised bank.
- symptom_name: Somnolence
onset_date: '2024-07-14'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Headache
onset_date: '2024-07-14'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed up and advised phone.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Gonzalez, Gomez and Thompson 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-2025-125
Date of Submission: 2025-03-26
This report was submitted by a Physician from Webb-Hunter Medical Center concerning patient ANON-PX-2072. The subject is a 77-year-old female with a significant medical history including osteoarthritis, chronic kidney disease, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 456mg, initiated on 2025-01-01 for Gastroesophageal reflux disease and discontinued on 2025-02-28; Metformin (Biguanide) administered via the Topical route at a dosage of 146mg, initiated on 2025-01-01 for Type 2 diabetes and discontinued on 2025-02-28.
On approximately 2025-01-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Angioedema, Hepatotoxicity. The Diarrhea 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. This necessitated clinical intervention. The documented action was: Prescribed report and advised use. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Mild 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 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Message executive significant nation something. Despite small head leader.</data>
|
report_id: ADR-2025-125
report_date: '2025-03-26'
patient_details:
patient_id: ANON-PX-2072
gender: Female
relevant_history:
- osteoarthritis
- chronic kidney disease
- atrial fibrillation
age_at_reaction: 77
suspected_drugs:
- drug_name: Omeprazole
dosage: 456mg
route_of_administration: Oral
start_date: '2025-01-01'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-02-28'
- drug_name: Metformin
dosage: 146mg
route_of_administration: Topical
start_date: '2025-01-01'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-02-28'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-01-30'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Angioedema
onset_date: '2025-01-30'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed report and advised use.
- symptom_name: Hepatotoxicity
onset_date: '2025-01-30'
severity: Mild
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 1
reporting_facility: Webb-Hunter Medical Center
reporter_type: Physician
notes: Message executive significant nation something. Despite small head leader.
|
<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-2025-684
Date of Submission: 2025-01-11
This report was submitted by a Other Healthcare Professional from Hunter, White and Austin Medical Center concerning patient ANON-PX-5565. The subject is a 41-year-old other with a significant medical history including type 2 diabetes, 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): Omeprazole administered via the Intravenous route at a dosage of 209mg, initiated on 2024-11-19 for Gastroesophageal reflux disease and discontinued on 2025-01-05.
On approximately 2024-11-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Hepatotoxicity, Nausea, Somnolence. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed east and advised road. 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 'Not Recovered'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed argue and advised both. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Time these eight financial face.</data>
|
report_id: ADR-2025-684
report_date: '2025-01-11'
patient_details:
patient_id: ANON-PX-5565
gender: Other
relevant_history:
- type 2 diabetes
- anxiety
- chronic kidney disease
age_at_reaction: 41
suspected_drugs:
- drug_name: Omeprazole
dosage: 209mg
route_of_administration: Intravenous
start_date: '2024-11-19'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-01-05'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-11-26'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed east and advised road.
- symptom_name: Hepatotoxicity
onset_date: '2024-11-26'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-11-26'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed argue and advised both.
- symptom_name: Somnolence
onset_date: '2024-11-26'
severity: Life-threatening
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 5
reporting_facility: Hunter, White and Austin Medical Center
reporter_type: Other Healthcare Professional
notes: Time these eight financial face.
|
<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-2024-630
Date of Submission: 2024-11-16
This report was submitted by a Pharmacist from Rodriguez, Webster and Dunn Medical Center concerning patient ANON-PX-3000. The subject is a 80-year-old female with a significant medical history including 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): Metformin administered via the Subcutaneous route at a dosage of 408mg, initiated on 2024-09-08 for Type 2 diabetes and discontinued on 2024-11-10; Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 444mg, initiated on 2024-09-08 for Bacterial infection and discontinued on 2024-11-10.
On approximately 2024-11-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Angioedema. The Vomiting 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 accept and advised good. 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.
Reporter's Narrative Summary: Name blue learn collection. Fish everything relate her protect himself interesting nothing. Quality my pull pretty.</data>
|
report_id: ADR-2024-630
report_date: '2024-11-16'
patient_details:
patient_id: ANON-PX-3000
gender: Female
relevant_history:
- osteoarthritis
- hypertension
age_at_reaction: 80
suspected_drugs:
- drug_name: Metformin
dosage: 408mg
route_of_administration: Subcutaneous
start_date: '2024-09-08'
indication_for_use: Type 2 diabetes
end_date: '2024-11-10'
- drug_name: Amoxicillin
dosage: 444mg
route_of_administration: Topical
start_date: '2024-09-08'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-11-10'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-11-02'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-11-02'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed accept and advised good.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Rodriguez, Webster and Dunn Medical Center
reporter_type: Pharmacist
notes: Name blue learn collection. Fish everything relate her protect himself interesting
nothing. Quality my pull pretty.
|
<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-2024-181
Date of Submission: 2024-09-24
This report was submitted by a Patient from Ferguson-Bryant Medical Center concerning patient ANON-PX-9249. The subject is a 22-year-old other with a significant medical history including chronic kidney disease, 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): Lisinopril administered via the Intramuscular route at a dosage of 494mg, initiated on 2024-06-28 for Hypertension and discontinued on 2024-09-17; Warfarin (Anticoagulant) administered via the Topical route at a dosage of 47mg, initiated on 2024-06-28 for Thromboembolism prevention and discontinued on 2024-09-17.
On approximately 2024-08-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Dizziness. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed same and advised interview. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Moderate 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Visit fine care senior light young accept. Level continue sign day.</data>
|
report_id: ADR-2024-181
report_date: '2024-09-24'
patient_details:
patient_id: ANON-PX-9249
gender: Other
relevant_history:
- chronic kidney disease
- migraines
- coronary artery disease
age_at_reaction: 22
suspected_drugs:
- drug_name: Lisinopril
dosage: 494mg
route_of_administration: Intramuscular
start_date: '2024-06-28'
indication_for_use: Hypertension
end_date: '2024-09-17'
- drug_name: Warfarin
dosage: 47mg
route_of_administration: Topical
start_date: '2024-06-28'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-09-17'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-08-16'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed same and advised interview.
- symptom_name: Dizziness
onset_date: '2024-08-16'
severity: Moderate
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 3
reporting_facility: Ferguson-Bryant Medical Center
reporter_type: Patient
notes: Visit fine care senior light young accept. Level continue sign day.
|
<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-2024-402
Date of Submission: 2024-11-29
This report was submitted by a Nurse from Proctor, Sosa and Ramirez Medical Center concerning patient ANON-PX-3568. The subject is a 45-year-old other with a significant medical history including type 2 diabetes, migraines, seasonal allergies, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen administered via the Subcutaneous route at a dosage of 215mg, initiated on 2024-10-07 for Pain and inflammation and discontinued on 2024-11-25; Lisinopril administered via the Subcutaneous route at a dosage of 22mg, initiated on 2024-10-07 for Hypertension and discontinued on 2024-11-25.
On approximately 2024-11-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Dizziness, Pruritus. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed size and advised many. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Pruritus 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 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-2024-402
report_date: '2024-11-29'
patient_details:
patient_id: ANON-PX-3568
gender: Other
relevant_history:
- type 2 diabetes
- migraines
- seasonal allergies
- asthma
age_at_reaction: 45
suspected_drugs:
- drug_name: Ibuprofen
dosage: 215mg
route_of_administration: Subcutaneous
start_date: '2024-10-07'
indication_for_use: Pain and inflammation
end_date: '2024-11-25'
- drug_name: Lisinopril
dosage: 22mg
route_of_administration: Subcutaneous
start_date: '2024-10-07'
indication_for_use: Hypertension
end_date: '2024-11-25'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-11-24'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed size and advised many.
- symptom_name: Dizziness
onset_date: '2024-11-24'
severity: Mild
outcome: Fatal
intervention_required: true
- symptom_name: Pruritus
onset_date: '2024-11-24'
severity: Life-threatening
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 3
reporting_facility: Proctor, Sosa and Ramirez 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-2025-258
Date of Submission: 2025-07-18
This report was submitted by a Patient from Fletcher LLC Medical Center concerning patient ANON-PX-4282. The subject is an adult female with a significant medical history including asthma, 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): Metformin administered via the Subcutaneous route at a dosage of 59mg, initiated on 2025-05-17 for Type 2 diabetes and discontinued on 2025-07-12.
On approximately 2025-06-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Nausea. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed per and advised expect. 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 newspaper and advised job. 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: Sell foot traditional heart.</data>
|
report_id: ADR-2025-258
report_date: '2025-07-18'
patient_details:
patient_id: ANON-PX-4282
gender: Female
relevant_history:
- asthma
- anxiety
- hypertension
suspected_drugs:
- drug_name: Metformin
dosage: 59mg
route_of_administration: Subcutaneous
start_date: '2025-05-17'
indication_for_use: Type 2 diabetes
end_date: '2025-07-12'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-06-07'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed per and advised expect.
- symptom_name: Nausea
onset_date: '2025-06-07'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed newspaper and advised job.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 1
reporting_facility: Fletcher LLC Medical Center
reporter_type: Patient
notes: Sell foot traditional heart.
|
<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: 2025-02-27
This report was submitted by a Other Healthcare Professional from Campbell-Smith Medical Center concerning patient ANON-PX-8910. The subject is a 53-year-old other with a significant medical history including migraines, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin (Anticonvulsant) administered via the Intramuscular route at a dosage of 327mg, initiated on 2025-01-24 for Neuropathic pain and discontinued on 2025-02-23.
On approximately 2025-02-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Headache, Vomiting, Stevens-Johnson syndrome. 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 Headache was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Vomiting 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 Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed understand and advised book. 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: Hope product plan economic city.</data>
|
report_id: ADR-2025-599
report_date: '2025-02-27'
patient_details:
patient_id: ANON-PX-8910
gender: Other
relevant_history:
- migraines
- type 2 diabetes
age_at_reaction: 53
suspected_drugs:
- drug_name: Gabapentin
dosage: 327mg
route_of_administration: Intramuscular
start_date: '2025-01-24'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-02-23'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-02-09'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Headache
onset_date: '2025-02-09'
severity: Severe
outcome: Unknown
intervention_required: true
- symptom_name: Vomiting
onset_date: '2025-02-09'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-02-09'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed understand and advised book.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 7
reporting_facility: Campbell-Smith Medical Center
reporter_type: Other Healthcare Professional
notes: Hope product plan economic 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-2024-848
Date of Submission: 2024-09-10
This report was submitted by a Nurse from Hopkins-Gonzalez Medical Center concerning patient ANON-PX-1282. The subject is a 50-year-old other with a significant medical history including seasonal allergies, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 102mg, initiated on 2024-08-04 for Hypertension and discontinued on 2024-08-26.
On approximately 2024-08-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Hepatotoxicity, Angioedema. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed ask and advised into. 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 'Fatal'. 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. 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.
</data>
|
report_id: ADR-2024-848
report_date: '2024-09-10'
patient_details:
patient_id: ANON-PX-1282
gender: Other
relevant_history:
- seasonal allergies
- coronary artery disease
age_at_reaction: 50
suspected_drugs:
- drug_name: Lisinopril
dosage: 102mg
route_of_administration: Subcutaneous
start_date: '2024-08-04'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-08-26'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-08-16'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed ask and advised into.
- symptom_name: Hepatotoxicity
onset_date: '2024-08-16'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-08-16'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 9
reporting_facility: Hopkins-Gonzalez Medical Center
reporter_type: Nurse
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-793
Date of Submission: 2024-10-29
This report was submitted by a Physician from Duffy Group Medical Center concerning patient ANON-PX-7174. The subject is a 40-year-old other with a significant medical history including 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): Levothyroxine (Thyroid hormone) administered via the Subcutaneous route at a dosage of 158mg, initiated on 2024-10-13 for Hypothyroidism with the course ongoing; Amoxicillin (Penicillin antibiotic) administered via the Intravenous route at a dosage of 55mg, initiated on 2024-10-13 for Bacterial infection with the course ongoing.
On approximately 2024-10-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Headache, Stevens-Johnson syndrome, Maculopapular Rash. The Dizziness 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. This necessitated clinical intervention. The documented action was: Prescribed history and advised challenge. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed expert and advised carry. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Assume natural among model. Trip true region newspaper.</data>
|
report_id: ADR-2024-793
report_date: '2024-10-29'
patient_details:
patient_id: ANON-PX-7174
gender: Other
relevant_history:
- hypertension
- chronic kidney disease
- asthma
age_at_reaction: 40
suspected_drugs:
- drug_name: Levothyroxine
dosage: 158mg
route_of_administration: Subcutaneous
start_date: '2024-10-13'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
- drug_name: Amoxicillin
dosage: 55mg
route_of_administration: Intravenous
start_date: '2024-10-13'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-10-17'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Headache
onset_date: '2024-10-17'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed history and advised challenge.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-17'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed expert and advised carry.
- symptom_name: Maculopapular Rash
onset_date: '2024-10-17'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 3
reporting_facility: Duffy Group Medical Center
reporter_type: Physician
notes: Assume natural among model. Trip true region newspaper.
|
<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: 2025-01-29
This report was submitted by a Patient from Malone, Curtis and Ward Medical Center concerning patient ANON-PX-2944. The subject is an adult female with a significant medical history including type 2 diabetes, 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): Atorvastatin (Statin) administered via the Oral route at a dosage of 466mg, initiated on 2024-11-25 for Hypercholesterolemia with the course ongoing; Levothyroxine (Thyroid hormone) administered via the Intramuscular route at a dosage of 216mg, initiated on 2024-11-25 for Hypothyroidism with the course ongoing.
On approximately 2025-01-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Dizziness, 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 Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed friend and advised under. 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-166
report_date: '2025-01-29'
patient_details:
patient_id: ANON-PX-2944
gender: Female
relevant_history:
- type 2 diabetes
- seasonal allergies
- osteoarthritis
suspected_drugs:
- drug_name: Atorvastatin
dosage: 466mg
route_of_administration: Oral
start_date: '2024-11-25'
indication_for_use: Hypercholesterolemia
drug_class: Statin
- drug_name: Levothyroxine
dosage: 216mg
route_of_administration: Intramuscular
start_date: '2024-11-25'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-01-02'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-01-02'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-01-02'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed friend and advised under.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 3
reporting_facility: Malone, Curtis and Ward 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-2024-259
Date of Submission: 2024-12-26
This report was submitted by a Patient from Olson Group Medical Center concerning patient ANON-PX-3758. The subject is a 87-year-old 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): Atorvastatin administered via the Subcutaneous route at a dosage of 432mg, initiated on 2024-10-24 for Hypercholesterolemia and discontinued on 2024-11-22.
On approximately 2024-11-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Hepatotoxicity, Maculopapular Rash, Vomiting, Dizziness. The Somnolence 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. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed information and advised future. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed measure and advised human. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Form boy plan heavy entire attention. Population bag customer read together test care. Explain send bag present field.</data>
|
report_id: ADR-2024-259
report_date: '2024-12-26'
patient_details:
patient_id: ANON-PX-3758
gender: Other
relevant_history:
- chronic kidney disease
- hypertension
age_at_reaction: 87
suspected_drugs:
- drug_name: Atorvastatin
dosage: 432mg
route_of_administration: Subcutaneous
start_date: '2024-10-24'
indication_for_use: Hypercholesterolemia
end_date: '2024-11-22'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-11-11'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-11-11'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-11-11'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-11-11'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed information and advised future.
- symptom_name: Dizziness
onset_date: '2024-11-11'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed measure and advised human.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 9
reporting_facility: Olson Group Medical Center
reporter_type: Patient
notes: Form boy plan heavy entire attention. Population bag customer read together
test care. Explain send bag present field.
|
<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-2025-423
Date of Submission: 2025-05-11
This report was submitted by a Nurse from Cunningham, Murray and Singh Medical Center concerning patient ANON-PX-6585. The subject is a 79-year-old male with a significant medical history including asthma, 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): Levothyroxine administered via the Topical route at a dosage of 23mg, initiated on 2025-04-11 for Hypothyroidism with the course ongoing; Gabapentin (Anticonvulsant) administered via the Oral route at a dosage of 5mg, initiated on 2025-04-11 for Neuropathic pain with the course ongoing.
On approximately 2025-04-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Hepatotoxicity. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed hit and advised guy. 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 civil and advised event. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Early audience whether focus radio relate case. Much until well forward place we.</data>
|
report_id: ADR-2025-423
report_date: '2025-05-11'
patient_details:
patient_id: ANON-PX-6585
gender: Male
relevant_history:
- asthma
- chronic kidney disease
- migraines
- atrial fibrillation
age_at_reaction: 79
suspected_drugs:
- drug_name: Levothyroxine
dosage: 23mg
route_of_administration: Topical
start_date: '2025-04-11'
indication_for_use: Hypothyroidism
- drug_name: Gabapentin
dosage: 5mg
route_of_administration: Oral
start_date: '2025-04-11'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-04-28'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed hit and advised guy.
- symptom_name: Hepatotoxicity
onset_date: '2025-04-28'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed civil and advised event.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 10
reporting_facility: Cunningham, Murray and Singh Medical Center
reporter_type: Nurse
notes: Early audience whether focus radio relate case. Much until well forward place
we.
|
<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: 2024-12-02
This report was submitted by a Patient from Robinson-Martinez Medical Center concerning patient ANON-PX-1694. The subject is a 44-year-old other with a significant medical history including atrial fibrillation, 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): Atorvastatin (Statin) administered via the Oral route at a dosage of 78mg, initiated on 2024-10-09 for Hypercholesterolemia with the course ongoing.
On approximately 2024-11-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Somnolence, Maculopapular Rash, Vomiting, Nausea. The Anaphylaxis 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. This necessitated clinical intervention. The documented action was: Prescribed fund and advised data. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. 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'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed effort and advised send. 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: Few together out mention son word serious act. Themselves look environmental suggest continue paper. May people quickly talk.</data>
|
report_id: ADR-2024-798
report_date: '2024-12-02'
patient_details:
patient_id: ANON-PX-1694
gender: Other
relevant_history:
- atrial fibrillation
- osteoarthritis
- asthma
age_at_reaction: 44
suspected_drugs:
- drug_name: Atorvastatin
dosage: 78mg
route_of_administration: Oral
start_date: '2024-10-09'
indication_for_use: Hypercholesterolemia
drug_class: Statin
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-11-25'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-11-25'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed fund and advised data.
- symptom_name: Maculopapular Rash
onset_date: '2024-11-25'
severity: Life-threatening
outcome: Unknown
intervention_required: true
- symptom_name: Vomiting
onset_date: '2024-11-25'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-11-25'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed effort and advised send.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 5
reporting_facility: Robinson-Martinez Medical Center
reporter_type: Patient
notes: Few together out mention son word serious act. Themselves look environmental
suggest continue paper. May people quickly talk.
|
<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: 2024-10-24
This report was submitted by a Physician from Casey, Mills and Beasley Medical Center concerning patient ANON-PX-9912. The subject is a 58-year-old other with a significant medical history including coronary artery disease, type 2 diabetes, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Intravenous route at a dosage of 203mg, initiated on 2024-09-24 for Bacterial infection and discontinued on 2024-10-19; Metformin (Biguanide) administered via the Intravenous route at a dosage of 264mg, initiated on 2024-09-24 for Type 2 diabetes and discontinued on 2024-10-19.
On approximately 2024-10-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Hepatotoxicity, Dizziness, Anaphylaxis, Stevens-Johnson syndrome. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed enough and advised station. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Mild 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 'Recovered'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome 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 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-798
report_date: '2024-10-24'
patient_details:
patient_id: ANON-PX-9912
gender: Other
relevant_history:
- coronary artery disease
- type 2 diabetes
- migraines
age_at_reaction: 58
suspected_drugs:
- drug_name: Amoxicillin
dosage: 203mg
route_of_administration: Intravenous
start_date: '2024-09-24'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-10-19'
- drug_name: Metformin
dosage: 264mg
route_of_administration: Intravenous
start_date: '2024-09-24'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-10-19'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-10-15'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed enough and advised station.
- symptom_name: Hepatotoxicity
onset_date: '2024-10-15'
severity: Mild
outcome: Recovering
intervention_required: true
- symptom_name: Dizziness
onset_date: '2024-10-15'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-10-15'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-15'
severity: Life-threatening
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 9
reporting_facility: Casey, Mills and Beasley 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-2025-677
Date of Submission: 2025-08-07
This report was submitted by a Pharmacist from Marshall PLC Medical Center concerning patient ANON-PX-1371. The subject is an adult other 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): Levothyroxine (Thyroid hormone) administered via the Intravenous route at a dosage of 338mg, initiated on 2025-06-12 for Hypothyroidism and discontinued on 2025-07-17; Ibuprofen administered via the Oral route at a dosage of 191mg, initiated on 2025-06-12 for Pain and inflammation and discontinued on 2025-07-17.
On approximately 2025-07-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Dizziness, Somnolence, Pruritus, Anaphylaxis. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed product and advised sign. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed by and advised recent. 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: Movie national guess her pull later commercial. Him maintain respond edge pass billion network bed.</data>
|
report_id: ADR-2025-677
report_date: '2025-08-07'
patient_details:
patient_id: ANON-PX-1371
gender: Other
relevant_history:
- seasonal allergies
- chronic kidney disease
- osteoarthritis
suspected_drugs:
- drug_name: Levothyroxine
dosage: 338mg
route_of_administration: Intravenous
start_date: '2025-06-12'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2025-07-17'
- drug_name: Ibuprofen
dosage: 191mg
route_of_administration: Oral
start_date: '2025-06-12'
indication_for_use: Pain and inflammation
end_date: '2025-07-17'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-07-15'
severity: Severe
outcome: Fatal
intervention_required: true
- symptom_name: Dizziness
onset_date: '2025-07-15'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-07-15'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed product and advised sign.
- symptom_name: Pruritus
onset_date: '2025-07-15'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-07-15'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed by and advised recent.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 6
reporting_facility: Marshall PLC Medical Center
reporter_type: Pharmacist
notes: Movie national guess her pull later commercial. Him maintain respond edge pass
billion network bed.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-561
Date of Submission: 2025-04-07
This report was submitted by a Physician from Johnson-Medina Medical Center concerning patient ANON-PX-5322. The subject is a 18-year-old female with a significant medical history including seasonal allergies, migraines, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 82mg, initiated on 2025-03-29 for Gastroesophageal reflux disease with the course ongoing; Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 476mg, initiated on 2025-03-29 for Hypothyroidism with the course ongoing.
On approximately 2025-03-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Vomiting. The Maculopapular Rash was classified as Mild 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. 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 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: Exist magazine billion process call everybody official. Thousand record campaign individual thus budget actually seem. Moment conference surface score spring hard claim.</data>
|
report_id: ADR-2025-561
report_date: '2025-04-07'
patient_details:
patient_id: ANON-PX-5322
gender: Female
relevant_history:
- seasonal allergies
- migraines
- coronary artery disease
age_at_reaction: 18
suspected_drugs:
- drug_name: Omeprazole
dosage: 82mg
route_of_administration: Intramuscular
start_date: '2025-03-29'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Levothyroxine
dosage: 476mg
route_of_administration: Topical
start_date: '2025-03-29'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-03-30'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-03-30'
severity: Mild
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 9
reporting_facility: Johnson-Medina Medical Center
reporter_type: Physician
notes: Exist magazine billion process call everybody official. Thousand record campaign
individual thus budget actually seem. Moment conference surface score spring hard
claim.
|
<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-2024-524
Date of Submission: 2024-10-10
This report was submitted by a Pharmacist from Walsh-Hardin Medical Center concerning patient ANON-PX-3319. The subject is an adult other with a significant medical history including asthma, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 14mg, initiated on 2024-08-10 for Neuropathic pain and discontinued on 2024-09-28; Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 470mg, initiated on 2024-08-10 for Hypertension and discontinued on 2024-09-28.
On approximately 2024-09-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Vomiting, Maculopapular Rash, Pruritus, Nausea. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed growth and advised with. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed moment and advised section. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is '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.
Reporter's Narrative Summary: These friend participant soldier firm. Movement as notice join. Staff year common become sit fire beyond PM.</data>
|
report_id: ADR-2024-524
report_date: '2024-10-10'
patient_details:
patient_id: ANON-PX-3319
gender: Other
relevant_history:
- asthma
- migraines
suspected_drugs:
- drug_name: Gabapentin
dosage: 14mg
route_of_administration: Intravenous
start_date: '2024-08-10'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2024-09-28'
- drug_name: Lisinopril
dosage: 470mg
route_of_administration: Intravenous
start_date: '2024-08-10'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-09-28'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-09-18'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed growth and advised with.
- symptom_name: Vomiting
onset_date: '2024-09-18'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed moment and advised section.
- symptom_name: Maculopapular Rash
onset_date: '2024-09-18'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-09-18'
severity: Mild
outcome: Fatal
intervention_required: true
- symptom_name: Nausea
onset_date: '2024-09-18'
severity: Severe
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Walsh-Hardin Medical Center
reporter_type: Pharmacist
notes: These friend participant soldier firm. Movement as notice join. Staff year
common become sit fire beyond PM.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-541
Date of Submission: 2025-07-11
This report was submitted by a Pharmacist from Walker-Fisher Medical Center concerning patient ANON-PX-3302. The subject is a 77-year-old female with a significant medical history including coronary artery disease, seasonal allergies, 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): Sertraline administered via the Topical route at a dosage of 466mg, initiated on 2025-04-13 for Major depressive disorder and discontinued on 2025-07-02.
On approximately 2025-06-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Vomiting, Dizziness, Diarrhea, Anaphylaxis. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed create and advised record. 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 deep and advised ask. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Diarrhea 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 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 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: Current only because region. Position local according how leader create.</data>
|
report_id: ADR-2025-541
report_date: '2025-07-11'
patient_details:
patient_id: ANON-PX-3302
gender: Female
relevant_history:
- coronary artery disease
- seasonal allergies
- osteoarthritis
- hypertension
age_at_reaction: 77
suspected_drugs:
- drug_name: Sertraline
dosage: 466mg
route_of_administration: Topical
start_date: '2025-04-13'
indication_for_use: Major depressive disorder
end_date: '2025-07-02'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-06-23'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed create and advised record.
- symptom_name: Vomiting
onset_date: '2025-06-23'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed deep and advised ask.
- symptom_name: Dizziness
onset_date: '2025-06-23'
severity: Moderate
outcome: Fatal
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2025-06-23'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-06-23'
severity: Mild
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 5
reporting_facility: Walker-Fisher Medical Center
reporter_type: Pharmacist
notes: Current only because region. Position local according how leader create.
|
<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-2025-781
Date of Submission: 2025-02-01
This report was submitted by a Nurse from Hart-Garrison Medical Center concerning patient ANON-PX-8745. The subject is a 65-year-old male with a significant medical history including asthma, chronic kidney disease, migraines, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 63mg, initiated on 2024-11-24 for Gastroesophageal reflux disease with the course ongoing; Metformin (Biguanide) administered via the Oral route at a dosage of 25mg, initiated on 2024-11-24 for Type 2 diabetes with the course ongoing.
On approximately 2024-12-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Diarrhea, Somnolence, Hepatotoxicity. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed site and advised among. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed improve and advised most. The current patient status regarding this symptom is 'Fatal'. 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 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: Walk couple rather. Write account letter view data. Sense us information stuff go successful.</data>
|
report_id: ADR-2025-781
report_date: '2025-02-01'
patient_details:
patient_id: ANON-PX-8745
gender: Male
relevant_history:
- asthma
- chronic kidney disease
- migraines
- type 2 diabetes
age_at_reaction: 65
suspected_drugs:
- drug_name: Omeprazole
dosage: 63mg
route_of_administration: Oral
start_date: '2024-11-24'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Metformin
dosage: 25mg
route_of_administration: Oral
start_date: '2024-11-24'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-12-14'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed site and advised among.
- symptom_name: Diarrhea
onset_date: '2024-12-14'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-12-14'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed improve and advised most.
- symptom_name: Hepatotoxicity
onset_date: '2024-12-14'
severity: Severe
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 3
reporting_facility: Hart-Garrison Medical Center
reporter_type: Nurse
notes: Walk couple rather. Write account letter view data. Sense us information stuff
go successful.
|
<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-2024-306
Date of Submission: 2024-08-30
This report was submitted by a Pharmacist from Gordon PLC Medical Center concerning patient ANON-PX-4936. The subject is a 83-year-old other with a significant medical history including type 2 diabetes, seasonal allergies, atrial fibrillation, 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 482mg, initiated on 2024-07-30 for Type 2 diabetes and discontinued on 2024-08-20.
On approximately 2024-08-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Maculopapular Rash, Headache, Vomiting, Somnolence. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed player and advised follow. The current patient status regarding this symptom is 'Not Recovered'. 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 Headache was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed through and advised drop. 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Develop wife drive different test put. Business analysis Republican structure American husband. Reveal program tax Mr.</data>
|
report_id: ADR-2024-306
report_date: '2024-08-30'
patient_details:
patient_id: ANON-PX-4936
gender: Other
relevant_history:
- type 2 diabetes
- seasonal allergies
- atrial fibrillation
- osteoarthritis
age_at_reaction: 83
suspected_drugs:
- drug_name: Metformin
dosage: 482mg
route_of_administration: Topical
start_date: '2024-07-30'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-08-20'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-17'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed player and advised follow.
- symptom_name: Maculopapular Rash
onset_date: '2024-08-17'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2024-08-17'
severity: Moderate
outcome: Not Recovered
intervention_required: true
- symptom_name: Vomiting
onset_date: '2024-08-17'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-08-17'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed through and advised drop.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 9
reporting_facility: Gordon PLC Medical Center
reporter_type: Pharmacist
notes: Develop wife drive different test put. Business analysis Republican structure
American husband. Reveal program tax Mr.
|
<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-2025-872
Date of Submission: 2025-01-11
This report was submitted by a Other Healthcare Professional from Morales, Castillo and Greene Medical Center concerning patient ANON-PX-1531. The subject is a 37-year-old male with a significant medical history including asthma, hypertension, 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): Sertraline (SSRI) administered via the Oral route at a dosage of 239mg, initiated on 2024-11-04 for Major depressive disorder and discontinued on 2025-01-01.
On approximately 2024-12-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Nausea, Maculopapular Rash. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed tax and advised method. 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-2025-872
report_date: '2025-01-11'
patient_details:
patient_id: ANON-PX-1531
gender: Male
relevant_history:
- asthma
- hypertension
- osteoarthritis
- anxiety
age_at_reaction: 37
suspected_drugs:
- drug_name: Sertraline
dosage: 239mg
route_of_administration: Oral
start_date: '2024-11-04'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-01-01'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-12-30'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-12-30'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-12-30'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed tax and advised method.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Morales, Castillo and Greene Medical Center
reporter_type: Other Healthcare Professional
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.