<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, 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.
