<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-196
Date of Submission: 2025-03-13

This report was submitted by a Physician from Hogan Ltd Medical Center concerning patient ANON-PX-2374. The subject is a 61-year-old male with a significant medical history including type 2 diabetes, anxiety, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities. 

Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 466mg, initiated on 2025-02-07 for Bacterial infection and discontinued on 2025-02-25; Sertraline administered via the Subcutaneous route at a dosage of 291mg, initiated on 2025-02-07 for Major depressive disorder and discontinued on 2025-02-25.

On approximately 2025-02-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Anaphylaxis, Vomiting, Angioedema. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed resource and advised event. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Chair far lose eye mention interesting some. Several low laugh piece production thing test.</data>
report_id: ADR-2025-196
report_date: '2025-03-13'
patient_details:
  patient_id: ANON-PX-2374
  gender: Male
  relevant_history:
  - type 2 diabetes
  - anxiety
  - atrial fibrillation
  age_at_reaction: 61
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 466mg
  route_of_administration: Oral
  start_date: '2025-02-07'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2025-02-25'
- drug_name: Sertraline
  dosage: 291mg
  route_of_administration: Subcutaneous
  start_date: '2025-02-07'
  indication_for_use: Major depressive disorder
  end_date: '2025-02-25'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2025-02-09'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-02-09'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-02-09'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-02-09'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed resource and advised event.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 2
reporting_facility: Hogan Ltd Medical Center
reporter_type: Physician
notes: Chair far lose eye mention interesting some. Several low laugh piece production
  thing test.
