<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-523
Date of Submission: 2025-02-20

This report was submitted by a Pharmacist from Avila-Chavez Medical Center concerning patient ANON-PX-2646. The subject is a 87-year-old male with a significant medical history including osteoarthritis, atrial fibrillation, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities. 

Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Topical route at a dosage of 20mg, initiated on 2025-01-13 for Major depressive disorder with the course ongoing; Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 120mg, initiated on 2025-01-13 for Neuropathic pain with the course ongoing.

On approximately 2025-02-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Anaphylaxis, Diarrhea, Somnolence, Nausea. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed few and advised point. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-523
report_date: '2025-02-20'
patient_details:
  patient_id: ANON-PX-2646
  gender: Male
  relevant_history:
  - osteoarthritis
  - atrial fibrillation
  - coronary artery disease
  age_at_reaction: 87
suspected_drugs:
- drug_name: Sertraline
  dosage: 20mg
  route_of_administration: Topical
  start_date: '2025-01-13'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
- drug_name: Gabapentin
  dosage: 120mg
  route_of_administration: Intravenous
  start_date: '2025-01-13'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-02-03'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-02-03'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-02-03'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-02-03'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed few and advised point.
- symptom_name: Nausea
  onset_date: '2025-02-03'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 8
reporting_facility: Avila-Chavez Medical Center
reporter_type: Pharmacist
