<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-2025-775
Date of Submission: 2025-07-02

This report was submitted by a Pharmacist from Farmer-Wood Medical Center concerning patient ANON-PX-6568. The subject is an adult female with a significant medical history including seasonal allergies, chronic kidney disease, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities. 

Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Topical route at a dosage of 119mg, initiated on 2025-05-03 for Major depressive disorder and discontinued on 2025-05-31.

On approximately 2025-05-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Nausea, Pruritus, Angioedema, Headache. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed agreement and advised Congress. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed relate and advised old. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 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: Pay service reach. State hit peace four.</data>
report_id: ADR-2025-775
report_date: '2025-07-02'
patient_details:
  patient_id: ANON-PX-6568
  gender: Female
  relevant_history:
  - seasonal allergies
  - chronic kidney disease
  - coronary artery disease
suspected_drugs:
- drug_name: Sertraline
  dosage: 119mg
  route_of_administration: Topical
  start_date: '2025-05-03'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-05-31'
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2025-05-04'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-05-04'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-05-04'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed agreement and advised Congress.
- symptom_name: Angioedema
  onset_date: '2025-05-04'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed relate and advised old.
- symptom_name: Headache
  onset_date: '2025-05-04'
  severity: Mild
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 5
reporting_facility: Farmer-Wood Medical Center
reporter_type: Pharmacist
notes: Pay service reach. State hit peace four.
