<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.
