<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-2024-150
Date of Submission: 2024-11-15

This report was submitted by a Patient from Kelly, Pena and Williams Medical Center concerning patient ANON-PX-1935. The subject is a 67-year-old female with a significant medical history including asthma, migraines, 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): Sertraline (SSRI) administered via the Topical route at a dosage of 455mg, initiated on 2024-09-15 for Major depressive disorder and discontinued on 2024-10-11; Atorvastatin (Statin) administered via the Oral route at a dosage of 24mg, initiated on 2024-09-15 for Hypercholesterolemia and discontinued on 2024-10-11.

On approximately 2024-09-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Dizziness, Hepatotoxicity. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed deal and advised production. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Right sit mother security offer assume letter. Summer art game late low option. Mrs rule sea somebody show conference.</data>
report_id: ADR-2024-150
report_date: '2024-11-15'
patient_details:
  patient_id: ANON-PX-1935
  gender: Female
  relevant_history:
  - asthma
  - migraines
  - atrial fibrillation
  age_at_reaction: 67
suspected_drugs:
- drug_name: Sertraline
  dosage: 455mg
  route_of_administration: Topical
  start_date: '2024-09-15'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-10-11'
- drug_name: Atorvastatin
  dosage: 24mg
  route_of_administration: Oral
  start_date: '2024-09-15'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2024-10-11'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-09-27'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Dizziness
  onset_date: '2024-09-27'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-09-27'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed deal and advised production.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 7
reporting_facility: Kelly, Pena and Williams Medical Center
reporter_type: Patient
notes: Right sit mother security offer assume letter. Summer art game late low option.
  Mrs rule sea somebody show conference.
