<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-2025-470
Date of Submission: 2025-08-03

This report was submitted by a Physician from Valencia PLC Medical Center concerning patient ANON-PX-7662. The subject is a 86-year-old male with a significant medical history including asthma, seasonal allergies. 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): Levothyroxine (Thyroid hormone) administered via the Subcutaneous route at a dosage of 283mg, initiated on 2025-05-22 for Hypothyroidism and discontinued on 2025-07-02; Sertraline administered via the Oral route at a dosage of 12mg, initiated on 2025-05-22 for Major depressive disorder and discontinued on 2025-07-02.

On approximately 2025-06-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Nausea, Angioedema. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed sure and advised whole. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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-2025-470
report_date: '2025-08-03'
patient_details:
  patient_id: ANON-PX-7662
  gender: Male
  relevant_history:
  - asthma
  - seasonal allergies
  age_at_reaction: 86
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 283mg
  route_of_administration: Subcutaneous
  start_date: '2025-05-22'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2025-07-02'
- drug_name: Sertraline
  dosage: 12mg
  route_of_administration: Oral
  start_date: '2025-05-22'
  indication_for_use: Major depressive disorder
  end_date: '2025-07-02'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-06-18'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
- symptom_name: Nausea
  onset_date: '2025-06-18'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed sure and advised whole.
- symptom_name: Angioedema
  onset_date: '2025-06-18'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Valencia PLC Medical Center
reporter_type: Physician
