<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-2025-329
Date of Submission: 2025-08-09

This report was submitted by a Nurse from Rose PLC Medical Center concerning patient ANON-PX-1889. The subject is a 69-year-old male with a significant medical history including osteoarthritis, type 2 diabetes, 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): Levothyroxine (Thyroid hormone) administered via the Intramuscular route at a dosage of 276mg, initiated on 2025-05-23 for Hypothyroidism with the course ongoing; Sertraline (SSRI) administered via the Topical route at a dosage of 274mg, initiated on 2025-05-23 for Major depressive disorder with the course ongoing.

On approximately 2025-07-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Diarrhea, Dizziness, Angioedema, Nausea. The Headache was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. 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 'Not Recovered'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Could low indicate language just. Network some know according hour action. Despite relationship money follow group purpose.</data>
report_id: ADR-2025-329
report_date: '2025-08-09'
patient_details:
  patient_id: ANON-PX-1889
  gender: Male
  relevant_history:
  - osteoarthritis
  - type 2 diabetes
  - hypertension
  age_at_reaction: 69
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 276mg
  route_of_administration: Intramuscular
  start_date: '2025-05-23'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
- drug_name: Sertraline
  dosage: 274mg
  route_of_administration: Topical
  start_date: '2025-05-23'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
adverse_reactions:
- symptom_name: Headache
  onset_date: '2025-07-06'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-07-06'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-07-06'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Angioedema
  onset_date: '2025-07-06'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
- symptom_name: Nausea
  onset_date: '2025-07-06'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 7
reporting_facility: Rose PLC Medical Center
reporter_type: Nurse
notes: Could low indicate language just. Network some know according hour action.
  Despite relationship money follow group purpose.
