<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-2024-958
Date of Submission: 2024-12-26

This report was submitted by a Physician from Mclaughlin PLC Medical Center concerning patient ANON-PX-5527. The subject is a 76-year-old other with a significant medical history including osteoarthritis, type 2 diabetes, seasonal allergies, 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): Ibuprofen administered via the Topical route at a dosage of 237mg, initiated on 2024-12-14 for Pain and inflammation and discontinued on 2024-12-23; Sertraline (SSRI) administered via the Intramuscular route at a dosage of 192mg, initiated on 2024-12-14 for Major depressive disorder and discontinued on 2024-12-23.

On approximately 2024-12-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Maculopapular Rash, Nausea. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed wish and advised between. The current patient status regarding this symptom is 'Not 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-958
report_date: '2024-12-26'
patient_details:
  patient_id: ANON-PX-5527
  gender: Other
  relevant_history:
  - osteoarthritis
  - type 2 diabetes
  - seasonal allergies
  - hypertension
  age_at_reaction: 76
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 237mg
  route_of_administration: Topical
  start_date: '2024-12-14'
  indication_for_use: Pain and inflammation
  end_date: '2024-12-23'
- drug_name: Sertraline
  dosage: 192mg
  route_of_administration: Intramuscular
  start_date: '2024-12-14'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-12-23'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-12-21'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-12-21'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-12-21'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed wish and advised between.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 5
reporting_facility: Mclaughlin PLC Medical Center
reporter_type: Physician
