<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-2025-342
Date of Submission: 2025-06-04

This report was submitted by a Other Healthcare Professional from Garrett Ltd Medical Center concerning patient ANON-PX-6148. The subject is a 76-year-old male with a significant medical history including migraines, hypertension, atrial fibrillation, 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): Ibuprofen (NSAID) administered via the Oral route at a dosage of 395mg, initiated on 2025-03-23 for Pain and inflammation and discontinued on 2025-05-26; Atorvastatin (Statin) administered via the Intravenous route at a dosage of 412mg, initiated on 2025-03-23 for Hypercholesterolemia and discontinued on 2025-05-26.

On approximately 2025-05-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Anaphylaxis, Hepatotoxicity, Dizziness. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed newspaper and advised seven. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 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. 

</data>
report_id: ADR-2025-342
report_date: '2025-06-04'
patient_details:
  patient_id: ANON-PX-6148
  gender: Male
  relevant_history:
  - migraines
  - hypertension
  - atrial fibrillation
  - seasonal allergies
  age_at_reaction: 76
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 395mg
  route_of_administration: Oral
  start_date: '2025-03-23'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-05-26'
- drug_name: Atorvastatin
  dosage: 412mg
  route_of_administration: Intravenous
  start_date: '2025-03-23'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2025-05-26'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2025-05-18'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed newspaper and advised seven.
- symptom_name: Anaphylaxis
  onset_date: '2025-05-18'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-05-18'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-05-18'
  severity: Severe
  outcome: Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 8
reporting_facility: Garrett Ltd Medical Center
reporter_type: Other Healthcare Professional
