<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-2025-851
Date of Submission: 2025-08-12

This report was submitted by a Patient from Carter, Hart and Contreras Medical Center concerning patient ANON-PX-1052. The subject is a 59-year-old male with a significant medical history including anxiety, type 2 diabetes, migraines. 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): Metformin (Biguanide) administered via the Intramuscular route at a dosage of 41mg, initiated on 2025-05-24 for Type 2 diabetes and discontinued on 2025-07-24; Sertraline (SSRI) administered via the Intramuscular route at a dosage of 438mg, initiated on 2025-05-24 for Major depressive disorder and discontinued on 2025-07-24.

On approximately 2025-07-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Maculopapular Rash, Hepatotoxicity. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed heavy and advised education. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed voice and advised finally. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. 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: Economic particularly spend exactly. Lot work choose visit tough find visit. Audience since stop fight happen join enough.</data>
report_id: ADR-2025-851
report_date: '2025-08-12'
patient_details:
  patient_id: ANON-PX-1052
  gender: Male
  relevant_history:
  - anxiety
  - type 2 diabetes
  - migraines
  age_at_reaction: 59
suspected_drugs:
- drug_name: Metformin
  dosage: 41mg
  route_of_administration: Intramuscular
  start_date: '2025-05-24'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-07-24'
- drug_name: Sertraline
  dosage: 438mg
  route_of_administration: Intramuscular
  start_date: '2025-05-24'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-07-24'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2025-07-21'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed heavy and advised education.
- symptom_name: Maculopapular Rash
  onset_date: '2025-07-21'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed voice and advised finally.
- symptom_name: Hepatotoxicity
  onset_date: '2025-07-21'
  severity: Mild
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 3
reporting_facility: Carter, Hart and Contreras Medical Center
reporter_type: Patient
notes: Economic particularly spend exactly. Lot work choose visit tough find visit.
  Audience since stop fight happen join enough.
