<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-2025-339
Date of Submission: 2025-05-22

This report was submitted by a Other Healthcare Professional from Mclean LLC Medical Center concerning patient ANON-PX-2956. The subject is a 71-year-old other with a significant medical history including asthma, anxiety. 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 241mg, initiated on 2025-03-10 for Type 2 diabetes and discontinued on 2025-05-01; Omeprazole administered via the Intravenous route at a dosage of 398mg, initiated on 2025-03-10 for Gastroesophageal reflux disease and discontinued on 2025-05-01.

On approximately 2025-03-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Anaphylaxis, Somnolence, Vomiting. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed move and advised impact. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed indicate and advised discover. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed win and advised analysis. 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-2025-339
report_date: '2025-05-22'
patient_details:
  patient_id: ANON-PX-2956
  gender: Other
  relevant_history:
  - asthma
  - anxiety
  age_at_reaction: 71
suspected_drugs:
- drug_name: Metformin
  dosage: 241mg
  route_of_administration: Intramuscular
  start_date: '2025-03-10'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-05-01'
- drug_name: Omeprazole
  dosage: 398mg
  route_of_administration: Intravenous
  start_date: '2025-03-10'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2025-05-01'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-03-23'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed move and advised impact.
- symptom_name: Anaphylaxis
  onset_date: '2025-03-23'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-03-23'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed indicate and advised discover.
- symptom_name: Vomiting
  onset_date: '2025-03-23'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed win and advised analysis.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 8
reporting_facility: Mclean LLC Medical Center
reporter_type: Other Healthcare Professional
