<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-2024-547
Date of Submission: 2024-08-28

This report was submitted by a Pharmacist from Hill-English Medical Center concerning patient ANON-PX-8200. The subject is a 43-year-old male with a significant medical history including asthma, atrial fibrillation. 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): Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 187mg, initiated on 2024-07-30 for Gastroesophageal reflux disease with the course ongoing; Metformin (Biguanide) administered via the Oral route at a dosage of 39mg, initiated on 2024-07-30 for Type 2 diabetes with the course ongoing.

On approximately 2024-08-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Headache, Stevens-Johnson syndrome, Dizziness, Somnolence. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed likely and advised culture. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Address owner main less. Collection she the protect. Maybe know behavior pass. Option ready democratic strong senior process.</data>
report_id: ADR-2024-547
report_date: '2024-08-28'
patient_details:
  patient_id: ANON-PX-8200
  gender: Male
  relevant_history:
  - asthma
  - atrial fibrillation
  age_at_reaction: 43
suspected_drugs:
- drug_name: Omeprazole
  dosage: 187mg
  route_of_administration: Intramuscular
  start_date: '2024-07-30'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
- drug_name: Metformin
  dosage: 39mg
  route_of_administration: Oral
  start_date: '2024-07-30'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-08-17'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
- symptom_name: Headache
  onset_date: '2024-08-17'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-08-17'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2024-08-17'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed likely and advised culture.
- symptom_name: Somnolence
  onset_date: '2024-08-17'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 1
reporting_facility: Hill-English Medical Center
reporter_type: Pharmacist
notes: Address owner main less. Collection she the protect. Maybe know behavior pass.
  Option ready democratic strong senior process.
