<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-2025-892
Date of Submission: 2025-02-25

This report was submitted by a Patient from Edwards, Garza and Thompson Medical Center concerning patient ANON-PX-3104. The subject is a 44-year-old male with a significant medical history including migraines, seasonal allergies, type 2 diabetes. 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 Oral route at a dosage of 38mg, initiated on 2025-02-09 for Type 2 diabetes with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 456mg, initiated on 2025-02-09 for Gastroesophageal reflux disease with the course ongoing.

On approximately 2025-02-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Maculopapular Rash, Somnolence, Anaphylaxis. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed size and advised case. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed option and advised home. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed modern and advised turn. The current patient status regarding this symptom is 'Fatal'. 

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: Interest usually actually trial blood arm population. Read author describe back budget interesting. Significant admit name never cup top skin.</data>
report_id: ADR-2025-892
report_date: '2025-02-25'
patient_details:
  patient_id: ANON-PX-3104
  gender: Male
  relevant_history:
  - migraines
  - seasonal allergies
  - type 2 diabetes
  age_at_reaction: 44
suspected_drugs:
- drug_name: Metformin
  dosage: 38mg
  route_of_administration: Oral
  start_date: '2025-02-09'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
- drug_name: Omeprazole
  dosage: 456mg
  route_of_administration: Subcutaneous
  start_date: '2025-02-09'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2025-02-19'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-02-19'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed size and advised case.
- symptom_name: Somnolence
  onset_date: '2025-02-19'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed option and advised home.
- symptom_name: Anaphylaxis
  onset_date: '2025-02-19'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed modern and advised turn.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 1
reporting_facility: Edwards, Garza and Thompson Medical Center
reporter_type: Patient
notes: Interest usually actually trial blood arm population. Read author describe
  back budget interesting. Significant admit name never cup top skin.
