<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-2025-633
Date of Submission: 2025-02-09

This report was submitted by a Nurse from Lozano, Weber and Weber Medical Center concerning patient ANON-PX-8255. The subject is an adult other with a significant medical history including hypertension, asthma, 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): Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 50mg, initiated on 2024-12-03 for Gastroesophageal reflux disease and discontinued on 2025-01-20; Levothyroxine administered via the Topical route at a dosage of 10mg, initiated on 2024-12-03 for Hypothyroidism and discontinued on 2025-01-20.

On approximately 2024-12-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Diarrhea, Angioedema, Hepatotoxicity. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed age and advised couple. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Pull likely its go yard. Play certainly read after PM. Training knowledge sign action.</data>
report_id: ADR-2025-633
report_date: '2025-02-09'
patient_details:
  patient_id: ANON-PX-8255
  gender: Other
  relevant_history:
  - hypertension
  - asthma
  - type 2 diabetes
suspected_drugs:
- drug_name: Omeprazole
  dosage: 50mg
  route_of_administration: Intramuscular
  start_date: '2024-12-03'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-01-20'
- drug_name: Levothyroxine
  dosage: 10mg
  route_of_administration: Topical
  start_date: '2024-12-03'
  indication_for_use: Hypothyroidism
  end_date: '2025-01-20'
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2024-12-30'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-12-30'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
- symptom_name: Angioedema
  onset_date: '2024-12-30'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed age and advised couple.
- symptom_name: Hepatotoxicity
  onset_date: '2024-12-30'
  severity: Severe
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 2
reporting_facility: Lozano, Weber and Weber Medical Center
reporter_type: Nurse
notes: Pull likely its go yard. Play certainly read after PM. Training knowledge sign
  action.
