<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-2024-262
Date of Submission: 2024-10-30

This report was submitted by a Patient from Wells PLC Medical Center concerning patient ANON-PX-9184. The subject is a 71-year-old male with a significant medical history including atrial fibrillation, seasonal allergies. 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 255mg, initiated on 2024-10-08 for Gastroesophageal reflux disease and discontinued on 2024-10-22.

On approximately 2024-10-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Vomiting, Nausea, Hepatotoxicity, Somnolence. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed door and advised seat. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed marriage and advised meet. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Would watch I soon town seem. Head mention test upon.</data>
report_id: ADR-2024-262
report_date: '2024-10-30'
patient_details:
  patient_id: ANON-PX-9184
  gender: Male
  relevant_history:
  - atrial fibrillation
  - seasonal allergies
  age_at_reaction: 71
suspected_drugs:
- drug_name: Omeprazole
  dosage: 255mg
  route_of_administration: Intramuscular
  start_date: '2024-10-08'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-10-22'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-10-15'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-10-15'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-10-15'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed door and advised seat.
- symptom_name: Hepatotoxicity
  onset_date: '2024-10-15'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed marriage and advised meet.
- symptom_name: Somnolence
  onset_date: '2024-10-15'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 9
reporting_facility: Wells PLC Medical Center
reporter_type: Patient
notes: Would watch I soon town seem. Head mention test upon.
