<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-2025-992
Date of Submission: 2025-05-28

This report was submitted by a Other Healthcare Professional from Cooper Ltd Medical Center concerning patient ANON-PX-2180. The subject is a 24-year-old male with a significant medical history including asthma, coronary artery disease. 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 Topical route at a dosage of 14mg, initiated on 2025-05-13 for Gastroesophageal reflux disease and discontinued on 2025-05-25.

On approximately 2025-05-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Nausea, Angioedema, Anaphylaxis. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed your and advised your. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed hard and advised become. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Expert form worry would raise result occur. Among drug artist water usually. Save ten staff we level.</data>
report_id: ADR-2025-992
report_date: '2025-05-28'
patient_details:
  patient_id: ANON-PX-2180
  gender: Male
  relevant_history:
  - asthma
  - coronary artery disease
  age_at_reaction: 24
suspected_drugs:
- drug_name: Omeprazole
  dosage: 14mg
  route_of_administration: Topical
  start_date: '2025-05-13'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-05-25'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2025-05-18'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed your and advised your.
- symptom_name: Nausea
  onset_date: '2025-05-18'
  severity: Severe
  outcome: Recovering
  intervention_required: true
- symptom_name: Angioedema
  onset_date: '2025-05-18'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
- symptom_name: Anaphylaxis
  onset_date: '2025-05-18'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed hard and advised become.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 4
reporting_facility: Cooper Ltd Medical Center
reporter_type: Other Healthcare Professional
notes: Expert form worry would raise result occur. Among drug artist water usually.
  Save ten staff we level.
