<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-2024-773
Date of Submission: 2024-10-13

This report was submitted by a Pharmacist from Hubbard-Rodriguez Medical Center concerning patient ANON-PX-8935. The subject is an adult female with a significant medical history including osteoarthritis, asthma. 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 477mg, initiated on 2024-07-20 for Gastroesophageal reflux disease and discontinued on 2024-08-19.

On approximately 2024-08-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Maculopapular Rash, Vomiting, Pruritus, Angioedema. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed material and advised both. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed nearly and advised federal. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed southern and advised food. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed ever and advised central. 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 dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Mean above interesting world reduce way. Here seven specific peace important. Woman town product.</data>
report_id: ADR-2024-773
report_date: '2024-10-13'
patient_details:
  patient_id: ANON-PX-8935
  gender: Female
  relevant_history:
  - osteoarthritis
  - asthma
suspected_drugs:
- drug_name: Omeprazole
  dosage: 477mg
  route_of_administration: Topical
  start_date: '2024-07-20'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-08-19'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2024-08-12'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-08-12'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed material and advised both.
- symptom_name: Vomiting
  onset_date: '2024-08-12'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed nearly and advised federal.
- symptom_name: Pruritus
  onset_date: '2024-08-12'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed southern and advised food.
- symptom_name: Angioedema
  onset_date: '2024-08-12'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed ever and advised central.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 4
reporting_facility: Hubbard-Rodriguez Medical Center
reporter_type: Pharmacist
notes: Mean above interesting world reduce way. Here seven specific peace important.
  Woman town product.
