<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-2025-513
Date of Submission: 2025-07-26

This report was submitted by a Physician from Booth-Bailey Medical Center concerning patient ANON-PX-2382. The subject is an adult other with a significant medical history including atrial fibrillation, chronic kidney disease, hypertension. 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 65mg, initiated on 2025-06-18 for Gastroesophageal reflux disease with the course ongoing; Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 328mg, initiated on 2025-06-18 for Hypothyroidism with the course ongoing.

On approximately 2025-06-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Somnolence, Nausea, Pruritus. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed about and advised environment. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed something and advised toward. 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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Hour they beyond court answer woman card. Drug bar skill thank.</data>
report_id: ADR-2025-513
report_date: '2025-07-26'
patient_details:
  patient_id: ANON-PX-2382
  gender: Other
  relevant_history:
  - atrial fibrillation
  - chronic kidney disease
  - hypertension
suspected_drugs:
- drug_name: Omeprazole
  dosage: 65mg
  route_of_administration: Topical
  start_date: '2025-06-18'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
- drug_name: Levothyroxine
  dosage: 328mg
  route_of_administration: Topical
  start_date: '2025-06-18'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2025-06-19'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed about and advised environment.
- symptom_name: Somnolence
  onset_date: '2025-06-19'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-06-19'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-06-19'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed something and advised toward.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 2
reporting_facility: Booth-Bailey Medical Center
reporter_type: Physician
notes: Hour they beyond court answer woman card. Drug bar skill thank.
