<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-2025-134
Date of Submission: 2025-07-27

This report was submitted by a Physician from Morgan, Zamora and Torres Medical Center concerning patient ANON-PX-1890. The subject is an adult female with a significant medical history including anxiety, type 2 diabetes, hypertension, migraines. 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): Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 440mg, initiated on 2025-05-08 for Neuropathic pain and discontinued on 2025-07-18; Metformin (Biguanide) administered via the Intravenous route at a dosage of 105mg, initiated on 2025-05-08 for Type 2 diabetes and discontinued on 2025-07-18.

On approximately 2025-05-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Vomiting, Maculopapular Rash, Angioedema. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed foreign and advised economic. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-134
report_date: '2025-07-27'
patient_details:
  patient_id: ANON-PX-1890
  gender: Female
  relevant_history:
  - anxiety
  - type 2 diabetes
  - hypertension
  - migraines
suspected_drugs:
- drug_name: Gabapentin
  dosage: 440mg
  route_of_administration: Topical
  start_date: '2025-05-08'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-07-18'
- drug_name: Metformin
  dosage: 105mg
  route_of_administration: Intravenous
  start_date: '2025-05-08'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-07-18'
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2025-05-15'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-05-15'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-05-15'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-05-15'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed foreign and advised economic.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 5
reporting_facility: Morgan, Zamora and Torres Medical Center
reporter_type: Physician
