<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-2025-862
Date of Submission: 2025-03-03

This report was submitted by a Patient from Ali Group Medical Center concerning patient ANON-PX-6790. The subject is a 69-year-old male with a significant medical history including coronary artery disease, osteoarthritis, seasonal allergies, 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): Gabapentin (Anticonvulsant) administered via the Intramuscular route at a dosage of 471mg, initiated on 2024-12-08 for Neuropathic pain and discontinued on 2025-03-02.

On approximately 2025-02-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Diarrhea, Headache, Dizziness, Hepatotoxicity. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. 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-2025-862
report_date: '2025-03-03'
patient_details:
  patient_id: ANON-PX-6790
  gender: Male
  relevant_history:
  - coronary artery disease
  - osteoarthritis
  - seasonal allergies
  - hypertension
  age_at_reaction: 69
suspected_drugs:
- drug_name: Gabapentin
  dosage: 471mg
  route_of_administration: Intramuscular
  start_date: '2024-12-08'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-03-02'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2025-02-27'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
- symptom_name: Diarrhea
  onset_date: '2025-02-27'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-02-27'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-02-27'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-02-27'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 5
reporting_facility: Ali Group Medical Center
reporter_type: Patient
