<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-2025-936
Date of Submission: 2025-02-20

This report was submitted by a Patient from Jones Ltd Medical Center concerning patient ANON-PX-4666. The subject is a 42-year-old male with a significant medical history including anxiety, osteoarthritis, atrial fibrillation, type 2 diabetes. 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): Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 321mg, initiated on 2024-12-28 for Major depressive disorder and discontinued on 2025-01-29; Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 373mg, initiated on 2024-12-28 for Neuropathic pain and discontinued on 2025-01-29.

On approximately 2025-01-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Anaphylaxis, Angioedema, Somnolence, Headache. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed what and advised black. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed Congress and advised the. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed same and advised always. The current patient status regarding this symptom is 'Recovered'. 

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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-936
report_date: '2025-02-20'
patient_details:
  patient_id: ANON-PX-4666
  gender: Male
  relevant_history:
  - anxiety
  - osteoarthritis
  - atrial fibrillation
  - type 2 diabetes
  age_at_reaction: 42
suspected_drugs:
- drug_name: Sertraline
  dosage: 321mg
  route_of_administration: Subcutaneous
  start_date: '2024-12-28'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-01-29'
- drug_name: Gabapentin
  dosage: 373mg
  route_of_administration: Intravenous
  start_date: '2024-12-28'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-01-29'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2025-01-04'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed what and advised black.
- symptom_name: Anaphylaxis
  onset_date: '2025-01-04'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-01-04'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-01-04'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed Congress and advised the.
- symptom_name: Headache
  onset_date: '2025-01-04'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed same and advised always.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 5
reporting_facility: Jones Ltd Medical Center
reporter_type: Patient
