<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-2024-375
Date of Submission: 2024-10-27

This report was submitted by a Nurse from Gillespie PLC Medical Center concerning patient ANON-PX-3288. The subject is a 53-year-old female with a significant medical history including osteoarthritis, 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): Ibuprofen (NSAID) administered via the Topical route at a dosage of 347mg, initiated on 2024-09-11 for Pain and inflammation with the course ongoing; Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 32mg, initiated on 2024-09-11 for Major depressive disorder with the course ongoing.

On approximately 2024-09-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Headache, Anaphylaxis, Pruritus. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. 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-2024-375
report_date: '2024-10-27'
patient_details:
  patient_id: ANON-PX-3288
  gender: Female
  relevant_history:
  - osteoarthritis
  - type 2 diabetes
  age_at_reaction: 53
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 347mg
  route_of_administration: Topical
  start_date: '2024-09-11'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
- drug_name: Sertraline
  dosage: 32mg
  route_of_administration: Subcutaneous
  start_date: '2024-09-11'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2024-09-18'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Headache
  onset_date: '2024-09-18'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-09-18'
  severity: Severe
  outcome: Unknown
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2024-09-18'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 1
reporting_facility: Gillespie PLC Medical Center
reporter_type: Nurse
