<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-2024-259
Date of Submission: 2024-09-08

This report was submitted by a Nurse from Madden, Welch and Hubbard Medical Center concerning patient ANON-PX-8336. The subject is a 37-year-old female with a significant medical history including type 2 diabetes, seasonal allergies. 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 95mg, initiated on 2024-07-02 for Pain and inflammation with the course ongoing; Metformin (Biguanide) administered via the Oral route at a dosage of 321mg, initiated on 2024-07-02 for Type 2 diabetes with the course ongoing.

On approximately 2024-09-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Angioedema, Pruritus, Somnolence. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed gun and advised hundred. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed environment and advised result. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed structure and advised help. The current patient status regarding this symptom is 'Unknown'. 

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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-259
report_date: '2024-09-08'
patient_details:
  patient_id: ANON-PX-8336
  gender: Female
  relevant_history:
  - type 2 diabetes
  - seasonal allergies
  age_at_reaction: 37
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 95mg
  route_of_administration: Topical
  start_date: '2024-07-02'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
- drug_name: Metformin
  dosage: 321mg
  route_of_administration: Oral
  start_date: '2024-07-02'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2024-09-03'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed gun and advised hundred.
- symptom_name: Angioedema
  onset_date: '2024-09-03'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2024-09-03'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed environment and advised result.
- symptom_name: Somnolence
  onset_date: '2024-09-03'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed structure and advised help.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 1
reporting_facility: Madden, Welch and Hubbard Medical Center
reporter_type: Nurse
