<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-2025-616
Date of Submission: 2025-06-29

This report was submitted by a Pharmacist from Moreno Group Medical Center concerning patient ANON-PX-9047. The subject is a 35-year-old female with a significant medical history including osteoarthritis, type 2 diabetes, anxiety. 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 administered via the Topical route at a dosage of 151mg, initiated on 2025-04-09 for Pain and inflammation and discontinued on 2025-06-03; Metformin administered via the Oral route at a dosage of 389mg, initiated on 2025-04-09 for Type 2 diabetes and discontinued on 2025-06-03.

On approximately 2025-05-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Angioedema, Pruritus, Dizziness, Maculopapular Rash. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed effort and advised me. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Severe 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 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Them than red glass require. Back must minute discuss authority evening authority. Clearly everybody close mission about trouble.</data>
report_id: ADR-2025-616
report_date: '2025-06-29'
patient_details:
  patient_id: ANON-PX-9047
  gender: Female
  relevant_history:
  - osteoarthritis
  - type 2 diabetes
  - anxiety
  age_at_reaction: 35
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 151mg
  route_of_administration: Topical
  start_date: '2025-04-09'
  indication_for_use: Pain and inflammation
  end_date: '2025-06-03'
- drug_name: Metformin
  dosage: 389mg
  route_of_administration: Oral
  start_date: '2025-04-09'
  indication_for_use: Type 2 diabetes
  end_date: '2025-06-03'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2025-05-25'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed effort and advised me.
- symptom_name: Angioedema
  onset_date: '2025-05-25'
  severity: Mild
  outcome: Unknown
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2025-05-25'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-05-25'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-05-25'
  severity: Severe
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 4
reporting_facility: Moreno Group Medical Center
reporter_type: Pharmacist
notes: Them than red glass require. Back must minute discuss authority evening authority.
  Clearly everybody close mission about trouble.
