Instruction:
SUBJECT: Formal adverse event notification Product A with continued Product B administration
Dear Drug Safety Department,
I am writing as the caregiver for my elderly aunt Stephanie Lane to report an adverse reaction they experienced with a recently started medication.

I wish to report an adverse event. The patient experienced a 58 year old male patient on Product A for 18 weeks who developed new-onset atrial fibrillation with rapid ventricular response, palpitations, and dyspnoea requiring electrical cardioversion and anticoagulation. The cardiologist identified Product A as a probable contributing factor and the drug was stopped with appropriate cardiac therapy instituted.

Additionally, The patient has been on Product B for chronic kidney disease for 30 months with stable renal parameters and no prior episodes of acute deterioration. The nephrologist has assessed the current event and explicitly stated that Product B is not a contributing factor and should be maintained at the current dose.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Thank you,
Mr. Larry Patterson, Caregiver

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 58 year old male patient on Product A for 18 weeks who developed new-onset atrial fibrillation with rapid ventricular response, palpitations, and dyspnoea requiring electrical cardioversion and anticoagulation, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a concomitant drug."}


Instruction:
SUBJECT: Product A adverse event and Product B past use excluded report
To Whom It May Concern,
I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated.

I wish to report an adverse event. The patient experienced a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding. The haematologist excluded other causes and attributed the event to Product A. The drug was stopped and platelet transfusion administered with haematology follow-up arranged.

With regard to medication history, Product B was administered for 20 weeks as part of a rehabilitation protocol and was completed 5 months ago with sustained functional improvement and no complications on follow-up. The specialist has confirmed Product B as historical medication with no temporal or causal relationship to the current symptoms.

Please formally record this report and confirm if any additional historical medication details are required for your assessment.

Appreciatively,
Mr. Katherine Lewis, Patient Representative

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "Analysis": "The email reports an adverse event a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as historical medication that was discontinued well before the onset of the current adverse event and is explicitly documented as not relevant to the current reaction by the treating physician, qualifying as a historical drug."}


Instruction:
SUBJECT: Product A adverse event and ongoing Product B treatment report
Dear Pharmacovigilance and Risk Management Team,
I am writing as the caregiver for my sister Mary Green to report an adverse reaction they experienced with a recently started medication.

I wish to report an adverse event. The patient experienced a 41 year old female patient on Product A for 11 weeks who experienced recurrent pancreatitis with severe epigastric pain, serum lipase 12 times upper limit of normal, and computed tomography showing pancreatic inflammation. The gastroenterologist determined Product A as the likely causative agent and the drug was stopped with supportive care initiated.

Additionally, The patient has received Product B for osteoporosis for 16 months with stable bone mineral density and no prior history of fracture. The endocrinologist has assessed the current event and documented that Product B is concomitant only and is not considered causative.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Respectfully,
Mr. Heather Harrison, Caregiver

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 41 year old female patient on Product A for 11 weeks who experienced recurrent pancreatitis with severe epigastric pain, serum lipase 12 times upper limit of normal, and computed tomography showing pancreatic inflammation, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a concomitant drug."}


Instruction:
SUBJECT: Serious adverse event report Product A and Product B ongoing without change
Hi,
I am the Clinical Pharmacy Director at a respiratory medicine centre and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.

I wish to report an adverse event. The patient experienced a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission. The allergist confirmed Product A as the trigger and the drug was permanently contraindicated.

Additionally, Product B was initiated 18 months ago for heart failure and has been well tolerated throughout with stable cardiac function documented on serial echocardiograms. The cardiologist has reviewed the case and explicitly stated that Product B is not implicated in the current presentation and should be continued without interruption.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Cordially,
Dr. Stephen Mason, Clinical Pharmacy Director

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a concomitant drug."}


Instruction:
SUBJECT: Suspected adverse event with Product A and Product B implicated only as concomitant
Dear Pharmacovigilance Team,
I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated.

I wish to report an adverse event. The patient experienced a 45 year old female patient initiated on Product A 10 weeks ago who developed severe depression with suicidal ideation, insomnia, and anhedonia requiring urgent psychiatric admission. The psychiatrist determined the temporal onset strongly implicated Product A and the drug was discontinued with antidepressant therapy and close psychiatric monitoring commenced.

Additionally, The patient has been on Product B for benign prostatic hyperplasia for 3 years with stable urinary symptoms and no prior history of orthostatic hypotension. The urologist has assessed the current presentation and confirmed that Product B is not suspected and will remain unchanged.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Thank you,
Ms. David Patterson, Patient Advocate

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 45 year old female patient initiated on Product A 10 weeks ago who developed severe depression with suicidal ideation, insomnia, and anhedonia requiring urgent psychiatric admission, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a concomitant drug."}


Instruction:
SUBJECT: Serious adverse event report Product A and Omeprazole excluded as causative agent
Dear Post-Marketing Surveillance Unit,
I am the Director of Clinical Services at a Veterans Affairs medical centre and I am formally notifying you of an adverse event report requiring pharmacovigilance review.

I wish to report an adverse event. The patient experienced a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission. The allergist confirmed Product A as the trigger and the drug was permanently contraindicated.

Additionally, Omeprazole was initiated 22 months ago for atrial fibrillation rate control and has maintained stable heart rhythm without any previous episodes of bradycardia or syncope. The cardiologist has reviewed the electrophysiology and confirmed that Omeprazole is not implicated and should be continued.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Cordially,
Dr. Sarah Bradley, Director of Clinical Services

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission, qualifying as an Adverse Event with Product A as the suspect drug. Omeprazole is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a non-company concomitant drug."}


Instruction:
SUBJECT: Adverse reaction report involving Product A and suspected combined effect Product A and Amoxicillin
Dear Adverse Events Reporting Centre,
I am the Pharmacy Operations Manager at a pathology and diagnostics consortium and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 76 year old female patient on Product A for 6 weeks who experienced syncopal episodes, documented bradycardia with heart rate 38 bpm, and dizziness requiring emergency department evaluation. The cardiologist identified complete heart block temporally related to Product A initiation. The drug was stopped and a temporary pacing wire inserted.

Additionally, the patient also experienced a 39 year old male patient on Amoxicillin for 10 days who developed acute interstitial nephritis with elevated creatinine, sterile pyuria, and eosinophiluria confirmed on urine microscopy. The nephrologist attributed the event to Amoxicillin hypersensitivity and the drug was stopped with corticosteroid therapy initiated.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Amoxicillin as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Thank you,
Mr. Sandra Duncan, Pharmacy Operations Manager

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 76 year old female patient on Product A for 6 weeks who experienced syncopal episodes, documented bradycardia with heart rate 38 bpm, and dizziness requiring emergency department evaluation, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 39 year old male patient on Amoxicillin for 10 days who developed acute interstitial nephritis with elevated creatinine, sterile pyuria, and eosinophiluria confirmed on urine microscopy, qualifying as an Adverse Event with Amoxicillin as a non-company suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A as the company suspect drug and Amoxicillin as the non-company suspect drug."}


Instruction:
SUBJECT: Adverse event report Product A plus Product B stopped months ago
Dear Corporate Drug Safety Department,
I am writing as the caregiver for my mother Nicole Nichols to report an adverse reaction they experienced with a recently started medication.

I wish to report an adverse event. The patient experienced a 37 year old female patient initiated on Product A 8 weeks ago who developed severe headache, visual field defects, and magnetic resonance imaging confirmed cerebral venous sinus thrombosis. The neurologist and haematologist jointly concluded Product A was the likely precipitant and the drug was discontinued with anticoagulation therapy commenced.

With regard to medication history, The patient was on Product B for 9 months and stopped it 5 months ago after achieving treatment goals with stable parameters maintained since discontinuation. The specialist has documented Product B as historical and stated there is no plausible mechanism linking it to the current adverse event.

Please formally record this report and confirm if any additional historical medication details are required for your assessment.

Regards,
Mr. Joyce Delgado, Caregiver

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "Analysis": "The email reports an adverse event a 37 year old female patient initiated on Product A 8 weeks ago who developed severe headache, visual field defects, and magnetic resonance imaging confirmed cerebral venous sinus thrombosis, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as historical medication that was discontinued well before the onset of the current adverse event and is explicitly documented as not relevant to the current reaction by the treating physician, qualifying as a historical drug."}


Instruction:
SUBJECT: Adverse reaction report involving Product A and Product B not suspected
To Whom It May Concern,
I am the Consultant Rheumatologist at a rheumatology clinic group and I am writing to formally report an adverse event involving a patient under my care.

I wish to report an adverse event. The patient experienced a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission. The allergist confirmed Product A as the trigger and the drug was permanently contraindicated.

Additionally, Product B was initiated 18 months ago for heart failure and has been well tolerated throughout with stable cardiac function documented on serial echocardiograms. The cardiologist has reviewed the case and explicitly stated that Product B is not implicated in the current presentation and should be continued without interruption.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Yours faithfully,
Dr. Donna Soto, Consultant Rheumatologist

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a concomitant drug."}


Instruction:
SUBJECT: Product A adverse event and suspect Product A with suspect Metformin report
Hi,
I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 58 year old male patient on Product A for 18 weeks who developed new-onset atrial fibrillation with rapid ventricular response, palpitations, and dyspnoea requiring electrical cardioversion and anticoagulation. The cardiologist identified Product A as a probable contributing factor and the drug was stopped with appropriate cardiac therapy instituted.

Additionally, the patient also experienced a 61 year old male patient on Metformin for 24 months who developed vitamin B12 deficiency with megaloblastic anaemia, peripheral neuropathy, and serum B12 level 98 pg/mL. The haematologist identified Metformin as the causative agent and the drug was stopped with intramuscular B12 replacement therapy initiated.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Metformin as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Warm regards,
Mr. Stephanie Nelson, Patient Representative

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 58 year old male patient on Product A for 18 weeks who developed new-onset atrial fibrillation with rapid ventricular response, palpitations, and dyspnoea requiring electrical cardioversion and anticoagulation, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 61 year old male patient on Metformin for 24 months who developed vitamin B12 deficiency with megaloblastic anaemia, peripheral neuropathy, and serum B12 level 98 pg/mL, qualifying as an Adverse Event with Metformin as a non-company suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A as the company suspect drug and Metformin as the non-company suspect drug."}


Instruction:
SUBJECT: Adverse reaction report involving Product A and ongoing Product B treatment
Good morning,
I am writing to report an adverse reaction I have experienced with a medication I was recently prescribed.

I wish to report an adverse event. The patient experienced a 41 year old female patient on Product A for 11 weeks who experienced recurrent pancreatitis with severe epigastric pain, serum lipase 12 times upper limit of normal, and computed tomography showing pancreatic inflammation. The gastroenterologist determined Product A as the likely causative agent and the drug was stopped with supportive care initiated.

Additionally, Product B has been prescribed for asthma maintenance for 4 years with stable lung function and no prior episodes of respiratory deterioration. The pulmonologist has reviewed the temporal relationship and confirmed that Product B is not suspected as a contributing factor to the current adverse event.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Many thanks,
Mr. Douglas Sullivan

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 41 year old female patient on Product A for 11 weeks who experienced recurrent pancreatitis with severe epigastric pain, serum lipase 12 times upper limit of normal, and computed tomography showing pancreatic inflammation, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a concomitant drug."}


Instruction:
SUBJECT: Pharmacovigilance report Product A with historical Product B use
Hi,
I am the Senior Consultant at a pharmaceutical benefit manager and I am writing to formally report an adverse event involving a patient under my care.

I wish to report an adverse event. The patient experienced a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission. The allergist confirmed Product A as the trigger and the drug was permanently contraindicated.

With regard to medication history, Product B was prescribed for 10 weeks for a seasonal condition and was last used 15 months ago with full resolution of the original indication. The clinician has reviewed the history and confirmed Product B as historical medication with no bearing on the current adverse event.

Please formally record this report and confirm if any additional historical medication details are required for your assessment.

In professional solidarity,
Dr. Ashley Parker, Senior Consultant

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "Analysis": "The email reports an adverse event a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as historical medication that was discontinued well before the onset of the current adverse event and is explicitly documented as not relevant to the current reaction by the treating physician, qualifying as a historical drug."}


Instruction:
SUBJECT: Urgent adverse event Product A and both Product A and Methotrexate identified as suspect
Dear Corporate Drug Safety Department,
I am writing as the caregiver for my husband David Gomez to report an adverse reaction they experienced with a recently started medication.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 67 year old female patient initiated on Product A 9 weeks ago who developed a severe generalized maculopapular rash covering more than 50% of body surface area, facial swelling, and eosinophilia. The dermatologist diagnosed a severe cutaneous adverse reaction likely due to Product A and the drug was permanently discontinued with systemic steroids initiated.

Additionally, the patient also experienced a 51 year old female patient on Methotrexate for 11 weeks who developed pancytopenia with white blood cell count 1.2 x10^9/L, haemoglobin 6.8 g/dL, and platelet count 18 x10^9/L with mucosal ulceration. The haematologist attributed the event to Methotrexate toxicity and the drug was stopped with folinic acid rescue and blood product support initiated.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Methotrexate as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Appreciatively,
Mr. Nicholas Soto, Caregiver

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 67 year old female patient initiated on Product A 9 weeks ago who developed a severe generalized maculopapular rash covering more than 50% of body surface area, facial swelling, and eosinophilia, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 51 year old female patient on Methotrexate for 11 weeks who developed pancytopenia with white blood cell count 1, qualifying as an Adverse Event with Methotrexate as a non-company suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A as the company suspect drug and Methotrexate as the non-company suspect drug."}


Instruction:
SUBJECT: Suspected adverse event with Product A and dual drug reaction Product A and Atorvastatin
Dear Patient Safety Team,
I am the Consultant Rheumatologist at a university hospital department and I am writing to formally report an adverse event involving a patient under my care.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 41 year old female patient on Product A for 11 weeks who experienced recurrent pancreatitis with severe epigastric pain, serum lipase 12 times upper limit of normal, and computed tomography showing pancreatic inflammation. The gastroenterologist determined Product A as the likely causative agent and the drug was stopped with supportive care initiated.

Additionally, the patient also experienced a 49 year old female patient on Atorvastatin for 8 weeks who developed cognitive impairment with memory loss, confusion, and disorientation confirmed on neuropsychological testing. The neurologist identified statin-associated cognitive decline related to Atorvastatin and the drug was stopped with cognitive rehabilitation and follow-up arranged.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Atorvastatin as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

In professional solidarity,
Dr. Shirley Medina, Consultant Rheumatologist

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 41 year old female patient on Product A for 11 weeks who experienced recurrent pancreatitis with severe epigastric pain, serum lipase 12 times upper limit of normal, and computed tomography showing pancreatic inflammation, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 49 year old female patient on Atorvastatin for 8 weeks who developed cognitive impairment with memory loss, confusion, and disorientation confirmed on neuropsychological testing, qualifying as an Adverse Event with Atorvastatin as a non-company suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A as the company suspect drug and Atorvastatin as the non-company suspect drug."}


Instruction:
SUBJECT: Serious adverse event report Product A and concomitant Product B exposure
Dear Sir or Madam,
I am writing as the caregiver for my wife Katherine Stevens to report an adverse reaction they experienced with a recently started medication.

I wish to report an adverse event. The patient experienced a 38 year old male patient on Product A for 12 weeks who developed acute kidney injury with serum creatinine rising from baseline 89 umol/L to 312 umol/L and reduced urine output. The nephrologist performed renal biopsy revealing acute interstitial nephritis consistent with hypersensitivity to Product A. The drug was stopped and corticosteroid therapy commenced.

Additionally, Product B has been used for epilepsy control for 5 years without breakthrough seizures or previous neuropsychiatric adverse events. The neurologist has reviewed the temporal association and explicitly excluded Product B as a suspect drug, confirming it should be continued without change.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Kind regards,
Mrs. Brenda Webb, Caregiver

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 38 year old male patient on Product A for 12 weeks who developed acute kidney injury with serum creatinine rising from baseline 89 umol/L to 312 umol/L and reduced urine output, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a concomitant drug."}


Instruction:
SUBJECT: Pharmacovigilance report Product A with Product B no current exposure
Dear Global Safety Unit,
I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated.

I wish to report an adverse event. The patient experienced a 34 year old female patient on Product A for 10 weeks who experienced severe abdominal pain, bloody diarrhoea more than 8 episodes per day, and colitis confirmed on flexible sigmoidoscopy. The gastroenterologist assessed the histopathology and concluded the pattern was consistent with drug-induced colitis attributed to Product A. The patient was admitted for intravenous corticosteroids and bowel rest.

With regard to medication history, Product B was used intermittently over a 5 month period and was last taken 10 months ago with no adverse events at any point during exposure. The clinician has confirmed that Product B is historical medication and is not considered in the differential diagnosis of the current event.

Please formally record this report and confirm if any additional historical medication details are required for your assessment.

Cordially,
Mr. Larry Owens, Patient Representative

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "Analysis": "The email reports an adverse event a 34 year old female patient on Product A for 10 weeks who experienced severe abdominal pain, bloody diarrhoea more than 8 episodes per day, and colitis confirmed on flexible sigmoidoscopy, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as historical medication that was discontinued well before the onset of the current adverse event and is explicitly documented as not relevant to the current reaction by the treating physician, qualifying as a historical drug."}


Instruction:
SUBJECT: Urgent adverse event Product A and dual drug reaction Product A and Amoxicillin
Dear Corporate Drug Safety Department,
I am the Head of Pharmacy Services at a womens health clinic group and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 37 year old female patient initiated on Product A 8 weeks ago who developed severe headache, visual field defects, and magnetic resonance imaging confirmed cerebral venous sinus thrombosis. The neurologist and haematologist jointly concluded Product A was the likely precipitant and the drug was discontinued with anticoagulation therapy commenced.

Additionally, the patient also experienced a 39 year old male patient on Amoxicillin for 10 days who developed acute interstitial nephritis with elevated creatinine, sterile pyuria, and eosinophiluria confirmed on urine microscopy. The nephrologist attributed the event to Amoxicillin hypersensitivity and the drug was stopped with corticosteroid therapy initiated.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Amoxicillin as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Appreciatively,
Ms. Daniel Stevens, Head of Pharmacy Services

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 37 year old female patient initiated on Product A 8 weeks ago who developed severe headache, visual field defects, and magnetic resonance imaging confirmed cerebral venous sinus thrombosis, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 39 year old male patient on Amoxicillin for 10 days who developed acute interstitial nephritis with elevated creatinine, sterile pyuria, and eosinophiluria confirmed on urine microscopy, qualifying as an Adverse Event with Amoxicillin as a non-company suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A as the company suspect drug and Amoxicillin as the non-company suspect drug."}


Instruction:
SUBJECT: Safety report Product A and Product B maintained during event
Dear Pharmacovigilance Team,
I am the Consultant Rheumatologist at a managed care organisation and I am writing to formally report an adverse event involving a patient under my care.

I wish to report an adverse event. The patient experienced a 59 year old male patient on Product A for 16 weeks who developed progressive peripheral neuropathy affecting both hands and feet with numbness, tingling, and loss of proprioception impacting daily function. The neurologist performed nerve conduction studies showing axonal degeneration and concluded Product A is the probable cause. Product A was stopped and the patient referred for rehabilitation.

Additionally, Product B was started 26 months ago for Parkinson disease and has provided stable motor control without any previous episodes of dyskinesia or hallucination. The neurologist has reviewed the temporal association and confirmed that Product B is not suspected and should be continued without dose adjustment.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Cordially,
Dr. Joseph Patel, Consultant Rheumatologist

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 59 year old male patient on Product A for 16 weeks who developed progressive peripheral neuropathy affecting both hands and feet with numbness, tingling, and loss of proprioception impacting daily function, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a concomitant drug."}


Instruction:
SUBJECT: Safety report Product A and suspect Product B also implicated
Dear Global Safety Unit,
I am the Consultant Endocrinologist at a specialist dermatology centre and I am writing to formally report an adverse event involving a patient under my care.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 50 year old female patient on Product A for 15 weeks who developed severe arthralgia involving multiple joints with morning stiffness exceeding 2 hours and elevated inflammatory markers. The rheumatologist assessed the presentation as drug-induced inflammatory arthritis attributed to Product A and the drug was discontinued with symptomatic management.

Additionally, the patient also experienced a 50 year old female patient on Product B for 15 weeks who developed severe arthralgia involving multiple joints with morning stiffness exceeding 2 hours and elevated inflammatory markers. The rheumatologist assessed the presentation as drug-induced inflammatory arthritis attributed to Product B and the drug was discontinued with symptomatic management.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Product B as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Best regards,
Dr. Ryan Patel, Consultant Endocrinologist

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 50 year old female patient on Product A for 15 weeks who developed severe arthralgia involving multiple joints with morning stiffness exceeding 2 hours and elevated inflammatory markers, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 50 year old female patient on Product B for 15 weeks who developed severe arthralgia involving multiple joints with morning stiffness exceeding 2 hours and elevated inflammatory markers, qualifying as an Adverse Event with Product B as a suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A and Product B as dual suspect drugs."}


Instruction:
SUBJECT: Suspected adverse event with Product A and dual drug reaction Product A and Levothyroxine
Dear Adverse Events Reporting Centre,
I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission. The allergist confirmed Product A as the trigger and the drug was permanently contraindicated.

Additionally, the patient also experienced a 29 year old female patient on Levothyroxine for 2 months who developed symptoms of thyrotoxicosis including palpitations, weight loss, heat intolerance, and atrial fibrillation with suppressed thyroid-stimulating hormone. The endocrinologist identified dose-related Levothyroxine toxicity and the dose was reduced with beta-blocker therapy initiated.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Levothyroxine as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Yours faithfully,
Ms. Nicole Hudson, Patient Advocate

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 29 year old female patient on Levothyroxine for 2 months who developed symptoms of thyrotoxicosis including palpitations, weight loss, heat intolerance, and atrial fibrillation with suppressed thyroid-stimulating hormone, qualifying as an Adverse Event with Levothyroxine as a non-company suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A as the company suspect drug and Levothyroxine as the non-company suspect drug."}


Instruction:
SUBJECT: Pharmacovigilance report Product A with Ibuprofen excluded as causative agent
Dear Adverse Events Reporting Centre,
I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated.

I wish to report an adverse event. The patient experienced a 34 year old female patient on Product A for 10 weeks who experienced severe abdominal pain, bloody diarrhoea more than 8 episodes per day, and colitis confirmed on flexible sigmoidoscopy. The gastroenterologist assessed the histopathology and concluded the pattern was consistent with drug-induced colitis attributed to Product A. The patient was admitted for intravenous corticosteroids and bowel rest.

Additionally, The patient has been maintained on Ibuprofen for 3 years with good control and no history of similar adverse events. The treating physician has assessed the current symptoms and confirmed that Ibuprofen is not suspected as a causative agent and should be continued as prescribed.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Yours faithfully,
Mr. Kimberly Harris, Patient Representative

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 34 year old female patient on Product A for 10 weeks who experienced severe abdominal pain, bloody diarrhoea more than 8 episodes per day, and colitis confirmed on flexible sigmoidoscopy, qualifying as an Adverse Event with Product A as the suspect drug. Ibuprofen is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a non-company concomitant drug."}


Instruction:
SUBJECT: Product A suspected adverse reaction with historical Product B use
To Whom It May Concern,
I am the Senior Nurse Practitioner at a gastroenterology clinic partnership and I am documenting this adverse event report on behalf of a patient under our ward care.

I wish to report an adverse event. The patient experienced a 41 year old female patient on Product A for 11 weeks who experienced recurrent pancreatitis with severe epigastric pain, serum lipase 12 times upper limit of normal, and computed tomography showing pancreatic inflammation. The gastroenterologist determined Product A as the likely causative agent and the drug was stopped with supportive care initiated.

With regard to medication history, Product B was prescribed for 10 weeks for a seasonal condition and was last used 15 months ago with full resolution of the original indication. The clinician has reviewed the history and confirmed Product B as historical medication with no bearing on the current adverse event.

Please formally record this report and confirm if any additional historical medication details are required for your assessment.

Many thanks,
Ms. Douglas Patterson, Senior Nurse Practitioner

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "Analysis": "The email reports an adverse event a 41 year old female patient on Product A for 11 weeks who experienced recurrent pancreatitis with severe epigastric pain, serum lipase 12 times upper limit of normal, and computed tomography showing pancreatic inflammation, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as historical medication that was discontinued well before the onset of the current adverse event and is explicitly documented as not relevant to the current reaction by the treating physician, qualifying as a historical drug."}


Instruction:
SUBJECT: Suspected adverse event with Product A and Levothyroxine excluded as causative agent
Hi,
I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated.

I wish to report an adverse event. The patient experienced a 50 year old female patient on Product A for 15 weeks who developed severe arthralgia involving multiple joints with morning stiffness exceeding 2 hours and elevated inflammatory markers. The rheumatologist assessed the presentation as drug-induced inflammatory arthritis attributed to Product A and the drug was discontinued with symptomatic management.

Additionally, Levothyroxine has been used for epilepsy control for 5 years without breakthrough seizures or previous neuropsychiatric adverse events. The neurologist has reviewed the temporal association and explicitly excluded Levothyroxine as a suspect drug, confirming it should be continued without change.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Yours faithfully,
Mr. Aaron Stone, Patient Representative

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 50 year old female patient on Product A for 15 weeks who developed severe arthralgia involving multiple joints with morning stiffness exceeding 2 hours and elevated inflammatory markers, qualifying as an Adverse Event with Product A as the suspect drug. Levothyroxine is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a non-company concomitant drug."}


Instruction:
SUBJECT: Product A adverse reaction with suspected Ibuprofen co-reaction
Dear Medical Affairs and Drug Safety,
I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 41 year old female patient on Product A for 11 weeks who experienced recurrent pancreatitis with severe epigastric pain, serum lipase 12 times upper limit of normal, and computed tomography showing pancreatic inflammation. The gastroenterologist determined Product A as the likely causative agent and the drug was stopped with supportive care initiated.

Additionally, the patient also experienced a 68 year old male patient on Ibuprofen 800 mg three times daily for 6 weeks who developed severe gastrointestinal bleeding with haematemesis, melaena, and haemoglobin drop from 13.2 g/dL to 7.1 g/dL. The gastroenterologist identified Ibuprofen as the probable cause and the drug was stopped with blood transfusion and urgent endoscopy arranged.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Ibuprofen as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Yours faithfully,
Ms. Brandon Hayes, Patient Advocate

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 41 year old female patient on Product A for 11 weeks who experienced recurrent pancreatitis with severe epigastric pain, serum lipase 12 times upper limit of normal, and computed tomography showing pancreatic inflammation, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 68 year old male patient on Ibuprofen 800 mg three times daily for 6 weeks who developed severe gastrointestinal bleeding with haematemesis, melaena, and haemoglobin drop from 13, qualifying as an Adverse Event with Ibuprofen as a non-company suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A as the company suspect drug and Ibuprofen as the non-company suspect drug."}


Instruction:
SUBJECT: Product A reaction report with concurrent Product B use
To Whom It May Concern,
I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated.

I wish to report an adverse event. The patient experienced a 76 year old female patient on Product A for 6 weeks who experienced syncopal episodes, documented bradycardia with heart rate 38 bpm, and dizziness requiring emergency department evaluation. The cardiologist identified complete heart block temporally related to Product A initiation. The drug was stopped and a temporary pacing wire inserted.

Additionally, Product B was started 14 months ago for chronic obstructive pulmonary disease and has provided stable respiratory function with no prior episodes of acute exacerbation. The pulmonologist has reviewed the temporal relationship and explicitly excluded Product B from the differential diagnosis of the current event.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Many thanks,
Mr. Nancy Hamilton, Patient Representative

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 76 year old female patient on Product A for 6 weeks who experienced syncopal episodes, documented bradycardia with heart rate 38 bpm, and dizziness requiring emergency department evaluation, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a concomitant drug."}


Instruction:
SUBJECT: Adverse reaction report involving Product A and past Product B exposure
To Whom It May Concern,
I am writing as the caregiver for my father Emma Boyd to report an adverse reaction they experienced with a recently started medication.

I wish to report an adverse event. The patient experienced a 48 year old female patient on Product A for 14 weeks who presented with new-onset shortness of breath, dry cough, and bilateral pulmonary infiltrates on chest imaging consistent with pneumonitis. The pulmonologist excluded infectious causes and concluded Product A is the likely culprit. Product A was stopped and high-dose corticosteroids commenced with planned repeat imaging in 4 weeks.

With regard to medication history, The patient used Product B for 13 months and stopped it 6 months ago upon relocation with stable disease maintained on alternative therapy since then. The treating physician has documented Product B as historical and explicitly excluded it from the current causality assessment.

Please formally record this report and confirm if any additional historical medication details are required for your assessment.

Regards,
Mrs. Karen Bradley, Caregiver

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "Analysis": "The email reports an adverse event a 48 year old female patient on Product A for 14 weeks who presented with new-onset shortness of breath, dry cough, and bilateral pulmonary infiltrates on chest imaging consistent with pneumonitis, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as historical medication that was discontinued well before the onset of the current adverse event and is explicitly documented as not relevant to the current reaction by the treating physician, qualifying as a historical drug."}


Instruction:
SUBJECT: Urgent adverse event Product A and Levothyroxine not implicated in adverse event
Dear Medical Affairs and Drug Safety,
I am the Consultant Pulmonologist at an integrated care system and I am writing to formally report an adverse event involving a patient under my care.

I wish to report an adverse event. The patient experienced a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission. The allergist confirmed Product A as the trigger and the drug was permanently contraindicated.

Additionally, Levothyroxine was initiated 22 months ago for atrial fibrillation rate control and has maintained stable heart rhythm without any previous episodes of bradycardia or syncope. The cardiologist has reviewed the electrophysiology and confirmed that Levothyroxine is not implicated and should be continued.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Warm regards,
Dr. Donna Hernandez, Consultant Pulmonologist

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission, qualifying as an Adverse Event with Product A as the suspect drug. Levothyroxine is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a non-company concomitant drug."}


Instruction:
SUBJECT: Safety report Product A and Lisinopril excluded as causative agent
Dear Drug Safety Department,
I am the Consultant Cardiologist at a group of private outpatient clinics and I am writing to formally report an adverse event involving a patient under my care.

I wish to report an adverse event. The patient experienced a 48 year old female patient on Product A for 14 weeks who presented with new-onset shortness of breath, dry cough, and bilateral pulmonary infiltrates on chest imaging consistent with pneumonitis. The pulmonologist excluded infectious causes and concluded Product A is the likely culprit. Product A was stopped and high-dose corticosteroids commenced with planned repeat imaging in 4 weeks.

Additionally, The patient has been maintained on Lisinopril for 3 years with good control and no history of similar adverse events. The treating physician has assessed the current symptoms and confirmed that Lisinopril is not suspected as a causative agent and should be continued as prescribed.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

With appreciation,
Dr. Jessica Boyd, Consultant Cardiologist

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 48 year old female patient on Product A for 14 weeks who presented with new-onset shortness of breath, dry cough, and bilateral pulmonary infiltrates on chest imaging consistent with pneumonitis, qualifying as an Adverse Event with Product A as the suspect drug. Lisinopril is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a non-company concomitant drug."}


Instruction:
SUBJECT: Formal adverse event notification Product A with Lisinopril stable during Product A reaction
Dear Adverse Events Reporting Centre,
I am writing to report an adverse reaction I have experienced with a medication I was recently prescribed.

I wish to report an adverse event. The patient experienced a 58 year old male patient on Product A for 18 weeks who developed new-onset atrial fibrillation with rapid ventricular response, palpitations, and dyspnoea requiring electrical cardioversion and anticoagulation. The cardiologist identified Product A as a probable contributing factor and the drug was stopped with appropriate cardiac therapy instituted.

Additionally, Lisinopril has been used for epilepsy control for 5 years without breakthrough seizures or previous neuropsychiatric adverse events. The neurologist has reviewed the temporal association and explicitly excluded Lisinopril as a suspect drug, confirming it should be continued without change.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Yours faithfully,
Ms. Ronald Ford

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 58 year old male patient on Product A for 18 weeks who developed new-onset atrial fibrillation with rapid ventricular response, palpitations, and dyspnoea requiring electrical cardioversion and anticoagulation, qualifying as an Adverse Event with Product A as the suspect drug. Lisinopril is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a non-company concomitant drug."}


Instruction:
SUBJECT: Product A suspected reaction with Product B excluded as cause – formal report
Dear Adverse Events Reporting Centre,
I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated.

I wish to report an adverse event. The patient experienced a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding. The haematologist excluded other causes and attributed the event to Product A. The drug was stopped and platelet transfusion administered with haematology follow-up arranged.

Additionally, Product B was initiated 18 months ago for heart failure and has been well tolerated throughout with stable cardiac function documented on serial echocardiograms. The cardiologist has reviewed the case and explicitly stated that Product B is not implicated in the current presentation and should be continued without interruption.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Sincerely,
Mr. Gary Vargas, Patient Representative

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a concomitant drug."}


Instruction:
SUBJECT: Adverse event report Product A plus suspect Product B also implicated
Dear Medical Affairs and Drug Safety,
I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding. The haematologist excluded other causes and attributed the event to Product A. The drug was stopped and platelet transfusion administered with haematology follow-up arranged.

Additionally, the patient also experienced a 55 year old female patient who was started on Product B 11 weeks ago for a chronic inflammatory condition. Over the past 6 weeks the patient has developed severe muscle weakness across both lower limbs, significant hair loss, and persistent nausea that have substantially affected quality of life. The treating specialist reviewed the case and is confident that Product B is responsible based on temporal association and clinical presentation. Product B has been withheld and the patient is under close specialist follow-up.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Product B as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Regards,
Ms. Thomas Hansen, Patient Advocate

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 55 year old female patient who was started on Product B 11 weeks ago for a chronic inflammatory condition, qualifying as an Adverse Event with Product B as a suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A and Product B as dual suspect drugs."}


Instruction:
SUBJECT: Pharmacovigilance report Product A with ongoing Product B treatment
Dear Drug Safety Department,
I am the Consultant Nephrologist at a childrens hospital outpatient department and I am writing to formally report an adverse event involving a patient under my care.

I wish to report an adverse event. The patient experienced a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding. The haematologist excluded other causes and attributed the event to Product A. The drug was stopped and platelet transfusion administered with haematology follow-up arranged.

Additionally, The patient has been maintained on Product B for type 2 diabetes for 3 years with good glycaemic control and no history of hypoglycaemic episodes. The endocrinologist has assessed the current symptoms and confirmed that Product B is not suspected as a causative agent and should be continued as prescribed.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

In professional solidarity,
Dr. Stephen Jordan, Consultant Nephrologist

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a concomitant drug."}


Instruction:
SUBJECT: Product A adverse reaction with suspect Product B also implicated
Good morning,
I am writing to report an adverse reaction I have experienced with a medication I was recently prescribed.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 41 year old female patient on Product A for 11 weeks who experienced recurrent pancreatitis with severe epigastric pain, serum lipase 12 times upper limit of normal, and computed tomography showing pancreatic inflammation. The gastroenterologist determined Product A as the likely causative agent and the drug was stopped with supportive care initiated.

Additionally, the patient also experienced a 42 year old male patient on Product B for 20 weeks who presented with new visual disturbances, blurred vision, and bilateral optic disc swelling on ophthalmic examination. The neuro-ophthalmologist identified the findings as consistent with drug-induced papilloedema related to Product B. The drug was stopped and lumbar puncture performed to exclude intracranial hypertension.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Product B as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Yours sincerely,
Ms. Larry Jenkins

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 41 year old female patient on Product A for 11 weeks who experienced recurrent pancreatitis with severe epigastric pain, serum lipase 12 times upper limit of normal, and computed tomography showing pancreatic inflammation, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 42 year old male patient on Product B for 20 weeks who presented with new visual disturbances, blurred vision, and bilateral optic disc swelling on ophthalmic examination, qualifying as an Adverse Event with Product B as a suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A and Product B as dual suspect drugs."}


Instruction:
SUBJECT: Pharmacovigilance report Product A with both Product A and Lisinopril identified as suspect
Dear Pharmacovigilance and Risk Management Team,
I am writing as the caregiver for my mother Kimberly Hunter to report an adverse reaction they experienced with a recently started medication.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 38 year old male patient on Product A for 12 weeks who developed acute kidney injury with serum creatinine rising from baseline 89 umol/L to 312 umol/L and reduced urine output. The nephrologist performed renal biopsy revealing acute interstitial nephritis consistent with hypersensitivity to Product A. The drug was stopped and corticosteroid therapy commenced.

Additionally, the patient also experienced a 82 year old female patient on Lisinopril for 5 weeks who developed symptomatic hypotension with blood pressure 78/42 mmHg, dizziness, and syncopal episodes leading to a fall and hip fracture. The geriatrician identified Lisinopril as the causative agent and the drug was stopped with orthostatic blood pressure monitoring and fracture management commenced.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Lisinopril as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Regards,
Mrs. Aaron Ferguson, Caregiver

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 38 year old male patient on Product A for 12 weeks who developed acute kidney injury with serum creatinine rising from baseline 89 umol/L to 312 umol/L and reduced urine output, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 82 year old female patient on Lisinopril for 5 weeks who developed symptomatic hypotension with blood pressure 78/42 mmHg, dizziness, and syncopal episodes leading to a fall and hip fracture, qualifying as an Adverse Event with Lisinopril as a non-company suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A as the company suspect drug and Lisinopril as the non-company suspect drug."}


Instruction:
SUBJECT: Product A adverse reaction with Amoxicillin concomitant medication only
Dear Post-Marketing Surveillance Unit,
I am the Clinical Pharmacist at a wound care centre network and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.

I wish to report an adverse event. The patient experienced a 59 year old male patient on Product A for 16 weeks who developed progressive peripheral neuropathy affecting both hands and feet with numbness, tingling, and loss of proprioception impacting daily function. The neurologist performed nerve conduction studies showing axonal degeneration and concluded Product A is the probable cause. Product A was stopped and the patient referred for rehabilitation.

Additionally, Amoxicillin was initiated 18 months ago for a chronic condition and has been well tolerated throughout with stable parameters documented on serial follow-ups. The specialist has reviewed the case and explicitly stated that Amoxicillin is not implicated in the current presentation and should be continued without interruption.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Yours sincerely,
Dr. Kimberly Jordan, Clinical Pharmacist

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 59 year old male patient on Product A for 16 weeks who developed progressive peripheral neuropathy affecting both hands and feet with numbness, tingling, and loss of proprioception impacting daily function, qualifying as an Adverse Event with Product A as the suspect drug. Amoxicillin is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a non-company concomitant drug."}


Instruction:
SUBJECT: Adverse event report Product A plus Product B taken alongside
Dear Pharmacovigilance and Risk Management Team,
I am writing to report an adverse reaction I have experienced with a medication I was recently prescribed.

I wish to report an adverse event. The patient experienced a 55 year old female patient who was started on Product A 11 weeks ago for a chronic inflammatory condition. Over the past 6 weeks the patient has developed severe muscle weakness across both lower limbs, significant hair loss, and persistent nausea that have substantially affected quality of life. The treating specialist reviewed the case and is confident that Product A is responsible based on temporal association and clinical presentation. Product A has been withheld and the patient is under close specialist follow-up.

Additionally, Product B was started 26 months ago for Parkinson disease and has provided stable motor control without any previous episodes of dyskinesia or hallucination. The neurologist has reviewed the temporal association and confirmed that Product B is not suspected and should be continued without dose adjustment.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Regards,
Mr. Eric Parker

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 55 year old female patient who was started on Product A 11 weeks ago for a chronic inflammatory condition, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a concomitant drug."}


Instruction:
SUBJECT: Urgent adverse event Product A and both Product A and Atorvastatin identified as suspect
To Whom It May Concern,
I am the Consultant Neurologist at a gastroenterology clinic partnership and I am writing to formally report an adverse event involving a patient under my care.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 42 year old male patient on Product A for 20 weeks who presented with new visual disturbances, blurred vision, and bilateral optic disc swelling on ophthalmic examination. The neuro-ophthalmologist identified the findings as consistent with drug-induced papilloedema related to Product A. The drug was stopped and lumbar puncture performed to exclude intracranial hypertension.

Additionally, the patient also experienced a 63 year old female patient on Atorvastatin for 12 weeks who developed new-onset type 2 diabetes with fasting glucose 9.8 mmol/L and HbA1c 7.4%. The endocrinologist identified statin-induced dysglycaemia related to Atorvastatin and the drug was stopped with lifestyle modification and metformin therapy commenced.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Atorvastatin as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Yours sincerely,
Dr. David Fox, Consultant Neurologist

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 42 year old male patient on Product A for 20 weeks who presented with new visual disturbances, blurred vision, and bilateral optic disc swelling on ophthalmic examination, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 63 year old female patient on Atorvastatin for 12 weeks who developed new-onset type 2 diabetes with fasting glucose 9, qualifying as an Adverse Event with Atorvastatin as a non-company suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A as the company suspect drug and Atorvastatin as the non-company suspect drug."}


Instruction:
SUBJECT: Serious adverse event report Product A and Metformin concomitant medication only
Hi,
I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated.

I wish to report an adverse event. The patient experienced a 55 year old female patient who was started on Product A 11 weeks ago for a chronic inflammatory condition. Over the past 6 weeks the patient has developed severe muscle weakness across both lower limbs, significant hair loss, and persistent nausea that have substantially affected quality of life. The treating specialist reviewed the case and is confident that Product A is responsible based on temporal association and clinical presentation. Product A has been withheld and the patient is under close specialist follow-up.

Additionally, Metformin has been used for epilepsy control for 5 years without breakthrough seizures or previous neuropsychiatric adverse events. The neurologist has reviewed the temporal association and explicitly excluded Metformin as a suspect drug, confirming it should be continued without change.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Warm regards,
Mr. Ashley Perez, Patient Representative

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 55 year old female patient who was started on Product A 11 weeks ago for a chronic inflammatory condition, qualifying as an Adverse Event with Product A as the suspect drug. Metformin is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a non-company concomitant drug."}


Instruction:
SUBJECT: Product A suspected reaction with Levothyroxine stable during Product A reaction – formal report
Dear Regional Pharmacovigilance Lead,
I am writing to report an adverse reaction I have experienced with a medication I was recently prescribed.

I wish to report an adverse event. The patient experienced a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding. The haematologist excluded other causes and attributed the event to Product A. The drug was stopped and platelet transfusion administered with haematology follow-up arranged.

Additionally, Levothyroxine was started 14 months ago and has provided stable disease management with no prior episodes of acute deterioration. The specialist has reviewed the temporal relationship and explicitly excluded Levothyroxine from the differential diagnosis of the current event.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Warm regards,
Mr. Carolyn Mendez

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding, qualifying as an Adverse Event with Product A as the suspect drug. Levothyroxine is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a non-company concomitant drug."}


Instruction:
SUBJECT: Serious adverse event report Product A and suspect Product B also implicated
Dear Regional Pharmacovigilance Lead,
I am the Senior Consultant at a private oncology clinic group and I am writing to formally report an adverse event involving a patient under my care.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 48 year old female patient on Product A for 14 weeks who presented with new-onset shortness of breath, dry cough, and bilateral pulmonary infiltrates on chest imaging consistent with pneumonitis. The pulmonologist excluded infectious causes and concluded Product A is the likely culprit. Product A was stopped and high-dose corticosteroids commenced with planned repeat imaging in 4 weeks.

Additionally, the patient also experienced a 71 year old male patient started on Product B 5 weeks ago for rheumatoid arthritis who developed acute confusion, fever to 39.2 C, and neutropenia with an absolute neutrophil count of 0.4 x10^9/L. The infectious disease team ruled out sepsis and the haematologist attributed the event to Product B. The drug was discontinued and granulocyte colony-stimulating factor administered.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Product B as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Regards,
Dr. Robert Griffin, Senior Consultant

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 48 year old female patient on Product A for 14 weeks who presented with new-onset shortness of breath, dry cough, and bilateral pulmonary infiltrates on chest imaging consistent with pneumonitis, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 71 year old male patient started on Product B 5 weeks ago for rheumatoid arthritis who developed acute confusion, fever to 39, qualifying as an Adverse Event with Product B as a suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A and Product B as dual suspect drugs."}


Instruction:
SUBJECT: Product A reaction and Amoxicillin taken concurrently not suspected formal notification
Dear Patient Safety Team,
I am the Consultant Hepatologist at a childrens hospital outpatient department and I am writing to formally report an adverse event involving a patient under my care.

I wish to report an adverse event. The patient experienced a 67 year old female patient initiated on Product A 9 weeks ago who developed a severe generalized maculopapular rash covering more than 50% of body surface area, facial swelling, and eosinophilia. The dermatologist diagnosed a severe cutaneous adverse reaction likely due to Product A and the drug was permanently discontinued with systemic steroids initiated.

Additionally, Amoxicillin has been prescribed for rheumatoid arthritis for 2 years with sustained disease remission and no prior history of similar adverse events. The rheumatologist has reviewed the case and confirmed that Amoxicillin is not suspected and will be continued without dose adjustment.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Yours faithfully,
Dr. Helen Simpson, Consultant Hepatologist

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 67 year old female patient initiated on Product A 9 weeks ago who developed a severe generalized maculopapular rash covering more than 50% of body surface area, facial swelling, and eosinophilia, qualifying as an Adverse Event with Product A as the suspect drug. Amoxicillin is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a non-company concomitant drug."}


Instruction:
SUBJECT: Adverse event report Product A plus suspect Product B also implicated
Dear Adverse Events Reporting Centre,
I am the Consultant Cardiologist at a respiratory medicine centre and I am writing to formally report an adverse event involving a patient under my care.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission. The allergist confirmed Product A as the trigger and the drug was permanently contraindicated.

Additionally, the patient also experienced a 45 year old female patient initiated on Product B 10 weeks ago who developed severe depression with suicidal ideation, insomnia, and anhedonia requiring urgent psychiatric admission. The psychiatrist determined the temporal onset strongly implicated Product B and the drug was discontinued with antidepressant therapy and close psychiatric monitoring commenced.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Product B as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Many thanks,
Dr. Matthew Jimenez, Consultant Cardiologist

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 45 year old female patient initiated on Product B 10 weeks ago who developed severe depression with suicidal ideation, insomnia, and anhedonia requiring urgent psychiatric admission, qualifying as an Adverse Event with Product B as a suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A and Product B as dual suspect drugs."}


Instruction:
SUBJECT: Formal adverse event notification Product A with suspect Product B also implicated
Dear Adverse Events Reporting Centre,
I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 58 year old male patient on Product A for 18 weeks who developed new-onset atrial fibrillation with rapid ventricular response, palpitations, and dyspnoea requiring electrical cardioversion and anticoagulation. The cardiologist identified Product A as a probable contributing factor and the drug was stopped with appropriate cardiac therapy instituted.

Additionally, the patient also experienced a 42 year old male patient on Product B for 20 weeks who presented with new visual disturbances, blurred vision, and bilateral optic disc swelling on ophthalmic examination. The neuro-ophthalmologist identified the findings as consistent with drug-induced papilloedema related to Product B. The drug was stopped and lumbar puncture performed to exclude intracranial hypertension.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Product B as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Yours sincerely,
Mr. Nicole Dixon, Patient Representative

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 58 year old male patient on Product A for 18 weeks who developed new-onset atrial fibrillation with rapid ventricular response, palpitations, and dyspnoea requiring electrical cardioversion and anticoagulation, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 42 year old male patient on Product B for 20 weeks who presented with new visual disturbances, blurred vision, and bilateral optic disc swelling on ophthalmic examination, qualifying as an Adverse Event with Product B as a suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A and Product B as dual suspect drugs."}


Instruction:
SUBJECT: Urgent adverse event Product A and suspect Product B also implicated
Dear Global Safety Unit,
I am the Consultant Dermatologist at a pain management clinic group and I am writing to formally report an adverse event involving a patient under my care.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding. The haematologist excluded other causes and attributed the event to Product A. The drug was stopped and platelet transfusion administered with haematology follow-up arranged.

Additionally, the patient also experienced a 67 year old female patient initiated on Product B 9 weeks ago who developed a severe generalized maculopapular rash covering more than 50% of body surface area, facial swelling, and eosinophilia. The dermatologist diagnosed a severe cutaneous adverse reaction likely due to Product B and the drug was permanently discontinued with systemic steroids initiated.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Product B as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Many thanks,
Dr. Rachel Mills, Consultant Dermatologist

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 67 year old female patient initiated on Product B 9 weeks ago who developed a severe generalized maculopapular rash covering more than 50% of body surface area, facial swelling, and eosinophilia, qualifying as an Adverse Event with Product B as a suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A and Product B as dual suspect drugs."}


Instruction:
SUBJECT: Safety report Product A and Product A and Ibuprofen jointly suspected
Dear Adverse Events Reporting Centre,
I am the Consultant Pulmonologist at a pharmaceutical benefit manager and I am writing to formally report an adverse event involving a patient under my care.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission. The allergist confirmed Product A as the trigger and the drug was permanently contraindicated.

Additionally, the patient also experienced a 74 year old female patient on Ibuprofen for 4 weeks who developed acute kidney injury with serum creatinine 298 umol/L and reduced urine output in the setting of concurrent dehydration. The nephrologist identified Ibuprofen as the causative agent and the drug was stopped with fluid resuscitation and renal monitoring arranged.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Ibuprofen as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Kind regards,
Dr. Sandra Green, Consultant Pulmonologist

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypotension requiring emergency adrenaline administration and intensive care admission, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 74 year old female patient on Ibuprofen for 4 weeks who developed acute kidney injury with serum creatinine 298 umol/L and reduced urine output in the setting of concurrent dehydration, qualifying as an Adverse Event with Ibuprofen as a non-company suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A as the company suspect drug and Ibuprofen as the non-company suspect drug."}


Instruction:
SUBJECT: Serious adverse event report Product A and Product B unchanged during reaction
Dear Global Safety Unit,
I am the Director of Clinical Services at a Veterans Affairs medical centre and I am formally notifying you of an adverse event report requiring pharmacovigilance review.

I wish to report an adverse event. The patient experienced a 68 year old male patient started on Product A 5 weeks ago for rheumatoid arthritis who developed acute confusion, fever to 39.2 C, and neutropenia with an absolute neutrophil count of 0.4 x10^9/L. The infectious disease team ruled out sepsis and the haematologist attributed the event to Product A. The drug was discontinued and granulocyte colony-stimulating factor administered.

Additionally, The patient has been maintained on Product B for type 2 diabetes for 3 years with good glycaemic control and no history of hypoglycaemic episodes. The endocrinologist has assessed the current symptoms and confirmed that Product B is not suspected as a causative agent and should be continued as prescribed.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Yours sincerely,
Dr. William Gonzales, Director of Clinical Services

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 68 year old male patient started on Product A 5 weeks ago for rheumatoid arthritis who developed acute confusion, fever to 39, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a concomitant drug."}


Instruction:
SUBJECT: Serious adverse event report Product A and Product B maintained during event
To Whom It May Concern,
I am writing to report an adverse reaction I have experienced with a medication I was recently prescribed.

I wish to report an adverse event. The patient experienced a 59 year old male patient on Product A for 16 weeks who developed progressive peripheral neuropathy affecting both hands and feet with numbness, tingling, and loss of proprioception impacting daily function. The neurologist performed nerve conduction studies showing axonal degeneration and concluded Product A is the probable cause. Product A was stopped and the patient referred for rehabilitation.

Additionally, The patient has been on Product B for chronic kidney disease for 30 months with stable renal parameters and no prior episodes of acute deterioration. The nephrologist has assessed the current event and explicitly stated that Product B is not a contributing factor and should be maintained at the current dose.

Please formally record this report in your pharmacovigilance database and advise on any additional documentation required.

Best regards,
Mr. Michelle Henderson

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 59 year old male patient on Product A for 16 weeks who developed progressive peripheral neuropathy affecting both hands and feet with numbness, tingling, and loss of proprioception impacting daily function, qualifying as an Adverse Event with Product A as the suspect drug. Product B is described as concomitant medication that has been used for an extended period without prior adverse events and is explicitly excluded as a causative factor by the treating physician, qualifying as a concomitant drug."}


Instruction:
SUBJECT: Product A suspected reaction with suspected Amlodipine co-reaction – formal report
To Whom It May Concern,
I am the Consultant Gastroenterologist at a tertiary referral hospital and I am writing to formally report an adverse event involving a patient under my care.

I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The patient experienced a 50 year old female patient on Product A for 15 weeks who developed severe arthralgia involving multiple joints with morning stiffness exceeding 2 hours and elevated inflammatory markers. The rheumatologist assessed the presentation as drug-induced inflammatory arthritis attributed to Product A and the drug was discontinued with symptomatic management.

Additionally, the patient also experienced a 69 year old male patient on Amlodipine for 7 weeks who developed severe gingival hyperplasia with bleeding gums and difficulty eating confirmed on dental examination. The dentist and cardiologist jointly identified Amlodipine as the causative agent and the drug was stopped with dental debridement and alternative antihypertensive therapy commenced.

The treating physician has reviewed both temporal associations and clinical presentations and explicitly suspects both Product A and Amlodipine as causative agents. Both drugs have been stopped and the patient is under close monitoring.

Please investigate this dual suspect drug report urgently.

Warm regards,
Dr. Susan Roberts, Consultant Gastroenterologist

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 50 year old female patient on Product A for 15 weeks who developed severe arthralgia involving multiple joints with morning stiffness exceeding 2 hours and elevated inflammatory markers, qualifying as an Adverse Event with Product A as a suspect drug. The email additionally reports another adverse event a 69 year old male patient on Amlodipine for 7 weeks who developed severe gingival hyperplasia with bleeding gums and difficulty eating confirmed on dental examination, qualifying as an Adverse Event with Amlodipine as a non-company suspect drug. The treating physician explicitly suspects both medications as contributory factors and has stopped both drugs, identifying Product A as the company suspect drug and Amlodipine as the non-company suspect drug."}