Instruction:
SUBJECT: Product A suspected reaction with concomitant Metformin therapy – formal report
Dear Global Safety Unit,
I am the Medical Director at a rheumatology clinic group 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 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, Metformin 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 Metformin is not implicated and should be continued.

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

Thank you,
Dr. Nathan Perez, Medical Director

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. 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: Safety report Product A and past Product B exposure
Dear Patient Safety 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 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.

With regard to medication history, The patient completed a standard 6 month course of Product B 4 months ago for a chronic condition and has been off the drug since with no withdrawal effects or delayed adverse events. The specialist has documented Product B as historical and stated it is not relevant to the current presentation.

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

Respectfully,
Ms. Nathan Coleman

Output: {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 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 concomitant Amoxicillin therapy
Dear Post-Marketing Surveillance Unit,
I am the Medical Director at a clinical research site network 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 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, Amoxicillin 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 Amoxicillin is not implicated and should be continued.

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

Yours sincerely,
Dr. Douglas Gonzalez, Medical Director

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 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: Product A suspected adverse reaction with dual suspect Product A and Levothyroxine
To Whom It May Concern,
I am writing as the caregiver for my sister Kenneth Hicks 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 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 also experienced a 42 year old female patient on Levothyroxine for 3 months who developed osteoporosis with new vertebral compression fracture on imaging and bone mineral density T-score of -3.2. The endocrinologist identified exogenous thyrotoxicosis from Levothyroxine overdose as the causative factor and the dose was adjusted with bisphosphonate 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.

With best wishes,
Mr. John Bryant, Caregiver

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 a suspect drug. The email additionally reports another adverse event a 42 year old female patient on Levothyroxine for 3 months who developed osteoporosis with new vertebral compression fracture on imaging and bone mineral density T-score of -3, 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 Product A and Ibuprofen jointly suspected
Dear Medical Affairs and Drug Safety,
I am the Consultant Hepatologist at a paediatric outpatient service 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 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.

Best regards,
Dr. Rebecca Phillips, Consultant Hepatologist

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 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: Product A adverse reaction with both Product A and Ibuprofen identified as suspect
Dear Adverse Events Reporting Centre,
I am writing as the caregiver for my husband Anna Ross 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 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, 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.

With appreciation,
Mr. Deborah Brooks, Caregiver

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 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: Safety report Product A and Product B maintained during event
Dear Corporate Drug Safety Department,
I am the Consultant Dermatologist at a mental health trust 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 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 taken Product B for hyperlipidaemia for over 4 years without any previous muscle symptoms or elevation in creatine kinase levels. The treating physician has documented that Product B is concomitant medication only and is not considered responsible for the current adverse presentation.

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

Regards,
Dr. Tyler Gray, Consultant Dermatologist

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: Adverse reaction report involving Product A and concomitant Omeprazole therapy
To Whom It May Concern,
I am the Pharmacy Operations Manager at a large academic medical 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 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 been maintained on Omeprazole for 3 years with good control and no history of similar adverse events. The treating physician has assessed the current symptoms and confirmed that Omeprazole 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,
Mr. Ashley Jordan, Pharmacy Operations Manager

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 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: Safety report Product A and Product A and Methotrexate both implicated
Good morning,
I am the Consultant Neurologist at a home healthcare nursing agency 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 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.

Many thanks,
Dr. Steven Fox, Consultant Neurologist

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 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: Product A reaction and previous Product B therapy formal notification
Dear Regional Pharmacovigilance Lead,
I am the Consultant Nephrologist at a surgical day case unit 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.

With regard to medication history, The patient completed a 3 month tapering course of Product B 16 months ago for a withdrawal protocol with no rebound symptoms or delayed adverse events observed since then. The clinician has documented Product B as historical and confirmed no association with the current adverse event.

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

Appreciatively,
Dr. Daniel Bryant, Consultant Nephrologist

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: Product A adverse reaction with suspect Product B also implicated
Dear Regional Pharmacovigilance Lead,
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 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 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,
Dr. Jacob Martin, Consultant Nephrologist

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 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: Adverse reaction report involving Product A and Product A and Metformin jointly suspected
Dear Pharmacovigilance and Risk Management Team,
I am writing as the caregiver for my mother Adam Coleman 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 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 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.

Appreciatively,
Mrs. Victoria Duncan, Caregiver

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 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."}