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SUBJECT: Safety report Product A and Product B taken alongside
Dear Post-Marketing Surveillance Unit,
I am the Attending Physician at a university hospital department and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report an adverse event. The patient experience... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "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 swe... |
SUBJECT: Adverse event notification for Product A with Product A and Amoxicillin jointly suspected
Dear Pharmacovigilance Team,
I am the Clinical Pharmacy Director at a specialist dermatology centre and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.
I wish to r... | {"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 cons... |
SUBJECT: Product A suspected reaction with suspect Product B also implicated – formal report
Dear Corporate Drug Safety Department,
I am the Consultant Dermatologist at a rural district hospital and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a serious adverse e... | {"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 hypo... |
SUBJECT: Serious adverse event report Product A and suspect Product B also implicated
Dear Adverse Events Reporting Centre,
I am the Medical Director at a Veterans Affairs medical centre and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report a serious adverse ev... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "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 ... |
SUBJECT: Adverse reaction report involving Product A and dual drug reaction Product A and Atorvastatin
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 a serious adverse event where the treating physician s... | {"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 swe... |
SUBJECT: Suspected adverse event with Product A and suspect Product B also implicated
Dear Post-Marketing Surveillance Unit,
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 med... | {"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... |
SUBJECT: Product A adverse reaction with Product B prior use not relevant
Dear Drug Safety Department,
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 58 year old male patient on... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 electr... |
SUBJECT: Product A suspected reaction with ongoing Methotrexate use alongside Product A – formal report
Dear Drug Safety Department,
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... | {"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 inflam... |
SUBJECT: Product A reaction and Levothyroxine taken concurrently not suspected formal notification
Dear Corporate Drug Safety Department,
I am the Ward Nurse Manager at a university hospital department and I am documenting this adverse event report on behalf of a patient under our ward care.
I wish to report an advers... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 64 year old male patient on Product A for 13 weeks who developed progressive dysphagia, odynophagia, and severe oesophageal ulceration on endoscopy, qualifying as an Adver... |
SUBJECT: Product A suspected adverse reaction with Product B stopped months ago
To Whom It May Concern,
I am the Director of Clinical Services at a childrens hospital outpatient department and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report an adverse event. ... | {"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 flexibl... |
SUBJECT: Product A reaction and Amlodipine concomitant medication only formal notification
Dear Regional Pharmacovigilance Lead,
I am writing as the caregiver for my husband Kimberly Robertson to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The pati... | {"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 dru... |
SUBJECT: Product A adverse event and Ibuprofen not implicated in adverse event report
Dear Global Safety Unit,
I am the Consultant Endocrinologist 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... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 60 year old male patient on Product A for 9 weeks who developed severe photosensitivity with blistering sunburn-like reaction on sun-exposed skin and skin biopsy showing v... |
SUBJECT: Urgent adverse event Product A and suspect Product B also implicated
Dear Post-Marketing Surveillance Unit,
I am the Pharmacy Operations Manager at a specialist neurology centre and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.
I wish to report a seri... | {"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 electr... |
SUBJECT: Adverse event report Product A plus concurrent Product B use
Dear Clinical Safety and Regulatory Affairs,
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 42 year old male patient on Product ... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "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,... |
SUBJECT: Product A suspected adverse reaction with suspect Product B also implicated
Dear Regional Pharmacovigilance Lead,
I am the Director of Clinical Services at a multi-site primary care network and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report a seriou... | {"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 Adver... |
SUBJECT: Product A suspected reaction with Lisinopril concomitant medication only – formal report
Dear Pharmacovigilance 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 adver... | {"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 flexibl... |
SUBJECT: Adverse event report Product A plus Product B stopped before symptoms began
Dear Adverse Events Reporting Centre,
I am the Consultant Neurologist at a rehabilitation and long-term care facility and I am writing to formally report an adverse event involving a patient under my care.
I wish to report an adverse ... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 dep... |
SUBJECT: Product A reaction and Lisinopril taken concurrently not suspected formal notification
Dear Sir or Madam,
I am writing as the caregiver for my father Linda Rose to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The patient experienced a 42 ye... | {"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,... |
SUBJECT: Product A suspected adverse reaction with Product B no current exposure
Dear Pharmacovigilance and Risk Management Team,
I am the Clinical Pharmacist 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... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 propr... |
SUBJECT: Product A reaction report with suspect Product A with suspect Methotrexate
Dear Corporate Drug Safety Department,
I am writing as the caregiver for my mother Deborah Nichols to report an adverse reaction they experienced with a recently started medication.
I wish to report a serious adverse event where the tr... | {"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.... |
SUBJECT: Urgent adverse event Product A and suspect Product B also implicated
Dear Global Safety Unit,
I am the Consultant Nephrologist 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... | {"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 inflam... |
SUBJECT: Safety report Product A and Metformin also suspected by physician
Dear Corporate Drug Safety Department,
I am the Director of Clinical Services at a pathology and diagnostics consortium and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report a serious ad... | {"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 swe... |
SUBJECT: Formal adverse event notification Product A with Product B no longer taken
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 58 year old male patient on P... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 electr... |
SUBJECT: Adverse event notification for Product A with dual suspect Product A and Atorvastatin
Dear Post-Marketing Surveillance Unit,
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... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 64 year old male patient on Product A for 13 weeks who developed progressive dysphagia, odynophagia, and severe oesophageal ulceration on endoscopy, qualifying as an Adver... |
SUBJECT: Urgent adverse event Product A and Product B historical exposure documented
Dear Pharmacovigilance Team,
I am writing as the caregiver for my elderly aunt Joshua Schmidt to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The patient experience... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 dep... |
SUBJECT: Product A adverse reaction with ongoing Product B treatment
Dear Corporate Drug Safety Department,
I am the Consultant Dermatologist at a large endocrinology centre 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 experience... | {"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 hypo... |
SUBJECT: Product A adverse reaction with Atorvastatin not implicated in adverse event
Dear Regional Pharmacovigilance Lead,
I am the Ward Nurse Manager at a hepatology referral centre 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 patie... | {"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 c... |
SUBJECT: Product A adverse event and suspect Product B also implicated report
Dear Post-Marketing Surveillance Unit,
I am the Medical Director at a tertiary referral hospital and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report a serious adverse event where th... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 62 year old male patient initiated on Product A 8 weeks ago for an autoimmune skin condition who has developed severely elevated liver enzymes confirmed on blood testing, ... |
SUBJECT: Suspected adverse event with Product A and Lisinopril excluded as causative agent
Dear Corporate Drug Safety Department,
I am the Clinical Pharmacy Director at an immunology and allergy clinic and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.
I wish t... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 64 year old male patient on Product A for 13 weeks who developed progressive dysphagia, odynophagia, and severe oesophageal ulceration on endoscopy, qualifying as an Adver... |
SUBJECT: Product A adverse event and Lisinopril concomitant medication only report
Dear Pharmacovigilance Team,
I am the Medical Director at a specialist neurology centre and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report an adverse event. The patient experi... | {"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 o... |
SUBJECT: Adverse reaction report involving Product A and previous Product B therapy
Dear Clinical Safety and Regulatory Affairs,
I am the Chief of Medicine at a mental health trust and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report an adverse event. The pati... | {"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 Adver... |
SUBJECT: Serious adverse event report Product A and Atorvastatin stable during Product A reaction
Dear Adverse Events Reporting Centre,
I am the Director of Clinical Services at a mental health trust and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report an adve... | {"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 inflam... |
SUBJECT: Product A reaction report with Product B stopped before symptoms began
Dear Patient Safety Team,
I am the Chief of Medicine at a corporate occupational health provider and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report an adverse event. The patient ... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 swe... |
SUBJECT: Pharmacovigilance report Product A with suspect Product B also implicated
Dear Sir or Madam,
I am writing as the caregiver for my father Andrew Castro to report an adverse reaction they experienced with a recently started medication.
I wish to report a serious adverse event where the treating physician suspec... | {"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 propr... |
SUBJECT: Adverse event report Product A plus Product B not currently administered
Dear Pharmacovigilance Team,
I am the Attending Physician at a specialist dermatology centre and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report an adverse event. The patient ex... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 inflam... |
SUBJECT: Formal adverse event notification Product A with ongoing Product B treatment
Dear Sir or Madam,
I am writing as the caregiver for my sister Jacob Kelly 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 fe... | {"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 c... |
SUBJECT: Urgent adverse event Product A and past Product B exposure
Dear Patient Safety Team,
I am the Consultant Hepatologist 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 an adverse event. The patient experienced a 59 year ol... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 propr... |
SUBJECT: Formal adverse event notification Product A with Product B completed course before reaction
Dear Medical Affairs and Drug Safety,
I am writing as the caregiver for my father Charles Vargas to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 inflam... |
SUBJECT: Product A reaction and previous Product B therapy formal notification
Hi,
I am the Chief of Medicine 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 fema... | {"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 hypo... |
SUBJECT: Product A suspected adverse reaction with Product B no current exposure
Dear Sir or Madam,
I am the Senior Consultant 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 29 year old ... | {"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 hypo... |
SUBJECT: Product A suspected reaction with Product B completed treatment historically – formal report
To Whom It May Concern,
I am the Consultant Pulmonologist 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 an adverse event. ... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "Analysis": "The email reports an adverse event a 60 year old male patient on Product A for 9 weeks who developed severe photosensitivity with blistering sunburn-like reaction on sun-exposed skin and skin biopsy showing v... |
SUBJECT: Product A reaction report with Product B stopped months ago
Dear Global Safety Unit,
I am the Senior Nurse Practitioner at a respiratory medicine centre 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 62 ye... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "Analysis": "The email reports an adverse event a 62 year old male patient initiated on Product A 8 weeks ago for an autoimmune skin condition who has developed severely elevated liver enzymes confirmed on blood testing, ... |
SUBJECT: Serious adverse event report Product A and Ibuprofen maintained as background medication
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 42 y... | {"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,... |
SUBJECT: Product A adverse event and continued Product B administration report
Dear Regional Pharmacovigilance Lead,
I am the Clinical Nurse Specialist at a geriatric medicine consortium 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 pa... | {"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 c... |
SUBJECT: Urgent adverse event Product A and suspect Product B also implicated
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 a serious adverse event where the treating physician suspects both medications ... | {"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 Adver... |
SUBJECT: Adverse reaction report involving Product A and Lisinopril taken concurrently not suspected
Dear Global Safety Unit,
I am the Consultant Rheumatologist at a specialist neurology centre and I am writing to formally report an adverse event involving a patient under my care.
I wish to report an adverse event. Th... | {"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 cons... |
SUBJECT: Product A suspected reaction with Product B prior use not relevant – formal report
Dear Drug Safety Department,
I am the Senior Nurse Practitioner at a Veterans Affairs medical centre and I am documenting this adverse event report on behalf of a patient under our ward care.
I wish to report an adverse event. ... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "Analysis": "The email reports an adverse event a 62 year old male patient initiated on Product A 8 weeks ago for an autoimmune skin condition who has developed severely elevated liver enzymes confirmed on blood testing, ... |
SUBJECT: Safety report Product A and suspect Product B also implicated
Dear Sir or Madam,
I am the Attending Physician at a dialysis centre network and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report a serious adverse event where the treating physician suspec... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 60 year old male patient on Product A for 9 weeks who developed severe photosensitivity with blistering sunburn-like reaction on sun-exposed skin and skin biopsy showing v... |
SUBJECT: Adverse event notification for Product A with historical Product B use
Dear Post-Marketing Surveillance Unit,
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 62 year old male patient initiat... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "Analysis": "The email reports an adverse event a 62 year old male patient initiated on Product A 8 weeks ago for an autoimmune skin condition who has developed severely elevated liver enzymes confirmed on blood testing, ... |
SUBJECT: Adverse event notification for Product A with dual drug reaction Product A and Levothyroxine
Dear Clinical Safety and Regulatory Affairs,
I am writing as the caregiver for my elderly aunt Gary Herrera to report an adverse reaction they experienced with a recently started medication.
I wish to report a serious... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "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... |
SUBJECT: Adverse event notification for Product A with Amoxicillin not implicated in adverse event
Dear Global Safety Unit,
I am the Chief of Medicine 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. Th... | {"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 dru... |
SUBJECT: Product A reaction report with Product B implicated only as concomitant
Dear Medical Affairs and Drug Safety,
I am the Consultant Rheumatologist at a dialysis centre network 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 e... | {"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 propr... |
SUBJECT: Safety report Product A and Atorvastatin taken concurrently not suspected
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 73 year old male patie... | {"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 Adver... |
SUBJECT: Adverse reaction report involving Product A and Lisinopril excluded as causative agent
Dear Post-Marketing Surveillance Unit,
I am the Head of Pharmacy Services 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.... | {"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... |
SUBJECT: Adverse event report Product A plus suspected combined effect Product A and Ibuprofen
Dear Patient Safety Team,
I am the Pharmacy Operations Manager at a faith-based hospital system and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.
I wish to report a ... | {"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,... |
SUBJECT: Urgent adverse event Product A and Product B as background therapy
Dear Pharmacovigilance and Risk Management Team,
I am the Clinical Pharmacist at a chain of retail pharmacies and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.
I wish to report an adve... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "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 swe... |
SUBJECT: Product A adverse event and Product B completed treatment historically report
Dear Global Safety Unit,
I am the Consultant Endocrinologist at an immunology and allergy clinic 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 ... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 propr... |
SUBJECT: Product A suspected reaction with suspect Product B also implicated – formal report
Hi,
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 a serious adverse event where the treating physicia... | {"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.... |
SUBJECT: Product A adverse reaction with suspect Product B also implicated
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 a serious adverse event where the treating physician suspects both med... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 64 year old male patient on Product A for 13 weeks who developed progressive dysphagia, odynophagia, and severe oesophageal ulceration on endoscopy, qualifying as an Adver... |
SUBJECT: Product A suspected reaction with suspect Product B also implicated – formal report
Dear Corporate Drug Safety Department,
I am the Consultant Cardiologist 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 a serious adverse ... | {"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.... |
SUBJECT: Serious adverse event report Product A and Amlodipine stable during Product A reaction
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 38 year old male patient on Pr... | {"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 o... |
SUBJECT: Product A reaction and suspect Product B also implicated formal notification
To Whom It May Concern,
I am writing as the caregiver for my elderly aunt Shirley White to report an adverse reaction they experienced with a recently started medication.
I wish to report a serious adverse event where the treating ph... | {"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 flexibl... |
SUBJECT: Safety report Product A and Product B stopped before symptoms began
Dear Medical Affairs and Drug Safety,
I am the Clinical Pharmacy Director at a dialysis 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 ev... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 electr... |
SUBJECT: Product A reaction and Product B completed treatment historically formal notification
Dear Regional Pharmacovigilance Lead,
I am the Consultant Pulmonologist at a corporate occupational health provider and I am writing to formally report an adverse event involving a patient under my care.
I wish to report an ... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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... |
SUBJECT: Product A reaction report with Product B not suspected
Good morning,
I am the Senior Consultant 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 59 year old male patient on Product ... | {"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 propr... |
SUBJECT: Product A adverse reaction with Product B historical exposure documented
Dear Regional Pharmacovigilance Lead,
I am writing as the caregiver for my sister Maria Cole to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The patient experienced a ... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "Analysis": "The email reports an adverse event a 60 year old male patient on Product A for 9 weeks who developed severe photosensitivity with blistering sunburn-like reaction on sun-exposed skin and skin biopsy showing v... |
SUBJECT: Urgent adverse event Product A and previous Product B therapy
Dear Post-Marketing Surveillance 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 41 year old female p... | {"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 c... |
SUBJECT: Product A reaction and Product B no longer taken 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 e... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 dru... |
SUBJECT: Product A suspected adverse reaction with Omeprazole taken concurrently not suspected
To Whom It May Concern,
I am the Clinical Nurse Specialist 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... | {"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 propr... |
SUBJECT: Pharmacovigilance report Product A with suspected combined effect Product A and Levothyroxine
To Whom It May Concern,
I am the Senior Consultant at a womens health 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 wher... | {"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 Adver... |
SUBJECT: Product A adverse event and concurrent Product B use report
Dear Pharmacovigilance and Risk Management Team,
I am the Attending Physician at a rural district hospital and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report an adverse event. The patient e... | {"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 dep... |
SUBJECT: Product A suspected adverse reaction with Product B excluded as cause
Dear Patient Safety Team,
I am the Clinical Nurse Specialist at a community health partnership covering 12 clinics and I am documenting this adverse event report on behalf of a patient under our ward care.
I wish to report an adverse event.... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 62 year old male patient initiated on Product A 8 weeks ago for an autoimmune skin condition who has developed severely elevated liver enzymes confirmed on blood testing, ... |
SUBJECT: Suspected adverse event with Product A and Ibuprofen unchanged during event onset
Dear Drug Safety Department,
I am the Consultant Endocrinologist at a private cardiology practice group and I am writing to formally report an adverse event involving a patient under my care.
I wish to report an adverse event. T... | {"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... |
SUBJECT: Formal adverse event notification Product A with dual suspect Product A and Amoxicillin
Dear Sir or Madam,
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 ... | {"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... |
SUBJECT: Adverse event notification for Product A with Amoxicillin continued without change
Good morning,
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 60 year old male patient... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 60 year old male patient on Product A for 9 weeks who developed severe photosensitivity with blistering sunburn-like reaction on sun-exposed skin and skin biopsy showing v... |
SUBJECT: Serious adverse event report Product A and Product B historical exposure documented
Hi,
I am the Consultant Dermatologist at a clinical research site network 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 ... | {"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 cons... |
SUBJECT: Product A suspected adverse reaction with suspected combined effect Product A and Methotrexate
Dear Medical Affairs and Drug Safety,
I am the Attending Physician at a rheumatology clinic group and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report a ser... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "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... |
SUBJECT: Product A suspected adverse reaction with ongoing Amoxicillin use alongside Product A
Dear Patient Safety Team,
I am the Ward Nurse Manager at a chain of retail pharmacies 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 ... | {"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 dep... |
SUBJECT: Serious adverse event report Product A and concomitant Lisinopril therapy
Dear Patient Safety Team,
I am the Attending Physician at a managed care organisation and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report an adverse event. The patient experien... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 62 year old male patient initiated on Product A 8 weeks ago for an autoimmune skin condition who has developed severely elevated liver enzymes confirmed on blood testing, ... |
SUBJECT: Product A suspected adverse reaction with Product B taken alongside
Dear Pharmacovigilance Team,
I am the Medical Director at a private oncology 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 experience... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 64 year old male patient on Product A for 13 weeks who developed progressive dysphagia, odynophagia, and severe oesophageal ulceration on endoscopy, qualifying as an Adver... |
SUBJECT: Product A adverse event and Amlodipine continued without change report
Dear Global Safety Unit,
I am the Chief of Medicine 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 experienc... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "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 ... |
SUBJECT: Suspected adverse event with Product A and Product B completed course before reaction
Dear Patient Safety Team,
I am the Consultant Gastroenterologist 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 an adverse event. T... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 inflam... |
SUBJECT: Product A reaction report with both Product A and Amlodipine identified as suspect
Dear Regional Pharmacovigilance Lead,
I am the Chief of Medicine at a pharmaceutical benefit manager and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report a serious adve... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 53 year old female patient started on Product A 7 weeks ago who developed profound fatigue, pallor, and symptomatic anaemia with haemoglobin of 7, qualifying as an Adverse... |
SUBJECT: Safety report Product A and Amlodipine not implicated in adverse event
Dear Sir or Madam,
I am the Medical Director at a community health partnership covering 12 clinics and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report an adverse event. The patien... | {"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 Adver... |
SUBJECT: Product A suspected reaction with Product B stopped months ago – formal report
Dear Adverse Events Reporting Centre,
I am the Consultant Cardiologist 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 an adverse event. T... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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,... |
SUBJECT: Adverse event notification for Product A with Product B as background therapy
Dear Patient Safety 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 68 year old male ... | {"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 ... |
SUBJECT: Serious adverse event report Product A and Amlodipine continued without change
Dear Regional Pharmacovigilance Lead,
I am the Consultant Rheumatologist at a regional hospital 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 pa... | {"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 dep... |
SUBJECT: Product A adverse event and concomitant Omeprazole therapy report
Dear Sir or Madam,
I am the Senior Nurse Practitioner at a geriatric medicine consortium 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 64 ... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 64 year old male patient on Product A for 13 weeks who developed progressive dysphagia, odynophagia, and severe oesophageal ulceration on endoscopy, qualifying as an Adver... |
SUBJECT: Adverse event notification for Product A with Product B stopped before symptoms began
Dear Regional Pharmacovigilance Lead,
I am writing as the caregiver for my sister Catherine Ferguson to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The p... | {"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 cons... |
SUBJECT: Suspected adverse event with Product A and suspect Product B also implicated
Dear Post-Marketing Surveillance Unit,
I am writing as the caregiver for my sister Ruth Baker to report an adverse reaction they experienced with a recently started medication.
I wish to report a serious adverse event where the treat... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 53 year old female patient started on Product A 7 weeks ago who developed profound fatigue, pallor, and symptomatic anaemia with haemoglobin of 7, qualifying as an Adverse... |
SUBJECT: Product A suspected adverse reaction with Product B historical medication only
Dear Global Safety Unit,
I am the Senior Consultant at a pathology and diagnostics consortium 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 ex... | {"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 Adver... |
SUBJECT: Pharmacovigilance report Product A with both Product A and Lisinopril identified as suspect
Dear Clinical Safety and Regulatory Affairs,
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 wher... | {"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 c... |
SUBJECT: Safety report Product A and Product B prior use not relevant
Dear Global Safety Unit,
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 ... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 dru... |
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Ramesh10/adverse-event-classification-dataset
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Usage
from datasets import load_dataset
dataset = load_dataset('Ramesh10/adverse-event-classification-dataset')
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