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SUBJECT: Urgent adverse event Product A and Product B as background therapy
Dear Pharmacovigilance Team,
I am the Consultant Rheumatologist at a multi-site primary care 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 experie... | {"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 dru... |
SUBJECT: Product A reaction report with suspect Product B also implicated
Dear Regional Pharmacovigilance Lead,
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 a serious adverse event where the treat... | {"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 adverse event and dual suspect Product A and Ibuprofen report
Dear Clinical Safety and Regulatory Affairs,
I am the Consultant Neurologist at a geriatric medicine consortium and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a serious adverse eve... | {"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: Formal adverse event notification Product A with Amlodipine excluded as causative agent
Dear Medical Affairs and Drug Safety,
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 60 year old male... | {"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: Product A suspected adverse reaction with concomitant Product B therapy
Hi,
I am writing as the caregiver for my mother David Gordon to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The patient experienced a 64 year old male patient on Produ... | {"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 reaction with suspect Product A with suspect Levothyroxine
Dear Regional Pharmacovigilance Lead,
I am the Consultant Hepatologist at a community health partnership covering 12 clinics and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a s... | {"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 Product B excluded as cause
Dear Sir or Madam,
I am the Consultant Dermatologist 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 an adverse event. The patient experienced a... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "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 report with historical Product B use
Dear Regional Pharmacovigilance Lead,
I am the Medical Director at a paediatric outpatient service 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... | {"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: Safety report Product A and both Product A and Levothyroxine identified as suspect
Dear Post-Marketing Surveillance Unit,
I am the Consultant Rheumatologist at a geriatric medicine consortium and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a serious adv... | {"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 A with suspect Ibuprofen
Dear Post-Marketing Surveillance Unit,
I am the Consultant Neurologist at a geriatric medicine consortium and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a serious adver... | {"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 suspected reaction with concomitant Product B therapy – formal report
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 37 year old ... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "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 reaction report with Lisinopril 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 60 year old mal... | {"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 report Product A plus Product B discontinued prior to event
To Whom It May Concern,
I am the Head of Pharmacy Services at a geriatric medicine consortium 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... | {"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 adverse event and ongoing Levothyroxine use alongside Product A report
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 an adverse event. The patient experienced a 60... | {"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: Pharmacovigilance report Product A with Omeprazole stable during Product A reaction
Dear Regional Pharmacovigilance Lead,
I am the Chief of Medicine at a residential care home network managing over 400 elderly residents across 5 facilities and I am formally notifying you of an adverse event report requiring ph... | {"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: Urgent adverse event Product A and suspect Product B also implicated
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 a serious adverse event where the treating physician suspects both m... | {"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: Formal adverse event notification Product A with Atorvastatin also suspected by physician
Dear Drug Safety Department,
I am the Attending Physician 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 seriou... | {"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: Adverse reaction report involving Product A and Ibuprofen not implicated in adverse event
Dear Pharmacovigilance and Risk Management Team,
I am the Ward Nurse Manager at a childrens hospital outpatient department and I am documenting this adverse event report on behalf of a patient under our ward care.
I wish... | {"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: Urgent adverse event Product A and Product B no longer taken
Dear Sir or Madam,
I am the Consultant Rheumatologist 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 an adverse event. The patient experienced a 38 ye... | {"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 o... |
SUBJECT: Serious adverse event report Product A and suspect Product B also implicated
Dear Regional Pharmacovigilance Lead,
I am the Consultant Cardiologist 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... | {"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: Safety report Product A and physician suspects both Product A and Atorvastatin
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 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 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 report Product A plus Omeprazole continued without change
Dear Drug Safety Department,
I am the Pharmacy Operations Manager at a pharmaceutical benefit manager 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... | {"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 Product B as background therapy
Dear Post-Marketing Surveillance Unit,
I am writing as the caregiver for my husband Robert Bradley to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The patient experi... | {"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 dru... |
SUBJECT: Formal adverse event notification Product A with Product B historical medication only
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 an adverse event. The patient experienced a 59 year old male patient on Product A... | {"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: Adverse event notification for Product A with Levothyroxine concomitant medication only
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 48 year... | {"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 reaction report with Product B historical medication only
Dear Sir or Madam,
I am the Pharmacy Operations Manager at a community health partnership covering 12 clinics and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.
I wish to report an adv... | {"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: Pharmacovigilance report Product A with both Product A and Levothyroxine identified as suspect
Dear Pharmacovigilance Team,
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 a... | {"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 reaction with suspected Methotrexate co-reaction
Dear Global Safety Unit,
I am writing as the caregiver for my elderly aunt Brian Jackson to report an adverse reaction they experienced with a recently started medication.
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 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: Adverse event notification for Product A with Product A and Levothyroxine both implicated
Dear Adverse Events Reporting Centre,
I am the Pharmacy Operations Manager at a surgical day case unit group and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.
I ... | {"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: Suspected adverse event with Product A and Product B implicated only as concomitant
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... | {"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 dru... |
SUBJECT: Adverse event report Product A plus Metformin excluded as causative agent
Dear Patient Safety Team,
I am the Consultant Rheumatologist 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 adverse event. The pati... | {"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: Formal adverse event notification Product A with suspect Product B also implicated
Dear Patient Safety Team,
I am writing as the caregiver for my elderly aunt Patrick Arnold 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 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 Omeprazole continued without change
Hi,
I am the Director of Clinical Services at a paediatric outpatient service 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 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 Product A and Amlodipine jointly suspected formal notification
Dear Corporate Drug Safety Department,
I am the Clinical Pharmacy Director at a childrens hospital outpatient department and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy servi... | {"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: Product A adverse event and Metformin stable during Product A reaction report
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 an adverse event. The patient experienced a 67 year old female patient initiated on Produ... | {"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: Pharmacovigilance report Product A with suspect Product B also implicated
Dear Medical Affairs and Drug Safety,
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 medicat... | {"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: Adverse event notification for Product A with Product B unchanged during reaction
Dear Corporate Drug Safety Department,
I am writing as the caregiver for my mother Sharon Delgado to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The patient ... | {"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: Pharmacovigilance report Product A with suspect Product B also implicated
Dear Regional Pharmacovigilance Lead,
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 ... | {"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: Adverse event notification for Product A with Lisinopril stable during Product A reaction
Dear Regional Pharmacovigilance Lead,
I am the Attending Physician at a surgical day case unit group 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 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 report with Product B historical medication only
Dear Adverse Events Reporting Centre,
I am the Consultant Cardiologist 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 an adverse event. The patient e... | {"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 adverse event and Amlodipine stable during Product A reaction report
Dear Regional Pharmacovigilance Lead,
I am the Consultant Neurologist 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 eve... | {"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: Formal adverse event notification Product A with suspect Product B also implicated
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 where the tre... | {"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 reaction and Ibuprofen concomitant medication only formal notification
Dear Regional Pharmacovigilance Lead,
I am writing as the caregiver for my sister Nancy Webb to report an adverse reaction they experienced with a recently started medication.
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 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: Suspected adverse event with Product A and Levothyroxine continued without change
Dear Pharmacovigilance Team,
I am the Consultant Cardiologist at a multi-site primary care 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 pa... | {"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 Product B completed treatment historically
Dear Regional Pharmacovigilance Lead,
I am the Clinical Pharmacy Director at a hepatology referral centre and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.
I wish... | {"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 adverse event and suspected combined effect Product A and Ibuprofen report
Dear Pharmacovigilance Team,
I am the Ward Nurse Manager at a paediatric outpatient service and I am documenting this adverse event report on behalf of a patient under our ward care.
I wish to report a serious adverse event w... | {"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: Pharmacovigilance report Product A with suspect Product B also implicated
Dear Medical Affairs and Drug Safety,
I am the Senior Nurse Practitioner at a regional hospital trust and I am documenting this adverse event report on behalf of a patient under our ward care.
I wish to report a serious adverse event wh... | {"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: Urgent adverse event Product A and suspect Product B also implicated
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 a serious adverse event where the treating physician suspects both medications as ... | {"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: Adverse reaction report involving Product A and concomitant Amlodipine therapy
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 50 year old female patient on Product A for 15 we... | {"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: Adverse reaction report involving Product A and Product B no current exposure
Dear Pharmacovigilance Team,
I am the Ward Nurse Manager 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 ex... | {"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 Ibuprofen concomitant medication only
Dear Corporate Drug Safety Department,
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 45 year old female patient initiated ... | {"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 report Product A plus Product B no longer taken
Dear Sir or Madam,
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 an adverse event. The patient exp... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 unchanged during reaction
Dear Global Safety Unit,
I am writing as the caregiver for my elderly aunt Charles Hoffman to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The patient experienced... | {"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: Pharmacovigilance report Product A with Product B historical medication only
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 an adverse event. The patient experienced a 59 year old male patient on Product A for 16 w... | {"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 concomitant Product B exposure
Dear Patient Safety Team,
I am writing as the caregiver for my husband Dennis Parker to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The patient experienced a 5... | {"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 electr... |
SUBJECT: Product A reaction and dual suspect Product A and Metformin formal notification
Dear Medical Affairs and Drug Safety,
I am the Chief of Medicine 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 eve... | {"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 notification for Product A with Product B as background therapy
Hi,
I am the Medical Director 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. The patient experienced a ... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "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 reaction report involving Product A and Product B implicated only as concomitant
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 an adverse event. The patient e... | {"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... |
SUBJECT: Pharmacovigilance report Product A with dual suspect Product A and Atorvastatin
Dear Pharmacovigilance and Risk Management Team,
I am writing as the caregiver for my elderly aunt Amanda Bailey to report an adverse reaction they experienced with a recently started medication.
I wish to report a serious adverse... | {"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 suspect Product B also implicated
Dear Drug Safety Department,
I am the Medical Director at a managed care organisation and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report a serious adverse event where the 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: Adverse event notification for Product A with Product B ongoing without change
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 50 year old female patien... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "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 suspected adverse reaction with Methotrexate concomitant medication only
Dear Clinical Safety and Regulatory Affairs,
I am the Senior Nurse Practitioner at a metropolitan ambulance service medical liaison office and I am documenting this adverse event report on behalf of a patient under our ward care... | {"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 reaction with suspect Product A with suspect Methotrexate
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 a serious adverse event where the treating physician suspects bot... | {"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: Adverse event report Product A plus suspect Product B also implicated
Dear Pharmacovigilance and Risk Management Team,
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 a seri... | {"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: Serious adverse event report Product A and ongoing Product B treatment
To Whom It May Concern,
I am the Consultant Rheumatologist 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 an adverse event. The patient experienced a... | {"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: Safety report Product A and Product B concomitant medication
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 76 year old female patient on Product A fo... | {"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 dual suspect Product A and Amoxicillin
Dear Medical Affairs and Drug Safety,
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 ... | {"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: Product A adverse event and Product B not suspected report
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 48 year old female patient on Product ... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "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 Atorvastatin continued without change
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 73 year old... | {"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 historical Product B use report
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 37 year old female patient initi... | {"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... |
SUBJECT: Pharmacovigilance report Product A 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 fac... | {"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: Product A reaction and Amlodipine maintained as background medication formal notification
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 41... | {"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: Adverse reaction report involving Product A and Metformin taken concurrently not suspected
Dear Pharmacovigilance 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 53 year old female pat... | {"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 adverse reaction with suspect Product B also implicated
Hi,
I am the Consultant Dermatologist 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 a serious adverse event where the treating physician susp... | {"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: Formal adverse event notification Product A with suspect Product B also implicated
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 a serious adverse event where the treating physician suspects both medication... | {"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: Suspected adverse event with Product A and Product B prior use not relevant
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 year old male ... | {"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 report Product A plus suspected Omeprazole co-reaction
To Whom It May Concern,
I am the Clinical Nurse Specialist at a clinical research site network and I am documenting this adverse event report on behalf of a patient under our ward care.
I wish to report a serious adverse event where the trea... | {"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 reaction report with Product B stopped months ago
Dear Sir or Madam,
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 48 year old female patient on Product A fo... | {"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: Urgent adverse event Product A and suspect Product B also implicated
Dear Corporate Drug Safety Department,
I am the Clinical Pharmacist at a pain management 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 adv... | {"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 reaction report involving Product A and Omeprazole also suspected by physician
Dear Pharmacovigilance and Risk Management Team,
I am the Chief of Medicine at a university hospital department and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report... | {"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: Pharmacovigilance report Product A with Product B ongoing without change
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 64 year old male pa... | {"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 suspected reaction with suspect Product B also implicated – formal report
Dear Pharmacovigilance and Risk Management Team,
I am the Medical Director 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 ... | {"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: Urgent adverse event Product A and Product B ongoing without change
Good morning,
I am the Consultant Endocrinologist 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 45 year old fe... | {"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... |
SUBJECT: Adverse reaction report involving Product A and suspect Product B also implicated
Dear Regional Pharmacovigilance Lead,
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 ph... | {"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: Product A suspected reaction with suspected Ibuprofen co-reaction – formal report
Dear Global Safety Unit,
I am the Director of Clinical Services at an immunology and allergy clinic and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report a serious advers... | {"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: Pharmacovigilance report Product A with suspect Product B also implicated
Dear Corporate Drug Safety Department,
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 medica... | {"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 suspected adverse reaction with Ibuprofen unchanged during event onset
Dear Adverse Events Reporting Centre,
I am the Pharmacy Operations Manager 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 ... | {"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 Amoxicillin also suspected by physician
Dear Drug Safety Department,
I am the Clinical Pharmacist 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 to report a serious adver... | {"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: Adverse event notification for Product A with Amlodipine maintained as background medication
Dear Post-Marketing Surveillance Unit,
I am the Senior Consultant 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... | {"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 reaction and suspect Product B also implicated formal notification
Dear Global Safety Unit,
I am the Attending Physician at a clinical research site network and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report a serious adverse event where t... | {"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 suspected adverse reaction with suspect Product B also implicated
Dear Patient Safety Team,
I am the Medical Director at a metropolitan ambulance service medical liaison office and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report a serious a... | {"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: Urgent adverse event Product A and suspect Product B also implicated
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 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: Safety report Product A and Product A and Lisinopril both 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 suspe... | {"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: Safety report Product A and Product A and Amlodipine both implicated
Dear Medical Affairs and Drug Safety,
I am the Ward Nurse Manager at a specialist neurology centre and I am documenting this adverse event report on behalf of a patient under our ward care.
I wish to report a serious adverse event where the ... | {"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 suspect Product B also implicated
Dear Drug Safety Department,
I am writing as the caregiver for my husband Kathleen Dixon 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 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: Safety report Product A and Product B discontinued prior to event
Dear Corporate 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 64 year old male... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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 reaction with Product B stopped before symptoms began
Hi,
I am the Clinical Pharmacist at an integrated care system 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 50 yea... | {"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: Adverse event notification for Product A with Product B not currently administered
Hi,
I am the Ward Nurse Manager at a pathology and diagnostics 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 6... | {"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: Product A adverse reaction with concurrent Product B use
Dear Medical Affairs and Drug Safety,
I am writing as the caregiver for my father Adam Nguyen to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The patient experienced a 62 year old mal... | {"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: Product A reaction and concomitant Product B exposure formal notification
To Whom It May Concern,
I am the Consultant Dermatologist at a wound care 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 experienced ... | {"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... |
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