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SUBJECT: Adverse event report Product A plus suspect Product B also implicated
Good morning,
I am the Clinical Nurse Specialist 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 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 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 Metformin excluded as causative agent
Dear Drug Safety Department,
I am the Director of Clinical Services 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. Th... | {"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: Pharmacovigilance report Product A with concomitant Product B exposure
Hi,
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 on Product A 10 weeks ago who ... | {"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: Product A suspected reaction with dual suspect Product A and Ibuprofen – formal report
Dear Corporate Drug Safety Department,
I am writing as the caregiver for my sister Aaron Hamilton to report an adverse reaction they experienced with a recently started medication.
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 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 report with previous Product B therapy
Dear Patient Safety Team,
I am writing as the caregiver for my elderly aunt Scott Dixon to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The patient experienced a 50 year old female p... | {"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 report Product A plus ongoing Product B treatment
Dear Clinical Safety and Regulatory Affairs,
I am the Consultant Pulmonologist 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 e... | {"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: Suspected adverse event with Product A and historical Product B use
Dear Global Safety Unit,
I am the Pharmacy Operations Manager 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 an adverse event. Th... | {"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: Formal adverse event notification Product A with suspect Product B also implicated
Dear Clinical Safety and Regulatory Affairs,
I am the Consultant Endocrinologist at a respiratory medicine centre and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a seriou... | {"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 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 73 year old male patient started on... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding, qualifying as an Adver... |
SUBJECT: Product A reaction and Product B historical exposure documented formal notification
Hi,
I am the Consultant Nephrologist at a pharmaceutical benefit manager and I am writing to formally report an adverse event involving a patient under my care.
I wish to report an adverse event. The patient experienced a 76 y... | {"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 event and suspected Atorvastatin co-reaction report
Dear Medical Affairs and Drug Safety,
I am the Ward Nurse Manager at a rural district hospital 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 tre... | {"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 excluded as cause
Dear Drug Safety Department,
I am the Chief of Medicine at a chain of retail pharmacies 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": "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 suspected reaction with dual suspect Product A and Omeprazole – formal report
Hi,
I am the Consultant Hepatologist at a chain of retail pharmacies 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 physi... | {"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: Suspected adverse event with Product A and suspected Methotrexate co-reaction
Dear Sir or Madam,
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 serious adverse eve... | {"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 reaction report with Product B taken alongside
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 experienced a 55 year old female ... | {"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 Product B unchanged during reaction
Dear Clinical Safety and Regulatory Affairs,
I am the Consultant Neurologist 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 pa... | {"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: Adverse reaction report involving Product A and suspect Product B also implicated
Hi,
I am the Consultant Cardiologist 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 a serious adverse event where the treating physici... | {"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 Levothyroxine
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 contributo... | {"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: Formal adverse event notification Product A with suspect Product B also implicated
Dear Medical Affairs and Drug Safety,
I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated.
I wish to report a serious adverse event where the treating p... | {"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 stable throughout event
Dear Medical Affairs and Drug Safety,
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 an adverse event. Th... | {"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: Safety report Product A and Product B discontinued prior to event
Dear Post-Marketing Surveillance Unit,
I am the Consultant Haematologist at a mental health trust and I am writing to formally report an adverse event involving a patient under my care.
I wish to report an adverse event. The patient experienced... | {"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: Adverse reaction report involving Product A and Product B taken alongside
Dear Clinical Safety and Regulatory Affairs,
I am the Consultant Nephrologist 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 an adverse event. T... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "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: Formal adverse event notification Product A with Product B taken alongside
Good morning,
I am the Clinical Pharmacist at a large endocrinology 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 expe... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "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 both Product A and Metformin identified as suspect
Dear Clinical Safety and Regulatory Affairs,
I am the Consultant Endocrinologist at a mental health trust and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a seri... | {"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 concomitant Product B therapy
Hi,
I am the Head of Pharmacy Services at a clinical research site network and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.
I wish to report an adverse event. The patient experi... | {"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 adverse reaction with Levothyroxine excluded as causative agent
To Whom It May Concern,
I am the Ward Nurse Manager at a large endocrinology 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 ... | {"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 concomitant Product B therapy – formal report
To Whom It May Concern,
I am writing as the caregiver for my wife Raymond Boyd to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The patient experienced a 29 year... | {"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: Adverse event report Product A plus Product B unchanged during reaction
Good morning,
I am the Consultant Hepatologist 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 event. The patient experien... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "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 Amoxicillin excluded as causative agent
Dear Adverse Events Reporting Centre,
I am the Consultant Haematologist at a metropolitan ambulance service medical liaison office and I am writing to formally report an adverse event involving a patient under my care.
I wis... | {"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 event notification for Product A with Product B stopped months ago
Dear Patient Safety Team,
I am the Clinical Pharmacist at a womens health clinic group and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.
I wish to report an adverse event. The ... | {"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: Formal adverse event notification Product A with Omeprazole excluded as causative agent
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 45 ye... | {"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 suspect Product B also implicated
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 a serious adverse event where the treating ... | {"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 reaction report with Product B excluded as cause
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 73 year old male patient started o... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding, qualifying as an Adver... |
SUBJECT: Product A suspected adverse reaction with suspect Product B also implicated
Dear Adverse Events Reporting Centre,
I am the Consultant Hepatologist at a mental health trust and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a serious adverse event where the... | {"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 notification for Product A with suspect Product A with suspect Omeprazole
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 co... | {"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 adverse reaction with Product B historical medication only
To Whom It May Concern,
I am writing to report an adverse reaction I have experienced with a medication I was recently prescribed.
I wish to report an adverse event. The patient experienced a 73 year old male patient started on Pro... | {"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: Product A reaction report with dual suspect Product A and Amlodipine
Dear Adverse Events Reporting Centre,
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 a serious adverse event where ... | {"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 suspected reaction with suspect Product B also implicated – formal report
Hi,
I am the Consultant Rheumatologist at a surgical day case unit group and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a serious adverse event where the treating physi... | {"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 Product B not suspected
Hi,
I am writing as the caregiver for my elderly aunt John White to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The patient experienced a 76 year old female patient o... | {"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 reaction and Product B as background therapy formal notification
Dear Pharmacovigilance Team,
I am the Clinical Pharmacy Director at a group of private outpatient 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 ... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding, qualifying as an Adver... |
SUBJECT: Safety report Product A and Amlodipine taken concurrently not suspected
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 68 year old male patient started on... | {"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 Corporate Drug Safety Department,
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 a serious adverse eve... | {"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 suspect Product B also implicated
Good morning,
I am the Ward Nurse Manager at a specialist dermatology 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 treating physi... | {"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: Urgent adverse event Product A and physician suspects both Product A and Ibuprofen
Dear Sir or Madam,
I am writing as the caregiver for my husband Michelle Griffin to report an adverse reaction they experienced with a recently started medication.
I wish to report a serious adverse event where the treating phy... | {"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: Formal adverse event notification Product A with suspected Methotrexate co-reaction
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 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: Product A reaction report with past Product B exposure
Dear Global Safety Unit,
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 event. The patient experienced a 58 year... | {"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 Product B implicated only as concomitant
Dear Pharmacovigilance and Risk Management 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... | {"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 adverse reaction with concomitant Methotrexate therapy
Dear Adverse Events Reporting Centre,
I am writing as the caregiver for my sister Eric Riley to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The patient experienced a 38 year ... | {"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: Serious adverse event report Product A and Product A and Amlodipine jointly suspected
Dear Global Safety Unit,
I am the Consultant Rheumatologist at a university hospital department and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a serious adverse event... | {"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 reaction report involving Product A and concomitant Product B exposure
Dear Patient Safety Team,
I am the Consultant Gastroenterologist at a tertiary referral hospital and I am writing to formally report an adverse event involving a patient under my care.
I wish to report 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 Product B discontinued prior to event
Dear Drug Safety Department,
I am the Consultant Cardiologist 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 exp... | {"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: Serious adverse event report Product A and Product B unchanged during reaction
Hi,
I am the Clinical Pharmacist 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 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: Product A suspected adverse reaction with concomitant Product B exposure
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... | {"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: Adverse reaction report involving Product A and suspect Product B also implicated
Dear Corporate Drug Safety Department,
I am the Consultant Hepatologist 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 a serious adverse even... | {"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 reaction with Product B ongoing without change – formal report
To Whom It May Concern,
I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated.
I wish to report an adverse event. The patient experienced a 38 year old ma... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 38 year old male patient on Product A for 12 weeks who developed acute kidney injury with serum creatinine rising from baseline 89 umol/L to 312 umol/L and reduced urine o... |
SUBJECT: Product A adverse reaction with Atorvastatin continued without change
Dear Clinical Safety and Regulatory Affairs,
I am writing as the caregiver for my father Eric Rivera to report an adverse reaction they experienced with a recently started medication.
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 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 suspect Product B also implicated
Dear Drug Safety Department,
I am the Consultant Cardiologist at a Veterans Affairs medical centre and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a serious adverse event where the treatin... | {"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 physician suspects both Product A and Amlodipine
Dear Adverse Events Reporting Centre,
I am the Consultant Haematologist at a paediatric outpatient service and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a s... | {"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 reaction report involving Product A and Product B not currently administered
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 58 year old male patient on Product A ... | {"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 adverse reaction with Product B stopped months ago
Dear Patient Safety Team,
I am the Medical Director 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 patient experienced a 50 year old fema... | {"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 suspect Product B also implicated
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 a serious adverse event where the treating physician suspects both medications as contributo... | {"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 A and Amlodipine jointly suspected
Dear Adverse Events Reporting Centre,
I am the Medical Director at a regional hospital trust and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
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: Safety report Product A and dual suspect Product A and Amoxicillin
Good morning,
I am writing as the caregiver for my mother Larry Andrews to report an adverse reaction they experienced with a recently started medication.
I wish to report a serious adverse event where the treating physician suspects both medi... | {"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 Product A and Omeprazole jointly suspected
Hi,
I am the Clinical Pharmacy Director at a pathology and diagnostics consortium and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.
I wish to report a serious adverse... | {"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: Formal adverse event notification Product A with Product A and Metformin jointly suspected
Dear Sir or Madam,
I am the Consultant Haematologist 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 whe... | {"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: Suspected adverse event with Product A and Product B not suspected
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 experienced a 53 year o... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "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: Pharmacovigilance report Product A with Product B implicated only as concomitant
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 an adverse event. The patient experienced a 68... | {"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: Product A adverse event and suspect Product B also implicated report
Dear Pharmacovigilance and Risk Management Team,
I am writing as the caregiver for my father Richard Sanchez to report an adverse reaction they experienced with a recently started medication.
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 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 Product B excluded as cause report
Dear Clinical Safety and Regulatory Affairs,
I am writing as the caregiver for my sister Carolyn Black 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": "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 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 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: Safety report Product A and Product B stopped months ago
Dear Patient Safety Team,
I am writing to report an adverse reaction I have experienced with a medication I was recently prescribed.
I wish to report an adverse event. The patient experienced a 58 year old male patient on Product A for 18 weeks who deve... | {"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 adverse reaction with Product B not currently administered
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 an adverse event. The patient experienced a 41 year old fe... | {"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 report with concomitant Product B therapy
Good morning,
I am writing as the caregiver for my wife Rebecca Snyder to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The patient experienced a 29 year old female patient started... | {"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: Adverse event notification for Product A with suspect Product B also implicated
Dear Pharmacovigilance Team,
I am the Senior Nurse Practitioner at a large endocrinology 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 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: Product A suspected reaction with suspect Product B also implicated – formal report
Dear Adverse Events Reporting Centre,
I am the Senior Consultant at a rheumatology clinic group and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a serious adverse event w... | {"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 past Product B exposure
Dear Patient Safety Team,
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 55 year... | {"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 adverse reaction with suspect Product A with suspect Lisinopril
Dear Regional Pharmacovigilance Lead,
I am the Pharmacy Operations Manager at a wound care centre network and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.
I wish to report a se... | {"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 reaction report with dual suspect Product A and Levothyroxine
Dear Sir or Madam,
I am the Ward Nurse Manager at a rheumatology clinic group 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 treating physician... | {"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: Serious adverse event report Product A and suspect Product B also implicated
Dear Pharmacovigilance Team,
I am writing as the caregiver for my mother Samantha Hunt to report an adverse reaction they experienced with a recently started medication.
I wish to report a serious adverse event where the treating phy... | {"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: Pharmacovigilance report Product A with Product B excluded as cause
Dear Patient Safety Team,
I am the Pharmacy Operations Manager at a multi-site primary care network and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.
I wish to report an adverse event... | {"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: Serious adverse event report Product A and physician suspects both Product A and Ibuprofen
Dear Corporate Drug Safety Department,
I am the Head of Pharmacy Services at a respiratory medicine centre and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.
I w... | {"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 concurrent Product B use
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 41 year old female patient on Product A for ... | {"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: Serious adverse event report Product A and Product B prior use not relevant
Dear Drug Safety Department,
I am the Attending Physician 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. Th... | {"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: Adverse event notification for Product A with Product B unchanged during reaction
Hi,
I am writing as the caregiver for my elderly aunt Jacob Olson to report an adverse reaction they experienced with a recently started medication.
I wish to report an adverse event. The patient experienced a 38 year old male p... | {"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 38 year old male patient on Product A for 12 weeks who developed acute kidney injury with serum creatinine rising from baseline 89 umol/L to 312 umol/L and reduced urine o... |
SUBJECT: Product A adverse reaction with suspect Product B also implicated
Dear Adverse Events Reporting Centre,
I am the Consultant Endocrinologist 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 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: Adverse event notification for Product A with both Product A and Methotrexate identified as suspect
Dear Patient Safety Team,
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... | {"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: Serious adverse event report Product A and suspect Product B also implicated
Dear Clinical Safety and Regulatory Affairs,
I am the Senior Consultant 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 a serious adverse... | {"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 adverse reaction with suspect Product B also implicated
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 a serious adverse event where the treating physician suspects both medic... | {"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 reaction with concomitant Metformin therapy – formal report
Dear Global Safety Unit,
I am the Medical Director at a rheumatology clinic group and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report an adverse event. The patient experi... | {"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 past Product B exposure
Dear Patient Safety Team,
I am writing to report an adverse reaction I have experienced with a medication I was recently prescribed.
I wish to report an adverse event. The patient experienced a 38 year old male patient on Product A for 12 weeks who developed... | {"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: Suspected adverse event with Product A and concomitant Amoxicillin therapy
Dear Post-Marketing Surveillance Unit,
I am the Medical Director at a clinical research site network and I am formally notifying you of an adverse event report requiring pharmacovigilance review.
I wish to report an adverse event. The ... | {"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 suspected adverse reaction with dual suspect Product A and Levothyroxine
To Whom It May Concern,
I am writing as the caregiver for my sister Kenneth Hicks to report an adverse reaction they experienced with a recently started medication.
I wish to report a serious adverse event where the treating 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: Pharmacovigilance report Product A with Product A and Ibuprofen jointly suspected
Dear Medical Affairs and Drug Safety,
I am the Consultant Hepatologist at a paediatric outpatient service and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a serious adverse... | {"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 adverse reaction with both Product A and Ibuprofen identified as suspect
Dear Adverse Events Reporting Centre,
I am writing as the caregiver for my husband Anna Ross to report an adverse reaction they experienced with a recently started medication.
I wish to report a serious adverse event where the ... | {"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 maintained during event
Dear Corporate Drug Safety Department,
I am the Consultant Dermatologist at a mental health trust and I am writing to formally report an adverse event involving a patient under my care.
I wish to report an adverse event. The patient experienced a 4... | {"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: Adverse reaction report involving Product A and concomitant Omeprazole therapy
To Whom It May Concern,
I am the Pharmacy Operations Manager at a large academic medical centre and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services.
I wish to report an advers... | {"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 A and Methotrexate both implicated
Good morning,
I am the Consultant Neurologist at a home healthcare nursing agency and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a serious adverse event where the treating physician... | {"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 and previous Product B therapy formal notification
Dear Regional Pharmacovigilance Lead,
I am the Consultant Nephrologist at a surgical day case unit group and I am writing to formally report an adverse event involving a patient under my care.
I wish to report an adverse event. The patient ... | {"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 adverse reaction with suspect Product B also implicated
Dear Regional Pharmacovigilance Lead,
I am the Consultant Nephrologist at a childrens hospital outpatient department and I am writing to formally report an adverse event involving a patient under my care.
I wish to report a serious adverse even... | {"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 Product A and Metformin jointly suspected
Dear Pharmacovigilance and Risk Management Team,
I am writing as the caregiver for my mother Adam Coleman to report an adverse reaction they experienced with a recently started medication.
I wish to report a serious adve... | {"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... |
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