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SUBJECT: Product A adverse event and both Product A and Methotrexate identified as suspect report Dear Drug Safety Department, I am the Consultant Rheumatologist at a pharmaceutical benefit manager and I am writing to formally report an adverse event involving a patient under my care. I wish to report a serious 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: Urgent adverse event Product A and dual suspect Product A and Omeprazole 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 medications as contr...
{"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 suspect Product A with suspect Lisinopril Dear Pharmacovigilance Team, I am the Consultant Dermatologist 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 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 report Product A plus both Product A and Methotrexate identified as suspect Dear Corporate Drug Safety Department, I am the Head of Pharmacy Services 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...
{"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 Methotrexate excluded as causative agent Hi, I am writing as the caregiver for my husband Brandon Sanders to report an adverse reaction they experienced with a recently started medication. I wish to report an adverse event. The patient experienced a 59 year old ma...
{"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: Urgent adverse event Product A and suspect Product B also implicated Dear Regional Pharmacovigilance Lead, I am the Consultant Endocrinologist at a pharmaceutical benefit manager and I am writing to formally report an adverse event involving a patient under my care. I wish to report a serious adverse event wh...
{"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: Safety report Product A and Product B no longer taken Dear Drug Safety Department, I am writing as the caregiver for my wife Donna Harris 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 patient o...
{"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 Omeprazole concomitant medication only To Whom It May Concern, I am writing as the caregiver for my wife Dennis King to report an adverse reaction they experienced with a recently started medication. I wish to report an adverse event. The patient experienced a 53 year old female...
{"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: Formal adverse event notification Product A with Product B unchanged during reaction Dear Clinical Safety and Regulatory Affairs, I am the Consultant Pulmonologist at a respiratory medicine centre and I am writing to formally report an adverse event involving a patient under my care. I wish to report an adver...
{"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 event report Product A plus Product B taken alongside Dear Drug Safety Department, I am the Head of Pharmacy Services at a mental health trust 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": "98%"}, "Analysis": "The email reports an adverse event a 59 year old male patient on Product A for 16 weeks who developed progressive peripheral neuropathy affecting both hands and feet with numbness, tingling, and loss of propr...
SUBJECT: Product A reaction and Product B taken alongside formal notification Dear Medical Affairs and Drug Safety, I am writing as the caregiver for my mother Sharon Patel to report an adverse reaction they experienced with a recently started medication. I wish to report an adverse event. The patient experienced a 29...
{"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 Product B implicated only as concomitant 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 67 ye...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 67 year old female patient initiated on Product A 9 weeks ago who developed a severe generalized maculopapular rash covering more than 50% of body surface area, facial swe...
SUBJECT: Product A reaction report with concomitant Product B exposure Dear Global Safety Unit, I am writing as the caregiver for my father Nathan Bailey to report an adverse reaction they experienced with a recently started medication. I wish to report an adverse event. The patient experienced a 60 year old male pati...
{"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: Pharmacovigilance report Product A with Amlodipine also suspected by physician Dear Drug Safety Department, I am writing as the caregiver for my wife Nicole Wilson 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 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 ongoing Amlodipine use alongside Product A Dear Global Safety Unit, I am the Consultant Pulmonologist at an immunology and allergy clinic and I am writing to formally report an adverse event involving a patient under my care. I wish to report an adverse event. The pa...
{"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 suspect Product B also implicated Dear Adverse Events Reporting Centre, I am the Consultant Hepatologist 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...
{"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 suspect Product B also implicated Dear Global Safety Unit, I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated. I wish to report 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 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 report Product A plus dual suspect Product A and Omeprazole Dear Pharmacovigilance 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 a serious adverse ev...
{"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 report Product A plus suspect Product B also implicated Dear Regional Pharmacovigilance Lead, I am the Consultant Haematologist 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 serious adver...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 45 year old female patient initiated on Product A 10 weeks ago who developed severe depression with suicidal ideation, insomnia, and anhedonia requiring urgent psychiatric...
SUBJECT: Product A suspected adverse reaction with Product B no current exposure Dear Adverse Events Reporting Centre, I am the Clinical Pharmacy Director 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 ad...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "Analysis": "The email reports an adverse event a 60 year old male patient on Product A for 9 weeks who developed severe photosensitivity with blistering sunburn-like reaction on sun-exposed skin and skin biopsy showing v...
SUBJECT: Product A reaction and dual drug reaction Product A and Omeprazole formal notification Dear Adverse Events Reporting Centre, I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated. I wish to report a serious adverse event where the treati...
{"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: Formal adverse event notification Product A with Amoxicillin also suspected by physician Dear Drug Safety Department, I am the Clinical Pharmacy Director at a dialysis centre network and I am submitting this adverse event report on behalf of a patient who presented to our pharmacy services. I wish to report a...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 42 year old male patient on Product A for 20 weeks who presented with new visual disturbances, blurred vision, and bilateral optic disc swelling on ophthalmic examination,...
SUBJECT: Serious adverse event report Product A and suspected combined effect Product A and Amlodipine 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...
{"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 Atorvastatin maintained as background medication To Whom It May Concern, I am writing as the caregiver for my wife Mark Fisher to report an adverse reaction they experienced with a recently started medication. I wish to report an adverse event. The patient expe...
{"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 Metformin maintained as background medication Dear Pharmacovigilance and Risk Management Team, I am writing as the caregiver for my wife Katherine Hill to report an adverse reaction they experienced with a recently started medication. I wish to report an adverse...
{"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: Serious adverse event report Product A and Omeprazole taken concurrently not suspected Hi, I am the Consultant Rheumatologist at a hepatology referral centre and I am writing to formally report an adverse event involving a patient under my care. I wish to report an adverse event. The patient experienced a 55 ...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 55 year old female patient who was started on Product A 11 weeks ago for a chronic inflammatory condition, qualifying as an Adverse Event with Product A as the suspect dru...
SUBJECT: Product A reaction and Product B stopped before symptoms began formal notification Dear Clinical Safety and Regulatory Affairs, I am the Consultant Cardiologist at a residential care home network managing over 400 elderly residents across 5 facilities and I am writing to formally report an adverse event involv...
{"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 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 medications as cont...
{"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: Pharmacovigilance report Product A with Product B no current exposure 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 42 year old male patient on Product A for 20 weeks who pre...
{"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: Product A reaction and continued Product B administration formal notification 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 45 ye...
{"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: Urgent adverse event Product A and Atorvastatin stable during Product A reaction Dear Regional Pharmacovigilance Lead, I am the Consultant Gastroenterologist at a cancer 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. Th...
{"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 adverse event and Ibuprofen concomitant medication only 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 62 year old male patient...
{"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 A with suspect Amlodipine Dear Pharmacovigilance Team, I am the Director of Clinical Services at a large endocrinology centre and I am formally notifying you of an adverse event report requiring pharmacovigilance review. I wish to report a serious adverse ev...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 42 year old male patient on Product A for 20 weeks who presented with new visual disturbances, blurred vision, and bilateral optic disc swelling on ophthalmic examination,...
SUBJECT: Product A suspected adverse reaction with concurrent Product B use Dear Clinical Safety and Regulatory Affairs, I am the Consultant Pulmonologist at a private cardiology practice group and I am writing to formally report an adverse event involving a patient under my care. I wish to report an adverse event. Th...
{"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: Urgent adverse event Product A and Product B prior use not relevant Dear Regional Pharmacovigilance Lead, I am the Consultant Neurologist at a respiratory medicine centre and I am writing to formally report an adverse event involving a patient under my care. I wish to report an adverse event. The patient expe...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "Analysis": "The email reports an adverse event a 53 year old female patient started on Product A 7 weeks ago who developed profound fatigue, pallor, and symptomatic anaemia with haemoglobin of 7, qualifying as an Adverse...
SUBJECT: Product A suspected adverse reaction with Product A and Methotrexate both implicated Dear Drug Safety Department, I am the Senior Nurse Practitioner at a Veterans Affairs medical centre and I am documenting this adverse event report on behalf of a patient under our ward care. I wish to report a serious advers...
{"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 suspected reaction with Product B stable throughout event – formal report Dear Pharmacovigilance and Risk Management Team, I am the Director of Clinical Services at a private oncology clinic group and I am formally notifying you of an adverse event report requiring pharmacovigilance review. I wish t...
{"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: Urgent adverse event Product A and Amlodipine also suspected by physician Good morning, I am the Chief of Medicine 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 treating physician...
{"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 concomitant Product B therapy 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 67 year old female patient i...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 67 year old female patient initiated on Product A 9 weeks ago who developed a severe generalized maculopapular rash covering more than 50% of body surface area, facial swe...
SUBJECT: Formal adverse event notification Product A with Product B no current exposure Dear Corporate Drug Safety Department, I am the Clinical Pharmacy Director at a corporate occupational health provider 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": "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 reaction and suspect Product B also implicated formal notification 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 med...
{"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 concomitant Product B exposure – formal report Dear Medical Affairs and Drug Safety, I am the Consultant Pulmonologist 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...
{"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: Product A suspected reaction with Product B stopped months ago – formal report Dear Clinical Safety and Regulatory Affairs, I am the Clinical Nurse Specialist at a pharmaceutical benefit manager and I am documenting this adverse event report on behalf of a patient under our ward care. I wish to report an adve...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "Analysis": "The email reports an adverse event a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypo...
SUBJECT: Product A suspected reaction with Product B unchanged during reaction – formal report Dear Corporate Drug Safety Department, I am writing as the caregiver for my husband Patricia Perry to report an adverse reaction they experienced with a recently started medication. I wish to report an adverse event. The pat...
{"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: Urgent adverse event Product A and Amlodipine not implicated in adverse event Hi, I am the Chief of Medicine at a rheumatology clinic group and I am formally notifying you of an adverse event report requiring pharmacovigilance review. I wish to report an adverse event. The patient experienced a 64 year old ma...
{"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 reaction and concomitant Product B therapy formal notification Dear Medical Affairs and Drug Safety, I am the Chief of Medicine at a geriatric medicine consortium and I am formally notifying you of an adverse event report requiring pharmacovigilance review. I wish to report an adverse event. The pat...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 67 year old female patient initiated on Product A 9 weeks ago who developed a severe generalized maculopapular rash covering more than 50% of body surface area, facial swe...
SUBJECT: Product A reaction report with Product B stable throughout event Hi, 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. The patient experienced a ...
{"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: Serious adverse event report Product A and Product B as background therapy 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 55 year ...
{"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: Pharmacovigilance report Product A with both Product A and Levothyroxine identified as suspect Dear Corporate Drug Safety Department, I am the Consultant Hepatologist 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...
{"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 reaction report involving Product A and previous Product B therapy Dear Global Safety Unit, I am the Senior Consultant 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 experienced a...
{"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: Adverse reaction report involving Product A and Product B maintained during event 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 34 year old female patient on Product A for 10 weeks who...
{"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 concomitant Product B therapy To Whom It May Concern, I am the Consultant Hepatologist 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 experienced a 73 yea...
{"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: Pharmacovigilance report Product A with Amoxicillin excluded as causative agent 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 67 year old ...
{"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 dual drug reaction Product A and Atorvastatin To Whom It May Concern, I am the Consultant Rheumatologist 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 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: Suspected adverse event with Product A and dual drug reaction Product A and Lisinopril Dear Pharmacovigilance and Risk Management Team, I am the Consultant Gastroenterologist 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...
{"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 reaction report with Product B discontinued prior to event 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 45 year old female patient initiated o...
{"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: Adverse reaction report involving Product A and Product B stopped before symptoms began Dear Adverse Events Reporting Centre, I am writing to report an adverse reaction I have experienced with a medication I was recently prescribed. I wish to report an adverse event. The patient experienced a 55 year old fema...
{"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: Adverse reaction report involving Product A and Product B stopped before symptoms began 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 76 year old fem...
{"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: Adverse event report Product A plus Product B historical medication only Dear Patient Safety Team, I am the Senior Nurse Practitioner 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 an adverse event. The patient ex...
{"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 Product B implicated only as concomitant Dear Patient Safety Team, 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 an adverse event. The patie...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypo...
SUBJECT: Product A suspected adverse reaction with Product B as background therapy Dear Adverse Events Reporting Centre, I am writing to report an adverse reaction I have experienced with a medication I was recently prescribed. I wish to report an adverse event. The patient experienced a 55 year old female patient who...
{"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 Amoxicillin not implicated in adverse event – formal report 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 67 year o...
{"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: Safety report Product A and both Product A and Atorvastatin identified as suspect Dear Pharmacovigilance and Risk Management Team, I am the Consultant Gastroenterologist at a large endocrinology centre and I am writing to formally report an adverse event involving a patient under my care. I wish to report a s...
{"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 adverse reaction with Omeprazole taken concurrently not suspected Dear Global Safety Unit, I am writing as the caregiver for my wife Gregory Berry to report an adverse reaction they experienced with a recently started medication. I wish to report an adverse event. The patient experienced a 48 year o...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 48 year old female patient on Product A for 14 weeks who presented with new-onset shortness of breath, dry cough, and bilateral pulmonary infiltrates on chest imaging cons...
SUBJECT: Product A suspected reaction with suspect Product B also implicated – formal report Dear Adverse Events Reporting Centre, I am writing to report an adverse reaction I have experienced with a medication I was recently prescribed. I wish to report a serious adverse event where the treating physician suspects bo...
{"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 unchanged during event onset Dear Adverse Events Reporting Centre, I am writing to report an adverse reaction I have experienced with a medication I was recently prescribed. I wish to report an adverse event. The patient experienced a 60 year old male p...
{"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: Suspected adverse event with Product A and Amoxicillin stable during Product A reaction 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 o...
{"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 adverse event and previous Product B therapy report Good morning, I am writing as the caregiver for my husband Jessica Fox to report an adverse reaction they experienced with a recently started medication. I wish to report an adverse event. The patient experienced a 37 year old female patient initia...
{"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: Formal adverse event notification Product A with suspect Product B also implicated Dear Corporate Drug Safety Department, I am the Consultant Haematologist at a respiratory medicine centre and I am writing to formally report an adverse event involving a patient under my care. I wish to report a serious advers...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 55 year old female patient who was started on Product A 11 weeks ago for a chronic inflammatory condition, qualifying as an Adverse Event with Product A as a suspect drug....
SUBJECT: Serious adverse event report Product A and suspect Product B also implicated To Whom It May Concern, 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 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 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: Adverse reaction report involving Product A and suspected combined effect Product A and Methotrexate Dear Regional Pharmacovigilance Lead, I am the Director of Clinical Services at a pharmaceutical benefit manager and I am formally notifying you of an adverse event report requiring pharmacovigilance review. I...
{"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: Formal adverse event notification Product A with Product B historical exposure documented Dear Clinical Safety and Regulatory Affairs, I am the Consultant Neurologist at a regional hospital trust and I am writing to formally report an adverse event involving a patient under my care. I wish to report an advers...
{"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: Safety report Product A and Product B implicated only as concomitant Dear 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 55 year old female patient who was started o...
{"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 adverse reaction with Product B stopped months ago Dear Regional Pharmacovigilance Lead, I am the Consultant Neurologist at a cancer 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 experie...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "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: Pharmacovigilance report Product A with Lisinopril excluded as causative agent 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 29 ...
{"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 suspected combined effect Product A and Methotrexate Hi, I am writing as the caregiver for my husband Sharon Castro to report an adverse reaction they experienced with a recently started medication. 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: Pharmacovigilance report Product A with Methotrexate continued without change Hi, I am the Clinical Pharmacy Director at a gastroenterology clinic partnership 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 pat...
{"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: Product A adverse event and dual drug reaction Product A and Atorvastatin report Dear 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 medicatio...
{"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 suspect Product B also implicated Dear Medical Affairs and Drug Safety, I am writing as the caregiver for my wife Anthony Nelson 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 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 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 medication...
{"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 Methotrexate excluded as causative agent Good morning, I am the Consultant Hepatologist at a rheumatology clinic group and I am writing to formally report an adverse event involving a patient under my care. I wish to report an adverse event. The patient experienced a...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 42 year old male patient on Product A for 20 weeks who presented with new visual disturbances, blurred vision, and bilateral optic disc swelling on ophthalmic examination,...
SUBJECT: Product A adverse reaction with suspect Product B also implicated Dear Adverse Events Reporting Centre, I am writing on behalf of a patient group member to report an adverse event involving a medication that was recently initiated. I wish to report a serious adverse event where the treating physician suspects...
{"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: Pharmacovigilance report Product A with concomitant Product B exposure To Whom It May Concern, I am the Director of Clinical Services at a home healthcare nursing agency and I am formally notifying you of an adverse event report requiring pharmacovigilance review. I wish to report an adverse event. The patien...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "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 reaction report with physician suspects both Product A and Levothyroxine Dear Global Safety Unit, I am writing as the caregiver for my father Frank Olson 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 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 dual suspect Product A and Amlodipine Hi, I am writing to report an adverse reaction I have experienced with a medication I was recently prescribed. I wish to report a serious adverse event where the treating physician suspects both medications as contributory factors. The pati...
{"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: Serious adverse event report Product A and suspect Product B also implicated Dear Regional Pharmacovigilance Lead, I am writing as the caregiver for my father Joseph Arnold to report an adverse reaction they experienced with a recently started medication. 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 report with Product B implicated only as concomitant Dear Sir or Madam, 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 an adverse event. The patient experienced a 76 y...
{"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 reaction with Product B unchanged during reaction – formal report Dear Pharmacovigilance and Risk Management Team, I am writing as the caregiver for my mother Aaron Hunt to report an adverse reaction they experienced with a recently started medication. 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 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 Amoxicillin excluded as causative agent Dear Sir or Madam, I am the Clinical Pharmacy Director 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. The p...
{"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 ongoing Ibuprofen use alongside Product A – formal report To Whom It May Concern, I am the Clinical Nurse Specialist at a womens health clinic group and I am documenting this adverse event report on behalf of a patient under our ward care. I wish to report an adverse event. T...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 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 stopped before symptoms began Dear Clinical Safety and Regulatory Affairs, I am writing as the caregiver for my wife Deborah Schmidt to report an adverse reaction they experienced with a recently started medication. I wish to report an adverse event. The pa...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "95%"}, "Analysis": "The email reports an adverse event a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding, qualifying as an Adver...
SUBJECT: Pharmacovigilance report Product A with physician suspects both Product A and Ibuprofen Dear Pharmacovigilance and Risk Management Team, I am the Chief of Medicine at a hepatology referral centre 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 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 dual suspect Product A and Ibuprofen Dear Medical Affairs and Drug Safety, I am the Pharmacy Operations Manager 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 r...
{"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: Urgent adverse event Product A and concomitant Product B exposure Dear Medical Affairs and Drug Safety, I am writing as the caregiver for my wife Ashley Thomas to report an adverse reaction they experienced with a recently started medication. I wish to report an adverse event. The patient experienced a 29 yea...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "98%"}, "Analysis": "The email reports an adverse event a 29 year old female patient started on Product A 4 weeks ago who experienced anaphylaxis within 30 minutes of dosing including urticaria, angioedema, bronchospasm, and hypo...
SUBJECT: Product A reaction report with suspect Product B also implicated Good morning, I am the Consultant Haematologist 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 event where the treating physician susp...
{"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 Amlodipine taken concurrently not suspected Dear Pharmacovigilance and Risk Management Team, I am the Consultant Endocrinologist 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 an...
{"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 concomitant Atorvastatin therapy 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 60 year old male patient on Product A for 9 weeks who devel...
{"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 reaction and Lisinopril stable during Product A reaction formal notification Good morning, 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 experie...
{"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 reaction with Product A and Amlodipine both implicated Dear Post-Marketing Surveillance Unit, I am the Consultant Cardiologist at a hepatology referral 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 wher...
{"Classification_of_request": {"Classification": "Adverse Event", "Confidence_percentage": "96%"}, "Analysis": "The email reports an adverse event a 73 year old male patient started on Product A 6 weeks ago who developed severe thrombocytopenia with platelet count 12 x10^9/L and mucosal bleeding, qualifying as an Adver...
SUBJECT: Suspected adverse event with Product A and suspect Product B also implicated Dear Pharmacovigilance and Risk Management Team, I am the Consultant Dermatologist 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 a seriou...
{"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...