chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Feeling abnormal, Hypoacusis, Immune system disorder, Increased upper airway secretion, Insomnia
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-JAN-2013, one day after vaccination with PNEUMOVAX23 (MARRS case 1308USA014836). On 15-AUG-2013, the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "Pregnazone" (Watson labs brand). At an unspecified dosage and frequency and an unspecified "Z-pack" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a Pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. The health care professional contacted during telephone follow up reported that the physician would be sending the information regarding the patient. Follow up information has been received from the patient and a pulmonary nurse (patient's daughter) indicating that the patient herself was desperately worried because she was following the same course as her sister. The patient reported that she herself felt like her immune system had gone crazy, felt exhausted and had not slept in weeks. The patient still had blurred vision and dizziness as well as difficulty hearing and speaking. The patient had computed axial tomography (CAT) scans on 26-AUG-2013 that "showed nothing" and x-ray (results not provided). Pulmonary nurse stated that hoped her mother would get better and though the problem might be a binder in the vaccine. The nurse suggested the chemist who makes the vaccines should look into it and see what could be harming people. At the time of the report, the patient's outcome for felt like her immune system had gone crazy, felt exhausted and had not slept in weeks was unknown. Upon internal review, difficulty hearing was considered to be medically significant. Additional information was received from the patient which reported that she "was sick after receiving the pneumonia vaccine and was experiencing dizziness, fevers and has quit breathing from (her) diaphragm. The patient stated she "did pulmonary exercises, and was still using prednisone (unspecified dosage/frequency and manufacturer) and hydrocodone (unspecified dosage/frequency and manufacturer) and felt drugged up. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Pyrexia, Respiration abnormal, Retching, Speech disorder, Vision blurred
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-JAN-2013, one day after vaccination with PNEUMOVAX23 (MARRS case 1308USA014836). On 15-AUG-2013, the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "Pregnazone" (Watson labs brand). At an unspecified dosage and frequency and an unspecified "Z-pack" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a Pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. The health care professional contacted during telephone follow up reported that the physician would be sending the information regarding the patient. Follow up information has been received from the patient and a pulmonary nurse (patient's daughter) indicating that the patient herself was desperately worried because she was following the same course as her sister. The patient reported that she herself felt like her immune system had gone crazy, felt exhausted and had not slept in weeks. The patient still had blurred vision and dizziness as well as difficulty hearing and speaking. The patient had computed axial tomography (CAT) scans on 26-AUG-2013 that "showed nothing" and x-ray (results not provided). Pulmonary nurse stated that hoped her mother would get better and though the problem might be a binder in the vaccine. The nurse suggested the chemist who makes the vaccines should look into it and see what could be harming people. At the time of the report, the patient's outcome for felt like her immune system had gone crazy, felt exhausted and had not slept in weeks was unknown. Upon internal review, difficulty hearing was considered to be medically significant. Additional information was received from the patient which reported that she "was sick after receiving the pneumonia vaccine and was experiencing dizziness, fevers and has quit breathing from (her) diaphragm. The patient stated she "did pulmonary exercises, and was still using prednisone (unspecified dosage/frequency and manufacturer) and hydrocodone (unspecified dosage/frequency and manufacturer) and felt drugged up. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Vomiting, Wheezing, X-ray
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-JAN-2013, one day after vaccination with PNEUMOVAX23 (MARRS case 1308USA014836). On 15-AUG-2013, the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "Pregnazone" (Watson labs brand). At an unspecified dosage and frequency and an unspecified "Z-pack" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a Pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. The health care professional contacted during telephone follow up reported that the physician would be sending the information regarding the patient. Follow up information has been received from the patient and a pulmonary nurse (patient's daughter) indicating that the patient herself was desperately worried because she was following the same course as her sister. The patient reported that she herself felt like her immune system had gone crazy, felt exhausted and had not slept in weeks. The patient still had blurred vision and dizziness as well as difficulty hearing and speaking. The patient had computed axial tomography (CAT) scans on 26-AUG-2013 that "showed nothing" and x-ray (results not provided). Pulmonary nurse stated that hoped her mother would get better and though the problem might be a binder in the vaccine. The nurse suggested the chemist who makes the vaccines should look into it and see what could be harming people. At the time of the report, the patient's outcome for felt like her immune system had gone crazy, felt exhausted and had not slept in weeks was unknown. Upon internal review, difficulty hearing was considered to be medically significant. Additional information was received from the patient which reported that she "was sick after receiving the pneumonia vaccine and was experiencing dizziness, fevers and has quit breathing from (her) diaphragm. The patient stated she "did pulmonary exercises, and was still using prednisone (unspecified dosage/frequency and manufacturer) and hydrocodone (unspecified dosage/frequency and manufacturer) and felt drugged up. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Pyrexia
Clinical narrative: This spontaneous report was received from a 33 year old female consumer, who was not in pregnant, with an allergy to latex and a history of anaphylactic reaction for latex (it was also reported that patient had none pertinent medical history). On 31-AUG-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot# were not reported). None concomitant medications were reported. The consumer stated that on 31-AUG-2013, she experienced localized erythema multiforme, knot in the muscle around the injection site and high fever. The patient sought unspecified medical attention. The has unspecified blood test (results not reported) on an unknown date in 2013, and she used ice and a heat pack on the injection site. The outcome of localized erythema multiforme, knot in the muscle around the injection site and high fever was reported as not recovered not resolved. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Blood test, Erythema multiforme, Injection site nodule, Pyrexia
Clinical narrative: This spontaneous report was received from a 33 year old female consumer, who was not in pregnant, with an allergy to latex and a history of anaphylactic reaction for latex (it was also reported that patient had none pertinent medical history). On 31-AUG-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot# were not reported). None concomitant medications were reported. The consumer stated that on 31-AUG-2013, she experienced localized erythema multiforme, knot in the muscle around the injection site and high fever. The patient sought unspecified medical attention. The has unspecified blood test (results not reported) on an unknown date in 2013, and she used ice and a heat pack on the injection site. The outcome of localized erythema multiforme, knot in the muscle around the injection site and high fever was reported as not recovered not resolved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure increased, Flushing, Injection site erythema, Injection site pain, Lacrimation increased
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 57 year old female patient with allergy to aspirin, penicillin, NSAID, oxycodone, corticosteroid and nitrofurantoin derivates and other highly sensitive and allergies to many things. On 13-SEP-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # J003483 expiration date 29-JUN-2014) subcutaneously. The pharmacist reported that on 14-SEP-2013, the patient presented at the emergency department of an unspecified hospital with shortness of breath and an anaphylactic reaction. It was unclear as to whether or not she was admitted to the hospital. The pharmacist stated that she received SOLUMEDROL IV in the emergency department. The patient was discharged with a prescription for prednisone. At the time of the report, the patient had recovered. Shortness of breath and anaphylactic reaction were considered to be medically significant and life threatening by the pharmacist. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Swelling face
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 57 year old female patient with allergy to aspirin, penicillin, NSAID, oxycodone, corticosteroid and nitrofurantoin derivates and other highly sensitive and allergies to many things. On 13-SEP-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # J003483 expiration date 29-JUN-2014) subcutaneously. The pharmacist reported that on 14-SEP-2013, the patient presented at the emergency department of an unspecified hospital with shortness of breath and an anaphylactic reaction. It was unclear as to whether or not she was admitted to the hospital. The pharmacist stated that she received SOLUMEDROL IV in the emergency department. The patient was discharged with a prescription for prednisone. At the time of the report, the patient had recovered. Shortness of breath and anaphylactic reaction were considered to be medically significant and life threatening by the pharmacist. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 57 year old female patient with allergy to aspirin, penicillin, NSAID, oxycodone, corticosteroid and nitrofurantoin derivates and other highly sensitive and allergies to many things. On 13-SEP-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # J003483 expiration date 29-JUN-2014) subcutaneously. The pharmacist reported that on 14-SEP-2013, the patient presented at the emergency department of an unspecified hospital with shortness of breath and an anaphylactic reaction. It was unclear as to whether or not she was admitted to the hospital. The pharmacist stated that she received SOLUMEDROL IV in the emergency department. The patient was discharged with a prescription for prednisone. At the time of the report, the patient had recovered. Shortness of breath and anaphylactic reaction were considered to be medically significant and life threatening by the pharmacist. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 68 year old female patient with allergic to penicillin. On 12-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (lot# H022280, expired date 16-JUL-2013) (0.5 ml, intramuscular). Concomitant therapies included ADVAIR and DYAZIDE. On an unknown date in September 2013 the patient developed redness that was about 4 cm in size and it was Z shaped and injection area was warm and patient also experienced nausea and fever. LEVAQUIN was given for adverse events as treatment. There was no lab diagnostics study performed. The outcome of adverse events was reported as recovered/resolved on an unspecified date (in September 2013). Action taken was not provided. The patient had office visit for medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site warmth, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 68 year old female patient with allergic to penicillin. On 12-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (lot# H022280, expired date 16-JUL-2013) (0.5 ml, intramuscular). Concomitant therapies included ADVAIR and DYAZIDE. On an unknown date in September 2013 the patient developed redness that was about 4 cm in size and it was Z shaped and injection area was warm and patient also experienced nausea and fever. LEVAQUIN was given for adverse events as treatment. There was no lab diagnostics study performed. The outcome of adverse events was reported as recovered/resolved on an unspecified date (in September 2013). Action taken was not provided. The patient had office visit for medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Anti-glomerular basement membrane antibody negative, Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Antinuclear antibody negative, Biopsy kidney abnormal
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09646. The following is verbatim from the article: "An active 75-year-old female with a past medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl was evaluated for acute kidney injury in January 2013. She developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl 4 weeks after an influenza vaccination in September 2012. She complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. Her blood work in January revealed blood urea nitrogen of 65 mg/dl and serum creatinine of 7.2 mg/dl. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA at a titer of 1: 320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. Her physical exam was remarkable for conjunctival pallor. Examination of the rest of the systems was unremarkable. Renal biopsy was performed and revealed necrotizing and crescentic pauci-immune glomerulonephritis. She was started on hemodialysis and treated with intravenous methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus involvement, she did not have any evidence of any other organ involvement. At 3 months after therapy, she was still dialysis dependent." Outcome was not reported. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Blood creatinine increased, Blood urea increased, Blood urine present, Conjunctival pallor, Decreased appetite
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09646. The following is verbatim from the article: "An active 75-year-old female with a past medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl was evaluated for acute kidney injury in January 2013. She developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl 4 weeks after an influenza vaccination in September 2012. She complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. Her blood work in January revealed blood urea nitrogen of 65 mg/dl and serum creatinine of 7.2 mg/dl. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA at a titer of 1: 320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. Her physical exam was remarkable for conjunctival pallor. Examination of the rest of the systems was unremarkable. Renal biopsy was performed and revealed necrotizing and crescentic pauci-immune glomerulonephritis. She was started on hemodialysis and treated with intravenous methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus involvement, she did not have any evidence of any other organ involvement. At 3 months after therapy, she was still dialysis dependent." Outcome was not reported. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Duodenitis, Epistaxis, Fatigue, Glomerulonephritis rapidly progressive, Haematuria
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09646. The following is verbatim from the article: "An active 75-year-old female with a past medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl was evaluated for acute kidney injury in January 2013. She developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl 4 weeks after an influenza vaccination in September 2012. She complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. Her blood work in January revealed blood urea nitrogen of 65 mg/dl and serum creatinine of 7.2 mg/dl. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA at a titer of 1: 320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. Her physical exam was remarkable for conjunctival pallor. Examination of the rest of the systems was unremarkable. Renal biopsy was performed and revealed necrotizing and crescentic pauci-immune glomerulonephritis. She was started on hemodialysis and treated with intravenous methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus involvement, she did not have any evidence of any other organ involvement. At 3 months after therapy, she was still dialysis dependent." Outcome was not reported. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Haemodialysis, Nausea, Oesophagogastroduodenoscopy abnormal, Plasmapheresis, Protein urine present
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09646. The following is verbatim from the article: "An active 75-year-old female with a past medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl was evaluated for acute kidney injury in January 2013. She developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl 4 weeks after an influenza vaccination in September 2012. She complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. Her blood work in January revealed blood urea nitrogen of 65 mg/dl and serum creatinine of 7.2 mg/dl. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA at a titer of 1: 320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. Her physical exam was remarkable for conjunctival pallor. Examination of the rest of the systems was unremarkable. Renal biopsy was performed and revealed necrotizing and crescentic pauci-immune glomerulonephritis. She was started on hemodialysis and treated with intravenous methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus involvement, she did not have any evidence of any other organ involvement. At 3 months after therapy, she was still dialysis dependent." Outcome was not reported. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Proteinuria, Red blood cells urine positive, Renal failure acute, Renal failure chronic, Scab
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09646. The following is verbatim from the article: "An active 75-year-old female with a past medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl was evaluated for acute kidney injury in January 2013. She developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl 4 weeks after an influenza vaccination in September 2012. She complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. Her blood work in January revealed blood urea nitrogen of 65 mg/dl and serum creatinine of 7.2 mg/dl. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA at a titer of 1: 320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. Her physical exam was remarkable for conjunctival pallor. Examination of the rest of the systems was unremarkable. Renal biopsy was performed and revealed necrotizing and crescentic pauci-immune glomerulonephritis. She was started on hemodialysis and treated with intravenous methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus involvement, she did not have any evidence of any other organ involvement. At 3 months after therapy, she was still dialysis dependent." Outcome was not reported. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Urinary casts present, Urine analysis abnormal, Weight decreased
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09646. The following is verbatim from the article: "An active 75-year-old female with a past medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl was evaluated for acute kidney injury in January 2013. She developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl 4 weeks after an influenza vaccination in September 2012. She complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. Her blood work in January revealed blood urea nitrogen of 65 mg/dl and serum creatinine of 7.2 mg/dl. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA at a titer of 1: 320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. Her physical exam was remarkable for conjunctival pallor. Examination of the rest of the systems was unremarkable. Renal biopsy was performed and revealed necrotizing and crescentic pauci-immune glomerulonephritis. She was started on hemodialysis and treated with intravenous methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus involvement, she did not have any evidence of any other organ involvement. At 3 months after therapy, she was still dialysis dependent." Outcome was not reported. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Blood creatinine increased, Blood urea increased, Conjunctival pallor, Decreased appetite, Duodenitis
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09646. The following is verbatim from the article: "An active 75-year-old female with a past medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl was evaluated for acute kidney injury in January 2013. She developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl 4 weeks after an influenza vaccination in September 2012. She complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. Her blood work in January revealed blood urea nitrogen of 65 mg/dl and serum creatinine of 7.2 mg/dl. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA at a titer of 1: 320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. Her physical exam was remarkable for conjunctival pallor. Examination of the rest of the systems was unremarkable. Renal biopsy was performed and revealed necrotizing and crescentic pauci-immune glomerulonephritis. She was started on hemodialysis and treated with intravenous methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus involvement, she did not have any evidence of any other organ involvement. At 3 months after therapy, she was still dialysis dependent." Outcome was not reported. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Epistaxis, Fatigue, Glomerulonephritis rapidly progressive, Granulomatosis with polyangiitis, Haematuria
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09646. The following is verbatim from the article: "An active 75-year-old female with a past medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl was evaluated for acute kidney injury in January 2013. She developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl 4 weeks after an influenza vaccination in September 2012. She complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. Her blood work in January revealed blood urea nitrogen of 65 mg/dl and serum creatinine of 7.2 mg/dl. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA at a titer of 1: 320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. Her physical exam was remarkable for conjunctival pallor. Examination of the rest of the systems was unremarkable. Renal biopsy was performed and revealed necrotizing and crescentic pauci-immune glomerulonephritis. She was started on hemodialysis and treated with intravenous methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus involvement, she did not have any evidence of any other organ involvement. At 3 months after therapy, she was still dialysis dependent." Outcome was not reported. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Haemodialysis, Nausea, Oesophagogastroduodenoscopy abnormal, Plasmapheresis, Proteinuria
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09646. The following is verbatim from the article: "An active 75-year-old female with a past medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl was evaluated for acute kidney injury in January 2013. She developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl 4 weeks after an influenza vaccination in September 2012. She complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. Her blood work in January revealed blood urea nitrogen of 65 mg/dl and serum creatinine of 7.2 mg/dl. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA at a titer of 1: 320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. Her physical exam was remarkable for conjunctival pallor. Examination of the rest of the systems was unremarkable. Renal biopsy was performed and revealed necrotizing and crescentic pauci-immune glomerulonephritis. She was started on hemodialysis and treated with intravenous methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus involvement, she did not have any evidence of any other organ involvement. At 3 months after therapy, she was still dialysis dependent." Outcome was not reported. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Renal failure acute, Renal failure chronic, Scab, Sinus disorder, Urinary casts present
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09646. The following is verbatim from the article: "An active 75-year-old female with a past medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl was evaluated for acute kidney injury in January 2013. She developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl 4 weeks after an influenza vaccination in September 2012. She complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. Her blood work in January revealed blood urea nitrogen of 65 mg/dl and serum creatinine of 7.2 mg/dl. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA at a titer of 1: 320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. Her physical exam was remarkable for conjunctival pallor. Examination of the rest of the systems was unremarkable. Renal biopsy was performed and revealed necrotizing and crescentic pauci-immune glomerulonephritis. She was started on hemodialysis and treated with intravenous methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus involvement, she did not have any evidence of any other organ involvement. At 3 months after therapy, she was still dialysis dependent." Outcome was not reported. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Urine analysis abnormal, Weight decreased
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09646. The following is verbatim from the article: "An active 75-year-old female with a past medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl was evaluated for acute kidney injury in January 2013. She developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl 4 weeks after an influenza vaccination in September 2012. She complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. Her blood work in January revealed blood urea nitrogen of 65 mg/dl and serum creatinine of 7.2 mg/dl. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA at a titer of 1: 320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. Her physical exam was remarkable for conjunctival pallor. Examination of the rest of the systems was unremarkable. Renal biopsy was performed and revealed necrotizing and crescentic pauci-immune glomerulonephritis. She was started on hemodialysis and treated with intravenous methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus involvement, she did not have any evidence of any other organ involvement. At 3 months after therapy, she was still dialysis dependent." Outcome was not reported. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Anti-glomerular basement membrane antibody negative, Antineutrophil cytoplasmic antibody positive, Antinuclear antibody negative, Biopsy kidney abnormal, Blood creatinine increased
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09646. The following is verbatim from the article: "An active 75-year-old female with a past medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl was evaluated for acute kidney injury in January 2013. She developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl 4 weeks after an influenza vaccination in September 2012. She complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. Her blood work in January revealed blood urea nitrogen of 65 mg/dl and serum creatinine of 7.2 mg/dl. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA at a titer of 1: 320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. Her physical exam was remarkable for conjunctival pallor. Examination of the rest of the systems was unremarkable. Renal biopsy was performed and revealed necrotizing and crescentic pauci-immune glomerulonephritis. She was started on hemodialysis and treated with intravenous methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus involvement, she did not have any evidence of any other organ involvement. At 3 months after therapy, she was still dialysis dependent." Outcome was not reported. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Blood urea increased, Blood urine present, Conjunctival pallor, Decreased appetite, Dialysis
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09646. The following is verbatim from the article: "An active 75-year-old female with a past medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl was evaluated for acute kidney injury in January 2013. She developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl 4 weeks after an influenza vaccination in September 2012. She complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. Her blood work in January revealed blood urea nitrogen of 65 mg/dl and serum creatinine of 7.2 mg/dl. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA at a titer of 1: 320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. Her physical exam was remarkable for conjunctival pallor. Examination of the rest of the systems was unremarkable. Renal biopsy was performed and revealed necrotizing and crescentic pauci-immune glomerulonephritis. She was started on hemodialysis and treated with intravenous methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus involvement, she did not have any evidence of any other organ involvement. At 3 months after therapy, she was still dialysis dependent." Outcome was not reported. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Proteinuria, Red blood cells urine positive, Renal failure acute, Scab, Sinus disorder
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09646. The following is verbatim from the article: "An active 75-year-old female with a past medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl was evaluated for acute kidney injury in January 2013. She developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl 4 weeks after an influenza vaccination in September 2012. She complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. Her blood work in January revealed blood urea nitrogen of 65 mg/dl and serum creatinine of 7.2 mg/dl. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA at a titer of 1: 320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. Her physical exam was remarkable for conjunctival pallor. Examination of the rest of the systems was unremarkable. Renal biopsy was performed and revealed necrotizing and crescentic pauci-immune glomerulonephritis. She was started on hemodialysis and treated with intravenous methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus involvement, she did not have any evidence of any other organ involvement. At 3 months after therapy, she was still dialysis dependent." Outcome was not reported. Documents held by sender: None.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Arthralgia, Biopsy kidney abnormal, Blood creatinine increased
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09645. The following is verbatim from the article: "A healthy 50-year-old male received the influenza vaccine in October 1997. Two days later he developed fatigue, chills and low-grade fevers. Over the next 4 weeks he experienced worsening joint pains and muscle aches. His physical exam was notable for splinter hemorrhages in his fingernails, but the rest of his exam was unremarkable. Workup at that time demonstrated an erythrocyte sedimentation rate of 56 mm/h, positive rheumatoid factor and positive cytoplasmic ANCA at a titer of 1:80 with a positive proteinase 3 ELISA. Blood cultures were negative. A transthoracic echocardiogram did not reveal any valvular vegetation. Two weeks later, he was noted to have microscopic hematuria and an increase in his serum creatinine from 0.9 to 1.3 mg/dl. Renal biopsy revealed necrotizing vasculitis and focal necrotizing pauci-immune glomerulonephritis. CT chest was unremarkable. He was treated with oral prednisone and oral cyclophosphamide; after achievement of remission of his vasculitis he was switched to azathioprine for maintenance of remission. His renal function was stable with a serum creatinine of 1.3 mg/dl at the time of his last follow-up in October 2012." Outcome was not reported. Documents held by sender: None.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chills, Computerised tomogram thorax normal, Echocardiogram, Echocardiogram normal, Fatigue
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09645. The following is verbatim from the article: "A healthy 50-year-old male received the influenza vaccine in October 1997. Two days later he developed fatigue, chills and low-grade fevers. Over the next 4 weeks he experienced worsening joint pains and muscle aches. His physical exam was notable for splinter hemorrhages in his fingernails, but the rest of his exam was unremarkable. Workup at that time demonstrated an erythrocyte sedimentation rate of 56 mm/h, positive rheumatoid factor and positive cytoplasmic ANCA at a titer of 1:80 with a positive proteinase 3 ELISA. Blood cultures were negative. A transthoracic echocardiogram did not reveal any valvular vegetation. Two weeks later, he was noted to have microscopic hematuria and an increase in his serum creatinine from 0.9 to 1.3 mg/dl. Renal biopsy revealed necrotizing vasculitis and focal necrotizing pauci-immune glomerulonephritis. CT chest was unremarkable. He was treated with oral prednisone and oral cyclophosphamide; after achievement of remission of his vasculitis he was switched to azathioprine for maintenance of remission. His renal function was stable with a serum creatinine of 1.3 mg/dl at the time of his last follow-up in October 2012." Outcome was not reported. Documents held by sender: None.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Glomerulonephritis rapidly progressive, Granulomatosis with polyangiitis, Haematuria, Myalgia, Pyrexia
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09645. The following is verbatim from the article: "A healthy 50-year-old male received the influenza vaccine in October 1997. Two days later he developed fatigue, chills and low-grade fevers. Over the next 4 weeks he experienced worsening joint pains and muscle aches. His physical exam was notable for splinter hemorrhages in his fingernails, but the rest of his exam was unremarkable. Workup at that time demonstrated an erythrocyte sedimentation rate of 56 mm/h, positive rheumatoid factor and positive cytoplasmic ANCA at a titer of 1:80 with a positive proteinase 3 ELISA. Blood cultures were negative. A transthoracic echocardiogram did not reveal any valvular vegetation. Two weeks later, he was noted to have microscopic hematuria and an increase in his serum creatinine from 0.9 to 1.3 mg/dl. Renal biopsy revealed necrotizing vasculitis and focal necrotizing pauci-immune glomerulonephritis. CT chest was unremarkable. He was treated with oral prednisone and oral cyclophosphamide; after achievement of remission of his vasculitis he was switched to azathioprine for maintenance of remission. His renal function was stable with a serum creatinine of 1.3 mg/dl at the time of his last follow-up in October 2012." Outcome was not reported. Documents held by sender: None.