chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of arm pain at injection site in a 61-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) and unspecified vaccine. A physician or other health care professional has not verified this report. Concurrent medications included Levothyroxine, CYMBALTA, Hormone replacement therapy, Vitamin D3 and Calcium. On 21 April 2013 at 13:00 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm). On 21 April 2013, immediately after vaccination with BOOSTRIX, the subject experienced arm pain at injection site, pain at site during injection and vaccine administered at inappropriate site. Since 21 April 2013 the subject has also experienced arm pain, inability to perform daily activities, unable to lift arm and awake at night. The subject received an intramuscular injection of BOOSTRIX in her upper left arm that was only about an inch from her shoulder. Her previous vaccine injections had always been lower on her arm and the subject thinks that she was injected in more of a joint area that was not very muscular [vaccine administered at inappropriate site]. The injection hurt really bad at the time of administration. Since that time, the pain in her left arm has gotten worse. The pain is limiting the subject from doing a lot of things and she is unable to lift the arm above her head. The pain is happening 24 hours, seven days a week and has also been keeping her awake at night. The subject has tried treating the pain with TYLENOL. At the time of reporting the pain at injection site, pain at site during injection and arm pain were worse; inability to perform daily activities, unable to lift arm and awake at night. The subject also reported experiencing injection site pain that resolved within 24 hours with previous, unspecified vaccination. No other details were provided.
Age: 61.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Insomnia
Clinical narrative: This case was reported by a consumer and described the occurrence of arm pain at injection site in a 61-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) and unspecified vaccine. A physician or other health care professional has not verified this report. Concurrent medications included Levothyroxine, CYMBALTA, Hormone replacement therapy, Vitamin D3 and Calcium. On 21 April 2013 at 13:00 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm). On 21 April 2013, immediately after vaccination with BOOSTRIX, the subject experienced arm pain at injection site, pain at site during injection and vaccine administered at inappropriate site. Since 21 April 2013 the subject has also experienced arm pain, inability to perform daily activities, unable to lift arm and awake at night. The subject received an intramuscular injection of BOOSTRIX in her upper left arm that was only about an inch from her shoulder. Her previous vaccine injections had always been lower on her arm and the subject thinks that she was injected in more of a joint area that was not very muscular [vaccine administered at inappropriate site]. The injection hurt really bad at the time of administration. Since that time, the pain in her left arm has gotten worse. The pain is limiting the subject from doing a lot of things and she is unable to lift the arm above her head. The pain is happening 24 hours, seven days a week and has also been keeping her awake at night. The subject has tried treating the pain with TYLENOL. At the time of reporting the pain at injection site, pain at site during injection and arm pain were worse; inability to perform daily activities, unable to lift arm and awake at night. The subject also reported experiencing injection site pain that resolved within 24 hours with previous, unspecified vaccination. No other details were provided.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This spontaneous VARIVAX (Merck) prospective pregnancy registry report was received from a female patient concerning herself. On an unknown date, the patient was vaccinated with VARIVAX (Merck). Dose, route and lot number were not provided. No other co-suspects were reported. No concomitant medications were reported. The patient reported that she received VARIVAX (Merck) and later on an unknown date, became pregnant. The LMP and EDD were not known. The patient did not have an adverse reaction to VARIVAX (Merck). The outcome was unknown. Follow up information was received from a registered nurse. The patient was going through a Controlled Ovarian Stimulation for In-vitro Fertilization. On 08-SEP-2012, she went for retrieval of her oocytes. On 11-SEP-2012, she had an embryo transfer. She was to have a blood pregnancy test on 22-SEP-2012, but did not have her blood pregnancy test (Beta HCG Level) till 25-SEp-2012. She was called with her blood pregnancy test (Beta HCG Level) results and became extremely upset stating "since she had vaginal bleeding and thought negative, she had gone to her primary care physician (name unknown0 on 25-SEP-2012 and had got the VARIVAX (Merck). Patient was following in our office, she had a Bio-chemical pregnancy and her blood pregnancy tests (Beta HCG Levels) were followed until negative. he patient was contacted several times by our office in follow-up to this but did not return calls or correspondence sent to her. On 25-SEP-2013, the patient left a message that she does not wish to sign the consent for any further follow-up and would like to put this event behind her and wish no further contact regarding the matter. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test negative, Pregnancy test positive, Vaginal haemorrhage
Clinical narrative: This spontaneous VARIVAX (Merck) prospective pregnancy registry report was received from a female patient concerning herself. On an unknown date, the patient was vaccinated with VARIVAX (Merck). Dose, route and lot number were not provided. No other co-suspects were reported. No concomitant medications were reported. The patient reported that she received VARIVAX (Merck) and later on an unknown date, became pregnant. The LMP and EDD were not known. The patient did not have an adverse reaction to VARIVAX (Merck). The outcome was unknown. Follow up information was received from a registered nurse. The patient was going through a Controlled Ovarian Stimulation for In-vitro Fertilization. On 08-SEP-2012, she went for retrieval of her oocytes. On 11-SEP-2012, she had an embryo transfer. She was to have a blood pregnancy test on 22-SEP-2012, but did not have her blood pregnancy test (Beta HCG Level) till 25-SEp-2012. She was called with her blood pregnancy test (Beta HCG Level) results and became extremely upset stating "since she had vaginal bleeding and thought negative, she had gone to her primary care physician (name unknown0 on 25-SEP-2012 and had got the VARIVAX (Merck). Patient was following in our office, she had a Bio-chemical pregnancy and her blood pregnancy tests (Beta HCG Levels) were followed until negative. he patient was contacted several times by our office in follow-up to this but did not return calls or correspondence sent to her. On 25-SEP-2013, the patient left a message that she does not wish to sign the consent for any further follow-up and would like to put this event behind her and wish no further contact regarding the matter. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 49 year old female patient. The patient had no pertinent medical history or drug allergies. On 10-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001693, expiry date 08-MAY-2014) route was unknown. There were no concomitant medications reported. On 11-SEP-2013, the patients arm was warm, red and swollen rash at the injection site and was about six inches in diameter. The patient experienced fever of 100.8 and was advised to contact her physician. No treatment was rendered for the events. No lab tests were performed. The patient stated that the rash had improved since the symptoms started. The outcome of the reported events were unknown. The patient sought medical attention. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 49 year old female patient. The patient had no pertinent medical history or drug allergies. On 10-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001693, expiry date 08-MAY-2014) route was unknown. There were no concomitant medications reported. On 11-SEP-2013, the patients arm was warm, red and swollen rash at the injection site and was about six inches in diameter. The patient experienced fever of 100.8 and was advised to contact her physician. No treatment was rendered for the events. No lab tests were performed. The patient stated that the rash had improved since the symptoms started. The outcome of the reported events were unknown. The patient sought medical attention. 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: This literature report (initial receipt 17-Sep-2013) concerns an active 75 year old female who had a medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl. On an unspecified date, in September 2012, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, four weeks after the influenza vaccination in September 2012, the patient developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl. The patient complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis, and was treated with omeprazole. Her nausea improved, but continued with poor appetite and lost 17 pounds. In January 2013, the patient was evaluated for acute kidney injury. Her blood work in January (unspecified year) 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 4 positive perinuclear ANCA (antineutrophil cytoplasmic antibody) at a titre of 1:320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. The patient developed conjunctival pallor. Examination of the rest of the systems was unremarkable. A renal biopsy revealed necrotizing and crescentic pauci-immune glomerulonephritis. Treatment included hemodialysis, intravenous (IV) methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus and kidney involvement, the patient did not have any evidence of any other organ involvement. The patient was diagnosed with antineutrophil cytoplasmic antibody-associated vasculitis (AAV), disease type GPA (granulomatosis with polyangiitis), ANCA type p/MPO (perinuclear myeloperoxidase). At three months after therapy, the patient was still dialysis-dependent and developed end-stage renal disease (ESRD) and achieved disease remission. Outcome was not reported (patient had achieved remission).
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: This literature report (initial receipt 17-Sep-2013) concerns an active 75 year old female who had a medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl. On an unspecified date, in September 2012, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, four weeks after the influenza vaccination in September 2012, the patient developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl. The patient complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis, and was treated with omeprazole. Her nausea improved, but continued with poor appetite and lost 17 pounds. In January 2013, the patient was evaluated for acute kidney injury. Her blood work in January (unspecified year) 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 4 positive perinuclear ANCA (antineutrophil cytoplasmic antibody) at a titre of 1:320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. The patient developed conjunctival pallor. Examination of the rest of the systems was unremarkable. A renal biopsy revealed necrotizing and crescentic pauci-immune glomerulonephritis. Treatment included hemodialysis, intravenous (IV) methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus and kidney involvement, the patient did not have any evidence of any other organ involvement. The patient was diagnosed with antineutrophil cytoplasmic antibody-associated vasculitis (AAV), disease type GPA (granulomatosis with polyangiitis), ANCA type p/MPO (perinuclear myeloperoxidase). At three months after therapy, the patient was still dialysis-dependent and developed end-stage renal disease (ESRD) and achieved disease remission. Outcome was not reported (patient had achieved remission).
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Duodenitis, Epistaxis, Fatigue, Glomerulonephritis rapidly progressive, Haematuria
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns an active 75 year old female who had a medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl. On an unspecified date, in September 2012, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, four weeks after the influenza vaccination in September 2012, the patient developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl. The patient complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis, and was treated with omeprazole. Her nausea improved, but continued with poor appetite and lost 17 pounds. In January 2013, the patient was evaluated for acute kidney injury. Her blood work in January (unspecified year) 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 4 positive perinuclear ANCA (antineutrophil cytoplasmic antibody) at a titre of 1:320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. The patient developed conjunctival pallor. Examination of the rest of the systems was unremarkable. A renal biopsy revealed necrotizing and crescentic pauci-immune glomerulonephritis. Treatment included hemodialysis, intravenous (IV) methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus and kidney involvement, the patient did not have any evidence of any other organ involvement. The patient was diagnosed with antineutrophil cytoplasmic antibody-associated vasculitis (AAV), disease type GPA (granulomatosis with polyangiitis), ANCA type p/MPO (perinuclear myeloperoxidase). At three months after therapy, the patient was still dialysis-dependent and developed end-stage renal disease (ESRD) and achieved disease remission. Outcome was not reported (patient had achieved remission).
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Haemodialysis, Nausea, Oesophagogastroduodenoscopy abnormal, Plasmapheresis, Protein urine present
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns an active 75 year old female who had a medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl. On an unspecified date, in September 2012, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, four weeks after the influenza vaccination in September 2012, the patient developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl. The patient complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis, and was treated with omeprazole. Her nausea improved, but continued with poor appetite and lost 17 pounds. In January 2013, the patient was evaluated for acute kidney injury. Her blood work in January (unspecified year) 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 4 positive perinuclear ANCA (antineutrophil cytoplasmic antibody) at a titre of 1:320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. The patient developed conjunctival pallor. Examination of the rest of the systems was unremarkable. A renal biopsy revealed necrotizing and crescentic pauci-immune glomerulonephritis. Treatment included hemodialysis, intravenous (IV) methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus and kidney involvement, the patient did not have any evidence of any other organ involvement. The patient was diagnosed with antineutrophil cytoplasmic antibody-associated vasculitis (AAV), disease type GPA (granulomatosis with polyangiitis), ANCA type p/MPO (perinuclear myeloperoxidase). At three months after therapy, the patient was still dialysis-dependent and developed end-stage renal disease (ESRD) and achieved disease remission. Outcome was not reported (patient had achieved remission).
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: This literature report (initial receipt 17-Sep-2013) concerns an active 75 year old female who had a medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl. On an unspecified date, in September 2012, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, four weeks after the influenza vaccination in September 2012, the patient developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl. The patient complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis, and was treated with omeprazole. Her nausea improved, but continued with poor appetite and lost 17 pounds. In January 2013, the patient was evaluated for acute kidney injury. Her blood work in January (unspecified year) 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 4 positive perinuclear ANCA (antineutrophil cytoplasmic antibody) at a titre of 1:320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. The patient developed conjunctival pallor. Examination of the rest of the systems was unremarkable. A renal biopsy revealed necrotizing and crescentic pauci-immune glomerulonephritis. Treatment included hemodialysis, intravenous (IV) methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus and kidney involvement, the patient did not have any evidence of any other organ involvement. The patient was diagnosed with antineutrophil cytoplasmic antibody-associated vasculitis (AAV), disease type GPA (granulomatosis with polyangiitis), ANCA type p/MPO (perinuclear myeloperoxidase). At three months after therapy, the patient was still dialysis-dependent and developed end-stage renal disease (ESRD) and achieved disease remission. Outcome was not reported (patient had achieved remission).
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Urinary casts present, Urine analysis abnormal, Weight decreased
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns an active 75 year old female who had a medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl. On an unspecified date, in September 2012, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, four weeks after the influenza vaccination in September 2012, the patient developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl. The patient complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis, and was treated with omeprazole. Her nausea improved, but continued with poor appetite and lost 17 pounds. In January 2013, the patient was evaluated for acute kidney injury. Her blood work in January (unspecified year) 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 4 positive perinuclear ANCA (antineutrophil cytoplasmic antibody) at a titre of 1:320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. The patient developed conjunctival pallor. Examination of the rest of the systems was unremarkable. A renal biopsy revealed necrotizing and crescentic pauci-immune glomerulonephritis. Treatment included hemodialysis, intravenous (IV) methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus and kidney involvement, the patient did not have any evidence of any other organ involvement. The patient was diagnosed with antineutrophil cytoplasmic antibody-associated vasculitis (AAV), disease type GPA (granulomatosis with polyangiitis), ANCA type p/MPO (perinuclear myeloperoxidase). At three months after therapy, the patient was still dialysis-dependent and developed end-stage renal disease (ESRD) and achieved disease remission. Outcome was not reported (patient had achieved remission).
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Blood creatinine increased, Blood urea increased, Conjunctival pallor, Decreased appetite, Duodenitis
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns an active 75 year old female who had a medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl. On an unspecified date, in September 2012, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, four weeks after the influenza vaccination in September 2012, the patient developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl. The patient complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis, and was treated with omeprazole. Her nausea improved, but continued with poor appetite and lost 17 pounds. In January 2013, the patient was evaluated for acute kidney injury. Her blood work in January (unspecified year) 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 4 positive perinuclear ANCA (antineutrophil cytoplasmic antibody) at a titre of 1:320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. The patient developed conjunctival pallor. Examination of the rest of the systems was unremarkable. A renal biopsy revealed necrotizing and crescentic pauci-immune glomerulonephritis. Treatment included hemodialysis, intravenous (IV) methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus and kidney involvement, the patient did not have any evidence of any other organ involvement. The patient was diagnosed with antineutrophil cytoplasmic antibody-associated vasculitis (AAV), disease type GPA (granulomatosis with polyangiitis), ANCA type p/MPO (perinuclear myeloperoxidase). At three months after therapy, the patient was still dialysis-dependent and developed end-stage renal disease (ESRD) and achieved disease remission. Outcome was not reported (patient had achieved remission).
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Epistaxis, Fatigue, Glomerulonephritis rapidly progressive, Granulomatosis with polyangiitis, Haematuria
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns an active 75 year old female who had a medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl. On an unspecified date, in September 2012, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, four weeks after the influenza vaccination in September 2012, the patient developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl. The patient complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis, and was treated with omeprazole. Her nausea improved, but continued with poor appetite and lost 17 pounds. In January 2013, the patient was evaluated for acute kidney injury. Her blood work in January (unspecified year) 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 4 positive perinuclear ANCA (antineutrophil cytoplasmic antibody) at a titre of 1:320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. The patient developed conjunctival pallor. Examination of the rest of the systems was unremarkable. A renal biopsy revealed necrotizing and crescentic pauci-immune glomerulonephritis. Treatment included hemodialysis, intravenous (IV) methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus and kidney involvement, the patient did not have any evidence of any other organ involvement. The patient was diagnosed with antineutrophil cytoplasmic antibody-associated vasculitis (AAV), disease type GPA (granulomatosis with polyangiitis), ANCA type p/MPO (perinuclear myeloperoxidase). At three months after therapy, the patient was still dialysis-dependent and developed end-stage renal disease (ESRD) and achieved disease remission. Outcome was not reported (patient had achieved remission).
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Haemodialysis, Nausea, Oesophagogastroduodenoscopy abnormal, Plasmapheresis, Proteinuria
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns an active 75 year old female who had a medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl. On an unspecified date, in September 2012, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, four weeks after the influenza vaccination in September 2012, the patient developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl. The patient complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis, and was treated with omeprazole. Her nausea improved, but continued with poor appetite and lost 17 pounds. In January 2013, the patient was evaluated for acute kidney injury. Her blood work in January (unspecified year) 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 4 positive perinuclear ANCA (antineutrophil cytoplasmic antibody) at a titre of 1:320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. The patient developed conjunctival pallor. Examination of the rest of the systems was unremarkable. A renal biopsy revealed necrotizing and crescentic pauci-immune glomerulonephritis. Treatment included hemodialysis, intravenous (IV) methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus and kidney involvement, the patient did not have any evidence of any other organ involvement. The patient was diagnosed with antineutrophil cytoplasmic antibody-associated vasculitis (AAV), disease type GPA (granulomatosis with polyangiitis), ANCA type p/MPO (perinuclear myeloperoxidase). At three months after therapy, the patient was still dialysis-dependent and developed end-stage renal disease (ESRD) and achieved disease remission. Outcome was not reported (patient had achieved remission).
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Renal failure acute, Renal failure chronic, Scab, Sinus disorder, Urinary casts present
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns an active 75 year old female who had a medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl. On an unspecified date, in September 2012, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, four weeks after the influenza vaccination in September 2012, the patient developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl. The patient complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis, and was treated with omeprazole. Her nausea improved, but continued with poor appetite and lost 17 pounds. In January 2013, the patient was evaluated for acute kidney injury. Her blood work in January (unspecified year) 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 4 positive perinuclear ANCA (antineutrophil cytoplasmic antibody) at a titre of 1:320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. The patient developed conjunctival pallor. Examination of the rest of the systems was unremarkable. A renal biopsy revealed necrotizing and crescentic pauci-immune glomerulonephritis. Treatment included hemodialysis, intravenous (IV) methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus and kidney involvement, the patient did not have any evidence of any other organ involvement. The patient was diagnosed with antineutrophil cytoplasmic antibody-associated vasculitis (AAV), disease type GPA (granulomatosis with polyangiitis), ANCA type p/MPO (perinuclear myeloperoxidase). At three months after therapy, the patient was still dialysis-dependent and developed end-stage renal disease (ESRD) and achieved disease remission. Outcome was not reported (patient had achieved remission).
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Urine analysis abnormal, Weight decreased
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns an active 75 year old female who had a medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl. On an unspecified date, in September 2012, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, four weeks after the influenza vaccination in September 2012, the patient developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl. The patient complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis, and was treated with omeprazole. Her nausea improved, but continued with poor appetite and lost 17 pounds. In January 2013, the patient was evaluated for acute kidney injury. Her blood work in January (unspecified year) 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 4 positive perinuclear ANCA (antineutrophil cytoplasmic antibody) at a titre of 1:320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. The patient developed conjunctival pallor. Examination of the rest of the systems was unremarkable. A renal biopsy revealed necrotizing and crescentic pauci-immune glomerulonephritis. Treatment included hemodialysis, intravenous (IV) methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus and kidney involvement, the patient did not have any evidence of any other organ involvement. The patient was diagnosed with antineutrophil cytoplasmic antibody-associated vasculitis (AAV), disease type GPA (granulomatosis with polyangiitis), ANCA type p/MPO (perinuclear myeloperoxidase). At three months after therapy, the patient was still dialysis-dependent and developed end-stage renal disease (ESRD) and achieved disease remission. Outcome was not reported (patient had achieved remission).
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: This literature report (initial receipt 17-Sep-2013) concerns an active 75 year old female who had a medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl. On an unspecified date, in September 2012, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, four weeks after the influenza vaccination in September 2012, the patient developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl. The patient complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis, and was treated with omeprazole. Her nausea improved, but continued with poor appetite and lost 17 pounds. In January 2013, the patient was evaluated for acute kidney injury. Her blood work in January (unspecified year) 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 4 positive perinuclear ANCA (antineutrophil cytoplasmic antibody) at a titre of 1:320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. The patient developed conjunctival pallor. Examination of the rest of the systems was unremarkable. A renal biopsy revealed necrotizing and crescentic pauci-immune glomerulonephritis. Treatment included hemodialysis, intravenous (IV) methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus and kidney involvement, the patient did not have any evidence of any other organ involvement. The patient was diagnosed with antineutrophil cytoplasmic antibody-associated vasculitis (AAV), disease type GPA (granulomatosis with polyangiitis), ANCA type p/MPO (perinuclear myeloperoxidase). At three months after therapy, the patient was still dialysis-dependent and developed end-stage renal disease (ESRD) and achieved disease remission. Outcome was not reported (patient had achieved remission).
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Blood urea increased, Blood urine present, Conjunctival pallor, Decreased appetite, Dialysis
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns an active 75 year old female who had a medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl. On an unspecified date, in September 2012, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, four weeks after the influenza vaccination in September 2012, the patient developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl. The patient complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis, and was treated with omeprazole. Her nausea improved, but continued with poor appetite and lost 17 pounds. In January 2013, the patient was evaluated for acute kidney injury. Her blood work in January (unspecified year) 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 4 positive perinuclear ANCA (antineutrophil cytoplasmic antibody) at a titre of 1:320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. The patient developed conjunctival pallor. Examination of the rest of the systems was unremarkable. A renal biopsy revealed necrotizing and crescentic pauci-immune glomerulonephritis. Treatment included hemodialysis, intravenous (IV) methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus and kidney involvement, the patient did not have any evidence of any other organ involvement. The patient was diagnosed with antineutrophil cytoplasmic antibody-associated vasculitis (AAV), disease type GPA (granulomatosis with polyangiitis), ANCA type p/MPO (perinuclear myeloperoxidase). At three months after therapy, the patient was still dialysis-dependent and developed end-stage renal disease (ESRD) and achieved disease remission. Outcome was not reported (patient had achieved remission).
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Proteinuria, Red blood cells urine positive, Renal failure acute, Scab, Sinus disorder
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns an active 75 year old female who had a medical history of chronic obstructive pulmonary disease and baseline serum creatinine of 0.7 mg/dl. On an unspecified date, in September 2012, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, four weeks after the influenza vaccination in September 2012, the patient developed progressive fatigue and was found to have an elevated serum creatinine of 1.8 mg/dl. The patient complained of epistaxis, nasal crusting, poor appetite and nausea during this period. She underwent esophagogastroduodenoscopy which revealed duodenitis, and was treated with omeprazole. Her nausea improved, but continued with poor appetite and lost 17 pounds. In January 2013, the patient was evaluated for acute kidney injury. Her blood work in January (unspecified year) 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 4 positive perinuclear ANCA (antineutrophil cytoplasmic antibody) at a titre of 1:320 with a positive myeloperoxidase ELISA at a titer of 78 units. Her antinuclear antibodies and antiglomerular basement membrane antibodies were negative. The patient developed conjunctival pallor. Examination of the rest of the systems was unremarkable. A renal biopsy revealed necrotizing and crescentic pauci-immune glomerulonephritis. Treatment included hemodialysis, intravenous (IV) methyl prednisone followed by oral prednisone, cyclophosphamide and plasmapheresis. Except for sinus and kidney involvement, the patient did not have any evidence of any other organ involvement. The patient was diagnosed with antineutrophil cytoplasmic antibody-associated vasculitis (AAV), disease type GPA (granulomatosis with polyangiitis), ANCA type p/MPO (perinuclear myeloperoxidase). At three months after therapy, the patient was still dialysis-dependent and developed end-stage renal disease (ESRD) and achieved disease remission. Outcome was not reported (patient had achieved remission).
Age: 83.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Microscopic polyangiitis
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns a 83 year old female. On an unspecified date, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, two weeks after receiving the influenza vaccine, the patient developed AAV (Antineutrophil Cytoplasmic Antibody Vasculitis). The disease type was MPA (microscopic polyangiitis). The ANCA (Antineutrophil cytoplasmic antibody) type was MPO (myeloperoxidase). Organs involved included kidney and lung. Treatment included cyclophosphamide (CYC) and prednisone (P). The outcome was not reported (The patient achieved disease remission).
Age: 83.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Lung disorder, Microscopic polyangiitis, Renal disorder
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns a 83 year old female. On an unspecified date, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, two weeks after receiving the influenza vaccine, the patient developed AAV (Antineutrophil Cytoplasmic Antibody Vasculitis). The disease type was MPA (microscopic polyangiitis). The ANCA (Antineutrophil cytoplasmic antibody) type was MPO (myeloperoxidase). Organs involved included kidney and lung. Treatment included cyclophosphamide (CYC) and prednisone (P). The outcome was not reported (The patient achieved disease remission).
Age: 70.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Death, Granulomatosis with polyangiitis, Renal failure chronic
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns a 70 year old male. On an unspecified date, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, three weeks after receiving the influenza vaccine, the patient developed AAV (Antineutrophil Cytoplasmic Antibody Vasculitis). The disease type was GPA (granulomatosis with polyangiitis). ANCA (Antineutrophil cytoplasmic antibody) type was p/MPO (perinuclear myeloperoxidase). Organs involved included the kidney. The patient also developed End Stage Renal Disease (ESRD). Treatment included cyclophosphamide (CYC) and prednisone (P). The outcome was reported as fatal.
Age: 70.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Death, Granulomatosis with polyangiitis, Renal disorder
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns a 70 year old male. On an unspecified date, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, three weeks after receiving the influenza vaccine, the patient developed AAV (Antineutrophil Cytoplasmic Antibody Vasculitis). The disease type was GPA (granulomatosis with polyangiitis). ANCA (Antineutrophil cytoplasmic antibody) type was p/MPO (perinuclear myeloperoxidase). Organs involved included the kidney. The patient also developed End Stage Renal Disease (ESRD). Treatment included cyclophosphamide (CYC) and prednisone (P). The outcome was reported as fatal.
Age: 70.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Renal failure chronic
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns a 70 year old male. On an unspecified date, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, three weeks after receiving the influenza vaccine, the patient developed AAV (Antineutrophil Cytoplasmic Antibody Vasculitis). The disease type was GPA (granulomatosis with polyangiitis). ANCA (Antineutrophil cytoplasmic antibody) type was p/MPO (perinuclear myeloperoxidase). Organs involved included the kidney. The patient also developed End Stage Renal Disease (ESRD). Treatment included cyclophosphamide (CYC) and prednisone (P). The outcome was reported as fatal.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Lung disorder, Microscopic polyangiitis, Plasmapheresis
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns a 55 year old female. On an unspecified date, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, three weeks after receiving the influenza vaccine, the patient developed AAV (Antineutrophil Cytoplasmic Antibody Vasculitis). The disease type was MPA (microscopic polyangiitis). The ANCA (Antineutrophil cytoplasmic antibody) type was p/MPO (perinuclear myeloperoxidase). Organs involved included kidney and lung. Treatment included cyclophosphamide (CYC), prednisone (P) and plasma exchange (PE). The patient was dialysis-independent. The outcome was not reported (The patient achieved disease remission).
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Renal disorder
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns a 55 year old female. On an unspecified date, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date, three weeks after receiving the influenza vaccine, the patient developed AAV (Antineutrophil Cytoplasmic Antibody Vasculitis). The disease type was MPA (microscopic polyangiitis). The ANCA (Antineutrophil cytoplasmic antibody) type was p/MPO (perinuclear myeloperoxidase). Organs involved included kidney and lung. Treatment included cyclophosphamide (CYC), prednisone (P) and plasma exchange (PE). The patient was dialysis-independent. The outcome was not reported (The patient achieved disease remission).
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Contusion, Injection site mass, Muscle spasms, Neck pain
Clinical narrative: Pain down arm, pain in elbow, deep purple bruise (lasted for 9 days) large lump at injection site, neck pain on side of injection, spasms in deltoid muscle down arm radiating to the hand, pain during night-causing me to wake, easily bruised, deep purple bruises-causes unknown.