chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Blood urea increased, Blood urine present, Conjunctival pallor, Decreased appetite, Dialysis
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 75-year-old female subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). The subject's medical history included chronic obstructive pulmonary disease. In August 2012, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, site of injection and batch number). 4 weeks after vaccination with Influenza vaccine (unspecified), the subject developed progressive fatigue and was found to have an elevated serum creatinine. She also complained of epistaxis, nasal crusting, poor appetite and nausea. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. In January 2013, 5 months after vaccination with Influenza vaccine (unspecified), the subject was evaluated for acute kidney injury. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA. 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. The subject was diagnosed as having ANCA associated vasculitis (AAV) (p/myeloperoxidase type). This case was assessed as medically serious by GSK. The subject was treated with hemodialysis, Methylprednisone, prednisone, cyclophosphamide and Plasmapheresis. After three months of therapy, the subject was still dialysis dependent. At the time of reporting, the subject was in a end-stage renal disease. The temporal association of AAV to influenza vaccination suggests that the vaccine might serve as a trigger for development of AAV in predisposed individuals.
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 case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 75-year-old female subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). The subject's medical history included chronic obstructive pulmonary disease. In August 2012, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, site of injection and batch number). 4 weeks after vaccination with Influenza vaccine (unspecified), the subject developed progressive fatigue and was found to have an elevated serum creatinine. She also complained of epistaxis, nasal crusting, poor appetite and nausea. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. In January 2013, 5 months after vaccination with Influenza vaccine (unspecified), the subject was evaluated for acute kidney injury. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA. 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. The subject was diagnosed as having ANCA associated vasculitis (AAV) (p/myeloperoxidase type). This case was assessed as medically serious by GSK. The subject was treated with hemodialysis, Methylprednisone, prednisone, cyclophosphamide and Plasmapheresis. After three months of therapy, the subject was still dialysis dependent. At the time of reporting, the subject was in a end-stage renal disease. The temporal association of AAV to influenza vaccination suggests that the vaccine might serve as a trigger for development of AAV in predisposed individuals.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Fatigue, Gait disturbance, Myalgia
Clinical narrative: Patient had severe muscle and joint pain, weakness, tiredness and was shaky walking. These symptoms began on 9/8/13 and continued to worsen. Emergency room visit was on 9/9/13. Taken by ambulance. Patient was given shot of Hydromorphone (Dilaudid 1 mg) at 7:03 PM.
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: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 50-year-old male subject who was vaccinated with influenza (unspecified), manufacturer unspecified). In October 1997, the subject received unspecified dose of influenza (unspecified) (unknown route, site of injection and batch number). In October 1997, 2 days after vaccination with influenza (unspecified), the subject experienced fatigue, chills and low-grade fevers. Two weeks after vaccination with influenza (unspecified), the subject was noted to have microscopic hematuria. Renal biopsy revealed necrotizing vasculitis and focal necrotizing pauci-immune glomerulonephritis. The subject was diagnosed as having ANCA associated vasculitis (AAV) (type: cytoplasmic/proteinase 3) and granulomatosis with polyangiitis. Over the next 4 weeks after vaccination with influenza (unspecified), he experienced worsening joint pains and muscle aches. His physical exam was notable for splinter hemorrhages in his finger nails, but the rest of his exam was unremarkable. This case was assessed as medically serious by GSK. The subject was treated with prednisone and cyclophosphamide. After achievement of remission of his vasculitis, he was switched to azathioprine for maintenance of remission. In October 2012, his renal function was stable. The temporal association of AAV to influenza vaccination suggests that the vaccine might serve as a trigger for development of AAV in predisposed individuals.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chills, Computerised tomogram thorax normal, Echocardiogram, Echocardiogram normal, Fatigue
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 50-year-old male subject who was vaccinated with influenza (unspecified), manufacturer unspecified). In October 1997, the subject received unspecified dose of influenza (unspecified) (unknown route, site of injection and batch number). In October 1997, 2 days after vaccination with influenza (unspecified), the subject experienced fatigue, chills and low-grade fevers. Two weeks after vaccination with influenza (unspecified), the subject was noted to have microscopic hematuria. Renal biopsy revealed necrotizing vasculitis and focal necrotizing pauci-immune glomerulonephritis. The subject was diagnosed as having ANCA associated vasculitis (AAV) (type: cytoplasmic/proteinase 3) and granulomatosis with polyangiitis. Over the next 4 weeks after vaccination with influenza (unspecified), he experienced worsening joint pains and muscle aches. His physical exam was notable for splinter hemorrhages in his finger nails, but the rest of his exam was unremarkable. This case was assessed as medically serious by GSK. The subject was treated with prednisone and cyclophosphamide. After achievement of remission of his vasculitis, he was switched to azathioprine for maintenance of remission. In October 2012, his renal function was stable. The temporal association of AAV to influenza vaccination suggests that the vaccine might serve as a trigger for development of AAV in predisposed individuals.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Glomerulonephritis rapidly progressive, Granulomatosis with polyangiitis, Haematuria, Myalgia, Pyrexia
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 50-year-old male subject who was vaccinated with influenza (unspecified), manufacturer unspecified). In October 1997, the subject received unspecified dose of influenza (unspecified) (unknown route, site of injection and batch number). In October 1997, 2 days after vaccination with influenza (unspecified), the subject experienced fatigue, chills and low-grade fevers. Two weeks after vaccination with influenza (unspecified), the subject was noted to have microscopic hematuria. Renal biopsy revealed necrotizing vasculitis and focal necrotizing pauci-immune glomerulonephritis. The subject was diagnosed as having ANCA associated vasculitis (AAV) (type: cytoplasmic/proteinase 3) and granulomatosis with polyangiitis. Over the next 4 weeks after vaccination with influenza (unspecified), he experienced worsening joint pains and muscle aches. His physical exam was notable for splinter hemorrhages in his finger nails, but the rest of his exam was unremarkable. This case was assessed as medically serious by GSK. The subject was treated with prednisone and cyclophosphamide. After achievement of remission of his vasculitis, he was switched to azathioprine for maintenance of remission. In October 2012, his renal function was stable. The temporal association of AAV to influenza vaccination suggests that the vaccine might serve as a trigger for development of AAV in predisposed individuals.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Red blood cell sedimentation rate increased, Rheumatoid factor positive, Splinter haemorrhages, Vasculitis necrotising
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 50-year-old male subject who was vaccinated with influenza (unspecified), manufacturer unspecified). In October 1997, the subject received unspecified dose of influenza (unspecified) (unknown route, site of injection and batch number). In October 1997, 2 days after vaccination with influenza (unspecified), the subject experienced fatigue, chills and low-grade fevers. Two weeks after vaccination with influenza (unspecified), the subject was noted to have microscopic hematuria. Renal biopsy revealed necrotizing vasculitis and focal necrotizing pauci-immune glomerulonephritis. The subject was diagnosed as having ANCA associated vasculitis (AAV) (type: cytoplasmic/proteinase 3) and granulomatosis with polyangiitis. Over the next 4 weeks after vaccination with influenza (unspecified), he experienced worsening joint pains and muscle aches. His physical exam was notable for splinter hemorrhages in his finger nails, but the rest of his exam was unremarkable. This case was assessed as medically serious by GSK. The subject was treated with prednisone and cyclophosphamide. After achievement of remission of his vasculitis, he was switched to azathioprine for maintenance of remission. In October 2012, his renal function was stable. The temporal association of AAV to influenza vaccination suggests that the vaccine might serve as a trigger for development of AAV in predisposed individuals.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Antineutrophil cytoplasmic antibody positive, Arthralgia, Biopsy kidney abnormal, Blood creatinine increased, Blood culture negative
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 50-year-old male subject who was vaccinated with influenza (unspecified), manufacturer unspecified). In October 1997, the subject received unspecified dose of influenza (unspecified) (unknown route, site of injection and batch number). In October 1997, 2 days after vaccination with influenza (unspecified), the subject experienced fatigue, chills and low-grade fevers. Two weeks after vaccination with influenza (unspecified), the subject was noted to have microscopic hematuria. Renal biopsy revealed necrotizing vasculitis and focal necrotizing pauci-immune glomerulonephritis. The subject was diagnosed as having ANCA associated vasculitis (AAV) (type: cytoplasmic/proteinase 3) and granulomatosis with polyangiitis. Over the next 4 weeks after vaccination with influenza (unspecified), he experienced worsening joint pains and muscle aches. His physical exam was notable for splinter hemorrhages in his finger nails, but the rest of his exam was unremarkable. This case was assessed as medically serious by GSK. The subject was treated with prednisone and cyclophosphamide. After achievement of remission of his vasculitis, he was switched to azathioprine for maintenance of remission. In October 2012, his renal function was stable. The temporal association of AAV to influenza vaccination suggests that the vaccine might serve as a trigger for development of AAV in predisposed individuals.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Glomerulonephritis, Haematuria, Myalgia, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 50-year-old male subject who was vaccinated with influenza (unspecified), manufacturer unspecified). In October 1997, the subject received unspecified dose of influenza (unspecified) (unknown route, site of injection and batch number). In October 1997, 2 days after vaccination with influenza (unspecified), the subject experienced fatigue, chills and low-grade fevers. Two weeks after vaccination with influenza (unspecified), the subject was noted to have microscopic hematuria. Renal biopsy revealed necrotizing vasculitis and focal necrotizing pauci-immune glomerulonephritis. The subject was diagnosed as having ANCA associated vasculitis (AAV) (type: cytoplasmic/proteinase 3) and granulomatosis with polyangiitis. Over the next 4 weeks after vaccination with influenza (unspecified), he experienced worsening joint pains and muscle aches. His physical exam was notable for splinter hemorrhages in his finger nails, but the rest of his exam was unremarkable. This case was assessed as medically serious by GSK. The subject was treated with prednisone and cyclophosphamide. After achievement of remission of his vasculitis, he was switched to azathioprine for maintenance of remission. In October 2012, his renal function was stable. The temporal association of AAV to influenza vaccination suggests that the vaccine might serve as a trigger for development of AAV in predisposed individuals.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Renal function test normal, Rheumatoid factor positive, Splinter haemorrhages, Vasculitis necrotising
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 50-year-old male subject who was vaccinated with influenza (unspecified), manufacturer unspecified). In October 1997, the subject received unspecified dose of influenza (unspecified) (unknown route, site of injection and batch number). In October 1997, 2 days after vaccination with influenza (unspecified), the subject experienced fatigue, chills and low-grade fevers. Two weeks after vaccination with influenza (unspecified), the subject was noted to have microscopic hematuria. Renal biopsy revealed necrotizing vasculitis and focal necrotizing pauci-immune glomerulonephritis. The subject was diagnosed as having ANCA associated vasculitis (AAV) (type: cytoplasmic/proteinase 3) and granulomatosis with polyangiitis. Over the next 4 weeks after vaccination with influenza (unspecified), he experienced worsening joint pains and muscle aches. His physical exam was notable for splinter hemorrhages in his finger nails, but the rest of his exam was unremarkable. This case was assessed as medically serious by GSK. The subject was treated with prednisone and cyclophosphamide. After achievement of remission of his vasculitis, he was switched to azathioprine for maintenance of remission. In October 2012, his renal function was stable. The temporal association of AAV to influenza vaccination suggests that the vaccine might serve as a trigger for development of AAV in predisposed individuals.
Age: 83.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Microscopic polyangiitis
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 83-year-old female subject who was vaccinated with Influenza vaccine (unspecified), manufacturer unspecified. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, site of injection and batch number). Two weeks after vaccination with Influenza vaccine (unspecified), the subject experienced anti-neutrophil cytoplasmic antibody positive vasculitis (myeloperoxidase) and microscopic polyangiitis. This case was assessed as medically serious by GSK. The subject was treated with cyclophosphamide and prednisone. At the time of reporting, the subject was in remission. This case is linked to 7 cases coming from the same publication.
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 case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 83-year-old female subject who was vaccinated with Influenza vaccine (unspecified), manufacturer unspecified. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, site of injection and batch number). Two weeks after vaccination with Influenza vaccine (unspecified), the subject experienced anti-neutrophil cytoplasmic antibody positive vasculitis (myeloperoxidase) and microscopic polyangiitis. This case was assessed as medically serious by GSK. The subject was treated with cyclophosphamide and prednisone. At the time of reporting, the subject was in remission. This case is linked to 7 cases coming from the same publication.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Lethargy, Malaise, Pain, Rash erythematous
Clinical narrative: According to patient injection was given near (R) elbow. Red rash over elbow painful not itchy. Pt. lethargic, chills, stated "just don't feel well".
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a female with no pertinent medical history who on 07-JUL-2011 was vaccinated IM with the second dose of 0.5 ml dose of GARDASIL (lot # not reported) and was pregnant. Pregnancy was confirmed by ultrasound. The patient was currently 6 weeks along and her last menstrual cycle was on 22-JUN-2011. The estimated delivery date was 28-MAR-2012. The patient was not experiencing any adverse effects. The patient contacted the physician. No treatment was given to the patient. This is one of several reports received from the same source. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Condition aggravated, Granulomatosis with polyangiitis, Lung disorder
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 67-year-old female subject who was vaccinated with influenza (unspecified), manufacturer unspecified). Concurrent medical conditions included anti-neutrophil cytoplasmic antibody positive vasculitis. On an unspecified date, the subject received unspecified dose of influenza (unspecified) (unknown route, site of injection and batch number). 12 days after vaccination with influenza (unspecified), the subject experienced a relapse of anti-neutrophil cytoplasmic antibody positive vasculitis (cytoplasmic/proteinase 3) and granulomatosis with polyangiitis. The organs involved were the kidney and the lung. This case was assessed as medically serious by GSK. The subject was treated with cyclophosphamide and prednisone. At the time of reporting, the subject was in remission. This case is linked to 7 cases coming from the same publication.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Renal disorder
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 67-year-old female subject who was vaccinated with influenza (unspecified), manufacturer unspecified). Concurrent medical conditions included anti-neutrophil cytoplasmic antibody positive vasculitis. On an unspecified date, the subject received unspecified dose of influenza (unspecified) (unknown route, site of injection and batch number). 12 days after vaccination with influenza (unspecified), the subject experienced a relapse of anti-neutrophil cytoplasmic antibody positive vasculitis (cytoplasmic/proteinase 3) and granulomatosis with polyangiitis. The organs involved were the kidney and the lung. This case was assessed as medically serious by GSK. The subject was treated with cyclophosphamide and prednisone. At the time of reporting, the subject was in remission. This case is linked to 7 cases coming from the same publication.
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 case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 70-year-old male subject who was vaccinated with Influenza vaccine (unspecified) (unknown route, site of injection and batch number). On on unspecified date, the subject received unspecified dose of influenza vaccine (unspecified) (unknown route, site of injection and batch number). Three weeks after vaccination with Influenza vaccine (unspecified), the subject experienced anti-neutrophil cytoplasmic antibody positive vasculitis (perinuclear/myeloperoxidase), granulomatosis with polyangiitis which led to a end-stage renal disease. The kidney was the only organ involved. The subject was treated with cyclophosphamide and prednisone. At an unspecified date, the subject died. In the article, the cause of death of two fatal cases was reported (refractory vasculitis and bilateral pneumonia). However, no precision was available to link this case to one these two reported causes of death. This case is linked to 7 cases coming from the same publication.
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 case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 70-year-old male subject who was vaccinated with Influenza vaccine (unspecified) (unknown route, site of injection and batch number). On on unspecified date, the subject received unspecified dose of influenza vaccine (unspecified) (unknown route, site of injection and batch number). Three weeks after vaccination with Influenza vaccine (unspecified), the subject experienced anti-neutrophil cytoplasmic antibody positive vasculitis (perinuclear/myeloperoxidase), granulomatosis with polyangiitis which led to a end-stage renal disease. The kidney was the only organ involved. The subject was treated with cyclophosphamide and prednisone. At an unspecified date, the subject died. In the article, the cause of death of two fatal cases was reported (refractory vasculitis and bilateral pneumonia). However, no precision was available to link this case to one these two reported causes of death. This case is linked to 7 cases coming from the same publication.
Age: 70.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Renal failure chronic
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 70-year-old male subject who was vaccinated with Influenza vaccine (unspecified) (unknown route, site of injection and batch number). On on unspecified date, the subject received unspecified dose of influenza vaccine (unspecified) (unknown route, site of injection and batch number). Three weeks after vaccination with Influenza vaccine (unspecified), the subject experienced anti-neutrophil cytoplasmic antibody positive vasculitis (perinuclear/myeloperoxidase), granulomatosis with polyangiitis which led to a end-stage renal disease. The kidney was the only organ involved. The subject was treated with cyclophosphamide and prednisone. At an unspecified date, the subject died. In the article, the cause of death of two fatal cases was reported (refractory vasculitis and bilateral pneumonia). However, no precision was available to link this case to one these two reported causes of death. This case is linked to 7 cases coming from the same publication.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Chest pain, Guillain-Barre syndrome, Hypoaesthesia, Neck pain
Clinical narrative: Pt reports he was diagnosed with Guillain-Barre Syndrome on follow up phone call yesterday (9/23/13). Started having neck pain / back pain / chest pain / numbness on 9/13/13. Was returned to ER - pt went but didn't stay because of cost on 9/17/13. Went back to urgent care on 9/18/13. Came back to work on 9/20/13. Went back to ER - was hospitalized thereafter for worsening symptoms.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Granulomatosis with polyangiitis, Lung disorder, Renal disorder
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 28-year-old female subject who was vaccinated with Influenza vaccine (unspecified), (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, site of injection and batch number). Two weeks after vaccination with Influenza vaccine (unspecified), the subject experienced anti-neutrophil cytoplasmic antibody positive vasculitis (cytoplasmic/ proteinase 3) and granulomatosis with polyangiitis. The kidney and the lung were the organs which were implicated. This case was assessed as medically serious by GSK. The subject was treated with cyclophosphamide and prednisone. At the time of reporting, the subject was in remission. This case is linked to 7 cases coming from the same publication.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Feeling hot, Retching
Clinical narrative: Patient coughed and gagged for 30 minutes after administration. Also complained of "hot" throat for a few hours after administration.
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 case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 55-year-old female subject who was vaccinated with Influenza vaccine (unspecified), manufacturer unspecified). On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, site of injection and batch number). Three weeks after vaccination with Influenza vaccine (unspecified), the subject experienced anti-neutrophil cytoplasmic antibody positive vasculitis (perinuclear/myeloperoxidase) and microscopic polyangiitis. The kidney and the lung were the organs which were implicated. This case was assessed as medically serious by GSK. The subject was treated with cyclophosphamide, prednisone and plasma exchange. At the time of reporting, the subject was in remission and dialysis independent. This case is linked to 7 cases coming from the same publication.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Renal disorder
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 55-year-old female subject who was vaccinated with Influenza vaccine (unspecified), manufacturer unspecified). On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, site of injection and batch number). Three weeks after vaccination with Influenza vaccine (unspecified), the subject experienced anti-neutrophil cytoplasmic antibody positive vasculitis (perinuclear/myeloperoxidase) and microscopic polyangiitis. The kidney and the lung were the organs which were implicated. This case was assessed as medically serious by GSK. The subject was treated with cyclophosphamide, prednisone and plasma exchange. At the time of reporting, the subject was in remission and dialysis independent. This case is linked to 7 cases coming from the same publication.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea
Clinical narrative: All over muscle soreness; nausea.
Age: 1.16
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Anaphylactic reaction, Face oedema, Respiratory tract oedema, Stridor, Urticaria
Clinical narrative: 5 min after vaccines - pt. with severe respiratory and abd. anaphylaxis with facial/airway edema, stridor and multiple emesis, urticaria all over body. 0.15mg Epi given and EMS called for transport to hosp.
Age: 1.16
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: 5 min after vaccines - pt. with severe respiratory and abd. anaphylaxis with facial/airway edema, stridor and multiple emesis, urticaria all over body. 0.15mg Epi given and EMS called for transport to hosp.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: Information has been received from a physician concerning a female patient who was known to be pregnant, in 1970 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (HSA). It was unknown if the patient had sought medical attention. Follow up information has been received from the physician who stated that the patient received the measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine (Wistar RA 27/3) (HSA) vaccine in the late 1970's. The physician did not remember the name or date of birth of the patient. The physician stated that the patient was an 18 year old mentally retarded female. The father of the baby was a 19 year old mildly retarded male. The physician stated that the patient decided to continue the pregnancy. The physician stated that the baby was normal. The physician followed the baby for two years and the child was developing "ok" with no sequelae from the measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (HSA) vaccine.  This was one of the several reports received from the same source. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling, redness, warm to touch at site of injection. Pt was seen at MD office a few days later and was given Prednisone.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Bedridden, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Bedridden due to flu like symptoms, fever, aches, headache, congestion in head.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Sinus congestion
Clinical narrative: Bedridden due to flu like symptoms, fever, aches, headache, congestion in head.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain, Swelling
Clinical narrative: Tdap 0.5 cc IM, R deltoid. Hard/painful w/swelling. Erythema 50cm x 30cm. No SOB. Wheeze. Airway open.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Red, warm, itchy and swollen injection site. Hives to left shoulder and upper back.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Red, warm, itchy and swollen injection site. Hives to left shoulder and upper back.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Local swelling, Pain in extremity, Pruritus
Clinical narrative: Patient's arm was sore, it swelled to twice it's normal size, and was itchy. This happened the evening of the shot, around 1 or 2 PM. By 9 AM the next day, patient was already feeling better.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site rash, Pain, Swelling
Clinical narrative: Swelling, soreness, chills - Wed night 9-11-13 rash, redness on arm between shoulder and elbow - Thurs, Friday 9-12-13 to 9-13-13. Sat - came in and it looked a lot better - he took some BENADRYL. Left arm - Pneumococcal. 9-18-13 patient is doing great!
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Pain in extremity
Clinical narrative: About 48 hrs after vaccine administered, patient complained about a sore arm. She said it felt pain like a tetanus shot. She 2 red rash around the injection site. I checked on her the next day and the pain was better and rash cleared.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Vaccinated 8/27/13 - evening. 5PM - all evening - very painful, stiff, starting from injection site to elbow. No swelling - just pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Nasopharyngitis, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a nurse referring on herself a female patient of currently 61 year old with urine uric acid, herpes simplex from some time ago and about 44 years ago had small pox injection as treatment for herpes outbreak, sensitivity to HALCION and PERCOCET. On 26-AUG-2013, the patient was vaccinated with ZOSTAVAX, vial 19400 PFU for prevention of shingles, lot number, dose and route were not reported. Concomitant therapies included allopurinol (manufacturer unknown), vitamin d (manufacturer unknown), ESTRACE, and omeprazole (manufacturer unknown). Approximately in August 2013, the patient experienced symptoms after receiving the ZOSTAVAX vaccination including vesicles on her left foot that reminded her of past Herpes Simplex outbreaks, two painful areas on her back near the armpit that ware red and itchy. Since the reporter had VALTREX in her home, she decided to take it to arrest any further outbreak. The patient reported that she developed cold symptoms after being on ZOSTATAV. The patient did not seek medical attention and did not plan to. None diagnostic studies were performed. The outcome of the events was reported as not recovered. The relation between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Warm, redness, swollen left arm.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Myalgia, Pain, Pyrexia
Clinical narrative: Bilateral chest tightness, fever, aches, muscle soreness, fever 101 at home. Injection 7/22/13. Seen by MD 7/23/13.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site swelling
Clinical narrative: Pt got severe swelling at injection site (size of half of a plum) within 30 sec. of administration. Once pt complained of SOB - EPIPEN was administered and swelling slow down instantly.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Muscle spasms, Nausea, Vomiting
Clinical narrative: Severe nausea, vomiting, diarrhea. Cramping diarrhea lasting several more days - Rx with antidiarrhea med for 2 doses.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Pain, Pyrexia
Clinical narrative: Chills, cough, low grade fever, soreness, headache like the worst case of the flu I have ever had.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Feeling cold, Headache, Pain, Tremor
Clinical narrative: Patient's wife called, said patient is shaking uncontrollably, cold to the touch, and is sick to the stomach. She also reported he was achy all over. Patient and his wife both received the vaccine a couple hours before and she is feeling fine. I recommended ibuprofen for the achiness. Pt also reported headache - which he normally doesn't get.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Skin irritation, Urticaria
Clinical narrative: Since day of immunization, patient experienced hive-like skin irritations, over several areas of her body. She went to a prompt care for treatment. She still is experiencing in isolated areas. She never had problem with flu shot in the past.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given FLUZONE 0.25 mL at age 4 mos. Manufacturer recommends age 6-35 months of age. Parent informed. No reactions noted.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Administration of Zostavax 9/20/13. Seen in primary care office 9/24/13 with acute outbreak of shingles. Placed on acyclovir and elavil.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Child had FLUMIST 9/23/13. Began having vomiting/diarrhea 9/24/13 AM. Resolved after 3 hrs.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Rash generalised, Rash pruritic
Clinical narrative: Vaccine administered 9/18/2013 patient started to break out with rash 9/19 and by 9/21 rash spread over body (streaks of rash) and became itchy and hot. Patient saw PCP on 9/23 and PCP indicated reaction was from flu vaccine. Started BENADRYL and famotidine.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Feeling hot, Paraesthesia
Clinical narrative: Severe back pain and weakness. Tingling and warm sensations in legs. I've never had neurological problems with my back injury. The sensations were a new experience.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Myalgia, Nausea, Vomiting
Clinical narrative: Ecchymosis at vaccination site, Nausea and vomiting. Myalgias.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Aches all over body and low grade fever, extreme soreness in arm of vaccination, took Aleve at 2:00 AM and fever subsided, still extremely sore...feel sick to my stomach...why such a bad reaction to this shot???
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypoaesthesia, Palpitations, Paraesthesia, Pruritus
Clinical narrative: Hives, itching, tingling, numbness, palpitations, short of breath.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives, itching, tingling, numbness, palpitations, short of breath.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Pallor, Syncope, Tremor
Clinical narrative: 0820 Syncopal episode (approx 2 minutes in length) immediately after being vaccinated with flu vaccine. Two person assist from chair to treatment bed. BP 118/62 HR 80 resp 18. Aware of surroundings. Verbalized needed to get to work. Ammonia capsule used.  0827 after sitting up for 3 minutes and denying dizziness, assisted to waiting area. 0830 summoned to waiting area. Pt seen slumped on chair then experiencing full body tremors for 30 seconds. Sat up and covered face with hands. Pale and diaphoretic. Call placed to  ED and transferred to ED via WC. Offered to call someone for her. She had just sent a text message to her mother.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Abnormal behaviour, Aggression, Anger, Fatigue, Patient restraint
Clinical narrative: Mom states child started acting strange within 1-2 hrs after receiving vaccines.  She started acting tired then started having a "meltdown" and being very angry and physically violent.  They had to restrain her because she was hitting and kicking dad when he was getting her out of the car.  Strange behavior continued at home.  Report was taken two days after vaccinations and mom states she is doing better but still some problems with behavior. Mom states child has a hx of behavior problems.  They will be talking to a counselor to help deal with her.  Mom requested VAERS be submitted.
Age: 55.0
Sex: M
Vaccine: YF
Symptoms: Computerised tomogram normal, Headache, Platelet count decreased, White blood cell count decreased
Clinical narrative: Developed headache at the base of the skull, nape of neck, right side. Subsided as day progressed. Awoke to headache the next morning and has not subsided. Aspirin and acetaminophen have no affect. Ibuprofen does provide relief. Sunday morning, went to ED. CT scan showed no abnormalities, with exception of an area on that side which they said was a normal abmormality subarachonoid granulation. Determined to be musculoskeletal although no injury.  Also, we also found in blood work that platelets and WBC's were abmormally low.  Following up on 9/24 with visit to PCP.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain, Pain in extremity, Skin warm
Clinical narrative: Employeed stated after she wake up Saturday at noon she noticed her left arm was sore. She also stated it was warm to touch, swollen, had a large red circle, and a stinging sensation.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Limb discomfort, X-ray limb normal
Clinical narrative: Pain at site of injection and discomfort left arm with movement. Client saw primary MD and had x-ray left upper arm with neg. results.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Urticaria, Wheezing
Clinical narrative: Child presented with hives over her trunk and face, also some swelling to her hands and feet. She was wheezing but not labored.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Chest pain, Fatigue, Headache, Pain in extremity, Rash pruritic
Clinical narrative: Client received vaccines at County Health Department on 9-19-13.  Per phone call from mom, client woke up at 6:00am on 9-20-13 c/o arms and chest hurting, feeling sluggish. On 9-21-13 client still felt tired.  On 9-22-13 in am client developed an itchy rash that mom thought was chickenpox but the rash went away with Benadryl. A very-itchy hive-like rash still appears when the next dose of Benadryl is due.  Client c/o headache, no cough or fever.  Referred client to a healthcare provider for evaluation.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Sluggishness, Urticaria
Clinical narrative: Client received vaccines at County Health Department on 9-19-13.  Per phone call from mom, client woke up at 6:00am on 9-20-13 c/o arms and chest hurting, feeling sluggish. On 9-21-13 client still felt tired.  On 9-22-13 in am client developed an itchy rash that mom thought was chickenpox but the rash went away with Benadryl. A very-itchy hive-like rash still appears when the next dose of Benadryl is due.  Client c/o headache, no cough or fever.  Referred client to a healthcare provider for evaluation.
Age: 14.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Cellulitis, Herpes zoster, Rash, Varicella virus test positive
Clinical narrative: Herpes zoster in a two dose varicella vaccine recipient who is immunocompromised (lupus, juvenile RA, Sjogren's Syndrome). Location of rash was on right side of face. Also developed cellulitis. Lasted <4 weeks. IV acyclovir given in hospital and continued valacyclovir at home. She reported no history of varicella disease.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abasia, Agitation, Blood culture negative, Blood pressure systolic decreased, Body temperature increased
Clinical narrative: Early a.m., pt c/o dizziness and "hot", crawling to BR; agitated disoriented, delirious, questionable rt sided lip droop. To ER - Brain and Neck CT and Brain/Neck MRI completed to r/o TIA or stroke. All negative. During a.m pt spiked temp to 38.6; and continued delirious with temp spikes;  blood cultures, lab, chest X Ray, Urine cultures drawn all negative;  During nite 09/21/2013, continued to have temps over 38 intermittently despite Tylenol 650 mg q 4 hours.  BP dec to 89/systolic;  IV fluid bolus given. Pt continued to c.o rt upper arm soreness.  Noted approx 3 inch induration around injection site rt deltoid which expanded over next 24 hours to a 4 inch x 8 in area of redness, hot to touch and extreme tenderness.   Additional CBC and Blood cultures drawn. Cultures all negative.  WBC inc to 16,000, with inc neutrophils, inc ESR and inc CRP.  IV antibiotics initiated and IV fluids.   Temp to normal on 9/22/13 and cognition back to baseline.  Discharge early evening 9/22/13 on po cefpodoxime 200 mg q 12 hours and will repeat CBC and CMP in one week.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: C-reactive protein increased, Chest X-ray normal, Computerised tomogram head, Computerised tomogram head normal, Computerised tomogram normal
Clinical narrative: Early a.m., pt c/o dizziness and "hot", crawling to BR; agitated disoriented, delirious, questionable rt sided lip droop. To ER - Brain and Neck CT and Brain/Neck MRI completed to r/o TIA or stroke. All negative. During a.m pt spiked temp to 38.6; and continued delirious with temp spikes;  blood cultures, lab, chest X Ray, Urine cultures drawn all negative;  During nite 09/21/2013, continued to have temps over 38 intermittently despite Tylenol 650 mg q 4 hours.  BP dec to 89/systolic;  IV fluid bolus given. Pt continued to c.o rt upper arm soreness.  Noted approx 3 inch induration around injection site rt deltoid which expanded over next 24 hours to a 4 inch x 8 in area of redness, hot to touch and extreme tenderness.   Additional CBC and Blood cultures drawn. Cultures all negative.  WBC inc to 16,000, with inc neutrophils, inc ESR and inc CRP.  IV antibiotics initiated and IV fluids.   Temp to normal on 9/22/13 and cognition back to baseline.  Discharge early evening 9/22/13 on po cefpodoxime 200 mg q 12 hours and will repeat CBC and CMP in one week.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Culture urine negative, Delirium, Disorientation, Dizziness, Feeling hot
Clinical narrative: Early a.m., pt c/o dizziness and "hot", crawling to BR; agitated disoriented, delirious, questionable rt sided lip droop. To ER - Brain and Neck CT and Brain/Neck MRI completed to r/o TIA or stroke. All negative. During a.m pt spiked temp to 38.6; and continued delirious with temp spikes;  blood cultures, lab, chest X Ray, Urine cultures drawn all negative;  During nite 09/21/2013, continued to have temps over 38 intermittently despite Tylenol 650 mg q 4 hours.  BP dec to 89/systolic;  IV fluid bolus given. Pt continued to c.o rt upper arm soreness.  Noted approx 3 inch induration around injection site rt deltoid which expanded over next 24 hours to a 4 inch x 8 in area of redness, hot to touch and extreme tenderness.   Additional CBC and Blood cultures drawn. Cultures all negative.  WBC inc to 16,000, with inc neutrophils, inc ESR and inc CRP.  IV antibiotics initiated and IV fluids.   Temp to normal on 9/22/13 and cognition back to baseline.  Discharge early evening 9/22/13 on po cefpodoxime 200 mg q 12 hours and will repeat CBC and CMP in one week.