chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare worker and the patient refers to a 51 year old female patient with no drug reactions/allergies. On 18-SEP-2013 the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (lot # reported as J004332; expire on 26-SEP-2014) (route not reported). Concomitant therapies included Flu vaccine (manufacturer unknown). Healthcare worker reported on 18-SEP-2013 the patient's "whole upper arm" was very tender, red, swollen and hot to touch, after she received PNEUMOVAX23. Patient went to an urgent care facility and was diagnosed with a "bacterial infection" of the upper arm and was treated with an unspecified steroid and an antibiotic injection and was given prescriptions for Prednisone and an unspecified antibiotic. Healthcare worker requested a lot check for lot # J004332 (exp. date 26-SEP-2014). It was also reported from the patient who explained that she also received an unspecified Flu vaccine on the day of vaccination with PNEUMNOVAX23 in the opposite arm, with no symptoms in the arm that received the flu vaccine. The patient also explained that she's had previous Pneumonia vaccines before without adverse reactions. Patient has also requested a lost check being done of the vaccine to determine if there were any irregularities with this vaccine, as she's never responded this way to this type of product and has no known medication allergies. At the time of reporting, the outcome was unknown. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Bacterial infection, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a healthcare worker and the patient refers to a 51 year old female patient with no drug reactions/allergies. On 18-SEP-2013 the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (lot # reported as J004332; expire on 26-SEP-2014) (route not reported). Concomitant therapies included Flu vaccine (manufacturer unknown). Healthcare worker reported on 18-SEP-2013 the patient's "whole upper arm" was very tender, red, swollen and hot to touch, after she received PNEUMOVAX23. Patient went to an urgent care facility and was diagnosed with a "bacterial infection" of the upper arm and was treated with an unspecified steroid and an antibiotic injection and was given prescriptions for Prednisone and an unspecified antibiotic. Healthcare worker requested a lot check for lot # J004332 (exp. date 26-SEP-2014). It was also reported from the patient who explained that she also received an unspecified Flu vaccine on the day of vaccination with PNEUMNOVAX23 in the opposite arm, with no symptoms in the arm that received the flu vaccine. The patient also explained that she's had previous Pneumonia vaccines before without adverse reactions. Patient has also requested a lost check being done of the vaccine to determine if there were any irregularities with this vaccine, as she's never responded this way to this type of product and has no known medication allergies. At the time of reporting, the outcome was unknown. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Laboratory test abnormal
Clinical narrative: This spontaneous report as received from a healthcare worker and the patient refers to a 51 year old female patient with no drug reactions/allergies. On 18-SEP-2013 the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (lot # reported as J004332; expire on 26-SEP-2014) (route not reported). Concomitant therapies included Flu vaccine (manufacturer unknown). Healthcare worker reported on 18-SEP-2013 the patient's "whole upper arm" was very tender, red, swollen and hot to touch, after she received PNEUMOVAX23. Patient went to an urgent care facility and was diagnosed with a "bacterial infection" of the upper arm and was treated with an unspecified steroid and an antibiotic injection and was given prescriptions for Prednisone and an unspecified antibiotic. Healthcare worker requested a lot check for lot # J004332 (exp. date 26-SEP-2014). It was also reported from the patient who explained that she also received an unspecified Flu vaccine on the day of vaccination with PNEUMNOVAX23 in the opposite arm, with no symptoms in the arm that received the flu vaccine. The patient also explained that she's had previous Pneumonia vaccines before without adverse reactions. Patient has also requested a lost check being done of the vaccine to determine if there were any irregularities with this vaccine, as she's never responded this way to this type of product and has no known medication allergies. At the time of reporting, the outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Swelling of eyes and lips. Not sure of time. I haven't called doctor yet. It is 745 and they open at 9. She has no other symptoms that I know of.
Age: 17.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Angioedema
Clinical narrative: Swelling of eyes and lips. Not sure of time. I haven't called doctor yet. It is 745 and they open at 9. She has no other symptoms that I know of.
Age: 17.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Cardiac disorder, Jaw disorder
Clinical narrative: 9-6-13 client c/o "heart did not feel right and jaws did not feel right" at 1140A. After receiving the vaccines named below.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Cheilitis, Pain
Clinical narrative: Rash around lips, aches and pains all over approx 1-2 hrs post vaccine. Dr prescribed BENADRYL and MEDROL Dose Pak.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Electroencephalogram, Full blood count, Hypotonia, Loss of consciousness, Metabolic function test
Clinical narrative: Had vaccines 9-17-13, on 9-18-13 outside playing c/o leg pain, went limp, passed out, out for one minute, came aroung but very sleepy for 20-30 min.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Had vaccines 9-17-13, on 9-18-13 outside playing c/o leg pain, went limp, passed out, out for one minute, came aroung but very sleepy for 20-30 min.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Healthy, stoic 11 year old male received vaccines, walked out, within 10 min nauseated, lightheaded, fatigued - unable to return to school. All symptoms cleared in about 3 hours. No previous hx similar. Ate breakfast.
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Joint injury
Clinical narrative: Initial information received from a non-healthcare professional who is the patient on 12 September 2013 via another manufacturer. This reporter also reported another adverse event which is captured in case number 2013-09547. The reporter is the patient's mother. The reporter received an unspecified TDAP vaccine on an unreported date. The batch, dose and route were not reported. The patient experienced an unspecified severe allergic reaction after receiving TDAP vaccine. The patient received the vaccine into her shoulder, side not specified, which according to the reporter may be "other than indicated". Following administration at an unreported time, the patient "blew out her shoulder" and was hospitalized at an unspecified hospital for an unspecified amount of time. The patient and her son have a history of severe allergy to nickel. No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: TDAP
Symptoms: Eczema, Hypersensitivity, Seborrhoeic dermatitis, Vomiting projectile
Clinical narrative: Initial information received from a non-healthcare professional who is the mother of the patient on 12 September 2013 via another manufacturer. This reporter also reported another adverse event which is captured in case number 2013-09546. The reporter is the patient. An unidentified male patient received an unspecified TDAP vaccine on an unreported date. The batch, dose and route were not reported. The patient experienced an unspecified severe allergic reaction after receiving TDAP. On an unspecified date, the patient experienced severe cradle cap, eczema on his face, legs and arms and projectile vomiting. The patient and mother have a history of a severe allergy to nickel. No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: None.
Age: 38.0
Sex: M
Vaccine: TTOX
Symptoms: Anaphylactic reaction, Mechanical ventilation
Clinical narrative: Initial report received from a healthcare professional (physician) on 17 September 2013 via another manufacturer. An unidentified 38 year old male patient had received an unspecified Tetanus booster, dose, route and site of administration were not reported, approximately 10 years ago, date not specified. On an unreported date, the patient experienced an anaphylactic reaction and wound up on a ventilator in the hospital. The dates of hospitalization were not reported. The patient's concomitant medications and medical history were not reported. Laboratory data was not reported or the duration of his stay in the hospital. The patient outcome was not reported. No further details were available at the time of this report. Documents held by sender: None.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Left arm edema - redness - erythema, warm to touch, itching. Noted at site where PNEUMOVAX was given.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema over right shoulder.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation
Clinical narrative: Inflammed back.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen at vaccine site, (left arm) not itchy, warm to touch 4 inches across (redness). 9/4: pt saw other RPh, who said see MD cellulitis diagnosis started ampicillin/AUGMENTIN 9/4/13.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient with no pertinent medical history and none drug reactions/allergies. On 30-AUG-2013 the patient ws vaccinated subcutaneously with a dose of ZOSTAVAX lot # J003359, expiry date 21-JUN-2014, 0.65 ml. There was none concomitant medication. On unknown date in 2013, after receiving ZOSTAVAX, the patient experienced itching (no rash) on arm at the injection site. The patient sought medical attention by calling pharmacy. There were no lab diagnostics studies performed and no treatment was given for adverse event. The outcome of itching on arm at the injection site was reported as not recovered. The relatedness between ZOSTAVAX and adverse event was not provided. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Symptoms and Signs: Right thigh is tender to touch, swelling and redness. Time Course: The symptoms were noticed on the night of 9/10/13. Treatment: Bactrim and Clindamycin for 7 days.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Injection site; red and swollen at onset of injection rash to head and neck - pt used BENADRYL without relief of symptoms and made appt with physician.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Nausea, Similar reaction on previous exposure to drug
Clinical narrative: Redness, swelling at site, slight nausea. Mother states she had the same type reaction to the flu vaccine last year. Area red, raised 2 inch in diameter. Encouraged ice thru today. Instructed to call clinic if redness increases. Directed to ER if worsening symptoms.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling, Pain, Rash, Swelling
Clinical narrative: This spontaneous report as received from a physician refers to an approximately 25 year old female nurse with no pertinent medical history. On 01-SEP-2013 the patient was vaccinated with a dose of GARDASIL, injection (lot #, expiration, dose unspecified), intramuscularly in the lower aspect of the lateral side of an unspecified leg. In September 2013 the patient complained of pain and swelling when walking. Physician stated after the injectio non 01-SEP-2013, the nurse stated the injection site hurt and the pain had progressively been getting worse along with swelling. The reporter also stated that the patient had experienced a rash from amoxicillin (manufacturer unknown) and LEVAQUIN. No lab diagnostics studies performed. The patient sought medical attention via office visit. No treatment was given. The event outcome was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via field employee refers to 3 patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (vial, strength, formulation, lot#, dose/frequency, route and duration were unspecified). The patients developed a rash at the injection site after receiving ZOSTAVAX (an unknown date). Patient had sought medical attention via contacting pharmacist. VZVIP packet faxed. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot number, dose, route and indication were not provided). The nurse reported that GARDASIL had been stored in the original box at temperatures between 2C to 8C, however, the lid of the GARDASIL box had been removed. GARDASIL had been exposed to an unspecified amount of light for an unspecified amount of time when the refrigerator door was periodically opened. This GARDASIL had been administered to an unspecified number of unspecified patients on unspecified dates. No adverse effects reported. The outcome and action taken were not provided. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial and follow-up information has been received from a registered nurse, concerning a patient of unknown age and gender, who on 09-AUG-2013, was vaccinated with a dose of GARDASIL (lot # H020002, exp: 08-AUG-2015) 0.5 ml, intramuscularly, which was improperly stored. The nurse reported that GARDASIL was exposed to a temperature of 62F for 360 hours from 06-AUG-2013 to 20-AUG-2013. The nurse did not have patient or physician details available at the time of call. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Inflammation, Pain, Pneumonia, Skin warm
Clinical narrative: Pt is a 78 year 2 month old, female is here for called stated 9/19 that she had pneumonia and flu shot recently and left arm is inflamed hot and achy plan to give KEFLEX for cellulitis and note that it will increase the pt INR of the COUMADIN so watch this I will set up RTC in 2 wks or sooner if not better.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old patient of unknown gender. On an unknown date, the 13 year old patient was vaccinated with a dose of PROQUAD, dose, route and lot # not reported. IT was not known if this was the first dose of PROQUAD this patient was administered. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patient's. Between dates 02-AUG-2013 and 09-AUG-2013 the patients might have been administered expired M-M-R II  lot # 1251AA, expiry date 01-AUG-2013, dose and route not provided. No adverse effects were reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 64 year old male patient. The patient had no pertinent medical history and no drug reactions/allergies. On 09-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # unspecified) (dose, route and location unspecified). Concomitant therapies included with LEXAPRO, LOVAZA, and vitamin E. On 09-SEP-2013 the patient was developed body aches, fever, malaise and rash on his legs and left thorax after receiving a dose of ZOSTAVAX on 09-SEP-2013 at a pharmacy. The patient was seen by his physician on 10-SEP-2013 and instructed to rest and increase his fluids. No lab diagnostic study was performed. At the time of report, the outcome of the events was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 4 unspecified patients of unknown age and gender. In September 2013 (thin the last 2 weeks), the patients were vaccinated with the dose of PNEUMOVAX23 (dose, lot number and route of administration were not reported). In September 2013 (within the week after receiving the vaccine) the patients developed cellulitis. The patient sought medical attention (unspecified). The outcome of cellulitis was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling, redness, warm to touch at injection site. No treatment necessary. Resolved on its own.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Influenza like illness, Nausea, Pain, Pruritus
Clinical narrative: Flu-like pain; temperature - 99-100 degrees; itching skin; sick to stomach - vomiting until following morning. (BENADRYL taken day after to relieve itching).
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Flu-like pain; temperature - 99-100 degrees; itching skin; sick to stomach - vomiting until following morning. (BENADRYL taken day after to relieve itching).
Age: 41.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Induration
Clinical narrative: Employee had reddened firm area measuring 6 x 5". Referred to PCP for follow up.
Age: 17.0
Sex: F
Vaccine: FLUX, HEP, MMR, TDAP, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test negative
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 17 year old female patient who had x-rays performed on 05-DEC-2011 and also on 05-DEC-2011, was vaccinated with a dose of VARIVAX (Merck), a Pregnancy Registry Product, (dose, route and lot number not reported). Other suspect therapy included MMR vaccine, hepatitis B virus vaccine (manufacturer unknown), influenza virus vaccine (manufacturer unknown). Concomitant therapy included Tdap. It was reported that the patient who stated that she was not pregnant, on 05-DEC-2011, received VARIVAX (Merck), MMR vaccine, hepatitis B virus vaccine (manufacturer unknown), influenza virus vaccine (manufacturer unknown), Tdap. The patient tested positive for pregnancy on 10-JAN-2012. Her last menstrual period was on 22-NOV-2011. Estimated delivery date was 28-AUG-2012. No adverse events seen. The patient sought medical attention, she came for pregnancy test. Follow up information has been received from the registered nurse who reported that she was not certain if the patient was given her first or second dose of VARIVAX (Merck), but stated that the health department only administrated one dose by their accounts. It was reported that the patient gave birth to a healthy baby (sex not known) on 22-AUG-2012 at 40 weeks gestation. The patient's vaginal delivery was uncomplicated and the baby weighed 8 lbs., 5 oz. and had no congenital anomalies. There was no other delivery record information available to report. Additional information is not expected.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Nausea, Pain
Clinical narrative: Throbbing all night; nausea; severe pain; redness down arm from shoulder to elbow.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Patient went to MD- he looked at the area which was red and swollen and said she had an adverse reaction . No TX was prescribed. She used warm compresses which helped.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Pyrexia, Somnolence, Vomiting projectile, X-ray normal
Clinical narrative: Received 4 mo. vaccines on 9/11/13. MOC called reporting increased sleep and fever 100.4 on 9/12/13 - early in day. In PM of 9/12 pt was projectile vomiting. Triaged in office by doc who sent to ER for eval/OBS. AGE dx - started on rehydration in ER. Abd. X-ray normal - ruled out intussusception.
Age: 0.51
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site induration, Injection site mass, Injection site nodule, Injection site reaction, Skin disorder
Clinical narrative: Right thigh "knot" which developed into subcutaneous firm approx. 1.5cm mass with overlying skin dimple.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Oral mucosal blistering, Pain
Clinical narrative: Temp. 101-103.4-cellulitis L upper arm. Body and muscle aches. Blisters inside mouth. Symptoms lasted 72 hours.
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 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: Blood creatinine increased, Blood urea increased, Blood urine present, Conjunctival pallor, Decreased appetite
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: Duodenitis, Epistaxis, Fatigue, Glomerulonephritis rapidly progressive, Haematuria
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: Haemodialysis, Nausea, Oesophagogastroduodenoscopy abnormal, Plasmapheresis, Protein urine present
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, Renal failure chronic, Scab
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: Urinary casts present, Urine analysis abnormal, Weight decreased
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: Blood creatinine increased, Blood urea increased, Conjunctival pallor, Decreased appetite, Duodenitis
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: Epistaxis, Fatigue, Glomerulonephritis rapidly progressive, Granulomatosis with polyangiitis, Haematuria
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: Haemodialysis, Nausea, Oesophagogastroduodenoscopy abnormal, Plasmapheresis, Proteinuria
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: Renal failure acute, Renal failure chronic, Scab, Sinus disorder, Urinary casts present
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: Urine analysis abnormal, Weight decreased
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: Anti-glomerular basement membrane antibody negative, Antineutrophil cytoplasmic antibody positive, Antinuclear antibody negative, 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 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.