chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 05Feb2021 as dose 2, single (Lot number: EL3247), in left arm and on 12Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Breast cancer history" (unspecified if ongoing); "celiac disease" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE, start date: 07Sep2021, stop date: 18May2022; ZOLOFT, start date: 17Aug2021, stop date: 18May2022. Past drug history included: Known allergies: cipro antibiotics, reaction(s): "Known allergies: Cipro antibiotics", notes: Known allergies: Cipro antibiotics. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive; (18May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Symptoms resolved over about 7 days. Felt almost fully recovered by day 11. Then symptoms (moderate - severe congestion, fatigue; but no fever) returned around day 13. It was day 15, from her first positive test (on day 1 of Paxlovid), and her rapid tested positive that evening. Antiviral details Product was COVID 19 Treatment, brand Paxlovid, treatment start date on 03May2022 and Treatment stop date on 07May2022, adverse event start date on 15May2022.
Age: 70.0
Sex: F
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: Intraocular pressure test, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: Caller received three doses of the Pfizer Covid-19 vaccine, however has tested positive for the Covid virus.; Caller received three doses of the Pfizer Covid-19 vaccine, however has tested positive for the Covid virus.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL3246), in arm, on 03Feb2021 as dose 2, single (Lot number: EL9264), in arm and on 25Sep2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 70 years, in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 12May2022, outcome "unknown" and all described as "Caller received three doses of the Pfizer Covid-19 vaccine, however has tested positive for the Covid virus.". The patient underwent the following laboratory tests and procedures: Intraocular pressure test: (unspecified date) eye pressure went up to 44, notes: eye pressure went up to 44; SARS-CoV-2 test: (12May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Clinical information:Has brain fog: Started feeling badly on Thursday, 12May2022 and Friday, 13May2022 got worse. Its just like dumb things like want to go get a cup from cabinet but walk in that direction and open fridge. Caller's husband said noticed. Caller's husband said for caller not to make any decisions about anything. Caller has to travel and has to apply with Covid information and husband said not to do it now because caller is not thinking straight, husbands notices more than caller. Tested positive for Covid: Took the covid test on 12May2022 and received result on 13May2022. Bebtelovimab: NDC/lot/expiration: Unknown, given IV on 13May2022. Bebtelovimab stays in body for 60 days but half of it is gone in 12 days. Caller has brain fog.Bebtelovimab possibly could interfere with body's own ability to fight off future infection as far as CoV2, may reduce body's immune system response to Vaccine for SARS CoV2. Caller questioning if Bebtelovimab would cause interference with Pfizer Covid 19 Vaccine. Additional lot numbers: First dose: EL3246, second dose: EL9264, third dose: 30135BA.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: Blindness, Feeling abnormal, Intraocular pressure test, Speech disorder
Clinical narrative: Caller received three doses of the Pfizer Covid-19 vaccine, however has tested positive for the Covid virus.; Caller received three doses of the Pfizer Covid-19 vaccine, however has tested positive for the Covid virus.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL3246), in arm, on 03Feb2021 as dose 2, single (Lot number: EL9264), in arm and on 25Sep2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 70 years, in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 12May2022, outcome "unknown" and all described as "Caller received three doses of the Pfizer Covid-19 vaccine, however has tested positive for the Covid virus.". The patient underwent the following laboratory tests and procedures: Intraocular pressure test: (unspecified date) eye pressure went up to 44, notes: eye pressure went up to 44; SARS-CoV-2 test: (12May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Clinical information:Has brain fog: Started feeling badly on Thursday, 12May2022 and Friday, 13May2022 got worse. Its just like dumb things like want to go get a cup from cabinet but walk in that direction and open fridge. Caller's husband said noticed. Caller's husband said for caller not to make any decisions about anything. Caller has to travel and has to apply with Covid information and husband said not to do it now because caller is not thinking straight, husbands notices more than caller. Tested positive for Covid: Took the covid test on 12May2022 and received result on 13May2022. Bebtelovimab: NDC/lot/expiration: Unknown, given IV on 13May2022. Bebtelovimab stays in body for 60 days but half of it is gone in 12 days. Caller has brain fog.Bebtelovimab possibly could interfere with body's own ability to fight off future infection as far as CoV2, may reduce body's immune system response to Vaccine for SARS CoV2. Caller questioning if Bebtelovimab would cause interference with Pfizer Covid 19 Vaccine. Additional lot numbers: First dose: EL3246, second dose: EL9264, third dose: 30135BA.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dural tear, Durotomy procedure, Foraminotomy, SARS-CoV-2 test positive
Clinical narrative: Fri Oct 01, 2021 2159 SARS CoV-2, PCR, Rapid, V(!): Detected 2202  Revision decompression L2-4.  4. Partial laminectomy L2, L4; laminectomy L3.  5. Bilateral foraminotomies L2, 3, 4.  6. Repair of incidental durotomy with 6-0 muscle patch and DuraSeal.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Spinal decompression, Spinal laminectomy
Clinical narrative: Fri Oct 01, 2021 2159 SARS CoV-2, PCR, Rapid, V(!): Detected 2202  Revision decompression L2-4.  4. Partial laminectomy L2, L4; laminectomy L3.  5. Bilateral foraminotomies L2, 3, 4.  6. Repair of incidental durotomy with 6-0 muscle patch and DuraSeal.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood gases, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Diarrhoea
Clinical narrative: 75-year-old woman who was recently admitted here with respiratory failure and has been at encompass Rehab since discharge who presents with worsening shortness of breath and hypoxia.  She was treated with steroids for possible organizing pneumonia after a COVID-19 infection.  She was discharged to rehab on 2-4 L of oxygen via nasal cannula.  Earlier today she was found to have an oxygen saturation 51% on this amount of oxygen and EMS was summoned.  Was brought to the ED and was on high-flow nasal cannula at 70 L and 100%.  She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful h She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful history during my evaluation.  Of note she had a CT scan on the 18th, yesterday, which was concerning for pneumonia.  In reviewing records from encompass she appears to have been on antibiotics since being over there.  He has been on Augmentin, cefepime and Zosyn at varying times.  It appears most recently she was on Zosyn.  She will be admitted to the ICU and pulmonology will be consulted.  Dr. in the ED discussed the case with her daughter who stated that the patient would want to be intubated.                                     PT REMAINS INPATIENT AT THIS TIME.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Feeling abnormal, Lung infiltration, Oxygen saturation decreased, SARS-CoV-2 test positive
Clinical narrative: 75-year-old woman who was recently admitted here with respiratory failure and has been at encompass Rehab since discharge who presents with worsening shortness of breath and hypoxia.  She was treated with steroids for possible organizing pneumonia after a COVID-19 infection.  She was discharged to rehab on 2-4 L of oxygen via nasal cannula.  Earlier today she was found to have an oxygen saturation 51% on this amount of oxygen and EMS was summoned.  Was brought to the ED and was on high-flow nasal cannula at 70 L and 100%.  She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful h She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful history during my evaluation.  Of note she had a CT scan on the 18th, yesterday, which was concerning for pneumonia.  In reviewing records from encompass she appears to have been on antibiotics since being over there.  He has been on Augmentin, cefepime and Zosyn at varying times.  It appears most recently she was on Zosyn.  She will be admitted to the ICU and pulmonology will be consulted.  Dr. in the ED discussed the case with her daughter who stated that the patient would want to be intubated.                                     PT REMAINS INPATIENT AT THIS TIME.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Computerised tomogram thorax abnormal, Dyspnoea, Endotracheal intubation, Hypoxia
Clinical narrative: 75-year-old woman who was recently admitted here with respiratory failure and has been at encompass Rehab since discharge who presents with worsening shortness of breath and hypoxia.  She was treated with steroids for possible organizing pneumonia after a COVID-19 infection.  She was discharged to rehab on 2-4 L of oxygen via nasal cannula.  Earlier today she was found to have an oxygen saturation 51% on this amount of oxygen and EMS was summoned.  Was brought to the ED and was on high-flow nasal cannula at 70 L and 100%.  She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful h She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful history during my evaluation.  Of note she had a CT scan on the 18th, yesterday, which was concerning for pneumonia.  In reviewing records from encompass she appears to have been on antibiotics since being over there.  He has been on Augmentin, cefepime and Zosyn at varying times.  It appears most recently she was on Zosyn.  She will be admitted to the ICU and pulmonology will be consulted.  Dr. in the ED discussed the case with her daughter who stated that the patient would want to be intubated.                                     PT REMAINS INPATIENT AT THIS TIME.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Intensive care, Oxygen saturation decreased, Positive airway pressure therapy, Respiratory failure
Clinical narrative: 75-year-old woman who was recently admitted here with respiratory failure and has been at encompass Rehab since discharge who presents with worsening shortness of breath and hypoxia.  She was treated with steroids for possible organizing pneumonia after a COVID-19 infection.  She was discharged to rehab on 2-4 L of oxygen via nasal cannula.  Earlier today she was found to have an oxygen saturation 51% on this amount of oxygen and EMS was summoned.  Was brought to the ED and was on high-flow nasal cannula at 70 L and 100%.  She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful h She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful history during my evaluation.  Of note she had a CT scan on the 18th, yesterday, which was concerning for pneumonia.  In reviewing records from encompass she appears to have been on antibiotics since being over there.  He has been on Augmentin, cefepime and Zosyn at varying times.  It appears most recently she was on Zosyn.  She will be admitted to the ICU and pulmonology will be consulted.  Dr. in the ED discussed the case with her daughter who stated that the patient would want to be intubated.                                     PT REMAINS INPATIENT AT THIS TIME.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Anaemia, Anaemia of chronic disease, Anti-neutrophil cytoplasmic antibody positive vasculitis, Asthenia
Clinical narrative: 75-year-old woman who was recently admitted here with respiratory failure and has been at encompass Rehab since discharge who presents with worsening shortness of breath and hypoxia.  She was treated with steroids for possible organizing pneumonia after a COVID-19 infection.  She was discharged to rehab on 2-4 L of oxygen via nasal cannula.  Earlier today she was found to have an oxygen saturation 51% on this amount of oxygen and EMS was summoned.  Was brought to the ED and was on high-flow nasal cannula at 70 L and 100%.  She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful h She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful history during my evaluation.  Of note she had a CT scan on the 18th, yesterday, which was concerning for pneumonia.  In reviewing records from encompass she appears to have been on antibiotics since being over there.  He has been on Augmentin, cefepime and Zosyn at varying times.  It appears most recently she was on Zosyn.  She will be admitted to the ICU and pulmonology will be consulted.  Dr. in the ED discussed the case with her daughter who stated that the patient would want to be intubated.                                     PT REMAINS INPATIENT AT THIS TIME.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood iron, Blood thyroid stimulating hormone decreased, COVID-19, Confusional state, Dyspnoea exertional
Clinical narrative: 75-year-old woman who was recently admitted here with respiratory failure and has been at encompass Rehab since discharge who presents with worsening shortness of breath and hypoxia.  She was treated with steroids for possible organizing pneumonia after a COVID-19 infection.  She was discharged to rehab on 2-4 L of oxygen via nasal cannula.  Earlier today she was found to have an oxygen saturation 51% on this amount of oxygen and EMS was summoned.  Was brought to the ED and was on high-flow nasal cannula at 70 L and 100%.  She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful h She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful history during my evaluation.  Of note she had a CT scan on the 18th, yesterday, which was concerning for pneumonia.  In reviewing records from encompass she appears to have been on antibiotics since being over there.  He has been on Augmentin, cefepime and Zosyn at varying times.  It appears most recently she was on Zosyn.  She will be admitted to the ICU and pulmonology will be consulted.  Dr. in the ED discussed the case with her daughter who stated that the patient would want to be intubated.                                     PT REMAINS INPATIENT AT THIS TIME.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Hyponatraemia, Inflammatory marker increased, Lung infiltration, Malaise
Clinical narrative: 75-year-old woman who was recently admitted here with respiratory failure and has been at encompass Rehab since discharge who presents with worsening shortness of breath and hypoxia.  She was treated with steroids for possible organizing pneumonia after a COVID-19 infection.  She was discharged to rehab on 2-4 L of oxygen via nasal cannula.  Earlier today she was found to have an oxygen saturation 51% on this amount of oxygen and EMS was summoned.  Was brought to the ED and was on high-flow nasal cannula at 70 L and 100%.  She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful h She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful history during my evaluation.  Of note she had a CT scan on the 18th, yesterday, which was concerning for pneumonia.  In reviewing records from encompass she appears to have been on antibiotics since being over there.  He has been on Augmentin, cefepime and Zosyn at varying times.  It appears most recently she was on Zosyn.  She will be admitted to the ICU and pulmonology will be consulted.  Dr. in the ED discussed the case with her daughter who stated that the patient would want to be intubated.                                     PT REMAINS INPATIENT AT THIS TIME.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Normocytic anaemia, Organising pneumonia, Pneumonia, Pneumonia bacterial, Respiratory failure
Clinical narrative: 75-year-old woman who was recently admitted here with respiratory failure and has been at encompass Rehab since discharge who presents with worsening shortness of breath and hypoxia.  She was treated with steroids for possible organizing pneumonia after a COVID-19 infection.  She was discharged to rehab on 2-4 L of oxygen via nasal cannula.  Earlier today she was found to have an oxygen saturation 51% on this amount of oxygen and EMS was summoned.  Was brought to the ED and was on high-flow nasal cannula at 70 L and 100%.  She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful h She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful history during my evaluation.  Of note she had a CT scan on the 18th, yesterday, which was concerning for pneumonia.  In reviewing records from encompass she appears to have been on antibiotics since being over there.  He has been on Augmentin, cefepime and Zosyn at varying times.  It appears most recently she was on Zosyn.  She will be admitted to the ICU and pulmonology will be consulted.  Dr. in the ED discussed the case with her daughter who stated that the patient would want to be intubated.                                     PT REMAINS INPATIENT AT THIS TIME.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Thyroxine free normal, Transfusion, Treatment noncompliance, Tri-iodothyronine free normal
Clinical narrative: 75-year-old woman who was recently admitted here with respiratory failure and has been at encompass Rehab since discharge who presents with worsening shortness of breath and hypoxia.  She was treated with steroids for possible organizing pneumonia after a COVID-19 infection.  She was discharged to rehab on 2-4 L of oxygen via nasal cannula.  Earlier today she was found to have an oxygen saturation 51% on this amount of oxygen and EMS was summoned.  Was brought to the ED and was on high-flow nasal cannula at 70 L and 100%.  She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful h She continued to have hypoxia and had to be upgraded to a BiPAP.  She continued to worsen on BiPAP and her O2 sat was in the low 80s by the time of my arrival.  She cannot provide any meaningful history during my evaluation.  Of note she had a CT scan on the 18th, yesterday, which was concerning for pneumonia.  In reviewing records from encompass she appears to have been on antibiotics since being over there.  He has been on Augmentin, cefepime and Zosyn at varying times.  It appears most recently she was on Zosyn.  She will be admitted to the ICU and pulmonology will be consulted.  Dr. in the ED discussed the case with her daughter who stated that the patient would want to be intubated.                                     PT REMAINS INPATIENT AT THIS TIME.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature increased, COVID-19, Chest X-ray normal, Lethargy, Malaise
Clinical narrative: Breakthrough COVID.  Patientt admitted 5/17/2022 with shortness of breath following COVID exposure.  79 year-old male a PMH of COPD, A-fib, HTN, DM , pituitary tumor resection (remote)  First dose 2/6/2021 EL 9265 Second dose 2/27/2021 EM 9810
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Mental status changes, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID.  Patientt admitted 5/17/2022 with shortness of breath following COVID exposure.  79 year-old male a PMH of COPD, A-fib, HTN, DM , pituitary tumor resection (remote)  First dose 2/6/2021 EL 9265 Second dose 2/27/2021 EM 9810
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Dyspnoea, Exposure to SARS-CoV-2, Intensive care
Clinical narrative: Breakthrough COVID.  Patientt admitted 5/17/2022 with shortness of breath following COVID exposure.  79 year-old male a PMH of COPD, A-fib, HTN, DM , pituitary tumor resection (remote)  First dose 2/6/2021 EL 9265 Second dose 2/27/2021 EM 9810
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Laboratory test normal, Positive airway pressure therapy, Respiratory distress, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID.  Patientt admitted 5/17/2022 with shortness of breath following COVID exposure.  79 year-old male a PMH of COPD, A-fib, HTN, DM , pituitary tumor resection (remote)  First dose 2/6/2021 EL 9265 Second dose 2/27/2021 EM 9810
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Coronavirus test positive, Dyspnoea, Exposure to SARS-CoV-2, Influenza virus test positive
Clinical narrative: Breakthrough COVID.  Patientt admitted 5/17/2022 with shortness of breath following COVID exposure.  79 year-old male a PMH of COPD, A-fib, HTN, DM , pituitary tumor resection (remote)  First dose 2/6/2021 EL 9265 Second dose 2/27/2021 EM 9810
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID.  Patientt admitted 5/17/2022 with shortness of breath following COVID exposure.  79 year-old male a PMH of COPD, A-fib, HTN, DM , pituitary tumor resection (remote)  First dose 2/6/2021 EL 9265 Second dose 2/27/2021 EM 9810
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Paralysis, Tremor
Clinical narrative: COVID Nasal swab testing: positive tests; COVID Nasal swab testing: positive tests; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. An 80-year-old female patient received BNT162b2 (BNT162B2), on 20Dec2020 at 10:00 as dose 1, single (Lot number: EJ1685), in right arm, on 12Jan2021 at 10:00 as dose 2, single (Lot number: EK9231), in right arm and on 28Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 80 years, in right arm, all intramuscular for covid-19 immunisation. The patient relevant medical history included: "Penicillin (Later developed allergy)" (unspecified if ongoing), notes: Illness/AE: Pneumonia, Onset date: 1996, Stop date: 1996, Pertinent details: Treated with Penicillin (Later developed allergy), "Pneumonia" (unspecified if ongoing), notes: Illness/AE: Pneumonia, Onset date: 1944, Stop date: 1944, Pertinent details: Treated with sulfa (later developed allergy), Illness/AE: Pneumonia, Onset date: 1963, Stop date: 1963, Pertinent details: Treated with Penicillin, Illness/AE: Pneumonia, Onset date: 1996, Stop date: 1996, Pertinent details: Treated with Penicillin (Later developed allergy). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE oral taken for hypertension, start date: 1996 (ongoing); BENAZEPRIL oral taken for hypertension, start date: 2006 (ongoing). Past drug history included: Sulfa for Pneumonia, reaction(s): "later developed allergy", notes: Illness/AE: Pneumonia, Onset date: 1944, Stop date: 1944, Pertinent details: Treated with sulfa (later developed allergy). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "COVID Nasal swab testing: positive tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jan2022) Positive, notes: Test: COVID Nasal SWAB testing. Date: 04Jan2022. Result: Through 28Jan2022 daily testing because of positive test (80 residents tested with only a few positives) my results were 100% negative.  Clinical course: Please complete the section below for 3rd administration. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 Complications). This is the shot that caused the reaction. The 1st 2 shots were only minor redness and chills. Vaccination facility type: Nursing Home/ Senior Living Facility. Medical history relevant to AE(S): Father died after many strokes (over years) in his 80'S. Mother had malignant hypertension and COPD Died at 90. Both parents were heavy smokers most of their adult lives. (I started at age 18 and smoked for 20 years) but basically since birth? is it safe for me to get further vaccinations?  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID Nasal swab testing: positive tests; COVID Nasal swab testing: positive tests; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. An 80-year-old female patient received BNT162b2 (BNT162B2), on 20Dec2020 at 10:00 as dose 1, single (Lot number: EJ1685), in right arm, on 12Jan2021 at 10:00 as dose 2, single (Lot number: EK9231), in right arm and on 28Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 80 years, in right arm, all intramuscular for covid-19 immunisation. The patient relevant medical history included: "Penicillin (Later developed allergy)" (unspecified if ongoing), notes: Illness/AE: Pneumonia, Onset date: 1996, Stop date: 1996, Pertinent details: Treated with Penicillin (Later developed allergy), "Pneumonia" (unspecified if ongoing), notes: Illness/AE: Pneumonia, Onset date: 1944, Stop date: 1944, Pertinent details: Treated with sulfa (later developed allergy), Illness/AE: Pneumonia, Onset date: 1963, Stop date: 1963, Pertinent details: Treated with Penicillin, Illness/AE: Pneumonia, Onset date: 1996, Stop date: 1996, Pertinent details: Treated with Penicillin (Later developed allergy). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE oral taken for hypertension, start date: 1996 (ongoing); BENAZEPRIL oral taken for hypertension, start date: 2006 (ongoing). Past drug history included: Sulfa for Pneumonia, reaction(s): "later developed allergy", notes: Illness/AE: Pneumonia, Onset date: 1944, Stop date: 1944, Pertinent details: Treated with sulfa (later developed allergy). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "COVID Nasal swab testing: positive tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jan2022) Positive, notes: Test: COVID Nasal SWAB testing. Date: 04Jan2022. Result: Through 28Jan2022 daily testing because of positive test (80 residents tested with only a few positives) my results were 100% negative.  Clinical course: Please complete the section below for 3rd administration. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 Complications). This is the shot that caused the reaction. The 1st 2 shots were only minor redness and chills. Vaccination facility type: Nursing Home/ Senior Living Facility. Medical history relevant to AE(S): Father died after many strokes (over years) in his 80'S. Mother had malignant hypertension and COPD Died at 90. Both parents were heavy smokers most of their adult lives. (I started at age 18 and smoked for 20 years) but basically since birth? is it safe for me to get further vaccinations?  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Dizziness, Fall, Fatigue, Nausea
Clinical narrative: On 18May2022, patient tested positive for COVID-19; On 18May2022, patient tested positive for COVID-19; Headache; Scratchy throat; Cough; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER8730), on 30Apr2021 as dose 2, single (Lot number: EW0153), on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030) and on 24Apr2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COUGH (non-serious) with onset May2022, outcome "unknown"; FATIGUE (non-serious) with onset May2022, outcome "unknown"; HEADACHE (non-serious) with onset May2022, outcome "unknown"; THROAT IRRITATION (non-serious) with onset May2022, outcome "unknown", described as "Scratchy throat"; COVID-19 (medically significant) with onset 18May2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "On 18May2022, patient tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive.  Clinical course: Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tooth injury
Clinical narrative: On 18May2022, patient tested positive for COVID-19; On 18May2022, patient tested positive for COVID-19; Headache; Scratchy throat; Cough; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER8730), on 30Apr2021 as dose 2, single (Lot number: EW0153), on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030) and on 24Apr2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COUGH (non-serious) with onset May2022, outcome "unknown"; FATIGUE (non-serious) with onset May2022, outcome "unknown"; HEADACHE (non-serious) with onset May2022, outcome "unknown"; THROAT IRRITATION (non-serious) with onset May2022, outcome "unknown", described as "Scratchy throat"; COVID-19 (medically significant) with onset 18May2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "On 18May2022, patient tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive.  Clinical course: Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: On 18May2022, patient tested positive for COVID-19; On 18May2022, patient tested positive for COVID-19; Headache; Scratchy throat; Cough; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER8730), on 30Apr2021 as dose 2, single (Lot number: EW0153), on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030) and on 24Apr2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COUGH (non-serious) with onset May2022, outcome "unknown"; FATIGUE (non-serious) with onset May2022, outcome "unknown"; HEADACHE (non-serious) with onset May2022, outcome "unknown"; THROAT IRRITATION (non-serious) with onset May2022, outcome "unknown", described as "Scratchy throat"; COVID-19 (medically significant) with onset 18May2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "On 18May2022, patient tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive.  Clinical course: Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, Vaccination failure
Clinical narrative: On 18May2022, patient tested positive for COVID-19; On 18May2022, patient tested positive for COVID-19; Headache; Scratchy throat; Cough; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER8730), on 30Apr2021 as dose 2, single (Lot number: EW0153), on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030) and on 24Apr2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COUGH (non-serious) with onset May2022, outcome "unknown"; FATIGUE (non-serious) with onset May2022, outcome "unknown"; HEADACHE (non-serious) with onset May2022, outcome "unknown"; THROAT IRRITATION (non-serious) with onset May2022, outcome "unknown", described as "Scratchy throat"; COVID-19 (medically significant) with onset 18May2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "On 18May2022, patient tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive.  Clinical course: Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Droopy right eyelid; He had chills; Fever that peaked at 101 degrees; This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2022, the patient received the 1st dose of Shingrix (intramuscular). On 10th May 2022, 6 hrs after receiving Shingrix, the patient experienced chills and fever. On 19th May 2022, the patient experienced eyelid ptosis. On an unknown date, the outcome of the chills and fever were recovered/resolved and the outcome of the eyelid ptosis was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever and eyelid ptosis to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comments: The patient reported case for himself. The patient received his Shingrix dose in left deltoid. The patient stated that 6 hours later he had chills and a fever that peaked at 101 degree F. He stated that the fever lowered to 99 degree F and lasted a few days on and off. On the morning of reporting day, 9 days after vaccination the patient was woke up with a droopy right eyelid. The reporter was consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Droopy right eyelid; He had chills; Fever that peaked at 101 degrees; This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2022, the patient received the 1st dose of Shingrix (intramuscular). On 10th May 2022, 6 hrs after receiving Shingrix, the patient experienced chills and fever. On 19th May 2022, the patient experienced eyelid ptosis. On an unknown date, the outcome of the chills and fever were recovered/resolved and the outcome of the eyelid ptosis was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever and eyelid ptosis to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comments: The patient reported case for himself. The patient received his Shingrix dose in left deltoid. The patient stated that 6 hours later he had chills and a fever that peaked at 101 degree F. He stated that the fever lowered to 99 degree F and lasted a few days on and off. On the morning of reporting day, 9 days after vaccination the patient was woke up with a droopy right eyelid. The reporter was consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Eyelid ptosis, Pyrexia
Clinical narrative: Droopy right eyelid; He had chills; Fever that peaked at 101 degrees; This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2022, the patient received the 1st dose of Shingrix (intramuscular). On 10th May 2022, 6 hrs after receiving Shingrix, the patient experienced chills and fever. On 19th May 2022, the patient experienced eyelid ptosis. On an unknown date, the outcome of the chills and fever were recovered/resolved and the outcome of the eyelid ptosis was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever and eyelid ptosis to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comments: The patient reported case for himself. The patient received his Shingrix dose in left deltoid. The patient stated that 6 hours later he had chills and a fever that peaked at 101 degree F. He stated that the fever lowered to 99 degree F and lasted a few days on and off. On the morning of reporting day, 9 days after vaccination the patient was woke up with a droopy right eyelid. The reporter was consented to follow up.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID rebound on day 13 from positive test (after taking Paxlovid on days 1-5); COVID rebound on day 13 from positive test (after taking Paxlovid on days 1-5); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 at 16:30 as dose 4 (booster), single (Lot number: FKP8P5) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Feb2021 at 15:00 as dose 1, single (Lot number: 031M20A), in left arm, on 27Mar2021 at 15:00 as dose 2, single (Lot number: 028A21A), in left arm and on 18Sep2021 at 10:00 as dose 3 (booster), single (Lot number: 048F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Unexplained immunocompromisation" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY, start date: Jan2006, stop date: May2022; WIXELA INHUB, start date: 30Apr2022, stop date: 11May2022; VITAMIN D NOS, start date: Apr2020, stop date: May2022; VITAMIN B NOS, start date: Apr2020, stop date: May2022; DYMISTA, start date: Jan2016; FAMOTIDINE, start date: Nov2016, stop date: May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13May2022 at 05:00, outcome "unknown" and all described as "COVID rebound on day 13 from positive test (after taking Paxlovid on days 1-5)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: COVID rebound on day 13 from positive test (after taking Paxlovid on days 1-5); COVID rebound on day 13 from positive test (after taking Paxlovid on days 1-5); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 at 16:30 as dose 4 (booster), single (Lot number: FKP8P5) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Feb2021 at 15:00 as dose 1, single (Lot number: 031M20A), in left arm, on 27Mar2021 at 15:00 as dose 2, single (Lot number: 028A21A), in left arm and on 18Sep2021 at 10:00 as dose 3 (booster), single (Lot number: 048F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Unexplained immunocompromisation" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY, start date: Jan2006, stop date: May2022; WIXELA INHUB, start date: 30Apr2022, stop date: 11May2022; VITAMIN D NOS, start date: Apr2020, stop date: May2022; VITAMIN B NOS, start date: Apr2020, stop date: May2022; DYMISTA, start date: Jan2016; FAMOTIDINE, start date: Nov2016, stop date: May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13May2022 at 05:00, outcome "unknown" and all described as "COVID rebound on day 13 from positive test (after taking Paxlovid on days 1-5)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphonia, Throat irritation, Vomiting, Wheelchair user
Clinical narrative: Pt reported vomiting, lip numbness, flushing/sweating, dizziness, throat itching, hoarse voice. Vitals: @19:05 159/98, 78, 22, 97.4F, 100% -- > @19:20 157/89, MAP 106, 78, 100% EMS called @1914.   19:27 EMS arrived and pt transported to the local Hospital  IN ED: she started experiencing a dry and itchy throat, her lips started to get swollen and numb, and she started having a rash. She was sent to the ER via 911. She was given 1 shot of epinephrine and 1 shot of Bendaryl. She stayed in the ED for 2-3 hours. She continued to feel a numb sensation in throat for 1 day after being discharged. She notes she was well prior to the vaccine and was on no new meds, supplements, diet, etc.  At follow up 5/25/22 Possible allergic reaction after first Covid vaccination 1 week ago (Pfizer). Initially throat sx, No hives. Later noted lip swelling (no pictures). No lung Or GI sx. No diffuse rash. No hx of allergic reactions to any meds except reactions to narcotics. Discussed with patient that research has shown that the majority of patients who had similar-type reaction to first dose of Covid vaccine have tolerated subsequent doses without problem. She does not desire to get vaccine, only done per her lawyer If subsequent dose needed will see about the skin test protocol, pre-treat w/ antihistamine and receive in medical facility.