chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Fatigue, Feeling abnormal, Ophthalmological examination normal, Pupil dilation procedure
Clinical narrative: getting covid shortly after both vaccines; Covid test result: Positive; Visual Disturbances/The correlation between my vision problems and vaccine is concering. My eyes have progressively gotten worse.; eye pain; headaches; This is a spontaneous report from a contactable consumer (patient) reporting in response to Non-HCP letter. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), intramuscularly, administered in Left arm on 15Apr2021 16:50 at the age of 53-years-old as dose 2, single dose for covid-19 immunisation. Medical history included ongoing Hashimoto's from Dec2016, hypothyroidism from an unknown date and unknown if ongoing, ongoing Autoimmunity. Concomitant medication included levothyroxine, liothyronine (NP THYROID, Route: oral) taken daily for hypothyroidism from Dec2018 and ongoing. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6205), via intramuscularly, administered in Left arm on 19Mar2021 at the age of 53-years-old 16:40 as dose 1, single dose for covid-19 immunisation. Patient age at time of vaccination was 53 Years. Vaccination facility type was workplace clinic. Prior Vaccinations were none. On 16Jun2021, the patient experienced getting covid shortly after both vaccines (vaccination failure) (medically significant) and covid test result: positive (covid-19) (medically significant). On 05May2021, the patient experienced visual disturbances. It was reported that the correlation between her vision problems and vaccines was concerning. Her eyes have progressively gotten worse, accompained by headaches and eye pain. Getting covid shortly after both vaccines just amplified it. She was hesitant due to autoimmunity and regret getting vaccinated. AE required visit to Physician office (5 visits to ophth. in 2months). Treatment for the events requiring intiation of new medication/other /treatment/ procedure was unknown. Awaiting more testing. The patient underwent lab tests and procedures which included Multiple eye exams (ophthalmological examination): inconclusive on an unspecified date and awating neurology appointment, Covid test (SARS-CoV-2 test): positive on 16Jun2021. The outcome of events, vaccination failure and covid-19 was unknown while other events were not recovered.  Follow-Up (26Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Scan, Visual impairment
Clinical narrative: getting covid shortly after both vaccines; Covid test result: Positive; Visual Disturbances/The correlation between my vision problems and vaccine is concering. My eyes have progressively gotten worse.; eye pain; headaches; This is a spontaneous report from a contactable consumer (patient) reporting in response to Non-HCP letter. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), intramuscularly, administered in Left arm on 15Apr2021 16:50 at the age of 53-years-old as dose 2, single dose for covid-19 immunisation. Medical history included ongoing Hashimoto's from Dec2016, hypothyroidism from an unknown date and unknown if ongoing, ongoing Autoimmunity. Concomitant medication included levothyroxine, liothyronine (NP THYROID, Route: oral) taken daily for hypothyroidism from Dec2018 and ongoing. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6205), via intramuscularly, administered in Left arm on 19Mar2021 at the age of 53-years-old 16:40 as dose 1, single dose for covid-19 immunisation. Patient age at time of vaccination was 53 Years. Vaccination facility type was workplace clinic. Prior Vaccinations were none. On 16Jun2021, the patient experienced getting covid shortly after both vaccines (vaccination failure) (medically significant) and covid test result: positive (covid-19) (medically significant). On 05May2021, the patient experienced visual disturbances. It was reported that the correlation between her vision problems and vaccines was concerning. Her eyes have progressively gotten worse, accompained by headaches and eye pain. Getting covid shortly after both vaccines just amplified it. She was hesitant due to autoimmunity and regret getting vaccinated. AE required visit to Physician office (5 visits to ophth. in 2months). Treatment for the events requiring intiation of new medication/other /treatment/ procedure was unknown. Awaiting more testing. The patient underwent lab tests and procedures which included Multiple eye exams (ophthalmological examination): inconclusive on an unspecified date and awating neurology appointment, Covid test (SARS-CoV-2 test): positive on 16Jun2021. The outcome of events, vaccination failure and covid-19 was unknown while other events were not recovered.  Follow-Up (26Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Disturbance in attention, Feeling abnormal, SARS-CoV-2 test, Visual impairment
Clinical narrative: getting covid shortly after both vaccines; Covid test result: Positive; Visual Disturbances/The correlation between my vision problems and vaccine is concering. My eyes have progressively gotten worse.; eye pain; headaches; This is a spontaneous report from a contactable consumer (patient) reporting in response to Non-HCP letter. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), intramuscularly, administered in Left arm on 15Apr2021 16:50 at the age of 53-years-old as dose 2, single dose for covid-19 immunisation. Medical history included ongoing Hashimoto's from Dec2016, hypothyroidism from an unknown date and unknown if ongoing, ongoing Autoimmunity. Concomitant medication included levothyroxine, liothyronine (NP THYROID, Route: oral) taken daily for hypothyroidism from Dec2018 and ongoing. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6205), via intramuscularly, administered in Left arm on 19Mar2021 at the age of 53-years-old 16:40 as dose 1, single dose for covid-19 immunisation. Patient age at time of vaccination was 53 Years. Vaccination facility type was workplace clinic. Prior Vaccinations were none. On 16Jun2021, the patient experienced getting covid shortly after both vaccines (vaccination failure) (medically significant) and covid test result: positive (covid-19) (medically significant). On 05May2021, the patient experienced visual disturbances. It was reported that the correlation between her vision problems and vaccines was concerning. Her eyes have progressively gotten worse, accompained by headaches and eye pain. Getting covid shortly after both vaccines just amplified it. She was hesitant due to autoimmunity and regret getting vaccinated. AE required visit to Physician office (5 visits to ophth. in 2months). Treatment for the events requiring intiation of new medication/other /treatment/ procedure was unknown. Awaiting more testing. The patient underwent lab tests and procedures which included Multiple eye exams (ophthalmological examination): inconclusive on an unspecified date and awating neurology appointment, Covid test (SARS-CoV-2 test): positive on 16Jun2021. The outcome of events, vaccination failure and covid-19 was unknown while other events were not recovered.  Follow-Up (26Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Eye pain, Headache, Ophthalmological examination, SARS-CoV-2 test
Clinical narrative: getting covid shortly after both vaccines; Covid test result: Positive; Visual Disturbances/The correlation between my vision problems and vaccine is concering. My eyes have progressively gotten worse.; eye pain; headaches; This is a spontaneous report from a contactable consumer (patient) reporting in response to Non-HCP letter. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), intramuscularly, administered in Left arm on 15Apr2021 16:50 at the age of 53-years-old as dose 2, single dose for covid-19 immunisation. Medical history included ongoing Hashimoto's from Dec2016, hypothyroidism from an unknown date and unknown if ongoing, ongoing Autoimmunity. Concomitant medication included levothyroxine, liothyronine (NP THYROID, Route: oral) taken daily for hypothyroidism from Dec2018 and ongoing. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6205), via intramuscularly, administered in Left arm on 19Mar2021 at the age of 53-years-old 16:40 as dose 1, single dose for covid-19 immunisation. Patient age at time of vaccination was 53 Years. Vaccination facility type was workplace clinic. Prior Vaccinations were none. On 16Jun2021, the patient experienced getting covid shortly after both vaccines (vaccination failure) (medically significant) and covid test result: positive (covid-19) (medically significant). On 05May2021, the patient experienced visual disturbances. It was reported that the correlation between her vision problems and vaccines was concerning. Her eyes have progressively gotten worse, accompained by headaches and eye pain. Getting covid shortly after both vaccines just amplified it. She was hesitant due to autoimmunity and regret getting vaccinated. AE required visit to Physician office (5 visits to ophth. in 2months). Treatment for the events requiring intiation of new medication/other /treatment/ procedure was unknown. Awaiting more testing. The patient underwent lab tests and procedures which included Multiple eye exams (ophthalmological examination): inconclusive on an unspecified date and awating neurology appointment, Covid test (SARS-CoV-2 test): positive on 16Jun2021. The outcome of events, vaccination failure and covid-19 was unknown while other events were not recovered.  Follow-Up (26Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination failure, Visual impairment
Clinical narrative: getting covid shortly after both vaccines; Covid test result: Positive; Visual Disturbances/The correlation between my vision problems and vaccine is concering. My eyes have progressively gotten worse.; eye pain; headaches; This is a spontaneous report from a contactable consumer (patient) reporting in response to Non-HCP letter. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), intramuscularly, administered in Left arm on 15Apr2021 16:50 at the age of 53-years-old as dose 2, single dose for covid-19 immunisation. Medical history included ongoing Hashimoto's from Dec2016, hypothyroidism from an unknown date and unknown if ongoing, ongoing Autoimmunity. Concomitant medication included levothyroxine, liothyronine (NP THYROID, Route: oral) taken daily for hypothyroidism from Dec2018 and ongoing. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6205), via intramuscularly, administered in Left arm on 19Mar2021 at the age of 53-years-old 16:40 as dose 1, single dose for covid-19 immunisation. Patient age at time of vaccination was 53 Years. Vaccination facility type was workplace clinic. Prior Vaccinations were none. On 16Jun2021, the patient experienced getting covid shortly after both vaccines (vaccination failure) (medically significant) and covid test result: positive (covid-19) (medically significant). On 05May2021, the patient experienced visual disturbances. It was reported that the correlation between her vision problems and vaccines was concerning. Her eyes have progressively gotten worse, accompained by headaches and eye pain. Getting covid shortly after both vaccines just amplified it. She was hesitant due to autoimmunity and regret getting vaccinated. AE required visit to Physician office (5 visits to ophth. in 2months). Treatment for the events requiring intiation of new medication/other /treatment/ procedure was unknown. Awaiting more testing. The patient underwent lab tests and procedures which included Multiple eye exams (ophthalmological examination): inconclusive on an unspecified date and awating neurology appointment, Covid test (SARS-CoV-2 test): positive on 16Jun2021. The outcome of events, vaccination failure and covid-19 was unknown while other events were not recovered.  Follow-Up (26Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myeloid leukaemia, Biopsy bone marrow abnormal, COVID-19, Chemotherapy, Chest X-ray abnormal
Clinical narrative: Pneumothorax; Acute megakaryocytic leukaemia; passed away; Diagnosed with COVID; bruises; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband stated, "Your vaccine killed my wife. She received her first dose of your COVID vaccine on 17Mar2021." The patient received her COVID vaccine on 17Mar2021 at a local clinic. She developed bruises within days after the shot on 30Mar2021. She pursued care and diagnosis and reporting with the vaccine administrator, but finally had to see PCP. After multiple visits, patient was sent to Hospital in the city was diagnosed with AML on 10Apr2021 (hospitalized 5 days: April 6-10, 2021) and started chemotherapy (outpatient on 19Apr2021). She returned to hospital on 25Apr2021 in distress and was diagnosed with COVID. The patient was put on a ventilator with pressor support on 01May2021 and passed away on 10May2021. The outcome of the events was unknown.  The course of the event was as follows: The patient received her COVID vaccine and developed bruises within days after the shot. She pursued care and diagnosis and reporting with vaccine administrator, but finally had to see PCP. After multiple visits, she was sent to a hospital in the city. She was diagnosed with AML (hospitalized 6 days) and started chemotherapy (outpatient). Then returned to the hospital 25Apr2021 in distress and diagnosed with COVID. On 17Mar2021, Pfizer vaccine. On 17Mar2021, immediate reactions to vaccine, physical and emotional distress. On 20Mar2021, 24 bruises by 30Mar2021. On 06Apr2021, hospital admission for AML diagnosed 10Apr2021. On 08Apr2021, bone marrow biopsy completed with report of 29% blasts, hypercellular bone marrow (60-70%) with significant granulocytic dysplasia and occasional diserythropoiesis. On 19Apr2021, first outpatient chemotherapy. On 25Apr2021, hospital admission and positive covid test: Labs were remarkable for Hgb 4.3, WBC 1.3, and PI-TK 10. Transfusion of 3 units pRBCs and 2 units PLT was ordered. After 2 units pRBC, Hgb up-trended from 4.3 to 6.0. Plan was for admission to P2, but the patient tested positive for COVID-19. Chest x ray was obtained and showed evidence of early multilobar pneumonia. On 30Apr2021, full oxygen mask ('trying to save her life'). On 01May2021, ventilator DSO. On 07May2021, subcutaneous emphysema, Family meeting at hospital, drug treatments discontinued. On 10May2021, pneumothorax, Ventilator discontinued, patient passed away. Prior to vaccination, the patient was a healthy 64 year old woman planning a vacation. The vaccination was intended to make the trip safer.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Death, Granulocytes abnormal, Haemoglobin decreased, Mechanical ventilation
Clinical narrative: Pneumothorax; Acute megakaryocytic leukaemia; passed away; Diagnosed with COVID; bruises; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband stated, "Your vaccine killed my wife. She received her first dose of your COVID vaccine on 17Mar2021." The patient received her COVID vaccine on 17Mar2021 at a local clinic. She developed bruises within days after the shot on 30Mar2021. She pursued care and diagnosis and reporting with the vaccine administrator, but finally had to see PCP. After multiple visits, patient was sent to Hospital in the city was diagnosed with AML on 10Apr2021 (hospitalized 5 days: April 6-10, 2021) and started chemotherapy (outpatient on 19Apr2021). She returned to hospital on 25Apr2021 in distress and was diagnosed with COVID. The patient was put on a ventilator with pressor support on 01May2021 and passed away on 10May2021. The outcome of the events was unknown.  The course of the event was as follows: The patient received her COVID vaccine and developed bruises within days after the shot. She pursued care and diagnosis and reporting with vaccine administrator, but finally had to see PCP. After multiple visits, she was sent to a hospital in the city. She was diagnosed with AML (hospitalized 6 days) and started chemotherapy (outpatient). Then returned to the hospital 25Apr2021 in distress and diagnosed with COVID. On 17Mar2021, Pfizer vaccine. On 17Mar2021, immediate reactions to vaccine, physical and emotional distress. On 20Mar2021, 24 bruises by 30Mar2021. On 06Apr2021, hospital admission for AML diagnosed 10Apr2021. On 08Apr2021, bone marrow biopsy completed with report of 29% blasts, hypercellular bone marrow (60-70%) with significant granulocytic dysplasia and occasional diserythropoiesis. On 19Apr2021, first outpatient chemotherapy. On 25Apr2021, hospital admission and positive covid test: Labs were remarkable for Hgb 4.3, WBC 1.3, and PI-TK 10. Transfusion of 3 units pRBCs and 2 units PLT was ordered. After 2 units pRBC, Hgb up-trended from 4.3 to 6.0. Plan was for admission to P2, but the patient tested positive for COVID-19. Chest x ray was obtained and showed evidence of early multilobar pneumonia. On 30Apr2021, full oxygen mask ('trying to save her life'). On 01May2021, ventilator DSO. On 07May2021, subcutaneous emphysema, Family meeting at hospital, drug treatments discontinued. On 10May2021, pneumothorax, Ventilator discontinued, patient passed away. Prior to vaccination, the patient was a healthy 64 year old woman planning a vacation. The vaccination was intended to make the trip safer.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myeloblast percentage increased, Packed red blood cell transfusion, Platelet count decreased, Platelet transfusion, Pneumonia
Clinical narrative: Pneumothorax; Acute megakaryocytic leukaemia; passed away; Diagnosed with COVID; bruises; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband stated, "Your vaccine killed my wife. She received her first dose of your COVID vaccine on 17Mar2021." The patient received her COVID vaccine on 17Mar2021 at a local clinic. She developed bruises within days after the shot on 30Mar2021. She pursued care and diagnosis and reporting with the vaccine administrator, but finally had to see PCP. After multiple visits, patient was sent to Hospital in the city was diagnosed with AML on 10Apr2021 (hospitalized 5 days: April 6-10, 2021) and started chemotherapy (outpatient on 19Apr2021). She returned to hospital on 25Apr2021 in distress and was diagnosed with COVID. The patient was put on a ventilator with pressor support on 01May2021 and passed away on 10May2021. The outcome of the events was unknown.  The course of the event was as follows: The patient received her COVID vaccine and developed bruises within days after the shot. She pursued care and diagnosis and reporting with vaccine administrator, but finally had to see PCP. After multiple visits, she was sent to a hospital in the city. She was diagnosed with AML (hospitalized 6 days) and started chemotherapy (outpatient). Then returned to the hospital 25Apr2021 in distress and diagnosed with COVID. On 17Mar2021, Pfizer vaccine. On 17Mar2021, immediate reactions to vaccine, physical and emotional distress. On 20Mar2021, 24 bruises by 30Mar2021. On 06Apr2021, hospital admission for AML diagnosed 10Apr2021. On 08Apr2021, bone marrow biopsy completed with report of 29% blasts, hypercellular bone marrow (60-70%) with significant granulocytic dysplasia and occasional diserythropoiesis. On 19Apr2021, first outpatient chemotherapy. On 25Apr2021, hospital admission and positive covid test: Labs were remarkable for Hgb 4.3, WBC 1.3, and PI-TK 10. Transfusion of 3 units pRBCs and 2 units PLT was ordered. After 2 units pRBC, Hgb up-trended from 4.3 to 6.0. Plan was for admission to P2, but the patient tested positive for COVID-19. Chest x ray was obtained and showed evidence of early multilobar pneumonia. On 30Apr2021, full oxygen mask ('trying to save her life'). On 01May2021, ventilator DSO. On 07May2021, subcutaneous emphysema, Family meeting at hospital, drug treatments discontinued. On 10May2021, pneumothorax, Ventilator discontinued, patient passed away. Prior to vaccination, the patient was a healthy 64 year old woman planning a vacation. The vaccination was intended to make the trip safer.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, White blood cell count decreased
Clinical narrative: Pneumothorax; Acute megakaryocytic leukaemia; passed away; Diagnosed with COVID; bruises; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband stated, "Your vaccine killed my wife. She received her first dose of your COVID vaccine on 17Mar2021." The patient received her COVID vaccine on 17Mar2021 at a local clinic. She developed bruises within days after the shot on 30Mar2021. She pursued care and diagnosis and reporting with the vaccine administrator, but finally had to see PCP. After multiple visits, patient was sent to Hospital in the city was diagnosed with AML on 10Apr2021 (hospitalized 5 days: April 6-10, 2021) and started chemotherapy (outpatient on 19Apr2021). She returned to hospital on 25Apr2021 in distress and was diagnosed with COVID. The patient was put on a ventilator with pressor support on 01May2021 and passed away on 10May2021. The outcome of the events was unknown.  The course of the event was as follows: The patient received her COVID vaccine and developed bruises within days after the shot. She pursued care and diagnosis and reporting with vaccine administrator, but finally had to see PCP. After multiple visits, she was sent to a hospital in the city. She was diagnosed with AML (hospitalized 6 days) and started chemotherapy (outpatient). Then returned to the hospital 25Apr2021 in distress and diagnosed with COVID. On 17Mar2021, Pfizer vaccine. On 17Mar2021, immediate reactions to vaccine, physical and emotional distress. On 20Mar2021, 24 bruises by 30Mar2021. On 06Apr2021, hospital admission for AML diagnosed 10Apr2021. On 08Apr2021, bone marrow biopsy completed with report of 29% blasts, hypercellular bone marrow (60-70%) with significant granulocytic dysplasia and occasional diserythropoiesis. On 19Apr2021, first outpatient chemotherapy. On 25Apr2021, hospital admission and positive covid test: Labs were remarkable for Hgb 4.3, WBC 1.3, and PI-TK 10. Transfusion of 3 units pRBCs and 2 units PLT was ordered. After 2 units pRBC, Hgb up-trended from 4.3 to 6.0. Plan was for admission to P2, but the patient tested positive for COVID-19. Chest x ray was obtained and showed evidence of early multilobar pneumonia. On 30Apr2021, full oxygen mask ('trying to save her life'). On 01May2021, ventilator DSO. On 07May2021, subcutaneous emphysema, Family meeting at hospital, drug treatments discontinued. On 10May2021, pneumothorax, Ventilator discontinued, patient passed away. Prior to vaccination, the patient was a healthy 64 year old woman planning a vacation. The vaccination was intended to make the trip safer.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myeloid leukaemia, COVID-19, Contusion, Death, Drug ineffective
Clinical narrative: Pneumothorax; Acute megakaryocytic leukaemia; passed away; Diagnosed with COVID; bruises; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband stated, "Your vaccine killed my wife. She received her first dose of your COVID vaccine on 17Mar2021." The patient received her COVID vaccine on 17Mar2021 at a local clinic. She developed bruises within days after the shot on 30Mar2021. She pursued care and diagnosis and reporting with the vaccine administrator, but finally had to see PCP. After multiple visits, patient was sent to Hospital in the city was diagnosed with AML on 10Apr2021 (hospitalized 5 days: April 6-10, 2021) and started chemotherapy (outpatient on 19Apr2021). She returned to hospital on 25Apr2021 in distress and was diagnosed with COVID. The patient was put on a ventilator with pressor support on 01May2021 and passed away on 10May2021. The outcome of the events was unknown.  The course of the event was as follows: The patient received her COVID vaccine and developed bruises within days after the shot. She pursued care and diagnosis and reporting with vaccine administrator, but finally had to see PCP. After multiple visits, she was sent to a hospital in the city. She was diagnosed with AML (hospitalized 6 days) and started chemotherapy (outpatient). Then returned to the hospital 25Apr2021 in distress and diagnosed with COVID. On 17Mar2021, Pfizer vaccine. On 17Mar2021, immediate reactions to vaccine, physical and emotional distress. On 20Mar2021, 24 bruises by 30Mar2021. On 06Apr2021, hospital admission for AML diagnosed 10Apr2021. On 08Apr2021, bone marrow biopsy completed with report of 29% blasts, hypercellular bone marrow (60-70%) with significant granulocytic dysplasia and occasional diserythropoiesis. On 19Apr2021, first outpatient chemotherapy. On 25Apr2021, hospital admission and positive covid test: Labs were remarkable for Hgb 4.3, WBC 1.3, and PI-TK 10. Transfusion of 3 units pRBCs and 2 units PLT was ordered. After 2 units pRBC, Hgb up-trended from 4.3 to 6.0. Plan was for admission to P2, but the patient tested positive for COVID-19. Chest x ray was obtained and showed evidence of early multilobar pneumonia. On 30Apr2021, full oxygen mask ('trying to save her life'). On 01May2021, ventilator DSO. On 07May2021, subcutaneous emphysema, Family meeting at hospital, drug treatments discontinued. On 10May2021, pneumothorax, Ventilator discontinued, patient passed away. Prior to vaccination, the patient was a healthy 64 year old woman planning a vacation. The vaccination was intended to make the trip safer.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Pneumothorax; Acute megakaryocytic leukaemia; passed away; Diagnosed with COVID; bruises; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband stated, "Your vaccine killed my wife. She received her first dose of your COVID vaccine on 17Mar2021." The patient received her COVID vaccine on 17Mar2021 at a local clinic. She developed bruises within days after the shot on 30Mar2021. She pursued care and diagnosis and reporting with the vaccine administrator, but finally had to see PCP. After multiple visits, patient was sent to Hospital in the city was diagnosed with AML on 10Apr2021 (hospitalized 5 days: April 6-10, 2021) and started chemotherapy (outpatient on 19Apr2021). She returned to hospital on 25Apr2021 in distress and was diagnosed with COVID. The patient was put on a ventilator with pressor support on 01May2021 and passed away on 10May2021. The outcome of the events was unknown.  The course of the event was as follows: The patient received her COVID vaccine and developed bruises within days after the shot. She pursued care and diagnosis and reporting with vaccine administrator, but finally had to see PCP. After multiple visits, she was sent to a hospital in the city. She was diagnosed with AML (hospitalized 6 days) and started chemotherapy (outpatient). Then returned to the hospital 25Apr2021 in distress and diagnosed with COVID. On 17Mar2021, Pfizer vaccine. On 17Mar2021, immediate reactions to vaccine, physical and emotional distress. On 20Mar2021, 24 bruises by 30Mar2021. On 06Apr2021, hospital admission for AML diagnosed 10Apr2021. On 08Apr2021, bone marrow biopsy completed with report of 29% blasts, hypercellular bone marrow (60-70%) with significant granulocytic dysplasia and occasional diserythropoiesis. On 19Apr2021, first outpatient chemotherapy. On 25Apr2021, hospital admission and positive covid test: Labs were remarkable for Hgb 4.3, WBC 1.3, and PI-TK 10. Transfusion of 3 units pRBCs and 2 units PLT was ordered. After 2 units pRBC, Hgb up-trended from 4.3 to 6.0. Plan was for admission to P2, but the patient tested positive for COVID-19. Chest x ray was obtained and showed evidence of early multilobar pneumonia. On 30Apr2021, full oxygen mask ('trying to save her life'). On 01May2021, ventilator DSO. On 07May2021, subcutaneous emphysema, Family meeting at hospital, drug treatments discontinued. On 10May2021, pneumothorax, Ventilator discontinued, patient passed away. Prior to vaccination, the patient was a healthy 64 year old woman planning a vacation. The vaccination was intended to make the trip safer.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute megakaryocytic leukaemia, Biopsy bone marrow, COVID-19, Contusion, Death
Clinical narrative: Pneumothorax; Acute megakaryocytic leukaemia; passed away; Diagnosed with COVID; bruises; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband stated, "Your vaccine killed my wife. She received her first dose of your COVID vaccine on 17Mar2021." The patient received her COVID vaccine on 17Mar2021 at a local clinic. She developed bruises within days after the shot on 30Mar2021. She pursued care and diagnosis and reporting with the vaccine administrator, but finally had to see PCP. After multiple visits, patient was sent to Hospital in the city was diagnosed with AML on 10Apr2021 (hospitalized 5 days: April 6-10, 2021) and started chemotherapy (outpatient on 19Apr2021). She returned to hospital on 25Apr2021 in distress and was diagnosed with COVID. The patient was put on a ventilator with pressor support on 01May2021 and passed away on 10May2021. The outcome of the events was unknown.  The course of the event was as follows: The patient received her COVID vaccine and developed bruises within days after the shot. She pursued care and diagnosis and reporting with vaccine administrator, but finally had to see PCP. After multiple visits, she was sent to a hospital in the city. She was diagnosed with AML (hospitalized 6 days) and started chemotherapy (outpatient). Then returned to the hospital 25Apr2021 in distress and diagnosed with COVID. On 17Mar2021, Pfizer vaccine. On 17Mar2021, immediate reactions to vaccine, physical and emotional distress. On 20Mar2021, 24 bruises by 30Mar2021. On 06Apr2021, hospital admission for AML diagnosed 10Apr2021. On 08Apr2021, bone marrow biopsy completed with report of 29% blasts, hypercellular bone marrow (60-70%) with significant granulocytic dysplasia and occasional diserythropoiesis. On 19Apr2021, first outpatient chemotherapy. On 25Apr2021, hospital admission and positive covid test: Labs were remarkable for Hgb 4.3, WBC 1.3, and PI-TK 10. Transfusion of 3 units pRBCs and 2 units PLT was ordered. After 2 units pRBC, Hgb up-trended from 4.3 to 6.0. Plan was for admission to P2, but the patient tested positive for COVID-19. Chest x ray was obtained and showed evidence of early multilobar pneumonia. On 30Apr2021, full oxygen mask ('trying to save her life'). On 01May2021, ventilator DSO. On 07May2021, subcutaneous emphysema, Family meeting at hospital, drug treatments discontinued. On 10May2021, pneumothorax, Ventilator discontinued, patient passed away. Prior to vaccination, the patient was a healthy 64 year old woman planning a vacation. The vaccination was intended to make the trip safer.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haemoglobin, Platelet count, Pneumothorax, SARS-CoV-2 test, White blood cell count
Clinical narrative: Pneumothorax; Acute megakaryocytic leukaemia; passed away; Diagnosed with COVID; bruises; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband stated, "Your vaccine killed my wife. She received her first dose of your COVID vaccine on 17Mar2021." The patient received her COVID vaccine on 17Mar2021 at a local clinic. She developed bruises within days after the shot on 30Mar2021. She pursued care and diagnosis and reporting with the vaccine administrator, but finally had to see PCP. After multiple visits, patient was sent to Hospital in the city was diagnosed with AML on 10Apr2021 (hospitalized 5 days: April 6-10, 2021) and started chemotherapy (outpatient on 19Apr2021). She returned to hospital on 25Apr2021 in distress and was diagnosed with COVID. The patient was put on a ventilator with pressor support on 01May2021 and passed away on 10May2021. The outcome of the events was unknown.  The course of the event was as follows: The patient received her COVID vaccine and developed bruises within days after the shot. She pursued care and diagnosis and reporting with vaccine administrator, but finally had to see PCP. After multiple visits, she was sent to a hospital in the city. She was diagnosed with AML (hospitalized 6 days) and started chemotherapy (outpatient). Then returned to the hospital 25Apr2021 in distress and diagnosed with COVID. On 17Mar2021, Pfizer vaccine. On 17Mar2021, immediate reactions to vaccine, physical and emotional distress. On 20Mar2021, 24 bruises by 30Mar2021. On 06Apr2021, hospital admission for AML diagnosed 10Apr2021. On 08Apr2021, bone marrow biopsy completed with report of 29% blasts, hypercellular bone marrow (60-70%) with significant granulocytic dysplasia and occasional diserythropoiesis. On 19Apr2021, first outpatient chemotherapy. On 25Apr2021, hospital admission and positive covid test: Labs were remarkable for Hgb 4.3, WBC 1.3, and PI-TK 10. Transfusion of 3 units pRBCs and 2 units PLT was ordered. After 2 units pRBC, Hgb up-trended from 4.3 to 6.0. Plan was for admission to P2, but the patient tested positive for COVID-19. Chest x ray was obtained and showed evidence of early multilobar pneumonia. On 30Apr2021, full oxygen mask ('trying to save her life'). On 01May2021, ventilator DSO. On 07May2021, subcutaneous emphysema, Family meeting at hospital, drug treatments discontinued. On 10May2021, pneumothorax, Ventilator discontinued, patient passed away. Prior to vaccination, the patient was a healthy 64 year old woman planning a vacation. The vaccination was intended to make the trip safer.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Migraine, Vertigo
Clinical narrative: high frequency hearing loss right ear; vertigo; vertigo; migraines; migraines; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EW0158), via intramuscular, administered in right arm on 09Apr2021 13:00 (at the age of 56-year-old) as dose 2, single for COVID-19 immunization.  Medical history migraines from 01Nov1980 and ongoing, seizure disorder from 17Aug2000 and ongoing, three years of out breast cancer, high blood pressure from 18May2020 and ongoing and penicillin allergy. The concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (BNT162B2, Lot Number: EN6204) intramuscular, administered in right arm on 19Mar2021 13:00 (at the age of 56-year-old) as single dose for COVID-19 immunization; and on 23Mar2021, experienced very loud tinnitus in right ear, self-spinning vertigo and an increase in frequency of and intensity of migraines. No COVID prior vaccination nor tested post vaccination. The patient experienced migraines on 10Apr2021, vertigo on 23Apr2021 and high frequency hearing loss right ear on 07Jun2021. The events migraines and vertigo resulted in doctor or other healthcare professional office/clinic visit. The events migraines and vertigo were assessed as serious Persistent/significant disability/ incapacity. The patient underwent laboratory test and procedure which included: blood work on 11Jul2021: low; MRI of brain on 27May2021: Normal; hearing test on 07Jun2021: high frequency hearing loss right ear; mind test, video test on 16Jun2021: Normal. The calcaric test was scheduled on 23Jul2021. Therapeutic measures were taken as a result of migraine which included trying Emgality; and vertigo which included increase in metaprolol. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Blood test, Condition aggravated, Deafness unilateral, Electroencephalogram
Clinical narrative: high frequency hearing loss right ear; vertigo; vertigo; migraines; migraines; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EW0158), via intramuscular, administered in right arm on 09Apr2021 13:00 (at the age of 56-year-old) as dose 2, single for COVID-19 immunization.  Medical history migraines from 01Nov1980 and ongoing, seizure disorder from 17Aug2000 and ongoing, three years of out breast cancer, high blood pressure from 18May2020 and ongoing and penicillin allergy. The concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (BNT162B2, Lot Number: EN6204) intramuscular, administered in right arm on 19Mar2021 13:00 (at the age of 56-year-old) as single dose for COVID-19 immunization; and on 23Mar2021, experienced very loud tinnitus in right ear, self-spinning vertigo and an increase in frequency of and intensity of migraines. No COVID prior vaccination nor tested post vaccination. The patient experienced migraines on 10Apr2021, vertigo on 23Apr2021 and high frequency hearing loss right ear on 07Jun2021. The events migraines and vertigo resulted in doctor or other healthcare professional office/clinic visit. The events migraines and vertigo were assessed as serious Persistent/significant disability/ incapacity. The patient underwent laboratory test and procedure which included: blood work on 11Jul2021: low; MRI of brain on 27May2021: Normal; hearing test on 07Jun2021: high frequency hearing loss right ear; mind test, video test on 16Jun2021: Normal. The calcaric test was scheduled on 23Jul2021. Therapeutic measures were taken as a result of migraine which included trying Emgality; and vertigo which included increase in metaprolol. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Migraine, Vertigo
Clinical narrative: high frequency hearing loss right ear; vertigo; vertigo; migraines; migraines; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EW0158), via intramuscular, administered in right arm on 09Apr2021 13:00 (at the age of 56-year-old) as dose 2, single for COVID-19 immunization.  Medical history migraines from 01Nov1980 and ongoing, seizure disorder from 17Aug2000 and ongoing, three years of out breast cancer, high blood pressure from 18May2020 and ongoing and penicillin allergy. The concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (BNT162B2, Lot Number: EN6204) intramuscular, administered in right arm on 19Mar2021 13:00 (at the age of 56-year-old) as single dose for COVID-19 immunization; and on 23Mar2021, experienced very loud tinnitus in right ear, self-spinning vertigo and an increase in frequency of and intensity of migraines. No COVID prior vaccination nor tested post vaccination. The patient experienced migraines on 10Apr2021, vertigo on 23Apr2021 and high frequency hearing loss right ear on 07Jun2021. The events migraines and vertigo resulted in doctor or other healthcare professional office/clinic visit. The events migraines and vertigo were assessed as serious Persistent/significant disability/ incapacity. The patient underwent laboratory test and procedure which included: blood work on 11Jul2021: low; MRI of brain on 27May2021: Normal; hearing test on 07Jun2021: high frequency hearing loss right ear; mind test, video test on 16Jun2021: Normal. The calcaric test was scheduled on 23Jul2021. Therapeutic measures were taken as a result of migraine which included trying Emgality; and vertigo which included increase in metaprolol. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; Expired dose of Pneumovax23 was administered to a male patient; This spontaneous report was received from a registered pharmacist and refers to a male patient of unknown age. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.     On 28-JUL-2021 the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S024808, expiration date 02-JUN-2021, 1 dosage form (route not reported) for prophylaxis. No additional adverse event reported, and no product quality complain. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Differential white blood cell count normal, Dysgeusia
Clinical narrative: SMELL CHANGED(PERFUMES AND CLEANING SUPPLIES SMELL SUPPER BITTER); LIQUIDS SOME TIMES TASTE LIKE METAL; SEVERE MIGRAINE; CHEST PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and other pre-existing medical conditions included patient have never suffer from headaches or migraine prior to been vaccinated. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 19-MAR-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal. On 19-APR-2021, the subject experienced severe migraine. On 19-APR-2021, the subject experienced chest pain. On MAY-2021, the subject experienced smell changed (perfumes and cleaning supplies smell supper bitter). On MAY-2021, the subject experienced liquids some times taste like metal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe migraine, and the outcome of chest pain, smell changed(perfumes and cleaning supplies smell supper bitter) and liquids some times taste like metal was not reported. This report was non-serious.