chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Swelling face
Clinical narrative: Mild headache and moderate fatigue exacerbated with activity; Mild headache and moderate fatigue exacerbated with activity; This is a spontaneous report received from a contactable nurse (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via unspecified route of administration in left arm on 12Feb2021, (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient was non-pregnant at the time of vaccination. The patient medical history included stage 1 hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19, undergone Nasal Swab on 21Feb2021 and resulted in negative. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient concomitant medication included multivitamin. The patient previously took Keflex and experienced allergy. On 13Feb2021, the patient experienced mild headache and moderate fatigue exacerbated with activity. The patient visited physician office for the events. The patient did not receive treatment for the events. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) in left arm on 09Mar2021 for COVID-19 immunisation. The seriousness of the events was reported as disability. The outcome of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Mild headache and moderate fatigue exacerbated with activity; Mild headache and moderate fatigue exacerbated with activity; This is a spontaneous report received from a contactable nurse (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via unspecified route of administration in left arm on 12Feb2021, (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient was non-pregnant at the time of vaccination. The patient medical history included stage 1 hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19, undergone Nasal Swab on 21Feb2021 and resulted in negative. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient concomitant medication included multivitamin. The patient previously took Keflex and experienced allergy. On 13Feb2021, the patient experienced mild headache and moderate fatigue exacerbated with activity. The patient visited physician office for the events. The patient did not receive treatment for the events. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) in left arm on 09Mar2021 for COVID-19 immunisation. The seriousness of the events was reported as disability. The outcome of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: Mild headache and moderate fatigue exacerbated with activity; Mild headache and moderate fatigue exacerbated with activity; This is a spontaneous report received from a contactable nurse (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via unspecified route of administration in left arm on 12Feb2021, (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient was non-pregnant at the time of vaccination. The patient medical history included stage 1 hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19, undergone Nasal Swab on 21Feb2021 and resulted in negative. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient concomitant medication included multivitamin. The patient previously took Keflex and experienced allergy. On 13Feb2021, the patient experienced mild headache and moderate fatigue exacerbated with activity. The patient visited physician office for the events. The patient did not receive treatment for the events. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) in left arm on 09Mar2021 for COVID-19 immunisation. The seriousness of the events was reported as disability. The outcome of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Epistaxis
Clinical narrative: pronounced nose bleed; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, via an unspecified route of administration on 26Jan2021 (Lot number: UNKNOWN) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 31Jan2021, the patient experienced pronounced nose bleed. The clinical course was reported as follows: The patient reported that she received her first dose of the Pfizer-Biontech Covid19 vaccine on 26Jan2021. Then, 5 days later, she had a "very pronounced nose bleed" which landed her in the ER, with the bleed having to be packed. She has since had cauterization done by two different ENTs to stop the residual bleeding. Her HCP said they did not believe the vaccine caused the nose bleed, and have given her the go-ahead to receive the second dose.  The clinical outcome of pronounced nose bleed was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Epistaxis, Nasal cavity packing, Vascular cauterisation
Clinical narrative: pronounced nose bleed; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, via an unspecified route of administration on 26Jan2021 (Lot number: UNKNOWN) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 31Jan2021, the patient experienced pronounced nose bleed. The clinical course was reported as follows: The patient reported that she received her first dose of the Pfizer-Biontech Covid19 vaccine on 26Jan2021. Then, 5 days later, she had a "very pronounced nose bleed" which landed her in the ER, with the bleed having to be packed. She has since had cauterization done by two different ENTs to stop the residual bleeding. Her HCP said they did not believe the vaccine caused the nose bleed, and have given her the go-ahead to receive the second dose.  The clinical outcome of pronounced nose bleed was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Epistaxis, Incomplete course of vaccination, Nasal cavity packing, Vascular cauterisation
Clinical narrative: pronounced nose bleed; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, via an unspecified route of administration on 26Jan2021 (Lot number: UNKNOWN) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 31Jan2021, the patient experienced pronounced nose bleed. The clinical course was reported as follows: The patient reported that she received her first dose of the Pfizer-Biontech Covid19 vaccine on 26Jan2021. Then, 5 days later, she had a "very pronounced nose bleed" which landed her in the ER, with the bleed having to be packed. She has since had cauterization done by two different ENTs to stop the residual bleeding. Her HCP said they did not believe the vaccine caused the nose bleed, and have given her the go-ahead to receive the second dose.  The clinical outcome of pronounced nose bleed was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Disease recurrence
Clinical narrative: A FIb kicked in/A Fib again; Meniere's attack/light headed and get winded very easily; This is a spontaneous report from a contactable consumer (patient and his spouse).  An 83-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2), intramuscular administered on arm left on 08Feb2021 08:00 (Batch/Lot Number: EL9269; Expiration Date: 02Feb2021) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing atrial fibrillation (AFib) and he had maybe once or twice a week but never felt it (before Pfizer shot), ongoing hypertension, and Meniere's disease which had attacks several times a year  and since he lost his hearing in his right ear the attacks were minor (he felt a little nauseous, similar to having a minor hang over and with a louder than normal ringing in his right ear -tinnitus). Concomitant medications included apixaban (ELIQUIS) taken for atrial fibrillation from 2016 (reported as 5 years ago) and ongoing; and hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for hypertension from 2011 (reported as 10 years ago) and ongoing. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Before the shots, he had an AFib attack maybe once or twice a week never felt it. He mentioned that the only way he knew he had it was using his fitness watch and take his pulse before several times a day (unknown results) and before he exercise (he will not exercise if he was in Afib  but it always went away overnight). His doctor recommends staying hydrated and will see a cardiologist if it does not stabilize. After his first vaccine shot on 21Jan2021  06:45 (Batch/Lot Number: EK9231) intramuscular administered on arm left and while he was at his car, the was in Afib which lasted for 5 days (26Jan2021) which was unprecedented. After about five days, his pulse stabilized and was back to normal having AFib again maybe only once a week (AER 2021194945). Then, the patient received the 2nd dose on 08Feb2021.  By 08:45, the patient was in AFib again for five days (13Feb2021) when it cleared but then it came back almost immediately for another two days and he was not back to normal even after 7 days. The patient also had Meniere's attack the same time (08Feb2021 08:45) with the Afib he had. He was little lightheaded and get winded very easily during that time and recovered by 13Feb2021 (same time with the Afib). The event of Afib noted on 08Feb2021 was persistent/Significant disability/Incapacity and did not received any treatment.   No follow up attempts are needed. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Heart rate, Meniere's disease
Clinical narrative: A FIb kicked in/A Fib again; Meniere's attack/light headed and get winded very easily; This is a spontaneous report from a contactable consumer (patient and his spouse).  An 83-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2), intramuscular administered on arm left on 08Feb2021 08:00 (Batch/Lot Number: EL9269; Expiration Date: 02Feb2021) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing atrial fibrillation (AFib) and he had maybe once or twice a week but never felt it (before Pfizer shot), ongoing hypertension, and Meniere's disease which had attacks several times a year  and since he lost his hearing in his right ear the attacks were minor (he felt a little nauseous, similar to having a minor hang over and with a louder than normal ringing in his right ear -tinnitus). Concomitant medications included apixaban (ELIQUIS) taken for atrial fibrillation from 2016 (reported as 5 years ago) and ongoing; and hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for hypertension from 2011 (reported as 10 years ago) and ongoing. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Before the shots, he had an AFib attack maybe once or twice a week never felt it. He mentioned that the only way he knew he had it was using his fitness watch and take his pulse before several times a day (unknown results) and before he exercise (he will not exercise if he was in Afib  but it always went away overnight). His doctor recommends staying hydrated and will see a cardiologist if it does not stabilize. After his first vaccine shot on 21Jan2021  06:45 (Batch/Lot Number: EK9231) intramuscular administered on arm left and while he was at his car, the was in Afib which lasted for 5 days (26Jan2021) which was unprecedented. After about five days, his pulse stabilized and was back to normal having AFib again maybe only once a week (AER 2021194945). Then, the patient received the 2nd dose on 08Feb2021.  By 08:45, the patient was in AFib again for five days (13Feb2021) when it cleared but then it came back almost immediately for another two days and he was not back to normal even after 7 days. The patient also had Meniere's attack the same time (08Feb2021 08:45) with the Afib he had. He was little lightheaded and get winded very easily during that time and recovered by 13Feb2021 (same time with the Afib). The event of Afib noted on 08Feb2021 was persistent/Significant disability/Incapacity and did not received any treatment.   No follow up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted positive for COVID-19 after; contracted positive for COVID-19 after; This is a spontaneous report from a Pfizer sponsored program. A contactable male consumer (patient) reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date in 2021, patient had contracted positive for COVID-19 after first dose of vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test,result: positive on unspecified date. The outcome of the events was reported as unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: contracted positive for COVID-19 after; contracted positive for COVID-19 after; This is a spontaneous report from a Pfizer sponsored program. A contactable male consumer (patient) reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date in 2021, patient had contracted positive for COVID-19 after first dose of vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test,result: positive on unspecified date. The outcome of the events was reported as unknown.  Information on Lot/Batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac failure congestive, Chest X-ray, Computerised tomogram head, Death, Dizziness
Clinical narrative: heart arrhythmia; cardiac arrest; This is a spontaneous report from a contactable consumer who reported for his wife. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number EM9810) via unspecified route of administration on 02Feb2021 (at the age of 81-year old) at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medication included metoprolol from Jan2021 for congestive heart failure. The patient received the first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number) on 12Jan2021 and on 15Jan2021, she had such trouble breathing diagnosed in the Urgent care as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. On 18Feb2021 she collapsed, went limp and went into the hospital and she was neurologically unresponsive. They tried to revive her and did bring her back with 5 epi shots, he was told that they did bring her back. When she got to the ER she went pulseless again and they gave her two more epi shots and got her back but she never did come out of a coma-like state. They admitted her to ICU. She stayed there until she passed away on the 22Feb2021. CT scans, X-rays, images of her heart, echocardiograms were performed. She was tested for COVID in Feb2021 and it was negative. They did a brain scan and there was no activity because she had been too long without oxygen. The consumer reported that the week before the cardiac arrest, she was feeling faint but she never passed out. Death certificate stated cause of death was heart arrhythmia and cardiac arrest. No autopsy was done.; Reported Cause(s) of Death: heart arrhythmia; cardiac arrest
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Hypotonia, Pulse absent, Respiratory arrest
Clinical narrative: heart arrhythmia; cardiac arrest; This is a spontaneous report from a contactable consumer who reported for his wife. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number EM9810) via unspecified route of administration on 02Feb2021 (at the age of 81-year old) at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medication included metoprolol from Jan2021 for congestive heart failure. The patient received the first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number) on 12Jan2021 and on 15Jan2021, she had such trouble breathing diagnosed in the Urgent care as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. On 18Feb2021 she collapsed, went limp and went into the hospital and she was neurologically unresponsive. They tried to revive her and did bring her back with 5 epi shots, he was told that they did bring her back. When she got to the ER she went pulseless again and they gave her two more epi shots and got her back but she never did come out of a coma-like state. They admitted her to ICU. She stayed there until she passed away on the 22Feb2021. CT scans, X-rays, images of her heart, echocardiograms were performed. She was tested for COVID in Feb2021 and it was negative. They did a brain scan and there was no activity because she had been too long without oxygen. The consumer reported that the week before the cardiac arrest, she was feeling faint but she never passed out. Death certificate stated cause of death was heart arrhythmia and cardiac arrest. No autopsy was done.; Reported Cause(s) of Death: heart arrhythmia; cardiac arrest
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: heart arrhythmia; cardiac arrest; This is a spontaneous report from a contactable consumer who reported for his wife. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number EM9810) via unspecified route of administration on 02Feb2021 (at the age of 81-year old) at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medication included metoprolol from Jan2021 for congestive heart failure. The patient received the first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number) on 12Jan2021 and on 15Jan2021, she had such trouble breathing diagnosed in the Urgent care as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. On 18Feb2021 she collapsed, went limp and went into the hospital and she was neurologically unresponsive. They tried to revive her and did bring her back with 5 epi shots, he was told that they did bring her back. When she got to the ER she went pulseless again and they gave her two more epi shots and got her back but she never did come out of a coma-like state. They admitted her to ICU. She stayed there until she passed away on the 22Feb2021. CT scans, X-rays, images of her heart, echocardiograms were performed. She was tested for COVID in Feb2021 and it was negative. They did a brain scan and there was no activity because she had been too long without oxygen. The consumer reported that the week before the cardiac arrest, she was feeling faint but she never passed out. Death certificate stated cause of death was heart arrhythmia and cardiac arrest. No autopsy was done.; Reported Cause(s) of Death: heart arrhythmia; cardiac arrest
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arrhythmia, Cardiac arrest, Cardiac failure congestive, Dyspnoea
Clinical narrative: heart arrhythmia; cardiac arrest; This is a spontaneous report from a contactable consumer who reported for his wife. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number EM9810) via unspecified route of administration on 02Feb2021 (at the age of 81-year old) at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medication included metoprolol from Jan2021 for congestive heart failure. The patient received the first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number) on 12Jan2021 and on 15Jan2021, she had such trouble breathing diagnosed in the Urgent care as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. On 18Feb2021 she collapsed, went limp and went into the hospital and she was neurologically unresponsive. They tried to revive her and did bring her back with 5 epi shots, he was told that they did bring her back. When she got to the ER she went pulseless again and they gave her two more epi shots and got her back but she never did come out of a coma-like state. They admitted her to ICU. She stayed there until she passed away on the 22Feb2021. CT scans, X-rays, images of her heart, echocardiograms were performed. She was tested for COVID in Feb2021 and it was negative. They did a brain scan and there was no activity because she had been too long without oxygen. The consumer reported that the week before the cardiac arrest, she was feeling faint but she never passed out. Death certificate stated cause of death was heart arrhythmia and cardiac arrest. No autopsy was done.; Reported Cause(s) of Death: heart arrhythmia; cardiac arrest
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac failure congestive, Computerised tomogram, Dizziness, Dyspnoea, Echocardiogram
Clinical narrative: heart arrhythmia; cardiac arrest; This is a spontaneous report from a contactable consumer who reported for his wife. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number EM9810) via unspecified route of administration on 02Feb2021 (at the age of 81-year old) at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medication included metoprolol from Jan2021 for congestive heart failure. The patient received the first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number) on 12Jan2021 and on 15Jan2021, she had such trouble breathing diagnosed in the Urgent care as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. On 18Feb2021 she collapsed, went limp and went into the hospital and she was neurologically unresponsive. They tried to revive her and did bring her back with 5 epi shots, he was told that they did bring her back. When she got to the ER she went pulseless again and they gave her two more epi shots and got her back but she never did come out of a coma-like state. They admitted her to ICU. She stayed there until she passed away on the 22Feb2021. CT scans, X-rays, images of her heart, echocardiograms were performed. She was tested for COVID in Feb2021 and it was negative. They did a brain scan and there was no activity because she had been too long without oxygen. The consumer reported that the week before the cardiac arrest, she was feeling faint but she never passed out. Death certificate stated cause of death was heart arrhythmia and cardiac arrest. No autopsy was done.; Reported Cause(s) of Death: heart arrhythmia; cardiac arrest
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, SARS-CoV-2 test, Syncope, X-ray
Clinical narrative: heart arrhythmia; cardiac arrest; This is a spontaneous report from a contactable consumer who reported for his wife. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number EM9810) via unspecified route of administration on 02Feb2021 (at the age of 81-year old) at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medication included metoprolol from Jan2021 for congestive heart failure. The patient received the first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number) on 12Jan2021 and on 15Jan2021, she had such trouble breathing diagnosed in the Urgent care as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. On 18Feb2021 she collapsed, went limp and went into the hospital and she was neurologically unresponsive. They tried to revive her and did bring her back with 5 epi shots, he was told that they did bring her back. When she got to the ER she went pulseless again and they gave her two more epi shots and got her back but she never did come out of a coma-like state. They admitted her to ICU. She stayed there until she passed away on the 22Feb2021. CT scans, X-rays, images of her heart, echocardiograms were performed. She was tested for COVID in Feb2021 and it was negative. They did a brain scan and there was no activity because she had been too long without oxygen. The consumer reported that the week before the cardiac arrest, she was feeling faint but she never passed out. Death certificate stated cause of death was heart arrhythmia and cardiac arrest. No autopsy was done.; Reported Cause(s) of Death: heart arrhythmia; cardiac arrest
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arrhythmia, Body height, Cardiac arrest, Computerised tomogram, Echocardiogram
Clinical narrative: heart arrhythmia; cardiac arrest; This is a spontaneous report from a contactable consumer who reported for his wife. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number EM9810) via unspecified route of administration on 02Feb2021 (at the age of 81-year old) at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medication included metoprolol from Jan2021 for congestive heart failure. The patient received the first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number) on 12Jan2021 and on 15Jan2021, she had such trouble breathing diagnosed in the Urgent care as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. On 18Feb2021 she collapsed, went limp and went into the hospital and she was neurologically unresponsive. They tried to revive her and did bring her back with 5 epi shots, he was told that they did bring her back. When she got to the ER she went pulseless again and they gave her two more epi shots and got her back but she never did come out of a coma-like state. They admitted her to ICU. She stayed there until she passed away on the 22Feb2021. CT scans, X-rays, images of her heart, echocardiograms were performed. She was tested for COVID in Feb2021 and it was negative. They did a brain scan and there was no activity because she had been too long without oxygen. The consumer reported that the week before the cardiac arrest, she was feeling faint but she never passed out. Death certificate stated cause of death was heart arrhythmia and cardiac arrest. No autopsy was done.; Reported Cause(s) of Death: heart arrhythmia; cardiac arrest
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Scan brain, Ultrasound scan, X-ray
Clinical narrative: heart arrhythmia; cardiac arrest; This is a spontaneous report from a contactable consumer who reported for his wife. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number EM9810) via unspecified route of administration on 02Feb2021 (at the age of 81-year old) at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medication included metoprolol from Jan2021 for congestive heart failure. The patient received the first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number) on 12Jan2021 and on 15Jan2021, she had such trouble breathing diagnosed in the Urgent care as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. On 18Feb2021 she collapsed, went limp and went into the hospital and she was neurologically unresponsive. They tried to revive her and did bring her back with 5 epi shots, he was told that they did bring her back. When she got to the ER she went pulseless again and they gave her two more epi shots and got her back but she never did come out of a coma-like state. They admitted her to ICU. She stayed there until she passed away on the 22Feb2021. CT scans, X-rays, images of her heart, echocardiograms were performed. She was tested for COVID in Feb2021 and it was negative. They did a brain scan and there was no activity because she had been too long without oxygen. The consumer reported that the week before the cardiac arrest, she was feeling faint but she never passed out. Death certificate stated cause of death was heart arrhythmia and cardiac arrest. No autopsy was done.; Reported Cause(s) of Death: heart arrhythmia; cardiac arrest
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Cardiac stress test normal, Catheterisation cardiac, Chest X-ray, Chest pain
Clinical narrative: I experienced intense pain in my back that radiated to my chest and left arm; attributed the pain to supposed pinched nerve; sore arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 12Feb2021 12:00 (Batch/Lot Number: EM9809) as single dose for COVID-19 immunisation. Medical history included partially blocked cardiac arteries and heart palpitation (in Nov2020, patient consulted a cardiologist for heart palpitations. He recommended that patient receive a calcium score test. Since this showed moderate risk in two arteries, he referred patient for an echocardiogram and a nuclear stress test, both of which were normal. Based on these results, he felt that patient's condition was stable and recommended against catheterization). Known allergies included Sulfa and ciprofloxacin (CIPRO). Concomitant medications included vitamin D at 1000 iU, taken for an unspecified indication, start and stop date were not reported. Patient received first BNT162B2 shot on 12Feb2021. The only initial side effect was a sore arm in Feb2021 that lasted for a day. However, about two weeks after the first shot (Feb2021), patient went for a two-mile walk. Soon after patient started, he experienced intense pain in back that radiated to chest and left arm. Patient returned home and the pain subsided quickly. Given his history, patient attributed the pain to his supposed pinched nerve. He tried walking on a couple of successive days, with the same result. Patient received his second vaccination on 05Mar2021 at 12:00 pm (lot number: EN6203) in left arm. Patient began to experience intense pain in back that radiated to chest and left arm about 24 hours later (06Mar2021 at 15:00).The event intense pain in back that radiated to chest and left arm resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Patient was hospitalized for 4 days and received treatment included catherization, insertion of stent. Nasal Swab PCR on 06Mar2021 was negative. Outcome of intense pain in my back that radiated to my chest and left arm and attributed the pain to supposed pinched nerve was resolving. Outcome of sore arm was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021426808 same patient and reporter, different dose and event
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Echocardiogram normal, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: I experienced intense pain in my back that radiated to my chest and left arm; attributed the pain to supposed pinched nerve; sore arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 12Feb2021 12:00 (Batch/Lot Number: EM9809) as single dose for COVID-19 immunisation. Medical history included partially blocked cardiac arteries and heart palpitation (in Nov2020, patient consulted a cardiologist for heart palpitations. He recommended that patient receive a calcium score test. Since this showed moderate risk in two arteries, he referred patient for an echocardiogram and a nuclear stress test, both of which were normal. Based on these results, he felt that patient's condition was stable and recommended against catheterization). Known allergies included Sulfa and ciprofloxacin (CIPRO). Concomitant medications included vitamin D at 1000 iU, taken for an unspecified indication, start and stop date were not reported. Patient received first BNT162B2 shot on 12Feb2021. The only initial side effect was a sore arm in Feb2021 that lasted for a day. However, about two weeks after the first shot (Feb2021), patient went for a two-mile walk. Soon after patient started, he experienced intense pain in back that radiated to chest and left arm. Patient returned home and the pain subsided quickly. Given his history, patient attributed the pain to his supposed pinched nerve. He tried walking on a couple of successive days, with the same result. Patient received his second vaccination on 05Mar2021 at 12:00 pm (lot number: EN6203) in left arm. Patient began to experience intense pain in back that radiated to chest and left arm about 24 hours later (06Mar2021 at 15:00).The event intense pain in back that radiated to chest and left arm resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Patient was hospitalized for 4 days and received treatment included catherization, insertion of stent. Nasal Swab PCR on 06Mar2021 was negative. Outcome of intense pain in my back that radiated to my chest and left arm and attributed the pain to supposed pinched nerve was resolving. Outcome of sore arm was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021426808 same patient and reporter, different dose and event
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocardial infarction, Nerve compression, Pain, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: I experienced intense pain in my back that radiated to my chest and left arm; attributed the pain to supposed pinched nerve; sore arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 12Feb2021 12:00 (Batch/Lot Number: EM9809) as single dose for COVID-19 immunisation. Medical history included partially blocked cardiac arteries and heart palpitation (in Nov2020, patient consulted a cardiologist for heart palpitations. He recommended that patient receive a calcium score test. Since this showed moderate risk in two arteries, he referred patient for an echocardiogram and a nuclear stress test, both of which were normal. Based on these results, he felt that patient's condition was stable and recommended against catheterization). Known allergies included Sulfa and ciprofloxacin (CIPRO). Concomitant medications included vitamin D at 1000 iU, taken for an unspecified indication, start and stop date were not reported. Patient received first BNT162B2 shot on 12Feb2021. The only initial side effect was a sore arm in Feb2021 that lasted for a day. However, about two weeks after the first shot (Feb2021), patient went for a two-mile walk. Soon after patient started, he experienced intense pain in back that radiated to chest and left arm. Patient returned home and the pain subsided quickly. Given his history, patient attributed the pain to his supposed pinched nerve. He tried walking on a couple of successive days, with the same result. Patient received his second vaccination on 05Mar2021 at 12:00 pm (lot number: EN6203) in left arm. Patient began to experience intense pain in back that radiated to chest and left arm about 24 hours later (06Mar2021 at 15:00).The event intense pain in back that radiated to chest and left arm resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Patient was hospitalized for 4 days and received treatment included catherization, insertion of stent. Nasal Swab PCR on 06Mar2021 was negative. Outcome of intense pain in my back that radiated to my chest and left arm and attributed the pain to supposed pinched nerve was resolving. Outcome of sore arm was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021426808 same patient and reporter, different dose and event
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: I experienced intense pain in my back that radiated to my chest and left arm; attributed the pain to supposed pinched nerve; sore arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 12Feb2021 12:00 (Batch/Lot Number: EM9809) as single dose for COVID-19 immunisation. Medical history included partially blocked cardiac arteries and heart palpitation (in Nov2020, patient consulted a cardiologist for heart palpitations. He recommended that patient receive a calcium score test. Since this showed moderate risk in two arteries, he referred patient for an echocardiogram and a nuclear stress test, both of which were normal. Based on these results, he felt that patient's condition was stable and recommended against catheterization). Known allergies included Sulfa and ciprofloxacin (CIPRO). Concomitant medications included vitamin D at 1000 iU, taken for an unspecified indication, start and stop date were not reported. Patient received first BNT162B2 shot on 12Feb2021. The only initial side effect was a sore arm in Feb2021 that lasted for a day. However, about two weeks after the first shot (Feb2021), patient went for a two-mile walk. Soon after patient started, he experienced intense pain in back that radiated to chest and left arm. Patient returned home and the pain subsided quickly. Given his history, patient attributed the pain to his supposed pinched nerve. He tried walking on a couple of successive days, with the same result. Patient received his second vaccination on 05Mar2021 at 12:00 pm (lot number: EN6203) in left arm. Patient began to experience intense pain in back that radiated to chest and left arm about 24 hours later (06Mar2021 at 15:00).The event intense pain in back that radiated to chest and left arm resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Patient was hospitalized for 4 days and received treatment included catherization, insertion of stent. Nasal Swab PCR on 06Mar2021 was negative. Outcome of intense pain in my back that radiated to my chest and left arm and attributed the pain to supposed pinched nerve was resolving. Outcome of sore arm was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021426808 same patient and reporter, different dose and event
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Blood calcium, Cardiac stress test, Echocardiogram, Nerve compression
Clinical narrative: I experienced intense pain in my back that radiated to my chest and left arm; attributed the pain to supposed pinched nerve; sore arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 12Feb2021 12:00 (Batch/Lot Number: EM9809) as single dose for COVID-19 immunisation. Medical history included partially blocked cardiac arteries and heart palpitation (in Nov2020, patient consulted a cardiologist for heart palpitations. He recommended that patient receive a calcium score test. Since this showed moderate risk in two arteries, he referred patient for an echocardiogram and a nuclear stress test, both of which were normal. Based on these results, he felt that patient's condition was stable and recommended against catheterization). Known allergies included Sulfa and ciprofloxacin (CIPRO). Concomitant medications included vitamin D at 1000 iU, taken for an unspecified indication, start and stop date were not reported. Patient received first BNT162B2 shot on 12Feb2021. The only initial side effect was a sore arm in Feb2021 that lasted for a day. However, about two weeks after the first shot (Feb2021), patient went for a two-mile walk. Soon after patient started, he experienced intense pain in back that radiated to chest and left arm. Patient returned home and the pain subsided quickly. Given his history, patient attributed the pain to his supposed pinched nerve. He tried walking on a couple of successive days, with the same result. Patient received his second vaccination on 05Mar2021 at 12:00 pm (lot number: EN6203) in left arm. Patient began to experience intense pain in back that radiated to chest and left arm about 24 hours later (06Mar2021 at 15:00).The event intense pain in back that radiated to chest and left arm resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Patient was hospitalized for 4 days and received treatment included catherization, insertion of stent. Nasal Swab PCR on 06Mar2021 was negative. Outcome of intense pain in my back that radiated to my chest and left arm and attributed the pain to supposed pinched nerve was resolving. Outcome of sore arm was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021426808 same patient and reporter, different dose and event
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: I experienced intense pain in my back that radiated to my chest and left arm; attributed the pain to supposed pinched nerve; sore arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 12Feb2021 12:00 (Batch/Lot Number: EM9809) as single dose for COVID-19 immunisation. Medical history included partially blocked cardiac arteries and heart palpitation (in Nov2020, patient consulted a cardiologist for heart palpitations. He recommended that patient receive a calcium score test. Since this showed moderate risk in two arteries, he referred patient for an echocardiogram and a nuclear stress test, both of which were normal. Based on these results, he felt that patient's condition was stable and recommended against catheterization). Known allergies included Sulfa and ciprofloxacin (CIPRO). Concomitant medications included vitamin D at 1000 iU, taken for an unspecified indication, start and stop date were not reported. Patient received first BNT162B2 shot on 12Feb2021. The only initial side effect was a sore arm in Feb2021 that lasted for a day. However, about two weeks after the first shot (Feb2021), patient went for a two-mile walk. Soon after patient started, he experienced intense pain in back that radiated to chest and left arm. Patient returned home and the pain subsided quickly. Given his history, patient attributed the pain to his supposed pinched nerve. He tried walking on a couple of successive days, with the same result. Patient received his second vaccination on 05Mar2021 at 12:00 pm (lot number: EN6203) in left arm. Patient began to experience intense pain in back that radiated to chest and left arm about 24 hours later (06Mar2021 at 15:00).The event intense pain in back that radiated to chest and left arm resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Patient was hospitalized for 4 days and received treatment included catherization, insertion of stent. Nasal Swab PCR on 06Mar2021 was negative. Outcome of intense pain in my back that radiated to my chest and left arm and attributed the pain to supposed pinched nerve was resolving. Outcome of sore arm was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021426808 same patient and reporter, different dose and event