chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: Patient experienced fever and chills day following vaccine. On day two after receiving vaccine, patient developed chest pain and presented to ED. Work up concerning for myocarditis due to chest pain in the setting of ECG changes and troponin elevation. Chest pain resolved prior to discharge from the hospital and patient was back to baseline.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Left ventricular dysfunction, Magnetic resonance imaging heart, Pyrexia, Troponin increased, Ventricular hypokinesia
Clinical narrative: Patient experienced fever and chills day following vaccine. On day two after receiving vaccine, patient developed chest pain and presented to ED. Work up concerning for myocarditis due to chest pain in the setting of ECG changes and troponin elevation. Chest pain resolved prior to discharge from the hospital and patient was back to baseline.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ventricular tachycardia
Clinical narrative: Patient experienced fever and chills day following vaccine. On day two after receiving vaccine, patient developed chest pain and presented to ED. Work up concerning for myocarditis due to chest pain in the setting of ECG changes and troponin elevation. Chest pain resolved prior to discharge from the hospital and patient was back to baseline.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Gait disturbance, Headache
Clinical narrative: 1st s/s started  3/14 w/ HA, fever, neck pain, bodyaches, fatigue,  COVID  tested NEG. x 3.  progressed and hospitalized ED 3/18 x 2  then admitted 3/19-3/23 .  Eventual DX of vaccine induced viral meningitis.  Off work 9 weeks . Cognitive effects continue.  Memory, problem solving.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Influenza like illness, Musculoskeletal stiffness, Myalgia, Nausea, Viral test
Clinical narrative: 1st s/s started  3/14 w/ HA, fever, neck pain, bodyaches, fatigue,  COVID  tested NEG. x 3.  progressed and hospitalized ED 3/18 x 2  then admitted 3/19-3/23 .  Eventual DX of vaccine induced viral meningitis.  Off work 9 weeks . Cognitive effects continue.  Memory, problem solving.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: 1st s/s started  3/14 w/ HA, fever, neck pain, bodyaches, fatigue,  COVID  tested NEG. x 3.  progressed and hospitalized ED 3/18 x 2  then admitted 3/19-3/23 .  Eventual DX of vaccine induced viral meningitis.  Off work 9 weeks . Cognitive effects continue.  Memory, problem solving.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cognitive disorder, Computerised tomogram head, Fatigue, Headache, Impaired work ability
Clinical narrative: 1st s/s started  3/14 w/ HA, fever, neck pain, bodyaches, fatigue,  COVID  tested NEG. x 3.  progressed and hospitalized ED 3/18 x 2  then admitted 3/19-3/23 .  Eventual DX of vaccine induced viral meningitis.  Off work 9 weeks . Cognitive effects continue.  Memory, problem solving.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Lumbar puncture, Magnetic resonance imaging head, Memory impairment, Meningitis viral
Clinical narrative: 1st s/s started  3/14 w/ HA, fever, neck pain, bodyaches, fatigue,  COVID  tested NEG. x 3.  progressed and hospitalized ED 3/18 x 2  then admitted 3/19-3/23 .  Eventual DX of vaccine induced viral meningitis.  Off work 9 weeks . Cognitive effects continue.  Memory, problem solving.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neck pain, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 1st s/s started  3/14 w/ HA, fever, neck pain, bodyaches, fatigue,  COVID  tested NEG. x 3.  progressed and hospitalized ED 3/18 x 2  then admitted 3/19-3/23 .  Eventual DX of vaccine induced viral meningitis.  Off work 9 weeks . Cognitive effects continue.  Memory, problem solving.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Disability, Headache, Impaired work ability, Incomplete course of vaccination
Clinical narrative: 1st s/s started  3/14 w/ HA, fever, neck pain, bodyaches, fatigue,  COVID  tested NEG. x 3.  progressed and hospitalized ED 3/18 x 2  then admitted 3/19-3/23 .  Eventual DX of vaccine induced viral meningitis.  Off work 9 weeks . Cognitive effects continue.  Memory, problem solving.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Meningitis aseptic, Musculoskeletal stiffness, Nausea, SARS-CoV-2 test negative
Clinical narrative: 1st s/s started  3/14 w/ HA, fever, neck pain, bodyaches, fatigue,  COVID  tested NEG. x 3.  progressed and hospitalized ED 3/18 x 2  then admitted 3/19-3/23 .  Eventual DX of vaccine induced viral meningitis.  Off work 9 weeks . Cognitive effects continue.  Memory, problem solving.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sick leave, Visual impairment, Vomiting
Clinical narrative: 1st s/s started  3/14 w/ HA, fever, neck pain, bodyaches, fatigue,  COVID  tested NEG. x 3.  progressed and hospitalized ED 3/18 x 2  then admitted 3/19-3/23 .  Eventual DX of vaccine induced viral meningitis.  Off work 9 weeks . Cognitive effects continue.  Memory, problem solving.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Blood test, Computerised tomogram abdomen abnormal
Clinical narrative: diagnosed with appendicitis; abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in right arm on 17May2021 at 14:15 (at age of 40 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization. Medical history included Penicillin allergy as a child. Concomitant medications included Daily Immunity Vitamin and fish oil. Prior to vaccination, the patient was not diagnosed with COVID-19. Starting around 04Jun2021, the patient started feeling abdominal pain. The pain slowly increased over the next few days. It became severe by 09Jun2021. He saw the primary care Dr in the morning of 09Jun2021. Dr sent he home with pain meds & ultrasound apt for the next day. The pain got so bad he went to ER 3:00 pm afternoon of 09Jun2021. At 10:30 pm on 09Jun2021, the patient was diagnosed with appendicitis. He had emergency appendectomy on morning of 10Jun2021. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Seriousness criteria reported as Life-threatening. The patient was hospitalized 2 days in Jun2021. The patient underwent lab tests and procedures which included covid-19 test: negative on 09Jun2021. The outcome of the events was recovering.  Information about batch/lot number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Appendicitis, SARS-CoV-2 test
Clinical narrative: diagnosed with appendicitis; abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in right arm on 17May2021 at 14:15 (at age of 40 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization. Medical history included Penicillin allergy as a child. Concomitant medications included Daily Immunity Vitamin and fish oil. Prior to vaccination, the patient was not diagnosed with COVID-19. Starting around 04Jun2021, the patient started feeling abdominal pain. The pain slowly increased over the next few days. It became severe by 09Jun2021. He saw the primary care Dr in the morning of 09Jun2021. Dr sent he home with pain meds & ultrasound apt for the next day. The pain got so bad he went to ER 3:00 pm afternoon of 09Jun2021. At 10:30 pm on 09Jun2021, the patient was diagnosed with appendicitis. He had emergency appendectomy on morning of 10Jun2021. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Seriousness criteria reported as Life-threatening. The patient was hospitalized 2 days in Jun2021. The patient underwent lab tests and procedures which included covid-19 test: negative on 09Jun2021. The outcome of the events was recovering.  Information about batch/lot number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Catheterisation cardiac, Chest X-ray, Computerised tomogram, Echocardiogram
Clinical narrative: I have been diagnosed with myocarditis and pericarditis as a result of getting the vaccine; I have been diagnosed with myocarditis and pericarditis as a result of getting the vaccine; This is a spontaneous report from a contactable consumer (patient). A 21-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8736), via an unspecified route of administration, administered in Arm Right on 05May2021 10:00 (at age of 21 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient's concomitant medications were none. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number=EW0158) on 14Apr2021 10:00 AM (at age of 21 years old) at right arm for COVID-19 immunisation, No reaction for 1st dose. Patient has been diagnosed with myocarditis and pericarditis on 31May2021 05:45PM as a result of getting the vaccine. This was Serious case with Seriousness criteria-Life threatening, Caused/prolonged hospitalization. No days hospitalization was 2. The adverse event result in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event (colchicine, rest). The outcome of the events was Recovering.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Extrasystoles, Magnetic resonance imaging heart, Myocarditis, Palpitations, Pericarditis
Clinical narrative: I have been diagnosed with myocarditis and pericarditis as a result of getting the vaccine; I have been diagnosed with myocarditis and pericarditis as a result of getting the vaccine; This is a spontaneous report from a contactable consumer (patient). A 21-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8736), via an unspecified route of administration, administered in Arm Right on 05May2021 10:00 (at age of 21 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient's concomitant medications were none. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number=EW0158) on 14Apr2021 10:00 AM (at age of 21 years old) at right arm for COVID-19 immunisation, No reaction for 1st dose. Patient has been diagnosed with myocarditis and pericarditis on 31May2021 05:45PM as a result of getting the vaccine. This was Serious case with Seriousness criteria-Life threatening, Caused/prolonged hospitalization. No days hospitalization was 2. The adverse event result in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event (colchicine, rest). The outcome of the events was Recovering.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Syncope, Troponin increased
Clinical narrative: I have been diagnosed with myocarditis and pericarditis as a result of getting the vaccine; I have been diagnosed with myocarditis and pericarditis as a result of getting the vaccine; This is a spontaneous report from a contactable consumer (patient). A 21-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8736), via an unspecified route of administration, administered in Arm Right on 05May2021 10:00 (at age of 21 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient's concomitant medications were none. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number=EW0158) on 14Apr2021 10:00 AM (at age of 21 years old) at right arm for COVID-19 immunisation, No reaction for 1st dose. Patient has been diagnosed with myocarditis and pericarditis on 31May2021 05:45PM as a result of getting the vaccine. This was Serious case with Seriousness criteria-Life threatening, Caused/prolonged hospitalization. No days hospitalization was 2. The adverse event result in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event (colchicine, rest). The outcome of the events was Recovering.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: I have been diagnosed with myocarditis and pericarditis as a result of getting the vaccine; I have been diagnosed with myocarditis and pericarditis as a result of getting the vaccine; This is a spontaneous report from a contactable consumer (patient). A 21-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8736), via an unspecified route of administration, administered in Arm Right on 05May2021 10:00 (at age of 21 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient's concomitant medications were none. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number=EW0158) on 14Apr2021 10:00 AM (at age of 21 years old) at right arm for COVID-19 immunisation, No reaction for 1st dose. Patient has been diagnosed with myocarditis and pericarditis on 31May2021 05:45PM as a result of getting the vaccine. This was Serious case with Seriousness criteria-Life threatening, Caused/prolonged hospitalization. No days hospitalization was 2. The adverse event result in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event (colchicine, rest). The outcome of the events was Recovering.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Myocarditis
Clinical narrative: could not breath , tightness , slumped over in pain, shoulder pain, signs of heart attack
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: could not breath , tightness , slumped over in pain, shoulder pain, signs of heart attack
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Enzyme level test, Musculoskeletal stiffness, Pain, Urine analysis
Clinical narrative: could not breath , tightness , slumped over in pain, shoulder pain, signs of heart attack
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Troponin
Clinical narrative: Fever 100 F 6/11/2021,  Tylenol Extra Strength 1 tablet Chest pain started about 6/12/2021, increased pain on 6/14/2021, took 1 tablet ibuprophen 200 mg Seen by Doctor at Urgent Care Clinic on 6/14/2021 EKG  showed mild ST elevation in the infeior lateral leads. Troponin, CRP tests ordered
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Myocarditis
Clinical narrative: Fever 100 F 6/11/2021,  Tylenol Extra Strength 1 tablet Chest pain started about 6/12/2021, increased pain on 6/14/2021, took 1 tablet ibuprophen 200 mg Seen by Doctor at Urgent Care Clinic on 6/14/2021 EKG  showed mild ST elevation in the infeior lateral leads. Troponin, CRP tests ordered
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Fever 100 F 6/11/2021,  Tylenol Extra Strength 1 tablet Chest pain started about 6/12/2021, increased pain on 6/14/2021, took 1 tablet ibuprophen 200 mg Seen by Doctor at Urgent Care Clinic on 6/14/2021 EKG  showed mild ST elevation in the infeior lateral leads. Troponin, CRP tests ordered
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Electrocardiogram ST segment elevation, Pyrexia, Troponin T increased
Clinical narrative: Fever 100 F 6/11/2021,  Tylenol Extra Strength 1 tablet Chest pain started about 6/12/2021, increased pain on 6/14/2021, took 1 tablet ibuprophen 200 mg Seen by Doctor at Urgent Care Clinic on 6/14/2021 EKG  showed mild ST elevation in the infeior lateral leads. Troponin, CRP tests ordered
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test, Chest discomfort, Chills, Cough
Clinical narrative: Intermittent increased heart rate and blood pressure.; intermittent increased heart rate and blood pressure.; tingling in her hands and from knees to feet.; sometimes cold and tingling in hands and from knees down to her feet; heaviness in chest; she has heat and burning; This is spontaneous report from a contactable consumer (patient).  A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17May2021 (Batch/Lot Number: EW0183) age at vaccination of 51-years-old, as single dose, for covid-19 immunisation. Medical history included ongoing corneal erosion (diagnosed about 20 years ago), ongoing sleep apnoea syndrome (diagnosed about a year ago). Concomitant medications included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported; naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.   The patient got the first dose of the Pfizer Covid vaccine on 17May2021 and within 5 minutes her hear rate (HR) and blood pressure were really high, stated her blood pressure was like 169/114 at the time or something like that. The patient also felt some weight on her chest, sometimes cold tingling in her hands and from knees to feet and heat and burning, all on 17May2021. The patient had no issues prior to the vaccine. The patient stated that over the last three weeks she has been to urgent care, her doctor's office, and even had an ambulance take her to the ER for high blood pressure and heart rate, stated she just keeps having episodes. The patient is now waiting on her cardiologist, stated they did tests at hospital yesterday, has had some EKGs and blood tests, no exact information known, states sent her home and had another episode not as bad. Doctor has not seen this type of reaction, wondering what is going on with this kind of reaction. They treated her high blood pressure with two different medications: carvedilol and tried a different one as well, metoprolol. The patient underwent lab tests and procedures which included blood pressure measurement 169/114  on 17May2021 within 5 minutes her HR and BP were really high, blood test unknown results on 17May2021, electrocardiogram unknown results on 17May2021, heart rate really high on 17May2021.  The patient was not recovered from the events blood pressure high, tingling feet/hands, cold hands & feet, chest heaviness while outcome of the other events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Feeling hot, Gait disturbance
Clinical narrative: Intermittent increased heart rate and blood pressure.; intermittent increased heart rate and blood pressure.; tingling in her hands and from knees to feet.; sometimes cold and tingling in hands and from knees down to her feet; heaviness in chest; she has heat and burning; This is spontaneous report from a contactable consumer (patient).  A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17May2021 (Batch/Lot Number: EW0183) age at vaccination of 51-years-old, as single dose, for covid-19 immunisation. Medical history included ongoing corneal erosion (diagnosed about 20 years ago), ongoing sleep apnoea syndrome (diagnosed about a year ago). Concomitant medications included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported; naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.   The patient got the first dose of the Pfizer Covid vaccine on 17May2021 and within 5 minutes her hear rate (HR) and blood pressure were really high, stated her blood pressure was like 169/114 at the time or something like that. The patient also felt some weight on her chest, sometimes cold tingling in her hands and from knees to feet and heat and burning, all on 17May2021. The patient had no issues prior to the vaccine. The patient stated that over the last three weeks she has been to urgent care, her doctor's office, and even had an ambulance take her to the ER for high blood pressure and heart rate, stated she just keeps having episodes. The patient is now waiting on her cardiologist, stated they did tests at hospital yesterday, has had some EKGs and blood tests, no exact information known, states sent her home and had another episode not as bad. Doctor has not seen this type of reaction, wondering what is going on with this kind of reaction. They treated her high blood pressure with two different medications: carvedilol and tried a different one as well, metoprolol. The patient underwent lab tests and procedures which included blood pressure measurement 169/114  on 17May2021 within 5 minutes her HR and BP were really high, blood test unknown results on 17May2021, electrocardiogram unknown results on 17May2021, heart rate really high on 17May2021.  The patient was not recovered from the events blood pressure high, tingling feet/hands, cold hands & feet, chest heaviness while outcome of the other events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Immediate post-injection reaction, Pain, Paraesthesia
Clinical narrative: Intermittent increased heart rate and blood pressure.; intermittent increased heart rate and blood pressure.; tingling in her hands and from knees to feet.; sometimes cold and tingling in hands and from knees down to her feet; heaviness in chest; she has heat and burning; This is spontaneous report from a contactable consumer (patient).  A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17May2021 (Batch/Lot Number: EW0183) age at vaccination of 51-years-old, as single dose, for covid-19 immunisation. Medical history included ongoing corneal erosion (diagnosed about 20 years ago), ongoing sleep apnoea syndrome (diagnosed about a year ago). Concomitant medications included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported; naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.   The patient got the first dose of the Pfizer Covid vaccine on 17May2021 and within 5 minutes her hear rate (HR) and blood pressure were really high, stated her blood pressure was like 169/114 at the time or something like that. The patient also felt some weight on her chest, sometimes cold tingling in her hands and from knees to feet and heat and burning, all on 17May2021. The patient had no issues prior to the vaccine. The patient stated that over the last three weeks she has been to urgent care, her doctor's office, and even had an ambulance take her to the ER for high blood pressure and heart rate, stated she just keeps having episodes. The patient is now waiting on her cardiologist, stated they did tests at hospital yesterday, has had some EKGs and blood tests, no exact information known, states sent her home and had another episode not as bad. Doctor has not seen this type of reaction, wondering what is going on with this kind of reaction. They treated her high blood pressure with two different medications: carvedilol and tried a different one as well, metoprolol. The patient underwent lab tests and procedures which included blood pressure measurement 169/114  on 17May2021 within 5 minutes her HR and BP were really high, blood test unknown results on 17May2021, electrocardiogram unknown results on 17May2021, heart rate really high on 17May2021.  The patient was not recovered from the events blood pressure high, tingling feet/hands, cold hands & feet, chest heaviness while outcome of the other events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Sensation of foreign body, Speech disorder
Clinical narrative: Intermittent increased heart rate and blood pressure.; intermittent increased heart rate and blood pressure.; tingling in her hands and from knees to feet.; sometimes cold and tingling in hands and from knees down to her feet; heaviness in chest; she has heat and burning; This is spontaneous report from a contactable consumer (patient).  A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17May2021 (Batch/Lot Number: EW0183) age at vaccination of 51-years-old, as single dose, for covid-19 immunisation. Medical history included ongoing corneal erosion (diagnosed about 20 years ago), ongoing sleep apnoea syndrome (diagnosed about a year ago). Concomitant medications included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported; naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.   The patient got the first dose of the Pfizer Covid vaccine on 17May2021 and within 5 minutes her hear rate (HR) and blood pressure were really high, stated her blood pressure was like 169/114 at the time or something like that. The patient also felt some weight on her chest, sometimes cold tingling in her hands and from knees to feet and heat and burning, all on 17May2021. The patient had no issues prior to the vaccine. The patient stated that over the last three weeks she has been to urgent care, her doctor's office, and even had an ambulance take her to the ER for high blood pressure and heart rate, stated she just keeps having episodes. The patient is now waiting on her cardiologist, stated they did tests at hospital yesterday, has had some EKGs and blood tests, no exact information known, states sent her home and had another episode not as bad. Doctor has not seen this type of reaction, wondering what is going on with this kind of reaction. They treated her high blood pressure with two different medications: carvedilol and tried a different one as well, metoprolol. The patient underwent lab tests and procedures which included blood pressure measurement 169/114  on 17May2021 within 5 minutes her HR and BP were really high, blood test unknown results on 17May2021, electrocardiogram unknown results on 17May2021, heart rate really high on 17May2021.  The patient was not recovered from the events blood pressure high, tingling feet/hands, cold hands & feet, chest heaviness while outcome of the other events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, Burning sensation, Chest discomfort, Electrocardiogram
Clinical narrative: Intermittent increased heart rate and blood pressure.; intermittent increased heart rate and blood pressure.; tingling in her hands and from knees to feet.; sometimes cold and tingling in hands and from knees down to her feet; heaviness in chest; she has heat and burning; This is spontaneous report from a contactable consumer (patient).  A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17May2021 (Batch/Lot Number: EW0183) age at vaccination of 51-years-old, as single dose, for covid-19 immunisation. Medical history included ongoing corneal erosion (diagnosed about 20 years ago), ongoing sleep apnoea syndrome (diagnosed about a year ago). Concomitant medications included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported; naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.   The patient got the first dose of the Pfizer Covid vaccine on 17May2021 and within 5 minutes her hear rate (HR) and blood pressure were really high, stated her blood pressure was like 169/114 at the time or something like that. The patient also felt some weight on her chest, sometimes cold tingling in her hands and from knees to feet and heat and burning, all on 17May2021. The patient had no issues prior to the vaccine. The patient stated that over the last three weeks she has been to urgent care, her doctor's office, and even had an ambulance take her to the ER for high blood pressure and heart rate, stated she just keeps having episodes. The patient is now waiting on her cardiologist, stated they did tests at hospital yesterday, has had some EKGs and blood tests, no exact information known, states sent her home and had another episode not as bad. Doctor has not seen this type of reaction, wondering what is going on with this kind of reaction. They treated her high blood pressure with two different medications: carvedilol and tried a different one as well, metoprolol. The patient underwent lab tests and procedures which included blood pressure measurement 169/114  on 17May2021 within 5 minutes her HR and BP were really high, blood test unknown results on 17May2021, electrocardiogram unknown results on 17May2021, heart rate really high on 17May2021.  The patient was not recovered from the events blood pressure high, tingling feet/hands, cold hands & feet, chest heaviness while outcome of the other events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Hypertension, Paraesthesia, Peripheral coldness
Clinical narrative: Intermittent increased heart rate and blood pressure.; intermittent increased heart rate and blood pressure.; tingling in her hands and from knees to feet.; sometimes cold and tingling in hands and from knees down to her feet; heaviness in chest; she has heat and burning; This is spontaneous report from a contactable consumer (patient).  A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17May2021 (Batch/Lot Number: EW0183) age at vaccination of 51-years-old, as single dose, for covid-19 immunisation. Medical history included ongoing corneal erosion (diagnosed about 20 years ago), ongoing sleep apnoea syndrome (diagnosed about a year ago). Concomitant medications included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported; naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.   The patient got the first dose of the Pfizer Covid vaccine on 17May2021 and within 5 minutes her hear rate (HR) and blood pressure were really high, stated her blood pressure was like 169/114 at the time or something like that. The patient also felt some weight on her chest, sometimes cold tingling in her hands and from knees to feet and heat and burning, all on 17May2021. The patient had no issues prior to the vaccine. The patient stated that over the last three weeks she has been to urgent care, her doctor's office, and even had an ambulance take her to the ER for high blood pressure and heart rate, stated she just keeps having episodes. The patient is now waiting on her cardiologist, stated they did tests at hospital yesterday, has had some EKGs and blood tests, no exact information known, states sent her home and had another episode not as bad. Doctor has not seen this type of reaction, wondering what is going on with this kind of reaction. They treated her high blood pressure with two different medications: carvedilol and tried a different one as well, metoprolol. The patient underwent lab tests and procedures which included blood pressure measurement 169/114  on 17May2021 within 5 minutes her HR and BP were really high, blood test unknown results on 17May2021, electrocardiogram unknown results on 17May2021, heart rate really high on 17May2021.  The patient was not recovered from the events blood pressure high, tingling feet/hands, cold hands & feet, chest heaviness while outcome of the other events was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Blood test, Loss of personal independence in daily activities, Pharyngeal swelling, Skin test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This is the report with the event related to the first vaccine dose. A 31-year-old female (no pregnancy) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 16:00 (Batch/Lot Number: En6204) as 1st dose, single for covid-19 immunisation. Medical history included hypothyroid. Concomitant medications were not reported. The patient developed chronic urticaria after her first shot at 14:00 on 17Mar2021. Patient had never had hives in her life and had never had any allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prednisone within 2 weeks of vaccination (at the time of the second shot). The adverse event result in emergency room/department or urgent care and life-threatening illness (immediate risk of death from the event). Patient had been on many medications to try and reduce for the event. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria chronic
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This is the report with the event related to the first vaccine dose. A 31-year-old female (no pregnancy) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 16:00 (Batch/Lot Number: En6204) as 1st dose, single for covid-19 immunisation. Medical history included hypothyroid. Concomitant medications were not reported. The patient developed chronic urticaria after her first shot at 14:00 on 17Mar2021. Patient had never had hives in her life and had never had any allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prednisone within 2 weeks of vaccination (at the time of the second shot). The adverse event result in emergency room/department or urgent care and life-threatening illness (immediate risk of death from the event). Patient had been on many medications to try and reduce for the event. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Cardiac arrest, Death
Clinical narrative: Died within 24 hours of taking vaccine; This is a spontaneous report from a contactable consumer. A 49-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 16Apr2021 (at age of 49 years old) as single dose for COVID-19 immunization. Medical history included Psyriosis, Hypertension. No known allergies. No COVID prior vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications the patient received within 2 weeks of vaccination: Hypertension med. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number=En6204), on 09Mar2021 (at age of 49 years old) at left arm for COVID-19 immunisation, No reaction on previous exposure to Vaccine. The patient Died within 24 hours of taking vaccine on 17Apr2021 02:30 AM, death cause: Cardiac arrest. AE resulted in: [Patient died]. Date of Death was 17Apr2021. Serious case with Seriousness criteria-Results in death. COVID tested post vaccination on 16Apr2021: Nasal Swab: Negative. Autopsy performed, autopsy remarks: Cardiac arrest. Treatment received.  information on the lot/batch number has been requested. ; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: Cardiac arrest
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: Died within 24 hours of taking vaccine; This is a spontaneous report from a contactable consumer. A 49-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 16Apr2021 (at age of 49 years old) as single dose for COVID-19 immunization. Medical history included Psyriosis, Hypertension. No known allergies. No COVID prior vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications the patient received within 2 weeks of vaccination: Hypertension med. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number=En6204), on 09Mar2021 (at age of 49 years old) at left arm for COVID-19 immunisation, No reaction on previous exposure to Vaccine. The patient Died within 24 hours of taking vaccine on 17Apr2021 02:30 AM, death cause: Cardiac arrest. AE resulted in: [Patient died]. Date of Death was 17Apr2021. Serious case with Seriousness criteria-Results in death. COVID tested post vaccination on 16Apr2021: Nasal Swab: Negative. Autopsy performed, autopsy remarks: Cardiac arrest. Treatment received.  information on the lot/batch number has been requested. ; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: Cardiac arrest
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, SARS-CoV-2 test
Clinical narrative: Died within 24 hours of taking vaccine; This is a spontaneous report from a contactable consumer. A 49-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 16Apr2021 (at age of 49 years old) as single dose for COVID-19 immunization. Medical history included Psyriosis, Hypertension. No known allergies. No COVID prior vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications the patient received within 2 weeks of vaccination: Hypertension med. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number=En6204), on 09Mar2021 (at age of 49 years old) at left arm for COVID-19 immunisation, No reaction on previous exposure to Vaccine. The patient Died within 24 hours of taking vaccine on 17Apr2021 02:30 AM, death cause: Cardiac arrest. AE resulted in: [Patient died]. Date of Death was 17Apr2021. Serious case with Seriousness criteria-Results in death. COVID tested post vaccination on 16Apr2021: Nasal Swab: Negative. Autopsy performed, autopsy remarks: Cardiac arrest. Treatment received.  information on the lot/batch number has been requested. ; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: Cardiac arrest
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a health care professional concerned an 88 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included home bound patient, and other pre-existing medical conditions included the patient has health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total, administered on right arm, on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient was home bound with health issues. On 13-MAY-2021, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20210642553-COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: History is provided by the patient. This is a 47 year old female with self reported past medical history of nephrolithiasis who presents to the ED with concerns for allergic reaction. Received second dose of the COVID vaccine around 08:00 am this morning. About 20 minutes later, she started to feel constant shortness of breath in addition to feeling like she was going to pass out with associated nausea and tingling to her hands and feet. No modifying factors reported. She presented to the ED for further evaluation. She had a similar reaction on receiving her first dose of the COVID vaccine, but notes this episode feels worse. Lungs are clear to auscultation. No signs of angioedema. No clinical signs of an allergic reaction. Due to patient's complaints, will provide Solu-Medrol, Benadryl, and famotidine. Will also obtain EKG. Discussed indications for epinephrine, will hold off epinephrine at this time and re-assess.   09:33- On re-assessment, patient now with periorbital edema. Airway still intact and voice is clear. However, will provide epinephrine now.   The patient was treated with intravenous fluids (IVFs) for the following reason: concerns for dehydration, dry mucous membranes. Patient improved after IV fluid administration.   Patient is reassessed multiple times, with improving symptoms At 4 hours status post epinephrine, patient with no rebound symptoms, patient states that she is feeling better, ready for discharge home. Due to anaphylaxis, will provide additional epinephrine prescription for home.  Allergy added to patient chart.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dehydration, Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: History is provided by the patient. This is a 47 year old female with self reported past medical history of nephrolithiasis who presents to the ED with concerns for allergic reaction. Received second dose of the COVID vaccine around 08:00 am this morning. About 20 minutes later, she started to feel constant shortness of breath in addition to feeling like she was going to pass out with associated nausea and tingling to her hands and feet. No modifying factors reported. She presented to the ED for further evaluation. She had a similar reaction on receiving her first dose of the COVID vaccine, but notes this episode feels worse. Lungs are clear to auscultation. No signs of angioedema. No clinical signs of an allergic reaction. Due to patient's complaints, will provide Solu-Medrol, Benadryl, and famotidine. Will also obtain EKG. Discussed indications for epinephrine, will hold off epinephrine at this time and re-assess.   09:33- On re-assessment, patient now with periorbital edema. Airway still intact and voice is clear. However, will provide epinephrine now.   The patient was treated with intravenous fluids (IVFs) for the following reason: concerns for dehydration, dry mucous membranes. Patient improved after IV fluid administration.   Patient is reassessed multiple times, with improving symptoms At 4 hours status post epinephrine, patient with no rebound symptoms, patient states that she is feeling better, ready for discharge home. Due to anaphylaxis, will provide additional epinephrine prescription for home.  Allergy added to patient chart.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mucosal dryness, Nausea, Paraesthesia, Periorbital oedema, Tryptase
Clinical narrative: History is provided by the patient. This is a 47 year old female with self reported past medical history of nephrolithiasis who presents to the ED with concerns for allergic reaction. Received second dose of the COVID vaccine around 08:00 am this morning. About 20 minutes later, she started to feel constant shortness of breath in addition to feeling like she was going to pass out with associated nausea and tingling to her hands and feet. No modifying factors reported. She presented to the ED for further evaluation. She had a similar reaction on receiving her first dose of the COVID vaccine, but notes this episode feels worse. Lungs are clear to auscultation. No signs of angioedema. No clinical signs of an allergic reaction. Due to patient's complaints, will provide Solu-Medrol, Benadryl, and famotidine. Will also obtain EKG. Discussed indications for epinephrine, will hold off epinephrine at this time and re-assess.   09:33- On re-assessment, patient now with periorbital edema. Airway still intact and voice is clear. However, will provide epinephrine now.   The patient was treated with intravenous fluids (IVFs) for the following reason: concerns for dehydration, dry mucous membranes. Patient improved after IV fluid administration.   Patient is reassessed multiple times, with improving symptoms At 4 hours status post epinephrine, patient with no rebound symptoms, patient states that she is feeling better, ready for discharge home. Due to anaphylaxis, will provide additional epinephrine prescription for home.  Allergy added to patient chart.