chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epstein-Barr virus test negative, Facial discomfort, Feeling abnormal, Feeling hot, Headache
Clinical narrative: Itching; An "electrical whooshing feeling" down through my whole body; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), intramuscular, administered in left arm on 22Mar2021 10:15 (at the age of 57 years old) as dose 1, single for COVID-19 immunization. Medical history included urinary tract infection (UTI). The patient is not pregnant at the time of vaccination and has not had COVID prior to vaccination. The patient has no known allergies. Concomitant medications included aciclovir sodium (ACYCLOVIR); nitrofurantoin (NITROFURANTOIN MONO/MAC) for urinary tract infection (UTI); fish oil; st john's wort; and curcuma longa root (TURMERIC CURCUMIN). No other vaccines were given in four weeks. On 22Mar2021 11:15, the patient experienced an "electrical whooshing feeling" down through her whole body, followed by itching. No difficulty breathing. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Unspecified treatment was given in response to the events. The outcome of the events was not recovered. The events were assessed as serious (Disability or permanent damage). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in left arm on 12Apr2021 10:00 as dose 2, single.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Hypoacusis, Hypoaesthesia, Hypoaesthesia oral, Joint noise
Clinical narrative: Itching; An "electrical whooshing feeling" down through my whole body; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), intramuscular, administered in left arm on 22Mar2021 10:15 (at the age of 57 years old) as dose 1, single for COVID-19 immunization. Medical history included urinary tract infection (UTI). The patient is not pregnant at the time of vaccination and has not had COVID prior to vaccination. The patient has no known allergies. Concomitant medications included aciclovir sodium (ACYCLOVIR); nitrofurantoin (NITROFURANTOIN MONO/MAC) for urinary tract infection (UTI); fish oil; st john's wort; and curcuma longa root (TURMERIC CURCUMIN). No other vaccines were given in four weeks. On 22Mar2021 11:15, the patient experienced an "electrical whooshing feeling" down through her whole body, followed by itching. No difficulty breathing. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Unspecified treatment was given in response to the events. The outcome of the events was not recovered. The events were assessed as serious (Disability or permanent damage). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in left arm on 12Apr2021 10:00 as dose 2, single.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging, Nausea, Neck pain, Pain
Clinical narrative: Itching; An "electrical whooshing feeling" down through my whole body; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), intramuscular, administered in left arm on 22Mar2021 10:15 (at the age of 57 years old) as dose 1, single for COVID-19 immunization. Medical history included urinary tract infection (UTI). The patient is not pregnant at the time of vaccination and has not had COVID prior to vaccination. The patient has no known allergies. Concomitant medications included aciclovir sodium (ACYCLOVIR); nitrofurantoin (NITROFURANTOIN MONO/MAC) for urinary tract infection (UTI); fish oil; st john's wort; and curcuma longa root (TURMERIC CURCUMIN). No other vaccines were given in four weeks. On 22Mar2021 11:15, the patient experienced an "electrical whooshing feeling" down through her whole body, followed by itching. No difficulty breathing. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Unspecified treatment was given in response to the events. The outcome of the events was not recovered. The events were assessed as serious (Disability or permanent damage). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in left arm on 12Apr2021 10:00 as dose 2, single.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pain in jaw, Palpitations, Paraesthesia, Parasite stool test negative
Clinical narrative: Itching; An "electrical whooshing feeling" down through my whole body; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), intramuscular, administered in left arm on 22Mar2021 10:15 (at the age of 57 years old) as dose 1, single for COVID-19 immunization. Medical history included urinary tract infection (UTI). The patient is not pregnant at the time of vaccination and has not had COVID prior to vaccination. The patient has no known allergies. Concomitant medications included aciclovir sodium (ACYCLOVIR); nitrofurantoin (NITROFURANTOIN MONO/MAC) for urinary tract infection (UTI); fish oil; st john's wort; and curcuma longa root (TURMERIC CURCUMIN). No other vaccines were given in four weeks. On 22Mar2021 11:15, the patient experienced an "electrical whooshing feeling" down through her whole body, followed by itching. No difficulty breathing. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Unspecified treatment was given in response to the events. The outcome of the events was not recovered. The events were assessed as serious (Disability or permanent damage). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in left arm on 12Apr2021 10:00 as dose 2, single.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Sleep disorder, Visual impairment
Clinical narrative: Itching; An "electrical whooshing feeling" down through my whole body; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), intramuscular, administered in left arm on 22Mar2021 10:15 (at the age of 57 years old) as dose 1, single for COVID-19 immunization. Medical history included urinary tract infection (UTI). The patient is not pregnant at the time of vaccination and has not had COVID prior to vaccination. The patient has no known allergies. Concomitant medications included aciclovir sodium (ACYCLOVIR); nitrofurantoin (NITROFURANTOIN MONO/MAC) for urinary tract infection (UTI); fish oil; st john's wort; and curcuma longa root (TURMERIC CURCUMIN). No other vaccines were given in four weeks. On 22Mar2021 11:15, the patient experienced an "electrical whooshing feeling" down through her whole body, followed by itching. No difficulty breathing. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Unspecified treatment was given in response to the events. The outcome of the events was not recovered. The events were assessed as serious (Disability or permanent damage). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in left arm on 12Apr2021 10:00 as dose 2, single.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electric shock sensation, Pruritus
Clinical narrative: Itching; An "electrical whooshing feeling" down through my whole body; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), intramuscular, administered in left arm on 22Mar2021 10:15 (at the age of 57 years old) as dose 1, single for COVID-19 immunization. Medical history included urinary tract infection (UTI). The patient is not pregnant at the time of vaccination and has not had COVID prior to vaccination. The patient has no known allergies. Concomitant medications included aciclovir sodium (ACYCLOVIR); nitrofurantoin (NITROFURANTOIN MONO/MAC) for urinary tract infection (UTI); fish oil; st john's wort; and curcuma longa root (TURMERIC CURCUMIN). No other vaccines were given in four weeks. On 22Mar2021 11:15, the patient experienced an "electrical whooshing feeling" down through her whole body, followed by itching. No difficulty breathing. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Unspecified treatment was given in response to the events. The outcome of the events was not recovered. The events were assessed as serious (Disability or permanent damage). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in left arm on 12Apr2021 10:00 as dose 2, single.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Aortic thrombosis, Compression garment application, Gait disturbance
Clinical narrative: leg weakness 2 days after vaccine, and by the 3rd day, he could not get out of bed and had difficulty walking. He had bilateral lower extremity pain (L>R)  with left leg swelling and shortly afterward was diagnosed with a left ilio-femoral deep vein thrombosis which was treated with Eliquis therapy for 3 months and compression socks. The Eliquis is now discontinued and the left leg swelling has resolved, however the patient continues to have bilateral lower extremity weakness, and aortic thrombus was suspected. Pt was ordered to have a CTA chest and arterial doppler studies with a hypercoagulable work-up. Imaging studies demonstrated bilateral ABI of 0.3 (previously palpable pedal pulses), and CTA demonstrates a mass-like consolidation at the right lower lobe with intraluminal filling defect of the pulmonary artery branch, and thrombus formation of the proximal abdominal aorta. Today, Pt ambulates with a cane, and has severe bilateral lower extremity claudication. He is unable to be active at his place of employment since receiving the vaccine
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Lung consolidation, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: leg weakness 2 days after vaccine, and by the 3rd day, he could not get out of bed and had difficulty walking. He had bilateral lower extremity pain (L>R)  with left leg swelling and shortly afterward was diagnosed with a left ilio-femoral deep vein thrombosis which was treated with Eliquis therapy for 3 months and compression socks. The Eliquis is now discontinued and the left leg swelling has resolved, however the patient continues to have bilateral lower extremity weakness, and aortic thrombus was suspected. Pt was ordered to have a CTA chest and arterial doppler studies with a hypercoagulable work-up. Imaging studies demonstrated bilateral ABI of 0.3 (previously palpable pedal pulses), and CTA demonstrates a mass-like consolidation at the right lower lobe with intraluminal filling defect of the pulmonary artery branch, and thrombus formation of the proximal abdominal aorta. Today, Pt ambulates with a cane, and has severe bilateral lower extremity claudication. He is unable to be active at his place of employment since receiving the vaccine
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pelvic venous thrombosis, Peripheral swelling, Ultrasound Doppler, Walking aid user
Clinical narrative: leg weakness 2 days after vaccine, and by the 3rd day, he could not get out of bed and had difficulty walking. He had bilateral lower extremity pain (L>R)  with left leg swelling and shortly afterward was diagnosed with a left ilio-femoral deep vein thrombosis which was treated with Eliquis therapy for 3 months and compression socks. The Eliquis is now discontinued and the left leg swelling has resolved, however the patient continues to have bilateral lower extremity weakness, and aortic thrombus was suspected. Pt was ordered to have a CTA chest and arterial doppler studies with a hypercoagulable work-up. Imaging studies demonstrated bilateral ABI of 0.3 (previously palpable pedal pulses), and CTA demonstrates a mass-like consolidation at the right lower lobe with intraluminal filling defect of the pulmonary artery branch, and thrombus formation of the proximal abdominal aorta. Today, Pt ambulates with a cane, and has severe bilateral lower extremity claudication. He is unable to be active at his place of employment since receiving the vaccine
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Ankle brachial index decreased, Anticoagulant therapy, Aortic thrombosis, Coagulation test abnormal
Clinical narrative: leg weakness 2 days after vaccine, and by the 3rd day, he could not get out of bed and had difficulty walking. He had bilateral lower extremity pain (L>R)  with left leg swelling and shortly afterward was diagnosed with a left ilio-femoral deep vein thrombosis which was treated with Eliquis therapy for 3 months and compression socks. The Eliquis is now discontinued and the left leg swelling has resolved, however the patient continues to have bilateral lower extremity weakness, and aortic thrombus was suspected. Pt was ordered to have a CTA chest and arterial doppler studies with a hypercoagulable work-up. Imaging studies demonstrated bilateral ABI of 0.3 (previously palpable pedal pulses), and CTA demonstrates a mass-like consolidation at the right lower lobe with intraluminal filling defect of the pulmonary artery branch, and thrombus formation of the proximal abdominal aorta. Today, Pt ambulates with a cane, and has severe bilateral lower extremity claudication. He is unable to be active at his place of employment since receiving the vaccine
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Compression garment application, Gait disturbance, Impaired work ability, Intermittent claudication, Lung consolidation
Clinical narrative: leg weakness 2 days after vaccine, and by the 3rd day, he could not get out of bed and had difficulty walking. He had bilateral lower extremity pain (L>R)  with left leg swelling and shortly afterward was diagnosed with a left ilio-femoral deep vein thrombosis which was treated with Eliquis therapy for 3 months and compression socks. The Eliquis is now discontinued and the left leg swelling has resolved, however the patient continues to have bilateral lower extremity weakness, and aortic thrombus was suspected. Pt was ordered to have a CTA chest and arterial doppler studies with a hypercoagulable work-up. Imaging studies demonstrated bilateral ABI of 0.3 (previously palpable pedal pulses), and CTA demonstrates a mass-like consolidation at the right lower lobe with intraluminal filling defect of the pulmonary artery branch, and thrombus formation of the proximal abdominal aorta. Today, Pt ambulates with a cane, and has severe bilateral lower extremity claudication. He is unable to be active at his place of employment since receiving the vaccine
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity, Pelvic venous thrombosis, Peripheral swelling
Clinical narrative: leg weakness 2 days after vaccine, and by the 3rd day, he could not get out of bed and had difficulty walking. He had bilateral lower extremity pain (L>R)  with left leg swelling and shortly afterward was diagnosed with a left ilio-femoral deep vein thrombosis which was treated with Eliquis therapy for 3 months and compression socks. The Eliquis is now discontinued and the left leg swelling has resolved, however the patient continues to have bilateral lower extremity weakness, and aortic thrombus was suspected. Pt was ordered to have a CTA chest and arterial doppler studies with a hypercoagulable work-up. Imaging studies demonstrated bilateral ABI of 0.3 (previously palpable pedal pulses), and CTA demonstrates a mass-like consolidation at the right lower lobe with intraluminal filling defect of the pulmonary artery branch, and thrombus formation of the proximal abdominal aorta. Today, Pt ambulates with a cane, and has severe bilateral lower extremity claudication. He is unable to be active at his place of employment since receiving the vaccine
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary artery thrombosis, Ultrasound Doppler abnormal, Walking aid user
Clinical narrative: leg weakness 2 days after vaccine, and by the 3rd day, he could not get out of bed and had difficulty walking. He had bilateral lower extremity pain (L>R)  with left leg swelling and shortly afterward was diagnosed with a left ilio-femoral deep vein thrombosis which was treated with Eliquis therapy for 3 months and compression socks. The Eliquis is now discontinued and the left leg swelling has resolved, however the patient continues to have bilateral lower extremity weakness, and aortic thrombus was suspected. Pt was ordered to have a CTA chest and arterial doppler studies with a hypercoagulable work-up. Imaging studies demonstrated bilateral ABI of 0.3 (previously palpable pedal pulses), and CTA demonstrates a mass-like consolidation at the right lower lobe with intraluminal filling defect of the pulmonary artery branch, and thrombus formation of the proximal abdominal aorta. Today, Pt ambulates with a cane, and has severe bilateral lower extremity claudication. He is unable to be active at his place of employment since receiving the vaccine
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood cholesterol, Blood glucose, Blood pressure measurement, Blood test
Clinical narrative: felt like she was going to die, felt really bad; Fever; Nausea; extreme headache; extreme weakness; Tachycardia; for 24 hours she was in bed; bad case of flu; chills; This is a spontaneous report from a contactable other hcp (patient) reported for herself. A 58-year-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in arm left on 25Jul2021 as DOSE 1, SINGLE (at the age of 58) for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not taking any other vaccines in four weeks. The patient reported as eight or seven hours later on 25Jul2021, started to have symptoms and thought that she should have symptoms after the second vaccine but not from the first one, symptom got worse felt like she was going to die, felt really bad, had tachycardia, chills, fever, nausea, extreme headache and extreme weakness and just felt like, really bad case of flu and was afraid was going to die, for 24 hours she was in bed. Patient didn't get the second shot, only had the first one and took that one felt really bad. Patient was not sure for this. maybe it's Apr2023 or Sep2023. Consumer stated, she is a nurse anesthetist, anesthesia provider, a healthcare professional." Consumer stated, "Is it normal to have a side effect from the first vaccine, I know it's gonna the first dose I know it's okay from the second dose but not on a first dose, right", "I just want to know if I had such a reaction from the first dose, is it safe for me to receive a second dose". In response Consumer was informed about the Role of Pfizer Drug Safety and requested to contact the Pfizer Medical Information Department.The patient underwent lab tests and procedures which included cholesterol, sugar, cardiogram, heart work, annual physical examination all was normal on unknown date in 2021 and had no problems. Therapeutic measures were taken as a result of events included took vitamin c and stayed in bed. The outcome of events nausea, extreme headache was not recovered, and it was unknown for other events. The Causality was reported for as possible.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body height, Chills, Dizziness, Electrocardiogram, Malaise
Clinical narrative: felt like she was going to die, felt really bad; Fever; Nausea; extreme headache; extreme weakness; Tachycardia; for 24 hours she was in bed; bad case of flu; chills; This is a spontaneous report from a contactable other hcp (patient) reported for herself. A 58-year-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in arm left on 25Jul2021 as DOSE 1, SINGLE (at the age of 58) for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not taking any other vaccines in four weeks. The patient reported as eight or seven hours later on 25Jul2021, started to have symptoms and thought that she should have symptoms after the second vaccine but not from the first one, symptom got worse felt like she was going to die, felt really bad, had tachycardia, chills, fever, nausea, extreme headache and extreme weakness and just felt like, really bad case of flu and was afraid was going to die, for 24 hours she was in bed. Patient didn't get the second shot, only had the first one and took that one felt really bad. Patient was not sure for this. maybe it's Apr2023 or Sep2023. Consumer stated, she is a nurse anesthetist, anesthesia provider, a healthcare professional." Consumer stated, "Is it normal to have a side effect from the first vaccine, I know it's gonna the first dose I know it's okay from the second dose but not on a first dose, right", "I just want to know if I had such a reaction from the first dose, is it safe for me to receive a second dose". In response Consumer was informed about the Role of Pfizer Drug Safety and requested to contact the Pfizer Medical Information Department.The patient underwent lab tests and procedures which included cholesterol, sugar, cardiogram, heart work, annual physical examination all was normal on unknown date in 2021 and had no problems. Therapeutic measures were taken as a result of events included took vitamin c and stayed in bed. The outcome of events nausea, extreme headache was not recovered, and it was unknown for other events. The Causality was reported for as possible.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Near death experience, Pyrexia, Tachycardia, Weight
Clinical narrative: felt like she was going to die, felt really bad; Fever; Nausea; extreme headache; extreme weakness; Tachycardia; for 24 hours she was in bed; bad case of flu; chills; This is a spontaneous report from a contactable other hcp (patient) reported for herself. A 58-year-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in arm left on 25Jul2021 as DOSE 1, SINGLE (at the age of 58) for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not taking any other vaccines in four weeks. The patient reported as eight or seven hours later on 25Jul2021, started to have symptoms and thought that she should have symptoms after the second vaccine but not from the first one, symptom got worse felt like she was going to die, felt really bad, had tachycardia, chills, fever, nausea, extreme headache and extreme weakness and just felt like, really bad case of flu and was afraid was going to die, for 24 hours she was in bed. Patient didn't get the second shot, only had the first one and took that one felt really bad. Patient was not sure for this. maybe it's Apr2023 or Sep2023. Consumer stated, she is a nurse anesthetist, anesthesia provider, a healthcare professional." Consumer stated, "Is it normal to have a side effect from the first vaccine, I know it's gonna the first dose I know it's okay from the second dose but not on a first dose, right", "I just want to know if I had such a reaction from the first dose, is it safe for me to receive a second dose". In response Consumer was informed about the Role of Pfizer Drug Safety and requested to contact the Pfizer Medical Information Department.The patient underwent lab tests and procedures which included cholesterol, sugar, cardiogram, heart work, annual physical examination all was normal on unknown date in 2021 and had no problems. Therapeutic measures were taken as a result of events included took vitamin c and stayed in bed. The outcome of events nausea, extreme headache was not recovered, and it was unknown for other events. The Causality was reported for as possible.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bedridden, Blood cholesterol, Blood glucose, Cardiac function test
Clinical narrative: felt like she was going to die, felt really bad; Fever; Nausea; extreme headache; extreme weakness; Tachycardia; for 24 hours she was in bed; bad case of flu; chills; This is a spontaneous report from a contactable other hcp (patient) reported for herself. A 58-year-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in arm left on 25Jul2021 as DOSE 1, SINGLE (at the age of 58) for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not taking any other vaccines in four weeks. The patient reported as eight or seven hours later on 25Jul2021, started to have symptoms and thought that she should have symptoms after the second vaccine but not from the first one, symptom got worse felt like she was going to die, felt really bad, had tachycardia, chills, fever, nausea, extreme headache and extreme weakness and just felt like, really bad case of flu and was afraid was going to die, for 24 hours she was in bed. Patient didn't get the second shot, only had the first one and took that one felt really bad. Patient was not sure for this. maybe it's Apr2023 or Sep2023. Consumer stated, she is a nurse anesthetist, anesthesia provider, a healthcare professional." Consumer stated, "Is it normal to have a side effect from the first vaccine, I know it's gonna the first dose I know it's okay from the second dose but not on a first dose, right", "I just want to know if I had such a reaction from the first dose, is it safe for me to receive a second dose". In response Consumer was informed about the Role of Pfizer Drug Safety and requested to contact the Pfizer Medical Information Department.The patient underwent lab tests and procedures which included cholesterol, sugar, cardiogram, heart work, annual physical examination all was normal on unknown date in 2021 and had no problems. Therapeutic measures were taken as a result of events included took vitamin c and stayed in bed. The outcome of events nausea, extreme headache was not recovered, and it was unknown for other events. The Causality was reported for as possible.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Electrocardiogram, Feeling abnormal, Headache, Influenza
Clinical narrative: felt like she was going to die, felt really bad; Fever; Nausea; extreme headache; extreme weakness; Tachycardia; for 24 hours she was in bed; bad case of flu; chills; This is a spontaneous report from a contactable other hcp (patient) reported for herself. A 58-year-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in arm left on 25Jul2021 as DOSE 1, SINGLE (at the age of 58) for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not taking any other vaccines in four weeks. The patient reported as eight or seven hours later on 25Jul2021, started to have symptoms and thought that she should have symptoms after the second vaccine but not from the first one, symptom got worse felt like she was going to die, felt really bad, had tachycardia, chills, fever, nausea, extreme headache and extreme weakness and just felt like, really bad case of flu and was afraid was going to die, for 24 hours she was in bed. Patient didn't get the second shot, only had the first one and took that one felt really bad. Patient was not sure for this. maybe it's Apr2023 or Sep2023. Consumer stated, she is a nurse anesthetist, anesthesia provider, a healthcare professional." Consumer stated, "Is it normal to have a side effect from the first vaccine, I know it's gonna the first dose I know it's okay from the second dose but not on a first dose, right", "I just want to know if I had such a reaction from the first dose, is it safe for me to receive a second dose". In response Consumer was informed about the Role of Pfizer Drug Safety and requested to contact the Pfizer Medical Information Department.The patient underwent lab tests and procedures which included cholesterol, sugar, cardiogram, heart work, annual physical examination all was normal on unknown date in 2021 and had no problems. Therapeutic measures were taken as a result of events included took vitamin c and stayed in bed. The outcome of events nausea, extreme headache was not recovered, and it was unknown for other events. The Causality was reported for as possible.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Physical examination, Pyrexia, Tachycardia
Clinical narrative: felt like she was going to die, felt really bad; Fever; Nausea; extreme headache; extreme weakness; Tachycardia; for 24 hours she was in bed; bad case of flu; chills; This is a spontaneous report from a contactable other hcp (patient) reported for herself. A 58-year-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in arm left on 25Jul2021 as DOSE 1, SINGLE (at the age of 58) for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not taking any other vaccines in four weeks. The patient reported as eight or seven hours later on 25Jul2021, started to have symptoms and thought that she should have symptoms after the second vaccine but not from the first one, symptom got worse felt like she was going to die, felt really bad, had tachycardia, chills, fever, nausea, extreme headache and extreme weakness and just felt like, really bad case of flu and was afraid was going to die, for 24 hours she was in bed. Patient didn't get the second shot, only had the first one and took that one felt really bad. Patient was not sure for this. maybe it's Apr2023 or Sep2023. Consumer stated, she is a nurse anesthetist, anesthesia provider, a healthcare professional." Consumer stated, "Is it normal to have a side effect from the first vaccine, I know it's gonna the first dose I know it's okay from the second dose but not on a first dose, right", "I just want to know if I had such a reaction from the first dose, is it safe for me to receive a second dose". In response Consumer was informed about the Role of Pfizer Drug Safety and requested to contact the Pfizer Medical Information Department.The patient underwent lab tests and procedures which included cholesterol, sugar, cardiogram, heart work, annual physical examination all was normal on unknown date in 2021 and had no problems. Therapeutic measures were taken as a result of events included took vitamin c and stayed in bed. The outcome of events nausea, extreme headache was not recovered, and it was unknown for other events. The Causality was reported for as possible.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 36 year old female.  The patient's pre-existing medical conditions included: The patient had no known drug or non-drug allergies. The Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: 21-SEP-2021) .5 ml, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955494 and 20211137862.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 36 year old female.  The patient's pre-existing medical conditions included: The patient had no known drug or non-drug allergies. The Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: 21-SEP-2021) .5 ml, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955494 and 20211137862.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Delusion, Insomnia, Pain
Clinical narrative: Neurology issues; Severely Altered Mental Status; booster; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received bnt162b2 (BNT162B2), dose 3 administered in Arm Left on 20Oct2021 16:30 (Batch/Lot number was not reported) at age of 50-year-old as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Facility type vaccine was Nursing Home/Senior Living Facility. Medical history included Asthma, Congestive Heart Failure, Traumatic brain injury (TBI). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included influenza vaccine (FLU VACCINE VII) (lot number=308520) in arm on 05Oct2021 for immunisation; carvedilol; apixaban (ELIQUIS); famotidine; lactulose; montelukast; quetiapine; sertraline; simvastatin; tamsulosin; torsemide ; tramadol hydrochloride (TRAMADOC). The patient previously took first dose of bnt162b2 (Lot number: CEK 4176) in Left arm on 05Jan2021 at age of 50-year-old for covid-19 immunisation, second dose of bnt162b2 (Lot number:EN 5318) in Left arm on 05Feb202 at age of 50-year-old for covid-19 immunisation, morphine and experienced hypersensitivity. Evening of Booster, the patient experienced Severely Altered Mental Status and Neurology issues on 20Oct2021 11:00 PM. AE resulted in Emergency room/department or urgent care, Hospitalization for 7 days. AE treatment included 5 Psyche meds. The outcome was Not recovered. Covid test post vaccination Nasal Swab on 26Oct2021 with Negative result. Events were assessed serious as Medically Significant and hospitalization.  The events occurred in a location different from that of the reporter. This may be a duplicate report if another reporter from the location where the event occurred has submitted the same information to his/her local regulatory agency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunisation, Mental status changes, Nervous system disorder
Clinical narrative: Neurology issues; Severely Altered Mental Status; booster; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received bnt162b2 (BNT162B2), dose 3 administered in Arm Left on 20Oct2021 16:30 (Batch/Lot number was not reported) at age of 50-year-old as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Facility type vaccine was Nursing Home/Senior Living Facility. Medical history included Asthma, Congestive Heart Failure, Traumatic brain injury (TBI). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included influenza vaccine (FLU VACCINE VII) (lot number=308520) in arm on 05Oct2021 for immunisation; carvedilol; apixaban (ELIQUIS); famotidine; lactulose; montelukast; quetiapine; sertraline; simvastatin; tamsulosin; torsemide ; tramadol hydrochloride (TRAMADOC). The patient previously took first dose of bnt162b2 (Lot number: CEK 4176) in Left arm on 05Jan2021 at age of 50-year-old for covid-19 immunisation, second dose of bnt162b2 (Lot number:EN 5318) in Left arm on 05Feb202 at age of 50-year-old for covid-19 immunisation, morphine and experienced hypersensitivity. Evening of Booster, the patient experienced Severely Altered Mental Status and Neurology issues on 20Oct2021 11:00 PM. AE resulted in Emergency room/department or urgent care, Hospitalization for 7 days. AE treatment included 5 Psyche meds. The outcome was Not recovered. Covid test post vaccination Nasal Swab on 26Oct2021 with Negative result. Events were assessed serious as Medically Significant and hospitalization.  The events occurred in a location different from that of the reporter. This may be a duplicate report if another reporter from the location where the event occurred has submitted the same information to his/her local regulatory agency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: A seizure and very  lethargic and unresponsive for majority of the day.  Included a concussion..  itchiness and hives
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Concussion, Lethargy, Pruritus, Seizure, Unresponsive to stimuli
Clinical narrative: A seizure and very  lethargic and unresponsive for majority of the day.  Included a concussion..  itchiness and hives
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: A seizure and very  lethargic and unresponsive for majority of the day.  Included a concussion..  itchiness and hives
Age: 43.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Pain in extremity
Clinical narrative: Injection site was in the wrong spot (too high, I am guessing because I am not a medical professional). My shoulder muscles have not been right since the injection (a lot of pain, especially after exercise/work). While lesser in intensity two months out, it still hurts, and was completely normal before the shot was given.
Age: 43.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Injection site was in the wrong spot (too high, I am guessing because I am not a medical professional). My shoulder muscles have not been right since the injection (a lot of pain, especially after exercise/work). While lesser in intensity two months out, it still hurts, and was completely normal before the shot was given.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Hours after receiving the Covid injection, I received a call from the pharmacist stating I had been given the wrong injection. He said the injection had expired because it had already been mixed and was no good after six hours. I asked if I could come back the next day to get reinjected. He said wait two weeks to return. The next morning around 9:00am, I experienced severe chest pains. I called my doctors office to explain what happened and was told to take some Advil for relief. The pain did not go away and the next morning I went to the ER. Several test and blood work was done and I was referred to my cardiologist. I have had other test done by my cardiologist. Two weeks later, I am still experiencing chest pains
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Computerised tomogram normal, Dizziness, Dyspnoea
Clinical narrative: Hours after receiving the Covid injection, I received a call from the pharmacist stating I had been given the wrong injection. He said the injection had expired because it had already been mixed and was no good after six hours. I asked if I could come back the next day to get reinjected. He said wait two weeks to return. The next morning around 9:00am, I experienced severe chest pains. I called my doctors office to explain what happened and was told to take some Advil for relief. The pain did not go away and the next morning I went to the ER. Several test and blood work was done and I was referred to my cardiologist. I have had other test done by my cardiologist. Two weeks later, I am still experiencing chest pains
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Fibrin D dimer increased, Monocyte count normal, Monocyte percentage increased
Clinical narrative: Hours after receiving the Covid injection, I received a call from the pharmacist stating I had been given the wrong injection. He said the injection had expired because it had already been mixed and was no good after six hours. I asked if I could come back the next day to get reinjected. He said wait two weeks to return. The next morning around 9:00am, I experienced severe chest pains. I called my doctors office to explain what happened and was told to take some Advil for relief. The pain did not go away and the next morning I went to the ER. Several test and blood work was done and I was referred to my cardiologist. I have had other test done by my cardiologist. Two weeks later, I am still experiencing chest pains
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inflammation, Mobility decreased
Clinical narrative: was not able to lift left hand; This is a spontaneous report from a contactable consumer (patient).   A 46-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Arm on 06May2021, at the age of 46-years-old, (Lot Number: EW0176) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Historical vaccine includes dose 1 of BNT162B2 received on 15Apr2021, lot number=ER8729 at left arm. There were no concomitant medications. The patient did not have COVID-19 prior and post vaccination. The patient was not able to lift left hand on 11Jun2021 til for the last 6 months.  The event was assessed as medically significant. The event required physician office visit. Therapeutic measures were taken as a result of the event (anti-inflammatory medicine and some exercise). The outcome of the event was not recovered.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injected limb mobility decreased
Clinical narrative: was not able to lift left hand; This is a spontaneous report from a contactable consumer (patient).   A 46-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Arm on 06May2021, at the age of 46-years-old, (Lot Number: EW0176) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Historical vaccine includes dose 1 of BNT162B2 received on 15Apr2021, lot number=ER8729 at left arm. There were no concomitant medications. The patient did not have COVID-19 prior and post vaccination. The patient was not able to lift left hand on 11Jun2021 til for the last 6 months.  The event was assessed as medically significant. The event required physician office visit. Therapeutic measures were taken as a result of the event (anti-inflammatory medicine and some exercise). The outcome of the event was not recovered.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: SIRVA /  FROZEN SHOULDER ACCORDING TO PATIENT WHO DID NOT LET US KNOW UNTIL 11/13/21
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Periarthritis, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA /  FROZEN SHOULDER ACCORDING TO PATIENT WHO DID NOT LET US KNOW UNTIL 11/13/21
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Affect lability, Chest discomfort, Chills, Consciousness fluctuating, Cough
Clinical narrative: As reported, "I had no reaction within the 15 minutes observation time, then I left. I went on a short hike and felt completely normal. By 10:30 that night I started suddenly convulsing, not shivers. I couldn't walk, couldn't drink and was shaking wildly. My roommate was home but I did not signal for help. As I was convulsing, I felt chest pressure and short of breath, like I could not breathe enough, felt like I was passing out, in and out of consciousness. Obviously my joints were stiff, muscles were really stiff. My head, the only way to describe it is as if my brain matter was pressing out in all directions. I couldn't tell the difference between convulsions, muscle tightness in my neck and back. I was in and out of consciousness. I remember waking up and looking at my phone to see it was 10 am the next morning. For the next couple of days my head was the worst pain I have felt in my life. I felt like my head wanting to leave my skull. That pain stayed and the short of breath up until last night (11/10/21). I couldn't catch a full breath, it was hard to breathe, there wsa weight on my chest like what people describe when they get COVID, that's what I felt. The coughing was not severe, it was light. Lights and sounds because my head hurt so much. My working memory wasn't functioning at normal capacity, I could not recall basic things. One minute I was thinking I'm okay, the next minute thinking, what's going on, like a complete loss. I became really dizzy each time I lost my breath. Yesterday not an exception I felt memory loss, headache, dizzy, fatigue, short of breath all happening. Last night while I was trying to take a deep breath starting on right side of spine I felt sensations like firecrackers  going off up and down my spine rapidly. Then right to left that pain repeatedly went up and down my spine. Exploding pain on both sides with an up and down movement, not stationary. I have since been to the Emergency Room. I do not have a primary care physician."