chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, SARS-CoV-2 test
Clinical narrative: lost vision in both eyes; passed out; dizzy; severe nausea set in with severe body pain; severe nausea set in with severe body pain; worst migraine of my life; low blood pressure; This is a spontaneous report received from a contactable consumer (patient).   A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 19-years-old), administered in Arm Left on 23Apr2021 13:00 (Lot Number: EW0169) as 1st dose, single for COVID-19 immunization. Medical history included anxiety, and allergies to mosquitoes, hotdogs, and sausage. The patient was not pregnant at the time of vaccination. Concomitant medications included citalopram and drospirenone, estradiol (EOS), IUD, daily supplements. The patient previously took oxycodone ("oxicodone") and percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced allergies. The patient, 48 hrs later, lost vision in both eyes, became dizzy, passed out multiple times. Later severe nausea set in with severe body pain. Went to Urgent Care the following day and was told side effects. That night had worst migraine of her life, low blood pressure, and continued nausea. Given some meds and sent home to rest. Took 2 full days to feel okay again. Onset date and time of events reported as 25Apr2021 13:00. The adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Treatment received for the adverse events included Toradol, Benadryl, and Reglan. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (Nasal Swab) on 27Apr2021. The outcome of the events was recovered with sequelae. The events "lost vision in both eyes" and "passed out" were considered as serious (medically significant).  Facility where the most recent COVID-19 vaccine was administered was  Clinic/facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible, no further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Thrombosis, Ultrasound scan
Clinical narrative: LEFT ANKLE STARTED SWELLING, LEFT ANKLE SWELLING INCREASED AND REACHED LEFT THIGH, WENT ULTRASOUND WHICH RESULT BLOOD CLOT; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 95.70 kilogram, and height was 167 centimeter. The patient's concurrent condition included Cholesterol. Patient was non alcohol user and non smoker.. Patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry date were unknown) dose was not reported, administered on 11-MAR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included pravastatin for cholesterol.  Around 19-MAR-2021 (approximately 1 week after the vaccine), the patient experienced left ankle swelling (as per patient, she did not think much of it, and just elevated her leg and applied hot-cold compress). Around 26-Apr-2021 the patient experienced increased left ankle swelling and had reached her left thigh. On 26-April-2021 patient went to the hospital and was hospitalized, was given an ultrasound procedure which result stated that she had blood clot. Patient was given Eliquis right away, while in the hospital. On an unspecified date patient was discharged and upon discharge she was prescribed Eliquis 5 mg for 2 times per day. Patient stated that she will go back to the doctor will be doing another ultrasound. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot. Patient stated her left leg swelling was not yet completely resolved, but not as worse, whenever she elevates her leg, the pain and swelling gets better, but once she gets up and move around, the swelling starts again. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210529680-covid-19 vaccine ad26.cov2.s ,LEFT ANKLE STARTED SWELLING, LEFT ANKLE SWELLING INCREASED AND REACHED LEFT THIGH, WENT ULTRASOUND WHICH RESULT BLOOD CLOT. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: LEFT ANKLE STARTED SWELLING, LEFT ANKLE SWELLING INCREASED AND REACHED LEFT THIGH, WENT ULTRASOUND WHICH RESULT BLOOD CLOT; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 95.70 kilogram, and height was 167 centimeter. The patient's concurrent condition included Cholesterol. Patient was non alcohol user and non smoker.. Patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry date were unknown) dose was not reported, administered on 11-MAR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included pravastatin for cholesterol.  Around 19-MAR-2021 (approximately 1 week after the vaccine), the patient experienced left ankle swelling (as per patient, she did not think much of it, and just elevated her leg and applied hot-cold compress). Around 26-Apr-2021 the patient experienced increased left ankle swelling and had reached her left thigh. On 26-April-2021 patient went to the hospital and was hospitalized, was given an ultrasound procedure which result stated that she had blood clot. Patient was given Eliquis right away, while in the hospital. On an unspecified date patient was discharged and upon discharge she was prescribed Eliquis 5 mg for 2 times per day. Patient stated that she will go back to the doctor will be doing another ultrasound. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot. Patient stated her left leg swelling was not yet completely resolved, but not as worse, whenever she elevates her leg, the pain and swelling gets better, but once she gets up and move around, the swelling starts again. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210529680-covid-19 vaccine ad26.cov2.s ,LEFT ANKLE STARTED SWELLING, LEFT ANKLE SWELLING INCREASED AND REACHED LEFT THIGH, WENT ULTRASOUND WHICH RESULT BLOOD CLOT. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: LEFT ANKLE STARTED SWELLING, LEFT ANKLE SWELLING INCREASED AND REACHED LEFT THIGH, WENT ULTRASOUND WHICH RESULT BLOOD CLOT; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 95.70 kilogram, and height was 167 centimeter. The patient's concurrent condition included Cholesterol. Patient was non alcohol user and non smoker.. Patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry date were unknown) dose was not reported, administered on 11-MAR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included pravastatin for cholesterol.  Around 19-MAR-2021 (approximately 1 week after the vaccine), the patient experienced left ankle swelling (as per patient, she did not think much of it, and just elevated her leg and applied hot-cold compress). Around 26-Apr-2021 the patient experienced increased left ankle swelling and had reached her left thigh. On 26-April-2021 patient went to the hospital and was hospitalized, was given an ultrasound procedure which result stated that she had blood clot. Patient was given Eliquis right away, while in the hospital. On an unspecified date patient was discharged and upon discharge she was prescribed Eliquis 5 mg for 2 times per day. Patient stated that she will go back to the doctor will be doing another ultrasound. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot. Patient stated her left leg swelling was not yet completely resolved, but not as worse, whenever she elevates her leg, the pain and swelling gets better, but once she gets up and move around, the swelling starts again. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210529680-covid-19 vaccine ad26.cov2.s ,LEFT ANKLE STARTED SWELLING, LEFT ANKLE SWELLING INCREASED AND REACHED LEFT THIGH, WENT ULTRASOUND WHICH RESULT BLOOD CLOT. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOT IN LEFT  LEG; This spontaneous report received from a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot in left leg from the vaccine. Patient stated that never in life had a blood clot before The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in left leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210529802-Covid-19 vaccine ad26.cov2.s-Blood clot in left leg. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOT IN LEFT  LEG; This spontaneous report received from a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot in left leg from the vaccine. Patient stated that never in life had a blood clot before The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in left leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210529802-Covid-19 vaccine ad26.cov2.s-Blood clot in left leg. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT IN LEFT  LEG; This spontaneous report received from a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot in left leg from the vaccine. Patient stated that never in life had a blood clot before The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in left leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210529802-Covid-19 vaccine ad26.cov2.s-Blood clot in left leg. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Computerised tomogram thorax normal, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: Patient presented with substernal pressure like chest pain within 1 day of his second Pfizer vaccine associated with fatigue and dyspnea on exertion.  He was found to have markedly elevated troponins without EKG changes.  He was admitted to the hospital for evaluation and monitoring where cardiac MRI showed myocardial infllammation consistent with myocarditis. There was no other apparent cause based on patient's history.  He was found to have a reduced ejection fraction on echocardiogram as a result of his myocarditis.  He continued to have dyspnea on exertion at discharge.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram normal, Magnetic resonance imaging heart, Myocarditis, Pericardial effusion, Troponin increased
Clinical narrative: Patient presented with substernal pressure like chest pain within 1 day of his second Pfizer vaccine associated with fatigue and dyspnea on exertion.  He was found to have markedly elevated troponins without EKG changes.  He was admitted to the hospital for evaluation and monitoring where cardiac MRI showed myocardial infllammation consistent with myocarditis. There was no other apparent cause based on patient's history.  He was found to have a reduced ejection fraction on echocardiogram as a result of his myocarditis.  He continued to have dyspnea on exertion at discharge.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ventricular hypokinesia
Clinical narrative: Patient presented with substernal pressure like chest pain within 1 day of his second Pfizer vaccine associated with fatigue and dyspnea on exertion.  He was found to have markedly elevated troponins without EKG changes.  He was admitted to the hospital for evaluation and monitoring where cardiac MRI showed myocardial infllammation consistent with myocarditis. There was no other apparent cause based on patient's history.  He was found to have a reduced ejection fraction on echocardiogram as a result of his myocarditis.  He continued to have dyspnea on exertion at discharge.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest discomfort, Chest pain, Dyspnoea exertional, Echocardiogram abnormal
Clinical narrative: Patient presented with substernal pressure like chest pain within 1 day of his second Pfizer vaccine associated with fatigue and dyspnea on exertion.  He was found to have markedly elevated troponins without EKG changes.  He was admitted to the hospital for evaluation and monitoring where cardiac MRI showed myocardial infllammation consistent with myocarditis. There was no other apparent cause based on patient's history.  He was found to have a reduced ejection fraction on echocardiogram as a result of his myocarditis.  He continued to have dyspnea on exertion at discharge.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ejection fraction decreased, Electrocardiogram normal, Fatigue, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: Patient presented with substernal pressure like chest pain within 1 day of his second Pfizer vaccine associated with fatigue and dyspnea on exertion.  He was found to have markedly elevated troponins without EKG changes.  He was admitted to the hospital for evaluation and monitoring where cardiac MRI showed myocardial infllammation consistent with myocarditis. There was no other apparent cause based on patient's history.  He was found to have a reduced ejection fraction on echocardiogram as a result of his myocarditis.  He continued to have dyspnea on exertion at discharge.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Right ventricular dilatation, Troponin increased, Ventricular hypokinesia
Clinical narrative: Patient presented with substernal pressure like chest pain within 1 day of his second Pfizer vaccine associated with fatigue and dyspnea on exertion.  He was found to have markedly elevated troponins without EKG changes.  He was admitted to the hospital for evaluation and monitoring where cardiac MRI showed myocardial infllammation consistent with myocarditis. There was no other apparent cause based on patient's history.  He was found to have a reduced ejection fraction on echocardiogram as a result of his myocarditis.  He continued to have dyspnea on exertion at discharge.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Grip strength decreased, Muscle spasms, Muscle twitching, Peripheral paralysis
Clinical narrative: lose movement control in his pinky finger of his left arm/This sensation in the pinky has since progressed to the ring and middle fingers in subsequent days; involuntary twitch in his left thumb; no strength, his hand was numb and more or less useless ("left arm, same as shot"); no strength, his hand was numb and more or less useless ("left arm, same as shot"); This is a spontaneous report received from a contactable consumer (patient). A male patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8737) via an unspecified route of administration on 10Apr2021 as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. On 11Apr2021, the patient experienced an involuntary twitch in his left thumb; 12 hours later it was twitching uncontrollably. On 12Apr2021 the patient started to lose movement control in his pinky finger of his left arm. He had it completely straight or curled with little control in between. On 13Apr2021 the sensation in the pinky spread to the ring finger. On 14Apr2021 it spread to the middle finger. On an unspecified date in Apr2021, his arm moved fine but his left had was "pretty much useless." He had no strength, his hand was numb and more or less useless ("left arm, same as shot"). It had just been getting progressively worse throughout the week. The patient did not report anything else out of the ordinary to have occurred. He had not fallen, slept funny or had any other accidents. The outcome of involuntary twitch in his left thumb was recovered on 12Apr2021. The outcomes of started to lose movement control in his pinky and sensation progressed to the ring and middle fingers, no strength and hand numb were not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyskinesia, Hypoaesthesia, Muscle twitching, Muscular weakness
Clinical narrative: lose movement control in his pinky finger of his left arm/This sensation in the pinky has since progressed to the ring and middle fingers in subsequent days; involuntary twitch in his left thumb; no strength, his hand was numb and more or less useless ("left arm, same as shot"); no strength, his hand was numb and more or less useless ("left arm, same as shot"); This is a spontaneous report received from a contactable consumer (patient). A male patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8737) via an unspecified route of administration on 10Apr2021 as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. On 11Apr2021, the patient experienced an involuntary twitch in his left thumb; 12 hours later it was twitching uncontrollably. On 12Apr2021 the patient started to lose movement control in his pinky finger of his left arm. He had it completely straight or curled with little control in between. On 13Apr2021 the sensation in the pinky spread to the ring finger. On 14Apr2021 it spread to the middle finger. On an unspecified date in Apr2021, his arm moved fine but his left had was "pretty much useless." He had no strength, his hand was numb and more or less useless ("left arm, same as shot"). It had just been getting progressively worse throughout the week. The patient did not report anything else out of the ordinary to have occurred. He had not fallen, slept funny or had any other accidents. The outcome of involuntary twitch in his left thumb was recovered on 12Apr2021. The outcomes of started to lose movement control in his pinky and sensation progressed to the ring and middle fingers, no strength and hand numb were not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Influenza like illness, Injection site swelling, Loss of consciousness, Pain in extremity
Clinical narrative: Missing muscle tissue in the left arm where the injection was given; chest pains; pulmonary embolism in the left lung.; Hives on my whole chest, neck, face, and left arm.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 via an unspecified route of administration in Arm Left on Mar2021 (Lot Number: EP6955, expiration date was unknown) at 39 years old at vaccination as 1st dose, single for covid-19 immunisation. Medical history included asthma and other known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. She used other medications received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was no pregnancy at time of vaccination. The patient experienced missing muscle tissue in the left arm where the injection was given, chest pains, pulmonary embolism in the left lung and hives on her whole chest, neck, face, and left arm on 06Apr2021 15:30 PM. She went to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care due to events. The patient was hospitalized in 2021 due to all events for 4 days. All events were reported as serious due to life threatening and hospitalization. The patient underwent lab tests which included: Covid test type post vaccination via nasal Swab on 14Apr2021was negative. She received blood thinner injections and intravenous (IV) antibiotics as treatment. The outcome of events was not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication
Clinical narrative: Missing muscle tissue in the left arm where the injection was given; chest pains; pulmonary embolism in the left lung.; Hives on my whole chest, neck, face, and left arm.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 via an unspecified route of administration in Arm Left on Mar2021 (Lot Number: EP6955, expiration date was unknown) at 39 years old at vaccination as 1st dose, single for covid-19 immunisation. Medical history included asthma and other known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. She used other medications received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was no pregnancy at time of vaccination. The patient experienced missing muscle tissue in the left arm where the injection was given, chest pains, pulmonary embolism in the left lung and hives on her whole chest, neck, face, and left arm on 06Apr2021 15:30 PM. She went to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care due to events. The patient was hospitalized in 2021 due to all events for 4 days. All events were reported as serious due to life threatening and hospitalization. The patient underwent lab tests which included: Covid test type post vaccination via nasal Swab on 14Apr2021was negative. She received blood thinner injections and intravenous (IV) antibiotics as treatment. The outcome of events was not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Muscle atrophy, Pulmonary embolism, SARS-CoV-2 test, Urticaria
Clinical narrative: Missing muscle tissue in the left arm where the injection was given; chest pains; pulmonary embolism in the left lung.; Hives on my whole chest, neck, face, and left arm.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 via an unspecified route of administration in Arm Left on Mar2021 (Lot Number: EP6955, expiration date was unknown) at 39 years old at vaccination as 1st dose, single for covid-19 immunisation. Medical history included asthma and other known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. She used other medications received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was no pregnancy at time of vaccination. The patient experienced missing muscle tissue in the left arm where the injection was given, chest pains, pulmonary embolism in the left lung and hives on her whole chest, neck, face, and left arm on 06Apr2021 15:30 PM. She went to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care due to events. The patient was hospitalized in 2021 due to all events for 4 days. All events were reported as serious due to life threatening and hospitalization. The patient underwent lab tests which included: Covid test type post vaccination via nasal Swab on 14Apr2021was negative. She received blood thinner injections and intravenous (IV) antibiotics as treatment. The outcome of events was not recovered.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute disseminated encephalomyelitis, Asthenia, Blood test, Cranial nerve disorder, Electromyogram
Clinical narrative: Received a request from a palliative care physician in contact with the patient's family, who were having difficulty accessing VAERS. Notified that the patient's neurologist had documented in the medical record " Cannot rule out autoimmune reaction after a COVID-19 vaccination(symptoms started 3 weeks after the 2nd vaccine shot with moderna)"  Originally started with dysarthria approximately 3 weeks prior to presentation on 3/18/21 (exact date of onset unknown). Diagnosed with a brain stem CVA. Continued to progressively worsen and readmitted 4/13/21. Eventually diagnosed w/ ADEM on top of neurovascular disease.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lumbar puncture abnormal, Magnetic resonance imaging head abnormal, Magnetic resonance imaging neck, Magnetic resonance imaging spinal
Clinical narrative: Received a request from a palliative care physician in contact with the patient's family, who were having difficulty accessing VAERS. Notified that the patient's neurologist had documented in the medical record " Cannot rule out autoimmune reaction after a COVID-19 vaccination(symptoms started 3 weeks after the 2nd vaccine shot with moderna)"  Originally started with dysarthria approximately 3 weeks prior to presentation on 3/18/21 (exact date of onset unknown). Diagnosed with a brain stem CVA. Continued to progressively worsen and readmitted 4/13/21. Eventually diagnosed w/ ADEM on top of neurovascular disease.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute disseminated encephalomyelitis, Death, Immunoglobulin therapy, Plasmapheresis
Clinical narrative: Received a request from a palliative care physician in contact with the patient's family, who were having difficulty accessing VAERS. Notified that the patient's neurologist had documented in the medical record " Cannot rule out autoimmune reaction after a COVID-19 vaccination(symptoms started 3 weeks after the 2nd vaccine shot with moderna)"  Originally started with dysarthria approximately 3 weeks prior to presentation on 3/18/21 (exact date of onset unknown). Diagnosed with a brain stem CVA. Continued to progressively worsen and readmitted 4/13/21. Eventually diagnosed w/ ADEM on top of neurovascular disease.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute disseminated encephalomyelitis, Brain stem infarction, Cerebrovascular disorder, Dysarthria, General physical health deterioration
Clinical narrative: Received a request from a palliative care physician in contact with the patient's family, who were having difficulty accessing VAERS. Notified that the patient's neurologist had documented in the medical record " Cannot rule out autoimmune reaction after a COVID-19 vaccination(symptoms started 3 weeks after the 2nd vaccine shot with moderna)"  Originally started with dysarthria approximately 3 weeks prior to presentation on 3/18/21 (exact date of onset unknown). Diagnosed with a brain stem CVA. Continued to progressively worsen and readmitted 4/13/21. Eventually diagnosed w/ ADEM on top of neurovascular disease.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ischaemia, Magnetic resonance imaging head abnormal, Osmotic demyelination syndrome
Clinical narrative: Received a request from a palliative care physician in contact with the patient's family, who were having difficulty accessing VAERS. Notified that the patient's neurologist had documented in the medical record " Cannot rule out autoimmune reaction after a COVID-19 vaccination(symptoms started 3 weeks after the 2nd vaccine shot with moderna)"  Originally started with dysarthria approximately 3 weeks prior to presentation on 3/18/21 (exact date of onset unknown). Diagnosed with a brain stem CVA. Continued to progressively worsen and readmitted 4/13/21. Eventually diagnosed w/ ADEM on top of neurovascular disease.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Chest pain, Hard to breath, severe pain down left side of body, shaking, lightheaded, dizzy, had to be taken to hospital via ambulance. Two weeks later experiencing severe pain in legs, still having headaches, dizziness, light headedness, chest pain/pressure, tingling feeling in fingers and toes, lower back pain, randomly hard to breath, lump on the back of left leg
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in jaw, Throat irritation
Clinical narrative: Chest pain, Hard to breath, severe pain down left side of body, shaking, lightheaded, dizzy, had to be taken to hospital via ambulance. Two weeks later experiencing severe pain in legs, still having headaches, dizziness, light headedness, chest pain/pressure, tingling feeling in fingers and toes, lower back pain, randomly hard to breath, lump on the back of left leg
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Burning sensation, Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Chest pain, Hard to breath, severe pain down left side of body, shaking, lightheaded, dizzy, had to be taken to hospital via ambulance. Two weeks later experiencing severe pain in legs, still having headaches, dizziness, light headedness, chest pain/pressure, tingling feeling in fingers and toes, lower back pain, randomly hard to breath, lump on the back of left leg
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Feeling hot, Heart rate increased, Laboratory test, Pain, Pain in jaw
Clinical narrative: Chest pain, Hard to breath, severe pain down left side of body, shaking, lightheaded, dizzy, had to be taken to hospital via ambulance. Two weeks later experiencing severe pain in legs, still having headaches, dizziness, light headedness, chest pain/pressure, tingling feeling in fingers and toes, lower back pain, randomly hard to breath, lump on the back of left leg
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Chest pain, Hard to breath, severe pain down left side of body, shaking, lightheaded, dizzy, had to be taken to hospital via ambulance. Two weeks later experiencing severe pain in legs, still having headaches, dizziness, light headedness, chest pain/pressure, tingling feeling in fingers and toes, lower back pain, randomly hard to breath, lump on the back of left leg
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Back pain, Blood test, Chest discomfort, Chest pain, Computerised tomogram head
Clinical narrative: Chest pain, Hard to breath, severe pain down left side of body, shaking, lightheaded, dizzy, had to be taken to hospital via ambulance. Two weeks later experiencing severe pain in legs, still having headaches, dizziness, light headedness, chest pain/pressure, tingling feeling in fingers and toes, lower back pain, randomly hard to breath, lump on the back of left leg
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Magnetic resonance imaging, Mass
Clinical narrative: Chest pain, Hard to breath, severe pain down left side of body, shaking, lightheaded, dizzy, had to be taken to hospital via ambulance. Two weeks later experiencing severe pain in legs, still having headaches, dizziness, light headedness, chest pain/pressure, tingling feeling in fingers and toes, lower back pain, randomly hard to breath, lump on the back of left leg
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Ultrasound Doppler
Clinical narrative: Chest pain, Hard to breath, severe pain down left side of body, shaking, lightheaded, dizzy, had to be taken to hospital via ambulance. Two weeks later experiencing severe pain in legs, still having headaches, dizziness, light headedness, chest pain/pressure, tingling feeling in fingers and toes, lower back pain, randomly hard to breath, lump on the back of left leg
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Burning sensation, Dizziness, Dyspnoea, Eye pain, Headache
Clinical narrative: Chest pain, Hard to breath, severe pain down left side of body, shaking, lightheaded, dizzy, had to be taken to hospital via ambulance. Two weeks later experiencing severe pain in legs, still having headaches, dizziness, light headedness, chest pain/pressure, tingling feeling in fingers and toes, lower back pain, randomly hard to breath, lump on the back of left leg
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Hypertension, Loss of consciousness, Muscular weakness, Musculoskeletal discomfort
Clinical narrative: Chest pain, Hard to breath, severe pain down left side of body, shaking, lightheaded, dizzy, had to be taken to hospital via ambulance. Two weeks later experiencing severe pain in legs, still having headaches, dizziness, light headedness, chest pain/pressure, tingling feeling in fingers and toes, lower back pain, randomly hard to breath, lump on the back of left leg
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nausea, Neck pain, Neuralgia, Pain, Pain in extremity
Clinical narrative: Chest pain, Hard to breath, severe pain down left side of body, shaking, lightheaded, dizzy, had to be taken to hospital via ambulance. Two weeks later experiencing severe pain in legs, still having headaches, dizziness, light headedness, chest pain/pressure, tingling feeling in fingers and toes, lower back pain, randomly hard to breath, lump on the back of left leg
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pharyngeal swelling, SARS-CoV-2 test, Thrombophlebitis superficial, Vision blurred
Clinical narrative: Chest pain, Hard to breath, severe pain down left side of body, shaking, lightheaded, dizzy, had to be taken to hospital via ambulance. Two weeks later experiencing severe pain in legs, still having headaches, dizziness, light headedness, chest pain/pressure, tingling feeling in fingers and toes, lower back pain, randomly hard to breath, lump on the back of left leg
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Hypoaesthesia, Skin disorder, Water pollution
Clinical narrative: Bell's Palsy; She was worried it could be a stroke; This is a spontaneous report received from a contactable consumer reporting for herself. This 73 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Apr2021, in left arm, for COVID-19 immunisation. Medical history included Bell's Palsy 20 years before the report, shingles in Nov2020, ongoing blood pressure, ongoing cholesterol and ongoing indigestion. Concomitant medications included omeprazole orally, 20 mg, 1x/day (1 capsule every morning), lisinopril/hydrochlorothiazide orally, 1 DF, 1x/day (in the morning), for blood pressure and ezetimibe for cholesterol. The patient experienced Bell's palsy following the first dose, since an unspecified date in 2021. She recovered quickly on an unspecified date in 2021. The event was described as "drool down one side, make sure close eyes at night or they dry out". The patient was drinking and it was leaking out the side of mouth, smiled and nothing was moving on the right side, right side of face went saggy. It was the right side that was messed up, the right eye didn't have the muscle coordination that the left eye did. The patient was worried it could be a stroke. She stated she will most likely not receive second dose.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Cerebrovascular accident
Clinical narrative: Bell's Palsy; She was worried it could be a stroke; This is a spontaneous report received from a contactable consumer reporting for herself. This 73 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Apr2021, in left arm, for COVID-19 immunisation. Medical history included Bell's Palsy 20 years before the report, shingles in Nov2020, ongoing blood pressure, ongoing cholesterol and ongoing indigestion. Concomitant medications included omeprazole orally, 20 mg, 1x/day (1 capsule every morning), lisinopril/hydrochlorothiazide orally, 1 DF, 1x/day (in the morning), for blood pressure and ezetimibe for cholesterol. The patient experienced Bell's palsy following the first dose, since an unspecified date in 2021. She recovered quickly on an unspecified date in 2021. The event was described as "drool down one side, make sure close eyes at night or they dry out". The patient was drinking and it was leaking out the side of mouth, smiled and nothing was moving on the right side, right side of face went saggy. It was the right side that was messed up, the right eye didn't have the muscle coordination that the left eye did. The patient was worried it could be a stroke. She stated she will most likely not receive second dose.  Information on the lot/batch number has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, Chest X-ray, Chest pain, Echocardiogram
Clinical narrative: back was hurting; acute chest pain; elevated white blood count; acute pericarditis; Arm pain; This is a spontaneous report from a contactable other health professional (parent). A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscular, administered in Arm Left on 29Apr2021 15:30 at the age of 16 years old (Lot Number: E000167) as 2nd dose, single for covid-19 immunisation. The patient had no medical history, no known allergies. Concomitant medications received within 2 weeks of vaccination included vitamins nos (MULTIVITAMIN [VITAMINS NOS]), acetaminophen. The patient previously received the first dose of bnt162b2 (lot number: EN6208) intramuscular in Arm left on 07Apr2021 13:00 at the age of 16 years old for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Arm pain the first few days after receiving vaccine (2021). Then last night (02May2021), at 03:00 he came to his parent's room and said his back was hurting. His parent gave him one Advil. He tried to go back to sleep but came back an hour later saying it felt like his heart was being squeezed. The doctor on call recommended they go to the ER. At the ER, they performed 2 EKGs, bloodwork, chest X-ray and an echocardiogram on 02May2021. His diagnosis upon discharge: acute chest pain and acute pericarditis on 02May2021. His bloodwork showed an elevated white blood count on 02May2021. They were to follow up with the pediatric cardiologist later this week. This events happened three days after his receiving his 2nd Covid vaccine shot. The adverse events result in Emergency room department or urgent care. Treatment received for the adverse events included Two EKGs, bloodwork, chest X-ray and echocardiogram. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: The causal relationship between BNT162B2 and the events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Pericarditis
Clinical narrative: back was hurting; acute chest pain; elevated white blood count; acute pericarditis; Arm pain; This is a spontaneous report from a contactable other health professional (parent). A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscular, administered in Arm Left on 29Apr2021 15:30 at the age of 16 years old (Lot Number: E000167) as 2nd dose, single for covid-19 immunisation. The patient had no medical history, no known allergies. Concomitant medications received within 2 weeks of vaccination included vitamins nos (MULTIVITAMIN [VITAMINS NOS]), acetaminophen. The patient previously received the first dose of bnt162b2 (lot number: EN6208) intramuscular in Arm left on 07Apr2021 13:00 at the age of 16 years old for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Arm pain the first few days after receiving vaccine (2021). Then last night (02May2021), at 03:00 he came to his parent's room and said his back was hurting. His parent gave him one Advil. He tried to go back to sleep but came back an hour later saying it felt like his heart was being squeezed. The doctor on call recommended they go to the ER. At the ER, they performed 2 EKGs, bloodwork, chest X-ray and an echocardiogram on 02May2021. His diagnosis upon discharge: acute chest pain and acute pericarditis on 02May2021. His bloodwork showed an elevated white blood count on 02May2021. They were to follow up with the pediatric cardiologist later this week. This events happened three days after his receiving his 2nd Covid vaccine shot. The adverse events result in Emergency room department or urgent care. Treatment received for the adverse events included Two EKGs, bloodwork, chest X-ray and echocardiogram. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: The causal relationship between BNT162B2 and the events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.