chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Brain fog, CSF oligoclonal band present, Dyspepsia, Hypoaesthesia
Clinical narrative: Brain fog; Digestive issues; Huge knot on his left arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the first vaccine dose.   A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in the left arm on 03May2021 at 10:00am (Batch/Lot Number: EW0176, at age 41-years-old at vaccination) as a single dose for COVID-19 immunisation at a pharmacy/drug store. Medical history and concomitant medications were not reported. The patient had no prior vaccinations (within 4 weeks) of the BNT162B2 vaccine. On 03May2021, the patient received the first dose of the BNT162B2 vaccine. On an unspecified date in May2021 (after the first vaccination), the patient experienced a huge knot on his left arm and it has remained the same. It was hard as a rock. The patent has been having a lot of side effects since the vaccine and one is brain fog which began around 18May2021 at the latest after the first dose of the vaccine and was ongoing and continues to get worse. He has an appointment with a neuropsychologist to undergo testing to see what was going on. He has a lot of digestive issues and was undergoing tests. The digestive issues also began around the same time as the brain fog and was ongoing and worst. Treatment for event digestive issues included taking Linzess 150mg once per day by mouth since 24Sep2021. The outcome of events huge knot on his left arm, brain fog and digestive issues was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101314920 Same patient/reporter; different dose/AE
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test normal, Lumbar puncture normal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal, Mass
Clinical narrative: Brain fog; Digestive issues; Huge knot on his left arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the first vaccine dose.   A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in the left arm on 03May2021 at 10:00am (Batch/Lot Number: EW0176, at age 41-years-old at vaccination) as a single dose for COVID-19 immunisation at a pharmacy/drug store. Medical history and concomitant medications were not reported. The patient had no prior vaccinations (within 4 weeks) of the BNT162B2 vaccine. On 03May2021, the patient received the first dose of the BNT162B2 vaccine. On an unspecified date in May2021 (after the first vaccination), the patient experienced a huge knot on his left arm and it has remained the same. It was hard as a rock. The patent has been having a lot of side effects since the vaccine and one is brain fog which began around 18May2021 at the latest after the first dose of the vaccine and was ongoing and continues to get worse. He has an appointment with a neuropsychologist to undergo testing to see what was going on. He has a lot of digestive issues and was undergoing tests. The digestive issues also began around the same time as the brain fog and was ongoing and worst. Treatment for event digestive issues included taking Linzess 150mg once per day by mouth since 24Sep2021. The outcome of events huge knot on his left arm, brain fog and digestive issues was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101314920 Same patient/reporter; different dose/AE
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myelitis transverse, Neuropathy peripheral, Pain in extremity, Paraesthesia, Paraplegia
Clinical narrative: Brain fog; Digestive issues; Huge knot on his left arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the first vaccine dose.   A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in the left arm on 03May2021 at 10:00am (Batch/Lot Number: EW0176, at age 41-years-old at vaccination) as a single dose for COVID-19 immunisation at a pharmacy/drug store. Medical history and concomitant medications were not reported. The patient had no prior vaccinations (within 4 weeks) of the BNT162B2 vaccine. On 03May2021, the patient received the first dose of the BNT162B2 vaccine. On an unspecified date in May2021 (after the first vaccination), the patient experienced a huge knot on his left arm and it has remained the same. It was hard as a rock. The patent has been having a lot of side effects since the vaccine and one is brain fog which began around 18May2021 at the latest after the first dose of the vaccine and was ongoing and continues to get worse. He has an appointment with a neuropsychologist to undergo testing to see what was going on. He has a lot of digestive issues and was undergoing tests. The digestive issues also began around the same time as the brain fog and was ongoing and worst. Treatment for event digestive issues included taking Linzess 150mg once per day by mouth since 24Sep2021. The outcome of events huge knot on his left arm, brain fog and digestive issues was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101314920 Same patient/reporter; different dose/AE
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspepsia, Feeling abnormal, Vaccination site induration
Clinical narrative: Brain fog; Digestive issues; Huge knot on his left arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the first vaccine dose.   A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in the left arm on 03May2021 at 10:00am (Batch/Lot Number: EW0176, at age 41-years-old at vaccination) as a single dose for COVID-19 immunisation at a pharmacy/drug store. Medical history and concomitant medications were not reported. The patient had no prior vaccinations (within 4 weeks) of the BNT162B2 vaccine. On 03May2021, the patient received the first dose of the BNT162B2 vaccine. On an unspecified date in May2021 (after the first vaccination), the patient experienced a huge knot on his left arm and it has remained the same. It was hard as a rock. The patent has been having a lot of side effects since the vaccine and one is brain fog which began around 18May2021 at the latest after the first dose of the vaccine and was ongoing and continues to get worse. He has an appointment with a neuropsychologist to undergo testing to see what was going on. He has a lot of digestive issues and was undergoing tests. The digestive issues also began around the same time as the brain fog and was ongoing and worst. Treatment for event digestive issues included taking Linzess 150mg once per day by mouth since 24Sep2021. The outcome of events huge knot on his left arm, brain fog and digestive issues was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101314920 Same patient/reporter; different dose/AE
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Migraine, Polymerase chain reaction
Clinical narrative: All over body itching with 2 minutes of vaccine.; All over body rash 2 weeks after vaccine requiring prednisone; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 11Mar2021 at 09:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, essential tremors, allergy (unspecified) and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included clonazepam (CLONAPIN) for unknown indication on unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 09:00, the patient experienced all over body itching with 2 minutes of vaccine. On an unknown date in Mar2021, the patient also experienced all over body rash 2 weeks after vaccine requiring prednisone (MANUFACTURER UNKNOWN). Therapeutic measures were taken as a result of events and included treatment with prednisone (MANUFACTURER UNKNOWN), diphenhydramine hydrochloride (BENADRYL) and monitoring. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events all over body itching with 2 minutes of vaccine; all over body rash 2 weeks after vaccine was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: All over body itching with 2 minutes of vaccine.; All over body rash 2 weeks after vaccine requiring prednisone; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 11Mar2021 at 09:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, essential tremors, allergy (unspecified) and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included clonazepam (CLONAPIN) for unknown indication on unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 09:00, the patient experienced all over body itching with 2 minutes of vaccine. On an unknown date in Mar2021, the patient also experienced all over body rash 2 weeks after vaccine requiring prednisone (MANUFACTURER UNKNOWN). Therapeutic measures were taken as a result of events and included treatment with prednisone (MANUFACTURER UNKNOWN), diphenhydramine hydrochloride (BENADRYL) and monitoring. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events all over body itching with 2 minutes of vaccine; all over body rash 2 weeks after vaccine was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arrhythmia, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Blood electrolytes normal, Blood pressure increased
Clinical narrative: 16 year old male presented with chest pain. Found to have elevated troponins, EKG changes, and clinical diagnosis of myocarditis. I was asked by the physician taking care of this patient to fill out this form.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Echocardiogram abnormal, Ejection fraction, Electrocardiogram ST segment elevation
Clinical narrative: 16 year old male presented with chest pain. Found to have elevated troponins, EKG changes, and clinical diagnosis of myocarditis. I was asked by the physician taking care of this patient to fill out this form.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count normal, Inflammatory marker test, Intensive care, Laboratory test normal, Liver function test increased
Clinical narrative: 16 year old male presented with chest pain. Found to have elevated troponins, EKG changes, and clinical diagnosis of myocarditis. I was asked by the physician taking care of this patient to fill out this form.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Pericarditis, Red blood cell sedimentation rate increased, Troponin increased, Ventricular hypokinesia
Clinical narrative: 16 year old male presented with chest pain. Found to have elevated troponins, EKG changes, and clinical diagnosis of myocarditis. I was asked by the physician taking care of this patient to fill out this form.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Myocarditis, Troponin increased
Clinical narrative: 16 year old male presented with chest pain. Found to have elevated troponins, EKG changes, and clinical diagnosis of myocarditis. I was asked by the physician taking care of this patient to fill out this form.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Blood electrolytes normal, Blood pressure increased, C-reactive protein increased
Clinical narrative: 16 year old male presented with chest pain. Found to have elevated troponins, EKG changes, and clinical diagnosis of myocarditis. I was asked by the physician taking care of this patient to fill out this form.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Diastolic dysfunction, Echocardiogram normal, Ejection fraction, Ejection fraction normal
Clinical narrative: 16 year old male presented with chest pain. Found to have elevated troponins, EKG changes, and clinical diagnosis of myocarditis. I was asked by the physician taking care of this patient to fill out this form.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Full blood count normal, Intensive care, Liver function test increased, Magnetic resonance imaging abnormal
Clinical narrative: 16 year old male presented with chest pain. Found to have elevated troponins, EKG changes, and clinical diagnosis of myocarditis. I was asked by the physician taking care of this patient to fill out this form.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Myocardial fibrosis, Myocarditis, Troponin I, Ventricular hypokinesia
Clinical narrative: 16 year old male presented with chest pain. Found to have elevated troponins, EKG changes, and clinical diagnosis of myocarditis. I was asked by the physician taking care of this patient to fill out this form.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Influenza like illness, Injection site pain, Vitreous floaters
Clinical narrative: Aching joints, fatigue, and eye floaters
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Vitreous floaters
Clinical narrative: Aching joints, fatigue, and eye floaters
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Areflexia, Blood test, C-reactive protein, CSF protein increased
Clinical narrative: Weakness in all 4 limbs the next day; Tingling and numbness in hand and feet on injection day; numbness in hand and feet on injection day with numbness in hand feet teeth legs arms; Spastic leg movements; This is a spontaneous report from a contactable consumer (patient). This 46-year-old male patient received bnt162b2 (brand: Pfizer), dose 2 via an unspecified route of administration, administered in arm left on 12Oct2021 12:45 (Batch/Lot Number: FH8070) as dose 2, single at the age of 46-year-old for covid-19 immunisation. Dose 1 was received on 22Sep2021, 12:15 PM (lot number: FFEE39) administered in arm left at the age of 46-year-old for covid-19 immunisation. Medical history was none. No known allergies. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient experienced tingling and numbness in hand and feet on injection day on 12Oct2021 16:00, numbness in hand and feet on injection day with numbness in hand feet teeth legs arms on 12Oct2021 16:00, spastic leg movements on 12Oct2021 16:00, weakness in all 4 limbs the next day on 13Oct2021. Adverse event reported as tingling and numbness in hand and feet on injection day (12Oct2021 16:00) with numbness in hand feet teeth legs arms and spastic leg movements and weakness in all 4 limbs the next day (13Oct2021) with no improvement 48 hours after the injection. Event resulted in emergency room/department or urgent care, hospitalization (from Oct2021), life threatening illness (immediate risk of death from the event), disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19: Covid test type post vaccination on 15Oct2021: Negative (Nasal Swab). Treatment included IVIG (Immunoglobulin). Serious due to life threatening, caused/prolonged hospitalization, disabling/incapacitating. The outcome of event weakness in all 4 limbs was not recovered. The outcome of other event was recovering.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: CSF white blood cell count decreased, Computerised tomogram head, Differential white blood cell count, Eye pain, Full blood count
Clinical narrative: Weakness in all 4 limbs the next day; Tingling and numbness in hand and feet on injection day; numbness in hand and feet on injection day with numbness in hand feet teeth legs arms; Spastic leg movements; This is a spontaneous report from a contactable consumer (patient). This 46-year-old male patient received bnt162b2 (brand: Pfizer), dose 2 via an unspecified route of administration, administered in arm left on 12Oct2021 12:45 (Batch/Lot Number: FH8070) as dose 2, single at the age of 46-year-old for covid-19 immunisation. Dose 1 was received on 22Sep2021, 12:15 PM (lot number: FFEE39) administered in arm left at the age of 46-year-old for covid-19 immunisation. Medical history was none. No known allergies. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient experienced tingling and numbness in hand and feet on injection day on 12Oct2021 16:00, numbness in hand and feet on injection day with numbness in hand feet teeth legs arms on 12Oct2021 16:00, spastic leg movements on 12Oct2021 16:00, weakness in all 4 limbs the next day on 13Oct2021. Adverse event reported as tingling and numbness in hand and feet on injection day (12Oct2021 16:00) with numbness in hand feet teeth legs arms and spastic leg movements and weakness in all 4 limbs the next day (13Oct2021) with no improvement 48 hours after the injection. Event resulted in emergency room/department or urgent care, hospitalization (from Oct2021), life threatening illness (immediate risk of death from the event), disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19: Covid test type post vaccination on 15Oct2021: Negative (Nasal Swab). Treatment included IVIG (Immunoglobulin). Serious due to life threatening, caused/prolonged hospitalization, disabling/incapacitating. The outcome of event weakness in all 4 limbs was not recovered. The outcome of other event was recovering.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia teeth, Intensive care
Clinical narrative: Weakness in all 4 limbs the next day; Tingling and numbness in hand and feet on injection day; numbness in hand and feet on injection day with numbness in hand feet teeth legs arms; Spastic leg movements; This is a spontaneous report from a contactable consumer (patient). This 46-year-old male patient received bnt162b2 (brand: Pfizer), dose 2 via an unspecified route of administration, administered in arm left on 12Oct2021 12:45 (Batch/Lot Number: FH8070) as dose 2, single at the age of 46-year-old for covid-19 immunisation. Dose 1 was received on 22Sep2021, 12:15 PM (lot number: FFEE39) administered in arm left at the age of 46-year-old for covid-19 immunisation. Medical history was none. No known allergies. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient experienced tingling and numbness in hand and feet on injection day on 12Oct2021 16:00, numbness in hand and feet on injection day with numbness in hand feet teeth legs arms on 12Oct2021 16:00, spastic leg movements on 12Oct2021 16:00, weakness in all 4 limbs the next day on 13Oct2021. Adverse event reported as tingling and numbness in hand and feet on injection day (12Oct2021 16:00) with numbness in hand feet teeth legs arms and spastic leg movements and weakness in all 4 limbs the next day (13Oct2021) with no improvement 48 hours after the injection. Event resulted in emergency room/department or urgent care, hospitalization (from Oct2021), life threatening illness (immediate risk of death from the event), disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19: Covid test type post vaccination on 15Oct2021: Negative (Nasal Swab). Treatment included IVIG (Immunoglobulin). Serious due to life threatening, caused/prolonged hospitalization, disabling/incapacitating. The outcome of event weakness in all 4 limbs was not recovered. The outcome of other event was recovering.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture abnormal, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test, Muscular weakness
Clinical narrative: Weakness in all 4 limbs the next day; Tingling and numbness in hand and feet on injection day; numbness in hand and feet on injection day with numbness in hand feet teeth legs arms; Spastic leg movements; This is a spontaneous report from a contactable consumer (patient). This 46-year-old male patient received bnt162b2 (brand: Pfizer), dose 2 via an unspecified route of administration, administered in arm left on 12Oct2021 12:45 (Batch/Lot Number: FH8070) as dose 2, single at the age of 46-year-old for covid-19 immunisation. Dose 1 was received on 22Sep2021, 12:15 PM (lot number: FFEE39) administered in arm left at the age of 46-year-old for covid-19 immunisation. Medical history was none. No known allergies. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient experienced tingling and numbness in hand and feet on injection day on 12Oct2021 16:00, numbness in hand and feet on injection day with numbness in hand feet teeth legs arms on 12Oct2021 16:00, spastic leg movements on 12Oct2021 16:00, weakness in all 4 limbs the next day on 13Oct2021. Adverse event reported as tingling and numbness in hand and feet on injection day (12Oct2021 16:00) with numbness in hand feet teeth legs arms and spastic leg movements and weakness in all 4 limbs the next day (13Oct2021) with no improvement 48 hours after the injection. Event resulted in emergency room/department or urgent care, hospitalization (from Oct2021), life threatening illness (immediate risk of death from the event), disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19: Covid test type post vaccination on 15Oct2021: Negative (Nasal Swab). Treatment included IVIG (Immunoglobulin). Serious due to life threatening, caused/prolonged hospitalization, disabling/incapacitating. The outcome of event weakness in all 4 limbs was not recovered. The outcome of other event was recovering.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Red blood cell sedimentation rate, SARS-CoV-2 test negative, Venogram
Clinical narrative: Weakness in all 4 limbs the next day; Tingling and numbness in hand and feet on injection day; numbness in hand and feet on injection day with numbness in hand feet teeth legs arms; Spastic leg movements; This is a spontaneous report from a contactable consumer (patient). This 46-year-old male patient received bnt162b2 (brand: Pfizer), dose 2 via an unspecified route of administration, administered in arm left on 12Oct2021 12:45 (Batch/Lot Number: FH8070) as dose 2, single at the age of 46-year-old for covid-19 immunisation. Dose 1 was received on 22Sep2021, 12:15 PM (lot number: FFEE39) administered in arm left at the age of 46-year-old for covid-19 immunisation. Medical history was none. No known allergies. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient experienced tingling and numbness in hand and feet on injection day on 12Oct2021 16:00, numbness in hand and feet on injection day with numbness in hand feet teeth legs arms on 12Oct2021 16:00, spastic leg movements on 12Oct2021 16:00, weakness in all 4 limbs the next day on 13Oct2021. Adverse event reported as tingling and numbness in hand and feet on injection day (12Oct2021 16:00) with numbness in hand feet teeth legs arms and spastic leg movements and weakness in all 4 limbs the next day (13Oct2021) with no improvement 48 hours after the injection. Event resulted in emergency room/department or urgent care, hospitalization (from Oct2021), life threatening illness (immediate risk of death from the event), disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19: Covid test type post vaccination on 15Oct2021: Negative (Nasal Swab). Treatment included IVIG (Immunoglobulin). Serious due to life threatening, caused/prolonged hospitalization, disabling/incapacitating. The outcome of event weakness in all 4 limbs was not recovered. The outcome of other event was recovering.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Muscle spasticity, Muscular weakness, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Weakness in all 4 limbs the next day; Tingling and numbness in hand and feet on injection day; numbness in hand and feet on injection day with numbness in hand feet teeth legs arms; Spastic leg movements; This is a spontaneous report from a contactable consumer (patient). This 46-year-old male patient received bnt162b2 (brand: Pfizer), dose 2 via an unspecified route of administration, administered in arm left on 12Oct2021 12:45 (Batch/Lot Number: FH8070) as dose 2, single at the age of 46-year-old for covid-19 immunisation. Dose 1 was received on 22Sep2021, 12:15 PM (lot number: FFEE39) administered in arm left at the age of 46-year-old for covid-19 immunisation. Medical history was none. No known allergies. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient experienced tingling and numbness in hand and feet on injection day on 12Oct2021 16:00, numbness in hand and feet on injection day with numbness in hand feet teeth legs arms on 12Oct2021 16:00, spastic leg movements on 12Oct2021 16:00, weakness in all 4 limbs the next day on 13Oct2021. Adverse event reported as tingling and numbness in hand and feet on injection day (12Oct2021 16:00) with numbness in hand feet teeth legs arms and spastic leg movements and weakness in all 4 limbs the next day (13Oct2021) with no improvement 48 hours after the injection. Event resulted in emergency room/department or urgent care, hospitalization (from Oct2021), life threatening illness (immediate risk of death from the event), disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19: Covid test type post vaccination on 15Oct2021: Negative (Nasal Swab). Treatment included IVIG (Immunoglobulin). Serious due to life threatening, caused/prolonged hospitalization, disabling/incapacitating. The outcome of event weakness in all 4 limbs was not recovered. The outcome of other event was recovering.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: ADMINISTRATION OF VACCINE TO 13 YEAR OLD PATIENT BY MISTAKE; This spontaneous report received from a pharmacist concerned a 13 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-OCT-2021, the patient experienced administration of vaccine to 13 year old patient by mistake. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine to 13 year old patient by mistake was not reported. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test abnormal, Chest X-ray abnormal, Chest pain, Computerised tomogram thorax abnormal, Pulmonary embolism
Clinical narrative: I received my second vaccine on 9-14-21 and started having chest pains two days later, on 9-16-21. I went into Hospital and was diagnosed with a pulmonary embolism. Bloodwork, X-ray, ultrasound and a CT scan was used to confirm the diagnosis.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan abnormal
Clinical narrative: I received my second vaccine on 9-14-21 and started having chest pains two days later, on 9-16-21. I went into Hospital and was diagnosed with a pulmonary embolism. Bloodwork, X-ray, ultrasound and a CT scan was used to confirm the diagnosis.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram normal, Confusional state, Disorientation, Electrocardiogram normal
Clinical narrative: Mental confusion and disorientation. Inability to discern if I was saying things or only thinking them. Symptoms started at 6 PM on 10/16. I went to the ER, where I was given a CT scan, EKG, blood work, etc. Was admitted to Hospital at 4 AM on 10/17 and discharged at 4 PM on 10/17 with a diagnosis of "transient global amnesia."
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Transient global amnesia, Ultrasound Doppler
Clinical narrative: Mental confusion and disorientation. Inability to discern if I was saying things or only thinking them. Symptoms started at 6 PM on 10/16. I went to the ER, where I was given a CT scan, EKG, blood work, etc. Was admitted to Hospital at 4 AM on 10/17 and discharged at 4 PM on 10/17 with a diagnosis of "transient global amnesia."
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eczema, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: 12 month vaccines given 10/19/2021. Parent called 10/22/21 due to concerns with a rash and low grade  fever 100.4  to torso 10/19/21 after vaccines. no swelling at injection site, rash did not appear painful or itchy. maculopapular  rash to torso. scattered dry patches (history of eczema) supportive care given and to monitor for worsening signs or symptoms
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Erythema multiforme, Pruritus, Rash
Clinical narrative: 09.10.2021: Mosquito bite-like bumps appeared on my feet, legs and elbows. The bumps were very itchy and kept me up at night.  09.23.2021: By this time, the bumps turned into big red welts - red circular rims surrounding each bump and about a 1/4 of an inch out from each bump. 09.24.2021: Went to an immediate care and the doctor thought it was bad bug bites or an allergic reaction to bug bites. I was prescribed topical steroid ointment and an antihistamine.  I was given the option for a prednisone fast pack, which I did not want to take. 09.30.2021: There still was no major improvement on the rashes with the topical steroid and they were actually getting darker red, so I went to a dermatologist and was diagnosed with Erythema Multiforme.  After being diagnosed, the bumps slowly faded and turned into dry skin. I still have bumps and they still itch from time to time, but nothing how it was between 9.10 and 9.30. Because I still see the rash and it still itches, putting that this is not completely recovered yet.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Urticaria
Clinical narrative: 09.10.2021: Mosquito bite-like bumps appeared on my feet, legs and elbows. The bumps were very itchy and kept me up at night.  09.23.2021: By this time, the bumps turned into big red welts - red circular rims surrounding each bump and about a 1/4 of an inch out from each bump. 09.24.2021: Went to an immediate care and the doctor thought it was bad bug bites or an allergic reaction to bug bites. I was prescribed topical steroid ointment and an antihistamine.  I was given the option for a prednisone fast pack, which I did not want to take. 09.30.2021: There still was no major improvement on the rashes with the topical steroid and they were actually getting darker red, so I went to a dermatologist and was diagnosed with Erythema Multiforme.  After being diagnosed, the bumps slowly faded and turned into dry skin. I still have bumps and they still itch from time to time, but nothing how it was between 9.10 and 9.30. Because I still see the rash and it still itches, putting that this is not completely recovered yet.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Skin warm
Clinical narrative: Rash from neck to thighs. Symmetrical rash.  Extreme redness, itching, skin warm to touch.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chills, Dizziness, Dyspnoea
Clinical narrative: ~8 hours after injection, and for the next 2 days: -Severe chills (fever of 103 degrees) -Severe shortness of breath -Racing heart (140 bpm) and High Blood Pressure -Body Aches -Blurry vision in both eyes -Nausea/vertigo/dizziness/headache  Most of the symptoms dissipated after a few days, but the shortness of breath and vision issues persisted for about a month.  After about a month's time, the vision issues went away, but the shortness of breath continues to this day.  I've been to the ER twice for the shortness of breath, and have been tested for C-19 SEVERAL times since the shot, all of which have been negative.  My primary care Doc prescribed me a rescue inhaler to help with the breathing difficulty, which only slightly helps.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Headache, Heart rate increased, Hypertension, Nausea
Clinical narrative: ~8 hours after injection, and for the next 2 days: -Severe chills (fever of 103 degrees) -Severe shortness of breath -Racing heart (140 bpm) and High Blood Pressure -Body Aches -Blurry vision in both eyes -Nausea/vertigo/dizziness/headache  Most of the symptoms dissipated after a few days, but the shortness of breath and vision issues persisted for about a month.  After about a month's time, the vision issues went away, but the shortness of breath continues to this day.  I've been to the ER twice for the shortness of breath, and have been tested for C-19 SEVERAL times since the shot, all of which have been negative.  My primary care Doc prescribed me a rescue inhaler to help with the breathing difficulty, which only slightly helps.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Nucleic acid test, Pain, Palpitations, Pyrexia, Urine analysis normal
Clinical narrative: ~8 hours after injection, and for the next 2 days: -Severe chills (fever of 103 degrees) -Severe shortness of breath -Racing heart (140 bpm) and High Blood Pressure -Body Aches -Blurry vision in both eyes -Nausea/vertigo/dizziness/headache  Most of the symptoms dissipated after a few days, but the shortness of breath and vision issues persisted for about a month.  After about a month's time, the vision issues went away, but the shortness of breath continues to this day.  I've been to the ER twice for the shortness of breath, and have been tested for C-19 SEVERAL times since the shot, all of which have been negative.  My primary care Doc prescribed me a rescue inhaler to help with the breathing difficulty, which only slightly helps.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vision blurred
Clinical narrative: ~8 hours after injection, and for the next 2 days: -Severe chills (fever of 103 degrees) -Severe shortness of breath -Racing heart (140 bpm) and High Blood Pressure -Body Aches -Blurry vision in both eyes -Nausea/vertigo/dizziness/headache  Most of the symptoms dissipated after a few days, but the shortness of breath and vision issues persisted for about a month.  After about a month's time, the vision issues went away, but the shortness of breath continues to this day.  I've been to the ER twice for the shortness of breath, and have been tested for C-19 SEVERAL times since the shot, all of which have been negative.  My primary care Doc prescribed me a rescue inhaler to help with the breathing difficulty, which only slightly helps.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Throat irritation
Clinical narrative: Rash, red hit, itchy to right back, itchy throat and face
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Eye pain, Headache
Clinical narrative: Worse headache ever, clogged ears, terrible eye pain
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Cerebrovascular accident, Computerised tomogram, Eyelid ptosis
Clinical narrative: Bell's Palsy: Symptoms were those of a cerebral stroke affecting the right side of my face - intermittent face, head and jaw pain, drooping right eyelid and eyebrow.  Had X-ray, cat scan, blood work in E.R. on April 4, 2021. E.R. physician settled on Bell's Palsy after eliminating other possible diagnoses. Prescribed Deltasone (prednisone) 10mg sequence for 7 days (180mg total) and Valacyclovir 500mg sequence for 7 days (21,000mg total). May have laso received medication for Lyme disease.  Within about 8 days the symptom were greatly diminished to the point of not needing any additional treatment. Mild headaches/jaw aches occurred infrequently for about three weeks that seemed to  be related to the Palsy.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Headache, Pain in jaw, X-ray
Clinical narrative: Bell's Palsy: Symptoms were those of a cerebral stroke affecting the right side of my face - intermittent face, head and jaw pain, drooping right eyelid and eyebrow.  Had X-ray, cat scan, blood work in E.R. on April 4, 2021. E.R. physician settled on Bell's Palsy after eliminating other possible diagnoses. Prescribed Deltasone (prednisone) 10mg sequence for 7 days (180mg total) and Valacyclovir 500mg sequence for 7 days (21,000mg total). May have laso received medication for Lyme disease.  Within about 8 days the symptom were greatly diminished to the point of not needing any additional treatment. Mild headaches/jaw aches occurred infrequently for about three weeks that seemed to  be related to the Palsy.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Condition aggravated, Full blood count, Metabolic function test, Migraine
Clinical narrative: SEVERE, INTRACTABLE MIGRAINE 19 + HOURS.  I HAVE A HISTORY OF MIGRAINES SINCE THE AGE OF 12.  I HAVE NEVER HAD A MIGRAINE WITH ANY OTHER VACCINE AND IT HAS NEVER BEEN TO THIS SEVERITY OR LAST THIS AMOUNT OF TIME WITH NO BREAK OR RELIEF.  I ATTEMPTED TO ALEVIATE THE PAIN WITH MAXALT, TYLENOL, AND ICE PACKS WITH NO RELIEF.  THE HOSPITAL GAVE ME 2 LITERS OF FLUID, BENADRYL, REGLAN, AND TORADOL WHICH  LESSENED THE PAIN.  AT THIS TIME I STILL HAVE A MINOR MIGRAINE.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: SEVERE, INTRACTABLE MIGRAINE 19 + HOURS.  I HAVE A HISTORY OF MIGRAINES SINCE THE AGE OF 12.  I HAVE NEVER HAD A MIGRAINE WITH ANY OTHER VACCINE AND IT HAS NEVER BEEN TO THIS SEVERITY OR LAST THIS AMOUNT OF TIME WITH NO BREAK OR RELIEF.  I ATTEMPTED TO ALEVIATE THE PAIN WITH MAXALT, TYLENOL, AND ICE PACKS WITH NO RELIEF.  THE HOSPITAL GAVE ME 2 LITERS OF FLUID, BENADRYL, REGLAN, AND TORADOL WHICH  LESSENED THE PAIN.  AT THIS TIME I STILL HAVE A MINOR MIGRAINE.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Soreness, redness, or swelling where the shot is given, muscle or joint pain in left shoulder. Injection site is warm to the touch.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Myalgia
Clinical narrative: Soreness, redness, or swelling where the shot is given, muscle or joint pain in left shoulder. Injection site is warm to the touch.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Fatigue, Headache, Intermenstrual bleeding, Muscle spasms
Clinical narrative: I was 1.5 years into menopause and started having tender breasts, tired, headache, cramps. I recognized that feeling all to well. Cramps started coming on stronger and then I started spotting and went into a full typical for what I used to have. And as I stated before I was almost one and a half years without having a period and had a hormonal test done and that had shown by my hormone levels that I was in fact post menopausal. It's been 21 days since that happened and I have started having the same symptoms again.  My last moderna shot was in May of 2021.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Tenderness
Clinical narrative: Sore, painful site under left arm (in arm pit), tender spot even when not being touched. Slight sore spot under right armpit, but only painful when pressed.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Migraine, Nausea, Vomiting
Clinical narrative: Body chills and shortness of breath @2100 on 10/21 Nausea and vomiting @ 2200 on 10/21 100.5 F temperature @ 2300 on 10/21 102.1 F temperature and migraine @ 1700 on 10/22
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest X-ray, Chest discomfort, Chest pain, Chills
Clinical narrative: fever, chills, body aches, shortness of breath, chest pain, cough, headache, dizzy, pelvic pain, weak and tired everyday.  Seen in  ED twice in October, 10 Doctor visits in the last 25 days. Still experiencing shortness of breath, chest pressure, weakness, dizzy spells. Given prednisone, rescue inhaler, z-pak, steroid inhaler, cough syrup. No  relief as of 10/22.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Laboratory test
Clinical narrative: fever, chills, body aches, shortness of breath, chest pain, cough, headache, dizzy, pelvic pain, weak and tired everyday.  Seen in  ED twice in October, 10 Doctor visits in the last 25 days. Still experiencing shortness of breath, chest pressure, weakness, dizzy spells. Given prednisone, rescue inhaler, z-pak, steroid inhaler, cough syrup. No  relief as of 10/22.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pelvic pain, Pyrexia
Clinical narrative: fever, chills, body aches, shortness of breath, chest pain, cough, headache, dizzy, pelvic pain, weak and tired everyday.  Seen in  ED twice in October, 10 Doctor visits in the last 25 days. Still experiencing shortness of breath, chest pressure, weakness, dizzy spells. Given prednisone, rescue inhaler, z-pak, steroid inhaler, cough syrup. No  relief as of 10/22.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dysphagia, Fatigue, Headache
Clinical narrative: on Sept 26, felt I was getting a cold - sore throat and congestion, fatigue. Gradually got better, then on October 8th, had a very sore throat in the back of my throat (hurt to swallow food), and soreness under my jaw on the right side, body aches, a slight headache, chills, and fatigue. This lasted about 2 days. Called doctor on Oct 11th and he said that I should rest and stay home, but he didn't think it was anything serious. After the sore throat and other symptoms got better, the congestion and congested cough seemed to come back worse than before. I'm mostly over it, but still have a little cough and congestion. (as of 10-23)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain, Pain in jaw, Respiratory tract congestion
Clinical narrative: on Sept 26, felt I was getting a cold - sore throat and congestion, fatigue. Gradually got better, then on October 8th, had a very sore throat in the back of my throat (hurt to swallow food), and soreness under my jaw on the right side, body aches, a slight headache, chills, and fatigue. This lasted about 2 days. Called doctor on Oct 11th and he said that I should rest and stay home, but he didn't think it was anything serious. After the sore throat and other symptoms got better, the congestion and congested cough seemed to come back worse than before. I'm mostly over it, but still have a little cough and congestion. (as of 10-23)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Seasonal affective disorder
Clinical narrative: on Sept 26, felt I was getting a cold - sore throat and congestion, fatigue. Gradually got better, then on October 8th, had a very sore throat in the back of my throat (hurt to swallow food), and soreness under my jaw on the right side, body aches, a slight headache, chills, and fatigue. This lasted about 2 days. Called doctor on Oct 11th and he said that I should rest and stay home, but he didn't think it was anything serious. After the sore throat and other symptoms got better, the congestion and congested cough seemed to come back worse than before. I'm mostly over it, but still have a little cough and congestion. (as of 10-23)
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blood glucose increased, Computerised tomogram head, Full blood count normal, Laboratory test normal
Clinical narrative: Bell's palsy developed on R face PM 10/22.  No additional neurologic findings on exam.  No additional abnormal physical findings.   Patient placed on Valtrex and prednisone for 7 days.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Pain, Pyrexia
Clinical narrative: Fever, chills, body ache, hand and feet numbness
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Incorrect dose administered, Pyrexia
Clinical narrative: Sweats fever Was given 0.5 ml dose instead of 0.25 ml