chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle tightness, Nausea, Neurological examination normal, Paraesthesia, Pyrexia
Clinical narrative: loss of speech; elevated blood pressure; paralysis (hemiplegia) of the right side of my body; full body weakness; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0170) via an unspecified route of administration, in left arm on 17Apr2021 15:00 (at the age of 42-years-old) as 1st dose, single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Device date reported 09Jun2021. Medical history was not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. Known allergies were reported guava's, latex, covid-19 vaccine (MRNA, Bnt162b2, Lnp-S), diphenhydramine, ketorolac, prochlorperazine. Concomitant medications included cetirizine and hydroxyzine both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any vaccines within four weeks prior to the vaccination. On 17Apr2021 15:15, the patient experienced extreme and debilitating symptoms including paralysis (hemiplegia) of the right side of his body, full body weakness, loss of speech and elevated blood pressure that have been present and persisting since immediately following his first dose. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability, or permanent damage. 08 days of hospitalisation were reported. Treatment received for the adverse event was blood pressure medications and PT. The patient underwent lab tests and procedures which included Covid-19 RNA, qualitative (M2000) nasal swab, negative on 18Apr2021, POCT COVID-19 RNA, Qualitative, nasal swab negative on 18Apr2021, COVID19 RNA, QUALITATIVE(M2000), nasal swab negative on 22Apr2021 and POCT COVID-19 RNA, Qualitative, nasal swab negative on 15May2021.The outcome of events was Not recovered .  Information on Lot/Batch number was available. Additional information has been requested
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rash macular, Rash pruritic, Scan abnormal
Clinical narrative: loss of speech; elevated blood pressure; paralysis (hemiplegia) of the right side of my body; full body weakness; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0170) via an unspecified route of administration, in left arm on 17Apr2021 15:00 (at the age of 42-years-old) as 1st dose, single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Device date reported 09Jun2021. Medical history was not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. Known allergies were reported guava's, latex, covid-19 vaccine (MRNA, Bnt162b2, Lnp-S), diphenhydramine, ketorolac, prochlorperazine. Concomitant medications included cetirizine and hydroxyzine both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any vaccines within four weeks prior to the vaccination. On 17Apr2021 15:15, the patient experienced extreme and debilitating symptoms including paralysis (hemiplegia) of the right side of his body, full body weakness, loss of speech and elevated blood pressure that have been present and persisting since immediately following his first dose. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability, or permanent damage. 08 days of hospitalisation were reported. Treatment received for the adverse event was blood pressure medications and PT. The patient underwent lab tests and procedures which included Covid-19 RNA, qualitative (M2000) nasal swab, negative on 18Apr2021, POCT COVID-19 RNA, Qualitative, nasal swab negative on 18Apr2021, COVID19 RNA, QUALITATIVE(M2000), nasal swab negative on 22Apr2021 and POCT COVID-19 RNA, Qualitative, nasal swab negative on 15May2021.The outcome of events was Not recovered .  Information on Lot/Batch number was available. Additional information has been requested
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure, Sensory loss, Skin burning sensation, Skin discolouration, Speech disorder
Clinical narrative: loss of speech; elevated blood pressure; paralysis (hemiplegia) of the right side of my body; full body weakness; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0170) via an unspecified route of administration, in left arm on 17Apr2021 15:00 (at the age of 42-years-old) as 1st dose, single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Device date reported 09Jun2021. Medical history was not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. Known allergies were reported guava's, latex, covid-19 vaccine (MRNA, Bnt162b2, Lnp-S), diphenhydramine, ketorolac, prochlorperazine. Concomitant medications included cetirizine and hydroxyzine both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any vaccines within four weeks prior to the vaccination. On 17Apr2021 15:15, the patient experienced extreme and debilitating symptoms including paralysis (hemiplegia) of the right side of his body, full body weakness, loss of speech and elevated blood pressure that have been present and persisting since immediately following his first dose. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability, or permanent damage. 08 days of hospitalisation were reported. Treatment received for the adverse event was blood pressure medications and PT. The patient underwent lab tests and procedures which included Covid-19 RNA, qualitative (M2000) nasal swab, negative on 18Apr2021, POCT COVID-19 RNA, Qualitative, nasal swab negative on 18Apr2021, COVID19 RNA, QUALITATIVE(M2000), nasal swab negative on 22Apr2021 and POCT COVID-19 RNA, Qualitative, nasal swab negative on 15May2021.The outcome of events was Not recovered .  Information on Lot/Batch number was available. Additional information has been requested
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: loss of speech; elevated blood pressure; paralysis (hemiplegia) of the right side of my body; full body weakness; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0170) via an unspecified route of administration, in left arm on 17Apr2021 15:00 (at the age of 42-years-old) as 1st dose, single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Device date reported 09Jun2021. Medical history was not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. Known allergies were reported guava's, latex, covid-19 vaccine (MRNA, Bnt162b2, Lnp-S), diphenhydramine, ketorolac, prochlorperazine. Concomitant medications included cetirizine and hydroxyzine both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any vaccines within four weeks prior to the vaccination. On 17Apr2021 15:15, the patient experienced extreme and debilitating symptoms including paralysis (hemiplegia) of the right side of his body, full body weakness, loss of speech and elevated blood pressure that have been present and persisting since immediately following his first dose. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability, or permanent damage. 08 days of hospitalisation were reported. Treatment received for the adverse event was blood pressure medications and PT. The patient underwent lab tests and procedures which included Covid-19 RNA, qualitative (M2000) nasal swab, negative on 18Apr2021, POCT COVID-19 RNA, Qualitative, nasal swab negative on 18Apr2021, COVID19 RNA, QUALITATIVE(M2000), nasal swab negative on 22Apr2021 and POCT COVID-19 RNA, Qualitative, nasal swab negative on 15May2021.The outcome of events was Not recovered .  Information on Lot/Batch number was available. Additional information has been requested
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Asthenia, Blood pressure increased, Hemiplegia, SARS-CoV-2 test negative
Clinical narrative: loss of speech; elevated blood pressure; paralysis (hemiplegia) of the right side of my body; full body weakness; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0170) via an unspecified route of administration, in left arm on 17Apr2021 15:00 (at the age of 42-years-old) as 1st dose, single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Device date reported 09Jun2021. Medical history was not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. Known allergies were reported guava's, latex, covid-19 vaccine (MRNA, Bnt162b2, Lnp-S), diphenhydramine, ketorolac, prochlorperazine. Concomitant medications included cetirizine and hydroxyzine both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any vaccines within four weeks prior to the vaccination. On 17Apr2021 15:15, the patient experienced extreme and debilitating symptoms including paralysis (hemiplegia) of the right side of his body, full body weakness, loss of speech and elevated blood pressure that have been present and persisting since immediately following his first dose. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability, or permanent damage. 08 days of hospitalisation were reported. Treatment received for the adverse event was blood pressure medications and PT. The patient underwent lab tests and procedures which included Covid-19 RNA, qualitative (M2000) nasal swab, negative on 18Apr2021, POCT COVID-19 RNA, Qualitative, nasal swab negative on 18Apr2021, COVID19 RNA, QUALITATIVE(M2000), nasal swab negative on 22Apr2021 and POCT COVID-19 RNA, Qualitative, nasal swab negative on 15May2021.The outcome of events was Not recovered .  Information on Lot/Batch number was available. Additional information has been requested
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Herpes zoster, Herpes zoster oticus
Clinical narrative: I developed a shingles outbreak in my ear which then led to Ramsay Hunt syndrome and facial paralysis. I cannot move half of my face anymore. This is also an extremely rare condition for a healthy 20; This is a spontaneous report received from a contactable consumer (patient). A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 15:00 (Lot Number: EW0172) (at age of 20-year-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient took the first dose of vaccine on 16Apr2021 02:30PM (Lot number: EW0170) (at age of 20-year-old) on Left Arm for covid-19 immunization. Pregnant at the time of vaccination was no. None known allergies. None medical history. The patient's concomitant medications was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed a shingles outbreak in ear which then led to ramsay hunt syndrome and facial paralysis. She cannot move half of her face anymore. This is also an extremely rare condition for a healthy 20 year old girl. The events onset date and outcome was reported as 17May2021 05:00 and recovering. Adverse events result in emergency room/department or urgent care/Doctor or other health care professional office. Treatment was yes. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster oticus
Clinical narrative: I developed a shingles outbreak in my ear which then led to Ramsay Hunt syndrome and facial paralysis. I cannot move half of my face anymore. This is also an extremely rare condition for a healthy 20; This is a spontaneous report received from a contactable consumer (patient). A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 15:00 (Lot Number: EW0172) (at age of 20-year-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient took the first dose of vaccine on 16Apr2021 02:30PM (Lot number: EW0170) (at age of 20-year-old) on Left Arm for covid-19 immunization. Pregnant at the time of vaccination was no. None known allergies. None medical history. The patient's concomitant medications was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed a shingles outbreak in ear which then led to ramsay hunt syndrome and facial paralysis. She cannot move half of her face anymore. This is also an extremely rare condition for a healthy 20 year old girl. The events onset date and outcome was reported as 17May2021 05:00 and recovering. Adverse events result in emergency room/department or urgent care/Doctor or other health care professional office. Treatment was yes. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Depression, Impaired work ability, Mobility decreased
Clinical narrative: extreme pain in location of shot - upper left arm. Substantial loss of mobility in left arm. Cortizon shot, prescription pain pills, physical therapy, but pain and mobility problems continue
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: extreme pain in location of shot - upper left arm. Substantial loss of mobility in left arm. Cortizon shot, prescription pain pills, physical therapy, but pain and mobility problems continue
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Magnetic resonance imaging, Mobility decreased, X-ray
Clinical narrative: extreme pain in location of shot - upper left arm. Substantial loss of mobility in left arm. Cortizon shot, prescription pain pills, physical therapy, but pain and mobility problems continue
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arteriogram coronary abnormal, Cardiac disorder, Cardiac imaging procedure abnormal, Catheterisation cardiac abnormal, Chest pain
Clinical narrative: Myocarditis; Chest pain, crushing pain in my heart; Fever; Body ache; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Myocarditis) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-May-2021 at 8:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills). On 25-May-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On 23-May-2021, PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills) had resolved. At the time of the report, MYOCARDITIS (Myocarditis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Angiogram: unknown Unknown. On 24-May-2021, Electrocardiogram: abnormal (abnormal) Abnormal. On 24-May-2021, Magnetic resonance imaging: unknown Unknown.         Concomitant product use was not reported.  It was reported that by that evening, patient felt the usual symptoms of fever, body ache and chills, which continued for the next 48 hours. By Sunday, 23-May-2021, patient was feeling back to normal and in good health. The next morning, Monday, 24-May-2021, patient woke up with chest pain, a crushing pain in heart and went to the ER. An EKG was taken, and the cardiologist mentioned that it was abnormal and that a catheter angiogram needed to be done to check the arteries.  Treatment included overnight monitoring by the cardiology team. Next morning, the cardiologist told the patient that the patient has myocarditis, and that it is showing up in younger adults who have taken the vaccine. Patient is currently on medication over the course of the next month, till follow up visit with the cardiologist.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Electrocardiogram abnormal, Feeling abnormal, Inflammation, Myocarditis
Clinical narrative: Myocarditis; Chest pain, crushing pain in my heart; Fever; Body ache; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Myocarditis) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-May-2021 at 8:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills). On 25-May-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On 23-May-2021, PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills) had resolved. At the time of the report, MYOCARDITIS (Myocarditis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Angiogram: unknown Unknown. On 24-May-2021, Electrocardiogram: abnormal (abnormal) Abnormal. On 24-May-2021, Magnetic resonance imaging: unknown Unknown.         Concomitant product use was not reported.  It was reported that by that evening, patient felt the usual symptoms of fever, body ache and chills, which continued for the next 48 hours. By Sunday, 23-May-2021, patient was feeling back to normal and in good health. The next morning, Monday, 24-May-2021, patient woke up with chest pain, a crushing pain in heart and went to the ER. An EKG was taken, and the cardiologist mentioned that it was abnormal and that a catheter angiogram needed to be done to check the arteries.  Treatment included overnight monitoring by the cardiology team. Next morning, the cardiologist told the patient that the patient has myocarditis, and that it is showing up in younger adults who have taken the vaccine. Patient is currently on medication over the course of the next month, till follow up visit with the cardiologist.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Myocarditis; Chest pain, crushing pain in my heart; Fever; Body ache; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Myocarditis) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-May-2021 at 8:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills). On 25-May-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On 23-May-2021, PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills) had resolved. At the time of the report, MYOCARDITIS (Myocarditis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Angiogram: unknown Unknown. On 24-May-2021, Electrocardiogram: abnormal (abnormal) Abnormal. On 24-May-2021, Magnetic resonance imaging: unknown Unknown.         Concomitant product use was not reported.  It was reported that by that evening, patient felt the usual symptoms of fever, body ache and chills, which continued for the next 48 hours. By Sunday, 23-May-2021, patient was feeling back to normal and in good health. The next morning, Monday, 24-May-2021, patient woke up with chest pain, a crushing pain in heart and went to the ER. An EKG was taken, and the cardiologist mentioned that it was abnormal and that a catheter angiogram needed to be done to check the arteries.  Treatment included overnight monitoring by the cardiology team. Next morning, the cardiologist told the patient that the patient has myocarditis, and that it is showing up in younger adults who have taken the vaccine. Patient is currently on medication over the course of the next month, till follow up visit with the cardiologist.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; Chest pain, crushing pain in my heart; Fever; Body ache; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Myocarditis) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-May-2021 at 8:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills). On 25-May-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On 23-May-2021, PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills) had resolved. At the time of the report, MYOCARDITIS (Myocarditis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Angiogram: unknown Unknown. On 24-May-2021, Electrocardiogram: abnormal (abnormal) Abnormal. On 24-May-2021, Magnetic resonance imaging: unknown Unknown.         Concomitant product use was not reported.  It was reported that by that evening, patient felt the usual symptoms of fever, body ache and chills, which continued for the next 48 hours. By Sunday, 23-May-2021, patient was feeling back to normal and in good health. The next morning, Monday, 24-May-2021, patient woke up with chest pain, a crushing pain in heart and went to the ER. An EKG was taken, and the cardiologist mentioned that it was abnormal and that a catheter angiogram needed to be done to check the arteries.  Treatment included overnight monitoring by the cardiology team. Next morning, the cardiologist told the patient that the patient has myocarditis, and that it is showing up in younger adults who have taken the vaccine. Patient is currently on medication over the course of the next month, till follow up visit with the cardiologist.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Chest pain, Chills, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: Myocarditis; Chest pain, crushing pain in my heart; Fever; Body ache; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Myocarditis) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-May-2021 at 8:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills). On 25-May-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On 23-May-2021, PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills) had resolved. At the time of the report, MYOCARDITIS (Myocarditis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Angiogram: unknown Unknown. On 24-May-2021, Electrocardiogram: abnormal (abnormal) Abnormal. On 24-May-2021, Magnetic resonance imaging: unknown Unknown.         Concomitant product use was not reported.  It was reported that by that evening, patient felt the usual symptoms of fever, body ache and chills, which continued for the next 48 hours. By Sunday, 23-May-2021, patient was feeling back to normal and in good health. The next morning, Monday, 24-May-2021, patient woke up with chest pain, a crushing pain in heart and went to the ER. An EKG was taken, and the cardiologist mentioned that it was abnormal and that a catheter angiogram needed to be done to check the arteries.  Treatment included overnight monitoring by the cardiology team. Next morning, the cardiologist told the patient that the patient has myocarditis, and that it is showing up in younger adults who have taken the vaccine. Patient is currently on medication over the course of the next month, till follow up visit with the cardiologist.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Myocarditis, Pyrexia
Clinical narrative: Myocarditis; Chest pain, crushing pain in my heart; Fever; Body ache; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Myocarditis) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-May-2021 at 8:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills). On 25-May-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On 23-May-2021, PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills) had resolved. At the time of the report, MYOCARDITIS (Myocarditis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Angiogram: unknown Unknown. On 24-May-2021, Electrocardiogram: abnormal (abnormal) Abnormal. On 24-May-2021, Magnetic resonance imaging: unknown Unknown.         Concomitant product use was not reported.  It was reported that by that evening, patient felt the usual symptoms of fever, body ache and chills, which continued for the next 48 hours. By Sunday, 23-May-2021, patient was feeling back to normal and in good health. The next morning, Monday, 24-May-2021, patient woke up with chest pain, a crushing pain in heart and went to the ER. An EKG was taken, and the cardiologist mentioned that it was abnormal and that a catheter angiogram needed to be done to check the arteries.  Treatment included overnight monitoring by the cardiology team. Next morning, the cardiologist told the patient that the patient has myocarditis, and that it is showing up in younger adults who have taken the vaccine. Patient is currently on medication over the course of the next month, till follow up visit with the cardiologist.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Electrocardiogram normal, Laboratory test, Syncope, Tooth fracture
Clinical narrative: Minutes after receiving the vaccine and being asked to relocate from room vaccine was given to an alternate waiting area - patient lost consciousness and hit the floor. He was extremely pale prior to this and during the event. He was unconscious for more than 1 minute, but less than 5. The fall caused him to break a tooth. He was taken by ambulance to the emergency department. The paramedics in the ambulance did an EKG and started an IV with fluids. Patient was spent about 5 hours in the emergency department where patient received an additional EKG, monitoring of his heart, respiratory function, and continued to receive fluids. He also had a chest X-Ray. The emergency room doctor advised she would be reporting to VAERS. Patient needs a root canal & crown as a result of the broken tooth that resulted from his fall. He's felt light headed with some dizziness and headache since the event, possible concussion. He is experiencing ongoing anxiety and heighted emotions.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Artificial crown procedure, Cardiac monitoring, Chest X-ray, Dental examination
Clinical narrative: Minutes after receiving the vaccine and being asked to relocate from room vaccine was given to an alternate waiting area - patient lost consciousness and hit the floor. He was extremely pale prior to this and during the event. He was unconscious for more than 1 minute, but less than 5. The fall caused him to break a tooth. He was taken by ambulance to the emergency department. The paramedics in the ambulance did an EKG and started an IV with fluids. Patient was spent about 5 hours in the emergency department where patient received an additional EKG, monitoring of his heart, respiratory function, and continued to receive fluids. He also had a chest X-Ray. The emergency room doctor advised she would be reporting to VAERS. Patient needs a root canal & crown as a result of the broken tooth that resulted from his fall. He's felt light headed with some dizziness and headache since the event, possible concussion. He is experiencing ongoing anxiety and heighted emotions.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram, Emotional disorder, Endodontic procedure, Fall
Clinical narrative: Minutes after receiving the vaccine and being asked to relocate from room vaccine was given to an alternate waiting area - patient lost consciousness and hit the floor. He was extremely pale prior to this and during the event. He was unconscious for more than 1 minute, but less than 5. The fall caused him to break a tooth. He was taken by ambulance to the emergency department. The paramedics in the ambulance did an EKG and started an IV with fluids. Patient was spent about 5 hours in the emergency department where patient received an additional EKG, monitoring of his heart, respiratory function, and continued to receive fluids. He also had a chest X-Ray. The emergency room doctor advised she would be reporting to VAERS. Patient needs a root canal & crown as a result of the broken tooth that resulted from his fall. He's felt light headed with some dizziness and headache since the event, possible concussion. He is experiencing ongoing anxiety and heighted emotions.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Loss of consciousness, Pallor, Pulmonary function test, Tooth fracture
Clinical narrative: Minutes after receiving the vaccine and being asked to relocate from room vaccine was given to an alternate waiting area - patient lost consciousness and hit the floor. He was extremely pale prior to this and during the event. He was unconscious for more than 1 minute, but less than 5. The fall caused him to break a tooth. He was taken by ambulance to the emergency department. The paramedics in the ambulance did an EKG and started an IV with fluids. Patient was spent about 5 hours in the emergency department where patient received an additional EKG, monitoring of his heart, respiratory function, and continued to receive fluids. He also had a chest X-Ray. The emergency room doctor advised she would be reporting to VAERS. Patient needs a root canal & crown as a result of the broken tooth that resulted from his fall. He's felt light headed with some dizziness and headache since the event, possible concussion. He is experiencing ongoing anxiety and heighted emotions.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram, Myocarditis, Troponin, X-ray normal
Clinical narrative: fever, chills, chest pain 2-3 days after the second COVID vaccine diagnosed with myopericarditis
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase, Chest pain, Chills, Myocarditis, Pyrexia
Clinical narrative: fever, chills, chest pain 2-3 days after the second COVID vaccine diagnosed with myopericarditis
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: fever, chills, chest pain 2-3 days after the second COVID vaccine diagnosed with myopericarditis
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute phase reaction, C-reactive protein, Chest discomfort, Electrocardiogram, Full blood count
Clinical narrative: myocarditis
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Pyrexia, Troponin I, Troponin I increased
Clinical narrative: myocarditis
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cerebrovascular accident, Headache, Magnetic resonance imaging, Migraine
Clinical narrative: MILD STROKE; This spontaneous report received from a patient concerned a 56 year old white, Hispanic or Latino 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: 1808609, expiry: unknown) dose was not reported, one total administered on 06-APR-2021 for prophylactic vaccination. Patient could not remembered which arm received the vaccine and thought it was upper right arm. No concomitant medications were reported. On 13-APR-2021, patient waked up with a very sharp headache pain on the right side of brain and had a blurry vision for entire day and much of next day. Since then until now patient still had a low and mild headache that comes and go and very mild nausea that comes and goes. On 01-JUN-2021, patient had an Magnetic resonance imaging (MRI) which showed result that patient had a mild stroke. On 09-JUN-2021, patient had an Magnetic resonance angiography (MRA) that revealed no plaque. Patient Stated that he had another MRV scheduled on day of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild stroke. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210626713-COVID-19 VACCINE AD26.COV2.S-Mild Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Specialist consultation, Vision blurred
Clinical narrative: MILD STROKE; This spontaneous report received from a patient concerned a 56 year old white, Hispanic or Latino 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: 1808609, expiry: unknown) dose was not reported, one total administered on 06-APR-2021 for prophylactic vaccination. Patient could not remembered which arm received the vaccine and thought it was upper right arm. No concomitant medications were reported. On 13-APR-2021, patient waked up with a very sharp headache pain on the right side of brain and had a blurry vision for entire day and much of next day. Since then until now patient still had a low and mild headache that comes and go and very mild nausea that comes and goes. On 01-JUN-2021, patient had an Magnetic resonance imaging (MRI) which showed result that patient had a mild stroke. On 09-JUN-2021, patient had an Magnetic resonance angiography (MRA) that revealed no plaque. Patient Stated that he had another MRV scheduled on day of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild stroke. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210626713-COVID-19 VACCINE AD26.COV2.S-Mild Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Cerebrovascular accident, Magnetic resonance imaging
Clinical narrative: MILD STROKE; This spontaneous report received from a patient concerned a 56 year old white, Hispanic or Latino 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: 1808609, expiry: unknown) dose was not reported, one total administered on 06-APR-2021 for prophylactic vaccination. Patient could not remembered which arm received the vaccine and thought it was upper right arm. No concomitant medications were reported. On 13-APR-2021, patient waked up with a very sharp headache pain on the right side of brain and had a blurry vision for entire day and much of next day. Since then until now patient still had a low and mild headache that comes and go and very mild nausea that comes and goes. On 01-JUN-2021, patient had an Magnetic resonance imaging (MRI) which showed result that patient had a mild stroke. On 09-JUN-2021, patient had an Magnetic resonance angiography (MRA) that revealed no plaque. Patient Stated that he had another MRV scheduled on day of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild stroke. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210626713-COVID-19 VACCINE AD26.COV2.S-Mild Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Pyrexia, Troponin
Clinical narrative: On 6/7/21 patient received Pfizer #2.  Two days later started to complain of moderate chest pain and SOB.  Seen the next day in clinic with chest pain.  Troponin found to be elevated (1.740) and CRP (4.9) with a normal EKG.  After discussing with Cardiology was decided to admit patient for further work up and pain control.  Admitted 6/10/21.  Cardiac MRI on 6/11/21 showed peri-myocarditis. Troponin trended down over 3 days stay in hospital.  Pain treated with NSAIDS, symptoms improved throughout stay.  Will follow  up with Cardiology in 2 weeks.  No strenuous activity at this time.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Cardiac imaging procedure abnormal, Chest pain, Dyspnoea, Echocardiogram normal
Clinical narrative: On 6/7/21 patient received Pfizer #2.  Two days later started to complain of moderate chest pain and SOB.  Seen the next day in clinic with chest pain.  Troponin found to be elevated (1.740) and CRP (4.9) with a normal EKG.  After discussing with Cardiology was decided to admit patient for further work up and pain control.  Admitted 6/10/21.  Cardiac MRI on 6/11/21 showed peri-myocarditis. Troponin trended down over 3 days stay in hospital.  Pain treated with NSAIDS, symptoms improved throughout stay.  Will follow  up with Cardiology in 2 weeks.  No strenuous activity at this time.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Magnetic resonance imaging heart, Myocarditis, SARS-CoV-2 test negative, Troponin increased
Clinical narrative: On 6/7/21 patient received Pfizer #2.  Two days later started to complain of moderate chest pain and SOB.  Seen the next day in clinic with chest pain.  Troponin found to be elevated (1.740) and CRP (4.9) with a normal EKG.  After discussing with Cardiology was decided to admit patient for further work up and pain control.  Admitted 6/10/21.  Cardiac MRI on 6/11/21 showed peri-myocarditis. Troponin trended down over 3 days stay in hospital.  Pain treated with NSAIDS, symptoms improved throughout stay.  Will follow  up with Cardiology in 2 weeks.  No strenuous activity at this time.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Viral test negative
Clinical narrative: On 6/7/21 patient received Pfizer #2.  Two days later started to complain of moderate chest pain and SOB.  Seen the next day in clinic with chest pain.  Troponin found to be elevated (1.740) and CRP (4.9) with a normal EKG.  After discussing with Cardiology was decided to admit patient for further work up and pain control.  Admitted 6/10/21.  Cardiac MRI on 6/11/21 showed peri-myocarditis. Troponin trended down over 3 days stay in hospital.  Pain treated with NSAIDS, symptoms improved throughout stay.  Will follow  up with Cardiology in 2 weeks.  No strenuous activity at this time.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Nausea, Pyrexia
Clinical narrative: Chest pain/Myocarditis, treated with colchicine and NSAIDS, required hospitalization
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary normal, Arteriogram coronary normal, Chest pain, Echocardiogram normal, Ejection fraction normal
Clinical narrative: Chest pain/Myocarditis, treated with colchicine and NSAIDS, required hospitalization
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Myocarditis, Troponin
Clinical narrative: Chest pain/Myocarditis, treated with colchicine and NSAIDS, required hospitalization
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Headache, Hypoaesthesia, Muscle spasms, Pain
Clinical narrative: Severe myalgia in all extremities
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Severe myalgia in all extremities
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: Severe myalgia in all extremities
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Henoch-Schonlein purpura, Laboratory test, Pain in extremity
Clinical narrative: The evening of 6/4 she came home from outside noticed mosquitos lower leg. On the next day the bumps became bigger,darker in appearance she took Benadryl. The following Monday the appearance looked purple color and lot more spots had occurred. Then on 6/8 becoming larger almost big as Mom palm. She was taken to Urgent Care after observation taken to ER. The medical staff confirmed that it was Purpura and doctor in the ER diagnosed with HSP(typically you see that after having viral or vaccine) was given pain injection. Also she had swollen under her left arm. She was prescribed Prednisone and Diclofenac.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urine analysis
Clinical narrative: The evening of 6/4 she came home from outside noticed mosquitos lower leg. On the next day the bumps became bigger,darker in appearance she took Benadryl. The following Monday the appearance looked purple color and lot more spots had occurred. Then on 6/8 becoming larger almost big as Mom palm. She was taken to Urgent Care after observation taken to ER. The medical staff confirmed that it was Purpura and doctor in the ER diagnosed with HSP(typically you see that after having viral or vaccine) was given pain injection. Also she had swollen under her left arm. She was prescribed Prednisone and Diclofenac.