chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Chest discomfort, Dizziness, Dyspnoea, Epinephrine
Clinical narrative: 4/3/21  30 seconds after 2nd dose - developed hot flashes, lightheadedness, and dizziness, 1 min later developed tachycardia, felt presyncopal, then crushing chest tightness, dyspnea. Given Epi at the site - symptoms plateaued immediately. Better within 30 mins. EMS - Benadryl 50mg. In ER - Solumedrol. Sent to ER - monitored for 4-6 hrs. D/c'ed home on Prednisone.  4/7/21  Now feeling some chest/abdominal bloating and tightness. Today feeling better. Full body aching.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Pain, Presyncope, Tachycardia, Tryptase
Clinical narrative: 4/3/21  30 seconds after 2nd dose - developed hot flashes, lightheadedness, and dizziness, 1 min later developed tachycardia, felt presyncopal, then crushing chest tightness, dyspnea. Given Epi at the site - symptoms plateaued immediately. Better within 30 mins. EMS - Benadryl 50mg. In ER - Solumedrol. Sent to ER - monitored for 4-6 hrs. D/c'ed home on Prednisone.  4/7/21  Now feeling some chest/abdominal bloating and tightness. Today feeling better. Full body aching.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest X-ray, Electrocardiogram, Heart rate increased, Myocardial necrosis marker
Clinical narrative: pulse went up; Itchy all over her body; blood pressure was elevated; Very tired/fatigue; This is a spontaneous report from a contactable physician. A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 20Mar2021 at 11:20 (at the age of 68-years) as single dose for COVID-19 immunization. Medical history included multiple allergies. There were no concomitant medications reported. Her cousin had a similar reaction to flu vaccine. On 20Mar2021, The patient experienced pulse went up, blood pressure was elevated, very tired and fatigue on 20Mar2021.On 22march, the experienced itchy all over her body. The patient was hospitalized for pulse went up from 20Mar2021 to 21Mar2021. The other events (blood pressure elevated, tired/fatigue, itchy) were reported as medically significant.  The patient underwent lab tests and procedures which included blood pressure measurement: it was 132/86 on 20Mar2021. At 18:15 pm elevated to 146/91, heart rate: pulse went up to 125 and stayed up for many hours on 20Mar2021 pulse of 118, at 18:15 pm pulse of 153. Therapeutic measures were taken as a result of pulse went up. The outcome of increased heart rate was recovered, elevated blood pressure and pruritus was recovering and fatigue was not recovered  Additional information on lot/batch number has been requested.; Sender's Comments: Based on the information currently available and plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events pulse went up, blood pressure was elevated, very tired and fatigue, and itchy all over her body cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: pulse went up; Itchy all over her body; blood pressure was elevated; Very tired/fatigue; This is a spontaneous report from a contactable physician. A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 20Mar2021 at 11:20 (at the age of 68-years) as single dose for COVID-19 immunization. Medical history included multiple allergies. There were no concomitant medications reported. Her cousin had a similar reaction to flu vaccine. On 20Mar2021, The patient experienced pulse went up, blood pressure was elevated, very tired and fatigue on 20Mar2021.On 22march, the experienced itchy all over her body. The patient was hospitalized for pulse went up from 20Mar2021 to 21Mar2021. The other events (blood pressure elevated, tired/fatigue, itchy) were reported as medically significant.  The patient underwent lab tests and procedures which included blood pressure measurement: it was 132/86 on 20Mar2021. At 18:15 pm elevated to 146/91, heart rate: pulse went up to 125 and stayed up for many hours on 20Mar2021 pulse of 118, at 18:15 pm pulse of 153. Therapeutic measures were taken as a result of pulse went up. The outcome of increased heart rate was recovered, elevated blood pressure and pruritus was recovering and fatigue was not recovered  Additional information on lot/batch number has been requested.; Sender's Comments: Based on the information currently available and plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events pulse went up, blood pressure was elevated, very tired and fatigue, and itchy all over her body cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Heart rate, Heart rate increased
Clinical narrative: pulse went up; Itchy all over her body; blood pressure was elevated; Very tired/fatigue; This is a spontaneous report from a contactable physician. A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 20Mar2021 at 11:20 (at the age of 68-years) as single dose for COVID-19 immunization. Medical history included multiple allergies. There were no concomitant medications reported. Her cousin had a similar reaction to flu vaccine. On 20Mar2021, The patient experienced pulse went up, blood pressure was elevated, very tired and fatigue on 20Mar2021.On 22march, the experienced itchy all over her body. The patient was hospitalized for pulse went up from 20Mar2021 to 21Mar2021. The other events (blood pressure elevated, tired/fatigue, itchy) were reported as medically significant.  The patient underwent lab tests and procedures which included blood pressure measurement: it was 132/86 on 20Mar2021. At 18:15 pm elevated to 146/91, heart rate: pulse went up to 125 and stayed up for many hours on 20Mar2021 pulse of 118, at 18:15 pm pulse of 153. Therapeutic measures were taken as a result of pulse went up. The outcome of increased heart rate was recovered, elevated blood pressure and pruritus was recovering and fatigue was not recovered  Additional information on lot/batch number has been requested.; Sender's Comments: Based on the information currently available and plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events pulse went up, blood pressure was elevated, very tired and fatigue, and itchy all over her body cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: pulse went up; Itchy all over her body; blood pressure was elevated; Very tired/fatigue; This is a spontaneous report from a contactable physician. A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 20Mar2021 at 11:20 (at the age of 68-years) as single dose for COVID-19 immunization. Medical history included multiple allergies. There were no concomitant medications reported. Her cousin had a similar reaction to flu vaccine. On 20Mar2021, The patient experienced pulse went up, blood pressure was elevated, very tired and fatigue on 20Mar2021.On 22march, the experienced itchy all over her body. The patient was hospitalized for pulse went up from 20Mar2021 to 21Mar2021. The other events (blood pressure elevated, tired/fatigue, itchy) were reported as medically significant.  The patient underwent lab tests and procedures which included blood pressure measurement: it was 132/86 on 20Mar2021. At 18:15 pm elevated to 146/91, heart rate: pulse went up to 125 and stayed up for many hours on 20Mar2021 pulse of 118, at 18:15 pm pulse of 153. Therapeutic measures were taken as a result of pulse went up. The outcome of increased heart rate was recovered, elevated blood pressure and pruritus was recovering and fatigue was not recovered  Additional information on lot/batch number has been requested.; Sender's Comments: Based on the information currently available and plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events pulse went up, blood pressure was elevated, very tired and fatigue, and itchy all over her body cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: The morning of April 3, staff at the  Community Vaccination Clinic discovered a discrepancy in the preparation of Pfizer vaccine doses. It was discovered that several undiluted vaccine doses were administered. Staff accounted for all unused undiluted vaccine doses. Unfortunately, 10 undiluted vaccine doses had been administered to patients and were not able to be retrieved. This patient received one of the undiluted doses.   The medical team contacted the CDC to determine the potential side effects and observation requirements of receiving an undiluted vaccine. The CDC confirmed that the recipients of the undiluted doses may experience stronger side effects and symptoms than someone who received the diluted dose (sore arm, flu-like symptoms, etc.).  The site public health officer spoke with suspected recipients of the undiluted vaccine to explain potential medical side effects. The  Health District will follow up to monitor their status.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: The morning of April 3, staff at the  Community Vaccination Clinic discovered a discrepancy in the preparation of Pfizer vaccine doses. It was discovered that several undiluted vaccine doses were administered. Staff accounted for all unused undiluted vaccine doses. Unfortunately, 10 undiluted vaccine doses had been administered to patients and were not able to be retrieved. This patient received one of the undiluted doses.   The medical team contacted the CDC to determine the potential side effects and observation requirements of receiving an undiluted vaccine. The CDC confirmed that the recipients of the undiluted doses may experience stronger side effects and symptoms than someone who received the diluted dose (sore arm, flu-like symptoms, etc.).  The site public health officer spoke with suspected recipients of the undiluted vaccine to explain potential medical side effects. The  Health District will follow up to monitor their status.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood blister, Blood pressure increased, Chest X-ray, Decreased appetite, Dyspnoea
Clinical narrative: SORENESS AT INJECTION SITE; FATIGUE; SHORTNESS OF BREATH; INCREASED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 79 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 (vaccinated at left arm) for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced shortness of breath. On 06-MAR-2021, the subject experienced increased blood pressure. On 06-MAR-2021, the subject experienced fatigue. On 07-MAR-2021, the subject experienced soreness at injection site. On 29-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 151/97 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection site on 10-MAR-2021, and had not recovered from shortness of breath, fatigue, and increased blood pressure. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Fatigue, Feeling abnormal, Groin pain, Laboratory test
Clinical narrative: SORENESS AT INJECTION SITE; FATIGUE; SHORTNESS OF BREATH; INCREASED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 79 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 (vaccinated at left arm) for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced shortness of breath. On 06-MAR-2021, the subject experienced increased blood pressure. On 06-MAR-2021, the subject experienced fatigue. On 07-MAR-2021, the subject experienced soreness at injection site. On 29-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 151/97 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection site on 10-MAR-2021, and had not recovered from shortness of breath, fatigue, and increased blood pressure. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Nausea, SARS-CoV-2 test, Ultrasound Doppler, Urine analysis
Clinical narrative: SORENESS AT INJECTION SITE; FATIGUE; SHORTNESS OF BREATH; INCREASED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 79 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 (vaccinated at left arm) for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced shortness of breath. On 06-MAR-2021, the subject experienced increased blood pressure. On 06-MAR-2021, the subject experienced fatigue. On 07-MAR-2021, the subject experienced soreness at injection site. On 29-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 151/97 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection site on 10-MAR-2021, and had not recovered from shortness of breath, fatigue, and increased blood pressure. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dyspnoea, Fatigue, Injection site pain
Clinical narrative: SORENESS AT INJECTION SITE; FATIGUE; SHORTNESS OF BREATH; INCREASED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 79 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 (vaccinated at left arm) for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced shortness of breath. On 06-MAR-2021, the subject experienced increased blood pressure. On 06-MAR-2021, the subject experienced fatigue. On 07-MAR-2021, the subject experienced soreness at injection site. On 29-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 151/97 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection site on 10-MAR-2021, and had not recovered from shortness of breath, fatigue, and increased blood pressure. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache
Clinical narrative: I got vaccinated on Friday. That night, I had chills and a headache, but this went away by Sunday morning.  On Monday, I woke up and I was too dizzy to walk. The initial dizziness subsided but I'm still having balance issues as of Wednesday night. A doctor prescribed meclizine which didn't help.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Chills, Dizziness, Headache
Clinical narrative: I got vaccinated on Friday. That night, I had chills and a headache, but this went away by Sunday morning.  On Monday, I woke up and I was too dizzy to walk. The initial dizziness subsided but I'm still having balance issues as of Wednesday night. A doctor prescribed meclizine which didn't help.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Catheterisation cardiac normal, Chest pain, Dyspnoea
Clinical narrative: myopericarditis after J&J COVID-19 vaccine admitted 4/5/2021 to Hospital ED with chest pain and shortness of breath after reportedly receiving J&J vaccine Saturday 4/3:developed chest pain in the afternoon as well as shortness of breath, nausea, neck pain, generalized body aches, fever, and chills.  Highest temperature at home was 100.8 Fahrenheit, he lives in a dorm, he denies exposure to anyone sick with COVID-19, meningitis, or encephalitis.   Patient states his chest pain started yesterday in the afternoon and ranging from 5-8 out of 10 in severity, last for 20 minutes when it comes, in the middle of the chest, no radiation to the pain.  Patient states the pain happened at rest.  Patient also complained of a headache that is 4 out of 10 in severity. EKG was normal, but HS troponin was > 500ng/L so was transferred to Clinic Main Campus Heart and Vascular Institute with concern for myopericarditis. On admission to Clinic: EKG concern for acute pericarditis, Cardiac Catheterization (was normal), ECHO and Cardiac MRI were performed.  MRI was consistent with  myopericarditis.  patient was discharged 4/7 on colchicine and ibuprofen for treatment of myopericarditis and will follow up with cardiologist
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Echocardiogram abnormal, Malaise, Myocardial necrosis marker increased, Neck pain, Pain in extremity
Clinical narrative: myopericarditis after J&J COVID-19 vaccine admitted 4/5/2021 to Hospital ED with chest pain and shortness of breath after reportedly receiving J&J vaccine Saturday 4/3:developed chest pain in the afternoon as well as shortness of breath, nausea, neck pain, generalized body aches, fever, and chills.  Highest temperature at home was 100.8 Fahrenheit, he lives in a dorm, he denies exposure to anyone sick with COVID-19, meningitis, or encephalitis.   Patient states his chest pain started yesterday in the afternoon and ranging from 5-8 out of 10 in severity, last for 20 minutes when it comes, in the middle of the chest, no radiation to the pain.  Patient states the pain happened at rest.  Patient also complained of a headache that is 4 out of 10 in severity. EKG was normal, but HS troponin was > 500ng/L so was transferred to Clinic Main Campus Heart and Vascular Institute with concern for myopericarditis. On admission to Clinic: EKG concern for acute pericarditis, Cardiac Catheterization (was normal), ECHO and Cardiac MRI were performed.  MRI was consistent with  myopericarditis.  patient was discharged 4/7 on colchicine and ibuprofen for treatment of myopericarditis and will follow up with cardiologist
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pericarditis, Pyrexia, Somnolence
Clinical narrative: myopericarditis after J&J COVID-19 vaccine admitted 4/5/2021 to Hospital ED with chest pain and shortness of breath after reportedly receiving J&J vaccine Saturday 4/3:developed chest pain in the afternoon as well as shortness of breath, nausea, neck pain, generalized body aches, fever, and chills.  Highest temperature at home was 100.8 Fahrenheit, he lives in a dorm, he denies exposure to anyone sick with COVID-19, meningitis, or encephalitis.   Patient states his chest pain started yesterday in the afternoon and ranging from 5-8 out of 10 in severity, last for 20 minutes when it comes, in the middle of the chest, no radiation to the pain.  Patient states the pain happened at rest.  Patient also complained of a headache that is 4 out of 10 in severity. EKG was normal, but HS troponin was > 500ng/L so was transferred to Clinic Main Campus Heart and Vascular Institute with concern for myopericarditis. On admission to Clinic: EKG concern for acute pericarditis, Cardiac Catheterization (was normal), ECHO and Cardiac MRI were performed.  MRI was consistent with  myopericarditis.  patient was discharged 4/7 on colchicine and ibuprofen for treatment of myopericarditis and will follow up with cardiologist
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature increased, Catheterisation cardiac normal, Chest pain, Chills, Dyspnoea
Clinical narrative: myopericarditis after J&J COVID-19 vaccine admitted 4/5/2021 to Hospital ED with chest pain and shortness of breath after reportedly receiving J&J vaccine Saturday 4/3:developed chest pain in the afternoon as well as shortness of breath, nausea, neck pain, generalized body aches, fever, and chills.  Highest temperature at home was 100.8 Fahrenheit, he lives in a dorm, he denies exposure to anyone sick with COVID-19, meningitis, or encephalitis.   Patient states his chest pain started yesterday in the afternoon and ranging from 5-8 out of 10 in severity, last for 20 minutes when it comes, in the middle of the chest, no radiation to the pain.  Patient states the pain happened at rest.  Patient also complained of a headache that is 4 out of 10 in severity. EKG was normal, but HS troponin was > 500ng/L so was transferred to Clinic Main Campus Heart and Vascular Institute with concern for myopericarditis. On admission to Clinic: EKG concern for acute pericarditis, Cardiac Catheterization (was normal), ECHO and Cardiac MRI were performed.  MRI was consistent with  myopericarditis.  patient was discharged 4/7 on colchicine and ibuprofen for treatment of myopericarditis and will follow up with cardiologist
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Headache, Magnetic resonance imaging abnormal, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: myopericarditis after J&J COVID-19 vaccine admitted 4/5/2021 to Hospital ED with chest pain and shortness of breath after reportedly receiving J&J vaccine Saturday 4/3:developed chest pain in the afternoon as well as shortness of breath, nausea, neck pain, generalized body aches, fever, and chills.  Highest temperature at home was 100.8 Fahrenheit, he lives in a dorm, he denies exposure to anyone sick with COVID-19, meningitis, or encephalitis.   Patient states his chest pain started yesterday in the afternoon and ranging from 5-8 out of 10 in severity, last for 20 minutes when it comes, in the middle of the chest, no radiation to the pain.  Patient states the pain happened at rest.  Patient also complained of a headache that is 4 out of 10 in severity. EKG was normal, but HS troponin was > 500ng/L so was transferred to Clinic Main Campus Heart and Vascular Institute with concern for myopericarditis. On admission to Clinic: EKG concern for acute pericarditis, Cardiac Catheterization (was normal), ECHO and Cardiac MRI were performed.  MRI was consistent with  myopericarditis.  patient was discharged 4/7 on colchicine and ibuprofen for treatment of myopericarditis and will follow up with cardiologist
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nausea, Neck pain, Pain, Pericarditis, Pyrexia
Clinical narrative: myopericarditis after J&J COVID-19 vaccine admitted 4/5/2021 to Hospital ED with chest pain and shortness of breath after reportedly receiving J&J vaccine Saturday 4/3:developed chest pain in the afternoon as well as shortness of breath, nausea, neck pain, generalized body aches, fever, and chills.  Highest temperature at home was 100.8 Fahrenheit, he lives in a dorm, he denies exposure to anyone sick with COVID-19, meningitis, or encephalitis.   Patient states his chest pain started yesterday in the afternoon and ranging from 5-8 out of 10 in severity, last for 20 minutes when it comes, in the middle of the chest, no radiation to the pain.  Patient states the pain happened at rest.  Patient also complained of a headache that is 4 out of 10 in severity. EKG was normal, but HS troponin was > 500ng/L so was transferred to Clinic Main Campus Heart and Vascular Institute with concern for myopericarditis. On admission to Clinic: EKG concern for acute pericarditis, Cardiac Catheterization (was normal), ECHO and Cardiac MRI were performed.  MRI was consistent with  myopericarditis.  patient was discharged 4/7 on colchicine and ibuprofen for treatment of myopericarditis and will follow up with cardiologist
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: myopericarditis after J&J COVID-19 vaccine admitted 4/5/2021 to Hospital ED with chest pain and shortness of breath after reportedly receiving J&J vaccine Saturday 4/3:developed chest pain in the afternoon as well as shortness of breath, nausea, neck pain, generalized body aches, fever, and chills.  Highest temperature at home was 100.8 Fahrenheit, he lives in a dorm, he denies exposure to anyone sick with COVID-19, meningitis, or encephalitis.   Patient states his chest pain started yesterday in the afternoon and ranging from 5-8 out of 10 in severity, last for 20 minutes when it comes, in the middle of the chest, no radiation to the pain.  Patient states the pain happened at rest.  Patient also complained of a headache that is 4 out of 10 in severity. EKG was normal, but HS troponin was > 500ng/L so was transferred to Clinic Main Campus Heart and Vascular Institute with concern for myopericarditis. On admission to Clinic: EKG concern for acute pericarditis, Cardiac Catheterization (was normal), ECHO and Cardiac MRI were performed.  MRI was consistent with  myopericarditis.  patient was discharged 4/7 on colchicine and ibuprofen for treatment of myopericarditis and will follow up with cardiologist
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: myopericarditis after J&J COVID-19 vaccine admitted 4/5/2021 to Hospital ED with chest pain and shortness of breath after reportedly receiving J&J vaccine Saturday 4/3:developed chest pain in the afternoon as well as shortness of breath, nausea, neck pain, generalized body aches, fever, and chills.  Highest temperature at home was 100.8 Fahrenheit, he lives in a dorm, he denies exposure to anyone sick with COVID-19, meningitis, or encephalitis.   Patient states his chest pain started yesterday in the afternoon and ranging from 5-8 out of 10 in severity, last for 20 minutes when it comes, in the middle of the chest, no radiation to the pain.  Patient states the pain happened at rest.  Patient also complained of a headache that is 4 out of 10 in severity. EKG was normal, but HS troponin was > 500ng/L so was transferred to Clinic Main Campus Heart and Vascular Institute with concern for myopericarditis. On admission to Clinic: EKG concern for acute pericarditis, Cardiac Catheterization (was normal), ECHO and Cardiac MRI were performed.  MRI was consistent with  myopericarditis.  patient was discharged 4/7 on colchicine and ibuprofen for treatment of myopericarditis and will follow up with cardiologist
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Heart injury, Magnetic resonance imaging heart, Myocarditis, Pain in extremity
Clinical narrative: myopericarditis after J&J COVID-19 vaccine admitted 4/5/2021 to Hospital ED with chest pain and shortness of breath after reportedly receiving J&J vaccine Saturday 4/3:developed chest pain in the afternoon as well as shortness of breath, nausea, neck pain, generalized body aches, fever, and chills.  Highest temperature at home was 100.8 Fahrenheit, he lives in a dorm, he denies exposure to anyone sick with COVID-19, meningitis, or encephalitis.   Patient states his chest pain started yesterday in the afternoon and ranging from 5-8 out of 10 in severity, last for 20 minutes when it comes, in the middle of the chest, no radiation to the pain.  Patient states the pain happened at rest.  Patient also complained of a headache that is 4 out of 10 in severity. EKG was normal, but HS troponin was > 500ng/L so was transferred to Clinic Main Campus Heart and Vascular Institute with concern for myopericarditis. On admission to Clinic: EKG concern for acute pericarditis, Cardiac Catheterization (was normal), ECHO and Cardiac MRI were performed.  MRI was consistent with  myopericarditis.  patient was discharged 4/7 on colchicine and ibuprofen for treatment of myopericarditis and will follow up with cardiologist
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache, Neck pain, Pain
Clinical narrative: myopericarditis after J&J COVID-19 vaccine admitted 4/5/2021 to Hospital ED with chest pain and shortness of breath after reportedly receiving J&J vaccine Saturday 4/3:developed chest pain in the afternoon as well as shortness of breath, nausea, neck pain, generalized body aches, fever, and chills.  Highest temperature at home was 100.8 Fahrenheit, he lives in a dorm, he denies exposure to anyone sick with COVID-19, meningitis, or encephalitis.   Patient states his chest pain started yesterday in the afternoon and ranging from 5-8 out of 10 in severity, last for 20 minutes when it comes, in the middle of the chest, no radiation to the pain.  Patient states the pain happened at rest.  Patient also complained of a headache that is 4 out of 10 in severity. EKG was normal, but HS troponin was > 500ng/L so was transferred to Clinic Main Campus Heart and Vascular Institute with concern for myopericarditis. On admission to Clinic: EKG concern for acute pericarditis, Cardiac Catheterization (was normal), ECHO and Cardiac MRI were performed.  MRI was consistent with  myopericarditis.  patient was discharged 4/7 on colchicine and ibuprofen for treatment of myopericarditis and will follow up with cardiologist
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: myopericarditis after J&J COVID-19 vaccine admitted 4/5/2021 to Hospital ED with chest pain and shortness of breath after reportedly receiving J&J vaccine Saturday 4/3:developed chest pain in the afternoon as well as shortness of breath, nausea, neck pain, generalized body aches, fever, and chills.  Highest temperature at home was 100.8 Fahrenheit, he lives in a dorm, he denies exposure to anyone sick with COVID-19, meningitis, or encephalitis.   Patient states his chest pain started yesterday in the afternoon and ranging from 5-8 out of 10 in severity, last for 20 minutes when it comes, in the middle of the chest, no radiation to the pain.  Patient states the pain happened at rest.  Patient also complained of a headache that is 4 out of 10 in severity. EKG was normal, but HS troponin was > 500ng/L so was transferred to Clinic Main Campus Heart and Vascular Institute with concern for myopericarditis. On admission to Clinic: EKG concern for acute pericarditis, Cardiac Catheterization (was normal), ECHO and Cardiac MRI were performed.  MRI was consistent with  myopericarditis.  patient was discharged 4/7 on colchicine and ibuprofen for treatment of myopericarditis and will follow up with cardiologist
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Palpitations
Clinical narrative: Difficulty swallowing, swollen throat, dizzy, rapid heart rate, high blood pressure within 5 mins of receiving vaccine. Nurse gave Allegra for throat.   Throat swollen after 24 hours lost vaccine
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Hypertension, Pharyngeal swelling, Tachycardia
Clinical narrative: Difficulty swallowing, swollen throat, dizzy, rapid heart rate, high blood pressure within 5 mins of receiving vaccine. Nurse gave Allegra for throat.   Throat swollen after 24 hours lost vaccine
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Heart rate increased, Oropharyngeal discomfort
Clinical narrative: Difficulty swallowing, swollen throat, dizzy, rapid heart rate, high blood pressure within 5 mins of receiving vaccine. Nurse gave Allegra for throat.   Throat swollen after 24 hours lost vaccine
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Dizziness, Fall, Fatigue, Lethargy
Clinical narrative: Within 15-20 minutes, I had extreme fatigue and overall lethargic behavior for a very health 62 year old energetic woman.  Brain Fog occurred and slowed speech.  Could not lift my arms or stand and needed to be placed in a wheelchair.  It took about an hour to start to feel more like myself and in 2-3 hours, I was able to walk out of the hospital emergency room by myself.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mouth swelling, Pallor, Paraesthesia oral, Peripheral coldness, Slow speech
Clinical narrative: Within 15-20 minutes, I had extreme fatigue and overall lethargic behavior for a very health 62 year old energetic woman.  Brain Fog occurred and slowed speech.  Could not lift my arms or stand and needed to be placed in a wheelchair.  It took about an hour to start to feel more like myself and in 2-3 hours, I was able to walk out of the hospital emergency room by myself.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Within 15-20 minutes, I had extreme fatigue and overall lethargic behavior for a very health 62 year old energetic woman.  Brain Fog occurred and slowed speech.  Could not lift my arms or stand and needed to be placed in a wheelchair.  It took about an hour to start to feel more like myself and in 2-3 hours, I was able to walk out of the hospital emergency room by myself.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood count, Electrocardiogram, Fatigue, Feeling abnormal, Lethargy
Clinical narrative: Within 15-20 minutes, I had extreme fatigue and overall lethargic behavior for a very health 62 year old energetic woman.  Brain Fog occurred and slowed speech.  Could not lift my arms or stand and needed to be placed in a wheelchair.  It took about an hour to start to feel more like myself and in 2-3 hours, I was able to walk out of the hospital emergency room by myself.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Slow speech, Urine analysis, X-ray
Clinical narrative: Within 15-20 minutes, I had extreme fatigue and overall lethargic behavior for a very health 62 year old energetic woman.  Brain Fog occurred and slowed speech.  Could not lift my arms or stand and needed to be placed in a wheelchair.  It took about an hour to start to feel more like myself and in 2-3 hours, I was able to walk out of the hospital emergency room by myself.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pancreatitis
Clinical narrative: Pancreatic attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PANCREATITIS (Pancreatic attack) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PANCREATITIS (Pancreatic attack) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 7 days due to PANCREATITIS. At the time of the report, PANCREATITIS (Pancreatic attack) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment received reported as intravenous treatment while hospitalized.  Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Developed bells palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Developed bells palsy) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced FACIAL PARALYSIS (Developed bells palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Developed bells palsy) outcome was unknown.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to events was not applicable. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Diagnosed yesterday with Bell's Palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Diagnosed yesterday with Bell's Palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced FACIAL PARALYSIS (Diagnosed yesterday with Bell's Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Diagnosed yesterday with Bell's Palsy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included prednisone.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Skin discolouration
Clinical narrative: Dime to nickel sized red blotches on both shoulders, chest, back and lower back 10-12 in all. They are not raised, not itchy. There are there just in color; His lower back on Saturday that look darker than the other ones; This is a spontaneous report from two contactable consumers (one is patient and other is patient's daughter) via medical information team. A 90-year-old male patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, expiration date: unknown), via an unspecified route of administration, on left arm on 20Jan2021 at 11:30 AM at the age of 90 years old at a single dose to Prevent COVID (COVID-19 immunization). The patient medical history was none. Family medical history was none. Relevant tests was none. Concomitant medications were none. Patient's daughter stated, her father received the Pfizer vaccine on wednesday 20Jan2021 then on 22Jan2021 (Friday) patient noticed (but not sure exactly when the rashes appeared) a rash after the first dose. The rashes are described as "dime to nickel sized red blotches on both shoulders, chest, back and lower back 10-12 in all on 22Jan2021. They are not raised, not itchy. There are there just in color. No other side effects, no difficulty breathing. Should he receive the second dose? Would it be ok if they prescribed him a steroid to clear it up?" was asked. Patient's daughter says he is 90 and he received it 20Jan2021 and next week he is supposed to receive the second dose and he is not sure when they appeared but he knows that he noticed 3 days later, it could have been sooner but he just didn't look at him self in the mirror. He noticed some spots on him maybe like a nickel size on his shoulder, chest, arm and on his backside, they are a little bit red, they are flat, not raised they are not itchy. They are not causing him a problem at they are just there. But they are concerned because he has to get second dose so they are wondering should he get it still or could it cause any problems. He confirmed it was actually 2 days after the vaccine that he noticed the rash. It was Friday the 22Jan2021 when he noticed it. They are ongoing and the patient thinks the spots may be a little bit lighter now, just a little bit. Patient's daughter says she noticed a couple on his lower back on Saturday that look darker than the other ones. She says it is hard for him to see all of them. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior and Since to vaccination, the patient was not diagnosed with COVID-19. Patient had not recovered from the event rash and for other events it was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: significant chills; slight dizziness; sore throat; had substantial body aches; fatigue; This is a spontaneous report from a contactable consumer (patient) A 44-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number el3248, Expiration date unknown), via an unspecified route of administration, in arm left on 01-FEB-2021 at 09:15 single dose for Covid-19 immunization. The patient previously took vaccine which included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number el3248, Expiration date unknown) via an unspecified route of administration, in arm left first dose on 12Jan2021 at 06:30 AM for Covid-19 immunization. Prior and Since to vaccination, the patient not diagnosed with COVID. Concomitant medication was not reported. on 02-FEB-2021 03:00 AM patient experienced significant chills, slight dizziness and a sore throat, substantial body aches and fatigue. The patient woke up at 3 am with significant chills, some slight dizziness and a sore throat. The patient was able to go back to sleep, when the patient woke up again in the morning the patient had substantial body aches and fatigue.  I took some motrin and tylenol in the morning. The symptoms subsided by the afternoon. The symptoms subsided by the afternoon. The outcome of event was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Sinus headache
Clinical narrative: This is a spontaneous report from a contactable elder female consumer. A unspecified age old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9263, expiration date: unknown) dose 2nd via an unspecified route of administration on 03Feb2021 on left arm at single dose for COVID-19 Immunization. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 04:45 AM, anatomical location was left arm. The medical history included osteoporosis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included Metoprolol, multivitamin, Caltrate, atorvastatin. On 03Feb2021 the patient experienced Sinus headache, nausea, joint pain. The patient did not receive any treatment for an event. The outcome of events was recovering at the time of report. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: anxious; This is a spontaneous report from a contactable physician. A 9-decade-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on Jan2021 as SINGLE DOSE for covid-19 immunization. Medical history included cardiovascular disorder and cerebrovascular accident. The patient's concomitant medications were not reported. The patient reported, he came in for dental appointment. Had received first dose of Pfizer Covid-19 vaccine late last week. Has multiple underlying cardiovascular issues including previous stroke. Normally very calm. Patient was extremely anxious and unable to sit long enough for dental appointment. Seemed somewhat agitated as well. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dysphagia, Lymphadenopathy
Clinical narrative: Experienced swelling in nodes at the base of her neck and had trouble swallowing; Had trouble swallowing; Anxious; This is a spontaneous report from a contactable Pharmacist. A adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown, Expiration Date: unknown) intramuscular in arm right on 18Jan2021 at 12:00 as a single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus. The patient's concomitant medications were not reported. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 18Jan2021 at 18:00, the patient experienced swelling in nodes at the base of her neck and had trouble swallowing, had trouble swallowing and anxious. Approximately 6 hours after injection (Patient) experienced swelling in nodes at the base of her neck and had trouble swallowing. She went to the emergency room and was treated with steroids and antihistamines. She was discontinued with Medrol dose Pak, Pepcid and antihistamines. The swelling improved. After completing the steroids, the swelling came back. She went to an allergist who placed her on frequent Claritin and Zyrtec, and hydroxyzine. The swelling goes down with the Claritin but has since come back. She has a history of ALL approximately 20 years ago, no history of reaction to vaccines. She has epipen but is quite anxious. The outcome of the events was not recovered.  Follow up attempts are needed. Further information is expected.   Follow up attempts are needed. Further information is expected.