chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Troponin increased
Clinical narrative: Received second pfizer vaccine Sunday 6/12. Developed fevers afterwards that improved. Chest pain starting 6/14 at midnight with shortness of breath, sweating, non blood emesis, and arm pain.  Elevated troponin found to have covid19 vaccine related myocarditis. Echo normal, cardiac MRI with delayed enhancement consistent with myocarditis. Pain relieved with NSAIDs and was symptom free at discharge. Was told to restrict exercise and will get follow up cardiac MRI in 3 months
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram normal, Hyperhidrosis, Magnetic resonance imaging heart
Clinical narrative: Received second pfizer vaccine Sunday 6/12. Developed fevers afterwards that improved. Chest pain starting 6/14 at midnight with shortness of breath, sweating, non blood emesis, and arm pain.  Elevated troponin found to have covid19 vaccine related myocarditis. Echo normal, cardiac MRI with delayed enhancement consistent with myocarditis. Pain relieved with NSAIDs and was symptom free at discharge. Was told to restrict exercise and will get follow up cardiac MRI in 3 months
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pain in extremity, Pyrexia, Troponin increased, Vomiting
Clinical narrative: Received second pfizer vaccine Sunday 6/12. Developed fevers afterwards that improved. Chest pain starting 6/14 at midnight with shortness of breath, sweating, non blood emesis, and arm pain.  Elevated troponin found to have covid19 vaccine related myocarditis. Echo normal, cardiac MRI with delayed enhancement consistent with myocarditis. Pain relieved with NSAIDs and was symptom free at discharge. Was told to restrict exercise and will get follow up cardiac MRI in 3 months
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adenovirus test, Angiogram normal, Brain natriuretic peptide increased, C-reactive protein increased, COVID-19
Clinical narrative: Myopericarditis presenting with chest pain and elevated troponin. Diffuse ST segment changes on EKG and preserved function by echo with no evidence of effusion. Cardiac MRI consistent with myocarditis with delayed enhancement in 30% of the myocardium and elevated ECV and T1 mapping. Administered IVIG and started on NSAID with resolution of chest pain and down trending troponin.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Cytomegalovirus test, Echocardiogram normal, Electrocardiogram ST segment elevation, Enterovirus test
Clinical narrative: Myopericarditis presenting with chest pain and elevated troponin. Diffuse ST segment changes on EKG and preserved function by echo with no evidence of effusion. Cardiac MRI consistent with myocarditis with delayed enhancement in 30% of the myocardium and elevated ECV and T1 mapping. Administered IVIG and started on NSAID with resolution of chest pain and down trending troponin.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Epstein-Barr virus test, Fibrin D dimer, Headache, Human herpes virus 6 serology, Liver function test increased
Clinical narrative: Myopericarditis presenting with chest pain and elevated troponin. Diffuse ST segment changes on EKG and preserved function by echo with no evidence of effusion. Cardiac MRI consistent with myocarditis with delayed enhancement in 30% of the myocardium and elevated ECV and T1 mapping. Administered IVIG and started on NSAID with resolution of chest pain and down trending troponin.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Parvovirus B19 test, Respiratory viral panel, SARS-CoV-2 antibody test positive, Troponin, Ultrasound scan normal
Clinical narrative: Myopericarditis presenting with chest pain and elevated troponin. Diffuse ST segment changes on EKG and preserved function by echo with no evidence of effusion. Cardiac MRI consistent with myocarditis with delayed enhancement in 30% of the myocardium and elevated ECV and T1 mapping. Administered IVIG and started on NSAID with resolution of chest pain and down trending troponin.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein, Chest pain, Echocardiogram, Electrocardiogram abnormal, Immunoglobulin therapy
Clinical narrative: Myopericarditis presenting with chest pain and elevated troponin. Diffuse ST segment changes on EKG and preserved function by echo with no evidence of effusion. Cardiac MRI consistent with myocarditis with delayed enhancement in 30% of the myocardium and elevated ECV and T1 mapping. Administered IVIG and started on NSAID with resolution of chest pain and down trending troponin.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging abnormal, Magnetic resonance imaging heart, Myocarditis, Procalcitonin, Red blood cell sedimentation rate
Clinical narrative: Myopericarditis presenting with chest pain and elevated troponin. Diffuse ST segment changes on EKG and preserved function by echo with no evidence of effusion. Cardiac MRI consistent with myocarditis with delayed enhancement in 30% of the myocardium and elevated ECV and T1 mapping. Administered IVIG and started on NSAID with resolution of chest pain and down trending troponin.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory viral panel, Thyroid function test, Troponin increased
Clinical narrative: Myopericarditis presenting with chest pain and elevated troponin. Diffuse ST segment changes on EKG and preserved function by echo with no evidence of effusion. Cardiac MRI consistent with myocarditis with delayed enhancement in 30% of the myocardium and elevated ECV and T1 mapping. Administered IVIG and started on NSAID with resolution of chest pain and down trending troponin.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Dyspnoea, Feeling abnormal, Flushing, Headache
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Mild, Systemic: Vomiting-Mild, Additional Details: Initial BP reading: 204/124 which reduced to 127/87 5 minutes later. HR readings every few minutes: 102, 120, 116, 112
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Hypoaesthesia, Lymphadenopathy, Palpitations
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Mild, Systemic: Vomiting-Mild, Additional Details: Initial BP reading: 204/124 which reduced to 127/87 5 minutes later. HR readings every few minutes: 102, 120, 116, 112
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Mild, Systemic: Vomiting-Mild, Additional Details: Initial BP reading: 204/124 which reduced to 127/87 5 minutes later. HR readings every few minutes: 102, 120, 116, 112
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Heart rate increased, Hypoaesthesia, Nausea, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Mild, Systemic: Vomiting-Mild, Additional Details: Initial BP reading: 204/124 which reduced to 127/87 5 minutes later. HR readings every few minutes: 102, 120, 116, 112
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Hypertension, Hypoaesthesia, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Mild, Systemic: Vomiting-Mild, Additional Details: Initial BP reading: 204/124 which reduced to 127/87 5 minutes later. HR readings every few minutes: 102, 120, 116, 112
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachycardia, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Mild, Systemic: Vomiting-Mild, Additional Details: Initial BP reading: 204/124 which reduced to 127/87 5 minutes later. HR readings every few minutes: 102, 120, 116, 112
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Caller states that she had COVID and was hospitalized for it.; Caller states that she had COVID and was hospitalized for it.; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included immunodeficiency. The patient previously took Ocrevus. The patient states that she receives this drug every six month in a two shot series and wants to know if Pfizer has done any studies on people with immunosuppression getting a booster shot and would also like to be involved in a study for immunocompromised patients if there is one. On 25Feb, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It is important to have a vaccine technology that allows us to provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine does not protect against. While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we are taking multiple steps to be ready in case a strain becomes resistant to the vaccine. The administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine is not approved. Pfizer is unable to make any recommendations regarding administration of a booster dose of Pfizer-BioNTech COVID-19 Vaccine; Pfizer does not suggest or recommend the use of the vaccine in any manner other than as described in the authorized EUA if authorized product monograph. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced that patient has covid and was hospitalized for it. The outcome of the event was unknown.   Information on the lot/batch, further information has been requested.
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller states that she had COVID and was hospitalized for it.; Caller states that she had COVID and was hospitalized for it.; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included immunodeficiency. The patient previously took Ocrevus. The patient states that she receives this drug every six month in a two shot series and wants to know if Pfizer has done any studies on people with immunosuppression getting a booster shot and would also like to be involved in a study for immunocompromised patients if there is one. On 25Feb, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It is important to have a vaccine technology that allows us to provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine does not protect against. While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we are taking multiple steps to be ready in case a strain becomes resistant to the vaccine. The administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine is not approved. Pfizer is unable to make any recommendations regarding administration of a booster dose of Pfizer-BioNTech COVID-19 Vaccine; Pfizer does not suggest or recommend the use of the vaccine in any manner other than as described in the authorized EUA if authorized product monograph. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced that patient has covid and was hospitalized for it. The outcome of the event was unknown.   Information on the lot/batch, further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: MYALGIA; This spontaneous report received from a physician concerned a 70 year old female. The patient's weight was 179 pounds, and height was 66 inches. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced myalgia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myalgia was not reported. This report was non-serious. This case, involving the same patient is linked to 20191205957.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time shortened, Antibody test negative, Blood fibrinogen increased, Differential white blood cell count, Fibrin D dimer
Clinical narrative: PETECHIAE ON MY SKIN, MORE ON ARMS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, hypothyroidism, and generalized anxiety.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. Concomitant medications included selegiline for depression, alprazolam for generalised anxeity, and levothyroxine for hypothyroidism. On 10-JUN-2021, the subject experienced petechiae on my skin, more on arms. On 11-JUN-2021, Laboratory data included: Laboratory test (NR: not provided) Normal. On 15-JUN-2021, Laboratory data included: Laboratory test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from petechiae on my skin, more on arms. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Glomerular filtration rate increased, Lymphocyte count, Metabolic function test normal, Neutrophil percentage
Clinical narrative: PETECHIAE ON MY SKIN, MORE ON ARMS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, hypothyroidism, and generalized anxiety.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. Concomitant medications included selegiline for depression, alprazolam for generalised anxeity, and levothyroxine for hypothyroidism. On 10-JUN-2021, the subject experienced petechiae on my skin, more on arms. On 11-JUN-2021, Laboratory data included: Laboratory test (NR: not provided) Normal. On 15-JUN-2021, Laboratory data included: Laboratory test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from petechiae on my skin, more on arms. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Petechiae, Prothrombin time
Clinical narrative: PETECHIAE ON MY SKIN, MORE ON ARMS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, hypothyroidism, and generalized anxiety.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. Concomitant medications included selegiline for depression, alprazolam for generalised anxeity, and levothyroxine for hypothyroidism. On 10-JUN-2021, the subject experienced petechiae on my skin, more on arms. On 11-JUN-2021, Laboratory data included: Laboratory test (NR: not provided) Normal. On 15-JUN-2021, Laboratory data included: Laboratory test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from petechiae on my skin, more on arms. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Petechiae
Clinical narrative: PETECHIAE ON MY SKIN, MORE ON ARMS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, hypothyroidism, and generalized anxiety.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. Concomitant medications included selegiline for depression, alprazolam for generalised anxeity, and levothyroxine for hypothyroidism. On 10-JUN-2021, the subject experienced petechiae on my skin, more on arms. On 11-JUN-2021, Laboratory data included: Laboratory test (NR: not provided) Normal. On 15-JUN-2021, Laboratory data included: Laboratory test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from petechiae on my skin, more on arms. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Laboratory test, Vertigo
Clinical narrative: EPISODES OF THE ROOM SPINNING UPON LAYING DOWN; This spontaneous report received from a physician concerned a 68 year old male. The patient's weight was 265 pounds, and height was 73 inches. The patient's past medical history included pinched nerves in the back, and concurrent conditions included alcohol user, non-smoker, and hay fever, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. The patient was previously treated with gabapentin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included hydrocodone bitartrate/paracetamol for pain. On 12-MAR-2021, the subject experienced episodes of the room spinning upon laying down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from episodes of the room spinning upon laying down. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: EPISODES OF THE ROOM SPINNING UPON LAYING DOWN; This spontaneous report received from a physician concerned a 68 year old male. The patient's weight was 265 pounds, and height was 73 inches. The patient's past medical history included pinched nerves in the back, and concurrent conditions included alcohol user, non-smoker, and hay fever, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. The patient was previously treated with gabapentin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included hydrocodone bitartrate/paracetamol for pain. On 12-MAR-2021, the subject experienced episodes of the room spinning upon laying down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from episodes of the room spinning upon laying down. This report was non-serious.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort
Clinical narrative: After the vaccine was advised by pharmacy to go Urgent Care exp chest tightness left side. We went to the Urgent Care checked his 02 saturation and vitals was told they was not equipped to deal with vaccine related reactions.Then went to ER had Chest X-ray and EKG done.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Electrocardiogram normal
Clinical narrative: After the vaccine was advised by pharmacy to go Urgent Care exp chest tightness left side. We went to the Urgent Care checked his 02 saturation and vitals was told they was not equipped to deal with vaccine related reactions.Then went to ER had Chest X-ray and EKG done.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Troponin I increased
Clinical narrative: Patient is a 15-year-old male who presents to the ED today with a first episode of chest pain. The pain woke him up this morning, had an intensity 8/10, was substernal, pressure-like, not radiating, not positional, with no changes with inspiration. He did not have any palpitations, shortness of breath, nausea, dizziness, nor any other associated symptoms. No fever, some mild clear rhinorrhea this morning. He did have a temperature to 37.7C and dry cough on June 11th, for which he was tested for SARS-Covid-2, that was negative. He did not take any medications for the pain. Of note, he had the second dose of the Pfizer SARS-CoV-2 vaccine on June 17th. Since the pain persisted, he presented to an ED. At the ER he was found to be hemodynamically stable, with normal vital signs for age, normal physical exam with no cardiac findings, a normal ECG, but increased troponin (2000, with N 0-47) and mildly increased CRP. Ibuprofen was administered for the pain, with good response (8/10 >2/10). He was then transferred to our ED.   In our ED he was found to have normal vital signs for age (HR 76, BP128/73 mmHg, SpO2 100%), had a not-toxic appearance, and was afebrile. Cardiology was consulted in the setting of possible myocarditis or COVID-vaccine related myocarditis.   Cardiology note: Patient is a 15 year old boy presenting with a classic story for COVID-vaccine myocarditis, with chest pain and elevated troponin 3 days after the second dose of Pfizer vaccine.  LVEF is at the lower limit of normal, and troponin has fallen today to 0.12 ng/ml.  EKG has shown minimal STTWC.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adenovirus test, Body temperature increased, Brain natriuretic peptide normal, C-reactive protein, C-reactive protein increased
Clinical narrative: Patient is a 15-year-old male who presents to the ED today with a first episode of chest pain. The pain woke him up this morning, had an intensity 8/10, was substernal, pressure-like, not radiating, not positional, with no changes with inspiration. He did not have any palpitations, shortness of breath, nausea, dizziness, nor any other associated symptoms. No fever, some mild clear rhinorrhea this morning. He did have a temperature to 37.7C and dry cough on June 11th, for which he was tested for SARS-Covid-2, that was negative. He did not take any medications for the pain. Of note, he had the second dose of the Pfizer SARS-CoV-2 vaccine on June 17th. Since the pain persisted, he presented to an ED. At the ER he was found to be hemodynamically stable, with normal vital signs for age, normal physical exam with no cardiac findings, a normal ECG, but increased troponin (2000, with N 0-47) and mildly increased CRP. Ibuprofen was administered for the pain, with good response (8/10 >2/10). He was then transferred to our ED.   In our ED he was found to have normal vital signs for age (HR 76, BP128/73 mmHg, SpO2 100%), had a not-toxic appearance, and was afebrile. Cardiology was consulted in the setting of possible myocarditis or COVID-vaccine related myocarditis.   Cardiology note: Patient is a 15 year old boy presenting with a classic story for COVID-vaccine myocarditis, with chest pain and elevated troponin 3 days after the second dose of Pfizer vaccine.  LVEF is at the lower limit of normal, and troponin has fallen today to 0.12 ng/ml.  EKG has shown minimal STTWC.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest discomfort, Chest pain, Cough, Differential white blood cell count normal
Clinical narrative: Patient is a 15-year-old male who presents to the ED today with a first episode of chest pain. The pain woke him up this morning, had an intensity 8/10, was substernal, pressure-like, not radiating, not positional, with no changes with inspiration. He did not have any palpitations, shortness of breath, nausea, dizziness, nor any other associated symptoms. No fever, some mild clear rhinorrhea this morning. He did have a temperature to 37.7C and dry cough on June 11th, for which he was tested for SARS-Covid-2, that was negative. He did not take any medications for the pain. Of note, he had the second dose of the Pfizer SARS-CoV-2 vaccine on June 17th. Since the pain persisted, he presented to an ED. At the ER he was found to be hemodynamically stable, with normal vital signs for age, normal physical exam with no cardiac findings, a normal ECG, but increased troponin (2000, with N 0-47) and mildly increased CRP. Ibuprofen was administered for the pain, with good response (8/10 >2/10). He was then transferred to our ED.   In our ED he was found to have normal vital signs for age (HR 76, BP128/73 mmHg, SpO2 100%), had a not-toxic appearance, and was afebrile. Cardiology was consulted in the setting of possible myocarditis or COVID-vaccine related myocarditis.   Cardiology note: Patient is a 15 year old boy presenting with a classic story for COVID-vaccine myocarditis, with chest pain and elevated troponin 3 days after the second dose of Pfizer vaccine.  LVEF is at the lower limit of normal, and troponin has fallen today to 0.12 ng/ml.  EKG has shown minimal STTWC.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram ST-T change, Electrocardiogram normal, Full blood count, Human metapneumovirus test
Clinical narrative: Patient is a 15-year-old male who presents to the ED today with a first episode of chest pain. The pain woke him up this morning, had an intensity 8/10, was substernal, pressure-like, not radiating, not positional, with no changes with inspiration. He did not have any palpitations, shortness of breath, nausea, dizziness, nor any other associated symptoms. No fever, some mild clear rhinorrhea this morning. He did have a temperature to 37.7C and dry cough on June 11th, for which he was tested for SARS-Covid-2, that was negative. He did not take any medications for the pain. Of note, he had the second dose of the Pfizer SARS-CoV-2 vaccine on June 17th. Since the pain persisted, he presented to an ED. At the ER he was found to be hemodynamically stable, with normal vital signs for age, normal physical exam with no cardiac findings, a normal ECG, but increased troponin (2000, with N 0-47) and mildly increased CRP. Ibuprofen was administered for the pain, with good response (8/10 >2/10). He was then transferred to our ED.   In our ED he was found to have normal vital signs for age (HR 76, BP128/73 mmHg, SpO2 100%), had a not-toxic appearance, and was afebrile. Cardiology was consulted in the setting of possible myocarditis or COVID-vaccine related myocarditis.   Cardiology note: Patient is a 15 year old boy presenting with a classic story for COVID-vaccine myocarditis, with chest pain and elevated troponin 3 days after the second dose of Pfizer vaccine.  LVEF is at the lower limit of normal, and troponin has fallen today to 0.12 ng/ml.  EKG has shown minimal STTWC.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Human rhinovirus test, Influenza A virus test negative, Influenza B virus test, Magnetic resonance imaging heart, Mitral valve incompetence
Clinical narrative: Patient is a 15-year-old male who presents to the ED today with a first episode of chest pain. The pain woke him up this morning, had an intensity 8/10, was substernal, pressure-like, not radiating, not positional, with no changes with inspiration. He did not have any palpitations, shortness of breath, nausea, dizziness, nor any other associated symptoms. No fever, some mild clear rhinorrhea this morning. He did have a temperature to 37.7C and dry cough on June 11th, for which he was tested for SARS-Covid-2, that was negative. He did not take any medications for the pain. Of note, he had the second dose of the Pfizer SARS-CoV-2 vaccine on June 17th. Since the pain persisted, he presented to an ED. At the ER he was found to be hemodynamically stable, with normal vital signs for age, normal physical exam with no cardiac findings, a normal ECG, but increased troponin (2000, with N 0-47) and mildly increased CRP. Ibuprofen was administered for the pain, with good response (8/10 >2/10). He was then transferred to our ED.   In our ED he was found to have normal vital signs for age (HR 76, BP128/73 mmHg, SpO2 100%), had a not-toxic appearance, and was afebrile. Cardiology was consulted in the setting of possible myocarditis or COVID-vaccine related myocarditis.   Cardiology note: Patient is a 15 year old boy presenting with a classic story for COVID-vaccine myocarditis, with chest pain and elevated troponin 3 days after the second dose of Pfizer vaccine.  LVEF is at the lower limit of normal, and troponin has fallen today to 0.12 ng/ml.  EKG has shown minimal STTWC.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Monocyte percentage increased, Myocarditis, Renal function test normal, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Patient is a 15-year-old male who presents to the ED today with a first episode of chest pain. The pain woke him up this morning, had an intensity 8/10, was substernal, pressure-like, not radiating, not positional, with no changes with inspiration. He did not have any palpitations, shortness of breath, nausea, dizziness, nor any other associated symptoms. No fever, some mild clear rhinorrhea this morning. He did have a temperature to 37.7C and dry cough on June 11th, for which he was tested for SARS-Covid-2, that was negative. He did not take any medications for the pain. Of note, he had the second dose of the Pfizer SARS-CoV-2 vaccine on June 17th. Since the pain persisted, he presented to an ED. At the ER he was found to be hemodynamically stable, with normal vital signs for age, normal physical exam with no cardiac findings, a normal ECG, but increased troponin (2000, with N 0-47) and mildly increased CRP. Ibuprofen was administered for the pain, with good response (8/10 >2/10). He was then transferred to our ED.   In our ED he was found to have normal vital signs for age (HR 76, BP128/73 mmHg, SpO2 100%), had a not-toxic appearance, and was afebrile. Cardiology was consulted in the setting of possible myocarditis or COVID-vaccine related myocarditis.   Cardiology note: Patient is a 15 year old boy presenting with a classic story for COVID-vaccine myocarditis, with chest pain and elevated troponin 3 days after the second dose of Pfizer vaccine.  LVEF is at the lower limit of normal, and troponin has fallen today to 0.12 ng/ml.  EKG has shown minimal STTWC.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tricuspid valve incompetence, Troponin T increased
Clinical narrative: Patient is a 15-year-old male who presents to the ED today with a first episode of chest pain. The pain woke him up this morning, had an intensity 8/10, was substernal, pressure-like, not radiating, not positional, with no changes with inspiration. He did not have any palpitations, shortness of breath, nausea, dizziness, nor any other associated symptoms. No fever, some mild clear rhinorrhea this morning. He did have a temperature to 37.7C and dry cough on June 11th, for which he was tested for SARS-Covid-2, that was negative. He did not take any medications for the pain. Of note, he had the second dose of the Pfizer SARS-CoV-2 vaccine on June 17th. Since the pain persisted, he presented to an ED. At the ER he was found to be hemodynamically stable, with normal vital signs for age, normal physical exam with no cardiac findings, a normal ECG, but increased troponin (2000, with N 0-47) and mildly increased CRP. Ibuprofen was administered for the pain, with good response (8/10 >2/10). He was then transferred to our ED.   In our ED he was found to have normal vital signs for age (HR 76, BP128/73 mmHg, SpO2 100%), had a not-toxic appearance, and was afebrile. Cardiology was consulted in the setting of possible myocarditis or COVID-vaccine related myocarditis.   Cardiology note: Patient is a 15 year old boy presenting with a classic story for COVID-vaccine myocarditis, with chest pain and elevated troponin 3 days after the second dose of Pfizer vaccine.  LVEF is at the lower limit of normal, and troponin has fallen today to 0.12 ng/ml.  EKG has shown minimal STTWC.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: After I got my second Moderna shot my right arm hurt but I thought it was normal but it has been almost 3 weeks and 3days ago it started to hurt really bad and now I can?t use my right arm because I have so much pain and I have no range of motion I can?t lift my right arm over my head or even out to my side I went to the emergency room and waited 3 hours to be seen and finally they took xrays and said I have bursitis in my right arm from getting the vaccine or how it was given to me I don?t think the girl gave me the shot in the right place and she gave it to me to high or to deep in my arm causing really bad pain now to wear my arm is in a sling!
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bursitis, Injected limb mobility decreased, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: After I got my second Moderna shot my right arm hurt but I thought it was normal but it has been almost 3 weeks and 3days ago it started to hurt really bad and now I can?t use my right arm because I have so much pain and I have no range of motion I can?t lift my right arm over my head or even out to my side I went to the emergency room and waited 3 hours to be seen and finally they took xrays and said I have bursitis in my right arm from getting the vaccine or how it was given to me I don?t think the girl gave me the shot in the right place and she gave it to me to high or to deep in my arm causing really bad pain now to wear my arm is in a sling!
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered at inappropriate site, Shoulder injury related to vaccine administration, X-ray limb abnormal
Clinical narrative: After I got my second Moderna shot my right arm hurt but I thought it was normal but it has been almost 3 weeks and 3days ago it started to hurt really bad and now I can?t use my right arm because I have so much pain and I have no range of motion I can?t lift my right arm over my head or even out to my side I went to the emergency room and waited 3 hours to be seen and finally they took xrays and said I have bursitis in my right arm from getting the vaccine or how it was given to me I don?t think the girl gave me the shot in the right place and she gave it to me to high or to deep in my arm causing really bad pain now to wear my arm is in a sling!
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Brain natriuretic peptide normal, C-reactive protein increased, Chest discomfort, Chills
Clinical narrative: Patient developed chest tightness and difficulty breathing starting about 8 hours after the 2nd dose of Pfizer vaccine.  Also c/o headache, chills.  Treated with ASA, colchicine.  Still in hospital - symptoms are improving.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Headache, Leukocytosis, Pericarditis, Respiration abnormal
Clinical narrative: Patient developed chest tightness and difficulty breathing starting about 8 hours after the 2nd dose of Pfizer vaccine.  Also c/o headache, chills.  Treated with ASA, colchicine.  Still in hospital - symptoms are improving.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: Patient developed chest tightness and difficulty breathing starting about 8 hours after the 2nd dose of Pfizer vaccine.  Also c/o headache, chills.  Treated with ASA, colchicine.  Still in hospital - symptoms are improving.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood creatine phosphokinase increased, Brain natriuretic peptide normal, Cardiac imaging procedure abnormal, Chest discomfort
Clinical narrative: Patient developed chest tightness and difficulty breathing starting about 8 hours after the 2nd dose of Pfizer vaccine.  Also c/o headache, chills.  Treated with ASA, colchicine.  Still in hospital - symptoms are improving.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Headache, Myocarditis, Pericardial effusion
Clinical narrative: Patient developed chest tightness and difficulty breathing starting about 8 hours after the 2nd dose of Pfizer vaccine.  Also c/o headache, chills.  Treated with ASA, colchicine.  Still in hospital - symptoms are improving.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin
Clinical narrative: Patient developed chest tightness and difficulty breathing starting about 8 hours after the 2nd dose of Pfizer vaccine.  Also c/o headache, chills.  Treated with ASA, colchicine.  Still in hospital - symptoms are improving.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Intensive care, Multisystem inflammatory syndrome in children, Myocarditis, Pain in jaw
Clinical narrative: 2 days after vaccine, developed mid-sternal chest pain, jaw pain, low grade fever and vomiting. Presented with tropinemia and abnormal echo concerning for perimyocarditis
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination complication, Vomiting
Clinical narrative: 2 days after vaccine, developed mid-sternal chest pain, jaw pain, low grade fever and vomiting. Presented with tropinemia and abnormal echo concerning for perimyocarditis
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Chest pain, Echocardiogram abnormal, Ejection fraction decreased, Left ventricular dysfunction
Clinical narrative: 2 days after vaccine, developed mid-sternal chest pain, jaw pain, low grade fever and vomiting. Presented with tropinemia and abnormal echo concerning for perimyocarditis
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, N-terminal prohormone brain natriuretic peptide normal, Pain in jaw, Pyrexia, Troponin I increased
Clinical narrative: 2 days after vaccine, developed mid-sternal chest pain, jaw pain, low grade fever and vomiting. Presented with tropinemia and abnormal echo concerning for perimyocarditis
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: 2 days after vaccine, developed mid-sternal chest pain, jaw pain, low grade fever and vomiting. Presented with tropinemia and abnormal echo concerning for perimyocarditis
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Pain
Clinical narrative: BRUISING; LIGHTHEADED; CHEST TIGHTNESS; SHORTNESS OF BREATH; RIGHT FROZEN SHOULDER; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included gallstones, and concurrent conditions included alcohol consume, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse. patient had 1-2 glasses of wine a day. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 11-JUN-2021 11:00:00 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced bruising. On 11-JUN-2021, the subject experienced lightheaded. On 11-JUN-2021, the subject experienced chest tightness. On 11-JUN-2021, the subject experienced shortness of breath. On 11-JUN-2021, the subject experienced right frozen shoulder. Laboratory data included: Blood pressure (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheaded, chest tightness, shortness of breath, and bruising, and the outcome of right frozen shoulder was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the is case assessed as non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Contusion, Dizziness, Dyspnoea
Clinical narrative: BRUISING; LIGHTHEADED; CHEST TIGHTNESS; SHORTNESS OF BREATH; RIGHT FROZEN SHOULDER; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included gallstones, and concurrent conditions included alcohol consume, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse. patient had 1-2 glasses of wine a day. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 11-JUN-2021 11:00:00 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced bruising. On 11-JUN-2021, the subject experienced lightheaded. On 11-JUN-2021, the subject experienced chest tightness. On 11-JUN-2021, the subject experienced shortness of breath. On 11-JUN-2021, the subject experienced right frozen shoulder. Laboratory data included: Blood pressure (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheaded, chest tightness, shortness of breath, and bruising, and the outcome of right frozen shoulder was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the is case assessed as non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Periarthritis
Clinical narrative: BRUISING; LIGHTHEADED; CHEST TIGHTNESS; SHORTNESS OF BREATH; RIGHT FROZEN SHOULDER; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included gallstones, and concurrent conditions included alcohol consume, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse. patient had 1-2 glasses of wine a day. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 11-JUN-2021 11:00:00 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced bruising. On 11-JUN-2021, the subject experienced lightheaded. On 11-JUN-2021, the subject experienced chest tightness. On 11-JUN-2021, the subject experienced shortness of breath. On 11-JUN-2021, the subject experienced right frozen shoulder. Laboratory data included: Blood pressure (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheaded, chest tightness, shortness of breath, and bruising, and the outcome of right frozen shoulder was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the is case assessed as non-serious.
Age: 1.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no other AEs reported; medical assistant reporting adminitration of ROTATEQ to a patient 13 months of age; This spontaneous report was received from a medical assistant referring to a 13-month-old patient of unknown gender.  Information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.  On 28-MAY-2021, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 1 dose by oral route for prophylaxis (with lot number 1742461 and expiration date 17-NOV-2021, which were verified to be valid; vaccination scheme frequency was not reported) (product administered to patient of inappropriate age). No other adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed with customer that no other AE occurred; PROQU AD was administered after experiencing a temperature excursion; This spontaneous report was received from a nurse concerning, a patient of an unknown age and gender.   The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.  On 27-APR-2021 the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), 1 dosage (lot # T005404, expiration date 12-AUG-2021 (reported as 24-MAR-2022), valid for company product) (strength, dose and route of administration were) for prophylaxis. No signs or symptoms were reported.  The doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were exposed to a temperature excursion of 37.2 degrees Celsius(°C) during a time frame of 3 hours, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; dose of PROQU AD was administered after experiencing a temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 25-MAR-2021, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (at the dose of 1 dosage form, lot # T005404, expiration date reported as 24-MAR-2022, but upon internal validation established as 12-AUG-2021) was administered as prophylaxis after experiencing a temperature excursion (product storage error). The temperature was 37.2 F and the time was 3 hours. No previous temperature excursion was reported. The call was because of a data logger. No other adverse event (AE) was reported.