chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram abdomen normal, Computerised tomogram pelvis, Electrocardiogram abnormal, Neck pain
Clinical narrative: NECK PAIN; UNDER ARM PAIN; PAIN IN THE ARMS RADIATES FROM ONE ARM TO THE OTHER (BOTH ARMS); CHEST PAIN; BURNING SMELL; STOMACH PAIN; DRY EYE; RED EYE; HEADACHE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, vitamin b12 allergy, and fish product allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced dry eye. On 10-APR-2021, the subject experienced red eye. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced burning smell. Laboratory data included: CT scan (NR: not provided) Normal. On 19-APR-2021, the subject experienced chest pain. On 19-APR-2021, the subject experienced pain in the arms radiates from one arm to the other (both arms). On 22-APR-2021, the subject experienced under arm pain. On 27-APR-2021, the subject experienced neck pain. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry eye, and red eye, was recovering from stomach pain, and had not recovered from chest pain, pain in the arms radiates from one arm to the other (both arms), headache, neck pain, burning smell, and under arm pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Scan with contrast normal, Ultrasound Doppler normal, Ultrasound thyroid normal
Clinical narrative: NECK PAIN; UNDER ARM PAIN; PAIN IN THE ARMS RADIATES FROM ONE ARM TO THE OTHER (BOTH ARMS); CHEST PAIN; BURNING SMELL; STOMACH PAIN; DRY EYE; RED EYE; HEADACHE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, vitamin b12 allergy, and fish product allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced dry eye. On 10-APR-2021, the subject experienced red eye. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced burning smell. Laboratory data included: CT scan (NR: not provided) Normal. On 19-APR-2021, the subject experienced chest pain. On 19-APR-2021, the subject experienced pain in the arms radiates from one arm to the other (both arms). On 22-APR-2021, the subject experienced under arm pain. On 27-APR-2021, the subject experienced neck pain. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry eye, and red eye, was recovering from stomach pain, and had not recovered from chest pain, pain in the arms radiates from one arm to the other (both arms), headache, neck pain, burning smell, and under arm pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Axillary pain, Chest pain, Computerised tomogram, Dry eye
Clinical narrative: NECK PAIN; UNDER ARM PAIN; PAIN IN THE ARMS RADIATES FROM ONE ARM TO THE OTHER (BOTH ARMS); CHEST PAIN; BURNING SMELL; STOMACH PAIN; DRY EYE; RED EYE; HEADACHE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, vitamin b12 allergy, and fish product allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced dry eye. On 10-APR-2021, the subject experienced red eye. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced burning smell. Laboratory data included: CT scan (NR: not provided) Normal. On 19-APR-2021, the subject experienced chest pain. On 19-APR-2021, the subject experienced pain in the arms radiates from one arm to the other (both arms). On 22-APR-2021, the subject experienced under arm pain. On 27-APR-2021, the subject experienced neck pain. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry eye, and red eye, was recovering from stomach pain, and had not recovered from chest pain, pain in the arms radiates from one arm to the other (both arms), headache, neck pain, burning smell, and under arm pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Neck pain, Ocular hyperaemia, Pain in extremity, Parosmia
Clinical narrative: NECK PAIN; UNDER ARM PAIN; PAIN IN THE ARMS RADIATES FROM ONE ARM TO THE OTHER (BOTH ARMS); CHEST PAIN; BURNING SMELL; STOMACH PAIN; DRY EYE; RED EYE; HEADACHE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, vitamin b12 allergy, and fish product allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced dry eye. On 10-APR-2021, the subject experienced red eye. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced burning smell. Laboratory data included: CT scan (NR: not provided) Normal. On 19-APR-2021, the subject experienced chest pain. On 19-APR-2021, the subject experienced pain in the arms radiates from one arm to the other (both arms). On 22-APR-2021, the subject experienced under arm pain. On 27-APR-2021, the subject experienced neck pain. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry eye, and red eye, was recovering from stomach pain, and had not recovered from chest pain, pain in the arms radiates from one arm to the other (both arms), headache, neck pain, burning smell, and under arm pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: NECK PAIN; UNDER ARM PAIN; PAIN IN THE ARMS RADIATES FROM ONE ARM TO THE OTHER (BOTH ARMS); CHEST PAIN; BURNING SMELL; STOMACH PAIN; DRY EYE; RED EYE; HEADACHE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, vitamin b12 allergy, and fish product allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced dry eye. On 10-APR-2021, the subject experienced red eye. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced burning smell. Laboratory data included: CT scan (NR: not provided) Normal. On 19-APR-2021, the subject experienced chest pain. On 19-APR-2021, the subject experienced pain in the arms radiates from one arm to the other (both arms). On 22-APR-2021, the subject experienced under arm pain. On 27-APR-2021, the subject experienced neck pain. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry eye, and red eye, was recovering from stomach pain, and had not recovered from chest pain, pain in the arms radiates from one arm to the other (both arms), headache, neck pain, burning smell, and under arm pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose increased, C-reactive protein increased, Chest pain, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: myocarditis; chest pain; fever; chills; myalgia; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) and CHEST PAIN (chest pain) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN and MYOCARDITIS. The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (myocarditis) was resolving and CHEST PAIN (chest pain), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: 4.8 (High) Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range.. In 2021, Ejection fraction: abnormal (abnormal) 50%, generalized hypokinesis. In 2021, Electrocardiogram: abnormal (abnormal) Diffuse STsegment elevation with depression in aVR. In 2021, Magnetic resonance imaging: abnormal (abnormal) Patchy subepicardial delayed enhancement. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Troponin: 104 (High) Baseline troponin 104  (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). and 285 (High) Peak value 285 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range)..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided.  It was reported that the patient was hemodynamically stable, no clinical heart failure.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer normal, Hypertension, Inflammatory marker increased, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: myocarditis; chest pain; fever; chills; myalgia; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) and CHEST PAIN (chest pain) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN and MYOCARDITIS. The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (myocarditis) was resolving and CHEST PAIN (chest pain), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: 4.8 (High) Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range.. In 2021, Ejection fraction: abnormal (abnormal) 50%, generalized hypokinesis. In 2021, Electrocardiogram: abnormal (abnormal) Diffuse STsegment elevation with depression in aVR. In 2021, Magnetic resonance imaging: abnormal (abnormal) Patchy subepicardial delayed enhancement. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Troponin: 104 (High) Baseline troponin 104  (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). and 285 (High) Peak value 285 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range)..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided.  It was reported that the patient was hemodynamically stable, no clinical heart failure.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate increased, Respiratory viral panel, SARS-CoV-2 test negative, Troponin increased
Clinical narrative: myocarditis; chest pain; fever; chills; myalgia; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) and CHEST PAIN (chest pain) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN and MYOCARDITIS. The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (myocarditis) was resolving and CHEST PAIN (chest pain), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: 4.8 (High) Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range.. In 2021, Ejection fraction: abnormal (abnormal) 50%, generalized hypokinesis. In 2021, Electrocardiogram: abnormal (abnormal) Diffuse STsegment elevation with depression in aVR. In 2021, Magnetic resonance imaging: abnormal (abnormal) Patchy subepicardial delayed enhancement. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Troponin: 104 (High) Baseline troponin 104  (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). and 285 (High) Peak value 285 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range)..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided.  It was reported that the patient was hemodynamically stable, no clinical heart failure.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Chest pain, Chills, Ejection fraction, Electrocardiogram
Clinical narrative: myocarditis; chest pain; fever; chills; myalgia; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) and CHEST PAIN (chest pain) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN and MYOCARDITIS. The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (myocarditis) was resolving and CHEST PAIN (chest pain), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: 4.8 (High) Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range.. In 2021, Ejection fraction: abnormal (abnormal) 50%, generalized hypokinesis. In 2021, Electrocardiogram: abnormal (abnormal) Diffuse STsegment elevation with depression in aVR. In 2021, Magnetic resonance imaging: abnormal (abnormal) Patchy subepicardial delayed enhancement. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Troponin: 104 (High) Baseline troponin 104  (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). and 285 (High) Peak value 285 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range)..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided.  It was reported that the patient was hemodynamically stable, no clinical heart failure.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Myalgia, Myocarditis, Pyrexia, SARS-CoV-2 test
Clinical narrative: myocarditis; chest pain; fever; chills; myalgia; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) and CHEST PAIN (chest pain) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN and MYOCARDITIS. The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (myocarditis) was resolving and CHEST PAIN (chest pain), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: 4.8 (High) Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range.. In 2021, Ejection fraction: abnormal (abnormal) 50%, generalized hypokinesis. In 2021, Electrocardiogram: abnormal (abnormal) Diffuse STsegment elevation with depression in aVR. In 2021, Magnetic resonance imaging: abnormal (abnormal) Patchy subepicardial delayed enhancement. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Troponin: 104 (High) Baseline troponin 104  (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). and 285 (High) Peak value 285 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range)..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided.  It was reported that the patient was hemodynamically stable, no clinical heart failure.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin
Clinical narrative: myocarditis; chest pain; fever; chills; myalgia; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) and CHEST PAIN (chest pain) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN and MYOCARDITIS. The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (myocarditis) was resolving and CHEST PAIN (chest pain), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: 4.8 (High) Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range.. In 2021, Ejection fraction: abnormal (abnormal) 50%, generalized hypokinesis. In 2021, Electrocardiogram: abnormal (abnormal) Diffuse STsegment elevation with depression in aVR. In 2021, Magnetic resonance imaging: abnormal (abnormal) Patchy subepicardial delayed enhancement. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Troponin: 104 (High) Baseline troponin 104  (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). and 285 (High) Peak value 285 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range)..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided.  It was reported that the patient was hemodynamically stable, no clinical heart failure.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Urticaria
Clinical narrative: Patient experienced painful, burning, red rash in armpit area and thighs on both sides of the body starting the day after the vaccine and continuing for several days afterward. No trouble breathing was reported. OTC treatment did not relieve symptoms. Patient went to PCP 3 days post vaccination and was given prednisone.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Rash, Rash erythematous
Clinical narrative: Patient experienced painful, burning, red rash in armpit area and thighs on both sides of the body starting the day after the vaccine and continuing for several days afterward. No trouble breathing was reported. OTC treatment did not relieve symptoms. Patient went to PCP 3 days post vaccination and was given prednisone.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Swelling face
Clinical narrative: Customer received first dose of Moderna vaccine on 5-19-2021 in her left arm and presented with swelling of her left side of face, ears, jawline and warm to touch. She said it stayed for 10 hours after and the same up until it got worst when she called the pharmacy on 5-24-2021.  She went to the ER and they diagnosed her with acute pruritis and gave her Clindamycin.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear swelling, Pruritus, Skin warm, Swelling face
Clinical narrative: Customer received first dose of Moderna vaccine on 5-19-2021 in her left arm and presented with swelling of her left side of face, ears, jawline and warm to touch. She said it stayed for 10 hours after and the same up until it got worst when she called the pharmacy on 5-24-2021.  She went to the ER and they diagnosed her with acute pruritis and gave her Clindamycin.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrioventricular block first degree, Chest pain, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Pyrexia
Clinical narrative: Vaccine-induced myocarditis; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDITIS (Vaccine-induced myocarditis) in an adolescent male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Vaccine-induced myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Vaccine-induced myocarditis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, Sinus arrhythmia, Sinus rhythm, Troponin increased
Clinical narrative: Vaccine-induced myocarditis; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDITIS (Vaccine-induced myocarditis) in an adolescent male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Vaccine-induced myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Vaccine-induced myocarditis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Vaccine-induced myocarditis; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDITIS (Vaccine-induced myocarditis) in an adolescent male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Vaccine-induced myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Vaccine-induced myocarditis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrioventricular block first degree, Chest pain, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Pyrexia
Clinical narrative: Vaccine-induced myocarditis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Vaccine-induced myocarditis) in an adolescent male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Vaccine-induced myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Vaccine-induced myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   A medical professional physician reported that a second case of apparent vaccine-induced myocarditis in a teenage male 3 days after Moderna vaccine was admitted. No concomitant medication reported. No treatment information was reported.  Company comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, Sinus arrhythmia, Sinus rhythm, Troponin increased
Clinical narrative: Vaccine-induced myocarditis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Vaccine-induced myocarditis) in an adolescent male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Vaccine-induced myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Vaccine-induced myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   A medical professional physician reported that a second case of apparent vaccine-induced myocarditis in a teenage male 3 days after Moderna vaccine was admitted. No concomitant medication reported. No treatment information was reported.  Company comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Vaccine-induced myocarditis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Vaccine-induced myocarditis) in an adolescent male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Vaccine-induced myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Vaccine-induced myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   A medical professional physician reported that a second case of apparent vaccine-induced myocarditis in a teenage male 3 days after Moderna vaccine was admitted. No concomitant medication reported. No treatment information was reported.  Company comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Dyspnoea, Hyperhidrosis, Hypoaesthesia, Nausea
Clinical narrative: I had a seizure and passed out within 5 mins of receiving shot.; I had a seizure and passed out within 5 mins of receiving shot.; temporarily blind; lost hearing; numbness in fingers and hands; lips turned white/skin turned white, cold, and pasty but was burning up on the inside; skin turned white, cold, and pasty but was burning up on the inside; skin turned white, cold, and pasty but was burning up on the inside; This is a spontaneous report from a contactable consumer.  A non-pregnant 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Jun2021 10:30 (Batch/Lot Number: EW0180) as dose 1, single (at the age of 17 year old) for COVID-19 immunisation.  Medical history included anaemia and known allergies: Environmental allergies. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced had a seizure and passed out within 5 mins of receiving shot (07Jun2021). Eventually came to but was temporarily blind, lost in hearing, and numbness fingers and hands; lips turned white; skin turned white, cold, and pasty but was burning up on the inside; water, Gatorade, and ice packs administered; 911 called; EMT assessed and since the patient appeared to be doing better, went home; eyesight restored except for peripherals and massive headache on left side. The patient's mother called Pediatrician and was advised to go to ER. The treatment received for the adverse event was pain meds. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19. The outcome of the events was recovered on Jun2021.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus, Tremor, Vision blurred
Clinical narrative: I had a seizure and passed out within 5 mins of receiving shot.; I had a seizure and passed out within 5 mins of receiving shot.; temporarily blind; lost hearing; numbness in fingers and hands; lips turned white/skin turned white, cold, and pasty but was burning up on the inside; skin turned white, cold, and pasty but was burning up on the inside; skin turned white, cold, and pasty but was burning up on the inside; This is a spontaneous report from a contactable consumer.  A non-pregnant 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Jun2021 10:30 (Batch/Lot Number: EW0180) as dose 1, single (at the age of 17 year old) for COVID-19 immunisation.  Medical history included anaemia and known allergies: Environmental allergies. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced had a seizure and passed out within 5 mins of receiving shot (07Jun2021). Eventually came to but was temporarily blind, lost in hearing, and numbness fingers and hands; lips turned white; skin turned white, cold, and pasty but was burning up on the inside; water, Gatorade, and ice packs administered; 911 called; EMT assessed and since the patient appeared to be doing better, went home; eyesight restored except for peripherals and massive headache on left side. The patient's mother called Pediatrician and was advised to go to ER. The treatment received for the adverse event was pain meds. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19. The outcome of the events was recovered on Jun2021.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness transient, Cold sweat, Deafness, Dysaesthesia, Hypoaesthesia
Clinical narrative: I had a seizure and passed out within 5 mins of receiving shot.; I had a seizure and passed out within 5 mins of receiving shot.; temporarily blind; lost hearing; numbness in fingers and hands; lips turned white/skin turned white, cold, and pasty but was burning up on the inside; skin turned white, cold, and pasty but was burning up on the inside; skin turned white, cold, and pasty but was burning up on the inside; This is a spontaneous report from a contactable consumer.  A non-pregnant 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Jun2021 10:30 (Batch/Lot Number: EW0180) as dose 1, single (at the age of 17 year old) for COVID-19 immunisation.  Medical history included anaemia and known allergies: Environmental allergies. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced had a seizure and passed out within 5 mins of receiving shot (07Jun2021). Eventually came to but was temporarily blind, lost in hearing, and numbness fingers and hands; lips turned white; skin turned white, cold, and pasty but was burning up on the inside; water, Gatorade, and ice packs administered; 911 called; EMT assessed and since the patient appeared to be doing better, went home; eyesight restored except for peripherals and massive headache on left side. The patient's mother called Pediatrician and was advised to go to ER. The treatment received for the adverse event was pain meds. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19. The outcome of the events was recovered on Jun2021.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness, Pallor, Seizure
Clinical narrative: I had a seizure and passed out within 5 mins of receiving shot.; I had a seizure and passed out within 5 mins of receiving shot.; temporarily blind; lost hearing; numbness in fingers and hands; lips turned white/skin turned white, cold, and pasty but was burning up on the inside; skin turned white, cold, and pasty but was burning up on the inside; skin turned white, cold, and pasty but was burning up on the inside; This is a spontaneous report from a contactable consumer.  A non-pregnant 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Jun2021 10:30 (Batch/Lot Number: EW0180) as dose 1, single (at the age of 17 year old) for COVID-19 immunisation.  Medical history included anaemia and known allergies: Environmental allergies. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced had a seizure and passed out within 5 mins of receiving shot (07Jun2021). Eventually came to but was temporarily blind, lost in hearing, and numbness fingers and hands; lips turned white; skin turned white, cold, and pasty but was burning up on the inside; water, Gatorade, and ice packs administered; 911 called; EMT assessed and since the patient appeared to be doing better, went home; eyesight restored except for peripherals and massive headache on left side. The patient's mother called Pediatrician and was advised to go to ER. The treatment received for the adverse event was pain meds. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19. The outcome of the events was recovered on Jun2021.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram normal, Headache, Memory impairment, Seizure like phenomena, Syncope
Clinical narrative: I had a seizure and passed out within 5 mins of receiving shot.; I had a seizure and passed out within 5 mins of receiving shot.; temporarily blind; lost hearing; numbness in fingers and hands; lips turned white/skin turned white, cold, and pasty but was burning up on the inside; skin turned white, cold, and pasty but was burning up on the inside; skin turned white, cold, and pasty but was burning up on the inside; This is a spontaneous report from a contactable consumer.  A non-pregnant 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Jun2021 10:30 (Batch/Lot Number: EW0180) as dose 1, single (at the age of 17 year old) for COVID-19 immunisation.  Medical history included anaemia and known allergies: Environmental allergies. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced had a seizure and passed out within 5 mins of receiving shot (07Jun2021). Eventually came to but was temporarily blind, lost in hearing, and numbness fingers and hands; lips turned white; skin turned white, cold, and pasty but was burning up on the inside; water, Gatorade, and ice packs administered; 911 called; EMT assessed and since the patient appeared to be doing better, went home; eyesight restored except for peripherals and massive headache on left side. The patient's mother called Pediatrician and was advised to go to ER. The treatment received for the adverse event was pain meds. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19. The outcome of the events was recovered on Jun2021.