chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin I
Clinical narrative: myocarditis; chest pain; This is a literature report.  A new trend of myocarditis among young adults who received mRNA vaccines for COVID-19 is emerging. The authors presented the case of a young adult who presented with chest pain 3 days after the second dose of Pfizer-BioNTech COVID-19 vaccine. He had elevated troponin I and C-reactive protein levels at the time of admission. Electrocardiogram (ECG) and echocardiogram findings were unremarkable. The patient improved with conservative management and was discharged home the next day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events myocarditis and chest pain cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase, Antinuclear antibody, Aspartate aminotransferase, Bilirubin conjugated, Blood alkaline phosphatase
Clinical narrative: myocarditis; chest pain; This is a literature report.  A new trend of myocarditis among young adults who received mRNA vaccines for COVID-19 is emerging. The authors presented the case of a young adult who presented with chest pain 3 days after the second dose of Pfizer-BioNTech COVID-19 vaccine. He had elevated troponin I and C-reactive protein levels at the time of admission. Electrocardiogram (ECG) and echocardiogram findings were unremarkable. The patient improved with conservative management and was discharged home the next day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events myocarditis and chest pain cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood bilirubin, C-reactive protein, Chest X-ray, Ejection fraction, Electrocardiogram
Clinical narrative: myocarditis; chest pain; This is a literature report.  A new trend of myocarditis among young adults who received mRNA vaccines for COVID-19 is emerging. The authors presented the case of a young adult who presented with chest pain 3 days after the second dose of Pfizer-BioNTech COVID-19 vaccine. He had elevated troponin I and C-reactive protein levels at the time of admission. Electrocardiogram (ECG) and echocardiogram findings were unremarkable. The patient improved with conservative management and was discharged home the next day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events myocarditis and chest pain cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Haemoglobin, Investigation, Myocarditis, Physical examination
Clinical narrative: myocarditis; chest pain; This is a literature report.  A new trend of myocarditis among young adults who received mRNA vaccines for COVID-19 is emerging. The authors presented the case of a young adult who presented with chest pain 3 days after the second dose of Pfizer-BioNTech COVID-19 vaccine. He had elevated troponin I and C-reactive protein levels at the time of admission. Electrocardiogram (ECG) and echocardiogram findings were unremarkable. The patient improved with conservative management and was discharged home the next day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events myocarditis and chest pain cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Red blood cell sedimentation rate normal, Sinus rhythm, Troponin I, Vital signs measurement
Clinical narrative: myocarditis; chest pain; This is a literature report.  A new trend of myocarditis among young adults who received mRNA vaccines for COVID-19 is emerging. The authors presented the case of a young adult who presented with chest pain 3 days after the second dose of Pfizer-BioNTech COVID-19 vaccine. He had elevated troponin I and C-reactive protein levels at the time of admission. Electrocardiogram (ECG) and echocardiogram findings were unremarkable. The patient improved with conservative management and was discharged home the next day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events myocarditis and chest pain cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count
Clinical narrative: myocarditis; chest pain; This is a literature report.  A new trend of myocarditis among young adults who received mRNA vaccines for COVID-19 is emerging. The authors presented the case of a young adult who presented with chest pain 3 days after the second dose of Pfizer-BioNTech COVID-19 vaccine. He had elevated troponin I and C-reactive protein levels at the time of admission. Electrocardiogram (ECG) and echocardiogram findings were unremarkable. The patient improved with conservative management and was discharged home the next day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events myocarditis and chest pain cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Chest pain, Echocardiogram, Electrocardiogram, Myocarditis
Clinical narrative: Myocarditis is rare but is increasingly being reported in young adults post vaccination for COVID-19.; This is a literature report from the Journal of Case reports in Internal Medicine, 2021, vol.8 (8); [DOI 10.12890/2021_002769] entitled Post-mRNA COVID-19 vaccination myocarditis.   A literature article was received where 27-year-old male presented to our emergency room with sharp, central, non-radiating chest pain associated with fatigue, 3 days after his second dose of Pfizer-BioNTech COVID-19 vaccine. Patient was detected with myocarditis, did not report any fever, chills, diaphoresis, upper or lower respiratory tract infection symptoms, nausea, vomiting or diarrhoea. He did not have any history of acute COVID-19 infection. Vitals were within normal limits. The physical examination was unremarkable. The ECG showed normal sinus rhythm without any ST-T changes. Chest x-ray showed no acute cardiopulmonary process. The patient was given aspirin 325 mg oral once and the symptoms resolved. Laboratory data showed elevated troponin I (0.245 ng/ml, normal 0-0.028 ng/ml) and C-reactive protein (44.2 mg/l, normal 0.0-8.0 mg/l) Troponin I peaked (0.391 ng/ml) 6 hours after the initial troponin. The echocardiogram showed a normal ejection fraction of 60% and no regional wall motion changes or pericardial effusion. The patient was monitored overnight in the hospital. Telemetry showed no arrhythmias. The patient was discharged home the next day.  The Laboratory tests included (name/value/reference range): Troponin I: 0.245 (0-0.028 ng/ml); WBC: 10 (4-11 K/ul); Hb: 15 1 (3.5-17.5 g/dl); Platelets: 127 (140-400 K/ul); Total bilirubin: 2.0 (0.2-1.2 mg/dl); Direct bilirubin: 0.7 (0-0.4 mg/dl); Alanine aminotransferase (ALT): 18 (0-55 U/l); Aspartate aminotransferase (AST): 23 (0-35 U/l); Alkaline phosphatase: 62 (30-150 U/l); C-reactive protein (CRP): 44.2 (0.0-8.0 mg/l); ESR: 7 (0- 14 mm/hr); D-dimer: < 0.27 (<0.49 ug/ml); ANA screen: Negative (Negative).  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported event myocarditis is consistent with the known safety profile of the suspect product Pfizer-BioNTech COVID-19 vaccine and considered as possibly related. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin I
Clinical narrative: Myocarditis is rare but is increasingly being reported in young adults post vaccination for COVID-19.; This is a literature report from the Journal of Case reports in Internal Medicine, 2021, vol.8 (8); [DOI 10.12890/2021_002769] entitled Post-mRNA COVID-19 vaccination myocarditis.   A literature article was received where 27-year-old male presented to our emergency room with sharp, central, non-radiating chest pain associated with fatigue, 3 days after his second dose of Pfizer-BioNTech COVID-19 vaccine. Patient was detected with myocarditis, did not report any fever, chills, diaphoresis, upper or lower respiratory tract infection symptoms, nausea, vomiting or diarrhoea. He did not have any history of acute COVID-19 infection. Vitals were within normal limits. The physical examination was unremarkable. The ECG showed normal sinus rhythm without any ST-T changes. Chest x-ray showed no acute cardiopulmonary process. The patient was given aspirin 325 mg oral once and the symptoms resolved. Laboratory data showed elevated troponin I (0.245 ng/ml, normal 0-0.028 ng/ml) and C-reactive protein (44.2 mg/l, normal 0.0-8.0 mg/l) Troponin I peaked (0.391 ng/ml) 6 hours after the initial troponin. The echocardiogram showed a normal ejection fraction of 60% and no regional wall motion changes or pericardial effusion. The patient was monitored overnight in the hospital. Telemetry showed no arrhythmias. The patient was discharged home the next day.  The Laboratory tests included (name/value/reference range): Troponin I: 0.245 (0-0.028 ng/ml); WBC: 10 (4-11 K/ul); Hb: 15 1 (3.5-17.5 g/dl); Platelets: 127 (140-400 K/ul); Total bilirubin: 2.0 (0.2-1.2 mg/dl); Direct bilirubin: 0.7 (0-0.4 mg/dl); Alanine aminotransferase (ALT): 18 (0-55 U/l); Aspartate aminotransferase (AST): 23 (0-35 U/l); Alkaline phosphatase: 62 (30-150 U/l); C-reactive protein (CRP): 44.2 (0.0-8.0 mg/l); ESR: 7 (0- 14 mm/hr); D-dimer: < 0.27 (<0.49 ug/ml); ANA screen: Negative (Negative).  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported event myocarditis is consistent with the known safety profile of the suspect product Pfizer-BioNTech COVID-19 vaccine and considered as possibly related. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase, Antinuclear antibody, Aspartate aminotransferase, Bilirubin conjugated, Blood alkaline phosphatase
Clinical narrative: Myocarditis is rare but is increasingly being reported in young adults post vaccination for COVID-19.; This is a literature report from the Journal of Case reports in Internal Medicine, 2021, vol.8 (8); [DOI 10.12890/2021_002769] entitled Post-mRNA COVID-19 vaccination myocarditis.   A literature article was received where 27-year-old male presented to our emergency room with sharp, central, non-radiating chest pain associated with fatigue, 3 days after his second dose of Pfizer-BioNTech COVID-19 vaccine. Patient was detected with myocarditis, did not report any fever, chills, diaphoresis, upper or lower respiratory tract infection symptoms, nausea, vomiting or diarrhoea. He did not have any history of acute COVID-19 infection. Vitals were within normal limits. The physical examination was unremarkable. The ECG showed normal sinus rhythm without any ST-T changes. Chest x-ray showed no acute cardiopulmonary process. The patient was given aspirin 325 mg oral once and the symptoms resolved. Laboratory data showed elevated troponin I (0.245 ng/ml, normal 0-0.028 ng/ml) and C-reactive protein (44.2 mg/l, normal 0.0-8.0 mg/l) Troponin I peaked (0.391 ng/ml) 6 hours after the initial troponin. The echocardiogram showed a normal ejection fraction of 60% and no regional wall motion changes or pericardial effusion. The patient was monitored overnight in the hospital. Telemetry showed no arrhythmias. The patient was discharged home the next day.  The Laboratory tests included (name/value/reference range): Troponin I: 0.245 (0-0.028 ng/ml); WBC: 10 (4-11 K/ul); Hb: 15 1 (3.5-17.5 g/dl); Platelets: 127 (140-400 K/ul); Total bilirubin: 2.0 (0.2-1.2 mg/dl); Direct bilirubin: 0.7 (0-0.4 mg/dl); Alanine aminotransferase (ALT): 18 (0-55 U/l); Aspartate aminotransferase (AST): 23 (0-35 U/l); Alkaline phosphatase: 62 (30-150 U/l); C-reactive protein (CRP): 44.2 (0.0-8.0 mg/l); ESR: 7 (0- 14 mm/hr); D-dimer: < 0.27 (<0.49 ug/ml); ANA screen: Negative (Negative).  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported event myocarditis is consistent with the known safety profile of the suspect product Pfizer-BioNTech COVID-19 vaccine and considered as possibly related. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood bilirubin, C-reactive protein, Chest X-ray, Ejection fraction, Electrocardiogram
Clinical narrative: Myocarditis is rare but is increasingly being reported in young adults post vaccination for COVID-19.; This is a literature report from the Journal of Case reports in Internal Medicine, 2021, vol.8 (8); [DOI 10.12890/2021_002769] entitled Post-mRNA COVID-19 vaccination myocarditis.   A literature article was received where 27-year-old male presented to our emergency room with sharp, central, non-radiating chest pain associated with fatigue, 3 days after his second dose of Pfizer-BioNTech COVID-19 vaccine. Patient was detected with myocarditis, did not report any fever, chills, diaphoresis, upper or lower respiratory tract infection symptoms, nausea, vomiting or diarrhoea. He did not have any history of acute COVID-19 infection. Vitals were within normal limits. The physical examination was unremarkable. The ECG showed normal sinus rhythm without any ST-T changes. Chest x-ray showed no acute cardiopulmonary process. The patient was given aspirin 325 mg oral once and the symptoms resolved. Laboratory data showed elevated troponin I (0.245 ng/ml, normal 0-0.028 ng/ml) and C-reactive protein (44.2 mg/l, normal 0.0-8.0 mg/l) Troponin I peaked (0.391 ng/ml) 6 hours after the initial troponin. The echocardiogram showed a normal ejection fraction of 60% and no regional wall motion changes or pericardial effusion. The patient was monitored overnight in the hospital. Telemetry showed no arrhythmias. The patient was discharged home the next day.  The Laboratory tests included (name/value/reference range): Troponin I: 0.245 (0-0.028 ng/ml); WBC: 10 (4-11 K/ul); Hb: 15 1 (3.5-17.5 g/dl); Platelets: 127 (140-400 K/ul); Total bilirubin: 2.0 (0.2-1.2 mg/dl); Direct bilirubin: 0.7 (0-0.4 mg/dl); Alanine aminotransferase (ALT): 18 (0-55 U/l); Aspartate aminotransferase (AST): 23 (0-35 U/l); Alkaline phosphatase: 62 (30-150 U/l); C-reactive protein (CRP): 44.2 (0.0-8.0 mg/l); ESR: 7 (0- 14 mm/hr); D-dimer: < 0.27 (<0.49 ug/ml); ANA screen: Negative (Negative).  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported event myocarditis is consistent with the known safety profile of the suspect product Pfizer-BioNTech COVID-19 vaccine and considered as possibly related. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Haemoglobin, Investigation, Myocarditis, Physical examination
Clinical narrative: Myocarditis is rare but is increasingly being reported in young adults post vaccination for COVID-19.; This is a literature report from the Journal of Case reports in Internal Medicine, 2021, vol.8 (8); [DOI 10.12890/2021_002769] entitled Post-mRNA COVID-19 vaccination myocarditis.   A literature article was received where 27-year-old male presented to our emergency room with sharp, central, non-radiating chest pain associated with fatigue, 3 days after his second dose of Pfizer-BioNTech COVID-19 vaccine. Patient was detected with myocarditis, did not report any fever, chills, diaphoresis, upper or lower respiratory tract infection symptoms, nausea, vomiting or diarrhoea. He did not have any history of acute COVID-19 infection. Vitals were within normal limits. The physical examination was unremarkable. The ECG showed normal sinus rhythm without any ST-T changes. Chest x-ray showed no acute cardiopulmonary process. The patient was given aspirin 325 mg oral once and the symptoms resolved. Laboratory data showed elevated troponin I (0.245 ng/ml, normal 0-0.028 ng/ml) and C-reactive protein (44.2 mg/l, normal 0.0-8.0 mg/l) Troponin I peaked (0.391 ng/ml) 6 hours after the initial troponin. The echocardiogram showed a normal ejection fraction of 60% and no regional wall motion changes or pericardial effusion. The patient was monitored overnight in the hospital. Telemetry showed no arrhythmias. The patient was discharged home the next day.  The Laboratory tests included (name/value/reference range): Troponin I: 0.245 (0-0.028 ng/ml); WBC: 10 (4-11 K/ul); Hb: 15 1 (3.5-17.5 g/dl); Platelets: 127 (140-400 K/ul); Total bilirubin: 2.0 (0.2-1.2 mg/dl); Direct bilirubin: 0.7 (0-0.4 mg/dl); Alanine aminotransferase (ALT): 18 (0-55 U/l); Aspartate aminotransferase (AST): 23 (0-35 U/l); Alkaline phosphatase: 62 (30-150 U/l); C-reactive protein (CRP): 44.2 (0.0-8.0 mg/l); ESR: 7 (0- 14 mm/hr); D-dimer: < 0.27 (<0.49 ug/ml); ANA screen: Negative (Negative).  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported event myocarditis is consistent with the known safety profile of the suspect product Pfizer-BioNTech COVID-19 vaccine and considered as possibly related. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Red blood cell sedimentation rate normal, Sinus rhythm, Troponin I, Vital signs measurement
Clinical narrative: Myocarditis is rare but is increasingly being reported in young adults post vaccination for COVID-19.; This is a literature report from the Journal of Case reports in Internal Medicine, 2021, vol.8 (8); [DOI 10.12890/2021_002769] entitled Post-mRNA COVID-19 vaccination myocarditis.   A literature article was received where 27-year-old male presented to our emergency room with sharp, central, non-radiating chest pain associated with fatigue, 3 days after his second dose of Pfizer-BioNTech COVID-19 vaccine. Patient was detected with myocarditis, did not report any fever, chills, diaphoresis, upper or lower respiratory tract infection symptoms, nausea, vomiting or diarrhoea. He did not have any history of acute COVID-19 infection. Vitals were within normal limits. The physical examination was unremarkable. The ECG showed normal sinus rhythm without any ST-T changes. Chest x-ray showed no acute cardiopulmonary process. The patient was given aspirin 325 mg oral once and the symptoms resolved. Laboratory data showed elevated troponin I (0.245 ng/ml, normal 0-0.028 ng/ml) and C-reactive protein (44.2 mg/l, normal 0.0-8.0 mg/l) Troponin I peaked (0.391 ng/ml) 6 hours after the initial troponin. The echocardiogram showed a normal ejection fraction of 60% and no regional wall motion changes or pericardial effusion. The patient was monitored overnight in the hospital. Telemetry showed no arrhythmias. The patient was discharged home the next day.  The Laboratory tests included (name/value/reference range): Troponin I: 0.245 (0-0.028 ng/ml); WBC: 10 (4-11 K/ul); Hb: 15 1 (3.5-17.5 g/dl); Platelets: 127 (140-400 K/ul); Total bilirubin: 2.0 (0.2-1.2 mg/dl); Direct bilirubin: 0.7 (0-0.4 mg/dl); Alanine aminotransferase (ALT): 18 (0-55 U/l); Aspartate aminotransferase (AST): 23 (0-35 U/l); Alkaline phosphatase: 62 (30-150 U/l); C-reactive protein (CRP): 44.2 (0.0-8.0 mg/l); ESR: 7 (0- 14 mm/hr); D-dimer: < 0.27 (<0.49 ug/ml); ANA screen: Negative (Negative).  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported event myocarditis is consistent with the known safety profile of the suspect product Pfizer-BioNTech COVID-19 vaccine and considered as possibly related. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count
Clinical narrative: Myocarditis is rare but is increasingly being reported in young adults post vaccination for COVID-19.; This is a literature report from the Journal of Case reports in Internal Medicine, 2021, vol.8 (8); [DOI 10.12890/2021_002769] entitled Post-mRNA COVID-19 vaccination myocarditis.   A literature article was received where 27-year-old male presented to our emergency room with sharp, central, non-radiating chest pain associated with fatigue, 3 days after his second dose of Pfizer-BioNTech COVID-19 vaccine. Patient was detected with myocarditis, did not report any fever, chills, diaphoresis, upper or lower respiratory tract infection symptoms, nausea, vomiting or diarrhoea. He did not have any history of acute COVID-19 infection. Vitals were within normal limits. The physical examination was unremarkable. The ECG showed normal sinus rhythm without any ST-T changes. Chest x-ray showed no acute cardiopulmonary process. The patient was given aspirin 325 mg oral once and the symptoms resolved. Laboratory data showed elevated troponin I (0.245 ng/ml, normal 0-0.028 ng/ml) and C-reactive protein (44.2 mg/l, normal 0.0-8.0 mg/l) Troponin I peaked (0.391 ng/ml) 6 hours after the initial troponin. The echocardiogram showed a normal ejection fraction of 60% and no regional wall motion changes or pericardial effusion. The patient was monitored overnight in the hospital. Telemetry showed no arrhythmias. The patient was discharged home the next day.  The Laboratory tests included (name/value/reference range): Troponin I: 0.245 (0-0.028 ng/ml); WBC: 10 (4-11 K/ul); Hb: 15 1 (3.5-17.5 g/dl); Platelets: 127 (140-400 K/ul); Total bilirubin: 2.0 (0.2-1.2 mg/dl); Direct bilirubin: 0.7 (0-0.4 mg/dl); Alanine aminotransferase (ALT): 18 (0-55 U/l); Aspartate aminotransferase (AST): 23 (0-35 U/l); Alkaline phosphatase: 62 (30-150 U/l); C-reactive protein (CRP): 44.2 (0.0-8.0 mg/l); ESR: 7 (0- 14 mm/hr); D-dimer: < 0.27 (<0.49 ug/ml); ANA screen: Negative (Negative).  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported event myocarditis is consistent with the known safety profile of the suspect product Pfizer-BioNTech COVID-19 vaccine and considered as possibly related. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dysstasia, Fatigue, Heart rate
Clinical narrative: Low heart rate 38-45 consistently for 48hrs; Couldn't stand for long periods both days; Fatigue with dizziness; Fatigue with dizziness; Nausea; Vomiting; Cold extremities; Low Blood pressure; This is a spontaneous report from a contactable (patient). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Aug2021 16:30 (at the age of 14-year-old) (Lot Number: FD8448) as dose 1, single for COVID-19 immunization. Medical history included murmur as a toddler with irregular HR. There were no concomitant medications. The patient previously took cefalexin monohydrate (KEFLEX) and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks of COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced fatigue with dizziness, nausea, vomiting and low heart rate 38-45 consistently for 48hrs, cold extremities, low Blood pressure, couldn't stand for long periods both days. The onset of events was reported as 19Aug2021 19:00. The patient did not receive treatment for the events. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate decreased, Hypotension, Nausea, Peripheral coldness, Vomiting
Clinical narrative: Low heart rate 38-45 consistently for 48hrs; Couldn't stand for long periods both days; Fatigue with dizziness; Fatigue with dizziness; Nausea; Vomiting; Cold extremities; Low Blood pressure; This is a spontaneous report from a contactable (patient). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Aug2021 16:30 (at the age of 14-year-old) (Lot Number: FD8448) as dose 1, single for COVID-19 immunization. Medical history included murmur as a toddler with irregular HR. There were no concomitant medications. The patient previously took cefalexin monohydrate (KEFLEX) and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks of COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced fatigue with dizziness, nausea, vomiting and low heart rate 38-45 consistently for 48hrs, cold extremities, low Blood pressure, couldn't stand for long periods both days. The onset of events was reported as 19Aug2021 19:00. The patient did not receive treatment for the events. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Dyspnoea
Clinical narrative: Difficulty breathing/ shortness of breath; Face and throat swelling; Face and throat swelling; Fast heartbeat; Bad rash all over my body; Dizziness and weakness; Dizziness and weakness; Pounding heart; Injection site pain and redness; Injection site pain and redness; Tiredness; Headache; Muscle pain; Chills; Joint pain; Nausea; Feeling unwell; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 31Aug2021 15:30 (at the age of 46-year-old) (Lot Number: FC3183) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 01Sep2021 20:00, the patient experienced difficulty breathing, face and throat swelling, fast heartbeat, bad rash all over my body, dizziness and weakness, shortness of breath, pounding heart, injection site pain and redness, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, swollen lymph nodes. The patient did not receive treatment for the events. The outcome of the events was not recovered. The reporter assessed the events as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Lymphadenopathy, Malaise
Clinical narrative: Difficulty breathing/ shortness of breath; Face and throat swelling; Face and throat swelling; Fast heartbeat; Bad rash all over my body; Dizziness and weakness; Dizziness and weakness; Pounding heart; Injection site pain and redness; Injection site pain and redness; Tiredness; Headache; Muscle pain; Chills; Joint pain; Nausea; Feeling unwell; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 31Aug2021 15:30 (at the age of 46-year-old) (Lot Number: FC3183) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 01Sep2021 20:00, the patient experienced difficulty breathing, face and throat swelling, fast heartbeat, bad rash all over my body, dizziness and weakness, shortness of breath, pounding heart, injection site pain and redness, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, swollen lymph nodes. The patient did not receive treatment for the events. The outcome of the events was not recovered. The reporter assessed the events as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Palpitations, Pharyngeal swelling, Rash
Clinical narrative: Difficulty breathing/ shortness of breath; Face and throat swelling; Face and throat swelling; Fast heartbeat; Bad rash all over my body; Dizziness and weakness; Dizziness and weakness; Pounding heart; Injection site pain and redness; Injection site pain and redness; Tiredness; Headache; Muscle pain; Chills; Joint pain; Nausea; Feeling unwell; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 31Aug2021 15:30 (at the age of 46-year-old) (Lot Number: FC3183) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 01Sep2021 20:00, the patient experienced difficulty breathing, face and throat swelling, fast heartbeat, bad rash all over my body, dizziness and weakness, shortness of breath, pounding heart, injection site pain and redness, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, swollen lymph nodes. The patient did not receive treatment for the events. The outcome of the events was not recovered. The reporter assessed the events as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vaccination site erythema, Vaccination site pain
Clinical narrative: Difficulty breathing/ shortness of breath; Face and throat swelling; Face and throat swelling; Fast heartbeat; Bad rash all over my body; Dizziness and weakness; Dizziness and weakness; Pounding heart; Injection site pain and redness; Injection site pain and redness; Tiredness; Headache; Muscle pain; Chills; Joint pain; Nausea; Feeling unwell; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 31Aug2021 15:30 (at the age of 46-year-old) (Lot Number: FC3183) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 01Sep2021 20:00, the patient experienced difficulty breathing, face and throat swelling, fast heartbeat, bad rash all over my body, dizziness and weakness, shortness of breath, pounding heart, injection site pain and redness, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, swollen lymph nodes. The patient did not receive treatment for the events. The outcome of the events was not recovered. The reporter assessed the events as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Diarrhoea, Disease recurrence, Fungal infection, Hypoaesthesia
Clinical narrative: Vomiting; Diarrhea; Swollen lymph nodes; Muscle spasms; Migraine; Migraine; Fungal infection; Pelvic pain; Breast pain; Numbness & tingling in extremities and face; Numbness & tingling in extremities and face; Vaginal discharge; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0181), via an unspecified route of administration, administered in Arm Left on 21Jun2021 12:00 at the age of 60-year-old as dose 1, single for covid-19 immunisation. Medical history included migraines, breast cancer (in remission for 13 years), Inflammatory bowel disease and patient had allergies to dilaudid, toradol, fiorocet. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced vomiting, diarrhea, migraine, swollen lymph nodes, fungal infection, pelvic pain, breast pain, numbness and tingling in extremities and face, muscle spasms and vaginal discharge. all beginning the same day or within two days of the injection and recurring ever since; sometimes with severity on 21Jun2021 18:00. The events result in emergency room/department or urgent care visit/ hospitalization prolonged and patient did not receive any treatment in response to the events. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Migraine, Muscle spasms, Paraesthesia, Pelvic pain
Clinical narrative: Vomiting; Diarrhea; Swollen lymph nodes; Muscle spasms; Migraine; Migraine; Fungal infection; Pelvic pain; Breast pain; Numbness & tingling in extremities and face; Numbness & tingling in extremities and face; Vaginal discharge; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0181), via an unspecified route of administration, administered in Arm Left on 21Jun2021 12:00 at the age of 60-year-old as dose 1, single for covid-19 immunisation. Medical history included migraines, breast cancer (in remission for 13 years), Inflammatory bowel disease and patient had allergies to dilaudid, toradol, fiorocet. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced vomiting, diarrhea, migraine, swollen lymph nodes, fungal infection, pelvic pain, breast pain, numbness and tingling in extremities and face, muscle spasms and vaginal discharge. all beginning the same day or within two days of the injection and recurring ever since; sometimes with severity on 21Jun2021 18:00. The events result in emergency room/department or urgent care visit/ hospitalization prolonged and patient did not receive any treatment in response to the events. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal discharge, Vomiting
Clinical narrative: Vomiting; Diarrhea; Swollen lymph nodes; Muscle spasms; Migraine; Migraine; Fungal infection; Pelvic pain; Breast pain; Numbness & tingling in extremities and face; Numbness & tingling in extremities and face; Vaginal discharge; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0181), via an unspecified route of administration, administered in Arm Left on 21Jun2021 12:00 at the age of 60-year-old as dose 1, single for covid-19 immunisation. Medical history included migraines, breast cancer (in remission for 13 years), Inflammatory bowel disease and patient had allergies to dilaudid, toradol, fiorocet. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced vomiting, diarrhea, migraine, swollen lymph nodes, fungal infection, pelvic pain, breast pain, numbness and tingling in extremities and face, muscle spasms and vaginal discharge. all beginning the same day or within two days of the injection and recurring ever since; sometimes with severity on 21Jun2021 18:00. The events result in emergency room/department or urgent care visit/ hospitalization prolonged and patient did not receive any treatment in response to the events. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Heart rate, Heart rate increased, Loss of consciousness
Clinical narrative: My vision was going black and I passed out; I had severe ringing in my ears/ Throughout the rest of the day my ears were ringing; Light headed /Dizzy; My heart rate was at 148bpm/ my resting heart beat never dropped below the 120s bpm.; Nausea; Bad headache; This is a spontaneous report from a contactable other health care professional (patient). A 24-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 10Sep2021 17:00 (at the age pf 24-year-old) (Lot Number: Fc3183) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included latex allergy. Concomitant medication included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 11Sep2021 10:30, the patient woke up and got up to brush her teeth and shower and had severe ringing in her ears, was light headed, dizzy, vision was going black and passed out. The patient's heart rate was at 148bpm when she regained consciousness. Throughout the rest of the day her ears were ringing, had a bad headache, nausea, and reported that her resting heart beat never dropped below the 120s bpm. The patient did not receive any treatment for the events. The outcome of the events was recovering.; Sender's Comments: Based on the reported information ,a causal relationship between the event loss of consciousness and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tinnitus
Clinical narrative: My vision was going black and I passed out; I had severe ringing in my ears/ Throughout the rest of the day my ears were ringing; Light headed /Dizzy; My heart rate was at 148bpm/ my resting heart beat never dropped below the 120s bpm.; Nausea; Bad headache; This is a spontaneous report from a contactable other health care professional (patient). A 24-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 10Sep2021 17:00 (at the age pf 24-year-old) (Lot Number: Fc3183) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included latex allergy. Concomitant medication included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 11Sep2021 10:30, the patient woke up and got up to brush her teeth and shower and had severe ringing in her ears, was light headed, dizzy, vision was going black and passed out. The patient's heart rate was at 148bpm when she regained consciousness. Throughout the rest of the day her ears were ringing, had a bad headache, nausea, and reported that her resting heart beat never dropped below the 120s bpm. The patient did not receive any treatment for the events. The outcome of the events was recovering.; Sender's Comments: Based on the reported information ,a causal relationship between the event loss of consciousness and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate