chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Drug screen negative, Dyspnoea, Electrocardiogram T wave abnormal, Electrocardiogram T wave inversion
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 21 year-old male subject with no significant medical history was found to have non-specific myocarditis 17 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 04 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 00.59, an abnormal ECG, a normal Echocardiogram and an abnormal MRI (heart). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Electrocardiogram abnormal, Fibrin D dimer normal, Full blood count normal, High density lipoprotein decreased, Hypoaesthesia
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 21 year-old male subject with no significant medical history was found to have non-specific myocarditis 17 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 04 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 00.59, an abnormal ECG, a normal Echocardiogram and an abnormal MRI (heart). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Limb discomfort, Low density lipoprotein normal, Metabolic function test, Metabolic function test normal, Myalgia
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 21 year-old male subject with no significant medical history was found to have non-specific myocarditis 17 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 04 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 00.59, an abnormal ECG, a normal Echocardiogram and an abnormal MRI (heart). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Neck pain, Pain in extremity, Pain in jaw, Paraesthesia, Pulmonary oedema
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 21 year-old male subject with no significant medical history was found to have non-specific myocarditis 17 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 04 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 00.59, an abnormal ECG, a normal Echocardiogram and an abnormal MRI (heart). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Red blood cell sedimentation rate normal, Sensation of pressure, Tenderness, Troponin I increased, Troponin T increased
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 21 year-old male subject with no significant medical history was found to have non-specific myocarditis 17 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 04 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 00.59, an abnormal ECG, a normal Echocardiogram and an abnormal MRI (heart). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Nuclear magnetic resonance imaging abnormal, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 21 year-old male subject with no significant medical history was found to have non-specific myocarditis 17 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 04 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 00.59, an abnormal ECG, a normal Echocardiogram and an abnormal MRI (heart). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Arthralgia, Basophil count normal, Basophil percentage decreased, Blood creatine phosphokinase MB, Blood creatine phosphokinase normal
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 416956. A 27-year-old male patient received the following vaccination on 31 January 2011: ACAM2000 (lot number VV04003A). The patient had no current illnesses. The patient had a history of asthma. On 13 February 2011, with one week history of myalgia and arthralgia and with chest discomfort not associated with position was found to have myocarditis likely related to the smallpox vaccine. An echocardiogram was within normal limits. The patient's laboratory findings were as follows on 14 February 2011 at 10:38: creatine kinase (CK) 76 IU/L, creatine kinase-MB fraction (CKMB) 2.2 ng/mL, percent CKMB 2.89%, and cardiac troponin I (cTnI) 0.25 ng/mL. The patient's laboratory findings were as follows on 14 February 2011 at 05:06: CK 91 IU/L, CKMB 2.8 ng/mL, percent CKMB 3.08%, and cTnI not provided. The following laboratory findings reported a decrease in level (date and value not reported): basophil percentage, mean platelet volume decreased, and red blood cell count. The following laboratory findings reported an increase in level (date and value not reported): C-reactive protein, mean cell haemoglobin, monocyte count, monocyte percentage, and red blood cell sedimentation rate. The following laboratory findings reported a normal level (date and value not reported): basophil count, eosinophil count, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, neutrophil count, platelet count, red cell distribution width and white blood cell count. The following laboratory findings were performed but no date or value was reported: eosinophil percentage, lymphocyte percentage, nucleated red cells and neutrophil percentage. A pulmonary artery pressure was done but results not reported. The patient was treated as an in-hospital patient with MOTRIN and prednisone. He performed activities of daily living (ADL), tolerated oral (PO) an was hemodynamically stable at this time. The patient was placed on light limited duty pending cardiologist's recommendations. The patient will be discharged with MOTRIN and prednisone. The outcome was reported as recovered. Follow-up information was received from the investigator on 10 June 2011. It was determined that this subject had been enrolled in a study. On 13 February 2011, the subject had a abnormal troponin I level of 1.56 (no units provided) and a normal electrocardiogram (ECG). On 14 February 2011, the subject had an abnormal echocardiogram. On 17 February 2011, the subject was diagnosed with unspecified disease of the pericardium. Additional information will be requested from the investigator. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: C-reactive protein, C-reactive protein increased, Chest discomfort, Echocardiogram normal, Eosinophil count normal
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 416956. A 27-year-old male patient received the following vaccination on 31 January 2011: ACAM2000 (lot number VV04003A). The patient had no current illnesses. The patient had a history of asthma. On 13 February 2011, with one week history of myalgia and arthralgia and with chest discomfort not associated with position was found to have myocarditis likely related to the smallpox vaccine. An echocardiogram was within normal limits. The patient's laboratory findings were as follows on 14 February 2011 at 10:38: creatine kinase (CK) 76 IU/L, creatine kinase-MB fraction (CKMB) 2.2 ng/mL, percent CKMB 2.89%, and cardiac troponin I (cTnI) 0.25 ng/mL. The patient's laboratory findings were as follows on 14 February 2011 at 05:06: CK 91 IU/L, CKMB 2.8 ng/mL, percent CKMB 3.08%, and cTnI not provided. The following laboratory findings reported a decrease in level (date and value not reported): basophil percentage, mean platelet volume decreased, and red blood cell count. The following laboratory findings reported an increase in level (date and value not reported): C-reactive protein, mean cell haemoglobin, monocyte count, monocyte percentage, and red blood cell sedimentation rate. The following laboratory findings reported a normal level (date and value not reported): basophil count, eosinophil count, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, neutrophil count, platelet count, red cell distribution width and white blood cell count. The following laboratory findings were performed but no date or value was reported: eosinophil percentage, lymphocyte percentage, nucleated red cells and neutrophil percentage. A pulmonary artery pressure was done but results not reported. The patient was treated as an in-hospital patient with MOTRIN and prednisone. He performed activities of daily living (ADL), tolerated oral (PO) an was hemodynamically stable at this time. The patient was placed on light limited duty pending cardiologist's recommendations. The patient will be discharged with MOTRIN and prednisone. The outcome was reported as recovered. Follow-up information was received from the investigator on 10 June 2011. It was determined that this subject had been enrolled in a study. On 13 February 2011, the subject had a abnormal troponin I level of 1.56 (no units provided) and a normal electrocardiogram (ECG). On 14 February 2011, the subject had an abnormal echocardiogram. On 17 February 2011, the subject was diagnosed with unspecified disease of the pericardium. Additional information will be requested from the investigator. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Eosinophil percentage, Haematocrit normal, Haemoglobin normal, Impaired work ability, Lymphocyte count normal
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 416956. A 27-year-old male patient received the following vaccination on 31 January 2011: ACAM2000 (lot number VV04003A). The patient had no current illnesses. The patient had a history of asthma. On 13 February 2011, with one week history of myalgia and arthralgia and with chest discomfort not associated with position was found to have myocarditis likely related to the smallpox vaccine. An echocardiogram was within normal limits. The patient's laboratory findings were as follows on 14 February 2011 at 10:38: creatine kinase (CK) 76 IU/L, creatine kinase-MB fraction (CKMB) 2.2 ng/mL, percent CKMB 2.89%, and cardiac troponin I (cTnI) 0.25 ng/mL. The patient's laboratory findings were as follows on 14 February 2011 at 05:06: CK 91 IU/L, CKMB 2.8 ng/mL, percent CKMB 3.08%, and cTnI not provided. The following laboratory findings reported a decrease in level (date and value not reported): basophil percentage, mean platelet volume decreased, and red blood cell count. The following laboratory findings reported an increase in level (date and value not reported): C-reactive protein, mean cell haemoglobin, monocyte count, monocyte percentage, and red blood cell sedimentation rate. The following laboratory findings reported a normal level (date and value not reported): basophil count, eosinophil count, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, neutrophil count, platelet count, red cell distribution width and white blood cell count. The following laboratory findings were performed but no date or value was reported: eosinophil percentage, lymphocyte percentage, nucleated red cells and neutrophil percentage. A pulmonary artery pressure was done but results not reported. The patient was treated as an in-hospital patient with MOTRIN and prednisone. He performed activities of daily living (ADL), tolerated oral (PO) an was hemodynamically stable at this time. The patient was placed on light limited duty pending cardiologist's recommendations. The patient will be discharged with MOTRIN and prednisone. The outcome was reported as recovered. Follow-up information was received from the investigator on 10 June 2011. It was determined that this subject had been enrolled in a study. On 13 February 2011, the subject had a abnormal troponin I level of 1.56 (no units provided) and a normal electrocardiogram (ECG). On 14 February 2011, the subject had an abnormal echocardiogram. On 17 February 2011, the subject was diagnosed with unspecified disease of the pericardium. Additional information will be requested from the investigator. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume normal, Mean platelet volume decreased
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 416956. A 27-year-old male patient received the following vaccination on 31 January 2011: ACAM2000 (lot number VV04003A). The patient had no current illnesses. The patient had a history of asthma. On 13 February 2011, with one week history of myalgia and arthralgia and with chest discomfort not associated with position was found to have myocarditis likely related to the smallpox vaccine. An echocardiogram was within normal limits. The patient's laboratory findings were as follows on 14 February 2011 at 10:38: creatine kinase (CK) 76 IU/L, creatine kinase-MB fraction (CKMB) 2.2 ng/mL, percent CKMB 2.89%, and cardiac troponin I (cTnI) 0.25 ng/mL. The patient's laboratory findings were as follows on 14 February 2011 at 05:06: CK 91 IU/L, CKMB 2.8 ng/mL, percent CKMB 3.08%, and cTnI not provided. The following laboratory findings reported a decrease in level (date and value not reported): basophil percentage, mean platelet volume decreased, and red blood cell count. The following laboratory findings reported an increase in level (date and value not reported): C-reactive protein, mean cell haemoglobin, monocyte count, monocyte percentage, and red blood cell sedimentation rate. The following laboratory findings reported a normal level (date and value not reported): basophil count, eosinophil count, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, neutrophil count, platelet count, red cell distribution width and white blood cell count. The following laboratory findings were performed but no date or value was reported: eosinophil percentage, lymphocyte percentage, nucleated red cells and neutrophil percentage. A pulmonary artery pressure was done but results not reported. The patient was treated as an in-hospital patient with MOTRIN and prednisone. He performed activities of daily living (ADL), tolerated oral (PO) an was hemodynamically stable at this time. The patient was placed on light limited duty pending cardiologist's recommendations. The patient will be discharged with MOTRIN and prednisone. The outcome was reported as recovered. Follow-up information was received from the investigator on 10 June 2011. It was determined that this subject had been enrolled in a study. On 13 February 2011, the subject had a abnormal troponin I level of 1.56 (no units provided) and a normal electrocardiogram (ECG). On 14 February 2011, the subject had an abnormal echocardiogram. On 17 February 2011, the subject was diagnosed with unspecified disease of the pericardium. Additional information will be requested from the investigator. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Monocyte count increased, Monocyte percentage increased, Myalgia, Myocarditis, Neutrophil count normal
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 416956. A 27-year-old male patient received the following vaccination on 31 January 2011: ACAM2000 (lot number VV04003A). The patient had no current illnesses. The patient had a history of asthma. On 13 February 2011, with one week history of myalgia and arthralgia and with chest discomfort not associated with position was found to have myocarditis likely related to the smallpox vaccine. An echocardiogram was within normal limits. The patient's laboratory findings were as follows on 14 February 2011 at 10:38: creatine kinase (CK) 76 IU/L, creatine kinase-MB fraction (CKMB) 2.2 ng/mL, percent CKMB 2.89%, and cardiac troponin I (cTnI) 0.25 ng/mL. The patient's laboratory findings were as follows on 14 February 2011 at 05:06: CK 91 IU/L, CKMB 2.8 ng/mL, percent CKMB 3.08%, and cTnI not provided. The following laboratory findings reported a decrease in level (date and value not reported): basophil percentage, mean platelet volume decreased, and red blood cell count. The following laboratory findings reported an increase in level (date and value not reported): C-reactive protein, mean cell haemoglobin, monocyte count, monocyte percentage, and red blood cell sedimentation rate. The following laboratory findings reported a normal level (date and value not reported): basophil count, eosinophil count, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, neutrophil count, platelet count, red cell distribution width and white blood cell count. The following laboratory findings were performed but no date or value was reported: eosinophil percentage, lymphocyte percentage, nucleated red cells and neutrophil percentage. A pulmonary artery pressure was done but results not reported. The patient was treated as an in-hospital patient with MOTRIN and prednisone. He performed activities of daily living (ADL), tolerated oral (PO) an was hemodynamically stable at this time. The patient was placed on light limited duty pending cardiologist's recommendations. The patient will be discharged with MOTRIN and prednisone. The outcome was reported as recovered. Follow-up information was received from the investigator on 10 June 2011. It was determined that this subject had been enrolled in a study. On 13 February 2011, the subject had a abnormal troponin I level of 1.56 (no units provided) and a normal electrocardiogram (ECG). On 14 February 2011, the subject had an abnormal echocardiogram. On 17 February 2011, the subject was diagnosed with unspecified disease of the pericardium. Additional information will be requested from the investigator. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Neutrophil percentage, Nucleated red cells, Platelet count normal, Pulmonary arterial pressure, Red blood cell count decreased
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 416956. A 27-year-old male patient received the following vaccination on 31 January 2011: ACAM2000 (lot number VV04003A). The patient had no current illnesses. The patient had a history of asthma. On 13 February 2011, with one week history of myalgia and arthralgia and with chest discomfort not associated with position was found to have myocarditis likely related to the smallpox vaccine. An echocardiogram was within normal limits. The patient's laboratory findings were as follows on 14 February 2011 at 10:38: creatine kinase (CK) 76 IU/L, creatine kinase-MB fraction (CKMB) 2.2 ng/mL, percent CKMB 2.89%, and cardiac troponin I (cTnI) 0.25 ng/mL. The patient's laboratory findings were as follows on 14 February 2011 at 05:06: CK 91 IU/L, CKMB 2.8 ng/mL, percent CKMB 3.08%, and cTnI not provided. The following laboratory findings reported a decrease in level (date and value not reported): basophil percentage, mean platelet volume decreased, and red blood cell count. The following laboratory findings reported an increase in level (date and value not reported): C-reactive protein, mean cell haemoglobin, monocyte count, monocyte percentage, and red blood cell sedimentation rate. The following laboratory findings reported a normal level (date and value not reported): basophil count, eosinophil count, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, neutrophil count, platelet count, red cell distribution width and white blood cell count. The following laboratory findings were performed but no date or value was reported: eosinophil percentage, lymphocyte percentage, nucleated red cells and neutrophil percentage. A pulmonary artery pressure was done but results not reported. The patient was treated as an in-hospital patient with MOTRIN and prednisone. He performed activities of daily living (ADL), tolerated oral (PO) an was hemodynamically stable at this time. The patient was placed on light limited duty pending cardiologist's recommendations. The patient will be discharged with MOTRIN and prednisone. The outcome was reported as recovered. Follow-up information was received from the investigator on 10 June 2011. It was determined that this subject had been enrolled in a study. On 13 February 2011, the subject had a abnormal troponin I level of 1.56 (no units provided) and a normal electrocardiogram (ECG). On 14 February 2011, the subject had an abnormal echocardiogram. On 17 February 2011, the subject was diagnosed with unspecified disease of the pericardium. Additional information will be requested from the investigator. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Red blood cell sedimentation rate increased, Red cell distribution width normal, Troponin I increased, White blood cell count normal
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 416956. A 27-year-old male patient received the following vaccination on 31 January 2011: ACAM2000 (lot number VV04003A). The patient had no current illnesses. The patient had a history of asthma. On 13 February 2011, with one week history of myalgia and arthralgia and with chest discomfort not associated with position was found to have myocarditis likely related to the smallpox vaccine. An echocardiogram was within normal limits. The patient's laboratory findings were as follows on 14 February 2011 at 10:38: creatine kinase (CK) 76 IU/L, creatine kinase-MB fraction (CKMB) 2.2 ng/mL, percent CKMB 2.89%, and cardiac troponin I (cTnI) 0.25 ng/mL. The patient's laboratory findings were as follows on 14 February 2011 at 05:06: CK 91 IU/L, CKMB 2.8 ng/mL, percent CKMB 3.08%, and cTnI not provided. The following laboratory findings reported a decrease in level (date and value not reported): basophil percentage, mean platelet volume decreased, and red blood cell count. The following laboratory findings reported an increase in level (date and value not reported): C-reactive protein, mean cell haemoglobin, monocyte count, monocyte percentage, and red blood cell sedimentation rate. The following laboratory findings reported a normal level (date and value not reported): basophil count, eosinophil count, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, neutrophil count, platelet count, red cell distribution width and white blood cell count. The following laboratory findings were performed but no date or value was reported: eosinophil percentage, lymphocyte percentage, nucleated red cells and neutrophil percentage. A pulmonary artery pressure was done but results not reported. The patient was treated as an in-hospital patient with MOTRIN and prednisone. He performed activities of daily living (ADL), tolerated oral (PO) an was hemodynamically stable at this time. The patient was placed on light limited duty pending cardiologist's recommendations. The patient will be discharged with MOTRIN and prednisone. The outcome was reported as recovered. Follow-up information was received from the investigator on 10 June 2011. It was determined that this subject had been enrolled in a study. On 13 February 2011, the subject had a abnormal troponin I level of 1.56 (no units provided) and a normal electrocardiogram (ECG). On 14 February 2011, the subject had an abnormal echocardiogram. On 17 February 2011, the subject was diagnosed with unspecified disease of the pericardium. Additional information will be requested from the investigator. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase MB increased, Cardiac enzymes increased, Myopericarditis, Troponin I increased
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 416956. A 27-year-old male patient received the following vaccination on 31 January 2011: ACAM2000 (lot number VV04003A). The patient had no current illnesses. The patient had a history of asthma. On 13 February 2011, with one week history of myalgia and arthralgia and with chest discomfort not associated with position was found to have myocarditis likely related to the smallpox vaccine. An echocardiogram was within normal limits. The patient's laboratory findings were as follows on 14 February 2011 at 10:38: creatine kinase (CK) 76 IU/L, creatine kinase-MB fraction (CKMB) 2.2 ng/mL, percent CKMB 2.89%, and cardiac troponin I (cTnI) 0.25 ng/mL. The patient's laboratory findings were as follows on 14 February 2011 at 05:06: CK 91 IU/L, CKMB 2.8 ng/mL, percent CKMB 3.08%, and cTnI not provided. The following laboratory findings reported a decrease in level (date and value not reported): basophil percentage, mean platelet volume decreased, and red blood cell count. The following laboratory findings reported an increase in level (date and value not reported): C-reactive protein, mean cell haemoglobin, monocyte count, monocyte percentage, and red blood cell sedimentation rate. The following laboratory findings reported a normal level (date and value not reported): basophil count, eosinophil count, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, neutrophil count, platelet count, red cell distribution width and white blood cell count. The following laboratory findings were performed but no date or value was reported: eosinophil percentage, lymphocyte percentage, nucleated red cells and neutrophil percentage. A pulmonary artery pressure was done but results not reported. The patient was treated as an in-hospital patient with MOTRIN and prednisone. He performed activities of daily living (ADL), tolerated oral (PO) an was hemodynamically stable at this time. The patient was placed on light limited duty pending cardiologist's recommendations. The patient will be discharged with MOTRIN and prednisone. The outcome was reported as recovered. Follow-up information was received from the investigator on 10 June 2011. It was determined that this subject had been enrolled in a study. On 13 February 2011, the subject had a abnormal troponin I level of 1.56 (no units provided) and a normal electrocardiogram (ECG). On 14 February 2011, the subject had an abnormal echocardiogram. On 17 February 2011, the subject was diagnosed with unspecified disease of the pericardium. Additional information will be requested from the investigator. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Arthralgia, Basophil count normal, Basophil percentage decreased, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase normal
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 416956. A 27-year-old male patient received the following vaccination on 31 January 2011: ACAM2000 (lot number VV04003A). The patient had no current illnesses. The patient had a history of asthma. On 13 February 2011, with one week history of myalgia and arthralgia and with chest discomfort not associated with position was found to have myocarditis likely related to the smallpox vaccine. An echocardiogram was within normal limits. The patient's laboratory findings were as follows on 14 February 2011 at 10:38: creatine kinase (CK) 76 IU/L, creatine kinase-MB fraction (CKMB) 2.2 ng/mL, percent CKMB 2.89%, and cardiac troponin I (cTnI) 0.25 ng/mL. The patient's laboratory findings were as follows on 14 February 2011 at 05:06: CK 91 IU/L, CKMB 2.8 ng/mL, percent CKMB 3.08%, and cTnI not provided. The following laboratory findings reported a decrease in level (date and value not reported): basophil percentage, mean platelet volume decreased, and red blood cell count. The following laboratory findings reported an increase in level (date and value not reported): C-reactive protein, mean cell haemoglobin, monocyte count, monocyte percentage, and red blood cell sedimentation rate. The following laboratory findings reported a normal level (date and value not reported): basophil count, eosinophil count, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, neutrophil count, platelet count, red cell distribution width and white blood cell count. The following laboratory findings were performed but no date or value was reported: eosinophil percentage, lymphocyte percentage, nucleated red cells and neutrophil percentage. A pulmonary artery pressure was done but results not reported. The patient was treated as an in-hospital patient with MOTRIN and prednisone. He performed activities of daily living (ADL), tolerated oral (PO) an was hemodynamically stable at this time. The patient was placed on light limited duty pending cardiologist's recommendations. The patient will be discharged with MOTRIN and prednisone. The outcome was reported as recovered. Follow-up information was received from the investigator on 10 June 2011. It was determined that this subject had been enrolled in a study. On 13 February 2011, the subject had a abnormal troponin I level of 1.56 (no units provided) and a normal electrocardiogram (ECG). On 14 February 2011, the subject had an abnormal echocardiogram. On 17 February 2011, the subject was diagnosed with unspecified disease of the pericardium. Additional information will be requested from the investigator. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: C-reactive protein increased, Chest discomfort, Echocardiogram abnormal, Electrocardiogram normal, Eosinophil count normal
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 416956. A 27-year-old male patient received the following vaccination on 31 January 2011: ACAM2000 (lot number VV04003A). The patient had no current illnesses. The patient had a history of asthma. On 13 February 2011, with one week history of myalgia and arthralgia and with chest discomfort not associated with position was found to have myocarditis likely related to the smallpox vaccine. An echocardiogram was within normal limits. The patient's laboratory findings were as follows on 14 February 2011 at 10:38: creatine kinase (CK) 76 IU/L, creatine kinase-MB fraction (CKMB) 2.2 ng/mL, percent CKMB 2.89%, and cardiac troponin I (cTnI) 0.25 ng/mL. The patient's laboratory findings were as follows on 14 February 2011 at 05:06: CK 91 IU/L, CKMB 2.8 ng/mL, percent CKMB 3.08%, and cTnI not provided. The following laboratory findings reported a decrease in level (date and value not reported): basophil percentage, mean platelet volume decreased, and red blood cell count. The following laboratory findings reported an increase in level (date and value not reported): C-reactive protein, mean cell haemoglobin, monocyte count, monocyte percentage, and red blood cell sedimentation rate. The following laboratory findings reported a normal level (date and value not reported): basophil count, eosinophil count, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, neutrophil count, platelet count, red cell distribution width and white blood cell count. The following laboratory findings were performed but no date or value was reported: eosinophil percentage, lymphocyte percentage, nucleated red cells and neutrophil percentage. A pulmonary artery pressure was done but results not reported. The patient was treated as an in-hospital patient with MOTRIN and prednisone. He performed activities of daily living (ADL), tolerated oral (PO) an was hemodynamically stable at this time. The patient was placed on light limited duty pending cardiologist's recommendations. The patient will be discharged with MOTRIN and prednisone. The outcome was reported as recovered. Follow-up information was received from the investigator on 10 June 2011. It was determined that this subject had been enrolled in a study. On 13 February 2011, the subject had a abnormal troponin I level of 1.56 (no units provided) and a normal electrocardiogram (ECG). On 14 February 2011, the subject had an abnormal echocardiogram. On 17 February 2011, the subject was diagnosed with unspecified disease of the pericardium. Additional information will be requested from the investigator. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Eosinophil percentage, Haematocrit normal, Haemoglobin normal, Impaired work ability, Laboratory test
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 416956. A 27-year-old male patient received the following vaccination on 31 January 2011: ACAM2000 (lot number VV04003A). The patient had no current illnesses. The patient had a history of asthma. On 13 February 2011, with one week history of myalgia and arthralgia and with chest discomfort not associated with position was found to have myocarditis likely related to the smallpox vaccine. An echocardiogram was within normal limits. The patient's laboratory findings were as follows on 14 February 2011 at 10:38: creatine kinase (CK) 76 IU/L, creatine kinase-MB fraction (CKMB) 2.2 ng/mL, percent CKMB 2.89%, and cardiac troponin I (cTnI) 0.25 ng/mL. The patient's laboratory findings were as follows on 14 February 2011 at 05:06: CK 91 IU/L, CKMB 2.8 ng/mL, percent CKMB 3.08%, and cTnI not provided. The following laboratory findings reported a decrease in level (date and value not reported): basophil percentage, mean platelet volume decreased, and red blood cell count. The following laboratory findings reported an increase in level (date and value not reported): C-reactive protein, mean cell haemoglobin, monocyte count, monocyte percentage, and red blood cell sedimentation rate. The following laboratory findings reported a normal level (date and value not reported): basophil count, eosinophil count, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, neutrophil count, platelet count, red cell distribution width and white blood cell count. The following laboratory findings were performed but no date or value was reported: eosinophil percentage, lymphocyte percentage, nucleated red cells and neutrophil percentage. A pulmonary artery pressure was done but results not reported. The patient was treated as an in-hospital patient with MOTRIN and prednisone. He performed activities of daily living (ADL), tolerated oral (PO) an was hemodynamically stable at this time. The patient was placed on light limited duty pending cardiologist's recommendations. The patient will be discharged with MOTRIN and prednisone. The outcome was reported as recovered. Follow-up information was received from the investigator on 10 June 2011. It was determined that this subject had been enrolled in a study. On 13 February 2011, the subject had a abnormal troponin I level of 1.56 (no units provided) and a normal electrocardiogram (ECG). On 14 February 2011, the subject had an abnormal echocardiogram. On 17 February 2011, the subject was diagnosed with unspecified disease of the pericardium. Additional information will be requested from the investigator. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume normal
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 416956. A 27-year-old male patient received the following vaccination on 31 January 2011: ACAM2000 (lot number VV04003A). The patient had no current illnesses. The patient had a history of asthma. On 13 February 2011, with one week history of myalgia and arthralgia and with chest discomfort not associated with position was found to have myocarditis likely related to the smallpox vaccine. An echocardiogram was within normal limits. The patient's laboratory findings were as follows on 14 February 2011 at 10:38: creatine kinase (CK) 76 IU/L, creatine kinase-MB fraction (CKMB) 2.2 ng/mL, percent CKMB 2.89%, and cardiac troponin I (cTnI) 0.25 ng/mL. The patient's laboratory findings were as follows on 14 February 2011 at 05:06: CK 91 IU/L, CKMB 2.8 ng/mL, percent CKMB 3.08%, and cTnI not provided. The following laboratory findings reported a decrease in level (date and value not reported): basophil percentage, mean platelet volume decreased, and red blood cell count. The following laboratory findings reported an increase in level (date and value not reported): C-reactive protein, mean cell haemoglobin, monocyte count, monocyte percentage, and red blood cell sedimentation rate. The following laboratory findings reported a normal level (date and value not reported): basophil count, eosinophil count, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, neutrophil count, platelet count, red cell distribution width and white blood cell count. The following laboratory findings were performed but no date or value was reported: eosinophil percentage, lymphocyte percentage, nucleated red cells and neutrophil percentage. A pulmonary artery pressure was done but results not reported. The patient was treated as an in-hospital patient with MOTRIN and prednisone. He performed activities of daily living (ADL), tolerated oral (PO) an was hemodynamically stable at this time. The patient was placed on light limited duty pending cardiologist's recommendations. The patient will be discharged with MOTRIN and prednisone. The outcome was reported as recovered. Follow-up information was received from the investigator on 10 June 2011. It was determined that this subject had been enrolled in a study. On 13 February 2011, the subject had a abnormal troponin I level of 1.56 (no units provided) and a normal electrocardiogram (ECG). On 14 February 2011, the subject had an abnormal echocardiogram. On 17 February 2011, the subject was diagnosed with unspecified disease of the pericardium. Additional information will be requested from the investigator. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Mean platelet volume decreased, Monocyte count increased, Monocyte percentage increased, Myalgia, Myocarditis
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 416956. A 27-year-old male patient received the following vaccination on 31 January 2011: ACAM2000 (lot number VV04003A). The patient had no current illnesses. The patient had a history of asthma. On 13 February 2011, with one week history of myalgia and arthralgia and with chest discomfort not associated with position was found to have myocarditis likely related to the smallpox vaccine. An echocardiogram was within normal limits. The patient's laboratory findings were as follows on 14 February 2011 at 10:38: creatine kinase (CK) 76 IU/L, creatine kinase-MB fraction (CKMB) 2.2 ng/mL, percent CKMB 2.89%, and cardiac troponin I (cTnI) 0.25 ng/mL. The patient's laboratory findings were as follows on 14 February 2011 at 05:06: CK 91 IU/L, CKMB 2.8 ng/mL, percent CKMB 3.08%, and cTnI not provided. The following laboratory findings reported a decrease in level (date and value not reported): basophil percentage, mean platelet volume decreased, and red blood cell count. The following laboratory findings reported an increase in level (date and value not reported): C-reactive protein, mean cell haemoglobin, monocyte count, monocyte percentage, and red blood cell sedimentation rate. The following laboratory findings reported a normal level (date and value not reported): basophil count, eosinophil count, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, neutrophil count, platelet count, red cell distribution width and white blood cell count. The following laboratory findings were performed but no date or value was reported: eosinophil percentage, lymphocyte percentage, nucleated red cells and neutrophil percentage. A pulmonary artery pressure was done but results not reported. The patient was treated as an in-hospital patient with MOTRIN and prednisone. He performed activities of daily living (ADL), tolerated oral (PO) an was hemodynamically stable at this time. The patient was placed on light limited duty pending cardiologist's recommendations. The patient will be discharged with MOTRIN and prednisone. The outcome was reported as recovered. Follow-up information was received from the investigator on 10 June 2011. It was determined that this subject had been enrolled in a study. On 13 February 2011, the subject had a abnormal troponin I level of 1.56 (no units provided) and a normal electrocardiogram (ECG). On 14 February 2011, the subject had an abnormal echocardiogram. On 17 February 2011, the subject was diagnosed with unspecified disease of the pericardium. Additional information will be requested from the investigator. List of documents held by sender: none.