chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram ST segment elevation, Electrocardiogram T wave normal, Electrocardiogram abnormal, Left ventricular hypertrophy, Myocarditis
Clinical narrative: Initial solicited report received from an investigator (Defense Health Agency) in the trial on 21 September 2017. An 18 year-old male subject with dizziness/fainting spells and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 21 July 2017. On 31 July 2017, 10 days after vaccination the subject was diagnosed with I30.9 acute pericarditis,  unspecified and I51.4 myocarditis, unspecified. The lab data included, ECG- Abnormal, and Echocardiogram - Normal, Troponin I result abnormal 0.14, all three done were on 31 July 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events, I30.9 acute pericarditis, unspecified and I51.4 myocarditis, unspecified was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as, on 31 July 2017 the troponin I results within 30 days post small pox vaccination was abnormal with highest value 0.14 ng/ml. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: On 31JUL2017, the subject had an abnormal ECG which showed NSR with left ventricular hypertrophy, early repolarization and QT/QTc = 380/416ms. Cardiologist notes included: ECG showed diffuse concave STE with J-point notching, incomplete RBBB, no significant PR depression or elevation, and large peaked T-wave. No significant ectopy or arrhythmia or telemetry. Echocardiogram performed on the same day, 31JUL2017, indicated cavity size was normal, RVSF, LVDF parameters and wall motion were normal. Wall thickness was at the upper limits of normal. SF was normal. The estimated EF was 60-65%. No pericardial effusion was seen. Impressions: Client felt dizzy and lightheaded several months prior to vaccination where he was diagnosed with a an upper respiratory infection with a cough, nose bleed, night sweats, headache, sore throat, nasal congestion and nasal discharge. Patient was administered Lactated Ringers, Acetaminophen, Flonase, Claritin, Cepacol, and oral hydration. Extremely high levels of CK were found but started to dissipate two (2) days later. It was noted that subject's lightheadedness restarted again during another training exercise a month later with a diagnosis of Chondrocostal junction syndrome.
Age: 18.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pericarditis, Troponin I increased
Clinical narrative: Initial solicited report received from an investigator (Defense Health Agency) in the trial on 21 September 2017. An 18 year-old male subject with dizziness/fainting spells and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 21 July 2017. On 31 July 2017, 10 days after vaccination the subject was diagnosed with I30.9 acute pericarditis,  unspecified and I51.4 myocarditis, unspecified. The lab data included, ECG- Abnormal, and Echocardiogram - Normal, Troponin I result abnormal 0.14, all three done were on 31 July 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events, I30.9 acute pericarditis, unspecified and I51.4 myocarditis, unspecified was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as, on 31 July 2017 the troponin I results within 30 days post small pox vaccination was abnormal with highest value 0.14 ng/ml. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: On 31JUL2017, the subject had an abnormal ECG which showed NSR with left ventricular hypertrophy, early repolarization and QT/QTc = 380/416ms. Cardiologist notes included: ECG showed diffuse concave STE with J-point notching, incomplete RBBB, no significant PR depression or elevation, and large peaked T-wave. No significant ectopy or arrhythmia or telemetry. Echocardiogram performed on the same day, 31JUL2017, indicated cavity size was normal, RVSF, LVDF parameters and wall motion were normal. Wall thickness was at the upper limits of normal. SF was normal. The estimated EF was 60-65%. No pericardial effusion was seen. Impressions: Client felt dizzy and lightheaded several months prior to vaccination where he was diagnosed with a an upper respiratory infection with a cough, nose bleed, night sweats, headache, sore throat, nasal congestion and nasal discharge. Patient was administered Lactated Ringers, Acetaminophen, Flonase, Claritin, Cepacol, and oral hydration. Extremely high levels of CK were found but started to dissipate two (2) days later. It was noted that subject's lightheadedness restarted again during another training exercise a month later with a diagnosis of Chondrocostal junction syndrome.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator in a trial. A 34-year-old male subject with medical history of high blood pressure and elevated cholesterol. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number, site of administration not reported) on 01 March 2017. On 12 March 2017, 11 days after vaccination the subject was diagnosed with myocarditis, unspecified. On 13 March 2017, 12 days after vaccination the subject was diagnosed with infective myocarditis/other acute myocarditis. The lab data of ECG- Normal, done on 12 March 2017, and Echocardiogram - Normal done on 13 March 2017, Troponin I result abnormal 00.62 done on 14 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. Outcome of the events, myocarditis, unspecified and infective myocarditis/other acute myocarditis was not reported. Relationship to investigational product according to company: associated. List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as, on 14 March 2017 the troponin I results within 30 days post smallpox vaccination was abnormal with highest value 0.62 ng/ml. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: On 12MAR2017, the subject had a normal ECG showing sinus tachycardia without evidence of STE myocardial infarction or acute coronary syndrome, and appropriate PR intervals without evidence of rate related ST depressions or elevations. There were no U waves or peaked T waves. It was also reported that the subject had a normal echocardiogram immediately post smallpox vaccination but a second echocardiogram done two weeks later 13MAR2017 showed enlarged LV and elevated pulmonary pressures. Patient was noted to have a history of atrial fibrillation and had experienced chest pain and elevated cardiac markers. Physician's impressions included BP and elevated cholesterol. It was noted that the subject's records showed medications for hypertension and cholesterol were taken for several years without EMR references until an appointment in January provided some details.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Echocardiogram abnormal, Electrocardiogram ST segment normal, Electrocardiogram T wave normal, Electrocardiogram normal
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator in a trial. A 34-year-old male subject with medical history of high blood pressure and elevated cholesterol. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number, site of administration not reported) on 01 March 2017. On 12 March 2017, 11 days after vaccination the subject was diagnosed with myocarditis, unspecified. On 13 March 2017, 12 days after vaccination the subject was diagnosed with infective myocarditis/other acute myocarditis. The lab data of ECG- Normal, done on 12 March 2017, and Echocardiogram - Normal done on 13 March 2017, Troponin I result abnormal 00.62 done on 14 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. Outcome of the events, myocarditis, unspecified and infective myocarditis/other acute myocarditis was not reported. Relationship to investigational product according to company: associated. List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as, on 14 March 2017 the troponin I results within 30 days post smallpox vaccination was abnormal with highest value 0.62 ng/ml. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: On 12MAR2017, the subject had a normal ECG showing sinus tachycardia without evidence of STE myocardial infarction or acute coronary syndrome, and appropriate PR intervals without evidence of rate related ST depressions or elevations. There were no U waves or peaked T waves. It was also reported that the subject had a normal echocardiogram immediately post smallpox vaccination but a second echocardiogram done two weeks later 13MAR2017 showed enlarged LV and elevated pulmonary pressures. Patient was noted to have a history of atrial fibrillation and had experienced chest pain and elevated cardiac markers. Physician's impressions included BP and elevated cholesterol. It was noted that the subject's records showed medications for hypertension and cholesterol were taken for several years without EMR references until an appointment in January provided some details.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Left ventricular enlargement, Myocardial necrosis marker increased, Myocarditis, Myocarditis infectious, Sinus tachycardia
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator in a trial. A 34-year-old male subject with medical history of high blood pressure and elevated cholesterol. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number, site of administration not reported) on 01 March 2017. On 12 March 2017, 11 days after vaccination the subject was diagnosed with myocarditis, unspecified. On 13 March 2017, 12 days after vaccination the subject was diagnosed with infective myocarditis/other acute myocarditis. The lab data of ECG- Normal, done on 12 March 2017, and Echocardiogram - Normal done on 13 March 2017, Troponin I result abnormal 00.62 done on 14 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. Outcome of the events, myocarditis, unspecified and infective myocarditis/other acute myocarditis was not reported. Relationship to investigational product according to company: associated. List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as, on 14 March 2017 the troponin I results within 30 days post smallpox vaccination was abnormal with highest value 0.62 ng/ml. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: On 12MAR2017, the subject had a normal ECG showing sinus tachycardia without evidence of STE myocardial infarction or acute coronary syndrome, and appropriate PR intervals without evidence of rate related ST depressions or elevations. There were no U waves or peaked T waves. It was also reported that the subject had a normal echocardiogram immediately post smallpox vaccination but a second echocardiogram done two weeks later 13MAR2017 showed enlarged LV and elevated pulmonary pressures. Patient was noted to have a history of atrial fibrillation and had experienced chest pain and elevated cardiac markers. Physician's impressions included BP and elevated cholesterol. It was noted that the subject's records showed medications for hypertension and cholesterol were taken for several years without EMR references until an appointment in January provided some details.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Troponin I increased
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator in a trial. A 34-year-old male subject with medical history of high blood pressure and elevated cholesterol. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number, site of administration not reported) on 01 March 2017. On 12 March 2017, 11 days after vaccination the subject was diagnosed with myocarditis, unspecified. On 13 March 2017, 12 days after vaccination the subject was diagnosed with infective myocarditis/other acute myocarditis. The lab data of ECG- Normal, done on 12 March 2017, and Echocardiogram - Normal done on 13 March 2017, Troponin I result abnormal 00.62 done on 14 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. Outcome of the events, myocarditis, unspecified and infective myocarditis/other acute myocarditis was not reported. Relationship to investigational product according to company: associated. List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as, on 14 March 2017 the troponin I results within 30 days post smallpox vaccination was abnormal with highest value 0.62 ng/ml. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: On 12MAR2017, the subject had a normal ECG showing sinus tachycardia without evidence of STE myocardial infarction or acute coronary syndrome, and appropriate PR intervals without evidence of rate related ST depressions or elevations. There were no U waves or peaked T waves. It was also reported that the subject had a normal echocardiogram immediately post smallpox vaccination but a second echocardiogram done two weeks later 13MAR2017 showed enlarged LV and elevated pulmonary pressures. Patient was noted to have a history of atrial fibrillation and had experienced chest pain and elevated cardiac markers. Physician's impressions included BP and elevated cholesterol. It was noted that the subject's records showed medications for hypertension and cholesterol were taken for several years without EMR references until an appointment in January provided some details.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Pericardial disease, Troponin I increased
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. This case involves a 24 year old male subject with no significant medical history. The subject received concomitant medication with Typhoid, Parenteral; japanese encephalitis - im (1); anthrax (1) on 05 May 2017. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 01 June 2017. On 11 June 2017, 10 days after vaccination the subject was diagnosed with I40.9 acute myocarditis, unspecified and on 14 June 2017, 13 days after vaccination the subject was diagnosed with I31.9 Disease of pericardium, unspecified. The subject's lab data included, Troponin I result abnormal 00.34, ECG- Abnormal both done on 11 June 2017 and Echocardiogram - Normal done on 12 June 2017. MRI of brain; spinal cord; heart; or Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events I40.9 acute myocarditis, unspecified and I31.9 Disease of pericardium, unspecified; was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as on 11 June 2017, the troponin I results within 30 days post small pox vaccination was abnormal with highest value 00.34 ng/ml. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, noninterventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: The subject had an abnormal ECG on 11JUN2017 showing sinus tachycardia, and t-wave abnormality (consider inferior and anterolateral ischemia) with QT/QTc = 302/401ms. Diffuse t-wave inversion was noted by physician. ECHO performed the following day indicated that the LV size, wall thickness, SF, and wall motion were normal with EF of 55%, RAP estimated at 3mmHg and PASP estimated at 27mmHg. No evidence of aortic stenosis or aortic regurgitation or pericardial effusion was seen. On 07AUG2017, despite ongoing discomfort, the subject's second ECHO was completely normal.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Discomfort, Echocardiogram normal, Ejection fraction normal, Electrocardiogram QT prolonged, Electrocardiogram T wave abnormal
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. This case involves a 24 year old male subject with no significant medical history. The subject received concomitant medication with Typhoid, Parenteral; japanese encephalitis - im (1); anthrax (1) on 05 May 2017. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 01 June 2017. On 11 June 2017, 10 days after vaccination the subject was diagnosed with I40.9 acute myocarditis, unspecified and on 14 June 2017, 13 days after vaccination the subject was diagnosed with I31.9 Disease of pericardium, unspecified. The subject's lab data included, Troponin I result abnormal 00.34, ECG- Abnormal both done on 11 June 2017 and Echocardiogram - Normal done on 12 June 2017. MRI of brain; spinal cord; heart; or Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events I40.9 acute myocarditis, unspecified and I31.9 Disease of pericardium, unspecified; was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as on 11 June 2017, the troponin I results within 30 days post small pox vaccination was abnormal with highest value 00.34 ng/ml. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, noninterventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: The subject had an abnormal ECG on 11JUN2017 showing sinus tachycardia, and t-wave abnormality (consider inferior and anterolateral ischemia) with QT/QTc = 302/401ms. Diffuse t-wave inversion was noted by physician. ECHO performed the following day indicated that the LV size, wall thickness, SF, and wall motion were normal with EF of 55%, RAP estimated at 3mmHg and PASP estimated at 27mmHg. No evidence of aortic stenosis or aortic regurgitation or pericardial effusion was seen. On 07AUG2017, despite ongoing discomfort, the subject's second ECHO was completely normal.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram T wave inversion, Electrocardiogram abnormal, Myocarditis, Pericardial disease, Sinus tachycardia
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. This case involves a 24 year old male subject with no significant medical history. The subject received concomitant medication with Typhoid, Parenteral; japanese encephalitis - im (1); anthrax (1) on 05 May 2017. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 01 June 2017. On 11 June 2017, 10 days after vaccination the subject was diagnosed with I40.9 acute myocarditis, unspecified and on 14 June 2017, 13 days after vaccination the subject was diagnosed with I31.9 Disease of pericardium, unspecified. The subject's lab data included, Troponin I result abnormal 00.34, ECG- Abnormal both done on 11 June 2017 and Echocardiogram - Normal done on 12 June 2017. MRI of brain; spinal cord; heart; or Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events I40.9 acute myocarditis, unspecified and I31.9 Disease of pericardium, unspecified; was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as on 11 June 2017, the troponin I results within 30 days post small pox vaccination was abnormal with highest value 00.34 ng/ml. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, noninterventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: The subject had an abnormal ECG on 11JUN2017 showing sinus tachycardia, and t-wave abnormality (consider inferior and anterolateral ischemia) with QT/QTc = 302/401ms. Diffuse t-wave inversion was noted by physician. ECHO performed the following day indicated that the LV size, wall thickness, SF, and wall motion were normal with EF of 55%, RAP estimated at 3mmHg and PASP estimated at 27mmHg. No evidence of aortic stenosis or aortic regurgitation or pericardial effusion was seen. On 07AUG2017, despite ongoing discomfort, the subject's second ECHO was completely normal.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Troponin I increased
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. This case involves a 24 year old male subject with no significant medical history. The subject received concomitant medication with Typhoid, Parenteral; japanese encephalitis - im (1); anthrax (1) on 05 May 2017. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 01 June 2017. On 11 June 2017, 10 days after vaccination the subject was diagnosed with I40.9 acute myocarditis, unspecified and on 14 June 2017, 13 days after vaccination the subject was diagnosed with I31.9 Disease of pericardium, unspecified. The subject's lab data included, Troponin I result abnormal 00.34, ECG- Abnormal both done on 11 June 2017 and Echocardiogram - Normal done on 12 June 2017. MRI of brain; spinal cord; heart; or Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events I40.9 acute myocarditis, unspecified and I31.9 Disease of pericardium, unspecified; was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as on 11 June 2017, the troponin I results within 30 days post small pox vaccination was abnormal with highest value 00.34 ng/ml. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, noninterventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: The subject had an abnormal ECG on 11JUN2017 showing sinus tachycardia, and t-wave abnormality (consider inferior and anterolateral ischemia) with QT/QTc = 302/401ms. Diffuse t-wave inversion was noted by physician. ECHO performed the following day indicated that the LV size, wall thickness, SF, and wall motion were normal with EF of 55%, RAP estimated at 3mmHg and PASP estimated at 27mmHg. No evidence of aortic stenosis or aortic regurgitation or pericardial effusion was seen. On 07AUG2017, despite ongoing discomfort, the subject's second ECHO was completely normal.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Pain, Swelling, Thrombosis
Clinical narrative: Improperly placed pneumonia shot, calcified hematoma with fascia involvement myositis, ossificans ROM and rehab. Physical therapy-8 sessions, severe pain with hard lumpy areas and redness.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Drug administered at inappropriate site, Erythema, Haematoma, Mass, Myositis ossificans
Clinical narrative: Improperly placed pneumonia shot, calcified hematoma with fascia involvement myositis, ossificans ROM and rehab. Physical therapy-8 sessions, severe pain with hard lumpy areas and redness.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Pain, Ultrasound scan normal
Clinical narrative: Improperly placed pneumonia shot, calcified hematoma with fascia involvement myositis, ossificans ROM and rehab. Physical therapy-8 sessions, severe pain with hard lumpy areas and redness.
Age: 56.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 56-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 10-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 injection (dose, route of administration were not reported; lot # reported as N024384;5/18/2019) for vaccination. In November 2017, the patient experienced of redness, swelling at the injection site along with fever and feeling sick. On a unspecified date, the patient went to the Emergency Room and was given unknown antibiotic as treatment. The reporter also stated that PNEUMOVAX 23 did not undergo a temperature excursion. The outcome of the events was recovering. The reporter did not assess relatedness between the events and vaccination with PNEUMOVAX 23.
Age: 56.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 56-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 10-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 injection (dose, route of administration were not reported; lot # reported as N024384;5/18/2019) for vaccination. In November 2017, the patient experienced of redness, swelling at the injection site along with fever and feeling sick. On a unspecified date, the patient went to the Emergency Room and was given unknown antibiotic as treatment. The reporter also stated that PNEUMOVAX 23 did not undergo a temperature excursion. The outcome of the events was recovering. The reporter did not assess relatedness between the events and vaccination with PNEUMOVAX 23.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Bone pain, Fatigue, Injection site reaction
Clinical narrative: This spontaneous report was received from a 61-year-old female patient, who was refering on herself. The pertinent medical history of the patient included asthma. The patient's medical history included unspecified allergies. Concomitant therapies included unspecified allergies shots, unspecified asthma medication. On 09-NOV-2017, the patient was vaccinated with ZOSTAVAX, injection, subcutaneously (dose, lot #, expiration date were not reported) for prevention for shingles. Other suspect therapy included sterile diluent (manufacturer unknown). On 10-NOV-2017, the patient experienced headache, and feels extremely tired. She also stated that her muscles and bones was ached. On 11-NOV-2017, the patient developed a 2 inch wide "welt" from the injection site to her elbow. The patient sought a medical attention and talked to the pharmacist. No treatment was given for the adverse events. No laboratory diagnostic studies were performed. The outcome of the events was not recovered. The reporter did not assess relatedness between the events and ZOSTAVAX.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity, Rash erythematous, Tenderness
Clinical narrative: This spontaneous report was received from a 61-year-old female patient, who was refering on herself. The pertinent medical history of the patient included asthma. The patient's medical history included unspecified allergies. Concomitant therapies included unspecified allergies shots, unspecified asthma medication. On 09-NOV-2017, the patient was vaccinated with ZOSTAVAX, injection, subcutaneously (dose, lot #, expiration date were not reported) for prevention for shingles. Other suspect therapy included sterile diluent (manufacturer unknown). On 10-NOV-2017, the patient experienced headache, and feels extremely tired. She also stated that her muscles and bones was ached. On 11-NOV-2017, the patient developed a 2 inch wide "welt" from the injection site to her elbow. The patient sought a medical attention and talked to the pharmacist. No treatment was given for the adverse events. No laboratory diagnostic studies were performed. The outcome of the events was not recovered. The reporter did not assess relatedness between the events and ZOSTAVAX.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bone pain, Fatigue, Headache, Injection site reaction, Myalgia
Clinical narrative: This spontaneous report was received from a 61-year-old female patient, who was refering on herself. The pertinent medical history of the patient included asthma. The patient's medical history included unspecified allergies. Concomitant therapies included unspecified allergies shots, unspecified asthma medication. On 09-NOV-2017, the patient was vaccinated with ZOSTAVAX, injection, subcutaneously (dose, lot #, expiration date were not reported) for prevention for shingles. Other suspect therapy included sterile diluent (manufacturer unknown). On 10-NOV-2017, the patient experienced headache, and feels extremely tired. She also stated that her muscles and bones was ached. On 11-NOV-2017, the patient developed a 2 inch wide "welt" from the injection site to her elbow. The patient sought a medical attention and talked to the pharmacist. No treatment was given for the adverse events. No laboratory diagnostic studies were performed. The outcome of the events was not recovered. The reporter did not assess relatedness between the events and ZOSTAVAX.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a 61-year-old female patient, who was refering on herself. The pertinent medical history of the patient included asthma. The patient's medical history included unspecified allergies. Concomitant therapies included unspecified allergies shots, unspecified asthma medication. On 09-NOV-2017, the patient was vaccinated with ZOSTAVAX, injection, subcutaneously (dose, lot #, expiration date were not reported) for prevention for shingles. Other suspect therapy included sterile diluent (manufacturer unknown). On 10-NOV-2017, the patient experienced headache, and feels extremely tired. She also stated that her muscles and bones was ached. On 11-NOV-2017, the patient developed a 2 inch wide "welt" from the injection site to her elbow. The patient sought a medical attention and talked to the pharmacist. No treatment was given for the adverse events. No laboratory diagnostic studies were performed. The outcome of the events was not recovered. The reporter did not assess relatedness between the events and ZOSTAVAX.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Rash, Rash generalised, Rash pruritic
Clinical narrative: Patches itching and it spreads.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Patches itching and it spreads.
Age: 60.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Urticaria
Clinical narrative: The patient states that she broke out in hives about 2 hours after receiving the vaccine. She ended up having hives for an extended time and had to take 3 weeks of prednisone.
Sex: U
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Arthralgia, Back pain, Condition aggravated, Insomnia
Clinical narrative: This is a spontaneous report based on information received by Pfizer from MERCK (Case number: 00671462). A patient of unspecified age ethnicity and gender received TRUMENBA (lot number R56659 expiration date 31Jan2019), via an unspecified route of administration on 28Nov2017 at a single dose and GARDASIL 9 (Manufacturer Merck), via an unspecified route of administration on 28Nov2017 at unspecified dose both given as immunization. The patient's medical history and concomitant medications were not reported. At an unspecified time on 28Nov2017, the patient "had difficulty sleeping" and "woke up with severe joint and back pain". The physician advised patient to take "Tylenol or Ibuprofen"' for "pain control''. The physician also ordered blood work (complete blood count and TSH) on29Nov2017. It was unknown if "blood work" has been completed at this time. Outcome of the adverse events was unknown.
Sex: U
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Arthralgia, Back pain, Insomnia
Clinical narrative: This is a spontaneous report based on information received by Pfizer from MERCK (Case number: 00671462). A patient of unspecified age ethnicity and gender received TRUMENBA (lot number R56659 expiration date 31Jan2019), via an unspecified route of administration on 28Nov2017 at a single dose and GARDASIL 9 (Manufacturer Merck), via an unspecified route of administration on 28Nov2017 at unspecified dose both given as immunization. The patient's medical history and concomitant medications were not reported. At an unspecified time on 28Nov2017, the patient "had difficulty sleeping" and "woke up with severe joint and back pain". The physician advised patient to take "Tylenol or Ibuprofen"' for "pain control''. The physician also ordered blood work (complete blood count and TSH) on29Nov2017. It was unknown if "blood work" has been completed at this time. Outcome of the adverse events was unknown.
Age: 69.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 69-year-old female patient received PREVNAR 13 (lot number: S51635, expiration date: Oct2018), intramuscular at right arm on 29Nov2017 at around 12:45 at 0.5 ml, single dose for pneumonia prevention at pharmacy/drug store. Patient has no medical history, denies other medical conditions. Concomitant medication included FLUZONE HD, intramuscular at left arm on 29Nov2017 at unknown dose, single for flu shot. Patient had no prior vaccination within 4 weeks. On 29Nov2017, the patient experienced redness and swelling. It was reported that patient knows redness and swelling are typical and confirmed she experienced these events. However, it was further reported that it still feels like a golf ball underneath the swelling and still feels like a lump in right arm where received injection. Patient added that there is still redness, like fever to it and confirmed does not have a fever, but just like a fever to the skin. Patient reported that events started same day received just got worse through the night. However, confirmed getting better now. It was reported that events did not require visit to the emergency room or physician office. Patient had no relevant test. Outcome of the events was recovering.
Age: 69.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Erythema, Injection site mass, Skin warm, Swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 69-year-old female patient received PREVNAR 13 (lot number: S51635, expiration date: Oct2018), intramuscular at right arm on 29Nov2017 at around 12:45 at 0.5 ml, single dose for pneumonia prevention at pharmacy/drug store. Patient has no medical history, denies other medical conditions. Concomitant medication included FLUZONE HD, intramuscular at left arm on 29Nov2017 at unknown dose, single for flu shot. Patient had no prior vaccination within 4 weeks. On 29Nov2017, the patient experienced redness and swelling. It was reported that patient knows redness and swelling are typical and confirmed she experienced these events. However, it was further reported that it still feels like a golf ball underneath the swelling and still feels like a lump in right arm where received injection. Patient added that there is still redness, like fever to it and confirmed does not have a fever, but just like a fever to the skin. Patient reported that events started same day received just got worse through the night. However, confirmed getting better now. It was reported that events did not require visit to the emergency room or physician office. Patient had no relevant test. Outcome of the events was recovering.
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Angiogram, Angiogram normal, Atrioventricular block, Brain natriuretic peptide increased, Cardiomegaly
Clinical narrative: The article notes a 36-year old male who presented for intolerance to exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, and edema, five weeks after smallpox vaccination. The patient was in mild distress, with severe orthopnea, tachypnea, tachycardia, bilateral crackles, and distant heart sounds. Electrocardiogram showed 2-to-1 AV block, with electrical cardioversion returning to sinus rhythm. A chest PA and lateral films revealed an enlarged cardiac silhouette. Laboratory investigation revealed an elevated brain natriuretic peptide (572pg/mL) and troponin (10.3ng/ml). An echocardiogram revealed an ejection fraction of 21%, an apical thrombus, pericardial effusion, diastolic dysfunction, global hypokenesis, and moderate tricuspid and mitral regurgitation. A CT Angiogram showed no evidence of coronary artery disease. A contrast MRI showed eosinophilic myocarditis. The patient was treated with furosemide, lisinopril, carvedilol, and rosuvastatin and the patient was discharged, sans carvedilol due to bradycardia. Lovenox was initiated for the LV thrombus and bridged to Warfarin for 6 months. As outpatient, cardiac function remains diminished with an EF of 20-25% with resolution of the thrombus. The patient's outcome was not reported in the article. No further information is expected.
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cardioversion, Chest X-ray abnormal, Chest pain, Crepitations, Diastolic dysfunction
Clinical narrative: The article notes a 36-year old male who presented for intolerance to exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, and edema, five weeks after smallpox vaccination. The patient was in mild distress, with severe orthopnea, tachypnea, tachycardia, bilateral crackles, and distant heart sounds. Electrocardiogram showed 2-to-1 AV block, with electrical cardioversion returning to sinus rhythm. A chest PA and lateral films revealed an enlarged cardiac silhouette. Laboratory investigation revealed an elevated brain natriuretic peptide (572pg/mL) and troponin (10.3ng/ml). An echocardiogram revealed an ejection fraction of 21%, an apical thrombus, pericardial effusion, diastolic dysfunction, global hypokenesis, and moderate tricuspid and mitral regurgitation. A CT Angiogram showed no evidence of coronary artery disease. A contrast MRI showed eosinophilic myocarditis. The patient was treated with furosemide, lisinopril, carvedilol, and rosuvastatin and the patient was discharged, sans carvedilol due to bradycardia. Lovenox was initiated for the LV thrombus and bridged to Warfarin for 6 months. As outpatient, cardiac function remains diminished with an EF of 20-25% with resolution of the thrombus. The patient's outcome was not reported in the article. No further information is expected.
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Dyspnoea paroxysmal nocturnal, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram abnormal, Eosinophilic myocarditis
Clinical narrative: The article notes a 36-year old male who presented for intolerance to exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, and edema, five weeks after smallpox vaccination. The patient was in mild distress, with severe orthopnea, tachypnea, tachycardia, bilateral crackles, and distant heart sounds. Electrocardiogram showed 2-to-1 AV block, with electrical cardioversion returning to sinus rhythm. A chest PA and lateral films revealed an enlarged cardiac silhouette. Laboratory investigation revealed an elevated brain natriuretic peptide (572pg/mL) and troponin (10.3ng/ml). An echocardiogram revealed an ejection fraction of 21%, an apical thrombus, pericardial effusion, diastolic dysfunction, global hypokenesis, and moderate tricuspid and mitral regurgitation. A CT Angiogram showed no evidence of coronary artery disease. A contrast MRI showed eosinophilic myocarditis. The patient was treated with furosemide, lisinopril, carvedilol, and rosuvastatin and the patient was discharged, sans carvedilol due to bradycardia. Lovenox was initiated for the LV thrombus and bridged to Warfarin for 6 months. As outpatient, cardiac function remains diminished with an EF of 20-25% with resolution of the thrombus. The patient's outcome was not reported in the article. No further information is expected.
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Exercise tolerance decreased, Heart sounds abnormal, Intracardiac thrombus, Mitral valve incompetence, Nuclear magnetic resonance imaging heart
Clinical narrative: The article notes a 36-year old male who presented for intolerance to exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, and edema, five weeks after smallpox vaccination. The patient was in mild distress, with severe orthopnea, tachypnea, tachycardia, bilateral crackles, and distant heart sounds. Electrocardiogram showed 2-to-1 AV block, with electrical cardioversion returning to sinus rhythm. A chest PA and lateral films revealed an enlarged cardiac silhouette. Laboratory investigation revealed an elevated brain natriuretic peptide (572pg/mL) and troponin (10.3ng/ml). An echocardiogram revealed an ejection fraction of 21%, an apical thrombus, pericardial effusion, diastolic dysfunction, global hypokenesis, and moderate tricuspid and mitral regurgitation. A CT Angiogram showed no evidence of coronary artery disease. A contrast MRI showed eosinophilic myocarditis. The patient was treated with furosemide, lisinopril, carvedilol, and rosuvastatin and the patient was discharged, sans carvedilol due to bradycardia. Lovenox was initiated for the LV thrombus and bridged to Warfarin for 6 months. As outpatient, cardiac function remains diminished with an EF of 20-25% with resolution of the thrombus. The patient's outcome was not reported in the article. No further information is expected.
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Oedema, Orthopnoea, Palpitations, Pericardial effusion, Scan with contrast abnormal
Clinical narrative: The article notes a 36-year old male who presented for intolerance to exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, and edema, five weeks after smallpox vaccination. The patient was in mild distress, with severe orthopnea, tachypnea, tachycardia, bilateral crackles, and distant heart sounds. Electrocardiogram showed 2-to-1 AV block, with electrical cardioversion returning to sinus rhythm. A chest PA and lateral films revealed an enlarged cardiac silhouette. Laboratory investigation revealed an elevated brain natriuretic peptide (572pg/mL) and troponin (10.3ng/ml). An echocardiogram revealed an ejection fraction of 21%, an apical thrombus, pericardial effusion, diastolic dysfunction, global hypokenesis, and moderate tricuspid and mitral regurgitation. A CT Angiogram showed no evidence of coronary artery disease. A contrast MRI showed eosinophilic myocarditis. The patient was treated with furosemide, lisinopril, carvedilol, and rosuvastatin and the patient was discharged, sans carvedilol due to bradycardia. Lovenox was initiated for the LV thrombus and bridged to Warfarin for 6 months. As outpatient, cardiac function remains diminished with an EF of 20-25% with resolution of the thrombus. The patient's outcome was not reported in the article. No further information is expected.
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Tachycardia, Tachypnoea, Tricuspid valve incompetence, Troponin increased, Ventricular hypokinesia
Clinical narrative: The article notes a 36-year old male who presented for intolerance to exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, and edema, five weeks after smallpox vaccination. The patient was in mild distress, with severe orthopnea, tachypnea, tachycardia, bilateral crackles, and distant heart sounds. Electrocardiogram showed 2-to-1 AV block, with electrical cardioversion returning to sinus rhythm. A chest PA and lateral films revealed an enlarged cardiac silhouette. Laboratory investigation revealed an elevated brain natriuretic peptide (572pg/mL) and troponin (10.3ng/ml). An echocardiogram revealed an ejection fraction of 21%, an apical thrombus, pericardial effusion, diastolic dysfunction, global hypokenesis, and moderate tricuspid and mitral regurgitation. A CT Angiogram showed no evidence of coronary artery disease. A contrast MRI showed eosinophilic myocarditis. The patient was treated with furosemide, lisinopril, carvedilol, and rosuvastatin and the patient was discharged, sans carvedilol due to bradycardia. Lovenox was initiated for the LV thrombus and bridged to Warfarin for 6 months. As outpatient, cardiac function remains diminished with an EF of 20-25% with resolution of the thrombus. The patient's outcome was not reported in the article. No further information is expected.