chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 20-NOV-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-AUG-2016, the patient was treated at a clinic for the onset of a severe vesicular which was diagnosed as herpes zoster or shingles. On or about 29-AUG-2016, the patient sought subsequent treatment at a clinic from a physician for a vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-AUG-2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX, PERCOCET and MEDROL for management of her painful symptoms and excruciating pain. On or about 25-AUG-2016, the patient sought subsequent treatment for a persistent vesicular rash, which was diagnosed as post-herpetic neuralgia. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-JAN-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-AUG-2016, the patient was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2016, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-SEP-2007, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 09-AUG-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster and post herpetic neuralgia. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by a nurse practitioner for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was then diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a hospital, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2017, the patient was treated by a hospital for a blistering vesicular outbreak, which was then diagnosed as herpes or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Conversion disorder, Injection site pain, Vomiting
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to a female patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, the patient was hysterical following the administration of the vaccine, because her arm was painful at the injection site. The physician mentioned the patient also started vomiting. Additionally, the physician sent the patient to the emergency room for treatment. The outcome of hysterical, vomiting and injection site pain was reported as recovered. Causality assessment was not provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 11-JUL-2018, the patient was inadvertently vaccinated with expired PNEUMOVAX 23 lot # M042599 with expiration date 17-JUN-2018, intramuscularly, for prophylaxis (dose was not reported). No adverse effects were reported.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: Information received from the review of scientific literature on 02JUL2018. This is case 1 of 6 (18000138LT, 18000139LT,18000140LT, 18000141LT, 18000142LT, 18000143LT). The article notes an 18-year-old male who presented to the ED with left-sided pleuritic chest pain, diffuse ST elevations with PR depressions on electrocardiogram (ECG) and positive troponin-I elevation of 0.14 ng/mL (normal <0.03 ng/mL). Ten days after vaccination with ACAM2000, AVA (BioThrax), and typhoid vaccine. He was admitted for further evaluation and management of myopericarditis. Transthoracic echocardiogram was normal. Consultation with cardiology confirmed that his presentation was consistent with smallpox vaccination-associated myopericarditis. He was discharged with colchicine, activity restrictions for 3 months and flagged as non-deployable. Three months after diagnosis, the patient developed sharp chest pain while running and was brought to the ED. An ECG was unchanged since prior and troponin was elevated but downtrending. The patient was discharged home, and on follow-up with cardiology his activity restrictions and nondeployable status were extended due to his continued chest pain. The patient's outcome was not reported in the article. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Myocarditis, Pleuritic pain, Troponin I increased
Clinical narrative: Information received from the review of scientific literature on 02JUL2018. This is case 1 of 6 (18000138LT, 18000139LT,18000140LT, 18000141LT, 18000142LT, 18000143LT). The article notes an 18-year-old male who presented to the ED with left-sided pleuritic chest pain, diffuse ST elevations with PR depressions on electrocardiogram (ECG) and positive troponin-I elevation of 0.14 ng/mL (normal <0.03 ng/mL). Ten days after vaccination with ACAM2000, AVA (BioThrax), and typhoid vaccine. He was admitted for further evaluation and management of myopericarditis. Transthoracic echocardiogram was normal. Consultation with cardiology confirmed that his presentation was consistent with smallpox vaccination-associated myopericarditis. He was discharged with colchicine, activity restrictions for 3 months and flagged as non-deployable. Three months after diagnosis, the patient developed sharp chest pain while running and was brought to the ED. An ECG was unchanged since prior and troponin was elevated but downtrending. The patient was discharged home, and on follow-up with cardiology his activity restrictions and nondeployable status were extended due to his continued chest pain. The patient's outcome was not reported in the article. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Echocardiogram abnormal, Electrocardiogram ST segment elevation
Clinical narrative: Information received from the review of scientific literature on 02JUL2018. This is case 2 of 6 (18000138LT, 18000139LT,18000140LT, 18000141LT,18000142LT, 18000143LT) The article notes a 27-year-old active duty male who presented to the ED with 3 days of left-sided pleuritic chest pain and shortness of breath 11 days after receiving vaccinations including ACAM2000. His pain was worsened when lying flat and improved with sitting up. His ECG showed ST elevation and PR repressions with a positive troponin-I of 5.69 (normal <0.03 ng/mL). A bedside transthoracic echocardiogram showed a small pericardial effusion without signs of cardiac tamponade. Cardiology at an outside hospital was consulted and the patient was transferred for further care of myopericarditis. He was discharged 3 days later on ibuprofen with cardiology follow-up. A repeat echocardiogram showed resolution of the pericardial effusion. Approximately 2 weeks after discharge, the patient returned to the ED with similar chest pain. His troponin-I was negative, a bedside transthoracic echocardiogram showed no evidence of pericardial effusion, and his ECG was consistent with resolving pericarditis. The patient was discharged to follow-up with cardiology. At the follow-up, he was given a medical profile, made non-deployable, and started on a 3-month regimen of colchicine. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Impaired work ability, Myocarditis, Pericardial effusion, Pericarditis, Pleuritic pain
Clinical narrative: Information received from the review of scientific literature on 02JUL2018. This is case 2 of 6 (18000138LT, 18000139LT,18000140LT, 18000141LT,18000142LT, 18000143LT) The article notes a 27-year-old active duty male who presented to the ED with 3 days of left-sided pleuritic chest pain and shortness of breath 11 days after receiving vaccinations including ACAM2000. His pain was worsened when lying flat and improved with sitting up. His ECG showed ST elevation and PR repressions with a positive troponin-I of 5.69 (normal <0.03 ng/mL). A bedside transthoracic echocardiogram showed a small pericardial effusion without signs of cardiac tamponade. Cardiology at an outside hospital was consulted and the patient was transferred for further care of myopericarditis. He was discharged 3 days later on ibuprofen with cardiology follow-up. A repeat echocardiogram showed resolution of the pericardial effusion. Approximately 2 weeks after discharge, the patient returned to the ED with similar chest pain. His troponin-I was negative, a bedside transthoracic echocardiogram showed no evidence of pericardial effusion, and his ECG was consistent with resolving pericarditis. The patient was discharged to follow-up with cardiology. At the follow-up, he was given a medical profile, made non-deployable, and started on a 3-month regimen of colchicine. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin I increased
Clinical narrative: Information received from the review of scientific literature on 02JUL2018. This is case 2 of 6 (18000138LT, 18000139LT,18000140LT, 18000141LT,18000142LT, 18000143LT) The article notes a 27-year-old active duty male who presented to the ED with 3 days of left-sided pleuritic chest pain and shortness of breath 11 days after receiving vaccinations including ACAM2000. His pain was worsened when lying flat and improved with sitting up. His ECG showed ST elevation and PR repressions with a positive troponin-I of 5.69 (normal <0.03 ng/mL). A bedside transthoracic echocardiogram showed a small pericardial effusion without signs of cardiac tamponade. Cardiology at an outside hospital was consulted and the patient was transferred for further care of myopericarditis. He was discharged 3 days later on ibuprofen with cardiology follow-up. A repeat echocardiogram showed resolution of the pericardial effusion. Approximately 2 weeks after discharge, the patient returned to the ED with similar chest pain. His troponin-I was negative, a bedside transthoracic echocardiogram showed no evidence of pericardial effusion, and his ECG was consistent with resolving pericarditis. The patient was discharged to follow-up with cardiology. At the follow-up, he was given a medical profile, made non-deployable, and started on a 3-month regimen of colchicine. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: C-reactive protein increased, Chest X-ray normal, Chest pain, Echocardiogram normal, Electrocardiogram ST segment abnormal
Clinical narrative: Information received from the review of scientific literature on 02JUL2018. This is case 3 of 6 (18000138LT, 18000139LT,18000140LT, 18000141LT,18000142LT, 18000143LT) The article notes a 25-year-old active duty male who presented to the ED with one day of achy chest pain 11 days after receiving ACAM2000. His chest pain was gradual in onset, centrally located, non-exertional, non-positional and without any radiation. The patient had no significant family history of cardiac disease. The ECG showed, ST depression in lead aVL and mild PR depression/ST elevations in lead I. These were new findings compared to a previous ECG. His troponin-I was elevated at 2.24, and his C-reactive protein was elevated at 1.49. No acute cardiopulmonary disease was seen in chest x-ray, and a bedside transthoracic echocardiogram showed no pericardial effusion. Cardiology was consulted from an outside hospital and the patient was transferred for further treatment of myocarditis. After discharge, the patient was placed on ibuprofen and instructed to follow-up with his primary care physician. At follow-up, he was placed on a 3-month medical profile and made non-deployable. He was to be followed by cardiology as an outpatient. The patient's outcome was not reported in the article. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Impaired work ability, Myocarditis, Troponin I increased
Clinical narrative: Information received from the review of scientific literature on 02JUL2018. This is case 3 of 6 (18000138LT, 18000139LT,18000140LT, 18000141LT,18000142LT, 18000143LT) The article notes a 25-year-old active duty male who presented to the ED with one day of achy chest pain 11 days after receiving ACAM2000. His chest pain was gradual in onset, centrally located, non-exertional, non-positional and without any radiation. The patient had no significant family history of cardiac disease. The ECG showed, ST depression in lead aVL and mild PR depression/ST elevations in lead I. These were new findings compared to a previous ECG. His troponin-I was elevated at 2.24, and his C-reactive protein was elevated at 1.49. No acute cardiopulmonary disease was seen in chest x-ray, and a bedside transthoracic echocardiogram showed no pericardial effusion. Cardiology was consulted from an outside hospital and the patient was transferred for further treatment of myocarditis. After discharge, the patient was placed on ibuprofen and instructed to follow-up with his primary care physician. At follow-up, he was placed on a 3-month medical profile and made non-deployable. He was to be followed by cardiology as an outpatient. The patient's outcome was not reported in the article. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Catheterisation cardiac normal, Chest X-ray normal, Chest pain, Echocardiogram normal, Electrocardiogram abnormal
Clinical narrative: Information received from the review of scientific literature on 02JUL2018. This is case 4 of 6 (18000138LT, 18000139LT,18000140LT, 18000141LT,18000142LT, 18000143LT) The article notes a 22-year-old active duty male who presented to the ED with aching centrally located chest pain approximately 9 days after receiving ACAM2000. His chest pain started earlier that morning, and was non-pleuritic, non-positional, non-exertional, and not radiating. The patient had no personal or family history of cardiac disease. His ECG showed sinus bradycardia at 53 bpm but was otherwise normal. A chest x-ray showed no acute cardiopulmonary disease. A troponin-I was elevated at 2.12. The case was discussed with Cardiology from an outside hospital and the patient was transferred for further care and evaluation of myopericarditis. As an inpatient, he had a normal cardiac catheterization and echocardiogram. After discharge, the patient was placed on a medical profile, made non-deployable, and was to be followed by cardiology as an outpatient. The patient's outcome was not reported in the article. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Impaired work ability, Myocarditis, Sinus bradycardia, Troponin I increased
Clinical narrative: Information received from the review of scientific literature on 02JUL2018. This is case 4 of 6 (18000138LT, 18000139LT,18000140LT, 18000141LT,18000142LT, 18000143LT) The article notes a 22-year-old active duty male who presented to the ED with aching centrally located chest pain approximately 9 days after receiving ACAM2000. His chest pain started earlier that morning, and was non-pleuritic, non-positional, non-exertional, and not radiating. The patient had no personal or family history of cardiac disease. His ECG showed sinus bradycardia at 53 bpm but was otherwise normal. A chest x-ray showed no acute cardiopulmonary disease. A troponin-I was elevated at 2.12. The case was discussed with Cardiology from an outside hospital and the patient was transferred for further care and evaluation of myopericarditis. As an inpatient, he had a normal cardiac catheterization and echocardiogram. After discharge, the patient was placed on a medical profile, made non-deployable, and was to be followed by cardiology as an outpatient. The patient's outcome was not reported in the article. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Chest X-ray normal, Chest pain, Echocardiogram abnormal, Ejection fraction normal, Electrocardiogram ST segment abnormal
Clinical narrative: Information received from the review of scientific literature on 02JUL2018. This is case 5 of 6 (18000138LT, 18000139LT, 18000140LT, 18000141LT, 18000142LT, 18000143LT) The article notes a 27-year-old active duty male who presented to the ED with left-sided pleuritic chest pain 11 days after receiving ACAM2000. His pain was worse with movement, but otherwise non-exertional or positional. His ECG showed diffuse ST elevations and PR depressions. The patient's chest x-ray and bedside transthoracic echocardiogram were unremarkable and his troponin-I was elevated at 0.25. Cardiology was consulted from an outside hospital, and the patient was then transferred for further evaluation and treatment of myopericarditis. The patient was given toradol and started on colchicine prior to transfer. As an inpatient, his formal echocardiogram showed trace effusion, but otherwise, there were no structural changes and he had a normal ejection fraction. Ibuprofen and colchicine were continued and he was followed by Cardiology as an outpatient. The patient was then made non-deployable and placed on a 6-month medical profile. Approximately 1 month after initial presentation to the ED, the patient returned with 1 day of similar chest pain. He had been compliant with medication and his initial ECG was normal without signs of ST elevation of PR depression. On repeat ECG, he showed non-specific ST changes in leads II, III, and aVL. His troponin-I was within normal limits and a bedside transthoracic echocardiogram was normal as well. Due to dynamic changes in ECG and recent history of myopericarditis, the patient was transferred to an outside hospital for further evaluation. The patient's outcome was not reported in the article. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Impaired work ability, Myocarditis, Pain, Pleural effusion, Pleuritic pain
Clinical narrative: Information received from the review of scientific literature on 02JUL2018. This is case 5 of 6 (18000138LT, 18000139LT, 18000140LT, 18000141LT, 18000142LT, 18000143LT) The article notes a 27-year-old active duty male who presented to the ED with left-sided pleuritic chest pain 11 days after receiving ACAM2000. His pain was worse with movement, but otherwise non-exertional or positional. His ECG showed diffuse ST elevations and PR depressions. The patient's chest x-ray and bedside transthoracic echocardiogram were unremarkable and his troponin-I was elevated at 0.25. Cardiology was consulted from an outside hospital, and the patient was then transferred for further evaluation and treatment of myopericarditis. The patient was given toradol and started on colchicine prior to transfer. As an inpatient, his formal echocardiogram showed trace effusion, but otherwise, there were no structural changes and he had a normal ejection fraction. Ibuprofen and colchicine were continued and he was followed by Cardiology as an outpatient. The patient was then made non-deployable and placed on a 6-month medical profile. Approximately 1 month after initial presentation to the ED, the patient returned with 1 day of similar chest pain. He had been compliant with medication and his initial ECG was normal without signs of ST elevation of PR depression. On repeat ECG, he showed non-specific ST changes in leads II, III, and aVL. His troponin-I was within normal limits and a bedside transthoracic echocardiogram was normal as well. Due to dynamic changes in ECG and recent history of myopericarditis, the patient was transferred to an outside hospital for further evaluation. The patient's outcome was not reported in the article. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin I increased
Clinical narrative: Information received from the review of scientific literature on 02JUL2018. This is case 5 of 6 (18000138LT, 18000139LT, 18000140LT, 18000141LT, 18000142LT, 18000143LT) The article notes a 27-year-old active duty male who presented to the ED with left-sided pleuritic chest pain 11 days after receiving ACAM2000. His pain was worse with movement, but otherwise non-exertional or positional. His ECG showed diffuse ST elevations and PR depressions. The patient's chest x-ray and bedside transthoracic echocardiogram were unremarkable and his troponin-I was elevated at 0.25. Cardiology was consulted from an outside hospital, and the patient was then transferred for further evaluation and treatment of myopericarditis. The patient was given toradol and started on colchicine prior to transfer. As an inpatient, his formal echocardiogram showed trace effusion, but otherwise, there were no structural changes and he had a normal ejection fraction. Ibuprofen and colchicine were continued and he was followed by Cardiology as an outpatient. The patient was then made non-deployable and placed on a 6-month medical profile. Approximately 1 month after initial presentation to the ED, the patient returned with 1 day of similar chest pain. He had been compliant with medication and his initial ECG was normal without signs of ST elevation of PR depression. On repeat ECG, he showed non-specific ST changes in leads II, III, and aVL. His troponin-I was within normal limits and a bedside transthoracic echocardiogram was normal as well. Due to dynamic changes in ECG and recent history of myopericarditis, the patient was transferred to an outside hospital for further evaluation. The patient's outcome was not reported in the article. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Echocardiogram, Echocardiogram abnormal, Ejection fraction normal, Electrocardiogram ST segment normal
Clinical narrative: Information received from the review of scientific literature on 02JUL2018. This is case 6 of 6 (18000138LT, 18000139LT, 18000140LT, 18000141LT, 18000142LT, 18000143LT) The article notes an otherwise previously healthy 19-year-old male who presented to the ED with centrally located pleuritic chest pain approximately 10 days after receiving ACAM2000. His pain started the previous night and had been constant and sharp. The patient's ECG was normal without any PR depressions or ST elevations. His troponin-I was positive at 0.83. A transthoracic bedside echocardiogram showed no pericardial effusion and a normal gross ejection fraction. Cardiology from an outside hospital was consulted and the patient was transferred for further evaluation and treatment of myocarditis. An echocardiogram as an inpatient showed systolic dysfunction without signs of heart failure. The patient was discharged 4 days later with instructions to take colchicine and metoprolol. He was being followed by cardiology as an outpatient, was started on ibuprofen, and was placed on activity restrictions for 30 days pending cardiology follow-up, and made non-deployable. The patient's outcome was not reported in the article. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Myocarditis, Pleuritic pain, Systolic dysfunction, Troponin I increased
Clinical narrative: Information received from the review of scientific literature on 02JUL2018. This is case 6 of 6 (18000138LT, 18000139LT, 18000140LT, 18000141LT, 18000142LT, 18000143LT) The article notes an otherwise previously healthy 19-year-old male who presented to the ED with centrally located pleuritic chest pain approximately 10 days after receiving ACAM2000. His pain started the previous night and had been constant and sharp. The patient's ECG was normal without any PR depressions or ST elevations. His troponin-I was positive at 0.83. A transthoracic bedside echocardiogram showed no pericardial effusion and a normal gross ejection fraction. Cardiology from an outside hospital was consulted and the patient was transferred for further evaluation and treatment of myocarditis. An echocardiogram as an inpatient showed systolic dysfunction without signs of heart failure. The patient was discharged 4 days later with instructions to take colchicine and metoprolol. He was being followed by cardiology as an outpatient, was started on ibuprofen, and was placed on activity restrictions for 30 days pending cardiology follow-up, and made non-deployable. The patient's outcome was not reported in the article. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Dyspnoea, Feeling cold, Headache
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shortness of breath in a 62-year-old male patient who received SHINGRIX (batch number LT533, expiry date unknown) for prophylaxis. On 28th June 2018, the patient received the 2nd dose of SHINGRIX. On 29th June 2018, 1 days after receiving SHINGRIX, the patient experienced shortness of breath, headache, loss of energy, chilliness, sleeplessness, feeling unwell, stomach cramps and chills. On an unknown date, the outcome of the shortness of breath, headache, loss of energy, chilliness, sleeplessness, feeling unwell, stomach cramps and chills were recovering/resolving. It was unknown if the reporter considered the shortness of breath, headache, loss of energy, chilliness, sleeplessness, feeling unwell, stomach cramps and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that at midnight after receiving the second dose of SHINGRIX the patient experienced short of breath, stomach started cramping, headache, chills, could not keep warm, almost went to the emergency room, did not sleep the rest of the night. The patient saw their cardiologist the next day.  The patient was still not feeling back on his feet yet and lacks energy to do things.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shortness of breath in a 62-year-old male patient who received SHINGRIX (batch number LT533, expiry date unknown) for prophylaxis. On 28th June 2018, the patient received the 2nd dose of SHINGRIX. On 29th June 2018, 1 days after receiving SHINGRIX, the patient experienced shortness of breath, headache, loss of energy, chilliness, sleeplessness, feeling unwell, stomach cramps and chills. On an unknown date, the outcome of the shortness of breath, headache, loss of energy, chilliness, sleeplessness, feeling unwell, stomach cramps and chills were recovering/resolving. It was unknown if the reporter considered the shortness of breath, headache, loss of energy, chilliness, sleeplessness, feeling unwell, stomach cramps and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that at midnight after receiving the second dose of SHINGRIX the patient experienced short of breath, stomach started cramping, headache, chills, could not keep warm, almost went to the emergency room, did not sleep the rest of the night. The patient saw their cardiologist the next day.  The patient was still not feeling back on his feet yet and lacks energy to do things.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Headache, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 27th June 2018, the patient received SHINGRIX (intramuscular) 50 mcg/mg. On 27th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, pain and pain in arm. On 28th June 2018, the patient experienced headache, extremities hot feeling of, erythema of extremities, swelling arm and feeling bad. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On 30th June 2018, the outcome of the headache, pain and feeling bad were recovered/resolved. On an unknown date, the outcome of the injection site pain, extremities hot feeling of, erythema of extremities, swelling arm and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, headache, extremities hot feeling of, erythema of extremities, swelling arm, pain, pain in arm and feeling bad to be related to SHINGRIX. Additional details were provided as follow:Wednesday, the patient experienced pain when given the SHINGRIX and on the same day in afternoon several hours after receiving SHINGRIX, her arm was sore for the remainder of the day. Less than a day after receiving SHINGRIX, the patient developed aches. On 28th June 2018 Thursday, 1 day after receiving SHINGRIX, when the patient awoke, she felt bad all over and in night she developed a severe headache and experienced swelling and redness on her arm and was hot to touch. On 29th June 2018 Saturday, when the patient awoke in morning, she felt better except her sore arm. The patient's husband actually noticed the swelling and redness on her arm. By Saturday night it had worsened but all other symptoms resolved. The patient's arm was redder and really hot to the touch and the area was much larger. Sunday morning it felt better but by that evening, it was larger and worse than on Saturday evening. As of today in the reporting date, it was not better. On 30th June 2018, in afternoon, the patient consulted with her pharmacist, who told her to put ice on it which did not help. Then on Saturday night the patient called a nurse who told her to put a warm compress on it.