chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Myocarditis, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: This is a follow-up to a previously submitted VAERS report 527631-1. 22 y/o male who on 23 MAR 2014 received his primary smallpox vaccine (left arm), along with AVA (1) and typhoid vaccines (right arm). He reports normal site progression of his smallpox site and no local site reactions at his other vaccination sites. On 3 APR, around 2100, patient noted the onset of constant, sharp chest pain along his left sternal border. Initially the pain was rated at an intensity level of 2/10, using a pain scale of 0 (= no pain) to 10 (= worst pain ever experienced). Within 2 hours, the chest pain intensified to a level 10/10 and was accompanied by shortness of breath and his heart was "beating hard". He denies nausea, vomiting, diaphoresis, and pedal edema. He noted the pain increased with deep breaths and when lying flat. He was most comfortable sitting straight up or standing. The pain did not radiate. Patient sought evaluation late evening of 3 APR at his local ER. He was told that he had an abnormal ECG and lab work, so he was transferred and admitted to another hospital. While admitted, he had an echocardiogram and coronary angiography, which patient reports were both normal. Patient does not recall when his chest pain resolved, but it was sometime after his cardiac cath. He has not experienced any recurrence of chest pain since his discharge on 6 APR. He was discharged on colchicine 0.4 mg twice daily and Metoprolol 25 mg daily and on an activity restriction x 3-6 months - "No strenuous activity". At time of discharge, patient was asymptomatic. Patient was seen as an outpatient at Cardiologist on 22 APR. He denies having lab work, echocardiogram, or an exercise stress test completed, but says he is to return for Cardiology appointment in JUN, which will include another echocardiogram. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for a family history of CAD. (Father had an MI in his 40s). Denies history of previous adverse events following immunizations. PMH: Negative. No history of eczema, allergies, or asthma. No history of chronic illnesses. No prior hospitalizations. No surgeries. Family Hx: Mother - 51 years old, history of breast cancer with treatment a few years ago. Father - 53 years old, history of CAD, with MI in his 40s. HTN. 1/2 Sister - age 27, in good health. No family hx of drownings, seizures, unexplained MVAs, and sudden death. Social Hx: Single. Tobacco - None. Alcohol - drinks 12-pack during the weekend. Exercise - Not sedentary. Performed routine group PT prior to recent hospitalization. Allergies: Denies allergies to medications, food, latex, and insect stings. ROS: Review of 13 systems. All systems negative, with the exceptions described in HPI.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Arteriogram coronary normal, Blood creatine phosphokinase MB increased, C-reactive protein increased, Catheterisation cardiac, Chest X-ray normal
Clinical narrative: This is a follow-up to a previously submitted VAERS report 527631-1. 22 y/o male who on 23 MAR 2014 received his primary smallpox vaccine (left arm), along with AVA (1) and typhoid vaccines (right arm). He reports normal site progression of his smallpox site and no local site reactions at his other vaccination sites. On 3 APR, around 2100, patient noted the onset of constant, sharp chest pain along his left sternal border. Initially the pain was rated at an intensity level of 2/10, using a pain scale of 0 (= no pain) to 10 (= worst pain ever experienced). Within 2 hours, the chest pain intensified to a level 10/10 and was accompanied by shortness of breath and his heart was "beating hard". He denies nausea, vomiting, diaphoresis, and pedal edema. He noted the pain increased with deep breaths and when lying flat. He was most comfortable sitting straight up or standing. The pain did not radiate. Patient sought evaluation late evening of 3 APR at his local ER. He was told that he had an abnormal ECG and lab work, so he was transferred and admitted to another hospital. While admitted, he had an echocardiogram and coronary angiography, which patient reports were both normal. Patient does not recall when his chest pain resolved, but it was sometime after his cardiac cath. He has not experienced any recurrence of chest pain since his discharge on 6 APR. He was discharged on colchicine 0.4 mg twice daily and Metoprolol 25 mg daily and on an activity restriction x 3-6 months - "No strenuous activity". At time of discharge, patient was asymptomatic. Patient was seen as an outpatient at Cardiologist on 22 APR. He denies having lab work, echocardiogram, or an exercise stress test completed, but says he is to return for Cardiology appointment in JUN, which will include another echocardiogram. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for a family history of CAD. (Father had an MI in his 40s). Denies history of previous adverse events following immunizations. PMH: Negative. No history of eczema, allergies, or asthma. No history of chronic illnesses. No prior hospitalizations. No surgeries. Family Hx: Mother - 51 years old, history of breast cancer with treatment a few years ago. Father - 53 years old, history of CAD, with MI in his 40s. HTN. 1/2 Sister - age 27, in good health. No family hx of drownings, seizures, unexplained MVAs, and sudden death. Social Hx: Single. Tobacco - None. Alcohol - drinks 12-pack during the weekend. Exercise - Not sedentary. Performed routine group PT prior to recent hospitalization. Allergies: Denies allergies to medications, food, latex, and insect stings. ROS: Review of 13 systems. All systems negative, with the exceptions described in HPI.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Exercise test
Clinical narrative: This is a follow-up to a previously submitted VAERS report 527631-1. 22 y/o male who on 23 MAR 2014 received his primary smallpox vaccine (left arm), along with AVA (1) and typhoid vaccines (right arm). He reports normal site progression of his smallpox site and no local site reactions at his other vaccination sites. On 3 APR, around 2100, patient noted the onset of constant, sharp chest pain along his left sternal border. Initially the pain was rated at an intensity level of 2/10, using a pain scale of 0 (= no pain) to 10 (= worst pain ever experienced). Within 2 hours, the chest pain intensified to a level 10/10 and was accompanied by shortness of breath and his heart was "beating hard". He denies nausea, vomiting, diaphoresis, and pedal edema. He noted the pain increased with deep breaths and when lying flat. He was most comfortable sitting straight up or standing. The pain did not radiate. Patient sought evaluation late evening of 3 APR at his local ER. He was told that he had an abnormal ECG and lab work, so he was transferred and admitted to another hospital. While admitted, he had an echocardiogram and coronary angiography, which patient reports were both normal. Patient does not recall when his chest pain resolved, but it was sometime after his cardiac cath. He has not experienced any recurrence of chest pain since his discharge on 6 APR. He was discharged on colchicine 0.4 mg twice daily and Metoprolol 25 mg daily and on an activity restriction x 3-6 months - "No strenuous activity". At time of discharge, patient was asymptomatic. Patient was seen as an outpatient at Cardiologist on 22 APR. He denies having lab work, echocardiogram, or an exercise stress test completed, but says he is to return for Cardiology appointment in JUN, which will include another echocardiogram. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for a family history of CAD. (Father had an MI in his 40s). Denies history of previous adverse events following immunizations. PMH: Negative. No history of eczema, allergies, or asthma. No history of chronic illnesses. No prior hospitalizations. No surgeries. Family Hx: Mother - 51 years old, history of breast cancer with treatment a few years ago. Father - 53 years old, history of CAD, with MI in his 40s. HTN. 1/2 Sister - age 27, in good health. No family hx of drownings, seizures, unexplained MVAs, and sudden death. Social Hx: Single. Tobacco - None. Alcohol - drinks 12-pack during the weekend. Exercise - Not sedentary. Performed routine group PT prior to recent hospitalization. Allergies: Denies allergies to medications, food, latex, and insect stings. ROS: Review of 13 systems. All systems negative, with the exceptions described in HPI.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Heart rate increased, Pain, Painful respiration, Red blood cell sedimentation rate increased, Troponin I increased
Clinical narrative: This is a follow-up to a previously submitted VAERS report 527631-1. 22 y/o male who on 23 MAR 2014 received his primary smallpox vaccine (left arm), along with AVA (1) and typhoid vaccines (right arm). He reports normal site progression of his smallpox site and no local site reactions at his other vaccination sites. On 3 APR, around 2100, patient noted the onset of constant, sharp chest pain along his left sternal border. Initially the pain was rated at an intensity level of 2/10, using a pain scale of 0 (= no pain) to 10 (= worst pain ever experienced). Within 2 hours, the chest pain intensified to a level 10/10 and was accompanied by shortness of breath and his heart was "beating hard". He denies nausea, vomiting, diaphoresis, and pedal edema. He noted the pain increased with deep breaths and when lying flat. He was most comfortable sitting straight up or standing. The pain did not radiate. Patient sought evaluation late evening of 3 APR at his local ER. He was told that he had an abnormal ECG and lab work, so he was transferred and admitted to another hospital. While admitted, he had an echocardiogram and coronary angiography, which patient reports were both normal. Patient does not recall when his chest pain resolved, but it was sometime after his cardiac cath. He has not experienced any recurrence of chest pain since his discharge on 6 APR. He was discharged on colchicine 0.4 mg twice daily and Metoprolol 25 mg daily and on an activity restriction x 3-6 months - "No strenuous activity". At time of discharge, patient was asymptomatic. Patient was seen as an outpatient at Cardiologist on 22 APR. He denies having lab work, echocardiogram, or an exercise stress test completed, but says he is to return for Cardiology appointment in JUN, which will include another echocardiogram. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for a family history of CAD. (Father had an MI in his 40s). Denies history of previous adverse events following immunizations. PMH: Negative. No history of eczema, allergies, or asthma. No history of chronic illnesses. No prior hospitalizations. No surgeries. Family Hx: Mother - 51 years old, history of breast cancer with treatment a few years ago. Father - 53 years old, history of CAD, with MI in his 40s. HTN. 1/2 Sister - age 27, in good health. No family hx of drownings, seizures, unexplained MVAs, and sudden death. Social Hx: Single. Tobacco - None. Alcohol - drinks 12-pack during the weekend. Exercise - Not sedentary. Performed routine group PT prior to recent hospitalization. Allergies: Denies allergies to medications, food, latex, and insect stings. ROS: Review of 13 systems. All systems negative, with the exceptions described in HPI.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Ventricular hypertrophy
Clinical narrative: This is a follow-up to a previously submitted VAERS report 527631-1. 22 y/o male who on 23 MAR 2014 received his primary smallpox vaccine (left arm), along with AVA (1) and typhoid vaccines (right arm). He reports normal site progression of his smallpox site and no local site reactions at his other vaccination sites. On 3 APR, around 2100, patient noted the onset of constant, sharp chest pain along his left sternal border. Initially the pain was rated at an intensity level of 2/10, using a pain scale of 0 (= no pain) to 10 (= worst pain ever experienced). Within 2 hours, the chest pain intensified to a level 10/10 and was accompanied by shortness of breath and his heart was "beating hard". He denies nausea, vomiting, diaphoresis, and pedal edema. He noted the pain increased with deep breaths and when lying flat. He was most comfortable sitting straight up or standing. The pain did not radiate. Patient sought evaluation late evening of 3 APR at his local ER. He was told that he had an abnormal ECG and lab work, so he was transferred and admitted to another hospital. While admitted, he had an echocardiogram and coronary angiography, which patient reports were both normal. Patient does not recall when his chest pain resolved, but it was sometime after his cardiac cath. He has not experienced any recurrence of chest pain since his discharge on 6 APR. He was discharged on colchicine 0.4 mg twice daily and Metoprolol 25 mg daily and on an activity restriction x 3-6 months - "No strenuous activity". At time of discharge, patient was asymptomatic. Patient was seen as an outpatient at Cardiologist on 22 APR. He denies having lab work, echocardiogram, or an exercise stress test completed, but says he is to return for Cardiology appointment in JUN, which will include another echocardiogram. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for a family history of CAD. (Father had an MI in his 40s). Denies history of previous adverse events following immunizations. PMH: Negative. No history of eczema, allergies, or asthma. No history of chronic illnesses. No prior hospitalizations. No surgeries. Family Hx: Mother - 51 years old, history of breast cancer with treatment a few years ago. Father - 53 years old, history of CAD, with MI in his 40s. HTN. 1/2 Sister - age 27, in good health. No family hx of drownings, seizures, unexplained MVAs, and sudden death. Social Hx: Single. Tobacco - None. Alcohol - drinks 12-pack during the weekend. Exercise - Not sedentary. Performed routine group PT prior to recent hospitalization. Allergies: Denies allergies to medications, food, latex, and insect stings. ROS: Review of 13 systems. All systems negative, with the exceptions described in HPI.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: C-reactive protein, Chest X-ray normal, Dyspnoea, Monocyte count increased, Myocarditis
Clinical narrative: This is a follow-up to a previously submitted VAERS report 527631-1. 22 y/o male who on 23 MAR 2014 received his primary smallpox vaccine (left arm), along with AVA (1) and typhoid vaccines (right arm). He reports normal site progression of his smallpox site and no local site reactions at his other vaccination sites. On 3 APR, around 2100, patient noted the onset of constant, sharp chest pain along his left sternal border. Initially the pain was rated at an intensity level of 2/10, using a pain scale of 0 (= no pain) to 10 (= worst pain ever experienced). Within 2 hours, the chest pain intensified to a level 10/10 and was accompanied by shortness of breath and his heart was "beating hard". He denies nausea, vomiting, diaphoresis, and pedal edema. He noted the pain increased with deep breaths and when lying flat. He was most comfortable sitting straight up or standing. The pain did not radiate. Patient sought evaluation late evening of 3 APR at his local ER. He was told that he had an abnormal ECG and lab work, so he was transferred and admitted to another hospital. While admitted, he had an echocardiogram and coronary angiography, which patient reports were both normal. Patient does not recall when his chest pain resolved, but it was sometime after his cardiac cath. He has not experienced any recurrence of chest pain since his discharge on 6 APR. He was discharged on colchicine 0.4 mg twice daily and Metoprolol 25 mg daily and on an activity restriction x 3-6 months - "No strenuous activity". At time of discharge, patient was asymptomatic. Patient was seen as an outpatient at Cardiologist on 22 APR. He denies having lab work, echocardiogram, or an exercise stress test completed, but says he is to return for Cardiology appointment in JUN, which will include another echocardiogram. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for a family history of CAD. (Father had an MI in his 40s). Denies history of previous adverse events following immunizations. PMH: Negative. No history of eczema, allergies, or asthma. No history of chronic illnesses. No prior hospitalizations. No surgeries. Family Hx: Mother - 51 years old, history of breast cancer with treatment a few years ago. Father - 53 years old, history of CAD, with MI in his 40s. HTN. 1/2 Sister - age 27, in good health. No family hx of drownings, seizures, unexplained MVAs, and sudden death. Social Hx: Single. Tobacco - None. Alcohol - drinks 12-pack during the weekend. Exercise - Not sedentary. Performed routine group PT prior to recent hospitalization. Allergies: Denies allergies to medications, food, latex, and insect stings. ROS: Review of 13 systems. All systems negative, with the exceptions described in HPI.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: This is a follow-up to a previously submitted VAERS report 527631-1. 22 y/o male who on 23 MAR 2014 received his primary smallpox vaccine (left arm), along with AVA (1) and typhoid vaccines (right arm). He reports normal site progression of his smallpox site and no local site reactions at his other vaccination sites. On 3 APR, around 2100, patient noted the onset of constant, sharp chest pain along his left sternal border. Initially the pain was rated at an intensity level of 2/10, using a pain scale of 0 (= no pain) to 10 (= worst pain ever experienced). Within 2 hours, the chest pain intensified to a level 10/10 and was accompanied by shortness of breath and his heart was "beating hard". He denies nausea, vomiting, diaphoresis, and pedal edema. He noted the pain increased with deep breaths and when lying flat. He was most comfortable sitting straight up or standing. The pain did not radiate. Patient sought evaluation late evening of 3 APR at his local ER. He was told that he had an abnormal ECG and lab work, so he was transferred and admitted to another hospital. While admitted, he had an echocardiogram and coronary angiography, which patient reports were both normal. Patient does not recall when his chest pain resolved, but it was sometime after his cardiac cath. He has not experienced any recurrence of chest pain since his discharge on 6 APR. He was discharged on colchicine 0.4 mg twice daily and Metoprolol 25 mg daily and on an activity restriction x 3-6 months - "No strenuous activity". At time of discharge, patient was asymptomatic. Patient was seen as an outpatient at Cardiologist on 22 APR. He denies having lab work, echocardiogram, or an exercise stress test completed, but says he is to return for Cardiology appointment in JUN, which will include another echocardiogram. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for a family history of CAD. (Father had an MI in his 40s). Denies history of previous adverse events following immunizations. PMH: Negative. No history of eczema, allergies, or asthma. No history of chronic illnesses. No prior hospitalizations. No surgeries. Family Hx: Mother - 51 years old, history of breast cancer with treatment a few years ago. Father - 53 years old, history of CAD, with MI in his 40s. HTN. 1/2 Sister - age 27, in good health. No family hx of drownings, seizures, unexplained MVAs, and sudden death. Social Hx: Single. Tobacco - None. Alcohol - drinks 12-pack during the weekend. Exercise - Not sedentary. Performed routine group PT prior to recent hospitalization. Allergies: Denies allergies to medications, food, latex, and insect stings. ROS: Review of 13 systems. All systems negative, with the exceptions described in HPI.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Pericarditis, Troponin I increased
Clinical narrative: This is a follow-up to a previously submitted VAERS report 527631-1. 22 y/o male who on 23 MAR 2014 received his primary smallpox vaccine (left arm), along with AVA (1) and typhoid vaccines (right arm). He reports normal site progression of his smallpox site and no local site reactions at his other vaccination sites. On 3 APR, around 2100, patient noted the onset of constant, sharp chest pain along his left sternal border. Initially the pain was rated at an intensity level of 2/10, using a pain scale of 0 (= no pain) to 10 (= worst pain ever experienced). Within 2 hours, the chest pain intensified to a level 10/10 and was accompanied by shortness of breath and his heart was "beating hard". He denies nausea, vomiting, diaphoresis, and pedal edema. He noted the pain increased with deep breaths and when lying flat. He was most comfortable sitting straight up or standing. The pain did not radiate. Patient sought evaluation late evening of 3 APR at his local ER. He was told that he had an abnormal ECG and lab work, so he was transferred and admitted to another hospital. While admitted, he had an echocardiogram and coronary angiography, which patient reports were both normal. Patient does not recall when his chest pain resolved, but it was sometime after his cardiac cath. He has not experienced any recurrence of chest pain since his discharge on 6 APR. He was discharged on colchicine 0.4 mg twice daily and Metoprolol 25 mg daily and on an activity restriction x 3-6 months - "No strenuous activity". At time of discharge, patient was asymptomatic. Patient was seen as an outpatient at Cardiologist on 22 APR. He denies having lab work, echocardiogram, or an exercise stress test completed, but says he is to return for Cardiology appointment in JUN, which will include another echocardiogram. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for a family history of CAD. (Father had an MI in his 40s). Denies history of previous adverse events following immunizations. PMH: Negative. No history of eczema, allergies, or asthma. No history of chronic illnesses. No prior hospitalizations. No surgeries. Family Hx: Mother - 51 years old, history of breast cancer with treatment a few years ago. Father - 53 years old, history of CAD, with MI in his 40s. HTN. 1/2 Sister - age 27, in good health. No family hx of drownings, seizures, unexplained MVAs, and sudden death. Social Hx: Single. Tobacco - None. Alcohol - drinks 12-pack during the weekend. Exercise - Not sedentary. Performed routine group PT prior to recent hospitalization. Allergies: Denies allergies to medications, food, latex, and insect stings. ROS: Review of 13 systems. All systems negative, with the exceptions described in HPI.
Age: 1.25
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: None Noted.
Age: 1.25
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None Noted.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 64 year old male patient with no known allergies. On 12-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J006827, expiration date 14-SEP-2014) 0.5 ml in the left arm. Concomitant therapies included PROVENTIL HFA inhaler. On 10-APR-2014, the patient experienced vesicular-red inflammation and herpes zoster. The number of lesions was 100 and the distribution of lesions was T12 dermatone L. The patient's temperature was normal. There was no rash occurred a the site of injection post vaccination. The patient didn't have recent VZV exposure to chickenpox or shingles. The outcome of the adverse event was reported as not recovered/not resolved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Inflammation, Skin lesion
Clinical narrative: This spontaneous report as received from a physician refers to a 64 year old male patient with no known allergies. On 12-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J006827, expiration date 14-SEP-2014) 0.5 ml in the left arm. Concomitant therapies included PROVENTIL HFA inhaler. On 10-APR-2014, the patient experienced vesicular-red inflammation and herpes zoster. The number of lesions was 100 and the distribution of lesions was T12 dermatone L. The patient's temperature was normal. There was no rash occurred a the site of injection post vaccination. The patient didn't have recent VZV exposure to chickenpox or shingles. The outcome of the adverse event was reported as not recovered/not resolved. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Eye swelling
Clinical narrative: This spontaneous report as received from a 62 year old male consumer reporting on himself. The patient did not have any illness at time of vaccination nor pre-existing physician-diagnosed allergies, birth defects or medical conditions. On 20-MAR-2014 at 10:50 hours, the patient was vaccinated with a dose of ZOSTAVAX (Lot # reported as J012661, exp date 10-JAN-2015) (dose and route not reported). The vaccine was received in a private doctor's office/hospital and was purchased with private funds. Concomitant therapy was not reported. On 24-MAR-2014, the patient experienced a blister on left side of face, eye swelling, and on an unknown date in 2014 he had to take off two days from work during the peak time when he could not open his left eye due to swelling. On an unknown date the patient had a doctor visit (responsible physician), and reported to the doctor the adverse events. The patient took Acyclovir for 10 days as a treatment for the adverse events, the patient also saw an ophthalmologist. So far, the patient made three visits to his primary care and ophthalmologist and they asked him to check back again in two to three weeks. The patient reported it has been three weeks since the onset of the blisters and he still has scabs and scars on his face (developed on an unknown date in 2014). Also the patient reported that had been a painful experience, not necessarily physical but rather emotionally (developed on an unknown date in 2014). The outcome of blister on left side of face, eye swollen and emotional disorder was unknown. The outcome of scabs on his face was not recovered. The relatedness between the events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Emotional distress, Eye swelling, Impaired work ability, Scab
Clinical narrative: This spontaneous report as received from a 62 year old male consumer reporting on himself. The patient did not have any illness at time of vaccination nor pre-existing physician-diagnosed allergies, birth defects or medical conditions. On 20-MAR-2014 at 10:50 hours, the patient was vaccinated with a dose of ZOSTAVAX (Lot # reported as J012661, exp date 10-JAN-2015) (dose and route not reported). The vaccine was received in a private doctor's office/hospital and was purchased with private funds. Concomitant therapy was not reported. On 24-MAR-2014, the patient experienced a blister on left side of face, eye swelling, and on an unknown date in 2014 he had to take off two days from work during the peak time when he could not open his left eye due to swelling. On an unknown date the patient had a doctor visit (responsible physician), and reported to the doctor the adverse events. The patient took Acyclovir for 10 days as a treatment for the adverse events, the patient also saw an ophthalmologist. So far, the patient made three visits to his primary care and ophthalmologist and they asked him to check back again in two to three weeks. The patient reported it has been three weeks since the onset of the blisters and he still has scabs and scars on his face (developed on an unknown date in 2014). Also the patient reported that had been a painful experience, not necessarily physical but rather emotionally (developed on an unknown date in 2014). The outcome of blister on left side of face, eye swollen and emotional disorder was unknown. The outcome of scabs on his face was not recovered. The relatedness between the events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Scar
Clinical narrative: This spontaneous report as received from a 62 year old male consumer reporting on himself. The patient did not have any illness at time of vaccination nor pre-existing physician-diagnosed allergies, birth defects or medical conditions. On 20-MAR-2014 at 10:50 hours, the patient was vaccinated with a dose of ZOSTAVAX (Lot # reported as J012661, exp date 10-JAN-2015) (dose and route not reported). The vaccine was received in a private doctor's office/hospital and was purchased with private funds. Concomitant therapy was not reported. On 24-MAR-2014, the patient experienced a blister on left side of face, eye swelling, and on an unknown date in 2014 he had to take off two days from work during the peak time when he could not open his left eye due to swelling. On an unknown date the patient had a doctor visit (responsible physician), and reported to the doctor the adverse events. The patient took Acyclovir for 10 days as a treatment for the adverse events, the patient also saw an ophthalmologist. So far, the patient made three visits to his primary care and ophthalmologist and they asked him to check back again in two to three weeks. The patient reported it has been three weeks since the onset of the blisters and he still has scabs and scars on his face (developed on an unknown date in 2014). Also the patient reported that had been a painful experience, not necessarily physical but rather emotionally (developed on an unknown date in 2014). The outcome of blister on left side of face, eye swollen and emotional disorder was unknown. The outcome of scabs on his face was not recovered. The relatedness between the events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HPV4, PNC13, RV5, DTAPHEPBIP, HPV4, PNC, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from nurse refers to a 2 month old male patient. On 21-APR-2014 the patient was inadvertently vaccinated with GARDASIL intramuscularly and no adverse effects were reported. The outcome of inadvertently administered a dose of GARDASIL and no adverse effects was unknown. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HPV4, PNC13, RV5, DTAPHEPBIP, HPV4, PNC, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a 2 month old male patient. On 21-APR-2014 the patient was inadvertently vaccinated with GARDASIL intramuscularly and no adverse effects were reported. The outcome of inadvertently administered a dose of GARDASIL and no adverse effects was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV, VARCEL
Symptoms: Agitation, Burning sensation, Cough, Eczema, Malaise
Clinical narrative: Red rash began to cover entire torso,arms,legs,neck. Rash was bumpy, itchy. Fever. Child had general sick feeling, cough. After 2 weeks the rash had turned flat, remained irritated and covering body. Fever, sickness was gone but rash still agitated child terribly, he felt "on fire" at some times. Doctor visit, Doc. called a consult, they determined it was "the worse eczema they have ever seen" (I think that is incorrect) this "rash" persisted almost 2 months and the child still suffers with mild rash and itching on arms/legs.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Rash pruritic, Skin irritation
Clinical narrative: Red rash began to cover entire torso,arms,legs,neck. Rash was bumpy, itchy. Fever. Child had general sick feeling, cough. After 2 weeks the rash had turned flat, remained irritated and covering body. Fever, sickness was gone but rash still agitated child terribly, he felt "on fire" at some times. Doctor visit, Doc. called a consult, they determined it was "the worse eczema they have ever seen" (I think that is incorrect) this "rash" persisted almost 2 months and the child still suffers with mild rash and itching on arms/legs.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Fainted/Collapsed- Was out for 20-25 seconds, nurses picked-up in hall and brought her back to room and gave her oj to drink once she was able to sit up.
Age: 1.41
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Pyrexia, Rash, Swollen tongue, Tongue pruritus, Urticaria
Clinical narrative: Fever, facial hives, rash on legs and arms, tongue itching w/swelling.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling and pain at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt had co red, slightly swollen area that was warm to touch where the injection was given. Called pt's doctor and they wanted her to stop by. She stated she was going to go see Dr.
Age: 1.02
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was erroneously administered an Inactivated Polio Vaccine. She was not due for the next shot in the series until 17 Apr 2017. The mistake occurred due to a misreading of the vaccine checklist printed from the database.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Injection site pain, Pain in extremity, Swelling
Clinical narrative: Acute pain (L) deltoid with pain radiating to chest down (L) arm - mild swelling.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, CSF test normal, Convulsion, Culture urine negative, Pyrexia
Clinical narrative: 2 mo old who 12 hrs after getting PEDIARIX, PCV13, ROTA and HIB developed a 102 fever and had a 1 min seizure. Neg sepsis w/u. Now doing well.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Discomfort, Erythema, Feeling hot, Swelling
Clinical narrative: Warmth, redness, swelling, discomfort. Treatment at this time Ibuprofen, ice, call tomorrow if larger.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt requested flu vaccine. Her web portal told her she needed one. Paperwork was completed before appt and given after appt. When entering into EMS it was noted she had had in already on 10/25/13. She was advised and not concerned. Pt stated "If 1 is good 2 should be better".
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Raised itchy area the night of vaccine, progressing to swollen left arm 3-4 inches in diameter, seen by Dr. who stated local reaction to vaccine - no infection.
Age: 10.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Chills, Headache, Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: 3/30/14 site pain/headache - TYLENOL, ice pack. 3/31/14 fever/chills/headache - Appt - TYLENOL/MOTRIN, ice. 4/1/14 site pain/rash/fever - BENADRYL, TYLENOL, MOTRIN, ice. 4/4/14 site pain/welts. 4/5/14 site pain, swelling -> Appt - Ice/MOTRIN.
Age: 10.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Injection site swelling, Pyrexia, Streptococcus test negative, Urticaria
Clinical narrative: 3/30/14 site pain/headache - TYLENOL, ice pack. 3/31/14 fever/chills/headache - Appt - TYLENOL/MOTRIN, ice. 4/1/14 site pain/rash/fever - BENADRYL, TYLENOL, MOTRIN, ice. 4/4/14 site pain/welts. 4/5/14 site pain, swelling -> Appt - Ice/MOTRIN.
Age: 27.0
Sex: U
Vaccine: TDAP
Symptoms: Rash generalised
Clinical narrative: Patient stated a body rash developed a few days after getting BOOSTRIX (unsure if related). Went to doctor and was prescribed a topical steroid cream.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Within 24 hours developed redness and swelling. Worsened over the course of several days. Sought medical care 2/22/14 and was diagnosed with cellulitis. Was given a course of antibiotics with subsequent resolution of problem. Did note fever also prior to medical care and treatment.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 24 hours after vaccine admin. pt presents with erythema and swelling at injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Injection site erythema, Pain in extremity, Pelvic pain, Rash
Clinical narrative: This spontaneous report as received from a 64 year old female patient refers to herself. On 18-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX in the left arm. On 18-MAR-2014 the consumer developed a "large pink circle" at the injection site of her left arm "right away" after receiving ZOSTAVAX and that "later that day" on 19-MAR-2014 she developed an unspecified rash on her unspecified arm. "A week after" receiving ZOSTAVAX on approximately 25-MAR-2014 she developed pain "where her legs meet her pelvis". The patient had been limping since 31-MAR-2014 and developed an unspecified rash on both of her legs "last Wednesday" on 02-APR-2014 but stated that her physician said that the rash was not shingles. The consumer was seen by the physician on 03-APR-2014 and the physician told the consumer to take ibuprofen every 6 hours. On 05-APR-2014 the pain she had "where her legs met her pelvis" moved to just the left side of her pelvis and left leg. The unspecified rash on an unspecified arm and both legs was "healing". The patient had gotten "slightly better" but was still difficult to walk upstairs. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Moderate swelling, redness, tenderness at injection site and distal to it. Newly diagnosed.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Feeling of body temperature change, Pyrexia
Clinical narrative: Fever, hot and cold chills (cellulitis). TX. KEFLEX, 1 tab, TID for 7 days - 500mg.
Age: 63.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Immediate post-injection reaction, Pruritus, Urticaria
Clinical narrative: Client reports - hives - itchiness (L) arm after PNEUMOVAX administration. Hives and itchiness immediately following lasting till AM. AM - arm 3-4 normal - redness - big ring around muscle - duration 1 week.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a female patient who is a physician refers to herself. On an unknown date the physician was vaccinated with ZOSTAVAX (lot # reported as K000455, Exp date: 30-OCT-2014), 0.65 ml, subcutaneous. The physician firstly reported 4 out of 10 patients were vaccinated with same lot of ZOSTAVAX and developed severe reactions (MARRS# 1404USA012020). Multiple injection site reactions which included: angry red swelling at the injection site which cascaded down the arm to the elbow. Redness and swelling circumference around the injected arm. Blisters at the site, which physician confirms was not shingles. Physician stated the last 4 weeks was the most adverse effects she had seen with the ZOSTAVAX vaccine. Physician stated she had seen this change since the last batch label change from 3 piece label to one label. Physician stated she also was vaccinated with the ZOSTAVAX in her left arm, and had the same type of reaction. ZOSTAVAX Lot Check Request K000455 Exp 30-OCT-2014. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unspecified demographics. The reporter stated that his office inadvertently stored single-dose vials of PNEUMOVAX 23 at 21 degrees C for 29 hours. On 21-APR-2014, the patient was vaccinated with improperly stored (inadvertently stored single-dose vials of PNEUMOVAX 23 at 21 degrees C for 29 hours) PNEUMOVAX 23 (dose, frequency, lot number and expiry dates were unspecified). Concomitant therapy was unspecified. No symptoms reported. No product quality complaint was involved. The outcome of patient received a dose of improperly stored PNEUMOVAX 23 was unknown. No other details provided. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site vesicles, Local swelling
Clinical narrative: This spontaneous report as received from a physician refers to four unspecified patients. On unknown dates the patients were vaccinated with ZOSTAVAX (lot # reported as K000455, Exp date: 30-OCT-2014), 0.65 ml, subcutaneous. The physician reported 4 out of 10 patients were vaccinated with same lot of ZOSTAVAX and developed severe reactions. Multiple injection site reactions which included: angry red swelling at the injection site which cascaded down the arm to the elbow. Redness and swelling circumference around the injected arm. Blisters at the site, which physician confirms was not shingles. Physician stated the last 4 weeks was the most adverse effects she had seen with the ZOSTAVAX vaccine. Physician stated she had seen this change since the last batch label change from 3 piece label to one label. The physician stated one of her patients, who had the reaction to ZOSTAVAX, was scheduled to come into the office today. The outcome of the events was unknown. ZOSTAVAX Lot Check Request K000455 Exp 30-OCT-2014. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker (CMA) refers to a patient of unknown age and gender. On 21-APR-2014, the patient was vaccinated with ROTATEQ SUSPENSION 2, lot # H017721, expiry date 01-APR-2014, dose (unknown), and route of administration (unknown), for vaccination, past its expiry date, in error. No concomitant medications were reported. No adverse effect reported. The outcome of event was unknown. No product quality complaint was involved. No other information to report. Additional infomration has been requested.
Sex: U
Vaccine: MMR
Symptoms: Influenza, Malaise, Measles post vaccine
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age. The patient claimed to be immunocompromised. Medical history and concomitant medication was unknown. On an unknown date the patient was vaccinated with M-M-R II. Patient posted in social media as some kids are just born immuno-compromised like patient was. The outcome of the event is unknown. The relatedness of M-M-R II with the event was not reported. Despite being vaccinated, patient had measles and had to stop taking the flu vaccine because patient stayed sick constantly and still got the flu (linked MARRS ID 1404USA011719). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, Injection site erythema, Injection site swelling, Injection site warmth, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 62 year old female patient. The patient had received a dose of PNEUMOVAX 23 on an unspecified date prior to 15-APR-2014 with no reaction reported. On 15-APR-2014 the patient was inadvertently administered an expired 0.1 ml dose of PNEUMOVAX 23 intradermally instead of a dose of MANTOUX SKIN TEST vaccine. On 16-APR-2014, the patient experienced redness, swelling and warmth at the unspecified vaccine injection site. Patient sought medical attention at the facility of healthcare professional reporter on 17-APR-2014. Patient was treated with heat and ice for the events. No lab diagnostics studies performed. The patient was recovering from the events. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report was received from a female patient of unknown age and refers to herself. In approximately March 2014 (reported as a month ago) the patient was vaccinated with a dose of ZOSTAVAX 1 time injection under the skin (dose, route, lot number not reported). On an unspecified date in 2014 the patient broke out with "herpes on the corner of her mouth". The outcome of broke out with "herpes on the corner of her mouth" was unknown. The relatedness between "herpes on the corner of her mouth" and ZOSTAVAX was not reported. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unspecified demographics. On 21-APR-2014, the patient received an expired dose of ROTATEQ suspension Strength 2, dose 2 ml, oral (lot number H020559, expiry date 17-APR-2014). Concomitant therapy was unspecified. No adverse effect reported. No product quality complaint was involved. The outcome of the patient received an expired dose of ROTATEQ was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23. No concomitant medication was reported. The patient told the pharmacist that on an unknown date after receiving the PNEUMOVAX 23 vaccine, he or she then contracted pneumonia. No treatment information was reported. The outcome of pneumonia is unknown. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Herpes zoster
Clinical narrative: This spontaneous report as received from a retired nurse refers to a female patient of unknown age, her friend. Pertinent medical history, concomitant medication, drug reactions and allergies were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). On approximately 07-APR-2014, reported as about one week ago, the patient was diagnosed with shingles "all over her trunk". The outcome of shingles "all over her trunk" was unknown. The patient sought unspecified medical attention. The relatedness between event and ZOSTAVAX was not reported. The reporter also noted that she had an unspecified reaction to an unspecified chemotherapeutic agent. Additional information has been requested.