chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Mood swings, Pain
Clinical narrative: Body felt like all my bones were broken when I woke up the next day I couldn't move I was in so much pain I could barely get out of bed for two weeks and the pain took 4 weeks to go away my mental health declined my meds didn't seem to be working I became very agitated for longer periods of time more manic than ever before as time went on I began to notice that now over a year later I have yet to be depressed once when before the booster shot I was depressed more than I was manic I would only have a manic episode maybe once every 6 months or so and it lasted only a day or two now it changes I'm never depressed but my manic episodes last anywhere from 3 days to the longest one lasting a week and a half and like right now I'm going on I guess you can call it a third manic cycle in a 3 week time span I finally come out of one just to go into another one a day or so later I'm starting to lose focus again I can't sleep the last time they happened like this I wasn't sleeping if I did it was only an hour or two and it lasted 3 months like this it's a total nightmare and instead of getting depressed it's like I'm a yoyo on a carnival ride doing jumping jacks that's how often my mood swings as and feelings and emotions change and there is nothing that can be done about it because it changes so often you can't learn anything from it to try and do anything about it and I think because of my mental health and lack of sleep it's caused short term memory loss issues I can't say it's for 100% sure the reason but idk what the cause is but it makes sense that it could be the booster shot completely changed my mental health and now I don't know how to deal with myself I can't function right I can't fix this I can't change this I'm am stuck and there's nothing that can help me so what am I suppose to do now
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Hypothyroidism, Thyroxine free
Clinical narrative: About two months after taking pfizer Covid booster, I was diagnosed with Hypothyroidism. I had no symptoms prior.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Agitation, Asthenia, Balance disorder, Chest X-ray normal
Clinical narrative: On 2/20/2023, patient presented to ED with his wife for chief complaint of hyperglycemia with complaints of fevers, high blood sugars, and bilateral nocturnal leg pain. Patient's wife reported patient has been having difficulty sleeping at night with complaints of being "hot" and pain in his left leg. Patient has medical history of dementia. Patient's wife reported concerns of overall general decline. Patient has not been attending physical therapy, and therefore has become weaker and unable to complete some ADLs independently. Patient has started to become agitated and combative if his requests are not met. Patient's wife expressed she can no longer care for him given his current cognitive decline and requested for placement. Patient is currently admitted and being observed. There are efforts on finding a memory care/long term care facility for the patient. Upon presentation to the ED, patient was hypertensive with blood pressure is 171/66. Heart rate 54. Respirations 16. SpO2 97% on room air. Temperature 36.3 degrees C. Lab workup including CBC and BMP ware unremarkable. Hemoglobin stable. No leukocytosis. SARs/influenza/RSV negative. CXR shows no acute cardiopulmonary disease. Bilateral lower extremity ultrasound negative for DVT. CT head without contrast negative for any acute intracranial findings. Patient did have prolonged ED stay due to no local bed availability until 02/22/2023. His ED stay had been uneventful. Patient denies nausea or vomiting. Denies any recent weight loss. Denies any chest pain, chest palpitations or any shortness of breath. Denies any bowel or urinary complaints. Social work has thus far been unsuccessful at obtaining placement. Patient was vaccinated with the Janssen Ad26.CoV2.S vaccine on 9/21/2022. At time of reporting, it would have been approximately five months since patient's vaccination of the Janssen Ad26.CoV2.S vaccine. Per PI of the research study, this adverse event is not related to the Janssen Ad26.CoV2.S vaccine that was administered on 9/21/2023. Constitutional: Positive for fatigue and fever. - Negative for loss of appetite, night sweats, weight gain of more than 10 pounds and weight loss of more than 10 pounds. Genitourinary: Positive for incontinence. Neurological: Positive for loss of balance or tendency to fall easily and weakness in arms or legs. - Negative for seizures, loss of consciousness, light-headedness, numbness or shooting pain in hands, arms, legs, or feet, headaches, blackouts and slurred speech. The following systems were negative: Skin, Eyes, ENT, Respiratory, Cardiovascular, Gastrointestinal, Hematologic, Musculoskeletal, Psychiatric. Lab workup including CBC and BMP ware unremarkable. Hemoglobin stable. No leukocytosis. SARs/influenza A and B/RSV negative. CXR shows no acute cardiopulmonary
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cognitive disorder, Condition aggravated, Fatigue, Feeling hot, Full blood count normal
Clinical narrative: On 2/20/2023, patient presented to ED with his wife for chief complaint of hyperglycemia with complaints of fevers, high blood sugars, and bilateral nocturnal leg pain. Patient's wife reported patient has been having difficulty sleeping at night with complaints of being "hot" and pain in his left leg. Patient has medical history of dementia. Patient's wife reported concerns of overall general decline. Patient has not been attending physical therapy, and therefore has become weaker and unable to complete some ADLs independently. Patient has started to become agitated and combative if his requests are not met. Patient's wife expressed she can no longer care for him given his current cognitive decline and requested for placement. Patient is currently admitted and being observed. There are efforts on finding a memory care/long term care facility for the patient. Upon presentation to the ED, patient was hypertensive with blood pressure is 171/66. Heart rate 54. Respirations 16. SpO2 97% on room air. Temperature 36.3 degrees C. Lab workup including CBC and BMP ware unremarkable. Hemoglobin stable. No leukocytosis. SARs/influenza/RSV negative. CXR shows no acute cardiopulmonary disease. Bilateral lower extremity ultrasound negative for DVT. CT head without contrast negative for any acute intracranial findings. Patient did have prolonged ED stay due to no local bed availability until 02/22/2023. His ED stay had been uneventful. Patient denies nausea or vomiting. Denies any recent weight loss. Denies any chest pain, chest palpitations or any shortness of breath. Denies any bowel or urinary complaints. Social work has thus far been unsuccessful at obtaining placement. Patient was vaccinated with the Janssen Ad26.CoV2.S vaccine on 9/21/2022. At time of reporting, it would have been approximately five months since patient's vaccination of the Janssen Ad26.CoV2.S vaccine. Per PI of the research study, this adverse event is not related to the Janssen Ad26.CoV2.S vaccine that was administered on 9/21/2023. Constitutional: Positive for fatigue and fever. - Negative for loss of appetite, night sweats, weight gain of more than 10 pounds and weight loss of more than 10 pounds. Genitourinary: Positive for incontinence. Neurological: Positive for loss of balance or tendency to fall easily and weakness in arms or legs. - Negative for seizures, loss of consciousness, light-headedness, numbness or shooting pain in hands, arms, legs, or feet, headaches, blackouts and slurred speech. The following systems were negative: Skin, Eyes, ENT, Respiratory, Cardiovascular, Gastrointestinal, Hematologic, Musculoskeletal, Psychiatric. Lab workup including CBC and BMP ware unremarkable. Hemoglobin stable. No leukocytosis. SARs/influenza A and B/RSV negative. CXR shows no acute cardiopulmonary
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Haemoglobin, Hyperglycaemia, Hypertension, Incontinence
Clinical narrative: On 2/20/2023, patient presented to ED with his wife for chief complaint of hyperglycemia with complaints of fevers, high blood sugars, and bilateral nocturnal leg pain. Patient's wife reported patient has been having difficulty sleeping at night with complaints of being "hot" and pain in his left leg. Patient has medical history of dementia. Patient's wife reported concerns of overall general decline. Patient has not been attending physical therapy, and therefore has become weaker and unable to complete some ADLs independently. Patient has started to become agitated and combative if his requests are not met. Patient's wife expressed she can no longer care for him given his current cognitive decline and requested for placement. Patient is currently admitted and being observed. There are efforts on finding a memory care/long term care facility for the patient. Upon presentation to the ED, patient was hypertensive with blood pressure is 171/66. Heart rate 54. Respirations 16. SpO2 97% on room air. Temperature 36.3 degrees C. Lab workup including CBC and BMP ware unremarkable. Hemoglobin stable. No leukocytosis. SARs/influenza/RSV negative. CXR shows no acute cardiopulmonary disease. Bilateral lower extremity ultrasound negative for DVT. CT head without contrast negative for any acute intracranial findings. Patient did have prolonged ED stay due to no local bed availability until 02/22/2023. His ED stay had been uneventful. Patient denies nausea or vomiting. Denies any recent weight loss. Denies any chest pain, chest palpitations or any shortness of breath. Denies any bowel or urinary complaints. Social work has thus far been unsuccessful at obtaining placement. Patient was vaccinated with the Janssen Ad26.CoV2.S vaccine on 9/21/2022. At time of reporting, it would have been approximately five months since patient's vaccination of the Janssen Ad26.CoV2.S vaccine. Per PI of the research study, this adverse event is not related to the Janssen Ad26.CoV2.S vaccine that was administered on 9/21/2023. Constitutional: Positive for fatigue and fever. - Negative for loss of appetite, night sweats, weight gain of more than 10 pounds and weight loss of more than 10 pounds. Genitourinary: Positive for incontinence. Neurological: Positive for loss of balance or tendency to fall easily and weakness in arms or legs. - Negative for seizures, loss of consciousness, light-headedness, numbness or shooting pain in hands, arms, legs, or feet, headaches, blackouts and slurred speech. The following systems were negative: Skin, Eyes, ENT, Respiratory, Cardiovascular, Gastrointestinal, Hematologic, Musculoskeletal, Psychiatric. Lab workup including CBC and BMP ware unremarkable. Hemoglobin stable. No leukocytosis. SARs/influenza A and B/RSV negative. CXR shows no acute cardiopulmonary
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza virus test negative, Insomnia, Loss of personal independence in daily activities, Metabolic function test, Muscular weakness
Clinical narrative: On 2/20/2023, patient presented to ED with his wife for chief complaint of hyperglycemia with complaints of fevers, high blood sugars, and bilateral nocturnal leg pain. Patient's wife reported patient has been having difficulty sleeping at night with complaints of being "hot" and pain in his left leg. Patient has medical history of dementia. Patient's wife reported concerns of overall general decline. Patient has not been attending physical therapy, and therefore has become weaker and unable to complete some ADLs independently. Patient has started to become agitated and combative if his requests are not met. Patient's wife expressed she can no longer care for him given his current cognitive decline and requested for placement. Patient is currently admitted and being observed. There are efforts on finding a memory care/long term care facility for the patient. Upon presentation to the ED, patient was hypertensive with blood pressure is 171/66. Heart rate 54. Respirations 16. SpO2 97% on room air. Temperature 36.3 degrees C. Lab workup including CBC and BMP ware unremarkable. Hemoglobin stable. No leukocytosis. SARs/influenza/RSV negative. CXR shows no acute cardiopulmonary disease. Bilateral lower extremity ultrasound negative for DVT. CT head without contrast negative for any acute intracranial findings. Patient did have prolonged ED stay due to no local bed availability until 02/22/2023. His ED stay had been uneventful. Patient denies nausea or vomiting. Denies any recent weight loss. Denies any chest pain, chest palpitations or any shortness of breath. Denies any bowel or urinary complaints. Social work has thus far been unsuccessful at obtaining placement. Patient was vaccinated with the Janssen Ad26.CoV2.S vaccine on 9/21/2022. At time of reporting, it would have been approximately five months since patient's vaccination of the Janssen Ad26.CoV2.S vaccine. Per PI of the research study, this adverse event is not related to the Janssen Ad26.CoV2.S vaccine that was administered on 9/21/2023. Constitutional: Positive for fatigue and fever. - Negative for loss of appetite, night sweats, weight gain of more than 10 pounds and weight loss of more than 10 pounds. Genitourinary: Positive for incontinence. Neurological: Positive for loss of balance or tendency to fall easily and weakness in arms or legs. - Negative for seizures, loss of consciousness, light-headedness, numbness or shooting pain in hands, arms, legs, or feet, headaches, blackouts and slurred speech. The following systems were negative: Skin, Eyes, ENT, Respiratory, Cardiovascular, Gastrointestinal, Hematologic, Musculoskeletal, Psychiatric. Lab workup including CBC and BMP ware unremarkable. Hemoglobin stable. No leukocytosis. SARs/influenza A and B/RSV negative. CXR shows no acute cardiopulmonary
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: On 2/20/2023, patient presented to ED with his wife for chief complaint of hyperglycemia with complaints of fevers, high blood sugars, and bilateral nocturnal leg pain. Patient's wife reported patient has been having difficulty sleeping at night with complaints of being "hot" and pain in his left leg. Patient has medical history of dementia. Patient's wife reported concerns of overall general decline. Patient has not been attending physical therapy, and therefore has become weaker and unable to complete some ADLs independently. Patient has started to become agitated and combative if his requests are not met. Patient's wife expressed she can no longer care for him given his current cognitive decline and requested for placement. Patient is currently admitted and being observed. There are efforts on finding a memory care/long term care facility for the patient. Upon presentation to the ED, patient was hypertensive with blood pressure is 171/66. Heart rate 54. Respirations 16. SpO2 97% on room air. Temperature 36.3 degrees C. Lab workup including CBC and BMP ware unremarkable. Hemoglobin stable. No leukocytosis. SARs/influenza/RSV negative. CXR shows no acute cardiopulmonary disease. Bilateral lower extremity ultrasound negative for DVT. CT head without contrast negative for any acute intracranial findings. Patient did have prolonged ED stay due to no local bed availability until 02/22/2023. His ED stay had been uneventful. Patient denies nausea or vomiting. Denies any recent weight loss. Denies any chest pain, chest palpitations or any shortness of breath. Denies any bowel or urinary complaints. Social work has thus far been unsuccessful at obtaining placement. Patient was vaccinated with the Janssen Ad26.CoV2.S vaccine on 9/21/2022. At time of reporting, it would have been approximately five months since patient's vaccination of the Janssen Ad26.CoV2.S vaccine. Per PI of the research study, this adverse event is not related to the Janssen Ad26.CoV2.S vaccine that was administered on 9/21/2023. Constitutional: Positive for fatigue and fever. - Negative for loss of appetite, night sweats, weight gain of more than 10 pounds and weight loss of more than 10 pounds. Genitourinary: Positive for incontinence. Neurological: Positive for loss of balance or tendency to fall easily and weakness in arms or legs. - Negative for seizures, loss of consciousness, light-headedness, numbness or shooting pain in hands, arms, legs, or feet, headaches, blackouts and slurred speech. The following systems were negative: Skin, Eyes, ENT, Respiratory, Cardiovascular, Gastrointestinal, Hematologic, Musculoskeletal, Psychiatric. Lab workup including CBC and BMP ware unremarkable. Hemoglobin stable. No leukocytosis. SARs/influenza A and B/RSV negative. CXR shows no acute cardiopulmonary
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Depression, Fatigue, Immediate post-injection reaction, Laboratory test normal
Clinical narrative: Hello, I am a licensed physician who had taken my first of two total COVID vaccination doses on 5/21/21. Since that time, (roughly 20 months) I have experienced both debilitating fatigue and depression. The symptoms started immediately after the vaccine and have persisted. My relevant laboratory data has been normal and there is no other explanation for my symptoms. I know that I am not alone with such manifestations from the vaccine and why I'm reporting it.
Sex: U
Vaccine: FLUX
Symptoms: Gastrostomy, Guillain-Barre syndrome, Quadriplegia, Tracheostomy
Clinical narrative: unclear if pt had the adverse event due to Dupixent or flu vaccine pt developed gullain barre syndrome resulting in quadriplegia, requiring trach/PEG
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Abdominal pain upper, Arthralgia, Asthenia, Body temperature increased
Clinical narrative: elevated temperature, aches and pains, change in taste of food and drinks. Sore throat, fluid in both ears. Heaviness in chest. Bruising at Injection site. muscle and joint pain. Stomach pain and upset, decreased appetite . feeling tired and weak with chills.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chills, Decreased appetite, Fatigue, Injection site bruising
Clinical narrative: elevated temperature, aches and pains, change in taste of food and drinks. Sore throat, fluid in both ears. Heaviness in chest. Bruising at Injection site. muscle and joint pain. Stomach pain and upset, decreased appetite . feeling tired and weak with chills.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Middle ear effusion, Myalgia, Oropharyngeal pain, Pain, Taste disorder
Clinical narrative: elevated temperature, aches and pains, change in taste of food and drinks. Sore throat, fluid in both ears. Heaviness in chest. Bruising at Injection site. muscle and joint pain. Stomach pain and upset, decreased appetite . feeling tired and weak with chills.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Adverse drug reaction, Ageusia, Back pain, Cardiac failure
Clinical narrative: Serious* adverse events (irrespective of attribution to Covid - 19 vaccination Moderna two doses ' shots and additional dose of Bivalent - Omicron Booster) Heart failure. Thrombosis Blood Clots blocking blood flow in both legs and ankles Edema that require medical and surgical intervention to prevent one of the outcomes heart attacks. Chronic venous insufficiency. Water retention - discoloration of skin. Swollen inflammation and fluid retention in the ankles, feet, legs and stomach and eyebrows. Loss of time at work, loss of promotion transfer opportunity and productivity due to illness and medical treatments. Experienced Inpatient hospitalization and prolongation of existing hospitalization. Taking medicines - such as some blood thinner medicines, contraceptive pills, therapy  A persistent, significant incapacity and substantial disruption of the ability to conduct normal life functions weakness of legs, not able to walk by myself without a worker, fatigue-tiredness, muscle and back and leg pains and vomiting. Loss of taste and appetite. Consisting dry cough. Unable to sleep. Sex and Intimacy with my husband due to chronic illness. Weight lost of over 20 pounds. Hospitalized numerous times on vaccine side effects, immune reaction and trombosis risk as per hospital studies consequences on health and many patients are experiencing due to Covid - 19 vaccinations and bosters.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Disease risk factor, Fatigue, Fluid retention
Clinical narrative: Serious* adverse events (irrespective of attribution to Covid - 19 vaccination Moderna two doses ' shots and additional dose of Bivalent - Omicron Booster) Heart failure. Thrombosis Blood Clots blocking blood flow in both legs and ankles Edema that require medical and surgical intervention to prevent one of the outcomes heart attacks. Chronic venous insufficiency. Water retention - discoloration of skin. Swollen inflammation and fluid retention in the ankles, feet, legs and stomach and eyebrows. Loss of time at work, loss of promotion transfer opportunity and productivity due to illness and medical treatments. Experienced Inpatient hospitalization and prolongation of existing hospitalization. Taking medicines - such as some blood thinner medicines, contraceptive pills, therapy  A persistent, significant incapacity and substantial disruption of the ability to conduct normal life functions weakness of legs, not able to walk by myself without a worker, fatigue-tiredness, muscle and back and leg pains and vomiting. Loss of taste and appetite. Consisting dry cough. Unable to sleep. Sex and Intimacy with my husband due to chronic illness. Weight lost of over 20 pounds. Hospitalized numerous times on vaccine side effects, immune reaction and trombosis risk as per hospital studies consequences on health and many patients are experiencing due to Covid - 19 vaccinations and bosters.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Illness, Immune system disorder, Impaired work ability, Inflammation
Clinical narrative: Serious* adverse events (irrespective of attribution to Covid - 19 vaccination Moderna two doses ' shots and additional dose of Bivalent - Omicron Booster) Heart failure. Thrombosis Blood Clots blocking blood flow in both legs and ankles Edema that require medical and surgical intervention to prevent one of the outcomes heart attacks. Chronic venous insufficiency. Water retention - discoloration of skin. Swollen inflammation and fluid retention in the ankles, feet, legs and stomach and eyebrows. Loss of time at work, loss of promotion transfer opportunity and productivity due to illness and medical treatments. Experienced Inpatient hospitalization and prolongation of existing hospitalization. Taking medicines - such as some blood thinner medicines, contraceptive pills, therapy  A persistent, significant incapacity and substantial disruption of the ability to conduct normal life functions weakness of legs, not able to walk by myself without a worker, fatigue-tiredness, muscle and back and leg pains and vomiting. Loss of taste and appetite. Consisting dry cough. Unable to sleep. Sex and Intimacy with my husband due to chronic illness. Weight lost of over 20 pounds. Hospitalized numerous times on vaccine side effects, immune reaction and trombosis risk as per hospital studies consequences on health and many patients are experiencing due to Covid - 19 vaccinations and bosters.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Joint swelling, Laboratory test, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Serious* adverse events (irrespective of attribution to Covid - 19 vaccination Moderna two doses ' shots and additional dose of Bivalent - Omicron Booster) Heart failure. Thrombosis Blood Clots blocking blood flow in both legs and ankles Edema that require medical and surgical intervention to prevent one of the outcomes heart attacks. Chronic venous insufficiency. Water retention - discoloration of skin. Swollen inflammation and fluid retention in the ankles, feet, legs and stomach and eyebrows. Loss of time at work, loss of promotion transfer opportunity and productivity due to illness and medical treatments. Experienced Inpatient hospitalization and prolongation of existing hospitalization. Taking medicines - such as some blood thinner medicines, contraceptive pills, therapy  A persistent, significant incapacity and substantial disruption of the ability to conduct normal life functions weakness of legs, not able to walk by myself without a worker, fatigue-tiredness, muscle and back and leg pains and vomiting. Loss of taste and appetite. Consisting dry cough. Unable to sleep. Sex and Intimacy with my husband due to chronic illness. Weight lost of over 20 pounds. Hospitalized numerous times on vaccine side effects, immune reaction and trombosis risk as per hospital studies consequences on health and many patients are experiencing due to Covid - 19 vaccinations and bosters.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oedema, Pain in extremity, Peripheral artery occlusion, Peripheral swelling
Clinical narrative: Serious* adverse events (irrespective of attribution to Covid - 19 vaccination Moderna two doses ' shots and additional dose of Bivalent - Omicron Booster) Heart failure. Thrombosis Blood Clots blocking blood flow in both legs and ankles Edema that require medical and surgical intervention to prevent one of the outcomes heart attacks. Chronic venous insufficiency. Water retention - discoloration of skin. Swollen inflammation and fluid retention in the ankles, feet, legs and stomach and eyebrows. Loss of time at work, loss of promotion transfer opportunity and productivity due to illness and medical treatments. Experienced Inpatient hospitalization and prolongation of existing hospitalization. Taking medicines - such as some blood thinner medicines, contraceptive pills, therapy  A persistent, significant incapacity and substantial disruption of the ability to conduct normal life functions weakness of legs, not able to walk by myself without a worker, fatigue-tiredness, muscle and back and leg pains and vomiting. Loss of taste and appetite. Consisting dry cough. Unable to sleep. Sex and Intimacy with my husband due to chronic illness. Weight lost of over 20 pounds. Hospitalized numerous times on vaccine side effects, immune reaction and trombosis risk as per hospital studies consequences on health and many patients are experiencing due to Covid - 19 vaccinations and bosters.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral venous disease, Sexual dysfunction, Skin discolouration, Surgery, Swelling face
Clinical narrative: Serious* adverse events (irrespective of attribution to Covid - 19 vaccination Moderna two doses ' shots and additional dose of Bivalent - Omicron Booster) Heart failure. Thrombosis Blood Clots blocking blood flow in both legs and ankles Edema that require medical and surgical intervention to prevent one of the outcomes heart attacks. Chronic venous insufficiency. Water retention - discoloration of skin. Swollen inflammation and fluid retention in the ankles, feet, legs and stomach and eyebrows. Loss of time at work, loss of promotion transfer opportunity and productivity due to illness and medical treatments. Experienced Inpatient hospitalization and prolongation of existing hospitalization. Taking medicines - such as some blood thinner medicines, contraceptive pills, therapy  A persistent, significant incapacity and substantial disruption of the ability to conduct normal life functions weakness of legs, not able to walk by myself without a worker, fatigue-tiredness, muscle and back and leg pains and vomiting. Loss of taste and appetite. Consisting dry cough. Unable to sleep. Sex and Intimacy with my husband due to chronic illness. Weight lost of over 20 pounds. Hospitalized numerous times on vaccine side effects, immune reaction and trombosis risk as per hospital studies consequences on health and many patients are experiencing due to Covid - 19 vaccinations and bosters.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Vomiting, Weight decreased
Clinical narrative: Serious* adverse events (irrespective of attribution to Covid - 19 vaccination Moderna two doses ' shots and additional dose of Bivalent - Omicron Booster) Heart failure. Thrombosis Blood Clots blocking blood flow in both legs and ankles Edema that require medical and surgical intervention to prevent one of the outcomes heart attacks. Chronic venous insufficiency. Water retention - discoloration of skin. Swollen inflammation and fluid retention in the ankles, feet, legs and stomach and eyebrows. Loss of time at work, loss of promotion transfer opportunity and productivity due to illness and medical treatments. Experienced Inpatient hospitalization and prolongation of existing hospitalization. Taking medicines - such as some blood thinner medicines, contraceptive pills, therapy  A persistent, significant incapacity and substantial disruption of the ability to conduct normal life functions weakness of legs, not able to walk by myself without a worker, fatigue-tiredness, muscle and back and leg pains and vomiting. Loss of taste and appetite. Consisting dry cough. Unable to sleep. Sex and Intimacy with my husband due to chronic illness. Weight lost of over 20 pounds. Hospitalized numerous times on vaccine side effects, immune reaction and trombosis risk as per hospital studies consequences on health and many patients are experiencing due to Covid - 19 vaccinations and bosters.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Intensive care
Clinical narrative: Stroke any medication with sulfa causes her a problem so she doesn't take it, she can't have certain antibiotics such as keflex because of an adverse reaction following catching Cdif in hospital and must be prescribed other antibiotics, she gets a cough from certain heart medications which she does not take, raw onion upsets her stomach, dairy causes her to have a nose bleed
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Patient developed rash and fever 7 days after getting vaccinated. Fever running 99-102. Mild pink rash throughout body. Treatment Tylenol and Benadryl PRN
Age: 60.0
Sex: U
Vaccine: UNK
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Patient complained of dizziness and lightheadedness. Assessment revealed facial pallor and diaphoresis. Vital signs were assessed at 10:35 and were as follows: BP: 102/70; HR: 30, irregular, O2 100% on RA, RR WNL. Patient was given 8 oz of water and placed in supine position in vehicle with legs elevated for 5 minutes.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hypoaesthesia, Hypoaesthesia oral, Oropharyngeal pain
Clinical narrative: 45 minutes after injection I experienced numbness in cheeks/face and lip. One hour later experienced sort throat and chills and dizziness. Numbness persisted in face and arms/hands for 3-4 hours.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Paraesthesia, Syncope
Clinical narrative: Within one day patient felt tingly, weak, and collapsed. Progressed into patients face and tongue currently.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event, Product administration error
Clinical narrative: Administration error -  Moderna Monovalent was given as the booster instead of the Bivalent. No adverse reaction.
Age: 2.6
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered, No adverse event, Product administration error
Clinical narrative: Administration error Moderna Monovalent was given as a booster instead of the Bivalent No adverse reaction
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Arrhythmia, Constipation, Palpitations, Tachycardia
Clinical narrative: Sudden, immediate and continued loss of scalp hair not gradual like normal aging; Chronic constipation; Heart arrhythmia; palpitations and inexplicable racing cadence; Possibly postural orthostatic tachycardia syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 02Jan2022 as dose 3 (booster), single (Lot number: FJ1611) at the age of 62 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. No other vaccine on same date of BNT162B2, no other vaccine in four weeks. Patient had no known allergies. The following information was reported: CONSTIPATION (disability) with onset Jan2022, outcome "not recovered", described as "Chronic constipation"; ARRHYTHMIA (disability) with onset Jan2022, outcome "not recovered", described as "Heart arrhythmia"; TACHYCARDIA (disability) with onset Jan2022, outcome "not recovered", described as "Possibly postural orthostatic tachycardia syndrome"; ALOPECIA (disability) with onset Jan2022, outcome "not recovered", described as "Sudden, immediate and continued loss of scalp hair not gradual like normal aging"; PALPITATIONS (disability) with onset Jan2022, outcome "not recovered", described as "palpitations and inexplicable racing cadence". It was unknown if therapeutic measures were taken as a result of alopecia, constipation, arrhythmia, palpitations, tachycardia.
Age: 71.0
Sex: F
Vaccine: VARZOS, COVID19, VARZOS
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Small itchy water blisters; Itching; This case was reported by a consumer via call center representative and described the occurrence of blister in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On 12th January 2023, the patient received Shingrix and the 1st dose of COVID VACCINE. In January 2023, less than a week after receiving Shingrix, the patient experienced blister and pruritus. The patient was treated with benadryl (nos) (Benadryl) and cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the blister and pruritus were unknown.   It was unknown if the reporter considered the blister and pruritus to be related to Shingrix.     Additional Information: Receipt Date: 21-Feb-2023 and 22-Feb-2023 Reporter's Comments: The patient was administered the Shingrix vaccination and Covid vaccine on the same day and about a day and a half later she broke out in small itchy water blisters all over her body.  The patient received the Covid vaccine in her right arm. The patient had been using Benadryl and cortisone cream to stop the itching. The physician was very informative on having a reaction to the Shingrix shot and she told the reporter pretty much what the reporter wanted to know, and she was sending her some information through the mail and the reporter do appreciate that. The reporter consented to follow up. Additional supportive information: It was unknown if the reporter considered the blister and pruritus to be related to Covid vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS, COVID19, VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: Small itchy water blisters; Itching; This case was reported by a consumer via call center representative and described the occurrence of blister in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On 12th January 2023, the patient received Shingrix and the 1st dose of COVID VACCINE. In January 2023, less than a week after receiving Shingrix, the patient experienced blister and pruritus. The patient was treated with benadryl (nos) (Benadryl) and cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the blister and pruritus were unknown.   It was unknown if the reporter considered the blister and pruritus to be related to Shingrix.     Additional Information: Receipt Date: 21-Feb-2023 and 22-Feb-2023 Reporter's Comments: The patient was administered the Shingrix vaccination and Covid vaccine on the same day and about a day and a half later she broke out in small itchy water blisters all over her body.  The patient received the Covid vaccine in her right arm. The patient had been using Benadryl and cortisone cream to stop the itching. The physician was very informative on having a reaction to the Shingrix shot and she told the reporter pretty much what the reporter wanted to know, and she was sending her some information through the mail and the reporter do appreciate that. The reporter consented to follow up. Additional supportive information: It was unknown if the reporter considered the blister and pruritus to be related to Covid vaccine.
Age: 9.0
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Medical assistant calling to report that a patient received a extra dose of VAQTA.; This spontaneous report was received from a medical assistant and referred to a 9-year-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.   On 02-FEB-2023, the patient received an extra dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W036135, expiration date: 13-MAY-2024, administered for prophylaxis (strength and route of administration were not provided) (extra dose administered). No other issue or concerns noted.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No reported patient side effects; An improperly stored dose of PROQUAD was inadvertently administered to a patient on 2/13/23; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 13-FEB-2023, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen was not reported), lot # W038815 rHA and expiration date 04-JUN-2024 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion in which it was stored in the refrigerator instead of the freezer for an unknown timeframe on 25-JAN-2023; no previous temperature excursions were reported.  No adverse symptoms were reported.  This case was classified as non-valid due to no adverse events.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired dose of RECOMBIVAX was administered; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 25-JAN-2023, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter, lot #U019135, expiration date: 22-NOV-2022 (Expired product administered), administered intramuscularly for prophylaxis (strength was not provided).  No additional adverse event was reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2302USA008323: US-009507513-2302USA008440: US-009507513-2302USA008328: US-009507513-2302USA008308: US-009507513-2302USA008289:
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster
Clinical narrative: hearing loss; shingles; Information has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. In or around April 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, lot #, expiration date, site and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles and hearing loss. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered both events to be disabling. Upon internal review, the event of hearing loss was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine, still get shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 26-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient had the vaccine and it did not work. The reporter reported that you could got the vaccine and still got shingles.  The reporter know, it happened him/her.  The PRN told that it was just like any other vaccine, some people it works for and some it did not, just like a flu shot. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case was 1 of 4 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR032444:same reporter US-GSK-US2023AMR032445:same reporter US-GSK-US2023AMR032461:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Eye swelling, Herpes zoster, Pain, Scar, Vaccination failure
Clinical narrative: got Shingles after the 2 series shot/suspected vaccination failure; shingles on face, not bad; scarred; Eye was swollen shut; pain was like burning; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, scar, eye swelling and pain burning. On an unknown date, the outcome of the vaccination failure, shingles, scar, eye swelling and pain burning were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, scar, eye swelling and pain burning to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 26-FEB-2023 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient received the two dose series of Shingrix and got still shingles only on left side of the face. The patient reported that it was not as bad due to shot but left the patient scarred. The patient reported that eye was swollen shut and pain was more like burning. The patient reported that shot help me not have as severe case of it and reported that eye swale shut but vision was not affected. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Age: 43.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Product administered to patient of inappropriate age
Clinical narrative: Muscle soreness; Tiredness; What about age 43, safe to say same; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 43-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced muscle soreness, tiredness and inappropriate age at vaccine administration. On an unknown date, the outcome of the muscle soreness, tiredness and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the muscle soreness and tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-Feb-2023 Reporter's comment: The patient stated that typically how long do the side effects last after the shot and had muscles soreness and tiredness were main ones. The patient asked what about 43 years, it safe to say same. The patient at least want to know now it should end soon. Additional supportive information: The patient received a dose of Shingles vaccine at inappropriate age, which led to inappropriate age at vaccine administration. The follow-up could not be possible as no contact detail available. As it was stated by the patient what about 43 years and safe to say same in relation to administration of vaccine therefore it was considered that the patient received the vaccine at inappropriate age and for the same age at vaccination and age at administration was captured.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm pain; Body aches; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the pain in arm and general body pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2023029285   Additional Information: GSK Receipt Date: 21-Feb-2023 Reporter's comments: The patient received a dose of Shingrix and experienced arm pain and body aches. The reporter consented to follow-up with health care professional (pharmacy). Additional supportive information: For tolerance of second dose, refer case US2023029285.; Sender's Comments:  US-GSK-US2023029285:Same reporter