chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast cancer female, Breast cancer metastatic, Breast cancer stage IV, Catheterisation cardiac abnormal, Coronary artery occlusion
Clinical narrative: Sob
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: Sob
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Bundle branch block right, Chest pain, Dementia Alzheimer's type, Electrocardiogram abnormal
Clinical narrative: Patient complained to her daughter since getting the Booster Shot on 8-23-21 of joint pain, neck pain and pain in her arm. When the daughter took the patient to a primary doctors visit on 10-8-21, the patient informed the primary doctor that she had been having pain in her arm and chest. During the office visit the Doctor, performed an ECG in the office. The Doctor was immediately concerned due to sinus rhythm (rapid) with right axis deviation. The Doctor instructed the daughter to take the patient to the Emergency Room.  At the Emergency room the patient was given another ECG. The diagnosis was Sinus Tachycardia, possible Left Atrial Enlargement, Rightward Axis, Incomplete Right Bundle Branch Block, Septal Infarct, Age Undetermined, Abnormal ECG when compared with ECG 7-22-21 Vent Rate has increased by 38 BPM, Incomplete Right Bundle Branch Block is Now Present, Septal Infract is Now Present. Patient has NEVER been diagnosed with COVID and ECG was abnormal AFTER the Booster Shot compared to a prior ECG. NT Pro NT Pro BNP High at 499.4 In addition, the family has noticed a significant increase in neurological issues starting after the Booster Shot and was seen by a Neurologist in 2022. Officially, diagnosed with Alzheimer?s Dementia in October 2022.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocardial infarction, N-terminal prohormone brain natriuretic peptide increased, Neck pain, Nervous system disorder, Neurological examination
Clinical narrative: Patient complained to her daughter since getting the Booster Shot on 8-23-21 of joint pain, neck pain and pain in her arm. When the daughter took the patient to a primary doctors visit on 10-8-21, the patient informed the primary doctor that she had been having pain in her arm and chest. During the office visit the Doctor, performed an ECG in the office. The Doctor was immediately concerned due to sinus rhythm (rapid) with right axis deviation. The Doctor instructed the daughter to take the patient to the Emergency Room.  At the Emergency room the patient was given another ECG. The diagnosis was Sinus Tachycardia, possible Left Atrial Enlargement, Rightward Axis, Incomplete Right Bundle Branch Block, Septal Infarct, Age Undetermined, Abnormal ECG when compared with ECG 7-22-21 Vent Rate has increased by 38 BPM, Incomplete Right Bundle Branch Block is Now Present, Septal Infract is Now Present. Patient has NEVER been diagnosed with COVID and ECG was abnormal AFTER the Booster Shot compared to a prior ECG. NT Pro NT Pro BNP High at 499.4 In addition, the family has noticed a significant increase in neurological issues starting after the Booster Shot and was seen by a Neurologist in 2022. Officially, diagnosed with Alzheimer?s Dementia in October 2022.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, QRS axis abnormal, Sinus tachycardia
Clinical narrative: Patient complained to her daughter since getting the Booster Shot on 8-23-21 of joint pain, neck pain and pain in her arm. When the daughter took the patient to a primary doctors visit on 10-8-21, the patient informed the primary doctor that she had been having pain in her arm and chest. During the office visit the Doctor, performed an ECG in the office. The Doctor was immediately concerned due to sinus rhythm (rapid) with right axis deviation. The Doctor instructed the daughter to take the patient to the Emergency Room.  At the Emergency room the patient was given another ECG. The diagnosis was Sinus Tachycardia, possible Left Atrial Enlargement, Rightward Axis, Incomplete Right Bundle Branch Block, Septal Infarct, Age Undetermined, Abnormal ECG when compared with ECG 7-22-21 Vent Rate has increased by 38 BPM, Incomplete Right Bundle Branch Block is Now Present, Septal Infract is Now Present. Patient has NEVER been diagnosed with COVID and ECG was abnormal AFTER the Booster Shot compared to a prior ECG. NT Pro NT Pro BNP High at 499.4 In addition, the family has noticed a significant increase in neurological issues starting after the Booster Shot and was seen by a Neurologist in 2022. Officially, diagnosed with Alzheimer?s Dementia in October 2022.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Asthenia, Fatigue
Clinical narrative: About 2 hours after getting the shot I began feeling very tired and low energy. By that evening my joints were really hurting me. It lasted about 48 hours.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Crying, Discomfort, Pyrexia
Clinical narrative: Patient had fevers that reached 104.6 on 1/20/23. I gave Tylenol and alternated Motrin 5ml. Fever would still not subside even with fever reducer. (Still 104.1) By 5:30pm on 1/20/23 I left message for a medical assistant because fever reducer was not working and my child was uncomfortable and crying non stop.
Age: 21.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest pain, Fatigue, Tinnitus
Clinical narrative: worsened tinnitus, slight chest pain, fatigue
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine increased, Chronic kidney disease, Laboratory test, Metabolic function test, Urine analysis
Clinical narrative: Elevated Creatinine 1.43mg/dl 4 months after 2nd injection. Chronic kidney disease stage 2, 15 Dec 2022 Chronic kidney disease stage 3, 19 April 2022
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin abnormal, Squamous cell carcinoma of skin
Clinical narrative: Invasive Squamous Cell Carcinoma in lower extremity
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain in extremity, Rotator cuff syndrome, X-ray
Clinical narrative: WITHIN 4 DAYS AFTER THE COVID 19 (PFIZER/BioNTech) BOOSTER, I DEVELOPED SEVERE BILATERAL SHOULDER AND ARM PAIN WITH LIMITED RANGE OF MOTION. I WENT TO ORTHOPEDIC AND SPINCE CLINIC AND SAW DR ON 09/7/2021 AND HE DIAGNOSED ME WITH BILATERAL ROTATOR CUFF TENDINITIS. TREATMENT: S/P TO BILATERALSUBACROMIAL SPACE WITH 40 MG KENALOG B/L SHOULDER BURSER ON 9/27/21. EXTREME PAIN RETURNED AND TREATMENT REPEATED WITH 40 MG KENALOG B.L SHOULDER BURSER ON 11/17/21 AND AGAIN IN 2/16/22. PRESCRIBED DICLOFENAC 75MG BID AS NEEDED. PHYSICAL THERAPY WILL START NEXT WEEK AND IF SYSMTOM RETURN, FR. WILL ORDER AN MRI
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Arrhythmia, Cardiac monitoring, Cardiac stress test, Chest pain
Clinical narrative: Healthy 55-year old who was into health and fitness since childhood. Worked out at least 5 times a week. Work out included running, lifting weights, bicycling, yoga, etc. Part of the fitness regimen and healthy eating was due to history of heart disease in family, which I was determined to avoid. Got regular heart checkups to make sure that did not get heart disease. Very low cholesterol levels, no high blood pressure, excellent BMI, and did excellent on the treadmill stress tests. I was unable to sleep at night because of the constant and irregular pounding of the heart. The sound was loud in my ears. This was accompanied with shortness of breath as though I had just run a marathon. These symptoms got progressively worse over the weeks. Initially we never made the connection between my symptoms and the vaccine because I thought my thyroid levels were off, which may be causing the irregular heartbeats, even though I had not experienced anything like this before. The irregular heartbeats got so bad that I stopped all my workouts and tried just walking instead. Even gentle walking trigger arrhythmia and rapid heartbeat. So I stopped walking as well. By mid-September, roughly 3 weeks after taking the first vaccine, my heartbeats were so irregular that I was massaging my heart constantly in an attempt to alleviate the symptoms. Not only was it skipping beats but also it felt like a burning sensation with mild moderate pain. I could not shake off the sensation that you get when you are in an airplane and it descends suddenly. After I got my second dose in October, I had fever for about 2-3 days. The irregular heartbeats and shortness of breath became even more acute. Just standing in one place triggered irregular heartbeats. Almost a year later, I have not been able to work out at all or perform any physical activity that elevates my heart rate. My life has completely changed. It is not an exaggeration to say that I am completely disabled. Unsurprisingly, this has had an adverse effect on my mental well-being.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased activity, Differential white blood cell count, Disability, Dyspnoea, Echocardiogram
Clinical narrative: Healthy 55-year old who was into health and fitness since childhood. Worked out at least 5 times a week. Work out included running, lifting weights, bicycling, yoga, etc. Part of the fitness regimen and healthy eating was due to history of heart disease in family, which I was determined to avoid. Got regular heart checkups to make sure that did not get heart disease. Very low cholesterol levels, no high blood pressure, excellent BMI, and did excellent on the treadmill stress tests. I was unable to sleep at night because of the constant and irregular pounding of the heart. The sound was loud in my ears. This was accompanied with shortness of breath as though I had just run a marathon. These symptoms got progressively worse over the weeks. Initially we never made the connection between my symptoms and the vaccine because I thought my thyroid levels were off, which may be causing the irregular heartbeats, even though I had not experienced anything like this before. The irregular heartbeats got so bad that I stopped all my workouts and tried just walking instead. Even gentle walking trigger arrhythmia and rapid heartbeat. So I stopped walking as well. By mid-September, roughly 3 weeks after taking the first vaccine, my heartbeats were so irregular that I was massaging my heart constantly in an attempt to alleviate the symptoms. Not only was it skipping beats but also it felt like a burning sensation with mild moderate pain. I could not shake off the sensation that you get when you are in an airplane and it descends suddenly. After I got my second dose in October, I had fever for about 2-3 days. The irregular heartbeats and shortness of breath became even more acute. Just standing in one place triggered irregular heartbeats. Almost a year later, I have not been able to work out at all or perform any physical activity that elevates my heart rate. My life has completely changed. It is not an exaggeration to say that I am completely disabled. Unsurprisingly, this has had an adverse effect on my mental well-being.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Emotional distress, Exercise test, Exercise tolerance decreased, Extrasystoles
Clinical narrative: Healthy 55-year old who was into health and fitness since childhood. Worked out at least 5 times a week. Work out included running, lifting weights, bicycling, yoga, etc. Part of the fitness regimen and healthy eating was due to history of heart disease in family, which I was determined to avoid. Got regular heart checkups to make sure that did not get heart disease. Very low cholesterol levels, no high blood pressure, excellent BMI, and did excellent on the treadmill stress tests. I was unable to sleep at night because of the constant and irregular pounding of the heart. The sound was loud in my ears. This was accompanied with shortness of breath as though I had just run a marathon. These symptoms got progressively worse over the weeks. Initially we never made the connection between my symptoms and the vaccine because I thought my thyroid levels were off, which may be causing the irregular heartbeats, even though I had not experienced anything like this before. The irregular heartbeats got so bad that I stopped all my workouts and tried just walking instead. Even gentle walking trigger arrhythmia and rapid heartbeat. So I stopped walking as well. By mid-September, roughly 3 weeks after taking the first vaccine, my heartbeats were so irregular that I was massaging my heart constantly in an attempt to alleviate the symptoms. Not only was it skipping beats but also it felt like a burning sensation with mild moderate pain. I could not shake off the sensation that you get when you are in an airplane and it descends suddenly. After I got my second dose in October, I had fever for about 2-3 days. The irregular heartbeats and shortness of breath became even more acute. Just standing in one place triggered irregular heartbeats. Almost a year later, I have not been able to work out at all or perform any physical activity that elevates my heart rate. My life has completely changed. It is not an exaggeration to say that I am completely disabled. Unsurprisingly, this has had an adverse effect on my mental well-being.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Heart rate increased, Heart rate irregular, Lipids, Loss of personal independence in daily activities
Clinical narrative: Healthy 55-year old who was into health and fitness since childhood. Worked out at least 5 times a week. Work out included running, lifting weights, bicycling, yoga, etc. Part of the fitness regimen and healthy eating was due to history of heart disease in family, which I was determined to avoid. Got regular heart checkups to make sure that did not get heart disease. Very low cholesterol levels, no high blood pressure, excellent BMI, and did excellent on the treadmill stress tests. I was unable to sleep at night because of the constant and irregular pounding of the heart. The sound was loud in my ears. This was accompanied with shortness of breath as though I had just run a marathon. These symptoms got progressively worse over the weeks. Initially we never made the connection between my symptoms and the vaccine because I thought my thyroid levels were off, which may be causing the irregular heartbeats, even though I had not experienced anything like this before. The irregular heartbeats got so bad that I stopped all my workouts and tried just walking instead. Even gentle walking trigger arrhythmia and rapid heartbeat. So I stopped walking as well. By mid-September, roughly 3 weeks after taking the first vaccine, my heartbeats were so irregular that I was massaging my heart constantly in an attempt to alleviate the symptoms. Not only was it skipping beats but also it felt like a burning sensation with mild moderate pain. I could not shake off the sensation that you get when you are in an airplane and it descends suddenly. After I got my second dose in October, I had fever for about 2-3 days. The irregular heartbeats and shortness of breath became even more acute. Just standing in one place triggered irregular heartbeats. Almost a year later, I have not been able to work out at all or perform any physical activity that elevates my heart rate. My life has completely changed. It is not an exaggeration to say that I am completely disabled. Unsurprisingly, this has had an adverse effect on my mental well-being.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Palpitations, Pyrexia, Sensory disturbance, Sleep disorder
Clinical narrative: Healthy 55-year old who was into health and fitness since childhood. Worked out at least 5 times a week. Work out included running, lifting weights, bicycling, yoga, etc. Part of the fitness regimen and healthy eating was due to history of heart disease in family, which I was determined to avoid. Got regular heart checkups to make sure that did not get heart disease. Very low cholesterol levels, no high blood pressure, excellent BMI, and did excellent on the treadmill stress tests. I was unable to sleep at night because of the constant and irregular pounding of the heart. The sound was loud in my ears. This was accompanied with shortness of breath as though I had just run a marathon. These symptoms got progressively worse over the weeks. Initially we never made the connection between my symptoms and the vaccine because I thought my thyroid levels were off, which may be causing the irregular heartbeats, even though I had not experienced anything like this before. The irregular heartbeats got so bad that I stopped all my workouts and tried just walking instead. Even gentle walking trigger arrhythmia and rapid heartbeat. So I stopped walking as well. By mid-September, roughly 3 weeks after taking the first vaccine, my heartbeats were so irregular that I was massaging my heart constantly in an attempt to alleviate the symptoms. Not only was it skipping beats but also it felt like a burning sensation with mild moderate pain. I could not shake off the sensation that you get when you are in an airplane and it descends suddenly. After I got my second dose in October, I had fever for about 2-3 days. The irregular heartbeats and shortness of breath became even more acute. Just standing in one place triggered irregular heartbeats. Almost a year later, I have not been able to work out at all or perform any physical activity that elevates my heart rate. My life has completely changed. It is not an exaggeration to say that I am completely disabled. Unsurprisingly, this has had an adverse effect on my mental well-being.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Thyroid function test, Troponin
Clinical narrative: Healthy 55-year old who was into health and fitness since childhood. Worked out at least 5 times a week. Work out included running, lifting weights, bicycling, yoga, etc. Part of the fitness regimen and healthy eating was due to history of heart disease in family, which I was determined to avoid. Got regular heart checkups to make sure that did not get heart disease. Very low cholesterol levels, no high blood pressure, excellent BMI, and did excellent on the treadmill stress tests. I was unable to sleep at night because of the constant and irregular pounding of the heart. The sound was loud in my ears. This was accompanied with shortness of breath as though I had just run a marathon. These symptoms got progressively worse over the weeks. Initially we never made the connection between my symptoms and the vaccine because I thought my thyroid levels were off, which may be causing the irregular heartbeats, even though I had not experienced anything like this before. The irregular heartbeats got so bad that I stopped all my workouts and tried just walking instead. Even gentle walking trigger arrhythmia and rapid heartbeat. So I stopped walking as well. By mid-September, roughly 3 weeks after taking the first vaccine, my heartbeats were so irregular that I was massaging my heart constantly in an attempt to alleviate the symptoms. Not only was it skipping beats but also it felt like a burning sensation with mild moderate pain. I could not shake off the sensation that you get when you are in an airplane and it descends suddenly. After I got my second dose in October, I had fever for about 2-3 days. The irregular heartbeats and shortness of breath became even more acute. Just standing in one place triggered irregular heartbeats. Almost a year later, I have not been able to work out at all or perform any physical activity that elevates my heart rate. My life has completely changed. It is not an exaggeration to say that I am completely disabled. Unsurprisingly, this has had an adverse effect on my mental well-being.
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse events to report.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiac ablation, Cardiac failure, Catheterisation cardiac, Electrocardiogram
Clinical narrative: Developed A Fib; heart failure; Tinnitus systems; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 at 12:00 as dose 2, single (Lot number: EL1284) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL; TRAZODONE; NAPROXIN [NAPROXEN SODIUM]. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EJ1685, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 30Dec2020, when the patient was 60-year-old, for Covid-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (hospitalization, disability, medically significant, life threatening) with onset 27Feb2021 at 09:00, outcome "recovered with sequelae", described as "Developed A Fib"; TINNITUS (hospitalization, disability, life threatening) with onset 27Feb2021 at 09:00, outcome "recovered with sequelae", described as "Tinnitus systems"; CARDIAC FAILURE (hospitalization, disability, medically significant, life threatening) with onset 27Feb2021 at 09:00, outcome "recovered with sequelae", described as "heart failure". The patient was hospitalized for atrial fibrillation, cardiac failure, tinnitus (hospitalization duration: 1 day(s)). The events "developed a fib", "heart failure" and "tinnitus systems" required physician office visit. Therapeutic measures were taken as a result of atrial fibrillation, cardiac failure, tinnitus.  Clinical course: Developed A Fib, heart failure and Tinnitus systems started 30 days after 2 vaccines. AE resulted in doctor or other healthcare professional office/clinic visit, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient was recovered with lasting effects. Patient had used cardiac ablation for an AE treatment. Patient had not covid prior vaccination. Patient had not covid tested post vaccination. Patient had not known allergies. Patient had no other medical history.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events Atrial fibrillation, tinnitus, cardiac failure and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging heart
Clinical narrative: Developed A Fib; heart failure; Tinnitus systems; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 at 12:00 as dose 2, single (Lot number: EL1284) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL; TRAZODONE; NAPROXIN [NAPROXEN SODIUM]. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EJ1685, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 30Dec2020, when the patient was 60-year-old, for Covid-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (hospitalization, disability, medically significant, life threatening) with onset 27Feb2021 at 09:00, outcome "recovered with sequelae", described as "Developed A Fib"; TINNITUS (hospitalization, disability, life threatening) with onset 27Feb2021 at 09:00, outcome "recovered with sequelae", described as "Tinnitus systems"; CARDIAC FAILURE (hospitalization, disability, medically significant, life threatening) with onset 27Feb2021 at 09:00, outcome "recovered with sequelae", described as "heart failure". The patient was hospitalized for atrial fibrillation, cardiac failure, tinnitus (hospitalization duration: 1 day(s)). The events "developed a fib", "heart failure" and "tinnitus systems" required physician office visit. Therapeutic measures were taken as a result of atrial fibrillation, cardiac failure, tinnitus.  Clinical course: Developed A Fib, heart failure and Tinnitus systems started 30 days after 2 vaccines. AE resulted in doctor or other healthcare professional office/clinic visit, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient was recovered with lasting effects. Patient had used cardiac ablation for an AE treatment. Patient had not covid prior vaccination. Patient had not covid tested post vaccination. Patient had not known allergies. Patient had no other medical history.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events Atrial fibrillation, tinnitus, cardiac failure and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiac failure, Tinnitus
Clinical narrative: Developed A Fib; heart failure; Tinnitus systems; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 at 12:00 as dose 2, single (Lot number: EL1284) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL; TRAZODONE; NAPROXIN [NAPROXEN SODIUM]. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EJ1685, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 30Dec2020, when the patient was 60-year-old, for Covid-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (hospitalization, disability, medically significant, life threatening) with onset 27Feb2021 at 09:00, outcome "recovered with sequelae", described as "Developed A Fib"; TINNITUS (hospitalization, disability, life threatening) with onset 27Feb2021 at 09:00, outcome "recovered with sequelae", described as "Tinnitus systems"; CARDIAC FAILURE (hospitalization, disability, medically significant, life threatening) with onset 27Feb2021 at 09:00, outcome "recovered with sequelae", described as "heart failure". The patient was hospitalized for atrial fibrillation, cardiac failure, tinnitus (hospitalization duration: 1 day(s)). The events "developed a fib", "heart failure" and "tinnitus systems" required physician office visit. Therapeutic measures were taken as a result of atrial fibrillation, cardiac failure, tinnitus.  Clinical course: Developed A Fib, heart failure and Tinnitus systems started 30 days after 2 vaccines. AE resulted in doctor or other healthcare professional office/clinic visit, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient was recovered with lasting effects. Patient had used cardiac ablation for an AE treatment. Patient had not covid prior vaccination. Patient had not covid tested post vaccination. Patient had not known allergies. Patient had no other medical history.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events Atrial fibrillation, tinnitus, cardiac failure and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Localized hives after dose 1 administration; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug allergies or reactions, concurrent conditions, and concomitant drugs were not reported.  On an unspecified date, the patient received the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for prophylaxis.   On an unspecified date immediately after varicella virus vaccine live (Oka/Merck) (VARIVAX), the patient got localized hives. The outcome of the hives, and the causal relationship between varicella virus vaccine live (Oka/Merck) (VARIVAX) and hives were not reported.   This case is non-valid due to the lack of identifiable patient information.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reported that GARDASIL 9 that underwent a temperature excursion was administered; No additional AE.; This spontaneous report has been received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date in December 2022 (reported as between 06-DEC-2022 and 22-DEC-2022), the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot # 1780867  confirmed to be valid for formulation syringe with expiration date 08-AUG-2023 (exact dose, dose number, route of administration, and anatomical location were not reported) for prophylaxis. On an unknown date before administration, the vaccine underwent a temperature excursion. Data regarding temperature excursion was not available. No additional adverse event was reported (no adverse event).  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2301USA003157:MSD US-009507513-2301USA003129:MSD US-009507513-2301USA003155:MSD US-009507513-2301USA003156:MSD
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, No adverse event, Product preparation error
Clinical narrative: No additional AE reported; Pharmacist reports an expired dose of sterile diluent [U035268 11/9/2022] was used to reconstitute VARIVAX [U030161 9/28/2023] and it was administered to a patient on 13DEC2022. Caller confirmed sterile diluent was not involved in a temperature excur; Pharmacist reports an expired dose of sterile diluent [U035268 11/9/2022] was used to reconstitute VARIVAX [U030161 9/28/2023]; This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 13-DEC-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, lot# U030161 confirmed to be valid with expiration date 28-SEP-2023 (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with an expired dose of sterile diluent, lot # U035268 confirmed to be valid with expiration date 09-NOV-2022 (exact dose was not reported) (expired product administered, product preparation error). The reporter confirmed that sterile diluent was not involved in a temperature excursion and was stored according to the recommended storage range until administration. There was no additional adverse event reported.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Physician reported she has a patient who received the first dose of ROTATEQ after 15 weeks of age; No additional AE reported; This spontaneous report was received from a physician referring to a 15-week-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1, oral (lot number and expiration date not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AEs; expired lot of MMR II was administered to patient; This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JAN-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) subcutaneous injection, 0.5ml/once, lot number T037029, expiration date: 03-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). There was no additional adverse event reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported at time of call.; a dose of VAQTA with a labeled expiry of 1/16/2023 was administered to a patient on 1/17/2023.; This spontaneous report was received from a nurse manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W007382, expiration date: 16-JAN-2023, administered for prophylaxis (strength, dose and route of administration were not provided) (Expired product administered). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reports there have been no additional adverse experiences reported.; an improperly stored vaccine was administered to a patient.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 09-JAN-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot #W023866 had been verified to be a valid number; expiration date 24-JAN-2024, and upon internal validation established as the same date) (dosage, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported). The administered dose of the vaccine was stored at a temperature of 10 degrees Celsius (C), for a time frame of 1 hour and 28 minutes, as recorded by a digital data logger. There was no previous temperature excursion reported. There was no adverse effect reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: unable to receive her third dose of GARDASIL 9; no additional AE's were reported; This spontaneous report was received from a health care professional (HCP) on behalf of themselves. The patient was a 61-year-old female. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date (at the age of 60 years old), the patient was vaccinated with first and second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. At the time of reporting (also reported as at 61 years old), the patient was unable to received her third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of vaccine administration). There was no adverse event reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported.; Caller reported expired VAQTA administered.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-JAN-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 25/0.5, 0.5 milliliter, lot #W007375, expiration date: 16-JAN-2023, administered intramuscularly for prophylaxis (strength was not provided) (Expired product administered). No adverse event was reported.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AEs; Caller reported patient received 1st dose of GARDASIL 9 on 9/15/2022, 2nd dose on 11/16/2022 and a third dose on 1/17/2023; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The information about the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 15-SEP-2022, the patient was vaccinated with the first dose of human papillomavirus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot# and expiry date were not provided) for prophylaxis. On 16-NOV-2022, the patient was vaccinated with the second dose of human papillomavirus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot# and expiry date were not provided) for prophylaxis. On 17-JAN-2023, the patient was vaccinated with the third dose of human papillomavirus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml intramuscularly (IM) in the right deltoid, lot #W015188, expiry date reported as 31-JAN-2025, but upon internal validation established as 06-JAN-2025 (conflicting information), for prophylaxis (inappropriate schedule of product administration). No additional adverse events (AEs) reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired VAQTA; This spontaneous report was received from a consumer (Healthcare Business Professional) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 17-JAN-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W007382, expiration date: 16-JAN-2023, administered for prophylaxis (strength, dose, dose number and route of administration were not provided) (expired product administered).  No additional adverse event reported.  This is one of 2 reports regarding the same reporter. ; Sender's Comments:  US-009507513-2301USA007085:MSD
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Completed series, got shingles/Suspected vaccination failure; About one week ago patient got shingles. Across t12 Dermatone -right side.; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male 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 1st dose of Shingrix and the 2nd dose of Shingrix. In January 2023, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.     Additional Information: GSK receipt date: 19-Jan-2023 Reporter's comment: The patient received Shingrix complete series approximately in 2022 and about one week ago the patient got shingles, across t12 dermatone in right side. The reporter consented to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: first singrex last October, had shingles in December; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number ae2j4, expiry date 30th March 2023) for prophylaxis.   On 25th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In December 2021, between 1 and 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Linked case(s) involving the same patient:  US2022132048, US2022AMR136275   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's comment: The patient self-reported this case. The patient received first dose of Shingrix last October and had a shingles in December. The patient got second dose today(on the day of reporting). The patient asked did he/she need another dose. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.   Follow-up information received on 13th SEP 2022. This follow-up was considered significant. Reporter's comment: The patient stated that she got shingles in December 2021 after she was getting the first Shingrix vaccine. Summary of Changes: The patient's demographics details, vaccination start date, patient route of administration, anatomical location, batch number and expiration date TTO details for shingles and narrative details were updated. The 2nd dose suspect with its events was deleted.; Sender's Comments:  US-GSK-US2022132048:Same reporter US-GSK-US2022AMR136275:Same patient- FU 1
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Tiredness; This case was reported by a consumer via other manufacturer and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix and COVID VACCINE. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR003782  Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's Comments: The patient was reporter himself. The patient received Shingrix and Covid vaccine at the same time. The reporter stated that for the first dose, he did not experience any side effects other than tiredness. No additional adverse event information provided. It was unknown if the reporter considered the tiredness to be related to Covid vaccine.  Additional Supportive Information: For tolerance of 2nd dose refer case US2023AMR003782.; Sender's Comments:  US-GSK-US2023AMR003782:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: it has been 2 years since patient received first dose of Shingrix; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago from the reporting date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's Comments: This case was reported via interactive digital media. The reporter asked, what if it had been 2 years since patient received first dose of Shingrix. Follow-up would not possible as no contact details were available. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. Note: The primary reporter was captured as other health professional conservatively due to limited information, as per source information reported into the narrative.
Age: 7.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7YO received Pediarix; This case was reported by a consumer via sales rep and described the occurrence of inappropriate age at vaccine administration in a 7-year-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (On 24th March 2021, patient received 1st dose).   On 27th August 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 27th August 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 11-Jan-2023. Reporter's Comments: The reporter consented to follow- up. No report of adverse effects. Additional Supportive Information: Patient received 2nd dose at 7 years of age, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: aching all over; shivering; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (at age 35).   On 9th January 2023, the patient received the 1st dose of Shingles vaccine. In January 2023, unknown after receiving Shingles vaccine, the patient experienced general body pain and shivering. On an unknown date, the outcome of the general body pain and shivering were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and shivering to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-JAN-2023 Reporter's comment:  This case was reported via interactive digital media. The patient reported that he/she got first dose 2 days ago, sitting here aching all over and shivering at 2:00am as speak.  The patient said but he or she remember chicken pox at age 35.  The patient did not want that hell again. Additional supportive information: Follow up would not possible, as no contact details were available.