chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Per documentation from health care provider, patient had an allergic reaction consisting of hives, swelling, elevated blood pressure, chest tightness and elevated pulse.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Heart rate increased, Hypersensitivity, Swelling
Clinical narrative: Per documentation from health care provider, patient had an allergic reaction consisting of hives, swelling, elevated blood pressure, chest tightness and elevated pulse.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Per documentation from health care provider, patient had an allergic reaction consisting of hives, swelling, elevated blood pressure, chest tightness and elevated pulse.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness transient, Diplopia, Headache, Neck pain, Rash
Clinical narrative: Rash initially on right arm, then it spread to face, other arm and legs. Severe occipital pain and loss of vision in right eye about 2 months later.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Vision blurred
Clinical narrative: Rash initially on right arm, then it spread to face, other arm and legs. Severe occipital pain and loss of vision in right eye about 2 months later.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness unilateral, Headache, Rash, Ultrasound Doppler normal
Clinical narrative: Rash initially on right arm, then it spread to face, other arm and legs. Severe occipital pain and loss of vision in right eye about 2 months later.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cardiac arrest, Death, Headache
Clinical narrative: death / Death cause Ventricular Fibrillation; This is a spontaneous report received from contactable reporter consumer via COVID-19 Adverse Event Self-Reporting Solution.  A 58 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 17May2021 (Lot number: EW0167) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "pain in her knees" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6206, Location of injection: Arm Right), administration date: 26Apr2021, when the patient was 58 years old, for Covid-19 immunization.  The following information was reported: VENTRICULAR FIBRILLATION (death, hospitalization, disability, life threatening) with onset 15Aug2021,at 16:00, outcome "fatal", described as "death / death cause ventricular fibrillation". The patient was hospitalized for ventricular fibrillation (hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: blood test: (16Aug2021) negative (elaborated as covid test type post vaccination: blood test). It was unknown if therapeutic measures were taken as a result of ventricular fibrillation. The patient date of death was 17Aug2021. The reported cause of death was ventricular fibrillation. No autopsy was performed.; Reported Cause(s) of Death: Ventricular fibrillation
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Ventricular fibrillation
Clinical narrative: death / Death cause Ventricular Fibrillation; This is a spontaneous report received from contactable reporter consumer via COVID-19 Adverse Event Self-Reporting Solution.  A 58 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 17May2021 (Lot number: EW0167) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "pain in her knees" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6206, Location of injection: Arm Right), administration date: 26Apr2021, when the patient was 58 years old, for Covid-19 immunization.  The following information was reported: VENTRICULAR FIBRILLATION (death, hospitalization, disability, life threatening) with onset 15Aug2021,at 16:00, outcome "fatal", described as "death / death cause ventricular fibrillation". The patient was hospitalized for ventricular fibrillation (hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: blood test: (16Aug2021) negative (elaborated as covid test type post vaccination: blood test). It was unknown if therapeutic measures were taken as a result of ventricular fibrillation. The patient date of death was 17Aug2021. The reported cause of death was ventricular fibrillation. No autopsy was performed.; Reported Cause(s) of Death: Ventricular fibrillation
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Dyspnoea, Laboratory test normal, Syncope
Clinical narrative: Patient presents for evaluation of worsening shortness of breath on the morning of arrival to hospital 11/20/2021.  The patient also endorses associated chest pain, abdominal pain, syncopal episode while going from standing position while getting the newspaper prior to admission.  Patient reports hitting his head on the cement with associated head trauma to posterior head.  Also endorses headache and cough.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Chest pain, Cough, Dyspnoea
Clinical narrative: Patient presents for evaluation of worsening shortness of breath on the morning of arrival to hospital 11/20/2021.  The patient also endorses associated chest pain, abdominal pain, syncopal episode while going from standing position while getting the newspaper prior to admission.  Patient reports hitting his head on the cement with associated head trauma to posterior head.  Also endorses headache and cough.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Head injury, Headache, SARS-CoV-2 test positive, Syncope
Clinical narrative: Patient presents for evaluation of worsening shortness of breath on the morning of arrival to hospital 11/20/2021.  The patient also endorses associated chest pain, abdominal pain, syncopal episode while going from standing position while getting the newspaper prior to admission.  Patient reports hitting his head on the cement with associated head trauma to posterior head.  Also endorses headache and cough.
Age: 97.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Asthenia, COVID-19, Confusional state, Death
Clinical narrative: Received Moderna COVID-19 vaccines on 1/20/21 and 2/17/21.  Developed symptoms of COVID-19 on 9/12/21 (nasal congestion, fatigue, loss of appetite, feeling weak, SOB). Tested positive on 9/16/21.  Received monoclonal antibody infusion on 9/18/21 (casirivimab-imdevimab).  Worsened as of 9/21/21 with hypoxemia.  Told his family that he did not want to go to the hospital and preferred transition to hospice care, which was arranged.   Died on 9/22/21.
Age: 97.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Depressed level of consciousness, Feeling abnormal, Hypertension, Hypoxia, Impaired driving ability
Clinical narrative: Received Moderna COVID-19 vaccines on 1/20/21 and 2/17/21.  Developed symptoms of COVID-19 on 9/12/21 (nasal congestion, fatigue, loss of appetite, feeling weak, SOB). Tested positive on 9/16/21.  Received monoclonal antibody infusion on 9/18/21 (casirivimab-imdevimab).  Worsened as of 9/21/21 with hypoxemia.  Told his family that he did not want to go to the hospital and preferred transition to hospice care, which was arranged.   Died on 9/22/21.
Age: 97.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Moaning, Oxygen saturation decreased, Respiratory tract congestion, Road traffic accident
Clinical narrative: Received Moderna COVID-19 vaccines on 1/20/21 and 2/17/21.  Developed symptoms of COVID-19 on 9/12/21 (nasal congestion, fatigue, loss of appetite, feeling weak, SOB). Tested positive on 9/16/21.  Received monoclonal antibody infusion on 9/18/21 (casirivimab-imdevimab).  Worsened as of 9/21/21 with hypoxemia.  Told his family that he did not want to go to the hospital and preferred transition to hospice care, which was arranged.   Died on 9/22/21.
Age: 97.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Speech disorder, Walking aid user
Clinical narrative: Received Moderna COVID-19 vaccines on 1/20/21 and 2/17/21.  Developed symptoms of COVID-19 on 9/12/21 (nasal congestion, fatigue, loss of appetite, feeling weak, SOB). Tested positive on 9/16/21.  Received monoclonal antibody infusion on 9/18/21 (casirivimab-imdevimab).  Worsened as of 9/21/21 with hypoxemia.  Told his family that he did not want to go to the hospital and preferred transition to hospice care, which was arranged.   Died on 9/22/21.
Age: 97.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Death, Decreased appetite, Dyspnoea
Clinical narrative: Received Moderna COVID-19 vaccines on 1/20/21 and 2/17/21.  Developed symptoms of COVID-19 on 9/12/21 (nasal congestion, fatigue, loss of appetite, feeling weak, SOB). Tested positive on 9/16/21.  Received monoclonal antibody infusion on 9/18/21 (casirivimab-imdevimab).  Worsened as of 9/21/21 with hypoxemia.  Told his family that he did not want to go to the hospital and preferred transition to hospice care, which was arranged.   Died on 9/22/21.
Age: 97.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Hypoxia, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: Received Moderna COVID-19 vaccines on 1/20/21 and 2/17/21.  Developed symptoms of COVID-19 on 9/12/21 (nasal congestion, fatigue, loss of appetite, feeling weak, SOB). Tested positive on 9/16/21.  Received monoclonal antibody infusion on 9/18/21 (casirivimab-imdevimab).  Worsened as of 9/21/21 with hypoxemia.  Told his family that he did not want to go to the hospital and preferred transition to hospice care, which was arranged.   Died on 9/22/21.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Cough, Malaise, Pulmonary embolism
Clinical narrative: Multiple Pulmonary embolism (bilateral) treatment began in ICU, heparin and Eliquis. Treatment on going as of December 2021; Joint Pain (All over, onset 6 hours); Muscle Pain (All over, back and neck mostly, onset 4 hours);   Low Energy & extreme fatigue; Chills ( onset 6 hours); Headache ( onset 8 hours); Injection Site Pain (onset 5 minutes); Extreme brain fog  ( onset seven days); Hypothyroidism (onset 30 days bring treated with Synthroid treatment ongoing as of December 2021); Minor chest pain - (pericarditis/myocarditis, onset 10 days and  symptoms lasted two months . Severe Cough (Onset three weeks). Still coughing and wheezing- missed 90 days of work in past 9 months; Pulmonary fibrosis ( onset 4 weeks); Bronchitis (onset three weeks); Asthma / Wheezing ( Onset - three weeks); Muscle weakness and tiredness ( onset 3 days - ongoing)
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Arthralgia, Asthenia, Asthma, Back pain
Clinical narrative: Multiple Pulmonary embolism (bilateral) treatment began in ICU, heparin and Eliquis. Treatment on going as of December 2021; Joint Pain (All over, onset 6 hours); Muscle Pain (All over, back and neck mostly, onset 4 hours);   Low Energy & extreme fatigue; Chills ( onset 6 hours); Headache ( onset 8 hours); Injection Site Pain (onset 5 minutes); Extreme brain fog  ( onset seven days); Hypothyroidism (onset 30 days bring treated with Synthroid treatment ongoing as of December 2021); Minor chest pain - (pericarditis/myocarditis, onset 10 days and  symptoms lasted two months . Severe Cough (Onset three weeks). Still coughing and wheezing- missed 90 days of work in past 9 months; Pulmonary fibrosis ( onset 4 weeks); Bronchitis (onset three weeks); Asthma / Wheezing ( Onset - three weeks); Muscle weakness and tiredness ( onset 3 days - ongoing)
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bronchitis, Chest X-ray, Chest pain, Chills, Computerised tomogram thorax abnormal
Clinical narrative: Multiple Pulmonary embolism (bilateral) treatment began in ICU, heparin and Eliquis. Treatment on going as of December 2021; Joint Pain (All over, onset 6 hours); Muscle Pain (All over, back and neck mostly, onset 4 hours);   Low Energy & extreme fatigue; Chills ( onset 6 hours); Headache ( onset 8 hours); Injection Site Pain (onset 5 minutes); Extreme brain fog  ( onset seven days); Hypothyroidism (onset 30 days bring treated with Synthroid treatment ongoing as of December 2021); Minor chest pain - (pericarditis/myocarditis, onset 10 days and  symptoms lasted two months . Severe Cough (Onset three weeks). Still coughing and wheezing- missed 90 days of work in past 9 months; Pulmonary fibrosis ( onset 4 weeks); Bronchitis (onset three weeks); Asthma / Wheezing ( Onset - three weeks); Muscle weakness and tiredness ( onset 3 days - ongoing)
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Feeling abnormal, Headache, Hypothyroidism
Clinical narrative: Multiple Pulmonary embolism (bilateral) treatment began in ICU, heparin and Eliquis. Treatment on going as of December 2021; Joint Pain (All over, onset 6 hours); Muscle Pain (All over, back and neck mostly, onset 4 hours);   Low Energy & extreme fatigue; Chills ( onset 6 hours); Headache ( onset 8 hours); Injection Site Pain (onset 5 minutes); Extreme brain fog  ( onset seven days); Hypothyroidism (onset 30 days bring treated with Synthroid treatment ongoing as of December 2021); Minor chest pain - (pericarditis/myocarditis, onset 10 days and  symptoms lasted two months . Severe Cough (Onset three weeks). Still coughing and wheezing- missed 90 days of work in past 9 months; Pulmonary fibrosis ( onset 4 weeks); Bronchitis (onset three weeks); Asthma / Wheezing ( Onset - three weeks); Muscle weakness and tiredness ( onset 3 days - ongoing)
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Injection site pain, Intensive care, Muscular weakness, Myalgia
Clinical narrative: Multiple Pulmonary embolism (bilateral) treatment began in ICU, heparin and Eliquis. Treatment on going as of December 2021; Joint Pain (All over, onset 6 hours); Muscle Pain (All over, back and neck mostly, onset 4 hours);   Low Energy & extreme fatigue; Chills ( onset 6 hours); Headache ( onset 8 hours); Injection Site Pain (onset 5 minutes); Extreme brain fog  ( onset seven days); Hypothyroidism (onset 30 days bring treated with Synthroid treatment ongoing as of December 2021); Minor chest pain - (pericarditis/myocarditis, onset 10 days and  symptoms lasted two months . Severe Cough (Onset three weeks). Still coughing and wheezing- missed 90 days of work in past 9 months; Pulmonary fibrosis ( onset 4 weeks); Bronchitis (onset three weeks); Asthma / Wheezing ( Onset - three weeks); Muscle weakness and tiredness ( onset 3 days - ongoing)
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Neck pain, Pericarditis, Pulmonary embolism, Pulmonary fibrosis
Clinical narrative: Multiple Pulmonary embolism (bilateral) treatment began in ICU, heparin and Eliquis. Treatment on going as of December 2021; Joint Pain (All over, onset 6 hours); Muscle Pain (All over, back and neck mostly, onset 4 hours);   Low Energy & extreme fatigue; Chills ( onset 6 hours); Headache ( onset 8 hours); Injection Site Pain (onset 5 minutes); Extreme brain fog  ( onset seven days); Hypothyroidism (onset 30 days bring treated with Synthroid treatment ongoing as of December 2021); Minor chest pain - (pericarditis/myocarditis, onset 10 days and  symptoms lasted two months . Severe Cough (Onset three weeks). Still coughing and wheezing- missed 90 days of work in past 9 months; Pulmonary fibrosis ( onset 4 weeks); Bronchitis (onset three weeks); Asthma / Wheezing ( Onset - three weeks); Muscle weakness and tiredness ( onset 3 days - ongoing)
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler, Wheezing
Clinical narrative: Multiple Pulmonary embolism (bilateral) treatment began in ICU, heparin and Eliquis. Treatment on going as of December 2021; Joint Pain (All over, onset 6 hours); Muscle Pain (All over, back and neck mostly, onset 4 hours);   Low Energy & extreme fatigue; Chills ( onset 6 hours); Headache ( onset 8 hours); Injection Site Pain (onset 5 minutes); Extreme brain fog  ( onset seven days); Hypothyroidism (onset 30 days bring treated with Synthroid treatment ongoing as of December 2021); Minor chest pain - (pericarditis/myocarditis, onset 10 days and  symptoms lasted two months . Severe Cough (Onset three weeks). Still coughing and wheezing- missed 90 days of work in past 9 months; Pulmonary fibrosis ( onset 4 weeks); Bronchitis (onset three weeks); Asthma / Wheezing ( Onset - three weeks); Muscle weakness and tiredness ( onset 3 days - ongoing)
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Blood test
Clinical narrative: Hair loss/Bald spots and thinning were clearly visible; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 15:00 (Lot number: EW0217) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. No Known allergies. The patient took concomitant medications. No other vaccine in four weeks. Other medications in two weeks included birth control. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0168, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 03Aug2021, when the patient was 26 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (disability) with onset 06Sep2021 12:00, outcome "not recovered", described as "Hair loss/Bald spots and thinning were clearly visible". The event "hair loss/bald spots and thinning were clearly visible" was evaluated at the physician office visit. Therapeutic measures were taken as a result of alopecia. Healthy 26 year old with no previous health conditions or hair loss/shedding incidents. Hair loss began two weeks after the second dose and gradually escalated to severe hair loss. 40% of hair has been lost. Bald spots and thinning were clearly visible. Hair loss has not stopped or slowed down. She had tried biotin, nutrafol, protein and home remedies such as rosemary, aloe vera and oils to stimulate hair growth consistently since the hair loss began with no results. No covid prior vaccination. No covid tested post vaccination.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss/Bald spots and thinning were clearly visible; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 15:00 (Lot number: EW0217) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. No Known allergies. The patient took concomitant medications. No other vaccine in four weeks. Other medications in two weeks included birth control. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0168, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 03Aug2021, when the patient was 26 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (disability) with onset 06Sep2021 12:00, outcome "not recovered", described as "Hair loss/Bald spots and thinning were clearly visible". The event "hair loss/bald spots and thinning were clearly visible" was evaluated at the physician office visit. Therapeutic measures were taken as a result of alopecia. Healthy 26 year old with no previous health conditions or hair loss/shedding incidents. Hair loss began two weeks after the second dose and gradually escalated to severe hair loss. 40% of hair has been lost. Bald spots and thinning were clearly visible. Hair loss has not stopped or slowed down. She had tried biotin, nutrafol, protein and home remedies such as rosemary, aloe vera and oils to stimulate hair growth consistently since the hair loss began with no results. No covid prior vaccination. No covid tested post vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiospasm, Computerised tomogram, Electrocardiogram, Electroencephalogram, Magnetic resonance imaging
Clinical narrative: Heart Palpations; Heart Spasms; dizzy/light headed; fainting; convulsions; This is a spontaneous report received from contactable reporter(Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16Apr2021 06:00 (Lot number: ER8731) at the age of 33 years as dose 1 single for covid-19 immunisation. Relevant medical history included: "Thyroid cancer" (unspecified if ongoing); "full thyroidectomy", start date: 2017, stop date: 2017. Concomitant medication(s) included: LEVOTHYROXINE SODIUM. No other vaccine in four weeks. No Known allergies.No covid prior vaccination. The following information was reported: PALPITATIONS (life threatening) with onset 16Apr2021 08:00, outcome "not recovered", described as "Heart Palpations"; ARTERIOSPASM CORONARY (life threatening) with onset 16Apr2021 08:00, outcome "not recovered", described as "Heart Spasms"; DIZZINESS (life threatening) with onset Apr2021, outcome "not recovered", described as "dizzy/light headed"; SYNCOPE (life threatening) with onset Apr2021, outcome "not recovered", described as "fainting"; SEIZURE (life threatening) with onset Apr2021, outcome "not recovered", described as "convulsions". The events "heart palpations", "heart spasms", "dizzy/light headed", "fainting" and "convulsions" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Oct2021) negative. Clinical course included Within hours after first dose, she experienced Heart Palpations and Heart Spasms. After about 7 days she would feel dizzy, light headed, fainting and convulsions. She tried to report these through military primary care physician on multiple occasions and she felt disregarded by the doctor as she feel they care more about the mission the reporting results. She had a history of thyroid cancer. She had a full thyroidectomy in 2017 so she do not have a thyroid. With that said she think more research needs to be done on patients with a history of thyroid cancer or thyroid disease.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Seizure, Syncope, Ultrasound scan
Clinical narrative: Heart Palpations; Heart Spasms; dizzy/light headed; fainting; convulsions; This is a spontaneous report received from contactable reporter(Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16Apr2021 06:00 (Lot number: ER8731) at the age of 33 years as dose 1 single for covid-19 immunisation. Relevant medical history included: "Thyroid cancer" (unspecified if ongoing); "full thyroidectomy", start date: 2017, stop date: 2017. Concomitant medication(s) included: LEVOTHYROXINE SODIUM. No other vaccine in four weeks. No Known allergies.No covid prior vaccination. The following information was reported: PALPITATIONS (life threatening) with onset 16Apr2021 08:00, outcome "not recovered", described as "Heart Palpations"; ARTERIOSPASM CORONARY (life threatening) with onset 16Apr2021 08:00, outcome "not recovered", described as "Heart Spasms"; DIZZINESS (life threatening) with onset Apr2021, outcome "not recovered", described as "dizzy/light headed"; SYNCOPE (life threatening) with onset Apr2021, outcome "not recovered", described as "fainting"; SEIZURE (life threatening) with onset Apr2021, outcome "not recovered", described as "convulsions". The events "heart palpations", "heart spasms", "dizzy/light headed", "fainting" and "convulsions" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Oct2021) negative. Clinical course included Within hours after first dose, she experienced Heart Palpations and Heart Spasms. After about 7 days she would feel dizzy, light headed, fainting and convulsions. She tried to report these through military primary care physician on multiple occasions and she felt disregarded by the doctor as she feel they care more about the mission the reporting results. She had a history of thyroid cancer. She had a full thyroidectomy in 2017 so she do not have a thyroid. With that said she think more research needs to be done on patients with a history of thyroid cancer or thyroid disease.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arteriospasm coronary, Dizziness, Palpitations, SARS-CoV-2 test, Seizure
Clinical narrative: Heart Palpations; Heart Spasms; dizzy/light headed; fainting; convulsions; This is a spontaneous report received from contactable reporter(Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16Apr2021 06:00 (Lot number: ER8731) at the age of 33 years as dose 1 single for covid-19 immunisation. Relevant medical history included: "Thyroid cancer" (unspecified if ongoing); "full thyroidectomy", start date: 2017, stop date: 2017. Concomitant medication(s) included: LEVOTHYROXINE SODIUM. No other vaccine in four weeks. No Known allergies.No covid prior vaccination. The following information was reported: PALPITATIONS (life threatening) with onset 16Apr2021 08:00, outcome "not recovered", described as "Heart Palpations"; ARTERIOSPASM CORONARY (life threatening) with onset 16Apr2021 08:00, outcome "not recovered", described as "Heart Spasms"; DIZZINESS (life threatening) with onset Apr2021, outcome "not recovered", described as "dizzy/light headed"; SYNCOPE (life threatening) with onset Apr2021, outcome "not recovered", described as "fainting"; SEIZURE (life threatening) with onset Apr2021, outcome "not recovered", described as "convulsions". The events "heart palpations", "heart spasms", "dizzy/light headed", "fainting" and "convulsions" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Oct2021) negative. Clinical course included Within hours after first dose, she experienced Heart Palpations and Heart Spasms. After about 7 days she would feel dizzy, light headed, fainting and convulsions. She tried to report these through military primary care physician on multiple occasions and she felt disregarded by the doctor as she feel they care more about the mission the reporting results. She had a history of thyroid cancer. She had a full thyroidectomy in 2017 so she do not have a thyroid. With that said she think more research needs to be done on patients with a history of thyroid cancer or thyroid disease.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Heart Palpations; Heart Spasms; dizzy/light headed; fainting; convulsions; This is a spontaneous report received from contactable reporter(Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16Apr2021 06:00 (Lot number: ER8731) at the age of 33 years as dose 1 single for covid-19 immunisation. Relevant medical history included: "Thyroid cancer" (unspecified if ongoing); "full thyroidectomy", start date: 2017, stop date: 2017. Concomitant medication(s) included: LEVOTHYROXINE SODIUM. No other vaccine in four weeks. No Known allergies.No covid prior vaccination. The following information was reported: PALPITATIONS (life threatening) with onset 16Apr2021 08:00, outcome "not recovered", described as "Heart Palpations"; ARTERIOSPASM CORONARY (life threatening) with onset 16Apr2021 08:00, outcome "not recovered", described as "Heart Spasms"; DIZZINESS (life threatening) with onset Apr2021, outcome "not recovered", described as "dizzy/light headed"; SYNCOPE (life threatening) with onset Apr2021, outcome "not recovered", described as "fainting"; SEIZURE (life threatening) with onset Apr2021, outcome "not recovered", described as "convulsions". The events "heart palpations", "heart spasms", "dizzy/light headed", "fainting" and "convulsions" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Oct2021) negative. Clinical course included Within hours after first dose, she experienced Heart Palpations and Heart Spasms. After about 7 days she would feel dizzy, light headed, fainting and convulsions. She tried to report these through military primary care physician on multiple occasions and she felt disregarded by the doctor as she feel they care more about the mission the reporting results. She had a history of thyroid cancer. She had a full thyroidectomy in 2017 so she do not have a thyroid. With that said she think more research needs to be done on patients with a history of thyroid cancer or thyroid disease.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Audiogram abnormal, Deafness unilateral, Ear, nose and throat examination, Tinnitus
Clinical narrative: Severe sudden onset tinnitus, starting in one ear and then turning into both ears; Some potential hearing loss in left ear per audiogram; ear fullness/pressure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 15:45 (Lot number: FH8030) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (disability) with onset 11Nov2021 17:30, outcome "not recovered", described as "Severe sudden onset tinnitus, starting in one ear and then turning into both ears"; DEAFNESS (disability) with onset 11Nov2021 17:30, outcome "not recovered", described as "Some potential hearing loss in left ear per audiogram"; EAR DISCOMFORT (disability) with onset 11Nov2021 17:30, outcome "not recovered", described as "ear fullness/pressure". The events "severe sudden onset tinnitus, starting in one ear and then turning into both ears", "some potential hearing loss in left ear per audiogram" and "ear fullness/pressure" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: audiogram: (11Nov2021) some potential hearing losses in left ear. Therapeutic measures were taken as a result of tinnitus, deafness, ear discomfort which included Prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Deafness, Ear discomfort, Tinnitus
Clinical narrative: Severe sudden onset tinnitus, starting in one ear and then turning into both ears; Some potential hearing loss in left ear per audiogram; ear fullness/pressure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 15:45 (Lot number: FH8030) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (disability) with onset 11Nov2021 17:30, outcome "not recovered", described as "Severe sudden onset tinnitus, starting in one ear and then turning into both ears"; DEAFNESS (disability) with onset 11Nov2021 17:30, outcome "not recovered", described as "Some potential hearing loss in left ear per audiogram"; EAR DISCOMFORT (disability) with onset 11Nov2021 17:30, outcome "not recovered", described as "ear fullness/pressure". The events "severe sudden onset tinnitus, starting in one ear and then turning into both ears", "some potential hearing loss in left ear per audiogram" and "ear fullness/pressure" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: audiogram: (11Nov2021) some potential hearing losses in left ear. Therapeutic measures were taken as a result of tinnitus, deafness, ear discomfort which included Prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Gait inability, Injection site pain, Pain in extremity
Clinical narrative: Initially had slight pain at injection site; started having extreme leg pain in both legs below the knees. Both the front of the leg and the calf were experiencing pain; started having extreme leg pain in both legs below the knees. Both the front of the leg and the calf were experiencing pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Sep2021 14:00 (Lot number: fh8028) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Sep2021 09:00, outcome "not recovered", described as "Initially had slight pain at injection site"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 04Sep2021 09:00, outcome "not recovered" and all described as "started having extreme leg pain in both legs below the knees. Both the front of the leg and the calf were experiencing pain". The events "initially had slight pain at injection site", "started having extreme leg pain in both legs below the knees. both the front of the leg and the calf were experiencing pain" and "started having extreme leg pain in both legs below the knees. both the front of the leg and the calf were experiencing pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, pain in extremity, pain in extremity.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Pain in extremity, Vaccination site pain
Clinical narrative: Initially had slight pain at injection site; started having extreme leg pain in both legs below the knees. Both the front of the leg and the calf were experiencing pain; started having extreme leg pain in both legs below the knees. Both the front of the leg and the calf were experiencing pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Sep2021 14:00 (Lot number: fh8028) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Sep2021 09:00, outcome "not recovered", described as "Initially had slight pain at injection site"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 04Sep2021 09:00, outcome "not recovered" and all described as "started having extreme leg pain in both legs below the knees. Both the front of the leg and the calf were experiencing pain". The events "initially had slight pain at injection site", "started having extreme leg pain in both legs below the knees. both the front of the leg and the calf were experiencing pain" and "started having extreme leg pain in both legs below the knees. both the front of the leg and the calf were experiencing pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, pain in extremity, pain in extremity.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Pulmonary embolism, Pyrexia
Clinical narrative: Including, but not limited to mild fever (+2 to 3 degrees), chills, body aches, increasing tightness left side of chest, radiating around rib cage to my back; increasing chest pains left side of chest; fatigue; pounding heart; went to Cedars-Sinai ER; diagnosed with multiple pulmonary emboli; elevated white blood cell count; given anticoagulant shots in abdomen; COVID-19 Tests Negative; admitted to hospital; prescribed Eliquis for 6 mos, then follow-up.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test, Chest discomfort, Chest pain, Chills
Clinical narrative: Including, but not limited to mild fever (+2 to 3 degrees), chills, body aches, increasing tightness left side of chest, radiating around rib cage to my back; increasing chest pains left side of chest; fatigue; pounding heart; went to Cedars-Sinai ER; diagnosed with multiple pulmonary emboli; elevated white blood cell count; given anticoagulant shots in abdomen; COVID-19 Tests Negative; admitted to hospital; prescribed Eliquis for 6 mos, then follow-up.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Fatigue, Magnetic resonance imaging, Pain, Palpitations
Clinical narrative: Including, but not limited to mild fever (+2 to 3 degrees), chills, body aches, increasing tightness left side of chest, radiating around rib cage to my back; increasing chest pains left side of chest; fatigue; pounding heart; went to Cedars-Sinai ER; diagnosed with multiple pulmonary emboli; elevated white blood cell count; given anticoagulant shots in abdomen; COVID-19 Tests Negative; admitted to hospital; prescribed Eliquis for 6 mos, then follow-up.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Pyrexia, SARS-CoV-2 test negative, White blood cell count increased, X-ray
Clinical narrative: Including, but not limited to mild fever (+2 to 3 degrees), chills, body aches, increasing tightness left side of chest, radiating around rib cage to my back; increasing chest pains left side of chest; fatigue; pounding heart; went to Cedars-Sinai ER; diagnosed with multiple pulmonary emboli; elevated white blood cell count; given anticoagulant shots in abdomen; COVID-19 Tests Negative; admitted to hospital; prescribed Eliquis for 6 mos, then follow-up.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Anti-thyroid antibody positive, Full blood count normal, Laboratory test normal, Thyroid function test normal
Clinical narrative: chronic hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Apr2021 19:39 (Lot number: ER8734) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose , LOT# (First dose): EP7534, Anatomical location of administration of the vaccine: Consumer stated, "Left arm, Route of administration of the vaccine: Intramuscular, Time of vaccination: Both shots: Consumer stated, "The time evening, let me see the exact time here, 7:39 in March and April was 7:39 also so 7:39 PM), administration date: 16Mar2021, for Covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The following information was reported: URTICARIA CHRONIC (medically significant) with onset 2021, outcome "unknown", described as "chronic hives". The patient underwent the following laboratory tests and procedures: blood test: normal, notes: Labs before shot were normal. Therapeutic measures were taken as a result of urticaria chronic. Patient received treatment of Anti histamine. Patient taking taking Zyrtec and also have steroids, Prednisone, had four different brands of steroids. taken it four times, four course. She taken four times a day. And also Famotidine."
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: chronic hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Apr2021 19:39 (Lot number: ER8734) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose , LOT# (First dose): EP7534, Anatomical location of administration of the vaccine: Consumer stated, "Left arm, Route of administration of the vaccine: Intramuscular, Time of vaccination: Both shots: Consumer stated, "The time evening, let me see the exact time here, 7:39 in March and April was 7:39 also so 7:39 PM), administration date: 16Mar2021, for Covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The following information was reported: URTICARIA CHRONIC (medically significant) with onset 2021, outcome "unknown", described as "chronic hives". The patient underwent the following laboratory tests and procedures: blood test: normal, notes: Labs before shot were normal. Therapeutic measures were taken as a result of urticaria chronic. Patient received treatment of Anti histamine. Patient taking taking Zyrtec and also have steroids, Prednisone, had four different brands of steroids. taken it four times, four course. She taken four times a day. And also Famotidine."
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Urticaria chronic
Clinical narrative: chronic hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Apr2021 19:39 (Lot number: ER8734) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose , LOT# (First dose): EP7534, Anatomical location of administration of the vaccine: Consumer stated, "Left arm, Route of administration of the vaccine: Intramuscular, Time of vaccination: Both shots: Consumer stated, "The time evening, let me see the exact time here, 7:39 in March and April was 7:39 also so 7:39 PM), administration date: 16Mar2021, for Covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The following information was reported: URTICARIA CHRONIC (medically significant) with onset 2021, outcome "unknown", described as "chronic hives". The patient underwent the following laboratory tests and procedures: blood test: normal, notes: Labs before shot were normal. Therapeutic measures were taken as a result of urticaria chronic. Patient received treatment of Anti histamine. Patient taking taking Zyrtec and also have steroids, Prednisone, had four different brands of steroids. taken it four times, four course. She taken four times a day. And also Famotidine."
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Malaise, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: positive covid test in fully vaccinated and symptomatic pt
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: positive covid test in fully vaccinated and symptomatic pt
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Learned subsequently that I was given a third dose, intended for immunocompromised individuals,  [.5 milliliters - full dose] in error.  I should have been given a booster dose of .25 milliliters.    The side effects I experienced were extreme chills, extreme leg cramps, headache, fatigue, and pain, tenderness, swelling, black and blue at the booster site.  Upon receiving the first two doses the only side effect I had was tenderness / pain at the immunization site.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Extra dose administered, Fatigue, Headache, Incorrect dose administered
Clinical narrative: Learned subsequently that I was given a third dose, intended for immunocompromised individuals,  [.5 milliliters - full dose] in error.  I should have been given a booster dose of .25 milliliters.    The side effects I experienced were extreme chills, extreme leg cramps, headache, fatigue, and pain, tenderness, swelling, black and blue at the booster site.  Upon receiving the first two doses the only side effect I had was tenderness / pain at the immunization site.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling, Muscle spasms
Clinical narrative: Learned subsequently that I was given a third dose, intended for immunocompromised individuals,  [.5 milliliters - full dose] in error.  I should have been given a booster dose of .25 milliliters.    The side effects I experienced were extreme chills, extreme leg cramps, headache, fatigue, and pain, tenderness, swelling, black and blue at the booster site.  Upon receiving the first two doses the only side effect I had was tenderness / pain at the immunization site.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Motor dysfunction, Muscular weakness
Clinical narrative: LOST ALL FEELING FROM THE UNDER ARM DOWN TO FINGERS; LOST THE ABILITY TO BUTTON USING THE LEFT ARM; ARM HAS GOTTEN WORSE; LEFT ARM (INJECTION SITE) WAS NUMB; ENTIRE ARM WAS TINGLING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the patient experienced left arm (injection site) was numb. On 12-APR-2021, the patient experienced entire arm was tingling. On an unspecified date, the patient experienced lost all feeling from the under arm down to fingers, lost the ability to button using the left arm, and arm has gotten worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm has gotten worse, lost all feeling from the under arm down to fingers, and lost the ability to button using the left arm, and the outcome of left arm (injection site) was numb and entire arm was tingling was not reported. This report was non-serious.