chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoxia, Idiopathic interstitial pneumonia, Interstitial lung disease, Lichenoid keratosis, Positron emission tomogram normal
Clinical narrative: patient was doing well as outpatient with no significant issues post-allogeneic hematopoietic cell transplant.  Received 1st Moderna COVID19 vaccine on 2/3/2021.  Developed a rash, biopsy showed lichenoid dermatitis, but no other symptoms after that first shot.  Received 2nd Moderna COVID19 vaccine on 3/12/21 and rash persisted (may or may not have worsened, hard to know from patient report) and the patient presented to medical attention on 3/23/21 acutely short of breath and hypoxic, after being able to exercise (walk 2 miles every other day, etc) prior.  Found to have biopsy proven lymphocytic interstitial pneumonitis with diffuse alveolar damage/ARDS requiring supplemental oxygen.  Started on systemic steroids without response.  Also with concurrent mild transaminitis.  From prior recent labs, LFTs were normal prior to presentation with hypoxia.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test negative
Clinical narrative: patient was doing well as outpatient with no significant issues post-allogeneic hematopoietic cell transplant.  Received 1st Moderna COVID19 vaccine on 2/3/2021.  Developed a rash, biopsy showed lichenoid dermatitis, but no other symptoms after that first shot.  Received 2nd Moderna COVID19 vaccine on 3/12/21 and rash persisted (may or may not have worsened, hard to know from patient report) and the patient presented to medical attention on 3/23/21 acutely short of breath and hypoxic, after being able to exercise (walk 2 miles every other day, etc) prior.  Found to have biopsy proven lymphocytic interstitial pneumonitis with diffuse alveolar damage/ARDS requiring supplemental oxygen.  Started on systemic steroids without response.  Also with concurrent mild transaminitis.  From prior recent labs, LFTs were normal prior to presentation with hypoxia.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fever around 100F for 10 consecutive days, fatigue for 10 consecutive days, intermittent headache and intermittent nausea (no vomiting) for 10 consecutive days.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Peripheral embolism
Clinical narrative: My my grandma got them a derma vaccine on January 22 she died on February 11 she was admitted to the hospital with a blood clot in her leg they tried to do surgery but when they put her under the anesthesia she never woke back up. She was 93 years old and had many other health conditions but when I called the doctors office to ask them if they reported my grandma they just kept giving me the runaround I tried to call hospital as well and I got the same thing they told me to go back to the doctor. I think someone should know and I think it?s way too difficult for family members to try to report adverse side effects it took me all day to find someone that could help me get to this website. I think there may be a lot more adverse side effects but people don?t know how to report them.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pallor, Poor peripheral circulation
Clinical narrative: Patient reported complaints of feeling pale and nauseated following vaccination around 10 mins post vaccination.   BP 120/73, Unable to obtain HR and O2 Sat with oximeter due to circulation problems  Patient given 8 oz OJ, crackers, and nut bar resolving current complaints stated above. No other complications and left site with resolution
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Throat tightness
Clinical narrative: Throat closed up - allergic reaction. Heat spread all over body.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Circulatory collapse, Dehydration, Dizziness, Dry mouth, Nausea
Clinical narrative: Circulation problems; Dehydration; Light-headed and dizziness; Nauseous; Dry mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CIRCULATORY COLLAPSE (Circulation problems) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psychiatric disorder NOS since an unknown date. Concomitant products included LITHIUM and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CIRCULATORY COLLAPSE (Circulation problems) (seriousness criterion medically significant), DEHYDRATION (Dehydration), DIZZINESS (Light-headed and dizziness), NAUSEA (Nauseous) and DRY MOUTH (Dry mouth). At the time of the report, CIRCULATORY COLLAPSE (Circulation problems), DEHYDRATION (Dehydration), DIZZINESS (Light-headed and dizziness), NAUSEA (Nauseous) and DRY MOUTH (Dry mouth) had not resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment:  Very limited information regarding these events have been provided at this time. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Nausea, headache, chills and fever. Tiredness and muscle aches for 4 days
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nausea, headache, chills and fever. Tiredness and muscle aches for 4 days
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: 12 hours after my second shot I started feeling exhauasted, then I got a headache and the chills. I had the chills for a while then got a fever. It hovered around 101 fever for a full 24 hours. I had body aches and generally just felt like I had the flu for a day. Then my fever broke and my body was less sore right around 24 hours later. I'm just extra tired now.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 12 hours after my second shot I started feeling exhauasted, then I got a headache and the chills. I had the chills for a while then got a fever. It hovered around 101 fever for a full 24 hours. I had body aches and generally just felt like I had the flu for a day. Then my fever broke and my body was less sore right around 24 hours later. I'm just extra tired now.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Pharyngeal swelling, Swollen tongue
Clinical narrative: Patient claimed she had swelling throat, tongue and cotton mouth,  MD assessed her and instructed her to stay at the pharmacy for 30 more minutes. Nurses measure Oxygen level and Blood pressure. She was getting better after 30 mins and Dr advised her to go home and report to ER if problem breathing occur.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Loss of consciousness
Clinical narrative: Patient was shopping in the store after receiving the vaccine and passed out. Patient's spouse lowered him to the ground. Upon arrival to the scene, patient was talking "saying i'm fine). I helped patient to sit up and eventually helped him to sit in a chair. Patient said he could taste the vaccine while receiving the shot and he told the immunizing technician about it. Patient left after 20 minutes without any treatment.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Fall, Headache, Malaise
Clinical narrative: My uncle unexpectedly passed away during the early morning hours of April 13.  He had reported to my aunt that he was having shortness of breath, headaches, and in general not feeling well.  She found him sitting up with a clear liquid pouring out of his nose and then he fell over dead.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: My uncle unexpectedly passed away during the early morning hours of April 13.  He had reported to my aunt that he was having shortness of breath, headaches, and in general not feeling well.  She found him sitting up with a clear liquid pouring out of his nose and then he fell over dead.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Myalgia
Clinical narrative: Sore left shoulder (muscle) on left arm  Light headache, dizziness
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site bruising, Pain, Rash, Rash pruritic
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA effects: bruising of injection site about size of golf ball, 6.5 hours after itchy rash on neck persisting for over 24 hours then on and off, whole body soreness and fatigue.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test, Cardiac failure, Cardiac failure congestive, Cardiac murmur, Chest X-ray abnormal
Clinical narrative: Patient presented to with 4 day history of progressively worsening pitting edema and swelling in bilateral lower extremities. She reports mild shortness of breath. She also reports flank pain and dysuria. Cardiac murmur and rales noted on exam. Patient found to have a heart failure exacerbation and UTI. Patient is being treated with levofloxacin and furosemide and is admitted to the hospital.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Dysuria, Effusion, Flank pain
Clinical narrative: Patient presented to with 4 day history of progressively worsening pitting edema and swelling in bilateral lower extremities. She reports mild shortness of breath. She also reports flank pain and dysuria. Cardiac murmur and rales noted on exam. Patient found to have a heart failure exacerbation and UTI. Patient is being treated with levofloxacin and furosemide and is admitted to the hospital.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin decreased, N-terminal prohormone brain natriuretic peptide increased, Nitrite urine present, Oedema peripheral, Peripheral swelling
Clinical narrative: Patient presented to with 4 day history of progressively worsening pitting edema and swelling in bilateral lower extremities. She reports mild shortness of breath. She also reports flank pain and dysuria. Cardiac murmur and rales noted on exam. Patient found to have a heart failure exacerbation and UTI. Patient is being treated with levofloxacin and furosemide and is admitted to the hospital.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rales, Urinary sediment present, Urinary tract infection, Urine analysis abnormal, White blood cells urine positive
Clinical narrative: Patient presented to with 4 day history of progressively worsening pitting edema and swelling in bilateral lower extremities. She reports mild shortness of breath. She also reports flank pain and dysuria. Cardiac murmur and rales noted on exam. Patient found to have a heart failure exacerbation and UTI. Patient is being treated with levofloxacin and furosemide and is admitted to the hospital.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling hot, Pain
Clinical narrative: I had the vaccine on Wednesday.   On Thursday, the next day, I had aches and no energy.  I spent the day in bed.  I felt fine Friday and Saturday,.  On Sunday, I woke up with hot and chills and aches.  I spent that day in bed.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Disturbance in attention, Seizure, Sleep disorder, Tinnitus
Clinical narrative: Patient experienced tinnitus four hours after injection.  The tinnitus occurred 24 hours per day and 7 days per week.  The volume fluctuated and was enough to interfere with level of focus and sleep.  Small seizure was experienced by the patient approximately 7 hours after second Moderna dose.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: It started about 7:30, tired, small headache, joint aches. About 10:30 or 11pm, it got real bad real fast. Chills, high fever (102, which is the highest temp I've ever had). Joints ached severely bad and headache was terrible. some short stabbing pains in lower abdomen for a few times. No nausea or vomiting . Chills were over about 5am. Fever, headache, and joint aches persisted most of the rest of the day, though not as high or as painful. By Friday, all reactions were over except tiredness.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: It started about 7:30, tired, small headache, joint aches. About 10:30 or 11pm, it got real bad real fast. Chills, high fever (102, which is the highest temp I've ever had). Joints ached severely bad and headache was terrible. some short stabbing pains in lower abdomen for a few times. No nausea or vomiting . Chills were over about 5am. Fever, headache, and joint aches persisted most of the rest of the day, though not as high or as painful. By Friday, all reactions were over except tiredness.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: 4/11/2021: Fever range 99-102.4+, body aches, chills, headache  4/12/2021: fever range 99-100, body aches, headache
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: By the end of day after the shot was administered into my  left arm I began to itch near and on the  injection area.  3 days later the area were shot was given began to turn red and 5 days later I notice swelling in that area and the itching continues.  On the 6th day the  itching subsided however the swelling remains.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Decreased appetite, Lymphadenopathy, Pyrexia
Clinical narrative: Bell's Palsy; Enlargement of lymph node; No appetite; High fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol (Tressor for cholesterol), Stress (Takes "stress pills") and Drug allergy (azithromycin (Zithromax)).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced LYMPHADENOPATHY (Enlargement of lymph node), DECREASED APPETITE (No appetite) and PYREXIA (High fever). On 10-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). On 05-Mar-2021, LYMPHADENOPATHY (Enlargement of lymph node), DECREASED APPETITE (No appetite) and PYREXIA (High fever) had resolved. At the time of the report, FACIAL PARALYSIS (Bell's Palsy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 10-Apr-2021, she experienced right-sided facial paralysis and was unable to keep her eyes closed. Her doctor subsequently diagnosed Bell's Palsy.  The patient inquired if there were patients who have experienced the same thing.  Action taken with mRNA in respect to the events was not applicable. Concomitant medications included stress pills and tressor for cholesterol. Treatment included prednisone, unspecified antiviral medication and eye drops for the right eye.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fatigue, headache, body aches, fever and chills
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Fatigue, Head discomfort
Clinical narrative: Days have passed and I?m still very tired and weak. Head feeling pressure. No fever but temperature is rising.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Pyrexia
Clinical narrative: Very low symptoms i.e., Low grade fewer ~97F, Fatigue and Body discomfort  during the day after the the inoculation.  Jus rest, No treatment. Everything was normal two days after the inoculation.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Vein disorder
Clinical narrative: Vein throbbing in leg and foot, started continuous for the first two days, initially started in upper leg by knee then mostly moved to foot. And now happens randomly throughout the day 10 times an hour approximately mostly in arm, but also in butt and shoulder and legs. I also feel heart jolts 2-3 times an hour.  Heart rate normal 55-90 when measured this last week. Based on a chat with a friend who is a cardiologist he recommended to stop exercise and caffeine,  and that has been the case for a week now. But currently still experiencing symptoms.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Finger numbness
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Eye pain, Fatigue, Headache
Clinical narrative: Loose BM, pounding headache, body aches, nausea, fatigue, sore arm,  chills , eyes hurt-sinus.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Sinus pain
Clinical narrative: Loose BM, pounding headache, body aches, nausea, fatigue, sore arm,  chills , eyes hurt-sinus.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypersomnia, Judgement impaired
Clinical narrative: Dizziness, cloudy judgement, feeling like about to pass out. Slept all day first day after the shot. Second day had a bit headache and still some cloudy judgement but was much better.  Third day fully recovered
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Nausea Headache Chills Fever
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bedridden, Gait disturbance, Myocardial infarction, Pain
Clinical narrative: heart attack; couldnt walk; couldnt get out of bed; body ache and pains; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 033A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neurological disorder NOS, Diabetes, peripheral artery disease, Disabled spouse (100% disable) and COPD. Concomitant products included GABAPENTIN for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 21-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criterion death), GAIT DISTURBANCE (couldnt walk), BEDRIDDEN (couldnt get out of bed) and PAIN (body ache and pains). The patient died on 21-Mar-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, GAIT DISTURBANCE (couldnt walk), BEDRIDDEN (couldnt get out of bed) and PAIN (body ache and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had a medical condition of "agent orange". The patient was a veteran. Treatment included for the events was acetaminophen (Tylenol).  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-075051 (Linked Report).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-075051:Case for second dose; Reported Cause(s) of Death: Heart attack
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Myocardial infarction, Pain
Clinical narrative: heart attack; couldnt walk; couldnt get out of bed; body ache and pains; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 033A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neurological disorder NOS, Diabetes, peripheral artery disease, Disabled spouse (100% disable) and COPD. Concomitant products included GABAPENTIN for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 21-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criterion death), GAIT DISTURBANCE (couldnt walk), BEDRIDDEN (couldnt get out of bed) and PAIN (body ache and pains). The patient died on 21-Mar-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, GAIT DISTURBANCE (couldnt walk), BEDRIDDEN (couldnt get out of bed) and PAIN (body ache and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had a medical condition of "agent orange". The patient was a veteran. Treatment included for the events was acetaminophen (Tylenol).  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-075051 (Linked Report).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-075051:Case for second dose; Reported Cause(s) of Death: Heart attack
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bedridden, Gait disturbance, Myocardial infarction, Pain
Clinical narrative: Couldn't walk/ couldn't get out of bed; Body aches and pains; Heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neurological disorder NOS, Diabetes, Peripheral vascular disease, COPD and Disability (100% disability).    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion death), GAIT DISTURBANCE (Couldn't walk/ couldn't get out of bed) and PAIN (Body aches and pains). The patient died on 21-Mar-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, GAIT DISTURBANCE (Couldn't walk/ couldn't get out of bed) and PAIN (Body aches and pains) outcome was unknown.            This case concerns death of a 72-year-old male patient 1 day post mRNA-1273 vaccination from myocardial infarction.  Although the patient had a medical history indicative of risk for the event to include diabetes and peripheral vascular disease, based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-075035 (E2B Linked Report).; Sender's Comments: This case concerns death of a 72-year-old male patient 1 day post mRNA-1273 vaccination from myocardial infarction.  Although the patient had a medical history indicative of risk for the event to include diabetes and peripheral vascular disease, based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-075035:Case for first dose; Reported Cause(s) of Death: Heart Attack
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Myocardial infarction, Pain
Clinical narrative: Couldn't walk/ couldn't get out of bed; Body aches and pains; Heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neurological disorder NOS, Diabetes, Peripheral vascular disease, COPD and Disability (100% disability).    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion death), GAIT DISTURBANCE (Couldn't walk/ couldn't get out of bed) and PAIN (Body aches and pains). The patient died on 21-Mar-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, GAIT DISTURBANCE (Couldn't walk/ couldn't get out of bed) and PAIN (Body aches and pains) outcome was unknown.            This case concerns death of a 72-year-old male patient 1 day post mRNA-1273 vaccination from myocardial infarction.  Although the patient had a medical history indicative of risk for the event to include diabetes and peripheral vascular disease, based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-075035 (E2B Linked Report).; Sender's Comments: This case concerns death of a 72-year-old male patient 1 day post mRNA-1273 vaccination from myocardial infarction.  Although the patient had a medical history indicative of risk for the event to include diabetes and peripheral vascular disease, based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-075035:Case for first dose; Reported Cause(s) of Death: Heart Attack
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye haemorrhage, Pain in extremity
Clinical narrative: bleeding in left eye; had little pain in arm; had some chills; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (bleeding in left eye) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (had little pain in arm) and CHILLS (had some chills). On 12-Apr-2021, the patient experienced EYE HAEMORRHAGE (bleeding in left eye) (seriousness criterion medically significant). At the time of the report, EYE HAEMORRHAGE (bleeding in left eye), PAIN IN EXTREMITY (had little pain in arm) and CHILLS (had some chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.  Reportedly, the patient does not know if the event of bleeding in left eye was from vaccine or not.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Transplant
Clinical narrative: needed kidney and/or bladder transplant; within 30 hs after second shot, she died; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (within 30 hs after second shot, she died) and TRANSPLANT (needed kidney and/or bladder transplant) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEATH (within 30 hs after second shot, she died) (seriousness criterion death) and TRANSPLANT (needed kidney and/or bladder transplant) (seriousness criteria death, hospitalization and medically significant). The cause of death was not reported. It is unknown if an autopsy was performed.            The reporter does not remember if this was from Pfizer or Moderna. Concomitant product us e was not provided. Treatment information was unknown.  This case concerns death of a 30 year old female 30 minutes after the administration of the mRNA-1273 vaccine.  Patient is reported to have no underlying issue. Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Th; Sender's Comments: This case concerns death of a 30 year old female 30 minutes after the administration of the mRNA-1273 vaccine.  Patient is reported to have no underlying issue. Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Bloody diarrhoea; diarrhea; nausea; vomiting; fever; minor sore left arm; This spontaneous case was reported by a non-health professional and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea) (seriousness criterion medically significant), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting). In March 2021, the patient experienced PAIN IN EXTREMITY (minor sore left arm) and PYREXIA (fever). On 04-Mar-2021, PAIN IN EXTREMITY (minor sore left arm) had resolved. On 15-Mar-2021, PYREXIA (fever) had resolved. On 16-Mar-2021, DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-075222 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. -MODERNATX, INC.-MOD-2021-075222:crosslinked to Dose2
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Bloody diarrhoea; diarrhea; nausea; vomiting; fever; minor sore left arm; This spontaneous case was reported by a non-health professional and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea) (seriousness criterion medically significant), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting). In March 2021, the patient experienced PAIN IN EXTREMITY (minor sore left arm) and PYREXIA (fever). On 04-Mar-2021, PAIN IN EXTREMITY (minor sore left arm) had resolved. On 15-Mar-2021, PYREXIA (fever) had resolved. On 16-Mar-2021, DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-075222 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. -MODERNATX, INC.-MOD-2021-075222:crosslinked to Dose2
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Chills, Delirium, Fall, Feeling abnormal
Clinical narrative: She was having difficulty moving her arms and legs; She did have a bump on the side of her head; fallen off her bed another time; she kept saying "I think I'm gonna die"; She felt delirious; did have pain with the second injection; She did have a bump on the side of her head; she experienced fever; strange behavior; chills; This spontaneous case was reported by a patient and describes the occurrence of DELIRIUM (She felt delirious) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced ABNORMAL BEHAVIOUR (strange behavior), CHILLS (chills) and PYREXIA (she experienced fever). On an unknown date, the patient experienced DELIRIUM (She felt delirious) (seriousness criterion medically significant), HYPOKINESIA (She was having difficulty moving her arms and legs), the first episode of HEAD INJURY (She did have a bump on the side of her head), FALL (fallen off her bed another time), FEELING ABNORMAL (she kept saying "I think I'm gonna die"), VACCINATION SITE PAIN (did have pain with the second injection) and the second episode of HEAD INJURY (She did have a bump on the side of her head). At the time of the report, DELIRIUM (She felt delirious), ABNORMAL BEHAVIOUR (strange behavior), HYPOKINESIA (She was having difficulty moving her arms and legs), FALL (fallen off her bed another time), FEELING ABNORMAL (she kept saying "I think I'm gonna die"), CHILLS (chills), VACCINATION SITE PAIN (did have pain with the second injection), PYREXIA (she experienced fever) and the last episode of HEAD INJURY (She did have a bump on the side of her head) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Hypokinesia, Pyrexia, Vaccination site pain
Clinical narrative: She was having difficulty moving her arms and legs; She did have a bump on the side of her head; fallen off her bed another time; she kept saying "I think I'm gonna die"; She felt delirious; did have pain with the second injection; She did have a bump on the side of her head; she experienced fever; strange behavior; chills; This spontaneous case was reported by a patient and describes the occurrence of DELIRIUM (She felt delirious) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced ABNORMAL BEHAVIOUR (strange behavior), CHILLS (chills) and PYREXIA (she experienced fever). On an unknown date, the patient experienced DELIRIUM (She felt delirious) (seriousness criterion medically significant), HYPOKINESIA (She was having difficulty moving her arms and legs), the first episode of HEAD INJURY (She did have a bump on the side of her head), FALL (fallen off her bed another time), FEELING ABNORMAL (she kept saying "I think I'm gonna die"), VACCINATION SITE PAIN (did have pain with the second injection) and the second episode of HEAD INJURY (She did have a bump on the side of her head). At the time of the report, DELIRIUM (She felt delirious), ABNORMAL BEHAVIOUR (strange behavior), HYPOKINESIA (She was having difficulty moving her arms and legs), FALL (fallen off her bed another time), FEELING ABNORMAL (she kept saying "I think I'm gonna die"), CHILLS (chills), VACCINATION SITE PAIN (did have pain with the second injection), PYREXIA (she experienced fever) and the last episode of HEAD INJURY (She did have a bump on the side of her head) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Gait disturbance, Headache, Respiratory rate decreased, Visual impairment
Clinical narrative: stroke; couldn't walk; Breathing was shower; eye sight was been worse; bad headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 245A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product AMLODIPINE for an unknown indication.    The patient's past medical history included No adverse event (No medical history reported. ).   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started AMLODIPINE (unknown route) at an unspecified dose. On 25-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), GAIT DISTURBANCE (couldn't walk), RESPIRATORY RATE DECREASED (Breathing was shower), VISUAL IMPAIRMENT (eye sight was been worse) and HEADACHE (bad headaches). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), GAIT DISTURBANCE (couldn't walk), RESPIRATORY RATE DECREASED (Breathing was shower), VISUAL IMPAIRMENT (eye sight was been worse) and HEADACHE (bad headaches) had not resolved. Not Provided          Treatment for the event included clonidine, aspirin (81mg) to try to thin the blood, losartan, atorvastatin and cyclobenzaprine.  Action taken with mRNA-1273 in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling cold, Loss of consciousness
Clinical narrative: Went into a seizure; Completely unconscious; Extreme arm pain; Arm swelling; Woke up freezing; Did not feel well; Body aches; Felt tiredness; Felt like fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Went into a seizure) and LOSS OF CONSCIOUSNESS (Completely unconscious) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced SEIZURE (Went into a seizure) (seriousness criteria hospitalization and medically significant), LOSS OF CONSCIOUSNESS (Completely unconscious) (seriousness criteria hospitalization and medically significant), PAIN IN EXTREMITY (Extreme arm pain), PERIPHERAL SWELLING (Arm swelling), FEELING COLD (Woke up freezing), MALAISE (Did not feel well), PAIN (Body aches), FATIGUE (Felt tiredness), PYREXIA (Felt like fever) and CHILLS (Chills). At the time of the report, SEIZURE (Went into a seizure), LOSS OF CONSCIOUSNESS (Completely unconscious), PAIN IN EXTREMITY (Extreme arm pain), PERIPHERAL SWELLING (Arm swelling), FEELING COLD (Woke up freezing), MALAISE (Did not feel well), PAIN (Body aches), FATIGUE (Felt tiredness), PYREXIA (Felt like fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: 99.5 (High) 99.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included paracetamol.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Went into a seizure; Completely unconscious; Extreme arm pain; Arm swelling; Woke up freezing; Did not feel well; Body aches; Felt tiredness; Felt like fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Went into a seizure) and LOSS OF CONSCIOUSNESS (Completely unconscious) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced SEIZURE (Went into a seizure) (seriousness criteria hospitalization and medically significant), LOSS OF CONSCIOUSNESS (Completely unconscious) (seriousness criteria hospitalization and medically significant), PAIN IN EXTREMITY (Extreme arm pain), PERIPHERAL SWELLING (Arm swelling), FEELING COLD (Woke up freezing), MALAISE (Did not feel well), PAIN (Body aches), FATIGUE (Felt tiredness), PYREXIA (Felt like fever) and CHILLS (Chills). At the time of the report, SEIZURE (Went into a seizure), LOSS OF CONSCIOUSNESS (Completely unconscious), PAIN IN EXTREMITY (Extreme arm pain), PERIPHERAL SWELLING (Arm swelling), FEELING COLD (Woke up freezing), MALAISE (Did not feel well), PAIN (Body aches), FATIGUE (Felt tiredness), PYREXIA (Felt like fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: 99.5 (High) 99.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included paracetamol.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.