chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Peripheral swelling, Renal failure, Renal pain
Clinical narrative: 3b kidney failure; hands were swollen; numb (hands); not eating because she gets kidney pains; lost 10 pounds; essential tremor got much worse; cannot work a 5 day week; This spontaneous case was reported by a health care professional and describes the occurrence of RENAL FAILURE (3b kidney failure) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038k20a and 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis. Concomitant products included HYDROXYZINE, TOLTERODINE, URO MP, MELOXICAM and CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRIN) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL FAILURE (3b kidney failure) (seriousness criterion medically significant), PERIPHERAL SWELLING (hands were swollen), HYPOAESTHESIA (numb (hands)), RENAL PAIN (not eating because she gets kidney pains), WEIGHT DECREASED (lost 10 pounds), TREMOR (essential tremor got much worse) and IMPAIRED WORK ABILITY (cannot work a 5 day week). At the time of the report, RENAL FAILURE (3b kidney failure), PERIPHERAL SWELLING (hands were swollen), HYPOAESTHESIA (numb (hands)), RENAL PAIN (not eating because she gets kidney pains), WEIGHT DECREASED (lost 10 pounds), TREMOR (essential tremor got much worse) and IMPAIRED WORK ABILITY (cannot work a 5 day week) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included hydrochlorothiazide and propranolol.  Reporter states has current medical condition autoimmune issues, Interstitial cystitis, essential tremor, spastic pelvic floor, arthritis.   Reporter did not allow further contact; 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.  The patient's current medical condition of autoimmune issues, interstitial cystitis, essential tremor, spastic pelvic floor, arthritis and product usage of NSAIDS remains confounders.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Weight decreased
Clinical narrative: 3b kidney failure; hands were swollen; numb (hands); not eating because she gets kidney pains; lost 10 pounds; essential tremor got much worse; cannot work a 5 day week; This spontaneous case was reported by a health care professional and describes the occurrence of RENAL FAILURE (3b kidney failure) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038k20a and 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis. Concomitant products included HYDROXYZINE, TOLTERODINE, URO MP, MELOXICAM and CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRIN) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL FAILURE (3b kidney failure) (seriousness criterion medically significant), PERIPHERAL SWELLING (hands were swollen), HYPOAESTHESIA (numb (hands)), RENAL PAIN (not eating because she gets kidney pains), WEIGHT DECREASED (lost 10 pounds), TREMOR (essential tremor got much worse) and IMPAIRED WORK ABILITY (cannot work a 5 day week). At the time of the report, RENAL FAILURE (3b kidney failure), PERIPHERAL SWELLING (hands were swollen), HYPOAESTHESIA (numb (hands)), RENAL PAIN (not eating because she gets kidney pains), WEIGHT DECREASED (lost 10 pounds), TREMOR (essential tremor got much worse) and IMPAIRED WORK ABILITY (cannot work a 5 day week) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included hydrochlorothiazide and propranolol.  Reporter states has current medical condition autoimmune issues, Interstitial cystitis, essential tremor, spastic pelvic floor, arthritis.   Reporter did not allow further contact; 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.  The patient's current medical condition of autoimmune issues, interstitial cystitis, essential tremor, spastic pelvic floor, arthritis and product usage of NSAIDS remains confounders.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: Severe acid reflux
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: Following morning severe upper arm pain and inability to move it. End up second day migraine, body aches, fever and diarrhea.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Neck pain, Pain
Clinical narrative: Some injection site discomfort in first 12 hours.   24 hours later increasing headache that became severe and lasted for two days. ( I am not prone to headaches,  just mild sinus discomfort or slight hangover from alcohol)    This headache was much worse.  Arm pain increased as time progressed and spread farther in arm and even neck and lasted for 5 days.   I felt tired for about 5 days.  I had some mild headaches more than normal after the five days and until present.  Added note.  I don?t get sick often.  I worked as a flight attendant for 28 years and exposed to lots of whatever.  I don?t get sick with more than a little cough or something but never miss work.  I felt pretty bad for 5 days after this vaccine.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Moderna COVID- 19 Vaccine EUA 04/09/2021 2300hrs: chills, fatigue, muscle & body aches, headache, dizziness (did not alleviate at all- current time 04/10/2021 0300hrs... all symptoms started within minutes of each other)
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Moderna COVID- 19 Vaccine EUA 04/09/2021 2300hrs: chills, fatigue, muscle & body aches, headache, dizziness (did not alleviate at all- current time 04/10/2021 0300hrs... all symptoms started within minutes of each other)
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Limb injury, Mobility decreased, Myalgia
Clinical narrative: Blood clot; Fatigue extreme; muscle soreness; loss of appetite; Unable to get out of bed for four days so then they took her to the ER; Lack of circulation on legs due to blood clot produced a wound to develop in her leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) and FATIGUE (Fatigue extreme) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-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 THROMBOSIS (Blood clot) (seriousness criteria hospitalization and medically significant), FATIGUE (Fatigue extreme) (seriousness criterion hospitalization), MYALGIA (muscle soreness), DECREASED APPETITE (loss of appetite), MOBILITY DECREASED (Unable to get out of bed for four days so then they took her to the ER) and LIMB INJURY (Lack of circulation on legs due to blood clot produced a wound to develop in her leg). The patient was hospitalized on 22-Mar-2021 due to FATIGUE and THROMBOSIS. At the time of the report, THROMBOSIS (Blood clot), FATIGUE (Fatigue extreme), MYALGIA (muscle soreness), DECREASED APPETITE (loss of appetite), MOBILITY DECREASED (Unable to get out of bed for four days so then they took her to the ER) and LIMB INJURY (Lack of circulation on legs due to blood clot produced a wound to develop in her leg) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; Fatigue extreme; muscle soreness; loss of appetite; Unable to get out of bed for four days so then they took her to the ER; Lack of circulation on legs due to blood clot produced a wound to develop in her leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) and FATIGUE (Fatigue extreme) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-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 THROMBOSIS (Blood clot) (seriousness criteria hospitalization and medically significant), FATIGUE (Fatigue extreme) (seriousness criterion hospitalization), MYALGIA (muscle soreness), DECREASED APPETITE (loss of appetite), MOBILITY DECREASED (Unable to get out of bed for four days so then they took her to the ER) and LIMB INJURY (Lack of circulation on legs due to blood clot produced a wound to develop in her leg). The patient was hospitalized on 22-Mar-2021 due to FATIGUE and THROMBOSIS. At the time of the report, THROMBOSIS (Blood clot), FATIGUE (Fatigue extreme), MYALGIA (muscle soreness), DECREASED APPETITE (loss of appetite), MOBILITY DECREASED (Unable to get out of bed for four days so then they took her to the ER) and LIMB INJURY (Lack of circulation on legs due to blood clot produced a wound to develop in her leg) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: She fell after; This spontaneous case was reported by a consumer and describes the occurrence of FALL (She fell after) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced FALL (She fell after) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on unspecified dates due to FALL. At the time of the report, FALL (She fell after) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Signs of early anaphylaxis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician assistant and describes the occurrence of ANAPHYLACTIC REACTION (Signs of early anaphylaxis) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Signs of early anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Signs of early anaphylaxis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported treatment information was not provided by reporter  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Hypersensitivity, Vaccination site swelling
Clinical narrative: Allergic reaction; Eyeballs were itching; Lump about the size of an egg at injection site; Whole body was red; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction) (seriousness criterion medically significant) and EYE PRURITUS (Eyeballs were itching). 29-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Lump about the size of an egg at injection site) and ERYTHEMA (Whole body was red). On 31-Mar-2021, EYE PRURITUS (Eyeballs were itching) had resolved. On 01-Apr-2021, HYPERSENSITIVITY (Allergic reaction) had resolved. At the time of the report, VACCINATION SITE SWELLING (Lump about the size of an egg at injection site) had resolved and ERYTHEMA (Whole body was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included patient was seen in emergency room and was given diphenhydramine and a steroid. She was released the same day.  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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pneumonia
Clinical narrative: Positive for Covid 19; Pneumonia; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive for Covid 19) and PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced COVID-19 (Positive for Covid 19) (seriousness criterion hospitalization) and PNEUMONIA (Pneumonia) (seriousness criterion hospitalization). The patient was hospitalized from sometime in March 2021 to 11-Mar-2021 due to COVID-19 and PNEUMONIA. At the time of the report, COVID-19 (Positive for Covid 19) and PNEUMONIA (Pneumonia) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided/unknown. Treatment for events included antibody therapy.  Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: Congestion; Respiratory issues; Oxygen breathing is off; Sweats; Coughing; Fever 100 point something; Really tired; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Congestion) in a 76-year-old male 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 Double vessel bypass graft.   On 17-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PULMONARY CONGESTION (Congestion) (seriousness criterion medically significant), RESPIRATORY DISORDER (Respiratory issues), DYSPNOEA (Oxygen breathing is off), HYPERHIDROSIS (Sweats), COUGH (Coughing), PYREXIA (Fever 100 point something), FATIGUE (Really tired) and NAUSEA (Nausea). At the time of the report, PULMONARY CONGESTION (Congestion), RESPIRATORY DISORDER (Respiratory issues), DYSPNOEA (Oxygen breathing is off), HYPERHIDROSIS (Sweats), COUGH (Coughing), PYREXIA (Fever 100 point something), FATIGUE (Really tired) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 100 point (Inconclusive) 100 point. In March 2021, Respiratory rate: 92-96-97 (Inconclusive) 92-96-97.         Concomitant product use was not provided by the reporter.  Treatment information was unknown.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pulmonary congestion, Pyrexia, Respiratory disorder, Respiratory rate
Clinical narrative: Congestion; Respiratory issues; Oxygen breathing is off; Sweats; Coughing; Fever 100 point something; Really tired; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Congestion) in a 76-year-old male 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 Double vessel bypass graft.   On 17-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PULMONARY CONGESTION (Congestion) (seriousness criterion medically significant), RESPIRATORY DISORDER (Respiratory issues), DYSPNOEA (Oxygen breathing is off), HYPERHIDROSIS (Sweats), COUGH (Coughing), PYREXIA (Fever 100 point something), FATIGUE (Really tired) and NAUSEA (Nausea). At the time of the report, PULMONARY CONGESTION (Congestion), RESPIRATORY DISORDER (Respiratory issues), DYSPNOEA (Oxygen breathing is off), HYPERHIDROSIS (Sweats), COUGH (Coughing), PYREXIA (Fever 100 point something), FATIGUE (Really tired) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 100 point (Inconclusive) 100 point. In March 2021, Respiratory rate: 92-96-97 (Inconclusive) 92-96-97.         Concomitant product use was not provided by the reporter.  Treatment information was unknown.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cellulitis, Erythema, Feeling hot, Pyrexia
Clinical narrative: Extreme cellulitis in the left leg; swelling; was warm to the touch; severe redness; Pain in his joints; Developed a fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Extreme cellulitis in the left leg) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. LTH037A213) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dialysis since an unknown date. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes, SEVELAMER CARBONATE and FERRIC CITRATE (AURYXIA) for Dialysis, ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ARTHRALGIA (Pain in his joints) and PYREXIA (Developed a fever). On 20-Mar-2021, the patient experienced CELLULITIS (Extreme cellulitis in the left leg) (seriousness criteria hospitalization and medically significant), SWELLING (swelling), VACCINATION SITE WARMTH (was warm to the touch) and ERYTHEMA (severe redness). At the time of the report, CELLULITIS (Extreme cellulitis in the left leg), SWELLING (swelling), VACCINATION SITE WARMTH (was warm to the touch), ERYTHEMA (severe redness), ARTHRALGIA (Pain in his joints) and PYREXIA (Developed a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment of the events included, vancomycin 1.25 g IV
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Extreme cellulitis in the left leg; swelling; was warm to the touch; severe redness; Pain in his joints; Developed a fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Extreme cellulitis in the left leg) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. LTH037A213) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dialysis since an unknown date. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes, SEVELAMER CARBONATE and FERRIC CITRATE (AURYXIA) for Dialysis, ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ARTHRALGIA (Pain in his joints) and PYREXIA (Developed a fever). On 20-Mar-2021, the patient experienced CELLULITIS (Extreme cellulitis in the left leg) (seriousness criteria hospitalization and medically significant), SWELLING (swelling), VACCINATION SITE WARMTH (was warm to the touch) and ERYTHEMA (severe redness). At the time of the report, CELLULITIS (Extreme cellulitis in the left leg), SWELLING (swelling), VACCINATION SITE WARMTH (was warm to the touch), ERYTHEMA (severe redness), ARTHRALGIA (Pain in his joints) and PYREXIA (Developed a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment of the events included, vancomycin 1.25 g IV
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's Palsy) 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.   Concomitant product use was not provided by the reporter. Treatment medication included high doses of steroids.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: loss of hearing right ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (loss of hearing right ear) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DEAFNESS (loss of hearing right ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS (loss of hearing right ear) had not resolved.            Additional information: On 15MAR2021 I went to the Emergency room. I then went to see an Ears Nose and Throat Doctor on 17MAR2021. The Doctor put me on Prednisone 60mg daily times one week. I then went to go see the Ears Nose and Throat Doctor again today 01APR2021and he gave me a steroid injection into my right ear.At this point the hearing has not returned to my right ear  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-065921 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Agitation, Anger, Confusional state, Feeling abnormal
Clinical narrative: Anger; High blood pressure; not being himself; Confused; Agitated; Combative, became aggressive; Crying, yelling, clapping; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ANGER (Anger), AGGRESSION (Combative, became aggressive) and MENTAL STATUS CHANGES (Crying, yelling, clapping) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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 adverse event history.). Concomitant products included METFORMIN, ATORVASTATIN CALCIUM (LIPITOR), ALLOPURINOL, DOXAZOSIN MESILATE (CARDURA), TELMISARTAN (MICARDIS) and AMLODIPINE.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced ANGER (Anger) (seriousness criterion hospitalization), AGGRESSION (Combative, became aggressive) (seriousness criteria medically significant and life threatening), MENTAL STATUS CHANGES (Crying, yelling, clapping) (seriousness criterion medically significant), FEELING ABNORMAL (not being himself), CONFUSIONAL STATE (Confused) and AGITATION (Agitated). On an unknown date, the patient experienced HYPERTENSION (High blood pressure). At the time of the report, ANGER (Anger), AGGRESSION (Combative, became aggressive), MENTAL STATUS CHANGES (Crying, yelling, clapping), HYPERTENSION (High blood pressure), FEELING ABNORMAL (not being himself), CONFUSIONAL STATE (Confused) and AGITATION (Agitated) 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.   Treatment of these events included Seroquel 400mg once a day.  Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Mental status changes
Clinical narrative: Anger; High blood pressure; not being himself; Confused; Agitated; Combative, became aggressive; Crying, yelling, clapping; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ANGER (Anger), AGGRESSION (Combative, became aggressive) and MENTAL STATUS CHANGES (Crying, yelling, clapping) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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 adverse event history.). Concomitant products included METFORMIN, ATORVASTATIN CALCIUM (LIPITOR), ALLOPURINOL, DOXAZOSIN MESILATE (CARDURA), TELMISARTAN (MICARDIS) and AMLODIPINE.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced ANGER (Anger) (seriousness criterion hospitalization), AGGRESSION (Combative, became aggressive) (seriousness criteria medically significant and life threatening), MENTAL STATUS CHANGES (Crying, yelling, clapping) (seriousness criterion medically significant), FEELING ABNORMAL (not being himself), CONFUSIONAL STATE (Confused) and AGITATION (Agitated). On an unknown date, the patient experienced HYPERTENSION (High blood pressure). At the time of the report, ANGER (Anger), AGGRESSION (Combative, became aggressive), MENTAL STATUS CHANGES (Crying, yelling, clapping), HYPERTENSION (High blood pressure), FEELING ABNORMAL (not being himself), CONFUSIONAL STATE (Confused) and AGITATION (Agitated) 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.   Treatment of these events included Seroquel 400mg once a day.  Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 1.75 mg three times a day. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (bad reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Choking, Cough, Fatigue, Pain in extremity
Clinical narrative: Choking; arm was really sore; Feels sleepy all the time; retching/gagging; Feels tired/fatigue; Anxiety; Cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHOKING (Choking) in a 74-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.     Concurrent medical conditions included Pulmonary arterial hypertension since 12-Feb-2021 and Anxiety since 04-Mar-2021. Concomitant products included TREPROSTINIL SODIUM for Primary pulmonary hypertension.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. In February 2021, the patient experienced COUGH (Cough). On 04-Mar-2021, the patient experienced ANXIETY (Anxiety). On an unknown date, the patient experienced CHOKING (Choking) (seriousness criterion medically significant), PAIN IN EXTREMITY (arm was really sore), SOMNOLENCE (Feels sleepy all the time), RETCHING (retching/gagging) and FATIGUE (Feels tired/fatigue). At the time of the report, CHOKING (Choking), PAIN IN EXTREMITY (arm was really sore), SOMNOLENCE (Feels sleepy all the time), ANXIETY (Anxiety) and FATIGUE (Feels tired/fatigue) outcome was unknown and COUGH (Cough) and RETCHING (retching/gagging) was resolving.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Retching, Somnolence
Clinical narrative: Choking; arm was really sore; Feels sleepy all the time; retching/gagging; Feels tired/fatigue; Anxiety; Cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHOKING (Choking) in a 74-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.     Concurrent medical conditions included Pulmonary arterial hypertension since 12-Feb-2021 and Anxiety since 04-Mar-2021. Concomitant products included TREPROSTINIL SODIUM for Primary pulmonary hypertension.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. In February 2021, the patient experienced COUGH (Cough). On 04-Mar-2021, the patient experienced ANXIETY (Anxiety). On an unknown date, the patient experienced CHOKING (Choking) (seriousness criterion medically significant), PAIN IN EXTREMITY (arm was really sore), SOMNOLENCE (Feels sleepy all the time), RETCHING (retching/gagging) and FATIGUE (Feels tired/fatigue). At the time of the report, CHOKING (Choking), PAIN IN EXTREMITY (arm was really sore), SOMNOLENCE (Feels sleepy all the time), ANXIETY (Anxiety) and FATIGUE (Feels tired/fatigue) outcome was unknown and COUGH (Cough) and RETCHING (retching/gagging) was resolving.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Presyncope, Tunnel vision
Clinical narrative: tunnel vision for a bit which then went away; felt like fainting; tinging in his toes and left arm and fingers.; This spontaneous case was reported by a consumer and describes the occurrence of TUNNEL VISION (tunnel vision for a bit which then went away) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A217) 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 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced TUNNEL VISION (tunnel vision for a bit which then went away) (seriousness criterion medically significant), PRESYNCOPE (felt like fainting) and PARAESTHESIA (tinging in his toes and left arm and fingers.). At the time of the report, TUNNEL VISION (tunnel vision for a bit which then went away), PRESYNCOPE (felt like fainting) and PARAESTHESIA (tinging in his toes and left arm and fingers.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment information were not reported.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Worsening of neuropathy of feet; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (Worsening of neuropathy of feet) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Hyperlipidemia (Patient had elevated   cholesterol), Osteoarthritis spinal (osteoarthritis  Of spine), Hypothyroidism, Aortic aneurysm and Migraine. Concomitant products included ROSUVASTATIN for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, SUMATRIPTAN SUCCINATE (IMITREX [SUMATRIPTAN SUCCINATE]) for Migraine.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Worsening of neuropathy of feet) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Worsening of neuropathy of feet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.    This case was linked.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: experienced blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (experienced blood clot) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Factor V Leiden mutation. Concomitant products included RIVAROXABAN (XARELTO) for Factor V Leiden mutation.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced THROMBOSIS (experienced blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (experienced blood clot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was treated with blood thinner Xarelto (rivaroxaban) on a daily basis for  factor V mutation and was treated with the same for blood clot.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's palsy) in a 59-year-old male 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 20-Mar-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced FACIAL PARALYSIS (Bell's palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's palsy) was resolving.        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.   Concomitant product use was not provided by the reporter. Treatment medication included Prednisone and an unspecified antiviral medication.  Based on the current information and the temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on the current information and the temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dizziness
Clinical narrative: stroke; light headed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included CML (CML Leukemia though she's in remission now) in 1999 and Surgery (Open eye surgery (2 & half year ago)). Concurrent medical conditions included Prediabetes, Blood pressure (Taking medication for blood pressure) and Renal disorder NOS (Taking medication for her kidneys). Concomitant products included METOPROLOL for BP, ATORVASTATIN for Cholesterol, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and life threatening). On 05-Apr-2021, the patient experienced DIZZINESS (light headed). The patient was hospitalized from 20-Mar-2021 to 23-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) had resolved and DIZZINESS (light headed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events were not 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. However,  patient's past medical history of CML, hypertension, Hyperlipidemia may contribute to this event. Further information is requested.; 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. However,  patient's past medical history of CML, hypertension, Hyperlipidemia may contribute to this event. Further information is requested.