chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Balance disorder, Dysstasia, Gait disturbance, Multiple sclerosis
Clinical narrative: Multiple sclerosis symptoms got significantly worse; Vertigo; Ataxia; Difficulty standing; Difficulty walking; Disequilibrium; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (Multiple sclerosis symptoms got significantly worse) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 03121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D3 for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-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 MULTIPLE SCLEROSIS (Multiple sclerosis symptoms got significantly worse) (seriousness criterion medically significant), VERTIGO (Vertigo), ATAXIA (Ataxia), DYSSTASIA (Difficulty standing), GAIT DISTURBANCE (Difficulty walking) and BALANCE DISORDER (Disequilibrium). At the time of the report, MULTIPLE SCLEROSIS (Multiple sclerosis symptoms got significantly worse), VERTIGO (Vertigo), ATAXIA (Ataxia), DYSSTASIA (Difficulty standing), GAIT DISTURBANCE (Difficulty walking) and BALANCE DISORDER (Disequilibrium) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Treatment information was not provided.  Company Comment:  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Multiple sclerosis symptoms got significantly worse; Vertigo; Ataxia; Difficulty standing; Difficulty walking; Disequilibrium; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (Multiple sclerosis symptoms got significantly worse) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 03121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D3 for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-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 MULTIPLE SCLEROSIS (Multiple sclerosis symptoms got significantly worse) (seriousness criterion medically significant), VERTIGO (Vertigo), ATAXIA (Ataxia), DYSSTASIA (Difficulty standing), GAIT DISTURBANCE (Difficulty walking) and BALANCE DISORDER (Disequilibrium). At the time of the report, MULTIPLE SCLEROSIS (Multiple sclerosis symptoms got significantly worse), VERTIGO (Vertigo), ATAXIA (Ataxia), DYSSTASIA (Difficulty standing), GAIT DISTURBANCE (Difficulty walking) and BALANCE DISORDER (Disequilibrium) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Treatment information was not provided.  Company Comment:  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Bladder dilatation, Hypokinesia, Monoplegia
Clinical narrative: Lost my taste during my hospitalization; I have a UTI; Lost my smell during my hospitalization; I had spinal edema; Bladder distension; I had increased paralysis from my right upper leg down, It later went from my left upper leg down; I couldn't get out of bed, I can't lift my legs. I'm unable to do; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MONOPLEGIA (I had increased paralysis from my right upper leg down, It later went from my left upper leg down) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced MONOPLEGIA (I had increased paralysis from my right upper leg down, It later went from my left upper leg down) (seriousness criterion medically significant) and HYPOKINESIA (I couldn't get out of bed, I can't lift my legs. I'm unable to do). On 15-Mar-2021, the patient experienced OEDEMA (I had spinal edema) and BLADDER DILATATION (Bladder distension). On 12-May-2021, the patient experienced AGEUSIA (Lost my taste during my hospitalization), URINARY TRACT INFECTION (I have a UTI) and ANOSMIA (Lost my smell during my hospitalization). At the time of the report, MONOPLEGIA (I had increased paralysis from my right upper leg down, It later went from my left upper leg down), HYPOKINESIA (I couldn't get out of bed, I can't lift my legs. I'm unable to do), OEDEMA (I had spinal edema), BLADDER DILATATION (Bladder distension), AGEUSIA (Lost my taste during my hospitalization), URINARY TRACT INFECTION (I have a UTI) and ANOSMIA (Lost my smell during my hospitalization) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment included were Tylenol, steroids, Gabapentin, plasmapheresis, and urinary catheter.  Action taken with mRNA-1273 in response to the event was Not Applicable  Company Comment:  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema, Urinary tract infection
Clinical narrative: Lost my taste during my hospitalization; I have a UTI; Lost my smell during my hospitalization; I had spinal edema; Bladder distension; I had increased paralysis from my right upper leg down, It later went from my left upper leg down; I couldn't get out of bed, I can't lift my legs. I'm unable to do; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MONOPLEGIA (I had increased paralysis from my right upper leg down, It later went from my left upper leg down) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced MONOPLEGIA (I had increased paralysis from my right upper leg down, It later went from my left upper leg down) (seriousness criterion medically significant) and HYPOKINESIA (I couldn't get out of bed, I can't lift my legs. I'm unable to do). On 15-Mar-2021, the patient experienced OEDEMA (I had spinal edema) and BLADDER DILATATION (Bladder distension). On 12-May-2021, the patient experienced AGEUSIA (Lost my taste during my hospitalization), URINARY TRACT INFECTION (I have a UTI) and ANOSMIA (Lost my smell during my hospitalization). At the time of the report, MONOPLEGIA (I had increased paralysis from my right upper leg down, It later went from my left upper leg down), HYPOKINESIA (I couldn't get out of bed, I can't lift my legs. I'm unable to do), OEDEMA (I had spinal edema), BLADDER DILATATION (Bladder distension), AGEUSIA (Lost my taste during my hospitalization), URINARY TRACT INFECTION (I have a UTI) and ANOSMIA (Lost my smell during my hospitalization) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment included were Tylenol, steroids, Gabapentin, plasmapheresis, and urinary catheter.  Action taken with mRNA-1273 in response to the event was Not Applicable  Company Comment:  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Diplopia, Hyperacusis, Pain in jaw, Trigeminal neuralgia
Clinical narrative: Bell's palsy; Trigeminal neuralgia; Can not tolerate loud noises; Jaw still hurts; Double vision in right eyes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant), TRIGEMINAL NEURALGIA (Trigeminal neuralgia), HYPERACUSIS (Can not tolerate loud noises), PAIN IN JAW (Jaw still hurts) and DIPLOPIA (Double vision in right eyes). At the time of the report, BELL'S PALSY (Bell's palsy), TRIGEMINAL NEURALGIA (Trigeminal neuralgia), HYPERACUSIS (Can not tolerate loud noises), PAIN IN JAW (Jaw still hurts) and DIPLOPIA (Double vision in right eyes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided/unknown.  The patient went to the emergency room twice. She was put on a steroid by her doctor.  She is undergoing treatment with a neurologist.  Company Comment: 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.; 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: pneumonia; did not receive second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 75-year-old female 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.     No medical history information was provided by the reporter.  Concomitant products included METFORMIN HYDROCHLORIDE (MEFORMIN) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant) and PRODUCT DOSE OMISSION ISSUE (did not receive second dose). At the time of the report, PNEUMONIA (pneumonia) and PRODUCT DOSE OMISSION ISSUE (did not receive second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Pills for the stomach,Pills for blood pressure.  Patient was scheduled for second shot on 10APR 2021 but as she got tested COVID positive on 05APR2021, she could not take the second shot. Patient did not developed symptoms but since her son tested positive, she went ahead and got tested. On her daughters recommendation she got admitted into a hospital  received medication for COVID-19, pain, Oxygen and vitamins. She spent 1 day in the hospital and feeling well now.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 13-may-2021 with additional information in the TCR form; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Thrombosis
Clinical narrative: Passed out multiple times; Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out multiple times) and THROMBOSIS (Blood clots) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out multiple times) (seriousness criterion medically significant) and THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out multiple times) and THROMBOSIS (Blood clots) 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 was not provided.  Patient was taken to hospital where it was discovered that he had blood clots that needed to be removed.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Barrett's oesophagus, Decreased appetite, Influenza like illness, Nausea, Oesophageal pain
Clinical narrative: Barrett's esophagus diagnosis by esophageal biopsy; Felt like having the flu/Like being knocked out; Fever of 101.6 degrees Fahrenheit; Super nauseated; Losing appetite; Feeling burning in the esophagus, so severe like being on fire, an intense burn; This spontaneous case was reported by a nurse and describes the occurrence of BARRETT'S OESOPHAGUS (Barrett's esophagus diagnosis by esophageal biopsy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Esophagogastroduodenoscopy in April 2021 and Biopsy (Esophageal biopsy- Barrett's esophagus diagnosis) in April 2021.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like having the flu/Like being knocked out) and PYREXIA (Fever of 101.6 degrees Fahrenheit). In February 2021, the patient experienced OESOPHAGEAL PAIN (Feeling burning in the esophagus, so severe like being on fire, an intense burn), DECREASED APPETITE (Losing appetite) and NAUSEA (Super nauseated). In April 2021, the patient experienced BARRETT'S OESOPHAGUS (Barrett's esophagus diagnosis by esophageal biopsy) (seriousness criterion medically significant). At the time of the report, BARRETT'S OESOPHAGUS (Barrett's esophagus diagnosis by esophageal biopsy), OESOPHAGEAL PAIN (Feeling burning in the esophagus, so severe like being on fire, an intense burn), INFLUENZA LIKE ILLNESS (Felt like having the flu/Like being knocked out), DECREASED APPETITE (Losing appetite), PYREXIA (Fever of 101.6 degrees Fahrenheit) and NAUSEA (Super nauseated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of events on 03-Feb-2021 was with Acetaminophen (Extra Strength Tylenol). Treatment on Apr2021: Unknown medication for Barrett's esophagus.  Concomitant medication was reported as cholesterol pill by the reporter.  Based on the pathology of Barrett's esophagus, the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the pathology of Barrett's esophagus, the event is assessed as unlikely related to mRNA-1273.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Barrett's esophagus diagnosis by esophageal biopsy; Felt like having the flu/Like being knocked out; Fever of 101.6 degrees Fahrenheit; Super nauseated; Losing appetite; Feeling burning in the esophagus, so severe like being on fire, an intense burn; This spontaneous case was reported by a nurse and describes the occurrence of BARRETT'S OESOPHAGUS (Barrett's esophagus diagnosis by esophageal biopsy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Esophagogastroduodenoscopy in April 2021 and Biopsy (Esophageal biopsy- Barrett's esophagus diagnosis) in April 2021.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like having the flu/Like being knocked out) and PYREXIA (Fever of 101.6 degrees Fahrenheit). In February 2021, the patient experienced OESOPHAGEAL PAIN (Feeling burning in the esophagus, so severe like being on fire, an intense burn), DECREASED APPETITE (Losing appetite) and NAUSEA (Super nauseated). In April 2021, the patient experienced BARRETT'S OESOPHAGUS (Barrett's esophagus diagnosis by esophageal biopsy) (seriousness criterion medically significant). At the time of the report, BARRETT'S OESOPHAGUS (Barrett's esophagus diagnosis by esophageal biopsy), OESOPHAGEAL PAIN (Feeling burning in the esophagus, so severe like being on fire, an intense burn), INFLUENZA LIKE ILLNESS (Felt like having the flu/Like being knocked out), DECREASED APPETITE (Losing appetite), PYREXIA (Fever of 101.6 degrees Fahrenheit) and NAUSEA (Super nauseated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of events on 03-Feb-2021 was with Acetaminophen (Extra Strength Tylenol). Treatment on Apr2021: Unknown medication for Barrett's esophagus.  Concomitant medication was reported as cholesterol pill by the reporter.  Based on the pathology of Barrett's esophagus, the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the pathology of Barrett's esophagus, the event is assessed as unlikely related to mRNA-1273.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: diagnosis of Bell's Palsy; This spontaneous case was reported by a non-health professional and describes the occurrence of BELL'S PALSY (diagnosis of Bell's Palsy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (diagnosis of Bell's Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (diagnosis of Bell's Palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatments were provided.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Hypokinesia, Loss of consciousness
Clinical narrative: I was like I had l ke passed out; I couldn't feel hungry anymore, I didn't have appetite; It was the first time I was feeling so unable to even; I would get like dizzy and just fall in my bed again; Fever; Muscle Pain; Horribly exhausted for 5 days, I was in bed; I couldn't even lift up my arm to get up and go and eat; This spontaneous case was reported by a non-health professional and describes the occurrence of LOSS OF CONSCIOUSNESS (I was like I had l ke passed out) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-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 LOSS OF CONSCIOUSNESS (I was like I had l ke passed out) (seriousness criterion medically significant), DECREASED APPETITE (I couldn't feel hungry anymore, I didn't have appetite), HYPOKINESIA (It was the first time I was feeling so unable to even), DIZZINESS (I would get like dizzy and just fall in my bed again), PYREXIA (Fever), MYALGIA (Muscle Pain), FATIGUE (Horribly exhausted for 5 days, I was in bed) and VACCINATION SITE PAIN (I couldn't even lift up my arm to get up and go and eat). At the time of the report, LOSS OF CONSCIOUSNESS (I was like I had l ke passed out), DECREASED APPETITE (I couldn't feel hungry anymore, I didn't have appetite), HYPOKINESIA (It was the first time I was feeling so unable to even), DIZZINESS (I would get like dizzy and just fall in my bed again), PYREXIA (Fever), MYALGIA (Muscle Pain), FATIGUE (Horribly exhausted for 5 days, I was in bed) and VACCINATION SITE PAIN (I couldn't even lift up my arm to get up and go and eat) outcome was unknown.            No concomitant medication reported.  The patient stated having similar symptoms following the first dose of the Moderna COVID-19 Vaccine.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: I was like I had l ke passed out; I couldn't feel hungry anymore, I didn't have appetite; It was the first time I was feeling so unable to even; I would get like dizzy and just fall in my bed again; Fever; Muscle Pain; Horribly exhausted for 5 days, I was in bed; I couldn't even lift up my arm to get up and go and eat; This spontaneous case was reported by a non-health professional and describes the occurrence of LOSS OF CONSCIOUSNESS (I was like I had l ke passed out) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-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 LOSS OF CONSCIOUSNESS (I was like I had l ke passed out) (seriousness criterion medically significant), DECREASED APPETITE (I couldn't feel hungry anymore, I didn't have appetite), HYPOKINESIA (It was the first time I was feeling so unable to even), DIZZINESS (I would get like dizzy and just fall in my bed again), PYREXIA (Fever), MYALGIA (Muscle Pain), FATIGUE (Horribly exhausted for 5 days, I was in bed) and VACCINATION SITE PAIN (I couldn't even lift up my arm to get up and go and eat). At the time of the report, LOSS OF CONSCIOUSNESS (I was like I had l ke passed out), DECREASED APPETITE (I couldn't feel hungry anymore, I didn't have appetite), HYPOKINESIA (It was the first time I was feeling so unable to even), DIZZINESS (I would get like dizzy and just fall in my bed again), PYREXIA (Fever), MYALGIA (Muscle Pain), FATIGUE (Horribly exhausted for 5 days, I was in bed) and VACCINATION SITE PAIN (I couldn't even lift up my arm to get up and go and eat) outcome was unknown.            No concomitant medication reported.  The patient stated having similar symptoms following the first dose of the Moderna COVID-19 Vaccine.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: He is falling asleep all the time and continues to get worse, not better; He is falling asleep all the time and continues to get worse, not better; Freezing cold all the time; feeling horrible; walking feebling at times; He has lost at least 10#, and lost three inches in waist,; stomach is bloated; he shuffles his feet-like his legs are stiff; balance is worse than ever; balance is worse than ever; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Freezing cold all the time) in a 77-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.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-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 HYPOTHERMIA (Freezing cold all the time) (seriousness criterion medically significant), VACCINATION COMPLICATION (feeling horrible), GAIT DISTURBANCE (walking feebling at times), WEIGHT DECREASED (He has lost at least 10#, and lost three inches in waist,), ABDOMINAL DISTENSION (stomach is bloated), MUSCULOSKELETAL STIFFNESS (he shuffles his feet-like his legs are stiff), BALANCE DISORDER (balance is worse than ever), CONDITION AGGRAVATED (balance is worse than ever), DECREASED APPETITE (no appetite), SOMNOLENCE (He is falling asleep all the time and continues to get worse, not better) and CONDITION AGGRAVATED (He is falling asleep all the time and continues to get worse, not better). At the time of the report, HYPOTHERMIA (Freezing cold all the time), VACCINATION COMPLICATION (feeling horrible), GAIT DISTURBANCE (walking feebling at times), WEIGHT DECREASED (He has lost at least 10#, and lost three inches in waist,), ABDOMINAL DISTENSION (stomach is bloated), MUSCULOSKELETAL STIFFNESS (he shuffles his feet-like his legs are stiff), BALANCE DISORDER (balance is worse than ever), CONDITION AGGRAVATED (balance is worse than ever), DECREASED APPETITE (no appetite) and CONDITION AGGRAVATED (He is falling asleep all the time and continues to get worse, not better) outcome was unknown and SOMNOLENCE (He is falling asleep all the time and continues to get worse, not better) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Stool analysis: negative negative (Negative) Stool sample was negative for blood.         No concomitant medications were reported.  Treatment information was not provided.  Very limited information regarding the events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-125899 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Syncope
Clinical narrative: fainted many times; ongoing diarrhea; This spontaneous case was reported by a non-health professional and describes the occurrence of SYNCOPE (fainted many times) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001c21a) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced SYNCOPE (fainted many times) (seriousness criterion medically significant) and DIARRHOEA (ongoing diarrhea). At the time of the report, SYNCOPE (fainted many times) outcome was unknown and DIARRHOEA (ongoing diarrhea) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment information were not provided.  Company Comment: 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asphyxia, Asthenia, Dyspnoea, Headache, Pyrexia
Clinical narrative: Suffocating; Vaccine went into my lungs and couldnt breathe; Weakness; Fever; Severe headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASPHYXIA (Suffocating), DYSPNOEA (Vaccine went into my lungs and couldnt breathe), ASTHENIA (Weakness), PYREXIA (Fever) and HEADACHE (Severe headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced ASPHYXIA (Suffocating) (seriousness criteria medically significant and intervention required), DYSPNOEA (Vaccine went into my lungs and couldnt breathe) (seriousness criterion intervention required), ASTHENIA (Weakness) (seriousness criterion intervention required), PYREXIA (Fever) (seriousness criterion intervention required) and HEADACHE (Severe headache) (seriousness criterion intervention required). On 03-May-2021, ASTHENIA (Weakness), PYREXIA (Fever) and HEADACHE (Severe headache) had resolved. At the time of the report, ASPHYXIA (Suffocating) and DYSPNOEA (Vaccine went into my lungs and couldnt breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.  Patient stated that the shot went into his lungs almost immediately and affected his breathing.  It was like he was suffocating for 4 days. He went to the emergency room and they checked him out. The emergency room ran some tests and wanted to admit him to the hospital, but he refused and left. His primary care physician told him to get the vaccine even though he had COVID-19 in January. He also had a fever, severe headache, and weakness after the vaccine. He was not on any concomitant medication. He had a pulmonary doctors appointment 14-Jun-2021 for this issue.  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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Blood pressure measurement, Diverticulitis, Loss of consciousness
Clinical narrative: passed out; very bad infection from the Diverticulitis in the bowel; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and DIVERTICULITIS (very bad infection from the Diverticulitis in the bowel) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included LISINOPRIL for Blood pressure, POTASSIUM and OMEPRAZOLE for an unknown indication.    On 04-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant) and DIVERTICULITIS (very bad infection from the Diverticulitis in the bowel) (seriousness criterion medically significant). On 04-May-2021, LOSS OF CONSCIOUSNESS (passed out) had resolved. At the time of the report, DIVERTICULITIS (very bad infection from the Diverticulitis in the bowel) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Blood potassium: Low. On 04-May-2021, Blood pressure measurement: Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Events included some other issues. Patient was treated with 2 unspecified antibiotics.  Company Comment: 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Neuropathy peripheral, Peripheral coldness
Clinical narrative: Peripheral Neuropathy; Numbness in hands and feet; Hands and feet feels cold; Feels super increase of headache; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral Neuropathy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness in hands and feet), PERIPHERAL COLDNESS (Hands and feet feels cold) and HEADACHE (Feels super increase of headache). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Peripheral Neuropathy) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral Neuropathy), HYPOAESTHESIA (Numbness in hands and feet), PERIPHERAL COLDNESS (Hands and feet feels cold) and HEADACHE (Feels super increase of headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. She consulted Neurologist and lab tests and EMG was done and diagnosed peripheral neuropathy. 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Cough, Dry skin, Hypokinesia, Immune system disorder
Clinical narrative: Left arm was so swollen; I guess infected inside; Has a cough; Skin is so dry with little spots; That look like my skin is peeling; My immune system had been compromised; Couldn't move my left arm at all/ cannot extend left arm upward/ cannot lift up; Pain was really awful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Left arm was so swollen) and INFECTION (I guess infected inside) in a 75-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.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced HYPOKINESIA (Couldn't move my left arm at all/ cannot extend left arm upward/ cannot lift up), PAIN (Pain was really awful) and IMMUNE SYSTEM DISORDER (My immune system had been compromised). On 26-Mar-2021, the patient experienced PERIPHERAL SWELLING (Left arm was so swollen) (seriousness criterion hospitalization) and INFECTION (I guess infected inside) (seriousness criterion hospitalization). On 13-May-2021, the patient experienced COUGH (Has a cough), DRY SKIN (Skin is so dry with little spots) and SKIN EXFOLIATION (That look like my skin is peeling). The patient was hospitalized from sometime in March 2021 to sometime in March 2021 due to INFECTION and PERIPHERAL SWELLING. At the time of the report, PERIPHERAL SWELLING (Left arm was so swollen), INFECTION (I guess infected inside), PAIN (Pain was really awful), COUGH (Has a cough), DRY SKIN (Skin is so dry with little spots), SKIN EXFOLIATION (That look like my skin is peeling) and IMMUNE SYSTEM DISORDER (My immune system had been compromised) outcome was unknown and HYPOKINESIA (Couldn't move my left arm at all/ cannot extend left arm upward/ cannot lift up) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood count: abnormal (abnormal) Almost having to have a blood transfusion.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included blood pressure pills and cholesterol pills.  Treatment for events included antibiotics, steroids and dilaudid injections.  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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Pain, Peripheral swelling, Skin exfoliation
Clinical narrative: Left arm was so swollen; I guess infected inside; Has a cough; Skin is so dry with little spots; That look like my skin is peeling; My immune system had been compromised; Couldn't move my left arm at all/ cannot extend left arm upward/ cannot lift up; Pain was really awful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Left arm was so swollen) and INFECTION (I guess infected inside) in a 75-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.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced HYPOKINESIA (Couldn't move my left arm at all/ cannot extend left arm upward/ cannot lift up), PAIN (Pain was really awful) and IMMUNE SYSTEM DISORDER (My immune system had been compromised). On 26-Mar-2021, the patient experienced PERIPHERAL SWELLING (Left arm was so swollen) (seriousness criterion hospitalization) and INFECTION (I guess infected inside) (seriousness criterion hospitalization). On 13-May-2021, the patient experienced COUGH (Has a cough), DRY SKIN (Skin is so dry with little spots) and SKIN EXFOLIATION (That look like my skin is peeling). The patient was hospitalized from sometime in March 2021 to sometime in March 2021 due to INFECTION and PERIPHERAL SWELLING. At the time of the report, PERIPHERAL SWELLING (Left arm was so swollen), INFECTION (I guess infected inside), PAIN (Pain was really awful), COUGH (Has a cough), DRY SKIN (Skin is so dry with little spots), SKIN EXFOLIATION (That look like my skin is peeling) and IMMUNE SYSTEM DISORDER (My immune system had been compromised) outcome was unknown and HYPOKINESIA (Couldn't move my left arm at all/ cannot extend left arm upward/ cannot lift up) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood count: abnormal (abnormal) Almost having to have a blood transfusion.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included blood pressure pills and cholesterol pills.  Treatment for events included antibiotics, steroids and dilaudid injections.  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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Appendicitis, Computerised tomogram, Dyspepsia
Clinical narrative: Stomach is "different", suddenly has to go to the bathroom; Fatigue; Appendicitis; Stomach pain / Stomach upset; Indigestion; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Appendectomy on 20-Apr-2021. Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach pain / Stomach upset), DYSPEPSIA (Indigestion), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue). On 13-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach is "different", suddenly has to go to the bathroom). The patient was treated with Surgery (Appendectomy) for Appendicitis. At the time of the report, APPENDICITIS (Appendicitis), ABDOMINAL PAIN UPPER (Stomach pain / Stomach upset), DYSPEPSIA (Indigestion), PAIN IN EXTREMITY (Pain in arm), ABDOMINAL DISCOMFORT (Stomach is "different", suddenly has to go to the bathroom) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, Computerised tomogram: revealed appendicitis Revealed appendicitis.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient took Pepto-Bismol (bismuth subsalicylate) and laxatives for stomach pain and indigestion.   She had appendectomy on 20-Apr-2021. She now reports that her stomach feels 'different' and she has sudden urges to go to the bathroom.  Treatment information was not provided.  Company Comment : 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.