chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Like she has Alzheimers; flu like symptoms; "brain dead"/ "foggy brain"; feels like she has short memory loss - when she is in the middle of doing something, she forgets what she was doing; paranoia; normal arm and body aches; Alzheimer's, as forgetfullness; Arm was sore; Arm was sore; flat fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (Like she has Alzheimers) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced DEMENTIA ALZHEIMER'S TYPE (Like she has Alzheimers) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL ("brain dead"/ "foggy brain"), AMNESIA (feels like she has short memory loss - when she is in the middle of doing something, she forgets what she was doing), PARANOIA (paranoia), PAIN (normal arm and body aches), MEMORY IMPAIRMENT (Alzheimer's, as forgetfullness), PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE PAIN (Arm was sore), PYREXIA (flat fever) and HEADACHE (headache). On 06-Apr-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (normal arm and body aches), PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE PAIN (Arm was sore), PYREXIA (flat fever) and HEADACHE (headache) had resolved. At the time of the report, DEMENTIA ALZHEIMER'S TYPE (Like she has Alzheimers), FEELING ABNORMAL ("brain dead"/ "foggy brain"), AMNESIA (feels like she has short memory loss - when she is in the middle of doing something, she forgets what she was doing), PARANOIA (paranoia) and MEMORY IMPAIRMENT (Alzheimer's, as forgetfullness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       A mother was reporting on behalf of her daughter. The patient's medical history, concomitant medications and treatment information was not reported.  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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Aortic aneurysm, Pancreatitis, Product dose omission issue
Clinical narrative: Pain in his Stomach; Pancreas was inflamed; was in the hospital for 1 week and missed the 23MAR2021 vaccination appointment; Small Aneurysm in the Aorta; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (Pain in his Stomach) and PANCREATITIS (Pancreas was inflamed) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery since December 2020.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain in his Stomach) (seriousness criterion hospitalization prolonged), PANCREATITIS (Pancreas was inflamed) (seriousness criterion hospitalization prolonged) and AORTIC ANEURYSM (Small Aneurysm in the Aorta). On 23-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (was in the hospital for 1 week and missed the 23MAR2021 vaccination appointment). The patient was hospitalized from 20-Mar-2021 to 27-Mar-2021 due to ABDOMINAL PAIN UPPER and PANCREATITIS. On 27-Mar-2021, ABDOMINAL PAIN UPPER (Pain in his Stomach), PANCREATITIS (Pancreas was inflamed) and AORTIC ANEURYSM (Small Aneurysm in the Aorta) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (was in the hospital for 1 week and missed the 23MAR2021 vaccination appointment) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and the temporal association between the product use and the start date of the events a causal relational cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relational cannot be excluded.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram, Extrapyramidal disorder, Magnetic resonance imaging, Seizure, Tremor
Clinical narrative: extrapyramidal syndrome from vaccine; shaking uncontrollably/ body tremors; uncontrolled convulsions/ seizure type activity; jaw was locked; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXTRAPYRAMIDAL DISORDER (extrapyramidal syndrome from vaccine), TREMOR (shaking uncontrollably/ body tremors) and SEIZURE (uncontrolled convulsions/ seizure type activity) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced TREMOR (shaking uncontrollably/ body tremors) (seriousness criterion hospitalization), SEIZURE (uncontrolled convulsions/ seizure type activity) (seriousness criterion medically significant) and TRISMUS (jaw was locked). On 30-Mar-2021, the patient experienced EXTRAPYRAMIDAL DISORDER (extrapyramidal syndrome from vaccine) (seriousness criterion hospitalization). The patient was hospitalized on 30-Mar-2021 due to EXTRAPYRAMIDAL DISORDER and TREMOR. At the time of the report, EXTRAPYRAMIDAL DISORDER (extrapyramidal syndrome from vaccine), TREMOR (shaking uncontrollably/ body tremors), SEIZURE (uncontrolled convulsions/ seizure type activity) and TRISMUS (jaw was locked) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electroencephalogram: Diagnosed Extrapyramidal syndrome from vaccine. On an unknown date, Magnetic resonance imaging: normal.     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.   Patient has always been healthy. She was prescribed high strength Benadryl and Vistaril. These treatment medications did not help her and she went back again to emergency room.  She was a college student and got vaccinated so she could continue her education in person. Concomitant medications were not reported.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Trismus
Clinical narrative: extrapyramidal syndrome from vaccine; shaking uncontrollably/ body tremors; uncontrolled convulsions/ seizure type activity; jaw was locked; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXTRAPYRAMIDAL DISORDER (extrapyramidal syndrome from vaccine), TREMOR (shaking uncontrollably/ body tremors) and SEIZURE (uncontrolled convulsions/ seizure type activity) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced TREMOR (shaking uncontrollably/ body tremors) (seriousness criterion hospitalization), SEIZURE (uncontrolled convulsions/ seizure type activity) (seriousness criterion medically significant) and TRISMUS (jaw was locked). On 30-Mar-2021, the patient experienced EXTRAPYRAMIDAL DISORDER (extrapyramidal syndrome from vaccine) (seriousness criterion hospitalization). The patient was hospitalized on 30-Mar-2021 due to EXTRAPYRAMIDAL DISORDER and TREMOR. At the time of the report, EXTRAPYRAMIDAL DISORDER (extrapyramidal syndrome from vaccine), TREMOR (shaking uncontrollably/ body tremors), SEIZURE (uncontrolled convulsions/ seizure type activity) and TRISMUS (jaw was locked) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electroencephalogram: Diagnosed Extrapyramidal syndrome from vaccine. On an unknown date, Magnetic resonance imaging: normal.     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.   Patient has always been healthy. She was prescribed high strength Benadryl and Vistaril. These treatment medications did not help her and she went back again to emergency room.  She was a college student and got vaccinated so she could continue her education in person. Concomitant medications were not reported.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Transient ischaemic attack
Clinical narrative: Ministroke; not able to get up on his own; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Ministroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 18-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 TRANSIENT ISCHAEMIC ATTACK (Ministroke) (seriousness criterion hospitalization) and HYPOKINESIA (not able to get up on his own). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Ministroke) and HYPOKINESIA (not able to get up on his own) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident
Clinical narrative: Stroke; Can not talk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and APHASIA (Can not talk) in a 76-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 03-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 CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization) and APHASIA (Can not talk) (seriousness criterion hospitalization). The patient was hospitalized on 23-Mar-2021 due to APHASIA and CEREBROVASCULAR ACCIDENT. On 13-Apr-2021, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. At the time of the report, APHASIA (Can not talk) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The wife reported on behalf of her husband. On 13 Apr 2021, the patient was transported to another facility by ambulance. The wife had no information about the lot numbers and was not even and was not sure about the date of first vaccine however, she did mention it could be 03 Mar 21.  No concomitant medications were reported. Treatment information was not reported.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Contusion, Erythema, Haemorrhage subcutaneous, Hypertension
Clinical narrative: injection arm started to swell real bad; hand swelled really bad; injection arm turned red; injection arm was bruising; blood pressure was really high; bleeding under her skin (getting larger everyday); right hand completely with blood under the skin; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE SUBCUTANEOUS (bleeding under her skin (getting larger everyday); right hand completely with blood under the skin) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 040A21A) 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 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 08-Apr-2021, the patient experienced PERIPHERAL SWELLING (injection arm started to swell real bad; hand swelled really bad), ERYTHEMA (injection arm turned red), CONTUSION (injection arm was bruising) and HYPERTENSION (blood pressure was really high). In April 2021, the patient experienced HAEMORRHAGE SUBCUTANEOUS (bleeding under her skin (getting larger everyday); right hand completely with blood under the skin) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE SUBCUTANEOUS (bleeding under her skin (getting larger everyday); right hand completely with blood under the skin), PERIPHERAL SWELLING (injection arm started to swell real bad; hand swelled really bad), ERYTHEMA (injection arm turned red), CONTUSION (injection arm was bruising) and HYPERTENSION (blood pressure was really high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: high (High) high blood pressure.         The patient did not go to hospital, instead went to her primary care doctor who said that bleeding under her skin and it is getting larger everyday; there is a complete band around her right forearm about 4-5 inches wide and 20 inches long. The patient saw the paramedics, her PCP, as well as the nurse at the site, as well as her surgeon who recommended she should go back to PCP to get some bloodwork done to check if she is bleeding elsewhere.  No treatment information was provided.; Sender's Comments: This case concerns a 60-year-old female with a serious unexpected event of hemorrhage subcutaneous, and nonserious unexpected contusion, erythema, peripheral swelling, hypertension. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: injection arm started to swell real bad; hand swelled really bad; injection arm turned red; injection arm was bruising; blood pressure was really high; bleeding under her skin (getting larger everyday); right hand completely with blood under the skin; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE SUBCUTANEOUS (bleeding under her skin (getting larger everyday); right hand completely with blood under the skin) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 040A21A) 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 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 08-Apr-2021, the patient experienced PERIPHERAL SWELLING (injection arm started to swell real bad; hand swelled really bad), ERYTHEMA (injection arm turned red), CONTUSION (injection arm was bruising) and HYPERTENSION (blood pressure was really high). In April 2021, the patient experienced HAEMORRHAGE SUBCUTANEOUS (bleeding under her skin (getting larger everyday); right hand completely with blood under the skin) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE SUBCUTANEOUS (bleeding under her skin (getting larger everyday); right hand completely with blood under the skin), PERIPHERAL SWELLING (injection arm started to swell real bad; hand swelled really bad), ERYTHEMA (injection arm turned red), CONTUSION (injection arm was bruising) and HYPERTENSION (blood pressure was really high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: high (High) high blood pressure.         The patient did not go to hospital, instead went to her primary care doctor who said that bleeding under her skin and it is getting larger everyday; there is a complete band around her right forearm about 4-5 inches wide and 20 inches long. The patient saw the paramedics, her PCP, as well as the nurse at the site, as well as her surgeon who recommended she should go back to PCP to get some bloodwork done to check if she is bleeding elsewhere.  No treatment information was provided.; Sender's Comments: This case concerns a 60-year-old female with a serious unexpected event of hemorrhage subcutaneous, and nonserious unexpected contusion, erythema, peripheral swelling, hypertension. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Platelet count, Platelet count decreased, Pyrexia, Rash
Clinical narrative: Platelets too low; Fever, 101.8F; Covid arm, rash at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLATELET COUNT DECREASED (Platelets too low) and PYREXIA (Fever, 101.8F) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bone marrow transplant (Patient had undergone bone marrow transplant 16 months ago.).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (Platelets too low) (seriousness criterion hospitalization), PYREXIA (Fever, 101.8F) (seriousness criterion hospitalization) and RASH (Covid arm, rash at injection site). At the time of the report, PLATELET COUNT DECREASED (Platelets too low), PYREXIA (Fever, 101.8F) and RASH (Covid arm, rash at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) 101.8 degree fahrenheit. On an unknown date, Platelet count: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient is hospitalized for further treatment. The case number is given to reporter and he is going to call back for those details. Gave consent for safety team to follow up.  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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: arm cannot stop bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (arm cannot stop bleeding) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (arm cannot stop bleeding) (seriousness criterion medically significant). At the time of the report, VACCINATION SITE HAEMORRHAGE (arm cannot stop bleeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unknown thyroid medication.   Treatment medications were not provided.  Very limited information regarding this event has been provided at this time. Further information has been requested. Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Fatigue, Vaccination site pain
Clinical narrative: arm was really sore; felt tired; passed away / she was dead; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (passed away / she was dead) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 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 VACCINATION SITE PAIN (arm was really sore) and FATIGUE (felt tired). The patient died on 13-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, VACCINATION SITE PAIN (arm was really sore) and FATIGUE (felt tired) outcome was unknown.       No treatment information was provided. No concomitant medications was provided.    Reporter did not allow further contact; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: arm was really sore; felt tired; passed away / she was dead; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (passed away / she was dead) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 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 VACCINATION SITE PAIN (arm was really sore) and FATIGUE (felt tired). The patient died on 13-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, VACCINATION SITE PAIN (arm was really sore) and FATIGUE (felt tired) outcome was unknown.       No treatment information was provided. No concomitant medications was provided.    Reporter did not allow further contact; Reported Cause(s) of Death: unknown cause of death
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Fatigue, Vaccination site pain
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 57-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 (Medical history was not reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 14-Apr-2021 The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information was provided. Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested. The cause of death was not reported. It is unknown if an autopsy was performed. Action taken with mRNA-1273 in response to the event was not applicable.; Sender's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested. The cause of death was not reported. It is unknown if an autopsy was performed.; Reported Cause(s) of Death: Unknown cause of death
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 57-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 (Medical history was not reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 14-Apr-2021 The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information was provided. Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested. The cause of death was not reported. It is unknown if an autopsy was performed. Action taken with mRNA-1273 in response to the event was not applicable.; Sender's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested. The cause of death was not reported. It is unknown if an autopsy was performed.; Reported Cause(s) of Death: Unknown cause of death
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Femur fracture
Clinical narrative: Slipped down; Left broken femur above the knee; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Slipped down) and FEMUR FRACTURE (Left broken femur above the knee) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Bone operation in April 2021.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced FALL (Slipped down) (seriousness criterion hospitalization) and FEMUR FRACTURE (Left broken femur above the knee) (seriousness criterion hospitalization). The patient was hospitalized from 01-Apr-2021 to 07-Apr-2021 due to FALL and FEMUR FRACTURE. At the time of the report, FALL (Slipped down) and FEMUR FRACTURE (Left broken femur above the knee) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was at nursing home at the time of reporting.  Concomitant product use was not provided by the reporter. No treatment information was provided.; 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: 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 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FACIAL PARALYSIS (Bell's palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's palsy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Soreness around her heart/chest wall pain; Soreness in left shoulder and around heart; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Soreness around her heart/chest wall pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for Covid-19 Vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDE, ACETAMINOPHEN, ALLOPURINOL, SIMVASTATIN, KETOCONAZOLE, FOLIC ACID, ALPRAZOLAM, PIOGLITAZONE HYDROCHLORIDE (ACTOS), MAGNESIUM OXIDE, TRIMETHOPRIM, MACROGOL 3350 (MIRALAX), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (FLUTICASONE PROPIONATE AND SALMETEROL) and DEXLANSOPRAZOLE (DEXILANT).  On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Apr-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Soreness around her heart/chest wall pain) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Soreness in left shoulder and around heart). On 13-Apr-2021, MUSCULOSKELETAL CHEST PAIN (Soreness around her heart/chest wall pain) and PAIN IN EXTREMITY (Soreness in left shoulder and around heart) outcome was unknown.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood test: 13-apr-2021 Inconclusive. On 13-Apr-2021, Chest X-ray: 13-apr-2021 Inconclusive. On 13-Apr-2021, Electrocardiogram: Inconclusive.  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.  Other Medication: oyster calcium tablet,Re senna  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. Further information has been 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. Further information has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, X-ray
Clinical narrative: Lung infection/ pneumonia/lower left lungs affected; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Lung infection/ pneumonia/lower left lungs affected) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037421B) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PNEUMONIA (Lung infection/ pneumonia/lower left lungs affected) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Lung infection/ pneumonia/lower left lungs affected) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: lower left lungs effected due to pneumonia (abnormal) Lower left lungs effected due to Pneumonia.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Patient was tested negative for COVID .He has not provided any concomitant medication information.The Patient has his 2 dose scheduled for 23 Apr 2021 and wants to know if he can extend the time frame to get his second dose. 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 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: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: 30 seconds after receiving the Moderna Vaccine patient passed out; Fell to floor after passing out; Body was stiff when fell to floor; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (30 seconds after receiving the Moderna Vaccine patient passed out) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A221A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Cephalexin). Concomitant products included VITAMIN B COMPLEX (VITAMIN B CO) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (30 seconds after receiving the Moderna Vaccine patient passed out) (seriousness criterion medically significant). 03-Apr-2021, the patient experienced FALL (Fell to floor after passing out) and MUSCULOSKELETAL STIFFNESS (Body was stiff when fell to floor). On 03-Apr-2021, LOSS OF CONSCIOUSNESS (30 seconds after receiving the Moderna Vaccine patient passed out), FALL (Fell to floor after passing out) and MUSCULOSKELETAL STIFFNESS (Body was stiff when fell to floor) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported mentioned that ambulance was called after the events and paramedics monitored the patient in the ambulance, patient had stable vital signs and it was offered it take him to the emergency room, but patient declined.; 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Retinal artery occlusion, Vision blurred
Clinical narrative: Renal left eye coagulation and couldn't see from left eye; Couldn't see from left eye; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL ARTERY OCCLUSION (Renal left eye coagulation and couldn't see from left eye) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included no adverse drug reaction (No Medical history reported.). Concomitant products included VITAMIN D [VITAMIN D NOS], VITAMIN E NOS and CENTRUM VITAMINTS.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced RETINAL ARTERY OCCLUSION (Renal left eye coagulation and couldn't see from left eye) (seriousness criterion medically significant) and VISION BLURRED (Couldn't see from left eye). At the time of the report, RETINAL ARTERY OCCLUSION (Renal left eye coagulation and couldn't see from left eye) and VISION BLURRED (Couldn't see from left eye) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Company Comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.   This case was linked; 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. Crossed linked
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary Embolism; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Pulmonary Embolism) in a 68-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 medical history reported).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-Mar-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary Embolism) (seriousness criterion hospitalization). The patient was hospitalized on 07-Mar-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary Embolism) outcome was unknown. Not Provided          Patient was prescribed Xarelto.  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. However, Very limited information regarding this event/s has been provided at this time.  Further information has been 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 event, a causal relationship cannot be excluded. However, Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium decreased, Dementia, Headache, Incontinence, Loss of consciousness
Clinical narrative: dementia; incontinency; passed out; 1 hour at home she was grabbing her head; She was responsive and was administered oxygen and taken to the Hospital; She was diagnosed as having low potassium; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out), HEADACHE (1 hour at home she was grabbing her head), OXYGEN CONSUMPTION (She was responsive and was administered oxygen and taken to the Hospital), BLOOD POTASSIUM DECREASED (She was diagnosed as having low potassium), DEMENTIA (dementia) and INCONTINENCE (incontinency) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).  Concomitant products included CARVEDILOL, AMLODIPINE, METOPROLOL, CLONIDINE and ATORVASTATIN for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 01-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criteria hospitalization and medically significant), HEADACHE (1 hour at home she was grabbing her head) (seriousness criterion hospitalization), OXYGEN CONSUMPTION (She was responsive and was administered oxygen and taken to the Hospital) (seriousness criterion hospitalization) and BLOOD POTASSIUM DECREASED (She was diagnosed as having low potassium) (seriousness criterion hospitalization). On an unknown date, the patient experienced DEMENTIA (dementia) (seriousness criterion hospitalization) and INCONTINENCE (incontinency) (seriousness criterion hospitalization). The patient was hospitalized on 01-Apr-2021 due to BLOOD POTASSIUM DECREASED, DEMENTIA, HEADACHE, INCONTINENCE, LOSS OF CONSCIOUSNESS and OXYGEN CONSUMPTION. At the time of the report, LOSS OF CONSCIOUSNESS (passed out), HEADACHE (1 hour at home she was grabbing her head), OXYGEN CONSUMPTION (She was responsive and was administered oxygen and taken to the Hospital), BLOOD POTASSIUM DECREASED (She was diagnosed as having low potassium), DEMENTIA (dementia) and INCONTINENCE (incontinency) had not resolved. Not Provided      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.   Patient was administered Oxygen by EMA, and taken to the ER (Emergency Room). Patient stayed over night at the Hospital. Patient is now admitted to a Nursing home.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Oxygen consumption
Clinical narrative: dementia; incontinency; passed out; 1 hour at home she was grabbing her head; She was responsive and was administered oxygen and taken to the Hospital; She was diagnosed as having low potassium; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out), HEADACHE (1 hour at home she was grabbing her head), OXYGEN CONSUMPTION (She was responsive and was administered oxygen and taken to the Hospital), BLOOD POTASSIUM DECREASED (She was diagnosed as having low potassium), DEMENTIA (dementia) and INCONTINENCE (incontinency) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).  Concomitant products included CARVEDILOL, AMLODIPINE, METOPROLOL, CLONIDINE and ATORVASTATIN for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 01-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criteria hospitalization and medically significant), HEADACHE (1 hour at home she was grabbing her head) (seriousness criterion hospitalization), OXYGEN CONSUMPTION (She was responsive and was administered oxygen and taken to the Hospital) (seriousness criterion hospitalization) and BLOOD POTASSIUM DECREASED (She was diagnosed as having low potassium) (seriousness criterion hospitalization). On an unknown date, the patient experienced DEMENTIA (dementia) (seriousness criterion hospitalization) and INCONTINENCE (incontinency) (seriousness criterion hospitalization). The patient was hospitalized on 01-Apr-2021 due to BLOOD POTASSIUM DECREASED, DEMENTIA, HEADACHE, INCONTINENCE, LOSS OF CONSCIOUSNESS and OXYGEN CONSUMPTION. At the time of the report, LOSS OF CONSCIOUSNESS (passed out), HEADACHE (1 hour at home she was grabbing her head), OXYGEN CONSUMPTION (She was responsive and was administered oxygen and taken to the Hospital), BLOOD POTASSIUM DECREASED (She was diagnosed as having low potassium), DEMENTIA (dementia) and INCONTINENCE (incontinency) had not resolved. Not Provided      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.   Patient was administered Oxygen by EMA, and taken to the ER (Emergency Room). Patient stayed over night at the Hospital. Patient is now admitted to a Nursing home.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded