chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Computerised tomogram head, Hypoaesthesia oral, Magnetic resonance imaging
Clinical narrative: Small blood clot on the left side of the brain/ 2 others on additional on the right side of the brain; Numbness in the right side of mouth; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL THROMBOSIS (Small blood clot on the left side of the brain/ 2 others on additional on the right side of the brain) and HYPOAESTHESIA ORAL (Numbness in the right side of mouth) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBRAL THROMBOSIS (Small blood clot on the left side of the brain/ 2 others on additional on the right side of the brain) (seriousness criteria medically significant and life threatening) and HYPOAESTHESIA ORAL (Numbness in the right side of mouth) (seriousness criterion medically significant). At the time of the report, CEREBRAL THROMBOSIS (Small blood clot on the left side of the brain/ 2 others on additional on the right side of the brain) and HYPOAESTHESIA ORAL (Numbness in the right side of mouth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram head: abnormal (abnormal) Small blood clot on the left side of brain. In 2021, Magnetic resonance imaging: abnormal (abnormal) 2 others on additional on the right side of the brain.         No relevant concomitant medication information provided. No relevant treatment information provided.  Patient received both vaccine doses. About 3 weeks after the second dose, the patient experienced numbness in the right side of their mouth with no other signs of a stroke. Per patient, there was no apparent reason for the strokes and the diagnostics were normal.  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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Death, Dyspnoea, Joint swelling
Clinical narrative: lungs filled up with fluids; terrible pain in his back; couldn't lay had to sleep sat down; swelling of his ankles; swelling of his hands; shortness of breath; chills; died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (died) and PULMONARY OEDEMA (lungs filled up with fluids) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Diabetes.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (lungs filled up with fluids) (seriousness criterion medically significant), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY OEDEMA (lungs filled up with fluids), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills) outcome was unknown.            No treatment medication was provided.  Patient took concomitant medication for Blood pressure and Diabetes.; Sender's Comments: This is case of death in a 72-year-old male patient with medical history of blood pressure and diabetes who died more than a month after receiving the mRNA-1273 vaccine. Cause of death was not reported. Very limited information regarding the event has been provided at this time.  Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Peripheral swelling, Pulmonary oedema
Clinical narrative: lungs filled up with fluids; terrible pain in his back; couldn't lay had to sleep sat down; swelling of his ankles; swelling of his hands; shortness of breath; chills; died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (died) and PULMONARY OEDEMA (lungs filled up with fluids) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Diabetes.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (lungs filled up with fluids) (seriousness criterion medically significant), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY OEDEMA (lungs filled up with fluids), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills) outcome was unknown.            No treatment medication was provided.  Patient took concomitant medication for Blood pressure and Diabetes.; Sender's Comments: This is case of death in a 72-year-old male patient with medical history of blood pressure and diabetes who died more than a month after receiving the mRNA-1273 vaccine. Cause of death was not reported. Very limited information regarding the event has been provided at this time.  Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Pulmonary congestion, Sinusitis
Clinical narrative: Congestion of lungs; Developed sinus like infection; Shortness of breath; Coughing; Sneezing; Feels dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Congestion of lungs) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), ALPRAZOLAM (XANAX) and CLONAZEPAM (CLONOPIN) for an unknown indication.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jul-2021, the patient experienced PULMONARY CONGESTION (Congestion of lungs) (seriousness criterion medically significant), SINUSITIS (Developed sinus like infection), DYSPNOEA (Shortness of breath), COUGH (Coughing), SNEEZING (Sneezing) and DIZZINESS (Feels dizzy). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PULMONARY CONGESTION (Congestion of lungs), SINUSITIS (Developed sinus like infection), DYSPNOEA (Shortness of breath), COUGH (Coughing), SNEEZING (Sneezing) and DIZZINESS (Feels dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Sinus infection medicine along with other medications.  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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Congestion of lungs; Developed sinus like infection; Shortness of breath; Coughing; Sneezing; Feels dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Congestion of lungs) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), ALPRAZOLAM (XANAX) and CLONAZEPAM (CLONOPIN) for an unknown indication.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jul-2021, the patient experienced PULMONARY CONGESTION (Congestion of lungs) (seriousness criterion medically significant), SINUSITIS (Developed sinus like infection), DYSPNOEA (Shortness of breath), COUGH (Coughing), SNEEZING (Sneezing) and DIZZINESS (Feels dizzy). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PULMONARY CONGESTION (Congestion of lungs), SINUSITIS (Developed sinus like infection), DYSPNOEA (Shortness of breath), COUGH (Coughing), SNEEZING (Sneezing) and DIZZINESS (Feels dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Sinus infection medicine along with other medications.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Bladder disorder, Dizziness, Pain, Somnambulism
Clinical narrative: fainting; pain; sleep walking; dizziness; Anemia; was very thirsty/drank lots of water, around 2-3 gallons a day; three interventions on her bladder; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainting), PAIN (pain), SOMNAMBULISM (sleep walking), DIZZINESS (dizziness), ANAEMIA (Anemia), THIRST (was very thirsty/drank lots of water, around 2-3 gallons a day) and BLADDER DISORDER (three interventions on her bladder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bladder disorder.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainting) (seriousness criteria hospitalization and medically significant), PAIN (pain) (seriousness criterion hospitalization), SOMNAMBULISM (sleep walking) (seriousness criterion hospitalization), DIZZINESS (dizziness) (seriousness criterion hospitalization), ANAEMIA (Anemia) (seriousness criterion hospitalization), THIRST (was very thirsty/drank lots of water, around 2-3 gallons a day) (seriousness criterion hospitalization) and BLADDER DISORDER (three interventions on her bladder) (seriousness criterion hospitalization). At the time of the report, SYNCOPE (fainting), PAIN (pain), SOMNAMBULISM (sleep walking), DIZZINESS (dizziness), ANAEMIA (Anemia), THIRST (was very thirsty/drank lots of water, around 2-3 gallons a day) and BLADDER DISORDER (three interventions on her bladder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Thirst
Clinical narrative: fainting; pain; sleep walking; dizziness; Anemia; was very thirsty/drank lots of water, around 2-3 gallons a day; three interventions on her bladder; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainting), PAIN (pain), SOMNAMBULISM (sleep walking), DIZZINESS (dizziness), ANAEMIA (Anemia), THIRST (was very thirsty/drank lots of water, around 2-3 gallons a day) and BLADDER DISORDER (three interventions on her bladder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bladder disorder.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainting) (seriousness criteria hospitalization and medically significant), PAIN (pain) (seriousness criterion hospitalization), SOMNAMBULISM (sleep walking) (seriousness criterion hospitalization), DIZZINESS (dizziness) (seriousness criterion hospitalization), ANAEMIA (Anemia) (seriousness criterion hospitalization), THIRST (was very thirsty/drank lots of water, around 2-3 gallons a day) (seriousness criterion hospitalization) and BLADDER DISORDER (three interventions on her bladder) (seriousness criterion hospitalization). At the time of the report, SYNCOPE (fainting), PAIN (pain), SOMNAMBULISM (sleep walking), DIZZINESS (dizziness), ANAEMIA (Anemia), THIRST (was very thirsty/drank lots of water, around 2-3 gallons a day) and BLADDER DISORDER (three interventions on her bladder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Bradycardia, Chest discomfort, Dizziness
Clinical narrative: patient very nearly loss consciousness and fell on the floor; felt worse; malaise; light headed / dizziness; felt pressure in his  chest; weakness; more  fatigue/extreme  fatigue; bradycardia effect / heart rate was 37 / slower heart rate; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (patient very nearly loss consciousness and fell on the floor) and BRADYCARDIA (bradycardia effect / heart rate was 37 / slower heart rate) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN and SUMATRIPTAN SUCCINATE (IMITREX [SUMATRIPTAN SUCCINATE]) for Migraine, MELOXICAM for Tennis elbow.   On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced BRADYCARDIA (bradycardia effect / heart rate was 37 / slower heart rate) (seriousness criterion medically significant), MALAISE (malaise), DIZZINESS (light headed / dizziness), CHEST DISCOMFORT (felt pressure in his  chest), ASTHENIA (weakness) and FATIGUE (more  fatigue/extreme  fatigue). On 01-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (patient very nearly loss consciousness and fell on the floor) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (felt worse). At the time of the report, LOSS OF CONSCIOUSNESS (patient very nearly loss consciousness and fell on the floor), BRADYCARDIA (bradycardia effect / heart rate was 37 / slower heart rate), FEELING ABNORMAL (felt worse), MALAISE (malaise), DIZZINESS (light headed / dizziness), CHEST DISCOMFORT (felt pressure in his  chest), ASTHENIA (weakness) and FATIGUE (more  fatigue/extreme  fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Heart rate: 37 37. On 01-Jul-2021, Blood pressure measurement: Abnormal. On 01-Jul-2021, Echocardiogram: dilation and leaky valve Dilation and leaky valve. On 01-Jul-2021, Heart rate: Normal resting heart rate was 62-64, now its 49-50. Patients standing and walking used to be 75-85, now its 58-57 (standing), 60 (walking).    Patient said that over the last two months his sleeping Heart Rate was 42 to 43 and dipped down to 39 sometimes. No treatment drug details was reported.   This case was linked to MOD-2021-253997 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Fatigue, Feeling abnormal, Heart rate, Loss of consciousness
Clinical narrative: patient very nearly loss consciousness and fell on the floor; felt worse; malaise; light headed / dizziness; felt pressure in his  chest; weakness; more  fatigue/extreme  fatigue; bradycardia effect / heart rate was 37 / slower heart rate; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (patient very nearly loss consciousness and fell on the floor) and BRADYCARDIA (bradycardia effect / heart rate was 37 / slower heart rate) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN and SUMATRIPTAN SUCCINATE (IMITREX [SUMATRIPTAN SUCCINATE]) for Migraine, MELOXICAM for Tennis elbow.   On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced BRADYCARDIA (bradycardia effect / heart rate was 37 / slower heart rate) (seriousness criterion medically significant), MALAISE (malaise), DIZZINESS (light headed / dizziness), CHEST DISCOMFORT (felt pressure in his  chest), ASTHENIA (weakness) and FATIGUE (more  fatigue/extreme  fatigue). On 01-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (patient very nearly loss consciousness and fell on the floor) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (felt worse). At the time of the report, LOSS OF CONSCIOUSNESS (patient very nearly loss consciousness and fell on the floor), BRADYCARDIA (bradycardia effect / heart rate was 37 / slower heart rate), FEELING ABNORMAL (felt worse), MALAISE (malaise), DIZZINESS (light headed / dizziness), CHEST DISCOMFORT (felt pressure in his  chest), ASTHENIA (weakness) and FATIGUE (more  fatigue/extreme  fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Heart rate: 37 37. On 01-Jul-2021, Blood pressure measurement: Abnormal. On 01-Jul-2021, Echocardiogram: dilation and leaky valve Dilation and leaky valve. On 01-Jul-2021, Heart rate: Normal resting heart rate was 62-64, now its 49-50. Patients standing and walking used to be 75-85, now its 58-57 (standing), 60 (walking).    Patient said that over the last two months his sleeping Heart Rate was 42 to 43 and dipped down to 39 sometimes. No treatment drug details was reported.   This case was linked to MOD-2021-253997 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: patient very nearly loss consciousness and fell on the floor; felt worse; malaise; light headed / dizziness; felt pressure in his  chest; weakness; more  fatigue/extreme  fatigue; bradycardia effect / heart rate was 37 / slower heart rate; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (patient very nearly loss consciousness and fell on the floor) and BRADYCARDIA (bradycardia effect / heart rate was 37 / slower heart rate) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN and SUMATRIPTAN SUCCINATE (IMITREX [SUMATRIPTAN SUCCINATE]) for Migraine, MELOXICAM for Tennis elbow.   On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced BRADYCARDIA (bradycardia effect / heart rate was 37 / slower heart rate) (seriousness criterion medically significant), MALAISE (malaise), DIZZINESS (light headed / dizziness), CHEST DISCOMFORT (felt pressure in his  chest), ASTHENIA (weakness) and FATIGUE (more  fatigue/extreme  fatigue). On 01-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (patient very nearly loss consciousness and fell on the floor) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (felt worse). At the time of the report, LOSS OF CONSCIOUSNESS (patient very nearly loss consciousness and fell on the floor), BRADYCARDIA (bradycardia effect / heart rate was 37 / slower heart rate), FEELING ABNORMAL (felt worse), MALAISE (malaise), DIZZINESS (light headed / dizziness), CHEST DISCOMFORT (felt pressure in his  chest), ASTHENIA (weakness) and FATIGUE (more  fatigue/extreme  fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Heart rate: 37 37. On 01-Jul-2021, Blood pressure measurement: Abnormal. On 01-Jul-2021, Echocardiogram: dilation and leaky valve Dilation and leaky valve. On 01-Jul-2021, Heart rate: Normal resting heart rate was 62-64, now its 49-50. Patients standing and walking used to be 75-85, now its 58-57 (standing), 60 (walking).    Patient said that over the last two months his sleeping Heart Rate was 42 to 43 and dipped down to 39 sometimes. No treatment drug details was reported.   This case was linked to MOD-2021-253997 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nausea
Clinical narrative: Nausea; 3 weeks after, the 2nd dose was given; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a female 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.     No Medical History information was reported.   In April 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) (unknown route) 1 dosage form. In April 2021, the patient experienced NAUSEA (Nausea) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 weeks after, the 2nd dose was given). At the time of the report, NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 weeks after, the 2nd dose was given) had resolved.            Concomitant medications were not reported. The patient was treated with unspecified medications for nausea.  On an unknown date, the patient had nausea after the vaccination which resolved after 24 hours. 3 weeks later, the patient had  the 2nd dose of the vaccine and since then had nausea. The patient was hospitalized twice due to the nausea and consulted with physician but the medications that were being given to the patient were not helping.  This report refers to a case of wrong schedule of product for mRNA-1273, lot # unknown with associated AE Nausea. Very limited information regarding the event Nausea has been provided at this time. Further information is not expected.   This case was linked to MOD-2021-254392 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This report refers to a case of wrong schedule of product for mRNA-1273, lot # unknown with associated AE Nausea. Very limited information regarding the event Nausea has been provided at this time. Further information is not expected.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Blindness, Deafness, Hypotension, Loss of consciousness
Clinical narrative: collapsed on the spot when she got second vaccine; lost her hearing/Got her hearing back; lost her vision; Blood pressure dangerously low/Blood pressure went back to normal 20 minutes later; a week later she followed up with her HCPs and primary care physician and it was determined that this was an allergic reaction to the Moderna Vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONSCIOUSNESS (collapsed on the spot when she got second vaccine) in a female 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.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (collapsed on the spot when she got second vaccine) (seriousness criterion medically significant), DEAFNESS (lost her hearing/Got her hearing back), BLINDNESS (lost her vision), HYPOTENSION (Blood pressure dangerously low/Blood pressure went back to normal 20 minutes later) and ALLERGY TO VACCINE (a week later she followed up with her HCPs and primary care physician and it was determined that this was an allergic reaction to the Moderna Vaccine). At the time of the report, LOSS OF CONSCIOUSNESS (collapsed on the spot when she got second vaccine), DEAFNESS (lost her hearing/Got her hearing back), BLINDNESS (lost her vision), HYPOTENSION (Blood pressure dangerously low/Blood pressure went back to normal 20 minutes later) and ALLERGY TO VACCINE (a week later she followed up with her HCPs and primary care physician and it was determined that this was an allergic reaction to the Moderna Vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) Blood pressure dangerously low/Blood pressure went back to normal 20 minutes later. On an unknown date, Scan brain: normal (normal) Normal.   No concomitant medication was reported.  No treatment medication was reported.  Company comment: Based on current available information and the temporal association between product use and the start dat of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start dat of the events a causal relationship cannot be excluded.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Myalgia, Pruritus
Clinical narrative: It got progressively worse & got hives; Both arms started itching, mostly the left at first; Lethargy; Soreness in left arm; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (It got progressively worse & got hives), PRURITUS (Both arms started itching, mostly the left at first), LETHARGY (Lethargy), MYALGIA (Soreness in left arm), HEADACHE (Headache) and CHILLS (Chills) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced LETHARGY (Lethargy) (seriousness criterion medically significant), MYALGIA (Soreness in left arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 02-Apr-2021, the patient experienced URTICARIA (It got progressively worse & got hives) (seriousness criterion medically significant) and PRURITUS (Both arms started itching, mostly the left at first) (seriousness criterion medically significant). The patient was treated with PREDNISONE on 05-Apr-2021 at a dose of 20 milligram and PREDNISONE on 14-Apr-2021 at a dose of 10 milligram. At the time of the report, URTICARIA (It got progressively worse & got hives), PRURITUS (Both arms started itching, mostly the left at first), LETHARGY (Lethargy), MYALGIA (Soreness in left arm), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by reporter.  On 05 Apr 2021, the patient went to the Emergency Room and was prescribed Prednisone 20 mg 2 tabs daily for four days. The hives went away after the 4th day but came right back.  On 14 Apr 2021, the patient went to the dermatologist. At that time the hives continued and were spread on quads, calves, hands and back. The dermatologist prescribed Prednisone 10mg with titrating dose over two weeks.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-254133 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Non significant follow up appended; 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: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: It got progressively worse & got hives; Both arms started itching, mostly the left at first; Lethargy; Soreness in left arm; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (It got progressively worse & got hives), PRURITUS (Both arms started itching, mostly the left at first), LETHARGY (Lethargy), MYALGIA (Soreness in left arm), HEADACHE (Headache) and CHILLS (Chills) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced LETHARGY (Lethargy) (seriousness criterion medically significant), MYALGIA (Soreness in left arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 02-Apr-2021, the patient experienced URTICARIA (It got progressively worse & got hives) (seriousness criterion medically significant) and PRURITUS (Both arms started itching, mostly the left at first) (seriousness criterion medically significant). The patient was treated with PREDNISONE on 05-Apr-2021 at a dose of 20 milligram and PREDNISONE on 14-Apr-2021 at a dose of 10 milligram. At the time of the report, URTICARIA (It got progressively worse & got hives), PRURITUS (Both arms started itching, mostly the left at first), LETHARGY (Lethargy), MYALGIA (Soreness in left arm), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by reporter.  On 05 Apr 2021, the patient went to the Emergency Room and was prescribed Prednisone 20 mg 2 tabs daily for four days. The hives went away after the 4th day but came right back.  On 14 Apr 2021, the patient went to the dermatologist. At that time the hives continued and were spread on quads, calves, hands and back. The dermatologist prescribed Prednisone 10mg with titrating dose over two weeks.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-254133 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Non significant follow up appended; 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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Lipoma, Mastitis, Skin discolouration, Vaccination site erythema
Clinical narrative: Mastitis in size of "egg" and "hot"; Lipoma; turned to brown like sun burn; Received antibiotics and she had harsh reaction to it; Itchy arm; "ed and itchy little dots" at the site of the injection which also relocated on her arm and turned to brown like "sun burn"; This spontaneous case was reported by a consumer and describes the occurrence of MASTITIS (Mastitis in size of "egg" and "hot") in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to Celebrex), Drug allergy (Allergy to Codeine), Allergy to antibiotic (Allergy to Erythromycin), Drug allergy (Allergy to Viax), Allergy to antibiotic (Allergy to Cefoxitin), Drug allergy (Allergy to Valdecoxib) and Infection. Concomitant products included AMLODIPINE, ROSUVASTATIN CALCIUM (CRESTOR), VALSARTAN (DIOVAN), HYDROCHLOROTHIAZIDE, METFORMIN, TRIAMCINOLONE and AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVUNATE POTASSIUM) for an unknown indication.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-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 MASTITIS (Mastitis in size of "egg" and "hot") (seriousness criterion medically significant), LIPOMA (Lipoma), SKIN DISCOLOURATION (turned to brown like sun burn), ADVERSE DRUG REACTION (Received antibiotics and she had harsh reaction to it), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA ("ed and itchy little dots" at the site of the injection which also relocated on her arm and turned to brown like "sun burn"). At the time of the report, MASTITIS (Mastitis in size of "egg" and "hot"), LIPOMA (Lipoma), SKIN DISCOLOURATION (turned to brown like sun burn), ADVERSE DRUG REACTION (Received antibiotics and she had harsh reaction to it), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA ("ed and itchy little dots" at the site of the injection which also relocated on her arm and turned to brown like "sun burn") outcome was unknown.            No relevant concomitant medications were reported. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.   This case was linked to MOD-2021-214864 (Patient Link).; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Mastitis in size of "egg" and "hot"; Lipoma; turned to brown like sun burn; Received antibiotics and she had harsh reaction to it; Itchy arm; "ed and itchy little dots" at the site of the injection which also relocated on her arm and turned to brown like "sun burn"; This spontaneous case was reported by a consumer and describes the occurrence of MASTITIS (Mastitis in size of "egg" and "hot") in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to Celebrex), Drug allergy (Allergy to Codeine), Allergy to antibiotic (Allergy to Erythromycin), Drug allergy (Allergy to Viax), Allergy to antibiotic (Allergy to Cefoxitin), Drug allergy (Allergy to Valdecoxib) and Infection. Concomitant products included AMLODIPINE, ROSUVASTATIN CALCIUM (CRESTOR), VALSARTAN (DIOVAN), HYDROCHLOROTHIAZIDE, METFORMIN, TRIAMCINOLONE and AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVUNATE POTASSIUM) for an unknown indication.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-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 MASTITIS (Mastitis in size of "egg" and "hot") (seriousness criterion medically significant), LIPOMA (Lipoma), SKIN DISCOLOURATION (turned to brown like sun burn), ADVERSE DRUG REACTION (Received antibiotics and she had harsh reaction to it), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA ("ed and itchy little dots" at the site of the injection which also relocated on her arm and turned to brown like "sun burn"). At the time of the report, MASTITIS (Mastitis in size of "egg" and "hot"), LIPOMA (Lipoma), SKIN DISCOLOURATION (turned to brown like sun burn), ADVERSE DRUG REACTION (Received antibiotics and she had harsh reaction to it), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA ("ed and itchy little dots" at the site of the injection which also relocated on her arm and turned to brown like "sun burn") outcome was unknown.            No relevant concomitant medications were reported. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.   This case was linked to MOD-2021-214864 (Patient Link).; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation, Product dose omission issue, Vaccination site swelling
Clinical narrative: She was in the hospital; Greater than 35 days since the patient received her first Moderna Covid-19 vaccine; Swelling in right arm injection site area; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (She was in the hospital) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swelling in right arm injection site area). On an unknown date, the patient experienced HOSPITALISATION (She was in the hospital) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient received her first Moderna Covid-19 vaccine). At the time of the report, HOSPITALISATION (She was in the hospital), PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient received her first Moderna Covid-19 vaccine) and VACCINATION SITE SWELLING (Swelling in right arm injection site area) 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.  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.  Further information about the event hospitalization has been requested.  This report refers to a case of product dose omission for mRNA-1273, lot # 037B21A.; 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.  Further information about the event hospitalization has been requested.  This report refers to a case of product dose omission for mRNA-1273, lot # 037B21A.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nausea
Clinical narrative: Nausea; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NAUSEA (Nausea) in a female 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.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, NAUSEA (Nausea) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No concomitant medications were reported. Treatment details included unspecified medications for nausea.  Very limited information regarding the events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-254067 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Toxicity to various agents
Clinical narrative: Toxic effects of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TOXICITY TO VARIOUS AGENTS (Toxic effects of Moderna vaccine) in a 26-year-old male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOXICITY TO VARIOUS AGENTS (Toxic effects of Moderna vaccine) (seriousness criterion death). The reported cause of death was toxic effects of moderna vaccine. It is unknown if an autopsy was performed.            No relevant concomitant medications were reported.  No treatment information was provided.  Company comment: Very limited information regarding this event has been provided at this time. Critical details including medical history, concomitant medication, date of vaccine administration and the event term, and cause of death is required for further assessment.; Sender's Comments: Very limited information regarding this event has been provided at this time. Critical details including medical history, concomitant medication, date of vaccine administration and the event term, and cause of death is required for further assessment.; Reported Cause(s) of Death: Toxic effects of Moderna vaccine
Age: 66.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis flare up; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis flare up.    The patient's past medical history included Rheumatoid arthritis since an unknown date.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) UNK dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE ACETATE (DEPOMEDROL) for Rheumatoid arthritis flare up, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not reported.  Very limited information regarding this event has been provided at this time. Further information will be requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-197904 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information will be requested. US-MODERNATX, INC.-MOD-2021-197904:Dose 1 Case