chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Malaise
Clinical narrative: Been in and out of the hospital all year and with it's pressure to the roof; Haven't been able to work; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Been in and out of the hospital all year and with it's pressure to the roof) 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.     No medical history was provided by the reporter.  Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) for Diabetes, LISINOPRIL DIHYDRATE (LIZINOPRIL), AMLODIPINE BESILATE (NORVASC), PROPRANOLOL, PRAVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), FISH OIL and ARGININE HYDROCHLORIDE (L ARGININ) for an unknown indication, IRON.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced HYPERTENSION (Been in and out of the hospital all year and with it's pressure to the roof) (seriousness criterion hospitalization) and MALAISE (Haven't been able to work). The patient was treated with METOPROLOL for Hypertension, at an unspecified dose and frequency; CLONIDINE for Hypertension, at an unspecified dose and frequency and HYDRALAZINE for Hypertension, at an unspecified dose and frequency. On 21-Jan-2021, HYPERTENSION (Been in and out of the hospital all year and with it's pressure to the roof) outcome was unknown. At the time of the report, MALAISE (Haven't been able to work) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Blood pressure measurement: 187/83 (High) 187/83.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 18 Jan 2021, the patient was admitted to the hospital and discharged on 21 Jan 2021. Since then, the patient reported he has been to the emergency department (ED) 4 or 5 times.  Treatment medications also included Clonidine patch.  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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Functional gastrointestinal disorder, Illness, SARS-CoV-2 test
Clinical narrative: stroke; tested positive for Covid; Covid-19; lost bowel function; got sick  4 hours later; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 62-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 COVID-19 in December 2020. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included INSULIN DETEMIR (LEVEMIR) and INSULIN for Type 2 diabetes mellitus.    On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced FUNCTIONAL GASTROINTESTINAL DISORDER (lost bowel function) and ILLNESS (got sick  4 hours later). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), SARS-COV-2 TEST POSITIVE (tested positive for Covid) and COVID-19 (Covid-19). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), FUNCTIONAL GASTROINTESTINAL DISORDER (lost bowel function), ILLNESS (got sick  4 hours later), SARS-COV-2 TEST POSITIVE (tested positive for Covid) and COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.         The patient had stroke 2 days later to the second dose vaccination and was rushed/admitted to the ER for a while.  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. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273.   This case was linked to MOD-2021-117175 (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 events, a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: stroke; tested positive for Covid; Covid-19; lost bowel function; got sick  4 hours later; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 62-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 COVID-19 in December 2020. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included INSULIN DETEMIR (LEVEMIR) and INSULIN for Type 2 diabetes mellitus.    On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced FUNCTIONAL GASTROINTESTINAL DISORDER (lost bowel function) and ILLNESS (got sick  4 hours later). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), SARS-COV-2 TEST POSITIVE (tested positive for Covid) and COVID-19 (Covid-19). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), FUNCTIONAL GASTROINTESTINAL DISORDER (lost bowel function), ILLNESS (got sick  4 hours later), SARS-COV-2 TEST POSITIVE (tested positive for Covid) and COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.         The patient had stroke 2 days later to the second dose vaccination and was rushed/admitted to the ER for a while.  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. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273.   This case was linked to MOD-2021-117175 (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 events, a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dizziness, Electric shock sensation, Fatigue, Pain in extremity
Clinical narrative: tired; heart flutter; sore arm; dizziness; brain shocks; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (heart flutter) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Floppy mitral valve. Concurrent medical conditions included Allergy to antibiotic. Concomitant products included PARACETAMOL (TYLENOL), MULTIVITAMIN [VITAMINS NOS], MAGNESIUM, COLECALCIFEROL (VITAMIN D3), LORATADINE (CLARITINE), DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]), PROBIOTICS NOS and TURMERIC [CURCUMA LONGA RHIZOME] 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 CARDIAC FLUTTER (heart flutter) (seriousness criterion medically significant), PAIN IN EXTREMITY (sore arm), DIZZINESS (dizziness) and ELECTRIC SHOCK SENSATION (brain shocks). On an unknown date, the patient experienced FATIGUE (tired). On 02-Apr-2021, CARDIAC FLUTTER (heart flutter), PAIN IN EXTREMITY (sore arm), DIZZINESS (dizziness) and ELECTRIC SHOCK SENSATION (brain shocks) had resolved. At the time of the report, FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-121826, MOD21-089543, MOD-2021-121826 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Address updated, medical history updated; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blindness, Dizziness, Vision blurred
Clinical narrative: sees everything cloudy\her vision started getting blurry; She started problem with her balance 3 days later; Every time, she walks now, she feels dizzy; Eye vision was lost 3 days after the second dose of Moderna vaccine; stopped working by 75%; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Eye vision was lost 3 days after the second dose of Moderna vaccine; stopped working by 75%) in a 67-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.     No medical history concomitant information was provided.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced BLINDNESS (Eye vision was lost 3 days after the second dose of Moderna vaccine; stopped working by 75%) (seriousness criteria disability and medically significant). On 12-May-2021, the patient experienced DIZZINESS (Every time, she walks now, she feels dizzy). On an unknown date, the patient experienced VISION BLURRED (sees everything cloudy\her vision started getting blurry) and BALANCE DISORDER (She started problem with her balance 3 days later). At the time of the report, BLINDNESS (Eye vision was lost 3 days after the second dose of Moderna vaccine; stopped working by 75%) had not resolved and VISION BLURRED (sees everything cloudy\her vision started getting blurry), BALANCE DISORDER (She started problem with her balance 3 days later) and DIZZINESS (Every time, she walks now, she feels dizzy) outcome was unknown.            Concomitant and treatment information were not provided.  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 has been provided at this time. Further information has been requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-125380 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-MAY-2021.with  events are updated and reporter details was also provided.cross linked with-MOD21-089545; 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 has been provided at this time. Further information has been requested. US-MODERNATX, INC.-MOD-2021-125380:Cluster case for lot of people who got problems with their eyes
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Heart rate irregular
Clinical narrative: Died; irregular heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died) and HEART RATE IRREGULAR (irregular heartbeat) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 DEATH (Died) (seriousness criteria death and medically significant) and HEART RATE IRREGULAR (irregular heartbeat) (seriousness criterion medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HEART RATE IRREGULAR (irregular heartbeat) outcome was unknown.            Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable.  Company comment:Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Cause of death not reported.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Cause of death not reported.; Reported Cause(s) of Death: Died
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling abnormal, Head discomfort, Inflammation
Clinical narrative: trouble thinking; body is inflamed.; coughing; she feels that her brain is two big for her head; she feels as though her body wants to jump out of her skin; waves of shivers, feeling of chills; This spontaneous case was reported by a non-health professional and describes the occurrence of MENTAL IMPAIRMENT (trouble thinking) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Coeliac disease.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced MENTAL IMPAIRMENT (trouble thinking) (seriousness criterion medically significant), INFLAMMATION (body is inflamed.), COUGH (coughing), HEAD DISCOMFORT (she feels that her brain is two big for her head), FEELING ABNORMAL (she feels as though her body wants to jump out of her skin) and CHILLS (waves of shivers, feeling of chills). At the time of the report, MENTAL IMPAIRMENT (trouble thinking), INFLAMMATION (body is inflamed.), COUGH (coughing), HEAD DISCOMFORT (she feels that her brain is two big for her head), FEELING ABNORMAL (she feels as though her body wants to jump out of her skin) and CHILLS (waves of shivers, feeling of chills) outcome was unknown.            Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.; 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment
Clinical narrative: trouble thinking; body is inflamed.; coughing; she feels that her brain is two big for her head; she feels as though her body wants to jump out of her skin; waves of shivers, feeling of chills; This spontaneous case was reported by a non-health professional and describes the occurrence of MENTAL IMPAIRMENT (trouble thinking) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Coeliac disease.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced MENTAL IMPAIRMENT (trouble thinking) (seriousness criterion medically significant), INFLAMMATION (body is inflamed.), COUGH (coughing), HEAD DISCOMFORT (she feels that her brain is two big for her head), FEELING ABNORMAL (she feels as though her body wants to jump out of her skin) and CHILLS (waves of shivers, feeling of chills). At the time of the report, MENTAL IMPAIRMENT (trouble thinking), INFLAMMATION (body is inflamed.), COUGH (coughing), HEAD DISCOMFORT (she feels that her brain is two big for her head), FEELING ABNORMAL (she feels as though her body wants to jump out of her skin) and CHILLS (waves of shivers, feeling of chills) outcome was unknown.            Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.; 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure systolic, Diarrhoea, Fall, Hypotension, Illness
Clinical narrative: Passed out; Fell from bed; Low systolic blood pressure at 54mmhg; Arm soreness; Felt sick; Diarrhea; Something was cooking in lung; Productive coughs; Vomiting; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), FALL (Fell from bed) and HYPOTENSION (Low systolic blood pressure at 54mmhg) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Diabetes. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), ILLNESS (Felt sick), DIARRHOEA (Diarrhea), LUNG DISORDER (Something was cooking in lung), PRODUCTIVE COUGH (Productive coughs), VOMITING (Vomiting) and NAUSEA (Nausea). On 22-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria medically significant and life threatening), FALL (Fell from bed) (seriousness criterion life threatening) and HYPOTENSION (Low systolic blood pressure at 54mmhg) (seriousness criterion life threatening). On 21-Apr-2021, PAIN IN EXTREMITY (Arm soreness), DIARRHOEA (Diarrhea), LUNG DISORDER (Something was cooking in lung), PRODUCTIVE COUGH (Productive coughs), VOMITING (Vomiting) and NAUSEA (Nausea) had resolved, ILLNESS (Felt sick) outcome was unknown. On 22-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out), FALL (Fell from bed) and HYPOTENSION (Low systolic blood pressure at 54mmhg) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Blood pressure systolic: 54 mmHg (Low) Low systolic blood pressure at 54mmhg.         Physician treated him with fludrocortisone until he felt better for five days.; 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Lung disorder, Nausea, Pain in extremity, Productive cough
Clinical narrative: Passed out; Fell from bed; Low systolic blood pressure at 54mmhg; Arm soreness; Felt sick; Diarrhea; Something was cooking in lung; Productive coughs; Vomiting; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), FALL (Fell from bed) and HYPOTENSION (Low systolic blood pressure at 54mmhg) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Diabetes. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), ILLNESS (Felt sick), DIARRHOEA (Diarrhea), LUNG DISORDER (Something was cooking in lung), PRODUCTIVE COUGH (Productive coughs), VOMITING (Vomiting) and NAUSEA (Nausea). On 22-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria medically significant and life threatening), FALL (Fell from bed) (seriousness criterion life threatening) and HYPOTENSION (Low systolic blood pressure at 54mmhg) (seriousness criterion life threatening). On 21-Apr-2021, PAIN IN EXTREMITY (Arm soreness), DIARRHOEA (Diarrhea), LUNG DISORDER (Something was cooking in lung), PRODUCTIVE COUGH (Productive coughs), VOMITING (Vomiting) and NAUSEA (Nausea) had resolved, ILLNESS (Felt sick) outcome was unknown. On 22-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out), FALL (Fell from bed) and HYPOTENSION (Low systolic blood pressure at 54mmhg) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Blood pressure systolic: 54 mmHg (Low) Low systolic blood pressure at 54mmhg.         Physician treated him with fludrocortisone until he felt better for five days.; 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Passed out; Fell from bed; Low systolic blood pressure at 54mmhg; Arm soreness; Felt sick; Diarrhea; Something was cooking in lung; Productive coughs; Vomiting; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), FALL (Fell from bed) and HYPOTENSION (Low systolic blood pressure at 54mmhg) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Diabetes. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), ILLNESS (Felt sick), DIARRHOEA (Diarrhea), LUNG DISORDER (Something was cooking in lung), PRODUCTIVE COUGH (Productive coughs), VOMITING (Vomiting) and NAUSEA (Nausea). On 22-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria medically significant and life threatening), FALL (Fell from bed) (seriousness criterion life threatening) and HYPOTENSION (Low systolic blood pressure at 54mmhg) (seriousness criterion life threatening). On 21-Apr-2021, PAIN IN EXTREMITY (Arm soreness), DIARRHOEA (Diarrhea), LUNG DISORDER (Something was cooking in lung), PRODUCTIVE COUGH (Productive coughs), VOMITING (Vomiting) and NAUSEA (Nausea) had resolved, ILLNESS (Felt sick) outcome was unknown. On 22-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out), FALL (Fell from bed) and HYPOTENSION (Low systolic blood pressure at 54mmhg) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Blood pressure systolic: 54 mmHg (Low) Low systolic blood pressure at 54mmhg.         Physician treated him with fludrocortisone until he felt better for five days.; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Haemoptysis, Illness, Pneumonia, Pyrexia
Clinical narrative: pneumonia; blood coming like yellow; extremely sick; Covid-19; High Fever; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SPIRONOLACTONE and PAROXETINE HYDROCHLORIDE (PAXIL CR) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced ILLNESS (sick at home). On 16-Jan-2021, the patient experienced PYREXIA (High Fever). On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant), HAEMOPTYSIS (blood coming like yellow) (seriousness criterion hospitalization), ILLNESS (extremely sick) (seriousness criterion hospitalization) and COVID-19 (Covid-19). The patient was hospitalized from 25-Jan-2021 to 01-Feb-2021 due to HAEMOPTYSIS, ILLNESS and PNEUMONIA. At the time of the report, PNEUMONIA (pneumonia), HAEMOPTYSIS (blood coming like yellow), ILLNESS (extremely sick), ILLNESS (sick at home), PYREXIA (High Fever) and COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test: positive positive (Positive) 21Jan2021 she received positive covid- 19 result.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 17-Jan-2021 Patient  was prescribed steroid, Z-pack, and zinc for Treatment of the events and steroids and antibiotics for Covid-19   This case was linked to US-MODERNATX, INC.-MOD-2021-118681 (E2B Linked Report).; Sender's Comments: The vaccine does not cause or result in full blown COVID 19, thus the event is assessed as unlikely related to mRNA-1273. In addition, based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-118681:Cross linked to Dose 2
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: pneumonia; blood coming like yellow; extremely sick; Covid-19; High Fever; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SPIRONOLACTONE and PAROXETINE HYDROCHLORIDE (PAXIL CR) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced ILLNESS (sick at home). On 16-Jan-2021, the patient experienced PYREXIA (High Fever). On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant), HAEMOPTYSIS (blood coming like yellow) (seriousness criterion hospitalization), ILLNESS (extremely sick) (seriousness criterion hospitalization) and COVID-19 (Covid-19). The patient was hospitalized from 25-Jan-2021 to 01-Feb-2021 due to HAEMOPTYSIS, ILLNESS and PNEUMONIA. At the time of the report, PNEUMONIA (pneumonia), HAEMOPTYSIS (blood coming like yellow), ILLNESS (extremely sick), ILLNESS (sick at home), PYREXIA (High Fever) and COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test: positive positive (Positive) 21Jan2021 she received positive covid- 19 result.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 17-Jan-2021 Patient  was prescribed steroid, Z-pack, and zinc for Treatment of the events and steroids and antibiotics for Covid-19   This case was linked to US-MODERNATX, INC.-MOD-2021-118681 (E2B Linked Report).; Sender's Comments: The vaccine does not cause or result in full blown COVID 19, thus the event is assessed as unlikely related to mRNA-1273. In addition, based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-118681:Cross linked to Dose 2
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fall, Fatigue, Feeling hot, Head injury
Clinical narrative: Collapsed; Hit her head; Arm feeling more warm; Hot flashes; Arm feeling sore, and bothersome; Felt tired throughout the day; Fever; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 12-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Collapsed) and HEAD INJURY (Hit her head) in a 59-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.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced FALL (Collapsed) (seriousness criterion hospitalization), HEAD INJURY (Hit her head) (seriousness criterion hospitalization), FEELING HOT (Arm feeling more warm), HOT FLUSH (Hot flashes), MYALGIA (Arm feeling sore, and bothersome), FATIGUE (Felt tired throughout the day), PYREXIA (Fever) and CHILLS (Chills). The patient was hospitalized on 08-May-2021 due to FALL and HEAD INJURY. At the time of the report, FALL (Collapsed), HEAD INJURY (Hit her head), FEELING HOT (Arm feeling more warm), HOT FLUSH (Hot flashes), MYALGIA (Arm feeling sore, and bothersome), FATIGUE (Felt tired throughout the day), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.Treatment medication was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.   This case was linked to MOD-2021-118931 (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 events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Myalgia, Pyrexia
Clinical narrative: Collapsed; Hit her head; Arm feeling more warm; Hot flashes; Arm feeling sore, and bothersome; Felt tired throughout the day; Fever; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 12-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Collapsed) and HEAD INJURY (Hit her head) in a 59-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.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced FALL (Collapsed) (seriousness criterion hospitalization), HEAD INJURY (Hit her head) (seriousness criterion hospitalization), FEELING HOT (Arm feeling more warm), HOT FLUSH (Hot flashes), MYALGIA (Arm feeling sore, and bothersome), FATIGUE (Felt tired throughout the day), PYREXIA (Fever) and CHILLS (Chills). The patient was hospitalized on 08-May-2021 due to FALL and HEAD INJURY. At the time of the report, FALL (Collapsed), HEAD INJURY (Hit her head), FEELING HOT (Arm feeling more warm), HOT FLUSH (Hot flashes), MYALGIA (Arm feeling sore, and bothersome), FATIGUE (Felt tired throughout the day), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.Treatment medication was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.   This case was linked to MOD-2021-118931 (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 events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Hemiparesis, Hypoaesthesia, Lacunar infarction, Magnetic resonance imaging
Clinical narrative: Hemiparesis; Hypoaesthesia; Lacunar infarction; Neurological symptom; This case was received FDA VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of HEMIPARESIS (Hemiparesis), HYPOAESTHESIA (Hypoaesthesia), LACUNAR INFARCTION (Lacunar infarction) and NEUROLOGICAL SYMPTOM (Neurological symptom) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hyperlipidemia, Hypothyroidism and Drug allergy (Amoxicillin, sulfa, azithromycin). Concomitant products included AMLODIPINE, ATORVASTATIN, DILTIAZEM, LISINOPRIL, HYDROCHLOROTHIAZIDE and LEVOTHYROXINE for an unknown indication.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 02-Apr-2021, the patient experienced HEMIPARESIS (Hemiparesis) (seriousness criteria hospitalization and medically significant), HYPOAESTHESIA (Hypoaesthesia) (seriousness criterion hospitalization), LACUNAR INFARCTION (Lacunar infarction) (seriousness criteria hospitalization and medically significant) and NEUROLOGICAL SYMPTOM (Neurological symptom) (seriousness criterion hospitalization). At the time of the report, HEMIPARESIS (Hemiparesis), HYPOAESTHESIA (Hypoaesthesia), LACUNAR INFARCTION (Lacunar infarction) and NEUROLOGICAL SYMPTOM (Neurological symptom) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Computerised tomogram abnormal: 4/5 (abnormal) abnormal. On 02-Apr-2021, Magnetic resonance imaging: 4/5 (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   On 02 Apr 2021, the patient developed stroke like symptoms that included weakness and numbness of the right extremities. A primary care provided ordered an magnetic resonance imaging the following Monday which showed an acute lacunar infarct of the left periventricular white matter between the caudate nucleus and thalamus, likely embolic from untreated afibrillation and CHADS-VASC 4.  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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: Hemiparesis; Hypoaesthesia; Lacunar infarction; Neurological symptom; This case was received FDA VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of HEMIPARESIS (Hemiparesis), HYPOAESTHESIA (Hypoaesthesia), LACUNAR INFARCTION (Lacunar infarction) and NEUROLOGICAL SYMPTOM (Neurological symptom) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hyperlipidemia, Hypothyroidism and Drug allergy (Amoxicillin, sulfa, azithromycin). Concomitant products included AMLODIPINE, ATORVASTATIN, DILTIAZEM, LISINOPRIL, HYDROCHLOROTHIAZIDE and LEVOTHYROXINE for an unknown indication.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 02-Apr-2021, the patient experienced HEMIPARESIS (Hemiparesis) (seriousness criteria hospitalization and medically significant), HYPOAESTHESIA (Hypoaesthesia) (seriousness criterion hospitalization), LACUNAR INFARCTION (Lacunar infarction) (seriousness criteria hospitalization and medically significant) and NEUROLOGICAL SYMPTOM (Neurological symptom) (seriousness criterion hospitalization). At the time of the report, HEMIPARESIS (Hemiparesis), HYPOAESTHESIA (Hypoaesthesia), LACUNAR INFARCTION (Lacunar infarction) and NEUROLOGICAL SYMPTOM (Neurological symptom) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Computerised tomogram abnormal: 4/5 (abnormal) abnormal. On 02-Apr-2021, Magnetic resonance imaging: 4/5 (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   On 02 Apr 2021, the patient developed stroke like symptoms that included weakness and numbness of the right extremities. A primary care provided ordered an magnetic resonance imaging the following Monday which showed an acute lacunar infarct of the left periventricular white matter between the caudate nucleus and thalamus, likely embolic from untreated afibrillation and CHADS-VASC 4.  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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Embolism arterial, Feeling hot, Full blood count, Herpes zoster, Limb discomfort
Clinical narrative: Embolism arterial; Thrombosis; Herpes zoster; Limb discomfort; Pain in extremity; Feeling hot; This case was received via VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EMBOLISM ARTERIAL (Embolism arterial), THROMBOSIS (Thrombosis), HERPES ZOSTER (Herpes zoster), LIMB DISCOMFORT (Limb discomfort), PAIN IN EXTREMITY (Pain in extremity) and FEELING HOT (Feeling hot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 31-Mar-2021, the patient experienced EMBOLISM ARTERIAL (Embolism arterial) (seriousness criteria hospitalization and medically significant), THROMBOSIS (Thrombosis) (seriousness criteria hospitalization and medically significant), HERPES ZOSTER (Herpes zoster) (seriousness criterion hospitalization), LIMB DISCOMFORT (Limb discomfort) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Pain in extremity) (seriousness criterion hospitalization) and FEELING HOT (Feeling hot) (seriousness criterion hospitalization). At the time of the report, EMBOLISM ARTERIAL (Embolism arterial), THROMBOSIS (Thrombosis), HERPES ZOSTER (Herpes zoster), LIMB DISCOMFORT (Limb discomfort), PAIN IN EXTREMITY (Pain in extremity) and FEELING HOT (Feeling hot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Full blood count: unknown (Inconclusive) Unknown. On 31-Mar-2021, Ultrasound Doppler: unknown (Inconclusive) Unknown. On 31-Mar-2021, Whole body scan: unknown (Inconclusive) Unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient went to hospital because of blood clots and he had an emergency surgery. It was a huge arterial clot and developed shingles.  Action taken with mRNA-1273 in response to the events was not applicable.  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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis, Ultrasound Doppler, Whole body scan
Clinical narrative: Embolism arterial; Thrombosis; Herpes zoster; Limb discomfort; Pain in extremity; Feeling hot; This case was received via VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EMBOLISM ARTERIAL (Embolism arterial), THROMBOSIS (Thrombosis), HERPES ZOSTER (Herpes zoster), LIMB DISCOMFORT (Limb discomfort), PAIN IN EXTREMITY (Pain in extremity) and FEELING HOT (Feeling hot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 31-Mar-2021, the patient experienced EMBOLISM ARTERIAL (Embolism arterial) (seriousness criteria hospitalization and medically significant), THROMBOSIS (Thrombosis) (seriousness criteria hospitalization and medically significant), HERPES ZOSTER (Herpes zoster) (seriousness criterion hospitalization), LIMB DISCOMFORT (Limb discomfort) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Pain in extremity) (seriousness criterion hospitalization) and FEELING HOT (Feeling hot) (seriousness criterion hospitalization). At the time of the report, EMBOLISM ARTERIAL (Embolism arterial), THROMBOSIS (Thrombosis), HERPES ZOSTER (Herpes zoster), LIMB DISCOMFORT (Limb discomfort), PAIN IN EXTREMITY (Pain in extremity) and FEELING HOT (Feeling hot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Full blood count: unknown (Inconclusive) Unknown. On 31-Mar-2021, Ultrasound Doppler: unknown (Inconclusive) Unknown. On 31-Mar-2021, Whole body scan: unknown (Inconclusive) Unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient went to hospital because of blood clots and he had an emergency surgery. It was a huge arterial clot and developed shingles.  Action taken with mRNA-1273 in response to the events was not applicable.  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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Electrocardiogram, Loss of consciousness
Clinical narrative: Blacked out unconsciousness following her first dose of Consentyx; This spontaneous case was reported by an other and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out unconsciousness following her first dose of Consentyx) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product SECUKINUMAB (COSENTYX) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and SECUKINUMAB (COSENTYX) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out unconsciousness following her first dose of Consentyx) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out unconsciousness following her first dose of Consentyx) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Electrocardiogram: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: Very limited information regarding this events has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested