chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Communication disorder, Inappropriate schedule of product administration, Pneumonia, Urinary tract infection
Clinical narrative: pneumonia; urinary tract infection (UTI); talking nonsense and not being clear; The reason the patient did not have the second dose one month from the first dose is because she got ill; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia), URINARY TRACT INFECTION (urinary tract infection (UTI)) and COMMUNICATION DISORDER (talking nonsense and not being clear) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medication history was provided). Concomitant products included ASCORBIC ACID, BETACAROTENE, COPPER, TOCOFERSOLAN, ZINC (OCUVITE [ASCORBIC ACID;BETACAROTENE;COPPER;TOCOFERSOLAN;ZINC]), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), METOPROLOL TARTRATE (METOPROLOL TARTRATE ACCORD), CLOPIDOGREL and DULOXETINE for an unknown indication, ACETYLSALICYLIC ACID (ASPIRIN 81).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion hospitalization), URINARY TRACT INFECTION (urinary tract infection (UTI)) (seriousness criterion hospitalization), COMMUNICATION DISORDER (talking nonsense and not being clear) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The reason the patient did not have the second dose one month from the first dose is because she got ill). At the time of the report, PNEUMONIA (pneumonia), URINARY TRACT INFECTION (urinary tract infection (UTI)), COMMUNICATION DISORDER (talking nonsense and not being clear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The reason the patient did not have the second dose one month from the first dose is because she got ill) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       While hospitalized she was diagnosed and treated for a UTI, with intravenous fluids and antibiotics. Patient was discharged from the hospital with Foley's catheter and rehabilitation was advised. While hospitalized she was due for her second dose but she got pneumonia, so she was not given the second dose. The reporter assumes the pneumonia was bacterial, because the patient was treated with antibiotics.  Very limited information regarding the events has been provided. Further information was requested.; Sender's Comments: Very limited information regarding the events has been provided. Further information was requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced COVID-19 (covid-19) (seriousness criterion hospitalization). At the time of the report, COVID-19 (covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.         Treatment information was not provided. Concomitant medications were not reported.  Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the event of COVID-19, is assessed as unlikely related.  Further information has been requested.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the event of COVID-19, is assessed as unlikely related.  Further information has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Oropharyngeal discomfort
Clinical narrative: lost hearing in his left ear; felt like something entered into his ear; [felt like something entered into his ear] and went down his throat; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (lost hearing in his left ear) in a 52-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 Insulin-requiring type II diabetes mellitus (insulin -dependent). Concomitant products included DOXYCYCLINE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DEAFNESS (lost hearing in his left ear) (seriousness criterion medically significant), EAR DISCOMFORT (felt like something entered into his ear) and OROPHARYNGEAL DISCOMFORT ([felt like something entered into his ear] and went down his throat). At the time of the report, DEAFNESS (lost hearing in his left ear), EAR DISCOMFORT (felt like something entered into his ear) and OROPHARYNGEAL DISCOMFORT ([felt like something entered into his ear] and went down his throat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Somnolence
Clinical narrative: Lethargic/ felt extremely weak lethargic/m body shut down; sleepy; lost appetite; couldn't use bathroom, open her eyes, or eat; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Lethargic/ felt extremely weak lethargic/m body shut down), SOMNOLENCE (sleepy), DECREASED APPETITE (lost appetite) and FEELING ABNORMAL (couldn't use bathroom, open her eyes, or eat) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (Lethargic/ felt extremely weak lethargic/m body shut down) (seriousness criteria hospitalization, disability and medically significant), SOMNOLENCE (sleepy) (seriousness criterion hospitalization), DECREASED APPETITE (lost appetite) (seriousness criterion hospitalization) and FEELING ABNORMAL (couldn't use bathroom, open her eyes, or eat) (seriousness criterion hospitalization). The patient was hospitalized on 09-Mar-2021 due to DECREASED APPETITE, FATIGUE, FEELING ABNORMAL and SOMNOLENCE. At the time of the report, FATIGUE (Lethargic/ felt extremely weak lethargic/m body shut down), SOMNOLENCE (sleepy), DECREASED APPETITE (lost appetite) and FEELING ABNORMAL (couldn't use bathroom, open her eyes, or eat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact; Sender's Comments: This case concerns a 91-year-old female hospitalized with serious unexpected events of fatigue, somnolence, decrease appetite, and feeling abnormal. Event onset Day 1 after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Nausea, Vaccination site bruising, Vaccination site pain, Vaccination site pruritus
Clinical narrative: The injection site is 4 inches and half and it is like cellulitis; First felt like a bruise and the bruise went away; It's very warm to the touch; It started Itching; Rash on the arm; First felt like a pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (The injection site is 4 inches and half and it is like cellulitis) 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 No adverse event (No reported medical events.).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced NAUSEA (Nausea). On 27-Mar-2021, the patient experienced CELLULITIS (The injection site is 4 inches and half and it is like cellulitis) (seriousness criterion medically significant), VACCINATION SITE BRUISING (First felt like a bruise and the bruise went away), VACCINATION SITE WARMTH (It's very warm to the touch), VACCINATION SITE PRURITUS (It started Itching), VACCINATION SITE RASH (Rash on the arm) and VACCINATION SITE PAIN (First felt like a pain). At the time of the report, CELLULITIS (The injection site is 4 inches and half and it is like cellulitis), VACCINATION SITE WARMTH (It's very warm to the touch), VACCINATION SITE PRURITUS (It started Itching), NAUSEA (Nausea), VACCINATION SITE RASH (Rash on the arm) and VACCINATION SITE PAIN (First felt like a pain) outcome was unknown and VACCINATION SITE BRUISING (First felt like a bruise and the bruise went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported.  No treatment.; 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: The injection site is 4 inches and half and it is like cellulitis; First felt like a bruise and the bruise went away; It's very warm to the touch; It started Itching; Rash on the arm; First felt like a pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (The injection site is 4 inches and half and it is like cellulitis) 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 No adverse event (No reported medical events.).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced NAUSEA (Nausea). On 27-Mar-2021, the patient experienced CELLULITIS (The injection site is 4 inches and half and it is like cellulitis) (seriousness criterion medically significant), VACCINATION SITE BRUISING (First felt like a bruise and the bruise went away), VACCINATION SITE WARMTH (It's very warm to the touch), VACCINATION SITE PRURITUS (It started Itching), VACCINATION SITE RASH (Rash on the arm) and VACCINATION SITE PAIN (First felt like a pain). At the time of the report, CELLULITIS (The injection site is 4 inches and half and it is like cellulitis), VACCINATION SITE WARMTH (It's very warm to the touch), VACCINATION SITE PRURITUS (It started Itching), NAUSEA (Nausea), VACCINATION SITE RASH (Rash on the arm) and VACCINATION SITE PAIN (First felt like a pain) outcome was unknown and VACCINATION SITE BRUISING (First felt like a bruise and the bruise went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported.  No treatment.; 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: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Decreased appetite, Diarrhoea, Haemorrhage, Paralysis
Clinical narrative: water and blood coming out the legs; paralyzed feeling in my legs completely, cant even walk around the house; uncontrollable diarrhea; severely decreased appetite; severe bloating; high body temperature of 103; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (water and blood coming out the legs) and PARALYSIS (paralyzed feeling in my legs completely, cant even walk around the house) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (water and blood coming out the legs) (seriousness criterion medically significant), PARALYSIS (paralyzed feeling in my legs completely, cant even walk around the house) (seriousness criterion medically significant), DIARRHOEA (uncontrollable diarrhea), DECREASED APPETITE (severely decreased appetite), ABDOMINAL DISTENSION (severe bloating) and PYREXIA (high body temperature of 103). At the time of the report, HAEMORRHAGE (water and blood coming out the legs), PARALYSIS (paralyzed feeling in my legs completely, cant even walk around the house), DIARRHOEA (uncontrollable diarrhea), DECREASED APPETITE (severely decreased appetite), ABDOMINAL DISTENSION (severe bloating) and PYREXIA (high body temperature of 103) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was included TORSEMIDE, CEFUROXIME and MUPIROCIN cream.  Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: water and blood coming out the legs; paralyzed feeling in my legs completely, cant even walk around the house; uncontrollable diarrhea; severely decreased appetite; severe bloating; high body temperature of 103; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (water and blood coming out the legs) and PARALYSIS (paralyzed feeling in my legs completely, cant even walk around the house) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (water and blood coming out the legs) (seriousness criterion medically significant), PARALYSIS (paralyzed feeling in my legs completely, cant even walk around the house) (seriousness criterion medically significant), DIARRHOEA (uncontrollable diarrhea), DECREASED APPETITE (severely decreased appetite), ABDOMINAL DISTENSION (severe bloating) and PYREXIA (high body temperature of 103). At the time of the report, HAEMORRHAGE (water and blood coming out the legs), PARALYSIS (paralyzed feeling in my legs completely, cant even walk around the house), DIARRHOEA (uncontrollable diarrhea), DECREASED APPETITE (severely decreased appetite), ABDOMINAL DISTENSION (severe bloating) and PYREXIA (high body temperature of 103) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was included TORSEMIDE, CEFUROXIME and MUPIROCIN cream.  Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Vaccination site pain
Clinical narrative: loss of sight in his eyes; Soreness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (loss of sight in his eyes) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness around the injection site). On 31-Mar-2021, the patient experienced BLINDNESS (loss of sight in his eyes) (seriousness criterion medically significant). At the time of the report, BLINDNESS (loss of sight in his eyes) and VACCINATION SITE PAIN (Soreness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site pain, a causal relationship cannot be excluded. However,very limited information regarding the event of Blindness has been provided at this time.  Further information has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Cold sweat, Dyspnoea, Heart rate decreased
Clinical narrative: fainted; HR - 46-48 beats per minute; cold sweats; chest pains localized in the apex of her heart; inflammation in the left upper arm extending to the back; hard time breathing; weak; This spontaneous case was reported by a nurse and describes the occurrence of SYNCOPE (fainted) and HEART RATE DECREASED (HR - 46-48 beats per minute) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 074M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), HEART RATE DECREASED (HR - 46-48 beats per minute) (seriousness criterion medically significant), COLD SWEAT (cold sweats), CHEST PAIN (chest pains localized in the apex of her heart), VACCINATION SITE INFLAMMATION (inflammation in the left upper arm extending to the back), DYSPNOEA (hard time breathing) and ASTHENIA (weak). On 01-Apr-2021, SYNCOPE (fainted), HEART RATE DECREASED (HR - 46-48 beats per minute), COLD SWEAT (cold sweats), CHEST PAIN (chest pains localized in the apex of her heart) and DYSPNOEA (hard time breathing) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (inflammation in the left upper arm extending to the back) and ASTHENIA (weak) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vaccination site inflammation
Clinical narrative: fainted; HR - 46-48 beats per minute; cold sweats; chest pains localized in the apex of her heart; inflammation in the left upper arm extending to the back; hard time breathing; weak; This spontaneous case was reported by a nurse and describes the occurrence of SYNCOPE (fainted) and HEART RATE DECREASED (HR - 46-48 beats per minute) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 074M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), HEART RATE DECREASED (HR - 46-48 beats per minute) (seriousness criterion medically significant), COLD SWEAT (cold sweats), CHEST PAIN (chest pains localized in the apex of her heart), VACCINATION SITE INFLAMMATION (inflammation in the left upper arm extending to the back), DYSPNOEA (hard time breathing) and ASTHENIA (weak). On 01-Apr-2021, SYNCOPE (fainted), HEART RATE DECREASED (HR - 46-48 beats per minute), COLD SWEAT (cold sweats), CHEST PAIN (chest pains localized in the apex of her heart) and DYSPNOEA (hard time breathing) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (inflammation in the left upper arm extending to the back) and ASTHENIA (weak) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; 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: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest pain, Troponin, Troponin increased
Clinical narrative: cardiac issue; Chest pain; elevated troponin level; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain), CARDIAC DISORDER (cardiac issue) and TROPONIN INCREASED (elevated troponin level) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack (was in hospital for 6 days) on 23-May-2020 and Quintuple coronary bypass (Had five bypass, two arteries they took) on 23-Oct-2020. Concurrent medical conditions included Diabetes and Chest pain since 2020. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and ACETYLSALICYLIC ACID for Anticoagulant therapy, AMLODIPINE, LISINOPRIL and METOPROLOL for Blood pressure abnormal, FISH OIL for Cardiac disorder NOS, ATORVASTATIN for Cholesterol, INSULIN for Diabetes, TIMOLOL MALEATE (TIMOPTIC) for Glaucoma, ISOSORBIDE for Heart disorder, PROGESTERONE (LUTEINA [PROGESTERONE]) for Retinal disorder NOS, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced TROPONIN INCREASED (elevated troponin level) (seriousness criterion hospitalization prolonged). On 25-Mar-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization prolonged) and CARDIAC DISORDER (cardiac issue) (seriousness criterion hospitalization). The patient was hospitalized on 25-Mar-2021 due to CARDIAC DISORDER and CHEST PAIN. On 27-Feb-2021, TROPONIN INCREASED (elevated troponin level) had resolved. At the time of the report, CHEST PAIN (Chest pain) and CARDIAC DISORDER (cardiac issue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Troponin: not elevated (normal) not elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Very limited information regarding these events has been provided at this time. Patient's advanced age along with underlying conditions and concomitant medications may have been contributory for the occurrence of the events. Further information has been requested.   This case was linked to MOD-2021-027718 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Patient's advanced age along with underlying conditions and concomitant medications may have been contributory for the occurrence of the events. Further information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Hypoaesthesia
Clinical narrative: She can't hear at all from her right ear; Her right ear was numb; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (She can't hear at all from her right ear) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not reported.).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DEAFNESS UNILATERAL (She can't hear at all from her right ear) (seriousness criterion medically significant) and HYPOAESTHESIA (Her right ear was numb). At the time of the report, DEAFNESS UNILATERAL (She can't hear at all from her right ear) and HYPOAESTHESIA (Her right ear was numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.   Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. 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 onset date of the reported events, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Seizure, Vertigo
Clinical narrative: Passed out and convulsed; Passed out and convulsed; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out and convulsed) and SEIZURE (Passed out and convulsed) 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.     The patient's past medical history included No adverse event (No reported medical history.).    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out and convulsed) (seriousness criterion medically significant), SEIZURE (Passed out and convulsed) (seriousness criterion medically significant) and VERTIGO (Vertigo). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out and convulsed), SEIZURE (Passed out and convulsed) and VERTIGO (Vertigo) outcome was unknown.            She received 2nd dose of Moderna vaccine 31 MAR 2021 and while she was at the pharmacy she passed out and convulsed, and later that night while at home she passed out and convulsed again.  Treatment information was not provided.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lordosis, Neuropathy peripheral, Spinal X-ray
Clinical narrative: Mild lordosis; Right leg neuropathy; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Right leg neuropathy), LORDOSIS (Mild lordosis) and SCOLIOSIS (Mild scoliosis) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Scoliosis.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (Right leg neuropathy) (seriousness criterion medically significant). On an unknown date, the patient experienced LORDOSIS (Mild lordosis) (seriousness criterion medically significant) and SCOLIOSIS (Mild scoliosis) (seriousness criterion medically significant). The patient was treated with Physical therapy (Has ben going to physical therapy for the last three weeks) for Neuropathy peripheral and Physical therapy (Has ben going to physical therapy for the last three weeks) for Lordosis. At the time of the report, NEUROPATHY PERIPHERAL (Right leg neuropathy), LORDOSIS (Mild lordosis) and SCOLIOSIS (Mild scoliosis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Spinal X-ray: abnormal (abnormal) a mild lordosis and mild scoliosis.         This case was linked to US-MODERNATX, INC.-MOD-2021-066395 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-066395:1st dose case
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NAUSEA (nausea) and VOMITING (Vomiting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (REMODULIN  IV) for Pulmonary arterial hypertension.    The patient's past medical history included Pulmonary arterial hypertension (Primary pulmonary arterial hypertension). Concomitant products included MACITENTAN (OPSUMIT) for an unknown indication.   On 10-Mar-2017, the patient started TREPROSTINIL SODIUM (REMODULIN IV) (unknown route) 5 mg/dl. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced NAUSEA (nausea) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). The patient was hospitalized on 21-Mar-2021 due to NAUSEA and VOMITING. At the time of the report, NAUSEA (nausea) and VOMITING (Vomiting) outcome was unknown.            The treatment medication was unknown.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  Concomitant use of IV treprostinil may have been contributory.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  Concomitant use of IV treprostinil may have been contributory.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Loss of consciousness, Presyncope
Clinical narrative: Patient blacked out on the way home after receiving the vaccine and was driving on the opposite side of traffic/ patient blacked out again; feels faint each time she stands; chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Patient blacked out on the way home after receiving the vaccine and was driving on the opposite side of traffic/ patient blacked out again) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Patient blacked out on the way home after receiving the vaccine and was driving on the opposite side of traffic/ patient blacked out again) (seriousness criterion medically significant), PRESYNCOPE (feels faint each time she stands) and CHILLS (chills). On 01-Apr-2021, LOSS OF CONSCIOUSNESS (Patient blacked out on the way home after receiving the vaccine and was driving on the opposite side of traffic/ patient blacked out again) had resolved. At the time of the report, PRESYNCOPE (feels faint each time she stands) and CHILLS (chills) outcome was unknown.            No concomitant medications reported by patient.  Treatment of these events included Zyrtec and Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization prolonged and life threatening). The patient was hospitalized on sometime in April 2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.Treatment information was not provided.  This case refers to a 67 year-old elderly female patient who developed pulmonary embolism about two weeks after receiving the second dose of mRNA-1273 vaccine. Very limited information has been provided at this time.; Sender's Comments: This case refers to a 67 year-old elderly female patient who developed pulmonary embolism about two weeks after receiving the second dose of mRNA-1273 vaccine. Very limited information has been provided at this time.
Age: 73.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Deep vein thrombosis, SARS-CoV-2 antibody test
Clinical narrative: Deep vein thrombosis; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for CLL.    The patient's past medical history included Blood immunoglobulin G (low levels from past 20 years). Concurrent medical conditions included Chronic lymphocytic leukemia, Depression, Drug allergy (allergic reaction to Rituxan.) and Glaucoma. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   In February 2020, the patient started IBRUTINIB (IMBRUVICA) (unknown route) 420 milligram once a day. On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 antibody test (610-1600): 347 (Negative) 347.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other history included:no alcohol use, no drug abuse, non smoker 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, the patient's past medical history of CLL and drug IBRUTINIB can contribute to this event. further information has been requested   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's past medical history of CLL and drug IBRUTINIB can contribute to this event. further information has been requested
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Onychalgia, Pain, Pruritus, Pyrexia
Clinical narrative: Diverticulitis acted up; bumps breaking out all over her body; itched; welts; fever of 100 degrees Fahrenheit; achiness; pain in toe nails and finger nails; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis acted up) in a 70-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 Diverticulitis.  Concomitant products included DULAGLUTIDE (TRULICITY), SIMVASTATIN, LOSARTAN, ESCITALOPRAM, ROPINIROLE HYDROCHLORIDE (REQUIP), GABAPENTIN, MELOXICAM, LEVOTHYROXINE, CANAGLIFLOZIN HEMIHYDRATE, METFORMIN HYDROCHLORIDE (INVOKANA DUO), METFORMIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 24HR), CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D3), CENTRUM SILVER +50, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and TRAMADOL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 10-Mar-2021, the patient experienced PAIN (achiness), ONYCHALGIA (pain in toe nails and finger nails) and PYREXIA (fever of 100 degrees Fahrenheit). On 20-Mar-2021, the patient experienced SKIN MASS (bumps breaking out all over her body), PRURITUS (itched) and URTICARIA (welts). On 21-Mar-2021, the patient experienced DIVERTICULITIS (Diverticulitis acted up) (seriousness criterion medically significant). On 23-Mar-2021, DIVERTICULITIS (Diverticulitis acted up), SKIN MASS (bumps breaking out all over her body), PRURITUS (itched) and URTICARIA (welts) outcome was unknown. At the time of the report, PAIN (achiness), ONYCHALGIA (pain in toe nails and finger nails) and PYREXIA (fever of 100 degrees Fahrenheit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included prednisone and benadryl.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded. Fever is consistent with the known safety profile of mRNA-1273
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass, Urticaria
Clinical narrative: Diverticulitis acted up; bumps breaking out all over her body; itched; welts; fever of 100 degrees Fahrenheit; achiness; pain in toe nails and finger nails; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis acted up) in a 70-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 Diverticulitis.  Concomitant products included DULAGLUTIDE (TRULICITY), SIMVASTATIN, LOSARTAN, ESCITALOPRAM, ROPINIROLE HYDROCHLORIDE (REQUIP), GABAPENTIN, MELOXICAM, LEVOTHYROXINE, CANAGLIFLOZIN HEMIHYDRATE, METFORMIN HYDROCHLORIDE (INVOKANA DUO), METFORMIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 24HR), CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D3), CENTRUM SILVER +50, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and TRAMADOL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 10-Mar-2021, the patient experienced PAIN (achiness), ONYCHALGIA (pain in toe nails and finger nails) and PYREXIA (fever of 100 degrees Fahrenheit). On 20-Mar-2021, the patient experienced SKIN MASS (bumps breaking out all over her body), PRURITUS (itched) and URTICARIA (welts). On 21-Mar-2021, the patient experienced DIVERTICULITIS (Diverticulitis acted up) (seriousness criterion medically significant). On 23-Mar-2021, DIVERTICULITIS (Diverticulitis acted up), SKIN MASS (bumps breaking out all over her body), PRURITUS (itched) and URTICARIA (welts) outcome was unknown. At the time of the report, PAIN (achiness), ONYCHALGIA (pain in toe nails and finger nails) and PYREXIA (fever of 100 degrees Fahrenheit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included prednisone and benadryl.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded. Fever is consistent with the known safety profile of mRNA-1273
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Contusion, Dizziness, Fatigue
Clinical narrative: passed out; not feeling well; dizziness; could not get up; slept all day on and off; bruised knees; washed in cold sweat; nausea; fatigue; vomiting; bad headache; tender arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL for Blood pressure.    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 VACCINATION SITE PAIN (tender arm). On 02-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), MALAISE (not feeling well), DIZZINESS (dizziness), ASTHENIA (could not get up), SOMNOLENCE (slept all day on and off), CONTUSION (bruised knees), COLD SWEAT (washed in cold sweat), NAUSEA (nausea), FATIGUE (fatigue), VOMITING (vomiting) and HEADACHE (bad headache). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), MALAISE (not feeling well), DIZZINESS (dizziness), ASTHENIA (could not get up), SOMNOLENCE (slept all day on and off), CONTUSION (bruised knees), COLD SWEAT (washed in cold sweat), NAUSEA (nausea), FATIGUE (fatigue), VOMITING (vomiting), VACCINATION SITE PAIN (tender arm) and HEADACHE (bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not receive any treatment for the events.  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.