chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Peripheral swelling
Clinical narrative: Cold; Arm swells up after injection; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma chronic, Diabetes, Blood pressure abnormal and Lipids abnormal. Concomitant products included METFORMIN and LISINOPRIL for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced NASOPHARYNGITIS (Cold) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Arm swells up after injection) and FATIGUE (Fatigue). At the time of the report, NASOPHARYNGITIS (Cold) and FATIGUE (Fatigue) had not resolved and PERIPHERAL SWELLING (Arm swells up after injection) outcome was unknown.            She was seen by her primary care physician who prescribed her antibiotics, name unknown.  Based on the current available information and the temporal association of the product and start date of the events a causal relationship cannot be excluded.; Sender's Comments: based on the current available information and the temporal association of the product and start date of the events a causal relationship cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate decreased, Immune thrombocytopenia, Platelet count
Clinical narrative: Acute ITP; Heart rate dropped to 47; Shortness of breath; Heart rate dropped to 47; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Acute ITP), the first episode of HEART RATE DECREASED (Heart rate dropped to 47), DYSPNOEA (Shortness of breath) and the second episode of HEART RATE DECREASED (Heart rate dropped to 47) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Acute ITP) (seriousness criterion hospitalization). On 01-Apr-2021, the patient experienced the first episode of HEART RATE DECREASED (Heart rate dropped to 47) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization prolonged) and the second episode of HEART RATE DECREASED (Heart rate dropped to 47) (seriousness criterion hospitalization). The patient was hospitalized on 29-Mar-2021 due to DYSPNOEA, HEART RATE DECREASED and IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Acute ITP) had not resolved and DYSPNOEA (Shortness of breath) and the last episode of HEART RATE DECREASED (Heart rate dropped to 47) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Platelet count: about 2000 (Low) About 2000. On 01-Apr-2021, Heart rate: dropped to 47 (abnormal) Dropped to 47. On 02-Apr-2021, Platelet count: low (Low) Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included: steroids [also noted as dexamethasone (DECADRON)] and IV IgG.  At the time of the report, the patient was being transferred to another hospital facility.  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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis bullous, Rash
Clinical narrative: she has half a millimeter bump; RASH ON HANDS AND FEET; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS BULLOUS (she has half a millimeter bump) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hand, foot and mouth disease (about three years ago).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DERMATITIS BULLOUS (she has half a millimeter bump) (seriousness criterion medically significant) and RASH (RASH ON HANDS AND FEET). At the time of the report, DERMATITIS BULLOUS (she has half a millimeter bump) and RASH (RASH ON HANDS AND FEET) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment:This case concerns a 46-year-old female with serious unexpected events of dermatitis bullous and rash. Event on set 11 days after first dose mRNA-1273. 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.; Sender's Comments: This case concerns a 46-year-old female with serious unexpected events of dermatitis bullous and rash. Event on set 11 days after first dose mRNA-1273. 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment information was provided
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test
Clinical narrative: Pneumonia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) and COVID-19 (Tested positive for COVID-19 virus after first vaccine dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025AZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID-19 virus after first vaccine dose) (seriousness criterion hospitalization). On 13-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 13-Mar-2021 to 17-Mar-2021 due to COVID-19 and PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia) and COVID-19 (Tested positive for COVID-19 virus after first vaccine dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Pneumonia
Clinical narrative: Shingles on his forehead; pneumonia; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 74-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 No adverse event (No medical history reported).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). In March 2021, the patient experienced HEADACHE (Headache). On 30-Mar-2021, the patient experienced HERPES ZOSTER (Shingles on his forehead). At the time of the report, PNEUMONIA (pneumonia), HEADACHE (Headache) and HERPES ZOSTER (Shingles on his forehead) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 11Mar2021, he went to the urgent care and was diagnosed to have pneumonia for which he was given Doxycycline 100 mg for 10 days. For experiencing headache. He was prescribed with Valacyclovir.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis; stress response caused her to also develop shingles; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis) (seriousness criterion medically significant) and HERPES ZOSTER (stress response caused her to also develop shingles). At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis) and HERPES ZOSTER (stress response caused her to also develop shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided  Very limited information regarding this event has been provided at this time.  No follow up is possible   This case was linked to MOD-2021-067542 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  No follow up is possible MOD-2021-067542:Valid case
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Pemphigoid
Clinical narrative: bollous pemphigold a diffuse reaction: back, chest, arm, back, thighs, and feet; This spontaneous case was reported by a physician and describes the occurrence of PEMPHIGOID (bollous pemphigold a diffuse reaction: back, chest, arm, back, thighs, and feet) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history) and Biopsy.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PEMPHIGOID (bollous pemphigold a diffuse reaction: back, chest, arm, back, thighs, and feet) (seriousness criterion medically significant). At the time of the report, PEMPHIGOID (bollous pemphigold a diffuse reaction: back, chest, arm, back, thighs, and feet) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Biopsy skin: abnormal (abnormal) Diffuse bullous pemphigoid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided.  Concomitant medication were not reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Tinnitus
Clinical narrative: Lost hearing in the left ear; Tinnitus (ringing in the left ear); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Lost hearing in the left ear) in a 62-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 No adverse event (No reported medical history). Concomitant products included LOSARTAN, AMOXICILLIN and PREDNISONE for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced TINNITUS (Tinnitus (ringing in the left ear)). On an unknown date, the patient experienced DEAFNESS (Lost hearing in the left ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Lost hearing in the left ear) and TINNITUS (Tinnitus (ringing in the left ear)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: abnormal (abnormal) Hearing loss.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was taking other unspecified concomitant  medications.  On an unknown date, the patient went to an urgent care ear throat specialist with a chief complaint of tinnitus and had a hearing test.  The patient was diagnosed with hearing loss in the left ear and was given a steroid prescription.  Based on the current available information and the 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 the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Syncope, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: fainting spells; Chills; Pain at site of the injection; itchiness at the site of the injection; rash at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainting spells) in an 81-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 Autoimmune disorder.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at site of the injection), VACCINATION SITE PRURITUS (itchiness at the site of the injection) and VACCINATION SITE RASH (rash at the site of the injection). On 02-Apr-2021, the patient experienced SYNCOPE (fainting spells) (seriousness criterion medically significant) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SYNCOPE (fainting spells), CHILLS (Chills), VACCINATION SITE PAIN (Pain at site of the injection), VACCINATION SITE PRURITUS (itchiness at the site of the injection) and VACCINATION SITE RASH (rash at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported. Treatment included Tylenol.  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: M
Vaccine: COVID19
Symptoms: Bradycardia, Diarrhoea, Dyspnoea, Feeling abnormal, Productive cough
Clinical narrative: dribbles; heart rate when down to 38 beats per minute; loose bowels; breathing situation has gotten worse; feels terrible; increased amount of phlegm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (heart rate when down to 38 beats per minute) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031a21a and 032L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Coronary artery disease, COPD, Enlarged prostate, Atrial fibrillation and Bronchitis. Concomitant products included WARFARIN for an unknown indication.   On 09-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. In March 2021, the patient experienced DIARRHOEA (loose bowels), DYSPNOEA (breathing situation has gotten worse), FEELING ABNORMAL (feels terrible) and PRODUCTIVE COUGH (increased amount of phlegm). On 21-Mar-2021, the patient experienced BRADYCARDIA (heart rate when down to 38 beats per minute) (seriousness criterion medically significant). On an unknown date, the patient experienced URINARY INCONTINENCE (dribbles). At the time of the report, BRADYCARDIA (heart rate when down to 38 beats per minute), DIARRHOEA (loose bowels), URINARY INCONTINENCE (dribbles), DYSPNOEA (breathing situation has gotten worse), FEELING ABNORMAL (feels terrible) and PRODUCTIVE COUGH (increased amount of phlegm) outcome was unknown. Not Provided          Treatment of these events included steroids.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: dribbles; heart rate when down to 38 beats per minute; loose bowels; breathing situation has gotten worse; feels terrible; increased amount of phlegm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (heart rate when down to 38 beats per minute) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031a21a and 032L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Coronary artery disease, COPD, Enlarged prostate, Atrial fibrillation and Bronchitis. Concomitant products included WARFARIN for an unknown indication.   On 09-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. In March 2021, the patient experienced DIARRHOEA (loose bowels), DYSPNOEA (breathing situation has gotten worse), FEELING ABNORMAL (feels terrible) and PRODUCTIVE COUGH (increased amount of phlegm). On 21-Mar-2021, the patient experienced BRADYCARDIA (heart rate when down to 38 beats per minute) (seriousness criterion medically significant). On an unknown date, the patient experienced URINARY INCONTINENCE (dribbles). At the time of the report, BRADYCARDIA (heart rate when down to 38 beats per minute), DIARRHOEA (loose bowels), URINARY INCONTINENCE (dribbles), DYSPNOEA (breathing situation has gotten worse), FEELING ABNORMAL (feels terrible) and PRODUCTIVE COUGH (increased amount of phlegm) outcome was unknown. Not Provided          Treatment of these events included steroids.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Syncope
Clinical narrative: Fainting for about 30 seconds to a minute in the bathroom; Feeling dizzy; Could not stand for a while when fell; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting for about 30 seconds to a minute in the bathroom) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 003A21A) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Apr-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 07-Apr-2021, the patient experienced DIZZINESS (Feeling dizzy) and DYSSTASIA (Could not stand for a while when fell). On 07-Apr-2021 at 4:00 AM, the patient experienced SYNCOPE (Fainting for about 30 seconds to a minute in the bathroom) (seriousness criterion medically significant). On 07-Apr-2021, DIZZINESS (Feeling dizzy) and DYSSTASIA (Could not stand for a while when fell) had resolved. On 07-Apr-2021 at 4:01 AM, SYNCOPE (Fainting for about 30 seconds to a minute in the bathroom) had resolved.            No concomitant medications were reported. Treatment included for the events was acetaminophen. Patient reported that he felt dizzy and fainted for about 30 seconds to 1 minute in his bathroom at around 4:00 am this morning after receiving his second dose of the vaccine yesterday on 6 April 2021.Also, he could not stand for a while when fell. The patient took energy drink. Patient confirmed that the symptom was one time and it has not come back.; 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: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). On 23-Mar-2021, ATRIAL FIBRILLATION (Atrial fibrillation) 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.   Concomitant product use was not provided by the reporter.  Treatment for the event included apixaban started on 24-Mar-2021.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea at rest, Headache, Vaccination complication
Clinical narrative: shortness of breath; Dizziness; All side effects on safety sheet of moderna vaccine except bad rash; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA AT REST (shortness of breath) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) 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).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DYSPNOEA AT REST (shortness of breath) (seriousness criterion medically significant), DIZZINESS (Dizziness), VACCINATION COMPLICATION (All side effects on safety sheet of moderna vaccine except bad rash) and HEADACHE (Headache). At the time of the report, DYSPNOEA AT REST (shortness of breath) and DIZZINESS (Dizziness) had resolved and VACCINATION COMPLICATION (All side effects on safety sheet of moderna vaccine except bad rash) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported.  Treatment drug included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fall, Product dose omission issue, Pruritus
Clinical narrative: felt down; redness on right arm and shoulder, redness on left arm and shoulder; itchiness on right arm and shoulder; Only first dose received; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (felt down) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history reported).    On 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced FALL (felt down) (seriousness criterion hospitalization). On 27-Feb-2021, the patient experienced ERYTHEMA (redness on right arm and shoulder, redness on left arm and shoulder) and PRURITUS (itchiness on right arm and shoulder). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Only first dose received). The patient was hospitalized on 21-Feb-2021 due to FALL. At the time of the report, FALL (felt down), ERYTHEMA (redness on right arm and shoulder, redness on left arm and shoulder), PRURITUS (itchiness on right arm and shoulder) and PRODUCT DOSE OMISSION ISSUE (Only first dose received) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      This report refers to a case of (Product dose omission issue) for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (fall, erythema, and pruritus), a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of (Product dose omission issue) for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (fall, erythema, and pruritus), a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Musculoskeletal stiffness, Ophthalmic herpes zoster
Clinical narrative: I developed shingles around the outside of my left eye; painful stiffness in the injection site arm; felt a little tired; joint pain in the injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC HERPES ZOSTER (I developed shingles around the outside of my left eye) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cataract (cataract surgery, left eye) on 26-Mar-2021. Previously administered products included for an unreported indication: SHINGRIX in 2020.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (painful stiffness in the injection site arm), FATIGUE (felt a little tired) and ARTHRALGIA (joint pain in the injection site arm). On 01-Apr-2021, the patient experienced OPHTHALMIC HERPES ZOSTER (I developed shingles around the outside of my left eye) (seriousness criterion medically significant). At the time of the report, OPHTHALMIC HERPES ZOSTER (I developed shingles around the outside of my left eye) had not resolved and MUSCULOSKELETAL STIFFNESS (painful stiffness in the injection site arm), FATIGUE (felt a little tired) and ARTHRALGIA (joint pain in the injection site arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the ophthalmic herpes zoster include sulfamethoxazole 160mg BID and valacyclovir 500mg 2 tablets TID. Company comment: Based on reporter's causality and recent history of cataract surgery the event eye herpes zoster is assessed as unlikely related to mRNA-1273. For the other events the causality cannot be excluded.   On 05Apr2021, his eye Dr assessed the area with shingles and thought that the shingles was most likely due to the trauma to the eye from the surgery.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Clot blood; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Clot blood) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medically reported history).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced THROMBOSIS (Clot blood) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Clot blood) outcome was unknown.            The patient was diagnosed with blood clots in legs and lung. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Dizziness, Magnetic resonance imaging, Nausea
Clinical narrative: Right side hearing loss; Dizziness; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Right side hearing loss) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced DEAFNESS (Right side hearing loss) (seriousness criterion medically significant), DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, DEAFNESS (Right side hearing loss), DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Magnetic resonance imaging: normal (normal) normal.         Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Eye infection, Feeling abnormal, Head injury
Clinical narrative: head injury/head trauma; eye infection; syncope/passed out; felling bad; has no balance; felt dizzied; irritated; This spontaneous case was reported by a consumer and describes the occurrence of HEAD INJURY (head injury/head trauma) and SYNCOPE (syncope/passed out) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma. Concomitant products included CLONAZEPAM (KLONOPIN) for Glaucoma.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced HEAD INJURY (head injury/head trauma) (seriousness criterion hospitalization), SYNCOPE (syncope/passed out) (seriousness criterion medically significant), FEELING ABNORMAL (felling bad), BALANCE DISORDER (has no balance), DIZZINESS (felt dizzied) and IRRITABILITY (irritated). On 25-Mar-2021, the patient experienced EYE INFECTION (eye infection). The patient was hospitalized from 09-Mar-2021 to 11-Mar-2021 due to HEAD INJURY. At the time of the report, HEAD INJURY (head injury/head trauma), SYNCOPE (syncope/passed out), FEELING ABNORMAL (felling bad), BALANCE DISORDER (has no balance), DIZZINESS (felt dizzied), IRRITABILITY (irritated) and EYE INFECTION (eye infection) outcome was unknown.            No treatment medication was included.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-071179 (E2B Linked Report). This case was linked to MOD-2021-071179 (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. US-MODERNATX, INC.-MOD-2021-071179:Case for first dose
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Syncope
Clinical narrative: head injury/head trauma; eye infection; syncope/passed out; felling bad; has no balance; felt dizzied; irritated; This spontaneous case was reported by a consumer and describes the occurrence of HEAD INJURY (head injury/head trauma) and SYNCOPE (syncope/passed out) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma. Concomitant products included CLONAZEPAM (KLONOPIN) for Glaucoma.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced HEAD INJURY (head injury/head trauma) (seriousness criterion hospitalization), SYNCOPE (syncope/passed out) (seriousness criterion medically significant), FEELING ABNORMAL (felling bad), BALANCE DISORDER (has no balance), DIZZINESS (felt dizzied) and IRRITABILITY (irritated). On 25-Mar-2021, the patient experienced EYE INFECTION (eye infection). The patient was hospitalized from 09-Mar-2021 to 11-Mar-2021 due to HEAD INJURY. At the time of the report, HEAD INJURY (head injury/head trauma), SYNCOPE (syncope/passed out), FEELING ABNORMAL (felling bad), BALANCE DISORDER (has no balance), DIZZINESS (felt dizzied), IRRITABILITY (irritated) and EYE INFECTION (eye infection) outcome was unknown.            No treatment medication was included.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-071179 (E2B Linked Report). This case was linked to MOD-2021-071179 (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. US-MODERNATX, INC.-MOD-2021-071179:Case for first dose
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood clot; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) 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 medical history reported.). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant) and COVID-19 (COVID-19). At the time of the report, THROMBOSIS (Blood clot) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) postive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included blood thinner medication. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Sepsis
Clinical narrative: Sepsis; Been 52 days for second dose of vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SEPSIS (Sepsis) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Been 52 days for second dose of vaccine). At the time of the report, SEPSIS (Sepsis) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Been 52 days for second dose of vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  The patient was hospitalized for almost 3 weeks for sepsis after receiving first dose. At the time of report, the patient was on 52nd day since receiving first dose.  Treatment information was not provided.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Seizure, Sinusitis
Clinical narrative: breakthrough seizures; sinus infection; She also missed her 2nd appointment on 5APR2021 due to sinus infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (breakthrough seizures) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizure.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced SEIZURE (breakthrough seizures) (seriousness criterion medically significant), SINUSITIS (sinus infection) and PRODUCT DOSE OMISSION ISSUE (She also missed her 2nd appointment on 5APR2021 due to sinus infection). On 04-Mar-2021, PRODUCT DOSE OMISSION ISSUE (She also missed her 2nd appointment on 5APR2021 due to sinus infection) had resolved. At the time of the report, SEIZURE (breakthrough seizures) and SINUSITIS (sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There were no concomitant medications reported. Treatment included antibiotics for the event sinus infection.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (seizure and sinusitis), a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cerebrovascular accident, Dysarthria, Headache
Clinical narrative: stroke; slurred speech; Almost Paralyzed (generalized weakness); headaches; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 36-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 Crohn's disease since an unknown date.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), DYSARTHRIA (slurred speech), ASTHENIA (Almost Paralyzed (generalized weakness)) and HEADACHE (headaches). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), DYSARTHRIA (slurred speech), ASTHENIA (Almost Paralyzed (generalized weakness)) and HEADACHE (headaches) had not resolved. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.   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 events, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cholecystitis infective, Laboratory test, Loss of consciousness
Clinical narrative: Passed out every time he stood up; Gallbladder infection; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out every time he stood up) and CHOLECYSTITIS INFECTIVE (Gallbladder infection) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out every time he stood up) (seriousness criterion hospitalization) and CHOLECYSTITIS INFECTIVE (Gallbladder infection) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 09-Mar-2021 due to CHOLECYSTITIS INFECTIVE and LOSS OF CONSCIOUSNESS. The patient was treated with Surgery for Cholecystitis infective. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out every time he stood up) and CHOLECYSTITIS INFECTIVE (Gallbladder infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Laboratory test: abnormal (abnormal) Gallbladder infection.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  This case concerns a 67-year-old male hospitalized with serious unexpected events of loss of consciousness and cholecystitis infective. Event onset 17 days after first dose mRNA-1273. Underwent surgery. Events resolved. 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.; Sender's Comments: This case concerns a 67-year-old male hospitalized with serious unexpected events of loss of consciousness and cholecystitis infective. Event onset 17 days after first dose mRNA-1273. Underwent surgery. Events resolved. 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.