chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Passed out; Dehydrated; kept vomiting; Chills; her arm was swollen, itching and caused pain; arm was swollen; caused pain; A spontaneous report was received from a consumer,  concerning a 69-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was swollen (peripheral swelling), itching (pruritus), and caused pain (pain in extremity), passed out (loss of consciousness), kept vomiting (vomiting), chills and was dehydrated (dehydration).  The patient's medical history was not provided.  Concomitant medications reported included ascorbic acid/biotin/dl-alpha tocopheryl acetate, nadolol, acetylsalicylic acid, sertraline, levothyroxine sodium and spironolactone.   On 13 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    On 13 Feb 2021, the patient's arm was swollen, itching and caused pain for about 2 days. On 14 Feb 2021, the passed out. The patient stated that she did not know how long she was out and that the event did not happen again. Since 14 Feb 2021, the patient kept vomiting where she couldn't eat or drink at all and she could eat on 20 Feb 2021. On 14 Feb 2021, the patient had the chills and was dehydrated which lasted for 7 days. The patients' doctor told her not to get the second Moderna COVID-19 vaccination.  Treatment information was not provided.    The patient was advised by her doctor to avoid getting the second dose of mRNA-1273.  The outcome of the events, arm was swollen, itching and caused pain, were considered resolved on 15 Feb 2021. The event, passed out, was considered resolved on 14 Feb 2021. The outcome of the  events, kept vomiting and could not eat or drink at all, were considered resolved on 20 Feb 2021. The events, chills and was dehydrated, were considered resolved on 21 Feb 2021.; Reporter'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: Nausea, Syncope, Vaccination site pain
Clinical narrative: Fainting; Injection site soreness in arm; nauseous; A spontaneous report was received from a consumer  concerning a 21-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced, fainting (syncope), injection site soreness in arm (vaccination site pain), and nausea (nausea).  The patient's medical history included vasovagal condition that cause heart rate and blood pressure to drop due to stress on body and dehydration resulting in fainting. Concomitant product use was not provided by the reporter.   On 09 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 09 Feb 2021, the patient was fine until about 11 pm after which she experienced arm soreness on the injection site and felt nauseous.   On 10 Feb 2021, at 5 am in the morning, the patient fainted. The patient assumed that shot might have added stress to her body which most likely caused her to faint.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown. There was no change planned to the dosing schedule of mRNA-1273 in response to the event as patient would be receiving second dose on 09 Mar 2021.  The outcome of events, fainted (syncope), injection site soreness in arm (vaccination site pain), and nauseous (nausea), were considered as unknown.; Reporter'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 of syncope, vaccination site pain, and nausea, a causal relationship cannot be excluded. Patient's prior medical history of vasovagal reactions is considered a contributing factor to syncope.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Hypoaesthesia, Multiple sclerosis relapse
Clinical narrative: Multiple sclerosis; Numbness in hands, on the right side of the body, on the left side of the body; Lost coordination; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M29) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness in hands, on the right side of the body, on the left side of the body) and COORDINATION ABNORMAL (Lost coordination). On an unknown date, the patient experienced MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis), HYPOAESTHESIA (Numbness in hands, on the right side of the body, on the left side of the body) and COORDINATION ABNORMAL (Lost coordination) 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.  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: Nerve injury, Pain
Clinical narrative: nerve damage; pain on their arm, like a burning pain, from the elbow to the shoulder blade; A spontaneous report was received from a consumer concerning herself 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain on their arm and nerve damage.   The patient's medical history included Migraine. Products known to have been used by patient, within two weeks prior to the event were not provided.  On 04-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) via unknown route on arm for prophylaxis of COVID-19 infection.   On 04-FEB-2021, after receiving mRNA-1273, patient experienced pain in her arm, like a burning pain from the elbow to the shoulder blade. Patient wonder if this is related to vaccine or nerve damage.  Treatment details were not provided/unknown.  Seriousness criteria included nerve damage which is a medically significant event.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the event experienced pain on their arm and nerve damage were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events and a causal relationship cannot be excluded. Further information has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Vomiting
Clinical narrative: Sore shoulder; Extreme Diarrhea; Extreme vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Extreme Diarrhea) and VOMITING (Extreme vomiting) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 041L20A) 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 LOSARTAN, GABAPENTIN, GLIMEPIRIDE, FLUOXETINE, ATORVASTATIN, OMEPRAZOLE, VITAMIN D2 and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-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 DIARRHOEA (Extreme Diarrhea) (seriousness criterion medically significant) and VOMITING (Extreme vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder). At the time of the report, DIARRHOEA (Extreme Diarrhea), VOMITING (Extreme vomiting) and ARTHRALGIA (Sore shoulder) outcome was unknown.            Concomitant drug included Pilomisitone 50mg. Treatment medication included equate anti diarrhea (loperamide, and its controlling the symptom). This case concerns an 81 Y/O M with a serious unexpected event of severe diarrhea and vomiting along with nonserious unexpected arthralgia. Event onset on day 2 after second 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.; Sender's Comments: This case concerns an 81 Y/O M with a serious unexpected event of severe diarrhea and vomiting along with nonserious unexpected arthralgia. Event onset on day 2 after second 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: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Dizziness, Dyspnoea, Nausea, Rash
Clinical narrative: Right eye twinching; lightheadedness; rash on hands; Nausea; DOB; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BLEPHAROSPASM (Right eye twinching), DIZZINESS (lightheadedness), RASH (rash on hands), NAUSEA (Nausea) and DYSPNOEA (DOB) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy since January 2021.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced BLEPHAROSPASM (Right eye twinching) (seriousness criterion hospitalization), DIZZINESS (lightheadedness) (seriousness criterion hospitalization), RASH (rash on hands) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization) and DYSPNOEA (DOB) (seriousness criterion hospitalization). At the time of the report, BLEPHAROSPASM (Right eye twinching), DIZZINESS (lightheadedness), RASH (rash on hands), NAUSEA (Nausea) and DYSPNOEA (DOB) 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.   Treatment for the events include 0.5ml Epinephrine on the left thigh  This case concerns an 18 Y/O F hospitalized with serious unexpected events of blepharospasm, dizziness, rash, nausea, dyspnea. 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.   Reporter did not allow further contact; Sender's Comments: This case concerns an 18 Y/O F hospitalized with serious unexpected events of blepharospasm, dizziness, rash, nausea, dyspnea. 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Musculoskeletal discomfort, Oropharyngeal blistering, Swelling
Clinical narrative: Blisters all over her neck, throat, upper arm, and chest; Blisters all over her neck, throat, upper arm, and chest; Rash that turned into welts; Red on neck; Uncomfortable on neck; Swelling on neck; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL BLISTERING (Blisters all over her neck, throat, upper arm, and chest) in a 68-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.     Concurrent medical conditions included Blood pressure high, High cholesterol and COPD.    On 02-Mar-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced OROPHARYNGEAL BLISTERING (Blisters all over her neck, throat, upper arm, and chest) (seriousness criterion medically significant), BLISTER (Blisters all over her neck, throat, upper arm, and chest), URTICARIA (Rash that turned into welts), ERYTHEMA (Red on neck), MUSCULOSKELETAL DISCOMFORT (Uncomfortable on neck) and SWELLING (Swelling on neck). At the time of the report, OROPHARYNGEAL BLISTERING (Blisters all over her neck, throat, upper arm, and chest), BLISTER (Blisters all over her neck, throat, upper arm, and chest), URTICARIA (Rash that turned into welts), ERYTHEMA (Red on neck) and MUSCULOSKELETAL DISCOMFORT (Uncomfortable on neck) had not resolved and SWELLING (Swelling on neck) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. Treatment information was not provided.  This case concerns a 68 Y/O F with a serious unexpected event of oropharyngeal blistering along with nonserious unexpected events of urticaria, blisters, erythema, swelling and musculoskeletal discomfort. Event onset the same day as first dose mRNA-1273. Events resolving. 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 68 Y/O F with a serious unexpected event of oropharyngeal blistering along with nonserious unexpected events of urticaria, blisters, erythema, swelling and musculoskeletal discomfort. Event onset the same day as first dose mRNA-1273. Events resolving. 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: Urticaria
Clinical narrative: Blisters all over her neck, throat, upper arm, and chest; Blisters all over her neck, throat, upper arm, and chest; Rash that turned into welts; Red on neck; Uncomfortable on neck; Swelling on neck; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL BLISTERING (Blisters all over her neck, throat, upper arm, and chest) in a 68-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.     Concurrent medical conditions included Blood pressure high, High cholesterol and COPD.    On 02-Mar-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced OROPHARYNGEAL BLISTERING (Blisters all over her neck, throat, upper arm, and chest) (seriousness criterion medically significant), BLISTER (Blisters all over her neck, throat, upper arm, and chest), URTICARIA (Rash that turned into welts), ERYTHEMA (Red on neck), MUSCULOSKELETAL DISCOMFORT (Uncomfortable on neck) and SWELLING (Swelling on neck). At the time of the report, OROPHARYNGEAL BLISTERING (Blisters all over her neck, throat, upper arm, and chest), BLISTER (Blisters all over her neck, throat, upper arm, and chest), URTICARIA (Rash that turned into welts), ERYTHEMA (Red on neck) and MUSCULOSKELETAL DISCOMFORT (Uncomfortable on neck) had not resolved and SWELLING (Swelling on neck) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. Treatment information was not provided.  This case concerns a 68 Y/O F with a serious unexpected event of oropharyngeal blistering along with nonserious unexpected events of urticaria, blisters, erythema, swelling and musculoskeletal discomfort. Event onset the same day as first dose mRNA-1273. Events resolving. 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 68 Y/O F with a serious unexpected event of oropharyngeal blistering along with nonserious unexpected events of urticaria, blisters, erythema, swelling and musculoskeletal discomfort. Event onset the same day as first dose mRNA-1273. Events resolving. 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dyspnoea, Fatigue, Haemoptysis
Clinical narrative: Pulmonary embolism; Spitting out blood clots; Labored breathing; Diarrhea; Body aches; Joint aches; Fever; Exhausted; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction (No medical history reported.). Concomitant products included METOPROLOL and LOVASTATIN.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen levels have gone as low as 76 and several in the 80's), HEART RATE INCREASED (Heart rate is normally around 60, and has been in the 90's several times), PAIN (Body aches), ARTHRALGIA (Joint aches), PYREXIA (Fever) and FATIGUE (Exhausted). On 07-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion medically significant), HAEMOPTYSIS (Spitting out blood clots), DYSPNOEA (Labored breathing) and VITAL CAPACITY ABNORMAL (Vitals are waked out). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism), HAEMOPTYSIS (Spitting out blood clots), DYSPNOEA (Labored breathing), OXYGEN SATURATION DECREASED (Oxygen levels have gone as low as 76 and several in the 80's), HEART RATE INCREASED (Heart rate is normally around 60, and has been in the 90's several times), VITAL CAPACITY ABNORMAL (Vitals are waked out), DIARRHOEA (Diarrhea), PAIN (Body aches), ARTHRALGIA (Joint aches), PYREXIA (Fever) and FATIGUE (Exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 103.7 (High) 103.7. In February 2021, Heart rate: 90s (abnormal) In the 90s several times. In February 2021, Oxygen saturation decreased: 76s (Low) has gone as low as 76 and in 80s. In February 2021, SARS-CoV-2 test negative: Negative and Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Myalgia, Oxygen saturation decreased, Pulmonary embolism, Pyrexia
Clinical narrative: Pulmonary embolism; Spitting out blood clots; Labored breathing; Diarrhea; Body aches; Joint aches; Fever; Exhausted; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction (No medical history reported.). Concomitant products included METOPROLOL and LOVASTATIN.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen levels have gone as low as 76 and several in the 80's), HEART RATE INCREASED (Heart rate is normally around 60, and has been in the 90's several times), PAIN (Body aches), ARTHRALGIA (Joint aches), PYREXIA (Fever) and FATIGUE (Exhausted). On 07-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion medically significant), HAEMOPTYSIS (Spitting out blood clots), DYSPNOEA (Labored breathing) and VITAL CAPACITY ABNORMAL (Vitals are waked out). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism), HAEMOPTYSIS (Spitting out blood clots), DYSPNOEA (Labored breathing), OXYGEN SATURATION DECREASED (Oxygen levels have gone as low as 76 and several in the 80's), HEART RATE INCREASED (Heart rate is normally around 60, and has been in the 90's several times), VITAL CAPACITY ABNORMAL (Vitals are waked out), DIARRHOEA (Diarrhea), PAIN (Body aches), ARTHRALGIA (Joint aches), PYREXIA (Fever) and FATIGUE (Exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 103.7 (High) 103.7. In February 2021, Heart rate: 90s (abnormal) In the 90s several times. In February 2021, Oxygen saturation decreased: 76s (Low) has gone as low as 76 and in 80s. In February 2021, SARS-CoV-2 test negative: Negative and Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Pulmonary embolism; Spitting out blood clots; Labored breathing; Diarrhea; Body aches; Joint aches; Fever; Exhausted; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction (No medical history reported.). Concomitant products included METOPROLOL and LOVASTATIN.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen levels have gone as low as 76 and several in the 80's), HEART RATE INCREASED (Heart rate is normally around 60, and has been in the 90's several times), PAIN (Body aches), ARTHRALGIA (Joint aches), PYREXIA (Fever) and FATIGUE (Exhausted). On 07-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion medically significant), HAEMOPTYSIS (Spitting out blood clots), DYSPNOEA (Labored breathing) and VITAL CAPACITY ABNORMAL (Vitals are waked out). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism), HAEMOPTYSIS (Spitting out blood clots), DYSPNOEA (Labored breathing), OXYGEN SATURATION DECREASED (Oxygen levels have gone as low as 76 and several in the 80's), HEART RATE INCREASED (Heart rate is normally around 60, and has been in the 90's several times), VITAL CAPACITY ABNORMAL (Vitals are waked out), DIARRHOEA (Diarrhea), PAIN (Body aches), ARTHRALGIA (Joint aches), PYREXIA (Fever) and FATIGUE (Exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 103.7 (High) 103.7. In February 2021, Heart rate: 90s (abnormal) In the 90s several times. In February 2021, Oxygen saturation decreased: 76s (Low) has gone as low as 76 and in 80s. In February 2021, SARS-CoV-2 test negative: Negative and Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cardiac flutter, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: fever today of 99.6 F; Heart feels a little fluttery; heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart feels a little fluttery) 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 history.).    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 CARDIAC FLUTTER (Heart feels a little fluttery) (seriousness criterion medically significant) and HEART RATE INCREASED (heart rate increased). On 10-Mar-2021, the patient experienced PYREXIA (fever today of 99.6 F). At the time of the report, CARDIAC FLUTTER (Heart feels a little fluttery), HEART RATE INCREASED (heart rate increased) and PYREXIA (fever today of 99.6 F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Electrocardiogram: normal (normal) normal. On 08-Mar-2021, Heart rate: 113 (Inconclusive) heart beats per minute. On 09-Mar-2021, Electrocardiogram: normal (normal) Normal. On 09-Mar-2021, Heart rate: 80 low 90s (Inconclusive) mid to high 80 low 90s beats per minute. On 10-Mar-2021, Body temperature: 99.6 (Inconclusive) 99.6 F. On 10-Mar-2021, Heart rate: 103-104 (Inconclusive) heart beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   This case concerns a 62 Y/O F with a serious unexpected event of cardiac flutter and nonserious unexpected heart rate increased and expected pyrexia. Event onset the same day as first dose mRNA-1273. Events not 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 62 Y/O F with a serious unexpected event of cardiac flutter and nonserious unexpected heart rate increased and expected pyrexia. Event onset the same day as first dose mRNA-1273. Events not 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever today of 99.6 F; Heart feels a little fluttery; heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart feels a little fluttery) 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 history.).    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 CARDIAC FLUTTER (Heart feels a little fluttery) (seriousness criterion medically significant) and HEART RATE INCREASED (heart rate increased). On 10-Mar-2021, the patient experienced PYREXIA (fever today of 99.6 F). At the time of the report, CARDIAC FLUTTER (Heart feels a little fluttery), HEART RATE INCREASED (heart rate increased) and PYREXIA (fever today of 99.6 F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Electrocardiogram: normal (normal) normal. On 08-Mar-2021, Heart rate: 113 (Inconclusive) heart beats per minute. On 09-Mar-2021, Electrocardiogram: normal (normal) Normal. On 09-Mar-2021, Heart rate: 80 low 90s (Inconclusive) mid to high 80 low 90s beats per minute. On 10-Mar-2021, Body temperature: 99.6 (Inconclusive) 99.6 F. On 10-Mar-2021, Heart rate: 103-104 (Inconclusive) heart beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   This case concerns a 62 Y/O F with a serious unexpected event of cardiac flutter and nonserious unexpected heart rate increased and expected pyrexia. Event onset the same day as first dose mRNA-1273. Events not 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 62 Y/O F with a serious unexpected event of cardiac flutter and nonserious unexpected heart rate increased and expected pyrexia. Event onset the same day as first dose mRNA-1273. Events not 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.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Myocardial infarction, Somnolence, Vomiting
Clinical narrative: felt like I was having a heart attack; severe chest pain twice; extremely weak; Sleep all day; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (felt like I was having a heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (felt like I was having a heart attack) (seriousness criterion medically significant), CHEST PAIN (severe chest pain twice), ASTHENIA (extremely weak), SOMNOLENCE (Sleep all day) and VOMITING (Vomiting). At the time of the report, MYOCARDIAL INFARCTION (felt like I was having a heart attack), CHEST PAIN (severe chest pain twice), ASTHENIA (extremely weak), SOMNOLENCE (Sleep all day) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case concerns a male of unknown age with a serious unexpected event of myocardial infarction, and nonserious events of unexpected chest pain, asthenia, somnolence and expected vomiting.  Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a male of unknown age with a serious unexpected event of myocardial infarction, and nonserious events of unexpected chest pain, asthenia, somnolence and expected vomiting.  Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was received from consumer concerning of an unknown age patient, who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and experienced diarrhea.   The patient's past medical history was not provided. Concomitant product use was not provided.  On an unknown date, prior to the onset of the symptoms, the patient received their doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced hospitalized will be released to assisted living and diarrhea. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not reported.  The outcome of the event diarrhea was not reported.; Reporter's Comments: This case concerns a male of unknown age hospitalized with a serious unexpected event of diarrhea.  Event onset with unknown latency after first dose mRNA-1273. Event outcome 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Diffusion-weighted brain MRI, Dizziness, Dysarthria, Facial paralysis
Clinical narrative: TIA; Right side of her face was drooping; Left arm was paralyzed; Slurred speech; Dizzy; Confused; A spontaneous report  was received from a consumer concerning a 46-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced TIA (transient ischaemic attack), dizzy (dizziness), her left arm was paralyzed (paralysis), right side of her face was drooping (facial paralysis), slurred speech (dysarthria), and she was confused (confusional state).   The patient denied having any allergies, past medical history or concomitant medications.  Therefore, no medical history or concomitant medications were reported.  On 14-Jan-2021, the patient received the first of two planned doses of mRNA-1273 (Lot #: 251L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10-Feb-2021, approximately twenty-four days prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Lot #: 16M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06-Mar-2021 the patient had a "TIA" (transient ischemic attack). She was sitting down and when she got up, she got dizzy and her left arm was paralyzed. The right side of her face was drooping, she had slurred speech and she was confused. The patient went to the hospital where she was hospitalized for 2 days. The MD (medical doctor) said she had a "7 mm focal diffusion."  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcomes of the events, TIA, dizzy, her left arm was paralyzed, right side of her face was drooping, slurred speech, and she was confused, were unknown.; Reporter'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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis, Transient ischaemic attack
Clinical narrative: TIA; Right side of her face was drooping; Left arm was paralyzed; Slurred speech; Dizzy; Confused; A spontaneous report  was received from a consumer concerning a 46-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced TIA (transient ischaemic attack), dizzy (dizziness), her left arm was paralyzed (paralysis), right side of her face was drooping (facial paralysis), slurred speech (dysarthria), and she was confused (confusional state).   The patient denied having any allergies, past medical history or concomitant medications.  Therefore, no medical history or concomitant medications were reported.  On 14-Jan-2021, the patient received the first of two planned doses of mRNA-1273 (Lot #: 251L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10-Feb-2021, approximately twenty-four days prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Lot #: 16M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06-Mar-2021 the patient had a "TIA" (transient ischemic attack). She was sitting down and when she got up, she got dizzy and her left arm was paralyzed. The right side of her face was drooping, she had slurred speech and she was confused. The patient went to the hospital where she was hospitalized for 2 days. The MD (medical doctor) said she had a "7 mm focal diffusion."  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcomes of the events, TIA, dizzy, her left arm was paralyzed, right side of her face was drooping, slurred speech, and she was confused, were unknown.; Reporter'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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral artery occlusion, Dyspnoea
Clinical narrative: Cerebral occlusion in middle cerebral artery; Developed SOB which lingered; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CEREBRAL ARTERY OCCLUSION (Cerebral occlusion in middle cerebral artery) 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.     Concurrent medical conditions included Diabetes mellitus, Hypertension and Hyperlipidemia.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DYSPNOEA (Developed SOB which lingered). On 03-Mar-2021, the patient experienced CEREBRAL ARTERY OCCLUSION (Cerebral occlusion in middle cerebral artery) (seriousness criterion hospitalization). The patient was hospitalized from 03-Mar-2021 to 06-Mar-2021 due to CEREBRAL ARTERY OCCLUSION. At the time of the report, CEREBRAL ARTERY OCCLUSION (Cerebral occlusion in middle cerebral artery) and DYSPNOEA (Developed SOB which lingered) 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.; 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. However, Patient's advanced age, hypertension, diabetes Miletus, hyperlipidemia may remain as risk factors for this event. Further information is requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Joint swelling, Rheumatoid arthritis
Clinical narrative: Rheumatoid flare-up that started in her hands and moved to her feet; Swollen joints/joints are swollen; Red and swollen joints; A spontaneous report  was received from a consumer, concerning an 81-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed rheumatoid flare-up, red/erythema and swollen joints/ joint swelling.  The patient's medical history included rheumatoid arthritis.  Products known to have been used by the patient, within two weeks prior to the event were not provided.  On 16 Feb 2021, the patient received first dose of mRNA-1273 (batch number: unknown) for prophylaxis of COVID-19 infection.  On 13 Mar 2021, prior to the onset of the events, the patient received their second dose of mRNA-1273 (batch number: unknown) on right arm for prophylaxis of COVID-19 infection.  On 14 Mar 2021, one day after vaccination, the patient experienced rheumatoid flare-up which started in her hands and moved to her feet which was considered as serious (medically significant). On 20 Mar 2021, the patient's joints were swollen and red.     Treatment for the event is not provided.   Action taken with mrna-1273 in response to the events was not provided  The outcome of the events were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. Elderly age and medical history of rheumatoid arthritis  are considered confounders.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: blood clot in brain/ stroke; A spontaneous report  was received from a consumer concerning an 75-year-old, male patient who was hospitalized due to Blood clot in brain and stroke.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 11 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 Batch no: 027A21A for prophylaxis of COVID-19 infection.  On 12 Mar 2021, It was reported that the patient experienced  Blood clot in brain and stroke and the patient was hospitalized for three days, from Friday 12 Mar 2021 to Sunday 14 Mar 2021. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event(s) Blood clot in brain and stroke was considered to be resolved.; Reporter's Comments: This is a case of cerebrovascular accident in a 75-year-old male patient with no medical hx provided who was hospitalized after experiencing blood clots in the brain and stroke after receiving first dose of vaccine. Very limited information has been provided at this time. Further information is expected
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Delirium, Dizziness, Dysgeusia, Fatigue
Clinical narrative: bad, bitter taste in the mouth; brain fog/not feeling themself; fatigue; sweats; delirious; severe vomiting for 12 hours non stop; chills; dizziness; nausea; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of delirium  in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 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 dizziness, nausea, fever and headache.   On 14-Mar-2021, the patient experienced delirium , sweats, severe vomiting for 12 hours non stop and chills,    On 14-Mar-2021, nausea, fever), severe vomiting for 12 hours non stop and headache had resolved.   On 18-Mar-2021, the patient experienced bad, bitter taste in the mouth, feeling abnormal, brain fog/not feeling themself and fatigue  bad, bitter taste in the mouth, feeling abnormal, brain fog/not feeling themself and fatigue  On 19-Mar-2021 bad,  bitter taste in the mouth, feeling abnormal, brain fog/not feeling themself, chills and fatigue, outcome were unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Patient believed they had a cytokine reaction.  Patient took Benadryl one hour before the vaccine and the night of the vaccine per physician recommendation. Patient took Tylenol for fever.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: bad, bitter taste in the mouth; brain fog/not feeling themself; fatigue; sweats; delirious; severe vomiting for 12 hours non stop; chills; dizziness; nausea; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of delirium  in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 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 dizziness, nausea, fever and headache.   On 14-Mar-2021, the patient experienced delirium , sweats, severe vomiting for 12 hours non stop and chills,    On 14-Mar-2021, nausea, fever), severe vomiting for 12 hours non stop and headache had resolved.   On 18-Mar-2021, the patient experienced bad, bitter taste in the mouth, feeling abnormal, brain fog/not feeling themself and fatigue  bad, bitter taste in the mouth, feeling abnormal, brain fog/not feeling themself and fatigue  On 19-Mar-2021 bad,  bitter taste in the mouth, feeling abnormal, brain fog/not feeling themself, chills and fatigue, outcome were unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Patient believed they had a cytokine reaction.  Patient took Benadryl one hour before the vaccine and the night of the vaccine per physician recommendation. Patient took Tylenol for fever.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: bad, bitter taste in the mouth; brain fog/not feeling themself; fatigue; sweats; delirious; severe vomiting for 12 hours non stop; chills; dizziness; nausea; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of delirium  in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 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 dizziness, nausea, fever and headache.   On 14-Mar-2021, the patient experienced delirium , sweats, severe vomiting for 12 hours non stop and chills,    On 14-Mar-2021, nausea, fever), severe vomiting for 12 hours non stop and headache had resolved.   On 18-Mar-2021, the patient experienced bad, bitter taste in the mouth, feeling abnormal, brain fog/not feeling themself and fatigue  bad, bitter taste in the mouth, feeling abnormal, brain fog/not feeling themself and fatigue  On 19-Mar-2021 bad,  bitter taste in the mouth, feeling abnormal, brain fog/not feeling themself, chills and fatigue, outcome were unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Patient believed they had a cytokine reaction.  Patient took Benadryl one hour before the vaccine and the night of the vaccine per physician recommendation. Patient took Tylenol for fever.