chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Had a spike in blood pressure (194/100); Increased heart rate; Toe injury/Minor bruising; Trouble sleeping; Sleeping pattern has changed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSIVE CRISIS (Had a spike in blood pressure (194/100)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Insomnia. Concurrent medical conditions included White coat hypertension. Concomitant products included CALCIUM for Calcium supplementation, MELATONIN for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced HYPERTENSIVE CRISIS (Had a spike in blood pressure (194/100)) (seriousness criterion medically significant), HEART RATE INCREASED (Increased heart rate), LIMB INJURY (Toe injury/Minor bruising), INSOMNIA (Trouble sleeping) and SLEEP DISORDER (Sleeping pattern has changed). At the time of the report, HYPERTENSIVE CRISIS (Had a spike in blood pressure (194/100)), HEART RATE INCREASED (Increased heart rate), LIMB INJURY (Toe injury/Minor bruising), INSOMNIA (Trouble sleeping) and SLEEP DISORDER (Sleeping pattern has changed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 194/100 (High) High.         Two weeks after receiving the vaccine the patient had trouble sleeping and sleeping pattern was changed. The patient reported that she had a spike in blood pressure (194/100) and increased heart rate when she went for doctor's appointment. She has white coat syndrome. The patient was prescribed Ativan 1-2 times a week as needed (after sleeping pattern changed). The patient consumed a cup of wine to help her fall asleep. On 06-Apr-2021 or 07-Apr-2021, the patient had a toe injury which caused minor bruising and sleep problems started around that time.  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. However, Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Epstein-Barr virus infection, Hepatomegaly
Clinical narrative: Epstein barr virus; Swollen liver; Pain in upper right quadrant; This spontaneous case was reported by a pharmacist and describes the occurrence of EPSTEIN-BARR VIRUS INFECTION (Epstein barr virus) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced EPSTEIN-BARR VIRUS INFECTION (Epstein barr virus) (seriousness criterion medically significant), HEPATOMEGALY (Swollen liver) and ABDOMINAL PAIN UPPER (Pain in upper right quadrant). At the time of the report, EPSTEIN-BARR VIRUS INFECTION (Epstein barr virus), HEPATOMEGALY (Swollen liver) and ABDOMINAL PAIN UPPER (Pain in upper right quadrant) 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.   No concomitant medications were taken, and no treatment was given. 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. However, Very limited information regarding these events has been provided. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information regarding these events has been provided. Further information has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fasting, Feeling abnormal, Hallucination, Myalgia
Clinical narrative: hallucinating; full day spent in bed feeling bad; chills; Body Aches; A little bit of a fever; didn't eat for 2 full days; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinating) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive (Patient with a prior, confirmed COVID 19 Infection requiring a ventilator in October and November.) in October 2020.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FASTING (didn't eat for 2 full days), CHILLS (chills), MYALGIA (Body Aches) and PYREXIA (A little bit of a fever). On 23-Apr-2021, the patient experienced FEELING ABNORMAL (full day spent in bed feeling bad). On an unknown date, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant). On 24-Apr-2021, HALLUCINATION (hallucinating), FASTING (didn't eat for 2 full days), FEELING ABNORMAL (full day spent in bed feeling bad), CHILLS (chills), MYALGIA (Body Aches) and PYREXIA (A little bit of a fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took Blood pressure medicine(Name Not specified) and aspirin as a concomitant medication.  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
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: hallucinating; full day spent in bed feeling bad; chills; Body Aches; A little bit of a fever; didn't eat for 2 full days; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinating) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive (Patient with a prior, confirmed COVID 19 Infection requiring a ventilator in October and November.) in October 2020.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FASTING (didn't eat for 2 full days), CHILLS (chills), MYALGIA (Body Aches) and PYREXIA (A little bit of a fever). On 23-Apr-2021, the patient experienced FEELING ABNORMAL (full day spent in bed feeling bad). On an unknown date, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant). On 24-Apr-2021, HALLUCINATION (hallucinating), FASTING (didn't eat for 2 full days), FEELING ABNORMAL (full day spent in bed feeling bad), CHILLS (chills), MYALGIA (Body Aches) and PYREXIA (A little bit of a fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took Blood pressure medicine(Name Not specified) and aspirin as a concomitant medication.  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
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Myalgia, Oropharyngeal blistering
Clinical narrative: Two blisters in the back of the throat; Dizziness; Arm hurts; Getting weak; Terrible chills; Terrible body aches; horrible fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL BLISTERING (Two blisters in the back of the throat) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced OROPHARYNGEAL BLISTERING (Two blisters in the back of the throat) (seriousness criterion medically significant), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm hurts), ASTHENIA (Getting weak), CHILLS (Terrible chills), MYALGIA (Terrible body aches) and PYREXIA (horrible fever). At the time of the report, OROPHARYNGEAL BLISTERING (Two blisters in the back of the throat), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm hurts), ASTHENIA (Getting weak), CHILLS (Terrible chills), MYALGIA (Terrible body aches) and PYREXIA (horrible fever) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  Acetaminophen was taken for symptoms.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.  Company 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.   This case was linked to MOD-2021-090318 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Two blisters in the back of the throat; Dizziness; Arm hurts; Getting weak; Terrible chills; Terrible body aches; horrible fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL BLISTERING (Two blisters in the back of the throat) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced OROPHARYNGEAL BLISTERING (Two blisters in the back of the throat) (seriousness criterion medically significant), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm hurts), ASTHENIA (Getting weak), CHILLS (Terrible chills), MYALGIA (Terrible body aches) and PYREXIA (horrible fever). At the time of the report, OROPHARYNGEAL BLISTERING (Two blisters in the back of the throat), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm hurts), ASTHENIA (Getting weak), CHILLS (Terrible chills), MYALGIA (Terrible body aches) and PYREXIA (horrible fever) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  Acetaminophen was taken for symptoms.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.  Company 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.   This case was linked to MOD-2021-090318 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalised for COVID-19; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (hospitalised for COVID-19) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (hospitalised for COVID-19) (seriousness criterion hospitalization). The patient was hospitalized until 22-Apr-2021 due to COVID-19. At the time of the report, COVID-19 (hospitalised for COVID-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took the first dose and she is due for second dose today. The patient was hospitalized for covid-19 and got out about 4 days ago. The patient was feeling better at the time of this report.   This case was linked to MOD21-081744, MOD21-081758 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested. MOD21-081744:crosslinked case MOD21-081758:crosslinked case
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal blistering
Clinical narrative: blisters in the back of throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL BLISTERING (blisters in the back of throat) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced OROPHARYNGEAL BLISTERING (blisters in the back of throat) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL BLISTERING (blisters in the back of throat) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant and treatment information not provided.  Treatment information was not provided.  Company Comment: This case concerns a 59-year-old female with a serious unexpected event of oropharyngeal blistering. Event onset 3 days after second 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.; Sender's Comments: This case concerns a 59-year-old female with a serious unexpected event of oropharyngeal blistering. Event onset 3 days after second 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.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Eye irritation, Headache, Hypoaesthesia
Clinical narrative: Can't breath; tongue swollen; throat is real red; Itches all over; rash on the upper part of body; Fever; eyes are burning; feels like she got pneumonia; arm felt numb; heada che; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Can't breath) and SWOLLEN TONGUE (tongue swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Bronchitis and Sinusitis.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced HYPOAESTHESIA (arm felt numb) and HEADACHE (heada che). On 07-Apr-2021, the patient experienced EYE IRRITATION (eyes are burning), CHEST DISCOMFORT (feels like she got pneumonia) and PYREXIA (Fever). On an unknown date, the patient experienced DYSPNOEA (Can't breath) (seriousness criterion life threatening), SWOLLEN TONGUE (tongue swollen) (seriousness criterion life threatening), PHARYNGEAL ERYTHEMA (throat is real red), PRURITUS (Itches all over) and RASH (rash on the upper part of body). At the time of the report, DYSPNOEA (Can't breath), SWOLLEN TONGUE (tongue swollen), HYPOAESTHESIA (arm felt numb), EYE IRRITATION (eyes are burning), CHEST DISCOMFORT (feels like she got pneumonia), PHARYNGEAL ERYTHEMA (throat is real red), PRURITUS (Itches all over), RASH (rash on the upper part of body), PYREXIA (Fever) and HEADACHE (heada che) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 98.3 (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient have not taken medical care at the time of report. No treatment information available. advised to seek medical care immediately.  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.   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.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal erythema, Pruritus, Pyrexia, Rash, Swollen tongue
Clinical narrative: Can't breath; tongue swollen; throat is real red; Itches all over; rash on the upper part of body; Fever; eyes are burning; feels like she got pneumonia; arm felt numb; heada che; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Can't breath) and SWOLLEN TONGUE (tongue swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Bronchitis and Sinusitis.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced HYPOAESTHESIA (arm felt numb) and HEADACHE (heada che). On 07-Apr-2021, the patient experienced EYE IRRITATION (eyes are burning), CHEST DISCOMFORT (feels like she got pneumonia) and PYREXIA (Fever). On an unknown date, the patient experienced DYSPNOEA (Can't breath) (seriousness criterion life threatening), SWOLLEN TONGUE (tongue swollen) (seriousness criterion life threatening), PHARYNGEAL ERYTHEMA (throat is real red), PRURITUS (Itches all over) and RASH (rash on the upper part of body). At the time of the report, DYSPNOEA (Can't breath), SWOLLEN TONGUE (tongue swollen), HYPOAESTHESIA (arm felt numb), EYE IRRITATION (eyes are burning), CHEST DISCOMFORT (feels like she got pneumonia), PHARYNGEAL ERYTHEMA (throat is real red), PRURITUS (Itches all over), RASH (rash on the upper part of body), PYREXIA (Fever) and HEADACHE (heada che) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 98.3 (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient have not taken medical care at the time of report. No treatment information available. advised to seek medical care immediately.  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.   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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus, Vertigo
Clinical narrative: Hearing loss; Vertigo; Tinnitus; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEAFNESS (Hearing loss) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was provided by the reporter.     On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DEAFNESS (Hearing loss) (seriousness criteria disability and medically significant), VERTIGO (Vertigo) and TINNITUS (Tinnitus). At the time of the report, DEAFNESS (Hearing loss), VERTIGO (Vertigo) and TINNITUS (Tinnitus) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Patient went to audiologist and was given a hearing aide.  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.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Dizziness, Feeling abnormal, Headache
Clinical narrative: Fainting; vertigo; spins; dizziness; confusion; fogginess; the craps; heart running; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainting) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history reported.  Concomitant products included LOSARTAN, METOPROLOL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 28-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 VERTIGO (vertigo; spins), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (fogginess), DIARRHOEA (the craps), HEART RATE INCREASED (heart running) and HEADACHE (headache). On an unknown date, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting), VERTIGO (vertigo; spins), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (fogginess), DIARRHOEA (the craps), HEART RATE INCREASED (heart running) and HEADACHE (headache) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Treatment in the ER included "methazine." The patient noted that he will not be getting the second planned vaccine dose.  Company Comment: This case concerns a 61-year-old male with a serious unexpected event of syncope, and nonserious unexpected vertigo, dizziness, heart rate increased, diarrhea, confusional state, feeling abnormal, and expected headache. Event onset with unknown latency after 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 61-year-old male with a serious unexpected event of syncope, and nonserious unexpected vertigo, dizziness, heart rate increased, diarrhea, confusional state, feeling abnormal, and expected headache. Event onset with unknown latency after 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Syncope, Vertigo
Clinical narrative: Fainting; vertigo; spins; dizziness; confusion; fogginess; the craps; heart running; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainting) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history reported.  Concomitant products included LOSARTAN, METOPROLOL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 28-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 VERTIGO (vertigo; spins), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (fogginess), DIARRHOEA (the craps), HEART RATE INCREASED (heart running) and HEADACHE (headache). On an unknown date, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting), VERTIGO (vertigo; spins), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (fogginess), DIARRHOEA (the craps), HEART RATE INCREASED (heart running) and HEADACHE (headache) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Treatment in the ER included "methazine." The patient noted that he will not be getting the second planned vaccine dose.  Company Comment: This case concerns a 61-year-old male with a serious unexpected event of syncope, and nonserious unexpected vertigo, dizziness, heart rate increased, diarrhea, confusional state, feeling abnormal, and expected headache. Event onset with unknown latency after 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 61-year-old male with a serious unexpected event of syncope, and nonserious unexpected vertigo, dizziness, heart rate increased, diarrhea, confusional state, feeling abnormal, and expected headache. Event onset with unknown latency after 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Fatigue, Haemorrhage urinary tract, Headache
Clinical narrative: blood in her urine with clots; felt bad like the flu; went to sleep and woke up dizzy; buzzing in her ears; she feels with altitude sickness; Plugged ears; tiredness; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (blood in her urine with clots) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No patient medical history reported.  Concomitant products included METOPROLOL for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced HAEMORRHAGE URINARY TRACT (blood in her urine with clots) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (felt bad like the flu), DIZZINESS (went to sleep and woke up dizzy), TINNITUS (buzzing in her ears), HYPOBARISM (she feels with altitude sickness), EAR DISCOMFORT (Plugged ears), FATIGUE (tiredness), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, HAEMORRHAGE URINARY TRACT (blood in her urine with clots), INFLUENZA LIKE ILLNESS (felt bad like the flu), DIZZINESS (went to sleep and woke up dizzy), TINNITUS (buzzing in her ears), HYPOBARISM (she feels with altitude sickness), EAR DISCOMFORT (Plugged ears), FATIGUE (tiredness), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.            Additional concomitant medications included reflux medication when needed and asthma medication when needed. This case concerns a 56-year-old female with a serious unexpected event of hemorrhage urinary tract, and nonserious unexpected Influenza like illness, dizziness, tinnitus, ear discomfort, hypobarism, and expected headache, fatigue, nausea. Hemorrhage urinary tract latency 22 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-090443, US-MODERNATX, INC.-MOD-2021-090371 (E2B Linked Report).; Sender's Comments: This case concerns a 56-year-old female with a serious unexpected event of hemorrhage urinary tract, and nonserious unexpected Influenza like illness, dizziness, tinnitus, ear discomfort, hypobarism, and expected headache, fatigue, nausea. Hemorrhage urinary tract latency 22 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-090443:Dose 1 US-MODERNATX, INC.-MOD-2021-090371:Son's case
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypobarism, Influenza like illness, Nausea, Tinnitus
Clinical narrative: blood in her urine with clots; felt bad like the flu; went to sleep and woke up dizzy; buzzing in her ears; she feels with altitude sickness; Plugged ears; tiredness; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (blood in her urine with clots) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No patient medical history reported.  Concomitant products included METOPROLOL for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced HAEMORRHAGE URINARY TRACT (blood in her urine with clots) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (felt bad like the flu), DIZZINESS (went to sleep and woke up dizzy), TINNITUS (buzzing in her ears), HYPOBARISM (she feels with altitude sickness), EAR DISCOMFORT (Plugged ears), FATIGUE (tiredness), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, HAEMORRHAGE URINARY TRACT (blood in her urine with clots), INFLUENZA LIKE ILLNESS (felt bad like the flu), DIZZINESS (went to sleep and woke up dizzy), TINNITUS (buzzing in her ears), HYPOBARISM (she feels with altitude sickness), EAR DISCOMFORT (Plugged ears), FATIGUE (tiredness), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.            Additional concomitant medications included reflux medication when needed and asthma medication when needed. This case concerns a 56-year-old female with a serious unexpected event of hemorrhage urinary tract, and nonserious unexpected Influenza like illness, dizziness, tinnitus, ear discomfort, hypobarism, and expected headache, fatigue, nausea. Hemorrhage urinary tract latency 22 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-090443, US-MODERNATX, INC.-MOD-2021-090371 (E2B Linked Report).; Sender's Comments: This case concerns a 56-year-old female with a serious unexpected event of hemorrhage urinary tract, and nonserious unexpected Influenza like illness, dizziness, tinnitus, ear discomfort, hypobarism, and expected headache, fatigue, nausea. Hemorrhage urinary tract latency 22 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-090443:Dose 1 US-MODERNATX, INC.-MOD-2021-090371:Son's case
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion death). The patient died on 05-Apr-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed.            Concomitant medications were not reported. The patient was not hospitalized prior to or during the stroke. The reporter mentioned that the organs were donated as the patient was on a ventilator.; Reported Cause(s) of Death: Stroke
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Ear infection, Facial discomfort, Headache, Meniere's disease
Clinical narrative: Meniere's Disease; ear infection; Autoimmune response to the vaccine; headaches; facial pressure; tinnitus; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENIERE'S DISEASE (Meniere's Disease) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced FACIAL DISCOMFORT (facial pressure), TINNITUS (tinnitus) and HEADACHE (headaches). On an unknown date, the patient experienced MENIERE'S DISEASE (Meniere's Disease) (seriousness criterion medically significant), EAR INFECTION (ear infection) and AUTOIMMUNE DISORDER (Autoimmune response to the vaccine). At the time of the report, MENIERE'S DISEASE (Meniere's Disease), FACIAL DISCOMFORT (facial pressure), EAR INFECTION (ear infection) and AUTOIMMUNE DISORDER (Autoimmune response to the vaccine) outcome was unknown and TINNITUS (tinnitus) and HEADACHE (headaches) had not resolved.            On unknown date, the patient was given antibiotics for a possible ear infection and the ears, nose and throat (ENT) physician put the patient on prednisone.  On unknown date, the patient was seen by a neurologist for the persistent headaches and tinnitus and was told by the doctor the patient had an autoimmune response to the vaccine that was affected the nerves.  This case concerns a 35-year-old male with a serious unexpected event of Meniere's disease, and nonserious unexpected autoimmune disorder, tinnitus, ear infection, facial discomfort, and expected headache. Event onset with unknown 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 35-year-old male with a serious unexpected event of Meniere's disease, and nonserious unexpected autoimmune disorder, tinnitus, ear infection, facial discomfort, and expected headache. Event onset with unknown after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Meniere's Disease; ear infection; Autoimmune response to the vaccine; headaches; facial pressure; tinnitus; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENIERE'S DISEASE (Meniere's Disease) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced FACIAL DISCOMFORT (facial pressure), TINNITUS (tinnitus) and HEADACHE (headaches). On an unknown date, the patient experienced MENIERE'S DISEASE (Meniere's Disease) (seriousness criterion medically significant), EAR INFECTION (ear infection) and AUTOIMMUNE DISORDER (Autoimmune response to the vaccine). At the time of the report, MENIERE'S DISEASE (Meniere's Disease), FACIAL DISCOMFORT (facial pressure), EAR INFECTION (ear infection) and AUTOIMMUNE DISORDER (Autoimmune response to the vaccine) outcome was unknown and TINNITUS (tinnitus) and HEADACHE (headaches) had not resolved.            On unknown date, the patient was given antibiotics for a possible ear infection and the ears, nose and throat (ENT) physician put the patient on prednisone.  On unknown date, the patient was seen by a neurologist for the persistent headaches and tinnitus and was told by the doctor the patient had an autoimmune response to the vaccine that was affected the nerves.  This case concerns a 35-year-old male with a serious unexpected event of Meniere's disease, and nonserious unexpected autoimmune disorder, tinnitus, ear infection, facial discomfort, and expected headache. Event onset with unknown 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 35-year-old male with a serious unexpected event of Meniere's disease, and nonserious unexpected autoimmune disorder, tinnitus, ear infection, facial discomfort, and expected headache. Event onset with unknown after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Vaccination complication
Clinical narrative: She could not breathe; she broke out; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She could not breathe) in a 49-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 Bronchitis. Concurrent medical conditions included Asthma.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (She could not breathe) (seriousness criterion medically significant) and VACCINATION COMPLICATION (she broke out). On 07-Apr-2021, DYSPNOEA (She could not breathe) had resolved. At the time of the report, VACCINATION COMPLICATION (she broke out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified medications used for asthma and bronchitis.  Treatment of these events were not reported.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea at rest, Dyspnoea exertional, Heart rate, Heart rate increased
Clinical narrative: Feels uneasy and weak; Pulse is consistently in the 90-100's range; She is out of breath at times with exertion; She is out of breath at times at rest; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DYSPNOEA AT REST (She is out of breath at times at rest) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced DYSPNOEA AT REST (She is out of breath at times at rest) (seriousness criterion medically significant) and DYSPNOEA EXERTIONAL (She is out of breath at times with exertion). On 26-Apr-2021, the patient experienced ASTHENIA (Feels uneasy and weak) and HEART RATE INCREASED (Pulse is consistently in the 90-100's range). At the time of the report, DYSPNOEA AT REST (She is out of breath at times at rest), ASTHENIA (Feels uneasy and weak), HEART RATE INCREASED (Pulse is consistently in the 90-100's range) and DYSPNOEA EXERTIONAL (She is out of breath at times with exertion) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Heart rate: 90-100's /min (High) 90-100's.         Concomitant product use was not reported.  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.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Dizziness, Headache, Tinnitus, Vertigo
Clinical narrative: Hearing Loss; Extreme ringing in the Ears/ buzzing all the time/tinnitus got worse as of today; Dizziness; Vertigo; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing Loss) in a 31-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.     Concurrent medical conditions included Ringing in ears.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DEAFNESS (Hearing Loss) (seriousness criterion medically significant), TINNITUS (Extreme ringing in the Ears/ buzzing all the time/tinnitus got worse as of today), DIZZINESS (Dizziness), VERTIGO (Vertigo) and HEADACHE (Headache). At the time of the report, DEAFNESS (Hearing Loss), DIZZINESS (Dizziness), VERTIGO (Vertigo) and HEADACHE (Headache) outcome was unknown and TINNITUS (Extreme ringing in the Ears/ buzzing all the time/tinnitus got worse as of today) had not resolved.        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 reported.  No treatment information provided.  Company Comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Headache is consistent with the product safety profile; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Headache is consistent with the product safety profile