chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Nausea, Pain, Rectal haemorrhage
Clinical narrative: had sore; Dizziness; swollen glands in the neck and back of her head; Extreme fatigue; She had nausea; Rectal bleeding; had a hard time walking; she was stiff; Wheezing; was short of breath; felt a vibration inside her body; This spontaneous case was reported by a patient and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary immunodeficiency syndrome (takes IGG replacement therapy) and Graves' disease (takes IGG replacement therapy).    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant), GAIT DISTURBANCE (had a hard time walking), MUSCULOSKELETAL STIFFNESS (she was stiff), WHEEZING (Wheezing), DYSPNOEA (was short of breath), FEELING ABNORMAL (felt a vibration inside her body), PAIN (had sore), DIZZINESS (Dizziness), LYMPHADENOPATHY (swollen glands in the neck and back of her head), FATIGUE (Extreme fatigue) and NAUSEA (She had nausea). At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding), GAIT DISTURBANCE (had a hard time walking), MUSCULOSKELETAL STIFFNESS (she was stiff), WHEEZING (Wheezing), DYSPNOEA (was short of breath), FEELING ABNORMAL (felt a vibration inside her body), PAIN (had sore), DIZZINESS (Dizziness), LYMPHADENOPATHY (swollen glands in the neck and back of her head), FATIGUE (Extreme fatigue) and NAUSEA (She had nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       After the first dose, the patient had extreme fatigue, rectal bleeding, had a hard time walking, she was stiff, had sore and swollen glands in the neck and back of her head. She had nausea, dizziness, wheezing, was short of breath and felt a vibration inside her body. This continued for 30 days after 1st shot and into 2nd shot. Mentioned that the patient has a pre-existing condition of primary immunodeficiency, autoimmune graves disease and for that patient was taking IGG replacement therapy. Concomitant medications were not reported. Treatment included steroids.  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.   This case was linked to MOD-2021-255830 (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.
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: had sore; Dizziness; swollen glands in the neck and back of her head; Extreme fatigue; She had nausea; Rectal bleeding; had a hard time walking; she was stiff; Wheezing; was short of breath; felt a vibration inside her body; This spontaneous case was reported by a patient and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary immunodeficiency syndrome (takes IGG replacement therapy) and Graves' disease (takes IGG replacement therapy).    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant), GAIT DISTURBANCE (had a hard time walking), MUSCULOSKELETAL STIFFNESS (she was stiff), WHEEZING (Wheezing), DYSPNOEA (was short of breath), FEELING ABNORMAL (felt a vibration inside her body), PAIN (had sore), DIZZINESS (Dizziness), LYMPHADENOPATHY (swollen glands in the neck and back of her head), FATIGUE (Extreme fatigue) and NAUSEA (She had nausea). At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding), GAIT DISTURBANCE (had a hard time walking), MUSCULOSKELETAL STIFFNESS (she was stiff), WHEEZING (Wheezing), DYSPNOEA (was short of breath), FEELING ABNORMAL (felt a vibration inside her body), PAIN (had sore), DIZZINESS (Dizziness), LYMPHADENOPATHY (swollen glands in the neck and back of her head), FATIGUE (Extreme fatigue) and NAUSEA (She had nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       After the first dose, the patient had extreme fatigue, rectal bleeding, had a hard time walking, she was stiff, had sore and swollen glands in the neck and back of her head. She had nausea, dizziness, wheezing, was short of breath and felt a vibration inside her body. This continued for 30 days after 1st shot and into 2nd shot. Mentioned that the patient has a pre-existing condition of primary immunodeficiency, autoimmune graves disease and for that patient was taking IGG replacement therapy. Concomitant medications were not reported. Treatment included steroids.  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.   This case was linked to MOD-2021-255830 (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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Disorientation, Product dose omission issue, Sepsis, Vaccination complication
Clinical narrative: septic; did not know who she was or where she was; missed second dose; acting like she had a stroke; feeling ill; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (septic) and DISORIENTATION (did not know who she was or where she was) in a 79-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.  Concomitant products included LEVOTHYROXINE, CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA), PREDNISONE and VITAMINS NOS for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DISORIENTATION (did not know who she was or where she was) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (feeling ill). On 25-Jan-2021, the patient experienced ABNORMAL BEHAVIOUR (acting like she had a stroke). On an unknown date, the patient experienced SEPSIS (septic) (seriousness criteria hospitalization and medically significant) and PRODUCT DOSE OMISSION ISSUE (missed second dose). The patient was hospitalized on 25-Jan-2021 due to DISORIENTATION and SEPSIS. At the time of the report, SEPSIS (septic), DISORIENTATION (did not know who she was or where she was), PRODUCT DOSE OMISSION ISSUE (missed second dose), VACCINATION COMPLICATION (feeling ill) and ABNORMAL BEHAVIOUR (acting like she had a stroke) 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 treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Decreased appetite, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Rectal bleeding; Chest felt tight; Shortness of breath; Wheezing; Hard time walking; Was stiff; Felt vibration inside body; Dizziness; Could hardly eat because so dizzy and nauseated; Sore and swollen glands in neck; Sore and swollen glands neck; Sore and swollen glands in back of head; Nausea; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary immunodeficiency syndrome and Graves' disease. Concomitant products included IMMUNOGLOBULIN G HUMAN (IGG) for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest felt tight), DYSPNOEA (Shortness of breath), WHEEZING (Wheezing), GAIT DISTURBANCE (Hard time walking), MUSCULOSKELETAL STIFFNESS (Was stiff), FEELING ABNORMAL (Felt vibration inside body), DIZZINESS (Dizziness), DECREASED APPETITE (Could hardly eat because so dizzy and nauseated), LYMPH NODE PAIN (Sore and swollen glands in neck), LYMPHADENOPATHY (Sore and swollen glands neck), HEADACHE (Sore and swollen glands in back of head), NAUSEA (Nausea) and FATIGUE (Extreme fatigue). The patient was treated with STEROIDS at an unspecified dose and frequency. At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding), CHEST DISCOMFORT (Chest felt tight), DYSPNOEA (Shortness of breath), WHEEZING (Wheezing), GAIT DISTURBANCE (Hard time walking), MUSCULOSKELETAL STIFFNESS (Was stiff), FEELING ABNORMAL (Felt vibration inside body), DIZZINESS (Dizziness), DECREASED APPETITE (Could hardly eat because so dizzy and nauseated), LYMPH NODE PAIN (Sore and swollen glands in neck), LYMPHADENOPATHY (Sore and swollen glands neck), HEADACHE (Sore and swollen glands in back of head), NAUSEA (Nausea) and FATIGUE (Extreme fatigue) outcome was unknown.            This case was linked to MOD-2021-255802 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time (no onset date of events given hence cannot establish temporal relationship). Further information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Rectal bleeding; Chest felt tight; Shortness of breath; Wheezing; Hard time walking; Was stiff; Felt vibration inside body; Dizziness; Could hardly eat because so dizzy and nauseated; Sore and swollen glands in neck; Sore and swollen glands neck; Sore and swollen glands in back of head; Nausea; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary immunodeficiency syndrome and Graves' disease. Concomitant products included IMMUNOGLOBULIN G HUMAN (IGG) for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest felt tight), DYSPNOEA (Shortness of breath), WHEEZING (Wheezing), GAIT DISTURBANCE (Hard time walking), MUSCULOSKELETAL STIFFNESS (Was stiff), FEELING ABNORMAL (Felt vibration inside body), DIZZINESS (Dizziness), DECREASED APPETITE (Could hardly eat because so dizzy and nauseated), LYMPH NODE PAIN (Sore and swollen glands in neck), LYMPHADENOPATHY (Sore and swollen glands neck), HEADACHE (Sore and swollen glands in back of head), NAUSEA (Nausea) and FATIGUE (Extreme fatigue). The patient was treated with STEROIDS at an unspecified dose and frequency. At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding), CHEST DISCOMFORT (Chest felt tight), DYSPNOEA (Shortness of breath), WHEEZING (Wheezing), GAIT DISTURBANCE (Hard time walking), MUSCULOSKELETAL STIFFNESS (Was stiff), FEELING ABNORMAL (Felt vibration inside body), DIZZINESS (Dizziness), DECREASED APPETITE (Could hardly eat because so dizzy and nauseated), LYMPH NODE PAIN (Sore and swollen glands in neck), LYMPHADENOPATHY (Sore and swollen glands neck), HEADACHE (Sore and swollen glands in back of head), NAUSEA (Nausea) and FATIGUE (Extreme fatigue) outcome was unknown.            This case was linked to MOD-2021-255802 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time (no onset date of events given hence cannot establish temporal relationship). Further information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Rectal haemorrhage, Wheezing
Clinical narrative: Rectal bleeding; Chest felt tight; Shortness of breath; Wheezing; Hard time walking; Was stiff; Felt vibration inside body; Dizziness; Could hardly eat because so dizzy and nauseated; Sore and swollen glands in neck; Sore and swollen glands neck; Sore and swollen glands in back of head; Nausea; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary immunodeficiency syndrome and Graves' disease. Concomitant products included IMMUNOGLOBULIN G HUMAN (IGG) for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest felt tight), DYSPNOEA (Shortness of breath), WHEEZING (Wheezing), GAIT DISTURBANCE (Hard time walking), MUSCULOSKELETAL STIFFNESS (Was stiff), FEELING ABNORMAL (Felt vibration inside body), DIZZINESS (Dizziness), DECREASED APPETITE (Could hardly eat because so dizzy and nauseated), LYMPH NODE PAIN (Sore and swollen glands in neck), LYMPHADENOPATHY (Sore and swollen glands neck), HEADACHE (Sore and swollen glands in back of head), NAUSEA (Nausea) and FATIGUE (Extreme fatigue). The patient was treated with STEROIDS at an unspecified dose and frequency. At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding), CHEST DISCOMFORT (Chest felt tight), DYSPNOEA (Shortness of breath), WHEEZING (Wheezing), GAIT DISTURBANCE (Hard time walking), MUSCULOSKELETAL STIFFNESS (Was stiff), FEELING ABNORMAL (Felt vibration inside body), DIZZINESS (Dizziness), DECREASED APPETITE (Could hardly eat because so dizzy and nauseated), LYMPH NODE PAIN (Sore and swollen glands in neck), LYMPHADENOPATHY (Sore and swollen glands neck), HEADACHE (Sore and swollen glands in back of head), NAUSEA (Nausea) and FATIGUE (Extreme fatigue) outcome was unknown.            This case was linked to MOD-2021-255802 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time (no onset date of events given hence cannot establish temporal relationship). Further information has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: fainted; started seeing everything blurry; arm tingling; pain on her arm; Fever; feeling like very high, like from a very strong medicine; chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced PYREXIA (Fever), FEELING ABNORMAL (feeling like very high, like from a very strong medicine) and CHILLS (chills). On 13-Jul-2021, the patient experienced PAIN IN EXTREMITY (pain on her arm). On 14-Jul-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), VISION BLURRED (started seeing everything blurry) and PARAESTHESIA (arm tingling). At the time of the report, SYNCOPE (fainted), PYREXIA (Fever), FEELING ABNORMAL (feeling like very high, like from a very strong medicine), CHILLS (chills), PAIN IN EXTREMITY (pain on her arm), VISION BLURRED (started seeing everything blurry) and PARAESTHESIA (arm tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  It was not reported if the patient was received any corrective treatment for the event.  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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vision blurred
Clinical narrative: fainted; started seeing everything blurry; arm tingling; pain on her arm; Fever; feeling like very high, like from a very strong medicine; chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced PYREXIA (Fever), FEELING ABNORMAL (feeling like very high, like from a very strong medicine) and CHILLS (chills). On 13-Jul-2021, the patient experienced PAIN IN EXTREMITY (pain on her arm). On 14-Jul-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), VISION BLURRED (started seeing everything blurry) and PARAESTHESIA (arm tingling). At the time of the report, SYNCOPE (fainted), PYREXIA (Fever), FEELING ABNORMAL (feeling like very high, like from a very strong medicine), CHILLS (chills), PAIN IN EXTREMITY (pain on her arm), VISION BLURRED (started seeing everything blurry) and PARAESTHESIA (arm tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  It was not reported if the patient was received any corrective treatment for the event.  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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Cardiac failure, Chest pain, Heart rate irregular, Loss of personal independence in daily activities
Clinical narrative: heart failure; had heart attack; heart palpitation; anxiety; heart was beating like crazy; had a burning sensation in the chest; very difficult for him to perform even a simple task; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (heart failure) and MYOCARDIAL INFARCTION (had heart attack) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE (heart failure) (seriousness criterion medically significant), MYOCARDIAL INFARCTION (had heart attack) (seriousness criterion medically significant), PALPITATIONS (heart palpitation), ANXIETY (anxiety), HEART RATE IRREGULAR (heart was beating like crazy), CHEST PAIN (had a burning sensation in the chest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (very difficult for him to perform even a simple task). At the time of the report, CARDIAC FAILURE (heart failure), MYOCARDIAL INFARCTION (had heart attack), PALPITATIONS (heart palpitation), ANXIETY (anxiety), HEART RATE IRREGULAR (heart was beating like crazy), CHEST PAIN (had a burning sensation in the chest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (very difficult for him to perform even a simple task) outcome was unknown.            Concomitant product use was not provided by the reporter.   ? No treatment information was provided.  Patient reported that he is a healthy person who exercises regularly, never used alcohol and never had a health issue.  Patient also insisted that he had been to the emergency Room 3 times in the past two weeks.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Palpitations
Clinical narrative: heart failure; had heart attack; heart palpitation; anxiety; heart was beating like crazy; had a burning sensation in the chest; very difficult for him to perform even a simple task; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (heart failure) and MYOCARDIAL INFARCTION (had heart attack) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE (heart failure) (seriousness criterion medically significant), MYOCARDIAL INFARCTION (had heart attack) (seriousness criterion medically significant), PALPITATIONS (heart palpitation), ANXIETY (anxiety), HEART RATE IRREGULAR (heart was beating like crazy), CHEST PAIN (had a burning sensation in the chest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (very difficult for him to perform even a simple task). At the time of the report, CARDIAC FAILURE (heart failure), MYOCARDIAL INFARCTION (had heart attack), PALPITATIONS (heart palpitation), ANXIETY (anxiety), HEART RATE IRREGULAR (heart was beating like crazy), CHEST PAIN (had a burning sensation in the chest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (very difficult for him to perform even a simple task) outcome was unknown.            Concomitant product use was not provided by the reporter.   ? No treatment information was provided.  Patient reported that he is a healthy person who exercises regularly, never used alcohol and never had a health issue.  Patient also insisted that he had been to the emergency Room 3 times in the past two weeks.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cardiomegaly, Carditis
Clinical narrative: Heart inflammation; Heart swelling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (Heart inflammation) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CARDITIS (Heart inflammation) (seriousness criterion medically significant) and CARDIOMEGALY (Heart swelling). At the time of the report, CARDITIS (Heart inflammation) and CARDIOMEGALY (Heart swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information provided.  Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: mini stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (mini stroke) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (mini stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (mini stroke) outcome was unknown.            Concomitant medications were not reported.  The reporter stated that, the patient had receive the second dose, and experienced a mini stroke within two weeks.  Treatment medications were not reported.  Company Comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Heart rate, Heart rate increased
Clinical narrative: kept going back and wanting to go to sleep; Fever; weak; chills were real bad, it made him shake; pulse has been high ever since the shot; has the thing you put on finger to read oxygen, it was 92 one time; arm sore; This is a spontaneous report from a contactable consumer(patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Deltoid Left on 11Feb2021 (at12:00) (Batch/Lot Number: EN9581) as Dose Number Unknown, 0.3ML Single for Covid-19 immunization. Medical history included Gastroesophageal reflux disease, Blood cholesterol; Only takes acid reflux and cholesterol medicine and Covid-19 From an unknown date and unknown if ongoing. The patients' concomitant medications were not reported. The patient experienced Arm sore on 11Feb2021, Fever on 12Feb2021 at 05:48, Chills were real bad, it made him shake, Pulse has been high ever since the shot and Has the thing you put on finger to read oxygen, it was 92 one time, weak on 12Feb2021, Kept going back and wanting to go to sleep on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 101 on 12Feb2021, Body temperature: 101.6 on 12Feb2021, Body temperature: 100.3 on 12Feb2021, Heart rate: high on 12Feb2021, Oxygen saturation: 96-98 on 12Feb2021, Oxygen saturation: was like 92 one time on 12Feb2021. There was no Assessment. A query was raised to confirm Patient's last name and then the response was received After listening to the recording. The outcome of event for Arm, Chills were real bad, it made him shake, Pulse has been high ever since the shot and Has the thing you put on finger to read oxygen, it was 92 one time, and Kept going back and wanting to go to sleep sore was unknown. The outcome for event Fever and weak was resolving.   Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Oxygen saturation, Oxygen saturation abnormal, Pain, Pyrexia
Clinical narrative: kept going back and wanting to go to sleep; Fever; weak; chills were real bad, it made him shake; pulse has been high ever since the shot; has the thing you put on finger to read oxygen, it was 92 one time; arm sore; This is a spontaneous report from a contactable consumer(patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Deltoid Left on 11Feb2021 (at12:00) (Batch/Lot Number: EN9581) as Dose Number Unknown, 0.3ML Single for Covid-19 immunization. Medical history included Gastroesophageal reflux disease, Blood cholesterol; Only takes acid reflux and cholesterol medicine and Covid-19 From an unknown date and unknown if ongoing. The patients' concomitant medications were not reported. The patient experienced Arm sore on 11Feb2021, Fever on 12Feb2021 at 05:48, Chills were real bad, it made him shake, Pulse has been high ever since the shot and Has the thing you put on finger to read oxygen, it was 92 one time, weak on 12Feb2021, Kept going back and wanting to go to sleep on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 101 on 12Feb2021, Body temperature: 101.6 on 12Feb2021, Body temperature: 100.3 on 12Feb2021, Heart rate: high on 12Feb2021, Oxygen saturation: 96-98 on 12Feb2021, Oxygen saturation: was like 92 one time on 12Feb2021. There was no Assessment. A query was raised to confirm Patient's last name and then the response was received After listening to the recording. The outcome of event for Arm, Chills were real bad, it made him shake, Pulse has been high ever since the shot and Has the thing you put on finger to read oxygen, it was 92 one time, and Kept going back and wanting to go to sleep sore was unknown. The outcome for event Fever and weak was resolving.   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Initial insomnia, Lymphadenopathy, Pain in extremity
Clinical narrative: My left axillary lymph nodes are swollen, and the swelling is now as big as the size of an egg, starting at about 24h post-vaccine; painful depending on how I move my arm; having trouble sleeping; This is a spontaneous report from a contactable other health care professional. A 48-year-old non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265 and Expiration date was unknown), via an unknown route of administration in left arm, on 11Feb2021 at 17:15 (at the age of 48 year-old), as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had not had COVID prior vaccination and not tested COVID post vaccination. The patient had not received any other vaccine with in four weeks and no other medications were received within two weeks. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247 and Expiration date was unknown), via an unknown route of administration in left arm, (at the age of 48 years), on 19Jan2021 at 17:15, as single dose for covid-19 immunisation. On 12Feb2021, patient left axillary lymph nodes are swollen, and the swelling is now as big as the size of an egg, starting at about 24h post vaccine. The swelling underarm was uncomfortable and painful depending on how she moves her arm, she was also having trouble sleeping because of it and felt limited in her daily activities. Tonight, she called urgent care clinic and was told to go in to be checked out. The patient received no treatment for events, the events resulted in emergency room/department or urgent care. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Diarrhoea, Oxygen saturation, Oxygen saturation abnormal
Clinical narrative: diarrhea; chills; o2 saturation is at 91; This is a spontaneous report from a Pfizer sponsored program. A contactable male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration on unspecified date as dose 1, single for COVID-19 Immunization. Patient medical history include he got his first dose last Friday prior to vaccination he fell on his knees four days ago. This Saturday he felt pain specifically joint pain and, on his knees, got bruises from the fall. Patients concomitant medications were not reported. On unspecified date, patient experienced diarrhea with chills, O2 saturation is at 91 percent, blood pressure is normal. Patient did not take any medications for events. Patient underwent lab test and procedures include Blood pressure measurement was normal and Oxygen saturation was 91% on unspecified date. Patient was asking if these are possible effects of the vaccine. The Outcome of all events was unknown.  Information about lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Subcutaneous abscess, Vaccination site pain
Clinical narrative: Body aches; soreness at injection site; lumps in left armpit; slight fever; This is a spontaneous report from a contactable consumer. A 27-years-old non-pregnant female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 13:15 (27-years-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation at workplace clinic. Patient is not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included norethisterone acetate taken for contraception, start and stop date were not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 11:00 AM for covid-19 immunisation. On 19Feb2021 09:00 the patient experienced body aches, soreness at injection site, lumps in left armpit, slight fever. Patient did not receive any treatment for adverse events. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia, Rash
Clinical narrative: breathing needs oxygen now; rash on legs; fever; This is a spontaneous report from a contactable consumer (patient). A 93-year-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269, expiration date not provided), via an unspecified route of administration in arm left on 08Feb2021 at 04:00 (age at vaccination 93-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient received facility type vaccine in the Hospital. The patient was not pregnant at the time of vaccination. The medical history included high blood pressure and she had an open-heart surgery. The patient had COVID prior to vaccination. The concomitant medication included amlodipine, pantoprazole, clopidogrel and atorvastatin. Patient did not receive other vaccine in four weeks of vaccination. The patient stated the other medications received in two weeks included amlodipine, pantoprazole, clopidogrel and atorvastatin. The COVID was not tested post vaccination. On 12Feb2021, patient's breathing needs oxygen now, rash on legs and fever. It was unknown if the patient received any treatment. The outcome of events was not recovered. The explicit consent was obtained as yes.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in right 15 days first dosage.; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 02Jan2021 16:00 (at the age of 36-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included blood pressure increases (high bp), ocular migraine. The patient had no known allergies. Concomitant medication(s) included amitriptyline; amlodipine, both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient had no covid prior vaccination and not tested post vaccination. The patient experienced tingling in right 15 days first dosage since 17Jan2021 12:00. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for the event. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Burning sensation, Electromyogram normal, Magnetic resonance imaging normal, Muscular weakness
Clinical narrative: Tingling in right 15 days first dosage.; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 02Jan2021 16:00 (at the age of 36-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included blood pressure increases (high bp), ocular migraine. The patient had no known allergies. Concomitant medication(s) included amitriptyline; amlodipine, both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient had no covid prior vaccination and not tested post vaccination. The patient experienced tingling in right 15 days first dosage since 17Jan2021 12:00. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for the event. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia, Peripheral nervous system function test, Small fibre neuropathy
Clinical narrative: Tingling in right 15 days first dosage.; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 02Jan2021 16:00 (at the age of 36-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included blood pressure increases (high bp), ocular migraine. The patient had no known allergies. Concomitant medication(s) included amitriptyline; amlodipine, both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient had no covid prior vaccination and not tested post vaccination. The patient experienced tingling in right 15 days first dosage since 17Jan2021 12:00. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for the event. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Ventricular extrasystoles
Clinical narrative: I feel up normal heart beats with kind of PVC events; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ENb202), via an unspecified route of administration, administered in arm left on 01Mar2021 at 12:00 PM as dose 1, single for COVID-19 immunization. Medical history included congenital heart disease- ASD, hypertension, acid reflux history. The patient concomitant medication included Vitamin D2 at a dose of 50,000 IU ERGO capsule RX from Walgreens (patient receive medication in two weeks) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 01Mar2021 at 04:00 PM, the patient experienced I feel up normal heart beats with kind of PVC events with some dizziness. The patient did not receive treatment for the events. Outcome of the events was not recovered
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Gait disturbance, Heart rate, Hypertension
Clinical narrative: 8 days after injection, injection site became very itchy and somewhat swollen; 8 days after injection, injection site became very itchy and somewhat swollen; extreme vertigo so that walking was not possible without support; extreme vertigo so that walking was not possible without support; extreme nausea with empty stomach retching; extreme nausea with empty stomach retching; blood pressure high (160/90), pulse 80, blood oxygen 94%; This is a spontaneous report from a contactable consumer. A 74-years-non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration in arm left on Feb2021 at 12:00 as single dose for COVID-19 immunization at 74-years age. Medical history included Low thyroid, slight cholesterol, and iodine (shellfish) allergy. Concomitant medication included pravastatin sodium (PRAVASTATIN SODIUM), levothyroxine sodium (LEVOTHYROXINE SODIUM) within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. After 8 days of vaccination (07Mar2021 at 16:00) patient experienced injection site very itchy and somewhat swollen, extreme vertigo so that walking was not possible without support, and extreme nausea with empty stomach retching. It's now been 28 hours with these symptoms. These symptoms matched a reaction at day 2, though those symptoms were modest and resolved overnight. The patient underwent lab tests and procedures which included blood pressure measurement high: 160/90, Temperature: normal, Pulse: 80 and Blood oxygen: 94%. Patient didn't received treatment for the events. The outcome of events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Nausea, Oxygen saturation, Retching, Vaccination site mass
Clinical narrative: 8 days after injection, injection site became very itchy and somewhat swollen; 8 days after injection, injection site became very itchy and somewhat swollen; extreme vertigo so that walking was not possible without support; extreme vertigo so that walking was not possible without support; extreme nausea with empty stomach retching; extreme nausea with empty stomach retching; blood pressure high (160/90), pulse 80, blood oxygen 94%; This is a spontaneous report from a contactable consumer. A 74-years-non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration in arm left on Feb2021 at 12:00 as single dose for COVID-19 immunization at 74-years age. Medical history included Low thyroid, slight cholesterol, and iodine (shellfish) allergy. Concomitant medication included pravastatin sodium (PRAVASTATIN SODIUM), levothyroxine sodium (LEVOTHYROXINE SODIUM) within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. After 8 days of vaccination (07Mar2021 at 16:00) patient experienced injection site very itchy and somewhat swollen, extreme vertigo so that walking was not possible without support, and extreme nausea with empty stomach retching. It's now been 28 hours with these symptoms. These symptoms matched a reaction at day 2, though those symptoms were modest and resolved overnight. The patient underwent lab tests and procedures which included blood pressure measurement high: 160/90, Temperature: normal, Pulse: 80 and Blood oxygen: 94%. Patient didn't received treatment for the events. The outcome of events was not recovered.  No follow up attempts are possible. No further information is expected.