chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: weakness; chills; shaking; vomiting; wretching; shaking with head bobbing; cytokine storm reaction; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weakness), CHILLS (chills), TREMOR (shaking), VOMITING (vomiting), RETCHING (wretching), HEAD TITUBATION (shaking with head bobbing) and CYTOKINE STORM (cytokine storm reaction) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ASTHENIA (weakness) (seriousness criterion hospitalization), CHILLS (chills) (seriousness criterion hospitalization), TREMOR (shaking) (seriousness criterion hospitalization), VOMITING (vomiting) (seriousness criterion hospitalization), RETCHING (wretching) (seriousness criterion hospitalization), HEAD TITUBATION (shaking with head bobbing) (seriousness criterion hospitalization) and CYTOKINE STORM (cytokine storm reaction) (seriousness criteria hospitalization and medically significant). At the time of the report, ASTHENIA (weakness), CHILLS (chills), TREMOR (shaking), VOMITING (vomiting), RETCHING (wretching), HEAD TITUBATION (shaking with head bobbing) and CYTOKINE STORM (cytokine storm reaction) 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.   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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood count, Haematocrit increased, Haemoglobin increased, Polycythaemia vera, Red blood cell count increased
Clinical narrative: His doctor said that the lab report looked like Polycythemia Vera, but they were not sure; This spontaneous case was reported by a consumer and describes the occurrence of POLYCYTHAEMIA VERA (His doctor said that the lab report looked like Polycythemia Vera, but they were not sure) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-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 POLYCYTHAEMIA VERA (His doctor said that the lab report looked like Polycythemia Vera, but they were not sure) (seriousness criterion medically significant). At the time of the report, POLYCYTHAEMIA VERA (His doctor said that the lab report looked like Polycythemia Vera, but they were not sure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Blood count: elevated (abnormal) Elevated. On 10-May-2021, Haematocrit increased: increased (abnormal) Increased. On 10-May-2021, Haemoglobin increased: increased (abnormal) Increased. On 10-May-2021, Red blood cell count increased: increased (abnormal) Increased.         It was reported that it look like Polycythemia. No concomitant medication was reported.   Treatment medication was not provided.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.Further information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram, Fatigue, Loss of consciousness, Product dose omission issue
Clinical narrative: Has no energy; 2nd dose: advised by HCP not to receive 2nd dose; Gets tired easily; Seizure; Passed out; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) and LOSS OF CONSCIOUSNESS (Passed out) in a 54-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 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHENIA (Has no energy), PRODUCT DOSE OMISSION ISSUE (2nd dose: advised by HCP not to receive 2nd dose) and FATIGUE (Gets tired easily). At the time of the report, SEIZURE (Seizure), LOSS OF CONSCIOUSNESS (Passed out), ASTHENIA (Has no energy), PRODUCT DOSE OMISSION ISSUE (2nd dose: advised by HCP not to receive 2nd dose) and FATIGUE (Gets tired easily) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Computerised tomogram: normal (normal) Normal. On 06-May-2021, Urine analysis: unknown (Inconclusive) unknown. On 06-May-2021, White blood cell count: wbc count was greater than 100 (High) WBC count was greater than 100 with normal range being "0-2.". In 2021, White blood cell count: started to come down (Low) Started to come down.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Urine analysis, White blood cell count
Clinical narrative: Has no energy; 2nd dose: advised by HCP not to receive 2nd dose; Gets tired easily; Seizure; Passed out; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) and LOSS OF CONSCIOUSNESS (Passed out) in a 54-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 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHENIA (Has no energy), PRODUCT DOSE OMISSION ISSUE (2nd dose: advised by HCP not to receive 2nd dose) and FATIGUE (Gets tired easily). At the time of the report, SEIZURE (Seizure), LOSS OF CONSCIOUSNESS (Passed out), ASTHENIA (Has no energy), PRODUCT DOSE OMISSION ISSUE (2nd dose: advised by HCP not to receive 2nd dose) and FATIGUE (Gets tired easily) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Computerised tomogram: normal (normal) Normal. On 06-May-2021, Urine analysis: unknown (Inconclusive) unknown. On 06-May-2021, White blood cell count: wbc count was greater than 100 (High) WBC count was greater than 100 with normal range being "0-2.". In 2021, White blood cell count: started to come down (Low) Started to come down.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of 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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling cold, Osteomyelitis, Pain in extremity, Peripheral artery thrombosis
Clinical narrative: blocked arteries in his right leg  2 out of 3 blocked arteries in his left leg; toe infection/ Osteomyelitis; toe pain right; toe redness; coldness in toe; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL ARTERY THROMBOSIS (blocked arteries in his right leg  2 out of 3 blocked arteries in his left leg) and OSTEOMYELITIS (toe infection/ Osteomyelitis) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Emergency care (Received antibiotics as reported by the patient.), Ankle brachial index on 12-Feb-2021, Angiogram (completely blocked arteries in his right leg and 2 out of 3 blocked arteries in his left leg.) on 17-Feb-2021, Toe amputation on 28-May-2021 and Arterial bypass operation on 09-Apr-2021. Concurrent medical conditions included Metabolic syndrome. Concomitant products included HEPARIN and RIVAROXABAN (XARELTO) for an unknown indication.   On 03-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PERIPHERAL ARTERY THROMBOSIS (blocked arteries in his right leg  2 out of 3 blocked arteries in his left leg) (seriousness criterion hospitalization). On an unknown date, the patient experienced OSTEOMYELITIS (toe infection/ Osteomyelitis) (seriousness criterion medically significant), PAIN IN EXTREMITY (toe pain right), ERYTHEMA (toe redness) and FEELING COLD (coldness in toe). The patient was hospitalized on 14-Feb-2021 due to PERIPHERAL ARTERY THROMBOSIS. At the time of the report, PERIPHERAL ARTERY THROMBOSIS (blocked arteries in his right leg  2 out of 3 blocked arteries in his left leg), OSTEOMYELITIS (toe infection/ Osteomyelitis), PAIN IN EXTREMITY (toe pain right), ERYTHEMA (toe redness) and FEELING COLD (coldness in toe) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has a well controlled HBA1-C and no diabetes.   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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Dysstasia, Heart rate, Heart rate increased
Clinical narrative: fainted; mildly ill; couldn't stand on her own; flu-like symptoms; no appetite; heart rate of 116; sore arm; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On 21-Jun-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), VACCINATION COMPLICATION (mildly ill), DYSSTASIA (couldn't stand on her own), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), HEART RATE INCREASED (heart rate of 116), MYALGIA (sore arm) and NAUSEA (nausea). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, SYNCOPE (fainted), VACCINATION COMPLICATION (mildly ill), DYSSTASIA (couldn't stand on her own), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), HEART RATE INCREASED (heart rate of 116), MYALGIA (sore arm) and NAUSEA (nausea) outcome was unknown and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jun-2021, Body temperature: 103 High and 101.6 High. On 20-Jun-2021, Heart rate: 116 High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  The patient temperature reached 103 degrees that fever was last measured at 101.6 (unspecified unit). The patient fainted around 3:30 AM, couldn't really stand on her own, had a sore arm, flu-like symptoms, nausea, no appetite, and a heart rate of 116 (unspecified unit). The patient heart rate was usually 60-80.  The patient took two ibuprofen that morning which lowered her fever, but did not feel much improved.  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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Nausea, Pyrexia, Syncope
Clinical narrative: fainted; mildly ill; couldn't stand on her own; flu-like symptoms; no appetite; heart rate of 116; sore arm; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On 21-Jun-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), VACCINATION COMPLICATION (mildly ill), DYSSTASIA (couldn't stand on her own), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), HEART RATE INCREASED (heart rate of 116), MYALGIA (sore arm) and NAUSEA (nausea). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, SYNCOPE (fainted), VACCINATION COMPLICATION (mildly ill), DYSSTASIA (couldn't stand on her own), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), HEART RATE INCREASED (heart rate of 116), MYALGIA (sore arm) and NAUSEA (nausea) outcome was unknown and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jun-2021, Body temperature: 103 High and 101.6 High. On 20-Jun-2021, Heart rate: 116 High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  The patient temperature reached 103 degrees that fever was last measured at 101.6 (unspecified unit). The patient fainted around 3:30 AM, couldn't really stand on her own, had a sore arm, flu-like symptoms, nausea, no appetite, and a heart rate of 116 (unspecified unit). The patient heart rate was usually 60-80.  The patient took two ibuprofen that morning which lowered her fever, but did not feel much improved.  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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: fainted; mildly ill; couldn't stand on her own; flu-like symptoms; no appetite; heart rate of 116; sore arm; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On 21-Jun-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), VACCINATION COMPLICATION (mildly ill), DYSSTASIA (couldn't stand on her own), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), HEART RATE INCREASED (heart rate of 116), MYALGIA (sore arm) and NAUSEA (nausea). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, SYNCOPE (fainted), VACCINATION COMPLICATION (mildly ill), DYSSTASIA (couldn't stand on her own), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), HEART RATE INCREASED (heart rate of 116), MYALGIA (sore arm) and NAUSEA (nausea) outcome was unknown and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jun-2021, Body temperature: 103 High and 101.6 High. On 20-Jun-2021, Heart rate: 116 High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  The patient temperature reached 103 degrees that fever was last measured at 101.6 (unspecified unit). The patient fainted around 3:30 AM, couldn't really stand on her own, had a sore arm, flu-like symptoms, nausea, no appetite, and a heart rate of 116 (unspecified unit). The patient heart rate was usually 60-80.  The patient took two ibuprofen that morning which lowered her fever, but did not feel much improved.  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: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia (had issues with swallowing and some went into her pulmonary area); This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia (had issues with swallowing and some went into her pulmonary area)) in an 89-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia (had issues with swallowing and some went into her pulmonary area)) (seriousness criteria hospitalization and medically significant). At the time of the report, PNEUMONIA (pneumonia (had issues with swallowing and some went into her pulmonary area)) had resolved.            No treatment medication were provided. Action taken with mRNA-1273 in response to the events was not applicable.  Reporter reported that his mother in-lawhad pneumonia (had issues with swallowing and some went into her pulmonary area) after getting the 2nd dose of the Moderna Covid-19 vaccine.  The vaccine was administered through a vaccination clinic organized by a local healthcare provider.; Sender's Comments: Very limited information has been provided at this time. Further information has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: 3 weeks after 1st dose of Moderna Covid-19 vaccine went into atrial fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (3 weeks after 1st dose of Moderna Covid-19 vaccine went into atrial fibrillation) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ATRIAL FIBRILLATION (3 weeks after 1st dose of Moderna Covid-19 vaccine went into atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (3 weeks after 1st dose of Moderna Covid-19 vaccine went into atrial fibrillation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-230057 (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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pneumonia
Clinical narrative: Infection in Lungs; SICKNESS; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Infection in Lungs) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic obstructive pulmonary disease, Bronchiectasis and Lung disease (Lung condition). Concomitant products included ALBUTEROL [SALBUTAMOL], SODIUM CHLORIDE, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), ALPRAZOLAM (XANAX), FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), ROFLUMILAST, TIZANIDINE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), GLYCERYL TRINITRATE (NITROGLYCERINE), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), MAGNESIUM, TRIAMCINOLONE, COLECALCIFEROL (D3) and OMEPRAZOLE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Infection in Lungs) (seriousness criterion medically significant) and ILLNESS (SICKNESS). At the time of the report, PNEUMONIA (Infection in Lungs) and ILLNESS (SICKNESS) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Echocardiogram
Clinical narrative: 2 weeks after 2nd dose of Moderna Covid-19 vaccine went into serious atrial fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (2 weeks after 2nd dose of Moderna Covid-19 vaccine went into serious atrial fibrillation) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced ATRIAL FIBRILLATION (2 weeks after 2nd dose of Moderna Covid-19 vaccine went into serious atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (2 weeks after 2nd dose of Moderna Covid-19 vaccine went into serious atrial fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: inconclusive (Inconclusive) Inconclusive.         No treatment medications were provided by the reporter.  The doctors took an echocardiogram and his heart is wonderful and they can not figure out why he went into atrial fibrillation. He now have to take an expensive medication to prevent his heart going into atrial fibrillation and we are wondering if it was possible he got it from  Moderna Covid-19 vaccine.  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-2021-230049 (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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Haematochezia, Pus in stool
Clinical narrative: Bowel movement had blood and pus; Bowel movement had blood and pus; Loose bowel movements; Joint pain; She had terrible stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Bowel movement had blood and pus) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Blood pressure abnormal.   On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced ABDOMINAL PAIN UPPER (She had terrible stomach cramps) and ARTHRALGIA (Joint pain). On 19-Jun-2021, the patient experienced HAEMATOCHEZIA (Bowel movement had blood and pus) (seriousness criterion medically significant), PUS IN STOOL (Bowel movement had blood and pus) and DIARRHOEA (Loose bowel movements). On 21-Jun-2021, HAEMATOCHEZIA (Bowel movement had blood and pus) and PUS IN STOOL (Bowel movement had blood and pus) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (She had terrible stomach cramps), DIARRHOEA (Loose bowel movements) and ARTHRALGIA (Joint pain) outcome was unknown.            Concomitant medications included blood pressure and antipsychotic medications. The patient was on multiple concomitant medications however the reporter did not have specific names and details for the medications.  Treatment information was not provided by the reporter.  This case concerns a 48-year-old female with a serious unexpected event of haematochezia, and nonserious abdominal pain upper, pus in stool, diarrhoea and arthralgia. Event latency 3 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-230296 (Patient Link).; Sender's Comments: This case concerns a 48-year-old female with a serious unexpected event of haematochezia, and nonserious abdominal pain upper, pus in stool, diarrhoea and arthralgia. Event latency 3 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Pain in extremity, Pruritus, Vaccination site bruising, Vaccination site erythema
Clinical narrative: cellulitis; arm was itching really badly during the night; Swollen; red circle around injection site; Small bluish bruise; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 11-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Small bluish bruise). On 21-Jan-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant), PRURITUS (arm was itching really badly during the night), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red circle around injection site). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Cellulitis, at a dose of 500 mg four times per day; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK UNK, qd and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form once a day. On 25-Jan-2021, CELLULITIS (cellulitis), PRURITUS (arm was itching really badly during the night), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red circle around injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore) and VACCINATION SITE BRUISING (Small bluish bruise) 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.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  Concomitant medication information was not provided.  The reporter's physician was not sure whether it was a bacterial infection or an allergic reaction as it was delayed.  Treatment information included Antibiotic as well.  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. Vaccination site swelling and vaccination site erythema are consistent with the known safety profile of the vaccine.; 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. Vaccination site swelling and vaccination site erythema are consistent with the known safety profile of the vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: cellulitis; arm was itching really badly during the night; Swollen; red circle around injection site; Small bluish bruise; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 11-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Small bluish bruise). On 21-Jan-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant), PRURITUS (arm was itching really badly during the night), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red circle around injection site). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Cellulitis, at a dose of 500 mg four times per day; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK UNK, qd and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form once a day. On 25-Jan-2021, CELLULITIS (cellulitis), PRURITUS (arm was itching really badly during the night), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red circle around injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore) and VACCINATION SITE BRUISING (Small bluish bruise) 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.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  Concomitant medication information was not provided.  The reporter's physician was not sure whether it was a bacterial infection or an allergic reaction as it was delayed.  Treatment information included Antibiotic as well.  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. Vaccination site swelling and vaccination site erythema are consistent with the known safety profile of the vaccine.; 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. Vaccination site swelling and vaccination site erythema are consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Head injury
Clinical narrative: I hit my head and went to the hospital; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced i hit my head and went to the hospital on an unspecified date. The caller spoke to safety before being transferred. Caller stated she hit her head and went to the hospital. She had a CT scan and was given a tetanus shot on 31Jan2021. she received her first dose of Covid-19 vaccine on 27Jan2021. She was scheduled to receive the second dose 19Feb2021. Caller wanted to know if this would have an impact on her. The patient underwent lab tests and procedures which included computerised tomogram resulted to unknown on an unknown date. The outcome for event was unknown.   Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Facial pain, Gingival pain, Gingival swelling, Gingival ulceration, Glossodynia
Clinical narrative: ulcerated tongue, cheeks and gums; ulcerated tongue, cheeks and gums; ulcerated tongue, cheeks and gums; Painful to eat; limited taste (similar to having seriously burned your tongue and mouth); tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; itchy throat; This is a spontaneous report from a contactable other hcp (patient). A 31-years-old non-pregnant female patient received second dose of BNT162B2 (CONMINTARY, Solution for injection, Lot No: EL3249 and Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 22Jan2021 at 10:00 AM (at the age of 31 years), as a single dose for covid-19 immunisation. The patient medical history included very minor latex irritation from an unknown date and unknown if ongoing. The patient concomitant medications received within 2 weeks included prenatal vitamin. Historical vaccine included first dose of BNT162B2 (CONMINTARY, Solution for injection, Lot No: EL1284 and Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 30Dec2020, as a single dose for covid-19 immunisation. The most recent covid-19 vaccine was administered in hospital. The patient didn't receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for covid-19. On 22Jan2021, 1-5 hours after injection, the patient had experienced tingling, painful and swollen mouth, gums, cheeks, tongue and lips on, itchy throat. On 23Jan2021, the patient had experienced ulcerated tongue, cheeks and gums on, painful to eat, limited taste. There was no treatment received for adverse events. Outcome of the events were recovered. The reporter seriousness was reported as Non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Lip pain, Lip swelling, Mouth swelling, Oral pain, Pain
Clinical narrative: ulcerated tongue, cheeks and gums; ulcerated tongue, cheeks and gums; ulcerated tongue, cheeks and gums; Painful to eat; limited taste (similar to having seriously burned your tongue and mouth); tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; itchy throat; This is a spontaneous report from a contactable other hcp (patient). A 31-years-old non-pregnant female patient received second dose of BNT162B2 (CONMINTARY, Solution for injection, Lot No: EL3249 and Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 22Jan2021 at 10:00 AM (at the age of 31 years), as a single dose for covid-19 immunisation. The patient medical history included very minor latex irritation from an unknown date and unknown if ongoing. The patient concomitant medications received within 2 weeks included prenatal vitamin. Historical vaccine included first dose of BNT162B2 (CONMINTARY, Solution for injection, Lot No: EL1284 and Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 30Dec2020, as a single dose for covid-19 immunisation. The most recent covid-19 vaccine was administered in hospital. The patient didn't receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for covid-19. On 22Jan2021, 1-5 hours after injection, the patient had experienced tingling, painful and swollen mouth, gums, cheeks, tongue and lips on, itchy throat. On 23Jan2021, the patient had experienced ulcerated tongue, cheeks and gums on, painful to eat, limited taste. There was no treatment received for adverse events. Outcome of the events were recovered. The reporter seriousness was reported as Non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Paraesthesia, Paraesthesia oral, Skin ulcer, Swelling face, Swollen tongue
Clinical narrative: ulcerated tongue, cheeks and gums; ulcerated tongue, cheeks and gums; ulcerated tongue, cheeks and gums; Painful to eat; limited taste (similar to having seriously burned your tongue and mouth); tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; itchy throat; This is a spontaneous report from a contactable other hcp (patient). A 31-years-old non-pregnant female patient received second dose of BNT162B2 (CONMINTARY, Solution for injection, Lot No: EL3249 and Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 22Jan2021 at 10:00 AM (at the age of 31 years), as a single dose for covid-19 immunisation. The patient medical history included very minor latex irritation from an unknown date and unknown if ongoing. The patient concomitant medications received within 2 weeks included prenatal vitamin. Historical vaccine included first dose of BNT162B2 (CONMINTARY, Solution for injection, Lot No: EL1284 and Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 30Dec2020, as a single dose for covid-19 immunisation. The most recent covid-19 vaccine was administered in hospital. The patient didn't receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for covid-19. On 22Jan2021, 1-5 hours after injection, the patient had experienced tingling, painful and swollen mouth, gums, cheeks, tongue and lips on, itchy throat. On 23Jan2021, the patient had experienced ulcerated tongue, cheeks and gums on, painful to eat, limited taste. There was no treatment received for adverse events. Outcome of the events were recovered. The reporter seriousness was reported as Non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Taste disorder, Throat irritation, Tongue ulceration
Clinical narrative: ulcerated tongue, cheeks and gums; ulcerated tongue, cheeks and gums; ulcerated tongue, cheeks and gums; Painful to eat; limited taste (similar to having seriously burned your tongue and mouth); tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; itchy throat; This is a spontaneous report from a contactable other hcp (patient). A 31-years-old non-pregnant female patient received second dose of BNT162B2 (CONMINTARY, Solution for injection, Lot No: EL3249 and Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 22Jan2021 at 10:00 AM (at the age of 31 years), as a single dose for covid-19 immunisation. The patient medical history included very minor latex irritation from an unknown date and unknown if ongoing. The patient concomitant medications received within 2 weeks included prenatal vitamin. Historical vaccine included first dose of BNT162B2 (CONMINTARY, Solution for injection, Lot No: EL1284 and Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 30Dec2020, as a single dose for covid-19 immunisation. The most recent covid-19 vaccine was administered in hospital. The patient didn't receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for covid-19. On 22Jan2021, 1-5 hours after injection, the patient had experienced tingling, painful and swollen mouth, gums, cheeks, tongue and lips on, itchy throat. On 23Jan2021, the patient had experienced ulcerated tongue, cheeks and gums on, painful to eat, limited taste. There was no treatment received for adverse events. Outcome of the events were recovered. The reporter seriousness was reported as Non-serious.  Follow-up attempts are completed. No further information is expected.