chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M2A and 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID], FENOFIBRATE, ATORVASTATIN CALCIUM (LIPITOR) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-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 MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization and medically significant). The patient was treated with METOPROLOL at a dose of 25 mg; CLOPIDOGREL BISULFATE (PLAVIX) at a dose of 75 mg and DILTIAZEM (CARDIZEM [DILTIAZEM]) at a dose of 120 mg. At the time of the report, MYOCARDIAL INFARCTION (heart attack) outcome 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. However, patient's age, and comorbidities may be confounding factors to the event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's age, and comorbidities may be confounding factors to the event.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Pyrexia
Clinical narrative: Rigors; Chest pain; pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Rigors), CHEST PAIN (Chest pain) and PYREXIA (pyrexia) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM inhalation gas for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 22-Apr-2021, the patient started TREPROSTINIL SODIUM (unknown route) at an unspecified dose four times per day. On 29-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced CHILLS (Rigors) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and PYREXIA (pyrexia) (seriousness criterion hospitalization). The patient was hospitalized from 30-May-2021 to 31-May-2021 due to CHEST PAIN, CHILLS and PYREXIA. At the time of the report, CHILLS (Rigors), CHEST PAIN (Chest pain) and PYREXIA (pyrexia) outcome was unknown.            Concomitant and treatment medications were not provided.  Based on current available information and the temporal association between produce use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between produce use and the start date of the events a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial Fibrillation Episode; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial Fibrillation Episode) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Cardiac ablation on 03-Jun-2021. Concomitant products included APIXABAN (ELIQUIS), LOSARTAN, LEVOTHYROXINE, LOVASTATIN, CHLORTALIDONE (CHLORTHALIDONE) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 06-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 ATRIAL FIBRILLATION (Atrial Fibrillation Episode) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 01-Jun-2021 to 04-Jun-2021 due to ATRIAL FIBRILLATION. The patient was treated with METOPROLOL ongoing since an unknown date for Atrial fibrillation, at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (Atrial Fibrillation Episode) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included Balance of Nature Supplement.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation, Product dose omission issue
Clinical narrative: hospitalization; Second dose not given within 21-42 day internval; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (hospitalization) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, METOLAZONE, LEVOTHYROXINE, OMEPRAZOLE, ALPRAZOLAM, AMIODARONE and IRON for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (hospitalization) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Second dose not given within 21-42 day internval). At the time of the report, HOSPITALISATION (hospitalization) and PRODUCT DOSE OMISSION ISSUE (Second dose not given within 21-42 day internval) 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 considered HOSPITALISATION (hospitalization) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (Second dose not given within 21-42 day internval).    Very limited information regarding this events has been provided at this time. Further information has been requested. This report also refers to a case of product dose omission issue for mRNA-1273 with no associated AEs.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. This report also refers to a case of product dose omission issue for mRNA-1273 with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: Cardiac flutter; This spontaneous case was reported by a non-health professional and describes the occurrence of CARDIAC FLUTTER (Cardiac flutter) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (Cardiac flutter) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (Cardiac flutter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  The patient did not receive any treatment. Lab details were not provided.  No treatment information was provided.  This case concerns an adult female with a serious unexpected event of cardiac flutter. Event onset with unknown latency after 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-2021-219960 (Patient Link).; Sender's Comments: This case concerns an adult female with a serious unexpected event of cardiac flutter. Event onset with unknown latency after 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Cough, Dyspnoea, Oxygen saturation decreased
Clinical narrative: Kidney function and platelets low; Chest Pain; A Lot of coughing; Phlegm; Feeling that something is sitting on my chest; Shortness of breath; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RENAL IMPAIRMENT (Kidney function and platelets low) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included LOSARTAN, ATORVASTATIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced CHEST PAIN (Chest Pain), COUGH (A Lot of coughing), PRODUCTIVE COUGH (Phlegm), CHEST DISCOMFORT (Feeling that something is sitting on my chest) and DYSPNOEA (Shortness of breath). On 27-May-2021, the patient experienced RENAL IMPAIRMENT (Kidney function and platelets low) (seriousness criterion medically significant). At the time of the report, RENAL IMPAIRMENT (Kidney function and platelets low), CHEST PAIN (Chest Pain), COUGH (A Lot of coughing), PRODUCTIVE COUGH (Phlegm), CHEST DISCOMFORT (Feeling that something is sitting on my chest) and DYSPNOEA (Shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Oxygen saturation decreased: low (Low) low. On 27-May-2021, Platelet count decreased: low (Low) low. On 27-May-2021, Renal function test: abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The labs include blood tests, chest scans, x-ray, CT scans, and echocardiogram whose results are not provided. Treatment information not given. The patient visited an urgent care, followed by Emergency department for the events and discharged on same day.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, Productive cough, Renal function test, Renal impairment
Clinical narrative: Kidney function and platelets low; Chest Pain; A Lot of coughing; Phlegm; Feeling that something is sitting on my chest; Shortness of breath; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RENAL IMPAIRMENT (Kidney function and platelets low) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included LOSARTAN, ATORVASTATIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced CHEST PAIN (Chest Pain), COUGH (A Lot of coughing), PRODUCTIVE COUGH (Phlegm), CHEST DISCOMFORT (Feeling that something is sitting on my chest) and DYSPNOEA (Shortness of breath). On 27-May-2021, the patient experienced RENAL IMPAIRMENT (Kidney function and platelets low) (seriousness criterion medically significant). At the time of the report, RENAL IMPAIRMENT (Kidney function and platelets low), CHEST PAIN (Chest Pain), COUGH (A Lot of coughing), PRODUCTIVE COUGH (Phlegm), CHEST DISCOMFORT (Feeling that something is sitting on my chest) and DYSPNOEA (Shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Oxygen saturation decreased: low (Low) low. On 27-May-2021, Platelet count decreased: low (Low) low. On 27-May-2021, Renal function test: abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The labs include blood tests, chest scans, x-ray, CT scans, and echocardiogram whose results are not provided. Treatment information not given. The patient visited an urgent care, followed by Emergency department for the events and discharged on same day.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Oesophageal carcinoma, Pain in extremity
Clinical narrative: Diagnosed with esophageal cancer after the first dose; soreness on the arm; soreness of the right arm after the first dose.; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGEAL CARCINOMA (Diagnosed with esophageal cancer after the first dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OESOPHAGEAL CARCINOMA (Diagnosed with esophageal cancer after the first dose) (seriousness criterion medically significant), PAIN IN EXTREMITY (soreness on the arm) and MYALGIA (soreness of the right arm after the first dose.). At the time of the report, OESOPHAGEAL CARCINOMA (Diagnosed with esophageal cancer after the first dose), PAIN IN EXTREMITY (soreness on the arm) and MYALGIA (soreness of the right arm after the first dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered OESOPHAGEAL CARCINOMA (Diagnosed with esophageal cancer after the first dose) to be not related. No further causality assessments were provided for PAIN IN EXTREMITY (soreness on the arm) and MYALGIA (soreness of the right arm after the first dose.).    No concomitant medications were reported.   Based on reporter's causality (the reported said that OESOPHAGEAL CARCINOMA is not related with the vaccine) this event is assessed as unlikely related to mRNA-1273.Otherwise, based on the current available information and temporal association between the use of the product and the start date of the event "pain in arm", a causal relationship cannot be excluded.; Sender's Comments: Based on reporter's causality (the reported said that OESOPHAGEAL CARCINOMA is not related with the vaccine) this event is assessed as unlikely related to mRNA-1273.Otherwise, based on the current available information and temporal association between the use of the product and the start date of the event "pain in arm", a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure; This spontaneous case was reported by an other and describes the occurrence of SEIZURE (Seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, the patient experienced SEIZURE (Seizure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 31-May-2021 due to SEIZURE. At the time of the report, SEIZURE (Seizure) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  It was reported that, the patient was not responding to anti convulsion meds.  Company Comment : Very limited information regarding this event has been provided at this time. Discharge summary/hospital notes with tests/diagnostics are required for further evaluation.; Sender's Comments: Very limited information regarding this event has been provided at this time. Discharge summary/hospital notes with tests/diagnostics are required for further evaluation.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.            Relevant concomitant medications were not reported.  The treatment information was  not provided.  The action taken with mRNA-1273 in response to event was not applicable.  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: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Motor dysfunction, Speech disorder, Spinal disorder, Vision blurred
Clinical narrative: Blurred Vision; Falling down; Speech; Motor skills/dropping fork; Lesions on spine; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (Blurred Vision), FALL (Falling down), SPEECH DISORDER (Speech), MOTOR DYSFUNCTION (Motor skills/dropping fork) and SPINAL DISORDER (Lesions on spine) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-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 10-Jun-2021, the patient experienced VISION BLURRED (Blurred Vision) (seriousness criterion hospitalization), FALL (Falling down) (seriousness criterion hospitalization), SPEECH DISORDER (Speech) (seriousness criterion hospitalization), MOTOR DYSFUNCTION (Motor skills/dropping fork) (seriousness criterion hospitalization) and SPINAL DISORDER (Lesions on spine) (seriousness criterion hospitalization). At the time of the report, VISION BLURRED (Blurred Vision), FALL (Falling down), SPEECH DISORDER (Speech), MOTOR DYSFUNCTION (Motor skills/dropping fork) and SPINAL DISORDER (Lesions on spine) had not resolved.            Concomitant product use was not provided by the reporter. No treatment information was provided.  On 28-Apr-2021 patient received his second dose of vaccine and after 13 days he started to felt the symptoms.    No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Bad headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Bad headache) (seriousness criterion hospitalization) and CHILLS (Chills). At the time of the report, HEADACHE (Bad headache) and CHILLS (Chills) outcome was unknown.            No concomitant medication reported. No treatment information was provided.  Company Comment: Very limited information regarding this event (headache) has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event (chills), a causal relationship cannot be excluded.   This case was linked to MOD-2021-218728 (Patient Link).; Sender's Comments: Very limited information regarding this event (headache) has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event (chills), a causal relationship cannot be excluded.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Foaming at mouth, Gait disturbance, Hypotonia, Seizure
Clinical narrative: Choked; Patient fainted; Began seizing for about 5 seconds; She began foaming saliva; hypotonia; Became limp; This case was received via FDA VAERS (Reference number: 1198924) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This regulatory authority case was reported by a health care professional and describes the occurrence of CHOKING (Choked), SYNCOPE (Patient fainted) and SEIZURE (Began seizing for about 5 seconds) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced CHOKING (Choked) (seriousness criterion medically significant), SYNCOPE (Patient fainted) (seriousness criterion medically significant), SEIZURE (Began seizing for about 5 seconds) (seriousness criterion medically significant), FOAMING AT MOUTH (She began foaming saliva), HYPOTONIA (hypotonia) and GAIT DISTURBANCE (Became limp). At the time of the report, CHOKING (Choked), SYNCOPE (Patient fainted), SEIZURE (Began seizing for about 5 seconds), FOAMING AT MOUTH (She began foaming saliva), HYPOTONIA (hypotonia) and GAIT DISTURBANCE (Became limp) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information was not reported.  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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Choked; Patient fainted; Began seizing for about 5 seconds; She began foaming saliva; hypotonia; Became limp; This case was received via FDA VAERS (Reference number: 1198924) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This regulatory authority case was reported by a health care professional and describes the occurrence of CHOKING (Choked), SYNCOPE (Patient fainted) and SEIZURE (Began seizing for about 5 seconds) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced CHOKING (Choked) (seriousness criterion medically significant), SYNCOPE (Patient fainted) (seriousness criterion medically significant), SEIZURE (Began seizing for about 5 seconds) (seriousness criterion medically significant), FOAMING AT MOUTH (She began foaming saliva), HYPOTONIA (hypotonia) and GAIT DISTURBANCE (Became limp). At the time of the report, CHOKING (Choked), SYNCOPE (Patient fainted), SEIZURE (Began seizing for about 5 seconds), FOAMING AT MOUTH (She began foaming saliva), HYPOTONIA (hypotonia) and GAIT DISTURBANCE (Became limp) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information was not reported.  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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Sore arm; Nausea; Vomiting; Extreme Headache; Exhaustion/ Tiredness; This is a spontaneous report received from a contactable consumer (the patient). A 29-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown), dose 2 via an unspecified route of administration on the left arm on 11Mar2021 at 02:15 pm (at the age of 29-year-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient medical history included Hashimoto's thyroiditis, allergy to gluten, dairy, eggs. The patient's concomitant medications included levothyroxine 112mcg, betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES), VITAMIN C [ASCORBIC ACID], colecalciferol (VITAMIN D) and MULTIVITAMINS [VITAMINS NOS]. The patient past drug history included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown), dose 1 via an unspecified route of administration in on the left arm at the age of 29-year-old on 17Feb2021 at 05:45 pm for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Mar2021, the patient experienced extreme headache that woke her up, nausea with vomiting most of the first day, exhaustion, and sore arm. The patient stated that headache and tiredness continued for 2 days. The patient stated that 5 days out now, the sore arm was mostly gone but was still tired and had a headache that comes and goes. The patient took tylenol as a treatment of these events. The clinical outcome of the events extreme headache that woke me up, exhaustion, nausea, vomiting and tiredness was resolved with sequelae. The outcome of the event sore arm was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated reporter and patient information and treatment information and Concomitant Therapy, medical history and historical vaccine added, suspect drug details, added, concomitant drug recoding.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 21May2021 at 11:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraine, fibromyalgia, Hashimoto's, depression, essential tremor, anxiety, and post-traumatic stress disorder (PTSD), all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in four weeks. Concomitant medications included levothyroxine, duloxetine, ibuprofen, and vitamin D, all from unknown dates for unknown indications. The patient previously received codeine from an unknown date for an unknown indication and experienced drug allergy; and a flu shot on an unknown date for immunisation and experienced vaccine allergy. On21May2021 the patient experienced metallic taste 20 minutes after she received her shot; and reported it didn't go away regardless of what she did. No treatment was received for the events. The clinical outcome of metallic taste was not recovered. It was also reported that the patient had not been tested for COVID-19 since vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Under the arm I got the injection in it has swelling the size of a grapefruit; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 20May2021 at 17:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in four weeks. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number unknown) on 27Apr2021 at 13:00 (at the age of 40-years-old) in the left arm for COVID-19 immunisation. On 22May2021 at 05:00 the patient experienced under the arm he got the injection in, it had a swelling the size of a grapefruit. No treatment was received for the events. The clinical outcome of under the arm he got the injection in, it had swelling the size of a grapefruit was not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Throat irritation
Clinical narrative: burning sensation in back of my throat; all I taste is saline; This is a spontaneous report from a contactable consumer (patient). This 31-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0171) via an unspecified route of administration on 22May2021 (at the age of 31-years-old) as a single dose in the left deltoid for COVID-19 immunization. Medial history included polycystic ovary syndrome (PCOS). Concomitant medications included ethinyl estradiol, ferrous bisglycinate, levonorgestrel (BALCOLTRA) from an unknown date for birth control. The patient previously received dose 1 of BNT162B2 on 01May2021 for COVID-19 immunization and experienced sore arm for a week and tired. On 22May2021, the patient experienced a burning sensation in the back of her throat and all she tasted was saline. She wanted to know if she had any allergic reaction. The patient did not receive any treatment for the events. The outcomes of burning sensation and tasted saline were unknown.   No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Illness, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: Extreme Stomach Pain; Vomiting; Really sick; Nausea; This is a spontaneous report from a contactable consumer (patient's husband). A 79-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly on Wednesday (19May2021) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had a COVID-19 test on 29Apr2021 with a result of negative. The patient previously received dose 1 of BNT162B2 on 28Apr2021 for COVID-19 immunization. On 22May2021, the patient experienced extreme stomach, vomiting, and nausea. She was really sick. The patient received treatment with bismuth salicylate (PEPTOBISMOL) 2 tablets to try to stop nausea. The outcomes of extreme stomach pain, vomiting, really sick, and nausea were unknown.  No follow-up attempts are possible. Information about batch/lot number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; I was tired; This is a spontaneous report from a contactable consumer (patient). This 31-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly on 01May2021 (at the age of 31-years-old) as a single dose in the left deltoid for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medications included ethinyl estradiol, ferrous bisglycinate, levonorgestrel (BALCOLTRA) from an unknown date for birth control. On an unspecified date after dose 1, the patient did not have any complication but a sore arm for a week and she was tired. The patient did not receive any treatment for the events. The outcomes of sore arm for a week and was tired were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Malaise, Migraine
Clinical narrative: migraine; headache; felling so ill; very light headed; fever; chills; she is breastfeeding; she is breastfeeding; arms little sore; This is a spontaneous report from a non-contactable consumer (patient's mother). A 32-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration "yesterday" (on 21May2021) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date for COVID-19 immunization and experienced no side effect. On 22May2021, the patient felt very lightheaded and had a fever and chills but she was breastfeeding and started pumping this morning. She had a very bad headache, she could barely sit up. She was pumping this morning because she was feeling so ill. The patient wanted to know if she could use the breastmilk. She had chills, was feverish and had a really bad headache like a migraine. "Arms were little sore." The outcomes of lightheaded, fever, chills, headache, arms were little sore were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021586275 same patient, different dose/event;US-PFIZER INC-2021586277 baby case
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Product use issue, Pyrexia
Clinical narrative: migraine; headache; felling so ill; very light headed; fever; chills; she is breastfeeding; she is breastfeeding; arms little sore; This is a spontaneous report from a non-contactable consumer (patient's mother). A 32-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration "yesterday" (on 21May2021) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date for COVID-19 immunization and experienced no side effect. On 22May2021, the patient felt very lightheaded and had a fever and chills but she was breastfeeding and started pumping this morning. She had a very bad headache, she could barely sit up. She was pumping this morning because she was feeling so ill. The patient wanted to know if she could use the breastmilk. She had chills, was feverish and had a really bad headache like a migraine. "Arms were little sore." The outcomes of lightheaded, fever, chills, headache, arms were little sore were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021586275 same patient, different dose/event;US-PFIZER INC-2021586277 baby case
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Computerised tomogram, Dyspnoea, Electrocardiogram
Clinical narrative: some with severe SOB ongoing; loss of taste and smell; loss of taste and smell; and had some symptoms on covid of flu dose; This is a spontaneous report from a contactable consumer. This is the first of 2 reports from the same reporter involving the same patient. The patient experienced adverse events with both 1st and 2nd dose of the vaccine. This is for the first dose of the vaccine. A 46-year-old (age at vaccination) patient of an unspecified gender received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9261), via intramuscular, at arm on 05Feb2021 at 10:20 as single dose for COVID-19 immunization. Medical history included Muno-Epstein Bar from Feb2020 it was ongoing (Pertinent details: ongoing fatigue resolved Aug2020), shingles 3x from 19Mar2016 (Pertinent details: Shingles 2x in 2016 and again in 2017 after vaccination). Concomitant medication included ibuprofen (IBUPROFEN ABECE) from Oct2010 to Apr2021 for EVLT procedure, progesterone (PROGESTERONE) and pregabalin (LYRICA) taken for Shingles from 2016 and it was ongoing. On an unspecified date, after vaccination with first dose the patient experienced severe sob ongoing, loss of taste and smell and had some symptoms on covid of flu. The patient underwent lab tests and procedures which included computerized tomogram: PE ruled out on 16Dec2020 COVID, computerized tomogram: PE ruled out on 17Feb2021 (COVID set back), electrocardiogram: stroked ruled out on 19Feb2021 (Ruling in POTS), magnetic resonance imaging: stroked ruled out on 19Feb2021 (Ruling in POTS), mast cell activation syndrome: unknown results on 14May2021, SARS-COV-2 test: negative on 16Jun2020 (Dr. indicated way for early likely COVID), SARS-COV-2 test: unknown results on 01Oct2020, SARS-COV-2 test: unknown results on 03Oct2020, SARS-COV-2 test: unknown results on 08Oct2020, SARS-COV-2 test: unknown results on 16Oct2020, SARS-COV-2 test: positive on 29Oct2020, tilt table test: + fo-positive on 15Apr2021 Covid induced POTS, ultrasound scan: stroked ruled out on 19Feb2021 Ruling in POTS , X-ray: PE ruled out on 16Dec2020 COVID set back PASC DX, X-ray: PE ruled out on 17Feb2021 COVID. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Influenza, Magnetic resonance imaging, Mast cell activation syndrome, SARS-CoV-2 test, Tilt table test
Clinical narrative: some with severe SOB ongoing; loss of taste and smell; loss of taste and smell; and had some symptoms on covid of flu dose; This is a spontaneous report from a contactable consumer. This is the first of 2 reports from the same reporter involving the same patient. The patient experienced adverse events with both 1st and 2nd dose of the vaccine. This is for the first dose of the vaccine. A 46-year-old (age at vaccination) patient of an unspecified gender received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9261), via intramuscular, at arm on 05Feb2021 at 10:20 as single dose for COVID-19 immunization. Medical history included Muno-Epstein Bar from Feb2020 it was ongoing (Pertinent details: ongoing fatigue resolved Aug2020), shingles 3x from 19Mar2016 (Pertinent details: Shingles 2x in 2016 and again in 2017 after vaccination). Concomitant medication included ibuprofen (IBUPROFEN ABECE) from Oct2010 to Apr2021 for EVLT procedure, progesterone (PROGESTERONE) and pregabalin (LYRICA) taken for Shingles from 2016 and it was ongoing. On an unspecified date, after vaccination with first dose the patient experienced severe sob ongoing, loss of taste and smell and had some symptoms on covid of flu. The patient underwent lab tests and procedures which included computerized tomogram: PE ruled out on 16Dec2020 COVID, computerized tomogram: PE ruled out on 17Feb2021 (COVID set back), electrocardiogram: stroked ruled out on 19Feb2021 (Ruling in POTS), magnetic resonance imaging: stroked ruled out on 19Feb2021 (Ruling in POTS), mast cell activation syndrome: unknown results on 14May2021, SARS-COV-2 test: negative on 16Jun2020 (Dr. indicated way for early likely COVID), SARS-COV-2 test: unknown results on 01Oct2020, SARS-COV-2 test: unknown results on 03Oct2020, SARS-COV-2 test: unknown results on 08Oct2020, SARS-COV-2 test: unknown results on 16Oct2020, SARS-COV-2 test: positive on 29Oct2020, tilt table test: + fo-positive on 15Apr2021 Covid induced POTS, ultrasound scan: stroked ruled out on 19Feb2021 Ruling in POTS , X-ray: PE ruled out on 16Dec2020 COVID set back PASC DX, X-ray: PE ruled out on 17Feb2021 COVID. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Ultrasound scan, X-ray
Clinical narrative: some with severe SOB ongoing; loss of taste and smell; loss of taste and smell; and had some symptoms on covid of flu dose; This is a spontaneous report from a contactable consumer. This is the first of 2 reports from the same reporter involving the same patient. The patient experienced adverse events with both 1st and 2nd dose of the vaccine. This is for the first dose of the vaccine. A 46-year-old (age at vaccination) patient of an unspecified gender received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9261), via intramuscular, at arm on 05Feb2021 at 10:20 as single dose for COVID-19 immunization. Medical history included Muno-Epstein Bar from Feb2020 it was ongoing (Pertinent details: ongoing fatigue resolved Aug2020), shingles 3x from 19Mar2016 (Pertinent details: Shingles 2x in 2016 and again in 2017 after vaccination). Concomitant medication included ibuprofen (IBUPROFEN ABECE) from Oct2010 to Apr2021 for EVLT procedure, progesterone (PROGESTERONE) and pregabalin (LYRICA) taken for Shingles from 2016 and it was ongoing. On an unspecified date, after vaccination with first dose the patient experienced severe sob ongoing, loss of taste and smell and had some symptoms on covid of flu. The patient underwent lab tests and procedures which included computerized tomogram: PE ruled out on 16Dec2020 COVID, computerized tomogram: PE ruled out on 17Feb2021 (COVID set back), electrocardiogram: stroked ruled out on 19Feb2021 (Ruling in POTS), magnetic resonance imaging: stroked ruled out on 19Feb2021 (Ruling in POTS), mast cell activation syndrome: unknown results on 14May2021, SARS-COV-2 test: negative on 16Jun2020 (Dr. indicated way for early likely COVID), SARS-COV-2 test: unknown results on 01Oct2020, SARS-COV-2 test: unknown results on 03Oct2020, SARS-COV-2 test: unknown results on 08Oct2020, SARS-COV-2 test: unknown results on 16Oct2020, SARS-COV-2 test: positive on 29Oct2020, tilt table test: + fo-positive on 15Apr2021 Covid induced POTS, ultrasound scan: stroked ruled out on 19Feb2021 Ruling in POTS , X-ray: PE ruled out on 16Dec2020 COVID set back PASC DX, X-ray: PE ruled out on 17Feb2021 COVID. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Condition aggravated, Hypoaesthesia, Peripheral coldness, Pruritus
Clinical narrative: After I had my second one, it got like a little worse; I am trying to scratch my thighs because they itch, they burn, they freeze and they are numb; I am trying to scratch my thighs because they itch, they burn, they freeze and they are numb.; I am trying to scratch my thighs because they itch, they burn, they freeze and they are numb.; I am trying to scratch my thighs because they itch, they burn, they freeze and they are numb.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on 20Apr2021 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: unknown, Expiration date: unknown) on 30Mar2021 as 1st dose, single for covid-19 immunisation and experienced weird numbing, tingling, burning, freezing sensations in  thighs. On an unspecified date in 2021, after second dose, the patient reported that "it got like a little worse, I am trying to scratch my thighs because they itch, they burn, they freeze and they are numbness in thighs."The outcome of the events ware not recovered.   Information on the lot/batch number has been requested.