chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Myelitis transverse, Paralysis
Clinical narrative: transverse myelitis; paralyzed waist down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYELITIS TRANSVERSE (transverse myelitis) and PARALYSIS (paralyzed waist down) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DOCUSATE SODIUM (STOOL SOFTENER) for Constipation.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MYELITIS TRANSVERSE (transverse myelitis) (seriousness criteria hospitalization prolonged, disability and medically significant) and PARALYSIS (paralyzed waist down) (seriousness criteria hospitalization prolonged, disability and medically significant). The patient was hospitalized from sometime in March 2021 to sometime in 2021 due to MYELITIS TRANSVERSE, and then on sometime in March 2021 due to PARALYSIS. At the time of the report, MYELITIS TRANSVERSE (transverse myelitis) outcome was unknown and PARALYSIS (paralyzed waist down) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included a non-specific antidepressant and rosacea medication. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Feeling abnormal, Painful respiration
Clinical narrative: collapsed left lung; Does not feel good; tired all the time; Left arm pain; feel terrible; Pain spread to middle of chest; Painful to breathe; Hard to get a breath; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PNEUMOTHORAX (collapsed left lung) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0470 2orZ 1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced PNEUMOTHORAX (collapsed left lung) (seriousness criteria hospitalization, medically significant and intervention required). On 20-May-2021 at 7:30 PM, the patient experienced FEELING ABNORMAL (feel terrible), CHEST PAIN (Pain spread to middle of chest), PAINFUL RESPIRATION (Painful to breathe), DYSPNOEA (Hard to get a breath) and VACCINATION SITE PAIN (Left arm pain). On an unknown date, the patient experienced FEELING ABNORMAL (Does not feel good) and FATIGUE (tired all the time). The patient was hospitalized for 3 days due to PNEUMOTHORAX. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and Surgery (Tube placement in her chest) for Pneumothorax. At the time of the report, PNEUMOTHORAX (collapsed left lung), FEELING ABNORMAL (feel terrible), CHEST PAIN (Pain spread to middle of chest), PAINFUL RESPIRATION (Painful to breathe), DYSPNOEA (Hard to get a breath), FEELING ABNORMAL (Does not feel good), VACCINATION SITE PAIN (Left arm pain) and FATIGUE (tired all the time) outcome was unknown. Not Provided          No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.  Patient stated that she had hole in the chest due to the tube placement to treat her collapsed lung.  It was reported that the patient experienced symptoms on 20 May 2021.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-169206 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pneumothorax, Vaccination site pain
Clinical narrative: collapsed left lung; Does not feel good; tired all the time; Left arm pain; feel terrible; Pain spread to middle of chest; Painful to breathe; Hard to get a breath; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PNEUMOTHORAX (collapsed left lung) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0470 2orZ 1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced PNEUMOTHORAX (collapsed left lung) (seriousness criteria hospitalization, medically significant and intervention required). On 20-May-2021 at 7:30 PM, the patient experienced FEELING ABNORMAL (feel terrible), CHEST PAIN (Pain spread to middle of chest), PAINFUL RESPIRATION (Painful to breathe), DYSPNOEA (Hard to get a breath) and VACCINATION SITE PAIN (Left arm pain). On an unknown date, the patient experienced FEELING ABNORMAL (Does not feel good) and FATIGUE (tired all the time). The patient was hospitalized for 3 days due to PNEUMOTHORAX. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and Surgery (Tube placement in her chest) for Pneumothorax. At the time of the report, PNEUMOTHORAX (collapsed left lung), FEELING ABNORMAL (feel terrible), CHEST PAIN (Pain spread to middle of chest), PAINFUL RESPIRATION (Painful to breathe), DYSPNOEA (Hard to get a breath), FEELING ABNORMAL (Does not feel good), VACCINATION SITE PAIN (Left arm pain) and FATIGUE (tired all the time) outcome was unknown. Not Provided          No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.  Patient stated that she had hole in the chest due to the tube placement to treat her collapsed lung.  It was reported that the patient experienced symptoms on 20 May 2021.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-169206 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: pulmonary embolism/blood clots; heart problems; blood clots; mild immune response; Headache; Little chillls; Really bad fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism/blood clots) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, POTASSIUM CITRATE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (pulmonary embolism/blood clots) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (heart problems), DYSPNOEA (blood clots), HYPERSENSITIVITY (mild immune response), HEADACHE (Headache), CHILLS (Little chillls) and FATIGUE (Really bad fatigue). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency and LEVOFLOXACIN (LOVENOX [LEVOFLOXACIN]) at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (pulmonary embolism/blood clots), CARDIAC DISORDER (heart problems), DYSPNOEA (blood clots), HYPERSENSITIVITY (mild immune response), HEADACHE (Headache), CHILLS (Little chillls) and FATIGUE (Really bad fatigue) outcome 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.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant Follow-up case booked in; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pulmonary embolism
Clinical narrative: pulmonary embolism/blood clots; heart problems; blood clots; mild immune response; Headache; Little chillls; Really bad fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism/blood clots) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, POTASSIUM CITRATE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (pulmonary embolism/blood clots) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (heart problems), DYSPNOEA (blood clots), HYPERSENSITIVITY (mild immune response), HEADACHE (Headache), CHILLS (Little chillls) and FATIGUE (Really bad fatigue). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency and LEVOFLOXACIN (LOVENOX [LEVOFLOXACIN]) at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (pulmonary embolism/blood clots), CARDIAC DISORDER (heart problems), DYSPNOEA (blood clots), HYPERSENSITIVITY (mild immune response), HEADACHE (Headache), CHILLS (Little chillls) and FATIGUE (Really bad fatigue) outcome 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.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant Follow-up case booked in; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Illness, Nausea
Clinical narrative: Nausea; getting more and more sick, it is getting worse as the day goes; stomach problems; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), ILLNESS (getting more and more sick, it is getting worse as the day goes) and ABDOMINAL DISCOMFORT (stomach problems) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C2HA) for COVID-19 vaccination.     The patient's past medical history included Back surgery (2 back surgeries) since an unknown date. Concurrent medical conditions included Hypertension, Epilepsy, Spinal cord disorder (Spinal problem) and Seizures.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), ILLNESS (getting more and more sick, it is getting worse as the day goes) (seriousness criterion medically significant) and ABDOMINAL DISCOMFORT (stomach problems) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea), ILLNESS (getting more and more sick, it is getting worse as the day goes) and ABDOMINAL DISCOMFORT (stomach problems) 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.   Concomitant medication included unspecified seizure medication, blood pressure patch and pain medicine.  No treatment products were reported.  Patient had her first dose on 20 May 2021 in her right dominant arm. On 21 May 2021, patient experienced nausea, getting more sick and worse as the day goes stomach problems. Patient called her family doctor but doctor was left for the day. Patient wanted to knowwhat to do about her side effects. Patient provided her doctor's contact information and permission to contact her doctor. The patient had her first dose in her doctor's office. No treatment medications were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up appended; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pulmonary embolism
Clinical narrative: Blood clots in both lungs; Feels really tired all the time; Joints hurt; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Blood clots in both lungs) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Acid reflux (esophageal) and Retinal migraine. Concomitant products included RABEPRAZOLE SODIUM for Acid reflux (esophageal), METOPROLOL for Retinal migraine.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (Feels really tired all the time) and ARTHRALGIA (Joints hurt). On an unknown date, the patient experienced PULMONARY EMBOLISM (Blood clots in both lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 10-Apr-2021 to 15-Apr-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Blood clots in both lungs) and ARTHRALGIA (Joints hurt) outcome was unknown and FATIGUE (Feels really tired all the time) had not resolved.            Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25 May 2021 contains no new information.; 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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cytomegalovirus infection, Pneumonia, Product dose omission issue, Sepsis
Clinical narrative: pneumonia; Sepsis; CMV virus and a lot others; he never got second shot; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia), SEPSIS (Sepsis) and CYTOMEGALOVIRUS INFECTION (CMV virus and a lot others) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion hospitalization prolonged), SEPSIS (Sepsis) (seriousness criteria hospitalization prolonged and medically significant), CYTOMEGALOVIRUS INFECTION (CMV virus and a lot others) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (he never got second shot). The patient was hospitalized on 04-Mar-2021 due to CYTOMEGALOVIRUS INFECTION, PNEUMONIA and SEPSIS. At the time of the report, PNEUMONIA (pneumonia), SEPSIS (Sepsis) and CYTOMEGALOVIRUS INFECTION (CMV virus and a lot others) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (he never got second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported. No treatment information was provided. The patient was coming back home on next Wednesday 2-Jun-2021.The patient was a part of a clinical trial which went completely wrong. The patient had number of diagnose like pneumonia, sepsis, CMV virus and a lot others.  Based on current available information and the temporal association between product use, the start date of the events and the evaluation by HCP's the events of Pneumonia, Sepsis and Cytomegalic virus infection is unlikely.; Sender's Comments: Based on current available information and the temporal association between product use, the start date of the events and the evaluation by HCP's the events of Pneumonia, Sepsis and Cytomegalic virus infection is unlikely.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Loss of consciousness, Malaise
Clinical narrative: Passed out in the shower; Could not taste; Could not smell; Fever; Chills; Very ill for 28 hours; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out in the shower) 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.   In February 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. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Very ill for 28 hours). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out in the shower) (seriousness criterion medically significant), AGEUSIA (Could not taste), ANOSMIA (Could not smell), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out in the shower), AGEUSIA (Could not taste), ANOSMIA (Could not smell), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown and MALAISE (Very ill for 28 hours) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.    Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Passed out in the shower; Could not taste; Could not smell; Fever; Chills; Very ill for 28 hours; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out in the shower) 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.   In February 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. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Very ill for 28 hours). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out in the shower) (seriousness criterion medically significant), AGEUSIA (Could not taste), ANOSMIA (Could not smell), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out in the shower), AGEUSIA (Could not taste), ANOSMIA (Could not smell), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown and MALAISE (Very ill for 28 hours) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.    Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Very limited information regarding the event, Myocardial infarction, has been provided at this time. There is no patient information, no onset date and on outcome of the event. No patient information to further follow-up.  This case was submitted via adverse event chatbot Text.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Schizophrenia
Clinical narrative: Schizophrenia; Condition aggravated; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health professional and describes the occurrence of SCHIZOPHRENIA (Schizophrenia) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Schizophrenia. Concurrent medical conditions included Drug allergy (peniciilin , erthromycin). Concomitant products included ARIPIPRAZOLE, ATORVASTATIN, SULFASALAZINE, AMLODIPINE BESYLATE, METOPROLOL, METFORMIN HCL, LOSARTAN, LEVOTHYROXINE, ACETYLSALICYLIC ACID (ASPIRIN 81), CALCIUM and COLECALCIFEROL (VIT D3) for an unknown indication.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced SCHIZOPHRENIA (Schizophrenia) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, SCHIZOPHRENIA (Schizophrenia) and CONDITION AGGRAVATED (Condition aggravated) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relapse of schizophrenia after 19 years of stable maintenance on antipsychotic drugs.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Atrial fibrillation, Gait disturbance, Poor peripheral circulation
Clinical narrative: AFib; I cant walk; Heart cant send blood to rest of my body; This is ruining my life; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (AFib) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ATRIAL FIBRILLATION (AFib) (seriousness criteria hospitalization and medically significant). 17-Feb-2021, the patient experienced POOR PERIPHERAL CIRCULATION (Heart cant send blood to rest of my body) and ANXIETY (This is ruining my life). On an unknown date, the patient experienced GAIT DISTURBANCE (I cant walk). The patient was treated with DIGOXIN at an unspecified dose and frequency and ACHILLEA MILLEFOLIUM, CRATAEGUS MONOGYNA, OLEA EUROPAEA, VALERIANA OFFICINALIS, VISCUM ALBUM (BP (BLOOD PRESSURE)) at an unspecified dose and frequency. On 17-Feb-2021 at 12:00 PM, ATRIAL FIBRILLATION (AFib) had not resolved. At the time of the report, POOR PERIPHERAL CIRCULATION (Heart cant send blood to rest of my body), ANXIETY (This is ruining my life) and GAIT DISTURBANCE (I cant walk) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Surgery
Clinical narrative: Surgery; Surgery interrupted 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (Surgery) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SURGERY (Surgery) (seriousness criterion medically significant) and INCOMPLETE COURSE OF VACCINATION (Surgery interrupted 2nd shot). At the time of the report, SURGERY (Surgery) and INCOMPLETE COURSE OF VACCINATION (Surgery interrupted 2nd shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by reporter. Treatment information was not applicable.  Very limited information regarding the events has been provided at this time. No further information is expected. Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely.; Sender's Comments: Very limited information regarding the events has been provided at this time. No further information is expected. Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic valve replacement, Product dose omission issue, Vascular graft
Clinical narrative: three "bypass" procedures; aortic valve replacement; 99 days have past since first dose in the series; This spontaneous case was reported by a pharmacist and describes the occurrence of VASCULAR GRAFT (three "bypass" procedures) and AORTIC VALVE REPLACEMENT (aortic valve replacement) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced VASCULAR GRAFT (three "bypass" procedures) (seriousness criterion hospitalization), AORTIC VALVE REPLACEMENT (aortic valve replacement) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (99 days have past since first dose in the series). At the time of the report, VASCULAR GRAFT (three "bypass" procedures), AORTIC VALVE REPLACEMENT (aortic valve replacement) and PRODUCT DOSE OMISSION ISSUE (99 days have past since first dose in the series) 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.   Concomitant medications were not reported. Treatment information in response to events was not provided.  Company comment: This case concerns a 73-year-old male who missed 2nd dose more than 99 days (MISSED DOSE).  The other events of aortic valve replacement and Bypass surgery are interventions for pre-existing conditions and as such are considered unlikely related to mRNA-1273 vaccination.  The event of missed dose is assessed as not applicable.; Sender's Comments: This case concerns a 73-year-old male who missed 2nd dose more than 99 days (MISSED DOSE).  The other events of aortic valve replacement and Bypass surgery are interventions for pre-existing conditions and as such are considered unlikely related to mRNA-1273 vaccination.  The event of missed dose is assessed as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: we got fell and me and my mom both at emergency room so the vaccine didn't go through,; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (we got fell and me and my mom both at emergency room so the vaccine didn't go through,) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (we got fell and me and my mom both at emergency room so the vaccine didn't go through,). On 24-May-2021, PRODUCT DOSE OMISSION ISSUE (we got fell and me and my mom both at emergency room so the vaccine didn't go through,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  Company 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.; Reporter's Comments: Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (we got fell and me and my mom both at emergency room so the vaccine didn't go through,) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (we got fell and me and my mom both at emergency room so the vaccine didn't go through,). On 24-May-2021, PRODUCT DOSE OMISSION ISSUE (we got fell and me and my mom both at emergency room so the vaccine didn't go through,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  Company 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.; 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: Dizziness, Gait disturbance
Clinical narrative: dizziness; at times could barely walk; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (dizziness) and GAIT DISTURBANCE (at times could barely walk) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) (seriousness criterion hospitalization) and GAIT DISTURBANCE (at times could barely walk) (seriousness criterion hospitalization). At the time of the report, DIZZINESS (dizziness) and GAIT DISTURBANCE (at times could barely walk) outcome was unknown.            Treatment and concomitant information was not provided by the reporter.  Action taken with mRNA-1273 in response to the drug 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.
Sex: U
Vaccine: COVID19
Symptoms: Colitis ulcerative
Clinical narrative: Ulcerativa colitis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Ulcerativa colitis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerativa colitis) (seriousness criterion medically significant). At the time of the report, COLITIS ULCERATIVE (Ulcerativa colitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. It was reported that the patient asked if they have UCI, can they get the vaccine. No treatment information 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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Joint injury, Loss of consciousness, Malaise
Clinical narrative: broke her ankle; blacked out and passed out; trouble breathing; didn't feel good; nauseated; felt light headed; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out and passed out) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included PREDNISOLONE, TIMOLOL, LABETALOL and LOSARTAN for an unknown indication.   On 09-Mar-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 09-Mar-2021, the patient experienced DIZZINESS (felt light headed), MALAISE (didn't feel good) and NAUSEA (nauseated). On 09-Apr-2021, the patient experienced DYSPNOEA (trouble breathing). On 11-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out and passed out) (seriousness criterion medically significant) and JOINT INJURY (broke her ankle). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out and passed out), DIZZINESS (felt light headed), JOINT INJURY (broke her ankle), DYSPNOEA (trouble breathing), MALAISE (didn't feel good) and NAUSEA (nauseated) outcome was unknown.            Treatment medications were not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: broke her ankle; blacked out and passed out; trouble breathing; didn't feel good; nauseated; felt light headed; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out and passed out) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included PREDNISOLONE, TIMOLOL, LABETALOL and LOSARTAN for an unknown indication.   On 09-Mar-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 09-Mar-2021, the patient experienced DIZZINESS (felt light headed), MALAISE (didn't feel good) and NAUSEA (nauseated). On 09-Apr-2021, the patient experienced DYSPNOEA (trouble breathing). On 11-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out and passed out) (seriousness criterion medically significant) and JOINT INJURY (broke her ankle). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out and passed out), DIZZINESS (felt light headed), JOINT INJURY (broke her ankle), DYSPNOEA (trouble breathing), MALAISE (didn't feel good) and NAUSEA (nauseated) outcome was unknown.            Treatment medications were not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Illness, Pain, Pyrexia
Clinical narrative: Feeling light headed of and on; Whole body sore; Tired; He just felt sick this morning; Felt warm; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL9264; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 02Feb2021 14:00 as 2nd dose, single dose; dose 1 on12Jan2021, in his right arm as 1st dose, single dose (Lot no: EL3302) for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously took bnt162b2. on 03Feb2021 the patient experienced feeling lightheaded off and on, whole body sore, tired, he just felt sick this morning, felt warm and He felt like he got tackled or hit by something. Therapeutic measures were taken with Tylenol and the patient felt better. The clinical outcome of the events Feeling light headed of and on, He just felt sick this morning was Not recovered/Not resolved and Whole body sore, Felt warm, Tired was Recovering/Resolving.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure fluctuation, Blood pressure measurement, Dizziness
Clinical narrative: weak; dizziness; She also stated that she took her blood pressure at home, the first reading was high and now its low; This is a spontaneous report from a contactable Consumer (Patient's husband).  A 67 years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration on 29Jan2021, as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 03Feb2021, the patient experienced dizziness which is unusual for her and she took her blood pressure at home, the first reading was high and now its low. She stated that she was supposed to take her husband to an appointment, today, but when she stood up to reach something on a tall shelf she felt dizzy and weak. She has since been taking it easy today and drinking plenty of water.  the patient wants to know how long symptoms typically last.  Caller also mentioned that her husband had recently tested positive for COVID, but completed his quarantine. On an unspecified date the patient experienced weak. All the events were non-serious. Duration for injection site reactions are reported as 2.5days, but patients were asked to reports symptoms for 7-days post-dose.  Lot/batch number was not obtained. Follow-up attempts are completed; information about lot/batch number was not obtained.
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge
Clinical narrative: Coughing up old mucus; This is a spontaneous report from a contactable consumer or other non hcp. A female patient (reporter mother) of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Feb2021 as unknown, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Reporter stated that patient (her mom) got the vaccine and had the same thing, the old mucus coming up. Reported stated she does not have time to complete a whole report because she needs to go get something to eat.   No further information provided. Information on lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: has a fever of 101 degrees Fahrenheit, sometimes a little higher/ 102 degrees Fahrenheit; chills; this time it hurt more; This is a spontaneous report from a contactable consumer reporting for herself. This is one of the two reports from same reporter. An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 (Batch/Lot Number: EM9809, Expiry Date is unknown) as single dose for covid-19 immunization. The patient medical history includes stroke which she has been taking medication for that for a while and was diagnosed 5 years ago, she said obesity was there, and she also has high blood pressure which was also diagnosed 5 years ago. She stated that sometimes she has a slight case of asthma, which she used to get frequently but while wearing masks she doesn't get infections like that anymore. There were no concomitant medications. Patient had her first dose of bnt162b2 on 21Jan2021 (LOT EI3247 or EL3247, as patient is not sure the way it is written she would guess the second letter is an I or a L.). After her first dose she had no fever just a slight sore shoulder, and this time it hurt more (unknown date in 2021). It was reported that, patient had the second dose of Pfizer's COVID vaccine yesterday on 11Feb2021. This afternoon, on 12Feb2021, she woke up with a fever of 101F-102F and was slowly going down now. The patient wanted to know if this could be a possible side effect and how long would it last. On 12Feb2021, the patient also had chills, and she took her temperature, and it was 101 degrees Fahrenheit and this afternoon it was almost 102 degrees Fahrenheit, she stated that, she always taken her temperature to make sure she was ok, and not getting COVID, which she asks if she has COVID after getting the shot. She took two Tylenol last night and two today, though she usually takes two every day. Unknown male took over the call briefly for caller and was given recording notification. He provided clarified product Acetaminophen Extra Strength 500mg, and says she took two before getting the shot, two last night, and two this morning so she has had 6 in the last 24 hours by mouth. On 12Feb2021, patient underwent lab tests and procedures which included Body temperature: 101-102 Fahrenheit. Therapeutic measures were taken as a result of events. The outcome of events was unknown.   Follow-up attempts completed. No further information expected.