chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Sarcoidosis
Clinical narrative: I had the first does of Moderna and due for the 2nd in a week my Doctor has prescribe Predinsone for my Sarcoidosis will this effect the vaccine potency or effectiveness; 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 SARCOIDOSIS (I had the first does of Moderna and due for the 2nd in a week my Doctor has prescribe Predinsone for my Sarcoidosis will this effect the vaccine potency or effectiveness) 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 SARCOIDOSIS (I had the first does of Moderna and due for the 2nd in a week my Doctor has prescribe Predinsone for my Sarcoidosis will this effect the vaccine potency or effectiveness) (seriousness criterion medically significant). At the time of the report, SARCOIDOSIS (I had the first does of Moderna and due for the 2nd in a week my Doctor has prescribe Predinsone for my Sarcoidosis will this effect the vaccine potency or effectiveness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.  This case concerns a patient of unknown age and gender with a serious unexpected event of sarcoidosis. Event onset with unknown latency after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a patient of unknown age and gender with a serious unexpected event of sarcoidosis. Event onset with unknown latency after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Biliary colic, Crohn's disease, Dyspnoea, Job dissatisfaction, Oropharyngeal pain
Clinical narrative: Crohns disease flared up; had to use an inhaler to breathe; arm really hurts; Sore throat; Gallbladder is causing me pain; lost so much work because of this; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohns disease flared up) and DYSPNOEA (had to use an inhaler to breathe) in a female patient of an unknown age 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 Crohn's disease.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (Crohns disease flared up) (seriousness criterion medically significant), DYSPNOEA (had to use an inhaler to breathe) (seriousness criterion medically significant), PAIN IN EXTREMITY (arm really hurts), OROPHARYNGEAL PAIN (Sore throat), BILIARY COLIC (Gallbladder is causing me pain) and JOB DISSATISFACTION (lost so much work because of this). At the time of the report, CROHN'S DISEASE (Crohns disease flared up), DYSPNOEA (had to use an inhaler to breathe), OROPHARYNGEAL PAIN (Sore throat), BILIARY COLIC (Gallbladder is causing me pain) and JOB DISSATISFACTION (lost so much work because of this) outcome was unknown and PAIN IN EXTREMITY (arm really hurts) had not resolved.            Concomitant medication was not reported.  Action taken with mRNA-1273 in response to the events was not Applicable.  It was reported that the second shot unfortunately made the patient sicker for 3 weeks same symptoms (severe) plus sore throat and arm was still hurting. Patient was using inhaler for breathing.  The reporter was unsure if this related to vaccination  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 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Followup was received on 24-May-2021 the case was upgraded to serious based on the additional 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Crohns disease flared up; had to use an inhaler to breathe; arm really hurts; Sore throat; Gallbladder is causing me pain; lost so much work because of this; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohns disease flared up) and DYSPNOEA (had to use an inhaler to breathe) in a female patient of an unknown age 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 Crohn's disease.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (Crohns disease flared up) (seriousness criterion medically significant), DYSPNOEA (had to use an inhaler to breathe) (seriousness criterion medically significant), PAIN IN EXTREMITY (arm really hurts), OROPHARYNGEAL PAIN (Sore throat), BILIARY COLIC (Gallbladder is causing me pain) and JOB DISSATISFACTION (lost so much work because of this). At the time of the report, CROHN'S DISEASE (Crohns disease flared up), DYSPNOEA (had to use an inhaler to breathe), OROPHARYNGEAL PAIN (Sore throat), BILIARY COLIC (Gallbladder is causing me pain) and JOB DISSATISFACTION (lost so much work because of this) outcome was unknown and PAIN IN EXTREMITY (arm really hurts) had not resolved.            Concomitant medication was not reported.  Action taken with mRNA-1273 in response to the events was not Applicable.  It was reported that the second shot unfortunately made the patient sicker for 3 weeks same symptoms (severe) plus sore throat and arm was still hurting. Patient was using inhaler for breathing.  The reporter was unsure if this related to vaccination  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 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Followup was received on 24-May-2021 the case was upgraded to serious based on the additional 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chest X-ray, Deep vein thrombosis, Pneumonia, Ultrasound Doppler
Clinical narrative: bilateral pneumonia; acute on chronic respiratory failure; left lower extremity deep vein thrombosis; This spontaneous case was reported by a physician and describes the occurrence of ACUTE RESPIRATORY FAILURE (acute on chronic respiratory failure), PNEUMONIA (bilateral pneumonia) and DEEP VEIN THROMBOSIS (left lower extremity deep vein thrombosis) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012LZ0A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (corn, dairy aid, peanuts,tomato), Drug allergy (codeine, aspirin, chlorine, tartrazine, lanolin, Prevnar, Pulmicort, penicillin.), Iodine contrast media allergy, Allergy (cat dander, yellow dye, purple dye), Latex allergy, Hypertension, COPD and Lung cancer. Concomitant products included ALPRAZOLAM, BENZONATATE, ENOXAPARIN, GABAPENTIN, HCTZ, HYDROCODONE, ACETAMINOPHEN, OMEPRAZOLE, PREDNISONE, PROCHLORPERAZINE EDISYLATE (COMPAZINE [PROCHLORPERAZINE EDISYLATE]), BECLOMETASONE DIPROPIONATE (QVAR), MONTELUKAST and CETIRIZINE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (left lower extremity deep vein thrombosis) (seriousness criterion medically significant). On 05-May-2021, the patient experienced ACUTE RESPIRATORY FAILURE (acute on chronic respiratory failure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PNEUMONIA (bilateral pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 05-May-2021 due to ACUTE RESPIRATORY FAILURE and PNEUMONIA. The patient was treated with Hospice care (increased supplemental oxygen) for Pneumonia. At the time of the report, ACUTE RESPIRATORY FAILURE (acute on chronic respiratory failure), PNEUMONIA (bilateral pneumonia) and DEEP VEIN THROMBOSIS (left lower extremity deep vein thrombosis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Ultrasound Doppler: unknown (Inconclusive) unknown. On 05-May-2021, Chest X-ray: unknown (Inconclusive) unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment includes IV antibiotics. concomitant medication includes duo-nebs.  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: Hallucination
Clinical narrative: hallucinating; 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 HALLUCINATION (hallucinating) 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 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 HALLUCINATION (hallucinating) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (hallucinating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The adverse event was submitted via chatbot.  Concomitant medications were not reported.  No treatment information was provided.  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; 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: Condition aggravated, Fatigue, Neuropathy peripheral
Clinical narrative: My neuropathy has really flared up; my neuropathy has really flared up; I feel tired nearly all the time; 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 NEUROPATHY PERIPHERAL (My neuropathy has really flared up) 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.     Concurrent medical conditions included Neuropathy NOS.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (My neuropathy has really flared up) (seriousness criterion medically significant), CONDITION AGGRAVATED (my neuropathy has really flared up) and FATIGUE (I feel tired nearly all the time). At the time of the report, NEUROPATHY PERIPHERAL (My neuropathy has really flared up), CONDITION AGGRAVATED (my neuropathy has really flared up) and FATIGUE (I feel tired nearly all the time) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events 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.  No further information is available for this case.; 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.  No further information is available for this case
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Myocardial infarction, Nasopharyngitis, Vomiting
Clinical narrative: heart attack; grand mal seizure episodes "for the first time in over 2 years", he didn't remember the episode; he was freezing and was cold; throwing up profusely; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) and GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure episodes "for the first time in over 2 years", he didn't remember the episode) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included LACOSAMIDE (VIMPAT) for Seizure.    On 21-Apr-2021 at 3:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-May-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure episodes "for the first time in over 2 years", he didn't remember the episode) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), NASOPHARYNGITIS (he was freezing and was cold) and VOMITING (throwing up profusely). The patient was hospitalized on 22-May-2021 due to GENERALISED TONIC-CLONIC SEIZURE and MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (heart attack), GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure episodes "for the last time in over 2 years", he didn't remember the episode), NASOPHARYNGITIS (he was freezing and was cold) and VOMITING (throwing up profusely) outcome was unknown.            Patient was admitted to hospital on 22-may-2021.patient lips were purple and had no pulse for 12 minutes, but was resuscitated.The hospital took out patient's breathing tube at  on 23May2021, and hospital staff stated he will remain there for a while.  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Vomiting is  consistent with the known safety profile of the product.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Vomiting is  consistent with the known safety profile of the product.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Catheterisation cardiac, Chest discomfort, Chest pain
Clinical narrative: chest pain that was sharp; feels an occasional slight chest discomfort; Elevated troponin levels; Blood pressure was ranging around 140/90; achy; fever 102; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain that was sharp) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 026A21A) 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 FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and AZELASTINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced MYALGIA (achy), PYREXIA (fever 102) and FATIGUE (felt tired). On 16-Apr-2021, the patient experienced CHEST PAIN (chest pain that was sharp) (seriousness criterion hospitalization), TROPONIN INCREASED (Elevated troponin levels) and BLOOD PRESSURE INCREASED (Blood pressure was ranging around 140/90). On 24-May-2021, the patient experienced CHEST DISCOMFORT (feels an occasional slight chest discomfort). The patient was hospitalized on 16-Apr-2021 due to CHEST PAIN. On 16-Apr-2021, TROPONIN INCREASED (Elevated troponin levels) had resolved. At the time of the report, CHEST PAIN (chest pain that was sharp), MYALGIA (achy), PYREXIA (fever 102) and FATIGUE (felt tired) was resolving and BLOOD PRESSURE INCREASED (Blood pressure was ranging around 140/90) and CHEST DISCOMFORT (feels an occasional slight chest discomfort) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood pressure measurement: 140/90 (High) His normal rage is 120/70. On 16-Apr-2021, Catheterisation cardiac: normal (normal) normal. On 16-Apr-2021, Echocardiogram: normal (normal) Normal. On 16-Apr-2021, Electrocardiogram: normal (normal) normal. On 16-Apr-2021, Pulmonary function test: clear (normal) Lung test was clear.. On 16-Apr-2021, Troponin: elevated (High) elevated, elevated (High) was elevated from the first. and normal (normal) the last test done was normal.         No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events 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: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Fatigue, Myalgia, Pulmonary function test
Clinical narrative: chest pain that was sharp; feels an occasional slight chest discomfort; Elevated troponin levels; Blood pressure was ranging around 140/90; achy; fever 102; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain that was sharp) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 026A21A) 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 FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and AZELASTINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced MYALGIA (achy), PYREXIA (fever 102) and FATIGUE (felt tired). On 16-Apr-2021, the patient experienced CHEST PAIN (chest pain that was sharp) (seriousness criterion hospitalization), TROPONIN INCREASED (Elevated troponin levels) and BLOOD PRESSURE INCREASED (Blood pressure was ranging around 140/90). On 24-May-2021, the patient experienced CHEST DISCOMFORT (feels an occasional slight chest discomfort). The patient was hospitalized on 16-Apr-2021 due to CHEST PAIN. On 16-Apr-2021, TROPONIN INCREASED (Elevated troponin levels) had resolved. At the time of the report, CHEST PAIN (chest pain that was sharp), MYALGIA (achy), PYREXIA (fever 102) and FATIGUE (felt tired) was resolving and BLOOD PRESSURE INCREASED (Blood pressure was ranging around 140/90) and CHEST DISCOMFORT (feels an occasional slight chest discomfort) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood pressure measurement: 140/90 (High) His normal rage is 120/70. On 16-Apr-2021, Catheterisation cardiac: normal (normal) normal. On 16-Apr-2021, Echocardiogram: normal (normal) Normal. On 16-Apr-2021, Electrocardiogram: normal (normal) normal. On 16-Apr-2021, Pulmonary function test: clear (normal) Lung test was clear.. On 16-Apr-2021, Troponin: elevated (High) elevated, elevated (High) was elevated from the first. and normal (normal) the last test done was normal.         No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events 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: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Troponin, Troponin increased
Clinical narrative: chest pain that was sharp; feels an occasional slight chest discomfort; Elevated troponin levels; Blood pressure was ranging around 140/90; achy; fever 102; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain that was sharp) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 026A21A) 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 FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and AZELASTINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced MYALGIA (achy), PYREXIA (fever 102) and FATIGUE (felt tired). On 16-Apr-2021, the patient experienced CHEST PAIN (chest pain that was sharp) (seriousness criterion hospitalization), TROPONIN INCREASED (Elevated troponin levels) and BLOOD PRESSURE INCREASED (Blood pressure was ranging around 140/90). On 24-May-2021, the patient experienced CHEST DISCOMFORT (feels an occasional slight chest discomfort). The patient was hospitalized on 16-Apr-2021 due to CHEST PAIN. On 16-Apr-2021, TROPONIN INCREASED (Elevated troponin levels) had resolved. At the time of the report, CHEST PAIN (chest pain that was sharp), MYALGIA (achy), PYREXIA (fever 102) and FATIGUE (felt tired) was resolving and BLOOD PRESSURE INCREASED (Blood pressure was ranging around 140/90) and CHEST DISCOMFORT (feels an occasional slight chest discomfort) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood pressure measurement: 140/90 (High) His normal rage is 120/70. On 16-Apr-2021, Catheterisation cardiac: normal (normal) normal. On 16-Apr-2021, Echocardiogram: normal (normal) Normal. On 16-Apr-2021, Electrocardiogram: normal (normal) normal. On 16-Apr-2021, Pulmonary function test: clear (normal) Lung test was clear.. On 16-Apr-2021, Troponin: elevated (High) elevated, elevated (High) was elevated from the first. and normal (normal) the last test done was normal.         No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events 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: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: terrible blood bleeding in both of her legs; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (terrible blood bleeding in both of her legs) 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 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 HAEMORRHAGE (terrible blood bleeding in both of her legs) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (terrible blood bleeding in both of her legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter reported on 22-MAY-2021 that her mother woke up to terrible bleeding in both of her legs after she has received the first dose of Moderna Covid-19 vaccine on 20-MAY-2021. No treatment or concomitant medications were reported by the reporter.  Company Comment: 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: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure episode; 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 SEIZURE (Seizure episode) 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 SEIZURE (Seizure episode) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure episode) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.  Company comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) in a male 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The patient's wife reported that the patient passed away a few weeks after taking the Moderna vaccine.  Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable  Company comment Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died) 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. Death occurred on 23-May-2021 The patient died on 23-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            The reporter mentioned that grandma got Moderna vaccine and died yesterday (23 -May-2021)  Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable  Company comment Very limited information regarding this event/s has been provided at this time.  Further information has not been requested since follow up was denied.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has not been requested since follow up was denied.; Reported Cause(s) of Death: Unknown cause of death
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Vaginal haemorrhage
Clinical narrative: Began bleeding; Began spotting; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Began bleeding) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 HAEMORRHAGE (Began bleeding) (seriousness criterion medically significant) and VAGINAL HAEMORRHAGE (Began spotting). At the time of the report, HAEMORRHAGE (Began bleeding) and VAGINAL HAEMORRHAGE (Began spotting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was 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.
Sex: M
Vaccine: COVID19
Symptoms: Accident, Incomplete course of vaccination, Joint dislocation, Skull fracture
Clinical narrative: Fractured his skull after 1st dose; Got into an accident after 1st dose; Dislocated his shoulder after 1st dose; Did not get 2nd dose within day 25-35 of the 1st dose; This spontaneous case was reported by a patient and describes the occurrence of SKULL FRACTURE (Fractured his skull after 1st dose) in a male patient of an unknown age 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKULL FRACTURE (Fractured his skull after 1st dose) (seriousness criterion medically significant), ACCIDENT (Got into an accident after 1st dose), JOINT DISLOCATION (Dislocated his shoulder after 1st dose) and INCOMPLETE COURSE OF VACCINATION (Did not get 2nd dose within day 25-35 of the 1st dose). At the time of the report, SKULL FRACTURE (Fractured his skull after 1st dose), ACCIDENT (Got into an accident after 1st dose), JOINT DISLOCATION (Dislocated his shoulder after 1st dose) and INCOMPLETE COURSE OF VACCINATION (Did not get 2nd dose within day 25-35 of the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       As per report patient received his 1st dose in March and was scheduled for his 2nd dose in April. Patient was unable to received 2nd dose due to an accident. It has been 51 days since 1st dose.  No relevant concomitant medication information provided.  No relevant treatment medication information provided.  This is a case of incomplete course of vaccination. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.; Sender's Comments: This is a case of incomplete course of vaccination. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Passed out; Seizure; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and SEIZURE (Seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and SEIZURE (Seizure) (seriousness criterion medically significant). On 22-May-2021, LOSS OF CONSCIOUSNESS (Passed out) and SEIZURE (Seizure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Company comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Genital haemorrhage, Pain in extremity, Urinary incontinence
Clinical narrative: been bleeding since I get the shot; felt like peeing and blood start pouring out; My left leg felt like it was coming apart,other staff is coming from my body; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HAEMORRHAGE (been bleeding since I get the shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN for an unknown indication.    On 03-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 GENITAL HAEMORRHAGE (been bleeding since I get the shot) (seriousness criterion medically significant), URINARY INCONTINENCE (felt like peeing and blood start pouring out) and PAIN IN EXTREMITY (My left leg felt like it was coming apart,other staff is coming from my body). At the time of the report, GENITAL HAEMORRHAGE (been bleeding since I get the shot), URINARY INCONTINENCE (felt like peeing and blood start pouring out) and PAIN IN EXTREMITY (My left leg felt like it was coming apart,other staff is coming from my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for pain in extremity included Tylenol.  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-2021-163847 (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: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Blood pressure measurement, Condition aggravated, Dizziness, Heart rate
Clinical narrative: I started to get an Arrhythmia; Palpitation; I am dizzier; this is aggravating of my pre-existing conditions/my acid reflux is no longer base line; This spontaneous case was reported by a patient and describes the occurrence of ARRHYTHMIA (I started to get an Arrhythmia) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dizziness since 1992, Malabsorption, Anaemia since 1992, LBBB since 26-Feb-2021 and GERD since 2000. Concomitant products included ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) for Acid reflux (oesophageal), ALPRAZOLAM for Imbalance hormonal.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (I started to get an Arrhythmia) (seriousness criterion medically significant), PALPITATIONS (Palpitation), DIZZINESS (I am dizzier) and CONDITION AGGRAVATED (this is aggravating of my pre-existing conditions/my acid reflux is no longer base line). At the time of the report, ARRHYTHMIA (I started to get an Arrhythmia), PALPITATIONS (Palpitation), DIZZINESS (I am dizzier) and CONDITION AGGRAVATED (this is aggravating of my pre-existing conditions/my acid reflux is no longer base line) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement (120-80): 184/110 (High) high and high (High) 140-150/80-90. In 2021, Heart rate: high (High) Rise in pulse rate.         Patient have numerous allergies which are not reported. Treatment information provided included 1mg of unknown medication. 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.   This case was linked to MOD-2021-080355 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: I started to get an Arrhythmia; Palpitation; I am dizzier; this is aggravating of my pre-existing conditions/my acid reflux is no longer base line; This spontaneous case was reported by a patient and describes the occurrence of ARRHYTHMIA (I started to get an Arrhythmia) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dizziness since 1992, Malabsorption, Anaemia since 1992, LBBB since 26-Feb-2021 and GERD since 2000. Concomitant products included ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) for Acid reflux (oesophageal), ALPRAZOLAM for Imbalance hormonal.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (I started to get an Arrhythmia) (seriousness criterion medically significant), PALPITATIONS (Palpitation), DIZZINESS (I am dizzier) and CONDITION AGGRAVATED (this is aggravating of my pre-existing conditions/my acid reflux is no longer base line). At the time of the report, ARRHYTHMIA (I started to get an Arrhythmia), PALPITATIONS (Palpitation), DIZZINESS (I am dizzier) and CONDITION AGGRAVATED (this is aggravating of my pre-existing conditions/my acid reflux is no longer base line) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement (120-80): 184/110 (High) high and high (High) 140-150/80-90. In 2021, Heart rate: high (High) Rise in pulse rate.         Patient have numerous allergies which are not reported. Treatment information provided included 1mg of unknown medication. 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.   This case was linked to MOD-2021-080355 (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: Death
Clinical narrative: got his grandma a covid-19 vaccine and she died /she's not the first i have heard about that died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (got his grandma a covid-19 vaccine and she died /she's not the first i have heard about that died) 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) (Intramuscular) 1 dosage form. Death occurred on 23-May-2021 The patient died on 23-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported.  It was reported that the reporter grandma received a covid-19 vaccine and died yesterday. Reporter also stated that it's not the first he has heard about that someone died from the covid-19 vaccine. The reporter did not specify it was the morderna Covid-19 vaccine he was referring to.  Company comment Very limited information regarding this event/s has been provided at this time.  Further information has not been requested since reporter did not share any personal information.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has not been requested since reporter did not share any personal information.; Reported Cause(s) of Death: unknown cause of death
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Coagulation test, Erythema, Feeding disorder, Incomplete course of vaccination
Clinical narrative: No blood clot but testing shows signs of blood clot; Unable to eat; Chest pains; Red spots; Muscles feel like needles; She has not taken second dose; Fainted; hand turned red; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (No blood clot but testing shows signs of blood clot) and SYNCOPE (Fainted) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), ERYTHEMA (hand turned red) and PALPITATIONS (Palpitations). On an unknown date, the patient experienced THROMBOSIS (No blood clot but testing shows signs of blood clot) (seriousness criterion medically significant), FEEDING DISORDER (Unable to eat), CHEST PAIN (Chest pains), RASH MACULAR (Red spots), MYALGIA (Muscles feel like needles) and INCOMPLETE COURSE OF VACCINATION (She has not taken second dose). At the time of the report, THROMBOSIS (No blood clot but testing shows signs of blood clot), SYNCOPE (Fainted), ERYTHEMA (hand turned red), PALPITATIONS (Palpitations), FEEDING DISORDER (Unable to eat), CHEST PAIN (Chest pains), RASH MACULAR (Red spots), MYALGIA (Muscles feel like needles) and INCOMPLETE COURSE OF VACCINATION (She has not taken second dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Coagulation test: signs of blood clot (abnormal) signs of blood clot.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that within 3 minutes of receiving dose, patient's hand turned red and she fainted. Patient was brought to the hospital and was released a couple hours later when palpitations stopped. No medication given to treat symptoms.  The patient was receiving unspecified acid reflux medication.   Company comment Very limited information regarding these events has been provided at this time. Further information has been requested. Company causality for events Thrombosis, Syncope, Erythema, Palpitations, Feeding disorder, Chest pain, Rash macular and Myalgia cannot be excluded, while company causality for Incomplete course of vaccination is assessed as not applicable.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. Company causality for events Thrombosis, Syncope, Erythema, Palpitations, Feeding disorder, Chest pain, Rash macular and Myalgia cannot be excluded, while company causality for Incomplete course of vaccination is assessed as not applicable.