chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Illness, Loss of consciousness, Nausea
Clinical narrative: she almost passed out; dizzy; fast hearth beats; sick; high fever; throwing up; nausea; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she almost passed out) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, COPD, Cholesterol, Hypertension and Cyst of kidney (Cyst in left kidney).    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (she almost passed out) (seriousness criterion medically significant), DIZZINESS (dizzy), HEART RATE INCREASED (fast hearth beats), ILLNESS (sick), PYREXIA (high fever), VOMITING (throwing up) and NAUSEA (nausea). At the time of the report, LOSS OF CONSCIOUSNESS (she almost passed out) had resolved and DIZZINESS (dizzy), HEART RATE INCREASED (fast hearth beats), ILLNESS (sick), PYREXIA (high fever), VOMITING (throwing up) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatments were reported. No concomitant medications were reported. Patient asked if she can receive another company's vaccine as a second dose.; Sender's Comments: This case concerns a 43-year-old female with a serious unexpected event of loss of consciousness, nonserious unexpected dizziness, heart rate increased, illness, and expected pyrexia, nausea, vomiting. Event onset the same day as first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: she almost passed out; dizzy; fast hearth beats; sick; high fever; throwing up; nausea; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she almost passed out) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, COPD, Cholesterol, Hypertension and Cyst of kidney (Cyst in left kidney).    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (she almost passed out) (seriousness criterion medically significant), DIZZINESS (dizzy), HEART RATE INCREASED (fast hearth beats), ILLNESS (sick), PYREXIA (high fever), VOMITING (throwing up) and NAUSEA (nausea). At the time of the report, LOSS OF CONSCIOUSNESS (she almost passed out) had resolved and DIZZINESS (dizzy), HEART RATE INCREASED (fast hearth beats), ILLNESS (sick), PYREXIA (high fever), VOMITING (throwing up) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatments were reported. No concomitant medications were reported. Patient asked if she can receive another company's vaccine as a second dose.; Sender's Comments: This case concerns a 43-year-old female with a serious unexpected event of loss of consciousness, nonserious unexpected dizziness, heart rate increased, illness, and expected pyrexia, nausea, vomiting. Event onset the same day as first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dehydration, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: Afib; Lightheaded/dizzy; nervous; Dehydrated; Problems with vision; Tachycardia; Problems concentrations; Fatigued/Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 098K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    The patient's past medical history included No adverse event (No reported medical history).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-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 ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), VISUAL IMPAIRMENT (Problems with vision), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired). At the time of the report, ATRIAL FIBRILLATION (Afib), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired) outcome was unknown and VISUAL IMPAIRMENT (Problems with vision) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Treatment included metoprolol, digoxin and diltiazem. No concomitant medication was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, The patient's advance age may remain a risk factor for the event Atrial fibrillation. Further information has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Tachycardia, Visual impairment
Clinical narrative: Afib; Lightheaded/dizzy; nervous; Dehydrated; Problems with vision; Tachycardia; Problems concentrations; Fatigued/Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 098K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    The patient's past medical history included No adverse event (No reported medical history).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-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 ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), VISUAL IMPAIRMENT (Problems with vision), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired). At the time of the report, ATRIAL FIBRILLATION (Afib), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired) outcome was unknown and VISUAL IMPAIRMENT (Problems with vision) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Treatment included metoprolol, digoxin and diltiazem. No concomitant medication was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, The patient's advance age may remain a risk factor for the event Atrial fibrillation. Further information has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram head
Clinical narrative: stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included AMLODIPINE, LOSARTAN, ATORVASTATIN, ALBUTEROL [SALBUTAMOL], ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN C [ASCORBIC ACID], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), COLECALCIFEROL (VIT D3), CLOPIDOGREL BISULFATE (PLAVIX), GARLIC [ALLIUM SATIVUM], LIDOCAINE, TIOTROPIUM and CYANOCOBALAMIN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 2 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Computerised tomogram head: abnormal (abnormal) CT scan of head and was told that he had a stroke.         No treatment information was provided. Additional concomitant medications included Circulant for an unknown indication. Additional diagnostic tests included magnetic resonance imaging, results not provided.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Anxiety, Decreased interest, Hallucination, auditory, Insomnia
Clinical narrative: told mother he could hear voices that were not there.; wont watch movies or play games; Agitation; Nervous; Anxious; couldnt sleep; This spontaneous case was reported by a physician assistant and describes the occurrence of HALLUCINATION, AUDITORY (told mother he could hear voices that were not there.) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Down's syndrome.   On 05-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) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced HALLUCINATION, AUDITORY (told mother he could hear voices that were not there.) (seriousness criterion medically significant), DECREASED INTEREST (wont watch movies or play games), AGITATION (Agitation), NERVOUSNESS (Nervous), ANXIETY (Anxious) and INSOMNIA (couldnt sleep). At the time of the report, HALLUCINATION, AUDITORY (told mother he could hear voices that were not there.), DECREASED INTEREST (wont watch movies or play games), AGITATION (Agitation), NERVOUSNESS (Nervous), ANXIETY (Anxious) and INSOMNIA (couldnt sleep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatments were 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. Patient's medical history of Down Syndrome may be contributory to the development of the psychiatric episode related-events.   This case was linked to US-MODERNATX, INC.-MOD-2021-075678 (E2B Linked Report).; 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. Patient's medical history of Down Syndrome may be contributory to the development of the psychiatric episode related-events. US-MODERNATX, INC.-MOD-2021-075678:Case for first dose
Sex: M
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: told mother he could hear voices that were not there.; wont watch movies or play games; Agitation; Nervous; Anxious; couldnt sleep; This spontaneous case was reported by a physician assistant and describes the occurrence of HALLUCINATION, AUDITORY (told mother he could hear voices that were not there.) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Down's syndrome.   On 05-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) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced HALLUCINATION, AUDITORY (told mother he could hear voices that were not there.) (seriousness criterion medically significant), DECREASED INTEREST (wont watch movies or play games), AGITATION (Agitation), NERVOUSNESS (Nervous), ANXIETY (Anxious) and INSOMNIA (couldnt sleep). At the time of the report, HALLUCINATION, AUDITORY (told mother he could hear voices that were not there.), DECREASED INTEREST (wont watch movies or play games), AGITATION (Agitation), NERVOUSNESS (Nervous), ANXIETY (Anxious) and INSOMNIA (couldnt sleep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatments were 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. Patient's medical history of Down Syndrome may be contributory to the development of the psychiatric episode related-events.   This case was linked to US-MODERNATX, INC.-MOD-2021-075678 (E2B Linked Report).; 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. Patient's medical history of Down Syndrome may be contributory to the development of the psychiatric episode related-events. US-MODERNATX, INC.-MOD-2021-075678:Case for first dose
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Vaccination site pain
Clinical narrative: Struck down with Bell's Palsy over the weekend and was treated; Patient also experienced soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Struck down with Bell's Palsy over the weekend and was treated) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VALACYCLOVIR [VALACICLOVIR] and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Bell's palsy, APIXABAN (ELIQUIS), METOPROLOL TARTRATE, AMLODIPINE, ATORVASTATIN, CARBAMAZEPINE, FAMOTIDINE (PEPCID [FAMOTIDINE]), PARACETAMOL (TYLENOL) and PREDNISONE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (Patient also experienced soreness at the injection site). On 17-Apr-2021, the patient experienced FACIAL PARALYSIS (Struck down with Bell's Palsy over the weekend and was treated) (seriousness criterion medically significant). On 19-Mar-2021, VACCINATION SITE PAIN (Patient also experienced soreness at the injection site) had resolved. On 18-Apr-2021, FACIAL PARALYSIS (Struck down with Bell's Palsy over the weekend and was treated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Valacyclovir and Eye drop were listed in concomitant medication for Bell's palsy. 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: Intentional self-injury
Clinical narrative: passed away from self inflicted injury; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INTENTIONAL SELF-INJURY (passed away from self inflicted injury) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-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 INTENTIONAL SELF-INJURY (passed away from self inflicted injury) (seriousness criterion death). The patient died on 18-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        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.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact; Sender's Comments: Patient died of an unknown cause from a self-inflicted injury nine days after receiving second dose of Moderna Vaccine. Very limited information regarding this event has been provided at this time.  Further information can not be requested.; Reported Cause(s) of Death: cause of death unknown
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Haematemesis, Headache, Malaise, Sluggishness
Clinical narrative: Stomach pain; Aslight headache before the first dose/headache was still bad; Threw up a significant amount approximately 4 ounce cup of bright red blood; Still not feeling well; Just sleeping; Not active; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (Threw up a significant amount approximately 4 ounce cup of bright red blood) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history 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 HAEMATEMESIS (Threw up a significant amount approximately 4 ounce cup of bright red blood) (seriousness criterion medically significant), MALAISE (Still not feeling well), SOMNOLENCE (Just sleeping), SLUGGISHNESS (Not active) and HEADACHE (Aslight headache before the first dose/headache was still bad). On 20-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain). On 04-Apr-2021, SOMNOLENCE (Just sleeping) and SLUGGISHNESS (Not active) had resolved. On 21-Apr-2021, ABDOMINAL PAIN UPPER (Stomach pain) had resolved. At the time of the report, HAEMATEMESIS (Threw up a significant amount approximately 4 ounce cup of bright red blood) and HEADACHE (Aslight headache before the first dose/headache was still bad) outcome was unknown and MALAISE (Still not feeling well) 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.   Treatment information included acetaminophen, aspirin and caffeine, Excedrin and adult Pedialyte.   On 02 Apr 2021, the patient woke up and threw up approximately 4 ounces of bright red blood. The patient's spouse called the emergency room (ER) who informed the spouse that was not uncommon, to have the patient come and recommended the patient drink adult Pedialyte and rest. The patient continued to feel unwell throughout the night. At 9:00 pm that evening, the patient was able to get up and eat.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Stomach pain; Aslight headache before the first dose/headache was still bad; Threw up a significant amount approximately 4 ounce cup of bright red blood; Still not feeling well; Just sleeping; Not active; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (Threw up a significant amount approximately 4 ounce cup of bright red blood) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history 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 HAEMATEMESIS (Threw up a significant amount approximately 4 ounce cup of bright red blood) (seriousness criterion medically significant), MALAISE (Still not feeling well), SOMNOLENCE (Just sleeping), SLUGGISHNESS (Not active) and HEADACHE (Aslight headache before the first dose/headache was still bad). On 20-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain). On 04-Apr-2021, SOMNOLENCE (Just sleeping) and SLUGGISHNESS (Not active) had resolved. On 21-Apr-2021, ABDOMINAL PAIN UPPER (Stomach pain) had resolved. At the time of the report, HAEMATEMESIS (Threw up a significant amount approximately 4 ounce cup of bright red blood) and HEADACHE (Aslight headache before the first dose/headache was still bad) outcome was unknown and MALAISE (Still not feeling well) 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.   Treatment information included acetaminophen, aspirin and caffeine, Excedrin and adult Pedialyte.   On 02 Apr 2021, the patient woke up and threw up approximately 4 ounces of bright red blood. The patient's spouse called the emergency room (ER) who informed the spouse that was not uncommon, to have the patient come and recommended the patient drink adult Pedialyte and rest. The patient continued to feel unwell throughout the night. At 9:00 pm that evening, the patient was able to get up and eat.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Blood Clot in the Lower Left Lung; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Blood Clot in the Lower Left Lung) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy bilateral on 20-Jan-2021 and Radiation therapy. Concurrent medical conditions included Breast cancer and Lung cancer (Has not been operated on as of yet).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PULMONARY EMBOLISM (Blood Clot in the Lower Left Lung) (seriousness criterion hospitalization). The patient was hospitalized on 10-Apr-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Blood Clot in the Lower Left Lung) outcome was unknown.            No concomitant medications reported.  The patient developed a blood clot in the lower left lung, and was hospitalized. The doctor told her that because of cancer, radiation and recent mastectomy surgery she was at risk of developing blood clots. Treatment medication included apixaban for six months. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company Comment: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. Patient's underlying cancer, radiation and recent mastectomy surgery were considered to be risk factors for developing blood clots.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. Patient's underlying cancer, radiation and recent mastectomy surgery were considered to be risk factors for developing blood clots.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Dyspnoea, Pulmonary embolism
Clinical narrative: Deep vein thrombosis; Pulmonary embolism; Shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 03-Jan-2021. Concomitant products included PARACETAMOL (TYLENOL), MAGNESIUM and VITAMIN B3 for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion hospitalization) and PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). The patient was hospitalized for 2 days due to DEEP VEIN THROMBOSIS and PULMONARY EMBOLISM. At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown and DYSPNOEA (Shortness of breath) had not resolved. Not Provided          The patient received Xarelto and IV blood thinner at hospital.  Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-083811 (Patient Link).; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Generalized rash, flares up; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH (Generalized rash, flares up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided).    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On an unknown date, the patient experienced RASH (Generalized rash, flares up) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to RASH. At the time of the report, RASH (Generalized rash, flares up) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was in hospital for 3 days. The patient had multiple consults and on 7 different medications.  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.   This case was linked to MOD21-079683, MOD21-079684, MOD21-079685 (Linked Report).; 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. MOD21-079683:2nd Patient case report MOD21-079684:3rd patient case report MOD21-079685:4th patient case report
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: Bilateral pulmonary embolism; DVT; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Bilateral pulmonary embolism) and DEEP VEIN THROMBOSIS (DVT) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Bilateral pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (DVT) (seriousness criterion hospitalization). At the time of the report, PULMONARY EMBOLISM (Bilateral pulmonary embolism) and DEEP VEIN THROMBOSIS (DVT) outcome was unknown.            The HCP got the vaccine several weeks after quarantine after that. After her second dose, she had a clotting issue which she had never had before. She experienced bilateral pulmonary embolism and DVT and was in the ICU twice.   Action taken with the mRNA 1273 in response to the events was not applicable as the patient completed both the doses.  Reporter did not provide the causality.  Treatment information was not 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.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Investigation, Vaccination site pruritus
Clinical narrative: had itching at the site of the injection/Injection site itching; This case has been upgraded to valid as there was new event has been reported after receiving the second dose of Product BNT162B2. Follow-up (16Feb2021): The initial case was missing the following minimum criteria: Upon receipt of follow-up information on 16Feb2021, this case now contains all required information to be considered valid.  This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported herself. A 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown Expiration date: unknown), second dose via an unspecified route of administration on 11Feb2021 as a single dose for COVID-19 immunisation. Patients' medical history included high blood pressure, cancer surgery in 1985. Patient concomitant medications were not reported. Patient stated that she guesses she received her first injection on 18Jan2021. It was reported that she was just aching with the first injection and she was alarmed when she started having itching with the second dose. Patient experienced itching at the site of the injection on 12Feb2021. The patient underwent unspecified lab test and procedures on 05Feb2021. The outcome of the event recovered in Feb2021.   Information on the lot/ batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Injection site haemorrhage, Malaise, Muscle spasms, Seizure
Clinical narrative: Patient received a second dose of Pfizer vaccine at 3 pm today 04/23/2021 at our store. After noticing some blood coming from the injection site patient became very worried and said she felt lightheaded. She was offered a chair to sit on but within 5 minutes of sitting down she said she was not feeling any better. While I was talking to her she seemed to have a mild seizure-like episode which lasted less than a minute. After she became alert she said her thumbs were cramping up and asked us to call 911 for her. Paramedics took her to the hospital.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: Patient received a second dose of Pfizer vaccine at 3 pm today 04/23/2021 at our store. After noticing some blood coming from the injection site patient became very worried and said she felt lightheaded. She was offered a chair to sit on but within 5 minutes of sitting down she said she was not feeling any better. While I was talking to her she seemed to have a mild seizure-like episode which lasted less than a minute. After she became alert she said her thumbs were cramping up and asked us to call 911 for her. Paramedics took her to the hospital.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Seizure a week after each shot
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Exposure during pregnancy, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: On day after vaccination, developed red area size of dime at injection site, continuously grew to two inch diameter circle, swollen and hot to touch, lasting over a week, extremely tender and painful wincing to touch, appears like a cellulitis. Injection technique unknown to this writer. As of this event report, area is still tender to touch and slight swelled but swelling markedly improved and redness nearly gone. Slight faded bruising noticeable. Patient is clearly more tired, unclear if attributable to pregnancy or vaccine or combination, has become more intolerant to cold, describes overall achiness. Never any fever over course.  Est date of pregnancy delivery Oct 6, 2021.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Pain, Temperature intolerance
Clinical narrative: On day after vaccination, developed red area size of dime at injection site, continuously grew to two inch diameter circle, swollen and hot to touch, lasting over a week, extremely tender and painful wincing to touch, appears like a cellulitis. Injection technique unknown to this writer. As of this event report, area is still tender to touch and slight swelled but swelling markedly improved and redness nearly gone. Slight faded bruising noticeable. Patient is clearly more tired, unclear if attributable to pregnancy or vaccine or combination, has become more intolerant to cold, describes overall achiness. Never any fever over course.  Est date of pregnancy delivery Oct 6, 2021.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Tongue blistering, Tongue movement disturbance
Clinical narrative: I had my first Moderna vaccine on February 13, and about 20 minutes later my tongue began to feel like novocaine wearing off. This lasted about two hours, and then I had no further reactions . My second shot was on March 13, and the same thing happened., tongue tingling, lasting 2 hours, then no further problems. On March 29 I woke up with lesions under my tongue, and a brief time of having difficulty moving my tongue. During the day my tongue felt strange and the lesions hurt. Since the 29th the lesions have disappeared, and each day my tongue improved.  Today, April 23, I would describe my tongue as feeling like I have burned it on something hot, uncomfortable but not painful.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Death, Dyspnoea, Headache, Hypertension
Clinical narrative: At first my mother had a headache. Then My mother was feeling weak and could not breathe.  She continued to suffer so went to the doctor to get a check up but continued to suffer and finally died on 2/8/21 due to a couple of reasons which include hypertension
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy red bumps
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Severe swelling, redness, hardness, itching around injection site, about 3 inches in diameter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: ?COVID arm? - red, swollen, itchy lesion appeared at the injection site 7 days post vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Tinnitus, Vertigo
Clinical narrative: Developed severe vertigo lasting over 1 month. Includes Tinnitus.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Haematochezia, Headache, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever, Diarrhea, headache, and blood in stool
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Unevaluable event
Clinical narrative: Patient did not report any adverse events. Received his second dose of MODERNA COVID vaccination to complete his series.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Body aches, fever, nausea
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: dizziness and weakness at morning and night multiples times every day
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood lactate dehydrogenase increased, Chills, Fatigue, Fibrin D dimer, Headache
Clinical narrative: Patient developed fatigue and headache within 24 hrs of receiving 1st vaccine, over the next several days she developed periorbital edema and cervical LAD.  6 days after vaccine she developed fever and chills and was febrile to 103.  She went to the ER and labs revealed pancytopenia.  She was admitted on the evening of 4/20 and was observed for 36 hrs.  Symptoms improved without antibiotics
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging head normal, Neutrophil count decreased, Pancytopenia, Periorbital oedema
Clinical narrative: Patient developed fatigue and headache within 24 hrs of receiving 1st vaccine, over the next several days she developed periorbital edema and cervical LAD.  6 days after vaccine she developed fever and chills and was febrile to 103.  She went to the ER and labs revealed pancytopenia.  She was admitted on the evening of 4/20 and was observed for 36 hrs.  Symptoms improved without antibiotics
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, Pyrexia, Viral test negative, White blood cell count decreased
Clinical narrative: Patient developed fatigue and headache within 24 hrs of receiving 1st vaccine, over the next several days she developed periorbital edema and cervical LAD.  6 days after vaccine she developed fever and chills and was febrile to 103.  She went to the ER and labs revealed pancytopenia.  She was admitted on the evening of 4/20 and was observed for 36 hrs.  Symptoms improved without antibiotics
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Heavy, irregular menstruation. Patient is also breastfeeding.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cardiac disorder, Chills, Headache, Negative thoughts
Clinical narrative: Chills, abdominal discomfort, headaches, heart abnormalities, odd thoughts
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen, itchy, pain at injection site
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Seizure, Tremor
Clinical narrative: Uncontrollable shaking/convulsions lasting about 45 minutes from onset at 6am accompanied by intense upper arm pain in injection arm. Low fever around 99 degrees Fahrenheit lasting most of the day. Arm pain diminished after a few hours and was a more mild throughout the remainder of the day into the next day. No treatment administered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy, Movement disorder, Musculoskeletal stiffness, Pharyngeal swelling
Clinical narrative: 4 days of a stiff  and immovable neck, sore lymph nodes in neck, base of skull & clavicle bone, swollen throat with difficulty swallowing, unable to sleep for 3 nights!
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: 4 days of a stiff  and immovable neck, sore lymph nodes in neck, base of skull & clavicle bone, swollen throat with difficulty swallowing, unable to sleep for 3 nights!
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Bone pain, Headache, Hypoaesthesia, Myalgia
Clinical narrative: Severe headache muscular skeletal pain and numbness in left arm
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain
Clinical narrative: Swollen cervical and axillary lymph nodes.  Pain. Extreme fatigue.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Red blood cell abnormality
Clinical narrative: Red rash and pain.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Blood test, Computerised tomogram, Muscle spasms
Clinical narrative: Lower right abdominal pain with cramping in right glut muscle.  I had my second Moderna vaccine Wednesday 21,April. The first time I experienced this abdominal pain was about 2 to 3 days after the 1st shot. Now, about the same time frame after the second, I have increased abdominal pain in the same area -my right lower abdomen.    Where it was more random, it is now constant.  I thought this was important to report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Thrombosis
Clinical narrative: I passed a number of large blood clots (the size of a walnut) from my body on the two days after I received the shot. The day that I got the shot coincided with the day that I got my period, so I was already menstruating when the clots passed from my body. The clots were much larger than normal, and much more frequent. I passed almost a half dozen large clots. By the third day, my menstruation flow started to subside (the first two days tend to be heavier days for me). I did not pass any large clots on the third day going forward.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Skin lesion
Clinical narrative: Night chills 12 hours after shot.  Red lesion one day after shot. Red lesion remains two days after shot.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Amnesia, Arthralgia, Behaviour disorder, Capillary fragility
Clinical narrative: I slept through several hours after receiving the vaccine. Later on that evening I began to feel nauseous and felt abdominal cramps. I had taken multiple paracetamol pills earlier in the night (Took 6 for the day maximum so could not take anymore). It was to relieve the muscle aches, cramps and joint pains. The pain was intense and I could not get back to sleep.   I took a quarter of a tablet of unisom to put me to sleep as the pain was agonizing. I was crying and whimpering and couldn't stay still. Suddenly I had to use the bathroom and throw up at once while my husband was asleep in the bedroom. I blacked out and do not remember the next 5 minutes. My husband came into the bathroom and said he saw me having a seizure. My eyes were open and dilated with jerking movements coming from my muscles. My husband put me on my side in recovery position as to avoid choking on my vomit and tongue. When I regained consciousness I did not know where I was or who I was for a moment, it was like temporary amnesia.   I vomited everywhere on the bathroom floor until the capillaries in my neck burst. I now have red petichiae all over my neck. The fall from the seizure caused me to severely bruise and damage my face. I cut my eyelid open and bashed my cheek, leaving a black eye and a laceration on the side of my face. I have been having severe exhaustion ever since and my motor skills are affected. I feel very clumsy and it is hard for me to write. All of my senses feel heightened and intensified.