chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea, SARS-CoV-2 test
Clinical narrative: COVID Diagnoses After Vaccination; Nasal congestion; Cough; Diarrhea; Loss of taste; Chills; Nausea; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID Diagnoses After Vaccination) in a 78-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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced COVID-19 (COVID Diagnoses After Vaccination) (seriousness criterion hospitalization). On an unknown date, the patient experienced NASAL CONGESTION (Nasal congestion), COUGH (Cough), DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, COVID-19 (COVID Diagnoses After Vaccination), NASAL CONGESTION (Nasal congestion), COUGH (Cough), DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: positive (Positive) Source of sample- Nasopharyngeal.     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.   Relevant concomitant medications were not reported.  Treatment information included Monoclonal antibody therapy as bamlanivimab infusion for the virus start on 19 Jan 2021.  Company Comment: This case concerns a 78-year-old female with a serious unexpected event of COVID-19, and nonserious unexpected nasal congestion, cough, diarrhea, ageusia, and nonserious expected chills, nausea. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. 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.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up information included adverse events (chills, cough, nausea, diarrhea, nasal congestion and loss of taste), hospitalization confirmation, laboratory exam performed date and treatment information as bamlanivimab infusion.; Sender's Comments: This case concerns a 78-year-old female with a serious unexpected event of COVID-19, and nonserious unexpected nasal congestion, cough, diarrhea, ageusia, and nonserious expected chills, nausea. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. 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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Epistaxis, Hypertension, Product dose omission issue
Clinical narrative: Nose bleeding; Second dose missed; Bad dizziness; High blood pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Nose bleeding), DIZZINESS (Bad dizziness) and HYPERTENSION (High blood pressure) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 AMLODIPINE, CLONIDINE and ATENOLOL for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced HYPERTENSION (High blood pressure) (seriousness criterion medically significant). On 24-Jan-2021, the patient experienced DIZZINESS (Bad dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced EPISTAXIS (Nose bleeding) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Second dose missed). At the time of the report, EPISTAXIS (Nose bleeding) and DIZZINESS (Bad dizziness) had resolved and HYPERTENSION (High blood pressure) and PRODUCT DOSE OMISSION ISSUE (Second dose missed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Blood pressure measurement: 180x105 (High) High Blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was evaluated at two different Emergency Departments on four separate occasions. Laboratory examination included CT scans, X-ray and other test with results were not provided. Treatment included antibiotics. High Blood pressure that started approximately two days after the vaccine and lasted for a month or two. Bad dizziness that started approximately two days after the vaccine and lasted for a month or two.  Bloody noses that lasted for the past several months, usually occurring in the morning but also occasionally happening in the evenings.  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, noting the patient's con meds as confounders.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow-up report included reporter's information, reported events medical care, Duration and onset of the events.; 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, noting the patient's con meds as confounders.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Headache, Influenza like illness, Lymphadenopathy
Clinical narrative: swelling in his left leg and has been hospitalized; Diarrhea; no appetite; swollen groin; swollen neck glands; bad headache; left arm was sore at injection site / sore arm; sore neck; flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NECK PAIN (sore neck) and VACCINATION SITE PAIN (left arm was sore at injection site / sore arm). On 12-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized) (seriousness criterion hospitalization). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (no appetite), SWELLING (swollen groin), LYMPHADENOPATHY (swollen neck glands) and HEADACHE (bad headache). At the time of the report, PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized), INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (Diarrhea), DECREASED APPETITE (no appetite), NECK PAIN (sore neck), SWELLING (swollen groin), LYMPHADENOPATHY (swollen neck glands), VACCINATION SITE PAIN (left arm was sore at injection site / sore arm) and HEADACHE (bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs 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.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: An additional information received on 27 Apr 2021 included information where seriousness criteria updated to serious, added serious event and onset dates; 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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Peripheral swelling, Swelling, Vaccination site pain
Clinical narrative: swelling in his left leg and has been hospitalized; Diarrhea; no appetite; swollen groin; swollen neck glands; bad headache; left arm was sore at injection site / sore arm; sore neck; flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NECK PAIN (sore neck) and VACCINATION SITE PAIN (left arm was sore at injection site / sore arm). On 12-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized) (seriousness criterion hospitalization). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (no appetite), SWELLING (swollen groin), LYMPHADENOPATHY (swollen neck glands) and HEADACHE (bad headache). At the time of the report, PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized), INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (Diarrhea), DECREASED APPETITE (no appetite), NECK PAIN (sore neck), SWELLING (swollen groin), LYMPHADENOPATHY (swollen neck glands), VACCINATION SITE PAIN (left arm was sore at injection site / sore arm) and HEADACHE (bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs 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.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: An additional information received on 27 Apr 2021 included information where seriousness criteria updated to serious, added serious event and onset dates; 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: clot in her lungs; This spontaneous case was reported by a non-health professional and describes the occurrence of PULMONARY EMBOLISM (clot in her lungs) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PULMONARY EMBOLISM (clot in her lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (clot in her lungs) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event of pulmonary embolism, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-075030 (E2B Linked Report).; 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 of pulmonary embolism, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-075030:Patient's brother in law case; cross linked case
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID-19 after the first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after the first dose of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after the first dose of vaccine) (seriousness criterion medically significant). At the time of the report, COVID-19 (Tested positive for COVID-19 after the first dose of vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, SARS-CoV-2 test: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event "COVID19 +" , a causal relationship is unlikely related; 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 "COVID19 +" , a causal relationship is unlikely related
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypotension, Intraventricular haemorrhage
Clinical narrative: Left lower ventricular bleed; Low blood pressure; Severe headache; This spontaneous case was reported by a nurse and describes the occurrence of INTRAVENTRICULAR HAEMORRHAGE (Left lower ventricular bleed), HYPOTENSION (Low blood pressure) and HEADACHE (Severe headache) 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 Hypothyroidism.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced INTRAVENTRICULAR HAEMORRHAGE (Left lower ventricular bleed) (seriousness criteria hospitalization and medically significant), HYPOTENSION (Low blood pressure) (seriousness criterion hospitalization) and HEADACHE (Severe headache) (seriousness criterion hospitalization). The patient was hospitalized on sometime in April 2021 due to HEADACHE, HYPOTENSION and INTRAVENTRICULAR HAEMORRHAGE. At the time of the report, INTRAVENTRICULAR HAEMORRHAGE (Left lower ventricular bleed), HYPOTENSION (Low blood pressure) and HEADACHE (Severe headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded   This case was linked to 1st 3rd and 4th patient reports. Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded 1st patient case report 3rd patient case report 4th patient case report
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Erythema, Fatigue, Hypertension
Clinical narrative: Hard time swallowing,swallowing issues is ongoing; blood pressure getting higher and higher; panting for air; heart racing; Thirsty; easily out of breath; rednes to right arm (opposite arm form vaccination); rash to right arm (opposite arm from vaccination); extremely tired (taking 3 hour naps per day); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPHAGIA (Hard time swallowing,swallowing issues is ongoing), HYPERTENSION (blood pressure getting higher and higher), RESPIRATORY RATE INCREASED (panting for air) and PALPITATIONS (heart racing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), MULTIVITAMIN [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DYSPHAGIA (Hard time swallowing,swallowing issues is ongoing) (seriousness criteria medically significant and life threatening). 29-Mar-2021, the patient experienced HYPERTENSION (blood pressure getting higher and higher) (seriousness criteria medically significant and life threatening), RESPIRATORY RATE INCREASED (panting for air) (seriousness criteria medically significant and life threatening), PALPITATIONS (heart racing) (seriousness criterion medically significant), THIRST (Thirsty), DYSPNOEA (easily out of breath), ERYTHEMA (rednes to right arm (opposite arm form vaccination)), RASH (rash to right arm (opposite arm from vaccination)) and FATIGUE (extremely tired (taking 3 hour naps per day)). On 29-Mar-2021, DYSPHAGIA (Hard time swallowing,swallowing issues is ongoing), HYPERTENSION (blood pressure getting higher and higher), RESPIRATORY RATE INCREASED (panting for air), PALPITATIONS (heart racing), THIRST (Thirsty) and ERYTHEMA (rednes to right arm (opposite arm form vaccination)) had resolved. On 01-Apr-2021, RASH (rash to right arm (opposite arm from vaccination)) had resolved. At the time of the report, DYSPNOEA (easily out of breath) and FATIGUE (extremely tired (taking 3 hour naps per day)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: The patient received epinephrine (Epi pen) on 29/Mar/2021.; Sender's Comments: This case concerns a 46-year-old female with serious unexpected events of dysphagia, hypertension, respiratory rate increased, palpitations, and nonserious unexpected dyspnea, thirst and expected rash, fatigue. Event onset 2 minutes after first dose mRNA-1273. Events resolved, but outcomes for dyspnea and fatigue unknown. 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Rash, Respiratory rate increased, Thirst
Clinical narrative: Hard time swallowing,swallowing issues is ongoing; blood pressure getting higher and higher; panting for air; heart racing; Thirsty; easily out of breath; rednes to right arm (opposite arm form vaccination); rash to right arm (opposite arm from vaccination); extremely tired (taking 3 hour naps per day); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPHAGIA (Hard time swallowing,swallowing issues is ongoing), HYPERTENSION (blood pressure getting higher and higher), RESPIRATORY RATE INCREASED (panting for air) and PALPITATIONS (heart racing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), MULTIVITAMIN [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DYSPHAGIA (Hard time swallowing,swallowing issues is ongoing) (seriousness criteria medically significant and life threatening). 29-Mar-2021, the patient experienced HYPERTENSION (blood pressure getting higher and higher) (seriousness criteria medically significant and life threatening), RESPIRATORY RATE INCREASED (panting for air) (seriousness criteria medically significant and life threatening), PALPITATIONS (heart racing) (seriousness criterion medically significant), THIRST (Thirsty), DYSPNOEA (easily out of breath), ERYTHEMA (rednes to right arm (opposite arm form vaccination)), RASH (rash to right arm (opposite arm from vaccination)) and FATIGUE (extremely tired (taking 3 hour naps per day)). On 29-Mar-2021, DYSPHAGIA (Hard time swallowing,swallowing issues is ongoing), HYPERTENSION (blood pressure getting higher and higher), RESPIRATORY RATE INCREASED (panting for air), PALPITATIONS (heart racing), THIRST (Thirsty) and ERYTHEMA (rednes to right arm (opposite arm form vaccination)) had resolved. On 01-Apr-2021, RASH (rash to right arm (opposite arm from vaccination)) had resolved. At the time of the report, DYSPNOEA (easily out of breath) and FATIGUE (extremely tired (taking 3 hour naps per day)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: The patient received epinephrine (Epi pen) on 29/Mar/2021.; Sender's Comments: This case concerns a 46-year-old female with serious unexpected events of dysphagia, hypertension, respiratory rate increased, palpitations, and nonserious unexpected dyspnea, thirst and expected rash, fatigue. Event onset 2 minutes after first dose mRNA-1273. Events resolved, but outcomes for dyspnea and fatigue unknown. 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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Ascites, COVID-19, Decreased appetite, Nausea, SARS-CoV-2 test
Clinical narrative: Fluid on stomach; Loss of appetite; Nausea; Vomiting; Test positive with COVID19 virus; This spontaneous case was reported by a consumer and describes the occurrence of ASCITES (Fluid on stomach) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Cardiac disorder NOS.  On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced COVID-19 (Test positive with COVID19 virus). On an unknown date, the patient experienced ASCITES (Fluid on stomach) (seriousness criterion medically significant), DECREASED APPETITE (Loss of appetite), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, ASCITES (Fluid on stomach), COVID-19 (Test positive with COVID19 virus), DECREASED APPETITE (Loss of appetite), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fluid on stomach; Loss of appetite; Nausea; Vomiting; Test positive with COVID19 virus; This spontaneous case was reported by a consumer and describes the occurrence of ASCITES (Fluid on stomach) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Cardiac disorder NOS.  On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced COVID-19 (Test positive with COVID19 virus). On an unknown date, the patient experienced ASCITES (Fluid on stomach) (seriousness criterion medically significant), DECREASED APPETITE (Loss of appetite), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, ASCITES (Fluid on stomach), COVID-19 (Test positive with COVID19 virus), DECREASED APPETITE (Loss of appetite), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: her arm, hand and face to go numb; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (her arm, hand and face to go numb) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) inhalation gas for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included BOSENTAN (TRACLEER [BOSENTAN]) and TADALAFIL (ADCIRCA) for an unknown indication.   On 29-Jun-2018, the patient started TREPROSTINIL SODIUM (TYVASO) (unknown route) .6 mg/dl every six hours. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced HYPOAESTHESIA (her arm, hand and face to go numb) (seriousness criterion hospitalization). At the time of the report, HYPOAESTHESIA (her arm, hand and face to go numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information of the events are not reported. Reporter assessed the events are not related to IH Treprostinil and TD-300/A device but most likely related to  post vaccination with COVID vaccine.  Company comment:Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Arthralgia, Fatigue, Hyperglycaemia, Pyrexia
Clinical narrative: soreness; sinus headache; hyperglycemia; fever; Angioedema; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes since 01-Jun-2016, Hypertension, GERD since 2001 and Cholesterol since 2018. Concomitant products included PANTOPRAZOLE for GERD, HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN & HCTZ) for Hypertension, EMPAGLIFLOZIN (JARDIANCE) for Product used for unknown indication, ATORVASTATIN CALCIUM (ATORVASTIN), LYSINE, VITAMIN D3 and MELATONIN for an unknown indication, ZINC.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), FATIGUE (fatigue), ARTHRALGIA (soreness), PYREXIA (fever), SINUS HEADACHE (sinus headache) and HYPERGLYCAEMIA (hyperglycemia). At the time of the report, ANGIOEDEMA (Angioedema), FATIGUE (fatigue), ARTHRALGIA (soreness), PYREXIA (fever), SINUS HEADACHE (sinus headache) and HYPERGLYCAEMIA (hyperglycemia) had resolved.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: soreness; sinus headache; hyperglycemia; fever; Angioedema; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes since 01-Jun-2016, Hypertension, GERD since 2001 and Cholesterol since 2018. Concomitant products included PANTOPRAZOLE for GERD, HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN & HCTZ) for Hypertension, EMPAGLIFLOZIN (JARDIANCE) for Product used for unknown indication, ATORVASTATIN CALCIUM (ATORVASTIN), LYSINE, VITAMIN D3 and MELATONIN for an unknown indication, ZINC.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), FATIGUE (fatigue), ARTHRALGIA (soreness), PYREXIA (fever), SINUS HEADACHE (sinus headache) and HYPERGLYCAEMIA (hyperglycemia). At the time of the report, ANGIOEDEMA (Angioedema), FATIGUE (fatigue), ARTHRALGIA (soreness), PYREXIA (fever), SINUS HEADACHE (sinus headache) and HYPERGLYCAEMIA (hyperglycemia) had resolved.            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: Unevaluable event
Clinical narrative: Unevaluable event (her brother is dying because of the Moderna vaccine); This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event (her brother is dying because of the Moderna vaccine)) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (Unevaluable event (her brother is dying because of the Moderna vaccine)) (seriousness criteria hospitalization and life threatening). At the time of the report, UNEVALUABLE EVENT (Unevaluable event (her brother is dying because of the Moderna vaccine)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was dying because of the company vaccine. Patient was admitted to a hospital.  No relevant concomitant medication information was provided. No relevant treatment medication information was provided.  Very limited information regarding this event 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 has been provided at this time.  Further information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Retinal tear
Clinical narrative: retinal tear; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL TEAR (retinal tear) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.  On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced RETINAL TEAR (retinal tear) (seriousness criterion medically significant). At the time of the report, RETINAL TEAR (retinal tear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were reported. No treatment information for the events was reported.  The patient noticed floaters in her left eye, 2 to 3 weeks after first dose of vaccine. The patient contacted her Ophthalmologist and was informed that she was having retinal tear.  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
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Tooth injury
Clinical narrative: fainting; hitting the floor; "knocking out" both of her front teeth when she fainted and hit the floor; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainting) in a 69-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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced SYNCOPE (fainting) (seriousness criterion medically significant), FALL (hitting the floor) and TOOTH INJURY ("knocking out" both of her front teeth when she fainted and hit the floor). On 12-Feb-2021, SYNCOPE (fainting) and FALL (hitting the floor) had resolved. At the time of the report, TOOTH INJURY ("knocking out" both of her front teeth when she fainted and hit the floor) was resolving. Unknown          She had a visit to Family Practice Physician, visit to Dentist and need for dental work.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, fainting and falling down, a causal relationship cannot be excluded. The event of tooth injury is  unlikely related to mRNA-1273 since this was directly related to the event, falling down.; 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, fainting and falling down, a causal relationship cannot be excluded. The event of tooth injury is  unlikely related to mRNA-1273 since this was directly related to the event, falling down.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Irritability, Thinking abnormal
Clinical narrative: Acting really weird; Irritable; Wasn't thinking clearly; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ABNORMAL BEHAVIOUR (Acting really weird), IRRITABILITY (Irritable) and THINKING ABNORMAL (Wasn't thinking clearly) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABNORMAL BEHAVIOUR (Acting really weird) (seriousness criterion hospitalization), IRRITABILITY (Irritable) (seriousness criterion hospitalization) and THINKING ABNORMAL (Wasn't thinking clearly) (seriousness criterion hospitalization). At the time of the report, ABNORMAL BEHAVIOUR (Acting really weird), IRRITABILITY (Irritable) and THINKING ABNORMAL (Wasn't thinking clearly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 25 Mar 2021, approximately 3 hours post vaccination, the reporter stated the patient lost his mind. The patient barrowed $6,000 for a motorcycle. Road the motorcycle into a snow storm. Went to jail for riding the motorcycle 130 miles per house. Has been scattered brain, incoherent. Tore up the vaccination card, threw hearing aids away, along with credit cards and cell phones. The reporter stated, the patient has been hospitalized in 3 psychiatric hospitals and at the time of this report, was hospitalized in one.   On 21 Apr 2021, the patient was normal for approximately 20 hours but resumed acting weird. The patient experiences brain fog in which he can't talk, had no refluxes, can't move but is able to hear.   Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to (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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Discomfort, Eustachian tube dysfunction, Inner ear inflammation, Tinnitus
Clinical narrative: Lost little bit of hearing; Tinnitus in both his ears; Inflammation in his inner ear; eustachian tubes draining; Discomfort; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Lost little bit of hearing) in a 38-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 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 06-Apr-2021, the patient experienced DEAFNESS (Lost little bit of hearing) (seriousness criterion medically significant), TINNITUS (Tinnitus in both his ears), INNER EAR INFLAMMATION (Inflammation in his inner ear), EUSTACHIAN TUBE DYSFUNCTION (eustachian tubes draining) and DISCOMFORT (Discomfort). At the time of the report, DEAFNESS (Lost little bit of hearing), TINNITUS (Tinnitus in both his ears), INNER EAR INFLAMMATION (Inflammation in his inner ear), EUSTACHIAN TUBE DYSFUNCTION (eustachian tubes draining) and DISCOMFORT (Discomfort) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information regarding these events has been provided at this time. Further information has been provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information regarding these events has been provided at this time. Further information has been provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Drug reaction with eosinophilia and systemic symptoms, Erythema, Rash
Clinical narrative: They are suspecting Dress Syndrome; erythema all over his body; broke out into a rash, started as a bulls eye rash in the arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (They are suspecting Dress Syndrome) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Parkinson's disease, Drug allergy (penicillin) and Drug allergy (ampicillin). Concomitant products included CEFALEXIN, CARBIDOPA, SILDENAFIL (VIAGRA [SILDENAFIL]) and DILTIAZEM for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (They are suspecting Dress Syndrome) (seriousness criterion medically significant), ERYTHEMA (erythema all over his body) and RASH (broke out into a rash, started as a bulls eye rash in the arm). At the time of the report, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (They are suspecting Dress Syndrome), ERYTHEMA (erythema all over his body) and RASH (broke out into a rash, started as a bulls eye rash in the arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter mentioned patient is a mostly healthy, active farmer.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Delirium, Impaired ability to use machinery, Influenza like illness, Pyrexia
Clinical narrative: Delirious; Severe flu like symptoms; Unable to use the cell phone; Joint pains; Temperature of 101.2 F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirious) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression, Chronic pain, Hypertension and Hyperlipidemia. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and GABAPENTIN for Chronic pain, FLUOXETINE HYDROCHLORIDE (PROZAC) for Depression, ATORVASTATIN for Hyperlipidemia, LOSARTAN for Hypertension.    On 13-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 DELIRIUM (Delirious) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Severe flu like symptoms), IMPAIRED ABILITY TO USE MACHINERY (Unable to use the cell phone), ARTHRALGIA (Joint pains) and PYREXIA (Temperature of 101.2 F). On 16-Apr-2021, IMPAIRED ABILITY TO USE MACHINERY (Unable to use the cell phone) and PYREXIA (Temperature of 101.2 F) had resolved. On 17-Apr-2021, DELIRIUM (Delirious), INFLUENZA LIKE ILLNESS (Severe flu like symptoms) and ARTHRALGIA (Joint pains) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Pyrexia: 101.2 degree f (High) 101.2 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included ibuprofen for joint pains.  Based on the current available information and temporal association between the use of the product and the start date of the event,s 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,s a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Pulmonary embolism, Thrombosis
Clinical narrative: blood clots in both legs; heart attack/blood clot in heart; Blood clots in lungs/shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots in both legs), MYOCARDIAL INFARCTION (heart attack/blood clot in heart) and PULMONARY EMBOLISM (Blood clots in lungs/shortness of breath) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 8077727310 and 012LZ0A) for COVID-19 vaccination.     No Medical History information was reported.   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 09-Apr-2021, the patient experienced THROMBOSIS (blood clots in both legs) (seriousness criteria hospitalization prolonged and life threatening), MYOCARDIAL INFARCTION (heart attack/blood clot in heart) (seriousness criteria hospitalization prolonged and life threatening) and PULMONARY EMBOLISM (Blood clots in lungs/shortness of breath) (seriousness criteria hospitalization prolonged and life threatening). The patient was hospitalized on 09-Apr-2021 due to MYOCARDIAL INFARCTION, PULMONARY EMBOLISM and THROMBOSIS. At the time of the report, THROMBOSIS (blood clots in both legs), MYOCARDIAL INFARCTION (heart attack/blood clot in heart) and PULMONARY EMBOLISM (Blood clots in lungs/shortness of breath) outcome was unknown.            No concomitant medications were reported.  Treatment of the events included Xarelto and unspecified IV medications.  Action taken with mRNA-1273 in response to the events was not applicable.   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.