chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: INJECTION SITE REACTION; FEVER; INJECTION SITE PAIN; INJECTION SITE SWELLING; HEADACHE; FATIGUE; MYALGIA; NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced injection site reaction. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced injection site pain. On 03-APR-2021, the subject experienced injection site swelling. On 03-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced myalgia. On 03-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site reaction, injection site pain, injection site swelling, headache, fatigue, myalgia, nausea and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, SARS-CoV-2 test, Vomiting
Clinical narrative: VOMITING; GOT SICK; DIARRHEA; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced got sick. On MAR-2021, the subject experienced diarrhea. On 13-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 23-MAR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and vomiting, and the outcome of got sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHINESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 18:01 for prophylactic vaccination on left arm. No concomitant medications were reported. On 04-APR-2021, the subject experienced itchiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itchiness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Hypoaesthesia, Influenza like illness, Muscle spasms, Neck pain
Clinical narrative: FLU-LIKE SYMPTOMS; MUSCLE SPASMS; ARM NUMBNESS; SHARP NECK PAIN; SHARP SPINE PAIN; EAR PRESSURE; FEVER; HIVES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and nut allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination to the Left Arm. No concomitant medications were reported. On an unspecified date, the subject experienced flu-like symptoms, muscle spasms, arm numbness, sharp neck pain, sharp spine pain, ear pressure, fever, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms, fever, muscle spasms, arm numbness, hives, sharp neck pain, sharp spine pain and ear pressure was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Spinal pain, Urticaria
Clinical narrative: FLU-LIKE SYMPTOMS; MUSCLE SPASMS; ARM NUMBNESS; SHARP NECK PAIN; SHARP SPINE PAIN; EAR PRESSURE; FEVER; HIVES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and nut allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination to the Left Arm. No concomitant medications were reported. On an unspecified date, the subject experienced flu-like symptoms, muscle spasms, arm numbness, sharp neck pain, sharp spine pain, ear pressure, fever, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms, fever, muscle spasms, arm numbness, hives, sharp neck pain, sharp spine pain and ear pressure was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pyrexia
Clinical narrative: FEVER; CHILLS; HEADACHE; NOT FEELING GOOD; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight, height, and medical history were not reported.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 09:30 for prophylactic vaccination on Left arm. No concomitant medications were reported. On an unspecified date, the subject experienced fever, chills, headache, and not feeling good. Treatment medications (dates unspecified) included: Acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, headache, and not feeling good. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disorientation, Ill-defined disorder, Limb discomfort, Myalgia
Clinical narrative: Having chills like she was convulsing; Arm felt unusable; Disoriented; Felt like she was hit by a bus; Extreme body aches; Temperature range of 102-104F that lasted around 24 hours; Chills like she was convulsing; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Having chills like she was convulsing) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No recorded medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Having chills like she was convulsing) (seriousness criterion medically significant), LIMB DISCOMFORT (Arm felt unusable), DISORIENTATION (Disoriented), ILL-DEFINED DISORDER (Felt like she was hit by a bus), MYALGIA (Extreme body aches), PYREXIA (Temperature range of 102-104F that lasted around 24 hours) and CHILLS (Chills like she was convulsing). At the time of the report, SEIZURE (Having chills like she was convulsing), LIMB DISCOMFORT (Arm felt unusable), DISORIENTATION (Disoriented), ILL-DEFINED DISORDER (Felt like she was hit by a bus), MYALGIA (Extreme body aches) and CHILLS (Chills like she was convulsing) was resolving and PYREXIA (Temperature range of 102-104F that lasted around 24 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included Ibuprofen and cold showers to relieve her symptoms.  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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Seizure
Clinical narrative: Having chills like she was convulsing; Arm felt unusable; Disoriented; Felt like she was hit by a bus; Extreme body aches; Temperature range of 102-104F that lasted around 24 hours; Chills like she was convulsing; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Having chills like she was convulsing) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No recorded medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Having chills like she was convulsing) (seriousness criterion medically significant), LIMB DISCOMFORT (Arm felt unusable), DISORIENTATION (Disoriented), ILL-DEFINED DISORDER (Felt like she was hit by a bus), MYALGIA (Extreme body aches), PYREXIA (Temperature range of 102-104F that lasted around 24 hours) and CHILLS (Chills like she was convulsing). At the time of the report, SEIZURE (Having chills like she was convulsing), LIMB DISCOMFORT (Arm felt unusable), DISORIENTATION (Disoriented), ILL-DEFINED DISORDER (Felt like she was hit by a bus), MYALGIA (Extreme body aches) and CHILLS (Chills like she was convulsing) was resolving and PYREXIA (Temperature range of 102-104F that lasted around 24 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included Ibuprofen and cold showers to relieve her symptoms.  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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19 5days afterward; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19 5days afterward) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19 5days afterward) (seriousness criterion hospitalization). The patient was hospitalized on 29-Dec-2020 due to SARS-COV-2 TEST POSITIVE. At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19 5days afterward) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, COVID-19: Positive.     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 for the event included Remdesivir; Sender's Comments: This case concerns a 48-year-old female hospitalized with a serious unexpected event of SARS-CoV-2 test positive. Event onset 6 days after first dose mRNA-1273. Treated with Remdesivir. 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Dizziness, Hypertensive crisis
Clinical narrative: High blood pressure 170s-200 approximately one week after receiving the vaccine; Dizziness; Difficulty speaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSIVE CRISIS (high blood pressure 170s-200 approximately one week after receiving the vaccine) 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.     The patient's past medical history included No adverse event (Medical history was not provided).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HYPERTENSIVE CRISIS (high blood pressure 170s-200 approximately one week after receiving the vaccine) (seriousness criteria hospitalization and medically significant), DIZZINESS (dizziness) and APHASIA (difficulty speaking). The patient was hospitalized from sometime in February 2021 to sometime in February 2021 due to HYPERTENSIVE CRISIS. At the time of the report, HYPERTENSIVE CRISIS (high blood pressure 170s-200 approximately one week after receiving the vaccine), DIZZINESS (dizziness) and APHASIA (difficulty speaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided  The patient's wife began experiencing dizziness, high blood pressure that ranged from 170s to 200, and difficulty speaking approximately one week after receiving the vaccine.  Treatment for the events, were not provided  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.  Further information has been requested.; 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.  Further information has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Hypothermia, Myalgia
Clinical narrative: Low temperature; Fatigue; Headache; Joint pain; nausea; Body aches; R arm of injection rash of 6-7 inches from high arm down to elbow; R arm of injection soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Low temperature) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic bronchitis since 2020 and Allergy. Concomitant products included MONTELUKAST, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), VITAMIN C [ASCORBIC ACID], OMEPRAZOLE, MULTIVITAMIN [VITAMINS NOS], ATORVASTATIN, ATORVASTATIN CALCIUM (LIPITOR), FISH OIL (OMEGA 3 [FISH OIL]), CALCIUM, COLECALCIFEROL (CALCIUM+VITAMIN D), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and POTASSIUM for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-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 HYPOTHERMIA (Low temperature) (seriousness criterion medically significant), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (nausea), MYALGIA (Body aches), VACCINATION SITE RASH (R arm of injection rash of 6-7 inches from high arm down to elbow) and VACCINATION SITE PAIN (R arm of injection soreness). At the time of the report, HYPOTHERMIA (Low temperature), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (nausea), MYALGIA (Body aches), VACCINATION SITE RASH (R arm of injection rash of 6-7 inches from high arm down to elbow) and VACCINATION SITE PAIN (R arm of injection soreness) outcome was unknown.            Concomitant medication includes joint pain medicine and eye medicine. The patient has allergies. The patient robbed cream on knees and muscle left heart to relief.  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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain, Vaccination site rash
Clinical narrative: Low temperature; Fatigue; Headache; Joint pain; nausea; Body aches; R arm of injection rash of 6-7 inches from high arm down to elbow; R arm of injection soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Low temperature) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic bronchitis since 2020 and Allergy. Concomitant products included MONTELUKAST, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), VITAMIN C [ASCORBIC ACID], OMEPRAZOLE, MULTIVITAMIN [VITAMINS NOS], ATORVASTATIN, ATORVASTATIN CALCIUM (LIPITOR), FISH OIL (OMEGA 3 [FISH OIL]), CALCIUM, COLECALCIFEROL (CALCIUM+VITAMIN D), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and POTASSIUM for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-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 HYPOTHERMIA (Low temperature) (seriousness criterion medically significant), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (nausea), MYALGIA (Body aches), VACCINATION SITE RASH (R arm of injection rash of 6-7 inches from high arm down to elbow) and VACCINATION SITE PAIN (R arm of injection soreness). At the time of the report, HYPOTHERMIA (Low temperature), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (nausea), MYALGIA (Body aches), VACCINATION SITE RASH (R arm of injection rash of 6-7 inches from high arm down to elbow) and VACCINATION SITE PAIN (R arm of injection soreness) outcome was unknown.            Concomitant medication includes joint pain medicine and eye medicine. The patient has allergies. The patient robbed cream on knees and muscle left heart to relief.  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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac flutter, Heart rate increased, Influenza like illness, Myocardial infarction
Clinical narrative: Heart beat of 200 bpm; Heart attack; Flu like symptoms; frequent urination; Dry heaves; Heart fluttering; Atrial Fibrillation; fever; Little flutter; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Heart beat of 200 bpm), MYOCARDIAL INFARCTION (Heart attack) and ATRIAL FIBRILLATION (Atrial Fibrillation) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac catheterisation (Found blockages which resulted in 2 stents.) on 17-Mar-2021.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PALPITATIONS (Little flutter). On an unknown date, the patient experienced HEART RATE INCREASED (Heart beat of 200 bpm) (seriousness criterion hospitalization), MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms), POLLAKIURIA (frequent urination), RETCHING (Dry heaves), CARDIAC FLUTTER (Heart fluttering), ATRIAL FIBRILLATION (Atrial Fibrillation) (seriousness criterion medically significant) and PYREXIA (fever). The patient was hospitalized on 16-Mar-2021 due to HEART RATE INCREASED. At the time of the report, HEART RATE INCREASED (Heart beat of 200 bpm), MYOCARDIAL INFARCTION (Heart attack), PALPITATIONS (Little flutter), INFLUENZA LIKE ILLNESS (Flu like symptoms), POLLAKIURIA (frequent urination), RETCHING (Dry heaves), CARDIAC FLUTTER (Heart fluttering), ATRIAL FIBRILLATION (Atrial Fibrillation) and PYREXIA (fever) outcome was unknown.            Patient went to the hospital in an ambulance.  Treatment information was not provided.   On 26 Mar 2021, the patient had to wear holter monitor for 1 month for observation of atrial fibrillation.   This case was linked to US-MODERNATX, INC.-MOD-2021-056770, US-MODERNATX, INC.-MOD-2021-056770 (E2B Linked Report).   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 US-MODERNATX, INC.-MOD-2021-056770:1st Dose Case US-MODERNATX, INC.-MOD-2021-056770:2nd dose case
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pollakiuria, Pyrexia, Retching
Clinical narrative: Heart beat of 200 bpm; Heart attack; Flu like symptoms; frequent urination; Dry heaves; Heart fluttering; Atrial Fibrillation; fever; Little flutter; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Heart beat of 200 bpm), MYOCARDIAL INFARCTION (Heart attack) and ATRIAL FIBRILLATION (Atrial Fibrillation) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac catheterisation (Found blockages which resulted in 2 stents.) on 17-Mar-2021.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PALPITATIONS (Little flutter). On an unknown date, the patient experienced HEART RATE INCREASED (Heart beat of 200 bpm) (seriousness criterion hospitalization), MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms), POLLAKIURIA (frequent urination), RETCHING (Dry heaves), CARDIAC FLUTTER (Heart fluttering), ATRIAL FIBRILLATION (Atrial Fibrillation) (seriousness criterion medically significant) and PYREXIA (fever). The patient was hospitalized on 16-Mar-2021 due to HEART RATE INCREASED. At the time of the report, HEART RATE INCREASED (Heart beat of 200 bpm), MYOCARDIAL INFARCTION (Heart attack), PALPITATIONS (Little flutter), INFLUENZA LIKE ILLNESS (Flu like symptoms), POLLAKIURIA (frequent urination), RETCHING (Dry heaves), CARDIAC FLUTTER (Heart fluttering), ATRIAL FIBRILLATION (Atrial Fibrillation) and PYREXIA (fever) outcome was unknown.            Patient went to the hospital in an ambulance.  Treatment information was not provided.   On 26 Mar 2021, the patient had to wear holter monitor for 1 month for observation of atrial fibrillation.   This case was linked to US-MODERNATX, INC.-MOD-2021-056770, US-MODERNATX, INC.-MOD-2021-056770 (E2B Linked Report).   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 US-MODERNATX, INC.-MOD-2021-056770:1st Dose Case US-MODERNATX, INC.-MOD-2021-056770:2nd dose case
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Inappropriate schedule of product administration, Pneumonia, Pyrexia
Clinical narrative: Unable to get second dose; physiologic arthritic flare; Physiologic arthritic flare; High Temperature; Small patches of pneumonia (pleuritis); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Small patches of pneumonia (pleuritis)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D1DM20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included PREDNISONE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PNEUMONIA (Small patches of pneumonia (pleuritis)) (seriousness criterion medically significant), ARTHRITIS (physiologic arthritic flare), ARTHRALGIA (Physiologic arthritic flare) and PYREXIA (High Temperature). On 10-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Unable to get second dose). On 10-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Unable to get second dose) had resolved. At the time of the report, PNEUMONIA (Small patches of pneumonia (pleuritis)), ARTHRITIS (physiologic arthritic flare), ARTHRALGIA (Physiologic arthritic flare) and PYREXIA (High Temperature) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by the reporter.  Based on the current available information and the Temporal association between the use of the product and start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the Temporal association between the use of the product and start date of the events a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Hypoxia, Illness
Clinical narrative: Pneumonia; Hypoxic; Tested positive for COVID; Became sick; A spontaneous report was received from a physician concerning a male patient of an unknown age patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced became sick/ illness, tested positive for COVID/ SARS-CoV-2 test positive, pneumonia and hypoxic.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 05 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 05 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly (injection site not provided) for prophylaxis of COVID-19 infection.   On an unspecified date, the patient became sick and he tested positive for COVID and experienced a medically significant events of pneumonia on x ray and hypoxic.   Treatment information was not 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.   The outcome of the events became sick, pneumonia, hypoxic and tested positive for COVID was not reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium decreased, Dizziness, Head injury, Headache, Loss of consciousness
Clinical narrative: Sodium levels dropped dangerously low; Passed out; Dizzy; Hit my head; Headachy; This spontaneous case was reported by a consumer and describes the occurrence of blood sodium decreased (Sodium levels dropped dangerously low) and loss of consciousness (Passed out) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 038A21A) 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 FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 15-Mar-2021, the patient experienced (Sodium levels dropped dangerously low (seriousness criterion hospitalization), Passed out (seriousness criterion medically significant), dizzy, Hit my head and Headache. The patient was hospitalized from 24-Mar-2021 to 26-Mar-2021 due to BLOOD SODIUM DECREASED. At the time of the report, BLOOD SODIUM DECREASED (Sodium levels dropped dangerously low) was resolving and LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Dizzy), HEAD INJURY (Hit my head) and HEADACHE (Headachy) outcome was unknown.      Treatment medication included intravenous sodium.. She was being monitored through blood samples and she was fine on 29 Mar 2021, she will have to do it one more time in a week.; Sender's Comments: Based on the current available information and temporal association between the use of the product and onset of the events of blood sodium decreased, loss of consciousness, dizziness, and headache, a causal relationship with the events cannot be excluded. Head injury was due to dizziness.  Headache is consistent with the product safety profile.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: right eye had blinding white aura for 15 minutes that seems like migraine lost vision; right eye had blinding white aura for 15 minutes that seems like migraine lost vision; felt like a flu; body ache; chills; headache; felt tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLINDNESS TRANSIENT (right eye had blinding white aura for 15 minutes that seems like migraine lost vision) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included ESZOPICLONE (LUNESTA) for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like a flu), PAIN (body ache), CHILLS (chills), HEADACHE (headache) and FATIGUE (felt tired). On 29-Mar-2021, the patient experienced BLINDNESS TRANSIENT (right eye had blinding white aura for 15 minutes that seems like migraine lost vision) (seriousness criterion medically significant) and MIGRAINE WITH AURA (right eye had blinding white aura for 15 minutes that seems like migraine lost vision). On 29-Mar-2021, BLINDNESS TRANSIENT (right eye had blinding white aura for 15 minutes that seems like migraine lost vision), MIGRAINE WITH AURA (right eye had blinding white aura for 15 minutes that seems like migraine lost vision), INFLUENZA LIKE ILLNESS (felt like a flu), PAIN (body ache), CHILLS (chills), HEADACHE (headache) and FATIGUE (felt tired) had resolved.            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.   This case was linked to US-MODERNATX, INC.-MOD-2021-061174 (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 these events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-061174:Dose 1
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine with aura, Pain
Clinical narrative: right eye had blinding white aura for 15 minutes that seems like migraine lost vision; right eye had blinding white aura for 15 minutes that seems like migraine lost vision; felt like a flu; body ache; chills; headache; felt tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLINDNESS TRANSIENT (right eye had blinding white aura for 15 minutes that seems like migraine lost vision) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included ESZOPICLONE (LUNESTA) for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like a flu), PAIN (body ache), CHILLS (chills), HEADACHE (headache) and FATIGUE (felt tired). On 29-Mar-2021, the patient experienced BLINDNESS TRANSIENT (right eye had blinding white aura for 15 minutes that seems like migraine lost vision) (seriousness criterion medically significant) and MIGRAINE WITH AURA (right eye had blinding white aura for 15 minutes that seems like migraine lost vision). On 29-Mar-2021, BLINDNESS TRANSIENT (right eye had blinding white aura for 15 minutes that seems like migraine lost vision), MIGRAINE WITH AURA (right eye had blinding white aura for 15 minutes that seems like migraine lost vision), INFLUENZA LIKE ILLNESS (felt like a flu), PAIN (body ache), CHILLS (chills), HEADACHE (headache) and FATIGUE (felt tired) had resolved.            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.   This case was linked to US-MODERNATX, INC.-MOD-2021-061174 (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 these events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-061174:Dose 1
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness neurosensory, Hypoacusis
Clinical narrative: Sensory hearing loss; hearing problem and could barely hear; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (hearing problem and could barely hear) and DEAFNESS NEUROSENSORY (Sensory hearing loss) in a 53-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.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced HYPOACUSIS (hearing problem and could barely hear) (seriousness criterion medically significant). On 27-Mar-2021, the patient experienced DEAFNESS NEUROSENSORY (Sensory hearing loss) (seriousness criterion medically significant). At the time of the report, HYPOACUSIS (hearing problem and could barely hear) and DEAFNESS NEUROSENSORY (Sensory hearing loss) outcome was unknown.            Treatment was provided with Prednisone and Valtrex  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Incomplete course of vaccination
Clinical narrative: Covid positive after 1st shot; If patient takes 2nd dose, interval will be more than 42 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Covid positive after 1st shot) in an 85-year-old male patient who received mRNA-1273 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 reported).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced COVID-19 (Covid positive after 1st shot) (seriousness criterion hospitalization). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (If patient takes 2nd dose, interval will be more than 42 days). At the time of the report, INCOMPLETE COURSE OF VACCINATION (If patient takes 2nd dose, interval will be more than 42 days) had resolved and COVID-19 (Covid positive after 1st shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       Concomitant medications not reported. Patient had COVID-19 one week after taking vaccine. Treatment medications not reported.; Sender's Comments: This report refers to a case of incomplete course of vaccination for mRNA-1273, lot # unknown  with associated AE COVID-19 positive result. 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: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Hypoaesthesia, Tinnitus
Clinical narrative: ringing in my right ear; experienced numbness in his right ear.; complete deafness in my right ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in my right ear), HYPOAESTHESIA (experienced numbness in his right ear.) and DEAFNESS UNILATERAL (complete deafness in my right ear) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced TINNITUS (ringing in my right ear) (seriousness criterion hospitalization), HYPOAESTHESIA (experienced numbness in his right ear.) (seriousness criterion hospitalization) and DEAFNESS UNILATERAL (complete deafness in my right ear) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 14-Mar-2021 to 15-Mar-2021 due to DEAFNESS UNILATERAL, HYPOAESTHESIA and TINNITUS. At the time of the report, TINNITUS (ringing in my right ear), HYPOAESTHESIA (experienced numbness in his right ear.) and DEAFNESS UNILATERAL (complete deafness in my right ear) outcome was unknown.            Patient mentioned Within 45 min after the injection, there was ringing in his right ear. 2 hrs after injection, he experienced numbness in his right ear. 3 hrs after injection, he experienced complete deafness in his right ear. 13Mar2021: He went to Urgent Care. 14Mar2011: He went to the Emergency Room. He stayed there under observation from 14Mar2021-15Mar2021. He saw neurologists, Internal medicine doctors, & a bunch of other doctors. No one could diagnose the problem.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: SARS-CoV-2 test positive; Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive) and COVID-19 (Covid-19) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No reported medical history).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive) (seriousness criteria hospitalization and life threatening) and COVID-19 (Covid-19) (seriousness criteria hospitalization and life threatening). The patient was hospitalized on 25-Mar-2021 due to SARS-COV-2 TEST POSITIVE. At the time of the report, SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive) was resolving and COVID-19 (Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was not reported/ unknown.  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of SARS-CoV-2 test positive and COVID-19 disease after vaccination, these events are assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of SARS-CoV-2 test positive and COVID-19 disease after vaccination, these events are assessed as unlikely related to mRNA-1273.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration, Respiratory arrest
Clinical narrative: Went down hill after receiving the 2nd shot and stopped breathing; Went down hill after receiving the 2nd shot and stopped breathing; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY ARREST (Went down hill after receiving the 2nd shot and stopped breathing) in a 92-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 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 22-Mar-2021, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Went down hill after receiving the 2nd shot and stopped breathing). On 24-Mar-2021, the patient experienced RESPIRATORY ARREST (Went down hill after receiving the 2nd shot and stopped breathing) (seriousness criteria death and medically significant).   On 24-Mar-2021, GENERAL PHYSICAL HEALTH DETERIORATION (Went down hill after receiving the 2nd shot and stopped breathing) outcome was unknown. The patient died on 24-Mar-2021. The reported cause of death was stopped breathing. It is unknown if an autopsy was performed.      Reporter wasn't sure if patient received Pfizer or Moderna vaccine.  The patient was in hospice care and reporter thought the patient received the vaccination from a local pharmacy.  Concomitant medications and treatment medications were not provided.; Reported Cause(s) of Death: Stopped breathing
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain in extremity, Syncope
Clinical narrative: Fainted twice; Soreness of right arm; Sweating; Feeling chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted twice) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 029A21A) 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.). Concomitant products included THYROID for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced SYNCOPE (Fainted twice) (seriousness criterion medically significant), PAIN IN EXTREMITY (Soreness of right arm), HYPERHIDROSIS (Sweating) and CHILLS (Feeling chills). At the time of the report, SYNCOPE (Fainted twice), PAIN IN EXTREMITY (Soreness of right arm), HYPERHIDROSIS (Sweating) and CHILLS (Feeling chills) outcome was unknown.            Treatment for the event included acetaminophen.  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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's palsy) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's palsy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was unknown by the reporter Treatment medication include steroids  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.