chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Malignant hypertension, Palpitations
Clinical narrative: Blood pressure through the roof 185/125; heart racing; Pulse rate increased; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALIGNANT HYPERTENSION (Blood pressure through the roof 185/125) and PALPITATIONS (heart racing) in a 70-year-old female 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.     Concurrent medical conditions included Breast cancer, Palpitations (Heart palpitations), Blood pressure high and High cholesterol. Concomitant products included LOSARTAN for Blood pressure management, TAMOXIFEN for Breast cancer, PRAVASTATIN for Cholesterol, METOPROLOL for Palpitations, LEVOTHYROXINE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced MALIGNANT HYPERTENSION (Blood pressure through the roof 185/125) (seriousness criteria hospitalization and medically significant), PALPITATIONS (heart racing) (seriousness criterion hospitalization) and HEART RATE INCREASED (Pulse rate increased). The patient was hospitalized on 14-Jan-2021 due to MALIGNANT HYPERTENSION and PALPITATIONS. On 14-Jan-2021, MALIGNANT HYPERTENSION (Blood pressure through the roof 185/125), PALPITATIONS (heart racing) and HEART RATE INCREASED (Pulse rate increased) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Blood pressure measurement: 185/125 (High) Blood pressure through the roof 185/125. On 14-Jan-2021, Heart rate: 150 (High) Pulse 150.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The Patient reported that about 3 minutes post receiving her first dose of vaccine her heart was racing and blood pressure was through the roof (185/125). The patient also had an elevated pulse rate of 150. The patient reported that the symptoms subsided after 15 to 20 minutes and was feeling better however the patient was still taken to the Emergency Room.. The Centers for Disease Control suggested to the patient that she not receive her second dose of the vaccine.   No treatment was provided to the patient in the emergency room. The patient had an Electrocardiogram  (EKG) test completed but no results were provided.  Company comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's past medical history may remain a contributing factors for this event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's past medical history may remain a contributing factors for this event.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Peripheral swelling
Clinical narrative: Right arm is bigger than left arm.; After 1st vaccine my right arm was little bigger than left arm but after 2nd vaccine it got worst; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Right arm is bigger than left arm.) and CONDITION AGGRAVATED (After 1st vaccine my right arm was little bigger than left arm but after 2nd vaccine it got worst) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included FLUDROCORTISONE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Right arm is bigger than left arm.) (seriousness criterion hospitalization) and CONDITION AGGRAVATED (After 1st vaccine my right arm was little bigger than left arm but after 2nd vaccine it got worst) (seriousness criterion hospitalization). The patient was hospitalized on 17-Apr-2021 due to CONDITION AGGRAVATED and PERIPHERAL SWELLING. At the time of the report, PERIPHERAL SWELLING (Right arm is bigger than left arm.) and CONDITION AGGRAVATED (After 1st vaccine my right arm was little bigger than left arm but after 2nd vaccine it got worst) outcome was unknown.            The patient also reported taking an unspecified birth control pill concomitantly. The patient reported going to the ER on 17-Apr-2021 due to possible blood clot in right arm. The doctor did not find any blood clot, and the patient was not prescribed anything.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.  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-2021-148205 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: No new information provided.; 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-2021-148205:First Dose Case
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein, Fatigue, Glomerulonephritis membranous, Hypokinesia
Clinical narrative: Triggered his autoimmune response; Pain kept him from sleep for 3 nights; He was frozen (could not roll in bed) this weekend; So much pain; Fatigue; Arm hurts really bad for 3 days; Diagnosed him with joint inflammation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GLOMERULONEPHRITIS MEMBRANOUS (Triggered his autoimmune response) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Membranous nephropathy (glomerular membranous nephropathy).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced ARTHRALGIA (Diagnosed him with joint inflammation). On an unknown date, the patient experienced GLOMERULONEPHRITIS MEMBRANOUS (Triggered his autoimmune response) (seriousness criteria hospitalization, disability and medically significant), INSOMNIA (Pain kept him from sleep for 3 nights), HYPOKINESIA (He was frozen (could not roll in bed) this weekend), PAIN (So much pain), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Arm hurts really bad for 3 days). At the time of the report, GLOMERULONEPHRITIS MEMBRANOUS (Triggered his autoimmune response), INSOMNIA (Pain kept him from sleep for 3 nights), HYPOKINESIA (He was frozen (could not roll in bed) this weekend), PAIN (So much pain), FATIGUE (Fatigue), PAIN IN EXTREMITY (Arm hurts really bad for 3 days) and ARTHRALGIA (Diagnosed him with joint inflammation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, C-reactive protein: high (High) Very High.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment - Based on current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: Triggered his autoimmune response; Pain kept him from sleep for 3 nights; He was frozen (could not roll in bed) this weekend; So much pain; Fatigue; Arm hurts really bad for 3 days; Diagnosed him with joint inflammation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GLOMERULONEPHRITIS MEMBRANOUS (Triggered his autoimmune response) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Membranous nephropathy (glomerular membranous nephropathy).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced ARTHRALGIA (Diagnosed him with joint inflammation). On an unknown date, the patient experienced GLOMERULONEPHRITIS MEMBRANOUS (Triggered his autoimmune response) (seriousness criteria hospitalization, disability and medically significant), INSOMNIA (Pain kept him from sleep for 3 nights), HYPOKINESIA (He was frozen (could not roll in bed) this weekend), PAIN (So much pain), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Arm hurts really bad for 3 days). At the time of the report, GLOMERULONEPHRITIS MEMBRANOUS (Triggered his autoimmune response), INSOMNIA (Pain kept him from sleep for 3 nights), HYPOKINESIA (He was frozen (could not roll in bed) this weekend), PAIN (So much pain), FATIGUE (Fatigue), PAIN IN EXTREMITY (Arm hurts really bad for 3 days) and ARTHRALGIA (Diagnosed him with joint inflammation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, C-reactive protein: high (High) Very High.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment - Based on current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Femur fracture, Product dose omission issue
Clinical narrative: 2nd dose appointment for 21Mar2021 but could not attend; Fractured his femur; Fell down; This spontaneous case was reported by a consumer and describes the occurrence of FEMUR FRACTURE (Fractured his femur) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced FEMUR FRACTURE (Fractured his femur) (seriousness criterion medically significant) and FALL (Fell down). On 21-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose appointment for 21Mar2021 but could not attend). At the time of the report, FEMUR FRACTURE (Fractured his femur), FALL (Fell down) and PRODUCT DOSE OMISSION ISSUE (2nd dose appointment for 21Mar2021 but could not attend) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking an unspecified blood pressure medication concomitantly.   Patient needed surgery for the fracture. No other treatment information was provided.  Company Comment - This report refers to a case of Product dose omission issue for mRNA-1273, lot #unknown with no associated AEs.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot #unknown with no associated AEs.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Brain stem stroke, COVID-19, Dysphagia, Nodule
Clinical narrative: Acute brain stem stroke; Lost vision in both eyes; Lumps on biceps of both arms; Couldn't swallow; Covid-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN STEM STROKE (Acute brain stem stroke) and BLINDNESS (Lost vision in both eyes) in a 66-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.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and LOSARTAN for Blood pressure management, ATORVASTATIN for Cholesterol, POTASSIUM for Hypokalemia.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced BRAIN STEM STROKE (Acute brain stem stroke) (seriousness criteria hospitalization and medically significant), BLINDNESS (Lost vision in both eyes) (seriousness criteria hospitalization and medically significant), DYSPHAGIA (Couldn't swallow) and COVID-19 (Covid-19). In February 2021, the patient experienced NODULE (Lumps on biceps of both arms). The patient was hospitalized on 22-Jan-2021 due to BLINDNESS and BRAIN STEM STROKE. On 01-Mar-2021, BLINDNESS (Lost vision in both eyes) had resolved. At the time of the report, BRAIN STEM STROKE (Acute brain stem stroke), COVID-19 (Covid-19) and NODULE (Lumps on biceps of both arms) outcome was unknown and DYSPHAGIA (Couldn't swallow) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Covid-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Company Comment - Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Acute brain stem stroke; Lost vision in both eyes; Lumps on biceps of both arms; Couldn't swallow; Covid-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN STEM STROKE (Acute brain stem stroke) and BLINDNESS (Lost vision in both eyes) in a 66-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.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and LOSARTAN for Blood pressure management, ATORVASTATIN for Cholesterol, POTASSIUM for Hypokalemia.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced BRAIN STEM STROKE (Acute brain stem stroke) (seriousness criteria hospitalization and medically significant), BLINDNESS (Lost vision in both eyes) (seriousness criteria hospitalization and medically significant), DYSPHAGIA (Couldn't swallow) and COVID-19 (Covid-19). In February 2021, the patient experienced NODULE (Lumps on biceps of both arms). The patient was hospitalized on 22-Jan-2021 due to BLINDNESS and BRAIN STEM STROKE. On 01-Mar-2021, BLINDNESS (Lost vision in both eyes) had resolved. At the time of the report, BRAIN STEM STROKE (Acute brain stem stroke), COVID-19 (Covid-19) and NODULE (Lumps on biceps of both arms) outcome was unknown and DYSPHAGIA (Couldn't swallow) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Covid-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Company Comment - Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pneumonia, SARS-CoV-2 test, Urinary tract infection
Clinical narrative: Patient was hospitalized due to pneumonia; Urinary track infection; Patient tested positive for covid at the hospital with a rapid test; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Patient was hospitalized due to pneumonia) and URINARY TRACT INFECTION (Urinary track infection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 030L20A) 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 TORASEMIDE (TORSEMIDE), METOPROLOL TARTRATE (METOPROLOL XL), LEVOTHYROXINE, TAMSULOSIN, APIXABAN (ELIQUIS), METFORMIN, FENOFIBRATE and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PNEUMONIA (Patient was hospitalized due to pneumonia) (seriousness criteria hospitalization and medically significant) and URINARY TRACT INFECTION (Urinary track infection) (seriousness criterion hospitalization). On 18-May-2021, the patient experienced COVID-19 (Patient tested positive for covid at the hospital with a rapid test). The patient was hospitalized on 30-Apr-2021 due to PNEUMONIA and URINARY TRACT INFECTION. The patient was treated with TAZOBACTAM (intravenous) at a dose of UNK dosage form and PIPERACILLIN (intravenous) at a dose of UNK dosage form. At the time of the report, PNEUMONIA (Patient was hospitalized due to pneumonia), URINARY TRACT INFECTION (Urinary track infection) and COVID-19 (Patient tested positive for covid at the hospital with a rapid test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, SARS-CoV-2 test: positive (Positive) Patient tested positive for COVID at the hospital with a rapid test.         Description: The patient was hospitalized on 30 Apr 2021 due to pneumonia and urinary tract infection. The patient was still in the hospital.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Product administration error for mRNA-1273, lot #  031L20A  with associated AEs. Additional information is 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 events, a causal relationship cannot be excluded. This report refers to a case of Product administration error for mRNA-1273, lot #  031L20A  with associated AEs. Additional information is requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Product dose omission issue, Pulmonary embolism
Clinical narrative: did not get second dose due to side effects from first dose; blood clot in lung; Really bad back pain; breathing was difficult; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (blood clot in lung) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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 16-Feb-2021, the patient experienced PULMONARY EMBOLISM (blood clot in lung) (seriousness criterion medically significant), BACK PAIN (Really bad back pain) and DYSPNOEA (breathing was difficult). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get second dose due to side effects from first dose). The patient was treated with APIXABAN at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (blood clot in lung), BACK PAIN (Really bad back pain), DYSPNOEA (breathing was difficult) and PRODUCT DOSE OMISSION ISSUE (did not get second dose due to side effects from first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products information was not provided. Patient experienced "really bad back pain" and "breathing was difficult". Went to see his doctor who then stated he had a blood clot in his lung. Caller stated he was then put on Eliquis and the doctor said he would have to take it for the rest of his life. Caller wanted to know if this was true or if he can eventually stop taking the Eliquis. He also wanted to know what caused him to get a blood clot.  Company comment: Very limited information regarding the events has been provided at this time.  Further information is expected.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine, Chills, Chromaturia, Fatigue, Pyrexia
Clinical narrative: I went to emergency and was hospitalized for 4 days due to rhabdomyolysis; Urine darkened; Chills; Slight fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of RHABDOMYOLYSIS (I went to emergency and was hospitalized for 4 days due to rhabdomyolysis) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pancreatic cancer. Previously administered products included for an unreported indication: Keytruda. Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for Pancreatic cancer.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced CHROMATURIA (Urine darkened), CHILLS (Chills), PYREXIA (Slight fever) and FATIGUE (Tired). On 22-Apr-2021, the patient experienced RHABDOMYOLYSIS (I went to emergency and was hospitalized for 4 days due to rhabdomyolysis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-Apr-2021 to 26-Apr-2021 due to RHABDOMYOLYSIS. At the time of the report, RHABDOMYOLYSIS (I went to emergency and was hospitalized for 4 days due to rhabdomyolysis), CHROMATURIA (Urine darkened), CHILLS (Chills), PYREXIA (Slight fever) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood creatine (70-90): high (High) Patient reported a blood creatinine level should have been 70-90 but was 38,000, which then dropped over 2 days.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rhabdomyolysis
Clinical narrative: I went to emergency and was hospitalized for 4 days due to rhabdomyolysis; Urine darkened; Chills; Slight fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of RHABDOMYOLYSIS (I went to emergency and was hospitalized for 4 days due to rhabdomyolysis) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pancreatic cancer. Previously administered products included for an unreported indication: Keytruda. Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for Pancreatic cancer.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced CHROMATURIA (Urine darkened), CHILLS (Chills), PYREXIA (Slight fever) and FATIGUE (Tired). On 22-Apr-2021, the patient experienced RHABDOMYOLYSIS (I went to emergency and was hospitalized for 4 days due to rhabdomyolysis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-Apr-2021 to 26-Apr-2021 due to RHABDOMYOLYSIS. At the time of the report, RHABDOMYOLYSIS (I went to emergency and was hospitalized for 4 days due to rhabdomyolysis), CHROMATURIA (Urine darkened), CHILLS (Chills), PYREXIA (Slight fever) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood creatine (70-90): high (High) Patient reported a blood creatinine level should have been 70-90 but was 38,000, which then dropped over 2 days.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Vertigo
Clinical narrative: Had vertigo; Patient can't hear out of his left ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Patient can't hear out of his left ear) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included MRI in May 2021.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced DEAFNESS (Patient can't hear out of his left ear) (seriousness criterion medically significant). On 03-May-2021, the patient experienced VERTIGO (Had vertigo). The patient was treated with CHLORAMPHENICOL (ANTIBIOTIC [CHLORAMPHENICOL]) in May 2021 at a dose of 1 dosage form. At the time of the report, DEAFNESS (Patient can't hear out of his left ear) and VERTIGO (Had vertigo) had not resolved.            The patient was not taking any concomitant medications.  Treatment for events included 2 steroids injections in ear.   Action taken with mRNA-1273 in response to the events was not Applicable.  Company comment: Very limited information regarding the events has been provided at this time.  Further information is requested.   This case was linked to MOD-2021-155536 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is requested.
Sex: M
Vaccine: COVID19
Symptoms: Central nervous system viral infection, Gait disturbance, Immunosuppression, Motor dysfunction, Speech disorder
Clinical narrative: he had a doormat virus that went viral in his brain; shut down his immune system; has to learn how to talk and walk again; has to learn how to talk and walk again; motor skills that were effected; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CENTRAL NERVOUS SYSTEM VIRAL INFECTION (he had a doormat virus that went viral in his brain), IMMUNOSUPPRESSION (shut down his immune system), GAIT DISTURBANCE (has to learn how to talk and walk again), SPEECH DISORDER (has to learn how to talk and walk again) and MOTOR DYSFUNCTION (motor skills that were effected) in an adult 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CENTRAL NERVOUS SYSTEM VIRAL INFECTION (he had a doormat virus that went viral in his brain) (seriousness criteria hospitalization prolonged, disability, medically significant and life threatening), IMMUNOSUPPRESSION (shut down his immune system) (seriousness criterion medically significant), GAIT DISTURBANCE (has to learn how to talk and walk again) (seriousness criterion medically significant), SPEECH DISORDER (has to learn how to talk and walk again) (seriousness criterion medically significant) and MOTOR DYSFUNCTION (motor skills that were effected) (seriousness criterion medically significant). The patient was hospitalized for 5 days due to CENTRAL NERVOUS SYSTEM VIRAL INFECTION. At the time of the report, CENTRAL NERVOUS SYSTEM VIRAL INFECTION (he had a doormat virus that went viral in his brain), IMMUNOSUPPRESSION (shut down his immune system), GAIT DISTURBANCE (has to learn how to talk and walk again), SPEECH DISORDER (has to learn how to talk and walk again) and MOTOR DYSFUNCTION (motor skills that were effected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter stated that the patient's age was 50-65 years and he was in really good health. After receiving the vaccine, the patient spent five days in the hospital and was on ventilators. At the time of reporting, the patient was wearing diapers. The reporter stated that they were not able to document the exact details of the motor skills that were effected from the Moderna vaccine which shut down the patient's immune system.   No relevant concomitant medications were reported.  Treatment medications were not provided.  Company comment: Very limited information regarding the events has been provided at this time.  Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Loss of consciousness, Pain in extremity, Rib fracture, Syncope
Clinical narrative: Unconscious; Fainted; head was rapidly spinning then developed severe vertigo; broke her 3 ribs on her left side; hurt her left leg; She thought "i was dying"; This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Unconscious) and SYNCOPE (Fainted) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic and Environmental allergy. Concomitant products included LIRAGLUTIDE (VICTOZA) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criterion medically significant), SYNCOPE (Fainted) (seriousness criterion medically significant), VERTIGO (head was rapidly spinning then developed severe vertigo), RIB FRACTURE (broke her 3 ribs on her left side), PAIN IN EXTREMITY (hurt her left leg) and FEELING ABNORMAL (She thought "i was dying"). The patient was treated with IBUPROFEN at a dose of for the first couple of weeks; ASPIRIN [ACETYLSALICYLIC ACID] at a dose of for the first couple of weeks and PARACETAMOL (TYLENOL) at a dose of for the first couple of weeks. At the time of the report, LOSS OF CONSCIOUSNESS (Unconscious), SYNCOPE (Fainted), VERTIGO (head was rapidly spinning then developed severe vertigo), RIB FRACTURE (broke her 3 ribs on her left side), PAIN IN EXTREMITY (hurt her left leg) and FEELING ABNORMAL (She thought "i was dying") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was unconscious on the bathroom floor but  unaware of how many minutes she was unconscious. It was reported that overall her pain scale was 8. The patient did not go to the hospital, just stayed at home and laid in bed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Unconscious; Fainted; head was rapidly spinning then developed severe vertigo; broke her 3 ribs on her left side; hurt her left leg; She thought "i was dying"; This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Unconscious) and SYNCOPE (Fainted) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic and Environmental allergy. Concomitant products included LIRAGLUTIDE (VICTOZA) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criterion medically significant), SYNCOPE (Fainted) (seriousness criterion medically significant), VERTIGO (head was rapidly spinning then developed severe vertigo), RIB FRACTURE (broke her 3 ribs on her left side), PAIN IN EXTREMITY (hurt her left leg) and FEELING ABNORMAL (She thought "i was dying"). The patient was treated with IBUPROFEN at a dose of for the first couple of weeks; ASPIRIN [ACETYLSALICYLIC ACID] at a dose of for the first couple of weeks and PARACETAMOL (TYLENOL) at a dose of for the first couple of weeks. At the time of the report, LOSS OF CONSCIOUSNESS (Unconscious), SYNCOPE (Fainted), VERTIGO (head was rapidly spinning then developed severe vertigo), RIB FRACTURE (broke her 3 ribs on her left side), PAIN IN EXTREMITY (hurt her left leg) and FEELING ABNORMAL (She thought "i was dying") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was unconscious on the bathroom floor but  unaware of how many minutes she was unconscious. It was reported that overall her pain scale was 8. The patient did not go to the hospital, just stayed at home and laid in bed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Feeling abnormal, Mental disorder, Muscle twitching, Speech disorder
Clinical narrative: Unusual symptoms; Unusual behavior; Almost like different person with mental problem; Can't complete a sentence; Muscle twitching; Cant stop shaking; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Unusual symptoms), ABNORMAL BEHAVIOUR (Unusual behavior), MENTAL DISORDER (Almost like different person with mental problem), SPEECH DISORDER (Can't complete a sentence), MUSCLE TWITCHING (Muscle twitching) and TREMOR (Cant stop shaking) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.  Concomitant products included WITHANIA SOMNIFERA ROOT (ASHWAGANDHA ROOT).   On 20-May-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) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced FEELING ABNORMAL (Unusual symptoms) (seriousness criterion hospitalization), ABNORMAL BEHAVIOUR (Unusual behavior) (seriousness criterion hospitalization), MENTAL DISORDER (Almost like different person with mental problem) (seriousness criterion hospitalization), SPEECH DISORDER (Can't complete a sentence) (seriousness criterion hospitalization), MUSCLE TWITCHING (Muscle twitching) (seriousness criterion hospitalization) and TREMOR (Cant stop shaking) (seriousness criterion hospitalization). At the time of the report, FEELING ABNORMAL (Unusual symptoms), ABNORMAL BEHAVIOUR (Unusual behavior), MENTAL DISORDER (Almost like different person with mental problem), SPEECH DISORDER (Can't complete a sentence), MUSCLE TWITCHING (Muscle twitching) and TREMOR (Cant stop shaking) outcome was unknown.            Received a call from the patient's father who wanted to report that his daughter received the 2nd shot of Moderna Covid 19 Vaccine last Thursday evening, 20-May-2021 along with her mother. On Friday, 21-May-2021, His daughter had unusual symptoms of unusual behavior, almost like different person with mental problem, can't complete a sentence, muscle twitching and can't stop shaking.  The unusual symptoms had not resolved.  On 22-May-2021, they went to the Emergency Room where his daughter was admitted. Treatment information was not  provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Unusual symptoms; Unusual behavior; Almost like different person with mental problem; Can't complete a sentence; Muscle twitching; Cant stop shaking; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Unusual symptoms), ABNORMAL BEHAVIOUR (Unusual behavior), MENTAL DISORDER (Almost like different person with mental problem), SPEECH DISORDER (Can't complete a sentence), MUSCLE TWITCHING (Muscle twitching) and TREMOR (Cant stop shaking) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.  Concomitant products included WITHANIA SOMNIFERA ROOT (ASHWAGANDHA ROOT).   On 20-May-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) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced FEELING ABNORMAL (Unusual symptoms) (seriousness criterion hospitalization), ABNORMAL BEHAVIOUR (Unusual behavior) (seriousness criterion hospitalization), MENTAL DISORDER (Almost like different person with mental problem) (seriousness criterion hospitalization), SPEECH DISORDER (Can't complete a sentence) (seriousness criterion hospitalization), MUSCLE TWITCHING (Muscle twitching) (seriousness criterion hospitalization) and TREMOR (Cant stop shaking) (seriousness criterion hospitalization). At the time of the report, FEELING ABNORMAL (Unusual symptoms), ABNORMAL BEHAVIOUR (Unusual behavior), MENTAL DISORDER (Almost like different person with mental problem), SPEECH DISORDER (Can't complete a sentence), MUSCLE TWITCHING (Muscle twitching) and TREMOR (Cant stop shaking) outcome was unknown.            Received a call from the patient's father who wanted to report that his daughter received the 2nd shot of Moderna Covid 19 Vaccine last Thursday evening, 20-May-2021 along with her mother. On Friday, 21-May-2021, His daughter had unusual symptoms of unusual behavior, almost like different person with mental problem, can't complete a sentence, muscle twitching and can't stop shaking.  The unusual symptoms had not resolved.  On 22-May-2021, they went to the Emergency Room where his daughter was admitted. Treatment information was not  provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Haemoglobin decreased, Malaise, Transfusion
Clinical narrative: blood transfusion; Hemoglobin dropped from 12 to 6; Feeling unwell; anemia; This spontaneous case was reported by a consumer and describes the occurrence of TRANSFUSION (blood transfusion), HAEMOGLOBIN DECREASED (Hemoglobin dropped from 12 to 6), MALAISE (Feeling unwell) and ANAEMIA (anemia) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TRANSFUSION (blood transfusion) (seriousness criterion hospitalization), HAEMOGLOBIN DECREASED (Hemoglobin dropped from 12 to 6) (seriousness criterion hospitalization), MALAISE (Feeling unwell) (seriousness criterion hospitalization) and ANAEMIA (anemia) (seriousness criterion hospitalization). At the time of the report, TRANSFUSION (blood transfusion), HAEMOGLOBIN DECREASED (Hemoglobin dropped from 12 to 6), MALAISE (Feeling unwell) and ANAEMIA (anemia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reportedly, patient's hemoglobin dropped from 12 to 6 after receiving her first dose of the Moderna COVID-19 vaccine on 03-March- 2021. Patient said about a week and half after receiving the vaccine, she was not feeling well. She is anemic. Two weeks prior to receiving the vaccine, her blood work showed her hemoglobin was 12. According to reporter two weeks after receiving the vaccine, she received a call and she was asked to go to the emergence room since her labs was showing her hemoglobin has dropped to 6. She went to the emergency room and she received blood transfusion. Patient said she went to the hospital maybe on the 14-Mar-2021 and she was in the emergency room for two days. At the time of the call, patient confirmed that she was doing fine and her hemoglobin was back to 12 which was her normal. According to the patient her doctors said they do not think this is from the vaccine.  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.