chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal distension, Abdominal pain, Blood glucose, Blood pressure measurement, Chest pain
Clinical narrative: Syncopal attack; Vaccination related malaise; Light-headed; Confusion; Chest pain; Swelling abdomen; Abdominal pain; Shortness of breath; Sweating; Pain localised; Diarrhea; Nausea; Chills; Vomiting; This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (Syncopal attack) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PANCREATIN (CREON) for an unknown indication.    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 and PANCREATIN (CREON) (Oral) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Syncopal attack) (seriousness criterion medically significant), VACCINATION COMPLICATION (Vaccination related malaise), DIZZINESS (Light-headed), CONFUSIONAL STATE (Confusion), CHEST PAIN (Chest pain), ABDOMINAL DISTENSION (Swelling abdomen), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweating), PAIN (Pain localised), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, SYNCOPE (Syncopal attack), VACCINATION COMPLICATION (Vaccination related malaise), DIZZINESS (Light-headed), CONFUSIONAL STATE (Confusion), CHEST PAIN (Chest pain), ABDOMINAL DISTENSION (Swelling abdomen), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweating), PAIN (Pain localised), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: normal (normal) Normal. On an unknown date, Blood pressure measurement: 114/65 (abnormal) 114/65 Blood Pressure Abnormal. On an unknown date, Heart rate: 40 (Low) 40  Heart rate decreased.     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.   No concomitant medication details was provided. No treatment Medication details was provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Confusional state, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Syncopal attack; Vaccination related malaise; Light-headed; Confusion; Chest pain; Swelling abdomen; Abdominal pain; Shortness of breath; Sweating; Pain localised; Diarrhea; Nausea; Chills; Vomiting; This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (Syncopal attack) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PANCREATIN (CREON) for an unknown indication.    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 and PANCREATIN (CREON) (Oral) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Syncopal attack) (seriousness criterion medically significant), VACCINATION COMPLICATION (Vaccination related malaise), DIZZINESS (Light-headed), CONFUSIONAL STATE (Confusion), CHEST PAIN (Chest pain), ABDOMINAL DISTENSION (Swelling abdomen), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweating), PAIN (Pain localised), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, SYNCOPE (Syncopal attack), VACCINATION COMPLICATION (Vaccination related malaise), DIZZINESS (Light-headed), CONFUSIONAL STATE (Confusion), CHEST PAIN (Chest pain), ABDOMINAL DISTENSION (Swelling abdomen), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweating), PAIN (Pain localised), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: normal (normal) Normal. On an unknown date, Blood pressure measurement: 114/65 (abnormal) 114/65 Blood Pressure Abnormal. On an unknown date, Heart rate: 40 (Low) 40  Heart rate decreased.     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.   No concomitant medication details was provided. No treatment Medication details was provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Heart rate, Hyperhidrosis, Nausea, Pain, Syncope
Clinical narrative: Syncopal attack; Vaccination related malaise; Light-headed; Confusion; Chest pain; Swelling abdomen; Abdominal pain; Shortness of breath; Sweating; Pain localised; Diarrhea; Nausea; Chills; Vomiting; This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (Syncopal attack) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PANCREATIN (CREON) for an unknown indication.    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 and PANCREATIN (CREON) (Oral) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Syncopal attack) (seriousness criterion medically significant), VACCINATION COMPLICATION (Vaccination related malaise), DIZZINESS (Light-headed), CONFUSIONAL STATE (Confusion), CHEST PAIN (Chest pain), ABDOMINAL DISTENSION (Swelling abdomen), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweating), PAIN (Pain localised), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, SYNCOPE (Syncopal attack), VACCINATION COMPLICATION (Vaccination related malaise), DIZZINESS (Light-headed), CONFUSIONAL STATE (Confusion), CHEST PAIN (Chest pain), ABDOMINAL DISTENSION (Swelling abdomen), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweating), PAIN (Pain localised), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: normal (normal) Normal. On an unknown date, Blood pressure measurement: 114/65 (abnormal) 114/65 Blood Pressure Abnormal. On an unknown date, Heart rate: 40 (Low) 40  Heart rate decreased.     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.   No concomitant medication details was provided. No treatment Medication details was provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination complication, Vomiting
Clinical narrative: Syncopal attack; Vaccination related malaise; Light-headed; Confusion; Chest pain; Swelling abdomen; Abdominal pain; Shortness of breath; Sweating; Pain localised; Diarrhea; Nausea; Chills; Vomiting; This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (Syncopal attack) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PANCREATIN (CREON) for an unknown indication.    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 and PANCREATIN (CREON) (Oral) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Syncopal attack) (seriousness criterion medically significant), VACCINATION COMPLICATION (Vaccination related malaise), DIZZINESS (Light-headed), CONFUSIONAL STATE (Confusion), CHEST PAIN (Chest pain), ABDOMINAL DISTENSION (Swelling abdomen), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweating), PAIN (Pain localised), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, SYNCOPE (Syncopal attack), VACCINATION COMPLICATION (Vaccination related malaise), DIZZINESS (Light-headed), CONFUSIONAL STATE (Confusion), CHEST PAIN (Chest pain), ABDOMINAL DISTENSION (Swelling abdomen), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweating), PAIN (Pain localised), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: normal (normal) Normal. On an unknown date, Blood pressure measurement: 114/65 (abnormal) 114/65 Blood Pressure Abnormal. On an unknown date, Heart rate: 40 (Low) 40  Heart rate decreased.     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.   No concomitant medication details was provided. No treatment Medication details was provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal vein occlusion
Clinical narrative: Retinal Vein Occlusion (right eye); This spontaneous case was reported by a consumer and describes the occurrence of RETINAL VEIN OCCLUSION (Retinal Vein Occlusion (right eye)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (morphine). Concomitant products included METFORMIN, LISINOPRIL and FINASTERIDE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced RETINAL VEIN OCCLUSION (Retinal Vein Occlusion (right eye)) (seriousness criterion medically significant). At the time of the report, RETINAL VEIN OCCLUSION (Retinal Vein Occlusion (right eye)) outcome was unknown.            Wife was reporting on behalf of her husband. The reporter stated that the patient had no history of retinal problems.  Treatment information was not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. 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 events, a causal relationship cannot be excluded. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Illness, Loss of consciousness, Nausea
Clinical narrative: blacked out; Was very sick on the Wednesday; feel weak; Lightheadedness; feel nauseas on and off; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (blacked out) (seriousness criterion medically significant), ILLNESS (Was very sick on the Wednesday), ASTHENIA (feel weak), DIZZINESS (Lightheadedness) and NAUSEA (feel nauseas on and off). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out), ILLNESS (Was very sick on the Wednesday), ASTHENIA (feel weak), DIZZINESS (Lightheadedness) and NAUSEA (feel nauseas on and off) outcome was unknown.            Concomitant product were not provided/unknown. Treatment medication were not reported/unknown.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Fatigue, Peripheral swelling, Tachycardia
Clinical narrative: I had brief episodes of atrial fibrillation lasting about 30 seconds; I woke up with tachycardia of a heart rate about 130 to 140 beats per minute; my arm had some swelling; I felt a little fatigue; This spontaneous case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (I had brief episodes of atrial fibrillation lasting about 30 seconds) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 250202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ATRIAL FIBRILLATION (I had brief episodes of atrial fibrillation lasting about 30 seconds) (seriousness criterion medically significant), TACHYCARDIA (I woke up with tachycardia of a heart rate about 130 to 140 beats per minute), PERIPHERAL SWELLING (my arm had some swelling) and FATIGUE (I felt a little fatigue). On 28-Feb-2021, ATRIAL FIBRILLATION (I had brief episodes of atrial fibrillation lasting about 30 seconds), TACHYCARDIA (I woke up with tachycardia of a heart rate about 130 to 140 beats per minute), PERIPHERAL SWELLING (my arm had some swelling) and FATIGUE (I felt a little fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter. Patient received vaccine in left non-dominant deltoid.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Deafness, Oropharyngeal pain, Pain in jaw
Clinical narrative: lost of hearing in the right side/lost hearing in one ear; is loosing balance; pain in right jaw; throat sore; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS (lost of hearing in the right side/lost hearing in one ear) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced DEAFNESS (lost of hearing in the right side/lost hearing in one ear) (seriousness criterion medically significant), BALANCE DISORDER (is loosing balance), PAIN IN JAW (pain in right jaw) and OROPHARYNGEAL PAIN (throat sore). At the time of the report, DEAFNESS (lost of hearing in the right side/lost hearing in one ear), BALANCE DISORDER (is loosing balance), PAIN IN JAW (pain in right jaw) and OROPHARYNGEAL PAIN (throat sore) 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.   No concomitant medications were reported.  The onset of events occurred 18 hours after the vaccination.  The patient saw his doctor and has an appointment scheduled with and eye and ear clinic.  It was not reported if any treatment was administered in response to the events.  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.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Verbatim added to event term; 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.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Product dose omission issue, Sepsis, Spinal disorder
Clinical narrative: developed sepsis; sepsis effected his spine needed a few surgeries; prevented him from walking for awhile; only received one dose; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (developed sepsis) and SPINAL DISORDER (sepsis effected his spine needed a few surgeries) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEPSIS (developed sepsis) (seriousness criteria hospitalization and medically significant), SPINAL DISORDER (sepsis effected his spine needed a few surgeries) (seriousness criterion medically significant), GAIT DISTURBANCE (prevented him from walking for awhile) and PRODUCT DOSE OMISSION ISSUE (only received one dose). The patient was treated with Surgery for Spinal disorder. At the time of the report, SEPSIS (developed sepsis), SPINAL DISORDER (sepsis effected his spine needed a few surgeries) and PRODUCT DOSE OMISSION ISSUE (only received one dose) outcome was unknown and GAIT DISTURBANCE (prevented him from walking for awhile) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not provided. Treatment medication were not reported  Patient was hospitalized for one month when he developed sepsis. Patient needed few surgeries that could prevent him from walking for a while. Patient was back to home and wanted to receive the second dose.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.            No concomitant medication information was provided. No treatment medication information was provided.  Action taken with mRNA-1273 in response to the drug was not applicable.   As per the report patient had heart attack after the second dose of the COVID-19 Vaccine however the reporter did not know the manufacturer.  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.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dry throat, Dyspnoea, Rash, Urticaria
Clinical narrative: hives breaking all over her body; rash; About one and half hour later she started to have symptoms of anaphylactic reactions; some trouble breathing; complained of dry throat; This spontaneous case was reported by a pharmacist and describes the occurrence of ANAPHYLACTIC REACTION (About one and half hour later she started to have symptoms of anaphylactic reactions) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy, Penicillin allergy, Drug hypersensitivity (Morphine), Drug hypersensitivity (Vicodin), Drug hypersensitivity (Oxycodone), Drug hypersensitivity (Azithromycin) and Drug hypersensitivity (Anaphylactic reaction to IV Benadryl).    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced ANAPHYLACTIC REACTION (About one and half hour later she started to have symptoms of anaphylactic reactions) (seriousness criterion medically significant), DYSPNOEA (some trouble breathing) and DRY THROAT (complained of dry throat). On an unknown date, the patient experienced URTICARIA (hives breaking all over her body) and RASH (rash). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) (oral) on 21-May-2021 for Anaphylactic reaction, at a dose of 1 dosage form. At the time of the report, ANAPHYLACTIC REACTION (About one and half hour later she started to have symptoms of anaphylactic reactions), DYSPNOEA (some trouble breathing), DRY THROAT (complained of dry throat) and URTICARIA (hives breaking all over her body) outcome was unknown and RASH (rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided/unknown. Patient was issued a box of Epipen used as needed. Rash on her body took three weeks to clear.  Company Comment : This case concerns a 42-year-old female with a serious unexpected event of anaphylactic reaction, and nonserious dyspnea, dry throat, urticaria, and rash. Event latency 1.5 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 42-year-old female with a serious unexpected event of anaphylactic reaction, and nonserious dyspnea, dry throat, urticaria, and rash. Event latency 1.5 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pericarditis
Clinical narrative: Pericarditis; Chest pain; This case was received via FDA VAERS (Reference number: 1391592) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of PERICARDITIS (Pericarditis) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM GENERIC), SILDENAFIL, VARENICLINE TARTRATE (CHANTIX), ZOLPIDEM TARTRATE (ZOLPIDEM TARTATE) and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 26-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) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant) and CHEST PAIN (Chest pain). The patient was treated with IBUPROFEN on 10-May-2021 at a dose of 600 mg three times a day and COLCHICINE (MITIGARE) at a dose of .6 mg twice a day. At the time of the report, PERICARDITIS (Pericarditis) and CHEST PAIN (Chest pain) had not resolved.        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.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram, Heart rate
Clinical narrative: ecg showed afib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (ecg showed afib) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Heart rate increased (rapid heart rate).    On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, the patient experienced ATRIAL FIBRILLATION (ecg showed afib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (ecg showed afib) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: abnormal (abnormal) a fib. On an unknown date, Heart rate: 109 (High) 109.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication information was provided by the reporter.  The patient's heart rate went up to 109 and ECG showed A-fib. The patient reported difficulty having their heart rate return to normal. No treatment information was provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Intracardiac thrombus, Nausea
Clinical narrative: she died from a blood clot that ran into her heart; felt very very tired; nauseas for the first couple of days; nauseas for the first couple of daysdidn't eat well for the first couple of days; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (she died from a blood clot that ran into her heart), FATIGUE (felt very very tired), NAUSEA (nauseas for the first couple of days) and DECREASED APPETITE (nauseas for the first couple of daysdidn't eat well for the first couple of days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced NAUSEA (nauseas for the first couple of days) (seriousness criterion death) and DECREASED APPETITE (nauseas for the first couple of daysdidn't eat well for the first couple of days) (seriousness criterion death). On 04-Apr-2021, the patient experienced FATIGUE (felt very very tired) (seriousness criterion death). On 08-Apr-2021, the patient experienced INTRACARDIAC THROMBUS (she died from a blood clot that ran into her heart) (seriousness criteria death and medically significant). The patient died on 08-Apr-2021. The reported cause of death was she died from a blood clot that ran into her heart. It is unknown if an autopsy was performed.            As per source document the patient received the 2nd dose on 4 or 5 April 2021 and she died from a blood clot that ran into her heart on 8Apr2021.  Treatment medication was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Relevant concomitant medications were not provided by the reporter.; 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.; Reported Cause(s) of Death: she died from a blood clot that ran into her heart
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Monoplegia, Muscle atrophy, Muscle spasms
Clinical narrative: Inability to use right leg; Loss of muscle mass; Spasms; Back pain; High fevers; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (Inability to use right leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product OFATUMUMAB (KESIMPTA) for an unknown indication.    No Medical History information was provided.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and OFATUMUMAB (KESIMPTA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MONOPLEGIA (Inability to use right leg) (seriousness criterion medically significant), MUSCLE ATROPHY (Loss of muscle mass), MUSCLE SPASMS (Spasms), BACK PAIN (Back pain), PYREXIA (High fevers) and CHILLS (Shivering). At the time of the report, MONOPLEGIA (Inability to use right leg), MUSCLE ATROPHY (Loss of muscle mass), MUSCLE SPASMS (Spasms), BACK PAIN (Back pain), PYREXIA (High fevers) and CHILLS (Shivering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported/unknown.  Patient had seen chiropractor and that helped to some extent.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Inability to use right leg; Loss of muscle mass; Spasms; Back pain; High fevers; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (Inability to use right leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product OFATUMUMAB (KESIMPTA) for an unknown indication.    No Medical History information was provided.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and OFATUMUMAB (KESIMPTA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MONOPLEGIA (Inability to use right leg) (seriousness criterion medically significant), MUSCLE ATROPHY (Loss of muscle mass), MUSCLE SPASMS (Spasms), BACK PAIN (Back pain), PYREXIA (High fevers) and CHILLS (Shivering). At the time of the report, MONOPLEGIA (Inability to use right leg), MUSCLE ATROPHY (Loss of muscle mass), MUSCLE SPASMS (Spasms), BACK PAIN (Back pain), PYREXIA (High fevers) and CHILLS (Shivering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported/unknown.  Patient had seen chiropractor and that helped to some extent.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Neck injury, Product dose omission issue
Clinical narrative: Fell and broke neck; Fell and broke neck; more than 35 days from 1st vaccination; This spontaneous case was reported by a consumer and describes the occurrence of NECK INJURY (Fell and broke neck) and FALL (Fell and broke neck) in a male patient of an unknown age 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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK INJURY (Fell and broke neck) (seriousness criterion hospitalization prolonged), FALL (Fell and broke neck) (seriousness criterion hospitalization prolonged) and PRODUCT DOSE OMISSION ISSUE (more than 35 days from 1st vaccination). At the time of the report, NECK INJURY (Fell and broke neck) and FALL (Fell and broke neck) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (more than 35 days from 1st vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.  Based on reporter's causality  the event is assessed as unlikely related to mRNA-1273. This report also refers to a case of Product dose omission  with no associated AEs, causality is Not applicable.; Sender's Comments: Based on reporter's causality  the event is assessed as unlikely related to mRNA-1273. This report also refers to a case of Product dose omission  with no associated AEs, causality is Not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: atrial fibrillation 5 days after taking the Moderna Covid-19 Vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation 5 days after taking the Moderna Covid-19 Vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation 5 days after taking the Moderna Covid-19 Vaccine.) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation 5 days after taking the Moderna Covid-19 Vaccine.) outcome was unknown.            No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.  The information agent cross-linked this case with MOD-2021-115288 (GB-MHRA-WEBCOVID-202105091055198620-VF4AC).   This case concerns a female of unknown age with a serious unexpected event atrial fibrillation. Event latency 5 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-115288 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This case concerns a female of unknown age with a serious unexpected event atrial fibrillation. Event latency 5 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Internal haemorrhage
Clinical narrative: Internal bleeding episodes; This spontaneous case was reported by a consumer and describes the occurrence of INTERNAL HAEMORRHAGE (Internal bleeding episodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTERNAL HAEMORRHAGE (Internal bleeding episodes) (seriousness criterion medically significant). At the time of the report, INTERNAL HAEMORRHAGE (Internal bleeding episodes) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  The reporter mentioned that the event occurred several weeks after receiving the second dose of the Moderna COVID vaccination.  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.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chest pain, Feeling abnormal, Hallucination, auditory
Clinical narrative: Mentioned wanting to kill himself; three voices in his head; Completely lost, he would not know who he was, where he was; Chest pain; Stomach pain; Hand pain/feet pain; Shaky feelings; Knee pain; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Mentioned wanting to kill himself) and HALLUCINATION, AUDITORY (three voices in his head) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hydrocephalus, Down's syndrome and Convulsions. Concomitant products included OXCARBAZEPINE (OXCARBAZEPIN) for an unknown indication.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SUICIDAL IDEATION (Mentioned wanting to kill himself) (seriousness criterion medically significant), HALLUCINATION, AUDITORY (three voices in his head) (seriousness criterion medically significant), FEELING ABNORMAL (Completely lost, he would not know who he was, where he was), CHEST PAIN (Chest pain), ABDOMINAL PAIN UPPER (Stomach pain), PAIN IN EXTREMITY (Hand pain/feet pain), NERVOUSNESS (Shaky feelings), ARTHRALGIA (Knee pain) and MYALGIA (Body ache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, SUICIDAL IDEATION (Mentioned wanting to kill himself), HALLUCINATION, AUDITORY (three voices in his head), FEELING ABNORMAL (Completely lost, he would not know who he was, where he was), CHEST PAIN (Chest pain), ABDOMINAL PAIN UPPER (Stomach pain), PAIN IN EXTREMITY (Hand pain/feet pain), NERVOUSNESS (Shaky feelings), ARTHRALGIA (Knee pain) and MYALGIA (Body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Scan brain: normal (normal) normal.         Patient prescribed anxiety and sleeping pills that the physician did not recommend that he take.  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. Unlikely, that the events are related to the vaccine due to existing comorbidities.   This case was linked to MOD-2021-235268 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Unlikely, that the events are related to the vaccine due to existing comorbidities.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nervousness, Pain in extremity, Scan brain, Suicidal ideation
Clinical narrative: Mentioned wanting to kill himself; three voices in his head; Completely lost, he would not know who he was, where he was; Chest pain; Stomach pain; Hand pain/feet pain; Shaky feelings; Knee pain; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Mentioned wanting to kill himself) and HALLUCINATION, AUDITORY (three voices in his head) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hydrocephalus, Down's syndrome and Convulsions. Concomitant products included OXCARBAZEPINE (OXCARBAZEPIN) for an unknown indication.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SUICIDAL IDEATION (Mentioned wanting to kill himself) (seriousness criterion medically significant), HALLUCINATION, AUDITORY (three voices in his head) (seriousness criterion medically significant), FEELING ABNORMAL (Completely lost, he would not know who he was, where he was), CHEST PAIN (Chest pain), ABDOMINAL PAIN UPPER (Stomach pain), PAIN IN EXTREMITY (Hand pain/feet pain), NERVOUSNESS (Shaky feelings), ARTHRALGIA (Knee pain) and MYALGIA (Body ache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, SUICIDAL IDEATION (Mentioned wanting to kill himself), HALLUCINATION, AUDITORY (three voices in his head), FEELING ABNORMAL (Completely lost, he would not know who he was, where he was), CHEST PAIN (Chest pain), ABDOMINAL PAIN UPPER (Stomach pain), PAIN IN EXTREMITY (Hand pain/feet pain), NERVOUSNESS (Shaky feelings), ARTHRALGIA (Knee pain) and MYALGIA (Body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Scan brain: normal (normal) normal.         Patient prescribed anxiety and sleeping pills that the physician did not recommend that he take.  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. Unlikely, that the events are related to the vaccine due to existing comorbidities.   This case was linked to MOD-2021-235268 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Unlikely, that the events are related to the vaccine due to existing comorbidities.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Cerebrovascular accident, Headache
Clinical narrative: Had stroke; Has loss of vision in right eye; Has headaches; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had stroke), BLINDNESS (Has loss of vision in right eye) and HEADACHE (Has headaches) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In June 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-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had stroke) (seriousness criteria hospitalization and medically significant), BLINDNESS (Has loss of vision in right eye) (seriousness criteria hospitalization and medically significant) and HEADACHE (Has headaches) (seriousness criterion hospitalization). The patient was hospitalized on 21-Jun-2021 due to BLINDNESS, CEREBROVASCULAR ACCIDENT and HEADACHE. At the time of the report, CEREBROVASCULAR ACCIDENT (Had stroke), BLINDNESS (Has loss of vision in right eye) and HEADACHE (Has headaches) outcome was unknown.            No concomitant medication information was provided by the reporter. Treatment information was unknown.  It was reported that the patient experienced stroke 3 days after receiving the 2nd dose of the vaccine. He was hospitalized on 21Jun2021. Patient also had headaches and loss of vision in right eye, and both started the day of stroke.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.