chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Dyspnoea, No adverse event, Sensory loss, Vital signs measurement
Clinical narrative: The patient received the injection, was monitored for 15minutes. He returned to his station at work. He had a sensation that he could not get an adequate breath. He says this started about fifteen minutes after the shot and observation had been done. He was assessed at 5:55pm on Friday (4/23/21). The pt had his vitals done at the area of injections. He was found to be stable. The pt walked under his own power to the medic clinic. There he was placed on a stretcher and vitals performed again. He was given a epic-pen injection in the left thigh, per author. This was a 6:35pm, approximately. He had no adverse effects from the epinephrine shot, with vitals still monitored. An ambulance arrived, report given and he was to be taken to the medical center for further observation.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Moderna Vaccine
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: MY HUSBAND DIED WITHIN 24 HOURS OF RECEIVING THE VACCINE.  I WANT TO CONFIRM THAT YOU KNOW ABOUT THIS. PLEASE CALL ME ON MY CELL PHONE ,  THANK YOU,
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aortic dissection, Aortic dissection rupture, Autopsy, Condition aggravated, Death
Clinical narrative: MY HUSBAND DIED WITHIN 24 HOURS OF RECEIVING THE VACCINE.  I WANT TO CONFIRM THAT YOU KNOW ABOUT THIS. PLEASE CALL ME ON MY CELL PHONE ,  THANK YOU,
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypertensive heart disease, Influenza A virus test negative, Influenza B virus test, Laboratory test, Pericardial haemorrhage
Clinical narrative: MY HUSBAND DIED WITHIN 24 HOURS OF RECEIVING THE VACCINE.  I WANT TO CONFIRM THAT YOU KNOW ABOUT THIS. PLEASE CALL ME ON MY CELL PHONE ,  THANK YOU,
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Toxicologic test normal
Clinical narrative: MY HUSBAND DIED WITHIN 24 HOURS OF RECEIVING THE VACCINE.  I WANT TO CONFIRM THAT YOU KNOW ABOUT THIS. PLEASE CALL ME ON MY CELL PHONE ,  THANK YOU,
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Deafness, Fatigue, Feeling abnormal, Insomnia
Clinical narrative: Terrible loud ringing in ears and buzzing in head, hearing loss (high frequency ),  fatigue, insomnia, fever, chills, brain fog
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Terrible loud ringing in ears and buzzing in head, hearing loss (high frequency ),  fatigue, insomnia, fever, chills, brain fog
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Insomnia, Polymerase chain reaction, Tinnitus
Clinical narrative: Terrible loud ringing in ears and buzzing in head, hearing loss (high frequency ),  fatigue, insomnia, fever, chills, brain fog
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lipoma, Peripheral swelling, Ultrasound scan
Clinical narrative: I developed a swollen area in my arm that turned into a lump. I had an ultrasound of the lump this week and I believe it was diagnosed as a lipoma.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Seizure, Vaccination site pain
Clinical narrative: Passed Out; Suspecting Seizures pending EEG Results; Sore Arm; This spontaneous case was reported by a pharmacist and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed Out) and SEIZURE (Suspecting Seizures pending EEG Results) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (medication history was not reported) and Pacemaker insertion (cardiac) since an unknown date.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm). On 13-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed Out) (seriousness criteria hospitalization and medically significant) and SEIZURE (Suspecting Seizures pending EEG Results) (seriousness criterion hospitalization). On 10-Apr-2021, VACCINATION SITE PAIN (Sore Arm) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Passed Out) and SEIZURE (Suspecting Seizures pending EEG Results) 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 information was not reported. diagnosis yet to be determent Suspecting Seizures pending EEG results  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information is available at this time. Further 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.However, Very limited information is available at this time. Further information is requested.
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Heart rate, Hypoaesthesia, Muscular weakness, Pain in jaw
Clinical narrative: extremely low heart rate; Right arm was weak; Fingers on right hand were numb; Pain in the jaw; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (extremely low heart rate) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history 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, the patient experienced BRADYCARDIA (extremely low heart rate) (seriousness criterion medically significant), MUSCULAR WEAKNESS (Right arm was weak), HYPOAESTHESIA (Fingers on right hand were numb) and PAIN IN JAW (Pain in the jaw). At the time of the report, BRADYCARDIA (extremely low heart rate), MUSCULAR WEAKNESS (Right arm was weak), HYPOAESTHESIA (Fingers on right hand were numb) and PAIN IN JAW (Pain in the jaw) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Heart rate: low (Low) Extremely low..         No concomitant medications were reported.  On an unspecified date, the patient's spouse reported that the primary doctor advised a cardiologist consult. The cardiologist recommended that he go to the emergency room.  No treatment information was reported.  Based in current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Very little information is provided for the event of bradycardia and further information has been requested.; Sender's Comments: Based in current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Very little information is provided for the event of bradycardia and further information has been requested.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cellulitis, Headache, Pyrexia
Clinical narrative: cellulitis was developed belowher injection site which is 3-5 inches in size; Fever 99.7 F; mild headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis was developed belowher injection site which is 3-5 inches in size) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced CELLULITIS (cellulitis was developed belowher injection site which is 3-5 inches in size) (seriousness criterion medically significant). In April 2021, the patient experienced PYREXIA (Fever 99.7 F) and HEADACHE (mild headache). At the time of the report, CELLULITIS (cellulitis was developed belowher injection site which is 3-5 inches in size) was resolving and PYREXIA (Fever 99.7 F) and HEADACHE (mild headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 99.7.         The patient was taking unspecified concomitant medication. The patient visited her Doctor's office and started treatment which her MD prescribed sulfamethoxazole oral antibiotic, and mupirocin 2% Ointment. Action taken with mRNA-1273 in response to events was not applicable. Treatment included Sulfamethoxaz and topical ointment. 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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Reporter details, event (fever 99.7) and treatment medications were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Nausea, SARS-CoV-2 test, SARS-CoV-2 test negative
Clinical narrative: Negative COVID test; nausea; passed out; chest pain; shortness of breath; Tested positive for COVID; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (passed out) in a 77-year-old male patient who received mRNA-1273  for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disease, unspecified and Atherosclerosis (blockage of artery was noted.). Concurrent medical conditions included Drug therapy (patient was on heart medications) and Drug therapy (patient was on antibiotic). Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]), CLOPIDOGREL BISULFATE (PLAVIX) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273  (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced SYNCOPE (passed out) (seriousness criterion medically significant), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath), SARS-COV-2 TEST POSITIVE (Tested positive for COVID) and NAUSEA (nausea). On an unknown date, the patient experienced SARS-COV-2 TEST NEGATIVE (Negative COVID test). At the time of the report, SYNCOPE (passed out), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath), SARS-COV-2 TEST POSITIVE (Tested positive for COVID), SARS-COV-2 TEST NEGATIVE (Negative COVID test) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: positive Positive. On 14-Apr-2021, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Unknown Route) was unknown.       This case concerns a 77-year-old male with a serious unexpected event of syncope, and nonserious unexpected chest pain, dyspnea, and expected nausea. SARS-CoV-2 test positive.  Treatment with Regeneron antibodies. Event onset 19 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 77-year-old male with a serious unexpected event of syncope, and nonserious unexpected chest pain, dyspnea, and expected nausea. SARS-CoV-2 test positive.  Treatment with Regeneron antibodies. Event onset 19 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Syncope
Clinical narrative: Negative COVID test; nausea; passed out; chest pain; shortness of breath; Tested positive for COVID; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (passed out) in a 77-year-old male patient who received mRNA-1273  for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disease, unspecified and Atherosclerosis (blockage of artery was noted.). Concurrent medical conditions included Drug therapy (patient was on heart medications) and Drug therapy (patient was on antibiotic). Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]), CLOPIDOGREL BISULFATE (PLAVIX) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273  (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced SYNCOPE (passed out) (seriousness criterion medically significant), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath), SARS-COV-2 TEST POSITIVE (Tested positive for COVID) and NAUSEA (nausea). On an unknown date, the patient experienced SARS-COV-2 TEST NEGATIVE (Negative COVID test). At the time of the report, SYNCOPE (passed out), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath), SARS-COV-2 TEST POSITIVE (Tested positive for COVID), SARS-COV-2 TEST NEGATIVE (Negative COVID test) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: positive Positive. On 14-Apr-2021, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Unknown Route) was unknown.       This case concerns a 77-year-old male with a serious unexpected event of syncope, and nonserious unexpected chest pain, dyspnea, and expected nausea. SARS-CoV-2 test positive.  Treatment with Regeneron antibodies. Event onset 19 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 77-year-old male with a serious unexpected event of syncope, and nonserious unexpected chest pain, dyspnea, and expected nausea. SARS-CoV-2 test positive.  Treatment with Regeneron antibodies. Event onset 19 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Helicobacter infection, Oropharyngeal discomfort, Pyrexia
Clinical narrative: after the vaccine, she had a bacteria in her stomach; Dysphonic; Woke up feeling bad of the throat; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HELICOBACTER INFECTION (after the vaccine, she had a bacteria in her stomach) in a 49-year-old female patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Reported having Coronavirus in December.) in December 2020. On 30-Mar-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced DYSPHONIA (Dysphonic), OROPHARYNGEAL DISCOMFORT (Woke up feeling bad of the throat) and PYREXIA (Fever). On an unknown date, the patient experienced HELICOBACTER INFECTION (after the vaccine, she had a bacteria in her stomach) (seriousness criterion medically significant). At the time of the report, HELICOBACTER INFECTION (after the vaccine, she had a bacteria in her stomach), DYSPHONIA (Dysphonic), OROPHARYNGEAL DISCOMFORT (Woke up feeling bad of the throat) and PYREXIA (Fever) outcome was unknown.  The action taken with mRNA-1273 (intramuscular) was unknown. Concomitant medications were not provided. Treatment for the events included Clarithromycin.   This case was linked to MOD21-078280 (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.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Migraine, Pruritus
Clinical narrative: migraine; Dizziness and lightheadedness; passed out; started developing itch; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PRURITUS (started developing itch). On 16-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant) and DIZZINESS (Dizziness and lightheadedness). On 19-Apr-2021, the patient experienced MIGRAINE (migraine). On 16-Apr-2021, LOSS OF CONSCIOUSNESS (passed out) had resolved. At the time of the report, PRURITUS (started developing itch) and DIZZINESS (Dizziness and lightheadedness) outcome was unknown and MIGRAINE (migraine) had not resolved.            No concomitant medications were reported.  Treatment of these events included Excedrin migraine.   Action taken with mRNA-1273 in response to the event was not applicable.  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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Pain, Paralysis
Clinical narrative: Paralysis from left arm down to feet; Unbearable pain; Could not walk; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PARALYSIS (Paralysis from left arm down to feet) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARALYSIS (Paralysis from left arm down to feet) (seriousness criterion medically significant), PAIN (Unbearable pain) and GAIT INABILITY (Could not walk). At the time of the report, PARALYSIS (Paralysis from left arm down to feet), PAIN (Unbearable pain) and GAIT INABILITY (Could not walk) 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.   Concomitant product use was not provided.  Treatment information was unknown.  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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Fatigue, Pain
Clinical narrative: Suffering from Diverticulitis; Soreness for a day; Little fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIVERTICULITIS (Suffering from Diverticulitis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (Soreness for a day) and FATIGUE (Little fatigue). On 18-Apr-2021, the patient experienced DIVERTICULITIS (Suffering from Diverticulitis) (seriousness criterion medically significant). On 25-Mar-2021, PAIN (Soreness for a day) and FATIGUE (Little fatigue) had resolved. At the time of the report, DIVERTICULITIS (Suffering from Diverticulitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient went to emergency.  Treatment for the event included IV ciprofloxacin and metronidazole.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Cough, Vaccination site pain
Clinical narrative: Doctor felt it was an anaphylaxis reaction; Cough; Left arm is still so sore she can not lift it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Doctor felt it was an anaphylaxis reaction) in a 55-year-old female 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.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced COUGH (Cough) and VACCINATION SITE PAIN (Left arm is still so sore she can not lift it). On 17-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Doctor felt it was an anaphylaxis reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Doctor felt it was an anaphylaxis reaction) outcome was unknown and COUGH (Cough) and VACCINATION SITE PAIN (Left arm is still so sore she can not lift it) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was treated with antihistamine for tingling in her lips and whole face became swollen and her lips were huge and it started to go away. On 18-APR-2021, it started again so patient had seen her physician on 19-APR-2021 who referred her to a specialist. The patient was tested for an allergy to the vaccine. The doctor felt it was an anaphylaxis reaction.  The reporter did not provide an assessment for the events.  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: F
Vaccine: COVID19
Symptoms: Haematochezia, Haemorrhoids, Rectal haemorrhage
Clinical narrative: Hemorrhoid; Minor bleeding issues/ hemorrhoid; Clot of blood in stool; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Minor bleeding issues/ hemorrhoid) and HAEMATOCHEZIA (Clot of blood in stool) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rectal bleeding (10 years ago).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced RECTAL HAEMORRHAGE (Minor bleeding issues/ hemorrhoid) (seriousness criterion medically significant) and HAEMATOCHEZIA (Clot of blood in stool) (seriousness criterion medically significant). On an unknown date, the patient experienced HAEMORRHOIDS (Hemorrhoid). At the time of the report, RECTAL HAEMORRHAGE (Minor bleeding issues/ hemorrhoid), HAEMATOCHEZIA (Clot of blood in stool) and HAEMORRHOIDS (Hemorrhoid) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  On unknown date, the evening after receiving the Moderna COVID-19 vaccine, the patient reported seeing a blood clot in the toilet. The patient stated it looked like hemorrhoids. The patient denied seeking medical care. The patient stated the bleeding is minor but at the time of this report, ongoing. The patient stated having similar minor bleeding approximately 10 years ago.  This case concerns a 63-year-old female with PMH of rectal bleeding had serious unexpected events of Rectal hemorrhage, hematochezia and non serious unexpected hemorrhoids. Event onset with unknown latency. after first dose mRNA-1273. Events ongoing. 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 63-year-old female with PMH of rectal bleeding had serious unexpected events of Rectal hemorrhage, hematochezia and nonserious unexpected hemorrhoids. Event onset with unknown latency. after first dose mRNA-1273. Events ongoing. 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Electrocardiogram, Facial paresis, Magnetic resonance imaging
Clinical narrative: I had a stroke; I now have weakness on my right leg; I now have weakness on my right arm; I now have weakness on my right face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (I had a stroke) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Diabetes. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (I had a stroke) (seriousness criteria hospitalization and medically significant). On 19-Apr-2021, the patient experienced MUSCULAR WEAKNESS (I now have weakness on my right leg), MUSCULAR WEAKNESS (I now have weakness on my right arm) and FACIAL PARESIS (I now have weakness on my right face). At the time of the report, CEREBROVASCULAR ACCIDENT (I had a stroke), MUSCULAR WEAKNESS (I now have weakness on my right leg), MUSCULAR WEAKNESS (I now have weakness on my right arm) and FACIAL PARESIS (I now have weakness on my right face) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerized tomogram: results are not mentioned (Inconclusive) Results are not mentioned. On an unknown date, Electrocardiogram: results are not mentioned (Inconclusive) Results are not mentioned. On an unknown date, Magnetic resonance imaging: 1 inch spot in brain (Inconclusive) Admits that the MRI showed that he had a 1 inch spot in his brain that was killed. 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. Concomitant product use was not provided by the reporter. The patient was admitted, couldn't talk and started to drool. The patient was taken to the hospital by the paramedics. The patient's reports that he bites his lip every time he chewed. Patient was wearing a heart monitor for 30 days. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's past history of diabetes Miletus may remain as risk factor 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 history of diabetes Miletus may remain as risk factor for this event.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: I had a stroke; I now have weakness on my right leg; I now have weakness on my right arm; I now have weakness on my right face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (I had a stroke) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Diabetes. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (I had a stroke) (seriousness criteria hospitalization and medically significant). On 19-Apr-2021, the patient experienced MUSCULAR WEAKNESS (I now have weakness on my right leg), MUSCULAR WEAKNESS (I now have weakness on my right arm) and FACIAL PARESIS (I now have weakness on my right face). At the time of the report, CEREBROVASCULAR ACCIDENT (I had a stroke), MUSCULAR WEAKNESS (I now have weakness on my right leg), MUSCULAR WEAKNESS (I now have weakness on my right arm) and FACIAL PARESIS (I now have weakness on my right face) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerized tomogram: results are not mentioned (Inconclusive) Results are not mentioned. On an unknown date, Electrocardiogram: results are not mentioned (Inconclusive) Results are not mentioned. On an unknown date, Magnetic resonance imaging: 1 inch spot in brain (Inconclusive) Admits that the MRI showed that he had a 1 inch spot in his brain that was killed. 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. Concomitant product use was not provided by the reporter. The patient was admitted, couldn't talk and started to drool. The patient was taken to the hospital by the paramedics. The patient's reports that he bites his lip every time he chewed. Patient was wearing a heart monitor for 30 days. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's past history of diabetes Miletus may remain as risk factor 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 history of diabetes Miletus may remain as risk factor for this event.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Transient ischemic attack; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) (seriousness criterion hospitalization). The patient was hospitalized from 15-Apr-2021 to 16-Apr-2021 due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) outcome was unknown. Not Provided      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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Chills, Loss of control of legs
Clinical narrative: acute renal failure; again he lost control of his legs in the middle of the night; elevated CPK; pretty bad chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACUTE KIDNEY INJURY (acute renal failure), LOSS OF CONTROL OF LEGS (again he lost control of his legs in the middle of the night) and BLOOD CREATINE PHOSPHOKINASE INCREASED (elevated CPK) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ALLOPURINOL for an unknown indication.   On 10-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. On 07-Apr-2021, the patient experienced LOSS OF CONTROL OF LEGS (again he lost control of his legs in the middle of the night) (seriousness criteria hospitalization and disability) and CHILLS (pretty bad chills). On 08-Apr-2021, the patient experienced ACUTE KIDNEY INJURY (acute renal failure) (seriousness criteria hospitalization and medically significant) and BLOOD CREATINE PHOSPHOKINASE INCREASED (elevated CPK) (seriousness criterion medically significant). The patient was hospitalized from 08-Apr-2021 to 11-Apr-2021 due to ACUTE KIDNEY INJURY and LOSS OF CONTROL OF LEGS. On 11-Apr-2021, ACUTE KIDNEY INJURY (acute renal failure) outcome was unknown, BLOOD CREATINE PHOSPHOKINASE INCREASED (elevated CPK) had resolved. At the time of the report, LOSS OF CONTROL OF LEGS (again he lost control of his legs in the middle of the night) and CHILLS (pretty bad chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Blood creatine phosphokinase: 22,000 High. On 10-Apr-2021, Blood creatine phosphokinase: 10,000 High. On 11-Apr-2021, Blood creatine phosphokinase: 6,412 High.   Acute renal failure was due to something in the vaccine that attacked the muscles in his legs.   IV saline was given as a treatment  HCP appointment is on the 19/apr/2021  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 case was linked to MOD-2021-080270 (E2B Linked Report).; Sender's Comments:  MOD-2021-080270:first dose
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia, Peripheral swelling
Clinical narrative: Guillain Barre syndrome; shortness of breath; tingling in her hands; legs were numb and tingling; feet were swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included AMLODIPINE and BISACODYL (LAXATIVE [BISACODYL]) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (feet were swollen). On 01-Apr-2021, the patient experienced HYPOAESTHESIA (legs were numb and tingling). On 02-Apr-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) (seriousness criteria hospitalization and medically significant). On 19-Apr-2021, the patient experienced DYSPNOEA (shortness of breath) and PARAESTHESIA (tingling in her hands). The patient was hospitalized from 02-Apr-2021 to 06-Apr-2021 due to GUILLAIN-BARRE SYNDROME. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome), DYSPNOEA (shortness of breath), PERIPHERAL SWELLING (feet were swollen), HYPOAESTHESIA (legs were numb and tingling) and PARAESTHESIA (tingling in her hands) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   treatment information not provided  Additional information:by 02Apr2021 she was admitted to the hospital and was diagnosed with GBS (Guillain Barre syndrome) She stayed in the hospital for 5 days.  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, Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Purpura
Clinical narrative: Blood vessels that bursts for two weeks; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PURPURA (Blood vessels that bursts for two weeks) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history was not 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, the patient experienced PURPURA (Blood vessels that bursts for two weeks) (seriousness criterion medically significant). At the time of the report, PURPURA (Blood vessels that bursts for two weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information was not reported.  Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-080340, US-MODERNATX, INC.-MOD-2021-080364 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested. US-MODERNATX, INC.-MOD-2021-080340: US-MODERNATX, INC.-MOD-2021-080364:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea at rest, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: no energy; pain all over body, feel like train wreck; pain all over body, feel like train wreck / every muscle in their body hurt; temperature 100F; patient is also very tired; shortness of breath; night of vaccination administration patient felt discomfort in neck and head on left side; night of vaccination administration patient felt discomfort in neck and head on left side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA AT REST (shortness of breath) in a 56-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 Arthritis, Osteoporosis, Multiple sclerosis spinal cord lesion and COPD.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DYSPNOEA AT REST (shortness of breath) (seriousness criterion medically significant), HEAD DISCOMFORT (night of vaccination administration patient felt discomfort in neck and head on left side), NECK PAIN (night of vaccination administration patient felt discomfort in neck and head on left side), MYALGIA (pain all over body, feel like train wreck / every muscle in their body hurt), PYREXIA (temperature 100F) and FATIGUE (patient is also very tired). On an unknown date, the patient experienced ASTHENIA (no energy) and FEELING ABNORMAL (pain all over body, feel like train wreck). At the time of the report, DYSPNOEA AT REST (shortness of breath), HEAD DISCOMFORT (night of vaccination administration patient felt discomfort in neck and head on left side), NECK PAIN (night of vaccination administration patient felt discomfort in neck and head on left side), ASTHENIA (no energy), FEELING ABNORMAL (pain all over body, feel like train wreck), MYALGIA (pain all over body, feel like train wreck / every muscle in their body hurt), PYREXIA (temperature 100F) and FATIGUE (patient is also very tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Pyrexia: 100 (High) 100 F.     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.   There is no concomitant list provided. 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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pyrexia
Clinical narrative: no energy; pain all over body, feel like train wreck; pain all over body, feel like train wreck / every muscle in their body hurt; temperature 100F; patient is also very tired; shortness of breath; night of vaccination administration patient felt discomfort in neck and head on left side; night of vaccination administration patient felt discomfort in neck and head on left side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA AT REST (shortness of breath) in a 56-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 Arthritis, Osteoporosis, Multiple sclerosis spinal cord lesion and COPD.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DYSPNOEA AT REST (shortness of breath) (seriousness criterion medically significant), HEAD DISCOMFORT (night of vaccination administration patient felt discomfort in neck and head on left side), NECK PAIN (night of vaccination administration patient felt discomfort in neck and head on left side), MYALGIA (pain all over body, feel like train wreck / every muscle in their body hurt), PYREXIA (temperature 100F) and FATIGUE (patient is also very tired). On an unknown date, the patient experienced ASTHENIA (no energy) and FEELING ABNORMAL (pain all over body, feel like train wreck). At the time of the report, DYSPNOEA AT REST (shortness of breath), HEAD DISCOMFORT (night of vaccination administration patient felt discomfort in neck and head on left side), NECK PAIN (night of vaccination administration patient felt discomfort in neck and head on left side), ASTHENIA (no energy), FEELING ABNORMAL (pain all over body, feel like train wreck), MYALGIA (pain all over body, feel like train wreck / every muscle in their body hurt), PYREXIA (temperature 100F) and FATIGUE (patient is also very tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Pyrexia: 100 (High) 100 F.     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.   There is no concomitant list provided. 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.