chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: Not responsive at all; Sleeping; Took her to the bathroom at 5 o´clock this morning and she was wet, she is in pull ups; This morning put her back to bed and then told me she is not herself today; Her eyes kind of closing; Threw up; She was tired about 7 o´clock in the evening and went to bed early; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Not responsive at all) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Insulin dependent diabetic. Concomitant products included LISINOPRIL, ATORVASTATIN and INSULIN for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced FATIGUE (She was tired about 7 o´clock in the evening and went to bed early). On 27-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Not responsive at all) (seriousness criterion medically significant), SOMNOLENCE (Sleeping), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Took her to the bathroom at 5 o´clock this morning and she was wet, she is in pull ups), ASTHENOPIA (Her eyes kind of closing), VOMITING (Threw up) and MALAISE (This morning put her back to bed and then told me she is not herself today). At the time of the report, LOSS OF CONSCIOUSNESS (Not responsive at all), SOMNOLENCE (Sleeping), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Took her to the bathroom at 5 o´clock this morning and she was wet, she is in pull ups), ASTHENOPIA (Her eyes kind of closing), VOMITING (Threw up), MALAISE (This morning put her back to bed and then told me she is not herself today) and FATIGUE (She was tired about 7 o´clock in the evening and went to bed early) 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.   Patient is insulin dependent. Takes blood pressure medication and cholesterol medication. Treatment information not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. However, the patient's age and medical history of insulin-dependent diabetes mellitus, hypertension and hypercholesterolemia, as well as intake of concomitant medications, are confounding factors that may play possible contributory roles.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out behind the wheel; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out behind the wheel) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out behind the wheel) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out behind the wheel) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medications were reported. Reportedly, the patient had the shot yesterday and passed out behind the wheel.  Very limited information regarding this event have been provided. No further information is expected.; Sender's Comments: Very limited information regarding this event have been provided. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Gait disturbance, Muscle spasms, Pyrexia, Tremor
Clinical narrative: Can barely walk/ Difficulty walking; Tremor; Muscle spasm; Fever of 102 degrees Fahrenhei; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Can barely walk/ Difficulty walking), TREMOR (Tremor), MUSCLE SPASMS (Muscle spasm) and PYREXIA (Fever of 102 degrees Fahrenhei) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Inflammation.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (Tremor) (seriousness criterion hospitalization), MUSCLE SPASMS (Muscle spasm) (seriousness criterion hospitalization) and PYREXIA (Fever of 102 degrees Fahrenhei) (seriousness criterion hospitalization). On an unknown date, the patient experienced GAIT DISTURBANCE (Can barely walk/ Difficulty walking) (seriousness criterion hospitalization). At the time of the report, GAIT DISTURBANCE (Can barely walk/ Difficulty walking), TREMOR (Tremor), MUSCLE SPASMS (Muscle spasm) and PYREXIA (Fever of 102 degrees Fahrenhei) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Body temperature: 102 degrees fahrenheit (High) 102 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was 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   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Additional information received included no new information. On 28-May-2021: Additional information received included additional events, information for first dose date, event onset dates, anatomic location for first dose, lab information.; 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: Hypothermia
Clinical narrative: hypothermia; 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 HYPOTHERMIA (hypothermia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOTHERMIA (hypothermia) (seriousness criterion medically significant). At the time of the report, HYPOTHERMIA (hypothermia) outcome was unknown.            No treatment medication were provided. No concomitant medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable.  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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Caused misscarrage; Vaccine exposure during pregnancy; Based on the current case data, this case has been classified as invalid. This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Caused misscarrage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Caused misscarrage) (seriousness criteria medically significant and congenital anomaly) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, ABORTION SPONTANEOUS (Caused misscarrage) outcome was unknown and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medications were reported.  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.  This is a case of product exposure during pregnancy with associated AE.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  This is a case of product exposure during pregnancy with associated AE .
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells palsy, Blink reflex abnormal, Facial discomfort, Eating disorder, Swallowing difficult; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bells palsy, Blink reflex abnormal, Facial discomfort, Eating disorder, Swallowing difficult) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced BELL'S PALSY (Bells palsy, Blink reflex abnormal, Facial discomfort, Eating disorder, Swallowing difficult) (seriousness criteria disability and medically significant). At the time of the report, BELL'S PALSY (Bells palsy, Blink reflex abnormal, Facial discomfort, Eating disorder, Swallowing difficult) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. Patient received Steroid injection.  Eye Lubricant as treatment medication. patient had to wear a patch and use eye lubricants to prevent permanent eye damage. Was told this may last for months and sometimes for life. This had affected their whole life.   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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Syncope
Clinical narrative: I passed out; Very hot; Very dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (I passed out) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, APIXABAN (ELIQUIS) and METOPROLOL for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced SYNCOPE (I passed out) (seriousness criterion medically significant), FEELING HOT (Very hot) and DIZZINESS (Very dizzy). The patient was treated with AMMONIA 28-Jan-2021 at an unspecified dose and frequency and OXYGEN 28-Jan-2021 at an unspecified dose and frequency. On 28-Jan-2021, SYNCOPE (I passed out), FEELING HOT (Very hot) and DIZZINESS (Very dizzy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and strong temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up report was received on 28 -MAY-2021, and included concomitant medication, AE verbatim as described at SD body narrative, onset date for AEs and outcome of event updated.; Sender's Comments: Based on the current available information and strong temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Loss of personal independence in daily activities, Red blood cell sedimentation rate normal, Rheumatoid arthritis
Clinical narrative: RA was extremely active; never been so inflammed; unable to conduct normal life functions; tired beyond what you can imagine; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (RA was extremely active) 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.     Concurrent medical conditions included Rheumatoid arthritis.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced RHEUMATOID ARTHRITIS (RA was extremely active) (seriousness criterion medically significant), INFLAMMATION (never been so inflammed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to conduct normal life functions) and FATIGUE (tired beyond what you can imagine). At the time of the report, RHEUMATOID ARTHRITIS (RA was extremely active), INFLAMMATION (never been so inflammed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to conduct normal life functions) and FATIGUE (tired beyond what you can imagine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Red blood cell sedimentation rate normal: 19 (normal) 19, steadily dropped that entire year (Inconclusive) steadily dropped that entire year, 72 (High) 72 and 89 (High) 89 (3 weeks after vaccine).         No concomitant or treatment medications were reported. The patient stated, "it has been almost 2 months and there are no improvements. Even though my life has come to an abrupt halt because I am not functional, I would still take the vaccine again".  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm has been in pretty serious pain ever since; 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 VACCINATION SITE PAIN (left arm has been in pretty serious pain ever since) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (left arm has been in pretty serious pain ever since) (seriousness criterion medically significant). At the time of the report, VACCINATION SITE PAIN (left arm has been in pretty serious pain ever since) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment for the event included 10 mg for one week of an unspecified medication.  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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Erythema, Eye swelling, Feeling abnormal
Clinical narrative: Flushing; Redness in face, big red patch on forehead and cheeks; Forgetfulness, memory is foggy; Weakness; Feels weird, doesn't fee herself/almost feels like a zombie; she needs her inhaler more often due to shortness of breath/ She feels like she can't breathe; Pounding headache, Her headaches have continued 24/7, she has nails in her head; Her eyes were swollen and droopy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Pounding headache, Her headaches have continued 24/7, she has nails in her head) 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 Migraine headache (once a year) and Asthma (used her inhaler as needed and not very often).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced HEADACHE (Pounding headache, Her headaches have continued 24/7, she has nails in her head) (seriousness criterion medically significant) and EYE SWELLING (Her eyes were swollen and droopy). On an unknown date, the patient experienced FLUSHING (Flushing), ERYTHEMA (Redness in face, big red patch on forehead and cheeks), MEMORY IMPAIRMENT (Forgetfulness, memory is foggy), ASTHENIA (Weakness), FEELING ABNORMAL (Feels weird, doesn't fee herself/almost feels like a zombie) and DYSPNOEA (she needs her inhaler more often due to shortness of breath/ She feels like she can't breathe). The patient was treated with MORPHINE (intravenous) at a dose of UNK dosage form. At the time of the report, HEADACHE (Pounding headache, Her headaches have continued 24/7, she has nails in her head), FLUSHING (Flushing), ERYTHEMA (Redness in face, big red patch on forehead and cheeks), MEMORY IMPAIRMENT (Forgetfulness, memory is foggy), ASTHENIA (Weakness), FEELING ABNORMAL (Feels weird, doesn't fee herself/almost feels like a zombie) and DYSPNOEA (she needs her inhaler more often due to shortness of breath/ She feels like she can't breathe) had not resolved and EYE SWELLING (Her eyes were swollen and droopy) outcome was unknown.            No concomitant medications were reported.  Lab data included a Computed tomography (CAT) scan in the emergency room with unknown results.  Other treatment medications included antibiotics and steroid injection.  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-2021-187087 (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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Memory impairment
Clinical narrative: Flushing; Redness in face, big red patch on forehead and cheeks; Forgetfulness, memory is foggy; Weakness; Feels weird, doesn't fee herself/almost feels like a zombie; she needs her inhaler more often due to shortness of breath/ She feels like she can't breathe; Pounding headache, Her headaches have continued 24/7, she has nails in her head; Her eyes were swollen and droopy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Pounding headache, Her headaches have continued 24/7, she has nails in her head) 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 Migraine headache (once a year) and Asthma (used her inhaler as needed and not very often).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced HEADACHE (Pounding headache, Her headaches have continued 24/7, she has nails in her head) (seriousness criterion medically significant) and EYE SWELLING (Her eyes were swollen and droopy). On an unknown date, the patient experienced FLUSHING (Flushing), ERYTHEMA (Redness in face, big red patch on forehead and cheeks), MEMORY IMPAIRMENT (Forgetfulness, memory is foggy), ASTHENIA (Weakness), FEELING ABNORMAL (Feels weird, doesn't fee herself/almost feels like a zombie) and DYSPNOEA (she needs her inhaler more often due to shortness of breath/ She feels like she can't breathe). The patient was treated with MORPHINE (intravenous) at a dose of UNK dosage form. At the time of the report, HEADACHE (Pounding headache, Her headaches have continued 24/7, she has nails in her head), FLUSHING (Flushing), ERYTHEMA (Redness in face, big red patch on forehead and cheeks), MEMORY IMPAIRMENT (Forgetfulness, memory is foggy), ASTHENIA (Weakness), FEELING ABNORMAL (Feels weird, doesn't fee herself/almost feels like a zombie) and DYSPNOEA (she needs her inhaler more often due to shortness of breath/ She feels like she can't breathe) had not resolved and EYE SWELLING (Her eyes were swollen and droopy) outcome was unknown.            No concomitant medications were reported.  Lab data included a Computed tomography (CAT) scan in the emergency room with unknown results.  Other treatment medications included antibiotics and steroid injection.  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-2021-187087 (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.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Erythema, Headache, Rash papular, Skin discolouration
Clinical narrative: blood clotting issues in his feet,clots on his legs; red places on both of his hands; bumps on legs/appeared as a raised portion on his leg; see the veins and blood in his feet; discoloration; veins more prominent in his feet and legs; headache; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs) in an 83-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.     Concomitant products included CARVEDILOL for Heart disorder, FAMOTIDINE, MULTIVITAMINS [VITAMINS NOS] and SERENOA REPENS FRUIT (SAW PALMETTO PROSTATE COMFORT) for an unknown indication.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HEADACHE (headache). On 27-May-2021, the patient experienced VARICOSE VEIN (veins more prominent in his feet and legs). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs) (seriousness criterion medically significant), ERYTHEMA (red places on both of his hands), RASH PAPULAR (bumps on legs/appeared as a raised portion on his leg), VARICOSE VEIN (see the veins and blood in his feet) and SKIN DISCOLOURATION (discoloration). On 28-May-2021, VARICOSE VEIN (veins more prominent in his feet and legs) was resolving. At the time of the report, DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs), ERYTHEMA (red places on both of his hands), RASH PAPULAR (bumps on legs/appeared as a raised portion on his leg), VARICOSE VEIN (see the veins and blood in his feet) and SKIN DISCOLOURATION (discoloration) outcome was unknown and HEADACHE (headache) had resolved.            Treatment information included the patient using compression hose. After the vaccination the patient experienced a headache for a day.The patient's legs and feet looked much better on 28-MAY-2021. The patient reported he was not on any blood thinners.  Company 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, 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. However, Further information has been requested.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Varicose vein
Clinical narrative: blood clotting issues in his feet,clots on his legs; red places on both of his hands; bumps on legs/appeared as a raised portion on his leg; see the veins and blood in his feet; discoloration; veins more prominent in his feet and legs; headache; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs) in an 83-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.     Concomitant products included CARVEDILOL for Heart disorder, FAMOTIDINE, MULTIVITAMINS [VITAMINS NOS] and SERENOA REPENS FRUIT (SAW PALMETTO PROSTATE COMFORT) for an unknown indication.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HEADACHE (headache). On 27-May-2021, the patient experienced VARICOSE VEIN (veins more prominent in his feet and legs). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs) (seriousness criterion medically significant), ERYTHEMA (red places on both of his hands), RASH PAPULAR (bumps on legs/appeared as a raised portion on his leg), VARICOSE VEIN (see the veins and blood in his feet) and SKIN DISCOLOURATION (discoloration). On 28-May-2021, VARICOSE VEIN (veins more prominent in his feet and legs) was resolving. At the time of the report, DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs), ERYTHEMA (red places on both of his hands), RASH PAPULAR (bumps on legs/appeared as a raised portion on his leg), VARICOSE VEIN (see the veins and blood in his feet) and SKIN DISCOLOURATION (discoloration) outcome was unknown and HEADACHE (headache) had resolved.            Treatment information included the patient using compression hose. After the vaccination the patient experienced a headache for a day.The patient's legs and feet looked much better on 28-MAY-2021. The patient reported he was not on any blood thinners.  Company 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, 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. However, Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Myocardial strain, Pulmonary embolism
Clinical narrative: Multiple Bilateral PE's; DVT; Right Heart Strain; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Multiple Bilateral PE's) and DEEP VEIN THROMBOSIS (DVT) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Multiple Bilateral PE's) (seriousness criterion medically significant), DEEP VEIN THROMBOSIS (DVT) (seriousness criterion medically significant) and MYOCARDIAL STRAIN (Right Heart Strain). At the time of the report, PULMONARY EMBOLISM (Multiple Bilateral PE's), DEEP VEIN THROMBOSIS (DVT) and MYOCARDIAL STRAIN (Right Heart Strain) outcome was unknown.            No concomitant medications nor treatment information was provided.  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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Infection, Inflammation, Itching scar
Clinical narrative: body is inflammed; body is completely red; Inflammation in ears and tongue; red line in her front; Chest pain; body is all disfigured; Headache; Hands were swollen; back of my was inflammed; balls at back of my head, red and hot areas; red and hot areas that itched; Inflammation of eyes; Chest pain; a little feverish; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (red line in her front) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulfa allergy). Concomitant products included SERTRALINE, BUPROPION, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ZOLPIDEM for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PYREXIA (a little feverish). On 26-May-2021, the patient experienced the first episode of CHEST PAIN (Chest pain), INFLAMMATION (Inflammation of eyes) and ITCHING SCAR (red and hot areas that itched). On 28-May-2021, the patient experienced SWOLLEN JOINT COUNT (Hands were swollen), INFLAMMATION (back of my was inflammed) and INFECTION (balls at back of my head, red and hot areas). On 30-May-2021, the patient experienced SEPSIS (red line in her front) (seriousness criterion medically significant), INFECTION (body is inflammed), INFECTION (body is completely red), INFLAMMATION (Inflammation in ears and tongue), the second episode of CHEST PAIN (Chest pain), WOUND (body is all disfigured) and HEADACHE (Headache). On 20-Apr-2021, PYREXIA (a little feverish) outcome was unknown. At the time of the report, SEPSIS (red line in her front), INFECTION (body is inflammed), INFECTION (body is completely red), INFLAMMATION (Inflammation in ears and tongue), INFLAMMATION (Inflammation of eyes), SWOLLEN JOINT COUNT (Hands were swollen), INFLAMMATION (back of my was inflammed), INFECTION (balls at back of my head, red and hot areas), ITCHING SCAR (red and hot areas that itched), the last episode of CHEST PAIN (Chest pain), WOUND (body is all disfigured) and HEADACHE (Headache) outcome was unknown.            Treatment medications included Injectable steroids, epinephrine, Benadryl and prednisone 20 mg.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Updated medication list and allergies.; 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sepsis, Swollen joint count, Wound
Clinical narrative: body is inflammed; body is completely red; Inflammation in ears and tongue; red line in her front; Chest pain; body is all disfigured; Headache; Hands were swollen; back of my was inflammed; balls at back of my head, red and hot areas; red and hot areas that itched; Inflammation of eyes; Chest pain; a little feverish; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (red line in her front) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulfa allergy). Concomitant products included SERTRALINE, BUPROPION, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ZOLPIDEM for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PYREXIA (a little feverish). On 26-May-2021, the patient experienced the first episode of CHEST PAIN (Chest pain), INFLAMMATION (Inflammation of eyes) and ITCHING SCAR (red and hot areas that itched). On 28-May-2021, the patient experienced SWOLLEN JOINT COUNT (Hands were swollen), INFLAMMATION (back of my was inflammed) and INFECTION (balls at back of my head, red and hot areas). On 30-May-2021, the patient experienced SEPSIS (red line in her front) (seriousness criterion medically significant), INFECTION (body is inflammed), INFECTION (body is completely red), INFLAMMATION (Inflammation in ears and tongue), the second episode of CHEST PAIN (Chest pain), WOUND (body is all disfigured) and HEADACHE (Headache). On 20-Apr-2021, PYREXIA (a little feverish) outcome was unknown. At the time of the report, SEPSIS (red line in her front), INFECTION (body is inflammed), INFECTION (body is completely red), INFLAMMATION (Inflammation in ears and tongue), INFLAMMATION (Inflammation of eyes), SWOLLEN JOINT COUNT (Hands were swollen), INFLAMMATION (back of my was inflammed), INFECTION (balls at back of my head, red and hot areas), ITCHING SCAR (red and hot areas that itched), the last episode of CHEST PAIN (Chest pain), WOUND (body is all disfigured) and HEADACHE (Headache) outcome was unknown.            Treatment medications included Injectable steroids, epinephrine, Benadryl and prednisone 20 mg.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Updated medication list and allergies.; 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: Contusion, Thrombosis
Clinical narrative: blood clot on the shaft of their penis; Bruise; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THROMBOSIS (blood clot on the shaft of their penis) in a male 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.     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, the patient experienced THROMBOSIS (blood clot on the shaft of their penis) (seriousness criterion medically significant) and CONTUSION (Bruise). At the time of the report, THROMBOSIS (blood clot on the shaft of their penis) and CONTUSION (Bruise) outcome was unknown.            No concomitant or treatment medications were reported.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   However, very limited information regarding this event/s has been provided at this time.  Further information cannot be requested because Consent to a follow up from  safety was not granted. The reporter did not provide further contact information.
Sex: U
Vaccine: COVID19
Symptoms: Foaming at mouth, Haematemesis, Secretion discharge
Clinical narrative: Regurtitate mucus and Blood,White substance in mouth; White foam like substance; Spitting up Mucus; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATEMESIS (Regurtitate mucus and Blood,White substance in mouth) 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) (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 HAEMATEMESIS (Regurtitate mucus and Blood,White substance in mouth) (seriousness criterion medically significant), FOAMING AT MOUTH (White foam like substance) and SECRETION DISCHARGE (Spitting up Mucus). At the time of the report, HAEMATEMESIS (Regurtitate mucus and Blood,White substance in mouth), FOAMING AT MOUTH (White foam like substance) and SECRETION DISCHARGE (Spitting up Mucus) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Very limited information regarding these events has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-102334 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Gastritis, Helicobacter test negative, Impaired gastric emptying
Clinical narrative: Gastroparesis; Mild Gastritis; This spontaneous case was reported by an other health care professional and describes the occurrence of IMPAIRED GASTRIC EMPTYING (Gastroparesis) and GASTRITIS (Mild Gastritis) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMPAIRED GASTRIC EMPTYING (Gastroparesis) (seriousness criteria hospitalization and medically significant) and GASTRITIS (Mild Gastritis) (seriousness criterion hospitalization). At the time of the report, IMPAIRED GASTRIC EMPTYING (Gastroparesis) and GASTRITIS (Mild Gastritis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: abnormal (abnormal) mild gastritis. In 2021, Helicobacter test negative: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. Treatment included an unspecified proton pump inhibitor (PPI).  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Pneumonia
Clinical narrative: Pneumonia; Shortness of breath (SOB); Back pain; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 66-year-old patient of an unknown 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 PNEUMONIA (Pneumonia) (seriousness criterion medically significant). an unknown date, the patient experienced DYSPNOEA (Shortness of breath (SOB)) and BACK PAIN (Back pain). At the time of the report, PNEUMONIA (Pneumonia), DYSPNOEA (Shortness of breath (SOB)) and BACK PAIN (Back pain) outcome was unknown.            Concomitant product use was not provided. 2 weeks after receiving 2nd injection, the patient developed shortness of breath (SOB), back pain, and was diagnosed with pneumonia, never had it before.  Treatment information was 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.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: he was in atrial fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (he was in atrial fibrillation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ATRIAL FIBRILLATION (he was in atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (he was in atrial fibrillation) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.  Patient experienced atrial fibrillation one week after receiving the second dose of the vaccine.  Company Comment: 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.
Sex: M
Vaccine: COVID19
Symptoms: Glossodynia, Platelet count decreased, Tongue discolouration, Vaccination complication
Clinical narrative: Platelet count decreased drastically; After that he developed adverse reaction; black sores, tongue; black sores, tongue; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (Platelet count decreased drastically), VACCINATION COMPLICATION (After that he developed adverse reaction), TONGUE DISCOLOURATION (black sores, tongue) and GLOSSODYNIA (black sores, tongue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concomitant products included OLMESARTAN for Blood pressure management, SIMVASTATIN for Cholesterol, NISOLDIPINE for Heart disease, unspecified.    On 29-Jan-2019, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (Platelet count decreased drastically) (seriousness criterion hospitalization), VACCINATION COMPLICATION (After that he developed adverse reaction) (seriousness criterion hospitalization), TONGUE DISCOLOURATION (black sores, tongue) (seriousness criterion hospitalization) and GLOSSODYNIA (black sores, tongue) (seriousness criterion hospitalization). The patient was treated with IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PLATELET COUNT DECREASED (Platelet count decreased drastically), VACCINATION COMPLICATION (After that he developed adverse reaction), TONGUE DISCOLOURATION (black sores, tongue) and GLOSSODYNIA (black sores, tongue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported, after the vaccination he developed adverse reaction and his platelet count dramatically decreased. 9 days later the patient had black sores, tongue. The patient got his blood work done and the patient was hospitalized for 2 days. The patient was given IVIG and steroid after which he was discharged. His symptoms resolved after some time but both his doctor and hematologist had concern and advice him not to get the 2nd dose of Moderna COVID-19 vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.