chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Chills, Feeling abnormal, Hypoaesthesia
Clinical narrative: Burning sensation and numbness on face immediately after vaccine administration; Chills; Low grade fever; Body ache; Joint pain; Not feeling well and feels worst than before; Burning sensation and numbness on face immediately after vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation and numbness on face immediately after vaccine administration), FEELING ABNORMAL (Not feeling well and feels worst than before), HYPOAESTHESIA (Burning sensation and numbness on face immediately after vaccine administration), CHILLS (Chills) and PYREXIA (Low grade fever) in a 62-year-old patient of an unknown gender 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.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BURNING SENSATION (Burning sensation and numbness on face immediately after vaccine administration). On 28-Apr-2021, the patient experienced FEELING ABNORMAL (Not feeling well and feels worst than before), CHILLS (Chills), PYREXIA (Low grade fever), MYALGIA (Body ache) and ARTHRALGIA (Joint pain). On an unknown date, the patient experienced HYPOAESTHESIA (Burning sensation and numbness on face immediately after vaccine administration). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Burning sensation and numbness on face immediately after vaccine administration), FEELING ABNORMAL (Not feeling well and feels worst than before), HYPOAESTHESIA (Burning sensation and numbness on face immediately after vaccine administration), CHILLS (Chills), PYREXIA (Low grade fever), MYALGIA (Body ache) and ARTHRALGIA (Joint pain) outcome was unknown.            The action taken with mRNa-1273 was Not Applicable. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT), NASAL ALLERGY MEDICINE.  Aspirin is included as treatment medication.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Burning sensation and numbness on face immediately after vaccine administration; Chills; Low grade fever; Body ache; Joint pain; Not feeling well and feels worst than before; Burning sensation and numbness on face immediately after vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation and numbness on face immediately after vaccine administration), FEELING ABNORMAL (Not feeling well and feels worst than before), HYPOAESTHESIA (Burning sensation and numbness on face immediately after vaccine administration), CHILLS (Chills) and PYREXIA (Low grade fever) in a 62-year-old patient of an unknown gender 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.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BURNING SENSATION (Burning sensation and numbness on face immediately after vaccine administration). On 28-Apr-2021, the patient experienced FEELING ABNORMAL (Not feeling well and feels worst than before), CHILLS (Chills), PYREXIA (Low grade fever), MYALGIA (Body ache) and ARTHRALGIA (Joint pain). On an unknown date, the patient experienced HYPOAESTHESIA (Burning sensation and numbness on face immediately after vaccine administration). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Burning sensation and numbness on face immediately after vaccine administration), FEELING ABNORMAL (Not feeling well and feels worst than before), HYPOAESTHESIA (Burning sensation and numbness on face immediately after vaccine administration), CHILLS (Chills), PYREXIA (Low grade fever), MYALGIA (Body ache) and ARTHRALGIA (Joint pain) outcome was unknown.            The action taken with mRNa-1273 was Not Applicable. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT), NASAL ALLERGY MEDICINE.  Aspirin is included as treatment medication.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Headache, Vaccination site pain
Clinical narrative: very disoriented; pain in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), CONFUSIONAL STATE (very disoriented) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C211A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Anticoagulant therapy, ALPRAZOLAM (XANAX) for Anxiety, SALBUTAMOL SULFATE (VENTOLIN [SALBUTAMOL SULFATE]) for Asthma.    On 25-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 PAIN IN EXTREMITY (pain in arm), CONFUSIONAL STATE (very disoriented) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain in arm), CONFUSIONAL STATE (very disoriented) and HEADACHE (Headache) 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.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; 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 URTICARIA (Hives) 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 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 24-May-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.            No concomitant medications reported by the reporter.    No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Had rapid heart beat; 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 HEART RATE INCREASED (Had rapid heart beat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Had rapid heart beat). At the time of the report, HEART RATE INCREASED (Had rapid heart beat) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness
Clinical narrative: she is complaining with flu kind symptoms; weakness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (she is complaining with flu kind symptoms) and ASTHENIA (weakness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 INFLUENZA LIKE ILLNESS (she is complaining with flu kind symptoms) and ASTHENIA (weakness). At the time of the report, INFLUENZA LIKE ILLNESS (she is complaining with flu kind symptoms) and ASTHENIA (weakness) outcome was unknown.            Relevant concomitant medications were not reported.  Treatment medication was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Limb discomfort, Swelling, Vaccination site swelling
Clinical narrative: That night her arm started to bother her/been bothering/it hurts just as bad at night time as the first day she received the second dose of the vaccine; Swelling; Tries to sleep it hurts; It makes her sit up straight; Injection site is big like a gulf ball; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (That night her arm started to bother her/been bothering/it hurts just as bad at night time as the first day she received the second dose of the vaccine), SWELLING (Swelling), INSOMNIA (Tries to sleep it hurts), LIMB DISCOMFORT (It makes her sit up straight) and VACCINATION SITE SWELLING (Injection site is big like a gulf ball) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 001CA1A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Patient has high blood pressure.) and Arthritis. Concomitant products included LISINOPRIL, METOPROLOL and CELECOXIB for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced LIMB DISCOMFORT (That night her arm started to bother her/been bothering/it hurts just as bad at night time as the first day she received the second dose of the vaccine), SWELLING (Swelling), INSOMNIA (Tries to sleep it hurts), LIMB DISCOMFORT (It makes her sit up straight) and VACCINATION SITE SWELLING (Injection site is big like a gulf ball). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form and ISOPROPANOL (RUBBING ALCOHOL) for Swelling, at a dose of 1 dosage form. At the time of the report, LIMB DISCOMFORT (That night her arm started to bother her/been bothering/it hurts just as bad at night time as the first day she received the second dose of the vaccine), SWELLING (Swelling), INSOMNIA (Tries to sleep it hurts), LIMB DISCOMFORT (It makes her sit up straight) and VACCINATION SITE SWELLING (Injection site is big like a gulf ball) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Fluid retention, Joint swelling, Oedema
Clinical narrative: She has no energy; She has little fatigue; 2 days after receiving 1st dose, she started retaining a lot of water.; Her whole body was swollen; Her hands are swollen; Ankle swollen; feet swollen; arms swollen; This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (2 days after receiving 1st dose, she started retaining a lot of water.), OEDEMA (Her whole body was swollen), ASTHENIA (She has no energy), SWELLING (Her hands are swollen) and JOINT SWELLING (Ankle swollen) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced FLUID RETENTION (2 days after receiving 1st dose, she started retaining a lot of water.), OEDEMA (Her whole body was swollen), SWELLING (Her hands are swollen), JOINT SWELLING (Ankle swollen), PERIPHERAL SWELLING (feet swollen) and PERIPHERAL SWELLING (arms swollen). On an unknown date, the patient experienced ASTHENIA (She has no energy) and FATIGUE (She has little fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FLUID RETENTION (2 days after receiving 1st dose, she started retaining a lot of water.), OEDEMA (Her whole body was swollen), ASTHENIA (She has no energy), SWELLING (Her hands are swollen), JOINT SWELLING (Ankle swollen), PERIPHERAL SWELLING (feet swollen), PERIPHERAL SWELLING (arms swollen) and FATIGUE (She has little fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling
Clinical narrative: She has no energy; She has little fatigue; 2 days after receiving 1st dose, she started retaining a lot of water.; Her whole body was swollen; Her hands are swollen; Ankle swollen; feet swollen; arms swollen; This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (2 days after receiving 1st dose, she started retaining a lot of water.), OEDEMA (Her whole body was swollen), ASTHENIA (She has no energy), SWELLING (Her hands are swollen) and JOINT SWELLING (Ankle swollen) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced FLUID RETENTION (2 days after receiving 1st dose, she started retaining a lot of water.), OEDEMA (Her whole body was swollen), SWELLING (Her hands are swollen), JOINT SWELLING (Ankle swollen), PERIPHERAL SWELLING (feet swollen) and PERIPHERAL SWELLING (arms swollen). On an unknown date, the patient experienced ASTHENIA (She has no energy) and FATIGUE (She has little fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FLUID RETENTION (2 days after receiving 1st dose, she started retaining a lot of water.), OEDEMA (Her whole body was swollen), ASTHENIA (She has no energy), SWELLING (Her hands are swollen), JOINT SWELLING (Ankle swollen), PERIPHERAL SWELLING (feet swollen), PERIPHERAL SWELLING (arms swollen) and FATIGUE (She has little fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: WBC count spiked to 14,000-23,000; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (WBC count spiked to 14,000-23,000) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included IBRUTINIB (IMBRUVICA) and VENETOCLAX (VENCLEXTA) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced WHITE BLOOD CELL COUNT INCREASED (WBC count spiked to 14,000-23,000). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (WBC count spiked to 14,000-23,000) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, White blood cell count: 14,000-23,000 (High) high.     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.   Since 2017, patient was taking Imbruzica 420mg 1/day. It's worked well. His new medicine is Venclexta 200mg at 8p tonight. It's being titrated up to a 400mg daily dose. he will receive IV treatment of Retuxin on his next appointment. he gets that every 28 days,its a 6 dose treatment.    treatment medication information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: people die from our vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (people die from our vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (people die from our vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (people die from our vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: big red mark at the injection side; pain; hardness on the injection side; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (big red mark at the injection side), VACCINATION SITE PAIN (pain) and VACCINATION SITE INDURATION (hardness on the injection side) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (big red mark at the injection side), VACCINATION SITE PAIN (pain) and VACCINATION SITE INDURATION (hardness on the injection side). At the time of the report, VACCINATION SITE ERYTHEMA (big red mark at the injection side), VACCINATION SITE PAIN (pain) and VACCINATION SITE INDURATION (hardness on the injection side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter   This case was linked to MOD-2021-175643 (Patient Link).   Reporter did not allow further contact
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Headache
Clinical narrative: spent two days in bed; scary headaches that are persistent; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (spent two days in bed) and HEADACHE (scary headaches that are persistent) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (spent two days in bed) and HEADACHE (scary headaches that are persistent). At the time of the report, BEDRIDDEN (spent two days in bed) outcome was unknown and HEADACHE (scary headaches that are persistent) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose fluctuation
Clinical narrative: Unable to properly monitor his blood sugars. It is very irregular; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE FLUCTUATION (Unable to properly monitor his blood sugars. It is very irregular) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   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 BLOOD GLUCOSE FLUCTUATION (Unable to properly monitor his blood sugars. It is very irregular). At the time of the report, BLOOD GLUCOSE FLUCTUATION (Unable to properly monitor his blood sugars. It is very irregular) outcome was unknown.            The action taken with mRNA-1273 was Not Applicable.  Concomitant product use was not provided.  Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: could not taste breakfast this morning/not being able to taste her food; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (could not taste breakfast this morning/not being able to taste her food) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025821A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, LISINOPRIL, APIXABAN (ELIQUIS), METOPROLOL TARTRATE (LOPRESSOR), SIMVASTATIN, GABAPENTIN, VITAMIN D NOS and FISH OIL for an unknown indication.   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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (could not taste breakfast this morning/not being able to taste her food). At the time of the report, AGEUSIA (could not taste breakfast this morning/not being able to taste her food) outcome was unknown.            No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received contains non-significant information- added reporter's address
Sex: U
Vaccine: COVID19
Symptoms: Illness, Sinusitis
Clinical narrative: currently sick w/ sinus infection; I am sick; 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 SINUSITIS (currently sick w/ sinus infection) and ILLNESS (I am sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection.    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 SINUSITIS (currently sick w/ sinus infection) and ILLNESS (I am sick). At the time of the report, SINUSITIS (currently sick w/ sinus infection) and ILLNESS (I am sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications was not provided.  Concomitant medications was not provided.  Patient is sick and don't know if patient can take second dose or wait.  After first dose patient experienced currently sick w/ sinus infection.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: My WBC count spiked, again, to 48,000/My blood work last week for my WBC was 90,000.; This spontaneous case was reported by a health care professional and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (My WBC count spiked, again, to 48,000/My blood work last week for my WBC was 90,000.) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concomitant products included IBRUTINIB and VENETOCLAX (VENCLEXTA) for an unknown indication.   On 06-Jan-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced WHITE BLOOD CELL COUNT INCREASED (My WBC count spiked, again, to 48,000/My blood work last week for my WBC was 90,000.). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (My WBC count spiked, again, to 48,000/My blood work last week for my WBC was 90,000.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and 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.   there are no concomitant medications  and treatment medication  was provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Ear discomfort, Headache, Heart rate
Clinical narrative: dizziness; Migraine; ears clogged; twich in the arm; uncontrolable shaking same day; saw things moving around; chills; headache; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MIGRAINE (Migraine), EAR DISCOMFORT (ears clogged), MUSCLE TWITCHING (twich in the arm) and TREMOR (uncontrolable shaking same day) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced DIZZINESS (dizziness), MIGRAINE (Migraine), EAR DISCOMFORT (ears clogged), MUSCLE TWITCHING (twich in the arm), VERTIGO (saw things moving around), CHILLS (chills), HEADACHE (headache) and MYALGIA (arm pain). 30-Apr-2021, the patient experienced TREMOR (uncontrolable shaking same day). At the time of the report, DIZZINESS (dizziness), MIGRAINE (Migraine), EAR DISCOMFORT (ears clogged), MUSCLE TWITCHING (twich in the arm), TREMOR (uncontrolable shaking same day), VERTIGO (saw things moving around), CHILLS (chills), HEADACHE (headache) and MYALGIA (arm pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: positive (Positive) positive. On 18-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 30-Apr-2021, Heart rate: 140 (abnormal) 140 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant and Treatment medicines were reported
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Muscle twitching, Myalgia, SARS-CoV-2 test, Tremor
Clinical narrative: dizziness; Migraine; ears clogged; twich in the arm; uncontrolable shaking same day; saw things moving around; chills; headache; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MIGRAINE (Migraine), EAR DISCOMFORT (ears clogged), MUSCLE TWITCHING (twich in the arm) and TREMOR (uncontrolable shaking same day) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced DIZZINESS (dizziness), MIGRAINE (Migraine), EAR DISCOMFORT (ears clogged), MUSCLE TWITCHING (twich in the arm), VERTIGO (saw things moving around), CHILLS (chills), HEADACHE (headache) and MYALGIA (arm pain). 30-Apr-2021, the patient experienced TREMOR (uncontrolable shaking same day). At the time of the report, DIZZINESS (dizziness), MIGRAINE (Migraine), EAR DISCOMFORT (ears clogged), MUSCLE TWITCHING (twich in the arm), TREMOR (uncontrolable shaking same day), VERTIGO (saw things moving around), CHILLS (chills), HEADACHE (headache) and MYALGIA (arm pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: positive (Positive) positive. On 18-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 30-Apr-2021, Heart rate: 140 (abnormal) 140 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant and Treatment medicines were reported
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: dizziness; Migraine; ears clogged; twich in the arm; uncontrolable shaking same day; saw things moving around; chills; headache; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MIGRAINE (Migraine), EAR DISCOMFORT (ears clogged), MUSCLE TWITCHING (twich in the arm) and TREMOR (uncontrolable shaking same day) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced DIZZINESS (dizziness), MIGRAINE (Migraine), EAR DISCOMFORT (ears clogged), MUSCLE TWITCHING (twich in the arm), VERTIGO (saw things moving around), CHILLS (chills), HEADACHE (headache) and MYALGIA (arm pain). 30-Apr-2021, the patient experienced TREMOR (uncontrolable shaking same day). At the time of the report, DIZZINESS (dizziness), MIGRAINE (Migraine), EAR DISCOMFORT (ears clogged), MUSCLE TWITCHING (twich in the arm), TREMOR (uncontrolable shaking same day), VERTIGO (saw things moving around), CHILLS (chills), HEADACHE (headache) and MYALGIA (arm pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: positive (Positive) positive. On 18-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 30-Apr-2021, Heart rate: 140 (abnormal) 140 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant and Treatment medicines were reported
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: wasn't able to get my second dose until 5/25; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (wasn't able to get my second dose until 5/25) 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 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (wasn't able to get my second dose until 5/25). On 25-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (wasn't able to get my second dose until 5/25) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: bad headache; injection site arm  itchy, blotched , red and lumpy; injection site arm itchy, blotched , red and lumpy; injection site arm itchy, blotched , red and lumpy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache), INJECTION SITE PRURITUS (injection site arm  itchy, blotched , red and lumpy), INJECTION SITE ERYTHEMA (injection site arm itchy, blotched , red and lumpy) and INJECTION SITE SWELLING (injection site arm itchy, blotched , red and lumpy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (bad headache), INJECTION SITE PRURITUS (injection site arm  itchy, blotched , red and lumpy), INJECTION SITE ERYTHEMA (injection site arm itchy, blotched , red and lumpy) and INJECTION SITE SWELLING (injection site arm itchy, blotched , red and lumpy). At the time of the report, HEADACHE (bad headache), INJECTION SITE PRURITUS (injection site arm  itchy, blotched , red and lumpy), INJECTION SITE ERYTHEMA (injection site arm itchy, blotched , red and lumpy) and INJECTION SITE SWELLING (injection site arm itchy, blotched , red and lumpy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: my 17 year old grand daughter was given Moderna vaccine in April; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (my 17 year old grand daughter was given Moderna vaccine in April) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (my 17 year old grand daughter was given Moderna vaccine in April). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (my 17 year old grand daughter was given Moderna vaccine in April) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Facial pain, Headache, Hypokinesia, Nausea
Clinical narrative: her face hurts when she chews; barely move her body; fever of 102.3F/went up to103.2F/now down to 102.0F/radiating a high fever; feels nauseous; has a terrible headache; feet are cold because of the chills; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (her face hurts when she chews), HYPOKINESIA (barely move her body), PYREXIA (fever of 102.3F/went up to103.2F/now down to 102.0F/radiating a high fever), NAUSEA (feels nauseous) and HEADACHE (has a terrible headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced FACIAL PAIN (her face hurts when she chews), HYPOKINESIA (barely move her body), PYREXIA (fever of 102.3F/went up to103.2F/now down to 102.0F/radiating a high fever), NAUSEA (feels nauseous), HEADACHE (has a terrible headache) and CHILLS (feet are cold because of the chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK. At the time of the report, FACIAL PAIN (her face hurts when she chews), HYPOKINESIA (barely move her body), PYREXIA (fever of 102.3F/went up to103.2F/now down to 102.0F/radiating a high fever), NAUSEA (feels nauseous), HEADACHE (has a terrible headache) and CHILLS (feet are cold because of the chills) outcome was unknown.            No concomitant medication was given. Patient took two extra strength Tylenol and try to eat ice chips.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: her face hurts when she chews; barely move her body; fever of 102.3F/went up to103.2F/now down to 102.0F/radiating a high fever; feels nauseous; has a terrible headache; feet are cold because of the chills; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (her face hurts when she chews), HYPOKINESIA (barely move her body), PYREXIA (fever of 102.3F/went up to103.2F/now down to 102.0F/radiating a high fever), NAUSEA (feels nauseous) and HEADACHE (has a terrible headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced FACIAL PAIN (her face hurts when she chews), HYPOKINESIA (barely move her body), PYREXIA (fever of 102.3F/went up to103.2F/now down to 102.0F/radiating a high fever), NAUSEA (feels nauseous), HEADACHE (has a terrible headache) and CHILLS (feet are cold because of the chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK. At the time of the report, FACIAL PAIN (her face hurts when she chews), HYPOKINESIA (barely move her body), PYREXIA (fever of 102.3F/went up to103.2F/now down to 102.0F/radiating a high fever), NAUSEA (feels nauseous), HEADACHE (has a terrible headache) and CHILLS (feet are cold because of the chills) outcome was unknown.            No concomitant medication was given. Patient took two extra strength Tylenol and try to eat ice chips.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; 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 DIARRHOEA (diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (unknown route) dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site dysaesthesia
Clinical narrative: "the upper arm still is very sensitive at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DYSAESTHESIA ("the upper arm still is very sensitive at injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DYSAESTHESIA ("the upper arm still is very sensitive at injection site). At the time of the report, VACCINATION SITE DYSAESTHESIA ("the upper arm still is very sensitive at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       for mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. treatment product included steroid cream no concomitant product was reported
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasal congestion, Pain, Pain in extremity, Sneezing
Clinical narrative: aches; congestion; sneezing; stuffy nose; soreness of arm; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (aches), NASAL CONGESTION (congestion), SNEEZING (sneezing), NASAL CONGESTION (stuffy nose) and PAIN IN EXTREMITY (soreness of arm) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PAIN (aches), NASAL CONGESTION (congestion), SNEEZING (sneezing), NASAL CONGESTION (stuffy nose), PAIN IN EXTREMITY (soreness of arm) and CHILLS (chills). On 08-May-2021, CHILLS (chills) outcome was unknown. On 15-May-2021, PAIN (aches), NASAL CONGESTION (congestion), SNEEZING (sneezing) and NASAL CONGESTION (stuffy nose) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.  PCP said symptoms might be from the people hangs out with. Mother believes the chills are from the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Injection site erythema, Pain, Vaccination site erythema
Clinical narrative: little red mark in the injection side.; injection site redness; pain; touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (little red mark in the injection side.), INJECTION SITE ERYTHEMA (injection site redness), PAIN (pain) and HYPERAESTHESIA (touch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 008C21A) for COVID-19 vaccination.     Patient medical history was not provided by the reporter.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (little red mark in the injection side.). an unknown date, the patient experienced INJECTION SITE ERYTHEMA (injection site redness), PAIN (pain) and HYPERAESTHESIA (touch). At the time of the report, VACCINATION SITE ERYTHEMA (little red mark in the injection side.), INJECTION SITE ERYTHEMA (injection site redness), PAIN (pain) and HYPERAESTHESIA (touch) outcome was unknown.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced CHEST PAIN (chest pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date for Chest pain, at a dose of UNK dosage form. At the time of the report, CHEST PAIN (chest pain) had resolved.        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.   No Concomitant medications and treatment medications was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: injection arm was not really sore like after the 1st dose; Shaking chills for a couple of hours or so; Really tired for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (injection arm was not really sore like after the 1st dose), CHILLS (Shaking chills for a couple of hours or so) and FATIGUE (Really tired for a day) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CHILLS (Shaking chills for a couple of hours or so) and FATIGUE (Really tired for a day). On an unknown date, the patient experienced PAIN IN EXTREMITY (injection arm was not really sore like after the 1st dose). On 09-Mar-2021, CHILLS (Shaking chills for a couple of hours or so) had resolved. On 10-Mar-2021, FATIGUE (Really tired for a day) had resolved. At the time of the report, PAIN IN EXTREMITY (injection arm was not really sore like after the 1st dose) had resolved.            Treatment information was not reported.  No concomitant medication was reported by the reporter.   This case was linked to MOD-2021-028994 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Event outcome updated.