chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fall, Hypoaesthesia, Peripheral swelling, Pruritus
Clinical narrative: possibility of a blood clot; Legs were numb; Rash on arm; Whole arm was totally swollen; whole arm Itchy; Fell down; weakness post-vaccination; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (possibility of a blood clot), HYPOAESTHESIA (Legs were numb), RASH (Rash on arm) and PERIPHERAL SWELLING (Whole arm was totally swollen) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 3020B1A and 044BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced THROMBOSIS (possibility of a blood clot) (seriousness criteria hospitalization and medically significant), HYPOAESTHESIA (Legs were numb) (seriousness criterion hospitalization), RASH (Rash on arm) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Whole arm was totally swollen) (seriousness criterion hospitalization), PRURITUS (whole arm Itchy), ASTHENIA (weakness post-vaccination) and PYREXIA (fever). 30-Apr-2021, the patient experienced FALL (Fell down). The patient was hospitalized on 30-Apr-2021 due to HYPOAESTHESIA and PERIPHERAL SWELLING. At the time of the report, THROMBOSIS (possibility of a blood clot), HYPOAESTHESIA (Legs were numb), RASH (Rash on arm), PERIPHERAL SWELLING (Whole arm was totally swollen), PRURITUS (whole arm Itchy), FALL (Fell down), ASTHENIA (weakness post-vaccination) and PYREXIA (fever) outcome was unknown.            No concomitant medications were reported.  Treatment for the events included IV antibiotics, medication to stop itching, oral cephalexin, and Tylenol.  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-2021-121103 (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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Thrombosis
Clinical narrative: possibility of a blood clot; Legs were numb; Rash on arm; Whole arm was totally swollen; whole arm Itchy; Fell down; weakness post-vaccination; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (possibility of a blood clot), HYPOAESTHESIA (Legs were numb), RASH (Rash on arm) and PERIPHERAL SWELLING (Whole arm was totally swollen) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 3020B1A and 044BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced THROMBOSIS (possibility of a blood clot) (seriousness criteria hospitalization and medically significant), HYPOAESTHESIA (Legs were numb) (seriousness criterion hospitalization), RASH (Rash on arm) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Whole arm was totally swollen) (seriousness criterion hospitalization), PRURITUS (whole arm Itchy), ASTHENIA (weakness post-vaccination) and PYREXIA (fever). 30-Apr-2021, the patient experienced FALL (Fell down). The patient was hospitalized on 30-Apr-2021 due to HYPOAESTHESIA and PERIPHERAL SWELLING. At the time of the report, THROMBOSIS (possibility of a blood clot), HYPOAESTHESIA (Legs were numb), RASH (Rash on arm), PERIPHERAL SWELLING (Whole arm was totally swollen), PRURITUS (whole arm Itchy), FALL (Fell down), ASTHENIA (weakness post-vaccination) and PYREXIA (fever) outcome was unknown.            No concomitant medications were reported.  Treatment for the events included IV antibiotics, medication to stop itching, oral cephalexin, and Tylenol.  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-2021-121103 (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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic Reaction following her second Moderna covid 19 vaccine; This case was received via VAERS (Reference number: 496918) on 05-May-2021 and was forwarded to Moderna on 05-May-2021.    This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic Reaction following her second Moderna Covid 19 vaccine) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0210Z1A and 006BZ1A) for COVID-19 vaccination. Concurrent medical conditions included Asthma, Allergy to animal (Report mentions allergy to Cat dancer), Allergy to metals (No details), Latex allergy (No details), Drug allergy (Neomycin), Drug allergy (Ativan), Environmental allergy (No details), Drug allergy (Risperdal), Drug allergy (Depakote) and Allergy to vaccine. Concomitant products included EPINEPHRINE (EPIPEN), CELECOXIB (CELEXA [CELECOXIB]), MONTELUKAST SODIUM (SINGULAIR), ETONOGESTREL (NEXPLANON), OMEPRAZOLE, FLUTICASONE and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (Allergic Reaction following her second Moderna covid 19 vaccine) (seriousness criterion life threatening). At the time of the report, HYPERSENSITIVITY (Allergic Reaction following her second Moderna covid 19 vaccine) had resolved. Patient presented to the emergency room by EMS for allergic reaction following her second Moderna covid 19 vaccine.  She received her shot and began to feel her tongue swelling and she developed body wide itching. Patient received an injection of her Epi-pen at the facility and transferred to the emergency room. She was observed on a cardiac monitor for several hours and discharged home. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included administration of the patient's prescribed Epi-pen. This was administered at the vaccine facility. The patient was subsequently transferred to the emergency room. The patient was on a cardiac monitoring in the emergency room for several hours and was ultimately discharged home. It was noted per source that COVID vaccination will now be listed as an allergy for the patient.  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: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: oxygen levels were down to 88; Diagnosed with COVID-19; Second dose will be greater than day 36; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19) and OXYGEN SATURATION DECREASED (oxygen levels were down to 88) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No medical history was provided by the reporter. The patient's past medical history included TIA (7-8 years ago). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), METOPROLOL, AMLODIPINE, ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]), CLOPIDOGREL BISULFATE (PLAVIX) and ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced COVID-19 (Diagnosed with COVID-19) (seriousness criterion hospitalization). On 15-Feb-2021, the patient experienced OXYGEN SATURATION DECREASED (oxygen levels were down to 88) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose will be greater than day 36). The patient was hospitalized from 15-Feb-2021 to sometime in March 2021 due to COVID-19 and OXYGEN SATURATION DECREASED. At the time of the report, COVID-19 (Diagnosed with COVID-19) and OXYGEN SATURATION DECREASED (oxygen levels were down to 88) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose will be greater than day 36) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Oxygen saturation: 88 (Low) 88 percent.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient doctor sent him to the emergency room on 15-Feb-2021 where the patient stayed on a ventilator for a month.  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 is unlikely or not applicable.; 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 is unlikely or not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Death
Clinical narrative: Change in patient's condition; Passed away; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Passed away) and ADVERSE EVENT (Change in patient's condition) 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 26-Apr-2021, the patient experienced ADVERSE EVENT (Change in patient's condition) (seriousness criterion hospitalization). The patient died on 06-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ADVERSE EVENT (Change in patient's condition) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No 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; Reported Cause(s) of Death: Unknown cause of death
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Belsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Belsy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 031B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ELETRIPTAN for Migraine, VITAMINS NOS for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BELL'S PALSY (Bell's Belsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Belsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Event treatment information was not provided by the reporter.  Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Patient was Hospitalized for two months DUE to COVID; The window for the second dose is missed; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient was Hospitalized for two months DUE to COVID) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient was Hospitalized for two months DUE to COVID) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (The window for the second dose is missed). The patient was hospitalized for 60 days due to COVID-19. At the time of the report, COVID-19 (Patient was Hospitalized for two months DUE to COVID) and PRODUCT DOSE OMISSION ISSUE (The window for the second dose is missed) 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.   Lab results included patient had a positive SARS-COV-2 test on an unknown date, after the first vaccine was administered. Treatment include patient received the antibodies and was hospitalized for two months due to COVID-19.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Unlikely that the events are related to the vaccine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Unlikely that the events are related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke (had 2nd dose of Moderna vaccine); This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke (had 2nd dose of Moderna vaccine)) 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) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke (had 2nd dose of Moderna vaccine)) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke (had 2nd dose of Moderna vaccine)) outcome was unknown. No treatment or concomitant medications reported.  A female patient of an unknown age who received mRNA-1273 experienced CEREBROVASCULAR ACCIDENT on an unknown date after the second dose of vaccine. No Medical History or concomitant medications reported. Very limited information has been reported at this time. Further information is expected.; Sender's Comments: A female patient of an unknown age who received mRNA-1273 experienced CEREBROVASCULAR ACCIDENT on an unknown date after the second dose of vaccine. No Medical History or concomitant medications reported. Very limited information has been reported at this time. Further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctival hyperaemia
Clinical narrative: Right eye that look like a rupture of a blood vessel; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HYPERAEMIA (Right eye that look like a rupture of a blood vessel) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced CONJUNCTIVAL HYPERAEMIA (Right eye that look like a rupture of a blood vessel). In April 2021, CONJUNCTIVAL HYPERAEMIA (Right eye that look like a rupture of a blood vessel) had resolved.            Treatment included Paracetamol and Ibuprofen.  Concomitant medication was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD21-086966 (E2B Linked Report). This case was linked to MOD-2021-109540 (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. MOD21-086966:Same reporter
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Contusion, Erythema, Fall, Feeling abnormal
Clinical narrative: Felt like he had COVID; Balance was off; Could not walk straight; Fell against wall, Busted left elbow from fall; Big bruise on left elbow from fall; Felt so bad, like he was going to die; Couldn't taste food; Couldn't smell food; seemed to have AFIB; Fever; Chills; Body hurt all over; Right arm was swollen; Right arm was red; Right arm hot like a firecracker fom the shot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (seemed to have AFIB) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red) and FEELING HOT (Right arm hot like a firecracker fom the shot). On an unknown date, the patient experienced ATRIAL FIBRILLATION (seemed to have AFIB) (seriousness criterion medically significant), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over). The patient was treated with Bed rest for Suspected COVID-19. At the time of the report, ATRIAL FIBRILLATION (seemed to have AFIB), PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), FEELING HOT (Right arm hot like a firecracker fom the shot), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: up (High) up. On an unknown date, Heart rate: 130 (abnormal) 130 per minute. On an unknown date, Hepatic enzyme: slightly elevated (High) slightly elevated. On an unknown date, White blood cell count: slightly elevated (High) slightly elevated.         The patient was under doctor's care at the time of report.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate, Hepatic enzyme, Myalgia, Peripheral swelling
Clinical narrative: Felt like he had COVID; Balance was off; Could not walk straight; Fell against wall, Busted left elbow from fall; Big bruise on left elbow from fall; Felt so bad, like he was going to die; Couldn't taste food; Couldn't smell food; seemed to have AFIB; Fever; Chills; Body hurt all over; Right arm was swollen; Right arm was red; Right arm hot like a firecracker fom the shot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (seemed to have AFIB) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red) and FEELING HOT (Right arm hot like a firecracker fom the shot). On an unknown date, the patient experienced ATRIAL FIBRILLATION (seemed to have AFIB) (seriousness criterion medically significant), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over). The patient was treated with Bed rest for Suspected COVID-19. At the time of the report, ATRIAL FIBRILLATION (seemed to have AFIB), PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), FEELING HOT (Right arm hot like a firecracker fom the shot), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: up (High) up. On an unknown date, Heart rate: 130 (abnormal) 130 per minute. On an unknown date, Hepatic enzyme: slightly elevated (High) slightly elevated. On an unknown date, White blood cell count: slightly elevated (High) slightly elevated.         The patient was under doctor's care at the time of report.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19, White blood cell count
Clinical narrative: Felt like he had COVID; Balance was off; Could not walk straight; Fell against wall, Busted left elbow from fall; Big bruise on left elbow from fall; Felt so bad, like he was going to die; Couldn't taste food; Couldn't smell food; seemed to have AFIB; Fever; Chills; Body hurt all over; Right arm was swollen; Right arm was red; Right arm hot like a firecracker fom the shot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (seemed to have AFIB) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red) and FEELING HOT (Right arm hot like a firecracker fom the shot). On an unknown date, the patient experienced ATRIAL FIBRILLATION (seemed to have AFIB) (seriousness criterion medically significant), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over). The patient was treated with Bed rest for Suspected COVID-19. At the time of the report, ATRIAL FIBRILLATION (seemed to have AFIB), PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), FEELING HOT (Right arm hot like a firecracker fom the shot), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: up (High) up. On an unknown date, Heart rate: 130 (abnormal) 130 per minute. On an unknown date, Hepatic enzyme: slightly elevated (High) slightly elevated. On an unknown date, White blood cell count: slightly elevated (High) slightly elevated.         The patient was under doctor's care at the time of report.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.  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 BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included prednisone and unspecified antivirals. No concomitant medications reported.  Company comment: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Small intestinal obstruction
Clinical narrative: small bowel obstruction; shortness of breath; This spontaneous case was reported by an other caregiver and describes the occurrence of SMALL INTESTINAL OBSTRUCTION (small bowel obstruction) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Small bowel obstruction. Concurrent medical conditions included Emphysema.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced DYSPNOEA (shortness of breath). On an unknown date, the patient experienced SMALL INTESTINAL OBSTRUCTION (small bowel obstruction) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 04-May-2021 due to SMALL INTESTINAL OBSTRUCTION. At the time of the report, SMALL INTESTINAL OBSTRUCTION (small bowel obstruction) and DYSPNOEA (shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included an unspecified inhaler for emphysema.   Treatment for the events included use of a tube and relive the pressure of the small bowel obstruction without surgery and an unspecified steroid medication to treat the shortness of breath.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate increased, Orthostatic hypotension
Clinical narrative: significant dropped in her systolic pressure; Feel like her heart is racing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ORTHOSTATIC HYPOTENSION (significant dropped in her systolic pressure) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (HYDROCHLOROTHIAZIDE WITH TRIAMTERENE) for Blood pressure management.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORTHOSTATIC HYPOTENSION (significant dropped in her systolic pressure) (seriousness criterion hospitalization) and HEART RATE INCREASED (Feel like her heart is racing). The patient was hospitalized from 26-Apr-2021 to 28-Apr-2021 due to ORTHOSTATIC HYPOTENSION. At the time of the report, ORTHOSTATIC HYPOTENSION (significant dropped in her systolic pressure) and HEART RATE INCREASED (Feel like her heart is racing) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: decreased (Low) decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 was not applicable.  On 26-Apr-2021, it was reported that the patient was admitted to the hospital for the adverse event and was discharged on 28-Apr-2021.  On 03-May-2021, the patient was re-admitted to the hospital and treatment provided included intra-venous fluids (IV fluids). It was also reported that concomitant medications, hydrochlorothiazide and triamterene were stopped.   This case was linked to MOD-2021-116530 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Incomplete course of vaccination
Clinical narrative: not going to receive 2nd dose; tonic-clonic seizure/intense seizure; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizure/intense seizure) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizure (1st time he had seizure when he took Benadryl 10 month ago when he was 17 year old).). Concurrent medical conditions included Autism. Concomitant products included LORATADINE (CLARITINE) 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 05-May-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizure/intense seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (not going to receive 2nd dose). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizure/intense seizure) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (not going to receive 2nd dose) had resolved. No treatment details provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication information was provided. The patient was on testing at the time of report. Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested. Causal relationship cannot be excluded for the event of Generalised tonic-clonic seizure. Company causality for Incomplete course of vaccination was assessed as not applicable.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Causal relationship cannot be excluded for the event of Generalised tonic-clonic seizure. Company causality for Incomplete course of vaccination was assessed as not applicable.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Possible Guillain-Barre; Weakness in his legs up through his abdomen and lower back; Numbness in his legs up through his abdomen and lower back; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Possible Guillain-Barre) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure abnormal and Blood cholesterol abnormal.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-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 GUILLAIN-BARRE SYNDROME (Possible Guillain-Barre) (seriousness criterion medically significant), ASTHENIA (Weakness in his legs up through his abdomen and lower back) and HYPOAESTHESIA (Numbness in his legs up through his abdomen and lower back). At the time of the report, GUILLAIN-BARRE SYNDROME (Possible Guillain-Barre), ASTHENIA (Weakness in his legs up through his abdomen and lower back) and HYPOAESTHESIA (Numbness in his legs up through his abdomen and lower back) outcome was unknown.            Concomitant medications included blood pressure medicine and cholesterol medicine.  Treatment information was not provided.  The caller stated that although they are still running some tests, his doctors believe that he developed Guillain-Barre after receiving the vaccine  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Loss my hearing in left ear; Light ringing/buzzing in right ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Loss my hearing in left ear) in a 61-year-old male patient 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 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DEAFNESS UNILATERAL (Loss my hearing in left ear) (seriousness criterion medically significant) and TINNITUS (Light ringing/buzzing in right ear). At the time of the report, DEAFNESS UNILATERAL (Loss my hearing in left ear) and TINNITUS (Light ringing/buzzing in right ear) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  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-2021-118211 (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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Grass allergy and Allergy to plants (to trees).    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (Allergic reaction) (seriousness criterion medically significant). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown. Medically Significant      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No relevant concomitant medications were provided.  Patient experienced allergic reaction immediately within 20 minutes. She was taken to the hospital and stayed there for 4 to 5 hours. Patient did not take the second dose as her doctor said not to take the second vaccine as she got an allergic reaction. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No treatment information was provided.  Company Comment: 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.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Fatigue, Feeling abnormal, Vertigo
Clinical narrative: feel 'really terrible'; fatigue; feel like my equilibrium is off; mild vertigo; wobbly; This is a spontaneous report from a contactable consumer (reported for himself).  A male patient (Age: 78, Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported) via an unknown route of administration on 13Jan2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 23Jan2021, the patient feels really terrible, fatigue, feel like my equilibrium is off, mild vertigo and wobbly. By the afternoon on 24Jan2021 it was all gone and on 25Jan2021, patient was fine. It was reported that on tuesday the events hit again also in morning but much milder. Patient questioned as he decides not to take the 2nd dose of the covid vaccine on 03Feb2021 as it was scheduled, could he take it 2-3 weeks later and how long the 1st dose will be effective for. Patient has already seen his doctor about his side effects but was told it was a mild case of vertigo. Patient is not satisfied with the response as he has not had a bout of vertigo in about 40-50 years. The outcome of the events was not recovered.  Information on LOT/ Batch number has been requested.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site pain
Clinical narrative: she has pain in the left arm where the injection was given; could not move her arm she had to use her opposite arm to lift her arm; This is a spontaneous report from a contactable registered nurse (patient, reported for herself). A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 27Jan2021 as single dose for covid-19 immunization. Medical history included ongoing migraine. The patient's concomitant medications were not reported. In Jan2021, the patient has pain in the left arm where the injection was given, could not move her arm she had to use her opposite arm to lift her arm. It was unknown whether the reporter was a healthcare professional or prescribing HCP. The reporter's contact information was available to a sub-contracted party. Patient reported that she has a history of migraines. Patient would like to know if it would be safe to take Imitrex, Sumatriptan, Eliquis, Propranolol, Crestor and Rosuvastatin after taking the Pfizer COVID vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (28Jan2021): This is a Follow-up spontaneous report from a Pfizer-sponsored program. A contactable Nurse reported that: Caller has received vaccine and wants to know if she can take Imitrex.  Follow-up attempts were completed. No further information was expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Dizziness, Oral pruritus, Paraesthesia
Clinical narrative: 10 minutes post-administration, patient developed itchy rash on right cheek.; Symptoms include itching, burning, and tingling at rash site/ Itching worsened and spread throughout body; Symptoms include itching, burning, and tingling at rash site.; Symptoms include itching, burning, and tingling at rash site.; Patient was also thirsty (was given water).; feverish; dizzy; Itching started in mouth; began to feel shaky and still feeling dizzy; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 67-year-old (non-pregnant) female patient who received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL3247) intramuscularly into the left arm on 28Jan2021 (at the age of 67-year-old) as first dose single for COVID-19 immunization. The patient medical history included hypertension, hypothyroid and known allergies to Aspirin, Codeine, Tolyn, Compazine, Nubain, Reglan, Toradol, Vicodin, morphine and Dilaudid at an unspecified date. Concomitant medications included Lisinopril, gabapentin, Ambien, Synthroid on an unspecified date. On an unspecified date, the patient had COVID prior vaccination and not tested post vaccination. On 28Jan2021, ten minutes post-administration, the patient developed itchy rash on right cheek. Symptoms included itching, burning and tingling at rash site. Patient was also thirsty (was given water). Benadryl oral was given. Symptoms were not resolving and patient began to feel feverish and dizzy. Itching worsened and spread throughout body. Dexamethasone oral was given. Itching started in mouth. EpiPen was administered intramuscularly to left vastus lateralis. Hypertension was seen. Itching in mouth subsided 15 minutes post EpiPen, but patient began to feel shaky and still feeling dizzy. The patient underwent lab tests which included body temperature as feverish on 28Jan2021. Monitored for additional 20 minutes. After, patient was stable and walked out via wheelchair enroute home. No other vaccines in four weeks. Treatment was received with Benadryl, dexamethasone, EpiPen. The outcome of the events were recovering.  Follow-up attempts are completed. No further information is expected.