chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Feeling hot, Gait disturbance, Pain
Clinical narrative: issues from the head down to the ankle on the left side; getting red and then it was red as a beat; swollen/swollen all the way down to the heel; hot; it hurt and is swollen all the way down to the heel; couldn't hardly walk; didn't even hurt for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (issues from the head down to the ankle on the left side), ERYTHEMA (getting red and then it was red as a beat), SWELLING (swollen/swollen all the way down to the heel), FEELING HOT (hot) and PAIN (it hurt and is swollen all the way down to the heel) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bee sting (Bees). Concomitant products included METOPROLOL, ALLOPURINOL (ALOPURINOL), CLOPIDOGREL BISULFATE (CLAVIXIN), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), VITAMIN B NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (issues from the head down to the ankle on the left side), ERYTHEMA (getting red and then it was red as a beat), SWELLING (swollen/swollen all the way down to the heel), FEELING HOT (hot), PAIN (it hurt and is swollen all the way down to the heel), GAIT DISTURBANCE (couldn't hardly walk) and PAIN IN EXTREMITY (didn't even hurt for 2 days). At the time of the report, DISCOMFORT (issues from the head down to the ankle on the left side), ERYTHEMA (getting red and then it was red as a beat), SWELLING (swollen/swollen all the way down to the heel), FEELING HOT (hot), PAIN (it hurt and is swollen all the way down to the heel), GAIT DISTURBANCE (couldn't hardly walk) and PAIN IN EXTREMITY (didn't even hurt for 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: issues from the head down to the ankle on the left side; getting red and then it was red as a beat; swollen/swollen all the way down to the heel; hot; it hurt and is swollen all the way down to the heel; couldn't hardly walk; didn't even hurt for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (issues from the head down to the ankle on the left side), ERYTHEMA (getting red and then it was red as a beat), SWELLING (swollen/swollen all the way down to the heel), FEELING HOT (hot) and PAIN (it hurt and is swollen all the way down to the heel) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bee sting (Bees). Concomitant products included METOPROLOL, ALLOPURINOL (ALOPURINOL), CLOPIDOGREL BISULFATE (CLAVIXIN), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), VITAMIN B NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (issues from the head down to the ankle on the left side), ERYTHEMA (getting red and then it was red as a beat), SWELLING (swollen/swollen all the way down to the heel), FEELING HOT (hot), PAIN (it hurt and is swollen all the way down to the heel), GAIT DISTURBANCE (couldn't hardly walk) and PAIN IN EXTREMITY (didn't even hurt for 2 days). At the time of the report, DISCOMFORT (issues from the head down to the ankle on the left side), ERYTHEMA (getting red and then it was red as a beat), SWELLING (swollen/swollen all the way down to the heel), FEELING HOT (hot), PAIN (it hurt and is swollen all the way down to the heel), GAIT DISTURBANCE (couldn't hardly walk) and PAIN IN EXTREMITY (didn't even hurt for 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: chest pains; heart palpitations; 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 CHEST PAIN (chest pains) and PALPITATIONS (heart palpitations) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pains) and PALPITATIONS (heart palpitations). At the time of the report, CHEST PAIN (chest pains) and PALPITATIONS (heart palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information is provided. No treatment information provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up received contains information about the event heart palpitations
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine administered to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to a patient) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to a patient). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to a patient) had 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Gait disturbance, Gait inability, Hypoaesthesia, Muscle spasms
Clinical narrative: like a cramp; started to limp; arthritis in my knee; pain is horrible; I can't walk; weak legs; muscle pain which started in my right arm; needles began in my body; numbness in my arm; pounding heart; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (needles began in my body), HYPOAESTHESIA (numbness in my arm), PALPITATIONS (pounding heart), MUSCLE SPASMS (like a cramp) and GAIT DISTURBANCE (started to limp) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia. Concomitant products included LOSARTAN and SIMVASTATIN for an unknown indication.   On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-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 PARAESTHESIA (needles began in my body), HYPOAESTHESIA (numbness in my arm), PALPITATIONS (pounding heart), MUSCLE SPASMS (like a cramp), GAIT DISTURBANCE (started to limp), ARTHRITIS (arthritis in my knee), PAIN (pain is horrible), GAIT INABILITY (I can't walk), MUSCULAR WEAKNESS (weak legs) and MYALGIA (muscle pain which started in my right arm). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and CORTISONE ACETATE (CORTISONE [CORTISONE ACETATE]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (needles began in my body), HYPOAESTHESIA (numbness in my arm), PALPITATIONS (pounding heart), MUSCLE SPASMS (like a cramp), GAIT DISTURBANCE (started to limp), ARTHRITIS (arthritis in my knee), PAIN (pain is horrible), GAIT INABILITY (I can't walk), MUSCULAR WEAKNESS (weak legs) and MYALGIA (muscle pain which started in my right arm) outcome was unknown.            Test done were ultrasound, X-ray result stated everything was fine First dose given in left non-dominant, Second dose scheduled for 16Aug2021 , numbness spread to my face, and then to my hands and feit was something that bothered me  yet, (muscle pain) was in the calf, after three days it was stronger, it then hit me in the back of my knee and thigh, numbness is in my left leg now, I have been walking with a walker CROSSLINK TO SON'S AE MOD21-128924
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Pain, Palpitations, Paraesthesia
Clinical narrative: like a cramp; started to limp; arthritis in my knee; pain is horrible; I can't walk; weak legs; muscle pain which started in my right arm; needles began in my body; numbness in my arm; pounding heart; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (needles began in my body), HYPOAESTHESIA (numbness in my arm), PALPITATIONS (pounding heart), MUSCLE SPASMS (like a cramp) and GAIT DISTURBANCE (started to limp) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia. Concomitant products included LOSARTAN and SIMVASTATIN for an unknown indication.   On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-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 PARAESTHESIA (needles began in my body), HYPOAESTHESIA (numbness in my arm), PALPITATIONS (pounding heart), MUSCLE SPASMS (like a cramp), GAIT DISTURBANCE (started to limp), ARTHRITIS (arthritis in my knee), PAIN (pain is horrible), GAIT INABILITY (I can't walk), MUSCULAR WEAKNESS (weak legs) and MYALGIA (muscle pain which started in my right arm). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and CORTISONE ACETATE (CORTISONE [CORTISONE ACETATE]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (needles began in my body), HYPOAESTHESIA (numbness in my arm), PALPITATIONS (pounding heart), MUSCLE SPASMS (like a cramp), GAIT DISTURBANCE (started to limp), ARTHRITIS (arthritis in my knee), PAIN (pain is horrible), GAIT INABILITY (I can't walk), MUSCULAR WEAKNESS (weak legs) and MYALGIA (muscle pain which started in my right arm) outcome was unknown.            Test done were ultrasound, X-ray result stated everything was fine First dose given in left non-dominant, Second dose scheduled for 16Aug2021 , numbness spread to my face, and then to my hands and feit was something that bothered me  yet, (muscle pain) was in the calf, after three days it was stronger, it then hit me in the back of my knee and thigh, numbness is in my left leg now, I have been walking with a walker CROSSLINK TO SON'S AE MOD21-128924
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: patient received 2 different manufactured doses of covid19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient received 2 different manufactured doses of covid19 vaccine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination.    No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient received 2 different manufactured doses of covid19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (patient received 2 different manufactured doses of covid19 vaccine) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow up received contains Non Significant Information.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Erythema, Paraesthesia, Product dose omission issue, Pruritus
Clinical narrative: sick to his stomach; itching on his hand and made it down to his feet; feet are tingly (bottom of feet and can't walk on carpet); little bumps on body; gets red and itch when exposed to the sun; itching; hands getting super tingly; legs start itching; Patient did not receive second dose; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to his stomach), PRURITUS (itching on his hand and made it down to his feet), PARAESTHESIA (feet are tingly (bottom of feet and can't walk on carpet)), SWELLING (little bumps on body) and ERYTHEMA (gets red and itch when exposed to the sun) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (sick to his stomach), PRURITUS (itching on his hand and made it down to his feet), PARAESTHESIA (feet are tingly (bottom of feet and can't walk on carpet)), SWELLING (little bumps on body), ERYTHEMA (gets red and itch when exposed to the sun), PRURITUS (itching), PARAESTHESIA (hands getting super tingly), PRURITUS (legs start itching) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (sick to his stomach), PRURITUS (itching on his hand and made it down to his feet), PARAESTHESIA (feet are tingly (bottom of feet and can't walk on carpet)), SWELLING (little bumps on body), ERYTHEMA (gets red and itch when exposed to the sun), PRURITUS (itching), PARAESTHESIA (hands getting super tingly) and PRURITUS (legs start itching) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that his face and arm were tanned, he could tolerate the sun. The patient reported his feet felt cold but not actually cold when he touched them. The patient reported going to the doctor and being prescribed something but he was unsure of the name of the medication because he had not picked it up yet.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: sick to his stomach; itching on his hand and made it down to his feet; feet are tingly (bottom of feet and can't walk on carpet); little bumps on body; gets red and itch when exposed to the sun; itching; hands getting super tingly; legs start itching; Patient did not receive second dose; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to his stomach), PRURITUS (itching on his hand and made it down to his feet), PARAESTHESIA (feet are tingly (bottom of feet and can't walk on carpet)), SWELLING (little bumps on body) and ERYTHEMA (gets red and itch when exposed to the sun) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (sick to his stomach), PRURITUS (itching on his hand and made it down to his feet), PARAESTHESIA (feet are tingly (bottom of feet and can't walk on carpet)), SWELLING (little bumps on body), ERYTHEMA (gets red and itch when exposed to the sun), PRURITUS (itching), PARAESTHESIA (hands getting super tingly), PRURITUS (legs start itching) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (sick to his stomach), PRURITUS (itching on his hand and made it down to his feet), PARAESTHESIA (feet are tingly (bottom of feet and can't walk on carpet)), SWELLING (little bumps on body), ERYTHEMA (gets red and itch when exposed to the sun), PRURITUS (itching), PARAESTHESIA (hands getting super tingly) and PRURITUS (legs start itching) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that his face and arm were tanned, he could tolerate the sun. The patient reported his feet felt cold but not actually cold when he touched them. The patient reported going to the doctor and being prescribed something but he was unsure of the name of the medication because he had not picked it up yet.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: sleepy; Tiredness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy) and FATIGUE (Tiredness) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepy) and FATIGUE (Tiredness). At the time of the report, SOMNOLENCE (sleepy) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-283057 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Incontinence, Pyrexia, Speech disorder
Clinical narrative: very difficult to walk,difficult time getting to bathroom; difficlty to speech; incontinence; 102 temp; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (very difficult to walk,difficult time getting to bathroom), SPEECH DISORDER (difficlty to speech), INCONTINENCE (incontinence) and PYREXIA (102 temp) 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 GAIT DISTURBANCE (very difficult to walk,difficult time getting to bathroom), SPEECH DISORDER (difficlty to speech), INCONTINENCE (incontinence) and PYREXIA (102 temp). At the time of the report, GAIT DISTURBANCE (very difficult to walk,difficult time getting to bathroom), SPEECH DISORDER (difficlty to speech), INCONTINENCE (incontinence) and PYREXIA (102 temp) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.  No concomitant medication was reported   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: First dose as Pfizer Covid19 Vaccine, second dose as Moderna; Pediatric patient received the Moderna Covid19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (First dose as Pfizer Covid19 Vaccine, second dose as Moderna) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received the Moderna Covid19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) 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, the patient experienced OFF LABEL USE (First dose as Pfizer Covid19 Vaccine, second dose as Moderna) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received the Moderna Covid19 Vaccine). At the time of the report, OFF LABEL USE (First dose as Pfizer Covid19 Vaccine, second dose as Moderna) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received the Moderna Covid19 Vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Oral discomfort
Clinical narrative: burning mouth; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (burning mouth) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL DISCOMFORT (burning mouth). At the time of the report, ORAL DISCOMFORT (burning mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product information was  provided. No Treatment information was  provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Fell out of bed while sister changing sheets (After second vaccine); This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell out of bed while sister changing sheets (After second vaccine)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Stroke (in early April) in April 2021.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FALL (Fell out of bed while sister changing sheets (After second vaccine)) (seriousness criterion hospitalization). At the time of the report, FALL (Fell out of bed while sister changing sheets (After second vaccine)) outcome was unknown.            It was stated that the rehab center has the records for the first vaccine but they could not find records of the second vaccine. Reporter stated that she was trying to change her sister's sheets and her sister fell out of bed. When emergency medical services  was taking her to the hospital, they her vaccination card. The reporter stated that her sister did not have any side effects after vaccination and the fall had nothing to do with the vaccine.   Concomitant medications were not reported . Treatment information was not provided.  Company comment Based on reporter's causality and the fact that patient fall out of bed during change of bedsheets, and patient did not experience any adverse reaction after vaccination, the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on reporter's causality and the fact that patient fall out of bed during change of bedsheets, and patient did not experience any adverse reaction after vaccination, the event is assessed as unlikely related to mRNA-1273.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Dizziness, Peripheral swelling, Somnolence
Clinical narrative: Drowsy; swollen left breast; Dizzy; swollen left arm/ swollen left under arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), SOMNOLENCE (Drowsy), PERIPHERAL SWELLING (swollen left arm/ swollen left under arm) and BREAST SWELLING (swollen left breast) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced DIZZINESS (Dizzy) and PERIPHERAL SWELLING (swollen left arm/ swollen left under arm). On 06-Aug-2021, the patient experienced BREAST SWELLING (swollen left breast). On an unknown date, the patient experienced SOMNOLENCE (Drowsy). On 09-Aug-2021, PERIPHERAL SWELLING (swollen left arm/ swollen left under arm) and BREAST SWELLING (swollen left breast) had resolved. At the time of the report, DIZZINESS (Dizzy) and SOMNOLENCE (Drowsy) outcome was unknown.        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 by the reporter
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Essential Thrombocytosis; Two strokes; Tingling in fingers and toes; Intermittent swooshing sound in both ears; Vision problems in both eyes; Lightheadedness/Dizziness; Joint pain; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ESSENTIAL THROMBOCYTHAEMIA (Essential Thrombocytosis) and CEREBROVASCULAR ACCIDENT (Two strokes) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included HYDROXYCARBAMIDE (HYDREA), PREDNISONE and APIXABAN (ELIQUIS) for an unknown indication.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ESSENTIAL THROMBOCYTHAEMIA (Essential Thrombocytosis) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (Two strokes) (seriousness criterion medically significant), PARAESTHESIA (Tingling in fingers and toes), TINNITUS (Intermittent swooshing sound in both ears), VISUAL IMPAIRMENT (Vision problems in both eyes), DIZZINESS (Lightheadedness/Dizziness), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue). At the time of the report, ESSENTIAL THROMBOCYTHAEMIA (Essential Thrombocytosis), CEREBROVASCULAR ACCIDENT (Two strokes), PARAESTHESIA (Tingling in fingers and toes), TINNITUS (Intermittent swooshing sound in both ears), VISUAL IMPAIRMENT (Vision problems in both eyes), DIZZINESS (Lightheadedness/Dizziness), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cytokine test: increase (High) Increase. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Abnormal MRI showed two strokes.. On an unknown date, Platelet count: 1.1 million to 1.8million (High) High.         Concomitant medication mentioned as Cholesterol pill ,Thyroid pill. Treatment information was not provided. On an unknown date the patient Cat Scan, blood work, bone marrow biopsy done , results were not reported.  Patient reported that she had four children with a 50 percent chance of passing on in particular the Essential Thrombocytosis.  The caller was advised not to get the vaccine, by her physician. When her mother tested for ET, Essential Thrombocytosis and said could have triggered this.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue
Clinical narrative: needle disconnected from the syringe during administration; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (needle disconnected from the syringe during administration) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021 at 5:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced DEVICE CONNECTION ISSUE (needle disconnected from the syringe during administration). At the time of the report, DEVICE CONNECTION ISSUE (needle disconnected from the syringe during administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo, Vomiting
Clinical narrative: felt like the room was spinning; Got really dizzy; Had nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (felt like the room was spinning), DIZZINESS (Got really dizzy), NAUSEA (Had nausea) and VOMITING (vomiting) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (felt like the room was spinning), DIZZINESS (Got really dizzy), NAUSEA (Had nausea) and VOMITING (vomiting). At the time of the report, VERTIGO (felt like the room was spinning), DIZZINESS (Got really dizzy), NAUSEA (Had nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Patient reported receiving medical care on 29APR2021. Treatment information included medication therapy.   This case was linked to MOD-2021-283235 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient was administered Pfizer vaccine as a second dose; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient was administered Pfizer vaccine as a second dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient was administered Pfizer vaccine as a second dose). On 09-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient was administered Pfizer vaccine as a second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information not reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Mycobacterium tuberculosis complex test, Tuberculosis
Clinical narrative: tested positive for tuberculosis; This spontaneous case was reported by a consumer and describes the occurrence of TUBERCULOSIS (tested positive for tuberculosis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease since 1970. Concomitant products included MESALAZINE (MESALAMINE DELAYED RELEASE), SERTRALINE HYDROCHLORIDE (ZOLOFT P), MULTIVITAMIN [VITAMINS NOS], DIAZEPAM (VALIUM) and INFLIXIMAB (INFLECTRA [INFLIXIMAB]) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-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 TUBERCULOSIS (tested positive for tuberculosis) (seriousness criterion medically significant). At the time of the report, TUBERCULOSIS (tested positive for tuberculosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) abnormal. On an unknown date, Mycobacterium tuberculosis complex test: positive (Positive) Positive.         Other concomitant medication included: Acycletere.  No treatment was reported.  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.  Fur the event Tuberculosis the drug Inflectra (Infliximab)  is a co suspect for the event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Fur the event Tuberculosis the drug Inflectra (Infliximab)  is a co suspect for the event.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Epstein-Barr symptoms have subtly disappeared, 3 weeks approximate after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Epstein-Barr symptoms have subtly disappeared, 3 weeks approximate after receiving the vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Epstein-Barr virus associated lymphoproliferative disorder (Patient experienced  Epstein-Barr virus (EBV) for already 3,5 years.).    On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Epstein-Barr symptoms have subtly disappeared, 3 weeks approximate after receiving the vaccine). The patient was treated with NALTREXONE for Epstein-Barr virus infection, at a dose of 18 months. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Epstein-Barr symptoms have subtly disappeared, 3 weeks approximate after receiving the vaccine) had resolved.            No concomitant medications reported. Treatment information not reported.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 year-old female received the 1st dose of Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year-old female received the 1st dose of Moderna COVID 19 vaccine) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year-old female received the 1st dose of Moderna COVID 19 vaccine). On 10-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year-old female received the 1st dose of Moderna COVID 19 vaccine) had 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.   No concomitant medications reported.  Treatment information not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurred vision). At the time of the report, VISION BLURRED (Blurred vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue
Clinical narrative: Developed red patches on both his arms and shoulders; Developed red patches on both his knees; Still very fatigued; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ERYTHEMA (Developed red patches on both his arms and shoulders), ERYTHEMA (Developed red patches on both his knees) and FATIGUE (Still very fatigued) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Brain injury (brain injury about 6 years ago). Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-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 ERYTHEMA (Developed red patches on both his arms and shoulders), ERYTHEMA (Developed red patches on both his knees) and FATIGUE (Still very fatigued). At the time of the report, ERYTHEMA (Developed red patches on both his arms and shoulders) and ERYTHEMA (Developed red patches on both his knees) outcome was unknown and FATIGUE (Still very fatigued) had not resolved.            No treatment medication were provided by the reporter
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to a 14 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 14 years old) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B12A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 14 years old). On 02-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 14 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  The patient did not have any side effects.  Treatment medications was not provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out with hives all over her body, including her arms, knees, elbows, and arms.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out with hives all over her body, including her arms, knees, elbows, and arms.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced URTICARIA (Broke out with hives all over her body, including her arms, knees, elbows, and arms.). At the time of the report, URTICARIA (Broke out with hives all over her body, including her arms, knees, elbows, and arms.) had not resolved.            No concomitant medication was taken. Treatment medication was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia, Vaccination complication
Clinical narrative: Did not have an easy second dose/ usual side effects; It was not painless; Really not well; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not have an easy second dose/ usual side effects), PAIN (It was not painless), MALAISE (Really not well) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-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 COMPLICATION (Did not have an easy second dose/ usual side effects), PAIN (It was not painless), MALAISE (Really not well) and PYREXIA (Fever). At the time of the report, VACCINATION COMPLICATION (Did not have an easy second dose/ usual side effects), PAIN (It was not painless), MALAISE (Really not well) and PYREXIA (Fever) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller reported pain on his feet after 2nd dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Caller reported pain on his feet after 2nd dose of Moderna 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Caller reported pain on his feet after 2nd dose of Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Caller reported pain on his feet after 2nd dose of Moderna vaccine) outcome was unknown.            No Concomitant Medications details were provided. No Treatment Medications details were provided.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Myalgia, Oropharyngeal pain
Clinical narrative: all the lymph nodes on the left side of my neck were hard and sore; all the lymph nodes on the left side of my neck were hard and sore; sore arm; sore throat, like strep throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat, like strep throat), LYMPHADENOPATHY (all the lymph nodes on the left side of my neck were hard and sore), LYMPH NODE PAIN (all the lymph nodes on the left side of my neck were hard and sore) and MYALGIA (sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced LYMPHADENOPATHY (all the lymph nodes on the left side of my neck were hard and sore), LYMPH NODE PAIN (all the lymph nodes on the left side of my neck were hard and sore) and MYALGIA (sore arm). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat, like strep throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat, like strep throat) had resolved and LYMPHADENOPATHY (all the lymph nodes on the left side of my neck were hard and sore), LYMPH NODE PAIN (all the lymph nodes on the left side of my neck were hard and sore) and MYALGIA (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-283227 (Patient Link).