chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Hypoaesthesia, Injection site pain
Clinical narrative: FEELS DRAINED; FEELS SLEEPY; HARDER TO BREATHE; LOSING TRACK OF THOUGHT/COGNATIVE THOUGHT IS OFF; TEETH ACHE; LOSS OF APPETITE; LIGHTHEADED; MASSIVE RINGING THE EARS; DRY MOUTH; LEFT HAND FEELS TINGLY; LEFT HAND FEELS NUMB; CHILLS; FEELS EXHAUSTED; LEFT ARM IS SORE AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 52 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced feels sleepy. On 08-MAY-2021, the subject experienced harder to breathe. On 08-MAY-2021, the subject experienced losing track of thought/cognative thought is off. On 08-MAY-2021, the subject experienced teeth ache. On 08-MAY-2021, the subject experienced loss of appetite. On 08-MAY-2021, the subject experienced lightheaded. On 08-MAY-2021, the subject experienced massive ringing the ears. On 08-MAY-2021, the subject experienced dry mouth. On 08-MAY-2021, the subject experienced left hand feels tingly. On 08-MAY-2021, the subject experienced left hand feels numb. On 08-MAY-2021, the subject experienced chills. On 08-MAY-2021, the subject experienced feels exhausted. On 08-MAY-2021, the subject experienced left arm is sore at the injection site. On 08-MAY-2021 20:00, the subject experienced feels drained. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from teeth ache, and massive ringing the ears, and had not recovered from feels drained, chills, feels sleepy, harder to breathe, losing track of thought/cognative thought is off, loss of appetite, lightheaded, dry mouth, left hand feels tingly, left arm is sore at the injection site, feels exhausted, and left hand feels numb. This report was non-serious.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia, Somnolence, Tinnitus, Toothache
Clinical narrative: FEELS DRAINED; FEELS SLEEPY; HARDER TO BREATHE; LOSING TRACK OF THOUGHT/COGNATIVE THOUGHT IS OFF; TEETH ACHE; LOSS OF APPETITE; LIGHTHEADED; MASSIVE RINGING THE EARS; DRY MOUTH; LEFT HAND FEELS TINGLY; LEFT HAND FEELS NUMB; CHILLS; FEELS EXHAUSTED; LEFT ARM IS SORE AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 52 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced feels sleepy. On 08-MAY-2021, the subject experienced harder to breathe. On 08-MAY-2021, the subject experienced losing track of thought/cognative thought is off. On 08-MAY-2021, the subject experienced teeth ache. On 08-MAY-2021, the subject experienced loss of appetite. On 08-MAY-2021, the subject experienced lightheaded. On 08-MAY-2021, the subject experienced massive ringing the ears. On 08-MAY-2021, the subject experienced dry mouth. On 08-MAY-2021, the subject experienced left hand feels tingly. On 08-MAY-2021, the subject experienced left hand feels numb. On 08-MAY-2021, the subject experienced chills. On 08-MAY-2021, the subject experienced feels exhausted. On 08-MAY-2021, the subject experienced left arm is sore at the injection site. On 08-MAY-2021 20:00, the subject experienced feels drained. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from teeth ache, and massive ringing the ears, and had not recovered from feels drained, chills, feels sleepy, harder to breathe, losing track of thought/cognative thought is off, loss of appetite, lightheaded, dry mouth, left hand feels tingly, left arm is sore at the injection site, feels exhausted, and left hand feels numb. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Heart rate normal
Clinical narrative: FASTER THAN USUAL HEART RATE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported. On MAY-2021, the subject experienced faster than usual heart rate. Laboratory data included: Heart rate increased (NR: not provided) 71 bpm. Laboratory data (dates unspecified) included: Heart rate increased (NR: not provided) 94-107 bpm, and Heart rate normal (NR: not provided) 58 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of faster than usual heart rate was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Dizziness, Fatigue, Headache
Clinical narrative: ABDOMINAL CRAMPING; BACK PAIN; DIZZY; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced abdominal cramping. On 07-MAY-2021, the subject experienced back pain. On 07-MAY-2021, the subject experienced dizzy. On 07-MAY-2021, the subject experienced headache. On 07-MAY-2021, the subject experienced fatigue. On 07-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal cramping, headache, back pain, fatigue, dizzy, and nausea. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: ABDOMINAL CRAMPING; BACK PAIN; DIZZY; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced abdominal cramping. On 07-MAY-2021, the subject experienced back pain. On 07-MAY-2021, the subject experienced dizzy. On 07-MAY-2021, the subject experienced headache. On 07-MAY-2021, the subject experienced fatigue. On 07-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal cramping, headache, back pain, fatigue, dizzy, and nausea. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE THAT WAS LEFT OUT OF FRIDGE FOR FOUR AND A HALF HOURS; This spontaneous report received from a pharmacist concerned an 18 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced administration of vaccine that was left out of fridge for four and a half hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine that was left out of fridge for four and a half hours was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Neck pain, Pyrexia
Clinical narrative: NECK PAIN VERY TENDER TO TOUCH; SHOULDER PAIN VERY TENDER TO TOUCH; LOW GRADE FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-MAY-2021 18:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAY-2021, the subject experienced low grade fever. On 07-MAY-2021, the subject experienced injection site pain. On 08-MAY-2021, the subject experienced neck pain very tender to touch. On 08-MAY-2021, the subject experienced shoulder pain very tender to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and injection site pain on 08-MAY-2021, and had not recovered from shoulder pain very tender to touch, and neck pain very tender to touch. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Lethargy, Pyrexia
Clinical narrative: FEVER DREAMS; LETHARGIC; FEVERISH; This spontaneous report received from a consumer concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-APR-2021, the subject experienced fever dreams. On 28-APR-2021, the subject experienced lethargic. On 28-APR-2021, the subject experienced feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever dreams, lethargic, and feverish on 29-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced chills. On 27-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 28-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210516323.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Dizziness, Pain, Pyrexia
Clinical narrative: SORENESS; DIARRHEA; DIZZINESS; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAY-2021, the subject experienced soreness. On 08-MAY-2021, the subject experienced diarrhea. On 08-MAY-2021, the subject experienced dizziness. On 08-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness, fever, diarrhea, and dizziness. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lip exfoliation, Oral herpes
Clinical narrative: FEVER BLISTER/ COLD SORES; LIPS  EXFOLIATING/ PEELING; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fever blister/ cold sores, and lips exfoliating/ peeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever blister/ cold sores and lips exfoliating/ peeling was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: EXTRA DOSE ADMINISTERED; This spontaneous report received from a physician concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021, and dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAY-2021, the subject experienced extra dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extra dose administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION BURNED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to pine trees and other pollen producing trees and grass, runny nose, cough, and watery eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included diphenhydramine hydrochloride for seasonal allergies. On 2021, the subject experienced injection burned. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection burned was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a health care professional concerned an elderly male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On MAY-2021, the subject experienced body aches. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache and body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: HEADACHES; MUSCLE PAIN/MUSCLES ACHES IN LEGS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced headaches. On 06-APR-2021, the subject experienced muscle pain/muscles aches in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headaches and muscle pain/muscle pain/muscles aches in leg was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Diarrhoea, Dizziness, Dysgeusia
Clinical narrative: PALPITATIONS; RIGHT CALF CRAMPS; DYSGEUSIA; TINNITUS; DIARRHEA; DIZZINESS; CHILLS; FEVER; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was 225 pounds, and height was 62 inches. The patient's concurrent conditions included chronic kidney disease, meniere's disease, anxiety, occasional drinker, non smoker, allergic to keflex, and environmental allergies, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for chronic kidney disease, and spironolactone for chronic kidney disease. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced tinnitus. On 14-APR-2021, the subject experienced diarrhea. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced chills. On 14-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced dysgeusia. On 03-MAY-2021, the subject experienced palpitations. On 03-MAY-2021, the subject experienced right calf cramps. On 05-MAY-2021, Laboratory data included: Doppler scan (NR: not provided) Negative, and Electrocardiogram (NR: not provided) Normal. On 07-MAY-2021, Laboratory data included: Blood test (NR: not provided) Unknown, and Urinalysis (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dysgeusia on 24-APR-2021, diarrhea on 14-APR-2021, right calf cramps on 04-MAY-2021, chills, and fever on 15-APR-2021, and nausea on 16-APR-2021, and was recovering from dizziness, tinnitus, palpitations, and fatigue. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Nausea, Pain in extremity, Palpitations
Clinical narrative: PALPITATIONS; RIGHT CALF CRAMPS; DYSGEUSIA; TINNITUS; DIARRHEA; DIZZINESS; CHILLS; FEVER; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was 225 pounds, and height was 62 inches. The patient's concurrent conditions included chronic kidney disease, meniere's disease, anxiety, occasional drinker, non smoker, allergic to keflex, and environmental allergies, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for chronic kidney disease, and spironolactone for chronic kidney disease. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced tinnitus. On 14-APR-2021, the subject experienced diarrhea. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced chills. On 14-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced dysgeusia. On 03-MAY-2021, the subject experienced palpitations. On 03-MAY-2021, the subject experienced right calf cramps. On 05-MAY-2021, Laboratory data included: Doppler scan (NR: not provided) Negative, and Electrocardiogram (NR: not provided) Normal. On 07-MAY-2021, Laboratory data included: Blood test (NR: not provided) Unknown, and Urinalysis (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dysgeusia on 24-APR-2021, diarrhea on 14-APR-2021, right calf cramps on 04-MAY-2021, chills, and fever on 15-APR-2021, and nausea on 16-APR-2021, and was recovering from dizziness, tinnitus, palpitations, and fatigue. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus, Ultrasound Doppler, Urine analysis
Clinical narrative: PALPITATIONS; RIGHT CALF CRAMPS; DYSGEUSIA; TINNITUS; DIARRHEA; DIZZINESS; CHILLS; FEVER; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was 225 pounds, and height was 62 inches. The patient's concurrent conditions included chronic kidney disease, meniere's disease, anxiety, occasional drinker, non smoker, allergic to keflex, and environmental allergies, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for chronic kidney disease, and spironolactone for chronic kidney disease. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced tinnitus. On 14-APR-2021, the subject experienced diarrhea. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced chills. On 14-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced dysgeusia. On 03-MAY-2021, the subject experienced palpitations. On 03-MAY-2021, the subject experienced right calf cramps. On 05-MAY-2021, Laboratory data included: Doppler scan (NR: not provided) Negative, and Electrocardiogram (NR: not provided) Normal. On 07-MAY-2021, Laboratory data included: Blood test (NR: not provided) Unknown, and Urinalysis (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dysgeusia on 24-APR-2021, diarrhea on 14-APR-2021, right calf cramps on 04-MAY-2021, chills, and fever on 15-APR-2021, and nausea on 16-APR-2021, and was recovering from dizziness, tinnitus, palpitations, and fatigue. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache
Clinical narrative: HEAVY BREATHING EVEN IF JUST TALKING/SHORTNESS OF BREATH; HEADACHES; HEAVINESS IN CHEST/FEELS LIKE SOMEONE IS SITTING ON MY CHEST; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced heaviness in chest/feels like someone is sitting on my chest. On 02-APR-2021, the subject experienced heavy breathing even if im just talking/shortness of breath. On 02-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy breathing even if  just talking/shortness of breath, and the outcome of headaches and heaviness in chest/feels like someone is sitting on my chest was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac stress test, Chest discomfort, Computerised tomogram, Dyspnoea
Clinical narrative: HEAVY BREATHING EVEN IF JUST TALKING/SHORTNESS OF BREATH; HEADACHES; HEAVINESS IN CHEST/FEELS LIKE SOMEONE IS SITTING ON MY CHEST; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced heaviness in chest/feels like someone is sitting on my chest. On 02-APR-2021, the subject experienced heavy breathing even if im just talking/shortness of breath. On 02-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy breathing even if  just talking/shortness of breath, and the outcome of headaches and heaviness in chest/feels like someone is sitting on my chest was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Scan with contrast, Ultrasound chest
Clinical narrative: HEAVY BREATHING EVEN IF JUST TALKING/SHORTNESS OF BREATH; HEADACHES; HEAVINESS IN CHEST/FEELS LIKE SOMEONE IS SITTING ON MY CHEST; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced heaviness in chest/feels like someone is sitting on my chest. On 02-APR-2021, the subject experienced heavy breathing even if im just talking/shortness of breath. On 02-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy breathing even if  just talking/shortness of breath, and the outcome of headaches and heaviness in chest/feels like someone is sitting on my chest was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: CARDIAC EVENT; This spontaneous report received from a patient via a company representative concerned a 42 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 01-MAY-2021, the subject experienced cardiac event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cardiac event on 08-MAY-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: GONE THROUGH HELL TODAY; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 08-MAY-2021, the subject experienced gone through hell today. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of gone through hell today was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: EXTREMELY TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced extremely tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extremely tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Headache, Nausea, Pain
Clinical narrative: ACHE; FEVER; HEADACHE; NAUSEOUS; BURNING SENSATION ON RIGHT ARM DOWN TO WRIST; This spontaneous report received from a patient concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 100.7 F. On 07-MAY-2021, the subject experienced burning sensation on right arm down to wrist. On 08-MAY-2021, the subject experienced ache. On 08-MAY-2021, the subject experienced fever. On 08-MAY-2021, the subject experienced headache. On 08-MAY-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation on right arm down to wrist on 07-MAY-2021, had not recovered from fever, headache, and nauseous, and the outcome of ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHE; FEVER; HEADACHE; NAUSEOUS; BURNING SENSATION ON RIGHT ARM DOWN TO WRIST; This spontaneous report received from a patient concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 100.7 F. On 07-MAY-2021, the subject experienced burning sensation on right arm down to wrist. On 08-MAY-2021, the subject experienced ache. On 08-MAY-2021, the subject experienced fever. On 08-MAY-2021, the subject experienced headache. On 08-MAY-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation on right arm down to wrist on 07-MAY-2021, had not recovered from fever, headache, and nauseous, and the outcome of ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: unusual side effects; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced unusual side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unusual side effects was not reported. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Fast Heart Beat; Lightheadedness; Shortness of breath; arrythmia; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrythmia) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement (Patient had a stent inserted in him 9 months ago) in May 2020. Concomitant products included PRAVASTATIN from 12-Sep-2014 to an unknown date for Cholesterol, ALLOPURINOL from 12-Mar-1999 to an unknown date for Gout, METFORMIN from 12-Jan-2008 to an unknown date for Prediabetes, TICAGRELOR (BRILINTA) from 12-May-2020 to 28-Dec-2020 for blood thinner, ACETYLSALICYLIC ACID (ASPRIN) from 12-May-2020 to an unknown date.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced ARRHYTHMIA (arrythmia) (seriousness criterion medically significant). On 03-Feb-2021, the patient experienced DIZZINESS (Lightheadedness) and DYSPNOEA (Shortness of breath). On 03-Feb-2021 at 5:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Fast Heart Beat). On 05-Jan-2021, ARRHYTHMIA (arrythmia) outcome was unknown. On 04-Feb-2021, HEART RATE INCREASED (Fast Heart Beat) had resolved. At the time of the report, DIZZINESS (Lightheadedness) and DYSPNOEA (Shortness of breath) had resolved.            Treatment information not provided.   Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded   This case was linked to MOD-2021-043170 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: New events added includes arrythmia, light headedness, dizziness and shortness of breath.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Myalgia, SARS-CoV-2 test, Vaccine breakthrough infection
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced MYALGIA (flulike muscle aches). On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested postive for SARS-CoV-2 RNA). On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). On 20-Feb-2021, MYALGIA (flulike muscle aches) had resolved. At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) and COVID-19 (tested postive for SARS-CoV-2 RNA) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient's symptoms included oropharyngeal pain, nasal congestion, anosmia and headache.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event (myalgia) a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273.; 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 (myalgia) a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Vaccination failure
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of VACCINATION FAILURE (vaccine response impaired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Non-ischaemic cardiomyopathy (cause or organ failure) and Solid organ transplant since an unknown date. Concomitant products included TACROLIMUS, MYCOPHENOLATE MOFETIL and PREDNISONE for Immunosuppression.    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 VACCINATION FAILURE (vaccine response impaired) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to VACCINATION FAILURE. At the time of the report, VACCINATION FAILURE (vaccine response impaired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: positive (Positive) Diagnosis of COVID-19 was confirmed in all patients with polymerase chain reaction (PCR) of nasal swabs..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION FAILURE (vaccine response impaired) to be possibly related.    Baseline immunosuppression for solid organ transplantation was achieved with basiliximab. Patient was hospitalized for 5 days and treated with Remdesivir and Convalescent Plasma. The patient was discharged on 2 Liters of oxygen. "The clinical presentation and course of these patients were comparable to those of SOTs who had COVID-19 infection and have not been vaccinated. This finding suggests that SOTs are still at risk of acquiring COVID-19 infection even after vaccination..."  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-094284, MOD-2021-094289, MOD-2021-094295 (E2B Linked Report). This case was linked to MOD-2021-094325 (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 event, a causal relationship cannot be excluded. MOD-2021-094284:Same literature article_Patient 3 MOD-2021-094289:Same literature article_Patient 3 MOD-2021-094295:Same literature article_Patient 5
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Computerised tomogram, Fatigue, Headache
Clinical narrative: headache; Pneumonia; covid-19; difficulty breathing from copd; Achey; tired; high fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) and COVID-19 (covid-19) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (difficulty breathing from copd), MYALGIA (Achey), FATIGUE (tired) and PYREXIA (high fever). On 12-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and COVID-19 (covid-19) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, PNEUMONIA (Pneumonia), COVID-19 (covid-19), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (difficulty breathing from copd), MYALGIA (Achey), FATIGUE (tired), HEADACHE (headache) and PYREXIA (high fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test positive: positive (Positive) positive. On 12-Apr-2021, Computerised tomogram: positive (Positive) positive for pneumonia.. On 12-Apr-2021, SARS-CoV-2 antibody test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient finished treatment with antibiotics and was tested positive for antibodies. Patient took Levofloxacin, inhaler (albuterol) and steroid dexamethasone medications as a treatment. There are no concomitant medication reported.  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.   Based on reporter's causality history a positive SARS-CoV-2 viral test event is assessed as unlikely related to mRNA-1273   This case was linked to MOD-2021-095577 (E2B Linked Report).; 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.   Based on reporter's causality history a positive SARS-CoV-2 viral test event is assessed as unlikely related to mRNA-1273 MOD-2021-095577:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pneumonia, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: headache; Pneumonia; covid-19; difficulty breathing from copd; Achey; tired; high fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) and COVID-19 (covid-19) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (difficulty breathing from copd), MYALGIA (Achey), FATIGUE (tired) and PYREXIA (high fever). On 12-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and COVID-19 (covid-19) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, PNEUMONIA (Pneumonia), COVID-19 (covid-19), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (difficulty breathing from copd), MYALGIA (Achey), FATIGUE (tired), HEADACHE (headache) and PYREXIA (high fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test positive: positive (Positive) positive. On 12-Apr-2021, Computerised tomogram: positive (Positive) positive for pneumonia.. On 12-Apr-2021, SARS-CoV-2 antibody test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient finished treatment with antibiotics and was tested positive for antibodies. Patient took Levofloxacin, inhaler (albuterol) and steroid dexamethasone medications as a treatment. There are no concomitant medication reported.  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.   Based on reporter's causality history a positive SARS-CoV-2 viral test event is assessed as unlikely related to mRNA-1273   This case was linked to MOD-2021-095577 (E2B Linked Report).; 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.   Based on reporter's causality history a positive SARS-CoV-2 viral test event is assessed as unlikely related to mRNA-1273 MOD-2021-095577: