chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: LEFT UPPER ARM DEVELOPED SEVERE WEAKNESS; LEFT UPPER ARM DEVELOPED PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced left upper arm developed severe weakness, and left upper arm developed pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left upper arm developed severe weakness and left upper arm developed pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210742246.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Severe pain radiating out of left upper are around injection site; upper arm to elbow and left shoulder front scapula area.   75% rededication in rotation of left arm.  75% decrease in strength.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Severe pain radiating out of left upper are around injection site; upper arm to elbow and left shoulder front scapula area.   75% rededication in rotation of left arm.  75% decrease in strength.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: TERRIBLE BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced terrible body aches, chills, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100-101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, terrible body aches, chills and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Migraine, Pyrexia
Clinical narrative: UNBEARABLE MIGRAINE; SORE ARM (JAB); CHILLS; FEVER; EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patients 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. Per procedure, no follow-up will be  requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced unbearable migraine, sore arm (jab), chills, fever, and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unbearable migraine, sore arm (jab), chills, fever, and extreme fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise
Clinical narrative: SOME CHILLS; FELT LIKE CRAP FOR A LITTLE BIT; HEADACHE; 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. No past medical history or concurrent conditions were 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced some chills, felt like crap for a little bit, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the some chills, headache and felt like crap for a little bit was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: FEELS LIKE SOMEONE PUNCHED IN THE ARM AND IT THROBS AT NIGHT; ARM FEEL WEAK AND LIMITS WHAT CAN DO; ARM HURTS ALMOST CONSTANTLY; PAINFUL SHOT/ARM REALLY HURTS IN THE INJECTION SITE AREA/THE SEVERITY OF THE PAIN FLUCTUATES; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced painful shot/arm really hurts in the injection site area/the severity of the pain fluctuates. On an unspecified date, the subject experienced feels like someone punched in the arm and it throbs at night, arm feel weak and limits what can do, and arm hurts almost constantly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful shot/arm really hurts in the injection site area/the severity of the pain fluctuates, arm feel weak and limits what can do, arm hurts almost constantly, and feels like someone punched in the arm and it throbs at night. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: HEADACHE; MUSCLES PAIN; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced headache, muscles pain, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, muscles pain, and tiredness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Heart rate
Clinical narrative: CHEST PAIN; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart attack, and concurrent conditions included allergic reaction, and other pre-existing medical conditions included patient had 2 stents in both main arteries of the heart. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, and expiry: unknown) dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-JUL-2021, the subject experienced chest pain. Laboratory data included: Electrocardiogram (NR: not provided) Irregular, EKG came back normal, and Heart rate (NR: not provided) Irregular. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Malaise
Clinical narrative: FELT DIZZY; NOT FELT WELL AFTER VACCINATION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced felt dizzy, and not felt well after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt dizzy, and not felt well after vaccination. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Poor quality sleep, Pruritus, Urticaria
Clinical narrative: NOT SLEEPING WELL; ITCHING ALL OVER BODY; BROKE OUT INTO HIVES; FLU-LIKE SYMPTOMS (COLD CHILLS, ACHES); SWEATING QUITE A BIT; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy experienced it as a childhood reaction, alcohol user 2-3 beers every night around supper time, and cigarette smoker 10 cigarettes per day, and other pre-existing medical conditions included 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: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 15-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-JUL-2021, the subject experienced flu-like symptoms (cold chills, aches). On 16-JUL-2021, the subject experienced sweating quite a bit. On 19-JUL-2021, the subject experienced not sleeping well. On 19-JUL-2021, the subject experienced itching all over body. On 19-JUL-2021, the subject experienced broke out into hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms (cold chills, aches), and sweating quite a bit on 17-JUL-2021, had not recovered from broke out into hives, and itching all over body, and the outcome of not sleeping well was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORED AT ROOM TEMPERATURE FOR 6 HOURS; VACCINE ADMINISTERED FROM VIAL STORED AT ROOM TEMPERATURE FOR 6 HOURS; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: 05-MAY-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced product stored at room temperature for 6 hours. On 12-APR-2021, the subject experienced vaccine administered from stored at room temperature for 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product stored at room temperature for 6 hours and vaccine administered from stored at room temperature for 6 hours was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Gait disturbance
Clinical narrative: CAN NOT WALK; MESSED ME UP; This spontaneous report received from a patient via a company representative . The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported 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 an unspecified date, the subject experienced can't walk, and messed me up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the can't walk and messed me up was not reported. This report was non-serious.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain assessment, Vaccination site mass, Vaccination site pain
Clinical narrative: SORENESS IN SHOULDER  AND NECK FORM ELBOW; BUMP UNDER NEATH INJECTION SITE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart failure, stent placement, heart attack, breakout in hives, and itching, and concurrent conditions included type 2 diabetes, hypertension, anxiety, penicillin allergy, iodine contrast dye, sulfur allergy, non smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 05-AUG-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Concomitant medications included insulin for type 2 diabetes. On 26-MAY-2021, the subject experienced pain at injection site. On 27-MAY-2021, the subject experienced bump under neath injection site. On an unspecified date, the subject experienced soreness in shoulder and neck form elbow. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 8 to 9 out of 10, 5 out of 10. Treatment medications (dates unspecified) included: lidocaine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, bump under neath injection site, and soreness in shoulder and neck form elbow. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: ARM PAIN WHERE THE SHOT WAS GIVEN; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were 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 arm pain where the shot was given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain where the shot was given. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Benign neoplasm of thyroid gland, Goitre, Lymphadenopathy, Thyroid mass
Clinical narrative: supraclavicular lymphadenopathy; Swelling on thyroid gland; Nodules on right side of thyroid; benigh lesions on the left side of the thyroid.; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (supraclavicular lymphadenopathy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid hormones increased. Concomitant products included ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (MULTIVITAMIN[ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), CALCIUM CARBONATE, COLECALCIFEROL, PHYTOMENADIONE (CALCIUM PLUS VITAMIN D & K) and VITAMIN D NOS for an unknown indication.   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 31-Jan-2021, the patient experienced LYMPHADENOPATHY (supraclavicular lymphadenopathy) (seriousness criterion hospitalization). On an unknown date, the patient experienced GOITRE (Swelling on thyroid gland), THYROID MASS (Nodules on right side of thyroid) and BENIGN NEOPLASM OF THYROID GLAND (benigh lesions on the left side of the thyroid.). The patient was hospitalized on 03-Mar-2021 due to LYMPHADENOPATHY. On 03-Mar-2021, LYMPHADENOPATHY (supraclavicular lymphadenopathy) had resolved. At the time of the report, GOITRE (Swelling on thyroid gland), THYROID MASS (Nodules on right side of thyroid) and BENIGN NEOPLASM OF THYROID GLAND (benigh lesions on the left side of the thyroid.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered LYMPHADENOPATHY (supraclavicular lymphadenopathy) to be possibly related. No further causality assessments were provided for GOITRE (Swelling on thyroid gland), THYROID MASS (Nodules on right side of thyroid) and BENIGN NEOPLASM OF THYROID GLAND (benigh lesions on the left side of the thyroid.).    Treatment information was not reported Patient was told to wait 6-8 weeks to repeat the thyroid tests and six months to have the sonogram repeated to look for changes. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant Follow-up information received on 14-JUL-2021: Updated event outcome for lymphadenopathy, Pregnancy info as no .; 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Fatigue, Ocular discomfort, Retinal tear, Tinnitus
Clinical narrative: developed tear on retina; " trouble in eyes"; annoyance in her right ear; noise in her ear, going away and she does have Tinnitus; severe fatigue and vaccine made her tired; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL TEAR (developed tear on retina) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EAR DISCOMFORT (annoyance in her right ear), TINNITUS (noise in her ear, going away and she does have Tinnitus) and FATIGUE (severe fatigue and vaccine made her tired). On an unknown date, the patient experienced RETINAL TEAR (developed tear on retina) (seriousness criterion medically significant) and OCULAR DISCOMFORT (" trouble in eyes"). The patient was treated with Laser therapy for Retinal tear and Laser therapy for Ocular discomfort. At the time of the report, RETINAL TEAR (developed tear on retina), OCULAR DISCOMFORT (" trouble in eyes"), EAR DISCOMFORT (annoyance in her right ear), TINNITUS (noise in her ear, going away and she does have Tinnitus) and FATIGUE (severe fatigue and vaccine made her tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.  The patient started having trouble in eyes and developed tear on retina(retinal tear) two weeks ago. She went to her doctor and received laser treatment.  Very limited information regarding the events has been provided at this time.  No further information is expected.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up information received on 16-Jul-2021 added new events.; Sender's Comments: Very limited information regarding the events has been provided at this time.  No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Chest discomfort, Chest pain, Dizziness
Clinical narrative: Diagnosed with AFIB; rapid heart beat; Palpitations; Shortness of breath; chest pain; chest heaviness; Dizziness; weakness; ftigue; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver transplant and Cardiac ablation (Patient had heart Ablation Surgery on 16-06-2021) on 16-Jun-2021.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Diagnosed with AFIB) (seriousness criteria hospitalization, disability, medically significant and life threatening), HEART RATE INCREASED (rapid heart beat) (seriousness criteria hospitalization, disability and life threatening), PALPITATIONS (Palpitations) (seriousness criteria hospitalization, disability and life threatening), DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization, disability and life threatening), CHEST PAIN (chest pain) (seriousness criteria hospitalization, disability and life threatening), CHEST DISCOMFORT (chest heaviness) (seriousness criteria hospitalization, disability and life threatening), DIZZINESS (Dizziness) (seriousness criteria hospitalization, disability and life threatening), ASTHENIA (weakness) (seriousness criteria hospitalization, disability and life threatening) and FATIGUE (ftigue) (seriousness criteria hospitalization, disability and life threatening). At the time of the report, ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Heart rate: high (High) High.         Concomitant medication and Treatment medication use was not provided by reporter.  Company Comment: Very limited information regarding this events has been provided at this time.   Further information has been requested.   This case was linked to MOD-2021-238357 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.   Further information has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate, Heart rate increased, Palpitations
Clinical narrative: Diagnosed with AFIB; rapid heart beat; Palpitations; Shortness of breath; chest pain; chest heaviness; Dizziness; weakness; ftigue; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver transplant and Cardiac ablation (Patient had heart Ablation Surgery on 16-06-2021) on 16-Jun-2021.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Diagnosed with AFIB) (seriousness criteria hospitalization, disability, medically significant and life threatening), HEART RATE INCREASED (rapid heart beat) (seriousness criteria hospitalization, disability and life threatening), PALPITATIONS (Palpitations) (seriousness criteria hospitalization, disability and life threatening), DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization, disability and life threatening), CHEST PAIN (chest pain) (seriousness criteria hospitalization, disability and life threatening), CHEST DISCOMFORT (chest heaviness) (seriousness criteria hospitalization, disability and life threatening), DIZZINESS (Dizziness) (seriousness criteria hospitalization, disability and life threatening), ASTHENIA (weakness) (seriousness criteria hospitalization, disability and life threatening) and FATIGUE (ftigue) (seriousness criteria hospitalization, disability and life threatening). At the time of the report, ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Heart rate: high (High) High.         Concomitant medication and Treatment medication use was not provided by reporter.  Company Comment: Very limited information regarding this events has been provided at this time.   Further information has been requested.   This case was linked to MOD-2021-238357 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.   Further information has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Diagnosed with AFIB; rapid heart beat; Palpitations; Shortness of breath; chest pain; chest heaviness; Dizziness; weakness; ftigue; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver transplant and Cardiac ablation (Patient had heart Ablation Surgery on 16-06-2021) on 16-Jun-2021.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Diagnosed with AFIB) (seriousness criteria hospitalization, disability, medically significant and life threatening), HEART RATE INCREASED (rapid heart beat) (seriousness criteria hospitalization, disability and life threatening), PALPITATIONS (Palpitations) (seriousness criteria hospitalization, disability and life threatening), DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization, disability and life threatening), CHEST PAIN (chest pain) (seriousness criteria hospitalization, disability and life threatening), CHEST DISCOMFORT (chest heaviness) (seriousness criteria hospitalization, disability and life threatening), DIZZINESS (Dizziness) (seriousness criteria hospitalization, disability and life threatening), ASTHENIA (weakness) (seriousness criteria hospitalization, disability and life threatening) and FATIGUE (ftigue) (seriousness criteria hospitalization, disability and life threatening). At the time of the report, ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Heart rate: high (High) High.         Concomitant medication and Treatment medication use was not provided by reporter.  Company Comment: Very limited information regarding this events has been provided at this time.   Further information has been requested.   This case was linked to MOD-2021-238357 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.   Further information has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency, Product dose omission issue
Clinical narrative: did not follow up with a second/No second dose administered yet > 3 months after the first shot; immune compromised and afraid to get the second vaccine; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jul-2021. The most recent information was received on 07-Jul-2021 and was forwarded to Moderna on 07-Jul-2021.    This spontaneous case was reported by a patient and describes the occurrence of IMMUNODEFICIENCY (immune compromised and afraid to get the second vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Diabetes and Overweight. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced IMMUNODEFICIENCY (immune compromised and afraid to get the second vaccine) (seriousness criterion medically significant). On 07-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not follow up with a second/No second dose administered yet > 3 months after the first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not follow up with a second/No second dose administered yet > 3 months after the first shot) and IMMUNODEFICIENCY (immune compromised and afraid to get the second vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported no problems after the first shot but friends and family were sick for weeks after the second shot (Case# MOD21-118557 Cross-Linked). patient was concerned if healthy family members had such experience with the second shot, what will happen to an immune compromised individual like him.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant Follow up received on 07-JUL-2021 contains adverse events, patient history, concomitant medication and patient demographics were updated
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood disorder
Clinical narrative: Blood disorder; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of BLOOD DISORDER (Blood disorder) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH 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 and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD DISORDER (Blood disorder) (seriousness criterion life threatening). At the time of the report, BLOOD DISORDER (Blood disorder) outcome was unknown. 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.   Concomitant product was not provided by the reporter. Treatment information was not provided.  Very limited info provided and further FU is required to clarify the SAE.; Sender's Comments: Very limited info provided and further FU is required to clarify the SAE.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Chills, Fatigue, Feeling cold
Clinical narrative: Anxiety; Rheumatoid arthritis aggravated; Feeling cold; Pyrexia; Teeth chattering; every joint in her body hurt; very bad headache; slept for 8 straight hours because she felt tired; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Asthma, Allergic reaction to drug (Allergic to Aspirin), Allergic reaction to drug (Allergic to Advil) and Arthritis.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ARTHRALGIA (every joint in her body hurt), HEADACHE (very bad headache) and FATIGUE (slept for 8 straight hours because she felt tired). On 12-Apr-2021, the patient experienced FEELING COLD (Feeling cold), PYREXIA (Pyrexia) and CHILLS (Teeth chattering). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated) (seriousness criterion medically significant) and ANXIETY (Anxiety). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated), FEELING COLD (Feeling cold), ANXIETY (Anxiety), ARTHRALGIA (every joint in her body hurt), HEADACHE (very bad headache), FATIGUE (slept for 8 straight hours because she felt tired), PYREXIA (Pyrexia) and CHILLS (Teeth chattering) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Pyrexia: 104.5 (abnormal) 104.5.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment information was provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-259499 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Rheumatoid arthritis
Clinical narrative: Anxiety; Rheumatoid arthritis aggravated; Feeling cold; Pyrexia; Teeth chattering; every joint in her body hurt; very bad headache; slept for 8 straight hours because she felt tired; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Asthma, Allergic reaction to drug (Allergic to Aspirin), Allergic reaction to drug (Allergic to Advil) and Arthritis.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ARTHRALGIA (every joint in her body hurt), HEADACHE (very bad headache) and FATIGUE (slept for 8 straight hours because she felt tired). On 12-Apr-2021, the patient experienced FEELING COLD (Feeling cold), PYREXIA (Pyrexia) and CHILLS (Teeth chattering). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated) (seriousness criterion medically significant) and ANXIETY (Anxiety). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated), FEELING COLD (Feeling cold), ANXIETY (Anxiety), ARTHRALGIA (every joint in her body hurt), HEADACHE (very bad headache), FATIGUE (slept for 8 straight hours because she felt tired), PYREXIA (Pyrexia) and CHILLS (Teeth chattering) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Pyrexia: 104.5 (abnormal) 104.5.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment information was provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-259499 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage; At the time of the shot she was 7 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage) in a 39-year-old female patient (gravida 1) 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 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Jul-2021, the patient experienced EXPOSURE DURING PREGNANCY (At the time of the shot she was 7 weeks pregnant). On 08-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage) (seriousness criteria medically significant, life threatening and congenital anomaly). On 07-Jul-2021, EXPOSURE DURING PREGNANCY (At the time of the shot she was 7 weeks pregnant) had resolved. On 09-Jul-2021, ABORTION SPONTANEOUS (Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage) 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.   Concomitant medication use information was not provided by reporter.  The laboratory exams performed to further understand the event included were ultrasound a week prior to the shot to show the babies heart rate. Treatment medication use information was not provided by reporter.; Sender's Comments: This case concerns a 39-year-old female patient gravida 1 who received mRNA-1273 at 7 weeks of pregnancy and experienced spotting one day post vaccination and spontaneous abortion 2 days post vaccination.  Last menstrual period and estimated date of delivery were not provided. Spontaneous abortion show temporal association with product use and a causal relationship cannot be excluded.  The event of exposure during pregnancy is assessed not applicable
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Syncope, Vomiting
Clinical narrative: collapsed after second dose; got really dizzy; since then really foggy & out of it; then vomitted; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (collapsed after second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Jul-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 18-Jul-2021, the patient experienced SYNCOPE (collapsed after second dose) (seriousness criterion medically significant), DIZZINESS (got really dizzy), FEELING ABNORMAL (since then really foggy & out of it) and VOMITING (then vomitted). At the time of the report, SYNCOPE (collapsed after second dose), DIZZINESS (got really dizzy), FEELING ABNORMAL (since then really foggy & out of it) and VOMITING (then vomitted) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Hepatic failure, Illness, Pancreatic failure
Clinical narrative: got very sick and ended up in the hospital; liver, kidneys, and pancreas shut down; liver, kidneys, and pancreas shut down; liver, kidneys, and pancreas shut down; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got very sick and ended up in the hospital), HEPATIC FAILURE (liver, kidneys, and pancreas shut down), ACUTE KIDNEY INJURY (liver, kidneys, and pancreas shut down) and PANCREATIC FAILURE (liver, kidneys, and pancreas shut down) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     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 ILLNESS (got very sick and ended up in the hospital) (seriousness criterion hospitalization), HEPATIC FAILURE (liver, kidneys, and pancreas shut down) (seriousness criteria hospitalization, medically significant and life threatening), ACUTE KIDNEY INJURY (liver, kidneys, and pancreas shut down) (seriousness criteria hospitalization, medically significant and life threatening) and PANCREATIC FAILURE (liver, kidneys, and pancreas shut down) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized for 14 days due to ACUTE KIDNEY INJURY, HEPATIC FAILURE, ILLNESS and PANCREATIC FAILURE. At the time of the report, ILLNESS (got very sick and ended up in the hospital), HEPATIC FAILURE (liver, kidneys, and pancreas shut down), ACUTE KIDNEY INJURY (liver, kidneys, and pancreas shut down) and PANCREATIC FAILURE (liver, kidneys, and pancreas shut down) 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.  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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Balance disorder, Blindness, Headache, Intentional dose omission
Clinical narrative: Completely lost vision in left eye; Optic nerve had been attacked; Could not see out of left eye; Right eye is tired; Difficulty with balance; Intentional dose omission; Headache; This spontaneous case was reported by a patient and describes the occurrence of BLINDNESS (Completely lost vision in left eye), OPTIC NERVE INJURY (Optic nerve had been attacked) and VISUAL IMPAIRMENT (Could not see out of left eye) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00921A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.     On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced OPTIC NERVE INJURY (Optic nerve had been attacked) (seriousness criteria hospitalization and medically significant) and VISUAL IMPAIRMENT (Could not see out of left eye) (seriousness criterion hospitalization). On 14-Jul-2021, the patient experienced BLINDNESS (Completely lost vision in left eye) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ASTHENOPIA (Right eye is tired), BALANCE DISORDER (Difficulty with balance), INTENTIONAL DOSE OMISSION (Intentional dose omission) and HEADACHE (Headache). The patient was hospitalized from 15-Jul-2021 to 17-Jul-2021 due to BLINDNESS, OPTIC NERVE INJURY and VISUAL IMPAIRMENT. At the time of the report, BLINDNESS (Completely lost vision in left eye) and VISUAL IMPAIRMENT (Could not see out of left eye) had not resolved, OPTIC NERVE INJURY (Optic nerve had been attacked), ASTHENOPIA (Right eye is tired), BALANCE DISORDER (Difficulty with balance) and HEADACHE (Headache) outcome was unknown and INTENTIONAL DOSE OMISSION (Intentional dose omission) 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.   The patient saw both ophthalmologist and the neuro-ophthalmologist and was told that, her optic nerve had been attacked. She never had eye problems. Her vision in her right eye was 20/20.  The patient received intravenous steroids 1060 mg each day when she was hospitalized on 15-Jul-2021. She is taking 60 mg of oral steroids after she was released from the hospital on 18-Jul-2021.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: It was reported that, the patient was hospitalized from 15-Jul-2021 to 17 Jul-2021.; 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.