chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder, Vomiting
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; INJECTION SITE PAIN; FATIGUE; VOMITING COULD NOT KEEP ANYTHING DOWN FOR 24 HOURS STRAIGHT; LOSS OF APPETITE; COULD NOT GET OUT OF THE BED; FEVER; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included cancer of unknown primary cause, rheumatoid arthritis, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage, the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine for drug used for unknown indication.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: Unknown) 1 total, dose was not reported, administered on 08-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included methotrexate and prednisone for rheumatoid arthritis.  On 08-APR-2021 (within 24 hours of getting the vaccine), the patient experienced vomiting (was not able to keep anything down for 24 hours straight), loss of appetite, fever, and injection site pain, and fatigue and could not get out of the bed. On 09-APR-2021, the patient started feeling injection site pain. The patient stated that she was not able to get out of the bed (could not get out of bed) from 8-APR-2021 to 11-APR-2021. The patient did not take any medications for any of the symptoms. On 20-MAY-2021, the patient was detected to have confirmed immunological vaccine failure (negative SARS-CoV-2 IgG antibody test). Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) Negative Test result of 0.20 negative value no signs of antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On 11-APR-2021 the patient recovered from could not get out of the bed. On 12-APR-2021 the patient recovered from vomiting could not keep anything down for 24 hours straight, loss of appetite, and fever. On an unknown date the patient recovered from injection site pain. On 22-APR-2021 the patient recovered from fatigue. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210622018- Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Sensory disturbance
Clinical narrative: FEELS LIKE PULSING SENSATION AND BLOOD IS NOT CIRCULATING PROPERLY; DISCOMFORT IN ARM AND LEG; This spontaneous report received from a consumer concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non -smoker, and other pre-existing medical conditions included patient has no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204AZIA, and expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced discomfort in arm and leg. On 07-JUN-2021, the subject experienced feels like pulsing sensation and blood is not circulating properly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from discomfort in arm and leg, and feels like pulsing sensation and blood is not circulating properly. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Limb mass
Clinical narrative: LUMP ON ARM; 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: Unknown) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced lump on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lump on arm was not reported. This report was non-serious.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling abnormal, Limb discomfort
Clinical narrative: DIZZINESS; WOBBLY; OVERALL FEELING TERRIBLE; FOOT ACHE; This spontaneous report received from a patient concerned a 91 year old female. 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced dizziness. On 17-MAY-2021, the subject experienced wobbly. On 17-MAY-2021, the subject experienced overall feeling terrible. On 17-MAY-2021, the subject experienced foot ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, foot ache, wobbly, and overall feeling terrible. This report was non-serious. This case, from the same reporter is linked to 20210622893.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus
Clinical narrative: LIP SWELLING; GENERALIZED ITCHING; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced generalized itching. On 10-JUN-2021, the subject experienced lip swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized itching, and lip swelling. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Malaise, Oropharyngeal pain
Clinical narrative: VERY PAINFUL THROAT PAIN; SLEEPING  RANDOMLY NOT WHOLE NIGHT/INSOMNIA; VERY VERY BAD, LIKE SOME SICKNESS; HEAVY HEADACHE; FEELS VERY TIRED AND STILL WANTS TO  SLEEP; This spontaneous report received from a patient concerned a 53 year old female. 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 was not reported, administered on 09-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUN-2021, the subject experienced very painful throat pain. On 09-JUN-2021, the subject experienced sleeping randomly not whole night/insomnia. On 09-JUN-2021, the subject experienced very very bad, like some sickness. On 09-JUN-2021, the subject experienced heavy headache. On 09-JUN-2021, the subject experienced feels very tired and still wants to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy headache, very painful throat pain, and very very bad, like some sickness, and the outcome of sleeping randomly not whole night/insomnia and feels very tired and still wants to sleep was not reported. This report was non-serious. This report was associated with product Quality complaint: 90000182408. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood test, C-reactive protein, Chills, Dyspnoea
Clinical narrative: TEETH WERE BLUE THAT HAD FILLINGS; HAIR LOSS; FATIGUE; DIFFICULTY FUNCTIONING; RACING HEART; BLURRED VISION; SHORTNESS OF BREATH; SLICK FINGERS; LACEY RASH TO ARMS, HANDS, LEGS, AND CHEST; SEVERE HEADACHES; CHILLS; RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast surgery, tonsillectomy, pulled chest wall muscle, rib separation, and eye surgery, and concurrent conditions included penicillin allergy, environmental allergies, and atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced right arm pain. On 08-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced severe headaches. On 15-APR-2021, the subject experienced lacey rash to arms, hands, legs, and chest. On 18-APR-2021, the subject experienced blurred vision. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced slick fingers. On 20-APR-2021, the subject experienced racing heart. On 25-APR-2021, the subject experienced difficulty functioning. On 25-APR-2021, the subject experienced fatigue. On 01-MAY-2021, the subject experienced hair loss. On 10-MAY-2021, Laboratory data included: C-reactive protein (NR: not provided) Elevated, and Sonogram (NR: not provided) normal. On 24-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 03-JUN-2021, the subject experienced teeth were blue that had fillings. On 08-JUN-2021, Laboratory data included: C-reactive protein (NR: not provided) Normal, and Complete blood count (NR: not provided) Normal. On 09-JUN-2021, Laboratory data included: Panoramic dental X-ray (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, difficulty functioning, and shortness of breath, right arm pain on 04-APR-2021, chills on 11-APR-2021, and severe headaches on 14-APR-2021, was recovering from lacey rash to arms, hands, legs, and chest, and fatigue, had not recovered from hair loss, teeth were blue that had fillings, and slick fingers, and the outcome of racing heart was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Headache, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: TEETH WERE BLUE THAT HAD FILLINGS; HAIR LOSS; FATIGUE; DIFFICULTY FUNCTIONING; RACING HEART; BLURRED VISION; SHORTNESS OF BREATH; SLICK FINGERS; LACEY RASH TO ARMS, HANDS, LEGS, AND CHEST; SEVERE HEADACHES; CHILLS; RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast surgery, tonsillectomy, pulled chest wall muscle, rib separation, and eye surgery, and concurrent conditions included penicillin allergy, environmental allergies, and atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced right arm pain. On 08-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced severe headaches. On 15-APR-2021, the subject experienced lacey rash to arms, hands, legs, and chest. On 18-APR-2021, the subject experienced blurred vision. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced slick fingers. On 20-APR-2021, the subject experienced racing heart. On 25-APR-2021, the subject experienced difficulty functioning. On 25-APR-2021, the subject experienced fatigue. On 01-MAY-2021, the subject experienced hair loss. On 10-MAY-2021, Laboratory data included: C-reactive protein (NR: not provided) Elevated, and Sonogram (NR: not provided) normal. On 24-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 03-JUN-2021, the subject experienced teeth were blue that had fillings. On 08-JUN-2021, Laboratory data included: C-reactive protein (NR: not provided) Normal, and Complete blood count (NR: not provided) Normal. On 09-JUN-2021, Laboratory data included: Panoramic dental X-ray (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, difficulty functioning, and shortness of breath, right arm pain on 04-APR-2021, chills on 11-APR-2021, and severe headaches on 14-APR-2021, was recovering from lacey rash to arms, hands, legs, and chest, and fatigue, had not recovered from hair loss, teeth were blue that had fillings, and slick fingers, and the outcome of racing heart was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Rash erythematous, Skin reaction, Thyroid function test, Tooth discolouration
Clinical narrative: TEETH WERE BLUE THAT HAD FILLINGS; HAIR LOSS; FATIGUE; DIFFICULTY FUNCTIONING; RACING HEART; BLURRED VISION; SHORTNESS OF BREATH; SLICK FINGERS; LACEY RASH TO ARMS, HANDS, LEGS, AND CHEST; SEVERE HEADACHES; CHILLS; RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast surgery, tonsillectomy, pulled chest wall muscle, rib separation, and eye surgery, and concurrent conditions included penicillin allergy, environmental allergies, and atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced right arm pain. On 08-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced severe headaches. On 15-APR-2021, the subject experienced lacey rash to arms, hands, legs, and chest. On 18-APR-2021, the subject experienced blurred vision. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced slick fingers. On 20-APR-2021, the subject experienced racing heart. On 25-APR-2021, the subject experienced difficulty functioning. On 25-APR-2021, the subject experienced fatigue. On 01-MAY-2021, the subject experienced hair loss. On 10-MAY-2021, Laboratory data included: C-reactive protein (NR: not provided) Elevated, and Sonogram (NR: not provided) normal. On 24-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 03-JUN-2021, the subject experienced teeth were blue that had fillings. On 08-JUN-2021, Laboratory data included: C-reactive protein (NR: not provided) Normal, and Complete blood count (NR: not provided) Normal. On 09-JUN-2021, Laboratory data included: Panoramic dental X-ray (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, difficulty functioning, and shortness of breath, right arm pain on 04-APR-2021, chills on 11-APR-2021, and severe headaches on 14-APR-2021, was recovering from lacey rash to arms, hands, legs, and chest, and fatigue, had not recovered from hair loss, teeth were blue that had fillings, and slick fingers, and the outcome of racing heart was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Vision blurred, X-ray dental
Clinical narrative: TEETH WERE BLUE THAT HAD FILLINGS; HAIR LOSS; FATIGUE; DIFFICULTY FUNCTIONING; RACING HEART; BLURRED VISION; SHORTNESS OF BREATH; SLICK FINGERS; LACEY RASH TO ARMS, HANDS, LEGS, AND CHEST; SEVERE HEADACHES; CHILLS; RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast surgery, tonsillectomy, pulled chest wall muscle, rib separation, and eye surgery, and concurrent conditions included penicillin allergy, environmental allergies, and atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced right arm pain. On 08-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced severe headaches. On 15-APR-2021, the subject experienced lacey rash to arms, hands, legs, and chest. On 18-APR-2021, the subject experienced blurred vision. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced slick fingers. On 20-APR-2021, the subject experienced racing heart. On 25-APR-2021, the subject experienced difficulty functioning. On 25-APR-2021, the subject experienced fatigue. On 01-MAY-2021, the subject experienced hair loss. On 10-MAY-2021, Laboratory data included: C-reactive protein (NR: not provided) Elevated, and Sonogram (NR: not provided) normal. On 24-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 03-JUN-2021, the subject experienced teeth were blue that had fillings. On 08-JUN-2021, Laboratory data included: C-reactive protein (NR: not provided) Normal, and Complete blood count (NR: not provided) Normal. On 09-JUN-2021, Laboratory data included: Panoramic dental X-ray (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, difficulty functioning, and shortness of breath, right arm pain on 04-APR-2021, chills on 11-APR-2021, and severe headaches on 14-APR-2021, was recovering from lacey rash to arms, hands, legs, and chest, and fatigue, had not recovered from hair loss, teeth were blue that had fillings, and slick fingers, and the outcome of racing heart was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Underdose
Clinical narrative: FEELS SHE DIDN'T GET THE DOSE; EXCESSIVE BLEEDING AT INJECTION SITE/BLOOD RAN DOWN TO HER ELBOW; This spontaneous report received from a pharmacist concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included denied taking any medication and history of bleeding disorder. no known drug allergies, 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: 1805029, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced feels she didn't get the dose. On 07-MAR-2021, the subject experienced excessive bleeding at injection site/blood ran down to her elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excessive bleeding at injection site/blood ran down to her elbow on 07-MAR-2021, and the outcome of feels she didn't get the dose was not reported. This report was non-serious.
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered
Clinical narrative: OFF LABEL USE; VACCINE WAS GIVEN 16 MINUTES PAST THE 6 HOUR USE TIME FRAME; This spontaneous report received from a health care professional concerned a 97 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: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced off label use. On 09-JUN-2021, the subject experienced vaccine was given 16 minutes past the 6 hour use time frame. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine was given 16 minutes past the 6 hour use time frame was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Bone pain, Nausea, Somnolence, Vomiting
Clinical narrative: BONES HURTING BAD ALL OVER (WORSE AT LEGS AND BOTH SHIN BONE PAIN); SLEEPY; NAUSEA; VOMITING; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 105 pounds, and height was 50 inches. The patient's concurrent conditions included non-smoker, and drink alcohol socially, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. the patient had not been vaccinated since 5 years of age.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13/JUN/2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced vomiting. On 02-APR-2021, the subject experienced sleepy. On 02-APR-2021, the subject experienced nausea. On 05-APR-2021, the subject experienced bones hurting bad all over (worse at legs and both shin bone pain). Laboratory data (dates unspecified) included: Blood test (NR: not provided) thyroid levels were normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bones hurting bad all over (worse at legs and both shin bone pain), nausea, vomiting, and sleepy. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS WHEN STANDS UP; This spontaneous report received from a patient concerned a 56 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: Unknown) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced dizziness when stands up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizziness when stands up was not reported. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dizziness postural, Magnetic resonance imaging
Clinical narrative: DIZZINESS WHEN STANDS UP; This spontaneous report received from a patient concerned a 56 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: Unknown) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced dizziness when stands up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizziness when stands up was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: 2 DAYS OF THE FLU; 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 was not reported, administered on 02-JUN-2021 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 JUN-2021, the subject experienced 2 days of the flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 2 days of the flu on JUN-2021. This report was non-serious. This case, from the same reporter is linked to 20210622311.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORENESS ON THE ARM FROM THE ELBOW UP; This spontaneous report received from a patient concerned an 86 year old female. The patient's weight was not reported and height was 65 inches. The patient's past medical history included colonoscopy, rheumatic fever, and whooping cough, and concurrent conditions included penicillin allergy, alcohol user, and non smoker. The patient experienced drug allergy when treated with sulfur, and tetanus vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 22202A, and expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-JUN-2021, the subject experienced soreness on the arm from the elbow up. Treatment medications (dates unspecified) included: magnesium sulfate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness on the arm from the elbow up. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Lymphadenopathy, Neck pain, Pain
Clinical narrative: SUBCLAVICAL LYMPH NODE SWELLING ON THE LEFT SIDE; RAISE AND TENDER ON THE RIDGE OF JAW; TENDER ON THE NECK WHEN PRESSED HURTS; LITTLE BIT WARM SWELLING ON THE RIDGE OF JAW; WARM SWELLING ON THE NECK; FATIGUE; BODY ACHES; FEVER OVER 101 DEGREES; This spontaneous report received from a patient concerned a 47 year old female. 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced body aches. On 07-JUN-2021, the subject experienced fever over 101 degrees. Laboratory data included: Body temperature (NR: not provided) Over 101 degrees. On 08-JUN-2021, the subject experienced subclavical lymph node swelling on the left side. On 08-JUN-2021, the subject experienced raise and tender on the ridge of jaw. On 08-JUN-2021, the subject experienced tender on the neck when pressed hurts. On 08-JUN-2021, the subject experienced little bit warm swelling on the ridge of jaw. On 08-JUN-2021, the subject experienced warm swelling on the neck. On 08-JUN-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 09-JUN-2021, and fever over 101 degrees on 08-JUN-2021, and had not recovered from subclavical lymph node swelling on the left side, raise and tender on the ridge of jaw, fatigue, tender on the neck when pressed hurts, little bit warm swelling on the ridge of jaw, and warm swelling on the neck. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Pyrexia, Swelling, Swelling face
Clinical narrative: SUBCLAVICAL LYMPH NODE SWELLING ON THE LEFT SIDE; RAISE AND TENDER ON THE RIDGE OF JAW; TENDER ON THE NECK WHEN PRESSED HURTS; LITTLE BIT WARM SWELLING ON THE RIDGE OF JAW; WARM SWELLING ON THE NECK; FATIGUE; BODY ACHES; FEVER OVER 101 DEGREES; This spontaneous report received from a patient concerned a 47 year old female. 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced body aches. On 07-JUN-2021, the subject experienced fever over 101 degrees. Laboratory data included: Body temperature (NR: not provided) Over 101 degrees. On 08-JUN-2021, the subject experienced subclavical lymph node swelling on the left side. On 08-JUN-2021, the subject experienced raise and tender on the ridge of jaw. On 08-JUN-2021, the subject experienced tender on the neck when pressed hurts. On 08-JUN-2021, the subject experienced little bit warm swelling on the ridge of jaw. On 08-JUN-2021, the subject experienced warm swelling on the neck. On 08-JUN-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 09-JUN-2021, and fever over 101 degrees on 08-JUN-2021, and had not recovered from subclavical lymph node swelling on the left side, raise and tender on the ridge of jaw, fatigue, tender on the neck when pressed hurts, little bit warm swelling on the ridge of jaw, and warm swelling on the neck. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: USE OF VACCINE OUTSIDE OF RECOMMENDED STORAGE TEMPERATURE; ADMINISTERED VACCINE THAT WAS AT ROOM TEMP FOR 4 HOURS; This spontaneous report received from a pharmacist 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: 1808986, expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced out of specification product use. On 10-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210616782.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dizziness, Dyspnoea, Fatigue
Clinical narrative: COUGH; FEET HURT; MUSCLE ACHE; FATIGUE; SHORTNESS OF BREATH; FELT DIZZINESS; CHEST HURT; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included panic attack, and quitted smoking, and concurrent conditions included anxiety, and cough.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 09-JUN-2021 to Left Arm for prophylactic vaccination. Concomitant medications included clonazepam for panic attack, and anxiety. On 10-JUN-2021, the subject experienced shortness of breath. On 10-JUN-2021, the subject experienced felt dizziness. On 10-JUN-2021, the subject experienced chest hurt. On 10-JUN-2021, the subject experienced feet hurt. On 10-JUN-2021, the subject experienced muscle ache. On 10-JUN-2021, the subject experienced fatigue. On an unspecified date, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, felt dizziness, chest hurt, feet hurt, muscle ache, and fatigue on 10-JUN-2021, and the outcome of cough was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: COUGH; FEET HURT; MUSCLE ACHE; FATIGUE; SHORTNESS OF BREATH; FELT DIZZINESS; CHEST HURT; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included panic attack, and quitted smoking, and concurrent conditions included anxiety, and cough.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 09-JUN-2021 to Left Arm for prophylactic vaccination. Concomitant medications included clonazepam for panic attack, and anxiety. On 10-JUN-2021, the subject experienced shortness of breath. On 10-JUN-2021, the subject experienced felt dizziness. On 10-JUN-2021, the subject experienced chest hurt. On 10-JUN-2021, the subject experienced feet hurt. On 10-JUN-2021, the subject experienced muscle ache. On 10-JUN-2021, the subject experienced fatigue. On an unspecified date, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, felt dizziness, chest hurt, feet hurt, muscle ache, and fatigue on 10-JUN-2021, and the outcome of cough was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation irregular, Pain, Pyrexia
Clinical narrative: IRREGULAR PERIOD; BODY ACHES; FEVER; MASSIVE HEADACHE; 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: 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 irregular period, body aches, fever, and massive headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from irregular period, and the outcome of fever, body aches and massive headache was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: PAIN ON LEFT BREAST; This spontaneous report received from a patient concerned a 45 year old female. 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: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced pain on left breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on left breast. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS GIVEN AFTER THE 6 HOURS LIMIT; POOR QUALITY PRODUCT ADMINISTERED; This spontaneous report received from a health care professional 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 was not reported, administered on 11-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-JUN-2021, the subject experienced vaccine was given after the 6 hours limit. On 11-JUN-2021, the subject experienced poor quality product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was given after the 6 hours limit and poor quality product administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 12-JUN-2021 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 13-JUN-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting. This report was non-serious.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 16 year old of unspecified 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 was not reported, administered on 11-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-JUN-2021, the subject experienced drug administered to subject of inappropriate age. On 11-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHES; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.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. 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 aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches. This report was non-serious. This case, from the same reporter is linked to 20210627564.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: she can't get up without passing out; chills; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she can't get up without passing out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 057G120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (she can't get up without passing out) (seriousness criterion medically significant), CHILLS (chills), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, LOSS OF CONSCIOUSNESS (she can't get up without passing out), CHILLS (chills), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Musculoskeletal stiffness, Myalgia, Pain in jaw
Clinical narrative: rheumatoid arthritis she had a flare; run over by a truck; became stiff and hurt all over; jaw hurt; headache; hurt all over/ achy feeling; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis she had a flare) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 029L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis she had a flare) (seriousness criterion medically significant), FEELING ABNORMAL (run over by a truck), MUSCULOSKELETAL STIFFNESS (became stiff and hurt all over), PAIN IN JAW (jaw hurt), HEADACHE (headache) and MYALGIA (hurt all over/ achy feeling). The patient was treated with Physical therapy for Rheumatoid arthritis; Physical therapy for Feeling abnormal; Physical therapy for Musculoskeletal stiffness; Physical therapy for Pain in jaw; Physical therapy for Headache and Physical therapy for Myalgia. On 17-Mar-2021, PAIN IN JAW (jaw hurt) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis she had a flare) had not resolved and FEELING ABNORMAL (run over by a truck), MUSCULOSKELETAL STIFFNESS (became stiff and hurt all over), HEADACHE (headache) and MYALGIA (hurt all over/ achy feeling) outcome was unknown.            No relevant concomitant medications were reported.  The patient stated how long this flare up would last and should she continue to go to physical therapy.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-048039 (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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis she had a flare; run over by a truck; became stiff and hurt all over; jaw hurt; headache; hurt all over/ achy feeling; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis she had a flare) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 029L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis she had a flare) (seriousness criterion medically significant), FEELING ABNORMAL (run over by a truck), MUSCULOSKELETAL STIFFNESS (became stiff and hurt all over), PAIN IN JAW (jaw hurt), HEADACHE (headache) and MYALGIA (hurt all over/ achy feeling). The patient was treated with Physical therapy for Rheumatoid arthritis; Physical therapy for Feeling abnormal; Physical therapy for Musculoskeletal stiffness; Physical therapy for Pain in jaw; Physical therapy for Headache and Physical therapy for Myalgia. On 17-Mar-2021, PAIN IN JAW (jaw hurt) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis she had a flare) had not resolved and FEELING ABNORMAL (run over by a truck), MUSCULOSKELETAL STIFFNESS (became stiff and hurt all over), HEADACHE (headache) and MYALGIA (hurt all over/ achy feeling) outcome was unknown.            No relevant concomitant medications were reported.  The patient stated how long this flare up would last and should she continue to go to physical therapy.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-048039 (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.