chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Blood immunoglobulin A, Diarrhoea, Fatigue, Gastrointestinal pain
Clinical narrative: HOT/COLD SWEATS; SEVERE DIARRHEA; AURA MIGRANE; HEAD PRESSURE/HEAVY HEAD; FATIGUE; HIT LOWER COLON; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included bowel resection, iga, ana, radioactive iodine treatment, graves syndromes, and autoimmune issues, and concurrent conditions included crohns disease, celiac disease, ms, lesions, and stenosis, and other pre-existing medical conditions included patient has no problems with bowel or bladder control. patient was not pregnant at time of vaccination. 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 21-JUN-2021 for prophylactic vaccination. Concomitant medications included siponimod fumarate for ms. The batch number was not reported and has been requested On 2011, Laboratory data included: Radioactive iodine therapy (NR: not provided) not reported. On 2021, the subject experienced hit lower colon. On 21-JUN-2021, the subject experienced head pressure/heavy head. On 21-JUN-2021, the subject experienced fatigue. On 21-JUN-2021, the subject experienced aura migraine. On 22-JUN-2021, the subject experienced hot/cold sweats. On 22-JUN-2021, the subject experienced severe diarrhea. Laboratory data (dates unspecified) included: ANA (NR: not provided) Abnormal, and IgA (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from head pressure/heavy head, hot/cold sweats, fatigue, severe diarrhea, and aura migraine, and the outcome of hit lower colon was not reported. This report was non-seriousc
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Hyperhidrosis, Migraine with aura, Radioactive iodine therapy
Clinical narrative: HOT/COLD SWEATS; SEVERE DIARRHEA; AURA MIGRANE; HEAD PRESSURE/HEAVY HEAD; FATIGUE; HIT LOWER COLON; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included bowel resection, iga, ana, radioactive iodine treatment, graves syndromes, and autoimmune issues, and concurrent conditions included crohns disease, celiac disease, ms, lesions, and stenosis, and other pre-existing medical conditions included patient has no problems with bowel or bladder control. patient was not pregnant at time of vaccination. 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 21-JUN-2021 for prophylactic vaccination. Concomitant medications included siponimod fumarate for ms. The batch number was not reported and has been requested On 2011, Laboratory data included: Radioactive iodine therapy (NR: not provided) not reported. On 2021, the subject experienced hit lower colon. On 21-JUN-2021, the subject experienced head pressure/heavy head. On 21-JUN-2021, the subject experienced fatigue. On 21-JUN-2021, the subject experienced aura migraine. On 22-JUN-2021, the subject experienced hot/cold sweats. On 22-JUN-2021, the subject experienced severe diarrhea. Laboratory data (dates unspecified) included: ANA (NR: not provided) Abnormal, and IgA (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from head pressure/heavy head, hot/cold sweats, fatigue, severe diarrhea, and aura migraine, and the outcome of hit lower colon was not reported. This report was non-seriousc
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN AT INJECTION; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 130 pounds, and height was 64 inches. The patient's concurrent conditions included non smoker, and no alcohol use, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2018218, expiry: 23-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 20-MAY-2021, the subject experienced pain at injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection on 20-MAY-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: THROWING UP ALL OVER THE PLACE; 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 was not reported, administered on 22-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 22-JUN-2021, the subject experienced throwing up all over the place. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of throwing up all over the place was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Dizziness, Dyspnoea, Fatigue
Clinical narrative: ACHEY; TIRED (EXHAUSTED); NO ENERGY; COULD NOT CATCH BREATH; FELT LIKE GOING TO PASS OUT (DIZZY); BLOOD CLOT IN LEG; This spontaneous report received from a patient concerned a 59 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: 043A21A, and expiry: unknown) dose was not reported, 1 total administered on right arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-APR-2021, the patient experienced severe pain and swelling in her right leg. On an unspecified date in APR-2021, the patient went to the emergency room and they did a lot of blood work and tests (results unspecified). The patient had ultrasound which revealed the diagnosed of blood clot in her right leg. The radiologist told her to use heat and elevate her leg and follow up with her primary care provider. The patient had an appointment with her doctor, who told her to come back in a week for a follow up ultrasound to make sure that the blood clot was gone. On 13-MAY-2021, she recognized the symptoms of another blood clot, so she used heat and elevated her leg again. On an unspecified date in MAY-2021 (reported as in mid to late May), the patient could not catch her breath and she felt like that she was going to pass out (dizzy). On an unspecified date, the patient experienced achy, tired (exhausted), and no energy. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot in leg, could not catch breath, and felt like going to pass out (dizzy) on an unspecified date, and achey, tired (exhausted), and no energy on an unspecified date in MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210654005-Covid-19 vaccine ad26.cov2.s-Blood clot in leg. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pain, Thrombosis, Ultrasound scan
Clinical narrative: ACHEY; TIRED (EXHAUSTED); NO ENERGY; COULD NOT CATCH BREATH; FELT LIKE GOING TO PASS OUT (DIZZY); BLOOD CLOT IN LEG; This spontaneous report received from a patient concerned a 59 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: 043A21A, and expiry: unknown) dose was not reported, 1 total administered on right arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-APR-2021, the patient experienced severe pain and swelling in her right leg. On an unspecified date in APR-2021, the patient went to the emergency room and they did a lot of blood work and tests (results unspecified). The patient had ultrasound which revealed the diagnosed of blood clot in her right leg. The radiologist told her to use heat and elevate her leg and follow up with her primary care provider. The patient had an appointment with her doctor, who told her to come back in a week for a follow up ultrasound to make sure that the blood clot was gone. On 13-MAY-2021, she recognized the symptoms of another blood clot, so she used heat and elevated her leg again. On an unspecified date in MAY-2021 (reported as in mid to late May), the patient could not catch her breath and she felt like that she was going to pass out (dizzy). On an unspecified date, the patient experienced achy, tired (exhausted), and no energy. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot in leg, could not catch breath, and felt like going to pass out (dizzy) on an unspecified date, and achey, tired (exhausted), and no energy on an unspecified date in MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210654005-Covid-19 vaccine ad26.cov2.s-Blood clot in leg. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: LEFT ARM SWELLING; This spontaneous report received from a consumer concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced left arm swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm swelling. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: TEMPERATURE EXCURSION ON PRODUCT; INCORRECT PRODUCT STORAGE; This spontaneous report received from a patient 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: 203A21A, expiry: 07-AUG-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced temperature excursion on product. On 24-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temperature excursion on product, and incorrect product storage on 24-JUN-2021. This report was non-serious. This report was associated with product quality complaint: 90000184025
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: HEAVY MENSTRUAL BLEEDING; EARLY MENSTRUAL BLEEDING; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 119 pounds, and height was 65 inches. The patient's past medical history included miscarriage, and concurrent conditions included pollen allergy, mold allergy, cedar allergy, mollusk muscles and clams allergy, alcohol user, non-smoker, endometriosis, fertility difficulties, and cyst on ovaries, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. 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 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced heavy menstrual bleeding. On 11-JUN-2021, the subject experienced early menstrual bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heavy menstrual bleeding, and early menstrual bleeding on JUN-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Productive cough, Pyrexia, Rhinorrhoea
Clinical narrative: SORE THROAT; RUNNY NOSE; HEADACHE; LOW GRADE FEVER; WET COUGH THAT'S INTERMITTENT AND THE COUGH IS PRODUCTIVE; THICK YELLOWISH GREEN DRAINAGE; This spontaneous report received from a patient via a company representative concerned a 62 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced wet cough that's intermittent and the cough is productive. On JUN-2021, the subject experienced thick yellowish-green drainage. On 12-JUN-2021, the subject experienced sore throat. On 12-JUN-2021, the subject experienced runny nose. On 12-JUN-2021, the subject experienced headache. On 12-JUN-2021, the subject experienced low-grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat, runny nose, headache, and low-grade fever. on JUN-2021, and had not recovered from wet cough that's intermittent and the cough is productive, and thick yellowish-green drainage. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge
Clinical narrative: SORE THROAT; RUNNY NOSE; HEADACHE; LOW GRADE FEVER; WET COUGH THAT'S INTERMITTENT AND THE COUGH IS PRODUCTIVE; THICK YELLOWISH GREEN DRAINAGE; This spontaneous report received from a patient via a company representative concerned a 62 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced wet cough that's intermittent and the cough is productive. On JUN-2021, the subject experienced thick yellowish-green drainage. On 12-JUN-2021, the subject experienced sore throat. On 12-JUN-2021, the subject experienced runny nose. On 12-JUN-2021, the subject experienced headache. On 12-JUN-2021, the subject experienced low-grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat, runny nose, headache, and low-grade fever. on JUN-2021, and had not recovered from wet cough that's intermittent and the cough is productive, and thick yellowish-green drainage. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram, Headache, Pain in extremity, Thrombosis
Clinical narrative: ABDOMINAL PAIN; LEG PAIN; HEADACHE; BLOOD CLOT IN THE RIGHT FEMORAL VEIN IN THE RIGHT THIGH; This spontaneous report received from a consumer concerned a 51 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: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 03-APR-2021 to right deltoid for prophylactic vaccination. Concomitant medications included valsartan 40mg. On 20-JUN-2021, the patient experienced blood clot in the right femoral vein in the right thigh which was found through computerised tomogram which was done when the patient had visited the doctor about the other symptoms of abdominal pain, leg pain and headaches. The health care professional had intended to visit another health care professional specialized in blood clot related issues. Laboratory data included: Computerised tomogram scan (NR: not provided) Blood clots observed in right femoral vein in the right thigh. On an unspecified date, the patient experienced abdominal pain, leg pain, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in the right femoral vein in the right thigh, leg pain, headache and abdominal pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210654370-COVID-19 VACCINE AD26.COV2.S-blood clot in the right femoral vein in the right thigh. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE PAIN; This spontaneous report received from a patient 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 MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-JUN-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Impaired work ability, Nausea
Clinical narrative: FEELING AWFUL; CAN'T WORK; EXTREME HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative 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 was not reported, administered on 22-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On JUN-2021, the subject experienced feeling awful. On JUN-2021, the subject experienced can't work. On JUN-2021, the subject experienced extreme headache. On JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling awful, extreme headache, nausea, and can't work. This report was non-serious.  .
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Headache, Limb discomfort, Muscle strain
Clinical narrative: DISCOMFORT IN UNDERSIDE OF RIB; DISCOMFORT IN LEFT ARM; NAUSEA; HEADACHE; TINGLING DOWN TO FINGERNAILS; PULLED A MUSCLE IN BACK; DIZZINESS, LIGHTHEADEDNESS UPON STANDING; DRY MOUTH; ARM HURTS WHEN STRETCHED; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included narcolepsy, and cluster headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. Concomitant medications included verapamil for cluster headache.  On JUN-2021, the subject experienced tingling down to fingernails. On JUN-2021, the subject experienced pulled a muscle in back. On JUN-2021, the subject experienced dizziness, lightheadedness upon standing. On JUN-2021, the subject experienced dry mouth. On JUN-2021, the subject experienced arm hurts when stretched. On 21-JUN-2021, the subject experienced discomfort in underside of rib. On 21-JUN-2021, the subject experienced discomfort in left arm. On 21-JUN-2021, the subject experienced nausea. On 21-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the discomfort in left arm, dizziness, lightheadedness upon standing, dry mouth, nausea, headache, pulled a muscle in back, arm hurts when stretched, discomfort in underside of rib and tingling down to fingernails was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: DISCOMFORT IN UNDERSIDE OF RIB; DISCOMFORT IN LEFT ARM; NAUSEA; HEADACHE; TINGLING DOWN TO FINGERNAILS; PULLED A MUSCLE IN BACK; DIZZINESS, LIGHTHEADEDNESS UPON STANDING; DRY MOUTH; ARM HURTS WHEN STRETCHED; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included narcolepsy, and cluster headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. Concomitant medications included verapamil for cluster headache.  On JUN-2021, the subject experienced tingling down to fingernails. On JUN-2021, the subject experienced pulled a muscle in back. On JUN-2021, the subject experienced dizziness, lightheadedness upon standing. On JUN-2021, the subject experienced dry mouth. On JUN-2021, the subject experienced arm hurts when stretched. On 21-JUN-2021, the subject experienced discomfort in underside of rib. On 21-JUN-2021, the subject experienced discomfort in left arm. On 21-JUN-2021, the subject experienced nausea. On 21-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the discomfort in left arm, dizziness, lightheadedness upon standing, dry mouth, nausea, headache, pulled a muscle in back, arm hurts when stretched, discomfort in underside of rib and tingling down to fingernails was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Exposure during pregnancy, Headache, Nausea
Clinical narrative: Severe joint pain in right hand started 9 hours after vaccine administered. Slight nausea and severe headache upon awakening at 4:45 am. Slightly elevated temperature (100.1). Currently 25 weeks pregnant.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Condition aggravated, Electrocardiogram, Electrocardiogram ambulatory, Sinus rhythm
Clinical narrative: Pt. has hysterical of atrial fibrillation, which had been successfully controlled for 1yr+3weeks prior to second dose. Pt experienced episode of atrial fibrillation ~2days subsequent to second dose of vaccine.  Pt. spontainiously converted to sinus rhythm ~ 2 weeks later.   Pt. Continued to have episodes of a-fib at increasing intervals and decreasing duration through March (approx 3 mos. after 2nd dose.)   About 4mos. subsequent to 2nd vaccine dose, pt experienced a persistent episode of atrial flutter, which was terminated via electrocardioversion after 4 weeks.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Chest pain, Electrocardiogram
Clinical narrative: Chest pressure, stabbing pain mostly on left side of chest. Diagnosed with pericarditis
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Chest pressure, stabbing pain mostly on left side of chest. Diagnosed with pericarditis
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Paraesthesia, Shoulder injury related to vaccine administration
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Decreased appetite, Fatigue, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: patient fainted 4 minutes after receiving vaccine. Patient said he did not eat or drink before getting vaccine. blood pressure 105/90. he recuperate quickly but mother wanted us to call 911 to check him. He was responsive and moving. episode only last 3 minutes. i gave him a bottle of water and he felt fine but tired.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Mild
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pyrexia, Tremor
Clinical narrative: April 13th i had the 1st Moderna shot and aside a sore arm I was perfectly fine. May 13 I had the 2nd shot and within 12h i got really sick, fever, cough, whole body shaking shivers. Lasted few days. Since then I have this cough that never left. It is not continuous, it is bouts of dry cough. Recently i started to spit watery transparent mucus. Note: we followed 100% covid restrictions since march 2020. Quarantine, social distancing, masks, etc. None of us ever got sick this whole time. My daughter is 13 and she had a cold in may but her school made us have her tested and she was covid negative.  Are there reports of people having  continuous cough bouts after the vaccine? My doctor says it shouldn't be related and my lungs sound fine I also have an oximeter and my 02/heart beats are perfect. No shortness of breath, no chest pain. Nothing. My husband had mild side effects from his vaccine but he healed after a few days. No one in the household has been sick recently.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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 headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: BODY HURTS; CHILLS; 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 body hurts, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body hurts, chills and headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Oropharyngeal pain, Productive cough
Clinical narrative: WET COUGH; RESPIRATORY INFLAMMATION; HEADACHE; FEVER; SORE THROAT; RUNNY NOSE; FEELING BAD; This spontaneous report received from a patient concerned a 64 year old male. The patient's weight was 225 pounds, and height was 73 inches. The patient's pre-existing medical conditions included the patient was prescribed an oral 7day unspecified steroid regimen for his respiratory inflammation, which he was still taking. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-JUN-2021, the subject experienced sore throat. On 17-JUN-2021, the subject experienced runny nose. On 17-JUN-2021, the subject experienced feeling bad. On 17-JUN-2021, the subject experienced headache. On 17-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99 F. On 19-JUN-2021, treatment medications included: azithromycin. On 22-JUN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On an unspecified date, the subject experienced wet cough, and respiratory inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat, runny nose, and headache, and fever on JUN-2021, had not recovered from wet cough, and the outcome of feeling bad and respiratory inflammation was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract inflammation, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: WET COUGH; RESPIRATORY INFLAMMATION; HEADACHE; FEVER; SORE THROAT; RUNNY NOSE; FEELING BAD; This spontaneous report received from a patient concerned a 64 year old male. The patient's weight was 225 pounds, and height was 73 inches. The patient's pre-existing medical conditions included the patient was prescribed an oral 7day unspecified steroid regimen for his respiratory inflammation, which he was still taking. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-JUN-2021, the subject experienced sore throat. On 17-JUN-2021, the subject experienced runny nose. On 17-JUN-2021, the subject experienced feeling bad. On 17-JUN-2021, the subject experienced headache. On 17-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99 F. On 19-JUN-2021, treatment medications included: azithromycin. On 22-JUN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On an unspecified date, the subject experienced wet cough, and respiratory inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat, runny nose, and headache, and fever on JUN-2021, had not recovered from wet cough, and the outcome of feeling bad and respiratory inflammation was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: VACCINE LEFT IN FRIDGE MORE THAN SIX HOURS ( ABOUT 12 HOURS); USE OF EXPIRED JANSSEN COVID-19  VACCINE/DID NOT CHECK THE VIAL OR TIME AND  JUST FOUND OUT ABOUT IT JUST NOW; 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: 203A21A, and  expiry: UNKONWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced vaccine left in fridge more than six hours ( about 12 hours), and use of expired Janssen covid-19 vaccine/did not check the vial or time and just found out about it just now.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine left in fridge more than six hours ( about 12 hours) and and use of expired Janssen covid-19 vaccine/did not check the vial or time and just found out about it just now. was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bradykinesia, Chills, Lethargy, Pain
Clinical narrative: RASH ON LEFT SIDE OF TRUNK OF BODY LOOK LIKE MOSQUITO BITES AND ON MIDDLE OF BODY; HIVES ON LEFT SIDE OF TRUNK OF BODY LOOK LIKE MOSQUITO BITES AND ON MIDDLE OF BODY; LOW GRADE FEVER; CHILLS; ACHINESS; LAGGY; LETHARGIC; This spontaneous report received from a patient concerned a 64 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: 1821288 expiry: UNKNOWN) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced achiness. On 18-JUN-2021, the subject experienced laggy. On 18-JUN-2021, the subject experienced lethargic. On 18-JUN-2021, the subject experienced chills. On 18-JUN-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications included: paracetamol. On 22-JUN-2021, the subject experienced rash on left side of trunk of body look like mosquito bites and on middle of body. On 22-JUN-2021, the subject experienced hives on left side of trunk of body look like mosquito bites and on middle of body. Treatment medications included: camphor/diphenhydramine hydrochloride/zinc oxide. On 23-JUN-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, laggy, lethargic, chills, and low grade fever on 19-JUN-2021, and was recovering from hives on left side of trunk of body look like mosquito bites and on middle of body, and rash on left side of trunk of body look like mosquito bites and on middle of body. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: RASH ON LEFT SIDE OF TRUNK OF BODY LOOK LIKE MOSQUITO BITES AND ON MIDDLE OF BODY; HIVES ON LEFT SIDE OF TRUNK OF BODY LOOK LIKE MOSQUITO BITES AND ON MIDDLE OF BODY; LOW GRADE FEVER; CHILLS; ACHINESS; LAGGY; LETHARGIC; This spontaneous report received from a patient concerned a 64 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: 1821288 expiry: UNKNOWN) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced achiness. On 18-JUN-2021, the subject experienced laggy. On 18-JUN-2021, the subject experienced lethargic. On 18-JUN-2021, the subject experienced chills. On 18-JUN-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications included: paracetamol. On 22-JUN-2021, the subject experienced rash on left side of trunk of body look like mosquito bites and on middle of body. On 22-JUN-2021, the subject experienced hives on left side of trunk of body look like mosquito bites and on middle of body. Treatment medications included: camphor/diphenhydramine hydrochloride/zinc oxide. On 23-JUN-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, laggy, lethargic, chills, and low grade fever on 19-JUN-2021, and was recovering from hives on left side of trunk of body look like mosquito bites and on middle of body, and rash on left side of trunk of body look like mosquito bites and on middle of body. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: HEADACHE; MUSCLE ACHES; This spontaneous report received from a patient via a company representative 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and muscle aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Joint injury, Pain
Clinical narrative: INJURY IN KNEES; PAIN; 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. 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 injury in knees, and pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain, and the outcome of injury in knees was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Insomnia, Pain
Clinical narrative: BODY ACHES; COULDN'T SLEEP FOR 4 HOURS; CHILLS; INJECTION SITE PAIN; 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 was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUN-2021, the subject experienced injection site pain. On 24-JUN-2021, the subject experienced body aches. On 24-JUN-2021, the subject experienced couldn't sleep for 4 hours. On 24-JUN-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, body aches, and couldn't sleep for 4 hours, and had not recovered from injection site pain. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Flatulence
Clinical narrative: GAS; INDIGESTION; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gas/indigestion issues, and multiple sclerosis exposure, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and expiry: 05-AUG-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included glatiramer acetate for multiple sclerosis exposure.  On 24-JUN-2021, the subject experienced gas. On 24-JUN-2021, the subject experienced indigestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from gas, and indigestion on 25-JUN-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM SORENESS FOR 5 DAYS; 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: 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 arm soreness for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm soreness for 5 days was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: BODY ACHES; WAS IN BED ALL DAY; FEVER; 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 body aches, was in bed all day, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the was in bed all day, body aches and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Nightmare
Clinical narrative: FEARFULL NIGHTMARE; FELT BAD AND DIE, NEVER RETURN; 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, intramuscular, 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 fearful nightmare, and felt bad and die, never return. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fearful nightmare and felt bad and die, never return was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Myocarditis
Clinical narrative: MYOCARDITIS; COMPUTERISED TOMOGRAM; ELECTROCARDIOGRAM; This spontaneous report was received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1395661) and concerned a 40 year old male of unknown race and ethnicity. The patient's height and weight were not reported. The patient had no medical history, no known allergies and no current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 10-MAY-2021 to left arm for prophylactic vaccination. The patient had no concomitant medications.  On 11-MAY-2021, the patient experienced myocarditis. He visited emergency room and underwent computerized tomogram (CT scan) and electrocardiogram (EKG); the results came up as myocarditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from the events. This report was serious (Other Medically Important Condition).; Sender's Comments: V1: This spontaneous report was received from a health care professional via VAERS (ID: 1395661) concerned a 40-year-old man (ethnicity unknown) who experienced myocarditis one day after vaccine. The patient had no medical history, no known allergies and no current illness at the time of vaccination. The patient had no concomitant medications.  On day 1, the patient experienced myocarditis. He visited emergency room and underwent computerized tomogram (CT scan) and electrocardiogram (EKG); the results came up as myocarditis. The patient recovered. Information is limited in this case, and the occurrence of myocarditis could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. More information will be requested if contact information is available.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: BAD SIDE EFFECTS; This spontaneous report received from a parent 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 bad side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20210660515 and 20210660645.