chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Injection site pain, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; VERY VERY LITTLE PAIN IN THE INJECTION SITE; This spontaneous report received from a patient concerned a 66 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included cardiac arrhythmia, and concurrent conditions included migraine headache, non-alcohol user, and non-smoker. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: unknown) dose was not reported, 1 total administered to left arm on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in JUN-2021, the patient experienced very little pain in the injection site. The shot never got hard or warm. Patient had no fever, no dizziness, no runny nose. Patient did the antibody test and on 31-Jul-2021 negative antibody result was found (confirmed immunological vaccine failure). Patient was not feeling protected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very very little pain in the injection site and confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210804980-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
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient was non alcohol user, non-smoker. The patient did not have any drug abuse/illicit drug use. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, 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 patient had a blood test for something else and decided to test for antibodies as well (since she got vaccinated). Her antibody test came out negative (suspected immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210805266.; Sender's Comments: V0: 20210805141-covid-19 vaccine ad26.cov2.s -Suspected 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
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort, Pyrexia
Clinical narrative: HEAD SEEMS LIKE IT WANTS TO EXPLODE; 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: Unk) dose was not reported, administered on 01-AUG-2021 for prophylactic vaccination. The batch number was not reported. the company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 02-AUG-2021, the subject experienced head seems like it wants to explode. On 02-AUG-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and head seems like it wants to explode was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: TWO HEART ATTACKS; This spontaneous report received from a patient via social media through 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, 1 total administered 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 patient experienced two heart attacks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two heart attacks was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210805250- COVID-19 VACCINE AD26.COV2.S-two heart attacks. 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: Back pain, Body temperature, Feeling abnormal, Feeling cold, Feeling drunk
Clinical narrative: 6 SHARP PAINS IN MY LEFT POSTERIOR BACK MEDIAL OF MY FLOATING RIBS; MUSCLE PAIN ON TOUCH FROM THE SHOT; FEELING COLD; FEELING OF BEING INTOXICATED; FELT LIKE SUPERWOMAN/URGENCY TO TAKE OFF RUNNING; 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) dose was not reported, administered on 29-JUL-2021 14:21 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUL-2021, the subject experienced feeling of being intoxicated. On 29-JUL-2021, the subject experienced felt like an urgency to take off running. On 29-JUL-2021, the subject experienced feeling cold. Laboratory data included: Body temperature (NR: not provided) Low, 97.6, and Heart rate (NR: not provided) 76, 61. On 30-JUL-2021, the subject experienced 6 sharp pains in my left posterior back medial of my floating ribs. On 30-JUL-2021, the subject experienced muscle pain on touch from the shot. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling of being intoxicated, felt like an urgency to take off running, feeling cold, muscle pain on touch from the shot and 6 sharp pains in my left posterior back medial of my floating ribs was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Myalgia
Clinical narrative: 6 SHARP PAINS IN MY LEFT POSTERIOR BACK MEDIAL OF MY FLOATING RIBS; MUSCLE PAIN ON TOUCH FROM THE SHOT; FEELING COLD; FEELING OF BEING INTOXICATED; FELT LIKE SUPERWOMAN/URGENCY TO TAKE OFF RUNNING; 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) dose was not reported, administered on 29-JUL-2021 14:21 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUL-2021, the subject experienced feeling of being intoxicated. On 29-JUL-2021, the subject experienced felt like an urgency to take off running. On 29-JUL-2021, the subject experienced feeling cold. Laboratory data included: Body temperature (NR: not provided) Low, 97.6, and Heart rate (NR: not provided) 76, 61. On 30-JUL-2021, the subject experienced 6 sharp pains in my left posterior back medial of my floating ribs. On 30-JUL-2021, the subject experienced muscle pain on touch from the shot. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling of being intoxicated, felt like an urgency to take off running, feeling cold, muscle pain on touch from the shot and 6 sharp pains in my left posterior back medial of my floating ribs was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer concerned an female of unspecified age and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included underlying disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, 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 31-JUL-2021, the patient died of unknown cause. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210805373-covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered un-assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 53 year old female of unknown race, and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, few days before the date of reporting the patient contracted Covid-19. Although she tested negative before coming back to the country she started to experience symptoms shortly after her return. She started to experience severe headaches and extreme fatigue.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210805573-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination 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
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE STORED OUTSIDE OF 6 HOURS TIME FRAME THE VIAL WAS REFRIGERATED FOR 46 HOURS; VIAL PUNCTURED AND REFRIGERATED 46 HOURS PRIOR TO DOSE DRAWN FROM VAIL; 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, 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 administration of vaccine stored outside of 6 hours time frame the vial was refrigerated for 46 hours, and vial punctured and refrigerated 46 hours prior to dose drawn from vail. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial punctured and refrigerated 46 hours prior to dose drawn from vail and administration of vaccine stored outside of 6 hours time frame the vial was refrigerated for 46 hours was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Antibody test, Chills, Nausea, Pain
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; ACHES AND PAINS; UPSET STOMACH; CHILLS; VERGE OF VOMITING; This spontaneous report received from a patient concerned a 68 year old female, unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriatic arthritis, reflux, formaldehyde pesticides and chlorine allergy, paint and natural gas allergy, detergent allergy, sulfa allergy, mold allergy, dust allergy, mites allergy, pollen allergy, dogs and cats allergy, asthma attack, cigarette smoke allergy, and fragrance allergy. The patient experienced bad headache, itchy and not feel good when treated with pneumococcal vaccine, and cyanocobalamin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: 23-AUG-2021) dose was not reported, one total administered on 01-APR-2021 in left arm for prophylactic vaccination. Concomitant medications included apremilast for psoriatic arthritis, salbutamol sulfate for reaction causing asthma attack, pantoprazole sodium sesquihydrate for reflux, bupropion hydrochloride, epinephrine, and thyroid.  On 01-APR-2021 patient experienced chills and upset stomach (verge of vomiting), which started at afternoon. The patient reports chills, and aches and pains that began in the evening 01-APR-2021. The patient reported that symptoms started feeling better/improving about 24 hours later, in the afternoon on 02-APR-2021, however, reports she felt much better on 03-APR-2021. The patient reported she had an antibody test performed 30-JUL-2021 which came back with a negative (confirmed immunological vaccine failure). The patient was not certain on which type of serologic test was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pains, upset stomach, chills, and verge of vomiting on 03-APR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210805910-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical immunological failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; ACHES AND PAINS; UPSET STOMACH; CHILLS; VERGE OF VOMITING; This spontaneous report received from a patient concerned a 68 year old female, unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriatic arthritis, reflux, formaldehyde pesticides and chlorine allergy, paint and natural gas allergy, detergent allergy, sulfa allergy, mold allergy, dust allergy, mites allergy, pollen allergy, dogs and cats allergy, asthma attack, cigarette smoke allergy, and fragrance allergy. The patient experienced bad headache, itchy and not feel good when treated with pneumococcal vaccine, and cyanocobalamin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: 23-AUG-2021) dose was not reported, one total administered on 01-APR-2021 in left arm for prophylactic vaccination. Concomitant medications included apremilast for psoriatic arthritis, salbutamol sulfate for reaction causing asthma attack, pantoprazole sodium sesquihydrate for reflux, bupropion hydrochloride, epinephrine, and thyroid.  On 01-APR-2021 patient experienced chills and upset stomach (verge of vomiting), which started at afternoon. The patient reports chills, and aches and pains that began in the evening 01-APR-2021. The patient reported that symptoms started feeling better/improving about 24 hours later, in the afternoon on 02-APR-2021, however, reports she felt much better on 03-APR-2021. The patient reported she had an antibody test performed 30-JUL-2021 which came back with a negative (confirmed immunological vaccine failure). The patient was not certain on which type of serologic test was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pains, upset stomach, chills, and verge of vomiting on 03-APR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210805910-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical immunological failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: CHILLS; FATIGUE; MILD HEADACHE; LOW 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 01-AUG-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On an unspecified date, the subject experienced chills, fatigue, mild headache, and low fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fatigue, mild headache and low fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Hyperhidrosis, Illness
Clinical narrative: CHEST HURTS/PAIN; SWEATING; TWITCHING; VERY SICK; CHILLS; FEVER; This spontaneous report received from a parent 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 03-AUG-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 03-AUG-2021, the subject experienced very sick. On 03-AUG-2021, the subject experienced chills. On 03-AUG-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.6 F. On 04-AUG-2021, the subject experienced chest hurts/pain. On 04-AUG-2021, the subject experienced sweating. On 04-AUG-2021, the subject experienced twitching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest hurts/pain, sweating, twitching, chills, fever, and very sick. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pyrexia
Clinical narrative: CHEST HURTS/PAIN; SWEATING; TWITCHING; VERY SICK; CHILLS; FEVER; This spontaneous report received from a parent 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 03-AUG-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 03-AUG-2021, the subject experienced very sick. On 03-AUG-2021, the subject experienced chills. On 03-AUG-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.6 F. On 04-AUG-2021, the subject experienced chest hurts/pain. On 04-AUG-2021, the subject experienced sweating. On 04-AUG-2021, the subject experienced twitching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest hurts/pain, sweating, twitching, chills, fever, and very sick. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Feeling hot, Flushing, Oropharyngeal pain
Clinical narrative: SORE THROAT; HANDS WARM TO TOUCH; FEVER; LOOKING FLUSHED; HANDS FELT HOT; This spontaneous report received from a patient concerned a 64 year old male. The patient's weight was 220 pounds, and height was not reported. The patient's past medical history included accident bruise in spine, neuropathy of four limbs, issues bowel movements after spinal surgery, shoulder surgery on both side, appendix taken out, tonsils taken out, and spinal surgery, and concurrent conditions included dog dander allergy, alcohol user, smoker, and controlled hypertension, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient allergic to mouse feces.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 09:15 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the subject experienced looking flushed. On 02-AUG-2021, the subject experienced hands felt hot. On 02-AUG-2021, the subject experienced hands warm to touch. On 02-AUG-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) Normal, and Body temperature (NR: not provided) 100.8 F, 98.9 F. On 03-AUG-2021, the subject experienced sore throat. Laboratory data included: Blood pressure (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from looking flushed, hands felt hot, and hands warm to touch on 02-AUG-2021, and fever on 03-AUG-2021, and had not recovered from sore throat. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Skin warm
Clinical narrative: SORE THROAT; HANDS WARM TO TOUCH; FEVER; LOOKING FLUSHED; HANDS FELT HOT; This spontaneous report received from a patient concerned a 64 year old male. The patient's weight was 220 pounds, and height was not reported. The patient's past medical history included accident bruise in spine, neuropathy of four limbs, issues bowel movements after spinal surgery, shoulder surgery on both side, appendix taken out, tonsils taken out, and spinal surgery, and concurrent conditions included dog dander allergy, alcohol user, smoker, and controlled hypertension, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient allergic to mouse feces.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 09:15 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the subject experienced looking flushed. On 02-AUG-2021, the subject experienced hands felt hot. On 02-AUG-2021, the subject experienced hands warm to touch. On 02-AUG-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) Normal, and Body temperature (NR: not provided) 100.8 F, 98.9 F. On 03-AUG-2021, the subject experienced sore throat. Laboratory data included: Blood pressure (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from looking flushed, hands felt hot, and hands warm to touch on 02-AUG-2021, and fever on 03-AUG-2021, and had not recovered from sore throat. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pyrexia, Testicular pain
Clinical narrative: PAIN AROUND MY TESTICLES; INNER FEVER/FEVER BECAME SEVER AND WORSE AFTER 48HOURS; SICK; 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: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUL-2021, the subject experienced sick. On 20-JUL-2021, the subject experienced inner fever/fever became sever and worse after 48hours. On an unspecified date, the subject experienced pain around my testicles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick, inner fever/fever became sever and worse after 48hours, and pain around my testicles. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a patient 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: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced incorrect product storage. On 29-APR-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210808095.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: CAN BARELY WALK ON MY LEG; LITTLE SWELLING IN ARM; ARM WAS NUMB; ARM WAS VERY PAINFUL/RIGHT LEG IS REALLY BAD; 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 29-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced can barely walk on my leg, arm was numb, little swelling in arm, and arm was very painful/right leg is really bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm was very painful/right leg is really bad, and can barely walk on my leg, and the outcome of arm was numb and little swelling in arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypopnoea, Myalgia, Palpitations, Pyrexia
Clinical narrative: HEART PALPITATING; SHALLOW BREATHS; CHILLS; FEVER; MUSCLE ACHES IN HIS GLUTS AND THIGHS; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to yellow jacket stings, and other pre-existing medical conditions included no known drug allergies. 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 03-AUG-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the subject experienced heart palpitating. On 04-AUG-2021, the subject experienced shallow breaths. On 04-AUG-2021, the subject experienced chills. On 04-AUG-2021, the subject experienced fever. On 04-AUG-2021, the subject experienced muscle aches in his gluts and thighs. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitating, and shallow breaths, and chills, fever, and muscle aches in his gluts and thighs on 04-AUG-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia, Nausea, Pain, Pyrexia
Clinical narrative: ACHY EVERYWHERE; COULDN'T SLEEP; FEELS HORRIBLE; FEVER; NAUSEA; This spontaneous report received from a parent concerned a 22 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: 1820095, expiry: UNKNOWN) dose was not reported, administered on 03-AUG-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the subject experienced achy everywhere. On 03-AUG-2021, the subject experienced couldn't sleep. On 03-AUG-2021, the subject experienced feels horrible. On 03-AUG-2021, the subject experienced fever. On 03-AUG-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, achy everywhere, and feels horrible, and the outcome of couldn't sleep was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Headache, Nasopharyngitis, Pyrexia
Clinical narrative: COLD-LIKE SYMPTOMS; HEADACHE; LOSS OF APPETITE; BODY JOINTS PAIN; FEVER; This spontaneous report received from a patient concerned a 50 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 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-JUL-2021, the subject experienced loss of appetite. On 30-JUL-2021, the subject experienced body joints pain. On 30-JUL-2021, the subject experienced fever. On an unspecified date, the subject experienced cold-like symptoms, and headache. Treatment medications (dates unspecified) included: caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of appetite, cold-like symptoms, body joints pain, fever and headache was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Pain
Clinical narrative: SEVERE/ EXCRUCIATING PAIN IN LEFT SIDE OF BODY; COULD NOT WALK; PAIN AT RIGHT KNEE; This spontaneous report received from a patient concerned a 64 year old female. 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 not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021, the subject experienced severe/ excruciating pain in left side of body. On 16-MAR-2021, the subject experienced could not walk. On 16-MAR-2021, the subject experienced pain at right knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe/ excruciating pain in left side of body, pain at right knee, and could not walk. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RED SPOT UNDER EYE, TINY RED PERFECTLY ROUND SPOT 1 INCH BELOW LOWER EYELID, THINKS IT WAS A PETECHIAE; This spontaneous report received from a patient concerned a 29 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: 182181, and expiry: UNKNOWN) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-AUG-2021, the subject experienced red spot under eye, tiny red perfectly round spot 1 inch below lower eyelid, thinks it was a petechiae. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red spot under eye, tiny red perfectly round spot 1 inch below lower eyelid, thinks it was a petechiae. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: FEELING OFF; UP ALL NIGHT WITH FEVER/LOW GRADE FEVER; 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) dose was not reported, administered on 28-JUL-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 28-JUL-2021, the subject experienced up all night with fever/low grade fever. On 03-AUG-2021, the subject experienced feeling off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from up all night with fever/low grade fever, and feeling off. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional 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: 1805020, expiry: 21-MAY-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Back pain, Chest pain, Chills
Clinical narrative: SWEATING ALL THE TIME; FEELING LIKE HOT FLASHES; NASAL CONGESTION; DIZZINESS; VERTIGO; TINGLING ON THE LEFT HAND; PAIN SHOOTS DOWN THE LEGS/SORENESS AROUND THE ARM; CHEST PAIN; COUGH/COUGHING UP STUFF; INTERNAL SHAKING; STOMACH IS ACTING UP; LITTLE FATIGUE; HEADACHES; LOWER BACK PAIN; LOWER ABDOMINAL PAIN; DISCOMFORT AROUND THE NECK; CHILLS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included vertigo, and uterus removed, and concurrent conditions included alcohol user, cigarette smoker, anxiety, melanoma on legs, and pinched nerve in the neck, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies and no history of abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. Concomitant medications included alprazolam for to help sleep, and anxiety. On 01-AUG-2021, the subject experienced lower back pain. On 01-AUG-2021, the subject experienced lower abdominal pain. On 01-AUG-2021, the subject experienced discomfort around the neck. On 01-AUG-2021, the subject experienced chills. On 01-AUG-2021, the subject experienced headaches. On an unspecified date, the subject experienced chest pain, cough/coughing up stuff, internal shaking, stomach is acting up, sweating all the time, feeling like hot flashes, nasal congestion, dizziness, vertigo, tingling on the left hand, pain shoots down the legs/soreness around the arm, and little fatigue. Treatment medications (dates unspecified) included: guaifenesin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating all the time, and feeling like hot flashes, and the outcome of chills, headaches, lower back pain, lower abdominal pain, chest pain, cough/coughing up stuff, tingling on the left hand, internal shaking, stomach is acting up, discomfort around the neck, little fatigue, pain shoots down the legs/soreness around the arm, nasal congestion, dizziness and vertigo was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Headache, Hot flush
Clinical narrative: SWEATING ALL THE TIME; FEELING LIKE HOT FLASHES; NASAL CONGESTION; DIZZINESS; VERTIGO; TINGLING ON THE LEFT HAND; PAIN SHOOTS DOWN THE LEGS/SORENESS AROUND THE ARM; CHEST PAIN; COUGH/COUGHING UP STUFF; INTERNAL SHAKING; STOMACH IS ACTING UP; LITTLE FATIGUE; HEADACHES; LOWER BACK PAIN; LOWER ABDOMINAL PAIN; DISCOMFORT AROUND THE NECK; CHILLS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included vertigo, and uterus removed, and concurrent conditions included alcohol user, cigarette smoker, anxiety, melanoma on legs, and pinched nerve in the neck, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies and no history of abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. Concomitant medications included alprazolam for to help sleep, and anxiety. On 01-AUG-2021, the subject experienced lower back pain. On 01-AUG-2021, the subject experienced lower abdominal pain. On 01-AUG-2021, the subject experienced discomfort around the neck. On 01-AUG-2021, the subject experienced chills. On 01-AUG-2021, the subject experienced headaches. On an unspecified date, the subject experienced chest pain, cough/coughing up stuff, internal shaking, stomach is acting up, sweating all the time, feeling like hot flashes, nasal congestion, dizziness, vertigo, tingling on the left hand, pain shoots down the legs/soreness around the arm, and little fatigue. Treatment medications (dates unspecified) included: guaifenesin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating all the time, and feeling like hot flashes, and the outcome of chills, headaches, lower back pain, lower abdominal pain, chest pain, cough/coughing up stuff, tingling on the left hand, internal shaking, stomach is acting up, discomfort around the neck, little fatigue, pain shoots down the legs/soreness around the arm, nasal congestion, dizziness and vertigo was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Musculoskeletal discomfort, Nasal congestion, Nervousness, Pain in extremity
Clinical narrative: SWEATING ALL THE TIME; FEELING LIKE HOT FLASHES; NASAL CONGESTION; DIZZINESS; VERTIGO; TINGLING ON THE LEFT HAND; PAIN SHOOTS DOWN THE LEGS/SORENESS AROUND THE ARM; CHEST PAIN; COUGH/COUGHING UP STUFF; INTERNAL SHAKING; STOMACH IS ACTING UP; LITTLE FATIGUE; HEADACHES; LOWER BACK PAIN; LOWER ABDOMINAL PAIN; DISCOMFORT AROUND THE NECK; CHILLS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included vertigo, and uterus removed, and concurrent conditions included alcohol user, cigarette smoker, anxiety, melanoma on legs, and pinched nerve in the neck, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies and no history of abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. Concomitant medications included alprazolam for to help sleep, and anxiety. On 01-AUG-2021, the subject experienced lower back pain. On 01-AUG-2021, the subject experienced lower abdominal pain. On 01-AUG-2021, the subject experienced discomfort around the neck. On 01-AUG-2021, the subject experienced chills. On 01-AUG-2021, the subject experienced headaches. On an unspecified date, the subject experienced chest pain, cough/coughing up stuff, internal shaking, stomach is acting up, sweating all the time, feeling like hot flashes, nasal congestion, dizziness, vertigo, tingling on the left hand, pain shoots down the legs/soreness around the arm, and little fatigue. Treatment medications (dates unspecified) included: guaifenesin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating all the time, and feeling like hot flashes, and the outcome of chills, headaches, lower back pain, lower abdominal pain, chest pain, cough/coughing up stuff, tingling on the left hand, internal shaking, stomach is acting up, discomfort around the neck, little fatigue, pain shoots down the legs/soreness around the arm, nasal congestion, dizziness and vertigo was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vertigo
Clinical narrative: SWEATING ALL THE TIME; FEELING LIKE HOT FLASHES; NASAL CONGESTION; DIZZINESS; VERTIGO; TINGLING ON THE LEFT HAND; PAIN SHOOTS DOWN THE LEGS/SORENESS AROUND THE ARM; CHEST PAIN; COUGH/COUGHING UP STUFF; INTERNAL SHAKING; STOMACH IS ACTING UP; LITTLE FATIGUE; HEADACHES; LOWER BACK PAIN; LOWER ABDOMINAL PAIN; DISCOMFORT AROUND THE NECK; CHILLS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included vertigo, and uterus removed, and concurrent conditions included alcohol user, cigarette smoker, anxiety, melanoma on legs, and pinched nerve in the neck, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies and no history of abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. Concomitant medications included alprazolam for to help sleep, and anxiety. On 01-AUG-2021, the subject experienced lower back pain. On 01-AUG-2021, the subject experienced lower abdominal pain. On 01-AUG-2021, the subject experienced discomfort around the neck. On 01-AUG-2021, the subject experienced chills. On 01-AUG-2021, the subject experienced headaches. On an unspecified date, the subject experienced chest pain, cough/coughing up stuff, internal shaking, stomach is acting up, sweating all the time, feeling like hot flashes, nasal congestion, dizziness, vertigo, tingling on the left hand, pain shoots down the legs/soreness around the arm, and little fatigue. Treatment medications (dates unspecified) included: guaifenesin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating all the time, and feeling like hot flashes, and the outcome of chills, headaches, lower back pain, lower abdominal pain, chest pain, cough/coughing up stuff, tingling on the left hand, internal shaking, stomach is acting up, discomfort around the neck, little fatigue, pain shoots down the legs/soreness around the arm, nasal congestion, dizziness and vertigo was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Hypoaesthesia, Muscle spasms, Muscular weakness, Paraesthesia
Clinical narrative: MUSCLE SPASMS IN THE RIGHT SHOULDER; RIGHT ARM AND LEG TINGLING; RIGHT ARM  AND LEG NUMBNESS; RIGHT ARM AND LEG WEAKNESS; FEELING VERY UNCOMFORTABLE; This spontaneous report received from a consumer concerned a 22 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 24-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-JUL-2021, the subject experienced feeling very uncomfortable. On 28-JUL-2021, the subject experienced right arm and leg tingling. On 28-JUL-2021, the subject experienced right arm and leg numbness. On 28-JUL-2021, the subject experienced right arm and leg weakness. On 03-AUG-2021, the subject experienced muscle spasms in the right shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle spasms in the right shoulder, feeling very uncomfortable, right arm and leg tingling, right arm and leg numbness, and right arm and leg weakness. This report was non-serious.