chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Fall, Seizure
Clinical narrative: SEIZURE; FELL ON THE FLOOR; This spontaneous report was received from a consumer and concerned multiple patients. The patients' weights, heights and medical histories were not reported. The patients received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported, batch number 1808978; expiry date not reported) doses not reported, administered on 02-APR-2021 for prophylactic vaccinations. No concomitant medications were reported. On 02-APR-2021, a total of 24 patients fell on the floor and experienced seizure. The consumer reported that they observed 4 people fall within 15 minutes of vaccination and have seizures, and they also reported that a fire chief had stated to them that an additional 20 patients had also fallen and had seizures. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcomes of the seizures and falls were not reported. This report was serious (other medically important condition).; Sender's Comments: v0 This report received from a consumer who reported seeing 4 people fell within 15 minutes and had "seizures" after receiving Janssen COVID-19 Vaccine Ad26.COV2 and also hearing that of an additional 20 patients who fell and had "seizures" from a fire chief.  Medical history, concomitant medications, and details of the events were not reported. This case has insufficient information to make a meaningful medical assessment. The case will be assessed further when additional information is received.
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Confusional state, Disorientation, Dyskinesia, Fall
Clinical narrative: PASSED OUT; ERRATIC BODILY MOVEMENT FOR THREE SECONDS; CONFUSED; SLOUCHED OVER IN CHAIR LIKE HE PASSED OUT; STARTLED; PALE; DID NOT KNOW NAME; FELT TIRED; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported that on 07-APR-2021, the patient while sitting in the observation area slouched over in chair like he had passed out. On 07-APR-2021, he began to have erratic bodily movement for three seconds. He lowered to the floor. He opened his eyes and was very startled and confused. He did not know name. He was evaluated by emergency medical services (EMS), and all the tests were normal. He refused transfer to the hospital. On 07-APR-2021, he complaint of feeling tired, and was pale. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the erratic bodily movement for three seconds, confused, felt tired, slouched over in chair like he passed out, startled, pale, passed out and did not know name was not reported.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210417256, 20210417209, 20210417456 and 20210417122.; Sender's Comments: V0-20210417550- Covid-19 vaccine ad26.cov2.s-Passed out. This event is considered unassessable. The event 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.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Laboratory test, Loss of consciousness, Pallor
Clinical narrative: PASSED OUT; ERRATIC BODILY MOVEMENT FOR THREE SECONDS; CONFUSED; SLOUCHED OVER IN CHAIR LIKE HE PASSED OUT; STARTLED; PALE; DID NOT KNOW NAME; FELT TIRED; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported that on 07-APR-2021, the patient while sitting in the observation area slouched over in chair like he had passed out. On 07-APR-2021, he began to have erratic bodily movement for three seconds. He lowered to the floor. He opened his eyes and was very startled and confused. He did not know name. He was evaluated by emergency medical services (EMS), and all the tests were normal. He refused transfer to the hospital. On 07-APR-2021, he complaint of feeling tired, and was pale. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the erratic bodily movement for three seconds, confused, felt tired, slouched over in chair like he passed out, startled, pale, passed out and did not know name was not reported.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210417256, 20210417209, 20210417456 and 20210417122.; Sender's Comments: V0-20210417550- Covid-19 vaccine ad26.cov2.s-Passed out. This event is considered unassessable. The event 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.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dysphagia, Eating disorder, Feeling hot
Clinical narrative: CONFUSION; PARANOIA; SWALLOWING DIFFICULT; SLEEPING ALL DAY; FELT EXTRA WARM; NOT EATING; NO ENERGY; NAUSEA; HALLUCINATIONS; AUDITORY HALLUCINATIONS; This spontaneous report received from a consumer concerned an 89 year old male. The patient's weight was 104.5 kilograms, and height was 185.42 centimeter. The patient's concurrent conditions included diabetes type 2 ( insulin dependent), hypertension, and cardiac heart failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: unknown) dose was not reported, 1 total administered on 19-MAR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported.The product was stored in appropriate temperature conditions and was it properly stored from receipt to administration. No concomitant medications were reported.  On 22-MAR-2021, The patient was not eating, had no energy and had nausea. On an unspecified date after 28-MAR-2021, the patient developed confusion, hallucinations, paranoia, auditory hallucinations and difficulty swallowing. On an unspecified date, the patient was sleeping all day, was confused about where he was. On 09-APR-2021, the patient felt extra warm. The patient's daughter was his caregiver, stated that the patient was mentally sharp before taking the covid-19 vaccine on 19-MAR-2021.The patient had doctor/healthcare professional office visit for not eating, no energy, nausea and felt extra warm. On 01-APR-2021, the lab test was done to see if the patient had an urinary tract infection, the results of the test were negative The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt extra warm, not eating, no energy, nausea, confusion, hallucinations, paranoia, auditory hallucinations, swallowing difficult and sleeping all day was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210419860-COVID-19 VACCINE AD26.COV2.S-hallucinations, auditory hallucinations. 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: M
Vaccine: COVID19
Symptoms: Hallucination, Hallucination, auditory, Hypersomnia, Nausea, Paranoia
Clinical narrative: CONFUSION; PARANOIA; SWALLOWING DIFFICULT; SLEEPING ALL DAY; FELT EXTRA WARM; NOT EATING; NO ENERGY; NAUSEA; HALLUCINATIONS; AUDITORY HALLUCINATIONS; This spontaneous report received from a consumer concerned an 89 year old male. The patient's weight was 104.5 kilograms, and height was 185.42 centimeter. The patient's concurrent conditions included diabetes type 2 ( insulin dependent), hypertension, and cardiac heart failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: unknown) dose was not reported, 1 total administered on 19-MAR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported.The product was stored in appropriate temperature conditions and was it properly stored from receipt to administration. No concomitant medications were reported.  On 22-MAR-2021, The patient was not eating, had no energy and had nausea. On an unspecified date after 28-MAR-2021, the patient developed confusion, hallucinations, paranoia, auditory hallucinations and difficulty swallowing. On an unspecified date, the patient was sleeping all day, was confused about where he was. On 09-APR-2021, the patient felt extra warm. The patient's daughter was his caregiver, stated that the patient was mentally sharp before taking the covid-19 vaccine on 19-MAR-2021.The patient had doctor/healthcare professional office visit for not eating, no energy, nausea and felt extra warm. On 01-APR-2021, the lab test was done to see if the patient had an urinary tract infection, the results of the test were negative The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt extra warm, not eating, no energy, nausea, confusion, hallucinations, paranoia, auditory hallucinations, swallowing difficult and sleeping all day was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210419860-COVID-19 VACCINE AD26.COV2.S-hallucinations, auditory hallucinations. 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: M
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: CONFUSION; PARANOIA; SWALLOWING DIFFICULT; SLEEPING ALL DAY; FELT EXTRA WARM; NOT EATING; NO ENERGY; NAUSEA; HALLUCINATIONS; AUDITORY HALLUCINATIONS; This spontaneous report received from a consumer concerned an 89 year old male. The patient's weight was 104.5 kilograms, and height was 185.42 centimeter. The patient's concurrent conditions included diabetes type 2 ( insulin dependent), hypertension, and cardiac heart failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: unknown) dose was not reported, 1 total administered on 19-MAR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported.The product was stored in appropriate temperature conditions and was it properly stored from receipt to administration. No concomitant medications were reported.  On 22-MAR-2021, The patient was not eating, had no energy and had nausea. On an unspecified date after 28-MAR-2021, the patient developed confusion, hallucinations, paranoia, auditory hallucinations and difficulty swallowing. On an unspecified date, the patient was sleeping all day, was confused about where he was. On 09-APR-2021, the patient felt extra warm. The patient's daughter was his caregiver, stated that the patient was mentally sharp before taking the covid-19 vaccine on 19-MAR-2021.The patient had doctor/healthcare professional office visit for not eating, no energy, nausea and felt extra warm. On 01-APR-2021, the lab test was done to see if the patient had an urinary tract infection, the results of the test were negative The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt extra warm, not eating, no energy, nausea, confusion, hallucinations, paranoia, auditory hallucinations, swallowing difficult and sleeping all day was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210419860-COVID-19 VACCINE AD26.COV2.S-hallucinations, auditory hallucinations. 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: Blood pressure measurement, Hypotension, Syncope
Clinical narrative: FAINTING; LOW BLOOD PRESSURE; This spontaneous report received from a consumer concerned multiple patients. The reporter saw this information on the news.  The patient's weight, height, and medical history were not reported. The multiple 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 multiple patient experienced fainting and low blood pressure after getting the covid-19 vaccine. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) as Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainting and low blood pressure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210420138; Sender's Comments: 20210420027-covid-19 vaccine ad26.cov2.s-Fainting. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Tremor
Clinical narrative: BREATHING DIFFICULTY; CHEST TIGHTNESS; SHAKY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported,1 total administered on 09-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, initially the patient felt fine. However, later she felt shaky and experience difficulty breathing and chest tightness. At the time of this report, due to possible side effects she experienced, she was advised to seek medical attention. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shaky, breathing difficulty, and chest tightness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420040-Covid-19 vaccine ad26.cov2.s- breathing difficulty. This event is considered unassessable. The event 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.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Syncope
Clinical narrative: FAINTED; UNSPECIFIED ADVERSE REACTIONS; This spontaneous report received from a consumer concerned multiple patients. The reporter saw this information on the media.  The patients' weight, height, and medical history were not reported.  The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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 patients had a couple of reactions and fainted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainted and unspecified adverse reactions was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210420119-covid-19 vaccine ad26.cov2.s-Fainted. This event(s) is considered unassessable. 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).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: HIGH BLOOD PRESSURE 155/110; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included borderline high blood pressure usually around 120/83-84.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included 10mg enalapril as maintenance for borderline high blood pressure.  On 07-APR-2021, 24 hours after receiving the vaccine, the patient experienced high blood pressure 155/110 and the patient also had slight dizziness and severe headaches.  Laboratory data included: Blood pressure (NR: not provided) 155/110. For treatment, the patient took 20mg enalapril after measuring blood pressure which was not therapeutic, so the patient took nifedipine 10mg which was effective. The patient was feeling well and had no symptoms or complaints at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure 155/110, slight dizziness, and severe headaches on APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210420121-covid-19 vaccine ad26.cov2.s - High blood pressure 155/110. 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: UNDERLYING DISEASE
Sex: U
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: INTENSIVE CARE UNIT; This spontaneous report received via social media from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown) dose, start therapy date were not reported, 1 total, 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, after the vaccination, the patient was in the intensive care unit (ICU), and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of intensive care unit was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210420177-covid-19 vaccine ad26.cov2.s-Hospitalization. This event(s) is considered unassessable. 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).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: SHAKES; CHILLS; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 227 pounds, and height was not reported. The patient's 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced shakes. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes, and chills on 10-APR-2021, and had not recovered from fever, headache, and fatigue. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: SHAKES; CHILLS; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 227 pounds, and height was not reported. The patient's 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced shakes. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes, and chills on 10-APR-2021, and had not recovered from fever, headache, and fatigue. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal, Blood pressure diastolic increased, Blood pressure measurement, Dizziness
Clinical narrative: BLOOD SUGAR WAS 9; BLOOD PRESSURE 132/95; NAUSEA; PAIN IN BACK OF HEAD; DIZZINESS; LOSS OF CONSCIOUSNESS; This spontaneous report received from a physician concerned a 26 year old male. The patient's weight was 245 pounds, and height was 172.7 centimeters. The patient had no known allergies and had no chronic medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 202A21A and expiry: unknown) dose was not reported, 1 total, administered on left deltoid on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient complained of dizziness, nausea and pain in back of his head. Once the nurse arrived at the cell, the patient was on the floor with loss of consciousness. He was placed on a stretcher following which he regained consciousness. His vitals signs (unspecified) were stable, blood sugar was 9 (unit not provided), blood pressure was 132/95 (unit not provided) and respiratory rate was at 18 (unit not provided) (NR: not provided for all tests). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness on APR-2021, had not recovered from dizziness, nausea, and pain in back of head, and the outcome of blood sugar was 9 and blood pressure 132/95 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210420193- Covid-19 vaccine ad26.cov2.s-loss of consciousness. This event is considered unassessable. The event 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.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Nausea, Respiratory rate, Vital signs measurement
Clinical narrative: BLOOD SUGAR WAS 9; BLOOD PRESSURE 132/95; NAUSEA; PAIN IN BACK OF HEAD; DIZZINESS; LOSS OF CONSCIOUSNESS; This spontaneous report received from a physician concerned a 26 year old male. The patient's weight was 245 pounds, and height was 172.7 centimeters. The patient had no known allergies and had no chronic medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 202A21A and expiry: unknown) dose was not reported, 1 total, administered on left deltoid on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient complained of dizziness, nausea and pain in back of his head. Once the nurse arrived at the cell, the patient was on the floor with loss of consciousness. He was placed on a stretcher following which he regained consciousness. His vitals signs (unspecified) were stable, blood sugar was 9 (unit not provided), blood pressure was 132/95 (unit not provided) and respiratory rate was at 18 (unit not provided) (NR: not provided for all tests). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness on APR-2021, had not recovered from dizziness, nausea, and pain in back of head, and the outcome of blood sugar was 9 and blood pressure 132/95 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210420193- Covid-19 vaccine ad26.cov2.s-loss of consciousness. This event is considered unassessable. The event 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.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Respiratory rate increased, Syncope
Clinical narrative: FAINTING; INCREASED BREATHING; DIZZINESS/ LIGHT HEADEDNESS; NAUSEA; This spontaneous report received from a company representative concerned patients. The patient's weight, height, and medical history were not reported.  The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one 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. The caller reported that she saw on the news that patients in Colorado experienced dizziness/ light headedness, nausea, fainting and increased breathing after getting Janssen Covid-19 vaccine and two out of the eleven patients went to the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness/ light headedness, nausea, increased breathing and fainting was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to: 20210420809; Sender's Comments: V0: 20210420362-COVID-19 VACCINE AD26.COV2.S-Fainting. This event is considered unassessable. The event 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.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: PASSED OUT; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age (young under 25) received via social media. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, frequency once total for prophylactic vaccination. The batch number was not reported. The batch number was not reported. As per procedure, no follow-up will be requested for this case No concomitant medications were reported.  On an unspecified date, the patient passed out in the waiting area and was quickly attended to by medical personnel. He was sitting up fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210420123 and 20210421172.; Sender's Comments: V0: 20210420375 -COVID-19 VACCINE AD26.COV2.S - Passed Out. This event is considered unassessable. The event 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.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chest X-ray, Fatigue, Gait inability
Clinical narrative: VOMITING/EMESIS; SHAKES; LEGS NUMB; FEVER; WEAKNESS; TIREDNESS; UNABLE TO WALK; This spontaneous report received from a physician concerned an 18 year old male. The patient's height, and weight were not reported. The patient's past medical history included Lyme disease, and seizure, and concurrent conditions included attention deficit hyperactivity disorder, intermittent asthma, migraines, psoriasis, and penicillin allergy, and other pre-existing medical conditions included currently not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported,1 total administered on 08-APR-2021 at 14:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021 around 19:30, the patient experienced vomiting, had fever, shakes and complained of numb legs and was unable to feel them. He was instructed by his physician to go to the nearest Emergency room (ER). The patient visited emergency room or department and physician office for treatment of the events. He went to ER but was unable to walk at that time and was carried in. The patient was evaluated, had normal chest X-ray (CXR), temperature up to 104, had emesis, underwent rapid covid test which was negative. He was given intravenous (IV) fluids, Zofran, Tylenol and was discharged home. It was reported that the patient was doing better but with continued tiredness, weakness, his legs were feeling better, temperature was down, coherent and was tolerating fluids. Laboratory data included: Body temperature (NR: not provided) 104, COVID-19 antigen test (NR: not provided) Negative, and CXR (NR: not provided) Normal. Treatment medications (dates unspecified) included: paracetamol, and ondansetron. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting/emesis, fever, shakes, and legs numb, had not recovered from weakness, and tiredness, and the outcome of unable to walk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420466-covid-19 vaccine ad26.cov2.s-vomiting/emesis, shakes, legs numb, unable to walk. 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). 20210420466-covid-19 vaccine ad26.cov2.s-Fever. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pyrexia, SARS-CoV-2 test, Tremor, Vomiting
Clinical narrative: VOMITING/EMESIS; SHAKES; LEGS NUMB; FEVER; WEAKNESS; TIREDNESS; UNABLE TO WALK; This spontaneous report received from a physician concerned an 18 year old male. The patient's height, and weight were not reported. The patient's past medical history included Lyme disease, and seizure, and concurrent conditions included attention deficit hyperactivity disorder, intermittent asthma, migraines, psoriasis, and penicillin allergy, and other pre-existing medical conditions included currently not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported,1 total administered on 08-APR-2021 at 14:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021 around 19:30, the patient experienced vomiting, had fever, shakes and complained of numb legs and was unable to feel them. He was instructed by his physician to go to the nearest Emergency room (ER). The patient visited emergency room or department and physician office for treatment of the events. He went to ER but was unable to walk at that time and was carried in. The patient was evaluated, had normal chest X-ray (CXR), temperature up to 104, had emesis, underwent rapid covid test which was negative. He was given intravenous (IV) fluids, Zofran, Tylenol and was discharged home. It was reported that the patient was doing better but with continued tiredness, weakness, his legs were feeling better, temperature was down, coherent and was tolerating fluids. Laboratory data included: Body temperature (NR: not provided) 104, COVID-19 antigen test (NR: not provided) Negative, and CXR (NR: not provided) Normal. Treatment medications (dates unspecified) included: paracetamol, and ondansetron. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting/emesis, fever, shakes, and legs numb, had not recovered from weakness, and tiredness, and the outcome of unable to walk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420466-covid-19 vaccine ad26.cov2.s-vomiting/emesis, shakes, legs numb, unable to walk. 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). 20210420466-covid-19 vaccine ad26.cov2.s-Fever. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic, Haemorrhoidal haemorrhage, Migraine, Urticaria
Clinical narrative: HIVES ON HER RIGHT ARM; BLOODY DIARRHEA; BLOOD FROM A HEMORRHOIDS; HUGE MIGRAINE/VISION IMPACTED; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 208 pounds, and height was not reported. The patient's past medical history included breast cancer left side, and hay fever, and concurrent conditions included allergic to anti-seizure drug cipro, pregabalin (Lyrica) and gabapentin, irritable bowel syndrome (IBS) (C and D), chronic migraines, hashimoto disease, seizures, non alcohol user, and non smoker. The patient did not have any drug abuse, illicit drug use. 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 dose administered on 06-APR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, after 45 min of vaccination, the patient experienced a huge migraine, which was worst in her life due to which she could hardly make it home. Her vision was impacted. On the same day, in evening she developed bloody diarrhea, blood from a hemorrhoid. She believed, the vaccine has exacerbated her underlying medical conditions. She also reported that, when she took off her clothing, she noticed that she developed hives on her right arm. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from huge migraine/vision impacted on 07-APR-2021, and had not recovered from hives on her right arm, bloody diarrhea, and blood from a hemorrhoids. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420554-Covid-19 vaccine ad26.cov2.s-Bloody diarrhea. 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).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION/LOSS OF SMELL/ MINOR COUGH; This spontaneous report received from a patient via a company representative concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-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 08-APR-2021, the patient experienced suspected clinical vaccination failure. On 08-APR-2021, the patient experienced suspected covid-19 infection/loss of smell/ minor cough. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection/loss of smell/ minor cough and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000175946.; Sender's Comments: V0: 20210420575-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination 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: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: 0.1ML OF VACCINE LEFT IN SYRINGE AFTER ADMINISTRATION; This spontaneous report received from a patient concerned multiple patients. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced 0.1ml of vaccine left in syringe after administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 0.1ml of vaccine left in syringe after administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210431378.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Dizziness, Flushing
Clinical narrative: MILD DIZZINESS; NERVOUS; STOMACH ISSUES; NOT FEELING WELL; HEADACHE; LOW GRADE FEVER 100F; NAUSEA/FEELING QUEASY; DIARRHEA; FLUSHED FACE; VOMITING; CHILLS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, non smoker, alcohol consumption, vertigo, hypertension, cancer, high cholesterol, and stomach issues.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 05-APR-2021 10:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021 17:00, the subject experienced chills. On 06-APR-2021, the subject experienced flushed face. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced diarrhea. On 06-APR-2021, the subject experienced nausea/feeling queasy. On 06-APR-2021, the subject experienced low grade fever 100f. On an unspecified date, the subject experienced mild dizziness, nervous, stomach issues, not feeling well, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed face, chills, headache, and low grade fever 100f on 06-APR-2021, and diarrhea, had not recovered from nausea/feeling queasy, and the outcome of vomiting, mild dizziness, not feeling well, nervous and stomach issues was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder, Headache, Malaise, Nausea, Nervousness
Clinical narrative: MILD DIZZINESS; NERVOUS; STOMACH ISSUES; NOT FEELING WELL; HEADACHE; LOW GRADE FEVER 100F; NAUSEA/FEELING QUEASY; DIARRHEA; FLUSHED FACE; VOMITING; CHILLS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, non smoker, alcohol consumption, vertigo, hypertension, cancer, high cholesterol, and stomach issues.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 05-APR-2021 10:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021 17:00, the subject experienced chills. On 06-APR-2021, the subject experienced flushed face. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced diarrhea. On 06-APR-2021, the subject experienced nausea/feeling queasy. On 06-APR-2021, the subject experienced low grade fever 100f. On an unspecified date, the subject experienced mild dizziness, nervous, stomach issues, not feeling well, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed face, chills, headache, and low grade fever 100f on 06-APR-2021, and diarrhea, had not recovered from nausea/feeling queasy, and the outcome of vomiting, mild dizziness, not feeling well, nervous and stomach issues was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: MILD DIZZINESS; NERVOUS; STOMACH ISSUES; NOT FEELING WELL; HEADACHE; LOW GRADE FEVER 100F; NAUSEA/FEELING QUEASY; DIARRHEA; FLUSHED FACE; VOMITING; CHILLS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, non smoker, alcohol consumption, vertigo, hypertension, cancer, high cholesterol, and stomach issues.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 05-APR-2021 10:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021 17:00, the subject experienced chills. On 06-APR-2021, the subject experienced flushed face. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced diarrhea. On 06-APR-2021, the subject experienced nausea/feeling queasy. On 06-APR-2021, the subject experienced low grade fever 100f. On an unspecified date, the subject experienced mild dizziness, nervous, stomach issues, not feeling well, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed face, chills, headache, and low grade fever 100f on 06-APR-2021, and diarrhea, had not recovered from nausea/feeling queasy, and the outcome of vomiting, mild dizziness, not feeling well, nervous and stomach issues was not reported. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure diastolic decreased, Blood pressure measurement, Dizziness, Hyperhidrosis
Clinical narrative: LOW DIASTOLIC PRESSURE OF 40; LIGHT HEADED; SWEATING; This spontaneous report received from a patient concerned a 26 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced low diastolic pressure of 40, light headed and sweating.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low diastolic pressure of 40, and had not recovered from light headed, and sweating. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420610-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood pressure diastolic low. This event is considered unassessable. The event 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.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: VACCINE GIVEN TO 16/17 YEAR OLD; This spontaneous report received from a patient concerned an adolescent of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, 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 no. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine given to 16/17 year old. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given to 16/17 year old was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included aspirin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 21:00, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.