chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Chills, Drug hypersensitivity, Myalgia, Pyrexia
Clinical narrative: allergic reaction to one of the ingredients in the Shingrix vaccine; rash / on the backs of both hands and both wrists; blisters on the backs of both hands and both wrists; chills; slight fever; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of chills in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th July 2021 10:00, the patient received the 1st dose of Shingrix (intramuscular). On 7th July 2021, 12 hrs after receiving Shingrix, the patient experienced chills, fever and muscle pain. On 8th July 2021, the patient experienced rash and blister. On an unknown date, the patient experienced allergic reaction to drug excipient. On 8th July 2021, the outcome of the chills, fever and muscle pain were recovered/resolved. On an unknown date, the outcome of the rash, blister and allergic reaction to drug excipient were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, muscle pain, rash, blister and allergic reaction to drug excipient to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient had taken first dose of Shingrix in her left arm at 10 am and experienced chills, slight fever, muscle aches approximately 12 hours after vaccination. The reporter stated that, day after patient received the Shigles vaccine and day after developed a rash and blisters on the backs of both hands and both wrists and it might be an allergic reaction to one of the ingredients in the Shingrix vaccine. On 13th July 2021 the rash and blisters are not resolved and some blister look worse. The HCP (Heath care professional), had prednisone Rx to the patient but she was unsure as whether to take it for fear of messing with the Shingrix vaccine. The reporter did not consented to follow up. The reporter does not give permission to contact HCP.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Dyspnoea exertional, Electrocardiogram abnormal, Laboratory test
Clinical narrative: Dizziness and shortness of breath with exertion; Dizziness and shortness of breath with exertion; This is a spontaneous report from a contactable other healthcare professional. A 38-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0170 and Expiry date was not reported) via an unspecified route of administration, administered in arm left on 25Jun2021 (at the age of 38-years-old) as dose 2, single for COVID-19 immunization at the hospital. Medical history included arthritis. Concomitant medications included tocopherol (VITAMIN E), magnesium sulfate, melatonine, paracetamol (TYLENOL) and ibuprofen (IBUPROFEN). Start and stop dates and dosing regimen details were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0175 and Expiry date was not reported) via an unspecified route of administration, administered in arm left on 04Jun2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since vaccination, the patient has not been tested for COVID-19. On 28Jun2021 16:45, the patient experienced dizziness and shortness of breath with exertion. The clinical outcome of the events was not recovered.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness exertional, Dyspnoea exertional
Clinical narrative: Dizziness and shortness of breath with exertion; Dizziness and shortness of breath with exertion; This is a spontaneous report from a contactable other healthcare professional. A 38-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0170 and Expiry date was not reported) via an unspecified route of administration, administered in arm left on 25Jun2021 (at the age of 38-years-old) as dose 2, single for COVID-19 immunization at the hospital. Medical history included arthritis. Concomitant medications included tocopherol (VITAMIN E), magnesium sulfate, melatonine, paracetamol (TYLENOL) and ibuprofen (IBUPROFEN). Start and stop dates and dosing regimen details were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0175 and Expiry date was not reported) via an unspecified route of administration, administered in arm left on 04Jun2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since vaccination, the patient has not been tested for COVID-19. On 28Jun2021 16:45, the patient experienced dizziness and shortness of breath with exertion. The clinical outcome of the events was not recovered.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Starting last night and continuing into today he reports he has red blotches all over his body; This is a spontaneous report from a contactable consumer or other non hcp. A 85-years-old elderly male patient received second dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection; Batch/Lot number: Not reported) via an unspecified route of administration on 07Jul2021 as a Dose 2,Single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Two days ago on 07Jul2021,the patient got the second shot and he got all red blotches starting last night and today on his body. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash macular
Clinical narrative: Starting last night and continuing into today he reports he has red blotches all over his body; This is a spontaneous report from a contactable consumer or other non hcp. A 85-years-old elderly male patient received second dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection; Batch/Lot number: Not reported) via an unspecified route of administration on 07Jul2021 as a Dose 2,Single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Two days ago on 07Jul2021,the patient got the second shot and he got all red blotches starting last night and today on his body. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Pt suffered a seizure approx. 10mins after receiving their vaccine. Recovered quickly and refused any additional treatment
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Chills, Decreased appetite, Dyskinesia, Electroencephalogram normal
Clinical narrative: CHEST PRESSURE; INVOLUNTARY MOVEMENTS OF HEAD, ARMS AND LEGS; CHILLS; TIREDNESS; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced tiredness. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. On 18-APR-2021, the subject experienced chest pressure. On 18-APR-2021, the subject experienced involuntary movements of head, arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, tiredness, muscle aches, and fever on 11-APR-2021, and had not recovered from chest pressure, and involuntary movements of head, arms and legs. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Magnetic resonance imaging normal, Movement disorder, Muscle spasms, Myalgia
Clinical narrative: CHEST PRESSURE; INVOLUNTARY MOVEMENTS OF HEAD, ARMS AND LEGS; CHILLS; TIREDNESS; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced tiredness. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. On 18-APR-2021, the subject experienced chest pressure. On 18-APR-2021, the subject experienced involuntary movements of head, arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, tiredness, muscle aches, and fever on 11-APR-2021, and had not recovered from chest pressure, and involuntary movements of head, arms and legs. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: CHEST PRESSURE; INVOLUNTARY MOVEMENTS OF HEAD, ARMS AND LEGS; CHILLS; TIREDNESS; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced tiredness. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. On 18-APR-2021, the subject experienced chest pressure. On 18-APR-2021, the subject experienced involuntary movements of head, arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, tiredness, muscle aches, and fever on 11-APR-2021, and had not recovered from chest pressure, and involuntary movements of head, arms and legs. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Dyskinesia, Fatigue, Myalgia
Clinical narrative: CHEST PRESSURE; INVOLUNTARY MOVEMENTS OF HEAD, ARMS AND LEGS; CHILLS; TIREDNESS; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced tiredness. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. On 18-APR-2021, the subject experienced chest pressure. On 18-APR-2021, the subject experienced involuntary movements of head, arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, tiredness, muscle aches, and fever on 11-APR-2021, and had not recovered from chest pressure, and involuntary movements of head, arms and legs. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: CHEST PRESSURE; INVOLUNTARY MOVEMENTS OF HEAD, ARMS AND LEGS; CHILLS; TIREDNESS; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced tiredness. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. On 18-APR-2021, the subject experienced chest pressure. On 18-APR-2021, the subject experienced involuntary movements of head, arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, tiredness, muscle aches, and fever on 11-APR-2021, and had not recovered from chest pressure, and involuntary movements of head, arms and legs. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Electrocardiogram, Magnetic resonance imaging, Migraine
Clinical narrative: PLATELET COUNT DECREASE; WHITE BLOOD CELL COUNT DECREASE; VERTIGO; HEART PALPITATIONS; CHEST PAIN ON THE LEFT SIDE OF THE HEART; MIGRAINE; A FEELING OF ROCKING LIKE ON A BOAT; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-JUN-2021, the subject experienced vertigo. On 19-JUN-2021, the subject experienced heart palpitations. On 19-JUN-2021, the subject experienced chest pain on the left side of the heart. On 19-JUN-2021, the subject experienced migraine. On 19-JUN-2021, the subject experienced a feeling of rocking like on a boat. On 23-JUN-2021, the subject experienced platelet count decrease. On 23-JUN-2021, the subject experienced white blood cell count decrease. Laboratory data included: Lab test (NR: not provided) Unknown, Platelet count (NR: not provided) Decreased, and White blood cell count (NR: not provided) Decreased. On 01-JUL-2021, Laboratory data included: Platelet count (NR: not provided) Normal, and White blood cell count (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from platelet count decrease, and white blood cell count decrease on 01-JUL-2021, vertigo, heart palpitations, and migraine on 29-JUN-2021, and chest pain on the left side of the heart, and had not recovered from a feeling of rocking like on a boat. 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: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan, Vertigo, White blood cell count decreased
Clinical narrative: PLATELET COUNT DECREASE; WHITE BLOOD CELL COUNT DECREASE; VERTIGO; HEART PALPITATIONS; CHEST PAIN ON THE LEFT SIDE OF THE HEART; MIGRAINE; A FEELING OF ROCKING LIKE ON A BOAT; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-JUN-2021, the subject experienced vertigo. On 19-JUN-2021, the subject experienced heart palpitations. On 19-JUN-2021, the subject experienced chest pain on the left side of the heart. On 19-JUN-2021, the subject experienced migraine. On 19-JUN-2021, the subject experienced a feeling of rocking like on a boat. On 23-JUN-2021, the subject experienced platelet count decrease. On 23-JUN-2021, the subject experienced white blood cell count decrease. Laboratory data included: Lab test (NR: not provided) Unknown, Platelet count (NR: not provided) Decreased, and White blood cell count (NR: not provided) Decreased. On 01-JUL-2021, Laboratory data included: Platelet count (NR: not provided) Normal, and White blood cell count (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from platelet count decrease, and white blood cell count decrease on 01-JUL-2021, vertigo, heart palpitations, and migraine on 29-JUN-2021, and chest pain on the left side of the heart, and had not recovered from a feeling of rocking like on a boat. 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: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Feeling abnormal, Laboratory test, Migraine, Palpitations
Clinical narrative: PLATELET COUNT DECREASE; WHITE BLOOD CELL COUNT DECREASE; VERTIGO; HEART PALPITATIONS; CHEST PAIN ON THE LEFT SIDE OF THE HEART; MIGRAINE; A FEELING OF ROCKING LIKE ON A BOAT; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-JUN-2021, the subject experienced vertigo. On 19-JUN-2021, the subject experienced heart palpitations. On 19-JUN-2021, the subject experienced chest pain on the left side of the heart. On 19-JUN-2021, the subject experienced migraine. On 19-JUN-2021, the subject experienced a feeling of rocking like on a boat. On 23-JUN-2021, the subject experienced platelet count decrease. On 23-JUN-2021, the subject experienced white blood cell count decrease. Laboratory data included: Lab test (NR: not provided) Unknown, Platelet count (NR: not provided) Decreased, and White blood cell count (NR: not provided) Decreased. On 01-JUL-2021, Laboratory data included: Platelet count (NR: not provided) Normal, and White blood cell count (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from platelet count decrease, and white blood cell count decrease on 01-JUL-2021, vertigo, heart palpitations, and migraine on 29-JUN-2021, and chest pain on the left side of the heart, and had not recovered from a feeling of rocking like on a boat. 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: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count, Platelet count decreased, Vertigo, White blood cell count, White blood cell count decreased
Clinical narrative: PLATELET COUNT DECREASE; WHITE BLOOD CELL COUNT DECREASE; VERTIGO; HEART PALPITATIONS; CHEST PAIN ON THE LEFT SIDE OF THE HEART; MIGRAINE; A FEELING OF ROCKING LIKE ON A BOAT; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-JUN-2021, the subject experienced vertigo. On 19-JUN-2021, the subject experienced heart palpitations. On 19-JUN-2021, the subject experienced chest pain on the left side of the heart. On 19-JUN-2021, the subject experienced migraine. On 19-JUN-2021, the subject experienced a feeling of rocking like on a boat. On 23-JUN-2021, the subject experienced platelet count decrease. On 23-JUN-2021, the subject experienced white blood cell count decrease. Laboratory data included: Lab test (NR: not provided) Unknown, Platelet count (NR: not provided) Decreased, and White blood cell count (NR: not provided) Decreased. On 01-JUL-2021, Laboratory data included: Platelet count (NR: not provided) Normal, and White blood cell count (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from platelet count decrease, and white blood cell count decrease on 01-JUL-2021, vertigo, heart palpitations, and migraine on 29-JUN-2021, and chest pain on the left side of the heart, and had not recovered from a feeling of rocking like on a boat. 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: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Moderna administered to a 12 yr old
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna administered to a 12 yr old
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: post menopausal bleeding 3 hours and 45 minutes later; This spontaneous case was reported by a patient and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (post menopausal bleeding 3 hours and 45 minutes later) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) and PROPRANOLOL for Migraine.    On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (post menopausal bleeding 3 hours and 45 minutes later) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (post menopausal bleeding 3 hours and 45 minutes later) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical treatment was reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Further information has been requested
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: Lymphodema super clavicular lasting longer than six weeks
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Lymphoedema
Clinical narrative: Lymphodema super clavicular lasting longer than six weeks
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Developed full body hives  30 minutes to an hour after vaccine administration.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Developed full body hives  30 minutes to an hour after vaccine administration.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Cardiac monitoring normal, Chest X-ray normal, Electrocardiogram normal, Electroencephalogram abnormal
Clinical narrative: SEIZURES; MINOR INJURIES; BRUISES WITH RUG BURN; FALLING ON THE CARPET; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight was 210 pounds, and height was 76 inches. The patient's concurrent conditions included alcohol use occasional, and non-smoker, and the patient had no known allergies and no history of drug abuse or illicit drug use. Patient had no history of epilepsy as well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: Unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 12-APR-2021, after six days of vaccination patient started experiencing seizures. Patient's wife found patient in office face down laying on stomach and was unconscious. In less than two minutes patient woke up confused, and disoriented. Patient had suffered some minor injuries, and bruises with rug burn due to falling on the carpet. Patient was taken to the urgent care on 12-APR-2021. Since 12-APR-2021 patient had five more seizures. On 12-APR-2021, Laboratory data included: Electrocardiogram (EKG) (NR: not provided) within normal range. On 26-APR-2021, Laboratory data included: Blood lactate dehydrogenase (NR: not provided) within normal range, Complete blood count (CBC) (NR: not provided) within normal range, Chest X-ray (NR: not provided) within normal range, Emergency room Magnetic resonance imaging (MRI) (NR: not provided) within normal range, and Troponin (NR: not provided) within normal range. On 09-JUN-2021, Laboratory data included: Electroencephalogram (EEG) (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures, minor injuries, bruises with rug burn and falling on the carpet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210738406-covid-19 vaccine ad26.cov2.s- seizures. 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: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Epilepsy, Laboratory test, Loss of consciousness, Magnetic resonance imaging head normal, Seizure
Clinical narrative: SEIZURES; MINOR INJURIES; BRUISES WITH RUG BURN; FALLING ON THE CARPET; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight was 210 pounds, and height was 76 inches. The patient's concurrent conditions included alcohol use occasional, and non-smoker, and the patient had no known allergies and no history of drug abuse or illicit drug use. Patient had no history of epilepsy as well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: Unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 12-APR-2021, after six days of vaccination patient started experiencing seizures. Patient's wife found patient in office face down laying on stomach and was unconscious. In less than two minutes patient woke up confused, and disoriented. Patient had suffered some minor injuries, and bruises with rug burn due to falling on the carpet. Patient was taken to the urgent care on 12-APR-2021. Since 12-APR-2021 patient had five more seizures. On 12-APR-2021, Laboratory data included: Electrocardiogram (EKG) (NR: not provided) within normal range. On 26-APR-2021, Laboratory data included: Blood lactate dehydrogenase (NR: not provided) within normal range, Complete blood count (CBC) (NR: not provided) within normal range, Chest X-ray (NR: not provided) within normal range, Emergency room Magnetic resonance imaging (MRI) (NR: not provided) within normal range, and Troponin (NR: not provided) within normal range. On 09-JUN-2021, Laboratory data included: Electroencephalogram (EEG) (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures, minor injuries, bruises with rug burn and falling on the carpet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210738406-covid-19 vaccine ad26.cov2.s- seizures. 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: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Snoring, Somnolence
Clinical narrative: SEIZURES; MINOR INJURIES; BRUISES WITH RUG BURN; FALLING ON THE CARPET; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight was 210 pounds, and height was 76 inches. The patient's concurrent conditions included alcohol use occasional, and non-smoker, and the patient had no known allergies and no history of drug abuse or illicit drug use. Patient had no history of epilepsy as well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: Unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 12-APR-2021, after six days of vaccination patient started experiencing seizures. Patient's wife found patient in office face down laying on stomach and was unconscious. In less than two minutes patient woke up confused, and disoriented. Patient had suffered some minor injuries, and bruises with rug burn due to falling on the carpet. Patient was taken to the urgent care on 12-APR-2021. Since 12-APR-2021 patient had five more seizures. On 12-APR-2021, Laboratory data included: Electrocardiogram (EKG) (NR: not provided) within normal range. On 26-APR-2021, Laboratory data included: Blood lactate dehydrogenase (NR: not provided) within normal range, Complete blood count (CBC) (NR: not provided) within normal range, Chest X-ray (NR: not provided) within normal range, Emergency room Magnetic resonance imaging (MRI) (NR: not provided) within normal range, and Troponin (NR: not provided) within normal range. On 09-JUN-2021, Laboratory data included: Electroencephalogram (EEG) (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures, minor injuries, bruises with rug burn and falling on the carpet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210738406-covid-19 vaccine ad26.cov2.s- seizures. 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: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood lactate dehydrogenase, Chest X-ray, Contusion, Electrocardiogram, Electroencephalogram
Clinical narrative: SEIZURES; MINOR INJURIES; BRUISES WITH RUG BURN; FALLING ON THE CARPET; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight was 210 pounds, and height was 76 inches. The patient's concurrent conditions included alcohol use occasional, and non-smoker, and the patient had no known allergies and no history of drug abuse or illicit drug use. Patient had no history of epilepsy as well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: Unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 12-APR-2021, after six days of vaccination patient started experiencing seizures. Patient's wife found patient in office face down laying on stomach and was unconscious. In less than two minutes patient woke up confused, and disoriented. Patient had suffered some minor injuries, and bruises with rug burn due to falling on the carpet. Patient was taken to the urgent care on 12-APR-2021. Since 12-APR-2021 patient had five more seizures. On 12-APR-2021, Laboratory data included: Electrocardiogram (EKG) (NR: not provided) within normal range. On 26-APR-2021, Laboratory data included: Blood lactate dehydrogenase (NR: not provided) within normal range, Complete blood count (CBC) (NR: not provided) within normal range, Chest X-ray (NR: not provided) within normal range, Emergency room Magnetic resonance imaging (MRI) (NR: not provided) within normal range, and Troponin (NR: not provided) within normal range. On 09-JUN-2021, Laboratory data included: Electroencephalogram (EEG) (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures, minor injuries, bruises with rug burn and falling on the carpet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210738406-covid-19 vaccine ad26.cov2.s- seizures. 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: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fall, Full blood count, Injury, Magnetic resonance imaging, Seizure
Clinical narrative: SEIZURES; MINOR INJURIES; BRUISES WITH RUG BURN; FALLING ON THE CARPET; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight was 210 pounds, and height was 76 inches. The patient's concurrent conditions included alcohol use occasional, and non-smoker, and the patient had no known allergies and no history of drug abuse or illicit drug use. Patient had no history of epilepsy as well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: Unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 12-APR-2021, after six days of vaccination patient started experiencing seizures. Patient's wife found patient in office face down laying on stomach and was unconscious. In less than two minutes patient woke up confused, and disoriented. Patient had suffered some minor injuries, and bruises with rug burn due to falling on the carpet. Patient was taken to the urgent care on 12-APR-2021. Since 12-APR-2021 patient had five more seizures. On 12-APR-2021, Laboratory data included: Electrocardiogram (EKG) (NR: not provided) within normal range. On 26-APR-2021, Laboratory data included: Blood lactate dehydrogenase (NR: not provided) within normal range, Complete blood count (CBC) (NR: not provided) within normal range, Chest X-ray (NR: not provided) within normal range, Emergency room Magnetic resonance imaging (MRI) (NR: not provided) within normal range, and Troponin (NR: not provided) within normal range. On 09-JUN-2021, Laboratory data included: Electroencephalogram (EEG) (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures, minor injuries, bruises with rug burn and falling on the carpet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210738406-covid-19 vaccine ad26.cov2.s- seizures. 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: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin
Clinical narrative: SEIZURES; MINOR INJURIES; BRUISES WITH RUG BURN; FALLING ON THE CARPET; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight was 210 pounds, and height was 76 inches. The patient's concurrent conditions included alcohol use occasional, and non-smoker, and the patient had no known allergies and no history of drug abuse or illicit drug use. Patient had no history of epilepsy as well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: Unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 12-APR-2021, after six days of vaccination patient started experiencing seizures. Patient's wife found patient in office face down laying on stomach and was unconscious. In less than two minutes patient woke up confused, and disoriented. Patient had suffered some minor injuries, and bruises with rug burn due to falling on the carpet. Patient was taken to the urgent care on 12-APR-2021. Since 12-APR-2021 patient had five more seizures. On 12-APR-2021, Laboratory data included: Electrocardiogram (EKG) (NR: not provided) within normal range. On 26-APR-2021, Laboratory data included: Blood lactate dehydrogenase (NR: not provided) within normal range, Complete blood count (CBC) (NR: not provided) within normal range, Chest X-ray (NR: not provided) within normal range, Emergency room Magnetic resonance imaging (MRI) (NR: not provided) within normal range, and Troponin (NR: not provided) within normal range. On 09-JUN-2021, Laboratory data included: Electroencephalogram (EEG) (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures, minor injuries, bruises with rug burn and falling on the carpet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210738406-covid-19 vaccine ad26.cov2.s- seizures. 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: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Differential white blood cell count, Fibrin D dimer, Full blood count, Magnetic resonance imaging head
Clinical narrative: SEIZURES; MINOR INJURIES; BRUISES WITH RUG BURN; FALLING ON THE CARPET; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight was 210 pounds, and height was 76 inches. The patient's concurrent conditions included alcohol use occasional, and non-smoker, and the patient had no known allergies and no history of drug abuse or illicit drug use. Patient had no history of epilepsy as well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: Unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 12-APR-2021, after six days of vaccination patient started experiencing seizures. Patient's wife found patient in office face down laying on stomach and was unconscious. In less than two minutes patient woke up confused, and disoriented. Patient had suffered some minor injuries, and bruises with rug burn due to falling on the carpet. Patient was taken to the urgent care on 12-APR-2021. Since 12-APR-2021 patient had five more seizures. On 12-APR-2021, Laboratory data included: Electrocardiogram (EKG) (NR: not provided) within normal range. On 26-APR-2021, Laboratory data included: Blood lactate dehydrogenase (NR: not provided) within normal range, Complete blood count (CBC) (NR: not provided) within normal range, Chest X-ray (NR: not provided) within normal range, Emergency room Magnetic resonance imaging (MRI) (NR: not provided) within normal range, and Troponin (NR: not provided) within normal range. On 09-JUN-2021, Laboratory data included: Electroencephalogram (EEG) (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures, minor injuries, bruises with rug burn and falling on the carpet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210738406-covid-19 vaccine ad26.cov2.s- seizures. 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: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Seizure, Troponin, Urine analysis
Clinical narrative: SEIZURES; MINOR INJURIES; BRUISES WITH RUG BURN; FALLING ON THE CARPET; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight was 210 pounds, and height was 76 inches. The patient's concurrent conditions included alcohol use occasional, and non-smoker, and the patient had no known allergies and no history of drug abuse or illicit drug use. Patient had no history of epilepsy as well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: Unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 12-APR-2021, after six days of vaccination patient started experiencing seizures. Patient's wife found patient in office face down laying on stomach and was unconscious. In less than two minutes patient woke up confused, and disoriented. Patient had suffered some minor injuries, and bruises with rug burn due to falling on the carpet. Patient was taken to the urgent care on 12-APR-2021. Since 12-APR-2021 patient had five more seizures. On 12-APR-2021, Laboratory data included: Electrocardiogram (EKG) (NR: not provided) within normal range. On 26-APR-2021, Laboratory data included: Blood lactate dehydrogenase (NR: not provided) within normal range, Complete blood count (CBC) (NR: not provided) within normal range, Chest X-ray (NR: not provided) within normal range, Emergency room Magnetic resonance imaging (MRI) (NR: not provided) within normal range, and Troponin (NR: not provided) within normal range. On 09-JUN-2021, Laboratory data included: Electroencephalogram (EEG) (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures, minor injuries, bruises with rug burn and falling on the carpet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210738406-covid-19 vaccine ad26.cov2.s- seizures. 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: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bedridden, Body temperature, Fatigue, Feeling cold, Hyperhidrosis
Clinical narrative: Chills and fever, wake up drenched in sweat, fatigued, muscle aches, 100.6-degree fever, sleeping fitfully, unable to shower, take medicine, etc. Took until 14-16 days later to recover, took Aleve on 5/23, did not help. Dr visit on 5/25, on 5/27 had hives on abdomen and arms, generally itchy everywhere, spread whenever scratched. Entirely gone by 6/3.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills and fever, wake up drenched in sweat, fatigued, muscle aches, 100.6-degree fever, sleeping fitfully, unable to shower, take medicine, etc. Took until 14-16 days later to recover, took Aleve on 5/23, did not help. Dr visit on 5/25, on 5/27 had hives on abdomen and arms, generally itchy everywhere, spread whenever scratched. Entirely gone by 6/3.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Insomnia, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Chills and fever, wake up drenched in sweat, fatigued, muscle aches, 100.6-degree fever, sleeping fitfully, unable to shower, take medicine, etc. Took until 14-16 days later to recover, took Aleve on 5/23, did not help. Dr visit on 5/25, on 5/27 had hives on abdomen and arms, generally itchy everywhere, spread whenever scratched. Entirely gone by 6/3.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Night sweats, Pruritus, Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: Chills and fever, wake up drenched in sweat, fatigued, muscle aches, 100.6-degree fever, sleeping fitfully, unable to shower, take medicine, etc. Took until 14-16 days later to recover, took Aleve on 5/23, did not help. Dr visit on 5/25, on 5/27 had hives on abdomen and arms, generally itchy everywhere, spread whenever scratched. Entirely gone by 6/3.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Chills and fever, wake up drenched in sweat, fatigued, muscle aches, 100.6-degree fever, sleeping fitfully, unable to shower, take medicine, etc. Took until 14-16 days later to recover, took Aleve on 5/23, did not help. Dr visit on 5/25, on 5/27 had hives on abdomen and arms, generally itchy everywhere, spread whenever scratched. Entirely gone by 6/3.