chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Consciousness fluctuating, Dyskinesia
Clinical narrative: LOSS OF CONSCIOUSNESS(PATIENT WAS COMING IN AND OUT OF CONSCIOUSNESS); BRADYCARDIA; SEIZURE (EYES ROLLED  BACK, HEAD WENT BACK); ARM WEAKNESS; PROFUSELY SWEATING; This spontaneous report received from a consumer concerned a 44-year-old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included patient did not have any known allergies. The patient did not have any reaction to vaccine before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported,  1 total administered on 09-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, five minutes after vaccination, patient started profusely sweating and he had a seizure (eyes rolled back, head went back) and lost consciousness. Paramedics were on site came and they did a Electrocardiogram. He had bradycardia (heartrate was very low : 30 bpm). During all this time, he kept on coming in and out of consciousness. Patient also had arm weakness. Paramedics took him by ambulance to the emergency room; they administered some kind of medication because of his heart rate. Reporter thought it was atropine and took him to the hospital. In emergency room, they did a chest x-ray, Computerised tomogram scan and blood work, they did not see anything abnormal that would have caused the seizure. Emergency room Doctor determined that, it was the vaccine or a component of the vaccine that caused the reaction. Laboratory data included Blood test (NR: not provided) Normal, Computerised tomogram scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and EKG (NR: not provided) 30 bpm. Treatment medications included atropine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure (eyes rolled back, head went back) on 09-APR-2021, and bradycardia on 10-APR-2021, and the outcome of arm weakness, loss of consciousness (patient was coming in and out of consciousness) and profusely sweating was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210422272- covid-19 vaccine ad26.cov2.s-loss of consciousness (patient was coming in and out of consciousness), bradycardia, seizure (eyes rolled back, head went back) . 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: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Eye movement disorder, Hot flush, Hyperhidrosis, Hypoaesthesia oral
Clinical narrative: LOSS OF CONSCIOUSNESS(PATIENT WAS COMING IN AND OUT OF CONSCIOUSNESS); BRADYCARDIA; SEIZURE (EYES ROLLED  BACK, HEAD WENT BACK); ARM WEAKNESS; PROFUSELY SWEATING; This spontaneous report received from a consumer concerned a 44-year-old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included patient did not have any known allergies. The patient did not have any reaction to vaccine before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported,  1 total administered on 09-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, five minutes after vaccination, patient started profusely sweating and he had a seizure (eyes rolled back, head went back) and lost consciousness. Paramedics were on site came and they did a Electrocardiogram. He had bradycardia (heartrate was very low : 30 bpm). During all this time, he kept on coming in and out of consciousness. Patient also had arm weakness. Paramedics took him by ambulance to the emergency room; they administered some kind of medication because of his heart rate. Reporter thought it was atropine and took him to the hospital. In emergency room, they did a chest x-ray, Computerised tomogram scan and blood work, they did not see anything abnormal that would have caused the seizure. Emergency room Doctor determined that, it was the vaccine or a component of the vaccine that caused the reaction. Laboratory data included Blood test (NR: not provided) Normal, Computerised tomogram scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and EKG (NR: not provided) 30 bpm. Treatment medications included atropine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure (eyes rolled back, head went back) on 09-APR-2021, and bradycardia on 10-APR-2021, and the outcome of arm weakness, loss of consciousness (patient was coming in and out of consciousness) and profusely sweating was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210422272- covid-19 vaccine ad26.cov2.s-loss of consciousness (patient was coming in and out of consciousness), bradycardia, seizure (eyes rolled back, head went back) . 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: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: LOSS OF CONSCIOUSNESS(PATIENT WAS COMING IN AND OUT OF CONSCIOUSNESS); BRADYCARDIA; SEIZURE (EYES ROLLED  BACK, HEAD WENT BACK); ARM WEAKNESS; PROFUSELY SWEATING; This spontaneous report received from a consumer concerned a 44-year-old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included patient did not have any known allergies. The patient did not have any reaction to vaccine before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported,  1 total administered on 09-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, five minutes after vaccination, patient started profusely sweating and he had a seizure (eyes rolled back, head went back) and lost consciousness. Paramedics were on site came and they did a Electrocardiogram. He had bradycardia (heartrate was very low : 30 bpm). During all this time, he kept on coming in and out of consciousness. Patient also had arm weakness. Paramedics took him by ambulance to the emergency room; they administered some kind of medication because of his heart rate. Reporter thought it was atropine and took him to the hospital. In emergency room, they did a chest x-ray, Computerised tomogram scan and blood work, they did not see anything abnormal that would have caused the seizure. Emergency room Doctor determined that, it was the vaccine or a component of the vaccine that caused the reaction. Laboratory data included Blood test (NR: not provided) Normal, Computerised tomogram scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and EKG (NR: not provided) 30 bpm. Treatment medications included atropine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure (eyes rolled back, head went back) on 09-APR-2021, and bradycardia on 10-APR-2021, and the outcome of arm weakness, loss of consciousness (patient was coming in and out of consciousness) and profusely sweating was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210422272- covid-19 vaccine ad26.cov2.s-loss of consciousness (patient was coming in and out of consciousness), bradycardia, seizure (eyes rolled back, head went back) . 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: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Bradycardia, Chest X-ray, Computerised tomogram, Electrocardiogram
Clinical narrative: LOSS OF CONSCIOUSNESS(PATIENT WAS COMING IN AND OUT OF CONSCIOUSNESS); BRADYCARDIA; SEIZURE (EYES ROLLED  BACK, HEAD WENT BACK); ARM WEAKNESS; PROFUSELY SWEATING; This spontaneous report received from a consumer concerned a 44-year-old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included patient did not have any known allergies. The patient did not have any reaction to vaccine before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported,  1 total administered on 09-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, five minutes after vaccination, patient started profusely sweating and he had a seizure (eyes rolled back, head went back) and lost consciousness. Paramedics were on site came and they did a Electrocardiogram. He had bradycardia (heartrate was very low : 30 bpm). During all this time, he kept on coming in and out of consciousness. Patient also had arm weakness. Paramedics took him by ambulance to the emergency room; they administered some kind of medication because of his heart rate. Reporter thought it was atropine and took him to the hospital. In emergency room, they did a chest x-ray, Computerised tomogram scan and blood work, they did not see anything abnormal that would have caused the seizure. Emergency room Doctor determined that, it was the vaccine or a component of the vaccine that caused the reaction. Laboratory data included Blood test (NR: not provided) Normal, Computerised tomogram scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and EKG (NR: not provided) 30 bpm. Treatment medications included atropine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure (eyes rolled back, head went back) on 09-APR-2021, and bradycardia on 10-APR-2021, and the outcome of arm weakness, loss of consciousness (patient was coming in and out of consciousness) and profusely sweating was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210422272- covid-19 vaccine ad26.cov2.s-loss of consciousness (patient was coming in and out of consciousness), bradycardia, seizure (eyes rolled back, head went back) . 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: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Hyperhidrosis, Loss of consciousness, Muscular weakness, Seizure
Clinical narrative: LOSS OF CONSCIOUSNESS(PATIENT WAS COMING IN AND OUT OF CONSCIOUSNESS); BRADYCARDIA; SEIZURE (EYES ROLLED  BACK, HEAD WENT BACK); ARM WEAKNESS; PROFUSELY SWEATING; This spontaneous report received from a consumer concerned a 44-year-old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included patient did not have any known allergies. The patient did not have any reaction to vaccine before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported,  1 total administered on 09-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, five minutes after vaccination, patient started profusely sweating and he had a seizure (eyes rolled back, head went back) and lost consciousness. Paramedics were on site came and they did a Electrocardiogram. He had bradycardia (heartrate was very low : 30 bpm). During all this time, he kept on coming in and out of consciousness. Patient also had arm weakness. Paramedics took him by ambulance to the emergency room; they administered some kind of medication because of his heart rate. Reporter thought it was atropine and took him to the hospital. In emergency room, they did a chest x-ray, Computerised tomogram scan and blood work, they did not see anything abnormal that would have caused the seizure. Emergency room Doctor determined that, it was the vaccine or a component of the vaccine that caused the reaction. Laboratory data included Blood test (NR: not provided) Normal, Computerised tomogram scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and EKG (NR: not provided) 30 bpm. Treatment medications included atropine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure (eyes rolled back, head went back) on 09-APR-2021, and bradycardia on 10-APR-2021, and the outcome of arm weakness, loss of consciousness (patient was coming in and out of consciousness) and profusely sweating was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210422272- covid-19 vaccine ad26.cov2.s-loss of consciousness (patient was coming in and out of consciousness), bradycardia, seizure (eyes rolled back, head went back) . 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, COVID19
Symptoms: Muscle spasms, Nasal congestion, Oropharyngeal pain, Pruritus
Clinical narrative: STUFFY NOSE; BACK PAIN; BODY ACHE; CHILLS; JOINT ACHE; FATIGUE; FEVER; This spontaneous report received from a patient concerned an adult 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, batch number: 1802068, and batch number: 1802068) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced stuffy nose. On 2021, the subject experienced back pain. On 2021, the subject experienced body ache. On 2021, the subject experienced chills. On 2021, the subject experienced joint ache. On 2021, the subject experienced fatigue. On 2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 104 deg. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, back pain, joint ache, stuffy nose, fatigue, fever, and chills. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Fatigue
Clinical narrative: STUFFY NOSE; BACK PAIN; BODY ACHE; CHILLS; JOINT ACHE; FATIGUE; FEVER; This spontaneous report received from a patient concerned an adult 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, batch number: 1802068, and batch number: 1802068) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced stuffy nose. On 2021, the subject experienced back pain. On 2021, the subject experienced body ache. On 2021, the subject experienced chills. On 2021, the subject experienced joint ache. On 2021, the subject experienced fatigue. On 2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 104 deg. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, back pain, joint ache, stuffy nose, fatigue, fever, and chills. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Pain, Pyrexia
Clinical narrative: STUFFY NOSE; BACK PAIN; BODY ACHE; CHILLS; JOINT ACHE; FATIGUE; FEVER; This spontaneous report received from a patient concerned an adult 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, batch number: 1802068, and batch number: 1802068) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced stuffy nose. On 2021, the subject experienced back pain. On 2021, the subject experienced body ache. On 2021, the subject experienced chills. On 2021, the subject experienced joint ache. On 2021, the subject experienced fatigue. On 2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 104 deg. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, back pain, joint ache, stuffy nose, fatigue, fever, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Pain, Pyrexia, Tremor
Clinical narrative: 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced heart is racing. On 09-APR-2021, the subject experienced vomiting. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, vomiting, and heart is racing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced heart is racing. On 09-APR-2021, the subject experienced vomiting. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, vomiting, and heart is racing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pyrexia, Vomiting
Clinical narrative: 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced heart is racing. On 09-APR-2021, the subject experienced vomiting. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, vomiting, and heart is racing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Dizziness, Electrocardiogram abnormal, Full blood count normal, Metabolic function test
Clinical narrative: FELT DIZZY; EXTREMELY HOT; VERY SWEATY; RIGID; EYES WERE OPEN /PUPILS DILATED; NAUSEOUS; DID NOT SLEEP WELL; FELT UNWELL; ACHEY; NON RESPONSIVE, THAT WENT ON FOR ABOUT A MINUTE; LOW BLOOD PRESSURE; SLOW HEART RATE; This spontaneous report received from a consumer concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient had no underlying medical condition at the time of vaccination. 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, 1 total administered on 08-APR-2021 09:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 21:00, 12 hours after vaccination the patient felt achey, she did not felt well, ran down and went to bed at 22:30. She could not sleep at all well, her husband used a fit bit to track sleep and it was up and down all night long. On 09-apr-2021, in the morning the patient came downstairs and she felt dizzy, then she was rigid, her eyes were wide open and pupils dilated. She was non-responsive, that went on for about a minute and then she came out of that. The patient's husband had called the emergency and the emergency technician came and did an EKG (electrocardiogram); also the patient had very low blood pressure and very low pulse. She was taken to the hospital and was treated with an unspecified IV. The patient stayed in the emergency room for few hours, her blood tests were normal and then the patient wanted to see a cardiologist. The patient was feeling better but was also feeling nauseous; she was extremely hot and very sweaty. The patient's husband was not clear if it was a seizure or not, that her muscles were locked up and rigid. The reporter said that the patient never had anything happened like this before and they were concerned and naturally linked the reactions to vaccine at the time of this report. The reporter also wanted to know if there was any correlation between vaccine and cardiovascular system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rigid, and eyes were open /pupils dilated, and was recovering from achey, non responsive, that went on for about a minute, felt unwell, low blood pressure, slow heart rate, nauseous, felt dizzy, did not sleep well, extremely hot, and very sweaty. This report was serious (Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210419979-covid-19 vaccine ad26.cov2.s-non responsive that went on for about a minute, low blood pressure, slow heart rate. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Mydriasis, Paraesthesia, Sleep disorder, Troponin I normal
Clinical narrative: FELT DIZZY; EXTREMELY HOT; VERY SWEATY; RIGID; EYES WERE OPEN /PUPILS DILATED; NAUSEOUS; DID NOT SLEEP WELL; FELT UNWELL; ACHEY; NON RESPONSIVE, THAT WENT ON FOR ABOUT A MINUTE; LOW BLOOD PRESSURE; SLOW HEART RATE; This spontaneous report received from a consumer concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient had no underlying medical condition at the time of vaccination. 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, 1 total administered on 08-APR-2021 09:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 21:00, 12 hours after vaccination the patient felt achey, she did not felt well, ran down and went to bed at 22:30. She could not sleep at all well, her husband used a fit bit to track sleep and it was up and down all night long. On 09-apr-2021, in the morning the patient came downstairs and she felt dizzy, then she was rigid, her eyes were wide open and pupils dilated. She was non-responsive, that went on for about a minute and then she came out of that. The patient's husband had called the emergency and the emergency technician came and did an EKG (electrocardiogram); also the patient had very low blood pressure and very low pulse. She was taken to the hospital and was treated with an unspecified IV. The patient stayed in the emergency room for few hours, her blood tests were normal and then the patient wanted to see a cardiologist. The patient was feeling better but was also feeling nauseous; she was extremely hot and very sweaty. The patient's husband was not clear if it was a seizure or not, that her muscles were locked up and rigid. The reporter said that the patient never had anything happened like this before and they were concerned and naturally linked the reactions to vaccine at the time of this report. The reporter also wanted to know if there was any correlation between vaccine and cardiovascular system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rigid, and eyes were open /pupils dilated, and was recovering from achey, non responsive, that went on for about a minute, felt unwell, low blood pressure, slow heart rate, nauseous, felt dizzy, did not sleep well, extremely hot, and very sweaty. This report was serious (Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210419979-covid-19 vaccine ad26.cov2.s-non responsive that went on for about a minute, low blood pressure, slow heart rate. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: FELT DIZZY; EXTREMELY HOT; VERY SWEATY; RIGID; EYES WERE OPEN /PUPILS DILATED; NAUSEOUS; DID NOT SLEEP WELL; FELT UNWELL; ACHEY; NON RESPONSIVE, THAT WENT ON FOR ABOUT A MINUTE; LOW BLOOD PRESSURE; SLOW HEART RATE; This spontaneous report received from a consumer concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient had no underlying medical condition at the time of vaccination. 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, 1 total administered on 08-APR-2021 09:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 21:00, 12 hours after vaccination the patient felt achey, she did not felt well, ran down and went to bed at 22:30. She could not sleep at all well, her husband used a fit bit to track sleep and it was up and down all night long. On 09-apr-2021, in the morning the patient came downstairs and she felt dizzy, then she was rigid, her eyes were wide open and pupils dilated. She was non-responsive, that went on for about a minute and then she came out of that. The patient's husband had called the emergency and the emergency technician came and did an EKG (electrocardiogram); also the patient had very low blood pressure and very low pulse. She was taken to the hospital and was treated with an unspecified IV. The patient stayed in the emergency room for few hours, her blood tests were normal and then the patient wanted to see a cardiologist. The patient was feeling better but was also feeling nauseous; she was extremely hot and very sweaty. The patient's husband was not clear if it was a seizure or not, that her muscles were locked up and rigid. The reporter said that the patient never had anything happened like this before and they were concerned and naturally linked the reactions to vaccine at the time of this report. The reporter also wanted to know if there was any correlation between vaccine and cardiovascular system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rigid, and eyes were open /pupils dilated, and was recovering from achey, non responsive, that went on for about a minute, felt unwell, low blood pressure, slow heart rate, nauseous, felt dizzy, did not sleep well, extremely hot, and very sweaty. This report was serious (Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210419979-covid-19 vaccine ad26.cov2.s-non responsive that went on for about a minute, low blood pressure, slow heart rate. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, Dizziness, Electrocardiogram, Feeling hot
Clinical narrative: FELT DIZZY; EXTREMELY HOT; VERY SWEATY; RIGID; EYES WERE OPEN /PUPILS DILATED; NAUSEOUS; DID NOT SLEEP WELL; FELT UNWELL; ACHEY; NON RESPONSIVE, THAT WENT ON FOR ABOUT A MINUTE; LOW BLOOD PRESSURE; SLOW HEART RATE; This spontaneous report received from a consumer concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient had no underlying medical condition at the time of vaccination. 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, 1 total administered on 08-APR-2021 09:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 21:00, 12 hours after vaccination the patient felt achey, she did not felt well, ran down and went to bed at 22:30. She could not sleep at all well, her husband used a fit bit to track sleep and it was up and down all night long. On 09-apr-2021, in the morning the patient came downstairs and she felt dizzy, then she was rigid, her eyes were wide open and pupils dilated. She was non-responsive, that went on for about a minute and then she came out of that. The patient's husband had called the emergency and the emergency technician came and did an EKG (electrocardiogram); also the patient had very low blood pressure and very low pulse. She was taken to the hospital and was treated with an unspecified IV. The patient stayed in the emergency room for few hours, her blood tests were normal and then the patient wanted to see a cardiologist. The patient was feeling better but was also feeling nauseous; she was extremely hot and very sweaty. The patient's husband was not clear if it was a seizure or not, that her muscles were locked up and rigid. The reporter said that the patient never had anything happened like this before and they were concerned and naturally linked the reactions to vaccine at the time of this report. The reporter also wanted to know if there was any correlation between vaccine and cardiovascular system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rigid, and eyes were open /pupils dilated, and was recovering from achey, non responsive, that went on for about a minute, felt unwell, low blood pressure, slow heart rate, nauseous, felt dizzy, did not sleep well, extremely hot, and very sweaty. This report was serious (Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210419979-covid-19 vaccine ad26.cov2.s-non responsive that went on for about a minute, low blood pressure, slow heart rate. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate decreased, Hyperhidrosis, Hypotension, Loss of consciousness
Clinical narrative: FELT DIZZY; EXTREMELY HOT; VERY SWEATY; RIGID; EYES WERE OPEN /PUPILS DILATED; NAUSEOUS; DID NOT SLEEP WELL; FELT UNWELL; ACHEY; NON RESPONSIVE, THAT WENT ON FOR ABOUT A MINUTE; LOW BLOOD PRESSURE; SLOW HEART RATE; This spontaneous report received from a consumer concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient had no underlying medical condition at the time of vaccination. 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, 1 total administered on 08-APR-2021 09:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 21:00, 12 hours after vaccination the patient felt achey, she did not felt well, ran down and went to bed at 22:30. She could not sleep at all well, her husband used a fit bit to track sleep and it was up and down all night long. On 09-apr-2021, in the morning the patient came downstairs and she felt dizzy, then she was rigid, her eyes were wide open and pupils dilated. She was non-responsive, that went on for about a minute and then she came out of that. The patient's husband had called the emergency and the emergency technician came and did an EKG (electrocardiogram); also the patient had very low blood pressure and very low pulse. She was taken to the hospital and was treated with an unspecified IV. The patient stayed in the emergency room for few hours, her blood tests were normal and then the patient wanted to see a cardiologist. The patient was feeling better but was also feeling nauseous; she was extremely hot and very sweaty. The patient's husband was not clear if it was a seizure or not, that her muscles were locked up and rigid. The reporter said that the patient never had anything happened like this before and they were concerned and naturally linked the reactions to vaccine at the time of this report. The reporter also wanted to know if there was any correlation between vaccine and cardiovascular system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rigid, and eyes were open /pupils dilated, and was recovering from achey, non responsive, that went on for about a minute, felt unwell, low blood pressure, slow heart rate, nauseous, felt dizzy, did not sleep well, extremely hot, and very sweaty. This report was serious (Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210419979-covid-19 vaccine ad26.cov2.s-non responsive that went on for about a minute, low blood pressure, slow heart rate. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Muscle rigidity, Mydriasis, Nausea, Pain
Clinical narrative: FELT DIZZY; EXTREMELY HOT; VERY SWEATY; RIGID; EYES WERE OPEN /PUPILS DILATED; NAUSEOUS; DID NOT SLEEP WELL; FELT UNWELL; ACHEY; NON RESPONSIVE, THAT WENT ON FOR ABOUT A MINUTE; LOW BLOOD PRESSURE; SLOW HEART RATE; This spontaneous report received from a consumer concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient had no underlying medical condition at the time of vaccination. 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, 1 total administered on 08-APR-2021 09:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 21:00, 12 hours after vaccination the patient felt achey, she did not felt well, ran down and went to bed at 22:30. She could not sleep at all well, her husband used a fit bit to track sleep and it was up and down all night long. On 09-apr-2021, in the morning the patient came downstairs and she felt dizzy, then she was rigid, her eyes were wide open and pupils dilated. She was non-responsive, that went on for about a minute and then she came out of that. The patient's husband had called the emergency and the emergency technician came and did an EKG (electrocardiogram); also the patient had very low blood pressure and very low pulse. She was taken to the hospital and was treated with an unspecified IV. The patient stayed in the emergency room for few hours, her blood tests were normal and then the patient wanted to see a cardiologist. The patient was feeling better but was also feeling nauseous; she was extremely hot and very sweaty. The patient's husband was not clear if it was a seizure or not, that her muscles were locked up and rigid. The reporter said that the patient never had anything happened like this before and they were concerned and naturally linked the reactions to vaccine at the time of this report. The reporter also wanted to know if there was any correlation between vaccine and cardiovascular system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rigid, and eyes were open /pupils dilated, and was recovering from achey, non responsive, that went on for about a minute, felt unwell, low blood pressure, slow heart rate, nauseous, felt dizzy, did not sleep well, extremely hot, and very sweaty. This report was serious (Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210419979-covid-19 vaccine ad26.cov2.s-non responsive that went on for about a minute, low blood pressure, slow heart rate. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality sleep
Clinical narrative: FELT DIZZY; EXTREMELY HOT; VERY SWEATY; RIGID; EYES WERE OPEN /PUPILS DILATED; NAUSEOUS; DID NOT SLEEP WELL; FELT UNWELL; ACHEY; NON RESPONSIVE, THAT WENT ON FOR ABOUT A MINUTE; LOW BLOOD PRESSURE; SLOW HEART RATE; This spontaneous report received from a consumer concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient had no underlying medical condition at the time of vaccination. 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, 1 total administered on 08-APR-2021 09:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 21:00, 12 hours after vaccination the patient felt achey, she did not felt well, ran down and went to bed at 22:30. She could not sleep at all well, her husband used a fit bit to track sleep and it was up and down all night long. On 09-apr-2021, in the morning the patient came downstairs and she felt dizzy, then she was rigid, her eyes were wide open and pupils dilated. She was non-responsive, that went on for about a minute and then she came out of that. The patient's husband had called the emergency and the emergency technician came and did an EKG (electrocardiogram); also the patient had very low blood pressure and very low pulse. She was taken to the hospital and was treated with an unspecified IV. The patient stayed in the emergency room for few hours, her blood tests were normal and then the patient wanted to see a cardiologist. The patient was feeling better but was also feeling nauseous; she was extremely hot and very sweaty. The patient's husband was not clear if it was a seizure or not, that her muscles were locked up and rigid. The reporter said that the patient never had anything happened like this before and they were concerned and naturally linked the reactions to vaccine at the time of this report. The reporter also wanted to know if there was any correlation between vaccine and cardiovascular system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rigid, and eyes were open /pupils dilated, and was recovering from achey, non responsive, that went on for about a minute, felt unwell, low blood pressure, slow heart rate, nauseous, felt dizzy, did not sleep well, extremely hot, and very sweaty. This report was serious (Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210419979-covid-19 vaccine ad26.cov2.s-non responsive that went on for about a minute, low blood pressure, slow heart rate. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Body temperature increased, Chills, Confusional state
Clinical narrative: TIGHT MUSCLES; RIGHT HIP JOINT PAIN; FAINTED; NUMB LEG; TINGLY FOOT; FLUSHED; HIT HIS HEAD; INSOMNIA; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 185 pounds, and height was 69 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982) dose was not reported, administered 1 total on 08-APR-2021 13:00 at Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the patient experienced insomnia and chills at night. On 09-APR-2021, patient was doing physical activity (walking around the store). Patient experienced really sharp and stabbing right hip joint pain, right leg numbness and his right foot felt tingly like it had fallen asleep. That got worse over 5 minutes. Patient experienced very hot and flushed and proceeded to go outside where he fainted (his vision was blurry and in a confused state of mind and experienced hot and nausea) and hit his head. He tried to get up again. He fainted again and eventually came to. He was given stiches. On 11-APR-2021, he was having pain in right joint hip and tight muscles. He visited hospital where an EKG (electrocardiogram) was performed and results was normal. Laboratory data included: EKG: electrocardiogram (NR: not provided) as Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted (nausea/hot/blurry vision/confused state of mind), insomnia, flushed, and chills on APR-2021, was recovering from right hip joint pain, and the outcome of numb leg, tingly foot, hit his head and tight muscles was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422158-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fainted. 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, COVID19
Symptoms: Dizziness, Ear discomfort, Electrocardiogram normal, Fall, Fatigue
Clinical narrative: TIGHT MUSCLES; RIGHT HIP JOINT PAIN; FAINTED; NUMB LEG; TINGLY FOOT; FLUSHED; HIT HIS HEAD; INSOMNIA; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 185 pounds, and height was 69 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982) dose was not reported, administered 1 total on 08-APR-2021 13:00 at Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the patient experienced insomnia and chills at night. On 09-APR-2021, patient was doing physical activity (walking around the store). Patient experienced really sharp and stabbing right hip joint pain, right leg numbness and his right foot felt tingly like it had fallen asleep. That got worse over 5 minutes. Patient experienced very hot and flushed and proceeded to go outside where he fainted (his vision was blurry and in a confused state of mind and experienced hot and nausea) and hit his head. He tried to get up again. He fainted again and eventually came to. He was given stiches. On 11-APR-2021, he was having pain in right joint hip and tight muscles. He visited hospital where an EKG (electrocardiogram) was performed and results was normal. Laboratory data included: EKG: electrocardiogram (NR: not provided) as Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted (nausea/hot/blurry vision/confused state of mind), insomnia, flushed, and chills on APR-2021, was recovering from right hip joint pain, and the outcome of numb leg, tingly foot, hit his head and tight muscles was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422158-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fainted. 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, COVID19
Symptoms: Feeling abnormal, Feeling hot, Gait disturbance, Hypoaesthesia, Insomnia
Clinical narrative: TIGHT MUSCLES; RIGHT HIP JOINT PAIN; FAINTED; NUMB LEG; TINGLY FOOT; FLUSHED; HIT HIS HEAD; INSOMNIA; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 185 pounds, and height was 69 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982) dose was not reported, administered 1 total on 08-APR-2021 13:00 at Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the patient experienced insomnia and chills at night. On 09-APR-2021, patient was doing physical activity (walking around the store). Patient experienced really sharp and stabbing right hip joint pain, right leg numbness and his right foot felt tingly like it had fallen asleep. That got worse over 5 minutes. Patient experienced very hot and flushed and proceeded to go outside where he fainted (his vision was blurry and in a confused state of mind and experienced hot and nausea) and hit his head. He tried to get up again. He fainted again and eventually came to. He was given stiches. On 11-APR-2021, he was having pain in right joint hip and tight muscles. He visited hospital where an EKG (electrocardiogram) was performed and results was normal. Laboratory data included: EKG: electrocardiogram (NR: not provided) as Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted (nausea/hot/blurry vision/confused state of mind), insomnia, flushed, and chills on APR-2021, was recovering from right hip joint pain, and the outcome of numb leg, tingly foot, hit his head and tight muscles was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422158-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fainted. 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.