chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: I  received my first dose of the Pfzer vaccine on 4/14/2021 I was asked to wait in a waiting area for 15 minutes to be monitored.  Within 5 minutes of receiving the vaccine.  I had a strong metal taste in my mouth and felt like my lips were swelling.  I alerted the medical staff team and they brought me back into a room to be monitored.  My mouth was numb.  (felt as if I was given numbing shots at a dental facility)    A nurse gave me a zyrtec and pepsid.    They monitored my for 30 minutes.  Numbness still was strong and present but I showed no signs of respiratory distress and they allowed me to go home.  I was told a staff would be calling on me to check on me later that day.  (this never occurred)     About 30 minutes later on my way home, the numbness I was experiencing in my mouth now was in my Right Arm starting at my elbow and was spreading upward toward my shoulder, neck and right side of my face.  I called the clinic back and was advised to go immediately to the ER.  I went to Hospital in.  I was checked out by a physician, given a neurological assessment, given 5 steroid pills and also given a eye exam.    The numbness was intensifying and I felt extreme pressure accompanied by blurred vision in my right eye.   My Blood pressure was also extremely elevated.   I was left in a exam room for 4 1/2 hours.  I had no signs of sensation returning to the numb areas.  ER Doctor consulted with the Neurologist and then advised me to follow up with my primary care for potential Neurologist referral for a MRI.  He stated that the medical staff was slammed and that I could not have a MRI at that time.  He felt that I wasn't critical and that a MRI could be scheduled at a later time.    I followed up with my Primary Care Physician.  She did blood work, another eye exam and referred me to see a Neurologist, Ophthalmologist and allergist.   I have made the necessary appointments and am awaiting further testing for ongoing issues.  (MRI,  VEP, & EMG)   Numbness lasted two days, followed by tingling for another day.  I continue to struggle with blurred vision in my right eye,  severe headaches and pain in my shoulder and neck area.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure increased, Blood test, Discomfort, Dysgeusia
Clinical narrative: I  received my first dose of the Pfzer vaccine on 4/14/2021 I was asked to wait in a waiting area for 15 minutes to be monitored.  Within 5 minutes of receiving the vaccine.  I had a strong metal taste in my mouth and felt like my lips were swelling.  I alerted the medical staff team and they brought me back into a room to be monitored.  My mouth was numb.  (felt as if I was given numbing shots at a dental facility)    A nurse gave me a zyrtec and pepsid.    They monitored my for 30 minutes.  Numbness still was strong and present but I showed no signs of respiratory distress and they allowed me to go home.  I was told a staff would be calling on me to check on me later that day.  (this never occurred)     About 30 minutes later on my way home, the numbness I was experiencing in my mouth now was in my Right Arm starting at my elbow and was spreading upward toward my shoulder, neck and right side of my face.  I called the clinic back and was advised to go immediately to the ER.  I went to Hospital in.  I was checked out by a physician, given a neurological assessment, given 5 steroid pills and also given a eye exam.    The numbness was intensifying and I felt extreme pressure accompanied by blurred vision in my right eye.   My Blood pressure was also extremely elevated.   I was left in a exam room for 4 1/2 hours.  I had no signs of sensation returning to the numb areas.  ER Doctor consulted with the Neurologist and then advised me to follow up with my primary care for potential Neurologist referral for a MRI.  He stated that the medical staff was slammed and that I could not have a MRI at that time.  He felt that I wasn't critical and that a MRI could be scheduled at a later time.    I followed up with my Primary Care Physician.  She did blood work, another eye exam and referred me to see a Neurologist, Ophthalmologist and allergist.   I have made the necessary appointments and am awaiting further testing for ongoing issues.  (MRI,  VEP, & EMG)   Numbness lasted two days, followed by tingling for another day.  I continue to struggle with blurred vision in my right eye,  severe headaches and pain in my shoulder and neck area.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Neck pain
Clinical narrative: I  received my first dose of the Pfzer vaccine on 4/14/2021 I was asked to wait in a waiting area for 15 minutes to be monitored.  Within 5 minutes of receiving the vaccine.  I had a strong metal taste in my mouth and felt like my lips were swelling.  I alerted the medical staff team and they brought me back into a room to be monitored.  My mouth was numb.  (felt as if I was given numbing shots at a dental facility)    A nurse gave me a zyrtec and pepsid.    They monitored my for 30 minutes.  Numbness still was strong and present but I showed no signs of respiratory distress and they allowed me to go home.  I was told a staff would be calling on me to check on me later that day.  (this never occurred)     About 30 minutes later on my way home, the numbness I was experiencing in my mouth now was in my Right Arm starting at my elbow and was spreading upward toward my shoulder, neck and right side of my face.  I called the clinic back and was advised to go immediately to the ER.  I went to Hospital in.  I was checked out by a physician, given a neurological assessment, given 5 steroid pills and also given a eye exam.    The numbness was intensifying and I felt extreme pressure accompanied by blurred vision in my right eye.   My Blood pressure was also extremely elevated.   I was left in a exam room for 4 1/2 hours.  I had no signs of sensation returning to the numb areas.  ER Doctor consulted with the Neurologist and then advised me to follow up with my primary care for potential Neurologist referral for a MRI.  He stated that the medical staff was slammed and that I could not have a MRI at that time.  He felt that I wasn't critical and that a MRI could be scheduled at a later time.    I followed up with my Primary Care Physician.  She did blood work, another eye exam and referred me to see a Neurologist, Ophthalmologist and allergist.   I have made the necessary appointments and am awaiting further testing for ongoing issues.  (MRI,  VEP, & EMG)   Numbness lasted two days, followed by tingling for another day.  I continue to struggle with blurred vision in my right eye,  severe headaches and pain in my shoulder and neck area.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ophthalmological examination, Paraesthesia, Vision blurred
Clinical narrative: I  received my first dose of the Pfzer vaccine on 4/14/2021 I was asked to wait in a waiting area for 15 minutes to be monitored.  Within 5 minutes of receiving the vaccine.  I had a strong metal taste in my mouth and felt like my lips were swelling.  I alerted the medical staff team and they brought me back into a room to be monitored.  My mouth was numb.  (felt as if I was given numbing shots at a dental facility)    A nurse gave me a zyrtec and pepsid.    They monitored my for 30 minutes.  Numbness still was strong and present but I showed no signs of respiratory distress and they allowed me to go home.  I was told a staff would be calling on me to check on me later that day.  (this never occurred)     About 30 minutes later on my way home, the numbness I was experiencing in my mouth now was in my Right Arm starting at my elbow and was spreading upward toward my shoulder, neck and right side of my face.  I called the clinic back and was advised to go immediately to the ER.  I went to Hospital in.  I was checked out by a physician, given a neurological assessment, given 5 steroid pills and also given a eye exam.    The numbness was intensifying and I felt extreme pressure accompanied by blurred vision in my right eye.   My Blood pressure was also extremely elevated.   I was left in a exam room for 4 1/2 hours.  I had no signs of sensation returning to the numb areas.  ER Doctor consulted with the Neurologist and then advised me to follow up with my primary care for potential Neurologist referral for a MRI.  He stated that the medical staff was slammed and that I could not have a MRI at that time.  He felt that I wasn't critical and that a MRI could be scheduled at a later time.    I followed up with my Primary Care Physician.  She did blood work, another eye exam and referred me to see a Neurologist, Ophthalmologist and allergist.   I have made the necessary appointments and am awaiting further testing for ongoing issues.  (MRI,  VEP, & EMG)   Numbness lasted two days, followed by tingling for another day.  I continue to struggle with blurred vision in my right eye,  severe headaches and pain in my shoulder and neck area.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Hypersomnia, Hypoaesthesia, Migraine
Clinical narrative: Approximately 2 minutes after administration of the vaccine, patient stated he was feeling light-headed, tingling sensation in fingers and beginning to sweat. He was instructed to sit back down, stay for a total of 30 minutes and let the pharmacist know if his condition worsens (his mother was with him). I, asked a technician to provide him with a bottle of cold water. After 4 to 5 minutes, his mother notified me his condition had worsened and the patient looked pale and sweat was visible on his forehead. Another pharmacist stepped in to assist because I was with a different patient. This pharmacist, aligned 3 to 4 chairs so the patient could lie down. He stayed with him until he stated he felt better, which was approximately 5 minutes later. For the record, the patient did not mention a headache or symptoms of a migraine. Patient called pharmacy on 4/14/21 and stated he's been suffering from a headache/migraine since the day of administration. The pharmacist recommended to follow up with PCP.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Peripheral coldness, Tinnitus
Clinical narrative: Approximately 2 minutes after administration of the vaccine, patient stated he was feeling light-headed, tingling sensation in fingers and beginning to sweat. He was instructed to sit back down, stay for a total of 30 minutes and let the pharmacist know if his condition worsens (his mother was with him). I, asked a technician to provide him with a bottle of cold water. After 4 to 5 minutes, his mother notified me his condition had worsened and the patient looked pale and sweat was visible on his forehead. Another pharmacist stepped in to assist because I was with a different patient. This pharmacist, aligned 3 to 4 chairs so the patient could lie down. He stayed with him until he stated he felt better, which was approximately 5 minutes later. For the record, the patient did not mention a headache or symptoms of a migraine. Patient called pharmacy on 4/14/21 and stated he's been suffering from a headache/migraine since the day of administration. The pharmacist recommended to follow up with PCP.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hyperhidrosis, Migraine, Pallor, Paraesthesia
Clinical narrative: Approximately 2 minutes after administration of the vaccine, patient stated he was feeling light-headed, tingling sensation in fingers and beginning to sweat. He was instructed to sit back down, stay for a total of 30 minutes and let the pharmacist know if his condition worsens (his mother was with him). I, asked a technician to provide him with a bottle of cold water. After 4 to 5 minutes, his mother notified me his condition had worsened and the patient looked pale and sweat was visible on his forehead. Another pharmacist stepped in to assist because I was with a different patient. This pharmacist, aligned 3 to 4 chairs so the patient could lie down. He stayed with him until he stated he felt better, which was approximately 5 minutes later. For the record, the patient did not mention a headache or symptoms of a migraine. Patient called pharmacy on 4/14/21 and stated he's been suffering from a headache/migraine since the day of administration. The pharmacist recommended to follow up with PCP.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Vomiting
Clinical narrative: I got the shot on Wed, April 14, 2021 on my right arm. I bled when I got the shot.   Within five minutes of getting the shot, I started feeling dizzy and felt very warm. I called the pharmacist and let her know. She called my sister right away and let her know of my reaction. I passed out. After  I gained consciousness I started throwing up. I do not have a fear of needles and this is the first time I have had such a reaction. I waited at the pharmacy for over 30 minutes trying to get my energy back. I was nauseous for over 24 hours after that and felt light headed on and off.  the site of the injection was bruised.   On tue, April 20, I noticed bruises on my right leg as well as on my hand. I also had moderate muscle stiffness. I followed up with my primary care physician.  She ran my bloodwork and everything was normal.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Dizziness, Feeling hot, Full blood count, Injection site bruising
Clinical narrative: I got the shot on Wed, April 14, 2021 on my right arm. I bled when I got the shot.   Within five minutes of getting the shot, I started feeling dizzy and felt very warm. I called the pharmacist and let her know. She called my sister right away and let her know of my reaction. I passed out. After  I gained consciousness I started throwing up. I do not have a fear of needles and this is the first time I have had such a reaction. I waited at the pharmacy for over 30 minutes trying to get my energy back. I was nauseous for over 24 hours after that and felt light headed on and off.  the site of the injection was bruised.   On tue, April 20, I noticed bruises on my right leg as well as on my hand. I also had moderate muscle stiffness. I followed up with my primary care physician.  She ran my bloodwork and everything was normal.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site haemorrhage, International normalised ratio, Lipids, Loss of consciousness, Metabolic function test
Clinical narrative: I got the shot on Wed, April 14, 2021 on my right arm. I bled when I got the shot.   Within five minutes of getting the shot, I started feeling dizzy and felt very warm. I called the pharmacist and let her know. She called my sister right away and let her know of my reaction. I passed out. After  I gained consciousness I started throwing up. I do not have a fear of needles and this is the first time I have had such a reaction. I waited at the pharmacy for over 30 minutes trying to get my energy back. I was nauseous for over 24 hours after that and felt light headed on and off.  the site of the injection was bruised.   On tue, April 20, I noticed bruises on my right leg as well as on my hand. I also had moderate muscle stiffness. I followed up with my primary care physician.  She ran my bloodwork and everything was normal.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Vitamin B12, Vitamin D
Clinical narrative: I got the shot on Wed, April 14, 2021 on my right arm. I bled when I got the shot.   Within five minutes of getting the shot, I started feeling dizzy and felt very warm. I called the pharmacist and let her know. She called my sister right away and let her know of my reaction. I passed out. After  I gained consciousness I started throwing up. I do not have a fear of needles and this is the first time I have had such a reaction. I waited at the pharmacy for over 30 minutes trying to get my energy back. I was nauseous for over 24 hours after that and felt light headed on and off.  the site of the injection was bruised.   On tue, April 20, I noticed bruises on my right leg as well as on my hand. I also had moderate muscle stiffness. I followed up with my primary care physician.  She ran my bloodwork and everything was normal.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral haemorrhage, Computerised tomogram head abnormal, Endotracheal intubation, Headache, Hypertension
Clinical narrative: BRAIN ANEURYSM; SHE STARTED FEELING NAUSEOUS; This spontaneous report received from a consumer via a news report by a company representative concerned a female of unspecified age and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The patient started feeling nauseous and was found on the floor unresponsive, and on 01-APR-2021, she was admitted to an area hospital. The reporter stated that the doctor couldn't figure out what was going on, a CT scan was performed and they found bleeding on the brain. It was reported to be massive, and at first that it was thought it was actually two aneurysms, but it was only one. On 09-APR-2021, it was reported that the patient died from brain aneurysm. It is unknown if an autopsy was done. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 09-APR-2021, and the outcome of she started feeling nauseous was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0 This report concerns an elderly female patient who died due to brain aneurysm, 10 days after receiving Jansen COVID-19 vaccine.  Two days after vaccination, the patient started nauseous.  She was found on the floor unresponsive and was admitted to the hospital.  A CT scan found bleeding on the brain.  It was reported "at first that it was thought it was actually two aneurysms, but it was only one."  The patient died due to brain aneurysm 10 days after vaccination.  Due to the nature of the event (slow development process) and lack of the biological plausibility, the event is considered not related to the COVID-19 vaccine. Additional information has been requested.; Reported Cause(s) of Death: BRAIN ANEURYSM
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Nausea, Pain, Unresponsive to stimuli, Vomiting
Clinical narrative: BRAIN ANEURYSM; SHE STARTED FEELING NAUSEOUS; This spontaneous report received from a consumer via a news report by a company representative concerned a female of unspecified age and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The patient started feeling nauseous and was found on the floor unresponsive, and on 01-APR-2021, she was admitted to an area hospital. The reporter stated that the doctor couldn't figure out what was going on, a CT scan was performed and they found bleeding on the brain. It was reported to be massive, and at first that it was thought it was actually two aneurysms, but it was only one. On 09-APR-2021, it was reported that the patient died from brain aneurysm. It is unknown if an autopsy was done. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 09-APR-2021, and the outcome of she started feeling nauseous was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0 This report concerns an elderly female patient who died due to brain aneurysm, 10 days after receiving Jansen COVID-19 vaccine.  Two days after vaccination, the patient started nauseous.  She was found on the floor unresponsive and was admitted to the hospital.  A CT scan found bleeding on the brain.  It was reported "at first that it was thought it was actually two aneurysms, but it was only one."  The patient died due to brain aneurysm 10 days after vaccination.  Due to the nature of the event (slow development process) and lack of the biological plausibility, the event is considered not related to the COVID-19 vaccine. Additional information has been requested.; Reported Cause(s) of Death: BRAIN ANEURYSM
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Intracranial aneurysm, Nausea
Clinical narrative: BRAIN ANEURYSM; SHE STARTED FEELING NAUSEOUS; This spontaneous report received from a consumer via a news report by a company representative concerned a female of unspecified age and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The patient started feeling nauseous and was found on the floor unresponsive, and on 01-APR-2021, she was admitted to an area hospital. The reporter stated that the doctor couldn't figure out what was going on, a CT scan was performed and they found bleeding on the brain. It was reported to be massive, and at first that it was thought it was actually two aneurysms, but it was only one. On 09-APR-2021, it was reported that the patient died from brain aneurysm. It is unknown if an autopsy was done. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 09-APR-2021, and the outcome of she started feeling nauseous was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0 This report concerns an elderly female patient who died due to brain aneurysm, 10 days after receiving Jansen COVID-19 vaccine.  Two days after vaccination, the patient started nauseous.  She was found on the floor unresponsive and was admitted to the hospital.  A CT scan found bleeding on the brain.  It was reported "at first that it was thought it was actually two aneurysms, but it was only one."  The patient died due to brain aneurysm 10 days after vaccination.  Due to the nature of the event (slow development process) and lack of the biological plausibility, the event is considered not related to the COVID-19 vaccine. Additional information has been requested.; Reported Cause(s) of Death: BRAIN ANEURYSM
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain in jaw, Pyrexia, Sleep disorder
Clinical narrative: JAW PAIN; DIFFICULT TO SLEEP; CHILLS; FEVER; This spontaneous report received from a patient concerned a 62 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On an unspecified date, the subject experienced jaw pain, and difficult to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from jaw pain, difficult to sleep, chills, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Insomnia, Pain in jaw, Pyrexia
Clinical narrative: JAW PAIN; DIFFICULT TO SLEEP; CHILLS; FEVER; This spontaneous report received from a patient concerned a 62 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On an unspecified date, the subject experienced jaw pain, and difficult to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from jaw pain, difficult to sleep, chills, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Cerebrovascular accident, Computerised tomogram abnormal, Computerised tomogram head, Gaze palsy
Clinical narrative: STROKE; 2 SMALL BRAIN ANEURYSMS; SORENESS AT INJECTION SITE; This spontaneous report received from a consumer concerned a female of unspecified age. Initial information was received on 13-APR-2021 and processed with additional information received on 19-APR-2021 via telephone log.  The patient's weight, height, and medical history were not reported.  The patient received JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered in right deltoid on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-MAR-2021, the patient experienced soreness at injection site, which she experienced immediately.  Approximately 8 days later, on 06-APR-2021, patient started feeling dizzy and her vision was obscured. Patient drank water and it passed. At 8 am the following day, patient was sitting with her mother and started feeling dizzy and stared off into space. The patient passed out and was looking up at her mother. Patient's right side of her face was drooped. The patient's mother called 911 and emergency medical technicians administered alteplase. She experienced a stroke. The patient was currently in inpatient in neuro intensive care unit and has 2 small brain aneurysms.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke, 2 small brain aneurysms, and the soreness at injection site was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a female patient of unspecified age who was hospitalized for a stroke and 2 small brain aneurysms approximately 9 days after receiving the Janssen Covid-19 vaccine. Information regarding age, past medical history, and concomitant medications was not provided.  On the day of her vaccination, the patient experienced injection site soreness immediately. Approximately 8 days later, she felt dizzy and had obscured vision but the events resolved after she drank water. The following morning at 8 am, she started feeling dizzy, was staring off into space, then passed out and was looking up at her mother, with right facial drooping. Her mother called 911 and emergency medical technicians administered alteplase. The patient experienced a stroke. As of the time of this report, she was hospitalized in the neuro intensive care unit and has "2 small brain aneurysms". Diagnostic test results, additional corrective treatment, and outcome were not provided. Based on the limited available information from the patient's mother, the relationship of the stroke with Janssen Covid-19 vaccine is considered indeterminant. The brain aneurysms are most likely underlying conditions and thus considered to have inconsistent relationship to vaccine. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hemiparesis, Intensive care, Magnetic resonance imaging head abnormal, Neck pain, Syncope
Clinical narrative: STROKE; 2 SMALL BRAIN ANEURYSMS; SORENESS AT INJECTION SITE; This spontaneous report received from a consumer concerned a female of unspecified age. Initial information was received on 13-APR-2021 and processed with additional information received on 19-APR-2021 via telephone log.  The patient's weight, height, and medical history were not reported.  The patient received JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered in right deltoid on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-MAR-2021, the patient experienced soreness at injection site, which she experienced immediately.  Approximately 8 days later, on 06-APR-2021, patient started feeling dizzy and her vision was obscured. Patient drank water and it passed. At 8 am the following day, patient was sitting with her mother and started feeling dizzy and stared off into space. The patient passed out and was looking up at her mother. Patient's right side of her face was drooped. The patient's mother called 911 and emergency medical technicians administered alteplase. She experienced a stroke. The patient was currently in inpatient in neuro intensive care unit and has 2 small brain aneurysms.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke, 2 small brain aneurysms, and the soreness at injection site was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a female patient of unspecified age who was hospitalized for a stroke and 2 small brain aneurysms approximately 9 days after receiving the Janssen Covid-19 vaccine. Information regarding age, past medical history, and concomitant medications was not provided.  On the day of her vaccination, the patient experienced injection site soreness immediately. Approximately 8 days later, she felt dizzy and had obscured vision but the events resolved after she drank water. The following morning at 8 am, she started feeling dizzy, was staring off into space, then passed out and was looking up at her mother, with right facial drooping. Her mother called 911 and emergency medical technicians administered alteplase. The patient experienced a stroke. As of the time of this report, she was hospitalized in the neuro intensive care unit and has "2 small brain aneurysms". Diagnostic test results, additional corrective treatment, and outcome were not provided. Based on the limited available information from the patient's mother, the relationship of the stroke with Janssen Covid-19 vaccine is considered indeterminant. The brain aneurysms are most likely underlying conditions and thus considered to have inconsistent relationship to vaccine. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Injection site pain, Intracranial aneurysm
Clinical narrative: STROKE; 2 SMALL BRAIN ANEURYSMS; SORENESS AT INJECTION SITE; This spontaneous report received from a consumer concerned a female of unspecified age. Initial information was received on 13-APR-2021 and processed with additional information received on 19-APR-2021 via telephone log.  The patient's weight, height, and medical history were not reported.  The patient received JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered in right deltoid on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-MAR-2021, the patient experienced soreness at injection site, which she experienced immediately.  Approximately 8 days later, on 06-APR-2021, patient started feeling dizzy and her vision was obscured. Patient drank water and it passed. At 8 am the following day, patient was sitting with her mother and started feeling dizzy and stared off into space. The patient passed out and was looking up at her mother. Patient's right side of her face was drooped. The patient's mother called 911 and emergency medical technicians administered alteplase. She experienced a stroke. The patient was currently in inpatient in neuro intensive care unit and has 2 small brain aneurysms.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke, 2 small brain aneurysms, and the soreness at injection site was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a female patient of unspecified age who was hospitalized for a stroke and 2 small brain aneurysms approximately 9 days after receiving the Janssen Covid-19 vaccine. Information regarding age, past medical history, and concomitant medications was not provided.  On the day of her vaccination, the patient experienced injection site soreness immediately. Approximately 8 days later, she felt dizzy and had obscured vision but the events resolved after she drank water. The following morning at 8 am, she started feeling dizzy, was staring off into space, then passed out and was looking up at her mother, with right facial drooping. Her mother called 911 and emergency medical technicians administered alteplase. The patient experienced a stroke. As of the time of this report, she was hospitalized in the neuro intensive care unit and has "2 small brain aneurysms". Diagnostic test results, additional corrective treatment, and outcome were not provided. Based on the limited available information from the patient's mother, the relationship of the stroke with Janssen Covid-19 vaccine is considered indeterminant. The brain aneurysms are most likely underlying conditions and thus considered to have inconsistent relationship to vaccine. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Gaze palsy, Head discomfort
Clinical narrative: SPECIFIC PRESSURE/PAIN IN THE LEFT SIDE OF MY HEAD/BRAIN; WEAKNESS; SEVERE HEADACHES FOR THE FIRST COUPLE OF WEEKS FOLLOWING THE VACCINE; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced specific pressure/pain in the left side of my head/brain, weakness, and severe headaches for the first couple of weeks following the vaccine. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headaches for the first couple of weeks following the vaccine, and specific pressure/pain in the left side of my head/brain, and the outcome of weakness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Head discomfort, Headache
Clinical narrative: SPECIFIC PRESSURE/PAIN IN THE LEFT SIDE OF MY HEAD/BRAIN; WEAKNESS; SEVERE HEADACHES FOR THE FIRST COUPLE OF WEEKS FOLLOWING THE VACCINE; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced specific pressure/pain in the left side of my head/brain, weakness, and severe headaches for the first couple of weeks following the vaccine. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headaches for the first couple of weeks following the vaccine, and specific pressure/pain in the left side of my head/brain, and the outcome of weakness was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Thrombosis
Clinical narrative: BLOOD CLOT; STROKE; PRODUCT LOT NUMBER ILLEGIBLE; HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a 59 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on left arm, 19-MAR-2021 for prophylactic vaccination. Patient took the product as directed. No concomitant medications were reported.  On 19-MAR-2021, the patient experienced headache and fatigue. On 27-MAR-2021 the patient experienced blood clot which caused a stroke. On same day, the patient was hospitalized and transferred from one hospital to another on 30-MAR-2021. On 06-APR-2021, the patient got discharged from hospital. The patient was hospitalized for 11 days. The reporter had difficulty reading the vaccination card over lot due to writing (product lot number illegible) possibly 1805029. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke, and blood clot on 06-APR-2021, and headache on 20-MAR-2021, had not recovered from fatigue, and the outcome of product lot number illegible was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This 59 year old male was hospitalized for blood clot which caused a stroke 8 days after receiving Janssen Covid-19 vaccination. Patient's height, weight, medical history and current medications were not reported. On the day the patient got vaccinated, he experienced headache and fatigue. 8 days later, patient experienced a stroke and was hospitalized. Stroke was allegedly caused by a blood clot. Patient was hospitalized for 11 days, eventually recovered and discharged. However, the patient still felt fatigued. The laboratory and diagnostic results were reported. Based on the limited information, the event is inconsistent with causal association to immunization, per the causality classification for adverse events following immunization.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Fatigue, Headache, Product lot number issue, Thrombosis
Clinical narrative: BLOOD CLOT; STROKE; PRODUCT LOT NUMBER ILLEGIBLE; HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a 59 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on left arm, 19-MAR-2021 for prophylactic vaccination. Patient took the product as directed. No concomitant medications were reported.  On 19-MAR-2021, the patient experienced headache and fatigue. On 27-MAR-2021 the patient experienced blood clot which caused a stroke. On same day, the patient was hospitalized and transferred from one hospital to another on 30-MAR-2021. On 06-APR-2021, the patient got discharged from hospital. The patient was hospitalized for 11 days. The reporter had difficulty reading the vaccination card over lot due to writing (product lot number illegible) possibly 1805029. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke, and blood clot on 06-APR-2021, and headache on 20-MAR-2021, had not recovered from fatigue, and the outcome of product lot number illegible was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This 59 year old male was hospitalized for blood clot which caused a stroke 8 days after receiving Janssen Covid-19 vaccination. Patient's height, weight, medical history and current medications were not reported. On the day the patient got vaccinated, he experienced headache and fatigue. 8 days later, patient experienced a stroke and was hospitalized. Stroke was allegedly caused by a blood clot. Patient was hospitalized for 11 days, eventually recovered and discharged. However, the patient still felt fatigued. The laboratory and diagnostic results were reported. Based on the limited information, the event is inconsistent with causal association to immunization, per the causality classification for adverse events following immunization.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Feeling abnormal, Headache, Miosis
Clinical narrative: BLURRY VISION; EYE SENSITIVITY TO LIGHT; HER PUPILS WERE REALLY SMALL; FEELING DIZZY; FEELING OUT OF IT/FELT SHE WAS HIGH ON DRUG; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy, hypothyroidism, and seasonal allergies, and other pre-existing medical conditions included patient was not breast feeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 21/JUN/2021) dose was not reported, administered on 06-APR-2021 19:25 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced blurry vision. On 06-APR-2021, the subject experienced eye sensitivity to light. On 06-APR-2021, the subject experienced her pupils were really small. On 06-APR-2021, the subject experienced feeling dizzy. On 06-APR-2021, the subject experienced feeling out of it/felt she was high on drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling dizzy, and feeling out of it/felt she was high on drug on 08-APR-2021, and was recovering from blurry vision, eye sensitivity to light, and her pupils were really small. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Nausea, Pain, Palpitations, Photophobia
Clinical narrative: BLURRY VISION; EYE SENSITIVITY TO LIGHT; HER PUPILS WERE REALLY SMALL; FEELING DIZZY; FEELING OUT OF IT/FELT SHE WAS HIGH ON DRUG; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy, hypothyroidism, and seasonal allergies, and other pre-existing medical conditions included patient was not breast feeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 21/JUN/2021) dose was not reported, administered on 06-APR-2021 19:25 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced blurry vision. On 06-APR-2021, the subject experienced eye sensitivity to light. On 06-APR-2021, the subject experienced her pupils were really small. On 06-APR-2021, the subject experienced feeling dizzy. On 06-APR-2021, the subject experienced feeling out of it/felt she was high on drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling dizzy, and feeling out of it/felt she was high on drug on 08-APR-2021, and was recovering from blurry vision, eye sensitivity to light, and her pupils were really small. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Vision blurred
Clinical narrative: BLURRY VISION; EYE SENSITIVITY TO LIGHT; HER PUPILS WERE REALLY SMALL; FEELING DIZZY; FEELING OUT OF IT/FELT SHE WAS HIGH ON DRUG; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy, hypothyroidism, and seasonal allergies, and other pre-existing medical conditions included patient was not breast feeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 21/JUN/2021) dose was not reported, administered on 06-APR-2021 19:25 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced blurry vision. On 06-APR-2021, the subject experienced eye sensitivity to light. On 06-APR-2021, the subject experienced her pupils were really small. On 06-APR-2021, the subject experienced feeling dizzy. On 06-APR-2021, the subject experienced feeling out of it/felt she was high on drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling dizzy, and feeling out of it/felt she was high on drug on 08-APR-2021, and was recovering from blurry vision, eye sensitivity to light, and her pupils were really small. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Euphoric mood, Miosis, Photophobia, Vision blurred
Clinical narrative: BLURRY VISION; EYE SENSITIVITY TO LIGHT; HER PUPILS WERE REALLY SMALL; FEELING DIZZY; FEELING OUT OF IT/FELT SHE WAS HIGH ON DRUG; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy, hypothyroidism, and seasonal allergies, and other pre-existing medical conditions included patient was not breast feeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 21/JUN/2021) dose was not reported, administered on 06-APR-2021 19:25 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced blurry vision. On 06-APR-2021, the subject experienced eye sensitivity to light. On 06-APR-2021, the subject experienced her pupils were really small. On 06-APR-2021, the subject experienced feeling dizzy. On 06-APR-2021, the subject experienced feeling out of it/felt she was high on drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling dizzy, and feeling out of it/felt she was high on drug on 08-APR-2021, and was recovering from blurry vision, eye sensitivity to light, and her pupils were really small. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.