chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test, Confusional state, Dizziness, Electrocardiogram
Clinical narrative: Mental confusion, tingling in the fingers, racing pulse, rapid heartbeat, dizziness, nausea, dry vomiting, fainting, elevated blood pressure, muscular weakness.  Symptoms occurred within 15-20 min after receiving the vaccine The Treatment included person removed to a resting area and then transported to the nearest ER for observation and testing. Released home after a couple hours, rest, f/u with PCP.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Palpitations, Paraesthesia, Retching, Syncope
Clinical narrative: Mental confusion, tingling in the fingers, racing pulse, rapid heartbeat, dizziness, nausea, dry vomiting, fainting, elevated blood pressure, muscular weakness.  Symptoms occurred within 15-20 min after receiving the vaccine The Treatment included person removed to a resting area and then transported to the nearest ER for observation and testing. Released home after a couple hours, rest, f/u with PCP.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: Mental confusion, tingling in the fingers, racing pulse, rapid heartbeat, dizziness, nausea, dry vomiting, fainting, elevated blood pressure, muscular weakness.  Symptoms occurred within 15-20 min after receiving the vaccine The Treatment included person removed to a resting area and then transported to the nearest ER for observation and testing. Released home after a couple hours, rest, f/u with PCP.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram
Clinical narrative: Stroke which has left her with left side paralysis
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Hemiplegia, Laboratory test
Clinical narrative: Stroke which has left her with left side paralysis
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Eyelid function disorder, Facial paralysis
Clinical narrative: Developed right sided facial droop, speech slurred, numb and tingling on my tongue, nostril plugged (numb)feeling on right side of my face and cheekbone pain in the right side.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Facial pain, Facial paralysis, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Developed right sided facial droop, speech slurred, numb and tingling on my tongue, nostril plugged (numb)feeling on right side of my face and cheekbone pain in the right side.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Nasal congestion, Paraesthesia oral
Clinical narrative: Developed right sided facial droop, speech slurred, numb and tingling on my tongue, nostril plugged (numb)feeling on right side of my face and cheekbone pain in the right side.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: CSF protein increased, Guillain-Barre syndrome, Magnetic resonance imaging head, Magnetic resonance imaging spinal abnormal, Muscular weakness
Clinical narrative: Guillian Barre Syndrome- 2 weeks after receiving J&J COVID  PLEX, IVIG received  HHV-6 on CSF panel
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Plasmapheresis
Clinical narrative: Guillian Barre Syndrome- 2 weeks after receiving J&J COVID  PLEX, IVIG received  HHV-6 on CSF panel
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ataxia, Back pain, Blood culture, Culture stool, Differential white blood cell count
Clinical narrative: Guillian Barre Syndrome- 2 weeks after receiving J&J COVID  PLEX, IVIG received  HHV-6 on CSF panel
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Full blood count, Guillain-Barre syndrome, Hypoaesthesia, Magnetic resonance imaging head
Clinical narrative: Guillian Barre Syndrome- 2 weeks after receiving J&J COVID  PLEX, IVIG received  HHV-6 on CSF panel
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test, Movement disorder, Muscular weakness, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Guillian Barre Syndrome- 2 weeks after receiving J&J COVID  PLEX, IVIG received  HHV-6 on CSF panel
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Treponema test
Clinical narrative: Guillian Barre Syndrome- 2 weeks after receiving J&J COVID  PLEX, IVIG received  HHV-6 on CSF panel
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood sodium decreased, CSF cell count, Guillain-Barre syndrome, Human herpes virus 6 serology, Immunoglobulin therapy
Clinical narrative: Guillian Barre Syndrome- 2 weeks after receiving J&J COVID  PLEX, IVIG received  HHV-6 on CSF panel
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Anxiety, Chills, Computerised tomogram, Feeling abnormal
Clinical narrative: The patient first experienced brain fogginess on day of vaccination. Then, approximately March 1 developed hip pain and went to ER. Then, feelings of surging adrenaline through body began. This feeling was associated with extreme anxiety, which was unrelated to any events. Other symptoms include: fight or flight feeling, shaking, jittery, feeling abnormal, internal tremors, muscle spasms and twitching, Shortly after these symptoms occurred, patient had numb heels , which progressed up to knees and waist.( Hypoesthesia) Then, she had experienced head pressure and pain. She described as an exploding pressure in head. This was associated with numb and tingling in head and face. ( Parathesia) Blood pressure was elevated.  She also, had burning sensation in limbs and chest. Symptoms continue to change and evolve as months go by. Patient is still experiencing many of these symptoms. She describes her experience as impaired quality of life.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Fibrin D dimer increased, Hypertension, Hypoaesthesia, Illness
Clinical narrative: The patient first experienced brain fogginess on day of vaccination. Then, approximately March 1 developed hip pain and went to ER. Then, feelings of surging adrenaline through body began. This feeling was associated with extreme anxiety, which was unrelated to any events. Other symptoms include: fight or flight feeling, shaking, jittery, feeling abnormal, internal tremors, muscle spasms and twitching, Shortly after these symptoms occurred, patient had numb heels , which progressed up to knees and waist.( Hypoesthesia) Then, she had experienced head pressure and pain. She described as an exploding pressure in head. This was associated with numb and tingling in head and face. ( Parathesia) Blood pressure was elevated.  She also, had burning sensation in limbs and chest. Symptoms continue to change and evolve as months go by. Patient is still experiencing many of these symptoms. She describes her experience as impaired quality of life.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Magnetic resonance imaging, Neurological symptom, Palpitations, Paraesthesia
Clinical narrative: The patient first experienced brain fogginess on day of vaccination. Then, approximately March 1 developed hip pain and went to ER. Then, feelings of surging adrenaline through body began. This feeling was associated with extreme anxiety, which was unrelated to any events. Other symptoms include: fight or flight feeling, shaking, jittery, feeling abnormal, internal tremors, muscle spasms and twitching, Shortly after these symptoms occurred, patient had numb heels , which progressed up to knees and waist.( Hypoesthesia) Then, she had experienced head pressure and pain. She described as an exploding pressure in head. This was associated with numb and tingling in head and face. ( Parathesia) Blood pressure was elevated.  She also, had burning sensation in limbs and chest. Symptoms continue to change and evolve as months go by. Patient is still experiencing many of these symptoms. She describes her experience as impaired quality of life.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Thinking abnormal, Tremor
Clinical narrative: The patient first experienced brain fogginess on day of vaccination. Then, approximately March 1 developed hip pain and went to ER. Then, feelings of surging adrenaline through body began. This feeling was associated with extreme anxiety, which was unrelated to any events. Other symptoms include: fight or flight feeling, shaking, jittery, feeling abnormal, internal tremors, muscle spasms and twitching, Shortly after these symptoms occurred, patient had numb heels , which progressed up to knees and waist.( Hypoesthesia) Then, she had experienced head pressure and pain. She described as an exploding pressure in head. This was associated with numb and tingling in head and face. ( Parathesia) Blood pressure was elevated.  She also, had burning sensation in limbs and chest. Symptoms continue to change and evolve as months go by. Patient is still experiencing many of these symptoms. She describes her experience as impaired quality of life.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure increased, Blood test, Burning sensation, Chest X-ray
Clinical narrative: The patient first experienced brain fogginess on day of vaccination. Then, approximately March 1 developed hip pain and went to ER. Then, feelings of surging adrenaline through body began. This feeling was associated with extreme anxiety, which was unrelated to any events. Other symptoms include: fight or flight feeling, shaking, jittery, feeling abnormal, internal tremors, muscle spasms and twitching, Shortly after these symptoms occurred, patient had numb heels , which progressed up to knees and waist.( Hypoesthesia) Then, she had experienced head pressure and pain. She described as an exploding pressure in head. This was associated with numb and tingling in head and face. ( Parathesia) Blood pressure was elevated.  She also, had burning sensation in limbs and chest. Symptoms continue to change and evolve as months go by. Patient is still experiencing many of these symptoms. She describes her experience as impaired quality of life.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Echocardiogram, Electrocardiogram, Feeling abnormal, Feeling jittery
Clinical narrative: The patient first experienced brain fogginess on day of vaccination. Then, approximately March 1 developed hip pain and went to ER. Then, feelings of surging adrenaline through body began. This feeling was associated with extreme anxiety, which was unrelated to any events. Other symptoms include: fight or flight feeling, shaking, jittery, feeling abnormal, internal tremors, muscle spasms and twitching, Shortly after these symptoms occurred, patient had numb heels , which progressed up to knees and waist.( Hypoesthesia) Then, she had experienced head pressure and pain. She described as an exploding pressure in head. This was associated with numb and tingling in head and face. ( Parathesia) Blood pressure was elevated.  She also, had burning sensation in limbs and chest. Symptoms continue to change and evolve as months go by. Patient is still experiencing many of these symptoms. She describes her experience as impaired quality of life.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Hip arthroplasty, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: The patient first experienced brain fogginess on day of vaccination. Then, approximately March 1 developed hip pain and went to ER. Then, feelings of surging adrenaline through body began. This feeling was associated with extreme anxiety, which was unrelated to any events. Other symptoms include: fight or flight feeling, shaking, jittery, feeling abnormal, internal tremors, muscle spasms and twitching, Shortly after these symptoms occurred, patient had numb heels , which progressed up to knees and waist.( Hypoesthesia) Then, she had experienced head pressure and pain. She described as an exploding pressure in head. This was associated with numb and tingling in head and face. ( Parathesia) Blood pressure was elevated.  She also, had burning sensation in limbs and chest. Symptoms continue to change and evolve as months go by. Patient is still experiencing many of these symptoms. She describes her experience as impaired quality of life.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Muscle twitching, Nerve conduction studies, Paraesthesia, Tremor
Clinical narrative: The patient first experienced brain fogginess on day of vaccination. Then, approximately March 1 developed hip pain and went to ER. Then, feelings of surging adrenaline through body began. This feeling was associated with extreme anxiety, which was unrelated to any events. Other symptoms include: fight or flight feeling, shaking, jittery, feeling abnormal, internal tremors, muscle spasms and twitching, Shortly after these symptoms occurred, patient had numb heels , which progressed up to knees and waist.( Hypoesthesia) Then, she had experienced head pressure and pain. She described as an exploding pressure in head. This was associated with numb and tingling in head and face. ( Parathesia) Blood pressure was elevated.  She also, had burning sensation in limbs and chest. Symptoms continue to change and evolve as months go by. Patient is still experiencing many of these symptoms. She describes her experience as impaired quality of life.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: The patient first experienced brain fogginess on day of vaccination. Then, approximately March 1 developed hip pain and went to ER. Then, feelings of surging adrenaline through body began. This feeling was associated with extreme anxiety, which was unrelated to any events. Other symptoms include: fight or flight feeling, shaking, jittery, feeling abnormal, internal tremors, muscle spasms and twitching, Shortly after these symptoms occurred, patient had numb heels , which progressed up to knees and waist.( Hypoesthesia) Then, she had experienced head pressure and pain. She described as an exploding pressure in head. This was associated with numb and tingling in head and face. ( Parathesia) Blood pressure was elevated.  She also, had burning sensation in limbs and chest. Symptoms continue to change and evolve as months go by. Patient is still experiencing many of these symptoms. She describes her experience as impaired quality of life.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dizziness, Nervousness, Palpitations
Clinical narrative: Racing heart; Hot feeling through body; Burning sensation in lungs; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Jul2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to sulfa and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 07Jul2021, 10 minutes after dose 1, the patient experienced racing heart, hot feeling through body and burning sensation in lungs. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events racing heart, hot feeling through body and burning sensation in lungs was resolved on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Chest X-ray, Chest pain, Differential white blood cell count, Electrocardiogram
Clinical narrative: Racing heart; Hot feeling through body; Burning sensation in lungs; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Jul2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to sulfa and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 07Jul2021, 10 minutes after dose 1, the patient experienced racing heart, hot feeling through body and burning sensation in lungs. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events racing heart, hot feeling through body and burning sensation in lungs was resolved on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Metabolic function test, Palpitations, Troponin, Urine analysis
Clinical narrative: Racing heart; Hot feeling through body; Burning sensation in lungs; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Jul2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to sulfa and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 07Jul2021, 10 minutes after dose 1, the patient experienced racing heart, hot feeling through body and burning sensation in lungs. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events racing heart, hot feeling through body and burning sensation in lungs was resolved on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Feeling hot, Palpitations, SARS-CoV-2 test
Clinical narrative: Racing heart; Hot feeling through body; Burning sensation in lungs; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Jul2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to sulfa and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 07Jul2021, 10 minutes after dose 1, the patient experienced racing heart, hot feeling through body and burning sensation in lungs. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events racing heart, hot feeling through body and burning sensation in lungs was resolved on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray abnormal, Condition aggravated, Confusional state, Cough, Infusion
Clinical narrative: Patient presents to ED with COVID symptoms. Received Regeneron antibodies. Fully vaccinated March 2021.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lung consolidation
Clinical narrative: Patient presents to ED with COVID symptoms. Received Regeneron antibodies. Fully vaccinated March 2021.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient presents to ED with COVID symptoms. Received Regeneron antibodies. Fully vaccinated March 2021.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Computerised tomogram normal, Electric shock sensation, Electrocardiogram, Head discomfort
Clinical narrative: pressure in her head specifically above her right ear; This is a spontaneous report from regulatory Authority.. A contactable 42-year-old female consumer (patient) reported. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0175), dose 1 via an unspecified route of administration, administered in Arm Right on 16Jun2021 09:15-09:30 (at the age of 42-years-old) as a single dose for covid-19 immunization. Medical history included surgery -she was under anesthesia 7 weeks prior for surgery, neoplasm -Tumor removed from her left breast, it was benign. Concomitant medication(s) included ibuprofen (ADVIL [IBUPROFEN]); paracetamol (TYLENOL). AE(s) following prior vaccinations was fainting with the flu shot. She lays down for 20 minutes after the flu shot. On 16Jun2021, the patient experienced pressure in her head specifically above her right ear. Caller received second dose of the vaccine on 08Jul2021, afterwards the pressure got worse. She took Advil and Tylenol neither of which helped. She was under anesthesia 7 weeks prior for surgery. The pressure started both times within an hour of getting the vaccine. She made appointment with a neurologist. She does not have a primary care physician to provide. She said that she does see a gastric doctor and a Gynecologic doctor. She has upcoming appointment with a neurologist. She needs to know if it is something more that she needs to be seen sooner. Adverse event did not required patient to visit emergency room, physician office. Outcome of the event was not recovered. Description of product complaint: She reported that she is experiencing pressure in her head above her right ear after the first dose and it got worse after the second dose. She took Advil and Tylenol for the pressure, but it did not cure the pressure. Tylenol Not provided Lot SMA071 Exp: Aug2022, Advil: Caller does not have the product information to provide including the , Lot or expiry date. Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging normal, Muscle spasms, Syncope, White blood cell count increased
Clinical narrative: pressure in her head specifically above her right ear; This is a spontaneous report from regulatory Authority.. A contactable 42-year-old female consumer (patient) reported. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0175), dose 1 via an unspecified route of administration, administered in Arm Right on 16Jun2021 09:15-09:30 (at the age of 42-years-old) as a single dose for covid-19 immunization. Medical history included surgery -she was under anesthesia 7 weeks prior for surgery, neoplasm -Tumor removed from her left breast, it was benign. Concomitant medication(s) included ibuprofen (ADVIL [IBUPROFEN]); paracetamol (TYLENOL). AE(s) following prior vaccinations was fainting with the flu shot. She lays down for 20 minutes after the flu shot. On 16Jun2021, the patient experienced pressure in her head specifically above her right ear. Caller received second dose of the vaccine on 08Jul2021, afterwards the pressure got worse. She took Advil and Tylenol neither of which helped. She was under anesthesia 7 weeks prior for surgery. The pressure started both times within an hour of getting the vaccine. She made appointment with a neurologist. She does not have a primary care physician to provide. She said that she does see a gastric doctor and a Gynecologic doctor. She has upcoming appointment with a neurologist. She needs to know if it is something more that she needs to be seen sooner. Adverse event did not required patient to visit emergency room, physician office. Outcome of the event was not recovered. Description of product complaint: She reported that she is experiencing pressure in her head above her right ear after the first dose and it got worse after the second dose. She took Advil and Tylenol for the pressure, but it did not cure the pressure. Tylenol Not provided Lot SMA071 Exp: Aug2022, Advil: Caller does not have the product information to provide including the , Lot or expiry date. Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort
Clinical narrative: pressure in her head specifically above her right ear; This is a spontaneous report from regulatory Authority.. A contactable 42-year-old female consumer (patient) reported. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0175), dose 1 via an unspecified route of administration, administered in Arm Right on 16Jun2021 09:15-09:30 (at the age of 42-years-old) as a single dose for covid-19 immunization. Medical history included surgery -she was under anesthesia 7 weeks prior for surgery, neoplasm -Tumor removed from her left breast, it was benign. Concomitant medication(s) included ibuprofen (ADVIL [IBUPROFEN]); paracetamol (TYLENOL). AE(s) following prior vaccinations was fainting with the flu shot. She lays down for 20 minutes after the flu shot. On 16Jun2021, the patient experienced pressure in her head specifically above her right ear. Caller received second dose of the vaccine on 08Jul2021, afterwards the pressure got worse. She took Advil and Tylenol neither of which helped. She was under anesthesia 7 weeks prior for surgery. The pressure started both times within an hour of getting the vaccine. She made appointment with a neurologist. She does not have a primary care physician to provide. She said that she does see a gastric doctor and a Gynecologic doctor. She has upcoming appointment with a neurologist. She needs to know if it is something more that she needs to be seen sooner. Adverse event did not required patient to visit emergency room, physician office. Outcome of the event was not recovered. Description of product complaint: She reported that she is experiencing pressure in her head above her right ear after the first dose and it got worse after the second dose. She took Advil and Tylenol for the pressure, but it did not cure the pressure. Tylenol Not provided Lot SMA071 Exp: Aug2022, Advil: Caller does not have the product information to provide including the , Lot or expiry date. Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Chills, Cough
Clinical narrative: Breakthrough COVID Janssen, patient expired 9/18/2021
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Intensive care, Nausea, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Breakthrough COVID Janssen, patient expired 9/18/2021
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID Janssen, patient expired 9/18/2021
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Chest X-ray normal, Chest discomfort, Chest pain, Decreased appetite
Clinical narrative: PER PT on 7/19/21, her "throat feels strange when I adjust the angle of my neck and I feel like I have a narrower space to breathe and swallow. i have been crying and can't sleep, my heart keeps racing, it feels like prickly tingling in my hands and arms, I feel very anxious and that not normal for me".  7/19/21 pt states "I spoke with nurse She believes it?s anxiety. They checked my oxygen, pulse and throat. Aside from my heart rate being elevated everything looked good" 8/17/21- This nurse received call from Pt, pt crying c/o increased heart rate, "something feels wrong, I cant rest, very emotional, pressure in chest when HR races" 8/17/21 -This RN advised pt to present to UC or ED to have dx tests performed to r/o any cardiac or neuro dx and to f/u w/PCP , 8/17 5:08 PM- Pt states "I went to the ER:- EKG looks good- Cardiac enzyme looks good,  Chest X-Ray looks good,No worries about heart issues from an emergency standpoint. I?ll go to my doctors on Thursday so see if I need more testing and next steps". 8/19/21 pt states "I spoke with my primary this morning. Although, I don?t have any urgent concerns heart-wise, she does think it?s vaccine-side effects. She took some blood this morning to test for inflammatory markers and blood clotting signs.' [8/23 5:54 AM]      Hello! I got the test results back from my doctor and the C-reactive protein D-Dimer, and erythrocyte sedimentation rate, all came back within normal limits. She?s believes that I am having side effects, but to just wait it out to see if the symptoms subside.'
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dry throat, Dysphagia, Dyspnoea, Electrocardiogram normal, Heart rate increased
Clinical narrative: PER PT on 7/19/21, her "throat feels strange when I adjust the angle of my neck and I feel like I have a narrower space to breathe and swallow. i have been crying and can't sleep, my heart keeps racing, it feels like prickly tingling in my hands and arms, I feel very anxious and that not normal for me".  7/19/21 pt states "I spoke with nurse She believes it?s anxiety. They checked my oxygen, pulse and throat. Aside from my heart rate being elevated everything looked good" 8/17/21- This nurse received call from Pt, pt crying c/o increased heart rate, "something feels wrong, I cant rest, very emotional, pressure in chest when HR races" 8/17/21 -This RN advised pt to present to UC or ED to have dx tests performed to r/o any cardiac or neuro dx and to f/u w/PCP , 8/17 5:08 PM- Pt states "I went to the ER:- EKG looks good- Cardiac enzyme looks good,  Chest X-Ray looks good,No worries about heart issues from an emergency standpoint. I?ll go to my doctors on Thursday so see if I need more testing and next steps". 8/19/21 pt states "I spoke with my primary this morning. Although, I don?t have any urgent concerns heart-wise, she does think it?s vaccine-side effects. She took some blood this morning to test for inflammatory markers and blood clotting signs.' [8/23 5:54 AM]      Hello! I got the test results back from my doctor and the C-reactive protein D-Dimer, and erythrocyte sedimentation rate, all came back within normal limits. She?s believes that I am having side effects, but to just wait it out to see if the symptoms subside.'
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Influenza virus test negative, Insomnia, Lethargy, Palpitations, Red blood cell count increased
Clinical narrative: PER PT on 7/19/21, her "throat feels strange when I adjust the angle of my neck and I feel like I have a narrower space to breathe and swallow. i have been crying and can't sleep, my heart keeps racing, it feels like prickly tingling in my hands and arms, I feel very anxious and that not normal for me".  7/19/21 pt states "I spoke with nurse She believes it?s anxiety. They checked my oxygen, pulse and throat. Aside from my heart rate being elevated everything looked good" 8/17/21- This nurse received call from Pt, pt crying c/o increased heart rate, "something feels wrong, I cant rest, very emotional, pressure in chest when HR races" 8/17/21 -This RN advised pt to present to UC or ED to have dx tests performed to r/o any cardiac or neuro dx and to f/u w/PCP , 8/17 5:08 PM- Pt states "I went to the ER:- EKG looks good- Cardiac enzyme looks good,  Chest X-Ray looks good,No worries about heart issues from an emergency standpoint. I?ll go to my doctors on Thursday so see if I need more testing and next steps". 8/19/21 pt states "I spoke with my primary this morning. Although, I don?t have any urgent concerns heart-wise, she does think it?s vaccine-side effects. She took some blood this morning to test for inflammatory markers and blood clotting signs.' [8/23 5:54 AM]      Hello! I got the test results back from my doctor and the C-reactive protein D-Dimer, and erythrocyte sedimentation rate, all came back within normal limits. She?s believes that I am having side effects, but to just wait it out to see if the symptoms subside.'
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Throat tightness, Troponin normal
Clinical narrative: PER PT on 7/19/21, her "throat feels strange when I adjust the angle of my neck and I feel like I have a narrower space to breathe and swallow. i have been crying and can't sleep, my heart keeps racing, it feels like prickly tingling in my hands and arms, I feel very anxious and that not normal for me".  7/19/21 pt states "I spoke with nurse She believes it?s anxiety. They checked my oxygen, pulse and throat. Aside from my heart rate being elevated everything looked good" 8/17/21- This nurse received call from Pt, pt crying c/o increased heart rate, "something feels wrong, I cant rest, very emotional, pressure in chest when HR races" 8/17/21 -This RN advised pt to present to UC or ED to have dx tests performed to r/o any cardiac or neuro dx and to f/u w/PCP , 8/17 5:08 PM- Pt states "I went to the ER:- EKG looks good- Cardiac enzyme looks good,  Chest X-Ray looks good,No worries about heart issues from an emergency standpoint. I?ll go to my doctors on Thursday so see if I need more testing and next steps". 8/19/21 pt states "I spoke with my primary this morning. Although, I don?t have any urgent concerns heart-wise, she does think it?s vaccine-side effects. She took some blood this morning to test for inflammatory markers and blood clotting signs.' [8/23 5:54 AM]      Hello! I got the test results back from my doctor and the C-reactive protein D-Dimer, and erythrocyte sedimentation rate, all came back within normal limits. She?s believes that I am having side effects, but to just wait it out to see if the symptoms subside.'
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Cough, Decreased appetite, Electrocardiogram, Fibrin D dimer
Clinical narrative: PER PT on 7/19/21, her "throat feels strange when I adjust the angle of my neck and I feel like I have a narrower space to breathe and swallow. i have been crying and can't sleep, my heart keeps racing, it feels like prickly tingling in my hands and arms, I feel very anxious and that not normal for me".  7/19/21 pt states "I spoke with nurse She believes it?s anxiety. They checked my oxygen, pulse and throat. Aside from my heart rate being elevated everything looked good" 8/17/21- This nurse received call from Pt, pt crying c/o increased heart rate, "something feels wrong, I cant rest, very emotional, pressure in chest when HR races" 8/17/21 -This RN advised pt to present to UC or ED to have dx tests performed to r/o any cardiac or neuro dx and to f/u w/PCP , 8/17 5:08 PM- Pt states "I went to the ER:- EKG looks good- Cardiac enzyme looks good,  Chest X-Ray looks good,No worries about heart issues from an emergency standpoint. I?ll go to my doctors on Thursday so see if I need more testing and next steps". 8/19/21 pt states "I spoke with my primary this morning. Although, I don?t have any urgent concerns heart-wise, she does think it?s vaccine-side effects. She took some blood this morning to test for inflammatory markers and blood clotting signs.' [8/23 5:54 AM]      Hello! I got the test results back from my doctor and the C-reactive protein D-Dimer, and erythrocyte sedimentation rate, all came back within normal limits. She?s believes that I am having side effects, but to just wait it out to see if the symptoms subside.'
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Head discomfort, Headache, Immunisation anxiety related reaction, Influenza virus test
Clinical narrative: PER PT on 7/19/21, her "throat feels strange when I adjust the angle of my neck and I feel like I have a narrower space to breathe and swallow. i have been crying and can't sleep, my heart keeps racing, it feels like prickly tingling in my hands and arms, I feel very anxious and that not normal for me".  7/19/21 pt states "I spoke with nurse She believes it?s anxiety. They checked my oxygen, pulse and throat. Aside from my heart rate being elevated everything looked good" 8/17/21- This nurse received call from Pt, pt crying c/o increased heart rate, "something feels wrong, I cant rest, very emotional, pressure in chest when HR races" 8/17/21 -This RN advised pt to present to UC or ED to have dx tests performed to r/o any cardiac or neuro dx and to f/u w/PCP , 8/17 5:08 PM- Pt states "I went to the ER:- EKG looks good- Cardiac enzyme looks good,  Chest X-Ray looks good,No worries about heart issues from an emergency standpoint. I?ll go to my doctors on Thursday so see if I need more testing and next steps". 8/19/21 pt states "I spoke with my primary this morning. Although, I don?t have any urgent concerns heart-wise, she does think it?s vaccine-side effects. She took some blood this morning to test for inflammatory markers and blood clotting signs.' [8/23 5:54 AM]      Hello! I got the test results back from my doctor and the C-reactive protein D-Dimer, and erythrocyte sedimentation rate, all came back within normal limits. She?s believes that I am having side effects, but to just wait it out to see if the symptoms subside.'
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Sensory loss, Troponin, Vaccination complication
Clinical narrative: PER PT on 7/19/21, her "throat feels strange when I adjust the angle of my neck and I feel like I have a narrower space to breathe and swallow. i have been crying and can't sleep, my heart keeps racing, it feels like prickly tingling in my hands and arms, I feel very anxious and that not normal for me".  7/19/21 pt states "I spoke with nurse She believes it?s anxiety. They checked my oxygen, pulse and throat. Aside from my heart rate being elevated everything looked good" 8/17/21- This nurse received call from Pt, pt crying c/o increased heart rate, "something feels wrong, I cant rest, very emotional, pressure in chest when HR races" 8/17/21 -This RN advised pt to present to UC or ED to have dx tests performed to r/o any cardiac or neuro dx and to f/u w/PCP , 8/17 5:08 PM- Pt states "I went to the ER:- EKG looks good- Cardiac enzyme looks good,  Chest X-Ray looks good,No worries about heart issues from an emergency standpoint. I?ll go to my doctors on Thursday so see if I need more testing and next steps". 8/19/21 pt states "I spoke with my primary this morning. Although, I don?t have any urgent concerns heart-wise, she does think it?s vaccine-side effects. She took some blood this morning to test for inflammatory markers and blood clotting signs.' [8/23 5:54 AM]      Hello! I got the test results back from my doctor and the C-reactive protein D-Dimer, and erythrocyte sedimentation rate, all came back within normal limits. She?s believes that I am having side effects, but to just wait it out to see if the symptoms subside.'
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, C-reactive protein normal, Chest X-ray normal, Chest discomfort, Crying
Clinical narrative: PER PT on 7/19/21, her "throat feels strange when I adjust the angle of my neck and I feel like I have a narrower space to breathe and swallow. i have been crying and can't sleep, my heart keeps racing, it feels like prickly tingling in my hands and arms, I feel very anxious and that not normal for me".  7/19/21 pt states "I spoke with nurse She believes it?s anxiety. They checked my oxygen, pulse and throat. Aside from my heart rate being elevated everything looked good" 8/17/21- This nurse received call from Pt, pt crying c/o increased heart rate, "something feels wrong, I cant rest, very emotional, pressure in chest when HR races" 8/17/21 -This RN advised pt to present to UC or ED to have dx tests performed to r/o any cardiac or neuro dx and to f/u w/PCP , 8/17 5:08 PM- Pt states "I went to the ER:- EKG looks good- Cardiac enzyme looks good,  Chest X-Ray looks good,No worries about heart issues from an emergency standpoint. I?ll go to my doctors on Thursday so see if I need more testing and next steps". 8/19/21 pt states "I spoke with my primary this morning. Although, I don?t have any urgent concerns heart-wise, she does think it?s vaccine-side effects. She took some blood this morning to test for inflammatory markers and blood clotting signs.' [8/23 5:54 AM]      Hello! I got the test results back from my doctor and the C-reactive protein D-Dimer, and erythrocyte sedimentation rate, all came back within normal limits. She?s believes that I am having side effects, but to just wait it out to see if the symptoms subside.'
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram normal, Emotional distress, Fibrin D dimer normal, Myocardial necrosis marker normal, Oropharyngeal discomfort
Clinical narrative: PER PT on 7/19/21, her "throat feels strange when I adjust the angle of my neck and I feel like I have a narrower space to breathe and swallow. i have been crying and can't sleep, my heart keeps racing, it feels like prickly tingling in my hands and arms, I feel very anxious and that not normal for me".  7/19/21 pt states "I spoke with nurse She believes it?s anxiety. They checked my oxygen, pulse and throat. Aside from my heart rate being elevated everything looked good" 8/17/21- This nurse received call from Pt, pt crying c/o increased heart rate, "something feels wrong, I cant rest, very emotional, pressure in chest when HR races" 8/17/21 -This RN advised pt to present to UC or ED to have dx tests performed to r/o any cardiac or neuro dx and to f/u w/PCP , 8/17 5:08 PM- Pt states "I went to the ER:- EKG looks good- Cardiac enzyme looks good,  Chest X-Ray looks good,No worries about heart issues from an emergency standpoint. I?ll go to my doctors on Thursday so see if I need more testing and next steps". 8/19/21 pt states "I spoke with my primary this morning. Although, I don?t have any urgent concerns heart-wise, she does think it?s vaccine-side effects. She took some blood this morning to test for inflammatory markers and blood clotting signs.' [8/23 5:54 AM]      Hello! I got the test results back from my doctor and the C-reactive protein D-Dimer, and erythrocyte sedimentation rate, all came back within normal limits. She?s believes that I am having side effects, but to just wait it out to see if the symptoms subside.'
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Paraesthesia, Red blood cell sedimentation rate normal, Sleep disorder
Clinical narrative: PER PT on 7/19/21, her "throat feels strange when I adjust the angle of my neck and I feel like I have a narrower space to breathe and swallow. i have been crying and can't sleep, my heart keeps racing, it feels like prickly tingling in my hands and arms, I feel very anxious and that not normal for me".  7/19/21 pt states "I spoke with nurse She believes it?s anxiety. They checked my oxygen, pulse and throat. Aside from my heart rate being elevated everything looked good" 8/17/21- This nurse received call from Pt, pt crying c/o increased heart rate, "something feels wrong, I cant rest, very emotional, pressure in chest when HR races" 8/17/21 -This RN advised pt to present to UC or ED to have dx tests performed to r/o any cardiac or neuro dx and to f/u w/PCP , 8/17 5:08 PM- Pt states "I went to the ER:- EKG looks good- Cardiac enzyme looks good,  Chest X-Ray looks good,No worries about heart issues from an emergency standpoint. I?ll go to my doctors on Thursday so see if I need more testing and next steps". 8/19/21 pt states "I spoke with my primary this morning. Although, I don?t have any urgent concerns heart-wise, she does think it?s vaccine-side effects. She took some blood this morning to test for inflammatory markers and blood clotting signs.' [8/23 5:54 AM]      Hello! I got the test results back from my doctor and the C-reactive protein D-Dimer, and erythrocyte sedimentation rate, all came back within normal limits. She?s believes that I am having side effects, but to just wait it out to see if the symptoms subside.'