chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Somnolence
Clinical narrative: After I administered the immunization to the patient I asked him to sit in the waiting area for 15 minutes.    About 4-5 minutes afterwards I saw he was approaching the consultation window, I thought he had a question.   He told me that he felt nauseous.  The next thing I new he was falling.  I ran out to grab him.  He never really lost consciousness but he was pretty out of it.   His mom walked up right after that and asked him why he got up, she said, " I told you to stay put"   She told me that he had told her that he felt dizzy so she got up to get him an OJ.    I asked her if this had ever happened before and and she said, no.   He wanted to keep closing his eyes.   He was profusely sweating and seemed very sleepy and said he was going to throw up.  We got him a garbage can to throw him, but he never threw up.  mom gave him a sip of OJ and he wanted to lay down.   I believed he hit his head when he fell but he says he didn't.    I asked him who the president was and what year it was and he was able to answer both questions.   I asked mom if he had eaten before the immunization and she stated that he hadn't eaten anything beforehand.   He wanted to lay down but he was in the corner of the counter so after he seemed stabilized his mom asked if he could sit in the chair.   It was very hot in the store so we got him to sit up in a chair and helped him  back to the immunization room where I put a fan on him and checked his blood pressure.   His blood pressure was very low.   After a couple minutes of having the fan on him and drinking some water now he said he felt better.    I checked his blood pressure again and asked mom if she wanted me to call emergency just to have him checked out.   She then asked me to call emergency since his BP was so low the first time and that was not normal for him.    we called emergency and the EMS team come.   They ended up taking him to the ER to have him checked out.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Got COVID on 5/13/2022. Positive antigen test. Taking Paxlovid.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot in abdomal/rib area.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Sudden hearing loss, Vertigo
Clinical narrative: Sudden hearing loss, vertigo.
Age: 67.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site pain, Paraesthesia, Sleep disorder
Clinical narrative: Patient reported waking up at 2am (~8 hours after vaccine) feeling a tingling sensation in her left toes, as if they had fallen asleep. This feeling spread to the right toes and has persisted throughout the day. Only other side effect noted was soreness at the injection site.
Age: 67.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient reported waking up at 2am (~8 hours after vaccine) feeling a tingling sensation in her left toes, as if they had fallen asleep. This feeling spread to the right toes and has persisted throughout the day. Only other side effect noted was soreness at the injection site.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Fall, Syncope
Clinical narrative: Patient was sitting down when he received the vaccination. After about 1 minute he stood up and we were talking. He fainted after he had been standing about 30 seconds. He was on the floor about 5 seconds when he woke up. At that time he was talking and knew who he was , where he was and the people around him.  Paramedics were call and when they arrive it had been about 6 minutes. He was sitting up . Paramedics check his blood pressure and blood sugar. Both were normal. Paramedics sat him in a chair then stood him up.  Patient did not want to  go to the ER. and left with grandmother and brother.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Eye discharge, Eye pain, Fatigue, Lymph node pain
Clinical narrative: Swollen lymph nodes in my left underarm for about two weeks, very painful. These symptoms subsided.  Metallic taste in my mouth for over a week. These symptoms have subsided.  Fatigue for two weeks. These symptoms have subsided.  Reddened, obvious veins all over my eyes eyes, sore eyes, pain in eyes, mucus in eyes. Very painful. Eyes get tired easily. These symptoms have improved but have not subsided entirely.  Tinnitus, started off very severe one night, in my right ear alone, now it's on and off daily in both ears, not as severe but still disturbing. These symptoms are still occurring intermittently on a daily basis.  No treatment, I don't have health insurance until July 1st, so I haven't been able to go to the doctor.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ocular hyperaemia, Tinnitus
Clinical narrative: Swollen lymph nodes in my left underarm for about two weeks, very painful. These symptoms subsided.  Metallic taste in my mouth for over a week. These symptoms have subsided.  Fatigue for two weeks. These symptoms have subsided.  Reddened, obvious veins all over my eyes eyes, sore eyes, pain in eyes, mucus in eyes. Very painful. Eyes get tired easily. These symptoms have improved but have not subsided entirely.  Tinnitus, started off very severe one night, in my right ear alone, now it's on and off daily in both ears, not as severe but still disturbing. These symptoms are still occurring intermittently on a daily basis.  No treatment, I don't have health insurance until July 1st, so I haven't been able to go to the doctor.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase normal, Bacterial test positive, C-reactive protein increased, Carbon dioxide normal, Differential white blood cell count normal
Clinical narrative: Papular rash (small itchy red spots) on all 4 extremities began 5/9 and continues today 5/18/22. Started on both thighs, spread down to the feet, then to both forearms, then to both upper arms. No rash on trunk or head. Treated with 1% hydrocortisone cream (no effect), Benadryl (no effect), Triamcinolone cream (no effect), aspiring (no effect). Cetirizine seems to be helping, though it may be just that enough time has gone by for the rash to begin subsiding.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Glomerular filtration rate normal, Laboratory test, Metabolic function test, Metabolic function test normal
Clinical narrative: Papular rash (small itchy red spots) on all 4 extremities began 5/9 and continues today 5/18/22. Started on both thighs, spread down to the feet, then to both forearms, then to both upper arms. No rash on trunk or head. Treated with 1% hydrocortisone cream (no effect), Benadryl (no effect), Triamcinolone cream (no effect), aspiring (no effect). Cetirizine seems to be helping, though it may be just that enough time has gone by for the rash to begin subsiding.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Occult blood, Rash erythematous, Rash papular, Rash pruritic, Red blood cell sedimentation rate normal
Clinical narrative: Papular rash (small itchy red spots) on all 4 extremities began 5/9 and continues today 5/18/22. Started on both thighs, spread down to the feet, then to both forearms, then to both upper arms. No rash on trunk or head. Treated with 1% hydrocortisone cream (no effect), Benadryl (no effect), Triamcinolone cream (no effect), aspiring (no effect). Cetirizine seems to be helping, though it may be just that enough time has gone by for the rash to begin subsiding.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary sediment present, Urine analysis abnormal, Urine leukocyte esterase positive, White blood cells urine positive
Clinical narrative: Papular rash (small itchy red spots) on all 4 extremities began 5/9 and continues today 5/18/22. Started on both thighs, spread down to the feet, then to both forearms, then to both upper arms. No rash on trunk or head. Treated with 1% hydrocortisone cream (no effect), Benadryl (no effect), Triamcinolone cream (no effect), aspiring (no effect). Cetirizine seems to be helping, though it may be just that enough time has gone by for the rash to begin subsiding.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Inflammation, Injection site pain
Clinical narrative: Headache, fatigue, inflammatory pain in hips, involuntary muscle contractions of legs, nausea and vomiting. Unable to keep down water for several hours. Pain to injection site.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary, Nausea, Vomiting
Clinical narrative: Headache, fatigue, inflammatory pain in hips, involuntary muscle contractions of legs, nausea and vomiting. Unable to keep down water for several hours. Pain to injection site.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Electrocardiogram normal, Hyperhidrosis, Hypertension, Muscle spasms
Clinical narrative: After getting the vaccine (booster #2) - an hour later the following happened.  Elevated blood pressure, sweating, leg swelling, leg cramps and heart palpitations.   My arm had a tingling sensation and so did my left side of my body.   The swelling on my legs was not intense but I feel it is not getting better.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Peripheral swelling
Clinical narrative: After getting the vaccine (booster #2) - an hour later the following happened.  Elevated blood pressure, sweating, leg swelling, leg cramps and heart palpitations.   My arm had a tingling sensation and so did my left side of my body.   The swelling on my legs was not intense but I feel it is not getting better.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, COVID-19, Deafness unilateral, Hypoacusis, Magnetic resonance imaging head normal
Clinical narrative: I received dose 1 pfeizer 12/21/20, dose 2 pfeizer 1/11/21 and months after several people in my life (family and coworkers) said they noticed I was hard of hearing. Joking with me that I was deaf. I told my PCP at my 40 year check up that I felt I was having trouble hearing people. She ordered a hearing test and with healthcare being so busy I didn?t get it done until this past March. I have permanent moderate to severe hearing loss in only  one ear, my right ear. I had an MRI which ruled out a brain tumor. I am getting fitted for a hearing aid in June. I have no comorbidities.  Also I was forced to get the covid booster this past February 2022 (month after having omicron) and now I have tinnitus 24/7 in the same right ear.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: I received dose 1 pfeizer 12/21/20, dose 2 pfeizer 1/11/21 and months after several people in my life (family and coworkers) said they noticed I was hard of hearing. Joking with me that I was deaf. I told my PCP at my 40 year check up that I felt I was having trouble hearing people. She ordered a hearing test and with healthcare being so busy I didn?t get it done until this past March. I have permanent moderate to severe hearing loss in only  one ear, my right ear. I had an MRI which ruled out a brain tumor. I am getting fitted for a hearing aid in June. I have no comorbidities.  Also I was forced to get the covid booster this past February 2022 (month after having omicron) and now I have tinnitus 24/7 in the same right ear.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness unilateral
Clinical narrative: I received dose 1 pfeizer 12/21/20, dose 2 pfeizer 1/11/21 and months after several people in my life (family and coworkers) said they noticed I was hard of hearing. Joking with me that I was deaf. I told my PCP at my 40 year check up that I felt I was having trouble hearing people. She ordered a hearing test and with healthcare being so busy I didn?t get it done until this past March. I have permanent moderate to severe hearing loss in only  one ear, my right ear. I had an MRI which ruled out a brain tumor. I am getting fitted for a hearing aid in June. I have no comorbidities.  Also I was forced to get the covid booster this past February 2022 (month after having omicron) and now I have tinnitus 24/7 in the same right ear.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Audiogram, COVID-19, Magnetic resonance imaging, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I received dose 1 pfeizer 12/21/20, dose 2 pfeizer 1/11/21 and months after several people in my life (family and coworkers) said they noticed I was hard of hearing. Joking with me that I was deaf. I told my PCP at my 40 year check up that I felt I was having trouble hearing people. She ordered a hearing test and with healthcare being so busy I didn?t get it done until this past March. I have permanent moderate to severe hearing loss in only  one ear, my right ear. I had an MRI which ruled out a brain tumor. I am getting fitted for a hearing aid in June. I have no comorbidities.  Also I was forced to get the covid booster this past February 2022 (month after having omicron) and now I have tinnitus 24/7 in the same right ear.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mild fever 99.7 within 24 hours of dose, lasted less than 24 hours
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Spoke with Doctor about issue & she felt there most likely would not be any adverse effects. (Grandma did not want to speak with doctor)
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Spoke with Dr. about Issue &she felt there most likely would not be any adverse effects (Grandma did not want to speak with doctor)
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Chest pain, Condition aggravated
Clinical narrative: Narrative:  74 yo M with PMH of asthma, received COVID-19 booster (3rd dose Pfizer) and within 4 hours had chest discomfort. Did not have any reaction to first two covid-19 vaccine doses. Evaluated by pulmonologist following 3rd dose, pulmonologist attributed chest pain to worsening asthma. Symptoms resolved within 1 month.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: Narrative:  Patient with historical report of nausea and vomiting from flu vaccine. No other information reported. Unknown time, date, vaccine, or locations of vaccination
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Generalized Hives (urticaria)
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Breast pain, Breast swelling, Dizziness, Gastrooesophageal reflux disease
Clinical narrative: Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 at 16:00 as dose 3 (booster), single (Lot number: Fj1611) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown"; COVID-19 (medically significant) with onset May2022, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: treatment stop date 13May2022. adverse event: I took paxlovid at 12:30pm was fine until 3:00pm where I got a sudden and severe dizzy spell. Got up to try and catch my breath and balance and ran to the bathroom, most severe diarrhoea Ive ever had. Then my stomach started cramping and I threw up multiple times violently. Laid down on the floor and continued to use the restroom until about 6:30 when I finally fell asleep after getting chills. Woke up at 7:00 feeling better but still severe stomach cramping and stomach noises. Cramps have yet to subside and its 8:19pm adverse event country: US. adverse event start date: 13May2022. adverse event start time: 03:00 PM.  if patient recovered: Recovering.Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Oedema peripheral, Pain, Pain in extremity, Urticaria
Clinical narrative: Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 at 16:00 as dose 3 (booster), single (Lot number: Fj1611) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown"; COVID-19 (medically significant) with onset May2022, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: treatment stop date 13May2022. adverse event: I took paxlovid at 12:30pm was fine until 3:00pm where I got a sudden and severe dizzy spell. Got up to try and catch my breath and balance and ran to the bathroom, most severe diarrhoea Ive ever had. Then my stomach started cramping and I threw up multiple times violently. Laid down on the floor and continued to use the restroom until about 6:30 when I finally fell asleep after getting chills. Woke up at 7:00 feeling better but still severe stomach cramping and stomach noises. Cramps have yet to subside and its 8:19pm adverse event country: US. adverse event start date: 13May2022. adverse event start time: 03:00 PM.  if patient recovered: Recovering.Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 at 16:00 as dose 3 (booster), single (Lot number: Fj1611) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown"; COVID-19 (medically significant) with onset May2022, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: treatment stop date 13May2022. adverse event: I took paxlovid at 12:30pm was fine until 3:00pm where I got a sudden and severe dizzy spell. Got up to try and catch my breath and balance and ran to the bathroom, most severe diarrhoea Ive ever had. Then my stomach started cramping and I threw up multiple times violently. Laid down on the floor and continued to use the restroom until about 6:30 when I finally fell asleep after getting chills. Woke up at 7:00 feeling better but still severe stomach cramping and stomach noises. Cramps have yet to subside and its 8:19pm adverse event country: US. adverse event start date: 13May2022. adverse event start time: 03:00 PM.  if patient recovered: Recovering.Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 at 16:00 as dose 3 (booster), single (Lot number: Fj1611) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown"; COVID-19 (medically significant) with onset May2022, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: treatment stop date 13May2022. adverse event: I took paxlovid at 12:30pm was fine until 3:00pm where I got a sudden and severe dizzy spell. Got up to try and catch my breath and balance and ran to the bathroom, most severe diarrhoea Ive ever had. Then my stomach started cramping and I threw up multiple times violently. Laid down on the floor and continued to use the restroom until about 6:30 when I finally fell asleep after getting chills. Woke up at 7:00 feeling better but still severe stomach cramping and stomach noises. Cramps have yet to subside and its 8:19pm adverse event country: US. adverse event start date: 13May2022. adverse event start time: 03:00 PM.  if patient recovered: Recovering.Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Acute kidney injury, Chills, Disseminated intravascular coagulation, Intensive care, Ischaemic hepatitis
Clinical narrative: 4/25/22 on date of vaccine patient had some chills, vomiting and not feeling well that evening.  Stayed home from work on 4/26/22 still not feeling well.  Around 1130 4/26/22 had sent a message to wife stating "HELP", once wife arrived at home, patient was responsive but had fallen and gotten up, stated he was weak and unable to walk. Torso, arms and face were turning purple per wife.  911 was called, responsive at start of transfer to local ER.  Upon arrival to ER, MD reported patient was unresponsive, was intubated and coded shortly thereafter but was brought back after one cycle of CPR.  Patient found to be septic, acute kidney failure and DIC.  FFP given as well as glucagon for glucose of 16.  Patient transferred around 8pm to Medical Center via helicopter.  Coded again at Medical Center, was brought back, also had to shock once for irregular heartbeat. Once at Medical Center, patient was started on continuous dialysis.  Patient passed away from these complications the morning of 4/27/22.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Multiple organ dysfunction syndrome, Myalgia, Pain, Pyrexia
Clinical narrative: 4/25/22 on date of vaccine patient had some chills, vomiting and not feeling well that evening.  Stayed home from work on 4/26/22 still not feeling well.  Around 1130 4/26/22 had sent a message to wife stating "HELP", once wife arrived at home, patient was responsive but had fallen and gotten up, stated he was weak and unable to walk. Torso, arms and face were turning purple per wife.  911 was called, responsive at start of transfer to local ER.  Upon arrival to ER, MD reported patient was unresponsive, was intubated and coded shortly thereafter but was brought back after one cycle of CPR.  Patient found to be septic, acute kidney failure and DIC.  FFP given as well as glucagon for glucose of 16.  Patient transferred around 8pm to Medical Center via helicopter.  Coded again at Medical Center, was brought back, also had to shock once for irregular heartbeat. Once at Medical Center, patient was started on continuous dialysis.  Patient passed away from these complications the morning of 4/27/22.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Acute kidney injury, Asthenia, Blood glucose decreased, Cardio-respiratory arrest, Cardioversion
Clinical narrative: 4/25/22 on date of vaccine patient had some chills, vomiting and not feeling well that evening.  Stayed home from work on 4/26/22 still not feeling well.  Around 1130 4/26/22 had sent a message to wife stating "HELP", once wife arrived at home, patient was responsive but had fallen and gotten up, stated he was weak and unable to walk. Torso, arms and face were turning purple per wife.  911 was called, responsive at start of transfer to local ER.  Upon arrival to ER, MD reported patient was unresponsive, was intubated and coded shortly thereafter but was brought back after one cycle of CPR.  Patient found to be septic, acute kidney failure and DIC.  FFP given as well as glucagon for glucose of 16.  Patient transferred around 8pm to Medical Center via helicopter.  Coded again at Medical Center, was brought back, also had to shock once for irregular heartbeat. Once at Medical Center, patient was started on continuous dialysis.  Patient passed away from these complications the morning of 4/27/22.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Computerised tomogram thorax, Death, Dialysis, Disseminated intravascular coagulation
Clinical narrative: 4/25/22 on date of vaccine patient had some chills, vomiting and not feeling well that evening.  Stayed home from work on 4/26/22 still not feeling well.  Around 1130 4/26/22 had sent a message to wife stating "HELP", once wife arrived at home, patient was responsive but had fallen and gotten up, stated he was weak and unable to walk. Torso, arms and face were turning purple per wife.  911 was called, responsive at start of transfer to local ER.  Upon arrival to ER, MD reported patient was unresponsive, was intubated and coded shortly thereafter but was brought back after one cycle of CPR.  Patient found to be septic, acute kidney failure and DIC.  FFP given as well as glucagon for glucose of 16.  Patient transferred around 8pm to Medical Center via helicopter.  Coded again at Medical Center, was brought back, also had to shock once for irregular heartbeat. Once at Medical Center, patient was started on continuous dialysis.  Patient passed away from these complications the morning of 4/27/22.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Endotracheal intubation, Fall, Gait inability, Heart rate irregular, Impaired work ability
Clinical narrative: 4/25/22 on date of vaccine patient had some chills, vomiting and not feeling well that evening.  Stayed home from work on 4/26/22 still not feeling well.  Around 1130 4/26/22 had sent a message to wife stating "HELP", once wife arrived at home, patient was responsive but had fallen and gotten up, stated he was weak and unable to walk. Torso, arms and face were turning purple per wife.  911 was called, responsive at start of transfer to local ER.  Upon arrival to ER, MD reported patient was unresponsive, was intubated and coded shortly thereafter but was brought back after one cycle of CPR.  Patient found to be septic, acute kidney failure and DIC.  FFP given as well as glucagon for glucose of 16.  Patient transferred around 8pm to Medical Center via helicopter.  Coded again at Medical Center, was brought back, also had to shock once for irregular heartbeat. Once at Medical Center, patient was started on continuous dialysis.  Patient passed away from these complications the morning of 4/27/22.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Lumbar puncture, Malaise, Renal impairment, Resuscitation
Clinical narrative: 4/25/22 on date of vaccine patient had some chills, vomiting and not feeling well that evening.  Stayed home from work on 4/26/22 still not feeling well.  Around 1130 4/26/22 had sent a message to wife stating "HELP", once wife arrived at home, patient was responsive but had fallen and gotten up, stated he was weak and unable to walk. Torso, arms and face were turning purple per wife.  911 was called, responsive at start of transfer to local ER.  Upon arrival to ER, MD reported patient was unresponsive, was intubated and coded shortly thereafter but was brought back after one cycle of CPR.  Patient found to be septic, acute kidney failure and DIC.  FFP given as well as glucagon for glucose of 16.  Patient transferred around 8pm to Medical Center via helicopter.  Coded again at Medical Center, was brought back, also had to shock once for irregular heartbeat. Once at Medical Center, patient was started on continuous dialysis.  Patient passed away from these complications the morning of 4/27/22.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: SARS-CoV-2 test, Sepsis, Skin discolouration, Transfusion, Ultrasound Doppler
Clinical narrative: 4/25/22 on date of vaccine patient had some chills, vomiting and not feeling well that evening.  Stayed home from work on 4/26/22 still not feeling well.  Around 1130 4/26/22 had sent a message to wife stating "HELP", once wife arrived at home, patient was responsive but had fallen and gotten up, stated he was weak and unable to walk. Torso, arms and face were turning purple per wife.  911 was called, responsive at start of transfer to local ER.  Upon arrival to ER, MD reported patient was unresponsive, was intubated and coded shortly thereafter but was brought back after one cycle of CPR.  Patient found to be septic, acute kidney failure and DIC.  FFP given as well as glucagon for glucose of 16.  Patient transferred around 8pm to Medical Center via helicopter.  Coded again at Medical Center, was brought back, also had to shock once for irregular heartbeat. Once at Medical Center, patient was started on continuous dialysis.  Patient passed away from these complications the morning of 4/27/22.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: 4/25/22 on date of vaccine patient had some chills, vomiting and not feeling well that evening.  Stayed home from work on 4/26/22 still not feeling well.  Around 1130 4/26/22 had sent a message to wife stating "HELP", once wife arrived at home, patient was responsive but had fallen and gotten up, stated he was weak and unable to walk. Torso, arms and face were turning purple per wife.  911 was called, responsive at start of transfer to local ER.  Upon arrival to ER, MD reported patient was unresponsive, was intubated and coded shortly thereafter but was brought back after one cycle of CPR.  Patient found to be septic, acute kidney failure and DIC.  FFP given as well as glucagon for glucose of 16.  Patient transferred around 8pm to Medical Center via helicopter.  Coded again at Medical Center, was brought back, also had to shock once for irregular heartbeat. Once at Medical Center, patient was started on continuous dialysis.  Patient passed away from these complications the morning of 4/27/22.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pneumonia; Asthma; Bronchitis; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing). Concomitant medication(s) included: ENALAPRIL MALEATE; AMLODIPINE BESYLATE; ESCITALOPRAM OXALATE; MONTELUKAST SODIUM; LEVOTHYROXINE SODIUM STAT RX; CALCIUM VITAMIN D; OMEGA 3 [FISH OIL].  The following information was reported: PNEUMONIA (medically significant), outcome "unknown"; ASTHMA (non-serious), outcome "unknown"; BRONCHITIS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Apr2022) positive; (26Apr2022) Negative.  Clinical course: The patient had taken Pfizer-BioNtech COVID-19 Vaccine on 09Feb2021, 06Mar2021 and 26sep2021 with lot numbers : EN6201, EN6198 and 30130BA respectively but not mentioned about doses. The patient was prescribed Paxlovid by my PMD after a positive Covid test. His primary symptoms were fever, cough, fatigue, headache. In addition to age (68) he had a history of asthma, pneumonia, bronchitis. I began Paxlovid the same day as positive Covid test and followed the severe gastric upset including diarrhea, muscle aches and a horrible metallic taste (constant) in my mouth. Patient began to feel better around day 7 or 8. However on day 11, the cough returned along with headache, fatigue, muscle aches. He made this report because he believed he experienced ''rebound'' after treatment and wanted this to be on record.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162B2  and the reported event pneumonia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Bronchitis, Pneumonia, SARS-CoV-2 test
Clinical narrative: Pneumonia; Asthma; Bronchitis; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing). Concomitant medication(s) included: ENALAPRIL MALEATE; AMLODIPINE BESYLATE; ESCITALOPRAM OXALATE; MONTELUKAST SODIUM; LEVOTHYROXINE SODIUM STAT RX; CALCIUM VITAMIN D; OMEGA 3 [FISH OIL].  The following information was reported: PNEUMONIA (medically significant), outcome "unknown"; ASTHMA (non-serious), outcome "unknown"; BRONCHITIS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Apr2022) positive; (26Apr2022) Negative.  Clinical course: The patient had taken Pfizer-BioNtech COVID-19 Vaccine on 09Feb2021, 06Mar2021 and 26sep2021 with lot numbers : EN6201, EN6198 and 30130BA respectively but not mentioned about doses. The patient was prescribed Paxlovid by my PMD after a positive Covid test. His primary symptoms were fever, cough, fatigue, headache. In addition to age (68) he had a history of asthma, pneumonia, bronchitis. I began Paxlovid the same day as positive Covid test and followed the severe gastric upset including diarrhea, muscle aches and a horrible metallic taste (constant) in my mouth. Patient began to feel better around day 7 or 8. However on day 11, the cough returned along with headache, fatigue, muscle aches. He made this report because he believed he experienced ''rebound'' after treatment and wanted this to be on record.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162B2  and the reported event pneumonia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 50 year old female. Initial information was processed along with the additional information on 16-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy, and other pre-existing medical conditions included: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: unknown) dose was not reported, 1 total, administered on 05-APR-2021 at 12:00 in right arm for prophylactic vaccination. Age at time of vaccination 49 years old. No concomitant medications were reported.  On an unspecified date in 2022, patient had confirmed clinical vaccination failure (dose number in series 1). The patient received additional non-company suspect vaccine included: Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, and route of admin were not reported, batch number: FG3527, expiry: unknown) dose was not reported, administered on 18-NOV-2021 at 13:00 in right arm for prophylactic vaccination. On 25-APR-2022, Laboratory data included: COVID-19 virus test (NR: not provided) positive. Patient received ritonavir (Paxlovid) for treatment of COVID-19 (coronavirus disease) from 25-APR-2022 to 29-APR-2022. On 08-MAY-2022 at 13:00, the patient got sick again and had rebound covid (coded to confirmed covid-19 infection) (dose number in series 2). On 09-MAY-2022, Laboratory data included: COVID-19 virus test (NR: not provided) Positive.  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000231244.; Sender's Comments: V0-20220530356-Covid-19 vaccine ad26.CoV-2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 50 year old female. Initial information was processed along with the additional information on 16-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy, and other pre-existing medical conditions included: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: unknown) dose was not reported, 1 total, administered on 05-APR-2021 at 12:00 in right arm for prophylactic vaccination. Age at time of vaccination 49 years old. No concomitant medications were reported.  On an unspecified date in 2022, patient had confirmed clinical vaccination failure (dose number in series 1). The patient received additional non-company suspect vaccine included: Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, and route of admin were not reported, batch number: FG3527, expiry: unknown) dose was not reported, administered on 18-NOV-2021 at 13:00 in right arm for prophylactic vaccination. On 25-APR-2022, Laboratory data included: COVID-19 virus test (NR: not provided) positive. Patient received ritonavir (Paxlovid) for treatment of COVID-19 (coronavirus disease) from 25-APR-2022 to 29-APR-2022. On 08-MAY-2022 at 13:00, the patient got sick again and had rebound covid (coded to confirmed covid-19 infection) (dose number in series 2). On 09-MAY-2022, Laboratory data included: COVID-19 virus test (NR: not provided) Positive.  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000231244.; Sender's Comments: V0-20220530356-Covid-19 vaccine ad26.CoV-2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest pain, Dizziness, Dyspnoea, Fluid retention
Clinical narrative: Approximately 1 week after receiving her second Pfizer Booster (4th dose) the patient developed chest pain. Booster was given on 3/10/22 and chest pain began ~ 3/17/22. On 3/30/22 she was admitted for progressive chest pain. On 4/5/22 she had an MRI showing evidence of myocarditis. She was given a clinical diagnosis of myopericarditis. She does have connective tissue disease which is an alternate risk for myocarditis, but the timing with regards to her Pfizer booster made us concerned for possible Vaccine adverse event.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Laboratory test, Myocarditis, Myopericarditis, Scan with contrast abnormal
Clinical narrative: Approximately 1 week after receiving her second Pfizer Booster (4th dose) the patient developed chest pain. Booster was given on 3/10/22 and chest pain began ~ 3/17/22. On 3/30/22 she was admitted for progressive chest pain. On 4/5/22 she had an MRI showing evidence of myocarditis. She was given a clinical diagnosis of myopericarditis. She does have connective tissue disease which is an alternate risk for myocarditis, but the timing with regards to her Pfizer booster made us concerned for possible Vaccine adverse event.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Magnetic resonance imaging abnormal, Magnetic resonance imaging heart, Myocarditis, Myopericarditis
Clinical narrative: Approximately 1 week after receiving her second Pfizer Booster (4th dose) the patient developed chest pain. Booster was given on 3/10/22 and chest pain began ~ 3/17/22. On 3/30/22 she was admitted for progressive chest pain. On 4/5/22 she had an MRI showing evidence of myocarditis. She was given a clinical diagnosis of myopericarditis. She does have connective tissue disease which is an alternate risk for myocarditis, but the timing with regards to her Pfizer booster made us concerned for possible Vaccine adverse event.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Feeding disorder, Hypersomnia, Nausea
Clinical narrative: stomach cramps around 6pm, then vomiting and cramping and aches all night, saturday vomitin, cramps and pains, nausea and fatigue and unable to eat saturday, slept all day saturday, up for a few hours then slept until sunday, felt some better nausea, unable to eat.  monday had slight nausea ate tiny bit, tuesday mild nausea and ate light foods, wednesday felt alot better byt fatigued
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: stomach cramps around 6pm, then vomiting and cramping and aches all night, saturday vomitin, cramps and pains, nausea and fatigue and unable to eat saturday, slept all day saturday, up for a few hours then slept until sunday, felt some better nausea, unable to eat.  monday had slight nausea ate tiny bit, tuesday mild nausea and ate light foods, wednesday felt alot better byt fatigued
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Fatigue, Urticaria
Clinical narrative: Hives on face, near eyes, chicks, necks. Chest, heart pain.  It got better but took a long time to recover. I had chest pain whenever I felt tired.  These symptoms last like couple weeks.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Cough, Dizziness, Dyspnoea
Clinical narrative: Dizzy, Tiredness, for 30 minutes and then it was hard to breath after 35~40 minutes. My heart beats were really fast.   It last about 15 minutes. I started to have fevers, muscle pain, and felt very cold.  On my 5th day, my throat was swollen, I felt dizzy, and felt like I am going to throw up. I had cough too.  It lasted over four days, starting from my 5th day after vaccination.  All these symptoms got better after 8 days.  Although these symptoms are gone, I still feel a bit of chest & heart pain whenever I feel tired.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Heart rate increased, Myalgia, Nausea
Clinical narrative: Dizzy, Tiredness, for 30 minutes and then it was hard to breath after 35~40 minutes. My heart beats were really fast.   It last about 15 minutes. I started to have fevers, muscle pain, and felt very cold.  On my 5th day, my throat was swollen, I felt dizzy, and felt like I am going to throw up. I had cough too.  It lasted over four days, starting from my 5th day after vaccination.  All these symptoms got better after 8 days.  Although these symptoms are gone, I still feel a bit of chest & heart pain whenever I feel tired.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pyrexia
Clinical narrative: Dizzy, Tiredness, for 30 minutes and then it was hard to breath after 35~40 minutes. My heart beats were really fast.   It last about 15 minutes. I started to have fevers, muscle pain, and felt very cold.  On my 5th day, my throat was swollen, I felt dizzy, and felt like I am going to throw up. I had cough too.  It lasted over four days, starting from my 5th day after vaccination.  All these symptoms got better after 8 days.  Although these symptoms are gone, I still feel a bit of chest & heart pain whenever I feel tired.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Full Movement of arm causes pain. Nausea after eating.