chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA Started with some headache 30 minutes after the vaccine and the following day in the afternoon the fever started (high 40/41C), nausea and intense body aches.   These symptoms lasted until Monday (2 full days).  Today is the 3rd day, and still with body aches a little nausea, very painful and warm arm but no fever. This was the first dose but the patient had Covid in March of 2020 ( at the time all the symptoms mentioned above were present with the addition of having lost taste and having some hallucinations.   No problem breathing.     Just letting you know for the purpose of statistics.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA Started with some headache 30 minutes after the vaccine and the following day in the afternoon the fever started (high 40/41C), nausea and intense body aches.   These symptoms lasted until Monday (2 full days).  Today is the 3rd day, and still with body aches a little nausea, very painful and warm arm but no fever. This was the first dose but the patient had Covid in March of 2020 ( at the time all the symptoms mentioned above were present with the addition of having lost taste and having some hallucinations.   No problem breathing.     Just letting you know for the purpose of statistics.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site pain, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: severe body ache  weakness the arm where vaccine is given was painful, itchy and is still swollen as big as my palm
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea, Pain
Clinical narrative: Fever; chills, body aches; shaking; sweating; nauseous; dizzy. Symptoms lasted over 24 hours.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever; chills, body aches; shaking; sweating; nauseous; dizzy. Symptoms lasted over 24 hours.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia oral, Vaccine positive rechallenge
Clinical narrative: Patient feels tingling in tongue and metallic taste; she reports she had the same side effects with her first dose and it went away after 12 hour. She was assessed and cleared with EMS.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: pt developed a DVT and is being treated with Eliquis for 3 months
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Covid Arm. Hard painful lump turning into a very large painful lump with itchy rash and now 2 weeks later it looks like a bull's eye with red outer itchy rash ring
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient called and stated that she had a DELAYED injection site reaction where the arm area was red and swollen and hard at the site of injection. The size of affected area was about 2" x 1.5" with no itching. The reaction didn't occur until 1 week after the injection.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, General physical health deterioration, Oxygen saturation decreased, SARS-CoV-2 test positive
Clinical narrative: Caller is nephew of patient. Patient was admitted to Hospital on 2/15/21 with Covid like symptoms and decreased O2 sat. He tested positive for Covid 2/15/21. Treated with Remdesivir. Patient status continued to decline and he passed away in hospital 2/22/21 0612.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Severe arm pain, nausea, vomiting, chills without fever, bone pain and headache.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe arm pain, nausea, vomiting, chills without fever, bone pain and headache.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Significant lip swelling, upper and lower lip.  Patient has lip filler.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Tiredness, extreme chills and shivering for 2 hours.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient inadvertently received Moderna vaccine as the second dose but first dose given at a different location was Pfizer. Patient does not report experiencing any sign or symptoms.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Swelling face
Clinical narrative: Moderate fatigue - unresolved mild headache - unresolved diarrhea - resolved 2/19/2021 joint pain - resolved 2/22/21 increased blood pressure - resolved 2/19/2021 swollen eye lids and upper checks - resolved 2/22/2021
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Moderate fatigue - unresolved mild headache - unresolved diarrhea - resolved 2/19/2021 joint pain - resolved 2/22/21 increased blood pressure - resolved 2/19/2021 swollen eye lids and upper checks - resolved 2/22/2021
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: Moderate fatigue - unresolved mild headache - unresolved diarrhea - resolved 2/19/2021 joint pain - resolved 2/22/21 increased blood pressure - resolved 2/19/2021 swollen eye lids and upper checks - resolved 2/22/2021
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: pt states that about a week after taking the covid vax that she became itchy and noticed a big red rash on her neck towards her shoulders and down to the breast.  She took an antihistamine that did not help so she took a Levocetirizine which helped some.  The red rash moved to both arms.  She woke up the next day and the rash was gone.  Once the medicine wore off that night the rash would come back.  She took more Levocetirizine which helps make the rash disappear.  Once the medicine wears off the rash comes back.  She had her virtual doctor appt today 3/2/2021.  Doctor thinks she is having a delayed reaction from the vaccination and to keep taking any medicine that seems to be helping her.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cold sweat, Decreased appetite, Fatigue
Clinical narrative: Fever of 101.3; severe headache; chills; body aches; fatigue. These symptoms lasted about 20 hours. The very first symptoms, about 4 hours after the vaccine was heavy thirst, neck ache, and loss of appetite. Besides the above symptoms, starting about 12 hours after vaccine, was severe nausea. Only able to drink water and some apple juice. Could not get out of bed the day after vaccine without getting chills, breaking out in cold sweat and nausea. This is now the second day since vaccine and I have no severe symptoms. I am only feeling weak.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Nausea, Neck pain, Pain
Clinical narrative: Fever of 101.3; severe headache; chills; body aches; fatigue. These symptoms lasted about 20 hours. The very first symptoms, about 4 hours after the vaccine was heavy thirst, neck ache, and loss of appetite. Besides the above symptoms, starting about 12 hours after vaccine, was severe nausea. Only able to drink water and some apple juice. Could not get out of bed the day after vaccine without getting chills, breaking out in cold sweat and nausea. This is now the second day since vaccine and I have no severe symptoms. I am only feeling weak.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Thirst
Clinical narrative: Fever of 101.3; severe headache; chills; body aches; fatigue. These symptoms lasted about 20 hours. The very first symptoms, about 4 hours after the vaccine was heavy thirst, neck ache, and loss of appetite. Besides the above symptoms, starting about 12 hours after vaccine, was severe nausea. Only able to drink water and some apple juice. Could not get out of bed the day after vaccine without getting chills, breaking out in cold sweat and nausea. This is now the second day since vaccine and I have no severe symptoms. I am only feeling weak.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Flatulence, Gastritis
Clinical narrative: Severe diarrhea for three days following shot beginning 12 hr post injection. (No consumed food suspected of causing this.)  Gastrointestinal tract noisy and gassy...gastritis. I eat healthy I.e. gentle, bland goods since starting diarrhea Sunday morning (currently Tuesday). Today I read the ingredients and two of them DO CAUSE digestive issues. Nit many reports of this symptom but maybe not enough people talk about it.  This is CRAZY diarrhea.  Other than this, my symptoms have been typical and mild.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Ear pain, Nausea, Pain, Pain in extremity
Clinical narrative: Information provided by patient as follows.  It does not appear patient was seen by a provider in the clinic or emergency room.  Besides normal side affects of fever, sore arm, nausea, diarrhea, I have been very itchy and had a rash on the back of both of my thighs as well as all around my belly and head. Also I have been experiencing small spurts of lock jaw and pain in my skull behind my ears.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Trismus
Clinical narrative: Information provided by patient as follows.  It does not appear patient was seen by a provider in the clinic or emergency room.  Besides normal side affects of fever, sore arm, nausea, diarrhea, I have been very itchy and had a rash on the back of both of my thighs as well as all around my belly and head. Also I have been experiencing small spurts of lock jaw and pain in my skull behind my ears.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Episodes of high blood pressure, treated with Amlodipine.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Feeling cold
Clinical narrative: 1st shot = only tender at injection site but remains tender. 2nd shot = 1 hr after injection: feelings of fatigue, soreness at injection site with swelling, slight throbbing in back of head/neck, later in PM ate late lunch Big Mac meal around 3:00 but not hungry though had no breakfast, aching in knee and hips began to become constant with movement.  Slept a couple of hours and began to feel chilled to bone rest of evening, headache continued, thirst and frequent urination (1 1l2 hr apart), had stopped all medication to allow shot to work.  Friday late evening early Saturday Am chill became violent in shakes used blankets/plastic sheets/socks to get warm.  Slept in 2 hrs increments all night.  Saturday sipped fluids
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site mass, Injection site pain, Injection site swelling, Pain
Clinical narrative: 1st shot = only tender at injection site but remains tender. 2nd shot = 1 hr after injection: feelings of fatigue, soreness at injection site with swelling, slight throbbing in back of head/neck, later in PM ate late lunch Big Mac meal around 3:00 but not hungry though had no breakfast, aching in knee and hips began to become constant with movement.  Slept a couple of hours and began to feel chilled to bone rest of evening, headache continued, thirst and frequent urination (1 1l2 hr apart), had stopped all medication to allow shot to work.  Friday late evening early Saturday Am chill became violent in shakes used blankets/plastic sheets/socks to get warm.  Slept in 2 hrs increments all night.  Saturday sipped fluids
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pollakiuria, Sleep disorder
Clinical narrative: 1st shot = only tender at injection site but remains tender. 2nd shot = 1 hr after injection: feelings of fatigue, soreness at injection site with swelling, slight throbbing in back of head/neck, later in PM ate late lunch Big Mac meal around 3:00 but not hungry though had no breakfast, aching in knee and hips began to become constant with movement.  Slept a couple of hours and began to feel chilled to bone rest of evening, headache continued, thirst and frequent urination (1 1l2 hr apart), had stopped all medication to allow shot to work.  Friday late evening early Saturday Am chill became violent in shakes used blankets/plastic sheets/socks to get warm.  Slept in 2 hrs increments all night.  Saturday sipped fluids
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: Generalized body rash involving areas from neck to knees. Red raised areas with itching. Still present on day 2. Went to ER in early evening on March 1, 2021. RX given for Pepcid and Kenalog. Dx: Allergic reaction to Covid-19 vaccine.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Cardiac stress test normal, Echocardiogram normal
Clinical narrative: within 2 min of sitting for observation period, pt reports heart was "fluttering".  Lasted about 2 min.  Notified staff.  BP was taken.  150/90.  Fluttering had already resolved at that time. FYI-pt states she completed her Z-pack on 1/26/21-sinus infection. PCP aware of above; recommends 2nd dose be given  in hospital setting.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Pain, Pruritus, Swelling
Clinical narrative: Red rash below site, swelling, itching in various places, 5 days later still itches, stings
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: My arm started hurting about 2 hours after my shot and that lasted from Saturday evening and had subsided by Tuesday.  Then, the following Saturday, (7 days after  the shot) my arm started to hurt again.  It's now Tuesday and it still hurts and feels stiff.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Erythema, Skin warm
Clinical narrative: A little lump developed on the front side of the arm on Monday, today hot and red but almost flat. Silver dollar size.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Pruritus
Clinical narrative: Large red oval rash at injection site, approx. 2 inches by 3 inches.   Started 5 or 6 days after injection.  Accompanied by intense itching which started at the same time.  Injection site was also hot and sore to the touch.  Now at day 11 after injection, arm is still red but only mildly itching.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Severe shooting pain in my shoulder that evening into the next day, body aches day after shot
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills, low-grade fever, slight headache (2nd shot only, no symptoms after the first shot in December)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Muscular weakness
Clinical narrative: Fever, chills, body aches, fatigue, muscle weakness, and injection site pain, redness and tenderness.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, fatigue, muscle weakness, and injection site pain, redness and tenderness.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Anion gap increased, Aspartate aminotransferase increased, Blood albumin decreased, Blood alkaline phosphatase normal
Clinical narrative: Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom.  Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course:   Examination.   Epinephrine 1 mg IO x4 CBC, CMP, cardiac panel MDM:   1447 patient arrival, per EMS report patient had been sick and vomiting all morning.  Bradycardia noted at arrival with rates in the 30s, CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device, 1 mg epinephrine given IV push 1451 CPR pause rhythm check.  CPR resumes 1453 CPR paused for rhythm check.  No central pulses, CPR resumed, glucose of 99 per fingerstick 1454 King tube removed.  Oral airway placed respirations by BVM.  1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check.  No central pulses noted.  CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via Lucas.  1 mg epinephrine IV push 1459 warm blankets applied.  CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed 1501 CPR pause for pulse and rhythm check.  No central pulses.  CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via the Lucas device 1506 resuscitation is ceased at this time.  Time of death recorded at 1506
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin increased, Blood calcium increased, Blood chloride normal, Blood creatine phosphokinase MB, Blood creatine phosphokinase MB decreased
Clinical narrative: Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom.  Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course:   Examination.   Epinephrine 1 mg IO x4 CBC, CMP, cardiac panel MDM:   1447 patient arrival, per EMS report patient had been sick and vomiting all morning.  Bradycardia noted at arrival with rates in the 30s, CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device, 1 mg epinephrine given IV push 1451 CPR pause rhythm check.  CPR resumes 1453 CPR paused for rhythm check.  No central pulses, CPR resumed, glucose of 99 per fingerstick 1454 King tube removed.  Oral airway placed respirations by BVM.  1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check.  No central pulses noted.  CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via Lucas.  1 mg epinephrine IV push 1459 warm blankets applied.  CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed 1501 CPR pause for pulse and rhythm check.  No central pulses.  CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via the Lucas device 1506 resuscitation is ceased at this time.  Time of death recorded at 1506
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase increased, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea increased
Clinical narrative: Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom.  Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course:   Examination.   Epinephrine 1 mg IO x4 CBC, CMP, cardiac panel MDM:   1447 patient arrival, per EMS report patient had been sick and vomiting all morning.  Bradycardia noted at arrival with rates in the 30s, CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device, 1 mg epinephrine given IV push 1451 CPR pause rhythm check.  CPR resumes 1453 CPR paused for rhythm check.  No central pulses, CPR resumed, glucose of 99 per fingerstick 1454 King tube removed.  Oral airway placed respirations by BVM.  1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check.  No central pulses noted.  CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via Lucas.  1 mg epinephrine IV push 1459 warm blankets applied.  CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed 1501 CPR pause for pulse and rhythm check.  No central pulses.  CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via the Lucas device 1506 resuscitation is ceased at this time.  Time of death recorded at 1506
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Carbon dioxide decreased, Death, Epinephrine, Full blood count
Clinical narrative: Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom.  Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course:   Examination.   Epinephrine 1 mg IO x4 CBC, CMP, cardiac panel MDM:   1447 patient arrival, per EMS report patient had been sick and vomiting all morning.  Bradycardia noted at arrival with rates in the 30s, CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device, 1 mg epinephrine given IV push 1451 CPR pause rhythm check.  CPR resumes 1453 CPR paused for rhythm check.  No central pulses, CPR resumed, glucose of 99 per fingerstick 1454 King tube removed.  Oral airway placed respirations by BVM.  1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check.  No central pulses noted.  CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via Lucas.  1 mg epinephrine IV push 1459 warm blankets applied.  CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed 1501 CPR pause for pulse and rhythm check.  No central pulses.  CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via the Lucas device 1506 resuscitation is ceased at this time.  Time of death recorded at 1506
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Globulins increased, Glomerular filtration rate decreased, Laboratory test, Malaise, Metabolic function test
Clinical narrative: Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom.  Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course:   Examination.   Epinephrine 1 mg IO x4 CBC, CMP, cardiac panel MDM:   1447 patient arrival, per EMS report patient had been sick and vomiting all morning.  Bradycardia noted at arrival with rates in the 30s, CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device, 1 mg epinephrine given IV push 1451 CPR pause rhythm check.  CPR resumes 1453 CPR paused for rhythm check.  No central pulses, CPR resumed, glucose of 99 per fingerstick 1454 King tube removed.  Oral airway placed respirations by BVM.  1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check.  No central pulses noted.  CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via Lucas.  1 mg epinephrine IV push 1459 warm blankets applied.  CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed 1501 CPR pause for pulse and rhythm check.  No central pulses.  CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via the Lucas device 1506 resuscitation is ceased at this time.  Time of death recorded at 1506
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Mydriasis, Myocardial necrosis marker, Myoglobin blood increased, Protein total normal, Pulse absent
Clinical narrative: Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom.  Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course:   Examination.   Epinephrine 1 mg IO x4 CBC, CMP, cardiac panel MDM:   1447 patient arrival, per EMS report patient had been sick and vomiting all morning.  Bradycardia noted at arrival with rates in the 30s, CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device, 1 mg epinephrine given IV push 1451 CPR pause rhythm check.  CPR resumes 1453 CPR paused for rhythm check.  No central pulses, CPR resumed, glucose of 99 per fingerstick 1454 King tube removed.  Oral airway placed respirations by BVM.  1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check.  No central pulses noted.  CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via Lucas.  1 mg epinephrine IV push 1459 warm blankets applied.  CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed 1501 CPR pause for pulse and rhythm check.  No central pulses.  CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via the Lucas device 1506 resuscitation is ceased at this time.  Time of death recorded at 1506
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pupil fixed, Resuscitation, Syncope, Troponin I increased, Unresponsive to stimuli
Clinical narrative: Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom.  Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course:   Examination.   Epinephrine 1 mg IO x4 CBC, CMP, cardiac panel MDM:   1447 patient arrival, per EMS report patient had been sick and vomiting all morning.  Bradycardia noted at arrival with rates in the 30s, CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device, 1 mg epinephrine given IV push 1451 CPR pause rhythm check.  CPR resumes 1453 CPR paused for rhythm check.  No central pulses, CPR resumed, glucose of 99 per fingerstick 1454 King tube removed.  Oral airway placed respirations by BVM.  1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check.  No central pulses noted.  CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via Lucas.  1 mg epinephrine IV push 1459 warm blankets applied.  CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed 1501 CPR pause for pulse and rhythm check.  No central pulses.  CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via the Lucas device 1506 resuscitation is ceased at this time.  Time of death recorded at 1506
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom.  Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course:   Examination.   Epinephrine 1 mg IO x4 CBC, CMP, cardiac panel MDM:   1447 patient arrival, per EMS report patient had been sick and vomiting all morning.  Bradycardia noted at arrival with rates in the 30s, CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device, 1 mg epinephrine given IV push 1451 CPR pause rhythm check.  CPR resumes 1453 CPR paused for rhythm check.  No central pulses, CPR resumed, glucose of 99 per fingerstick 1454 King tube removed.  Oral airway placed respirations by BVM.  1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check.  No central pulses noted.  CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via Lucas.  1 mg epinephrine IV push 1459 warm blankets applied.  CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed 1501 CPR pause for pulse and rhythm check.  No central pulses.  CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via the Lucas device 1506 resuscitation is ceased at this time.  Time of death recorded at 1506
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Injection site swelling, Myalgia, Paraesthesia
Clinical narrative: Within 10 minutes of injection, felt tingling in left arm from just above the elbow to the tips of my fingers. Sensation last for several hours and has recurred, multiple times a day, ever since. Nothing makes it feel better or abate, and nothing makes it worse. This is a symptom I experienced while sick with Covid-19, but it had abated ~10 days before vaccination. I also experienced soreness and swelling at the site of the injection, chills, and muscle aches, but these all abated within 72 hours.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Photophobia
Clinical narrative: About one hour post inoculation my speech became jibberish. Cognitively, I could organize my thoughts and knew exactly what I wanted to express to my husband and our waitress, but when I opened my mouth to speak, only jibberish came out.  I couldn't say anything meaningful.  It lasted about 2+ hours and hasn't reoccured.   That night when I went to bed I was extrememly light sensitive.  We had the usual degree of light in our bedroom but with my eyes closed it felt like all the overhead lights in the room were on.  I had to block out the alarm clock, but that was the only adjustment that could be made.  Drapes were closed and no other lights of any kind were on.  That was bothersome for the first couple of nights. I'm still having a difficult time falling asleep when I go to bed and staying asleep all night.  My "fight or flight" response is highly charged.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Oral pain, Swollen tongue
Clinical narrative: The roof of his mouth became sore and raw and  his tongue swelled.   He had to resort to a liquid diet for a few days, and  today he states that he still has some minor  mouth soreness
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Random hard chest pains that spontaneously happens throughout the day. Has been going on everyday since I was given the shot.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Rash
Clinical narrative: lip swelling,  rash
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Headache, nausea, dizzy
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, fatigue
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Pain
Clinical narrative: Is anyone tracking reactions to the second dose? Of the 33% who experience a reaction, I didn?t expect to be that miserable. Vaccination site had an odd shaped reddishness. At one point I had on 4 layers of clothing and still shivered so put on my winter coat and tucked a heating pad inside. Temperature was a little above 100 accompanied by aching which all lasted 24 hours.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Nausea, Pyrexia, Syncope
Clinical narrative: Fever 100 - 101.5 24+ hours Chills 3.5 hours at noon 2-28, dizziness, nausea 2-3 hours one episode syncope with fall, no injury extreme lassitude 24 hours
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Dizziness, Fall, Fatigue, Inappropriate schedule of product administration
Clinical narrative: Fever 100 - 101.5 24+ hours Chills 3.5 hours at noon 2-28, dizziness, nausea 2-3 hours one episode syncope with fall, no injury extreme lassitude 24 hours
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Off label use, Pyrexia, Syncope
Clinical narrative: Fever 100 - 101.5 24+ hours Chills 3.5 hours at noon 2-28, dizziness, nausea 2-3 hours one episode syncope with fall, no injury extreme lassitude 24 hours
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Bulbar palsy, Cognitive disorder, Coordination abnormal, Death
Clinical narrative: [COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): He presented 10 days after first COVID-19 Vaccine with Progressive neurological deficits with bulbar manifestations - dysarthria, dysphagia and bilateral arm weakness and incoordiantion, worse on right. MRI brain was negative for acute stroke and MRI cervical, showed degenerative changes. Transferred from community hospital to tertiary center where the diagnosis was made of AIDP. He was intubated at that time in Neuro ICU. Given Steroids and IVIG but no improvement and was either will need to have Trach and PEG vs CMP and family honored the patient's wishes and made him CMO. signs of severe demyelination and AIDP was diagnosed.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Demyelination, Dysarthria, Dysphagia, Electromyogram abnormal, Endotracheal intubation
Clinical narrative: [COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): He presented 10 days after first COVID-19 Vaccine with Progressive neurological deficits with bulbar manifestations - dysarthria, dysphagia and bilateral arm weakness and incoordiantion, worse on right. MRI brain was negative for acute stroke and MRI cervical, showed degenerative changes. Transferred from community hospital to tertiary center where the diagnosis was made of AIDP. He was intubated at that time in Neuro ICU. Given Steroids and IVIG but no improvement and was either will need to have Trach and PEG vs CMP and family honored the patient's wishes and made him CMO. signs of severe demyelination and AIDP was diagnosed.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care, Magnetic resonance imaging brain normal, Magnetic resonance imaging neck
Clinical narrative: [COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): He presented 10 days after first COVID-19 Vaccine with Progressive neurological deficits with bulbar manifestations - dysarthria, dysphagia and bilateral arm weakness and incoordiantion, worse on right. MRI brain was negative for acute stroke and MRI cervical, showed degenerative changes. Transferred from community hospital to tertiary center where the diagnosis was made of AIDP. He was intubated at that time in Neuro ICU. Given Steroids and IVIG but no improvement and was either will need to have Trach and PEG vs CMP and family honored the patient's wishes and made him CMO. signs of severe demyelination and AIDP was diagnosed.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Nervous system disorder, Progressive bulbar palsy, Spinal osteoarthritis
Clinical narrative: [COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): He presented 10 days after first COVID-19 Vaccine with Progressive neurological deficits with bulbar manifestations - dysarthria, dysphagia and bilateral arm weakness and incoordiantion, worse on right. MRI brain was negative for acute stroke and MRI cervical, showed degenerative changes. Transferred from community hospital to tertiary center where the diagnosis was made of AIDP. He was intubated at that time in Neuro ICU. Given Steroids and IVIG but no improvement and was either will need to have Trach and PEG vs CMP and family honored the patient's wishes and made him CMO. signs of severe demyelination and AIDP was diagnosed.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: developed painful outbreak of shingles; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about November 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequent to the zoster vaccine live (ZOSTAVAX) vaccine being administered (date not reported), the patient developed a painful outbreak of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of painful outbreak of shingles was considered not recovered. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event; an additional dose of VARlVAX/ administered an "extra" dose of VARlVAX on 15 FEB 2021.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 15-FEB-2021, the patient was vaccinated with an extra dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002848 with expiration date on 23-JAN-2022 (exact dose, route of administration were unknown) for prophylaxis. No adverse events was reported.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no adverse events reported; a pediatric patient received an adult dose of VAQTA; This spontaneous report was received from a registered nurse and refers to a 18-month-old female patient. She had no known drug allergies, pertinent medical history. The patient has not been using any medications nor vaccinations concomitantly.  On 23-FEB-2021, the patient was vaccinated with an adult dose of hepatitis A vaccine, inactivated (VAQTA) 1 ml (instead of 0.5 ml), intramuscularly, in the left thigh, lot # reported as G99R4, expiration date 20-MAY-2022 for prophylaxis. No adverse events were reported.  Lot number G99R4 is an invalid lot number for hepatitis A vaccine, inactivated (VAQTA). Lot number G99R4 does not match any Company product as confirmed by Lot Verification team.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: joint pain; muscle and joint pain; pain; This case was reported by a consumer and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced joint pain, muscle pain and pain. On an unknown date, the outcome of the joint pain, muscle pain and pain were unknown.   It was unknown if the reporter considered the joint pain, muscle pain and pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vacccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The reporter asked if could symptoms of Shingrix vaccine show up 3 weeks after injection and could there be pain, muscle and joint pain associated with vaccine. The reporter asked if shingrix made from same MRNA as Covid vaccine. The follow-up would not possible as no contact details were provided.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Flu shots and had very sore arm. No other information was available. The information regarding consent to follow up was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased, Blood pressure increased, Cold sweat, Feeling cold, Hyperhidrosis
Clinical narrative: was cold and clammy; Clammy; diaphoretic; having to clear his throat; blood sugar was 245; blood pressure was 175/111; runny nose; delayed allergic response; This case was reported by a nurse via other manufacturer and described the occurrence of cold in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included partial gastrectomy and stroke. Previously administered products included Flu vaccine with an associated reaction of no adverse event (kind of vaccine with no reaction) and Hepatits vaccine with an associated reaction of no adverse event (kind of vaccine with no reaction). Concurrent medical conditions included dementia, diabetes (since from 2005) and allergy nos.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced cold, clamminess, diaphoresis, throat clearing, blood sugar increased, increased blood pressure, runny nose and allergic reaction. On an unknown date, the outcome of the cold, clamminess, diaphoresis, throat clearing, blood sugar increased, increased blood pressure and allergic reaction were recovered/resolved and the outcome of the runny nose was unknown.   It was unknown if the reporter considered the cold, clamminess, diaphoresis, throat clearing, blood sugar increased, increased blood pressure, runny nose and allergic reaction to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient's spouse. The age at vaccination was not reported but it could be 71 or 72 years old. The patient was allergic to various things and would had to clear patient's throat. The patient has not had the reaction in the past to the vaccines received and he had every kind of vaccine with no reaction. The patient did not have the reaction to the Flu or Hepatitis vaccines. The patient received 1st dose of Shingrix vaccine that summer and had clod, clammy, diaphoretic, he was having to clear his throat. The patient dose had the little dementia and was diabetic and his blood sugar was 245, his blood pressure was 175/111 and he had a runny nose. The patient did not have any chest pain. The patient was unable to explain what was happening. The patient's spouse checked his blood pressure again manually and the results were the same. The patient went to the hospital and they monitored the patient and they said that was not because of the vaccine. The patient did not have NDC, lot or expiry to provide. The reporter tried to saw if there were components that match up but she did not see any components that were the same. The reporter consented to follow up. For further tolerance of 2nd dose, refer case US2021AMR032634, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR032634:Same patient, same reporter, same product, different dose (2nd dose)
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rhinorrhoea, Throat clearing
Clinical narrative: was cold and clammy; Clammy; diaphoretic; having to clear his throat; blood sugar was 245; blood pressure was 175/111; runny nose; delayed allergic response; This case was reported by a nurse via other manufacturer and described the occurrence of cold in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included partial gastrectomy and stroke. Previously administered products included Flu vaccine with an associated reaction of no adverse event (kind of vaccine with no reaction) and Hepatits vaccine with an associated reaction of no adverse event (kind of vaccine with no reaction). Concurrent medical conditions included dementia, diabetes (since from 2005) and allergy nos.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced cold, clamminess, diaphoresis, throat clearing, blood sugar increased, increased blood pressure, runny nose and allergic reaction. On an unknown date, the outcome of the cold, clamminess, diaphoresis, throat clearing, blood sugar increased, increased blood pressure and allergic reaction were recovered/resolved and the outcome of the runny nose was unknown.   It was unknown if the reporter considered the cold, clamminess, diaphoresis, throat clearing, blood sugar increased, increased blood pressure, runny nose and allergic reaction to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient's spouse. The age at vaccination was not reported but it could be 71 or 72 years old. The patient was allergic to various things and would had to clear patient's throat. The patient has not had the reaction in the past to the vaccines received and he had every kind of vaccine with no reaction. The patient did not have the reaction to the Flu or Hepatitis vaccines. The patient received 1st dose of Shingrix vaccine that summer and had clod, clammy, diaphoretic, he was having to clear his throat. The patient dose had the little dementia and was diabetic and his blood sugar was 245, his blood pressure was 175/111 and he had a runny nose. The patient did not have any chest pain. The patient was unable to explain what was happening. The patient's spouse checked his blood pressure again manually and the results were the same. The patient went to the hospital and they monitored the patient and they said that was not because of the vaccine. The patient did not have NDC, lot or expiry to provide. The reporter tried to saw if there were components that match up but she did not see any components that were the same. The reporter consented to follow up. For further tolerance of 2nd dose, refer case US2021AMR032634, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR032634:Same patient, same reporter, same product, different dose (2nd dose)