chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: COVID19-2, FLU4, FLUC3
Symptoms: Ejection fraction normal, Electrocardiogram T wave inversion, Gastrointestinal disorder, Hypokinesia, Lethargy
Clinical narrative: Patient obtained both a flu and COVID vaccine on Monday 1/23/23 and for the next 2 days subsequently felt relatively usual post vaccination including some fevers and lethargy.  Then on Thursday 1/26 developed a GI illness with 2 to 3 days of diarrhea and abdominal pain. Patient presented to the emergency department 1/29/2023 with chest pressure. He was found in his work-up to have elevated troponin to 1700 for which cardiology was consulted. An echocardiogram which showed mild hypokinesis of the basal anterior wall segment but otherwise normal ejection fraction at 56%. He was monitored in the hospital and was found to have rising troponins (peak level 8359), EKG was normal on admission however changed to show inferolateral T wave inversions. Given his progression of hospital course, it was decided to take him to the Cardiac Cath Lab 1/30/2023 which showed normal coronaries.  Given this finding, his most likely clinical scenario fit with myocarditis post COVID-vaccine and recent GI illness, he was started on NSAIDs and colchicine. He was discharged home on 1/31 on colchicine 0.6 mg/day x 3 months and ibuprofen 600 mg 3 times daily x 4 weeks.  He will follow-up with heart doctor in the next 2 to 3 weeks with plan for repeat echocardiogram in 3 months.
Age: 34.0
Sex: M
Vaccine: COVID19-2, FLU4, FLUC3
Symptoms: Myocarditis, Pyrexia, Troponin increased
Clinical narrative: Patient obtained both a flu and COVID vaccine on Monday 1/23/23 and for the next 2 days subsequently felt relatively usual post vaccination including some fevers and lethargy.  Then on Thursday 1/26 developed a GI illness with 2 to 3 days of diarrhea and abdominal pain. Patient presented to the emergency department 1/29/2023 with chest pressure. He was found in his work-up to have elevated troponin to 1700 for which cardiology was consulted. An echocardiogram which showed mild hypokinesis of the basal anterior wall segment but otherwise normal ejection fraction at 56%. He was monitored in the hospital and was found to have rising troponins (peak level 8359), EKG was normal on admission however changed to show inferolateral T wave inversions. Given his progression of hospital course, it was decided to take him to the Cardiac Cath Lab 1/30/2023 which showed normal coronaries.  Given this finding, his most likely clinical scenario fit with myocarditis post COVID-vaccine and recent GI illness, he was started on NSAIDs and colchicine. He was discharged home on 1/31 on colchicine 0.6 mg/day x 3 months and ibuprofen 600 mg 3 times daily x 4 weeks.  He will follow-up with heart doctor in the next 2 to 3 weeks with plan for repeat echocardiogram in 3 months.
Age: 34.0
Sex: M
Vaccine: COVID19-2, FLU4, FLUC3
Symptoms: Myocarditis, Product administration error, Pyrexia, Troponin increased
Clinical narrative: Patient obtained both a flu and COVID vaccine on Monday 1/23/23 and for the next 2 days subsequently felt relatively usual post vaccination including some fevers and lethargy.  Then on Thursday 1/26 developed a GI illness with 2 to 3 days of diarrhea and abdominal pain. Patient presented to the emergency department 1/29/2023 with chest pressure. He was found in his work-up to have elevated troponin to 1700 for which cardiology was consulted. An echocardiogram which showed mild hypokinesis of the basal anterior wall segment but otherwise normal ejection fraction at 56%. He was monitored in the hospital and was found to have rising troponins (peak level 8359), EKG was normal on admission however changed to show inferolateral T wave inversions. Given his progression of hospital course, it was decided to take him to the Cardiac Cath Lab 1/30/2023 which showed normal coronaries.  Given this finding, his most likely clinical scenario fit with myocarditis post COVID-vaccine and recent GI illness, he was started on NSAIDs and colchicine. He was discharged home on 1/31 on colchicine 0.6 mg/day x 3 months and ibuprofen 600 mg 3 times daily x 4 weeks.  He will follow-up with heart doctor in the next 2 to 3 weeks with plan for repeat echocardiogram in 3 months.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Moderna 3/4/21 Lot# 029A21a;  Moderna 4/1/21 Lot# 028A21A;  Moderna 11/17/21 Lot# 939909;  Moderna 5/24/22 Lot# 056M21A
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Malaise
Clinical narrative: Started feeling "unwell" sometime around midnight morning of Saturday, April 24, 2021. Was found deceased 10:00am CST Saturday, April 24, 2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines  Pfizer 8/7/21 Lot# FA7484;  Pfizer 9/4/21 Lot# FC3184
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines  Pfizer 3/27/21 Lot# ER8732;  Pfizer 4/17/21 Lot# Ew0169
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Oropharyngeal pain, Pain
Clinical narrative: I experienced COVID-19 99.6 fever; sore throat; body aches; & chills I am currently taking ibuprofen.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Blood test, Dyspnoea, Eye pain
Clinical narrative: Neuological! constant pain and pressure behind my eyes 24 / 7  blurred vision, chronic fatigue, memory loss, shortness of breath and general weakness.   My doctors have no idea what is wrong with me.  Two Mri's, many different types of blood work, spinal fluid tap and no diagnosis! More testing is going to scheduled....
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lumbar puncture, Magnetic resonance imaging, Neurological symptom, Ocular discomfort
Clinical narrative: Neuological! constant pain and pressure behind my eyes 24 / 7  blurred vision, chronic fatigue, memory loss, shortness of breath and general weakness.   My doctors have no idea what is wrong with me.  Two Mri's, many different types of blood work, spinal fluid tap and no diagnosis! More testing is going to scheduled....
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Neuological! constant pain and pressure behind my eyes 24 / 7  blurred vision, chronic fatigue, memory loss, shortness of breath and general weakness.   My doctors have no idea what is wrong with me.  Two Mri's, many different types of blood work, spinal fluid tap and no diagnosis! More testing is going to scheduled....
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthma, Atrial fibrillation, Blood test, Cardiac monitoring, Cardiac stress test
Clinical narrative: Developed asthma Developed A fib
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray, Echocardiogram, Pulmonary function test
Clinical narrative: Developed asthma Developed A fib
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Pain in extremity, Swelling
Clinical narrative: Began the day after, including arm soreness, "swelling" above the clavicle, and headache.  Symptoms lasted 3-4 days.  Presented to Dr office 2/2/2023 with vaccine reaction concern
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 3/27/21 Lot# Er8732;  Pfizer 4/17/21 Lot# EW0169
Age: 4.0
Sex: F
Vaccine: DTAPIPV, IPV, MMR, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Child was given Kinrix instead of DTAP and was also given IPOL on the same date. No known reactions from patient.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 4/11/21 Lot# Ew0162;  Pfizer 5/2/21 Lot# Ew0179
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 12/28/20 Lot# 01L20A;  Moderna 12/27/21 Lot# 028K21A
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Malaise, Pain
Clinical narrative: I had a sore arm for a couple of days. I began feeling unwell with sniffles and a cough. The next day, I had body aches and fatigue. I tested positive for COVID-19 on 02/01/2023. I contacted my doctor and was given a prescription for steroids. I have tested positive for COVID-19 multiple times. I tested positive on 06/05/2022 and 12/31/2022.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had a sore arm for a couple of days. I began feeling unwell with sniffles and a cough. The next day, I had body aches and fatigue. I tested positive for COVID-19 on 02/01/2023. I contacted my doctor and was given a prescription for steroids. I have tested positive for COVID-19 multiple times. I tested positive on 06/05/2022 and 12/31/2022.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Moderna 2/3/21 Lot# 013M20A;  Moderna 3/3/21 Lot# 030A21A;  Moderna 11/16/21 Lot# 005C21A;  Moderna 4/19/22 Lot# 005M21A
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 2/24/21 Lot# EN6200  Pfizer 3/18/21 Lot# EN6208;  Pfizer 10/2/21 Lot# FF2588
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 4/12/21 Ew0150;  Pfizer 5/3/21 Lot# Ew0164
Age: 2.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site reaction
Clinical narrative: Allergic reaztion at the site of injection
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines Moderna 2/27/21 Lot# 025A21A;  Moderna 3/26/21 Lot# 008B21A;  Moderna 10/26/21 Lot# 012 LAST LOT # IS TAKEN FROM               DATABASE
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache, Nausea
Clinical narrative: Pericarditis. Chest pain. Fatigue. Shortness of breath. Headache. Nausea.
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pericarditis
Clinical narrative: Pericarditis. Chest pain. Fatigue. Shortness of breath. Headache. Nausea.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood test, Catheter placement, Cerebral haemorrhage, Cerebrovascular accident
Clinical narrative: He got his vaccine, didn't have any reaction.  He was told to take his temp for a couple of days, but no reaction.  His legs went out from underneath him, fell onto his cough as he was walking through the ER.  His sons took him to the ER and he was put in a waiting room sitting in a wheelchair for about 3 hours.  When he was seen the doctor asked what was wrong, and he told him to prove it to him.  The doctor put a walker in front of him to stand up, and told him that he couldn't stand up.  The doctor had a nurse pull him up, did not lock the bed down and the bed collapsed underneath him, and smashed his hard on the ground, and broke his glasses.  They kept him for 3 days and did 6 CAT Scans and 6 MRIs on his brain and said that he had a mild brain bled.  He was then put on Eliquis twice a day.  He is to go back to 3/2/23 to have tests run again.    One of the nurses he heard talking and said that he had a subdural hematoma due to him being dropped on his head.  He could not walk due to him having a stroke. He has real limited use of his left hand, and is in a hospital bed.  He has had home health to help him walk, and he had to walk with a walker and they follow him in a wheelchair as he tends to fall backwards.  The PT thought by last year he would be OK, and he quit coming as his insurance wouldn't pay for him, and now he has gone backwards in his recovery and now his family has to do the PT and he can only do about half as much.   He also had to wear a catheter up until a month and a half ago.  He told them that he could not take it anymore and was deflated.  He does not have control of his bladder yet, but it is getting better.   He was not able to sit up at first, and has lost a lot of weight and had to buy a special toilet to be able to stay on it.  He has been gaining some weight back.  He has to have assistance to get on and off of the bathroom and other duties.    He went to the Hospital.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Cough, Dysstasia, Fall, Gait inability
Clinical narrative: He got his vaccine, didn't have any reaction.  He was told to take his temp for a couple of days, but no reaction.  His legs went out from underneath him, fell onto his cough as he was walking through the ER.  His sons took him to the ER and he was put in a waiting room sitting in a wheelchair for about 3 hours.  When he was seen the doctor asked what was wrong, and he told him to prove it to him.  The doctor put a walker in front of him to stand up, and told him that he couldn't stand up.  The doctor had a nurse pull him up, did not lock the bed down and the bed collapsed underneath him, and smashed his hard on the ground, and broke his glasses.  They kept him for 3 days and did 6 CAT Scans and 6 MRIs on his brain and said that he had a mild brain bled.  He was then put on Eliquis twice a day.  He is to go back to 3/2/23 to have tests run again.    One of the nurses he heard talking and said that he had a subdural hematoma due to him being dropped on his head.  He could not walk due to him having a stroke. He has real limited use of his left hand, and is in a hospital bed.  He has had home health to help him walk, and he had to walk with a walker and they follow him in a wheelchair as he tends to fall backwards.  The PT thought by last year he would be OK, and he quit coming as his insurance wouldn't pay for him, and now he has gone backwards in his recovery and now his family has to do the PT and he can only do about half as much.   He also had to wear a catheter up until a month and a half ago.  He told them that he could not take it anymore and was deflated.  He does not have control of his bladder yet, but it is getting better.   He was not able to sit up at first, and has lost a lot of weight and had to buy a special toilet to be able to stay on it.  He has been gaining some weight back.  He has to have assistance to get on and off of the bathroom and other duties.    He went to the Hospital.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Head injury, Loss of personal independence in daily activities, Magnetic resonance imaging head, Mobility decreased, Muscular weakness
Clinical narrative: He got his vaccine, didn't have any reaction.  He was told to take his temp for a couple of days, but no reaction.  His legs went out from underneath him, fell onto his cough as he was walking through the ER.  His sons took him to the ER and he was put in a waiting room sitting in a wheelchair for about 3 hours.  When he was seen the doctor asked what was wrong, and he told him to prove it to him.  The doctor put a walker in front of him to stand up, and told him that he couldn't stand up.  The doctor had a nurse pull him up, did not lock the bed down and the bed collapsed underneath him, and smashed his hard on the ground, and broke his glasses.  They kept him for 3 days and did 6 CAT Scans and 6 MRIs on his brain and said that he had a mild brain bled.  He was then put on Eliquis twice a day.  He is to go back to 3/2/23 to have tests run again.    One of the nurses he heard talking and said that he had a subdural hematoma due to him being dropped on his head.  He could not walk due to him having a stroke. He has real limited use of his left hand, and is in a hospital bed.  He has had home health to help him walk, and he had to walk with a walker and they follow him in a wheelchair as he tends to fall backwards.  The PT thought by last year he would be OK, and he quit coming as his insurance wouldn't pay for him, and now he has gone backwards in his recovery and now his family has to do the PT and he can only do about half as much.   He also had to wear a catheter up until a month and a half ago.  He told them that he could not take it anymore and was deflated.  He does not have control of his bladder yet, but it is getting better.   He was not able to sit up at first, and has lost a lot of weight and had to buy a special toilet to be able to stay on it.  He has been gaining some weight back.  He has to have assistance to get on and off of the bathroom and other duties.    He went to the Hospital.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Subdural haematoma, Urinary incontinence, Walking aid user, Weight decreased, Wheelchair user
Clinical narrative: He got his vaccine, didn't have any reaction.  He was told to take his temp for a couple of days, but no reaction.  His legs went out from underneath him, fell onto his cough as he was walking through the ER.  His sons took him to the ER and he was put in a waiting room sitting in a wheelchair for about 3 hours.  When he was seen the doctor asked what was wrong, and he told him to prove it to him.  The doctor put a walker in front of him to stand up, and told him that he couldn't stand up.  The doctor had a nurse pull him up, did not lock the bed down and the bed collapsed underneath him, and smashed his hard on the ground, and broke his glasses.  They kept him for 3 days and did 6 CAT Scans and 6 MRIs on his brain and said that he had a mild brain bled.  He was then put on Eliquis twice a day.  He is to go back to 3/2/23 to have tests run again.    One of the nurses he heard talking and said that he had a subdural hematoma due to him being dropped on his head.  He could not walk due to him having a stroke. He has real limited use of his left hand, and is in a hospital bed.  He has had home health to help him walk, and he had to walk with a walker and they follow him in a wheelchair as he tends to fall backwards.  The PT thought by last year he would be OK, and he quit coming as his insurance wouldn't pay for him, and now he has gone backwards in his recovery and now his family has to do the PT and he can only do about half as much.   He also had to wear a catheter up until a month and a half ago.  He told them that he could not take it anymore and was deflated.  He does not have control of his bladder yet, but it is getting better.   He was not able to sit up at first, and has lost a lot of weight and had to buy a special toilet to be able to stay on it.  He has been gaining some weight back.  He has to have assistance to get on and off of the bathroom and other duties.    He went to the Hospital.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram neck, Death, Ischaemic stroke, SARS-CoV-2 test positive
Clinical narrative: TESTED + FOR COVID ON         12-14-2022           AND WAS ADMITTED ON       12-7-22 FOR ACUTE ISCHEMIC STROKE AND DECEASED 12-18-22.    PRESENTED TO ER OUTSIDE WINDOW FOR TPA.   HAD LARGE VESSEL OCCLUSION PER CT OF NECK.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vascular occlusion
Clinical narrative: TESTED + FOR COVID ON         12-14-2022           AND WAS ADMITTED ON       12-7-22 FOR ACUTE ISCHEMIC STROKE AND DECEASED 12-18-22.    PRESENTED TO ER OUTSIDE WINDOW FOR TPA.   HAD LARGE VESSEL OCCLUSION PER CT OF NECK.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PT aged out of appropriate age for vaccine.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after one done Janssen vaccine
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Incorrect dose administered, Injection site pain, No adverse event
Clinical narrative: No adverse effects. Pt received 0.5mL dose of Pfizer bivalent booster instead of 0.3mL. When pt called after mistake was realized, he reported soreness at injection site and increased fatigue
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 7/30/21 lot# Ew0198;  Pfizer 8/20/21 Lot# FC3183
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: PATIENT REQUIRED A 2ND MMR BUT WAS GIVEN A VARICELLA.  THE MMR WAS PROVIDED AFTER THE MISTAKE WAS DISCOVERED..  PT ALREADY HAD 2 VALID DOSES OF VARICELLA.  PATIENT DID NOT HAVE ANY ADVERSE REACTION TO THE VARICELLA.  PATIENT AND FATHER WERE INFORMED OF THE MISTAKE AT THE TIME OF VISIT.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 5 vaccines Pfizer 1/27/21 Lot# EL9261;  Pfizer 2/17/21 Lot# EL9265;  Pfizer 9/26/21 Lot# FF2587;  Pfizer 4/5/22 Lot# FK9895;  Pfizer 9/20/22 Lot# GJ5342
Age: 21.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MNQ
Symptoms: Expired product administered
Clinical narrative: HEPA VACCINE ADMINISTERED AND WAS OUT OF DATE.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 2/28/21 Lot# 025A21A;  Moderna 3/24/21 Lot# 045A21A
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Productive cough, Pulmonary function test normal, Secretion discharge
Clinical narrative: On approximately 10/31/2022, I started coughing with a lot of mucus. The cough would go on all day long and into the evening. It is an irritating cough that sounds bad but I feel fine, just a chronic cough. I went to my allergist and nothing has been decided. I continue to have the cough today.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Pemphigoid, Rash, Rash pruritic
Clinical narrative: Body coveted with itchy painful rash. Biopsy revealed Bullous pemphigoid. Still have it after 1.5 years
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/26/21 Lot# 030A21A;  Moderna 4/13/21 Lot# 025B21A
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 3/6/21 Lot# 029A21A;  Moderna 4/3/21 Lot# 045A21A;  Moderna 10/28/21 Lot# 071F21A
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Cervical radiculopathy, Inflammation, Lymphadenopathy, Osteoarthritis
Clinical narrative: 1) Large swollen lymph nodes under armpit (vaccination arm/left) lasting for several months.  2) Osteoarthritis in both hands 3) General body inflammation 4) Cervical radiculopathy 5) Tinnitus  6) Loss of menses
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: 1) Large swollen lymph nodes under armpit (vaccination arm/left) lasting for several months.  2) Osteoarthritis in both hands 3) General body inflammation 4) Cervical radiculopathy 5) Tinnitus  6) Loss of menses
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Dyspepsia, Feeding disorder
Clinical narrative: Patient reported bad stomach ache and not being able to eat for 3 months.  She mentioned Heartburn as well.  I asked if she saw a doctor and she said no,  she said that they could not see her until April 2023
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Employee was scheduled to receive the Pfizer bivalent dose and instead received the Pfizer monovalent dose for her last dose of the series.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Confusional state, Death, SARS-CoV-2 test positive
Clinical narrative: .   HAD BEEN ADMITTED 7-31-22 FOR  CONFUSION AT HOSPITAL, TESTED + FOR COVID 8-16-22  AND WAS TRANSFERRED TO ANOTHER HOSPITAL ON 8-31-22 WHERE SHE REMAINED  UNTIL 9-9-2022  DECEASED ON  11-23-2022
Age: 11.0
Sex: F
Vaccine: COVID19-2, FLU4, HPV9, MNQ, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given 12+ Bivalent Booster instead of 5-11 Bivalent Booster. Patient was not given an age appropriate vaccine. No treatment needed. Parents will be notified of even.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: Arm pain
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac disorder, Cardiac imaging procedure abnormal, Echocardiogram abnormal, Fatigue
Clinical narrative: In early November my husband went to the cardiologist complaining of fatigue.  After an echocardiogram, a cardiac MRI, and a lexiscan, results are still inclusive but there is significant heart damage.  Accdg to the echocardiogram, the injection fraction in his LV is 20%..  We are still in the diagnostic stage but his cardiologist is adjusting meds as we go.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bronchitis, Chest X-ray abnormal, Dizziness, Dizziness postural
Clinical narrative: I started with a lot of pain in my left shoulder, it's hard for me to comb my hair, I have weakness in my shoulder and now after the vaccine my arm hurts. I feel a lot of headache, I have dizziness. I went to the doctor and he told me that it was possible Vertigo. He recommended an MRI I'm afraid to do it. When I go to bed and get up I get very dizzy. The Sciatic on  my left leg hurts a lot, buttocks and waist hurt. They made a chest x-ray because I am short of breath, the doctor told me that I have the beginnings of Bronchitis. They prescribed me only Ibuprofen and a depression pill
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Injected limb mobility decreased, Injection site pain, Laboratory test normal
Clinical narrative: I started with a lot of pain in my left shoulder, it's hard for me to comb my hair, I have weakness in my shoulder and now after the vaccine my arm hurts. I feel a lot of headache, I have dizziness. I went to the doctor and he told me that it was possible Vertigo. He recommended an MRI I'm afraid to do it. When I go to bed and get up I get very dizzy. The Sciatic on  my left leg hurts a lot, buttocks and waist hurt. They made a chest x-ray because I am short of breath, the doctor told me that I have the beginnings of Bronchitis. They prescribed me only Ibuprofen and a depression pill
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Sciatica
Clinical narrative: I started with a lot of pain in my left shoulder, it's hard for me to comb my hair, I have weakness in my shoulder and now after the vaccine my arm hurts. I feel a lot of headache, I have dizziness. I went to the doctor and he told me that it was possible Vertigo. He recommended an MRI I'm afraid to do it. When I go to bed and get up I get very dizzy. The Sciatic on  my left leg hurts a lot, buttocks and waist hurt. They made a chest x-ray because I am short of breath, the doctor told me that I have the beginnings of Bronchitis. They prescribed me only Ibuprofen and a depression pill
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: had covid test that was positive on 10-17-22 and admitted at hospital 10-17-2022 discharge was ordered 10-23-22 deceased at Rehab facility on 10-28-22
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: Fatigue, shortness of breathe, imbalance, tachycardia.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling, tenderness, and redness
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymph node pain, Lymphadenopathy, Oedema peripheral, Swelling, Ultrasound scan normal
Clinical narrative: Significant lymphadenopathy swelling of axilla, head and neck. exam with axillary,  supraclavicular ,  cervical and posterior auricular  LN enlargement with tenderness.   Confirmed by US.  Symptoms starting to improve after 10 days.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient had breakthrough and passed away.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Embolism venous, Ligament sprain, Pulmonary embolism, Right ventricular dysfunction, Thrombectomy
Clinical narrative: Patient admitted with submassive PE requiring thrombectomy. He did not have acute respiratory failure but did have RV strain. His SEROVITAL supplement was evaluated by endocrinology and not determined to increase risk of thrombus. He did have a mild left calf strain, but insufficient provocation found for VTE
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Anticoagulant therapy, Balance disorder, Electrocardiogram normal, Hemiparesis, Ischaemic stroke
Clinical narrative: I received my 4th dose of Pfizer Bivalent booster on 10/31/2022. On 12/10/2022 in the morning I had a stroke while having breakfast with my wife. I went to an urgent care but they advised me to go the the Emergency room instead. In the emergency room they did MRI, and EKG which were normal along with other tests. They diagnosed me with Acute  Ischemic Stroke. I am going to a physical therapist since my right side is weak and I have balance issues. They added Clopidogrel to my current medication and they increased Atorvastatin to 80 milligrams .
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Laboratory test normal, Magnetic resonance imaging normal
Clinical narrative: I received my 4th dose of Pfizer Bivalent booster on 10/31/2022. On 12/10/2022 in the morning I had a stroke while having breakfast with my wife. I went to an urgent care but they advised me to go the the Emergency room instead. In the emergency room they did MRI, and EKG which were normal along with other tests. They diagnosed me with Acute  Ischemic Stroke. I am going to a physical therapist since my right side is weak and I have balance issues. They added Clopidogrel to my current medication and they increased Atorvastatin to 80 milligrams .
Age: 62.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: COVID-19, Chills, Cough, Dysphonia, Headache
Clinical narrative: I started out being hoarse, nausea, achy, headache, head congestion, and chills. I tested positive for COVID-19 and my doctor prescribed me Promethazine DM. I have a cough, head congestion, and nausea.
Age: 62.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Nausea, Pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I started out being hoarse, nausea, achy, headache, head congestion, and chills. I tested positive for COVID-19 and my doctor prescribed me Promethazine DM. I have a cough, head congestion, and nausea.
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Pfizer maroon monovalent vial was undiluted and a 0.2mL dose was given to patient. Patient monitored for 30 minutes before being released from clinic and no reaction noted.  Patient 's mother was informed and instructed on what to look for and when to call 911. Patient was checked on next day and mother states no side effects for patient at that time.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt  was given Bivalent Covid vaccine .25ml for age 6y and above. Pt was suppose to receive Monovalent vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, X-ray normal
Clinical narrative: COVID-19 mRNA LNP-S, bivalen7 PF 12yrs-adult booster (Pfizer), 30 mcg/0.3mL. this information is taken from my app (Immunizations section).  On 12/28/22 one day after vaccine I noticed inability to raise voice as if losing voice.  Unable to "vocalize" like before.  Voice sort of strains, so I have to speak in a lower tone.  Described almost as if a teenage boy with changes trying to speak,  voice cracks. It's been several weeks and no change.  I've belonged to choirs previously but cannot "sound" off loudly anymore. Mentioned this to my primary physician as well as an ER doctor (visit unrelated to vaccine).  Not sure if anyone has had this side effect before after a booster, but I will no longer take another.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: I got both my Pfizer shots but it only took one to injure me.   One day after my first shot I started noticing severe tinnitus in my right ear (same side as shot)  There are no real treatments out there for tinnitus, but I know in my heart of hearts that the "vaccine" caused it. I went from having never had tinnitus in my entire life to now having a very loud persistent ringing in my ear to this day.  It was extremely noticeable the next night after I got my first shot. It has persisted since.  I've tried lipoflavinoids, ginko baloba etc, none of that actually works.  Over a year later I am still suffering from severe ringing in my right ear since the day after I got my first shot.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Patient presented the next day to the clinic with swelling, redness, rash, and pain in the left arm.
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Covid Vaccine was left out in room temperature for 13hrs.
Age: 24.0
Sex: M
Vaccine: ANTH, RAB, TYP, YF
Symptoms: Urticaria
Clinical narrative: Patient received multiple vaccines ,  patient was given Yellow Fever, anthrax, typhoid and Rabies vaccines today then went home and started experiencing hives.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Amnesia, Confusional state, Electric shock sensation, Seizure, Syncope
Clinical narrative: Vasovagal Syncope episode 5 minutes post injection seizure with full body shaking and electrical shock like feeling throughout body. Amnesia and confusion
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Tremor
Clinical narrative: Vasovagal Syncope episode 5 minutes post injection seizure with full body shaking and electrical shock like feeling throughout body. Amnesia and confusion
Age: 65.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Cough, Nasal congestion, SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: Stuffy nose, cough, post-nasal drip
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE details; Inbound call from HCP who stated MMR-II was inadvertently administered IM vs. SQ.; This spontaneous report was received from the Nurse and refers to a patient of unknown age, and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 09-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant Human albumin) subcutaneous injection, administered intramuscularly (incorrect route of product administration), 0.5 milliliter, lot #U029794, expiration date: 23-SEP-2023, for prophylaxis (strength was not provided); with sterile diluent, solution for injection/infusion, lot #, U013297, verified as non-valid after internal review, expiration date: 15-SEP-2023 (strength, route of administration, and indication were not provided). No symptomatic side effects were reported, no additional adverse event details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: shingles; Other Zoster Conidtions; death; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 10-APR-2014, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the prophylaxis.  On an unspecified date, subsequent to the patient vaccination, the patient was experienced shingles and other zoster related conditions as a result of the receipt of the zoster vaccine live (ZOSTAVAX) vaccine. On 07-APR-2021, the patient died due to an unknown reason; it was unknown if an autopsy was performed. At the patient's death, the outcome of shingles and other zoster related conditions were not reported.   The reporter considered the events of shingles and other zoster related conditions to be related to zoster vaccine live (ZOSTAVAX). The causality assessment between the patient's death and the vaccine was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; Caller is a HBP in charge of vaccine storage. She reports one dose of VARIVAX that had experienced multiple excursions throughout the month of January was administered to one patient. Product was administered 1/25/2023; This spontaneous report has been received from an office Manager, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 25-JAN-2023, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection as prophylaxis (lot number: U039949, which was determined to be valid, with an expiration date on 16-DEC-2023) (strength, dose, schemer, route and anatomical location of administration were not reported) (product storage error). The administered dose underwent a temperature excursion, but as they did not use a data logger, they did not have cumulative data to know at what temperature and during which period of time it was improperly storage, but after completing temperature check it was noted the temperature excursion happened multiple times throughout the month of January. The highest temperature noted was 12.9 degrees Fahrenheit (F).  It was reported that there was not any previous temperature excursion. No additional adverse event was reported.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; administration of expired lot of PNEUMOVAX 23 on 1/30/2023; This spontaneous report was received from a medical assistant referring to a 62-year-old male patient. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On 30-JAN-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (0.5 milliliter, once, lot # U026796, expiration date upon internal review was established as 28-JAN-2023, strength and route of administration were not provided) for prophylaxis (expired product administered). No additional AEs (no adverse event).
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; PROQUAD was administered to a patient on 01/30/2023 after a temperature excursion.; This spontaneous report was received from medical assistant and refers to a 5-year-old patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 30-JAN-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, lot # W024972, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location, and route of administration were not provided), after a temperature excursion (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 14 degrees Fahrenheit (F) up to 46 F (37 F) for 4 hours, no previous temperature excursion was reported.  There were no adverse events reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AEs; a patient was administered an expired dose of PROQUAD on 04/25/2022; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The information about the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On 25-APR-2022, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T034828, expiry date not reported, but upon internal review established as 11-APR-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse events (AEs) reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no additional AE; MMRII was given IM instead of subcutaneously; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 31-JAN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) 0.5 ml, lot #U031360, expiration date was reported as 17-OCT-2023, but upon internal review established as 07-OCT-2023, administered intramuscularly (formulation and administration site were not provided) for prophylaxis (incorrect route of product administration). No additional adverse events (AE) were reported (no adverse event).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Herpes zoster, Mobility decreased, Muscle spasms, Vaccination failure
Clinical narrative: Got 2 shots, still gets shingles/ Suspected vaccination failure; Still gets shingles; back muscles locked up; Was in bed for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, muscle spasm and bedridden. On an unknown date, the outcome of the vaccination failure, shingles, muscle spasm and bedridden were unknown.   The reporter considered the vaccination failure, shingles, muscle spasm and bedridden to be possibly related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media.  The reporters husband got 2 shots and still gets shingles. After the 2nd shot they drove straight home, got out of the car to go in the house. The patient's muscles in his back locked up. The reporter could not get him in the house, so she called the neighbors to help. The patient was in bed for 3 days. The reporter considered the events might had been to be related to Shingles vaccine. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had It, this is awful/Suspected vaccination failure; Had It, this is awful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 27-Jan-2023  Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the Shingles shot. The patient stated that this was awful the patient was at the end the patient hope, the patient had it (shingles) for three weeks. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Shot hurts for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 24-Jan-2023 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient stated that he/she never had shingles but did know that dang shot hurts for 3 days. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 years between their two shingles shots; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date, two years before).   On 25th January 2023, the patient received the 2nd dose of Shingrix. On 25th January 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comments: An adult female patient received her first dose of Shingrix about two years ago. She received her second dose day before reporting. Nothing else were reported. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended schedule, which led to lengthening of the vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, 2nd never; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date, 2 years before date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: The reporter reported the case via interactive digital media. The patient received her/ his first Shingrix shot 2 years ago. The reporter asked could he/she take her/ his second shot now or did she/he need to take the first shot again. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.