chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Type 2 diabetes mellitus, Urine osmolarity, Urine sodium increased, Vomiting
Clinical narrative: Patient is a 83 y.o. female patient of, MD with history of COVID 19 ( 12/11/22), DM, HTN  presented to Hospital with nausea, emesis, and diarrhea   Hyponatremia Secondary to dehydration from vomiting / COVID  Corrected sodium on admission 124 Patient was given 1 L NS bolus in ED BMP every 6 hours 12/14/22 Na+ 122. Stop hydrochlorothiazide and spirolactone  Ur osm 360, Ur Na 46 Ser Osm 272 0.9NS at 75cc/hr completed Na fluctuating 126 (12/18/22), not much improvement with IV hydration. Added salt tabs  Continue salt tabs. Na improving 130 12/19 => 134 12/20 TSH nl Will check bmp in 1 week   COVID-19 Infection Generalized weakness   Symptoms onset 12/9/22, positive test date 12/11/22 No current oxygen demand Continue paxlovid Anticoagulation: Heparin SQ Consider discontinuation of isolation 12/21/22 PT recommended intensity of skilled Therapy5 to 7 days per week/Duration 10 - 30 days. Swing bed likely 12/20   Sepsis without organ dysfunction - resolved Secondary to  COVID-19 and possible left lower lobe PNA  & POA Presented with tachycardia and leukocytosis. QSOFA score 0 Hemodynamically stable, not requiring vasopressors. Lactic acid 2.0 Pro calc nl Received  1 L NS bolus  in ED.  Workup: CXR with left lower lobe atelectasis and/or airspace disease Blood cultures NGTD urine culture neg Completed Ceftriaxone and azithromycin.    Hypokalemia-resolved  3.1 on presentation Magnesium 1.6 Replace and recheck K of 4.1 (12/18)  DM2 with hyperglycemia Hold home oral medication, Diet Special; Diabetic, Cardiac; Carbohydrate Consistent 60g/meal (1500-2000 kCal equivalent) diet, sensitive SSI + BG checks ACHS, hypoglycemic protocol, and target BG 140-180 Added Lantus 30 units (12/18) titrate based on BG Continue home meds   HTN  Elevated blood pressure Continue nifedipine, clonidine, and aldactone   Constipation - resolved Reports no BM since admission Added schedule laxative and senna s
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Headache, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, mild cough, fever, head pain in temple region (still have)
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was given outside of the recommended storage time at room temperature
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was administered outside of recommended storage temperature and time.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Presyncope
Clinical narrative: Patient and Parent presented to Immunization clinic with order from provider for vaccines. Vaccines were administered and patient and parent were given VIS form. Patient was directed to wait in the lobby for atleast 15 minutes. About 5 minutes after patient entered lobby, he had a vasovagal reaction. Patient was caught by bystander. EMS was called and the closest provider and nurse team was brought to the scene. Vitals were performed and oxygen was given until EMS arrived and took patient to ER.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hemiplegia
Clinical narrative: I had the first vacination injected at the local Pharmacy. Had a stroke 48 hrs later. Was admitted to local Hospitol for weeks due to a stroke.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Computerised tomogram, Laboratory test, Transient ischaemic attack, Ultrasound Doppler
Clinical narrative: mini stroke aka TIA on May 16.2022   extreme BP
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Magnetic resonance imaging, Migraine
Clinical narrative: Recurring Migraine continues as of 1/13/2022
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Autopsy, Headache, Hypersensitivity, Malaise
Clinical narrative: He got sick on 07/13/2021 finally ended up going to the hospital 07/16/2021 for body aches headache  & weakness they sent him home and said it was a allergic reaction no bloodwork  they prescribed him Zoltan oft 4 mg oral tablet
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: He got sick on 07/13/2021 finally ended up going to the hospital 07/16/2021 for body aches headache  & weakness they sent him home and said it was a allergic reaction no bloodwork  they prescribed him Zoltan oft 4 mg oral tablet
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: I still have a sore lymph node in armpit on side vaccine was given all these months later. I got the bivalent vaccine also, but the sore lymph node started with the booster noted in this form.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: I woke up and threw up. I had a terrible cough, sore throat, fever of 102, and fatigue. I tested positive for COVID-19 on 12/25/2022. I spoke to my doctor and said he didn't need to see me. I started feeling better in a couple days.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: I woke up and threw up. I had a terrible cough, sore throat, fever of 102, and fatigue. I tested positive for COVID-19 on 12/25/2022. I spoke to my doctor and said he didn't need to see me. I started feeling better in a couple days.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Anticoagulant therapy, Bladder catheterisation, Blood creatinine increased, Chest X-ray normal
Clinical narrative: Patient is a 68 y.o. male patient of MD with past medical history of hypertension, hyperlipidemia, coronary artery disease, diastolic congestive heart failure, type 2 diabetes mellitus insulin-dependent, CKD stage IV, moderate obesity body mass index 39, presented with decreased urine output and abnormal labs   Acute kidney injury, ATN, creatinine on admission 4 CKD stage IV, baseline creatinine 2 IV fluid hydration Foley catheter placement Closely monitor urine output and kidney function test Daily BMP and magnesium Follow with  nephrology CT abdomen pelvis showed no hydronephrosis. Serum Cr improved close to baseline   Covid-19 Virus Infection Date of onset of symptoms: 12/18/2022 Symptoms present on admission: Generalized tiredness and fatigue and decreased urine output Date of covid positive test: 12/20/2022 Vaccination status: vaccinated Imaging: Chest x-ray no acute finding Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: steroids, will discontinue patient is on room air Consultants following: ID Anticipated special isolation end date: 12/28/2022   Insulin-dependent diabetes mellitus with hyperglycemia Hemoglobin A1c Resume Lantus Insulin sliding scale.   Hypertension Norvasc 5 mg daily Carvedilol 6.25 mg twice daily, increase to 12.5 twice daily, increase to home dose of 25 twice daily Isordil 20 mg 3 times daily, add hydralazine 50 3 times daily   IV hydralazine and labetalol as needed  Coronary artery disease Hyperlipidemia Guideline directed medical therapy Currently on Eliquis and Plavix Echocardiogram 3/22/2022 showed EF 73% with normal LV systolic and diastolic function.  Leukocytosis Concern of acute lower urinary tract infection Broad-spectrum IV antibiotics Urine culture Follow with infectious disease team   Morbid obesity Body mass index 39.3 Encouraged weight loss and lifestyle modification
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic kidney disease, Computerised tomogram abdomen normal, Condition aggravated, Culture urine, Echocardiogram normal
Clinical narrative: Patient is a 68 y.o. male patient of MD with past medical history of hypertension, hyperlipidemia, coronary artery disease, diastolic congestive heart failure, type 2 diabetes mellitus insulin-dependent, CKD stage IV, moderate obesity body mass index 39, presented with decreased urine output and abnormal labs   Acute kidney injury, ATN, creatinine on admission 4 CKD stage IV, baseline creatinine 2 IV fluid hydration Foley catheter placement Closely monitor urine output and kidney function test Daily BMP and magnesium Follow with  nephrology CT abdomen pelvis showed no hydronephrosis. Serum Cr improved close to baseline   Covid-19 Virus Infection Date of onset of symptoms: 12/18/2022 Symptoms present on admission: Generalized tiredness and fatigue and decreased urine output Date of covid positive test: 12/20/2022 Vaccination status: vaccinated Imaging: Chest x-ray no acute finding Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: steroids, will discontinue patient is on room air Consultants following: ID Anticipated special isolation end date: 12/28/2022   Insulin-dependent diabetes mellitus with hyperglycemia Hemoglobin A1c Resume Lantus Insulin sliding scale.   Hypertension Norvasc 5 mg daily Carvedilol 6.25 mg twice daily, increase to 12.5 twice daily, increase to home dose of 25 twice daily Isordil 20 mg 3 times daily, add hydralazine 50 3 times daily   IV hydralazine and labetalol as needed  Coronary artery disease Hyperlipidemia Guideline directed medical therapy Currently on Eliquis and Plavix Echocardiogram 3/22/2022 showed EF 73% with normal LV systolic and diastolic function.  Leukocytosis Concern of acute lower urinary tract infection Broad-spectrum IV antibiotics Urine culture Follow with infectious disease team   Morbid obesity Body mass index 39.3 Encouraged weight loss and lifestyle modification
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Laboratory test abnormal, Leukocytosis, Renal tubular necrosis, SARS-CoV-2 test positive
Clinical narrative: Patient is a 68 y.o. male patient of MD with past medical history of hypertension, hyperlipidemia, coronary artery disease, diastolic congestive heart failure, type 2 diabetes mellitus insulin-dependent, CKD stage IV, moderate obesity body mass index 39, presented with decreased urine output and abnormal labs   Acute kidney injury, ATN, creatinine on admission 4 CKD stage IV, baseline creatinine 2 IV fluid hydration Foley catheter placement Closely monitor urine output and kidney function test Daily BMP and magnesium Follow with  nephrology CT abdomen pelvis showed no hydronephrosis. Serum Cr improved close to baseline   Covid-19 Virus Infection Date of onset of symptoms: 12/18/2022 Symptoms present on admission: Generalized tiredness and fatigue and decreased urine output Date of covid positive test: 12/20/2022 Vaccination status: vaccinated Imaging: Chest x-ray no acute finding Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: steroids, will discontinue patient is on room air Consultants following: ID Anticipated special isolation end date: 12/28/2022   Insulin-dependent diabetes mellitus with hyperglycemia Hemoglobin A1c Resume Lantus Insulin sliding scale.   Hypertension Norvasc 5 mg daily Carvedilol 6.25 mg twice daily, increase to 12.5 twice daily, increase to home dose of 25 twice daily Isordil 20 mg 3 times daily, add hydralazine 50 3 times daily   IV hydralazine and labetalol as needed  Coronary artery disease Hyperlipidemia Guideline directed medical therapy Currently on Eliquis and Plavix Echocardiogram 3/22/2022 showed EF 73% with normal LV systolic and diastolic function.  Leukocytosis Concern of acute lower urinary tract infection Broad-spectrum IV antibiotics Urine culture Follow with infectious disease team   Morbid obesity Body mass index 39.3 Encouraged weight loss and lifestyle modification
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Urine output decreased
Clinical narrative: Patient is a 68 y.o. male patient of MD with past medical history of hypertension, hyperlipidemia, coronary artery disease, diastolic congestive heart failure, type 2 diabetes mellitus insulin-dependent, CKD stage IV, moderate obesity body mass index 39, presented with decreased urine output and abnormal labs   Acute kidney injury, ATN, creatinine on admission 4 CKD stage IV, baseline creatinine 2 IV fluid hydration Foley catheter placement Closely monitor urine output and kidney function test Daily BMP and magnesium Follow with  nephrology CT abdomen pelvis showed no hydronephrosis. Serum Cr improved close to baseline   Covid-19 Virus Infection Date of onset of symptoms: 12/18/2022 Symptoms present on admission: Generalized tiredness and fatigue and decreased urine output Date of covid positive test: 12/20/2022 Vaccination status: vaccinated Imaging: Chest x-ray no acute finding Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: steroids, will discontinue patient is on room air Consultants following: ID Anticipated special isolation end date: 12/28/2022   Insulin-dependent diabetes mellitus with hyperglycemia Hemoglobin A1c Resume Lantus Insulin sliding scale.   Hypertension Norvasc 5 mg daily Carvedilol 6.25 mg twice daily, increase to 12.5 twice daily, increase to home dose of 25 twice daily Isordil 20 mg 3 times daily, add hydralazine 50 3 times daily   IV hydralazine and labetalol as needed  Coronary artery disease Hyperlipidemia Guideline directed medical therapy Currently on Eliquis and Plavix Echocardiogram 3/22/2022 showed EF 73% with normal LV systolic and diastolic function.  Leukocytosis Concern of acute lower urinary tract infection Broad-spectrum IV antibiotics Urine culture Follow with infectious disease team   Morbid obesity Body mass index 39.3 Encouraged weight loss and lifestyle modification
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Blood test abnormal, Diarrhoea, Dysphagia, Eating disorder
Clinical narrative: gastrointestinal pain, explosive diarrhea, stomach upset, stopped eating 4 days , couldn't swallow or ingest anything, I was gagging and couldn't keep anything down. low white blood cells.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Gastrointestinal pain, Haematocrit decreased, Haemoglobin decreased, International normalised ratio normal, Neutrophil count decreased
Clinical narrative: gastrointestinal pain, explosive diarrhea, stomach upset, stopped eating 4 days , couldn't swallow or ingest anything, I was gagging and couldn't keep anything down. low white blood cells.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Platelet count decreased, Prothrombin level increased, Red blood cell count decreased, Retching, Vomiting
Clinical narrative: gastrointestinal pain, explosive diarrhea, stomach upset, stopped eating 4 days , couldn't swallow or ingest anything, I was gagging and couldn't keep anything down. low white blood cells.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: White blood cell count decreased
Clinical narrative: gastrointestinal pain, explosive diarrhea, stomach upset, stopped eating 4 days , couldn't swallow or ingest anything, I was gagging and couldn't keep anything down. low white blood cells.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Influenza A virus test negative, SARS-CoV-2 test negative, Sinusitis
Clinical narrative: Sinus infection treated with Augmentin for 8 days. From start to finish, infection lasted 2 weeks.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient is an 18-year-old who got a flu shot on 1/9/23 whose had increasing redness swelling and tenderness over the site since.  It is also itchy. Treated in PCP clinic with Albuterol Inhaler, Cephlexin Oral, Singulair, Iron Chews
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was inadvertently given a 3rd unneeded dose.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Computerised tomogram head abnormal, Feeling abnormal, Headache
Clinical narrative: Immediate intense headache. Was not able to go to work the next day. Due to pain. Not feeling like myself. On the 2nd or third day Couldn't speak and went to Hospital. Went in having a stoke and had a second one the night I went in. I should never have a stroke which produces blood clots because my blood doesn't clot properly due to my platelet due to my storage pool disorder.  When I get cut, I bleed and have trouble stopping the bleeding.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Impaired work ability, Magnetic resonance imaging head abnormal, Pain, Speech disorder
Clinical narrative: Immediate intense headache. Was not able to go to work the next day. Due to pain. Not feeling like myself. On the 2nd or third day Couldn't speak and went to Hospital. Went in having a stoke and had a second one the night I went in. I should never have a stroke which produces blood clots because my blood doesn't clot properly due to my platelet due to my storage pool disorder.  When I get cut, I bleed and have trouble stopping the bleeding.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging, Paralysis
Clinical narrative: Guillian Barres Syndrom - Causing  her to become paralyzed.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fall, Muscular weakness, Parkinson's disease, Walking aid user
Clinical narrative: Extreme weakness in hips and legs evidencing Parkinson's.  Previously reported on. Went to physical therapy at 2:00 after receiving the shot about 11:30.  Walked in, having been walking all along.  PT said she fell or almost fell several times during PT.  When finished came out to the car using a walker with the PT holding her by a belt around her waist.  Has had to use the walker ever since. Diagnosed with Parkinson's on 7-16-22 by MD.  Did the Covid shot trigger the Parkinson's?
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Asthenia, Blood creatinine increased, COVID-19
Clinical narrative: 88 y.o. male patient of DO who presented with cough, weakness and fever and was found to have COVID-19 respiratory infection.  He had elevated creatinine and change in mental status.  His head CT showed 1 cm linear area of hypoattenuation relatively new and concerning for recent infarct.   Hospital course?   COVID-19 respiratory infection Acute hypoxic respiratory failure Pneumonia due to COVID-19 Onset of symptoms was on 12/5/2022, presented with cough and shortness of breath.  Chest x-ray showed pneumonia.  He was requiring 2 L of oxygen on presentation.  He was treated with steroids.  ID was of assistance in management.  He was on room air prior to discharge.   Acute metabolic encephalopathy Small subacute right parietal ischemic stroke with petechial hemorrhage He had head CT and MRI as noted above.  Was evaluated by neurology.  He was continued on Plavix and statin.  PT/OT followed during this admission.   Status post fall Fall precautions observed.  PT/OT continued.   AKI on CKD III His creatinine was back to baseline at 1.63 on discharge.  Nephrotoxins were avoided.   CAD/HTN There were no acute issues.  His antihypertensives were continued.     Diabetes mellitus II He was continued on Lantus and SSI as above.   HLD He was continued on statins.   He was discharged to ECF for ongoing therapy.  He was discharged in a stable condition.  He will follow-up with his PCP outpatient.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Central nervous system lesion, Cerebral haemorrhage, Chest X-ray abnormal, Computerised tomogram head abnormal
Clinical narrative: 88 y.o. male patient of DO who presented with cough, weakness and fever and was found to have COVID-19 respiratory infection.  He had elevated creatinine and change in mental status.  His head CT showed 1 cm linear area of hypoattenuation relatively new and concerning for recent infarct.   Hospital course?   COVID-19 respiratory infection Acute hypoxic respiratory failure Pneumonia due to COVID-19 Onset of symptoms was on 12/5/2022, presented with cough and shortness of breath.  Chest x-ray showed pneumonia.  He was requiring 2 L of oxygen on presentation.  He was treated with steroids.  ID was of assistance in management.  He was on room air prior to discharge.   Acute metabolic encephalopathy Small subacute right parietal ischemic stroke with petechial hemorrhage He had head CT and MRI as noted above.  Was evaluated by neurology.  He was continued on Plavix and statin.  PT/OT followed during this admission.   Status post fall Fall precautions observed.  PT/OT continued.   AKI on CKD III His creatinine was back to baseline at 1.63 on discharge.  Nephrotoxins were avoided.   CAD/HTN There were no acute issues.  His antihypertensives were continued.     Diabetes mellitus II He was continued on Lantus and SSI as above.   HLD He was continued on statins.   He was discharged to ECF for ongoing therapy.  He was discharged in a stable condition.  He will follow-up with his PCP outpatient.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fall, Ischaemic stroke, Magnetic resonance imaging head abnormal
Clinical narrative: 88 y.o. male patient of DO who presented with cough, weakness and fever and was found to have COVID-19 respiratory infection.  He had elevated creatinine and change in mental status.  His head CT showed 1 cm linear area of hypoattenuation relatively new and concerning for recent infarct.   Hospital course?   COVID-19 respiratory infection Acute hypoxic respiratory failure Pneumonia due to COVID-19 Onset of symptoms was on 12/5/2022, presented with cough and shortness of breath.  Chest x-ray showed pneumonia.  He was requiring 2 L of oxygen on presentation.  He was treated with steroids.  ID was of assistance in management.  He was on room air prior to discharge.   Acute metabolic encephalopathy Small subacute right parietal ischemic stroke with petechial hemorrhage He had head CT and MRI as noted above.  Was evaluated by neurology.  He was continued on Plavix and statin.  PT/OT followed during this admission.   Status post fall Fall precautions observed.  PT/OT continued.   AKI on CKD III His creatinine was back to baseline at 1.63 on discharge.  Nephrotoxins were avoided.   CAD/HTN There were no acute issues.  His antihypertensives were continued.     Diabetes mellitus II He was continued on Lantus and SSI as above.   HLD He was continued on statins.   He was discharged to ECF for ongoing therapy.  He was discharged in a stable condition.  He will follow-up with his PCP outpatient.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Mental status changes, Metabolic encephalopathy, Neurological examination, Pyrexia
Clinical narrative: 88 y.o. male patient of DO who presented with cough, weakness and fever and was found to have COVID-19 respiratory infection.  He had elevated creatinine and change in mental status.  His head CT showed 1 cm linear area of hypoattenuation relatively new and concerning for recent infarct.   Hospital course?   COVID-19 respiratory infection Acute hypoxic respiratory failure Pneumonia due to COVID-19 Onset of symptoms was on 12/5/2022, presented with cough and shortness of breath.  Chest x-ray showed pneumonia.  He was requiring 2 L of oxygen on presentation.  He was treated with steroids.  ID was of assistance in management.  He was on room air prior to discharge.   Acute metabolic encephalopathy Small subacute right parietal ischemic stroke with petechial hemorrhage He had head CT and MRI as noted above.  Was evaluated by neurology.  He was continued on Plavix and statin.  PT/OT followed during this admission.   Status post fall Fall precautions observed.  PT/OT continued.   AKI on CKD III His creatinine was back to baseline at 1.63 on discharge.  Nephrotoxins were avoided.   CAD/HTN There were no acute issues.  His antihypertensives were continued.     Diabetes mellitus II He was continued on Lantus and SSI as above.   HLD He was continued on statins.   He was discharged to ECF for ongoing therapy.  He was discharged in a stable condition.  He will follow-up with his PCP outpatient.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Adenocarcinoma, Biopsy bone, Death
Clinical narrative: BRIEF HOSPITAL COURSE:  The patient was an unfortunate male, who was initially brought to the hospital after involved in a rollover motor vehicle accident.  He was injected from the vehicle.  He had numerous injuries as detailed above.  He was initially treated at the original hospital.  He did undergo a left-sided craniotomy with evacuation on September 9, 2022.  Respiratory pneumonia, encephalopathy, and anemia.  Tracheostomy and G-tube were replaced on September 15, 2022.  He underwent splenic artery embolization and thoracentesis on September 20, 2022.    On October 2, 2022, he was transferred to another hospital for further evaluation and management.  He was placed on ventilator weaning protocol.  He completed a course of Levaquin for pneumonia.  Oral vancomycin course was extended for C. difficile prophylaxis.  He was continued on heparin.  Tube feeds were continued.  DVT workup prophylaxis was continued.    Unfortunately, he really never made any sustained progress in weaning off the ventilator.  In the process of performing some followup CT scans for orthopedic reasons, he was found to have extensive osseous metastases.  He underwent a biopsy of the left sacrum on November 30, 2022.  This revealed an adenocarcinoma.  Oncology was consulted.  This was felt to be stage IV adenocarcinoma of unknown primary.  He was really not felt to be a candidate for any type of treatment.  After extensive discussions with the family, it was decided to make him DNR and withdraw care.  He was taken off the ventilator on January 6, 2023.  He was pronounced dead at 01:17 p.m.  Family aware.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Angiogram pulmonary abnormal, Bronchitis, COVID-19, Chest X-ray abnormal
Clinical narrative: Patient is a 95 y.o. female patient of MD with history of HTN, HLD, COPD presented to a local Hospital with SOB .   Acute hypoxic respiratory failure COVID-19 virus infection Tested positive: 12/13/2022 Fully vaccinated Oxygen requirements at baseline: Room air Current oxygen requirement: The patient initially had worsening of her respiratory status and required increasing levels of supplemental oxygen.  However this improved and the patient was weaned off of oxygen to room air. Treatment: Dexamethasone     COPD with exacerbation Chest x-ray and CT angiogram consistent with acute bronchitis Patient is improved noting improvement in her respiratory status. Continue azithromycin and guaifenesin. Continue nebulizer treatments as needed.   Essential hypertension Continue losartan   Hyperlipidemia Continue statin
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Respiratory disorder, SARS-CoV-2 test positive
Clinical narrative: Patient is a 95 y.o. female patient of MD with history of HTN, HLD, COPD presented to a local Hospital with SOB .   Acute hypoxic respiratory failure COVID-19 virus infection Tested positive: 12/13/2022 Fully vaccinated Oxygen requirements at baseline: Room air Current oxygen requirement: The patient initially had worsening of her respiratory status and required increasing levels of supplemental oxygen.  However this improved and the patient was weaned off of oxygen to room air. Treatment: Dexamethasone     COPD with exacerbation Chest x-ray and CT angiogram consistent with acute bronchitis Patient is improved noting improvement in her respiratory status. Continue azithromycin and guaifenesin. Continue nebulizer treatments as needed.   Essential hypertension Continue losartan   Hyperlipidemia Continue statin
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Memory impairment, Pain
Clinical narrative: body aches, joint pains, memory issues.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: OB GYNE provider ordered HPV injection to be given due to no previous history was seen on the chart at the time. no adverse events noted. pt was called and no symptoms noted per patient.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Asthenia, Blood culture negative, C-reactive protein increased, COVID-19
Clinical narrative: Patient is a 69 y.o. male patient of CNP with history of COPD, basal cell carcinoma, mantle cell lymphoma, GERD, presented to Hospital with cough fever shortness of breath.   COVID-19 infection Acute hypoxic acute respiratory failure probable atypical, most likely viral pneumonia, concern for superimposed bacterial infection. History of COPD; no clinical evidence of clinical exacerbation Immunocompromised, history of mantle cell lymphoma on chemotherapy. Presented with cough of 3 weeks duration, progressive shortness of breath worsening over the last 24 hours, fever. Vaccination status; vaccinated, and boosted. VBG; pH 7.37/45.5/29. COVID-19 positive, influenza A and B Undetected CRP 176 admission, CXR;Hazy interstitial opacities are present in the bilateral lung bases, left greater than right, suggestive of atypical infectious infiltrate/viral pneumonia. Urine Legionella, streptococcal antigen is ordered and is pending. Blood cultures X 2 is negative , urine culture is negative.  Started on vancomycin and Zosyn.  Discontinue 12/19 as cultures remain negative.  MRSA swab negative Continue supplemental oxygen currently on 2 L supplemental oxygen, titrate to keep saturation above 92. Given elevated CRP patient started on IV dexamethasone.  Patient successfully weaned off supplemental O2 on 12/20.  CRP downtrending on recheck 132.    History of Mantle cell lymphoma of lymph nodes of neck Diagnosed 10/21 Planning stem cell transplant was counseled about a month ago due to illness, has an upcoming PET scan next week Thursday. Does follows up with hematology oncologist. Completed 6 cycles of R-CHOP; C6 (last) on 2/16/2022.Currently On Q 2 monthly Rituximab last infusion was about 10 to 11 days ago.   H/O  Barrett's esophagus. Patient verbally reported planned EGD 12/20/22, however oncologist documented delay EGD until he is done with his treatment   Leukocytosis . Etiology unknown per documentation  was started filgrastim 10/28. Will monitor given possible ongoing infection.   Deconditioning weakness severe malnutrition related to chronic illness/injury
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest X-ray abnormal, Cough, Culture urine negative, Dyspnoea, Influenza A virus test negative
Clinical narrative: Patient is a 69 y.o. male patient of CNP with history of COPD, basal cell carcinoma, mantle cell lymphoma, GERD, presented to Hospital with cough fever shortness of breath.   COVID-19 infection Acute hypoxic acute respiratory failure probable atypical, most likely viral pneumonia, concern for superimposed bacterial infection. History of COPD; no clinical evidence of clinical exacerbation Immunocompromised, history of mantle cell lymphoma on chemotherapy. Presented with cough of 3 weeks duration, progressive shortness of breath worsening over the last 24 hours, fever. Vaccination status; vaccinated, and boosted. VBG; pH 7.37/45.5/29. COVID-19 positive, influenza A and B Undetected CRP 176 admission, CXR;Hazy interstitial opacities are present in the bilateral lung bases, left greater than right, suggestive of atypical infectious infiltrate/viral pneumonia. Urine Legionella, streptococcal antigen is ordered and is pending. Blood cultures X 2 is negative , urine culture is negative.  Started on vancomycin and Zosyn.  Discontinue 12/19 as cultures remain negative.  MRSA swab negative Continue supplemental oxygen currently on 2 L supplemental oxygen, titrate to keep saturation above 92. Given elevated CRP patient started on IV dexamethasone.  Patient successfully weaned off supplemental O2 on 12/20.  CRP downtrending on recheck 132.    History of Mantle cell lymphoma of lymph nodes of neck Diagnosed 10/21 Planning stem cell transplant was counseled about a month ago due to illness, has an upcoming PET scan next week Thursday. Does follows up with hematology oncologist. Completed 6 cycles of R-CHOP; C6 (last) on 2/16/2022.Currently On Q 2 monthly Rituximab last infusion was about 10 to 11 days ago.   H/O  Barrett's esophagus. Patient verbally reported planned EGD 12/20/22, however oncologist documented delay EGD until he is done with his treatment   Leukocytosis . Etiology unknown per documentation  was started filgrastim 10/28. Will monitor given possible ongoing infection.   Deconditioning weakness severe malnutrition related to chronic illness/injury
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Influenza B virus test, Legionella test, Leukocytosis, Lung infiltration, Malnutrition
Clinical narrative: Patient is a 69 y.o. male patient of CNP with history of COPD, basal cell carcinoma, mantle cell lymphoma, GERD, presented to Hospital with cough fever shortness of breath.   COVID-19 infection Acute hypoxic acute respiratory failure probable atypical, most likely viral pneumonia, concern for superimposed bacterial infection. History of COPD; no clinical evidence of clinical exacerbation Immunocompromised, history of mantle cell lymphoma on chemotherapy. Presented with cough of 3 weeks duration, progressive shortness of breath worsening over the last 24 hours, fever. Vaccination status; vaccinated, and boosted. VBG; pH 7.37/45.5/29. COVID-19 positive, influenza A and B Undetected CRP 176 admission, CXR;Hazy interstitial opacities are present in the bilateral lung bases, left greater than right, suggestive of atypical infectious infiltrate/viral pneumonia. Urine Legionella, streptococcal antigen is ordered and is pending. Blood cultures X 2 is negative , urine culture is negative.  Started on vancomycin and Zosyn.  Discontinue 12/19 as cultures remain negative.  MRSA swab negative Continue supplemental oxygen currently on 2 L supplemental oxygen, titrate to keep saturation above 92. Given elevated CRP patient started on IV dexamethasone.  Patient successfully weaned off supplemental O2 on 12/20.  CRP downtrending on recheck 132.    History of Mantle cell lymphoma of lymph nodes of neck Diagnosed 10/21 Planning stem cell transplant was counseled about a month ago due to illness, has an upcoming PET scan next week Thursday. Does follows up with hematology oncologist. Completed 6 cycles of R-CHOP; C6 (last) on 2/16/2022.Currently On Q 2 monthly Rituximab last infusion was about 10 to 11 days ago.   H/O  Barrett's esophagus. Patient verbally reported planned EGD 12/20/22, however oncologist documented delay EGD until he is done with his treatment   Leukocytosis . Etiology unknown per documentation  was started filgrastim 10/28. Will monitor given possible ongoing infection.   Deconditioning weakness severe malnutrition related to chronic illness/injury
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Physical deconditioning, Pneumonia viral, Pyrexia, SARS-CoV-2 test positive, Staphylococcus test negative
Clinical narrative: Patient is a 69 y.o. male patient of CNP with history of COPD, basal cell carcinoma, mantle cell lymphoma, GERD, presented to Hospital with cough fever shortness of breath.   COVID-19 infection Acute hypoxic acute respiratory failure probable atypical, most likely viral pneumonia, concern for superimposed bacterial infection. History of COPD; no clinical evidence of clinical exacerbation Immunocompromised, history of mantle cell lymphoma on chemotherapy. Presented with cough of 3 weeks duration, progressive shortness of breath worsening over the last 24 hours, fever. Vaccination status; vaccinated, and boosted. VBG; pH 7.37/45.5/29. COVID-19 positive, influenza A and B Undetected CRP 176 admission, CXR;Hazy interstitial opacities are present in the bilateral lung bases, left greater than right, suggestive of atypical infectious infiltrate/viral pneumonia. Urine Legionella, streptococcal antigen is ordered and is pending. Blood cultures X 2 is negative , urine culture is negative.  Started on vancomycin and Zosyn.  Discontinue 12/19 as cultures remain negative.  MRSA swab negative Continue supplemental oxygen currently on 2 L supplemental oxygen, titrate to keep saturation above 92. Given elevated CRP patient started on IV dexamethasone.  Patient successfully weaned off supplemental O2 on 12/20.  CRP downtrending on recheck 132.    History of Mantle cell lymphoma of lymph nodes of neck Diagnosed 10/21 Planning stem cell transplant was counseled about a month ago due to illness, has an upcoming PET scan next week Thursday. Does follows up with hematology oncologist. Completed 6 cycles of R-CHOP; C6 (last) on 2/16/2022.Currently On Q 2 monthly Rituximab last infusion was about 10 to 11 days ago.   H/O  Barrett's esophagus. Patient verbally reported planned EGD 12/20/22, however oncologist documented delay EGD until he is done with his treatment   Leukocytosis . Etiology unknown per documentation  was started filgrastim 10/28. Will monitor given possible ongoing infection.   Deconditioning weakness severe malnutrition related to chronic illness/injury
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Streptococcus test
Clinical narrative: Patient is a 69 y.o. male patient of CNP with history of COPD, basal cell carcinoma, mantle cell lymphoma, GERD, presented to Hospital with cough fever shortness of breath.   COVID-19 infection Acute hypoxic acute respiratory failure probable atypical, most likely viral pneumonia, concern for superimposed bacterial infection. History of COPD; no clinical evidence of clinical exacerbation Immunocompromised, history of mantle cell lymphoma on chemotherapy. Presented with cough of 3 weeks duration, progressive shortness of breath worsening over the last 24 hours, fever. Vaccination status; vaccinated, and boosted. VBG; pH 7.37/45.5/29. COVID-19 positive, influenza A and B Undetected CRP 176 admission, CXR;Hazy interstitial opacities are present in the bilateral lung bases, left greater than right, suggestive of atypical infectious infiltrate/viral pneumonia. Urine Legionella, streptococcal antigen is ordered and is pending. Blood cultures X 2 is negative , urine culture is negative.  Started on vancomycin and Zosyn.  Discontinue 12/19 as cultures remain negative.  MRSA swab negative Continue supplemental oxygen currently on 2 L supplemental oxygen, titrate to keep saturation above 92. Given elevated CRP patient started on IV dexamethasone.  Patient successfully weaned off supplemental O2 on 12/20.  CRP downtrending on recheck 132.    History of Mantle cell lymphoma of lymph nodes of neck Diagnosed 10/21 Planning stem cell transplant was counseled about a month ago due to illness, has an upcoming PET scan next week Thursday. Does follows up with hematology oncologist. Completed 6 cycles of R-CHOP; C6 (last) on 2/16/2022.Currently On Q 2 monthly Rituximab last infusion was about 10 to 11 days ago.   H/O  Barrett's esophagus. Patient verbally reported planned EGD 12/20/22, however oncologist documented delay EGD until he is done with his treatment   Leukocytosis . Etiology unknown per documentation  was started filgrastim 10/28. Will monitor given possible ongoing infection.   Deconditioning weakness severe malnutrition related to chronic illness/injury
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: OBGYN provider ordered Gardasil injection to be given during clinic visit. injection given to pt as ordered by provider. no adverse event noted.
Age: 0.83
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; ROTATEQ was administered to a 10 month old; This spontaneous report was received from a medical assistant and refers to a 10-month-old infant of unknown gender.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 27-OCT-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892788, expiration date: 02-DEC-2023, administered for prophylaxis (strength, dose, and route of administration were not provided) (product administered to patient of inappropriate age).  No additional adverse event reported.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Herpes zoster, Vaccination failure
Clinical narrative: Shingles 2 years after both doses of Shingrix/suspected vaccination failure; Shingles two years after receiving both doses of Shingrix at age 84 yo; Inflammatory arthritis; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received Zostavax 10 years prior to receiving Shingrix ).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inflammatory arthritis. The patient was treated with prednisone. On an unknown date, the outcome of the vaccination failure, shingles and inflammatory arthritis were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and inflammatory arthritis to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 6-Jan-2023 Reporter's comment: The patient received Shingrix two doses around 81 to 82 years of age and experienced shingles two years after receiving both doses of Shingrix at age 84 years.  The patient was on a low dose of Prednisone (2.5 mg) for inflammatory arthritis. The reporter consented to follow-up via email. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: FLUX
Symptoms: Illness, Influenza, Vaccination failure
Clinical narrative: still got flu/Suspected vaccination faliure; still got the flu; Got sick; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 18-year-old patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), sickness and influenza. On an unknown date, the outcome of the vaccination failure, sickness and influenza were unknown.   The reporter considered the vaccination failure, sickness and influenza to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 05-Jan-2023 Reporter's Comments: The reporter was patient's parent. The reporter reported that the patient had only received the flu shot once as toddlers.  The patient got sick that year and never had the flu or shot since.  As a family, decided that it would be better to option out of the flu shot.  The consumer stated that kids rarely get sick and they tried to refrain from prescription meds as much as possible. The CDC and FDA are money makers.  These people could not be encouraging anyone to vaccinate their children.  They should be encouraging people to do what would best for their family. 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 flu were unknown at the time of reporting. This case had been linked with US2023AMR001616, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR001616:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Loss of personal independence in daily activities, Pain, Vaccination failure
Clinical narrative: Vaccinated a year ago, got shingles/Suspected vaccination failure; Shingles/ Got shingles; Small blisters full of water on my right chest; Tremendous, lot of, pain/a lot of pain and it spread to my back until it surrounded me; I couldn't do nothing; 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), shingles, blister, pain and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, shingles, blister, pain and activities of daily living impaired were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister, pain and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK receipt date: 6-Jan-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient got shingles but the good thing was that a year ago, he/she had been vaccinated and it started with some small blisters full of water on his/her right chest and a lot of pain and they spread to his/her back until it surrounded him/her and with small blisters on his/her back. The patient stated that he/she could not did nothing because of the tremendous pain it was horrible. The patient did not wish this to happen to anyone get vaccinated. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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, Pruritus, Sleep disorder
Clinical narrative: shingles; Itchy feeling, constant itch, it itched; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 shingles and pruritus. On an unknown date, the outcome of the shingles and pruritus were unknown.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 04-Jan-2023. Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that the Shingles was not fun. The patient start getting that itchy feeling in an area on your body that hits when he/she was trying to sleep. Had that happen to patient.  The patient stated that it was a constant itch that would not go away unless you see a doctor. The patient had to did that. When the patient showed the doctor where it itched, he said shingles. The patient already had one shingles shot. If the patient would not have that shot it could had been a lot worse. The patient stated to get that shot. Better to get it than have the itch. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Got sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   The reporter considered the sickness to be possibly related to Influenza vaccine.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's comment: This case was reported by the patient via interactive digital media. The patient got Influenza vaccine once, but he/she did not like it, because he/she still got sick at the time of reporting, as usual so he/she did not see a point of it. The reporter thought that the event might had been related to product/device. Additional supportive information: This case was one of the three case reported by the same reporter for different patient.  Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR001600:same reporter US-GSK-US2023AMR001606:same reporter