chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Dizziness, Gait disturbance, Influenza like illness, Magnetic resonance imaging head abnormal
Clinical narrative: Patient is a 66 year old female patient of, PA-C with a past medical history of hypertension, hyperlipidemia, depression, GERD, NPH, prior TBI, frequent falls, physical deconditioning, non-ambulatory status, sarcoidosis of lung who presented to ED 4/8/2023 due to fever, dizziness, weakness.  Positive for COVID-19 in ED.  She has been placed in observation for further workup/management.  Course thus far is remarkable for:   Covid-19 Virus Infection Date of onset of symptoms:  Per ED documentation: "there were no family members that were tested, however, they did have flulike symptoms last week" as reported 4/8/23; patient is poor historian Symptoms present on admission: Fever, weakness, cough Date of covid positive test: 4/8/2023 Vaccination status: vaccinated Imaging: CXR non-acute Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated Consultants following: None Anticipated special isolation end date: S/p supportive IV fluids; now with adequate PO intake Out of isolation on 4-19-2023 Discharging patient to nursing home today in very stable condition Out of isolation Normal pressure hydrocephalus Generalized weakness Gait instability Impaired cognition Recently seen by Dr Neurosurgery on 4/3/2023 Per his documentation: "MRI brain shows enlarged ventricle system with Evans Ratio of 0.42" Noted patient's extremely de-conditioned state Recommended ongoing PT; did NOT recommend drain trial PT/OT/CM consults completed Planning for after 4-19 -2023 when out of isolation   Constipation, resolved Bowel regimen adjusted to PRN    Hypertension Continue home lisinopril, atenolol, amlodipine Hold for SBP<100   Hyperlipidemia Continue home statin   Depression Continue home Zoloft   Urinary incontinence Continue home Detrol   Chronic pain  Continue home PRN tramadol- controlled
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Normal pressure hydrocephalus, Physical deconditioning, Pyrexia, SARS-CoV-2 test positive, Ventricular enlargement
Clinical narrative: Patient is a 66 year old female patient of, PA-C with a past medical history of hypertension, hyperlipidemia, depression, GERD, NPH, prior TBI, frequent falls, physical deconditioning, non-ambulatory status, sarcoidosis of lung who presented to ED 4/8/2023 due to fever, dizziness, weakness.  Positive for COVID-19 in ED.  She has been placed in observation for further workup/management.  Course thus far is remarkable for:   Covid-19 Virus Infection Date of onset of symptoms:  Per ED documentation: "there were no family members that were tested, however, they did have flulike symptoms last week" as reported 4/8/23; patient is poor historian Symptoms present on admission: Fever, weakness, cough Date of covid positive test: 4/8/2023 Vaccination status: vaccinated Imaging: CXR non-acute Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated Consultants following: None Anticipated special isolation end date: S/p supportive IV fluids; now with adequate PO intake Out of isolation on 4-19-2023 Discharging patient to nursing home today in very stable condition Out of isolation Normal pressure hydrocephalus Generalized weakness Gait instability Impaired cognition Recently seen by Dr Neurosurgery on 4/3/2023 Per his documentation: "MRI brain shows enlarged ventricle system with Evans Ratio of 0.42" Noted patient's extremely de-conditioned state Recommended ongoing PT; did NOT recommend drain trial PT/OT/CM consults completed Planning for after 4-19 -2023 when out of isolation   Constipation, resolved Bowel regimen adjusted to PRN    Hypertension Continue home lisinopril, atenolol, amlodipine Hold for SBP<100   Hyperlipidemia Continue home statin   Depression Continue home Zoloft   Urinary incontinence Continue home Detrol   Chronic pain  Continue home PRN tramadol- controlled
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bacteriuria, Blood creatinine, Blood lactic acid, Blood magnesium, Blood potassium normal
Clinical narrative: Patient is a 79 y.o. female patient of a MD with history of CAD s/p CABG x3, DM 2, HTN, hyperlipidemia presented to the Hospital with myalgias.   On 4/16 she is feeling much better. Lungs clear, abd soft and non tender, no diarrhea.   Covid-19 Virus Infection Date of onset of symptoms: 4/10 Symptoms present on admission: malaise, cough Date of covid positive test: 4/13 Vaccination status: vaccinated Imaging: CXR negative Oxygen requirements on admission: none Current oxygen requirements: none Medical therapy: Paxlovid started 4/13, continue at discharge Consultants following: none Anticipated special isolation end date: 4/23    ESBL Klebsiella pneumonia bacteriuria Diagnosed 4/6/2023, initially treated with Keflex and transition to levofloxacin once results known on 4/8/2023, Pt states she did not take levaquin Previously treated with Macrobid x2 rounds prior to 4/6/2023 Follows with urology office, has been on vaginal cream in past Changed to Cipro on 4/13, continue at discharge   Wide complex tachycardia CAD s/p CABG x3 Continue Plavix, aspirin, metoprolol, statin Asymptomatic K is 3.7 Mg is 1.5 on 4/14, TSH 2.3, echo with LVEF 50%, mild valve disease Suspect related to COVID infection, continue to monitor as outpatient, continues to be asymptomatic Increased toprol to 75mg daily Follow up with cardiology as outpatient   Diabetes mellitus type 2 with hyperglycemia insulin-dependent Resume home regimen   Lactic acidosis  Lactic acid 4.2 Stop metformin Repeat lactic acid normal   HTN, essential Cr 1.18 Continue lisinopril, metoprolol  Hyperlipidemia Continue rosuvastatin
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood thyroid stimulating hormone normal, COVID-19, Cardiac valve disease, Chest X-ray normal, Condition aggravated
Clinical narrative: Patient is a 79 y.o. female patient of a MD with history of CAD s/p CABG x3, DM 2, HTN, hyperlipidemia presented to the Hospital with myalgias.   On 4/16 she is feeling much better. Lungs clear, abd soft and non tender, no diarrhea.   Covid-19 Virus Infection Date of onset of symptoms: 4/10 Symptoms present on admission: malaise, cough Date of covid positive test: 4/13 Vaccination status: vaccinated Imaging: CXR negative Oxygen requirements on admission: none Current oxygen requirements: none Medical therapy: Paxlovid started 4/13, continue at discharge Consultants following: none Anticipated special isolation end date: 4/23    ESBL Klebsiella pneumonia bacteriuria Diagnosed 4/6/2023, initially treated with Keflex and transition to levofloxacin once results known on 4/8/2023, Pt states she did not take levaquin Previously treated with Macrobid x2 rounds prior to 4/6/2023 Follows with urology office, has been on vaginal cream in past Changed to Cipro on 4/13, continue at discharge   Wide complex tachycardia CAD s/p CABG x3 Continue Plavix, aspirin, metoprolol, statin Asymptomatic K is 3.7 Mg is 1.5 on 4/14, TSH 2.3, echo with LVEF 50%, mild valve disease Suspect related to COVID infection, continue to monitor as outpatient, continues to be asymptomatic Increased toprol to 75mg daily Follow up with cardiology as outpatient   Diabetes mellitus type 2 with hyperglycemia insulin-dependent Resume home regimen   Lactic acidosis  Lactic acid 4.2 Stop metformin Repeat lactic acid normal   HTN, essential Cr 1.18 Continue lisinopril, metoprolol  Hyperlipidemia Continue rosuvastatin
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Echocardiogram normal, Ejection fraction normal, Essential hypertension, Hyperlipidaemia
Clinical narrative: Patient is a 79 y.o. female patient of a MD with history of CAD s/p CABG x3, DM 2, HTN, hyperlipidemia presented to the Hospital with myalgias.   On 4/16 she is feeling much better. Lungs clear, abd soft and non tender, no diarrhea.   Covid-19 Virus Infection Date of onset of symptoms: 4/10 Symptoms present on admission: malaise, cough Date of covid positive test: 4/13 Vaccination status: vaccinated Imaging: CXR negative Oxygen requirements on admission: none Current oxygen requirements: none Medical therapy: Paxlovid started 4/13, continue at discharge Consultants following: none Anticipated special isolation end date: 4/23    ESBL Klebsiella pneumonia bacteriuria Diagnosed 4/6/2023, initially treated with Keflex and transition to levofloxacin once results known on 4/8/2023, Pt states she did not take levaquin Previously treated with Macrobid x2 rounds prior to 4/6/2023 Follows with urology office, has been on vaginal cream in past Changed to Cipro on 4/13, continue at discharge   Wide complex tachycardia CAD s/p CABG x3 Continue Plavix, aspirin, metoprolol, statin Asymptomatic K is 3.7 Mg is 1.5 on 4/14, TSH 2.3, echo with LVEF 50%, mild valve disease Suspect related to COVID infection, continue to monitor as outpatient, continues to be asymptomatic Increased toprol to 75mg daily Follow up with cardiology as outpatient   Diabetes mellitus type 2 with hyperglycemia insulin-dependent Resume home regimen   Lactic acidosis  Lactic acid 4.2 Stop metformin Repeat lactic acid normal   HTN, essential Cr 1.18 Continue lisinopril, metoprolol  Hyperlipidemia Continue rosuvastatin
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lactic acidosis, Malaise, Myalgia, Pathogen resistance, Pneumonia klebsiella
Clinical narrative: Patient is a 79 y.o. female patient of a MD with history of CAD s/p CABG x3, DM 2, HTN, hyperlipidemia presented to the Hospital with myalgias.   On 4/16 she is feeling much better. Lungs clear, abd soft and non tender, no diarrhea.   Covid-19 Virus Infection Date of onset of symptoms: 4/10 Symptoms present on admission: malaise, cough Date of covid positive test: 4/13 Vaccination status: vaccinated Imaging: CXR negative Oxygen requirements on admission: none Current oxygen requirements: none Medical therapy: Paxlovid started 4/13, continue at discharge Consultants following: none Anticipated special isolation end date: 4/23    ESBL Klebsiella pneumonia bacteriuria Diagnosed 4/6/2023, initially treated with Keflex and transition to levofloxacin once results known on 4/8/2023, Pt states she did not take levaquin Previously treated with Macrobid x2 rounds prior to 4/6/2023 Follows with urology office, has been on vaginal cream in past Changed to Cipro on 4/13, continue at discharge   Wide complex tachycardia CAD s/p CABG x3 Continue Plavix, aspirin, metoprolol, statin Asymptomatic K is 3.7 Mg is 1.5 on 4/14, TSH 2.3, echo with LVEF 50%, mild valve disease Suspect related to COVID infection, continue to monitor as outpatient, continues to be asymptomatic Increased toprol to 75mg daily Follow up with cardiology as outpatient   Diabetes mellitus type 2 with hyperglycemia insulin-dependent Resume home regimen   Lactic acidosis  Lactic acid 4.2 Stop metformin Repeat lactic acid normal   HTN, essential Cr 1.18 Continue lisinopril, metoprolol  Hyperlipidemia Continue rosuvastatin
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Tachycardia
Clinical narrative: Patient is a 79 y.o. female patient of a MD with history of CAD s/p CABG x3, DM 2, HTN, hyperlipidemia presented to the Hospital with myalgias.   On 4/16 she is feeling much better. Lungs clear, abd soft and non tender, no diarrhea.   Covid-19 Virus Infection Date of onset of symptoms: 4/10 Symptoms present on admission: malaise, cough Date of covid positive test: 4/13 Vaccination status: vaccinated Imaging: CXR negative Oxygen requirements on admission: none Current oxygen requirements: none Medical therapy: Paxlovid started 4/13, continue at discharge Consultants following: none Anticipated special isolation end date: 4/23    ESBL Klebsiella pneumonia bacteriuria Diagnosed 4/6/2023, initially treated with Keflex and transition to levofloxacin once results known on 4/8/2023, Pt states she did not take levaquin Previously treated with Macrobid x2 rounds prior to 4/6/2023 Follows with urology office, has been on vaginal cream in past Changed to Cipro on 4/13, continue at discharge   Wide complex tachycardia CAD s/p CABG x3 Continue Plavix, aspirin, metoprolol, statin Asymptomatic K is 3.7 Mg is 1.5 on 4/14, TSH 2.3, echo with LVEF 50%, mild valve disease Suspect related to COVID infection, continue to monitor as outpatient, continues to be asymptomatic Increased toprol to 75mg daily Follow up with cardiology as outpatient   Diabetes mellitus type 2 with hyperglycemia insulin-dependent Resume home regimen   Lactic acidosis  Lactic acid 4.2 Stop metformin Repeat lactic acid normal   HTN, essential Cr 1.18 Continue lisinopril, metoprolol  Hyperlipidemia Continue rosuvastatin
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chest discomfort, Electrocardiogram normal, Heart rate increased, Malaise
Clinical narrative: FEELING OF RAPID HEARTBEAT AND SOMEONE SITTING ON HIS CHEST (STARTING THE AFTERNOON AFTER THE VACCINE) MOM DROVE HIM TO URGENT CARE- EKG AND VITALS TAKEN.  NO MEDS GIVEN.  ORDERS AFTER OBSERVATION WAS TO  GO HOME AND REST. MOM STATES PT. DIDN'T FEEL WELL THE REST OF THE NIGHT BUT BETTER THE NEXT DAY
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anticoagulant therapy, Anxiety, Atrial fibrillation, Blood glucose increased
Clinical narrative: Patient is a 59 y.o. female patient of, MD with history of Atrial fibrillation/flutter, COPD, DM type 2, Depression, Hypertension, parkinson's disease who presented to Hospital with shortness of breath was found to have acute hypoxic respiratory failure, COVID infection, COPD, and CHF exacerbation.   Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 4/15/2023 Symptoms present on admission: cough and shortness of breath Date of covid positive test: 4/19/23 Vaccination status: vaccinated Imaging: CXR with mild CHF and background pHTN pattern consistent with COPD Oxygen requirements on admission: 2LNC Current oxygen requirements: 1LNC (not on home O2) Medical therapy: remdesivir and steroids Consultants following: none  Anticipated special isolation end date: 4/29/23 Home O2 eval revealed no home O2 needs and patient declined home O2 setup even if qualified as family members are smokers and she is concerned for fire   Acute COPD exacerbation Dyspnea, coughing CXR mild CHF and COPD changes Improved with albuterol inhalation Continue spiriva, xopenex, symbicort, azithromycin decadron Wean O2 to RA, did not qualify for home O2   Acute on chronic HFpEF exacerbation Dyspnea and hypoxia on admit CXR with mild CHF vascular congestion Received IV lasix x1 with clinical improvement TTE 08/2022 with EF 70% with severe MS Lowered home PO lasix with renal recovery Clinically appears euvolemic 4/21 Severe mitral valve stenosis Afib with RVR Warfarin induced coagulopathy Trop 15-17, flat HR 140's in RVR on 4/19 Due to hypoxia/COVID and albuterol inh Resumed home metoprolol and cardizem Goal HR<120 prn lopressor IVP Switched albuterol to xopenex INR 3.7 on warfarin, pharmacy to dose HR controlled since 4/20, INR 1.9   Uncontrolled DM type 2 BG 422, not in DKA; HbA1c 10.3 Suspect due to systemic steroids for COVID/COPD and lack of home insulin Uncontrolled despite home lantus and SSI Increased lantus to 50 U BID in addition to lispor 25U Qac and home metformin Adjust insulin as needed for optimal control   Pseudohyponatremia Na 129 due to hyperglycemia Corrected Na normal on 4/21   Depression and anxiety Wellbutrin    Obesity BMI 44.29 Lifestyle changes recommended
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium decreased, COVID-19, Cardiac failure, Cardiac failure acute, Cardiac failure congestive
Clinical narrative: Patient is a 59 y.o. female patient of, MD with history of Atrial fibrillation/flutter, COPD, DM type 2, Depression, Hypertension, parkinson's disease who presented to Hospital with shortness of breath was found to have acute hypoxic respiratory failure, COVID infection, COPD, and CHF exacerbation.   Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 4/15/2023 Symptoms present on admission: cough and shortness of breath Date of covid positive test: 4/19/23 Vaccination status: vaccinated Imaging: CXR with mild CHF and background pHTN pattern consistent with COPD Oxygen requirements on admission: 2LNC Current oxygen requirements: 1LNC (not on home O2) Medical therapy: remdesivir and steroids Consultants following: none  Anticipated special isolation end date: 4/29/23 Home O2 eval revealed no home O2 needs and patient declined home O2 setup even if qualified as family members are smokers and she is concerned for fire   Acute COPD exacerbation Dyspnea, coughing CXR mild CHF and COPD changes Improved with albuterol inhalation Continue spiriva, xopenex, symbicort, azithromycin decadron Wean O2 to RA, did not qualify for home O2   Acute on chronic HFpEF exacerbation Dyspnea and hypoxia on admit CXR with mild CHF vascular congestion Received IV lasix x1 with clinical improvement TTE 08/2022 with EF 70% with severe MS Lowered home PO lasix with renal recovery Clinically appears euvolemic 4/21 Severe mitral valve stenosis Afib with RVR Warfarin induced coagulopathy Trop 15-17, flat HR 140's in RVR on 4/19 Due to hypoxia/COVID and albuterol inh Resumed home metoprolol and cardizem Goal HR<120 prn lopressor IVP Switched albuterol to xopenex INR 3.7 on warfarin, pharmacy to dose HR controlled since 4/20, INR 1.9   Uncontrolled DM type 2 BG 422, not in DKA; HbA1c 10.3 Suspect due to systemic steroids for COVID/COPD and lack of home insulin Uncontrolled despite home lantus and SSI Increased lantus to 50 U BID in addition to lispor 25U Qac and home metformin Adjust insulin as needed for optimal control   Pseudohyponatremia Na 129 due to hyperglycemia Corrected Na normal on 4/21   Depression and anxiety Wellbutrin    Obesity BMI 44.29 Lifestyle changes recommended
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Chronic obstructive pulmonary disease, Coagulopathy, Condition aggravated, Cough
Clinical narrative: Patient is a 59 y.o. female patient of, MD with history of Atrial fibrillation/flutter, COPD, DM type 2, Depression, Hypertension, parkinson's disease who presented to Hospital with shortness of breath was found to have acute hypoxic respiratory failure, COVID infection, COPD, and CHF exacerbation.   Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 4/15/2023 Symptoms present on admission: cough and shortness of breath Date of covid positive test: 4/19/23 Vaccination status: vaccinated Imaging: CXR with mild CHF and background pHTN pattern consistent with COPD Oxygen requirements on admission: 2LNC Current oxygen requirements: 1LNC (not on home O2) Medical therapy: remdesivir and steroids Consultants following: none  Anticipated special isolation end date: 4/29/23 Home O2 eval revealed no home O2 needs and patient declined home O2 setup even if qualified as family members are smokers and she is concerned for fire   Acute COPD exacerbation Dyspnea, coughing CXR mild CHF and COPD changes Improved with albuterol inhalation Continue spiriva, xopenex, symbicort, azithromycin decadron Wean O2 to RA, did not qualify for home O2   Acute on chronic HFpEF exacerbation Dyspnea and hypoxia on admit CXR with mild CHF vascular congestion Received IV lasix x1 with clinical improvement TTE 08/2022 with EF 70% with severe MS Lowered home PO lasix with renal recovery Clinically appears euvolemic 4/21 Severe mitral valve stenosis Afib with RVR Warfarin induced coagulopathy Trop 15-17, flat HR 140's in RVR on 4/19 Due to hypoxia/COVID and albuterol inh Resumed home metoprolol and cardizem Goal HR<120 prn lopressor IVP Switched albuterol to xopenex INR 3.7 on warfarin, pharmacy to dose HR controlled since 4/20, INR 1.9   Uncontrolled DM type 2 BG 422, not in DKA; HbA1c 10.3 Suspect due to systemic steroids for COVID/COPD and lack of home insulin Uncontrolled despite home lantus and SSI Increased lantus to 50 U BID in addition to lispor 25U Qac and home metformin Adjust insulin as needed for optimal control   Pseudohyponatremia Na 129 due to hyperglycemia Corrected Na normal on 4/21   Depression and anxiety Wellbutrin    Obesity BMI 44.29 Lifestyle changes recommended
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Diabetes mellitus inadequate control, Dyspnoea, Echocardiogram, Ejection fraction normal
Clinical narrative: Patient is a 59 y.o. female patient of, MD with history of Atrial fibrillation/flutter, COPD, DM type 2, Depression, Hypertension, parkinson's disease who presented to Hospital with shortness of breath was found to have acute hypoxic respiratory failure, COVID infection, COPD, and CHF exacerbation.   Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 4/15/2023 Symptoms present on admission: cough and shortness of breath Date of covid positive test: 4/19/23 Vaccination status: vaccinated Imaging: CXR with mild CHF and background pHTN pattern consistent with COPD Oxygen requirements on admission: 2LNC Current oxygen requirements: 1LNC (not on home O2) Medical therapy: remdesivir and steroids Consultants following: none  Anticipated special isolation end date: 4/29/23 Home O2 eval revealed no home O2 needs and patient declined home O2 setup even if qualified as family members are smokers and she is concerned for fire   Acute COPD exacerbation Dyspnea, coughing CXR mild CHF and COPD changes Improved with albuterol inhalation Continue spiriva, xopenex, symbicort, azithromycin decadron Wean O2 to RA, did not qualify for home O2   Acute on chronic HFpEF exacerbation Dyspnea and hypoxia on admit CXR with mild CHF vascular congestion Received IV lasix x1 with clinical improvement TTE 08/2022 with EF 70% with severe MS Lowered home PO lasix with renal recovery Clinically appears euvolemic 4/21 Severe mitral valve stenosis Afib with RVR Warfarin induced coagulopathy Trop 15-17, flat HR 140's in RVR on 4/19 Due to hypoxia/COVID and albuterol inh Resumed home metoprolol and cardizem Goal HR<120 prn lopressor IVP Switched albuterol to xopenex INR 3.7 on warfarin, pharmacy to dose HR controlled since 4/20, INR 1.9   Uncontrolled DM type 2 BG 422, not in DKA; HbA1c 10.3 Suspect due to systemic steroids for COVID/COPD and lack of home insulin Uncontrolled despite home lantus and SSI Increased lantus to 50 U BID in addition to lispor 25U Qac and home metformin Adjust insulin as needed for optimal control   Pseudohyponatremia Na 129 due to hyperglycemia Corrected Na normal on 4/21   Depression and anxiety Wellbutrin    Obesity BMI 44.29 Lifestyle changes recommended
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin increased, Hyperglycaemia, Hypoxia, International normalised ratio increased, Mitral valve stenosis
Clinical narrative: Patient is a 59 y.o. female patient of, MD with history of Atrial fibrillation/flutter, COPD, DM type 2, Depression, Hypertension, parkinson's disease who presented to Hospital with shortness of breath was found to have acute hypoxic respiratory failure, COVID infection, COPD, and CHF exacerbation.   Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 4/15/2023 Symptoms present on admission: cough and shortness of breath Date of covid positive test: 4/19/23 Vaccination status: vaccinated Imaging: CXR with mild CHF and background pHTN pattern consistent with COPD Oxygen requirements on admission: 2LNC Current oxygen requirements: 1LNC (not on home O2) Medical therapy: remdesivir and steroids Consultants following: none  Anticipated special isolation end date: 4/29/23 Home O2 eval revealed no home O2 needs and patient declined home O2 setup even if qualified as family members are smokers and she is concerned for fire   Acute COPD exacerbation Dyspnea, coughing CXR mild CHF and COPD changes Improved with albuterol inhalation Continue spiriva, xopenex, symbicort, azithromycin decadron Wean O2 to RA, did not qualify for home O2   Acute on chronic HFpEF exacerbation Dyspnea and hypoxia on admit CXR with mild CHF vascular congestion Received IV lasix x1 with clinical improvement TTE 08/2022 with EF 70% with severe MS Lowered home PO lasix with renal recovery Clinically appears euvolemic 4/21 Severe mitral valve stenosis Afib with RVR Warfarin induced coagulopathy Trop 15-17, flat HR 140's in RVR on 4/19 Due to hypoxia/COVID and albuterol inh Resumed home metoprolol and cardizem Goal HR<120 prn lopressor IVP Switched albuterol to xopenex INR 3.7 on warfarin, pharmacy to dose HR controlled since 4/20, INR 1.9   Uncontrolled DM type 2 BG 422, not in DKA; HbA1c 10.3 Suspect due to systemic steroids for COVID/COPD and lack of home insulin Uncontrolled despite home lantus and SSI Increased lantus to 50 U BID in addition to lispor 25U Qac and home metformin Adjust insulin as needed for optimal control   Pseudohyponatremia Na 129 due to hyperglycemia Corrected Na normal on 4/21   Depression and anxiety Wellbutrin    Obesity BMI 44.29 Lifestyle changes recommended
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Obesity, Pseudohyponatraemia, Pulmonary congestion, Pulmonary hypertension, SARS-CoV-2 test positive
Clinical narrative: Patient is a 59 y.o. female patient of, MD with history of Atrial fibrillation/flutter, COPD, DM type 2, Depression, Hypertension, parkinson's disease who presented to Hospital with shortness of breath was found to have acute hypoxic respiratory failure, COVID infection, COPD, and CHF exacerbation.   Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 4/15/2023 Symptoms present on admission: cough and shortness of breath Date of covid positive test: 4/19/23 Vaccination status: vaccinated Imaging: CXR with mild CHF and background pHTN pattern consistent with COPD Oxygen requirements on admission: 2LNC Current oxygen requirements: 1LNC (not on home O2) Medical therapy: remdesivir and steroids Consultants following: none  Anticipated special isolation end date: 4/29/23 Home O2 eval revealed no home O2 needs and patient declined home O2 setup even if qualified as family members are smokers and she is concerned for fire   Acute COPD exacerbation Dyspnea, coughing CXR mild CHF and COPD changes Improved with albuterol inhalation Continue spiriva, xopenex, symbicort, azithromycin decadron Wean O2 to RA, did not qualify for home O2   Acute on chronic HFpEF exacerbation Dyspnea and hypoxia on admit CXR with mild CHF vascular congestion Received IV lasix x1 with clinical improvement TTE 08/2022 with EF 70% with severe MS Lowered home PO lasix with renal recovery Clinically appears euvolemic 4/21 Severe mitral valve stenosis Afib with RVR Warfarin induced coagulopathy Trop 15-17, flat HR 140's in RVR on 4/19 Due to hypoxia/COVID and albuterol inh Resumed home metoprolol and cardizem Goal HR<120 prn lopressor IVP Switched albuterol to xopenex INR 3.7 on warfarin, pharmacy to dose HR controlled since 4/20, INR 1.9   Uncontrolled DM type 2 BG 422, not in DKA; HbA1c 10.3 Suspect due to systemic steroids for COVID/COPD and lack of home insulin Uncontrolled despite home lantus and SSI Increased lantus to 50 U BID in addition to lispor 25U Qac and home metformin Adjust insulin as needed for optimal control   Pseudohyponatremia Na 129 due to hyperglycemia Corrected Na normal on 4/21   Depression and anxiety Wellbutrin    Obesity BMI 44.29 Lifestyle changes recommended
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Patient is a 59 y.o. female patient of, MD with history of Atrial fibrillation/flutter, COPD, DM type 2, Depression, Hypertension, parkinson's disease who presented to Hospital with shortness of breath was found to have acute hypoxic respiratory failure, COVID infection, COPD, and CHF exacerbation.   Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 4/15/2023 Symptoms present on admission: cough and shortness of breath Date of covid positive test: 4/19/23 Vaccination status: vaccinated Imaging: CXR with mild CHF and background pHTN pattern consistent with COPD Oxygen requirements on admission: 2LNC Current oxygen requirements: 1LNC (not on home O2) Medical therapy: remdesivir and steroids Consultants following: none  Anticipated special isolation end date: 4/29/23 Home O2 eval revealed no home O2 needs and patient declined home O2 setup even if qualified as family members are smokers and she is concerned for fire   Acute COPD exacerbation Dyspnea, coughing CXR mild CHF and COPD changes Improved with albuterol inhalation Continue spiriva, xopenex, symbicort, azithromycin decadron Wean O2 to RA, did not qualify for home O2   Acute on chronic HFpEF exacerbation Dyspnea and hypoxia on admit CXR with mild CHF vascular congestion Received IV lasix x1 with clinical improvement TTE 08/2022 with EF 70% with severe MS Lowered home PO lasix with renal recovery Clinically appears euvolemic 4/21 Severe mitral valve stenosis Afib with RVR Warfarin induced coagulopathy Trop 15-17, flat HR 140's in RVR on 4/19 Due to hypoxia/COVID and albuterol inh Resumed home metoprolol and cardizem Goal HR<120 prn lopressor IVP Switched albuterol to xopenex INR 3.7 on warfarin, pharmacy to dose HR controlled since 4/20, INR 1.9   Uncontrolled DM type 2 BG 422, not in DKA; HbA1c 10.3 Suspect due to systemic steroids for COVID/COPD and lack of home insulin Uncontrolled despite home lantus and SSI Increased lantus to 50 U BID in addition to lispor 25U Qac and home metformin Adjust insulin as needed for optimal control   Pseudohyponatremia Na 129 due to hyperglycemia Corrected Na normal on 4/21   Depression and anxiety Wellbutrin    Obesity BMI 44.29 Lifestyle changes recommended
Age: 0.67
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient given vaccine 11 days after published expiration date.  Per Moderna stability report, " The vaccine administered on June 20, 2023 from lot number AS7170B   maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic kidney disease, Glomerular filtration rate decreased
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 4/14/2023 CKD STAGE 3B (GFR 30-44)
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Patient presented with redness, swelling, pain on the Left arm below the deltoid muscle where the vaccine was given. The redness is approx. 4 in x 2 in on an angle.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Attention deficit hyperactivity disorder, Coronary artery disease
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 4/9/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA ADHD, UNSPECIFIED
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Hypoxia
Clinical narrative: HYPOXEMIA 4/1/2023 ATRIAL FIBRILLATION, UNSPECIFIED
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Large erythema and bruising noted to Left thigh. Patient states it is not painful, but very itchy. Swelling has started to go down. Treatment includes:  Benadryl liquid 10 ml twice a day for next few days   Topical triamcinolone cream twice a day for up to 7 days (until clear)    Cool pack or heat pack (would like to try warm with the bruising under rash area)    Ibuprofen as needed for pain
Age: 1.83
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Nurse preparing vaccine errrantly diluted vaccine vial with 0.22ml  of saline when 2.2ml of saline is required by manufacturer to dilute vaccine vial. Nurse gave 0.2ml dose of concentrated vaccine to patient. When realized error after vaccine already administered,patient had already gone home. Nurse  notified MD and Nurse Manger. Nurse manager notified parent of patient of concentrated dose adminsered in error. Parent reported patient was busy coloring and watching favorite movie and decline phone appointment with MD. Parent give MD instruction via Nurse Manager to observe for 24 hours for adverse affects and call if concerns/questions. Telephone appt made for next day for follow up if needed.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Hypotension, Hypoxia, Pneumonia, Respiratory failure
Clinical narrative: I95.9 HYPOTENSION 4/15/2023 PNEUMONIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/21/2023 PNEUMONIA R09.02 HYPOXIA 4/15/2023 PNEUMONIA
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cholecystitis acute, Hypotension
Clinical narrative: I95.9 HYPOTENSION 4/14/2023 ACUTE CHOLECYSTITIS
Age: 17.0
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, IPV, MMR, MNQ, PNC15, TDAP, VARCEL
Symptoms: Tuberculin test positive
Clinical narrative: No symptoms have been reported
Age: 61.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: COVID-19, Exposure to SARS-CoV-2, Nasal congestion, Pulmonary embolism, Rhinorrhoea
Clinical narrative: In January 2023, I was admitted to the hospital to be treated for multiple pulmonary embolisms. On 1/27/2023, I was transferred to a rehabilitation center. While I was at the rehabilitation center, I was exposed to COVID-19. On 2/11/2023, I developed a stuffy, runny nose. I was still in the rehab center, and they administered a rapid antigen test, which yielded a positive result. They told me that if I wished to receive antivirals, I would have to travel back and forth between the rehab center and the hospital daily to receive them. I didn't want to go through that hassle, so I decided not to get the antivirals. While I was at the rehabilitation center, I was given guaifenesin. Overall, my symptoms were mild. I didn't develop any symptoms besides a stuffy, runny nose, which lasted for only about three days. I quickly recovered from the COVID-19 and was released from the rehab center on 2/21/2023 or 2/22/2023.
Age: 61.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: SARS-CoV-2 test positive
Clinical narrative: In January 2023, I was admitted to the hospital to be treated for multiple pulmonary embolisms. On 1/27/2023, I was transferred to a rehabilitation center. While I was at the rehabilitation center, I was exposed to COVID-19. On 2/11/2023, I developed a stuffy, runny nose. I was still in the rehab center, and they administered a rapid antigen test, which yielded a positive result. They told me that if I wished to receive antivirals, I would have to travel back and forth between the rehab center and the hospital daily to receive them. I didn't want to go through that hassle, so I decided not to get the antivirals. While I was at the rehabilitation center, I was given guaifenesin. Overall, my symptoms were mild. I didn't develop any symptoms besides a stuffy, runny nose, which lasted for only about three days. I quickly recovered from the COVID-19 and was released from the rehab center on 2/21/2023 or 2/22/2023.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Pyrexia
Clinical narrative: Erythema, induration, fever
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; administered MMR-II following the temperature excursion; This spontaneous report was received from a healthcare business professional (HBP) referring to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 13-JUN-2023, the patient received improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) 0.5 milliliter once (strength and dose not reported, lot # W035040, expiration date: 10-MAY-2024) for prophylaxis (product storage error). The vaccine was exposed to 48.8 degrees Fahrenheit for 0 hours 40 minutes 0 seconds. No additional adverse events were reported.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2306USA008250:
Sex: U
Vaccine: MMR, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No additional AE; vaccines that underwent a temperature excursion evaluated; a patient was administered ROTATEQ and MMR-II; This spontaneous report was received from a healthcare business professional (HBP) referring to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 06-JUN-2023, the patient received improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter once orally (strength not reported, lot # 1837119, expiration date: 25-SEP-2023) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) 0.5 milliliter once (strength and route not reported, lot # W035040, expiration date: 10-MAY-2024) for prophylaxis (product storage error, product administered to patient of inappropriate age). Both vaccines were exposed to 48.8 degrees Fahrenheit (F) for 0 hours 40 minutes 0 seconds. The vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had a previous temperature excursion 58.2 F for 8 hours 7 minutes and 50 seconds. No data logger was involved. No additional adverse events were reported.; Sender's Comments:  US-009507513-2306USA008245:
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; Temperature: 70F, Time frame: 0 Hours 9 Minutes 0 Seconds; This spontaneous report was received from a pharmacist and a registered nurse referring to a 13 months old patient of unknown gender. No information on the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided.  On 02-MAR-2023, varicella virus vaccine live (Oka/Merck) (VARIVAX) was exposed to 70 degrees Fahrenheit (F) for 0 hours 9 minutes 0 seconds. On 06-JUN-2023, the patient received the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter once (strength and route not reported, lot # W025273, expiration date: 10-AUG-2024) for prophylaxis (product storage error). No additional adverse events were reported.  This is one of multiple cases from the same reporter.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP reported that she gave an 18 year old patient; No additional AE; This spontaneous report was received from an other health professional and refers to a 18-year-old of unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.     On an unknown date the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (exact dose, dose number, route and site of administration, lot# and expiration date were not provided) (product administered to patient of inappropriate age and no adverse event).
Age: 1.5
Sex: M
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effects were reported; TE for vaccines which was also administered to a patient; This spontaneous report was received from a medical assistant and refers to 18-month-old male patient. Information about the patient's medical history, concomitant medications and current conditions was not provided.  On 20-JUN-2023, the patient was vaccinated with improperly stored dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (formulation pre-filled syringe, 0.5 mL, in right thigh, lot #W039033, expiration date 01-OCT-2024, route of administration was not provided) for prophylaxis (Product storage error).  The suspect vaccine experienced a temperature excursion of 49.1 degrees Fahrenheit (F) for 34 minutes and previous excursions of 35.9 F for 2 minutes and again 35.9 F for 2 minutes. No adverse side effects were reported with the administration of the vaccine. No additional adverse event (AE) information provided (No adverse event). No product quality complaint (PQC).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: HCP called to report AE for supported VARIVAX TE administered to patient; No additional AE; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On an unknown date the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # W039697 and expiration date 13-DEC-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product storage error and no adverse event). The temperature excursion was from 6°F up to 14°F (7.5) for 597 Hours 0 Minutes 0 Seconds. No Previous Excursions.
Sex: M
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effectes were reported; HCP called to report a TE for VAXNEUVANCE (Lot #W039033; Expiration 10/01/2024; current excursion (49.1F) for 34 minutes; with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes) and ROTATEQ (Lot #1968385; Expiration; This spontaneous report was received from a medical assistant and refers to a 4 month old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 08-JUN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) 0.5 mL (lot # W039033, expiration date: 01-OCT-2024) in the left thigh (route of administration not provided); and with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 mL (lot # 1968385, expiration date: 22-MAY-2024), orally, both as prophylaxis; which underwent a current temperature excursion at 49.1 Fahrenheit (F) for 34 minutes (with 2 previous temperature excursions at 35.9 F for 2 minutes each). No adverse side effects were reported for the patient.
Sex: U
Vaccine: MMRV
Symptoms: Product expiration date issue, Product storage error
Clinical narrative: The vaccines were "short dated" and new expiration date of 6/30/2023 was given; Caller reports that they had a temperature excursion 3/31/2023 which they called into the regulatory agency. The vaccines were "short dated" and a new expiration date of 6/30/2023 was given. She states that the products were labeled but still accidentally adminis; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 31-MAR-2023, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # W035470, expiration date reported as 02-MAY-2024,  but upon internal review stablished as 06-MAY-2024) underwent a temperature excursion between 6 up to 14 Fahrenheit (F) for 4 hours, 14 F up to 46 F for 4 hours and 47 F to 77 F (50 F) for 3 hours and 57 minutes for a total time frame of excursion of 11 hours 57 minutes (product storage error). It was reported that due to the temperature excursion, the expiration date of the vaccine was short date to 30-JUN-2023 (product expiration date issue); however, on this date, the patient was accidentally vaccinated with a dose of this vaccine 0.5 mL (route of administration, anatomical location not provided) as prophylaxis. No additional information provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional adverse events; HCP reports that the patient  missed her normal dosing schedule of GARDASIL 9. Patient received first dose in  November 2022 ( exact date unknown) and her second dose on 05/21/2023( this is  beyond the recommendation of dosing schedule). Exact date; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       In November 2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL/series, for prophylaxis. Then,  on 21-MAY-2023 the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL/series, for prophylaxis (strength, route of administration, lot # and expiration date were not reported). The reporter stated this was beyond the recommendation of dosing schedule (inappropriate schedule of product administration). The exact date patient the should have received her second dose was unknown. No additional adverse events were reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse Event; Customer reported an AE for MMRII. The caller said she reported this to Merck previously, however original case was not able to be located. Company awareness date marked 7/12/2023. The caller said the patient received a dose of MMRII on 7/10/2023, af; This spontaneous report as received from an other health care professional refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JUL-2023, the patient was vaccinated with improper storage dose of (1 dose) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin), (M-M-R II) lot #w039699, expiration date: 25-MAY-2024, (exact dose, route of administration and anatomical location were not reported) for prophylaxis. On the same day, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin), (M-M-R II) was exposed to the temperature excursion of 48.8 degrees Fahrenheit for 7 hours and 45 minutes (product storage error). There were no additional adverse events reported (no adverse event).  Lot number w039699 (expiration date: 25-MAY-2024 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with albumin status rHa.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My husband got that illness and he got two vaccines /suspected vaccination failure; My husband got that shingles illness; This serious 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: My husband got that illness and he got two vaccines /suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: My husband got that shingles illness). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUL-2023 This case was reported by a patient's wife via interactive digital media. The reporter reported that the patient experienced that shingles illness and he received two shingles vaccine. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.