chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium decreased, COVID-19, COVID-19 pneumonia, Condition aggravated, Cough
Clinical narrative: Clinical Summary Patient is a 82 y.o. female with a history of Afib, HTN, provoked PE who presented to the ED with cough, shortness of breath, found to have COVID 19 with hypoxic and was transferred to the ICU 12/15/2022 for further care and required HHFNC. Another HCF assumed care out of ICU.   1. Acute hypoxic respiratory failure: secondary to COVID 19. CTPA was negative for PE, with pulmonary edema and small Rt pleural effusion. Was initially on NRB then HHFNC and now weaned to RA. S/P diuresis. Home O2 evaluation completed no need for home o2.  2. COVID 19 pneumonia: vaccinated. Symptom onset 12/14. Positve on 12/15/22. Continued dexamethasone (started 12/15/22).  3. Afib: with brief episode of RVR on admission. Secondary to MR. Continued BB (pt stated she is not sure if she will continue this at home as how it makes her feel). Not on AC or antiarrythmic, stopped taking 1 year ago recommended continue AC and discuss with her PCP prior to stopping pt stated she is not sure if she will take it. Continue to monitor.  4. HTN: Per history. BP stable. Continued current medications (on half of home dose BB). Continue to monitor as outpatient 5. Hypokalemia: K 3.2. monitor and replace as needed. Resolved 6. Hyponatremia: Na 130. Improving. Resolved. 7. Elevated troponin: suspected demand ischemia secondary to hypoxia. Denies chest pain. Down trended. No further ischemic evaluation at this time 8. Reported weight loss: 10-12 lbs in the past year. May consider OP work up.  9. Incidental finding: Aortic root dilation seen on ECHO mild 3.5 cm. Recommend OP follow up with ECHO.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Diuretic therapy, Dyspnoea, Echocardiogram abnormal, Hypokalaemia, Hyponatraemia
Clinical narrative: Clinical Summary Patient is a 82 y.o. female with a history of Afib, HTN, provoked PE who presented to the ED with cough, shortness of breath, found to have COVID 19 with hypoxic and was transferred to the ICU 12/15/2022 for further care and required HHFNC. Another HCF assumed care out of ICU.   1. Acute hypoxic respiratory failure: secondary to COVID 19. CTPA was negative for PE, with pulmonary edema and small Rt pleural effusion. Was initially on NRB then HHFNC and now weaned to RA. S/P diuresis. Home O2 evaluation completed no need for home o2.  2. COVID 19 pneumonia: vaccinated. Symptom onset 12/14. Positve on 12/15/22. Continued dexamethasone (started 12/15/22).  3. Afib: with brief episode of RVR on admission. Secondary to MR. Continued BB (pt stated she is not sure if she will continue this at home as how it makes her feel). Not on AC or antiarrythmic, stopped taking 1 year ago recommended continue AC and discuss with her PCP prior to stopping pt stated she is not sure if she will take it. Continue to monitor.  4. HTN: Per history. BP stable. Continued current medications (on half of home dose BB). Continue to monitor as outpatient 5. Hypokalemia: K 3.2. monitor and replace as needed. Resolved 6. Hyponatremia: Na 130. Improving. Resolved. 7. Elevated troponin: suspected demand ischemia secondary to hypoxia. Denies chest pain. Down trended. No further ischemic evaluation at this time 8. Reported weight loss: 10-12 lbs in the past year. May consider OP work up.  9. Incidental finding: Aortic root dilation seen on ECHO mild 3.5 cm. Recommend OP follow up with ECHO.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Intensive care, Malaise, Mitral valve incompetence, Myocardial ischaemia
Clinical narrative: Clinical Summary Patient is a 82 y.o. female with a history of Afib, HTN, provoked PE who presented to the ED with cough, shortness of breath, found to have COVID 19 with hypoxic and was transferred to the ICU 12/15/2022 for further care and required HHFNC. Another HCF assumed care out of ICU.   1. Acute hypoxic respiratory failure: secondary to COVID 19. CTPA was negative for PE, with pulmonary edema and small Rt pleural effusion. Was initially on NRB then HHFNC and now weaned to RA. S/P diuresis. Home O2 evaluation completed no need for home o2.  2. COVID 19 pneumonia: vaccinated. Symptom onset 12/14. Positve on 12/15/22. Continued dexamethasone (started 12/15/22).  3. Afib: with brief episode of RVR on admission. Secondary to MR. Continued BB (pt stated she is not sure if she will continue this at home as how it makes her feel). Not on AC or antiarrythmic, stopped taking 1 year ago recommended continue AC and discuss with her PCP prior to stopping pt stated she is not sure if she will take it. Continue to monitor.  4. HTN: Per history. BP stable. Continued current medications (on half of home dose BB). Continue to monitor as outpatient 5. Hypokalemia: K 3.2. monitor and replace as needed. Resolved 6. Hyponatremia: Na 130. Improving. Resolved. 7. Elevated troponin: suspected demand ischemia secondary to hypoxia. Denies chest pain. Down trended. No further ischemic evaluation at this time 8. Reported weight loss: 10-12 lbs in the past year. May consider OP work up.  9. Incidental finding: Aortic root dilation seen on ECHO mild 3.5 cm. Recommend OP follow up with ECHO.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, Pulmonary oedema, SARS-CoV-2 test positive, Troponin increased, Weight decreased
Clinical narrative: Clinical Summary Patient is a 82 y.o. female with a history of Afib, HTN, provoked PE who presented to the ED with cough, shortness of breath, found to have COVID 19 with hypoxic and was transferred to the ICU 12/15/2022 for further care and required HHFNC. Another HCF assumed care out of ICU.   1. Acute hypoxic respiratory failure: secondary to COVID 19. CTPA was negative for PE, with pulmonary edema and small Rt pleural effusion. Was initially on NRB then HHFNC and now weaned to RA. S/P diuresis. Home O2 evaluation completed no need for home o2.  2. COVID 19 pneumonia: vaccinated. Symptom onset 12/14. Positve on 12/15/22. Continued dexamethasone (started 12/15/22).  3. Afib: with brief episode of RVR on admission. Secondary to MR. Continued BB (pt stated she is not sure if she will continue this at home as how it makes her feel). Not on AC or antiarrythmic, stopped taking 1 year ago recommended continue AC and discuss with her PCP prior to stopping pt stated she is not sure if she will take it. Continue to monitor.  4. HTN: Per history. BP stable. Continued current medications (on half of home dose BB). Continue to monitor as outpatient 5. Hypokalemia: K 3.2. monitor and replace as needed. Resolved 6. Hyponatremia: Na 130. Improving. Resolved. 7. Elevated troponin: suspected demand ischemia secondary to hypoxia. Denies chest pain. Down trended. No further ischemic evaluation at this time 8. Reported weight loss: 10-12 lbs in the past year. May consider OP work up.  9. Incidental finding: Aortic root dilation seen on ECHO mild 3.5 cm. Recommend OP follow up with ECHO.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever, chills, headache
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: RESIDENT HAD ALREADY RECEIVED A PFIZER BIVALENT BOOSTER  IN OCTOBER 2022 BUT DUE TO BOOKKEEPING ERROR SHE WAS ADMINISTERD A MODERNA BIVALENT BOOSTER  TODAY 1/6/2023
Age: 74.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Resident received 2 Bivalents, Moderna - 3 months apart. Bivalent 1 on 10/05/2022 (lot #AS7165B) and Bivalent 2 on 01/05/2023 (lot #AS7171B). No adverse ill effects noted. Notified attending PA-C and Pharmacist Consultant no recommendations for treatment, but to monitor resident for potential, common, adverse effects.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Colon cancer stage IV, Dyspnoea, Lymphoma, Metastases to lung
Clinical narrative: Since Jan 2022 had unintentional weight loss of 45 lb. Then in nov 2022 had shortness of breath. Work up eventually showed stage 4 colon cancer with Mets to lungs and also diagnosed with lymphoma.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Chronic obstructive pulmonary disease, Computerised tomogram abdomen abnormal
Clinical narrative: Clinical Summary Patient is a 88 y.o. female with a history of HTN and COPD who presented to Observation 12/16/2022 with 10 days of fatigue, cough, malaise and home positive COVID-19 test 12/12/22. She required O2 on admit. Course prolonged by placement.    1. COVID-19 Pneumonia: Positive home test on 12/12/22 and PCP started Paxlovid 12/14/22. Positive COVID-19 on 12/16/22 at the HCF. Required O2 on admit. Decadron x 10 days, completed on 12/26/22. 2. Acute COPD Exacerbation: with concomitant smoking. Increased mucous production and hypoxia and underlying COVID. S/p course of zithromax and omnicef. Steroids continued as above. Inhalers continued. 3. Acute Hypoxic Respiratory Failure: Not on home O2. Due to COVID. Requiring 2L O2; CT PE 12/24/22: no PE, showed R lower lobe pneumonia. Monitor at SNF, RA at discharge. 4. Community acquired pneumonia: seen on CT PE 12/24/22: posterior consolidative mass L lower lobe. Ceftriaxone / azithromycin continued. Radiology recommended follow-up imaging 4-6 weeks post treatment is recommended to assess for malignancy, if in line with goals of care. 5. Elevated Troponins: suspect demand ischemia. Troponin 45 to 41. EKG nonacute. TTE 12/19/22 showed stable EF 51%, no wall motion abnormalities 6. Abnormal CT scan: CT PE 12/24/22: gastric wall thickening, could be gastritis or infiltrative process. Pt declined GI consult for upper endoscopy  7. Hydronephrosis: bilateral hydronephrosis, with severely distended left extrarenal pelvis or large parapelvic cyst on CT chest 12/24/22, radiology suggested correlation with CT urogram, pt declined on multiple occasions. Deferred urology consult as creatinine normal, recommend outpatient urology referral.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Condition aggravated, Cough, Echocardiogram normal, Ejection fraction normal
Clinical narrative: Clinical Summary Patient is a 88 y.o. female with a history of HTN and COPD who presented to Observation 12/16/2022 with 10 days of fatigue, cough, malaise and home positive COVID-19 test 12/12/22. She required O2 on admit. Course prolonged by placement.    1. COVID-19 Pneumonia: Positive home test on 12/12/22 and PCP started Paxlovid 12/14/22. Positive COVID-19 on 12/16/22 at the HCF. Required O2 on admit. Decadron x 10 days, completed on 12/26/22. 2. Acute COPD Exacerbation: with concomitant smoking. Increased mucous production and hypoxia and underlying COVID. S/p course of zithromax and omnicef. Steroids continued as above. Inhalers continued. 3. Acute Hypoxic Respiratory Failure: Not on home O2. Due to COVID. Requiring 2L O2; CT PE 12/24/22: no PE, showed R lower lobe pneumonia. Monitor at SNF, RA at discharge. 4. Community acquired pneumonia: seen on CT PE 12/24/22: posterior consolidative mass L lower lobe. Ceftriaxone / azithromycin continued. Radiology recommended follow-up imaging 4-6 weeks post treatment is recommended to assess for malignancy, if in line with goals of care. 5. Elevated Troponins: suspect demand ischemia. Troponin 45 to 41. EKG nonacute. TTE 12/19/22 showed stable EF 51%, no wall motion abnormalities 6. Abnormal CT scan: CT PE 12/24/22: gastric wall thickening, could be gastritis or infiltrative process. Pt declined GI consult for upper endoscopy  7. Hydronephrosis: bilateral hydronephrosis, with severely distended left extrarenal pelvis or large parapelvic cyst on CT chest 12/24/22, radiology suggested correlation with CT urogram, pt declined on multiple occasions. Deferred urology consult as creatinine normal, recommend outpatient urology referral.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fatigue, Gastrointestinal wall thickening, Hydronephrosis, Hypoxia
Clinical narrative: Clinical Summary Patient is a 88 y.o. female with a history of HTN and COPD who presented to Observation 12/16/2022 with 10 days of fatigue, cough, malaise and home positive COVID-19 test 12/12/22. She required O2 on admit. Course prolonged by placement.    1. COVID-19 Pneumonia: Positive home test on 12/12/22 and PCP started Paxlovid 12/14/22. Positive COVID-19 on 12/16/22 at the HCF. Required O2 on admit. Decadron x 10 days, completed on 12/26/22. 2. Acute COPD Exacerbation: with concomitant smoking. Increased mucous production and hypoxia and underlying COVID. S/p course of zithromax and omnicef. Steroids continued as above. Inhalers continued. 3. Acute Hypoxic Respiratory Failure: Not on home O2. Due to COVID. Requiring 2L O2; CT PE 12/24/22: no PE, showed R lower lobe pneumonia. Monitor at SNF, RA at discharge. 4. Community acquired pneumonia: seen on CT PE 12/24/22: posterior consolidative mass L lower lobe. Ceftriaxone / azithromycin continued. Radiology recommended follow-up imaging 4-6 weeks post treatment is recommended to assess for malignancy, if in line with goals of care. 5. Elevated Troponins: suspect demand ischemia. Troponin 45 to 41. EKG nonacute. TTE 12/19/22 showed stable EF 51%, no wall motion abnormalities 6. Abnormal CT scan: CT PE 12/24/22: gastric wall thickening, could be gastritis or infiltrative process. Pt declined GI consult for upper endoscopy  7. Hydronephrosis: bilateral hydronephrosis, with severely distended left extrarenal pelvis or large parapelvic cyst on CT chest 12/24/22, radiology suggested correlation with CT urogram, pt declined on multiple occasions. Deferred urology consult as creatinine normal, recommend outpatient urology referral.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Lung consolidation, Malaise, Myocardial ischaemia, Pneumonia, Pulmonary mass
Clinical narrative: Clinical Summary Patient is a 88 y.o. female with a history of HTN and COPD who presented to Observation 12/16/2022 with 10 days of fatigue, cough, malaise and home positive COVID-19 test 12/12/22. She required O2 on admit. Course prolonged by placement.    1. COVID-19 Pneumonia: Positive home test on 12/12/22 and PCP started Paxlovid 12/14/22. Positive COVID-19 on 12/16/22 at the HCF. Required O2 on admit. Decadron x 10 days, completed on 12/26/22. 2. Acute COPD Exacerbation: with concomitant smoking. Increased mucous production and hypoxia and underlying COVID. S/p course of zithromax and omnicef. Steroids continued as above. Inhalers continued. 3. Acute Hypoxic Respiratory Failure: Not on home O2. Due to COVID. Requiring 2L O2; CT PE 12/24/22: no PE, showed R lower lobe pneumonia. Monitor at SNF, RA at discharge. 4. Community acquired pneumonia: seen on CT PE 12/24/22: posterior consolidative mass L lower lobe. Ceftriaxone / azithromycin continued. Radiology recommended follow-up imaging 4-6 weeks post treatment is recommended to assess for malignancy, if in line with goals of care. 5. Elevated Troponins: suspect demand ischemia. Troponin 45 to 41. EKG nonacute. TTE 12/19/22 showed stable EF 51%, no wall motion abnormalities 6. Abnormal CT scan: CT PE 12/24/22: gastric wall thickening, could be gastritis or infiltrative process. Pt declined GI consult for upper endoscopy  7. Hydronephrosis: bilateral hydronephrosis, with severely distended left extrarenal pelvis or large parapelvic cyst on CT chest 12/24/22, radiology suggested correlation with CT urogram, pt declined on multiple occasions. Deferred urology consult as creatinine normal, recommend outpatient urology referral.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Renal cyst, SARS-CoV-2 test positive, Secretion discharge, Tobacco user, Troponin increased
Clinical narrative: Clinical Summary Patient is a 88 y.o. female with a history of HTN and COPD who presented to Observation 12/16/2022 with 10 days of fatigue, cough, malaise and home positive COVID-19 test 12/12/22. She required O2 on admit. Course prolonged by placement.    1. COVID-19 Pneumonia: Positive home test on 12/12/22 and PCP started Paxlovid 12/14/22. Positive COVID-19 on 12/16/22 at the HCF. Required O2 on admit. Decadron x 10 days, completed on 12/26/22. 2. Acute COPD Exacerbation: with concomitant smoking. Increased mucous production and hypoxia and underlying COVID. S/p course of zithromax and omnicef. Steroids continued as above. Inhalers continued. 3. Acute Hypoxic Respiratory Failure: Not on home O2. Due to COVID. Requiring 2L O2; CT PE 12/24/22: no PE, showed R lower lobe pneumonia. Monitor at SNF, RA at discharge. 4. Community acquired pneumonia: seen on CT PE 12/24/22: posterior consolidative mass L lower lobe. Ceftriaxone / azithromycin continued. Radiology recommended follow-up imaging 4-6 weeks post treatment is recommended to assess for malignancy, if in line with goals of care. 5. Elevated Troponins: suspect demand ischemia. Troponin 45 to 41. EKG nonacute. TTE 12/19/22 showed stable EF 51%, no wall motion abnormalities 6. Abnormal CT scan: CT PE 12/24/22: gastric wall thickening, could be gastritis or infiltrative process. Pt declined GI consult for upper endoscopy  7. Hydronephrosis: bilateral hydronephrosis, with severely distended left extrarenal pelvis or large parapelvic cyst on CT chest 12/24/22, radiology suggested correlation with CT urogram, pt declined on multiple occasions. Deferred urology consult as creatinine normal, recommend outpatient urology referral.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Contracted Covid after receiving vaccine.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: At injection site: redness, firm/indurated, very tender. Overall: severe headache developed at 3pm (3 hours after vaccine injection) with no other cause which was not otherwise responsive to acetaminophen or hydration.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Death
Clinical narrative: Patient expired within 30 days of administration of bivalent.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia, Laboratory test abnormal, Rectal cancer
Clinical narrative: Patient had blood in stool. Tests and workup showed rectal cancer
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Developed a mild case of Covid in December. Aches, sore throat, fatigue, cough, runny nose
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Developed a mild case of Covid in December. Aches, sore throat, fatigue, cough, runny nose
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blood gases, Blood pH decreased, COVID-19, COVID-19 pneumonia
Clinical narrative: 66 y.o. male patient with history of COPD and hypertension presented to hospital with acute respiratory failure with COVID-19 pneumonia   Covid-19 Viral Pneumonia Date of onset of symptoms: 12/22/2022 Symptoms present on admission: shortness of breath Date of covid positive test: 12/23/2022 Vaccination status: vaccinated but did not get 2022 booster Imaging: CXR with left lower lobe infiltrate Oxygen requirements on admission: BiPAP Current oxygen requirements: NC Medical therapy: steroids (continue 2 more days), rocephin, and zithromax (completed); started remdesivir 12/26 (completed)  Consultants following: Pulm Anticipated special isolation end date: 1/2/2023 Weaned down to 6L NC 12/29 -> weaned to 4 L NC prior to discharge, patient uses 3-6 L at home.  He has a pulse ox at home and was instructed to keep O2 sat greater than 88%.  He also has a CPAP machine that he uses at night.  He will need to follow up with his PCP and pulmonology    Acute on chronic hypoxic and hypercapnic respiratory failure Community acquired pneumonia Normally wears 3L O2 at home but occasionally bumps up O2 to 6L with activity, required BiPAP at 50% FiO2 on transfer VBG - pH 7.31, pCO2 77, pO2 58 CXR as above appears concerning for CAP in addition to COVID-19 PNA Azithromycin (completed 5 days) and Rocephin completed 7 days  Wean oxygen as tolerated Continue pulmonary toilet, showed patient how to use incentive spirometer  Pulmonology following   COPD exacerbation Increasing dyspnea, cough, and sputum production w/ color change Gold stage IV with FEV1 0.65 25% Treating above underlying causes Duonebs and inhalers ordered   Primary hypertension Continue lisinopril Restarting home amlodipine 12/29
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Chronic obstructive pulmonary disease, Condition aggravated, Cough, Dyspnoea
Clinical narrative: 66 y.o. male patient with history of COPD and hypertension presented to hospital with acute respiratory failure with COVID-19 pneumonia   Covid-19 Viral Pneumonia Date of onset of symptoms: 12/22/2022 Symptoms present on admission: shortness of breath Date of covid positive test: 12/23/2022 Vaccination status: vaccinated but did not get 2022 booster Imaging: CXR with left lower lobe infiltrate Oxygen requirements on admission: BiPAP Current oxygen requirements: NC Medical therapy: steroids (continue 2 more days), rocephin, and zithromax (completed); started remdesivir 12/26 (completed)  Consultants following: Pulm Anticipated special isolation end date: 1/2/2023 Weaned down to 6L NC 12/29 -> weaned to 4 L NC prior to discharge, patient uses 3-6 L at home.  He has a pulse ox at home and was instructed to keep O2 sat greater than 88%.  He also has a CPAP machine that he uses at night.  He will need to follow up with his PCP and pulmonology    Acute on chronic hypoxic and hypercapnic respiratory failure Community acquired pneumonia Normally wears 3L O2 at home but occasionally bumps up O2 to 6L with activity, required BiPAP at 50% FiO2 on transfer VBG - pH 7.31, pCO2 77, pO2 58 CXR as above appears concerning for CAP in addition to COVID-19 PNA Azithromycin (completed 5 days) and Rocephin completed 7 days  Wean oxygen as tolerated Continue pulmonary toilet, showed patient how to use incentive spirometer  Pulmonology following   COPD exacerbation Increasing dyspnea, cough, and sputum production w/ color change Gold stage IV with FEV1 0.65 25% Treating above underlying causes Duonebs and inhalers ordered   Primary hypertension Continue lisinopril Restarting home amlodipine 12/29
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Forced expiratory volume, Fraction of inspired oxygen, Lung infiltration, PCO2 increased, PO2 decreased
Clinical narrative: 66 y.o. male patient with history of COPD and hypertension presented to hospital with acute respiratory failure with COVID-19 pneumonia   Covid-19 Viral Pneumonia Date of onset of symptoms: 12/22/2022 Symptoms present on admission: shortness of breath Date of covid positive test: 12/23/2022 Vaccination status: vaccinated but did not get 2022 booster Imaging: CXR with left lower lobe infiltrate Oxygen requirements on admission: BiPAP Current oxygen requirements: NC Medical therapy: steroids (continue 2 more days), rocephin, and zithromax (completed); started remdesivir 12/26 (completed)  Consultants following: Pulm Anticipated special isolation end date: 1/2/2023 Weaned down to 6L NC 12/29 -> weaned to 4 L NC prior to discharge, patient uses 3-6 L at home.  He has a pulse ox at home and was instructed to keep O2 sat greater than 88%.  He also has a CPAP machine that he uses at night.  He will need to follow up with his PCP and pulmonology    Acute on chronic hypoxic and hypercapnic respiratory failure Community acquired pneumonia Normally wears 3L O2 at home but occasionally bumps up O2 to 6L with activity, required BiPAP at 50% FiO2 on transfer VBG - pH 7.31, pCO2 77, pO2 58 CXR as above appears concerning for CAP in addition to COVID-19 PNA Azithromycin (completed 5 days) and Rocephin completed 7 days  Wean oxygen as tolerated Continue pulmonary toilet, showed patient how to use incentive spirometer  Pulmonology following   COPD exacerbation Increasing dyspnea, cough, and sputum production w/ color change Gold stage IV with FEV1 0.65 25% Treating above underlying causes Duonebs and inhalers ordered   Primary hypertension Continue lisinopril Restarting home amlodipine 12/29
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Pneumonia viral, Positive airway pressure therapy, Productive cough, Respiratory failure
Clinical narrative: 66 y.o. male patient with history of COPD and hypertension presented to hospital with acute respiratory failure with COVID-19 pneumonia   Covid-19 Viral Pneumonia Date of onset of symptoms: 12/22/2022 Symptoms present on admission: shortness of breath Date of covid positive test: 12/23/2022 Vaccination status: vaccinated but did not get 2022 booster Imaging: CXR with left lower lobe infiltrate Oxygen requirements on admission: BiPAP Current oxygen requirements: NC Medical therapy: steroids (continue 2 more days), rocephin, and zithromax (completed); started remdesivir 12/26 (completed)  Consultants following: Pulm Anticipated special isolation end date: 1/2/2023 Weaned down to 6L NC 12/29 -> weaned to 4 L NC prior to discharge, patient uses 3-6 L at home.  He has a pulse ox at home and was instructed to keep O2 sat greater than 88%.  He also has a CPAP machine that he uses at night.  He will need to follow up with his PCP and pulmonology    Acute on chronic hypoxic and hypercapnic respiratory failure Community acquired pneumonia Normally wears 3L O2 at home but occasionally bumps up O2 to 6L with activity, required BiPAP at 50% FiO2 on transfer VBG - pH 7.31, pCO2 77, pO2 58 CXR as above appears concerning for CAP in addition to COVID-19 PNA Azithromycin (completed 5 days) and Rocephin completed 7 days  Wean oxygen as tolerated Continue pulmonary toilet, showed patient how to use incentive spirometer  Pulmonology following   COPD exacerbation Increasing dyspnea, cough, and sputum production w/ color change Gold stage IV with FEV1 0.65 25% Treating above underlying causes Duonebs and inhalers ordered   Primary hypertension Continue lisinopril Restarting home amlodipine 12/29
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sputum discoloured
Clinical narrative: 66 y.o. male patient with history of COPD and hypertension presented to hospital with acute respiratory failure with COVID-19 pneumonia   Covid-19 Viral Pneumonia Date of onset of symptoms: 12/22/2022 Symptoms present on admission: shortness of breath Date of covid positive test: 12/23/2022 Vaccination status: vaccinated but did not get 2022 booster Imaging: CXR with left lower lobe infiltrate Oxygen requirements on admission: BiPAP Current oxygen requirements: NC Medical therapy: steroids (continue 2 more days), rocephin, and zithromax (completed); started remdesivir 12/26 (completed)  Consultants following: Pulm Anticipated special isolation end date: 1/2/2023 Weaned down to 6L NC 12/29 -> weaned to 4 L NC prior to discharge, patient uses 3-6 L at home.  He has a pulse ox at home and was instructed to keep O2 sat greater than 88%.  He also has a CPAP machine that he uses at night.  He will need to follow up with his PCP and pulmonology    Acute on chronic hypoxic and hypercapnic respiratory failure Community acquired pneumonia Normally wears 3L O2 at home but occasionally bumps up O2 to 6L with activity, required BiPAP at 50% FiO2 on transfer VBG - pH 7.31, pCO2 77, pO2 58 CXR as above appears concerning for CAP in addition to COVID-19 PNA Azithromycin (completed 5 days) and Rocephin completed 7 days  Wean oxygen as tolerated Continue pulmonary toilet, showed patient how to use incentive spirometer  Pulmonology following   COPD exacerbation Increasing dyspnea, cough, and sputum production w/ color change Gold stage IV with FEV1 0.65 25% Treating above underlying causes Duonebs and inhalers ordered   Primary hypertension Continue lisinopril Restarting home amlodipine 12/29
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: patient was under-dosed
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anaemia, Angiogram pulmonary abnormal, Blood iron normal, Bronchiectasis
Clinical narrative: Patient is a 97 y.o. female with history of CAD, prior CABG, aortic stenosis, GERD, COPD, CHF, HTN, HLD, recent TAVR, presented to Medical Center as a transfer from Adena with shortness of breath in the setting of recent TAVR, and current COVID infection.  Treated with oxygen, paxlovid, azithromycin.  Weaned to room air.  Discharged to SNF.   Covid-19 Virus Infection Date of onset of symptoms: 12/10 Symptoms present on admission: Cough, SOB, Date of covid positive test: 12/12 Vaccination status: vaccinated Imaging: CXR (12/12) nonacute; CTA chest (12/12) bilateral tree-in-bud nodules, infectious bronchiolitis, stable bronchiectasis and consolidation in RML Oxygen requirements on admission: Room air Current oxygen requirements: Room air as of 12/19 Medical therapy:  -Decadron started 12/17 given patient now requiring O2  ID cs'd to assess eligibility for additional covid treatment- paxlovid, zithromax added 12/18 Anticipated special isolation end date: 12/22 , and will be able to trasnport to SNF/rehab on that date Weaned to room air and ready for D/c   Acute Hypoxemic Respiratory Failure - resolved Etiology: covid Baseline O2 requirements: room air Current O2 requirements: room air Continue pulmonary hygiene- IS q 1hr Continue treatment of underlying etiologies as outlined   History of TAVR CAD Chronic HFpEF Clinically euvolemic, no chest pain or shortness of breath at this time Underwent TAVR at GMC on 12/9 Although patient presented to OLH, suspect secondary to COVID infection BNP at OLH was less than her baseline Troponin was elevated but flat at OLH Patient might benefit from echocardiogram given her recent TAVR, however this does not seem urgent at this time Defer cardiology consultation for now Resume home aspirin, statin, Plavix, Cardizem, Lasix, lisinopril   Acute on Chronic Anemia Baseline Hgb 8-10 No evidence of active bleeding Hgb 8.2 12/16 Iron studies WNL  HTN Well-controlled Resume home antihypertensives   HLD Continue statin   COPD without exacerbation Not in acute exacerbation On chronic prednisone, continue at discharge Continue controller meds, Albuterol as needed   Bilateral lower extremity wounds Bilateral lower extremity wounds present on admission, reportedly traumatic  Not actively infected Wound care consulted and following
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchiolitis, COVID-19, Chest X-ray normal, Cough, Dyspnoea
Clinical narrative: Patient is a 97 y.o. female with history of CAD, prior CABG, aortic stenosis, GERD, COPD, CHF, HTN, HLD, recent TAVR, presented to Medical Center as a transfer from Adena with shortness of breath in the setting of recent TAVR, and current COVID infection.  Treated with oxygen, paxlovid, azithromycin.  Weaned to room air.  Discharged to SNF.   Covid-19 Virus Infection Date of onset of symptoms: 12/10 Symptoms present on admission: Cough, SOB, Date of covid positive test: 12/12 Vaccination status: vaccinated Imaging: CXR (12/12) nonacute; CTA chest (12/12) bilateral tree-in-bud nodules, infectious bronchiolitis, stable bronchiectasis and consolidation in RML Oxygen requirements on admission: Room air Current oxygen requirements: Room air as of 12/19 Medical therapy:  -Decadron started 12/17 given patient now requiring O2  ID cs'd to assess eligibility for additional covid treatment- paxlovid, zithromax added 12/18 Anticipated special isolation end date: 12/22 , and will be able to trasnport to SNF/rehab on that date Weaned to room air and ready for D/c   Acute Hypoxemic Respiratory Failure - resolved Etiology: covid Baseline O2 requirements: room air Current O2 requirements: room air Continue pulmonary hygiene- IS q 1hr Continue treatment of underlying etiologies as outlined   History of TAVR CAD Chronic HFpEF Clinically euvolemic, no chest pain or shortness of breath at this time Underwent TAVR at GMC on 12/9 Although patient presented to OLH, suspect secondary to COVID infection BNP at OLH was less than her baseline Troponin was elevated but flat at OLH Patient might benefit from echocardiogram given her recent TAVR, however this does not seem urgent at this time Defer cardiology consultation for now Resume home aspirin, statin, Plavix, Cardizem, Lasix, lisinopril   Acute on Chronic Anemia Baseline Hgb 8-10 No evidence of active bleeding Hgb 8.2 12/16 Iron studies WNL  HTN Well-controlled Resume home antihypertensives   HLD Continue statin   COPD without exacerbation Not in acute exacerbation On chronic prednisone, continue at discharge Continue controller meds, Albuterol as needed   Bilateral lower extremity wounds Bilateral lower extremity wounds present on admission, reportedly traumatic  Not actively infected Wound care consulted and following
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Injury, Limb injury, Lung consolidation, Malaise
Clinical narrative: Patient is a 97 y.o. female with history of CAD, prior CABG, aortic stenosis, GERD, COPD, CHF, HTN, HLD, recent TAVR, presented to Medical Center as a transfer from Adena with shortness of breath in the setting of recent TAVR, and current COVID infection.  Treated with oxygen, paxlovid, azithromycin.  Weaned to room air.  Discharged to SNF.   Covid-19 Virus Infection Date of onset of symptoms: 12/10 Symptoms present on admission: Cough, SOB, Date of covid positive test: 12/12 Vaccination status: vaccinated Imaging: CXR (12/12) nonacute; CTA chest (12/12) bilateral tree-in-bud nodules, infectious bronchiolitis, stable bronchiectasis and consolidation in RML Oxygen requirements on admission: Room air Current oxygen requirements: Room air as of 12/19 Medical therapy:  -Decadron started 12/17 given patient now requiring O2  ID cs'd to assess eligibility for additional covid treatment- paxlovid, zithromax added 12/18 Anticipated special isolation end date: 12/22 , and will be able to trasnport to SNF/rehab on that date Weaned to room air and ready for D/c   Acute Hypoxemic Respiratory Failure - resolved Etiology: covid Baseline O2 requirements: room air Current O2 requirements: room air Continue pulmonary hygiene- IS q 1hr Continue treatment of underlying etiologies as outlined   History of TAVR CAD Chronic HFpEF Clinically euvolemic, no chest pain or shortness of breath at this time Underwent TAVR at GMC on 12/9 Although patient presented to OLH, suspect secondary to COVID infection BNP at OLH was less than her baseline Troponin was elevated but flat at OLH Patient might benefit from echocardiogram given her recent TAVR, however this does not seem urgent at this time Defer cardiology consultation for now Resume home aspirin, statin, Plavix, Cardizem, Lasix, lisinopril   Acute on Chronic Anemia Baseline Hgb 8-10 No evidence of active bleeding Hgb 8.2 12/16 Iron studies WNL  HTN Well-controlled Resume home antihypertensives   HLD Continue statin   COPD without exacerbation Not in acute exacerbation On chronic prednisone, continue at discharge Continue controller meds, Albuterol as needed   Bilateral lower extremity wounds Bilateral lower extremity wounds present on admission, reportedly traumatic  Not actively infected Wound care consulted and following
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary mass, SARS-CoV-2 test positive, Transcatheter aortic valve implantation, Troponin increased
Clinical narrative: Patient is a 97 y.o. female with history of CAD, prior CABG, aortic stenosis, GERD, COPD, CHF, HTN, HLD, recent TAVR, presented to Medical Center as a transfer from Adena with shortness of breath in the setting of recent TAVR, and current COVID infection.  Treated with oxygen, paxlovid, azithromycin.  Weaned to room air.  Discharged to SNF.   Covid-19 Virus Infection Date of onset of symptoms: 12/10 Symptoms present on admission: Cough, SOB, Date of covid positive test: 12/12 Vaccination status: vaccinated Imaging: CXR (12/12) nonacute; CTA chest (12/12) bilateral tree-in-bud nodules, infectious bronchiolitis, stable bronchiectasis and consolidation in RML Oxygen requirements on admission: Room air Current oxygen requirements: Room air as of 12/19 Medical therapy:  -Decadron started 12/17 given patient now requiring O2  ID cs'd to assess eligibility for additional covid treatment- paxlovid, zithromax added 12/18 Anticipated special isolation end date: 12/22 , and will be able to trasnport to SNF/rehab on that date Weaned to room air and ready for D/c   Acute Hypoxemic Respiratory Failure - resolved Etiology: covid Baseline O2 requirements: room air Current O2 requirements: room air Continue pulmonary hygiene- IS q 1hr Continue treatment of underlying etiologies as outlined   History of TAVR CAD Chronic HFpEF Clinically euvolemic, no chest pain or shortness of breath at this time Underwent TAVR at GMC on 12/9 Although patient presented to OLH, suspect secondary to COVID infection BNP at OLH was less than her baseline Troponin was elevated but flat at OLH Patient might benefit from echocardiogram given her recent TAVR, however this does not seem urgent at this time Defer cardiology consultation for now Resume home aspirin, statin, Plavix, Cardizem, Lasix, lisinopril   Acute on Chronic Anemia Baseline Hgb 8-10 No evidence of active bleeding Hgb 8.2 12/16 Iron studies WNL  HTN Well-controlled Resume home antihypertensives   HLD Continue statin   COPD without exacerbation Not in acute exacerbation On chronic prednisone, continue at discharge Continue controller meds, Albuterol as needed   Bilateral lower extremity wounds Bilateral lower extremity wounds present on admission, reportedly traumatic  Not actively infected Wound care consulted and following
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation error
Clinical narrative: Vaccine was not diluted prior to vaccination.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Flu vaccine given in left deltoid.  Patient left to go back to work, came back to the clinic complaining of arm pain, numbness,
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation error
Clinical narrative: Vaccine was not diluted prior to vaccination.
Age: 70.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Cough, Headache, Influenza, Influenza virus test positive, Pyrexia
Clinical narrative: My flu symptoms started on 11/03/2022 in the morning around 8:00am. I had a cough, headache, chest congestions and fever. On 11/25/2022 I  went to my doctor's office who prescribe me with Tamiflu  2 times a day for  5 days. My doctor  tested me for COVID-19, Flu, and RSV.  I  tested negative for COVID-19 and RSV, but I tested positive for flu.   I Completely recovered from flu on 12/10/2022.
Age: 70.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Respiratory syncytial virus test negative, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: My flu symptoms started on 11/03/2022 in the morning around 8:00am. I had a cough, headache, chest congestions and fever. On 11/25/2022 I  went to my doctor's office who prescribe me with Tamiflu  2 times a day for  5 days. My doctor  tested me for COVID-19, Flu, and RSV.  I  tested negative for COVID-19 and RSV, but I tested positive for flu.   I Completely recovered from flu on 12/10/2022.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation error
Clinical narrative: Vaccine was not diluted prior to vaccination.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Asthenia, Chest pain, Condition aggravated, Economic problem
Clinical narrative: Immediately following injection my heart rate increased to 170 bpm intermittent chest pain has continued since. At times it feel like someone is squeezing my heart. Energy levels have remained low in comparison to before I am ALWAYS tired.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Immediate post-injection reaction
Clinical narrative: Immediately following injection my heart rate increased to 170 bpm intermittent chest pain has continued since. At times it feel like someone is squeezing my heart. Energy levels have remained low in comparison to before I am ALWAYS tired.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Influenza virus test positive, Sinusitis
Clinical narrative: Got sinus infection went to urgent care prescribed antibiotic for infection.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation error
Clinical narrative: Vaccine was no diluted prior to vaccination.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation error
Clinical narrative: Vaccine was not diluted prior to vaccination.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Cerebrovascular accident
Clinical narrative: Congestive heart Failure/ Stroke
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Musculoskeletal discomfort
Clinical narrative: Patient received vaccine on 09/15 and patient has reported shoulder soreness and discomfort on 01/05/22. Patient reports having to use physical therapy including pulleys, ropes, and exercises to help with this issue. The patient believes the shot might  have been given in the wrong area causing this issue.
Age: 63.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 6 weeks after vaccine; Primary care doctor prescribed PAXLOVID; Took another COVID-19 test and it was negative.
Age: 10.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Blood glucose normal, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: The patient left the exam room. Then the patient was walking in the lobby and he passed out. Pt was alert, oriented, pale and diaphoretic.  BS was 87.  Pt was moved to exam room and legs elevated. Pt was given apple juice and reported improved symptoms.  BP 1331- 92/59, HR 71, pulse ox 98%   Pt rechecked at 1346- pt continues to feel back to baseline. Pallor has resolved.  BP 105/64, HE 90, pulse ox 100%.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Tenderness
Clinical narrative: Intended to administer PFIZER BIVALENT BOOSTER, instead administered PFIZER MONOVALENT ADULT gray cap.  Patient on 1/6 stated feeling fine, having tenderness on the arm. Denies anything unusual.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Induration, Mammogram abnormal, Rash erythematous, Rash pruritic
Clinical narrative: After I received my vaccination my tieder went down to 235 when it was 4449. After I took my Evushield injection again, I got a red and itchy rash on my arms, legs, and neck for 1-2 weeks. My doctor prescribed me topical steroid cream which didn?t help. It got better then it came back very itchy, firm, and had puss. I have been taking Benadryl every night for 3 weeks to stop the itching. I am going to a dermatologist for the rash. I went to a checkup, and I had a positive mammogram in my left breast as well. I don?t know if it cancerous yet.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pustular
Clinical narrative: After I received my vaccination my tieder went down to 235 when it was 4449. After I took my Evushield injection again, I got a red and itchy rash on my arms, legs, and neck for 1-2 weeks. My doctor prescribed me topical steroid cream which didn?t help. It got better then it came back very itchy, firm, and had puss. I have been taking Benadryl every night for 3 weeks to stop the itching. I am going to a dermatologist for the rash. I went to a checkup, and I had a positive mammogram in my left breast as well. I don?t know if it cancerous yet.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Pain in extremity
Clinical narrative: Intended to administer ADULT PFIZER BIVALENT BOOSTER, instead administered ADULT PFIZER MONOVALENT gray cap.  Patient on 1/6 stated feeling great, with the arm feeling a little sore. Denies anything unusual.
Age: 51.0
Sex: M
Vaccine: COVID19, PNC20
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Hypotension, Pallor
Clinical narrative: Pt received both vaccines then came here less than an hour later to his wound care clinic appointment presenting with: hypotension 81/55, tachycardia 104, dizziness, SOB, diaphoresis, and pallor. Vital signs were reassessed and patient was encouraged to drink fluids. O2 95%, BP started to come up over the next half an hour, other symptoms subsided but diaphoresis persisted for 45 minutes. Orthostatics were taken half an hour later when deciding to send pt to ED or not. Sitting VS: 102/58, pulse 103; standing VS: 119/102, pulse 100. Pt denied any further symptoms, diaphoresis stopped, color had returned to face, episode appeared to be resolved. Pt advised to continue to monitor, low threshold for presenting to ED should symptoms recur., PCP notified.
Age: 51.0
Sex: M
Vaccine: COVID19, PNC20
Symptoms: Tachycardia
Clinical narrative: Pt received both vaccines then came here less than an hour later to his wound care clinic appointment presenting with: hypotension 81/55, tachycardia 104, dizziness, SOB, diaphoresis, and pallor. Vital signs were reassessed and patient was encouraged to drink fluids. O2 95%, BP started to come up over the next half an hour, other symptoms subsided but diaphoresis persisted for 45 minutes. Orthostatics were taken half an hour later when deciding to send pt to ED or not. Sitting VS: 102/58, pulse 103; standing VS: 119/102, pulse 100. Pt denied any further symptoms, diaphoresis stopped, color had returned to face, episode appeared to be resolved. Pt advised to continue to monitor, low threshold for presenting to ED should symptoms recur., PCP notified.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Inappropriate formulation given (monovalent given, bivalent indicated).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome; Chronic Inflammatory Demyelinating Polyneuropathy; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 25-JUN-2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist in a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by unspecified providers for Guillain Barre Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy. The outcome of Guillain Barre Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy was unknown and the causal relationship between the events and zoster vaccine live (ZOSTAVAX) was considered related.   Upon internal review, the events Guillain Barre Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy were considered medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; VARIVAX was administered to a patient on 15-DEC-2022 after a supported temperature excursion that took place; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 15-DEC-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) at a dose of 0.5 ml, (lot W018825 had been verified to be a valid number; expiration date 14-JUN-2024, and upon internal validation established as the same date) for prophylaxis (vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported). On 01-DEC-2022, the administered dose of the vaccine was stored at a temperature of 19.47 degrees Fahrenheit (F), during a time frame of 0 hours and 50 minutes, as recorded by a digital data logger. There was no previous temperature excursion reported. There was no adverse effect reported.