chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Diuretic therapy, Dyspnoea, Dyspnoea exertional, Echocardiogram abnormal
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "74yoF ho coronary artery disease, there is stenosis, hypertension, dm 2, HLD, BPH, MI 2003, paroxysmal SVT presenting on 12/05 for progressive shortness of breath.  Three day duration, never had the past, exacerbated by exertion, relieved with rest, denies chest discomfort, endorses nonproductive cough.  Found to be in atrial tachycardia with rate exceeding 140, CXR suggesting volume overload versus pulmonary edema.  Initial blood pressure 172/113 and hypoxic to 80% on room air.  CTA negative for PE revealed bilateral effusions and ground-glass opacities with mosaic attenuation consistent with pulmonary edema.  Also found be COVID positive.  Troponin/EKG unremarkable for ischemia.  Blood pressure and hypoxia improved with IV diuretics and rate control.  Echo revealed reduced EF 20% with severe global hypokinesis.  Compared to 2021 echo EF 55%.  Cardiology consulted and recommend LifeVest on discharge with repeat echo as NM stress test on 12/01 was negative for ischemia.  Patient discharged without requirements for therapy or home oxygen.    Acute hypoxic respiratory failure due to new HFrEF exacerbation  -transition IV Lasix to oral, GDMT valsartan and beta-blocker.  Selected tartrate for rate control and patient could not afford Entresto.  Life vest given on discharge.  Close cardiology follow-up.  Consider SGLT2.  Multifocal atrial tachycardia with history SVT  -SVT seen on outpatient cardiac monitor and MATseen on tele/EKG while inpatient, amiodarone 400mg q12h 10 days, 200mg daily thereafter, metoprolol tartrate  COVID-19 infection  -likely minimal contribution, respiratory status improved with control of HR, BP, and volume status, continue supportive care outpatient"
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ejection fraction decreased, Electrocardiogram abnormal, Hypervolaemia, Hypokinesia, Hypoxia
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "74yoF ho coronary artery disease, there is stenosis, hypertension, dm 2, HLD, BPH, MI 2003, paroxysmal SVT presenting on 12/05 for progressive shortness of breath.  Three day duration, never had the past, exacerbated by exertion, relieved with rest, denies chest discomfort, endorses nonproductive cough.  Found to be in atrial tachycardia with rate exceeding 140, CXR suggesting volume overload versus pulmonary edema.  Initial blood pressure 172/113 and hypoxic to 80% on room air.  CTA negative for PE revealed bilateral effusions and ground-glass opacities with mosaic attenuation consistent with pulmonary edema.  Also found be COVID positive.  Troponin/EKG unremarkable for ischemia.  Blood pressure and hypoxia improved with IV diuretics and rate control.  Echo revealed reduced EF 20% with severe global hypokinesis.  Compared to 2021 echo EF 55%.  Cardiology consulted and recommend LifeVest on discharge with repeat echo as NM stress test on 12/01 was negative for ischemia.  Patient discharged without requirements for therapy or home oxygen.    Acute hypoxic respiratory failure due to new HFrEF exacerbation  -transition IV Lasix to oral, GDMT valsartan and beta-blocker.  Selected tartrate for rate control and patient could not afford Entresto.  Life vest given on discharge.  Close cardiology follow-up.  Consider SGLT2.  Multifocal atrial tachycardia with history SVT  -SVT seen on outpatient cardiac monitor and MATseen on tele/EKG while inpatient, amiodarone 400mg q12h 10 days, 200mg daily thereafter, metoprolol tartrate  COVID-19 infection  -likely minimal contribution, respiratory status improved with control of HR, BP, and volume status, continue supportive care outpatient"
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lung opacity, Pleural effusion, Pulmonary oedema, SARS-CoV-2 test positive, Supraventricular tachycardia
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "74yoF ho coronary artery disease, there is stenosis, hypertension, dm 2, HLD, BPH, MI 2003, paroxysmal SVT presenting on 12/05 for progressive shortness of breath.  Three day duration, never had the past, exacerbated by exertion, relieved with rest, denies chest discomfort, endorses nonproductive cough.  Found to be in atrial tachycardia with rate exceeding 140, CXR suggesting volume overload versus pulmonary edema.  Initial blood pressure 172/113 and hypoxic to 80% on room air.  CTA negative for PE revealed bilateral effusions and ground-glass opacities with mosaic attenuation consistent with pulmonary edema.  Also found be COVID positive.  Troponin/EKG unremarkable for ischemia.  Blood pressure and hypoxia improved with IV diuretics and rate control.  Echo revealed reduced EF 20% with severe global hypokinesis.  Compared to 2021 echo EF 55%.  Cardiology consulted and recommend LifeVest on discharge with repeat echo as NM stress test on 12/01 was negative for ischemia.  Patient discharged without requirements for therapy or home oxygen.    Acute hypoxic respiratory failure due to new HFrEF exacerbation  -transition IV Lasix to oral, GDMT valsartan and beta-blocker.  Selected tartrate for rate control and patient could not afford Entresto.  Life vest given on discharge.  Close cardiology follow-up.  Consider SGLT2.  Multifocal atrial tachycardia with history SVT  -SVT seen on outpatient cardiac monitor and MATseen on tele/EKG while inpatient, amiodarone 400mg q12h 10 days, 200mg daily thereafter, metoprolol tartrate  COVID-19 infection  -likely minimal contribution, respiratory status improved with control of HR, BP, and volume status, continue supportive care outpatient"
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin normal
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "74yoF ho coronary artery disease, there is stenosis, hypertension, dm 2, HLD, BPH, MI 2003, paroxysmal SVT presenting on 12/05 for progressive shortness of breath.  Three day duration, never had the past, exacerbated by exertion, relieved with rest, denies chest discomfort, endorses nonproductive cough.  Found to be in atrial tachycardia with rate exceeding 140, CXR suggesting volume overload versus pulmonary edema.  Initial blood pressure 172/113 and hypoxic to 80% on room air.  CTA negative for PE revealed bilateral effusions and ground-glass opacities with mosaic attenuation consistent with pulmonary edema.  Also found be COVID positive.  Troponin/EKG unremarkable for ischemia.  Blood pressure and hypoxia improved with IV diuretics and rate control.  Echo revealed reduced EF 20% with severe global hypokinesis.  Compared to 2021 echo EF 55%.  Cardiology consulted and recommend LifeVest on discharge with repeat echo as NM stress test on 12/01 was negative for ischemia.  Patient discharged without requirements for therapy or home oxygen.    Acute hypoxic respiratory failure due to new HFrEF exacerbation  -transition IV Lasix to oral, GDMT valsartan and beta-blocker.  Selected tartrate for rate control and patient could not afford Entresto.  Life vest given on discharge.  Close cardiology follow-up.  Consider SGLT2.  Multifocal atrial tachycardia with history SVT  -SVT seen on outpatient cardiac monitor and MATseen on tele/EKG while inpatient, amiodarone 400mg q12h 10 days, 200mg daily thereafter, metoprolol tartrate  COVID-19 infection  -likely minimal contribution, respiratory status improved with control of HR, BP, and volume status, continue supportive care outpatient"
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient described reaction as "Covid arm" (redness, swelling, and warmth at injection site)
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Dehydration, Dysstasia, Electrocardiogram abnormal, Fall
Clinical narrative: 11/11/2022 after getting up that morning, I was watering a plant and was unable to stand. I fell, vomited and had dry heaving. I did a 2 channel EKG to check for AFIB. I was in AFIB. I spent two hours in bed. I went to the emergency room and stayed in the hospital emergency room overnight in an observation room. The doctor said I was severely dehydrated and wanted to change my heart medications to bisoprolol dropping out the diuretic part. I was on an IV for dehydration which was part of the reason for the fainting spell. The next day I was able to stand up and did not feel dizzy at all. Since then I have had follow up with the Cardiologist, he changed my bisoprolol to half dose.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Mobility decreased, Retching, Syncope, Vomiting
Clinical narrative: 11/11/2022 after getting up that morning, I was watering a plant and was unable to stand. I fell, vomited and had dry heaving. I did a 2 channel EKG to check for AFIB. I was in AFIB. I spent two hours in bed. I went to the emergency room and stayed in the hospital emergency room overnight in an observation room. The doctor said I was severely dehydrated and wanted to change my heart medications to bisoprolol dropping out the diuretic part. I was on an IV for dehydration which was part of the reason for the fainting spell. The next day I was able to stand up and did not feel dizzy at all. Since then I have had follow up with the Cardiologist, he changed my bisoprolol to half dose.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient who is an adult was given 0.25mL of the Moderna Bivalent COVID booster vaccine, which is less than the authorized dose of 0.50mL.  No adverse events were noted at the time of the administration.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alcohol use, Blood glucose normal, Bronchial wall thickening, COVID-19, Cardiac flutter
Clinical narrative: Patient with history of 2 COVID vaccines who admitted with COVID detected PCR and dyspnea.  Provider d/c note:  "75 YO year old male with past medical history of Severe COPD, chronic hypotension on Fludrocortisone, alcohol use disorder,  presenting to the local Hospital with complaint of SOB. Patient started to have SOB and increase sputum production and cough 1 week ago. He was seen in ED and found to have positive COVID. Patient was given Prednisone 50 mg QD, Zpack and Paxlovid 5 days. Patient improved the symptoms until 2 days ago. Patient continues to increase dyspnea, cough and sputum production.    Patient saw Dr. as pulmonologist, but last seen 2020, COPD exacerbation since 2016, roughly 3-4 exacerbation a year. Patient last hospitalization was at June/22 with infection of influenza. Was never been intubated. Patient is not on oxygen at baseline since his saturation always above 88%. He smoked 75 pack year, quit 10 years ago.    He uses alcohol on a daily basis 2-6 beers a day, never had a withdrawal symptoms. Last drink 12/9 2 beers, but 6 beers 12/8.    ED Course: In ED, patient has documented hypoxia 86% improved with 2L oxygen, now on RA. SBP 100-130s. WBC 19.6, BG 150, mild hyponatremia, hypochloremia. EKG sinus tachycardia. BCx pending. CXR shows Hyperinflated lungs with underlying emphysema. Right apical/pleural parenchymal opacity. CT chest shows Central peribronchial thickening with peribronchial vascular groundglass, tree-in-bud opacities and more discrete right middle/lower lobe airspace disease compatible with infectious process. Pulmonary emphysema with stable biapical fibrocalcific change; chronic scarring favored. Patient was treated with Rocephin and doxycycline, 500 mL NS. Patient took last dose of Steroid 50 mg this AM. Admitted to the General unit for further management.    Upon admission, patient was treated with additional Prednisone, DuoNeb nebulizer, LABA/LAMA/ICS, VS q4h, Tele, IS, Flutter. Rocephin and doxycycline was given. Patient remains in RA throughout the hospital stay. Patient passed the walk test and will be discharged home with additional 4 days of Augmentin, Mucinex and follow up with PCP for his COPD and will need referral back to Pulmonology as COPD frequent exacerbation.   "
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac telemetry, Chest X-ray abnormal, Chronic obstructive pulmonary disease, Computerised tomogram thorax abnormal, Condition aggravated
Clinical narrative: Patient with history of 2 COVID vaccines who admitted with COVID detected PCR and dyspnea.  Provider d/c note:  "75 YO year old male with past medical history of Severe COPD, chronic hypotension on Fludrocortisone, alcohol use disorder,  presenting to the local Hospital with complaint of SOB. Patient started to have SOB and increase sputum production and cough 1 week ago. He was seen in ED and found to have positive COVID. Patient was given Prednisone 50 mg QD, Zpack and Paxlovid 5 days. Patient improved the symptoms until 2 days ago. Patient continues to increase dyspnea, cough and sputum production.    Patient saw Dr. as pulmonologist, but last seen 2020, COPD exacerbation since 2016, roughly 3-4 exacerbation a year. Patient last hospitalization was at June/22 with infection of influenza. Was never been intubated. Patient is not on oxygen at baseline since his saturation always above 88%. He smoked 75 pack year, quit 10 years ago.    He uses alcohol on a daily basis 2-6 beers a day, never had a withdrawal symptoms. Last drink 12/9 2 beers, but 6 beers 12/8.    ED Course: In ED, patient has documented hypoxia 86% improved with 2L oxygen, now on RA. SBP 100-130s. WBC 19.6, BG 150, mild hyponatremia, hypochloremia. EKG sinus tachycardia. BCx pending. CXR shows Hyperinflated lungs with underlying emphysema. Right apical/pleural parenchymal opacity. CT chest shows Central peribronchial thickening with peribronchial vascular groundglass, tree-in-bud opacities and more discrete right middle/lower lobe airspace disease compatible with infectious process. Pulmonary emphysema with stable biapical fibrocalcific change; chronic scarring favored. Patient was treated with Rocephin and doxycycline, 500 mL NS. Patient took last dose of Steroid 50 mg this AM. Admitted to the General unit for further management.    Upon admission, patient was treated with additional Prednisone, DuoNeb nebulizer, LABA/LAMA/ICS, VS q4h, Tele, IS, Flutter. Rocephin and doxycycline was given. Patient remains in RA throughout the hospital stay. Patient passed the walk test and will be discharged home with additional 4 days of Augmentin, Mucinex and follow up with PCP for his COPD and will need referral back to Pulmonology as COPD frequent exacerbation.   "
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Electrocardiogram abnormal, Emphysema, Hypochloraemia
Clinical narrative: Patient with history of 2 COVID vaccines who admitted with COVID detected PCR and dyspnea.  Provider d/c note:  "75 YO year old male with past medical history of Severe COPD, chronic hypotension on Fludrocortisone, alcohol use disorder,  presenting to the local Hospital with complaint of SOB. Patient started to have SOB and increase sputum production and cough 1 week ago. He was seen in ED and found to have positive COVID. Patient was given Prednisone 50 mg QD, Zpack and Paxlovid 5 days. Patient improved the symptoms until 2 days ago. Patient continues to increase dyspnea, cough and sputum production.    Patient saw Dr. as pulmonologist, but last seen 2020, COPD exacerbation since 2016, roughly 3-4 exacerbation a year. Patient last hospitalization was at June/22 with infection of influenza. Was never been intubated. Patient is not on oxygen at baseline since his saturation always above 88%. He smoked 75 pack year, quit 10 years ago.    He uses alcohol on a daily basis 2-6 beers a day, never had a withdrawal symptoms. Last drink 12/9 2 beers, but 6 beers 12/8.    ED Course: In ED, patient has documented hypoxia 86% improved with 2L oxygen, now on RA. SBP 100-130s. WBC 19.6, BG 150, mild hyponatremia, hypochloremia. EKG sinus tachycardia. BCx pending. CXR shows Hyperinflated lungs with underlying emphysema. Right apical/pleural parenchymal opacity. CT chest shows Central peribronchial thickening with peribronchial vascular groundglass, tree-in-bud opacities and more discrete right middle/lower lobe airspace disease compatible with infectious process. Pulmonary emphysema with stable biapical fibrocalcific change; chronic scarring favored. Patient was treated with Rocephin and doxycycline, 500 mL NS. Patient took last dose of Steroid 50 mg this AM. Admitted to the General unit for further management.    Upon admission, patient was treated with additional Prednisone, DuoNeb nebulizer, LABA/LAMA/ICS, VS q4h, Tele, IS, Flutter. Rocephin and doxycycline was given. Patient remains in RA throughout the hospital stay. Patient passed the walk test and will be discharged home with additional 4 days of Augmentin, Mucinex and follow up with PCP for his COPD and will need referral back to Pulmonology as COPD frequent exacerbation.   "
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyponatraemia, Hypoxia, Influenza, Lung disorder, Lung hyperinflation
Clinical narrative: Patient with history of 2 COVID vaccines who admitted with COVID detected PCR and dyspnea.  Provider d/c note:  "75 YO year old male with past medical history of Severe COPD, chronic hypotension on Fludrocortisone, alcohol use disorder,  presenting to the local Hospital with complaint of SOB. Patient started to have SOB and increase sputum production and cough 1 week ago. He was seen in ED and found to have positive COVID. Patient was given Prednisone 50 mg QD, Zpack and Paxlovid 5 days. Patient improved the symptoms until 2 days ago. Patient continues to increase dyspnea, cough and sputum production.    Patient saw Dr. as pulmonologist, but last seen 2020, COPD exacerbation since 2016, roughly 3-4 exacerbation a year. Patient last hospitalization was at June/22 with infection of influenza. Was never been intubated. Patient is not on oxygen at baseline since his saturation always above 88%. He smoked 75 pack year, quit 10 years ago.    He uses alcohol on a daily basis 2-6 beers a day, never had a withdrawal symptoms. Last drink 12/9 2 beers, but 6 beers 12/8.    ED Course: In ED, patient has documented hypoxia 86% improved with 2L oxygen, now on RA. SBP 100-130s. WBC 19.6, BG 150, mild hyponatremia, hypochloremia. EKG sinus tachycardia. BCx pending. CXR shows Hyperinflated lungs with underlying emphysema. Right apical/pleural parenchymal opacity. CT chest shows Central peribronchial thickening with peribronchial vascular groundglass, tree-in-bud opacities and more discrete right middle/lower lobe airspace disease compatible with infectious process. Pulmonary emphysema with stable biapical fibrocalcific change; chronic scarring favored. Patient was treated with Rocephin and doxycycline, 500 mL NS. Patient took last dose of Steroid 50 mg this AM. Admitted to the General unit for further management.    Upon admission, patient was treated with additional Prednisone, DuoNeb nebulizer, LABA/LAMA/ICS, VS q4h, Tele, IS, Flutter. Rocephin and doxycycline was given. Patient remains in RA throughout the hospital stay. Patient passed the walk test and will be discharged home with additional 4 days of Augmentin, Mucinex and follow up with PCP for his COPD and will need referral back to Pulmonology as COPD frequent exacerbation.   "
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lung opacity, Pneumonia, Pulmonary calcification, Pulmonary fibrosis, SARS-CoV-2 test positive
Clinical narrative: Patient with history of 2 COVID vaccines who admitted with COVID detected PCR and dyspnea.  Provider d/c note:  "75 YO year old male with past medical history of Severe COPD, chronic hypotension on Fludrocortisone, alcohol use disorder,  presenting to the local Hospital with complaint of SOB. Patient started to have SOB and increase sputum production and cough 1 week ago. He was seen in ED and found to have positive COVID. Patient was given Prednisone 50 mg QD, Zpack and Paxlovid 5 days. Patient improved the symptoms until 2 days ago. Patient continues to increase dyspnea, cough and sputum production.    Patient saw Dr. as pulmonologist, but last seen 2020, COPD exacerbation since 2016, roughly 3-4 exacerbation a year. Patient last hospitalization was at June/22 with infection of influenza. Was never been intubated. Patient is not on oxygen at baseline since his saturation always above 88%. He smoked 75 pack year, quit 10 years ago.    He uses alcohol on a daily basis 2-6 beers a day, never had a withdrawal symptoms. Last drink 12/9 2 beers, but 6 beers 12/8.    ED Course: In ED, patient has documented hypoxia 86% improved with 2L oxygen, now on RA. SBP 100-130s. WBC 19.6, BG 150, mild hyponatremia, hypochloremia. EKG sinus tachycardia. BCx pending. CXR shows Hyperinflated lungs with underlying emphysema. Right apical/pleural parenchymal opacity. CT chest shows Central peribronchial thickening with peribronchial vascular groundglass, tree-in-bud opacities and more discrete right middle/lower lobe airspace disease compatible with infectious process. Pulmonary emphysema with stable biapical fibrocalcific change; chronic scarring favored. Patient was treated with Rocephin and doxycycline, 500 mL NS. Patient took last dose of Steroid 50 mg this AM. Admitted to the General unit for further management.    Upon admission, patient was treated with additional Prednisone, DuoNeb nebulizer, LABA/LAMA/ICS, VS q4h, Tele, IS, Flutter. Rocephin and doxycycline was given. Patient remains in RA throughout the hospital stay. Patient passed the walk test and will be discharged home with additional 4 days of Augmentin, Mucinex and follow up with PCP for his COPD and will need referral back to Pulmonology as COPD frequent exacerbation.   "
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinus tachycardia, Sputum increased, Walking distance test normal, White blood cell count increased
Clinical narrative: Patient with history of 2 COVID vaccines who admitted with COVID detected PCR and dyspnea.  Provider d/c note:  "75 YO year old male with past medical history of Severe COPD, chronic hypotension on Fludrocortisone, alcohol use disorder,  presenting to the local Hospital with complaint of SOB. Patient started to have SOB and increase sputum production and cough 1 week ago. He was seen in ED and found to have positive COVID. Patient was given Prednisone 50 mg QD, Zpack and Paxlovid 5 days. Patient improved the symptoms until 2 days ago. Patient continues to increase dyspnea, cough and sputum production.    Patient saw Dr. as pulmonologist, but last seen 2020, COPD exacerbation since 2016, roughly 3-4 exacerbation a year. Patient last hospitalization was at June/22 with infection of influenza. Was never been intubated. Patient is not on oxygen at baseline since his saturation always above 88%. He smoked 75 pack year, quit 10 years ago.    He uses alcohol on a daily basis 2-6 beers a day, never had a withdrawal symptoms. Last drink 12/9 2 beers, but 6 beers 12/8.    ED Course: In ED, patient has documented hypoxia 86% improved with 2L oxygen, now on RA. SBP 100-130s. WBC 19.6, BG 150, mild hyponatremia, hypochloremia. EKG sinus tachycardia. BCx pending. CXR shows Hyperinflated lungs with underlying emphysema. Right apical/pleural parenchymal opacity. CT chest shows Central peribronchial thickening with peribronchial vascular groundglass, tree-in-bud opacities and more discrete right middle/lower lobe airspace disease compatible with infectious process. Pulmonary emphysema with stable biapical fibrocalcific change; chronic scarring favored. Patient was treated with Rocephin and doxycycline, 500 mL NS. Patient took last dose of Steroid 50 mg this AM. Admitted to the General unit for further management.    Upon admission, patient was treated with additional Prednisone, DuoNeb nebulizer, LABA/LAMA/ICS, VS q4h, Tele, IS, Flutter. Rocephin and doxycycline was given. Patient remains in RA throughout the hospital stay. Patient passed the walk test and will be discharged home with additional 4 days of Augmentin, Mucinex and follow up with PCP for his COPD and will need referral back to Pulmonology as COPD frequent exacerbation.   "
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Burning sensation, Herpes zoster, Pain, Rash
Clinical narrative: rash on back of body calf and thigh; severe burning pain on body; symptoms/developed shingles; severe burning sensation as fire on body and ankle; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2022, the patient received the 1st dose of Shingrix. In June 2022, 7 days after receiving Shingrix, the patient experienced shingles, burning sensation and pain burning. In July 2022, the patient experienced rash. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)), methylprednisolone and valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, burning sensation, rash and pain burning were recovered/resolved.   It was unknown if the reporter considered the shingles, burning sensation, rash and pain burning to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-DEC-2022. Reporter's Comment: The reporter was the patient.  The patient received his Shingrix dose and seven days later he experienced developed symptoms of shingles burning in the left side of my body severe burning sensation was on "fire" going towards my ankle left side only.  The reporter stated fourteen days after vaccination, he developed a rash on the back of his left calf and thigh.  The patient saw his primary physician who prescribed methylprednisolone dose pack.  The patient then saw a dermatologist who diagnosed the rash as shingles and prescribed valacyclovir for 7 days.  Physician said to go ahead and get the 2nd dose, worried if it would be worse than the first one. Dermatologist prescribed antiviral on 6th July 2022 and in 14 days the rash was gone. Nothing else was reported.  The reporter did not to consent to follow-up. Additional supportive information: The case US2022182839 was identified as duplicate of US2022182844. The case US2022182844 would be voided, and all the future correspondence would be added in this case US2022182839 which stands as a case of record for this patient.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Pain, Respiratory tract congestion
Clinical narrative: Patient came to the ED with increased congestion and cough.  Symptoms started 8 days prior and was Covid positive and treated with oral antiviral therapy.  He finished treatment and then progressively got worse.  Patient also has complaints of feeling weak and achy all over.  Patient was admitted to the hospital and treated with remdesivir.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient came to the ED with increased congestion and cough.  Symptoms started 8 days prior and was Covid positive and treated with oral antiviral therapy.  He finished treatment and then progressively got worse.  Patient also has complaints of feeling weak and achy all over.  Patient was admitted to the hospital and treated with remdesivir.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test
Clinical narrative: Severe shoulder pain lasting for months, now mild chronic with occasional increased severity
Age: 9.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was in the clinic for a routine physical and Mother requested for patient to start the COVID-19 Pfizer series. A Pfizer 5-11 year old Bivalent dose was given as first dose in error instead of a Monovalent Pfizer primary series dose. Mother was notified and voiced understanding. Mother reports patient is doing well.
Age: 43.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Bed sharing, Cough, Fatigue, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I was doing fine until I got COVID-19 last week, I had congestion, fatigue, a little cough but not much, like a cold, I had a COVID-19 home test, and it was negative (Friday night), on Sunday I took another hoe test, and it was positive. I called the doctor on Monday and he prescribed PAXLOVID.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient who is an adult was given 0.25mL of the Moderna Bivalent COVID booster vaccine, which is less than the authorized dose of 0.50mL.  No adverse events were noted at the time of the administration.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given 5-11 year COVID vaccine instead of 6 months-4years.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given 5-11 year COVID vaccine instead of 6 months-4years.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix instead of a regular Dtap vaccine; 17 months received Kinrix; was 4th dose of DTaP; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 17-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th December 2022, the patient received the 4th dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 5th December 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: Nurse reported that a 17 months female child received by error Kinrix instead of a regular Dtap vaccine.  This would be a fourth IPV portion on patient´s schedule.  Kinrix was the patients 4th dose of DTaP as well. The reporter consented to follow up via email. Additional Supportive Information: The 17 month patient was administered with kinrix instead of regular Dtap, which led to inappropriate age at vaccine administration and wrong vaccine administered and inappropriate schedule of vaccine administered.
Age: 33.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Chills, Cough, Dysphonia, Influenza virus test positive, Laboratory test abnormal
Clinical narrative: My adverse event started on 10/28/2022 in the evening I had a horse voice, cough, chills and body aches. I was tested at the urgent care for flu on 10/30/2022 which was negative. I was tested on 10/31/2022 for flu and Pneumonia in the ER which were positive. I went to the urgent care 1 time and 2 times ER visit. I was given 3 antibiotics in total to take.
Age: 33.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Pain, Pneumonia, SARS-CoV-2 test negative
Clinical narrative: My adverse event started on 10/28/2022 in the evening I had a horse voice, cough, chills and body aches. I was tested at the urgent care for flu on 10/30/2022 which was negative. I was tested on 10/31/2022 for flu and Pneumonia in the ER which were positive. I went to the urgent care 1 time and 2 times ER visit. I was given 3 antibiotics in total to take.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Parkinson's disease, Scan abnormal, Tremor
Clinical narrative: I started to experience body tremors. It was prominent to my left arm and hand. I am still experiencing the tremors almost two years later. I have received 4 doses of Pfizer and they have all been in my left shoulder. I went to see a neurologist, she told me to follow up with her a year after my exam on 04/01/2021, since the tremors were small. I followed up with her 03/2022, and that was at the time where it seemed to have gotten a little worse. She recommended a DAT scan to see if there was anything abnormal or to rule out muscle fatigue. We went over the results. There was an abnormality found in my scan. I do not have family history of tremors. Parkinson's has been ruled in, but it could be something else. She said that only time will tell if it is definitely Parkinson's because everyone reacts differently to the disease. There are options for medications, but I don't feel there is a hinderance at this time to take any. I will be following up with the neurologist every six months.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient who is an adult was given 0.25mL of the Moderna Bivalent COVID booster vaccine, which is less than the authorized dose of 0.50mL.  No adverse events were noted at the time of the administration.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea, Vomiting
Clinical narrative: About 7 minutes after shot, patient experienced nausea and vomiting, Episode lasted about 5 minutes and then patient felt better.  They stayed 10 more minutes and still felt fine and chose to leave.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine increased, COVID-19, Condition aggravated, Cough, Death
Clinical narrative: pt to ED with increasing creatinine, worsening SOB and cough; found to be positive for COVID; given Dexamethasone;O2 supplementation; pneumonia; renal and respiratory failure worsened; ICU; on Vapotherm; given ABX; O2 requirement increased and pt was placed on comfort care; she passed away in the hospital
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Intensive care, Pneumonia, Renal failure, Respiratory failure
Clinical narrative: pt to ED with increasing creatinine, worsening SOB and cough; found to be positive for COVID; given Dexamethasone;O2 supplementation; pneumonia; renal and respiratory failure worsened; ICU; on Vapotherm; given ABX; O2 requirement increased and pt was placed on comfort care; she passed away in the hospital
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: pt to ED with increasing creatinine, worsening SOB and cough; found to be positive for COVID; given Dexamethasone;O2 supplementation; pneumonia; renal and respiratory failure worsened; ICU; on Vapotherm; given ABX; O2 requirement increased and pt was placed on comfort care; she passed away in the hospital
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue, Underdose
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient who is an adult was given 0.25mL of the Moderna Bivalent COVID booster vaccine, which is less than the authorized dose of 0.50mL.  No adverse events were noted at the time of the administration.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Nasopharyngitis, Respiratory tract congestion, SARS-CoV-2 test negative, Viral infection
Clinical narrative: 12/01/2022 I had a bad cold that lasted for 14 days. I had severe congestion and a mild cough. I took an at home COVID test which was negative. On 12/2/22. I had a telehealth visit on 12/7/2022. She determined I had a viral cold and did not have a secondary infection. She said after a few days, I need to stop the TYLENOL and over the counter cough medicine in a few days. I am feeling fine, no congestion only a mild cough.
Age: 44.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased, Myalgia
Clinical narrative: Reports right shoulder/bicep pain at time of injection and decreased ROM since then.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram normal
Clinical narrative: In August I was diagnosed with Afib in which my doctor checked my heart with an EKG and my heart was fine.  I was put on Metroprolol 50 mg.  The medication appears to be working keeping my blood pressure down.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death on 12/08/2022.
Age: 2.0
Sex: M
Vaccine: COVID19, DTAP, FLU4, HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect pfizer covid vaccine was administered. Patient received the 10mcg/0.2ml concentrations. No adverse events or outcomes, to this day, have been reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram head normal, Computerised tomogram neck, Magnetic resonance imaging head, Vertigo
Clinical narrative: Severe and debilitating vertigo that lasted until 09/22
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vestibular function test normal
Clinical narrative: Severe and debilitating vertigo that lasted until 09/22
Age: 2.0
Sex: F
Vaccine: COVID19, DTAP, FLU4, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Incorrect pfizer covid vaccine was administered. Patient received the 10mcg/0.2ml concentration. No adverse events, signs/symptoms, or outcomes have been reported to this day.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue, Underdose
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Hypersomnia, Influenza like illness, Nasal congestion
Clinical narrative: Woke up feeling very flu like. Couldn't stay awake and slept most of the day. My husband went and got me OTC cold and flu meds that helped. Had cough, congestion, sore throat, and body aches. Symptoms continued and I slept most of the day. Took at home COVID-19 on Thursday and it was negative. Retested on Monday and it was positive. Called PCP after positive COVID-19 test and she prescribed Z-PAK and steroids. Didn't notice any real difference after beginning those drugs. Symptoms have mostly resolved except for nasal congestion and drainage.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pain, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: Woke up feeling very flu like. Couldn't stay awake and slept most of the day. My husband went and got me OTC cold and flu meds that helped. Had cough, congestion, sore throat, and body aches. Symptoms continued and I slept most of the day. Took at home COVID-19 on Thursday and it was negative. Retested on Monday and it was positive. Called PCP after positive COVID-19 test and she prescribed Z-PAK and steroids. Didn't notice any real difference after beginning those drugs. Symptoms have mostly resolved except for nasal congestion and drainage.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Woke up feeling very flu like. Couldn't stay awake and slept most of the day. My husband went and got me OTC cold and flu meds that helped. Had cough, congestion, sore throat, and body aches. Symptoms continued and I slept most of the day. Took at home COVID-19 on Thursday and it was negative. Retested on Monday and it was positive. Called PCP after positive COVID-19 test and she prescribed Z-PAK and steroids. Didn't notice any real difference after beginning those drugs. Symptoms have mostly resolved except for nasal congestion and drainage.
Age: 87.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: Patient developed blister on left arm around area of the vaccination. It appeared in the morning, raising the bandaid. Patient removed band-aid. States area is itchy. This was the booster vaccine Bivalent Pfizer
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Feeling cold, Tremor
Clinical narrative: Started feeling tired about 4 hours after the vaccine.  Then around 5pm 8 hours after the vaccine, I was very cold and shaking.  I had a fever of 100.    The next day the fever was gone but still cold and very tired all day.   Friday, about 75% back to normal, only a little tired.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Skin lesion
Clinical narrative: Mild shingles; Few lesions; 1st dose earlier this year, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, skin lesion and incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the skin lesion was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles and skin lesion to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comment: The reporter was a patient. The patient reported that she received 1st dose of Shingrix vaccine in early 2022. The patient stated that few days ago after received Shingrix vaccine she experienced mild case of shingles, The patient stated that the symptoms were getting better, but she still had few lesions. The patient reported that she did not receive the 2nd dose of Shingrix vaccine and she confirmed that it had been greater than 6 months since the received first dose. The reporter requested to consent to follow up. She had no further information regarding the vaccine itself or when she got the vaccine.  Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: FLU vaccine administered to client per  RN to left deltoid.  About 15 min after injection, client complaining of "severe itching" at site.  Redness and swelling also noted at site.  Client denies  shortness of breath, headache, or any other complaints.  Children's Liquid Benadryl 10ml given perRn to client.  Client refused adult dose.  Client stated "itching", along with redness had resolved about 15 after taking Benadryl.  No other complaints voiced.
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Constipation
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR and COVID PNA.  Provider d/c note:  "94-year-old female past medical history of hypertension and hyperlipidemia who presented with 4 day onset of sore throat, increased secretions, and generalized malaise.  Upon arrival to the emergency department, she was afebrile, hemodynamically stable, and maintaining adequate oxygenation on room air.  Viral respiratory panel was positive for COVID-19, otherwise negative.  Other initial intake lab work was unremarkable, including sputum culture. CXR showed subtle interstitial opacities raise concern for COVID pneumonia.  She was provided supportive care including scheduled DuoNeb treatments, no steroids nor antivirals were given.  Overnight, she demonstrated improvement in her presenting symptoms without developing any worsening respiratory distress nor acute hypoxic respiratory failure.  She was medically optimized and subsequently discharged home in stable condition.   Hospital Course:    This 94-year-old female with a medical history of hypertension and hyperlipidemia presents with generalized body aches, weakness, and cough, COVID-19 rapid PCR positive.   COVID-19 Infection - suspect viral syndrome causing her generalized body aches and weakness - symptom onset 12/8/2022 - Respiratory panel only positive for COVID-19, otherwise negative - no known risk factors for decompensation - maintained adequate oxygenation at room air, afebrile, 0/4 SIRS criteria - supportive care - sputum sample collected and showed normal oropharyngeal flora - scheduled Duonebs twice daily - severe isolation precautions   Hypertension - resume benazepril given hemodynamic stability overnight, BP above goal   Chronic BLE edema - holding lasix on discharge for concern of limited oral intake with active infection   Hyperlipidemia - not on statin   Osteopenia - noted on DEXA scan 8/4/2021 with low bone mass in bilateral hips - calcium and vitamin D3 supplementation   Hypokalemia - trend, supplemented as needed   Constipation - Bowel regimen   History of iron deficiency anemia - hold supplemental iron in setting of infection   Chronic arthralgias, back pain - hold home ASA 325 mg daily, discontinued on discharge - lidocaine patch PRN"