chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Overgrowth fungal, Pneumonia, Pneumonia viral, Pneumonitis, Procalcitonin
Clinical narrative: Patient is a 81 y.o. female patient of local MD with history of  COPD, osteoporosis, squamous cell carcinoma of the tongue, arctic aneurysm, recent diagnosis of PE on Coumadin for anticoagulation is presenting with chief complaint of shortness of breath, cough with green sputum for about a week.     Covid-19 Virus Infection Date of onset of symptoms: A week ago was around 12/18.  Symptoms present on admission: Yes Date of covid positive test: 12/24 Vaccination status: vaccinated Imaging: CTPA?no acute PE with mild bilateral lower lung GGO which could reflect underlying mild pneumonitis.  Borderline prominent heart size with suspected mild pulmonary hypertension.  Extensive bilateral centrilobular and bullous emphysema with large hiatal hernia Oxygen requirements on admission: 3L patient is on 3 L oxygen chronically. Current oxygen requirements: 2-3 lit Medical therapy: Decadron started 12/27 given into no above home O2 demands. Remdesivir started 12/27 per HCP Consultants following: HCP Anticipated special isolation end date:  1/4/23 Breathing improving   Pneumonia- viral  CT pulmonary angiogram shows mild bilateral lower lung groundglass opacities at the right middle, bilateral lower lobes and left lingula.  Findings reflect underlying mild pneumonitis. Afebrile.  Vital stable.  Oxygen saturation 96% on 3 L oxygen. Lactic acid 2.7, WBC 3.8. She was initiated on Rocephin CAP. Procalcitonin <0.06. Stop Rocephin,  Check urine antigen- negative  BC negative at 48 hours Sputum culture normal flora after 24 hrs with heavy growth yeast. Discussed with HCP- likely a commensal mucinex Incentive spirometry/PEP Episode of hemoptysis 1/01- now resolved- likely due to recent pulmonary infection in the setting of AC use Pulmonary consulted. 1/02 CT chest demonstrated developing segmenta and subsegmental bronchial airway endobronchial density likely due to mucus plugging. Mild multifocal bilateral lower lung ground-glass opacities/pneumonitis have intervally decreased when compared to CT 12/24/2022.  Recent history of pulmonary embolism in November 2022 Hemoptysis. She is compliant with Coumadin, INR 2.7-- > 2.5 Patient reports specks of blood in the sputum for last 2 days prior to admission. Now ressolved CT chest as above. Continue Coumadin- dosing per pharmacy.   Given return, consult pulm for evaluation Increase mucinex to 1200mg BID   COPD Chronic respiratory failure She is on 3 L oxygen at baseline. Doxycycline- complete course Resume home inhalers.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, Pulmonary hypertension, SARS-CoV-2 test positive, Sputum culture, Sputum discoloured
Clinical narrative: Patient is a 81 y.o. female patient of local MD with history of  COPD, osteoporosis, squamous cell carcinoma of the tongue, arctic aneurysm, recent diagnosis of PE on Coumadin for anticoagulation is presenting with chief complaint of shortness of breath, cough with green sputum for about a week.     Covid-19 Virus Infection Date of onset of symptoms: A week ago was around 12/18.  Symptoms present on admission: Yes Date of covid positive test: 12/24 Vaccination status: vaccinated Imaging: CTPA?no acute PE with mild bilateral lower lung GGO which could reflect underlying mild pneumonitis.  Borderline prominent heart size with suspected mild pulmonary hypertension.  Extensive bilateral centrilobular and bullous emphysema with large hiatal hernia Oxygen requirements on admission: 3L patient is on 3 L oxygen chronically. Current oxygen requirements: 2-3 lit Medical therapy: Decadron started 12/27 given into no above home O2 demands. Remdesivir started 12/27 per HCP Consultants following: HCP Anticipated special isolation end date:  1/4/23 Breathing improving   Pneumonia- viral  CT pulmonary angiogram shows mild bilateral lower lung groundglass opacities at the right middle, bilateral lower lobes and left lingula.  Findings reflect underlying mild pneumonitis. Afebrile.  Vital stable.  Oxygen saturation 96% on 3 L oxygen. Lactic acid 2.7, WBC 3.8. She was initiated on Rocephin CAP. Procalcitonin <0.06. Stop Rocephin,  Check urine antigen- negative  BC negative at 48 hours Sputum culture normal flora after 24 hrs with heavy growth yeast. Discussed with HCP- likely a commensal mucinex Incentive spirometry/PEP Episode of hemoptysis 1/01- now resolved- likely due to recent pulmonary infection in the setting of AC use Pulmonary consulted. 1/02 CT chest demonstrated developing segmenta and subsegmental bronchial airway endobronchial density likely due to mucus plugging. Mild multifocal bilateral lower lung ground-glass opacities/pneumonitis have intervally decreased when compared to CT 12/24/2022.  Recent history of pulmonary embolism in November 2022 Hemoptysis. She is compliant with Coumadin, INR 2.7-- > 2.5 Patient reports specks of blood in the sputum for last 2 days prior to admission. Now ressolved CT chest as above. Continue Coumadin- dosing per pharmacy.   Given return, consult pulm for evaluation Increase mucinex to 1200mg BID   COPD Chronic respiratory failure She is on 3 L oxygen at baseline. Doxycycline- complete course Resume home inhalers.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Urine antigen test, White blood cell count decreased
Clinical narrative: Patient is a 81 y.o. female patient of local MD with history of  COPD, osteoporosis, squamous cell carcinoma of the tongue, arctic aneurysm, recent diagnosis of PE on Coumadin for anticoagulation is presenting with chief complaint of shortness of breath, cough with green sputum for about a week.     Covid-19 Virus Infection Date of onset of symptoms: A week ago was around 12/18.  Symptoms present on admission: Yes Date of covid positive test: 12/24 Vaccination status: vaccinated Imaging: CTPA?no acute PE with mild bilateral lower lung GGO which could reflect underlying mild pneumonitis.  Borderline prominent heart size with suspected mild pulmonary hypertension.  Extensive bilateral centrilobular and bullous emphysema with large hiatal hernia Oxygen requirements on admission: 3L patient is on 3 L oxygen chronically. Current oxygen requirements: 2-3 lit Medical therapy: Decadron started 12/27 given into no above home O2 demands. Remdesivir started 12/27 per HCP Consultants following: HCP Anticipated special isolation end date:  1/4/23 Breathing improving   Pneumonia- viral  CT pulmonary angiogram shows mild bilateral lower lung groundglass opacities at the right middle, bilateral lower lobes and left lingula.  Findings reflect underlying mild pneumonitis. Afebrile.  Vital stable.  Oxygen saturation 96% on 3 L oxygen. Lactic acid 2.7, WBC 3.8. She was initiated on Rocephin CAP. Procalcitonin <0.06. Stop Rocephin,  Check urine antigen- negative  BC negative at 48 hours Sputum culture normal flora after 24 hrs with heavy growth yeast. Discussed with HCP- likely a commensal mucinex Incentive spirometry/PEP Episode of hemoptysis 1/01- now resolved- likely due to recent pulmonary infection in the setting of AC use Pulmonary consulted. 1/02 CT chest demonstrated developing segmenta and subsegmental bronchial airway endobronchial density likely due to mucus plugging. Mild multifocal bilateral lower lung ground-glass opacities/pneumonitis have intervally decreased when compared to CT 12/24/2022.  Recent history of pulmonary embolism in November 2022 Hemoptysis. She is compliant with Coumadin, INR 2.7-- > 2.5 Patient reports specks of blood in the sputum for last 2 days prior to admission. Now ressolved CT chest as above. Continue Coumadin- dosing per pharmacy.   Given return, consult pulm for evaluation Increase mucinex to 1200mg BID   COPD Chronic respiratory failure She is on 3 L oxygen at baseline. Doxycycline- complete course Resume home inhalers.
Age: 46.0
Sex: U
Vaccine: COVID19-2
Symptoms: Pruritus
Clinical narrative: 20 minutes after vaccination pat left arm started itching, nothing around injection site. Pt didn't have any other adverse reaction. Pt left clinic after 40 minutes.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient presented for her last Hep B vaccination. Nurse accidentally administerd pediatric dose of Hep B instead of adult dose of Hep B.  No adverse reactions noted.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pain and redness above middle finger on top of hand in right arm 3 days after injection. Increased redness and swelling noted
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received moderna  covid-19 vaccine for ages 6-11yrs of age instead of updated moderna bivalent booster.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: There are no known adverse events to report. The pt. was to receive his second dose of Novavax  vaccine but received Moderna monovalent as his second dose.  The medical error occurred  because the pt. arrived to the appt. without his original vaccination card. Staff of the clinic assisted in making him a new card  but mistakenly documented on the card that he received Moderna monovalent as his first dose. Before I vaccinated the pt. I asked him before the medication was drawn and before I gave him the medication was this the vaccine he was receiving. He stated "yes". The pt. also waited in the clinic with the nurses for 20min to assure no adverse reactions.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: I contracted COVID. I have a slight cough and a sore throat. It progressed to a fever and congestion. I had fatigue also. I called my doctor because I am a transplant patient and was given oral medication and after 5 or 6 days I felt normal again. Molnupiravir was the name of the medication.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I contracted COVID. I have a slight cough and a sore throat. It progressed to a fever and congestion. I had fatigue also. I called my doctor because I am a transplant patient and was given oral medication and after 5 or 6 days I felt normal again. Molnupiravir was the name of the medication.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Aphasia, Brain neoplasm, Computerised tomogram head, Craniotomy, Echocardiogram
Clinical narrative: Onset of intermittent headaches and tingling of the right hand began in mid December. The 2nd week of January, I had a transient episode of expressive aphasia that lasted about 1 minute. A week after that, a 2nd episode of expressive aphasia happened that was much longer which resulted in an ER visit and hospital admission. The subsequent work up showed a brain tumor in the left parietal lobe on an MRI scan. On 01/17/2023 I had a craniotomy which removed most of the tumor. Now I'm waiting for an oncology evaluation.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Electrocardiogram, Headache, Laboratory test, Magnetic resonance imaging head abnormal, Paraesthesia
Clinical narrative: Onset of intermittent headaches and tingling of the right hand began in mid December. The 2nd week of January, I had a transient episode of expressive aphasia that lasted about 1 minute. A week after that, a 2nd episode of expressive aphasia happened that was much longer which resulted in an ER visit and hospital admission. The subsequent work up showed a brain tumor in the left parietal lobe on an MRI scan. On 01/17/2023 I had a craniotomy which removed most of the tumor. Now I'm waiting for an oncology evaluation.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient reported red, hard, swollen lump at injection site the day after administration. Also reported injection site to be hot and sore to touch. Symptoms still present as of 2/1/23 when reported.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth
Clinical narrative: Patient reported red, hard, swollen lump at injection site the day after administration. Also reported injection site to be hot and sore to touch. Symptoms still present as of 2/1/23 when reported.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered with moderna covid-19 vaccine for ages 6-11yrs of age instead of the updated Moderna bivalent booster.
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: fever of 103.3
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Paranasal sinus hypersecretion, Respiratory tract congestion, Rhinorrhoea, Sinus disorder
Clinical narrative: I had a sinus Infection that has been going on forever. Since mid-December I have had constant sinus problems. I did not have before this 5th shot. I often feel congestion. I have runny nose drainage. I have a cough and just overall sinusitis. I contacted my Teladoc and was given antibiotics.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sinusitis
Clinical narrative: I had a sinus Infection that has been going on forever. Since mid-December I have had constant sinus problems. I did not have before this 5th shot. I often feel congestion. I have runny nose drainage. I have a cough and just overall sinusitis. I contacted my Teladoc and was given antibiotics.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anxiety, COVID-19, Chronic obstructive pulmonary disease, Computerised tomogram head normal
Clinical narrative: The patient is a 75 y.o. female with a history of Chronic hypoxemic respiratory failure (3-4L), COPD, HTN, HFpEF, R eye blindness who presented to the hospital 1/3/2023 with recurrent falls at home and confusion. CT head negative. Found to be COVID 19 +. Hospitalization complicated by AE COPD with hypercapnic respiratory failure requiring bipap.    1. Acute on chronic hypoxemic and hypercapnic respiratory failure: Baseline 3-4L Suspect acute shunt related to viral pneumonia on chronic VQ mismatch from COPD.  Briefly on 4-5 liters and improved to baseline. 1/8/2022 Worsened mental status and CO2 > 100, transferred to intermediate and placed on continuous BiPAP. Weaned to LFNC with BIPAP prn.  2. Acute metabolic encephalopathy: Multifactorial likely secondary to hypercapnia, dehydration, and polypharmacy. CT head and MRI brain nonacute.  Sleep hygiene ordered.  Discussed delirium precautions. Worsened 1/8/2022 and since improved. Resolved. 3. Acute exacerbation of COPD: Initially had mild wheezing then developed a progressive cough and sputum volume. No PFT on file. Pulmonology following. S/p Azithro. Pulm following, IV solumedrol followed by PO prednisone with steroid taper, 40mg daily taper by 10q3 days.  4. COVID-19 infection: Positive contacts at home, tested positive on 1/3/23.  Continue steroids.  5. Recurrent falls: 2 falls on day of admission, likely secondary to orthostatic hypotension and altered mentation in the setting of viral illness.  PT/OT. 6. Anxiety: PRN Klonopin initially held for AMS. Resumed home dose once mental status improved. Klonopin available prn. 7. HFpEF: Remains clinically hypovolemic.  Held home Lasix. 8. R eye blindness: Per Hx
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Confusional state, Cough, Dehydration, Delirium
Clinical narrative: The patient is a 75 y.o. female with a history of Chronic hypoxemic respiratory failure (3-4L), COPD, HTN, HFpEF, R eye blindness who presented to the hospital 1/3/2023 with recurrent falls at home and confusion. CT head negative. Found to be COVID 19 +. Hospitalization complicated by AE COPD with hypercapnic respiratory failure requiring bipap.    1. Acute on chronic hypoxemic and hypercapnic respiratory failure: Baseline 3-4L Suspect acute shunt related to viral pneumonia on chronic VQ mismatch from COPD.  Briefly on 4-5 liters and improved to baseline. 1/8/2022 Worsened mental status and CO2 > 100, transferred to intermediate and placed on continuous BiPAP. Weaned to LFNC with BIPAP prn.  2. Acute metabolic encephalopathy: Multifactorial likely secondary to hypercapnia, dehydration, and polypharmacy. CT head and MRI brain nonacute.  Sleep hygiene ordered.  Discussed delirium precautions. Worsened 1/8/2022 and since improved. Resolved. 3. Acute exacerbation of COPD: Initially had mild wheezing then developed a progressive cough and sputum volume. No PFT on file. Pulmonology following. S/p Azithro. Pulm following, IV solumedrol followed by PO prednisone with steroid taper, 40mg daily taper by 10q3 days.  4. COVID-19 infection: Positive contacts at home, tested positive on 1/3/23.  Continue steroids.  5. Recurrent falls: 2 falls on day of admission, likely secondary to orthostatic hypotension and altered mentation in the setting of viral illness.  PT/OT. 6. Anxiety: PRN Klonopin initially held for AMS. Resumed home dose once mental status improved. Klonopin available prn. 7. HFpEF: Remains clinically hypovolemic.  Held home Lasix. 8. R eye blindness: Per Hx
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hypovolaemia, Magnetic resonance imaging head normal, Mental status changes, Metabolic encephalopathy
Clinical narrative: The patient is a 75 y.o. female with a history of Chronic hypoxemic respiratory failure (3-4L), COPD, HTN, HFpEF, R eye blindness who presented to the hospital 1/3/2023 with recurrent falls at home and confusion. CT head negative. Found to be COVID 19 +. Hospitalization complicated by AE COPD with hypercapnic respiratory failure requiring bipap.    1. Acute on chronic hypoxemic and hypercapnic respiratory failure: Baseline 3-4L Suspect acute shunt related to viral pneumonia on chronic VQ mismatch from COPD.  Briefly on 4-5 liters and improved to baseline. 1/8/2022 Worsened mental status and CO2 > 100, transferred to intermediate and placed on continuous BiPAP. Weaned to LFNC with BIPAP prn.  2. Acute metabolic encephalopathy: Multifactorial likely secondary to hypercapnia, dehydration, and polypharmacy. CT head and MRI brain nonacute.  Sleep hygiene ordered.  Discussed delirium precautions. Worsened 1/8/2022 and since improved. Resolved. 3. Acute exacerbation of COPD: Initially had mild wheezing then developed a progressive cough and sputum volume. No PFT on file. Pulmonology following. S/p Azithro. Pulm following, IV solumedrol followed by PO prednisone with steroid taper, 40mg daily taper by 10q3 days.  4. COVID-19 infection: Positive contacts at home, tested positive on 1/3/23.  Continue steroids.  5. Recurrent falls: 2 falls on day of admission, likely secondary to orthostatic hypotension and altered mentation in the setting of viral illness.  PT/OT. 6. Anxiety: PRN Klonopin initially held for AMS. Resumed home dose once mental status improved. Klonopin available prn. 7. HFpEF: Remains clinically hypovolemic.  Held home Lasix. 8. R eye blindness: Per Hx
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple drug therapy, Orthostatic hypotension, Pneumonia viral, Positive airway pressure therapy, Respiratory failure
Clinical narrative: The patient is a 75 y.o. female with a history of Chronic hypoxemic respiratory failure (3-4L), COPD, HTN, HFpEF, R eye blindness who presented to the hospital 1/3/2023 with recurrent falls at home and confusion. CT head negative. Found to be COVID 19 +. Hospitalization complicated by AE COPD with hypercapnic respiratory failure requiring bipap.    1. Acute on chronic hypoxemic and hypercapnic respiratory failure: Baseline 3-4L Suspect acute shunt related to viral pneumonia on chronic VQ mismatch from COPD.  Briefly on 4-5 liters and improved to baseline. 1/8/2022 Worsened mental status and CO2 > 100, transferred to intermediate and placed on continuous BiPAP. Weaned to LFNC with BIPAP prn.  2. Acute metabolic encephalopathy: Multifactorial likely secondary to hypercapnia, dehydration, and polypharmacy. CT head and MRI brain nonacute.  Sleep hygiene ordered.  Discussed delirium precautions. Worsened 1/8/2022 and since improved. Resolved. 3. Acute exacerbation of COPD: Initially had mild wheezing then developed a progressive cough and sputum volume. No PFT on file. Pulmonology following. S/p Azithro. Pulm following, IV solumedrol followed by PO prednisone with steroid taper, 40mg daily taper by 10q3 days.  4. COVID-19 infection: Positive contacts at home, tested positive on 1/3/23.  Continue steroids.  5. Recurrent falls: 2 falls on day of admission, likely secondary to orthostatic hypotension and altered mentation in the setting of viral illness.  PT/OT. 6. Anxiety: PRN Klonopin initially held for AMS. Resumed home dose once mental status improved. Klonopin available prn. 7. HFpEF: Remains clinically hypovolemic.  Held home Lasix. 8. R eye blindness: Per Hx
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Shunt infection, Sputum increased, Wheezing
Clinical narrative: The patient is a 75 y.o. female with a history of Chronic hypoxemic respiratory failure (3-4L), COPD, HTN, HFpEF, R eye blindness who presented to the hospital 1/3/2023 with recurrent falls at home and confusion. CT head negative. Found to be COVID 19 +. Hospitalization complicated by AE COPD with hypercapnic respiratory failure requiring bipap.    1. Acute on chronic hypoxemic and hypercapnic respiratory failure: Baseline 3-4L Suspect acute shunt related to viral pneumonia on chronic VQ mismatch from COPD.  Briefly on 4-5 liters and improved to baseline. 1/8/2022 Worsened mental status and CO2 > 100, transferred to intermediate and placed on continuous BiPAP. Weaned to LFNC with BIPAP prn.  2. Acute metabolic encephalopathy: Multifactorial likely secondary to hypercapnia, dehydration, and polypharmacy. CT head and MRI brain nonacute.  Sleep hygiene ordered.  Discussed delirium precautions. Worsened 1/8/2022 and since improved. Resolved. 3. Acute exacerbation of COPD: Initially had mild wheezing then developed a progressive cough and sputum volume. No PFT on file. Pulmonology following. S/p Azithro. Pulm following, IV solumedrol followed by PO prednisone with steroid taper, 40mg daily taper by 10q3 days.  4. COVID-19 infection: Positive contacts at home, tested positive on 1/3/23.  Continue steroids.  5. Recurrent falls: 2 falls on day of admission, likely secondary to orthostatic hypotension and altered mentation in the setting of viral illness.  PT/OT. 6. Anxiety: PRN Klonopin initially held for AMS. Resumed home dose once mental status improved. Klonopin available prn. 7. HFpEF: Remains clinically hypovolemic.  Held home Lasix. 8. R eye blindness: Per Hx
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Depressed level of consciousness, Endotracheal intubation, Mental status changes, Occult blood positive
Clinical narrative: Hospitalized 3/24/22-4/13/22. Respiratory failure, obtunded>intubation, PNA, sepsis, altered mental status, CHF,  +FOB, pulmonary edema, O2, UTI.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Pulmonary oedema, Respiratory failure, Sepsis, Urinary tract infection
Clinical narrative: Hospitalized 3/24/22-4/13/22. Respiratory failure, obtunded>intubation, PNA, sepsis, altered mental status, CHF,  +FOB, pulmonary edema, O2, UTI.
Age: 1.17
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pt was given Moderna vaccine for dose one.  Pfizer vaccine administered as dose two.  Not interchangeable.  No reports of harm to pt.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Confusional state, Dementia, Mental status changes, SARS-CoV-2 test positive
Clinical narrative: Patient is a 74 y.o. female who presented from home on 12/12/2022 with altered mental status thought to be undiagnosed dementia. Expanded workup considered based on reported rapid progression but did not tolerate LP. Family elected to forego any further procedures. Found to have low B1 level. The patient was to be discharged on 12/30, though cancelled due to positive COVID test.  During hospital course patient had remained pleasantly confused, out of COVID isolation 1/8. Patient discharged on 1/9/23.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B1 decreased
Clinical narrative: Patient is a 74 y.o. female who presented from home on 12/12/2022 with altered mental status thought to be undiagnosed dementia. Expanded workup considered based on reported rapid progression but did not tolerate LP. Family elected to forego any further procedures. Found to have low B1 level. The patient was to be discharged on 12/30, though cancelled due to positive COVID test.  During hospital course patient had remained pleasantly confused, out of COVID isolation 1/8. Patient discharged on 1/9/23.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Disorientation, Dizziness, Electrocardiogram abnormal
Clinical narrative: He was complaining of being tired and decided to go to sleep. The next morning, he was very tired/fatigue and asked for some water for hydration. After that, he said he felt very faint and passed out after saying that. He wasn't responsive to me when trying to wake him. I called 911 when he wouldn't respond; he was passed out for about a minute before he woke and was very disoriented after. The paramedics arrived after; they assessed him for a normal heartrate but pretty fast EKG. He was complaining about chest pain as well. They asked did he want to go the hospital, and he opted in. They were no conclusive results from the blood work and EKG testing done at the hospital. The doctor said the chest pain was probably from a muscle injury from prior to the vaccine and was told to take ibuprofen to aid the pain he was feeling. He was suggested to see a cardiologist as well; when they were prepping him for a CT scan, he fainted again for about 30 seconds or so. Fast forward weeks later to now, he's doing pretty better, but he's still being monitored for an upcoming appointment for another heart assessment.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: He was complaining of being tired and decided to go to sleep. The next morning, he was very tired/fatigue and asked for some water for hydration. After that, he said he felt very faint and passed out after saying that. He wasn't responsive to me when trying to wake him. I called 911 when he wouldn't respond; he was passed out for about a minute before he woke and was very disoriented after. The paramedics arrived after; they assessed him for a normal heartrate but pretty fast EKG. He was complaining about chest pain as well. They asked did he want to go the hospital, and he opted in. They were no conclusive results from the blood work and EKG testing done at the hospital. The doctor said the chest pain was probably from a muscle injury from prior to the vaccine and was told to take ibuprofen to aid the pain he was feeling. He was suggested to see a cardiologist as well; when they were prepping him for a CT scan, he fainted again for about 30 seconds or so. Fast forward weeks later to now, he's doing pretty better, but he's still being monitored for an upcoming appointment for another heart assessment.
Age: 48.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Abdominal discomfort, Appendicectomy, Appendicitis, Computerised tomogram abdomen abnormal, Flatulence
Clinical narrative: 11/10/2022 was making dinner and began feeling like I had an upset stomach. Thought it could be gas and took gas meds with no relief. Vomited on the way to the car when I went to ER. Went to walk-in clinic and was transported by EMS to ER. ER started an IV and pain meds. Did CT with contrast and it was determined that it was acute appendicitis and was admitted for an emergency appendectomy. Appendix and everything surrounding it was inflamed. Was discharged on Sunday 11/13/2022.
Age: 48.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Inflammation, Scan with contrast abnormal, Vomiting
Clinical narrative: 11/10/2022 was making dinner and began feeling like I had an upset stomach. Thought it could be gas and took gas meds with no relief. Vomited on the way to the car when I went to ER. Went to walk-in clinic and was transported by EMS to ER. ER started an IV and pain meds. Did CT with contrast and it was determined that it was acute appendicitis and was admitted for an emergency appendectomy. Appendix and everything surrounding it was inflamed. Was discharged on Sunday 11/13/2022.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered with moderna covid-19 vaccine for 6-11 yrs of age instead of the updated moderna bivalent booster
Age: 27.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dry mouth, Feeling hot, Nausea
Clinical narrative: I was find all day with no symptoms.  My normal diet and normal activities that day.  Retired around 9 p.m.  Awoke at 1:00 a.m. in a cold clammy sweat, warm all over.  Did not take my temperature.  Got up to go to the bathroom and felt very weak all over, nearly passed out.  Called to my husband to help me.  He helped me get to the sofa in the living room.  I felt very nauseous and nervous. At first I thought I was coming down with the flu.  My mouth was extremely dry.  After about 5 hours, I fell asleep.  I awoke at 8 a.m. and felt somewhat better.  In another hour or so, I was basically back to normal.  It was a terrible experience.  I felt that I was going to die.  I would like to add additional information if it makes a difference.  My appointment was for 10 a.m.  When I arrived, there was a long line outside and the facility administering the Covid-19 vaccine was closed.  We were told that there was a power outage and the vials had to placed back into the freezer.  Once the power was back on, they started to defrost the vials and it was going to take an hour.  In about an hour, the line of people were allowed into the facility and administered the vaccine.    I am now scared to get the second vaccine, which is due to be administered on April 6.   Thank you.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Presyncope
Clinical narrative: I was find all day with no symptoms.  My normal diet and normal activities that day.  Retired around 9 p.m.  Awoke at 1:00 a.m. in a cold clammy sweat, warm all over.  Did not take my temperature.  Got up to go to the bathroom and felt very weak all over, nearly passed out.  Called to my husband to help me.  He helped me get to the sofa in the living room.  I felt very nauseous and nervous. At first I thought I was coming down with the flu.  My mouth was extremely dry.  After about 5 hours, I fell asleep.  I awoke at 8 a.m. and felt somewhat better.  In another hour or so, I was basically back to normal.  It was a terrible experience.  I felt that I was going to die.  I would like to add additional information if it makes a difference.  My appointment was for 10 a.m.  When I arrived, there was a long line outside and the facility administering the Covid-19 vaccine was closed.  We were told that there was a power outage and the vials had to placed back into the freezer.  Once the power was back on, they started to defrost the vials and it was going to take an hour.  In about an hour, the line of people were allowed into the facility and administered the vaccine.    I am now scared to get the second vaccine, which is due to be administered on April 6.   Thank you.
Age: 0.58
Sex: M
Vaccine: PNC13
Symptoms: Gastrooesophageal reflux disease, Hiccups, Vomiting
Clinical narrative: Vomiting every morning for weeks and consistent hiccups/reflux when there had been none.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: A 5 year old patient received a dose of the Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) booster for 6 months to 5 years  following the completion of primary vaccination with Pfizer COVID-19 Vaccine.  ?
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: It was noticed by office staff on 01/24/2023 that the ProQuad had been stored in the vaccine fridge and not the vaccine freezer.  Patient had not reported any side effects from the initial vaccine, but will need to be revaccinated due to improper storage of the vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Patient was administered with moderna covid-19 vaccine for 6-11yrs of age instead of the updated moderna bivalent booster.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills and body aches.  Then, at 6:00pm, fever begins 100 degrees, 102.5 at 10:00pm, broke at 1:00am
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: It was discovered on 01/24/2023 that our ProQuad vaccine had been stored in the fridge and not the freezer.  Patient was given a dose of ProQuad that had been stored improperly.  Patient has not reported any adverse reactions from the initial vaccine, but will be brought into clinic to be revaccinated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Arthralgia, Laboratory test abnormal, Pain in extremity
Clinical narrative: Developed arthritic pain in my hands and feet and right elbow.  Also had pain in left foot that lasted for 16 hours then disappeared spontaneously.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated that starting the next morning her arm became red and swollen to the size of a baseball and very painful. She alerted us on day 5 when the symptoms have resolved. She took no intervention.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 237c4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 24-JAN-2023 Reporter's Comments: Office manager reported that medical assistant administered an expired dose of kinrix on 23rd January 2023, whereas kinrix was expired on 13th January 2023. The reporter consented to follow up. Additional Supportive Information: the patient received vaccine, which was expired on 17th January 2023.
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 12/2022, 2nd dose on on 01/24/2023; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 25-year-old male patient who received HAV (Havrix) (batch number 3J9G4, expiry date 30th August 2025) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 24th January 2023, the patient received Havrix. On 24th January 2023, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 24-JAN-2023 Reporter's Comments: Nurse reporting primary dose of Havrix administered in December 2022 and booster dose administered less than 6 months later on 24th January 2023. The reporter consented to follow up. Additional Supportive Information: the patient received booster dose on 24th January 2023, earlier than recommended standard schedule, which led to shortening of the vaccination schedule.
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: was administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 36-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 17th January 2023, the patient received Havrix. On 17th January 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comments: Nurse reported a patient was administered an expired dose of havrix on 17th January 2023 and expired on 16th December 2022. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The patient received dose of Havrix which was already expired on 16th December 2022.
Age: 57.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 57-year-old male patient who received HAB (Twinrix) (batch number 3PP42, expiry date 16th March 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th January 2023, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 25th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 25-JAN-2023 Reporter's Comments: Nurse reported that a male patient received a dose of Twinrix, administered by a different nurse, which had an expiration date of 16th March 2022.   This was the patient's third dose in the series.   At the time of reporting, the patient had not been revaccinated. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Twinrix which was already expired on 16th March 2022.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Extensive rash; Soreness; Completed series in 2020, has shingles now/suspected vaccination failure; Shingles, diagnosed by HCP; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male 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 2nd dose of Shingrix and the 1st dose of Shingrix. On 18th January 2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced rash and pain. On an unknown date, the outcome of the vaccination failure, rash and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 25-Jan-2023 Reporter's comment: The patient's wife reported that the patient completed his Shingrix series in 2020 and now had shingles, diagnosed by his health care professional. The reporter stated that the patient had quite an extensive rash with soreness but no nerve pain. The reporter did not consent to follow-up. The case was linked with case US2023AMR010171 reported by same reporter for herself. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Regarding the outcome date clarification request was raised and meanwhile the outcome was captured based upon the reported information.; Sender's Comments:  US-GSK-US2023AMR010171:Same reporter
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix administered to a 15 months-old; Kinrix administered instead of dtap vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-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 25th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong 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: 25-JAN-2023 Reporter's Comments: Nurse reported a 15-month-old patient received a dose of the kinrix vaccine inadvertently instead of the dtap vaccine on 25th January 2023. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Kinrix, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental overdose, Incorrect dose administered, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: 3YO received adult dose; 3YO received adult dose; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 3-year-old female patient who received HAV (Havrix adult) (batch number 55M72, expiry date unknown) for prophylaxis.   On 25th January 2023, the patient received the 2nd dose of Havrix adult. On 25th January 2023, unknown after receiving Havrix adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.    Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comments: Medical Assistant administered by error to a 3-year-old female patient, Havrix dose adult formulation. Expiration date of the vaccines was no available at the moment of the call. The reporter consented to follow up via email. Additional Supportive Information: The child patient received adult formulation of havrix, which led to accidental overdose and adult product administered to child.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: On 01/24/2022 it was discovered by the clinic staff that the ProQuad vaccine was being stored in the fridge and not the freezer.  Patient was identified as someone who was given a dose of the vaccine that was stored improperly and will need to come back to clinic to be revaccinated.  There were no other complaints of adverse reactions from the vaccine.
Age: 72.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: 72 YO received pediatric dose; 72 YO received pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 72-year-old female patient who received HAV (Havrix 720) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th July 2022, the patient received the 1st dose of Havrix 720 and Havrix Pre-Filled Syringe Device. On 9th July 2022, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product 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: 25-JAN-2023 Reporter's Comments: Pharmacist reported a female patient was administered a dose of Havrix on 9th July 2022. The patient came back into the pharmacy to request second dose, the system rejected the dosing because of her age and at that time they realized she had received a pediatric dose for the first dose.   At the time of reporting, additional dosing had not been administered. Additional Supportive Information: The adult patient received pediatric formulation of Havrix, which led to accidental underdose and adult use of a child product.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Chest X-ray normal, Condition aggravated, Feeling hot, Heart rate increased
Clinical narrative: I have a rescue medication that I have for when my heart rate is really high. On Wednesday I had an episode of tachycardia which was four days after my COVID-19 shot. I was out shopping and my heart rate jumped up into the typical tachycardia pattern, I felt this warmth around my head and then my heart rate shot up. I had my medication for when this happens on me, I took a half of the dose at that time. That resolved and I was able to make it home and I really forgot about it. The next day I was finishing lunch around 2:30PM in the afternoon. I had another episode, and my heart rate went up to about 230-240. I was able to get it down with a half a pill, but it went back up. I then took a whole dose and did the things I am supposed to do. I put ice on my neck on my face and lay down, but this kept happening. I would get it calmed down but about thirty minutes later it would be back up. It calmed down over Friday, I did take my medication again on Friday during the episode and I had upped my regular beta blockers that night as well. By Saturday night this was still happening I had gone to bed, but it was still happening, and I ended up going up and I ended up going to the ER around 1AM that morning. They did do lab work and took a chest x-ray at the ER but they did not see anything. I am following up with a cardiologist to see if we cannot figure out what is going on. My blood pressure has been fluctuating and I did cancel travel plans because of this. I have my tachycardia issues under control with medication for the last two years and getting this last COVID-19 shot seems to have caused it flare up and have issues.