chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pneumonia, Positive airway pressure therapy, Pulmonary oedema, SARS-CoV-2 test positive, Sepsis
Clinical narrative: Patient is a 69 y.o. female patient of MD.   Report on admission: Patient is a 69 y.o. female presenting from home with c/o 69-year-old female with a history of COPD presents emergency department with shortness of breath for 1 week.  Shortness of breath definitely worsened despite taking her inhaler at home.  Patient was admitted in November for same and was in the ICU on BiPAP.  Patient also reports COVID-positive end of December Husband at bedside reports at the trach location there is airway stenosis which is inoperable.   Hospital course as below.  Cardiology and pulmonology followed patient during stay.  Patient improved with medical treatment.  Patient discharged to SNF in stable condition.  Patient will need close monitoring of vital signs.   1.  COVID PNA: -pulm followed -COVID +12/26, positive again on 1/7/2023 -CT chest with very low lung volumes, bilateral groundglass infiltrates reflecting pulmonary edema versus pneumonia -isolation completed 1/18/23  2.  Asthma: -pulm consulted  3.  Acute hypoxic respiratory failure: -Likely in setting of above -Wean oxygen as able  4.  Sepsis trigger: -1/7 blood cultures no growth to date  5.  Type 2 diabetes, hyperglycemia/hypoglycemia: -In setting of steroids -A1c 7.5 -Sliding scale insulin, adjust home meds  6.  UTI: -Urine culture positive for enterococcus faecalis -abx completed   7. Tachycardia: -cardio consulted
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tachycardia, Total lung capacity decreased, Tracheal stenosis, Tracheostomy, Urinary tract infection
Clinical narrative: Patient is a 69 y.o. female patient of MD.   Report on admission: Patient is a 69 y.o. female presenting from home with c/o 69-year-old female with a history of COPD presents emergency department with shortness of breath for 1 week.  Shortness of breath definitely worsened despite taking her inhaler at home.  Patient was admitted in November for same and was in the ICU on BiPAP.  Patient also reports COVID-positive end of December Husband at bedside reports at the trach location there is airway stenosis which is inoperable.   Hospital course as below.  Cardiology and pulmonology followed patient during stay.  Patient improved with medical treatment.  Patient discharged to SNF in stable condition.  Patient will need close monitoring of vital signs.   1.  COVID PNA: -pulm followed -COVID +12/26, positive again on 1/7/2023 -CT chest with very low lung volumes, bilateral groundglass infiltrates reflecting pulmonary edema versus pneumonia -isolation completed 1/18/23  2.  Asthma: -pulm consulted  3.  Acute hypoxic respiratory failure: -Likely in setting of above -Wean oxygen as able  4.  Sepsis trigger: -1/7 blood cultures no growth to date  5.  Type 2 diabetes, hyperglycemia/hypoglycemia: -In setting of steroids -A1c 7.5 -Sliding scale insulin, adjust home meds  6.  UTI: -Urine culture positive for enterococcus faecalis -abx completed   7. Tachycardia: -cardio consulted
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Muscle twitching, Neurological symptom, Pain, Post herpetic neuralgia
Clinical narrative: PT HAS PHN ADVERSE EFFECTS -POST HERPETIC NEURALGIA, INSOMINA, PAIN ,ANKLE TWITCHING, TROUBLE SLEEPING, STATES HIS NEUROLOGICAL SYMPTOMS ARE BEYOUND JUST NORMAL SHINGLES
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient received duplicate therapy of Pfizer Bivalent Updated Booster. Patient received first dose of Pfizer bivalent in September 2022 from a different pharmacy and patient received a second dose of Bivalent in March 2023. Patient was not aware that they were not supposed to get two doses of Bivalent.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Corrective lens user, Cough, Flushing, Laboratory test abnormal
Clinical narrative: stood up after meeting at work and went blind/greyed out, sight came back in right eye after a minute, left eye stayed out and gradually gained sections of vision over 3 day period. Still have vision dead spot Eye Stroke, after the 2nd injection- determined thru eye exam when getting new pair of glasses. performed extra tests to confirm. also after booster started experiencing syncopy/flushing when coughing or sneezing, that has been ongoing ever since, duration and intensity was worse at beginning.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal artery occlusion, Sneezing, Syncope, Visual field defect
Clinical narrative: stood up after meeting at work and went blind/greyed out, sight came back in right eye after a minute, left eye stayed out and gradually gained sections of vision over 3 day period. Still have vision dead spot Eye Stroke, after the 2nd injection- determined thru eye exam when getting new pair of glasses. performed extra tests to confirm. also after booster started experiencing syncopy/flushing when coughing or sneezing, that has been ongoing ever since, duration and intensity was worse at beginning.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Bed rest, Blood culture positive, Brain natriuretic peptide increased, COVID-19
Clinical narrative: Patient is a 65 y.o. female with a PMHx of Asthma, Chronic respiratory failure, HLD, HTN, DMII, CHF, RA, anemia who presents with shortness of breath and found to have acute resp failure with hypoxia. presented with 2-3 days of worsening SOB. Pt states having sob at rest and with exertion. Husband is sick at home. Pt is on 3L O2 at home chronically. Pt tested + on 2/12 for covid. Clinical respiratory status worsened and was brought to the ICU on HHF. Due to patient's history of kidney transplant and current immunosuppression from post-transplant medications, it would be in the patients best interest to be transferred for further management and care.    Assessment and Plan:   Acute respiratory failure with hypoxia Covid-19 infection Respiratory acidosis MRSA Bacteremia Sepsis Requiring HHF D-Dimer elevated to 11 Heparin gtt started by ED, continued Bed rest orders: Purewick ordered Unable to order CTA due to renal function, VQ scan contraindicated due to Restarted home inhalers Coughing up frothy red sputum Procal mildly elevated in the setting of CKD Blood cultures 2/15 grew 1 of 2 MRSA    - Continue Vancomycin - HHF during day, BiPAP at night - Will hold remdesevir per ID - Decadron 6mg every day  - ID consult for Covid-19 - Ur pna ags pending - Sputum culture, repeat cultures pending   Presumed Pulmonary embolism Hypotension Elevated troponins Noted on admission, bp was 80/40s fluid responsive Requiring repeat bolus after admission Unable to confirm PE via imaging: CTPA contraindicated due to renal function, VQ scan contraindicated due to covid New Frothy red sputum production, BNP 31k, D-dimer of 11, Trop 85->73 EKG with no signs of acute ischemia does have right axis and chronic T wave inversions in inferolateral leads Echo 2/15 shows EF 55%, severely enlarged RV with severely reducede function. Severe tricuspid regurgitation, s/p mitral valve repair. Mild MV regurg   -
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic kidney disease, Dyspnoea, Dyspnoea at rest, Dyspnoea exertional, Echocardiogram abnormal
Clinical narrative: Patient is a 65 y.o. female with a PMHx of Asthma, Chronic respiratory failure, HLD, HTN, DMII, CHF, RA, anemia who presents with shortness of breath and found to have acute resp failure with hypoxia. presented with 2-3 days of worsening SOB. Pt states having sob at rest and with exertion. Husband is sick at home. Pt is on 3L O2 at home chronically. Pt tested + on 2/12 for covid. Clinical respiratory status worsened and was brought to the ICU on HHF. Due to patient's history of kidney transplant and current immunosuppression from post-transplant medications, it would be in the patients best interest to be transferred for further management and care.    Assessment and Plan:   Acute respiratory failure with hypoxia Covid-19 infection Respiratory acidosis MRSA Bacteremia Sepsis Requiring HHF D-Dimer elevated to 11 Heparin gtt started by ED, continued Bed rest orders: Purewick ordered Unable to order CTA due to renal function, VQ scan contraindicated due to Restarted home inhalers Coughing up frothy red sputum Procal mildly elevated in the setting of CKD Blood cultures 2/15 grew 1 of 2 MRSA    - Continue Vancomycin - HHF during day, BiPAP at night - Will hold remdesevir per ID - Decadron 6mg every day  - ID consult for Covid-19 - Ur pna ags pending - Sputum culture, repeat cultures pending   Presumed Pulmonary embolism Hypotension Elevated troponins Noted on admission, bp was 80/40s fluid responsive Requiring repeat bolus after admission Unable to confirm PE via imaging: CTPA contraindicated due to renal function, VQ scan contraindicated due to covid New Frothy red sputum production, BNP 31k, D-dimer of 11, Trop 85->73 EKG with no signs of acute ischemia does have right axis and chronic T wave inversions in inferolateral leads Echo 2/15 shows EF 55%, severely enlarged RV with severely reducede function. Severe tricuspid regurgitation, s/p mitral valve repair. Mild MV regurg   -
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ejection fraction normal, Electrocardiogram T wave inversion, Fibrin D dimer increased, Hypotension, Intensive care
Clinical narrative: Patient is a 65 y.o. female with a PMHx of Asthma, Chronic respiratory failure, HLD, HTN, DMII, CHF, RA, anemia who presents with shortness of breath and found to have acute resp failure with hypoxia. presented with 2-3 days of worsening SOB. Pt states having sob at rest and with exertion. Husband is sick at home. Pt is on 3L O2 at home chronically. Pt tested + on 2/12 for covid. Clinical respiratory status worsened and was brought to the ICU on HHF. Due to patient's history of kidney transplant and current immunosuppression from post-transplant medications, it would be in the patients best interest to be transferred for further management and care.    Assessment and Plan:   Acute respiratory failure with hypoxia Covid-19 infection Respiratory acidosis MRSA Bacteremia Sepsis Requiring HHF D-Dimer elevated to 11 Heparin gtt started by ED, continued Bed rest orders: Purewick ordered Unable to order CTA due to renal function, VQ scan contraindicated due to Restarted home inhalers Coughing up frothy red sputum Procal mildly elevated in the setting of CKD Blood cultures 2/15 grew 1 of 2 MRSA    - Continue Vancomycin - HHF during day, BiPAP at night - Will hold remdesevir per ID - Decadron 6mg every day  - ID consult for Covid-19 - Ur pna ags pending - Sputum culture, repeat cultures pending   Presumed Pulmonary embolism Hypotension Elevated troponins Noted on admission, bp was 80/40s fluid responsive Requiring repeat bolus after admission Unable to confirm PE via imaging: CTPA contraindicated due to renal function, VQ scan contraindicated due to covid New Frothy red sputum production, BNP 31k, D-dimer of 11, Trop 85->73 EKG with no signs of acute ischemia does have right axis and chronic T wave inversions in inferolateral leads Echo 2/15 shows EF 55%, severely enlarged RV with severely reducede function. Severe tricuspid regurgitation, s/p mitral valve repair. Mild MV regurg   -
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Mitral valve incompetence, Mitral valve repair, Positive airway pressure therapy, Procalcitonin increased
Clinical narrative: Patient is a 65 y.o. female with a PMHx of Asthma, Chronic respiratory failure, HLD, HTN, DMII, CHF, RA, anemia who presents with shortness of breath and found to have acute resp failure with hypoxia. presented with 2-3 days of worsening SOB. Pt states having sob at rest and with exertion. Husband is sick at home. Pt is on 3L O2 at home chronically. Pt tested + on 2/12 for covid. Clinical respiratory status worsened and was brought to the ICU on HHF. Due to patient's history of kidney transplant and current immunosuppression from post-transplant medications, it would be in the patients best interest to be transferred for further management and care.    Assessment and Plan:   Acute respiratory failure with hypoxia Covid-19 infection Respiratory acidosis MRSA Bacteremia Sepsis Requiring HHF D-Dimer elevated to 11 Heparin gtt started by ED, continued Bed rest orders: Purewick ordered Unable to order CTA due to renal function, VQ scan contraindicated due to Restarted home inhalers Coughing up frothy red sputum Procal mildly elevated in the setting of CKD Blood cultures 2/15 grew 1 of 2 MRSA    - Continue Vancomycin - HHF during day, BiPAP at night - Will hold remdesevir per ID - Decadron 6mg every day  - ID consult for Covid-19 - Ur pna ags pending - Sputum culture, repeat cultures pending   Presumed Pulmonary embolism Hypotension Elevated troponins Noted on admission, bp was 80/40s fluid responsive Requiring repeat bolus after admission Unable to confirm PE via imaging: CTPA contraindicated due to renal function, VQ scan contraindicated due to covid New Frothy red sputum production, BNP 31k, D-dimer of 11, Trop 85->73 EKG with no signs of acute ischemia does have right axis and chronic T wave inversions in inferolateral leads Echo 2/15 shows EF 55%, severely enlarged RV with severely reducede function. Severe tricuspid regurgitation, s/p mitral valve repair. Mild MV regurg   -
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Renal impairment, Respiratory acidosis, Right ventricular dysfunction, Right ventricular enlargement
Clinical narrative: Patient is a 65 y.o. female with a PMHx of Asthma, Chronic respiratory failure, HLD, HTN, DMII, CHF, RA, anemia who presents with shortness of breath and found to have acute resp failure with hypoxia. presented with 2-3 days of worsening SOB. Pt states having sob at rest and with exertion. Husband is sick at home. Pt is on 3L O2 at home chronically. Pt tested + on 2/12 for covid. Clinical respiratory status worsened and was brought to the ICU on HHF. Due to patient's history of kidney transplant and current immunosuppression from post-transplant medications, it would be in the patients best interest to be transferred for further management and care.    Assessment and Plan:   Acute respiratory failure with hypoxia Covid-19 infection Respiratory acidosis MRSA Bacteremia Sepsis Requiring HHF D-Dimer elevated to 11 Heparin gtt started by ED, continued Bed rest orders: Purewick ordered Unable to order CTA due to renal function, VQ scan contraindicated due to Restarted home inhalers Coughing up frothy red sputum Procal mildly elevated in the setting of CKD Blood cultures 2/15 grew 1 of 2 MRSA    - Continue Vancomycin - HHF during day, BiPAP at night - Will hold remdesevir per ID - Decadron 6mg every day  - ID consult for Covid-19 - Ur pna ags pending - Sputum culture, repeat cultures pending   Presumed Pulmonary embolism Hypotension Elevated troponins Noted on admission, bp was 80/40s fluid responsive Requiring repeat bolus after admission Unable to confirm PE via imaging: CTPA contraindicated due to renal function, VQ scan contraindicated due to covid New Frothy red sputum production, BNP 31k, D-dimer of 11, Trop 85->73 EKG with no signs of acute ischemia does have right axis and chronic T wave inversions in inferolateral leads Echo 2/15 shows EF 55%, severely enlarged RV with severely reducede function. Severe tricuspid regurgitation, s/p mitral valve repair. Mild MV regurg   -
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis, Sputum culture, Staphylococcal bacteraemia, Staphylococcus test positive
Clinical narrative: Patient is a 65 y.o. female with a PMHx of Asthma, Chronic respiratory failure, HLD, HTN, DMII, CHF, RA, anemia who presents with shortness of breath and found to have acute resp failure with hypoxia. presented with 2-3 days of worsening SOB. Pt states having sob at rest and with exertion. Husband is sick at home. Pt is on 3L O2 at home chronically. Pt tested + on 2/12 for covid. Clinical respiratory status worsened and was brought to the ICU on HHF. Due to patient's history of kidney transplant and current immunosuppression from post-transplant medications, it would be in the patients best interest to be transferred for further management and care.    Assessment and Plan:   Acute respiratory failure with hypoxia Covid-19 infection Respiratory acidosis MRSA Bacteremia Sepsis Requiring HHF D-Dimer elevated to 11 Heparin gtt started by ED, continued Bed rest orders: Purewick ordered Unable to order CTA due to renal function, VQ scan contraindicated due to Restarted home inhalers Coughing up frothy red sputum Procal mildly elevated in the setting of CKD Blood cultures 2/15 grew 1 of 2 MRSA    - Continue Vancomycin - HHF during day, BiPAP at night - Will hold remdesevir per ID - Decadron 6mg every day  - ID consult for Covid-19 - Ur pna ags pending - Sputum culture, repeat cultures pending   Presumed Pulmonary embolism Hypotension Elevated troponins Noted on admission, bp was 80/40s fluid responsive Requiring repeat bolus after admission Unable to confirm PE via imaging: CTPA contraindicated due to renal function, VQ scan contraindicated due to covid New Frothy red sputum production, BNP 31k, D-dimer of 11, Trop 85->73 EKG with no signs of acute ischemia does have right axis and chronic T wave inversions in inferolateral leads Echo 2/15 shows EF 55%, severely enlarged RV with severely reducede function. Severe tricuspid regurgitation, s/p mitral valve repair. Mild MV regurg   -
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tricuspid valve incompetence, Troponin increased
Clinical narrative: Patient is a 65 y.o. female with a PMHx of Asthma, Chronic respiratory failure, HLD, HTN, DMII, CHF, RA, anemia who presents with shortness of breath and found to have acute resp failure with hypoxia. presented with 2-3 days of worsening SOB. Pt states having sob at rest and with exertion. Husband is sick at home. Pt is on 3L O2 at home chronically. Pt tested + on 2/12 for covid. Clinical respiratory status worsened and was brought to the ICU on HHF. Due to patient's history of kidney transplant and current immunosuppression from post-transplant medications, it would be in the patients best interest to be transferred for further management and care.    Assessment and Plan:   Acute respiratory failure with hypoxia Covid-19 infection Respiratory acidosis MRSA Bacteremia Sepsis Requiring HHF D-Dimer elevated to 11 Heparin gtt started by ED, continued Bed rest orders: Purewick ordered Unable to order CTA due to renal function, VQ scan contraindicated due to Restarted home inhalers Coughing up frothy red sputum Procal mildly elevated in the setting of CKD Blood cultures 2/15 grew 1 of 2 MRSA    - Continue Vancomycin - HHF during day, BiPAP at night - Will hold remdesevir per ID - Decadron 6mg every day  - ID consult for Covid-19 - Ur pna ags pending - Sputum culture, repeat cultures pending   Presumed Pulmonary embolism Hypotension Elevated troponins Noted on admission, bp was 80/40s fluid responsive Requiring repeat bolus after admission Unable to confirm PE via imaging: CTPA contraindicated due to renal function, VQ scan contraindicated due to covid New Frothy red sputum production, BNP 31k, D-dimer of 11, Trop 85->73 EKG with no signs of acute ischemia does have right axis and chronic T wave inversions in inferolateral leads Echo 2/15 shows EF 55%, severely enlarged RV with severely reducede function. Severe tricuspid regurgitation, s/p mitral valve repair. Mild MV regurg   -
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, C-reactive protein increased, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Severe muscle pain in both upper arms, more in the biceps than the triceps. Also, base of the neck pain and knee pain in both knees. This pain was only somewhat alleviated with Naproxen and or acetaminophen for a month and half. In November, I went to my Dr.. I had a CRP of 71.40 mg/L (normal is 0-2.99). Sedimentation rate was 61 mm/hr (normal is 1 - 20 mm/hr). Dr. put me on 40 mg prednisone for 5 days and the symptoms went away. They came back after the 5 days. I have since been on Prednisone, tapering down to find the smallest effective dose.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Severe muscle pain in both upper arms, more in the biceps than the triceps. Also, base of the neck pain and knee pain in both knees. This pain was only somewhat alleviated with Naproxen and or acetaminophen for a month and half. In November, I went to my Dr.. I had a CRP of 71.40 mg/L (normal is 0-2.99). Sedimentation rate was 61 mm/hr (normal is 1 - 20 mm/hr). Dr. put me on 40 mg prednisone for 5 days and the symptoms went away. They came back after the 5 days. I have since been on Prednisone, tapering down to find the smallest effective dose.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient requested to receive a 2nd dose of Shingrix to a technician.  Pharmacist confirmed with the patient that she is going to receive a 2nd dose of new Shingles vaccine(Shingrix) and after receiving patient asked about coming for a next dose. So, after further talking to the patient and checking system,  it was found that patient was under the impression that she got Zostavax in 2019 and wanted to get Shingrix since Dr. told her to get the new Shingles vaccines. Basically, in 2019 patient completed 2 dose series of Shingrix and in March 2023 she ended up getting a 3rd dose of Shingrix. Patient was observed for 30 minutes and was informed about the situation as well.  Patient was feeling fine and had not reaction, hence was sent home.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Hypoxia
Clinical narrative: Patient received first of 2 low-dose flu vaccines (all that was left by this time in the season) January 27 in the clinic.  He's had flu shots before and tolerated well.  He came back as follow up on 3/6/23 with plan to get the 2nd dose however he reported that 2 days after he'd received the vaccine he had profound hypoxia which he was unable to correct for using the oxygen concentrator.  His oxygen saturations were in the 70s and 80s for a month.  He has slowly recovered but wanted to report his possible adverse reaction and wasn't sure if he should get the second dose.  We advised him not to.  Of note he has end-stage severe COPD and uses O2 24/7; this was just a profound worsening that was unexpected by patient.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site pain, Tenderness
Clinical narrative: Patient received on 2/21/23 a Menquadfi on left deltoid and a Bexsero on the right deltoid. The next day she had mild tenderness on both arms. On 2/26/23-2/28/23. She had more pain on right deltoid. No erythema or warmth at time of visit and no fever. Her left deltoid felt fine at this visit of 2/28/23. She has taken Motrin with no relief. No redness or swelling of right deltoid but is tender to palpation, no bruising.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Vomiting projectile
Clinical narrative: Mom called on 3/3/2023 to report that patient developed projectile vomiting that would not stop. She was taken to ER and after 3 hrs wait and no further vomiting, she was taken home without further evaluation. Mom called to inform us that she did not want patient to receive any further combo vaccines and wanted to only give single vaccines one at a time.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: "fever" & vomiting the day after vaccine
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, General physical condition abnormal, Pallor
Clinical narrative: Patient got Gardasil on his right deltoid. He was sitting by himself, took injection well - was even talking. After injection putting on bandaid, he walked to the waiting room then complained of having dizzy, looked weak & pale. Father walked him back to the exam room. He was talking, feeling dizzy. I checked his vitals - BP was 90/60 - 100/32; Pulse 69; Then regained his pink glow BP 100/62, PR 69 - BP 94/68 PR 66. By now his BP was 108/67, PR 76, BP 116/74 PR 71 at 12:30pm. Patient left after 12:30pm with his father & mother & 3 siblings. They were going to eat. Patient did not eat breakfast.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Rash, Urticaria
Clinical narrative: Thursday 3/2/23 started with headache, Friday 3/3/23 started dizziness, Saturday 3/4/24 started with Rash/hives on Face and arms.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose administered on 07-Mar-2021 and second dose administered on 03-Jun-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 07-Mar-2021 and second dose administered on 03-Jun-2021) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 224E21A, 036B21B, 032H21A and 056022A) for COVID-19 prophylaxis.     The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Prevnar 20 (Patient had a Prevnar20 on B14H00L but does not remember on what date). Past adverse reactions to the above products included No adverse event with Prevnar 20. Concurrent medical conditions included Multiple sclerosis (Using Kesimpta Injection once a month) since 2011. Concomitant products included OFATUMUMAB (KESIMPTA) for Multiple sclerosis.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 07-Mar-2021 and second dose administered on 03-Jun-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 07-Mar-2021 and second dose administered on 03-Jun-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 07-Mar-2021 and second dose administered on 03-Jun-2021).    The patient had been using the Kesimpta injection once a month during all COVID Vaccinations. No treatment medication was provided.   This case was linked to MOD-2023-713714.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocardial infarction
Clinical narrative: Chest pains
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Death, Myocardial infarction
Clinical narrative: Chest pains
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Arthralgia, Autonomic nervous system imbalance, Bladder dysfunction, Blood test
Clinical narrative: I am injured and need help; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team, Program ID: The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EN6205) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY (non-serious), outcome "unknown", described as "I am injured and need help". Additional information: It was reported that the there were lot of adverse reactions with this lot number. The patient was unaware of the ability to check the numbers until today. The patient had injured and need help. The patient wanted to help those who took the vaccine and now need help. The patient was draining with his/her retirement to stay alive.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chest pain, Gait inability, Imaging procedure, Immediate post-injection reaction
Clinical narrative: I am injured and need help; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team, Program ID: The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EN6205) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY (non-serious), outcome "unknown", described as "I am injured and need help". Additional information: It was reported that the there were lot of adverse reactions with this lot number. The patient was unaware of the ability to check the numbers until today. The patient had injured and need help. The patient wanted to help those who took the vaccine and now need help. The patient was draining with his/her retirement to stay alive.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain, Palpitations, Peripheral swelling, Postural orthostatic tachycardia syndrome
Clinical narrative: I am injured and need help; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team, Program ID: The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EN6205) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY (non-serious), outcome "unknown", described as "I am injured and need help". Additional information: It was reported that the there were lot of adverse reactions with this lot number. The patient was unaware of the ability to check the numbers until today. The patient had injured and need help. The patient wanted to help those who took the vaccine and now need help. The patient was draining with his/her retirement to stay alive.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Rash, Sensory disturbance, Vibratory sense increased
Clinical narrative: I am injured and need help; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team, Program ID: The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EN6205) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY (non-serious), outcome "unknown", described as "I am injured and need help". Additional information: It was reported that the there were lot of adverse reactions with this lot number. The patient was unaware of the ability to check the numbers until today. The patient had injured and need help. The patient wanted to help those who took the vaccine and now need help. The patient was draining with his/her retirement to stay alive.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Injury
Clinical narrative: I am injured and need help; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team, Program ID: The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EN6205) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY (non-serious), outcome "unknown", described as "I am injured and need help". Additional information: It was reported that the there were lot of adverse reactions with this lot number. The patient was unaware of the ability to check the numbers until today. The patient had injured and need help. The patient wanted to help those who took the vaccine and now need help. The patient was draining with his/her retirement to stay alive.
Age: 50.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Condition aggravated, Hypoaesthesia, Neuropathy peripheral, Urticaria
Clinical narrative: PATIENT EXPERIENCED HIVES AND NEUROLOGICAL SYMPTOMS.
Age: 50.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Neurological symptom, Urticaria
Clinical narrative: PATIENT EXPERIENCED HIVES AND NEUROLOGICAL SYMPTOMS.
Age: 0.75
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse effects were noted; The patient was scheduled to receive PENTACEL, unspecified brand of "PCV 13", and and unspecified brand of a "Hep B vaccine". The patient received the PENTACEL, "HEP B" vaccine, and VAQTA instead.; a dose of VAQTA was inadvertently administered to a 9 month old.; This spontaneous report was received from a nurse referring to a 9-month-old patient of unspecified gender. Information regarding medical history and concurrent conditions was not provided. Concomitant vaccines included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and hepatitis B vaccine (recombinant) (manufacturer unknown).  On 08-FEB-2023, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) (dose, anatomical site of vaccination and route of administration were not reported; lot number W021491 has been verified to be valid, expiration date reported and established as 14-DEC-2023) for prophylaxis, instead of pneumococcal 13 valent vaccine (reported as "PCV 13", manufacturer unknown) (wrong product administered, product administered to patient of inappropriate age). No adverse effects were reported (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: No additional adverse event; Caller reported expired dose of RECOMBIVAX was administered.; This spontaneous report was received from a medical assistant and refers to a unknown age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 11-JAN-2023, the patient was vaccinated with an expired dose of with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, at a dose of 0.5 milliliter, lot #U019135, expiration date: 22-NOV-2022 who had been verified to be a valid number and established the same date, administered for prophylaxis (strength and anatomical site of injection were not provided) (expired product administered).
Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; very sick (Dose 2: 23-OCT-2022; Covid-19 positive:10-FEB-2023); Covid-19; Got very sick; This non-serious, initial spontaneous safety report was received by Novavax on 19-FEB-2023 from a consumer via the customer experience center.  A female of an unspecified age and race was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 and dose 2 on unspecified dates.  It was reported the individual was very healthy and not immune compromised at all; no additional medical history was reported.   No concomitant medications were reported.  On an unspecified day in FEB-2023, after vaccination (about a week prior to reporting), the individual experienced Covid-19; very sick (PT: COVID-19). It was reported that the individual was not hospitalized but did go to the emergency room where she worked.   At the time of reporting, the event outcome of COVID-19 was unknown.  Lot number was not provided in the report.  On 21-FEB-2023, significant additional information was received from a consumer. The consumer reported the dates she received Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 as 24-SEP-2022 and dose 2 as 23-OCT-2022 at a pharmacy. The lot number for both doses were reported. Additionally, the individual provided the following lab test: SARS-CoV-2 test (Result: Virus detected; 10-FEB-2023). After additional information about the timeline of events was reported, the PT: COVID-19 was changed to PT: Breakthrough COVID-19. On 10-FEB-2023, the individual experienced covid-19(PT: Breakthrough COVID-19), and they got very sick (PT: Illness) on an unspecified date in FEB-2023. Therefore on 24-SEP-2022, the individual experienced covid-19 (PT: Vaccination failure). At the time of reporting, the event outcomes of Breakthrough COVID-19 and Illness were unknown and Vaccination failure was recovered/resolved and event stop date was 24-SEP-2022. No other additional information was reported.  On 03-MAR-2023, a significant case correction with Day 0 of 19-FEB-2023 was identified. The following information was updated: The event Vaccination failure was updated to be serious (Serious: Medically Significant) and this case was upgraded to serious. The reporter causality was updated to Related' and the onset from last dose' for the event Vaccination failure was updated to be 1 day.; Sender's Comments: This 56 year-old female experienced: Vaccination failure, Breakthrough COVID-19 and Illness after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Vaccination failure was assessed as serious. The events Breakthrough COVID-19 and Illness were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: one syringe is broken; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 28Feb2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GM9409, Expiration Date: Mar2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "one syringe is broken". Additional information: Caller stated that she was calling about the Pfizer Product:  Prevnar 20 (NDC number: 00052000-10). They have a box containing a broken syringe.  The container had not yet been opened.  Caller stated that there were 10 syringes in a box, there was containers in the box each containing 5 syringes. The container with the broken syringe in it was still sealed and unopened. Caller stated that no patients had received the affected medication. Caller stated that the affected syringe was available to be sent to Pfizer for evaluation if it was requested.  Caller stated that they were not going to open the container that the affected syringe was in, so all 5 syringes in that container were available if needed.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: PNC20
Symptoms: Liquid product physical issue, Wrong technique in device usage process
Clinical narrative: Describe the method of shaking and for how long: Rubbed back in forth between my hands; noticed that there are some floaties in prefilled syringes; The initial case was missing the following minimum criteria: product complaint only. Upon receipt of follow-up information on [27Feb2023], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter (Other HCP) from product quality group, Program ID: (004756).  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GD8455, Expiration Date: Apr2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG TECHNIQUE IN DEVICE USAGE PROCESS (non-serious), described as "Describe the method of shaking and for how long: Rubbed back in forth between my hands"; LIQUID PRODUCT PHYSICAL ISSUE (non-serious), described as "noticed that there are some floaties in prefilled syringes".  Additional information: They have a box of Prevnar 20 and noticed that there are some floaties in prefilled syringes. There was one Prevnar 20 given to a patient from that box, and it was confirmed that the one given did not have floaties. There is one syringe that is cloudy and one syringe that the particles can be seen in, these have not been administered to a patient. The floaties as they have kind of formed on the side of the prefilled syringe and looks like a little white cloud as it has been sitting there. White circles floated before shaking. After shaking, particles approximately 2mm didn't dissolve, they just floated. They were mild but visible. Method of shaking was described as rubbed back in forth between hands. Color did not change after shaking. The product was stored in refrigerator near the middle of the shelf in the box.  Follow up (22Feb2023): This is a spontaneous follow-up report from a product quality group. Updated information include: The event liquid product physical issue was added. Device reportability assessment updated.
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac disorder, White blood cell count, White blood cell count decreased
Clinical narrative: Has heart problems; Low white blood cell count; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Lot number: GJ6665) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Has heart problems"; WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "Low white blood cell count". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that she took the bivalent vaccine at the end of Oct last year. However, she mentioned that one of her doctors told her that she should have not taken that bivalent COVID vaccine as there would be another COVID vaccine that has wider coverage. She called in regards to Pfizer COVID-19 vaccine bivalent formulation for adults. She wanted to know if there is a new bivalent COVID vaccine that was released. She also wanted to check if what she received was the bivalent COVID-19 vaccine. She provided the lot number GJ6665. She also asked if she would be considered immunocompromised as she had breast cancer before, has heart problems and low white blood cell count. She also asked about what is bivalent. Dose/Dosage Form was reported as Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), less or equal to 12 years - 15/15 mcg per dose.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: after previous bout with COVID, now has asthma; " COVID" (unspecified if ongoing), notes: after previous bout with COVID, now has asthma. The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "known allergies: Demerol", notes: known allergies: Demerol; Cedar, reaction(s): "known allergies: Cedar", notes: known allergies: Cedar. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective with Paxlovid from 27Feb2023 to 28Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The association between the event lack of effect (COVID-19) with BNT162b2 can not be fully excluded.
Sex: F
Vaccine: COVID19-2
Symptoms: Pain
Clinical narrative: She did not have any bad reactions to the previous COVID-19 vaccines other than soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 82-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tetanus toxoid, reaction(s): "Allergies", notes: she had allergies before with the tetanus toxoid and could not take any diphtheria toxoid. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization, reaction(s): "she did not have any bad reactions to the previous COVID-19 vaccines other than soreness"; Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "she did not have any bad reactions to the previous COVID-19 vaccines other than soreness". The following information was reported: PAIN (non-serious), outcome "unknown", described as "She did not have any bad reactions to the previous COVID-19 vaccines other than soreness".  Additional information: Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than or equal to 12 years - 15/15 mcg per dos. 82-year-old female patient wanted to know what the Pfizer COVID-19 Vaccine Bivalent contained and how often elderly female patients experienced side effects. Caller mentioned that her doctor recommended her to get it. Caller mentioned she had allergies before with the tetanus toxoid and could not take any diphtheria toxoid. Caller also wanted to confirm if the vaccine is still being studied and under emergency use. Caller wanted to know what the Pfizer COVID-19 Vaccine Bivalent contained and if it contained any tetanus toxoid or diphtheria toxoid. Pfizer's 4th vaccine shot, the COVID-19 vaccine, the latest vaccine for the Omicron. She wants to know what are the adverse effects. She's 82-year-old and is leery of taking this vaccine. She reacted before to Tetanus toxoid. There's other vaccines she cannot take because they contain the diphtheria toxoid. No other product names provided. She worked as a medical secretary. She has a hard time hearing. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300087801 same patient/event, different vaccine dose;