chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: COVID19-2, HPV9
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was to get 0.3ml of the COVID 19 Bivalent vaccine but received 0.5ml instead.  Patient was in office for 30 minutes  with mother and sister after the vaccine was given with no reports of any signs or symptoms of any adverse reactions.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: Extreme pain that interfered with sleep on the first night. The injection site still aches severely at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI 1/31/2023  &  1/26/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Brain fog, Chills, Disturbance in attention
Clinical narrative: Minor pain at injection site. Malaise during day 9/13, but then had the worst night of my life and feared I was actually going to die. Temperature kept spiking up to 104-105, chills to the point of continual physical shaking/ shuddering, heart racing with fitbit showing 150, could not sleep, extreme weakness, mental fog and couldn't think. Switched to low grade fever and fatigue by about 5 in morning.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Malaise, Palpitations, Sleep disorder
Clinical narrative: Minor pain at injection site. Malaise during day 9/13, but then had the worst night of my life and feared I was actually going to die. Temperature kept spiking up to 104-105, chills to the point of continual physical shaking/ shuddering, heart racing with fitbit showing 150, could not sleep, extreme weakness, mental fog and couldn't think. Switched to low grade fever and fatigue by about 5 in morning.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Minor pain at injection site. Malaise during day 9/13, but then had the worst night of my life and feared I was actually going to die. Temperature kept spiking up to 104-105, chills to the point of continual physical shaking/ shuddering, heart racing with fitbit showing 150, could not sleep, extreme weakness, mental fog and couldn't think. Switched to low grade fever and fatigue by about 5 in morning.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Seizure, Seizure like phenomena, Tension
Clinical narrative: passed out after receiving last administered vaccination which was the HPV vaccine. signs of seizure noted after passing out such as very tensed arms and legs and very mild convulsions. this only lasted approximately 45 seconds but happened twice within seconds of each other
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy
Clinical narrative: EPILEPSY, INTRACTABLE
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Right leg at injection site became hard (size of lemon), redness, itching, and trouble walking.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Hypoxia
Clinical narrative: HYPOTENSION HYPOXIA
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT RECEIVED THE 2ND SHINGRIX DOSE ONE MONTH AFTER THE FIRST DOSE (04/18/2023).
Age: 27.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccine at a pharmacy on 7/25, and came into clinic on 7/27. Patient states that on 7/25 she had fever and redness/swelling. Patient felt like her arm was getting bigger.  Patient stated she treated symptoms at home with over the counter medications. Afebrile at appointment, but noticeable redness and swelling at injection site. Left arm with roughly 8 cm x 8 cm erythema, warmth, induration but no drainage. Treated for cellulitis - and started on cephalexin.
Age: 27.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient received vaccine at a pharmacy on 7/25, and came into clinic on 7/27. Patient states that on 7/25 she had fever and redness/swelling. Patient felt like her arm was getting bigger.  Patient stated she treated symptoms at home with over the counter medications. Afebrile at appointment, but noticeable redness and swelling at injection site. Left arm with roughly 8 cm x 8 cm erythema, warmth, induration but no drainage. Treated for cellulitis - and started on cephalexin.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's mother reported an area of redness about 4 inches above and below the injection site on her deltoid, along with warmth and swelling. The patient denied itching, no hives noted, no swelling or redness anywhere other than the patient's left arm. Patient's mother has been giving her tylenol. Primary care provider instructed the mother to give her benadryl as well.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Vaccine positive rechallenge
Clinical narrative: Patient reported 2 clusters of blister on his low back and mid back. Starting 1 - 2 days after his SHingrix vaccine,. Patient reported this happened after first vaccine also, but he did not associate it with the vaccine. The blisters resolved after the first vaccine and he has not had them again until now after his second dose.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Urticaria chronic
Clinical narrative: As has happened after every Covid vaccine I've received, approximately two months after the injection I broke out in chronic hives which lasted for months. This time, the hives weren't confined to my face and neck, but covered my entire body, requiring  trips to doctors and dermatologists. I have made several reports to the VAERS site, and I have never received a response. Except for one dermatologist, none of my doctors acknowledged chronic spontaneous urticaria as a potential side effect of the vaccine. I see now that several studies have documented a link, which I hope will inspire researchers to explore this serious side effect.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Pain, Pain in extremity
Clinical narrative: BULLSEYE-TYPE RASH AT INJECTION SITE THAT IS LARGE, PAINFUL, AND HOT TO TOUCH.  PAIN RADIATES DOWN THE LEFT ARM.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered on 7/23/23, 2 days beyond BUD (7/21/23)
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Anxiety, Dyspnoea, Feeling abnormal, Nervousness
Clinical narrative: pt felt shaky, said she had 'heavy breathing' and just felt weird. patient states she was anxious due to h/o reaction with covid vaccine. initial vitals were 144/95 pulse 98 O2 100%, after a few minutes she reported feeling better and wanted to leave. 2nd set of vitals were 113/77 P 95 O2 99%
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered on 7/23/23, 2 days beyond BUD (7/21/23)
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Bacterial test positive, Bladder catheterisation, Blood creatinine normal
Clinical narrative: Patient is a 59 y.o. male patient of a MD with history of hypertension, hyperlipidemia, seizures, schizophrenia presented to a local Hospital with shortness of breath.  Patient lives in nursing home and was found to be 66% on room air.  Patient does not wear oxygen at home.  While in the ER patient was febrile with fever of 103.2 °F, lactate was elevated to 4.1.  Patient was placed on 4 L nasal cannula with improvement in oxygenation.  Patient tested positive for COVID-19 and is admitted for further evaluation and management.   COVID-19 infection COVID-19 pneumonia Acute on chronic respiratory failure Started patient on Decadron and remdesivir Patient is vaccinated Weaned  3 L nasal cannula patient is down to room air ID consult Status post discontinuation of IV vancomycin S/p IV remdesivir and dexamethasone Out of bed when possible   UTI not due to indwelling chronic catheter Urine culture showing Pseudomonas and providencia susceptible to Zosyn Severe sepsis 2/2 above E. coli bacteremia Patient has chronic Foley Continue IV Zosyn. Blood cultures E. coli on 618 repeat blood cultures on 621 no growth  Urine culture grew Pseudomonas and providencia ID is on board We will discharge on IV Zosyn for 14 days Mild AKI resolved Improved with IV fluids.  Creatinine back to 0.75   Elevated troponin Acute myocarditis Patient EKG was concerning for some ST changes Reviewed by cardiology, no acute intervention is planned Echocardiogram reviewed showed EF 74% with normal diastolic function Continue to trend troponin. Start patient on aspirin, continue home statin   Hypernatremia resolved   Hypertension Holding lisinopril due to sepsis and septic shock Resume on discharge   Partial idiopathic epilepsy with seizures Continue home medications including Keppra 500 mg twice daily, Dilantin 100 mg 3 times daily, phenobarbital 64.8 mg daily Follows with Dr. as outpatient.   Schizophrenia: Continue Haldol
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood culture positive, Blood lactic acid increased, COVID-19, COVID-19 pneumonia, Culture urine positive
Clinical narrative: Patient is a 59 y.o. male patient of a MD with history of hypertension, hyperlipidemia, seizures, schizophrenia presented to a local Hospital with shortness of breath.  Patient lives in nursing home and was found to be 66% on room air.  Patient does not wear oxygen at home.  While in the ER patient was febrile with fever of 103.2 °F, lactate was elevated to 4.1.  Patient was placed on 4 L nasal cannula with improvement in oxygenation.  Patient tested positive for COVID-19 and is admitted for further evaluation and management.   COVID-19 infection COVID-19 pneumonia Acute on chronic respiratory failure Started patient on Decadron and remdesivir Patient is vaccinated Weaned  3 L nasal cannula patient is down to room air ID consult Status post discontinuation of IV vancomycin S/p IV remdesivir and dexamethasone Out of bed when possible   UTI not due to indwelling chronic catheter Urine culture showing Pseudomonas and providencia susceptible to Zosyn Severe sepsis 2/2 above E. coli bacteremia Patient has chronic Foley Continue IV Zosyn. Blood cultures E. coli on 618 repeat blood cultures on 621 no growth  Urine culture grew Pseudomonas and providencia ID is on board We will discharge on IV Zosyn for 14 days Mild AKI resolved Improved with IV fluids.  Creatinine back to 0.75   Elevated troponin Acute myocarditis Patient EKG was concerning for some ST changes Reviewed by cardiology, no acute intervention is planned Echocardiogram reviewed showed EF 74% with normal diastolic function Continue to trend troponin. Start patient on aspirin, continue home statin   Hypernatremia resolved   Hypertension Holding lisinopril due to sepsis and septic shock Resume on discharge   Partial idiopathic epilepsy with seizures Continue home medications including Keppra 500 mg twice daily, Dilantin 100 mg 3 times daily, phenobarbital 64.8 mg daily Follows with Dr. as outpatient.   Schizophrenia: Continue Haldol
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram normal, Ejection fraction normal, Electrocardiogram ST segment abnormal, Escherichia bacteraemia
Clinical narrative: Patient is a 59 y.o. male patient of a MD with history of hypertension, hyperlipidemia, seizures, schizophrenia presented to a local Hospital with shortness of breath.  Patient lives in nursing home and was found to be 66% on room air.  Patient does not wear oxygen at home.  While in the ER patient was febrile with fever of 103.2 °F, lactate was elevated to 4.1.  Patient was placed on 4 L nasal cannula with improvement in oxygenation.  Patient tested positive for COVID-19 and is admitted for further evaluation and management.   COVID-19 infection COVID-19 pneumonia Acute on chronic respiratory failure Started patient on Decadron and remdesivir Patient is vaccinated Weaned  3 L nasal cannula patient is down to room air ID consult Status post discontinuation of IV vancomycin S/p IV remdesivir and dexamethasone Out of bed when possible   UTI not due to indwelling chronic catheter Urine culture showing Pseudomonas and providencia susceptible to Zosyn Severe sepsis 2/2 above E. coli bacteremia Patient has chronic Foley Continue IV Zosyn. Blood cultures E. coli on 618 repeat blood cultures on 621 no growth  Urine culture grew Pseudomonas and providencia ID is on board We will discharge on IV Zosyn for 14 days Mild AKI resolved Improved with IV fluids.  Creatinine back to 0.75   Elevated troponin Acute myocarditis Patient EKG was concerning for some ST changes Reviewed by cardiology, no acute intervention is planned Echocardiogram reviewed showed EF 74% with normal diastolic function Continue to trend troponin. Start patient on aspirin, continue home statin   Hypernatremia resolved   Hypertension Holding lisinopril due to sepsis and septic shock Resume on discharge   Partial idiopathic epilepsy with seizures Continue home medications including Keppra 500 mg twice daily, Dilantin 100 mg 3 times daily, phenobarbital 64.8 mg daily Follows with Dr. as outpatient.   Schizophrenia: Continue Haldol
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Escherichia test positive, Hypernatraemia, Myocarditis, Pseudomonas test positive, Pyrexia
Clinical narrative: Patient is a 59 y.o. male patient of a MD with history of hypertension, hyperlipidemia, seizures, schizophrenia presented to a local Hospital with shortness of breath.  Patient lives in nursing home and was found to be 66% on room air.  Patient does not wear oxygen at home.  While in the ER patient was febrile with fever of 103.2 °F, lactate was elevated to 4.1.  Patient was placed on 4 L nasal cannula with improvement in oxygenation.  Patient tested positive for COVID-19 and is admitted for further evaluation and management.   COVID-19 infection COVID-19 pneumonia Acute on chronic respiratory failure Started patient on Decadron and remdesivir Patient is vaccinated Weaned  3 L nasal cannula patient is down to room air ID consult Status post discontinuation of IV vancomycin S/p IV remdesivir and dexamethasone Out of bed when possible   UTI not due to indwelling chronic catheter Urine culture showing Pseudomonas and providencia susceptible to Zosyn Severe sepsis 2/2 above E. coli bacteremia Patient has chronic Foley Continue IV Zosyn. Blood cultures E. coli on 618 repeat blood cultures on 621 no growth  Urine culture grew Pseudomonas and providencia ID is on board We will discharge on IV Zosyn for 14 days Mild AKI resolved Improved with IV fluids.  Creatinine back to 0.75   Elevated troponin Acute myocarditis Patient EKG was concerning for some ST changes Reviewed by cardiology, no acute intervention is planned Echocardiogram reviewed showed EF 74% with normal diastolic function Continue to trend troponin. Start patient on aspirin, continue home statin   Hypernatremia resolved   Hypertension Holding lisinopril due to sepsis and septic shock Resume on discharge   Partial idiopathic epilepsy with seizures Continue home medications including Keppra 500 mg twice daily, Dilantin 100 mg 3 times daily, phenobarbital 64.8 mg daily Follows with Dr. as outpatient.   Schizophrenia: Continue Haldol
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis, Septic shock, Troponin increased, Urinary tract infection
Clinical narrative: Patient is a 59 y.o. male patient of a MD with history of hypertension, hyperlipidemia, seizures, schizophrenia presented to a local Hospital with shortness of breath.  Patient lives in nursing home and was found to be 66% on room air.  Patient does not wear oxygen at home.  While in the ER patient was febrile with fever of 103.2 °F, lactate was elevated to 4.1.  Patient was placed on 4 L nasal cannula with improvement in oxygenation.  Patient tested positive for COVID-19 and is admitted for further evaluation and management.   COVID-19 infection COVID-19 pneumonia Acute on chronic respiratory failure Started patient on Decadron and remdesivir Patient is vaccinated Weaned  3 L nasal cannula patient is down to room air ID consult Status post discontinuation of IV vancomycin S/p IV remdesivir and dexamethasone Out of bed when possible   UTI not due to indwelling chronic catheter Urine culture showing Pseudomonas and providencia susceptible to Zosyn Severe sepsis 2/2 above E. coli bacteremia Patient has chronic Foley Continue IV Zosyn. Blood cultures E. coli on 618 repeat blood cultures on 621 no growth  Urine culture grew Pseudomonas and providencia ID is on board We will discharge on IV Zosyn for 14 days Mild AKI resolved Improved with IV fluids.  Creatinine back to 0.75   Elevated troponin Acute myocarditis Patient EKG was concerning for some ST changes Reviewed by cardiology, no acute intervention is planned Echocardiogram reviewed showed EF 74% with normal diastolic function Continue to trend troponin. Start patient on aspirin, continue home statin   Hypernatremia resolved   Hypertension Holding lisinopril due to sepsis and septic shock Resume on discharge   Partial idiopathic epilepsy with seizures Continue home medications including Keppra 500 mg twice daily, Dilantin 100 mg 3 times daily, phenobarbital 64.8 mg daily Follows with Dr. as outpatient.   Schizophrenia: Continue Haldol
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered on 7/24/23, 3 days beyond BUD (7/21/23)
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Palpitations
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered on 7/24/23, 3 days beyond BUD (7/21/23)
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute left ventricular failure, Acute myocardial infarction, Acute respiratory failure, Antiplatelet therapy, Asthma
Clinical narrative: Acute Respiratory Failure with Hypoxia, Resolved -Secondary to asthma exacerbation, COVID-19 infection and CHF exacerbation. On 2L NC on admit -Treat asthma exacerbation as below, supportive care for COVID, and diuresis as below.    Acute Asthma Exacerbation Mild intermittent asthma -With significantly decreased air passage and bilateral expiratory wheezes noted on exam.  Likely due to COVID-19. -S/p Decadron in the ED and pred 40mg x4 days -Continue prednisone taper with 30mg x4d and 20mg x4d. Continue scheduled bronchodilators. Continue incentive spirometry.   Acute on chronic diastolic CHF -Echo March 2023 EF of 69%, grade 2 diastolic dysfunction, moderate mitral regurg, RSVP 35, post TAVR. On Bumex 0.5mg prn at -Continue home PO bumex.    COVID Infection -Patient states she is vaccinated x3, last vaccination was in November 2022. Symptoms began 3 days PTA.  Her husband also tested positive for COVID. -With fevers, vomiting, coughing. -S/p Decadron in the ED. Hold Paxlovid given interactions with home meds, esp Plavix given she had recent coronary intervention -Prednisone as above. Supportive care. Special isolation until 6/24/23   Thrombocytopenia, POA -Etiology unclear. Chronic in nature -Plts 122 on admit (baseline 120-140 COVID Infection -Patient states she is vaccinated x3, last vaccination was in November 2022. Symptoms began 3 days PTA.  Her husband also tested positive for COVID. -With fevers, vomiting, coughing. -S/p Decadron in the ED. Hold Paxlovid given interactions with home meds, esp Plavix given she had recent coronary intervention -Prednisone as above. Supportive care. Special isolation until 6/24/23   Thrombocytopenia, POA -Etiology unclear. Chronic in nature -Plts 122 on admit (baseline 120-140)   Recent Non-STEMI due to restenosis  CAD -During 5/2023 hospitalization. -LHC 5/24 and found to have SVG-D1 restenosis of prior stent s/p DES to prox and mid vein graft -Patient has not been able to tolerate medications in the past few days due to emesis from COVID. -Continue DAPT, beta-blocker, statin.   CAD post CABG -S/p 3V CABG 1986, subsequent DES -Follows with Dr.  -Continue DAPT, beta-blocker, statin, Imdur.   Essential hypertension -Continue home beta-blocker and Imdur   Aortic stenosis -S/p TAVR 2/15/2021 -valve well seated on repeat Echo
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Breath sounds abnormal, COVID-19, Cardiac failure congestive, Catheterisation cardiac abnormal, Chronic left ventricular failure
Clinical narrative: Acute Respiratory Failure with Hypoxia, Resolved -Secondary to asthma exacerbation, COVID-19 infection and CHF exacerbation. On 2L NC on admit -Treat asthma exacerbation as below, supportive care for COVID, and diuresis as below.    Acute Asthma Exacerbation Mild intermittent asthma -With significantly decreased air passage and bilateral expiratory wheezes noted on exam.  Likely due to COVID-19. -S/p Decadron in the ED and pred 40mg x4 days -Continue prednisone taper with 30mg x4d and 20mg x4d. Continue scheduled bronchodilators. Continue incentive spirometry.   Acute on chronic diastolic CHF -Echo March 2023 EF of 69%, grade 2 diastolic dysfunction, moderate mitral regurg, RSVP 35, post TAVR. On Bumex 0.5mg prn at -Continue home PO bumex.    COVID Infection -Patient states she is vaccinated x3, last vaccination was in November 2022. Symptoms began 3 days PTA.  Her husband also tested positive for COVID. -With fevers, vomiting, coughing. -S/p Decadron in the ED. Hold Paxlovid given interactions with home meds, esp Plavix given she had recent coronary intervention -Prednisone as above. Supportive care. Special isolation until 6/24/23   Thrombocytopenia, POA -Etiology unclear. Chronic in nature -Plts 122 on admit (baseline 120-140 COVID Infection -Patient states she is vaccinated x3, last vaccination was in November 2022. Symptoms began 3 days PTA.  Her husband also tested positive for COVID. -With fevers, vomiting, coughing. -S/p Decadron in the ED. Hold Paxlovid given interactions with home meds, esp Plavix given she had recent coronary intervention -Prednisone as above. Supportive care. Special isolation until 6/24/23   Thrombocytopenia, POA -Etiology unclear. Chronic in nature -Plts 122 on admit (baseline 120-140)   Recent Non-STEMI due to restenosis  CAD -During 5/2023 hospitalization. -LHC 5/24 and found to have SVG-D1 restenosis of prior stent s/p DES to prox and mid vein graft -Patient has not been able to tolerate medications in the past few days due to emesis from COVID. -Continue DAPT, beta-blocker, statin.   CAD post CABG -S/p 3V CABG 1986, subsequent DES -Follows with Dr.  -Continue DAPT, beta-blocker, statin, Imdur.   Essential hypertension -Continue home beta-blocker and Imdur   Aortic stenosis -S/p TAVR 2/15/2021 -valve well seated on repeat Echo
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Cough, Diastolic dysfunction, Diuretic therapy, Drug tolerance decreased
Clinical narrative: Acute Respiratory Failure with Hypoxia, Resolved -Secondary to asthma exacerbation, COVID-19 infection and CHF exacerbation. On 2L NC on admit -Treat asthma exacerbation as below, supportive care for COVID, and diuresis as below.    Acute Asthma Exacerbation Mild intermittent asthma -With significantly decreased air passage and bilateral expiratory wheezes noted on exam.  Likely due to COVID-19. -S/p Decadron in the ED and pred 40mg x4 days -Continue prednisone taper with 30mg x4d and 20mg x4d. Continue scheduled bronchodilators. Continue incentive spirometry.   Acute on chronic diastolic CHF -Echo March 2023 EF of 69%, grade 2 diastolic dysfunction, moderate mitral regurg, RSVP 35, post TAVR. On Bumex 0.5mg prn at -Continue home PO bumex.    COVID Infection -Patient states she is vaccinated x3, last vaccination was in November 2022. Symptoms began 3 days PTA.  Her husband also tested positive for COVID. -With fevers, vomiting, coughing. -S/p Decadron in the ED. Hold Paxlovid given interactions with home meds, esp Plavix given she had recent coronary intervention -Prednisone as above. Supportive care. Special isolation until 6/24/23   Thrombocytopenia, POA -Etiology unclear. Chronic in nature -Plts 122 on admit (baseline 120-140 COVID Infection -Patient states she is vaccinated x3, last vaccination was in November 2022. Symptoms began 3 days PTA.  Her husband also tested positive for COVID. -With fevers, vomiting, coughing. -S/p Decadron in the ED. Hold Paxlovid given interactions with home meds, esp Plavix given she had recent coronary intervention -Prednisone as above. Supportive care. Special isolation until 6/24/23   Thrombocytopenia, POA -Etiology unclear. Chronic in nature -Plts 122 on admit (baseline 120-140)   Recent Non-STEMI due to restenosis  CAD -During 5/2023 hospitalization. -LHC 5/24 and found to have SVG-D1 restenosis of prior stent s/p DES to prox and mid vein graft -Patient has not been able to tolerate medications in the past few days due to emesis from COVID. -Continue DAPT, beta-blocker, statin.   CAD post CABG -S/p 3V CABG 1986, subsequent DES -Follows with Dr.  -Continue DAPT, beta-blocker, statin, Imdur.   Essential hypertension -Continue home beta-blocker and Imdur   Aortic stenosis -S/p TAVR 2/15/2021 -valve well seated on repeat Echo
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Echocardiogram abnormal, Ejection fraction normal, Interventional procedure, Malaise, Mitral valve incompetence
Clinical narrative: Acute Respiratory Failure with Hypoxia, Resolved -Secondary to asthma exacerbation, COVID-19 infection and CHF exacerbation. On 2L NC on admit -Treat asthma exacerbation as below, supportive care for COVID, and diuresis as below.    Acute Asthma Exacerbation Mild intermittent asthma -With significantly decreased air passage and bilateral expiratory wheezes noted on exam.  Likely due to COVID-19. -S/p Decadron in the ED and pred 40mg x4 days -Continue prednisone taper with 30mg x4d and 20mg x4d. Continue scheduled bronchodilators. Continue incentive spirometry.   Acute on chronic diastolic CHF -Echo March 2023 EF of 69%, grade 2 diastolic dysfunction, moderate mitral regurg, RSVP 35, post TAVR. On Bumex 0.5mg prn at -Continue home PO bumex.    COVID Infection -Patient states she is vaccinated x3, last vaccination was in November 2022. Symptoms began 3 days PTA.  Her husband also tested positive for COVID. -With fevers, vomiting, coughing. -S/p Decadron in the ED. Hold Paxlovid given interactions with home meds, esp Plavix given she had recent coronary intervention -Prednisone as above. Supportive care. Special isolation until 6/24/23   Thrombocytopenia, POA -Etiology unclear. Chronic in nature -Plts 122 on admit (baseline 120-140 COVID Infection -Patient states she is vaccinated x3, last vaccination was in November 2022. Symptoms began 3 days PTA.  Her husband also tested positive for COVID. -With fevers, vomiting, coughing. -S/p Decadron in the ED. Hold Paxlovid given interactions with home meds, esp Plavix given she had recent coronary intervention -Prednisone as above. Supportive care. Special isolation until 6/24/23   Thrombocytopenia, POA -Etiology unclear. Chronic in nature -Plts 122 on admit (baseline 120-140)   Recent Non-STEMI due to restenosis  CAD -During 5/2023 hospitalization. -LHC 5/24 and found to have SVG-D1 restenosis of prior stent s/p DES to prox and mid vein graft -Patient has not been able to tolerate medications in the past few days due to emesis from COVID. -Continue DAPT, beta-blocker, statin.   CAD post CABG -S/p 3V CABG 1986, subsequent DES -Follows with Dr.  -Continue DAPT, beta-blocker, statin, Imdur.   Essential hypertension -Continue home beta-blocker and Imdur   Aortic stenosis -S/p TAVR 2/15/2021 -valve well seated on repeat Echo
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Platelet count decreased, Pyrexia, Right ventricular systolic pressure, Thrombocytopenia, Vascular stent stenosis
Clinical narrative: Acute Respiratory Failure with Hypoxia, Resolved -Secondary to asthma exacerbation, COVID-19 infection and CHF exacerbation. On 2L NC on admit -Treat asthma exacerbation as below, supportive care for COVID, and diuresis as below.    Acute Asthma Exacerbation Mild intermittent asthma -With significantly decreased air passage and bilateral expiratory wheezes noted on exam.  Likely due to COVID-19. -S/p Decadron in the ED and pred 40mg x4 days -Continue prednisone taper with 30mg x4d and 20mg x4d. Continue scheduled bronchodilators. Continue incentive spirometry.   Acute on chronic diastolic CHF -Echo March 2023 EF of 69%, grade 2 diastolic dysfunction, moderate mitral regurg, RSVP 35, post TAVR. On Bumex 0.5mg prn at -Continue home PO bumex.    COVID Infection -Patient states she is vaccinated x3, last vaccination was in November 2022. Symptoms began 3 days PTA.  Her husband also tested positive for COVID. -With fevers, vomiting, coughing. -S/p Decadron in the ED. Hold Paxlovid given interactions with home meds, esp Plavix given she had recent coronary intervention -Prednisone as above. Supportive care. Special isolation until 6/24/23   Thrombocytopenia, POA -Etiology unclear. Chronic in nature -Plts 122 on admit (baseline 120-140 COVID Infection -Patient states she is vaccinated x3, last vaccination was in November 2022. Symptoms began 3 days PTA.  Her husband also tested positive for COVID. -With fevers, vomiting, coughing. -S/p Decadron in the ED. Hold Paxlovid given interactions with home meds, esp Plavix given she had recent coronary intervention -Prednisone as above. Supportive care. Special isolation until 6/24/23   Thrombocytopenia, POA -Etiology unclear. Chronic in nature -Plts 122 on admit (baseline 120-140)   Recent Non-STEMI due to restenosis  CAD -During 5/2023 hospitalization. -LHC 5/24 and found to have SVG-D1 restenosis of prior stent s/p DES to prox and mid vein graft -Patient has not been able to tolerate medications in the past few days due to emesis from COVID. -Continue DAPT, beta-blocker, statin.   CAD post CABG -S/p 3V CABG 1986, subsequent DES -Follows with Dr.  -Continue DAPT, beta-blocker, statin, Imdur.   Essential hypertension -Continue home beta-blocker and Imdur   Aortic stenosis -S/p TAVR 2/15/2021 -valve well seated on repeat Echo
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting, Wheezing
Clinical narrative: Acute Respiratory Failure with Hypoxia, Resolved -Secondary to asthma exacerbation, COVID-19 infection and CHF exacerbation. On 2L NC on admit -Treat asthma exacerbation as below, supportive care for COVID, and diuresis as below.    Acute Asthma Exacerbation Mild intermittent asthma -With significantly decreased air passage and bilateral expiratory wheezes noted on exam.  Likely due to COVID-19. -S/p Decadron in the ED and pred 40mg x4 days -Continue prednisone taper with 30mg x4d and 20mg x4d. Continue scheduled bronchodilators. Continue incentive spirometry.   Acute on chronic diastolic CHF -Echo March 2023 EF of 69%, grade 2 diastolic dysfunction, moderate mitral regurg, RSVP 35, post TAVR. On Bumex 0.5mg prn at -Continue home PO bumex.    COVID Infection -Patient states she is vaccinated x3, last vaccination was in November 2022. Symptoms began 3 days PTA.  Her husband also tested positive for COVID. -With fevers, vomiting, coughing. -S/p Decadron in the ED. Hold Paxlovid given interactions with home meds, esp Plavix given she had recent coronary intervention -Prednisone as above. Supportive care. Special isolation until 6/24/23   Thrombocytopenia, POA -Etiology unclear. Chronic in nature -Plts 122 on admit (baseline 120-140 COVID Infection -Patient states she is vaccinated x3, last vaccination was in November 2022. Symptoms began 3 days PTA.  Her husband also tested positive for COVID. -With fevers, vomiting, coughing. -S/p Decadron in the ED. Hold Paxlovid given interactions with home meds, esp Plavix given she had recent coronary intervention -Prednisone as above. Supportive care. Special isolation until 6/24/23   Thrombocytopenia, POA -Etiology unclear. Chronic in nature -Plts 122 on admit (baseline 120-140)   Recent Non-STEMI due to restenosis  CAD -During 5/2023 hospitalization. -LHC 5/24 and found to have SVG-D1 restenosis of prior stent s/p DES to prox and mid vein graft -Patient has not been able to tolerate medications in the past few days due to emesis from COVID. -Continue DAPT, beta-blocker, statin.   CAD post CABG -S/p 3V CABG 1986, subsequent DES -Follows with Dr.  -Continue DAPT, beta-blocker, statin, Imdur.   Essential hypertension -Continue home beta-blocker and Imdur   Aortic stenosis -S/p TAVR 2/15/2021 -valve well seated on repeat Echo
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Facial paresis
Clinical narrative: Left-sided facial weakness c/w Bell's Palsy, starting 2 weeks after vaccination. Treated with prednisolone, acyclovir.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine BUD
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED AFTER BUD
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED AFTER BUD
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine BUD
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine BUD
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; adult patient was dosed with pediatric dose inadvertently; Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  The patient was dosed with pediatric dose (1mL) of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (lot number, expiration date and route of administration not provided) inadvertently (product administered to patient of inappropriate age) in December 2022. No adverse event was reported.
Age: 17.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: HCP calling to report a child was inadvertently administered a third dose of MMRII and a third dose of VARIVAX. The patient has had no side effects. No further information provided. No additional AE/PQC.; HCP calling to report a child was inadvertently administered a third dose of MMRII and a third dose of VARIVAX. The patient has had no side effects. No further information provided. No additional AE/PQC.; This spontaneous report was received from a registered nurse referring to 17-year-old male patient. The patient's concurrent condition, and medical history were not provided. Concomitant medication included sterile diluent.  On 31-MAY-2023, the patient was inadvertently administered a third dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection 0.5 mL (route of administration and anatomical location not provided; lot# U022983, expiry date: 22-JUL-2023) and a third dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection 0.5 mL (route of administration and anatomical location not provided; lot# U029621, expiry date: 22-SEP-2023) as prophylaxis (extra dose administered). The patient had no side effects and there was no additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HBP reporting that VARIVAX was administered after it experienced a supported temperature excursion.; This spontaneous report as received from an administrator and refers to a patient of unknown age and gender. No information on patient's medical history and current conditions was provided. Concomitant therapies included sterile diluent.      On 12-JUL-2023 the patient was vaccinated with first dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # W025277 and expiration date 10-AUG-2024, 0.5 milliliter for prophylaxis (route and site of administration were not provided) (product storage error and no adverse event).  The temperature excursion was -8.6 degrees Celsius and lasted for 51 minutes. There was previous excursion that lasted 1 hour, 16 minutes, 0 seconds and the temperature was -11 degrees Celsius.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HBP reporting that VARIVAX was administered after it experienced a supported temperature excursion.; This spontaneous report as received from an administrator and refers to a patient of unknown age and gender. No information on patient's medical history and current conditions was provided. Concomitant therapies included sterile diluent.      On 12-JUL-2023 the patient was vaccinated with first dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # W025277 and expiration date 10-AUG-2024, 0.5 milliliter for prophylaxis (route and site of administration were not provided) (product storage error and no adverse event). The temperature excursion was -8.6 degrees Celsius and lasted for 51 minutes. There was previous excursion that lasted 1 hour, 16 minutes, 0 seconds and the temperature was -11 degrees Celsius.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Inbound call from customer to provide updated temperature excursion information. She also provided names and administration dates of improperly stored administered ROTATEQ that was not supported. See original AE case 02429442 which did not include un; This spontaneous report was received from a consumer refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 18-JUL-2023, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1968392 and expiration date 24-MAY-2024, 2 milliliter for prophylaxis (dose number and site of administration were not provided) (product storage error). On 20-JUN-2023, temperature excursion was 34.9 degrees Fahrenheit (F) for 6 hours 34 minutes 0 seconds. On 03-JUL-2023, temperature excursion was 51.1F for 24 hours 0 minutes 0 seconds. On 05-JUL-2023, temperature excursion was 50.7F for 9 hours 27 minutes 0 seconds. No previous excursions.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored administered ROTATEQ; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, concomitant medications, or relevant medical history. On 06-JUL-2023, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1968392, expiration date 22-MAY-2024; dose: 2 milliliters; dose# not provided), orally for prophylaxis (improper storage of product in use). The vaccine underwent multiple temperature excursions since 20-JUN-2023 until 05-JUL-2023. There were no previous temperature excursions reported.  This is one of several cases received from the same reporter (cross-referenced with US-009507513-2307USA009292).; Sender's Comments:  US-009507513-2307USA009292:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; to report inadvertent administration of ROTATEQ to a patient after a temperature excursion.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 18-JUL-2023, the patient was vaccinated with an improperly stored dose of  rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # X004919, oral (strength, dose number, dose, and expiration date were not provided) for prophylaxis during 32 minutes under temperature of 08.4°C (product storage error). There was no previous temperature excursion.  The nurse stated product was not expired but would call back to provide the specific expiration date. No additional  adverse event reported.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: administering ROTATEQ third dose only 2 weeks after administering ROTATEQ second dose to a patient; No additional AE; This spontaneous report was received from a physician and refers to an 18-week-old (reported as 4.5-month-old) patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown dates, the patient received the first and the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally (strength, lot #, expiration date were not provided) for prophylaxis. On an unknown date, only 2 weeks after administering second dose, the patient received the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, administered orally (strength, lot #, expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). The physician stated that at the reporting time, no symptoms were reported in the past 24 hours. No additional adverse event reported.
Sex: F
Vaccine: PNC15
Symptoms: Accident at work, Skin laceration, Syringe issue
Clinical narrative: a minor cut from the syringe; a minor cut from the syringe; the finger flange was broken and the glass from the finger flange had broken off into one additional piece; This spontaneous report has been received from a nurse, reporting on herself, a 51-year-old female patient. There was no information regarding the patient's medical history, concurrent conditions and concomitant medicatons provided.  On 20-JUL-2023, another healthcare professional (HCP) handed the reporter the pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) syringe (lot #X004289, expiration date: 10-DEC-2024) and the reporter got a minor cut from the syringe (Skin laceration; Injury associated with device). The finger flange was broken and the glass from the finger flange had broken off into one additional piece (Syringe issue). The reporter stated that the cut was small and the only treatment needed was a band aid. She did not seek medical attention. On the same date (20-JUL-2023), the patient recovered from the event. The reporter stated that she did not have the product for return as the syringe was already disposed of. Moreover, no photos were available to be sent, they did not take any photos prior to discarding syringe. No additional details were available at this time.  The causal relationship between Skin laceration and the suspect vaccine was not provided.
Age: 0.17
Sex: M
Vaccine: PNC13, RV5, UNK
Symptoms: Pyrexia
Clinical narrative: had a fever of 105 degrees (rectal reading); This spontaneous report has been received from a physician via field-based employee (FBE) referring to a 11-week-old (also reported as 2 months, conflict information) male patient. The patient's medical history included umbilical hernia. The patient's concurrent conditions and concomitant therapies were not reported. There was no other vaccine within 4 weeks prior to the suspect vaccines. The patient had no illness at time of vaccination.  On 06-JUL-2023, the patient was vaccinated with the first dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7536AA, expiration date: 30-SEP-2025, administered intramuscularly (IM) at left thigh for prophylaxis (strength and dose were not provided); the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #X002251, expiration date: 03-JUN-2024, administered orally (PO) for prophylaxis (strength and dose were not provided); the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVENAR 13), batch# GH6086, expiration date reported as 31-MAY-2025, administered intramuscularly at right thigh for prophylaxis (strength, formulation, and dose were not provided). The patient was given the vaccines appropriately at private doctor's office/hospital by a registered nurse (RN) who was trained, and the vaccines were used according to the instruction leaflet. The vaccines were purchased with private funds. There was no temperature excursion occur as a result of a reading from a Data Logger. There was no product quality complaint.  On 07-JUL-2023, the baby had fever of 105 degree Fahrenheit (rectal reading). He continued with lower temperatures on the same date. The fever went down and resolved within 24 hours, and the patient did not spike to 105 degree Fahrenheit again. The patient had sought for medical attention. The vaccines were not available for return or evaluation as they were disposed after administration.   It was reported the event fever was attributable to the suspect vaccines.