chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Laboratory test, Loss of consciousness, Malaise, Nausea
Clinical narrative: COVID Vaccine Breakthrough Case  J&J Dose 7/23/21 (206A21A) COVID Positive 10/27/21  10/26/21: Patient is an African American male with past medical history of hypertension not on any medication, asthma, history of gun shot who presented to the ED with fatigue, shortness of breath cough, chills and body ache.  Patient reports he has been sick for the past 6 days.  Patient has also been having abdomen pain, nausea vomiting.  Two days ago patient reports he was vomiting and he passed out.  Patient also reports left-sided midclavicular to chest pain, intermittent, 5/10, nonradiating, worse with coughing and no alleviating factor.  Patient took the J&J COVID 19 vaccine in July 2021. Patient smokes marijuana intermittently.  Patient reports he has not been taking blood pressure medication for some years.   Patient did test + COVID 19 4 days ago. Family history significant for both parents dying from MI in the 50s, cousin dying from MI 3 weeks ago at age 40.At this time patient endorses headache have but denies fever, abdomen pain, blurred vision, dizziness or any focal deficits.   Initially in the ED blood pressure 193/125, heart rate 97, RR 22, 100% room air, temp 99.8°.  Chest x-ray did not show any acute process, official read pending.  CT head negative for acute intracranial abnormality, did note sinusitis. Lab works not remarkable.  Patient received nitro in the ED.  10/28/21:  40-year-old man presented with complaints of chest discomfort, nausea, generalized malaise following recent COVID diagnosis.  He is fully vaccinated,  apprehensive about COVID diagnosis as both parents died of COVID last year.  Blood pressures were noted to be markedly elevated on presentation to the emergency department, known history of hypertension noncompliant with medications and has lost primary care provider.  He was admitted to the hospitalist Service, has remained minimally symptomatic and hemodynamically stable with no oxygen requirements.  At this time he does not meet criteria for inpatient treatment for COVID infection with antiviral therapy, steroids or Actemra.  He was started on oral antihypertensive with improvement in blood pressures, medication compliance and the need to establish care with primary care has been counseled.  He has been discharged in stable medical condition to be followed up by the COVID safe at home program.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test positive, Sinusitis, Vaccine breakthrough infection, Vomiting
Clinical narrative: COVID Vaccine Breakthrough Case  J&J Dose 7/23/21 (206A21A) COVID Positive 10/27/21  10/26/21: Patient is an African American male with past medical history of hypertension not on any medication, asthma, history of gun shot who presented to the ED with fatigue, shortness of breath cough, chills and body ache.  Patient reports he has been sick for the past 6 days.  Patient has also been having abdomen pain, nausea vomiting.  Two days ago patient reports he was vomiting and he passed out.  Patient also reports left-sided midclavicular to chest pain, intermittent, 5/10, nonradiating, worse with coughing and no alleviating factor.  Patient took the J&J COVID 19 vaccine in July 2021. Patient smokes marijuana intermittently.  Patient reports he has not been taking blood pressure medication for some years.   Patient did test + COVID 19 4 days ago. Family history significant for both parents dying from MI in the 50s, cousin dying from MI 3 weeks ago at age 40.At this time patient endorses headache have but denies fever, abdomen pain, blurred vision, dizziness or any focal deficits.   Initially in the ED blood pressure 193/125, heart rate 97, RR 22, 100% room air, temp 99.8°.  Chest x-ray did not show any acute process, official read pending.  CT head negative for acute intracranial abnormality, did note sinusitis. Lab works not remarkable.  Patient received nitro in the ED.  10/28/21:  40-year-old man presented with complaints of chest discomfort, nausea, generalized malaise following recent COVID diagnosis.  He is fully vaccinated,  apprehensive about COVID diagnosis as both parents died of COVID last year.  Blood pressures were noted to be markedly elevated on presentation to the emergency department, known history of hypertension noncompliant with medications and has lost primary care provider.  He was admitted to the hospitalist Service, has remained minimally symptomatic and hemodynamically stable with no oxygen requirements.  At this time he does not meet criteria for inpatient treatment for COVID infection with antiviral therapy, steroids or Actemra.  He was started on oral antihypertensive with improvement in blood pressures, medication compliance and the need to establish care with primary care has been counseled.  He has been discharged in stable medical condition to be followed up by the COVID safe at home program.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered expired dose.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: The Gray cap Pfizer Covid 19 vaccine for ages 12 and up was diluted with 1.3ml of 0.9% saline and then drawn up 0.3ml and administered  in error to patient under 12 years old.  SPoke to vaccine unit and they told me to contact the nurse, RN, which I did and she told me to contact Pfizer to find out what they have to say about wrong vaccine given to patient. I spoke to another RN and another RN at Pfizer and they reviewed the Covid vaccines the gray cap 12 and older and the orange cap 5-11 years and it was determined that the dose the pt received was larger than the recommended dose and parents were notified.  Pfizer said not repeat the dose and to monitor for side effects and if they do not develop any significant side effects then they can receive their second dose 21 days later.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypertension, Ill-defined disorder, Laboratory test abnormal, Troponin increased
Clinical narrative: Patient wound up in the hospital multiple times for severe HTN  and other maladies
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Paraesthesia, Rash, Rash erythematous
Clinical narrative: Chills on day 1; feeling of needles poking at me in night 2; morning of day 3:  bright red rash on my  neck and chest - not painful or itchy
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: About 12.5 cm X 10 cm red warmness around vaccine site. Treat with ice pack.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: ADAMTS13 activity normal, Angiogram abnormal, Anticoagulant therapy, C-reactive protein increased, COVID-19
Clinical narrative: COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/26/21 (EN6200) Pfizer Dose 2 3/24/21 (ER2613) Pfizer Dose 3 8/19/21 (EW0170) COVID Positive 9/29/21  10/4/21: The patient had COVID-19 pneumonitis on September last year, he is vaccinated and he had his booster vaccine this year, complaining from fever and chills with sputum productive cough and shortness of breath progressively worsen, no chest pain or palpitation or dizziness or orthopnea or lower limb swelling.  Known to have COPD not oxygen dependent at home.   At emergency, he was hypoxic oxygen saturation 86% and require 3 L of oxygen to maintain SpO2 above 94%, his labs show positive COVID-19 test, elevated D-dimer and proBNP and troponin and CRP, EKG show sinus rhythm without signs of acute ischemia.  CT chest angiogram did not show pulmonary embolism and show bilateral ground-glass opacity and emphysema.  11/1/21: Patient is admitted hospital on 10/04/2021 for COVID pneumonia with hypoxic respiratory failure, started on IV remdesivir, IV dexamethasone along with antibiotics. Rest of the medications were continued.  His condition got worse and, oxygen requirements went up, was placed on OptiFlow and pulmonology consult was requested.  Patient is seen and followed by pulmonary team, continued management as per their recommendations.  His home medication Tofacitinib was held during acute illness while in hospital.  Patient had severe thrombocytopenia, Oncology consult was requested, TTP over suspected and the ADAMTS 13 was ordered and was reported negative.  His recent SPEP from July 2021 did not show M spike, is suspected to have MGUS, and Oncology recommended to repeat SPEP and immunofixation.  Patient condition has gradually improved, started working with physical therapy and occupational therapy.  Pulmonology has cleared the patient for discharge to home.  Physical therapy and occupation therapy evaluation is done and patient and the spouse preferred for discharge to home with visiting nurse and physical therapy service.  His thrombocytopenia has resolved.  Patient does have significant elevated D-dimer and for that reason at the time of discharge he is discharged on Xarelto 10 mg for prophylactic anticoagulation.  Patient is to follow up with primary care physician in 1 week, his pulmonologist Dr. in 3-4 weeks and Oncology in 2 weeks.  Discharge plan is discussed with the spouse.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chills, Dyspnoea, Electrocardiogram, Emphysema
Clinical narrative: COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/26/21 (EN6200) Pfizer Dose 2 3/24/21 (ER2613) Pfizer Dose 3 8/19/21 (EW0170) COVID Positive 9/29/21  10/4/21: The patient had COVID-19 pneumonitis on September last year, he is vaccinated and he had his booster vaccine this year, complaining from fever and chills with sputum productive cough and shortness of breath progressively worsen, no chest pain or palpitation or dizziness or orthopnea or lower limb swelling.  Known to have COPD not oxygen dependent at home.   At emergency, he was hypoxic oxygen saturation 86% and require 3 L of oxygen to maintain SpO2 above 94%, his labs show positive COVID-19 test, elevated D-dimer and proBNP and troponin and CRP, EKG show sinus rhythm without signs of acute ischemia.  CT chest angiogram did not show pulmonary embolism and show bilateral ground-glass opacity and emphysema.  11/1/21: Patient is admitted hospital on 10/04/2021 for COVID pneumonia with hypoxic respiratory failure, started on IV remdesivir, IV dexamethasone along with antibiotics. Rest of the medications were continued.  His condition got worse and, oxygen requirements went up, was placed on OptiFlow and pulmonology consult was requested.  Patient is seen and followed by pulmonary team, continued management as per their recommendations.  His home medication Tofacitinib was held during acute illness while in hospital.  Patient had severe thrombocytopenia, Oncology consult was requested, TTP over suspected and the ADAMTS 13 was ordered and was reported negative.  His recent SPEP from July 2021 did not show M spike, is suspected to have MGUS, and Oncology recommended to repeat SPEP and immunofixation.  Patient condition has gradually improved, started working with physical therapy and occupational therapy.  Pulmonology has cleared the patient for discharge to home.  Physical therapy and occupation therapy evaluation is done and patient and the spouse preferred for discharge to home with visiting nurse and physical therapy service.  His thrombocytopenia has resolved.  Patient does have significant elevated D-dimer and for that reason at the time of discharge he is discharged on Xarelto 10 mg for prophylactic anticoagulation.  Patient is to follow up with primary care physician in 1 week, his pulmonologist Dr. in 3-4 weeks and Oncology in 2 weeks.  Discharge plan is discussed with the spouse.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, General physical health deterioration, Hypergammaglobulinaemia benign monoclonal, Hypoxia, Illness
Clinical narrative: COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/26/21 (EN6200) Pfizer Dose 2 3/24/21 (ER2613) Pfizer Dose 3 8/19/21 (EW0170) COVID Positive 9/29/21  10/4/21: The patient had COVID-19 pneumonitis on September last year, he is vaccinated and he had his booster vaccine this year, complaining from fever and chills with sputum productive cough and shortness of breath progressively worsen, no chest pain or palpitation or dizziness or orthopnea or lower limb swelling.  Known to have COPD not oxygen dependent at home.   At emergency, he was hypoxic oxygen saturation 86% and require 3 L of oxygen to maintain SpO2 above 94%, his labs show positive COVID-19 test, elevated D-dimer and proBNP and troponin and CRP, EKG show sinus rhythm without signs of acute ischemia.  CT chest angiogram did not show pulmonary embolism and show bilateral ground-glass opacity and emphysema.  11/1/21: Patient is admitted hospital on 10/04/2021 for COVID pneumonia with hypoxic respiratory failure, started on IV remdesivir, IV dexamethasone along with antibiotics. Rest of the medications were continued.  His condition got worse and, oxygen requirements went up, was placed on OptiFlow and pulmonology consult was requested.  Patient is seen and followed by pulmonary team, continued management as per their recommendations.  His home medication Tofacitinib was held during acute illness while in hospital.  Patient had severe thrombocytopenia, Oncology consult was requested, TTP over suspected and the ADAMTS 13 was ordered and was reported negative.  His recent SPEP from July 2021 did not show M spike, is suspected to have MGUS, and Oncology recommended to repeat SPEP and immunofixation.  Patient condition has gradually improved, started working with physical therapy and occupational therapy.  Pulmonology has cleared the patient for discharge to home.  Physical therapy and occupation therapy evaluation is done and patient and the spouse preferred for discharge to home with visiting nurse and physical therapy service.  His thrombocytopenia has resolved.  Patient does have significant elevated D-dimer and for that reason at the time of discharge he is discharged on Xarelto 10 mg for prophylactic anticoagulation.  Patient is to follow up with primary care physician in 1 week, his pulmonologist Dr. in 3-4 weeks and Oncology in 2 weeks.  Discharge plan is discussed with the spouse.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lung opacity, Productive cough, Prohormone brain natriuretic peptide increased, Pyrexia
Clinical narrative: COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/26/21 (EN6200) Pfizer Dose 2 3/24/21 (ER2613) Pfizer Dose 3 8/19/21 (EW0170) COVID Positive 9/29/21  10/4/21: The patient had COVID-19 pneumonitis on September last year, he is vaccinated and he had his booster vaccine this year, complaining from fever and chills with sputum productive cough and shortness of breath progressively worsen, no chest pain or palpitation or dizziness or orthopnea or lower limb swelling.  Known to have COPD not oxygen dependent at home.   At emergency, he was hypoxic oxygen saturation 86% and require 3 L of oxygen to maintain SpO2 above 94%, his labs show positive COVID-19 test, elevated D-dimer and proBNP and troponin and CRP, EKG show sinus rhythm without signs of acute ischemia.  CT chest angiogram did not show pulmonary embolism and show bilateral ground-glass opacity and emphysema.  11/1/21: Patient is admitted hospital on 10/04/2021 for COVID pneumonia with hypoxic respiratory failure, started on IV remdesivir, IV dexamethasone along with antibiotics. Rest of the medications were continued.  His condition got worse and, oxygen requirements went up, was placed on OptiFlow and pulmonology consult was requested.  Patient is seen and followed by pulmonary team, continued management as per their recommendations.  His home medication Tofacitinib was held during acute illness while in hospital.  Patient had severe thrombocytopenia, Oncology consult was requested, TTP over suspected and the ADAMTS 13 was ordered and was reported negative.  His recent SPEP from July 2021 did not show M spike, is suspected to have MGUS, and Oncology recommended to repeat SPEP and immunofixation.  Patient condition has gradually improved, started working with physical therapy and occupational therapy.  Pulmonology has cleared the patient for discharge to home.  Physical therapy and occupation therapy evaluation is done and patient and the spouse preferred for discharge to home with visiting nurse and physical therapy service.  His thrombocytopenia has resolved.  Patient does have significant elevated D-dimer and for that reason at the time of discharge he is discharged on Xarelto 10 mg for prophylactic anticoagulation.  Patient is to follow up with primary care physician in 1 week, his pulmonologist Dr. in 3-4 weeks and Oncology in 2 weeks.  Discharge plan is discussed with the spouse.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure, SARS-CoV-2 test positive, Sinus rhythm, Thrombocytopenia, Troponin increased
Clinical narrative: COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/26/21 (EN6200) Pfizer Dose 2 3/24/21 (ER2613) Pfizer Dose 3 8/19/21 (EW0170) COVID Positive 9/29/21  10/4/21: The patient had COVID-19 pneumonitis on September last year, he is vaccinated and he had his booster vaccine this year, complaining from fever and chills with sputum productive cough and shortness of breath progressively worsen, no chest pain or palpitation or dizziness or orthopnea or lower limb swelling.  Known to have COPD not oxygen dependent at home.   At emergency, he was hypoxic oxygen saturation 86% and require 3 L of oxygen to maintain SpO2 above 94%, his labs show positive COVID-19 test, elevated D-dimer and proBNP and troponin and CRP, EKG show sinus rhythm without signs of acute ischemia.  CT chest angiogram did not show pulmonary embolism and show bilateral ground-glass opacity and emphysema.  11/1/21: Patient is admitted hospital on 10/04/2021 for COVID pneumonia with hypoxic respiratory failure, started on IV remdesivir, IV dexamethasone along with antibiotics. Rest of the medications were continued.  His condition got worse and, oxygen requirements went up, was placed on OptiFlow and pulmonology consult was requested.  Patient is seen and followed by pulmonary team, continued management as per their recommendations.  His home medication Tofacitinib was held during acute illness while in hospital.  Patient had severe thrombocytopenia, Oncology consult was requested, TTP over suspected and the ADAMTS 13 was ordered and was reported negative.  His recent SPEP from July 2021 did not show M spike, is suspected to have MGUS, and Oncology recommended to repeat SPEP and immunofixation.  Patient condition has gradually improved, started working with physical therapy and occupational therapy.  Pulmonology has cleared the patient for discharge to home.  Physical therapy and occupation therapy evaluation is done and patient and the spouse preferred for discharge to home with visiting nurse and physical therapy service.  His thrombocytopenia has resolved.  Patient does have significant elevated D-dimer and for that reason at the time of discharge he is discharged on Xarelto 10 mg for prophylactic anticoagulation.  Patient is to follow up with primary care physician in 1 week, his pulmonologist Dr. in 3-4 weeks and Oncology in 2 weeks.  Discharge plan is discussed with the spouse.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/26/21 (EN6200) Pfizer Dose 2 3/24/21 (ER2613) Pfizer Dose 3 8/19/21 (EW0170) COVID Positive 9/29/21  10/4/21: The patient had COVID-19 pneumonitis on September last year, he is vaccinated and he had his booster vaccine this year, complaining from fever and chills with sputum productive cough and shortness of breath progressively worsen, no chest pain or palpitation or dizziness or orthopnea or lower limb swelling.  Known to have COPD not oxygen dependent at home.   At emergency, he was hypoxic oxygen saturation 86% and require 3 L of oxygen to maintain SpO2 above 94%, his labs show positive COVID-19 test, elevated D-dimer and proBNP and troponin and CRP, EKG show sinus rhythm without signs of acute ischemia.  CT chest angiogram did not show pulmonary embolism and show bilateral ground-glass opacity and emphysema.  11/1/21: Patient is admitted hospital on 10/04/2021 for COVID pneumonia with hypoxic respiratory failure, started on IV remdesivir, IV dexamethasone along with antibiotics. Rest of the medications were continued.  His condition got worse and, oxygen requirements went up, was placed on OptiFlow and pulmonology consult was requested.  Patient is seen and followed by pulmonary team, continued management as per their recommendations.  His home medication Tofacitinib was held during acute illness while in hospital.  Patient had severe thrombocytopenia, Oncology consult was requested, TTP over suspected and the ADAMTS 13 was ordered and was reported negative.  His recent SPEP from July 2021 did not show M spike, is suspected to have MGUS, and Oncology recommended to repeat SPEP and immunofixation.  Patient condition has gradually improved, started working with physical therapy and occupational therapy.  Pulmonology has cleared the patient for discharge to home.  Physical therapy and occupation therapy evaluation is done and patient and the spouse preferred for discharge to home with visiting nurse and physical therapy service.  His thrombocytopenia has resolved.  Patient does have significant elevated D-dimer and for that reason at the time of discharge he is discharged on Xarelto 10 mg for prophylactic anticoagulation.  Patient is to follow up with primary care physician in 1 week, his pulmonologist Dr. in 3-4 weeks and Oncology in 2 weeks.  Discharge plan is discussed with the spouse.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: EXPIRED DOSE ADMINISTERED.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Had Moderna in the mornig for second dose approximately 9:00 a.m.  About 10:00 p.m. body started to feel achy.  At around 1:00 a.m., woke up in extreme pain from head to toe, could eeven feel pain in my toes.  Felt so horrible I wanted to go Urgent Care or ER but never did.  Had an extreme headache, couldn't lay down, had to walk around body was in so much pain. Had chills and sweats.  Fell asleep sitting up and woke up about 3:00 a.m. vomitting for about 30 minutes. Next day, felt fatigued but no longer vomitting and the pain was mostly gone, just achy.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: Had Moderna in the mornig for second dose approximately 9:00 a.m.  About 10:00 p.m. body started to feel achy.  At around 1:00 a.m., woke up in extreme pain from head to toe, could eeven feel pain in my toes.  Felt so horrible I wanted to go Urgent Care or ER but never did.  Had an extreme headache, couldn't lay down, had to walk around body was in so much pain. Had chills and sweats.  Fell asleep sitting up and woke up about 3:00 a.m. vomitting for about 30 minutes. Next day, felt fatigued but no longer vomitting and the pain was mostly gone, just achy.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Patient received 1st dose of Covid -19 vaccine Moderna Lot # 025J20  01/8/2021 Patient received 2nd dose Covid -19 vaccine Moderna Lot 042L20A with a HCF in Left Deltoid 02/09/2021 Patient received a 3rd dose Covid -19 vaccine Pfizer Lot # EW0169 Right Deltoid at a HCF 05/14/2021
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: The Gray cap Pfizer Covid 19 vaccine for ages 12 and up was diluted with 1.3ml of 0.9% saline and then drawn up 0.3ml and administered  in error to patient under 12 years old.  Spoke to vaccine unit and they told me to contact the public health nurse, which I did and she told me to contact Pfizer to find out what they have to say about wrong vaccine given to patient. I spoke to (Privacy), RN and (Privacy), RN at Pfizer and they reviewed the Covid vaccines the gray cap 12 and older and the orange cap 5-11 years and it was determined that the dose the pt received was larger than the recommended dose and parents were notified.  Pfizer said not repeat the dose and to monitor for side effects and if they do not develop any significant side effects then they can receive their second dose 21 days later.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: duplicate vaccine. First dose given 3-3-22. Second dose 3-25-22 Dr office notified. Patient aware, Followed up with clinical services.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given her 2nd Moderna vaccine 10 days before the recommended time between the 1st and 2nd dose.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: The Gray cap Pfizer Covid 19 vaccine for ages 12 and up was diluted with 1.3ml of 0.9% saline and then drawn up 0.3ml and administered  in error to patient under 12 years old.  Spoke to DPH vaccine unit and they told me to contact the DPH  public health nurse, which I did and she told me to contact Pfizer to find out what they have to say about wrong vaccine given to patient. I spoke to RN and RN at Pfizer and they reviewed the Covid vaccines the gray cap 12 and older and the orange cap 5-11 years and it was determined that the dose the pt received was larger than the recommended dose and parents were notified.  Pfizer said not repeat the dose and to monitor for side effects and if they do not develop any significant side effects then they can receive their second dose 21 days later.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received dose #1 on 2/14/2022, then received dose #2 on 3/7/2022. Dose #2 was not documented in our system, nor were his consent forms scanned into the system for verification. This made it appear as if the patient were still missing dose #2, so it was administered on 3/23/2022.  After looking through piles of records, his consent form from 3/7/2022 was found.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient should have received 0.5mL but received 0.25mL instead.  He has not had any adverse reaction
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hemiplegia, Ischaemic stroke
Clinical narrative: Right flaccid hemiplegia; large left MCA ischemic stroke; treated and then moved to inpatient rehab. Hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Hospitalization within 6 weeks of COVID vaccination.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Atrophy, Biopsy muscle abnormal, Blood creatine phosphokinase increased, Electromyogram, Pain in extremity
Clinical narrative: Patient has been reporting bilateral severe calf pain since the above date.  Biopsy has (reportedly) demonstrated neurogenic atrophy, w/u is in progress.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: EXPIRED DOSE ADMINISTERED.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Leiomyosarcoma, Tumour excision
Clinical narrative: Patient underwent wide resection of a suspected leiomyosarcoma in the deep muscles in the posterior aspect of the left hip on 12/17/2021 and was then admitted to (Medical Center) for post-op care. Hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Hospitalization within 6 weeks of COVID vaccination.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hypercalcaemia
Clinical narrative: Patient admitted with symptomatic hypercalcemia. Gave calcitonin and IV fluids. Patient was appropriate for discharge and close outpatient follow-up. ED visit 10 days later for the same problem. Treated and released. ED visit and hospital admission within 6 weeks of receiving the COVID-19 vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray, Full blood count, Incorrect dose administered, Lethargy
Clinical narrative: Patient given Moderna COVID-19 vaccine 1st dose (0.5mL) due to how the consent form was filled-out (not received COVID-19 vaccine in the past). The administrator later found out the patient received both the 1st and 2nd dose of Moderna vaccine on 2/10/2021 and 3/10/2021. The patient reported to be weak and lethargic on the morning of 3/25/2022. No other adverse events noted.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Urine analysis
Clinical narrative: Patient given Moderna COVID-19 vaccine 1st dose (0.5mL) due to how the consent form was filled-out (not received COVID-19 vaccine in the past). The administrator later found out the patient received both the 1st and 2nd dose of Moderna vaccine on 2/10/2021 and 3/10/2021. The patient reported to be weak and lethargic on the morning of 3/25/2022. No other adverse events noted.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: EXPIRED DOSE ADMINISTERED.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Disturbance in attention, Fatigue, Imaging procedure, Laboratory test normal
Clinical narrative: Fatigue, skin changes, pain, difficulty concentrating,
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Rheumatoid factor negative, Skin disorder
Clinical narrative: Fatigue, skin changes, pain, difficulty concentrating,
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Bladder catheter replacement, Catheter removal, Death, Device leakage
Clinical narrative: ED visit for Urinary catheter leaking - removed and replaced. Hospital admission @ 1 month later - admitted to superior hospital 2/28 through 3/1 for abdominal pain and diarrhea but transfer to hospital after having episodes of hypotension requiring vasoactive medications.  He passed away on 3/1. ED visit, hospital admission and death within 6 weeks of receiving the COVID vaccine.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Hypotension
Clinical narrative: ED visit for Urinary catheter leaking - removed and replaced. Hospital admission @ 1 month later - admitted to superior hospital 2/28 through 3/1 for abdominal pain and diarrhea but transfer to hospital after having episodes of hypotension requiring vasoactive medications.  He passed away on 3/1. ED visit, hospital admission and death within 6 weeks of receiving the COVID vaccine.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered expired dose.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Sepsis, Septic shock
Clinical narrative: Patient presented to the ED and was subsequently hospitalized for sepsis with a cute renal failure and septic shock within 6 weeks of receiving covid vaccination.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cardiac arrest, Death, Dialysis
Clinical narrative: pt presents to ED from dialysis where she was told her BP was low; states had a positive COVID test earlier in the week; c/o weakness and fatigue x 2 days; admitted to hosp; pt experienced cardiac arrest; ACLS was done but unable to revive pt; she passed away in the hosp
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypotension, Life support, SARS-CoV-2 test positive
Clinical narrative: pt presents to ED from dialysis where she was told her BP was low; states had a positive COVID test earlier in the week; c/o weakness and fatigue x 2 days; admitted to hosp; pt experienced cardiac arrest; ACLS was done but unable to revive pt; she passed away in the hosp
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: EXPIRED DOSE ADMINISTERED.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Biopsy, Cervix disorder, Discomfort, Dizziness
Clinical narrative: I am not sure when my symptoms started but I noticed my periods got very heavy. I first saw my doctor in June 2021 she did CBC and lipid panel. My hemoglobin is low and I had anemia. I had the labs on July 23, 2021.  Hemoglobin 10.7 Hematocrit 34. On January 14, 2022, I saw my doctor again July 23,2021 I saw here for tingling in lower extremities (worse on the left side) and she suspected Anemia so she ordered the follow-up labs. My NP recommended me just to take OTC Pure Micronutrients Iron Plus every other day on July 27, 2021. My labs in January 15 2022, I was in the middle of my period but my Iron was still low and was advised by my doctor advised the Iron with Vitamin C for better absorption because my Iron saturation was even lower at 9%. During a shower, right after my period, I felt lightheaded, dizzy, and short of breath in shower.  I did recover from that but I also saw my OB/GYN June 25, 2021 for pelvic pressure. My cervix has thickened and I am having ablation done to deal with heavy periods. My period was also late. I requested a Pap and discussed IUD for heavy period. NP Ob/GYN said she would monitor and would consider the Ultrasound in future. We decided on ablation but I am awaiting on results from Biopsy. My follow-up is April 13th with OB/GYN. Based on the results on the biopsy I will have either ablation or Hysterectomy. I am not sure if this is from my vaccination but I didn't have this issue prior and my labs were normal. On November 30, 2019, my Hemoglobin and Hematocrit was normal.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Endometrial hyperplasia, Full blood count, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: I am not sure when my symptoms started but I noticed my periods got very heavy. I first saw my doctor in June 2021 she did CBC and lipid panel. My hemoglobin is low and I had anemia. I had the labs on July 23, 2021.  Hemoglobin 10.7 Hematocrit 34. On January 14, 2022, I saw my doctor again July 23,2021 I saw here for tingling in lower extremities (worse on the left side) and she suspected Anemia so she ordered the follow-up labs. My NP recommended me just to take OTC Pure Micronutrients Iron Plus every other day on July 27, 2021. My labs in January 15 2022, I was in the middle of my period but my Iron was still low and was advised by my doctor advised the Iron with Vitamin C for better absorption because my Iron saturation was even lower at 9%. During a shower, right after my period, I felt lightheaded, dizzy, and short of breath in shower.  I did recover from that but I also saw my OB/GYN June 25, 2021 for pelvic pressure. My cervix has thickened and I am having ablation done to deal with heavy periods. My period was also late. I requested a Pap and discussed IUD for heavy period. NP Ob/GYN said she would monitor and would consider the Ultrasound in future. We decided on ablation but I am awaiting on results from Biopsy. My follow-up is April 13th with OB/GYN. Based on the results on the biopsy I will have either ablation or Hysterectomy. I am not sure if this is from my vaccination but I didn't have this issue prior and my labs were normal. On November 30, 2019, my Hemoglobin and Hematocrit was normal.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Lipids, Menstruation delayed, Paraesthesia, Transferrin saturation decreased
Clinical narrative: I am not sure when my symptoms started but I noticed my periods got very heavy. I first saw my doctor in June 2021 she did CBC and lipid panel. My hemoglobin is low and I had anemia. I had the labs on July 23, 2021.  Hemoglobin 10.7 Hematocrit 34. On January 14, 2022, I saw my doctor again July 23,2021 I saw here for tingling in lower extremities (worse on the left side) and she suspected Anemia so she ordered the follow-up labs. My NP recommended me just to take OTC Pure Micronutrients Iron Plus every other day on July 27, 2021. My labs in January 15 2022, I was in the middle of my period but my Iron was still low and was advised by my doctor advised the Iron with Vitamin C for better absorption because my Iron saturation was even lower at 9%. During a shower, right after my period, I felt lightheaded, dizzy, and short of breath in shower.  I did recover from that but I also saw my OB/GYN June 25, 2021 for pelvic pressure. My cervix has thickened and I am having ablation done to deal with heavy periods. My period was also late. I requested a Pap and discussed IUD for heavy period. NP Ob/GYN said she would monitor and would consider the Ultrasound in future. We decided on ablation but I am awaiting on results from Biopsy. My follow-up is April 13th with OB/GYN. Based on the results on the biopsy I will have either ablation or Hysterectomy. I am not sure if this is from my vaccination but I didn't have this issue prior and my labs were normal. On November 30, 2019, my Hemoglobin and Hematocrit was normal.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound uterus abnormal
Clinical narrative: I am not sure when my symptoms started but I noticed my periods got very heavy. I first saw my doctor in June 2021 she did CBC and lipid panel. My hemoglobin is low and I had anemia. I had the labs on July 23, 2021.  Hemoglobin 10.7 Hematocrit 34. On January 14, 2022, I saw my doctor again July 23,2021 I saw here for tingling in lower extremities (worse on the left side) and she suspected Anemia so she ordered the follow-up labs. My NP recommended me just to take OTC Pure Micronutrients Iron Plus every other day on July 27, 2021. My labs in January 15 2022, I was in the middle of my period but my Iron was still low and was advised by my doctor advised the Iron with Vitamin C for better absorption because my Iron saturation was even lower at 9%. During a shower, right after my period, I felt lightheaded, dizzy, and short of breath in shower.  I did recover from that but I also saw my OB/GYN June 25, 2021 for pelvic pressure. My cervix has thickened and I am having ablation done to deal with heavy periods. My period was also late. I requested a Pap and discussed IUD for heavy period. NP Ob/GYN said she would monitor and would consider the Ultrasound in future. We decided on ablation but I am awaiting on results from Biopsy. My follow-up is April 13th with OB/GYN. Based on the results on the biopsy I will have either ablation or Hysterectomy. I am not sure if this is from my vaccination but I didn't have this issue prior and my labs were normal. On November 30, 2019, my Hemoglobin and Hematocrit was normal.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: I gave the patient a pediatric dosage instead of an adult dosage. The only difference was a .1ml difference.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Cerebral artery occlusion, Computerised tomogram abdomen normal, Computerised tomogram thorax normal, Dysarthria
Clinical narrative: Presented 3/21/22 with acute onset left sided weakness and slured speech. CTA demonstrated right M1 occlusion. CT perfusion was favorable. She received TNK and underwent thrombectomy, TICI 2b. Despite these interventions, she has persistent severe deficits including left facial droop, slurred speech, and paralysis of her left arm and leg.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram normal, Facial paralysis, Glycosylated haemoglobin, Hemiparesis, Low density lipoprotein increased
Clinical narrative: Presented 3/21/22 with acute onset left sided weakness and slured speech. CTA demonstrated right M1 occlusion. CT perfusion was favorable. She received TNK and underwent thrombectomy, TICI 2b. Despite these interventions, she has persistent severe deficits including left facial droop, slurred speech, and paralysis of her left arm and leg.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Monoplegia, Thrombectomy, Thrombotic cerebral infarction
Clinical narrative: Presented 3/21/22 with acute onset left sided weakness and slured speech. CTA demonstrated right M1 occlusion. CT perfusion was favorable. She received TNK and underwent thrombectomy, TICI 2b. Despite these interventions, she has persistent severe deficits including left facial droop, slurred speech, and paralysis of her left arm and leg.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: EXPIRED DOSE ADMINISTERED.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patients upper left arm was red and swollen
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event known to date. 15 year old patient received 0.3 mL (30 mcg) booster dose of the Pfizer COVID vaccine that was prepared from a Pfizer COVID vaccine 5 year to 11 year old vial. Patient should have received this dose prepared from the Pfizer COVID vaccine 12 year and up vial.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: After the first 24 hours, unable to lift arm fully. Arm more sore than first vaccination. Normal post-vaccination symptoms such as fatigue, tiredness, redness, heat at injection site and pain at injection site. Arm range of motion and muscular pain at injection site did not improve over the next few days. It took about 4 months before I had range of motion in arm and little to no pain. Went to see my general practitioner on 4/27/2021, ran several tests and said it could be an effect of the vaccine or it could be SIRVA from the vaccine administration. It's possible the needle damaged the muscle. Went to see my doctor again on 12/22/2021 for checkup on arm, which appeared normal.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Joint range of motion decreased, Pain in extremity
Clinical narrative: After the first 24 hours, unable to lift arm fully. Arm more sore than first vaccination. Normal post-vaccination symptoms such as fatigue, tiredness, redness, heat at injection site and pain at injection site. Arm range of motion and muscular pain at injection site did not improve over the next few days. It took about 4 months before I had range of motion in arm and little to no pain. Went to see my general practitioner on 4/27/2021, ran several tests and said it could be an effect of the vaccine or it could be SIRVA from the vaccine administration. It's possible the needle damaged the muscle. Went to see my doctor again on 12/22/2021 for checkup on arm, which appeared normal.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Condition aggravated, Fatigue, Headache
Clinical narrative: For 2 days: Fever 101' Body aches from head to toe Chills Headaches Herpes flare up Stomach upset Nausea Exhaustion
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection, Influenza virus test negative, Interchange of vaccine products, Nausea, Pain
Clinical narrative: For 2 days: Fever 101' Body aches from head to toe Chills Headaches Herpes flare up Stomach upset Nausea Exhaustion
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: For 2 days: Fever 101' Body aches from head to toe Chills Headaches Herpes flare up Stomach upset Nausea Exhaustion
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, COVID-19, Death, Diarrhoea
Clinical narrative: pt presents to ED with weakness, diarrhea, nausea; hypoxic; positive for COVID; O2 supplementation; transferred to ICU; O2 needs increased; intubated; AKI; family decided to not do dialysis; DNR; pt passed away in the hosp
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Endotracheal intubation, Hypoxia, Intensive care, Nausea, SARS-CoV-2 test positive
Clinical narrative: pt presents to ED with weakness, diarrhea, nausea; hypoxic; positive for COVID; O2 supplementation; transferred to ICU; O2 needs increased; intubated; AKI; family decided to not do dialysis; DNR; pt passed away in the hosp
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Asthenia, Chest pain, Chills, Cough
Clinical narrative: Started with sore arm; progressed to inability to move arm. Fever, headache, body aches, chills, cough, fatigue, and a sharp, stabbing intermittent pain in upper right chest, which can best be described as heart pain (upon exertion). I also had trouble using my hands. Loss of strength and dexterity. Fingers somewhat in curled position. I was sick for almost 2 weeks. The last symptoms to resolve were the chest pain and cough. Cough lasted longer than the 2 weeks but I cannot say how long. I did not report because a hospital trip was pointless. Our hospitals were swamped with at least 6 hour ER wait times. I attributed my response to my immune system recognizing the vaccine ingredients and doing it's job by producing antibodies.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Extremity contracture, Fatigue, Fine motor skill dysfunction, Headache, Illness
Clinical narrative: Started with sore arm; progressed to inability to move arm. Fever, headache, body aches, chills, cough, fatigue, and a sharp, stabbing intermittent pain in upper right chest, which can best be described as heart pain (upon exertion). I also had trouble using my hands. Loss of strength and dexterity. Fingers somewhat in curled position. I was sick for almost 2 weeks. The last symptoms to resolve were the chest pain and cough. Cough lasted longer than the 2 weeks but I cannot say how long. I did not report because a hospital trip was pointless. Our hospitals were swamped with at least 6 hour ER wait times. I attributed my response to my immune system recognizing the vaccine ingredients and doing it's job by producing antibodies.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: Started with sore arm; progressed to inability to move arm. Fever, headache, body aches, chills, cough, fatigue, and a sharp, stabbing intermittent pain in upper right chest, which can best be described as heart pain (upon exertion). I also had trouble using my hands. Loss of strength and dexterity. Fingers somewhat in curled position. I was sick for almost 2 weeks. The last symptoms to resolve were the chest pain and cough. Cough lasted longer than the 2 weeks but I cannot say how long. I did not report because a hospital trip was pointless. Our hospitals were swamped with at least 6 hour ER wait times. I attributed my response to my immune system recognizing the vaccine ingredients and doing it's job by producing antibodies.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic valve stenosis, Atrial fibrillation, Echocardiogram abnormal, Haematoma, Transcatheter aortic valve implantation
Clinical narrative: Patient hospitalized for echocardiogram due to nonrheumatic aortic valve stenosis, atrial fibrillation on 12/2/21. Patient presented to the ED on 12/4/21 for hematoma. She then had a TAVR on 12/21/21. These visits are within 6 weeks of receiving COVID vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: Patient accidentally received a full dose of Moderna instead of a booster dose.  Her first vaccine was a J and J so this should have been a booster dose to complete the series but was given a full dose.  No adverse effect.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Food intolerance
Clinical narrative: Pt reported constant diarrhea, stomach upset for 3 weeks after vaccination. Pt reports recurrent episodes of diarrhea about every three weeks and increased intolerance of fermented foods, dairy even with use of Lactaid, fatty foods. Possibly related to the second dose of vaccination. (Will submit another adverse event for the second dose.)