chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, Interchange of vaccine products
Clinical narrative: Patient did not complete Pfizer series. First dose: 6/17/2021. Received J&J vaccine dose 09/02/2021.  Too early for a booster, wrong booster, incomplete series.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Vaccinated with Jannsen and boosted twice.
Age: 52.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Mass, Pruritus
Clinical narrative: Itchy red lump
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasal congestion, Pharyngitis streptococcal, SARS-CoV-2 test positive
Clinical narrative: I received strep throat; stuffy sinus; coughing for 4 days and I took PAXLOVID and felt better.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Diarrhoea, Myalgia
Clinical narrative: chills, fever, cough, diarrhea, arthralgias, myalgias
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills, fever, cough, diarrhea, arthralgias, myalgias
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022.  Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted.  The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the CDC and the local Department of Public Health and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022.  Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly ?invalid? dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been more than 8 weeks since that clinic and this child has been offered an additional dose.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Decreased appetite, General physical health deterioration, SARS-CoV-2 test positive
Clinical narrative: MODERNA COVID VACCINE GIVEN 12/29/21, LOT #066H21A; patient in and out of hospital and rehab since September 2021; January 2022 another hospitalization with DX of sepsis and UTI; no hospitalization records received in records from nursing home; 2/10/22 patient had a positive COVID test in rehab facility. Patient's condition continued to worsen with loss of appetite, vomiting and weight loss; patient passed away in the Nursing Home.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis, Urinary tract infection, Vomiting, Weight decreased
Clinical narrative: MODERNA COVID VACCINE GIVEN 12/29/21, LOT #066H21A; patient in and out of hospital and rehab since September 2021; January 2022 another hospitalization with DX of sepsis and UTI; no hospitalization records received in records from nursing home; 2/10/22 patient had a positive COVID test in rehab facility. Patient's condition continued to worsen with loss of appetite, vomiting and weight loss; patient passed away in the Nursing Home.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Oropharyngeal pain
Clinical narrative: chills, sore throat, myalgias
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Feeling abnormal
Clinical narrative: (Short turn)Memory loss  Drained/ tried  Brain fog
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site nodule
Clinical narrative: After receive the shot I had a bump in the injection site. She told me to make sure I didn?t bother it. It?s been 2 weeks now and it?s still there. Is there any type of cream I can put on it to go away. Not much information was passed along.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated and boosted twice.   COVID breakthrough infection
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nauseau and vomiting. Vomiting lasted 18 hours. Nauseau still continues. Prescribed  ONDANSETRON ODT 4 MG TABLET  if  needed.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: blood and mucus in the stool on 8 /20 and again on 8/28 no pain no fever
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: 5-hydroxyindolacetic acid, Blood catecholamines normal, Blood test normal, Feeling hot, Flushing
Clinical narrative: Chronic flushing of the face, neck, chest, and arms with extreme heat.  Started shortly after the second vaccine dose.  Over time, occurred more and more frequently.  Almost always accompanies eating, regardless of what food.  Lasts 30-60 minutes
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Immunisation reaction, Tryptase, Ultrasound scan normal, Urine analysis normal
Clinical narrative: Chronic flushing of the face, neck, chest, and arms with extreme heat.  Started shortly after the second vaccine dose.  Over time, occurred more and more frequently.  Almost always accompanies eating, regardless of what food.  Lasts 30-60 minutes
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Disease complication, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient had breakthrough infection and passed away due to complications
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Computerised tomogram thorax abnormal, Cough, Death
Clinical narrative: The patient presented to the Medical Center on 02/17/2022 with SOB.  She was diagnosed with Covid-19 1 month prior.  Over the past two weeks, the patient has had worsening body aches, fevers, generalized weakness, SOB, cough, HA, and nausea.  She was given multiple courses of antibiotics and steroids by her PCP.  On arrival at the ED, the patient's oxygen was 89% on RA.  CT Regulatory AUthority study showed moderate bilateral PNA, left worse than right.  The patient was given IV fluids and antibiotics in the ED.  The patient was admitted to the hospital.  During her hospitalization, oxygen requirements continued to trend up.  The patient was transferred to the ICU on 03/04/2022 for worsening hypoxemia.  The patient decided on DNR.  The patient remained on vapotherm and nonrebreather.  The patient transitioned to comfort care.  The patient expired on 03/06/2022.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Hypoxia, Intensive care, Nausea
Clinical narrative: The patient presented to the Medical Center on 02/17/2022 with SOB.  She was diagnosed with Covid-19 1 month prior.  Over the past two weeks, the patient has had worsening body aches, fevers, generalized weakness, SOB, cough, HA, and nausea.  She was given multiple courses of antibiotics and steroids by her PCP.  On arrival at the ED, the patient's oxygen was 89% on RA.  CT Regulatory AUthority study showed moderate bilateral PNA, left worse than right.  The patient was given IV fluids and antibiotics in the ED.  The patient was admitted to the hospital.  During her hospitalization, oxygen requirements continued to trend up.  The patient was transferred to the ICU on 03/04/2022 for worsening hypoxemia.  The patient decided on DNR.  The patient remained on vapotherm and nonrebreather.  The patient transitioned to comfort care.  The patient expired on 03/06/2022.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pneumonia, Pyrexia
Clinical narrative: The patient presented to the Medical Center on 02/17/2022 with SOB.  She was diagnosed with Covid-19 1 month prior.  Over the past two weeks, the patient has had worsening body aches, fevers, generalized weakness, SOB, cough, HA, and nausea.  She was given multiple courses of antibiotics and steroids by her PCP.  On arrival at the ED, the patient's oxygen was 89% on RA.  CT Regulatory AUthority study showed moderate bilateral PNA, left worse than right.  The patient was given IV fluids and antibiotics in the ED.  The patient was admitted to the hospital.  During her hospitalization, oxygen requirements continued to trend up.  The patient was transferred to the ICU on 03/04/2022 for worsening hypoxemia.  The patient decided on DNR.  The patient remained on vapotherm and nonrebreather.  The patient transitioned to comfort care.  The patient expired on 03/06/2022.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Appetite change, fatigue, pain, visual disturbance, dizziness, weakness, and headaches.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Visual impairment
Clinical narrative: Appetite change, fatigue, pain, visual disturbance, dizziness, weakness, and headaches.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: red warm inch circumference around vaccination injection site. Also states she had a low grade fever for 24 hours. Stated she took Benadryl one time and is feeling much better today. red area with less circumference today as well
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test positive
Clinical narrative: fatigue
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: chills, fever, congestion, cough, weakness
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Gait disturbance, Peroneal nerve palsy, Spinal X-ray, X-ray
Clinical narrative: She got her vaccine, she started limping and it got worse.  Two months later in June she started falling tripping over her own foot.  She went to the doctor on 8/12/22 and informed that she had drop foot and to go see a podiatrist.  The podiatrist could not figure it out as he had never seen it before.  She went to see a neurologist who had never seen it before.  She is scheduled to have an MRI tomorrow.  Her friend told her to go to a chiropractor and he asked about the vaccines, and he said that the vaccine was the only thing that changed in her life to cause it.  She did not have any problems with limping or foot prior to the vaccines.  The chiropractor.  He sent her to get x-rays and said that her left side of her body from her head to her foot is messed up and unbalanced to the other side.   He is thinking that she has a pinched nerve or something, but waiting to have x-rays and MRI reports to make a treatment plan.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, Blood test abnormal, COVID-19, Cough, Dyspnoea
Clinical narrative: I started with a sore throat and a fever. I tested myself on the 2nd of June and was positive. I was given PAXLOVID. It was the PAXLOVID gave me a Hepatitis flare up so I had to stop. I tried to get the infusion but they could not do it because I had started the PAXLOVID. The symptoms were the same for my asthma and COVID-19 symptoms. I had shortness of breath, coughing and body aches. It was almost like having the flu. I took ibuprofen, purchased an air purifiers and used a lot of nebulizer medication for breathing treatments. It took me about 5 weeks to completely recover. I went back to my doctor for a check up and ended up having a bacterial infections but the doctor did not think it related.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test negative, Malaise, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: I started with a sore throat and a fever. I tested myself on the 2nd of June and was positive. I was given PAXLOVID. It was the PAXLOVID gave me a Hepatitis flare up so I had to stop. I tried to get the infusion but they could not do it because I had started the PAXLOVID. The symptoms were the same for my asthma and COVID-19 symptoms. I had shortness of breath, coughing and body aches. It was almost like having the flu. I took ibuprofen, purchased an air purifiers and used a lot of nebulizer medication for breathing treatments. It took me about 5 weeks to completely recover. I went back to my doctor for a check up and ended up having a bacterial infections but the doctor did not think it related.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, White blood cell count increased
Clinical narrative: I started with a sore throat and a fever. I tested myself on the 2nd of June and was positive. I was given PAXLOVID. It was the PAXLOVID gave me a Hepatitis flare up so I had to stop. I tried to get the infusion but they could not do it because I had started the PAXLOVID. The symptoms were the same for my asthma and COVID-19 symptoms. I had shortness of breath, coughing and body aches. It was almost like having the flu. I took ibuprofen, purchased an air purifiers and used a lot of nebulizer medication for breathing treatments. It took me about 5 weeks to completely recover. I went back to my doctor for a check up and ended up having a bacterial infections but the doctor did not think it related.
Age: 48.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Attempted ID administration of vaccine, did not achieve wheal on left arm.  Tried again with fresh dose and needle, achieved wheal on right forearm.  No injury to patient.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue
Clinical narrative: activity change, fatigue, cough
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022.  Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted.  The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the CDC and the local Department of Public Health and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022.  Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly ?invalid? dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been 8 weeks since that clinic and this child has been offered an additional dose.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient had breakthrough infection and passed away.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Swelling, itching, redness from elbow to shoulder. Hives and itching on back of neck and lower scalp.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cardiac arrest, Cardioversion, Death, Endotracheal intubation
Clinical narrative: The patient presented to Hospital on 02/20/2022 in cardiac arrest.  Pre-arrival treatment included CPR, Oxygen, intubation, defibrillated, and epi.  ROSC was achieved prior to arrival.  The patient's hospital course was complicated by aspiration PNA and Covid.  The patient worsened throughout the ICU course.  Palliative care was consulted on 02/23/2022.  The patient was transitioned to comfort care on 02/26/2022.  The patient expired on 02/27/2022.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration, Intensive care, Pneumonia aspiration, Resuscitation
Clinical narrative: The patient presented to Hospital on 02/20/2022 in cardiac arrest.  Pre-arrival treatment included CPR, Oxygen, intubation, defibrillated, and epi.  ROSC was achieved prior to arrival.  The patient's hospital course was complicated by aspiration PNA and Covid.  The patient worsened throughout the ICU course.  Palliative care was consulted on 02/23/2022.  The patient was transitioned to comfort care on 02/26/2022.  The patient expired on 02/27/2022.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, COVID-19, Cardiomegaly, Chest X-ray abnormal, Chills
Clinical narrative: 1/12/22 pt to ED after a week of cough, fever, chills, decrease in appetite, SOB; SOB worsening when came to ED; O2 supplementation; positive for COVID; CXR showed diffuse bilateral infiltrates, right > left; cardiomegaly; admitted; given Decadron, Remdesivir; AKI on CKD; DNR/DNI; pt's condition worsened; oxygenation worsened; comfort measures instituted; pt passed away in the hospital
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Death, Decreased appetite, Dyspnoea, General physical health deterioration
Clinical narrative: 1/12/22 pt to ED after a week of cough, fever, chills, decrease in appetite, SOB; SOB worsening when came to ED; O2 supplementation; positive for COVID; CXR showed diffuse bilateral infiltrates, right > left; cardiomegaly; admitted; given Decadron, Remdesivir; AKI on CKD; DNR/DNI; pt's condition worsened; oxygenation worsened; comfort measures instituted; pt passed away in the hospital
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Lung infiltration, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 1/12/22 pt to ED after a week of cough, fever, chills, decrease in appetite, SOB; SOB worsening when came to ED; O2 supplementation; positive for COVID; CXR showed diffuse bilateral infiltrates, right > left; cardiomegaly; admitted; given Decadron, Remdesivir; AKI on CKD; DNR/DNI; pt's condition worsened; oxygenation worsened; comfort measures instituted; pt passed away in the hospital
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022.  Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted.  The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the CDC and the Department of Public Health and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022.  Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly ?invalid? dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been 8 weeks since that clinic and this child has been offered an additional dose.
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Cough, Croup infectious, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test
Clinical narrative: Pt had a fever and then barky cough and had croup. We saw the doctor and they gave a steroid so he could breath better.
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Pt had a fever and then barky cough and had croup. We saw the doctor and they gave a steroid so he could breath better.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022. Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted. The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the CDC and the local Department of Public Health and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022. Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly "invalid" dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been 8 weeks since that clinic and this child has been offered an additional dose.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given an adult dose of Moderna Covid Vaccine (100mcg) when he should have been given Moderna 6-11year Vaccine (50mcg)
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: Did not have adverse event. Did not complete Pfizer series: first dose - 4/29/2021. Received J&J vaccination: 09/02/2021. J&J vaccination was not uploaded into WIR until 07/14/2022 Manual Entry.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Basophil percentage decreased, Full blood count, Haematocrit decreased, Haemoglobin decreased, Lymphocyte percentage increased
Clinical narrative: Developed a fever on 8/19/22 that lasted for 4 days, up to 102.   Also was found to haven Neutropenia.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Monocyte percentage increased, Neutropenia, Platelet count normal, Pyrexia, White blood cell count decreased
Clinical narrative: Developed a fever on 8/19/22 that lasted for 4 days, up to 102.   Also was found to haven Neutropenia.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Delivery, SARS-CoV-2 test positive
Clinical narrative: PCR positve on routine testing  ,Labor & Delivery , asymptomatic  8/28/22
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Exercise tolerance decreased, Fibromyalgia, Myalgia, Pain in extremity
Clinical narrative: Around 3 days after receiving my second dose of Pfizer, my legs began to hurt, specifically in my calf. I experienced similar pain after my first dose but attributed it to normal leg pain and it went away after a few weeks. However, this pain did not go away and lasted until December of 2021. In January, the pain came back. In March the pain began to spread to other muscles like arms and back. I went to my doctor in July, as the pain was still persisting. They ran blood tests and other tests for lupus, diabetes, and other illnesses but were unable to find anything. My doctor advised that the only thing they could think of was that I was developing fibromyalgia. I have never had issues with pain in the past and have been a fairly active and healthy person. I have not been able to work out or be very active at this point.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022.  Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted.  The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the regulatory authority and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022.  Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly ?invalid? dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been 8 weeks since that clinic and this child has been offered an additional dose.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Chills, Dizziness, Hyperhidrosis
Clinical narrative: Fever, chills, burning in the arm, Dizziness, sweating, palpitations and chest pain. It all happened within 5 minutes of giving me the vaccine.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Fever, chills, burning in the arm, Dizziness, sweating, palpitations and chest pain. It all happened within 5 minutes of giving me the vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Atelectasis, Bronchial wall thickening, COVID-19, Chest tube insertion
Clinical narrative: The patient was transferred to the Hospital on 03/05/2022 for a higher level of care from the Medical Center.  He had a recent COVID infection, became SOB, and was diagnosed with bilateral PNA and sepsis.   CTA of chest was obtained d/t elevated D dimer which was negative for pulmonary embolus or aortic dissection.  Had significant interval worsening in the appearance of the lungs with increased infiltrates superimposed on chronic emphysema with areas of nodular consolidation, bronchial wall thickening, and trace bilateral pleural effusions and atelectasis.  The patient's hgb was low and received 2 units of PRBC.  On the floor, the patient was treated with Rocephin in addition to DuoNeb breathing treatments.  The patient had a complicated course requiring oral intubation and mechanical vent when he failed Bipap.  He could not be weaned from vent, and underwent chest tube placement for left-side pneumo.  The patient was taken off sedation but remained unresponsive.  The patient had profound encephalopathy.  The patient expired on 04/01/2022.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Emphysema, Encephalopathy, Endotracheal intubation
Clinical narrative: The patient was transferred to the Hospital on 03/05/2022 for a higher level of care from the Medical Center.  He had a recent COVID infection, became SOB, and was diagnosed with bilateral PNA and sepsis.   CTA of chest was obtained d/t elevated D dimer which was negative for pulmonary embolus or aortic dissection.  Had significant interval worsening in the appearance of the lungs with increased infiltrates superimposed on chronic emphysema with areas of nodular consolidation, bronchial wall thickening, and trace bilateral pleural effusions and atelectasis.  The patient's hgb was low and received 2 units of PRBC.  On the floor, the patient was treated with Rocephin in addition to DuoNeb breathing treatments.  The patient had a complicated course requiring oral intubation and mechanical vent when he failed Bipap.  He could not be weaned from vent, and underwent chest tube placement for left-side pneumo.  The patient was taken off sedation but remained unresponsive.  The patient had profound encephalopathy.  The patient expired on 04/01/2022.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Haemoglobin decreased, Lung consolidation, Lung infiltration, Mechanical ventilation
Clinical narrative: The patient was transferred to the Hospital on 03/05/2022 for a higher level of care from the Medical Center.  He had a recent COVID infection, became SOB, and was diagnosed with bilateral PNA and sepsis.   CTA of chest was obtained d/t elevated D dimer which was negative for pulmonary embolus or aortic dissection.  Had significant interval worsening in the appearance of the lungs with increased infiltrates superimposed on chronic emphysema with areas of nodular consolidation, bronchial wall thickening, and trace bilateral pleural effusions and atelectasis.  The patient's hgb was low and received 2 units of PRBC.  On the floor, the patient was treated with Rocephin in addition to DuoNeb breathing treatments.  The patient had a complicated course requiring oral intubation and mechanical vent when he failed Bipap.  He could not be weaned from vent, and underwent chest tube placement for left-side pneumo.  The patient was taken off sedation but remained unresponsive.  The patient had profound encephalopathy.  The patient expired on 04/01/2022.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pleural effusion, Pneumonia, Positive airway pressure therapy, Pulmonary mass, Red blood cell transfusion
Clinical narrative: The patient was transferred to the Hospital on 03/05/2022 for a higher level of care from the Medical Center.  He had a recent COVID infection, became SOB, and was diagnosed with bilateral PNA and sepsis.   CTA of chest was obtained d/t elevated D dimer which was negative for pulmonary embolus or aortic dissection.  Had significant interval worsening in the appearance of the lungs with increased infiltrates superimposed on chronic emphysema with areas of nodular consolidation, bronchial wall thickening, and trace bilateral pleural effusions and atelectasis.  The patient's hgb was low and received 2 units of PRBC.  On the floor, the patient was treated with Rocephin in addition to DuoNeb breathing treatments.  The patient had a complicated course requiring oral intubation and mechanical vent when he failed Bipap.  He could not be weaned from vent, and underwent chest tube placement for left-side pneumo.  The patient was taken off sedation but remained unresponsive.  The patient had profound encephalopathy.  The patient expired on 04/01/2022.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis, Unresponsive to stimuli
Clinical narrative: The patient was transferred to the Hospital on 03/05/2022 for a higher level of care from the Medical Center.  He had a recent COVID infection, became SOB, and was diagnosed with bilateral PNA and sepsis.   CTA of chest was obtained d/t elevated D dimer which was negative for pulmonary embolus or aortic dissection.  Had significant interval worsening in the appearance of the lungs with increased infiltrates superimposed on chronic emphysema with areas of nodular consolidation, bronchial wall thickening, and trace bilateral pleural effusions and atelectasis.  The patient's hgb was low and received 2 units of PRBC.  On the floor, the patient was treated with Rocephin in addition to DuoNeb breathing treatments.  The patient had a complicated course requiring oral intubation and mechanical vent when he failed Bipap.  He could not be weaned from vent, and underwent chest tube placement for left-side pneumo.  The patient was taken off sedation but remained unresponsive.  The patient had profound encephalopathy.  The patient expired on 04/01/2022.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022.  Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted.  The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the CDC and the Department of Public Health and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022.  Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly ?invalid? dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been 8 weeks since that clinic and this child has been offered an additional dose.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Lethargy, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 89 year old male who presents from local medical care facility due to lethargy and fever. COVID positive 8/28/22, vaccinated 3/6/21, 2/13/21.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atelectasis, COVID-19, COVID-19 pneumonia, Cardiac arrest
Clinical narrative: 12/31/21 pt had a positive COVID test; sx - SOB, fever, weakness, O2 saturation 89-90% on RA; 1/7/22 to ED with increasing SOB; CXR showed atelectasis; CT chest negative for pulmonary embolism, bandlike infiltrate left lower lung lobe, ground-glass densities right upper lung lobe; sent home with inhaler and Tessalon; 1/11/22 increase in weakness and continued cough, fever, headache; back to ED; PCP (name not included in records) had called in prednisone and ABX the week before; COVID pneumonia and respiratory failure; given Dexamethasone and empiric doxycycline; pt's respiratory status continued to worsen; Vapotherm; 1/21/22 emergent code blue called; ACLS/CPR done; asystole; continued with ACLS/CPR without any success; pt passed away in the hospital
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cardio-respiratory arrest, Chest X-ray abnormal, Computerised tomogram thorax normal, Cough, Death
Clinical narrative: 12/31/21 pt had a positive COVID test; sx - SOB, fever, weakness, O2 saturation 89-90% on RA; 1/7/22 to ED with increasing SOB; CXR showed atelectasis; CT chest negative for pulmonary embolism, bandlike infiltrate left lower lung lobe, ground-glass densities right upper lung lobe; sent home with inhaler and Tessalon; 1/11/22 increase in weakness and continued cough, fever, headache; back to ED; PCP (name not included in records) had called in prednisone and ABX the week before; COVID pneumonia and respiratory failure; given Dexamethasone and empiric doxycycline; pt's respiratory status continued to worsen; Vapotherm; 1/21/22 emergent code blue called; ACLS/CPR done; asystole; continued with ACLS/CPR without any success; pt passed away in the hospital
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pyrexia, Respiratory failure, Resuscitation
Clinical narrative: 12/31/21 pt had a positive COVID test; sx - SOB, fever, weakness, O2 saturation 89-90% on RA; 1/7/22 to ED with increasing SOB; CXR showed atelectasis; CT chest negative for pulmonary embolism, bandlike infiltrate left lower lung lobe, ground-glass densities right upper lung lobe; sent home with inhaler and Tessalon; 1/11/22 increase in weakness and continued cough, fever, headache; back to ED; PCP (name not included in records) had called in prednisone and ABX the week before; COVID pneumonia and respiratory failure; given Dexamethasone and empiric doxycycline; pt's respiratory status continued to worsen; Vapotherm; 1/21/22 emergent code blue called; ACLS/CPR done; asystole; continued with ACLS/CPR without any success; pt passed away in the hospital
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 12/31/21 pt had a positive COVID test; sx - SOB, fever, weakness, O2 saturation 89-90% on RA; 1/7/22 to ED with increasing SOB; CXR showed atelectasis; CT chest negative for pulmonary embolism, bandlike infiltrate left lower lung lobe, ground-glass densities right upper lung lobe; sent home with inhaler and Tessalon; 1/11/22 increase in weakness and continued cough, fever, headache; back to ED; PCP (name not included in records) had called in prednisone and ABX the week before; COVID pneumonia and respiratory failure; given Dexamethasone and empiric doxycycline; pt's respiratory status continued to worsen; Vapotherm; 1/21/22 emergent code blue called; ACLS/CPR done; asystole; continued with ACLS/CPR without any success; pt passed away in the hospital
Age: 25.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Incorrect dose administered, Wrong technique in product usage process
Clinical narrative: Patient came to clinic for first dose of Monkeypox vaccine.  The patient moved her arm during the intradermal dose administration, the wheel was not achieved.   The patient requested a subcutaneous dose.  Subcutaneous dose administered without incident.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Diarrhoea, Hypervolaemia, Laboratory test normal
Clinical narrative: The patient was admitted to the hospital with diarrhea after recently taking antibiotics for otitis media. infectious workup unremarkable. Ultimately amoxicillin was restarted for otitis media. The patient was noted to be oxygen requiring during the hospital stay and felt to be volume overloaded following lV fluid resuscitation and was diuresis not requiring oxygen at the time of discharge.  The patient was discharged to a Health care facility.  The patient tested positive for COVID-19 on 01/26/2022.  The patient expired on 02/23/2022.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Otitis media, Polyuria, SARS-CoV-2 test positive
Clinical narrative: The patient was admitted to the hospital with diarrhea after recently taking antibiotics for otitis media. infectious workup unremarkable. Ultimately amoxicillin was restarted for otitis media. The patient was noted to be oxygen requiring during the hospital stay and felt to be volume overloaded following lV fluid resuscitation and was diuresis not requiring oxygen at the time of discharge.  The patient was discharged to a Health care facility.  The patient tested positive for COVID-19 on 01/26/2022.  The patient expired on 02/23/2022.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient had breakthrough infection and passed away.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022.  Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted.  The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the CDC and the local Department of Public Health and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022.  Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly ?invalid? dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been 8 weeks since that clinic and this child has been offered an additional dose.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: covid positive 8/26/22, some hypoxia, but now on room air
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022.  Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted.  The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the CDC and the local Department of Public Health and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022.  Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly ?invalid? dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been 8 weeks since that clinic and this child has been offered an additional dose.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Epistaxis, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Immediately following injection pain and tingling in my arm down to my hand that lasted for 7 days. Rash on left arm from shoulder to elbow, raised bump at injection site that was hot to the touch and itchy, lasted 7 days. Nauseous and couldn't eat for two days. Fever 101, for 36 hours. Fatigue for a week. Headache that continued from first vaccine and never went away and became very painful and still have them to date (mostly over my right eye and the base of my head on the right side, now have also progressed to my entire head and very painful). Nosebleeds for 3 days (from day 2 to 4). While I did not visit the doctor, I notified my doctor via the patient portal.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Nausea, Paraesthesia
Clinical narrative: Immediately following injection pain and tingling in my arm down to my hand that lasted for 7 days. Rash on left arm from shoulder to elbow, raised bump at injection site that was hot to the touch and itchy, lasted 7 days. Nauseous and couldn't eat for two days. Fever 101, for 36 hours. Fatigue for a week. Headache that continued from first vaccine and never went away and became very painful and still have them to date (mostly over my right eye and the base of my head on the right side, now have also progressed to my entire head and very painful). Nosebleeds for 3 days (from day 2 to 4). While I did not visit the doctor, I notified my doctor via the patient portal.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Immediately following injection pain and tingling in my arm down to my hand that lasted for 7 days. Rash on left arm from shoulder to elbow, raised bump at injection site that was hot to the touch and itchy, lasted 7 days. Nauseous and couldn't eat for two days. Fever 101, for 36 hours. Fatigue for a week. Headache that continued from first vaccine and never went away and became very painful and still have them to date (mostly over my right eye and the base of my head on the right side, now have also progressed to my entire head and very painful). Nosebleeds for 3 days (from day 2 to 4). While I did not visit the doctor, I notified my doctor via the patient portal.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Positive Covid Test.  Mild sore throat and headache for approx 2 days.  General fatique for a week.  Received Paxlovid within 12 hours of the positive test.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Acute respiratory distress syndrome, Acute respiratory failure, Aspartate aminotransferase increased, Biopsy liver
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA Rec'd Pfizer-BioNTech COVID Vaccine on 3/3/21 and 3/28/21. Admitted 8/12/22 @ 37wk gestation for tx of sickle cell pain crisis w/IVF and pain relief. ED labs - Tbili 3.2, Alk phos 172, AST 80, Hgb 11.2, Hematocrit 31.1, SARS-CoV-2 detected, CXR revealing Increased interstitial markings bilaterally. 8/13/22 clinical course c/b nonreassuring FHR strip, acute mental status changese and hypoxia. Underwent Cesarean 2/2 IUFD, DIC/abruption noted. Rec'd 4u pRBC, u1 FFP, 1u Plts. Transferred to ICU intubated. POD #1 c/b resp failure & liver shock. Postop course c/b worsening resp status w/sickle cell crisis, acute hypox resp fail. severe Covid PNA, asp PNA, AKI, leukocytosis, transaminitis, reactive hyperglycemia and thrombocytopenia. Pulmonary status cont to decline; VV ecmo started w/improvement in sats. Severe ARDS w/refractory hypoxia present; trach place 8/23/22. 8/25/22 PEA arrest c/b multiorgan failure. On 8/25/22 overall condition determined to be terminal and irreversible. Status changed to DNAR and transitioned to comfort care. Tx'd w/decadron, , zosyn,cefepime, clindamycin, azithroycin, flagyl and remdesivir. Expired 8/26/22.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood alkaline phosphatase increased, Blood bilirubin increased, COVID-19 pneumonia, Caesarean section, Cardiac arrest
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA Rec'd Pfizer-BioNTech COVID Vaccine on 3/3/21 and 3/28/21. Admitted 8/12/22 @ 37wk gestation for tx of sickle cell pain crisis w/IVF and pain relief. ED labs - Tbili 3.2, Alk phos 172, AST 80, Hgb 11.2, Hematocrit 31.1, SARS-CoV-2 detected, CXR revealing Increased interstitial markings bilaterally. 8/13/22 clinical course c/b nonreassuring FHR strip, acute mental status changese and hypoxia. Underwent Cesarean 2/2 IUFD, DIC/abruption noted. Rec'd 4u pRBC, u1 FFP, 1u Plts. Transferred to ICU intubated. POD #1 c/b resp failure & liver shock. Postop course c/b worsening resp status w/sickle cell crisis, acute hypox resp fail. severe Covid PNA, asp PNA, AKI, leukocytosis, transaminitis, reactive hyperglycemia and thrombocytopenia. Pulmonary status cont to decline; VV ecmo started w/improvement in sats. Severe ARDS w/refractory hypoxia present; trach place 8/23/22. 8/25/22 PEA arrest c/b multiorgan failure. On 8/25/22 overall condition determined to be terminal and irreversible. Status changed to DNAR and transitioned to comfort care. Tx'd w/decadron, , zosyn,cefepime, clindamycin, azithroycin, flagyl and remdesivir. Expired 8/26/22.