chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase normal, Blood bicarbonate normal, Blood bilirubin normal, Blood calcium decreased, Blood chloride normal
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine increased, Blood gases, Blood glucose increased, Blood magnesium normal, Blood osmolarity decreased
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pH normal, Blood potassium normal, Blood pressure inadequately controlled, Blood sodium normal, Blood urea increased
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide increased, C-reactive protein increased, COVID-19, Carbon dioxide normal, Cardiac failure congestive
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chronic kidney disease, Condition aggravated, Coronary artery disease, Cough
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diastolic dysfunction, Differential white blood cell count, Dyspnoea, Echocardiogram, Echocardiogram abnormal
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Ejection fraction, Electrocardiogram PR interval, Electrocardiogram QT interval, Electrocardiogram T wave abnormal, Electrocardiogram abnormal
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram repolarisation abnormality, Eosinophil count decreased, Eosinophil percentage decreased, Fibrin D dimer normal, Full blood count
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate decreased, Haematocrit decreased, Haemoglobin decreased, Inappropriate schedule of product administration, Left atrial enlargement
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Left ventricular hypertrophy, Lung opacity, Lymphocyte count decreased, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell haemoglobin decreased, Mean cell haemoglobin normal, Mean cell volume decreased, Mean cell volume normal, Mean platelet volume normal
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Mitral valve incompetence, Monocyte count, Monocyte percentage, Neutrophil count
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Neutrophil percentage increased, PCO2 normal, PO2 normal, Platelet count normal, Poikilocytosis
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Polychromasia, Procalcitonin increased, Protein total decreased, Pulmonary mass, Pulmonary oedema
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: QRS axis, Red blood cell acanthocytes present, Red blood cell anisocytes present, Red blood cell count decreased, Red blood cell morphology abnormal
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell poikilocytes present, Red blood cell sedimentation rate increased, Red cell distribution width increased, Right ventricular systolic pressure decreased, SARS-CoV-2 RNA
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Serum ferritin increased, Troponin I normal, Type 2 diabetes mellitus, Ultrasound Doppler abnormal
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count decreased, White blood cell count normal
Clinical narrative: 76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP), Program ID: (176890). A 51-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1; Lot number: unknown), for COVID-19 immunization, reaction: "I  was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid"; Bnt162b2 (Dose: 1; Lot number: unknown), for Covid-19 immunization, reaction: "I  was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid", "I  was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid"; Bnt162b2 (Dose: 2; Lot number: unknown), for Covid-19 immunization, reaction: "I  was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid"; Bnt162b2 (Dose: 2; Lot number: unknown), for Covid-19 Immunization, reaction: "I  was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid", "I  was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I  was reminded of my booster which made me sick for two days". Additional information: Patient was reminded of her booster which made her sick for two days just like the first two shots of the vaccine, and then she still got Covid and thought she might not make it. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Altered state of consciousness, COVID-19, Dysarthria, SARS-CoV-2 test positive
Clinical narrative: ADMITTED TO HOSPITAL 7/3/2022 older woman was admitted with altered level of consciousness and slurred speech.  She was seen by neurology who did not feel that she had any acute cva.  She has improved.    She did test positive for covid and did receive remdesivir
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Illness, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (176890). A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), ILLNESS (non-serious), outcome "unknown" and all described as "I  was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: I still got Covid, notes: then I still got Covid and thought I might not make it. Additional information: I was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid and thought I might not make it. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: That I got the first two shots and still got covid; That I got the first two shots and still got covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient (age 50 without unit) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "That I got the first two shots and still got covid". The patient said another shot is not going to do anything. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: cusion on paternal side, has/had lymph node enlargement after vaccine booster in Jan2022, size going down; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 66-year-old patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization complete; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Jan2022, outcome "unknown", described as "cusion on paternal side, has/had lymph node enlargement after vaccine booster in Jan2022, size going down".  Family Medical history relevant to AE (s): Cousin on paternal side, age 66 has/had lymph node enlargement after vaccine booster in Jan2022, size going down.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug hypersensitivity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-000002852. A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; macrogol 3350 (MIRALAX), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION COMPLETED, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG HYPERSENSITIVITY, outcome "unknown", described as "developed an allergy to Miralax after getting the third dose". The action taken for macrogol 3350 was unknown. Adverse event information: On 03Aug2022 it was reported that a patient started treatment on an unspecified date with Pfizer Bion-tech Covid-19 Vaccine - third dose. It was reported the patient developed an allergy to Miralax after getting the third dose. No further follow up is anticipated. Reporter type: Consumer. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown".  Clinical course: After the booster shot, patient got a reaction from the booster (myocarditis) , and ended up in (hospital name withheld) Patient do not have health insurance, so now the hospital is trying to charge 31k for 24hrs in the hospital. Patient wondered if you know anyway and can handle this situation, or help because 31k patient do not have.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4509360-00 (Agency).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 01Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Aug2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2022) Positive, notes: On 16Aug2022, the patient experienced COVID-19. The action taken for adalimumab was unknown. Clinical course: Solicited report from a consumer of a 58 year old male with an event of non-serious covid-19 with Humira (adalimumab). There was no reported medical history. It was unknown if patient was enrolled in a covid-19 vaccine trial. The event abate after stopping drug was NA. Concomitant drugs not reported. Other relevant history was Not reported.  Causality for Humira (adalimumab): The reporter causality for the event(s) of covid-19 with humira(adalimumab) was no reasonable possibility. Causality: Covid-19 (covid-19). Action(s) taken with drug: unknown. Causality as per reporter (drug/vaccine): not related. Dechallenge: N/A Causality: Covid-19 (covid-19). Action(s) taken with drug: unknown. Causality as per reporter (drug/vaccine): possible. Dechallenge: N/A.  The reporter considered covid-19 related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective and covid 19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction / throat was closing / rashes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002880 (Novavax).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylactic reaction / throat was closing / rashes".  Clinical course: On 04Aug2022, it was reported that a patient started treatment on an unspecified date with Pfizer Biontech Covid-19 Vaccine at 'shot 1' for an unspecified indication. It was reported the patient had an anaphylactic reaction, throat was closing, and rashes were coming out. No further follow-up is anticipated  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Cough, Drug hypersensitivity, Pain
Clinical narrative: allergies; on the floor in pain; bedridden; hard coughing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002855.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 11Jun2021 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies"; PAIN (non-serious), outcome "unknown", described as "on the floor in pain"; BEDRIDDEN (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown", described as "hard coughing".  Additional Information: On 03Aug2022, it was reported that a patient started treatment on 11Jun2021 with Pfizer dose 1 for COVID-19 immunization. It was reported the patient experienced: allergies, was bedridden, had hard coughing, and was on the floor in pain. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Kidney infection, Urinary tract infection
Clinical narrative: this is a solicited report received from contactable Consumer. The reporter is the patient. Other Case identifier(s): 22K-163-4504995-00. A 57-year-old female patient received BNT162b2 (BNT162B2), on 19May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), since 10Aug2022 (Batch/Lot number: unknown), subcutaneous for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , intramuscular), administration date: 11Apr2021, when the patient was 56-year-old, for Covid-19 immunization. Solicited report by a consumer of a 57-year-old female with events of non-serious kidney infection and urinary tract infection with Risankizumab. In Aug2022, the patient experienced kidney infection and urinary tract infection. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. On 10Aug2022, the patient had her first injection of Skyrizi. Since then her back was hurting for a few days but that stopped. On 14Aug2022, she had been urinating a lot like every 45 minutes. She went to emergency room two days after first injection for back pain. She was diagnosed and treated for urinary tract infection and kidney infection. It was unknown if patient was enrolled in a covid-19 vaccine trial. Primary reporter did not have the lot number information, because the information was not available in the patient's file. The action taken for risankizumab was unknown. Outcome of the events was recovering. The reporter's assessment of the causal relationship of "kidney infection" and "urinary tract infection" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's causality for suspect drug Risankizumab in response to the events of kidney infection and urinary tract infection was not provided. No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Kidney infection and Urinary tract infection and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "I got the booster shot in January ever since I got it I have a severe rash in different parts of my body". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient got the booster shot in January ever since patient got it, had a severe rash in different parts of patient's body was that normal and patient had done various test with Dr. still can't figure out what it could be. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Die". The patient date of death was unknown. Reported cause of death: "Die". It was not reported if an autopsy was performed. Clinical course: it was reported patient died in the first day of trials. One died instantly. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201082234 Same reporter, event, drug, different patient;US-PFIZER INC-202201082235 Same reporter, event, drug, different patient;US-PFIZER INC-202201082233 Same reporter, event, drug, different patient;US-PFIZER INC-202201082236 Same reporter, event, drug, different patient;; Reported Cause(s) of Death: Die
Sex: U
Vaccine: COVID19
Symptoms: Abnormal behaviour
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABNORMAL BEHAVIOUR (non-serious), outcome "unknown", described as "contracted trinities". Additional information: The patient reported contracted trinities after being vaccinated for Covid. It was problematic. Patient asked what help was available that subs for prednisone.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Cancer screening, Cardiac function test, Coagulation test, Deep vein thrombosis
Clinical narrative: This is a literature report for the following literature source(s): "Upper Extremity Deep Venous Thrombosis after BNT162B2 mRNA COVID-19 Vaccine", Journal of General Internal Medicine, 2022. A 60-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "nephrolithiasis" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: 4 months prior; "no tobacco use" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown), for COVID-19 immunisation. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), 6 days after the suspect product(s) administration, outcome "unknown", described as "Upper Extremity Deep Venous Thrombosis after BNT162B2 mRNA COVID-19 Vaccine". The event "upper extremity deep venous thrombosis after bnt162b2 mRNA covid-19 vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: Angiogram: was confirmatory; Cancer screening: unknown result; Cardiac function test: unremarkable; Coagulation test: Negative; Electrocardiogram: was notable for more pronounced t-wave inversions, notes: in III and aVF; Left bicep circumference: 31cm versus 28cm on the right; SARS-CoV-2 test: negative, notes: and denied shortness of breath, cough, fever, or dyspnea on exertion; Ultrasound scan: deep venous thrombosis (DVT), notes: deep venous thrombosis (DVT) left internal jugular, subclavian, axillary, and basilic veins; Venogram: showed persistent clot burden in the left, notes: axillary, mid-subclavian, and brachiocephalic veins. Eleven days later. Therapeutic measures were taken as a result of deep vein thrombosis. Sender's Comments: As there is limited information in the case provided, the causal association between the event deep vein thrombosis with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Investigation, SARS-CoV-2 test, Ultrasound scan, Venogram
Clinical narrative: This is a literature report for the following literature source(s): "Upper Extremity Deep Venous Thrombosis after BNT162B2 mRNA COVID-19 Vaccine", Journal of General Internal Medicine, 2022. A 60-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "nephrolithiasis" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: 4 months prior; "no tobacco use" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown), for COVID-19 immunisation. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), 6 days after the suspect product(s) administration, outcome "unknown", described as "Upper Extremity Deep Venous Thrombosis after BNT162B2 mRNA COVID-19 Vaccine". The event "upper extremity deep venous thrombosis after bnt162b2 mRNA covid-19 vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: Angiogram: was confirmatory; Cancer screening: unknown result; Cardiac function test: unremarkable; Coagulation test: Negative; Electrocardiogram: was notable for more pronounced t-wave inversions, notes: in III and aVF; Left bicep circumference: 31cm versus 28cm on the right; SARS-CoV-2 test: negative, notes: and denied shortness of breath, cough, fever, or dyspnea on exertion; Ultrasound scan: deep venous thrombosis (DVT), notes: deep venous thrombosis (DVT) left internal jugular, subclavian, axillary, and basilic veins; Venogram: showed persistent clot burden in the left, notes: axillary, mid-subclavian, and brachiocephalic veins. Eleven days later. Therapeutic measures were taken as a result of deep vein thrombosis. Sender's Comments: As there is limited information in the case provided, the causal association between the event deep vein thrombosis with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.