chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: 04/14/2021: Patient currently being seen in ER for ? of reaction to Janssen COVID-19 vaccine.  She reports  SOB, dizziness, tachycardia that started the day before.  She is awaiting results of CT scan and blood work.  Will follow-up with her at a later time. 04/15/2021:  call made to Patient.  She is presently in the hospital, was admitted yesterday afternoon after work-up revealed pulmonary emboli.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hot flush, Myalgia, Peripheral swelling, Swelling face
Clinical narrative: 04/14/2021: Patient currently being seen in ER for ? of reaction to Janssen COVID-19 vaccine.  She reports  SOB, dizziness, tachycardia that started the day before.  She is awaiting results of CT scan and blood work.  Will follow-up with her at a later time. 04/15/2021:  call made to Patient.  She is presently in the hospital, was admitted yesterday afternoon after work-up revealed pulmonary emboli.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Dyspnoea, Headache, Peripheral swelling, Pulmonary embolism
Clinical narrative: 04/14/2021: Patient currently being seen in ER for ? of reaction to Janssen COVID-19 vaccine.  She reports  SOB, dizziness, tachycardia that started the day before.  She is awaiting results of CT scan and blood work.  Will follow-up with her at a later time. 04/15/2021:  call made to Patient.  She is presently in the hospital, was admitted yesterday afternoon after work-up revealed pulmonary emboli.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling face, Tachycardia
Clinical narrative: 04/14/2021: Patient currently being seen in ER for ? of reaction to Janssen COVID-19 vaccine.  She reports  SOB, dizziness, tachycardia that started the day before.  She is awaiting results of CT scan and blood work.  Will follow-up with her at a later time. 04/15/2021:  call made to Patient.  She is presently in the hospital, was admitted yesterday afternoon after work-up revealed pulmonary emboli.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test abnormal, Computerised tomogram, Dizziness, Dyspnoea, Pulmonary embolism
Clinical narrative: 04/14/2021: Patient currently being seen in ER for ? of reaction to Janssen COVID-19 vaccine.  She reports  SOB, dizziness, tachycardia that started the day before.  She is awaiting results of CT scan and blood work.  Will follow-up with her at a later time. 04/15/2021:  call made to Patient.  She is presently in the hospital, was admitted yesterday afternoon after work-up revealed pulmonary emboli.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: 04/14/2021: Patient currently being seen in ER for ? of reaction to Janssen COVID-19 vaccine.  She reports  SOB, dizziness, tachycardia that started the day before.  She is awaiting results of CT scan and blood work.  Will follow-up with her at a later time. 04/15/2021:  call made to Patient.  She is presently in the hospital, was admitted yesterday afternoon after work-up revealed pulmonary emboli.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Mechanical ventilation, SARS-CoV-2 test positive
Clinical narrative: Received 1st dose Pfizer 3/31/2021.  On 4/1, she developed progressive dyspnea, cough, weakness, fatigue, and anorexia.  She tested (+) for COVID-19 4/5 and started Decadron on 4/7.  She presented to ER 4/9 with hypoxemia (SaO2 in 80s) with a lactate of 4.1.    She was admitted and continued on Decadron.  She had progressive oxygen needs with increased inflammatory markers and was given Tocilizumab 4/10.   She required intubation 4/11 after failing BiPAP.  Her d-dimer went up to 5156 on 4/11.  She had persistent high oxygen demands - requiring 100% FiO2 and PEEP +20.  She also had multiple runs of nonsustained VT 4/11 that improved with some magnesium and cool left foot.  She was transferred to medical facility for ECMO eval and further care, en route required escalating doses of NE gtt.  On arrival she was requiring high-dose NE.  Bedside TTE was done and showed evidence of a large RV thrombus.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bilevel positive airway pressure, Blood lactic acid normal, COVID-19, Chest X-ray abnormal
Clinical narrative: Received 1st dose Pfizer 3/31/2021.  On 4/1, she developed progressive dyspnea, cough, weakness, fatigue, and anorexia.  She tested (+) for COVID-19 4/5 and started Decadron on 4/7.  She presented to ER 4/9 with hypoxemia (SaO2 in 80s) with a lactate of 4.1.    She was admitted and continued on Decadron.  She had progressive oxygen needs with increased inflammatory markers and was given Tocilizumab 4/10.   She required intubation 4/11 after failing BiPAP.  Her d-dimer went up to 5156 on 4/11.  She had persistent high oxygen demands - requiring 100% FiO2 and PEEP +20.  She also had multiple runs of nonsustained VT 4/11 that improved with some magnesium and cool left foot.  She was transferred to medical facility for ECMO eval and further care, en route required escalating doses of NE gtt.  On arrival she was requiring high-dose NE.  Bedside TTE was done and showed evidence of a large RV thrombus.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Cough, Decreased appetite, Dyspnoea, Endotracheal intubation
Clinical narrative: Received 1st dose Pfizer 3/31/2021.  On 4/1, she developed progressive dyspnea, cough, weakness, fatigue, and anorexia.  She tested (+) for COVID-19 4/5 and started Decadron on 4/7.  She presented to ER 4/9 with hypoxemia (SaO2 in 80s) with a lactate of 4.1.    She was admitted and continued on Decadron.  She had progressive oxygen needs with increased inflammatory markers and was given Tocilizumab 4/10.   She required intubation 4/11 after failing BiPAP.  Her d-dimer went up to 5156 on 4/11.  She had persistent high oxygen demands - requiring 100% FiO2 and PEEP +20.  She also had multiple runs of nonsustained VT 4/11 that improved with some magnesium and cool left foot.  She was transferred to medical facility for ECMO eval and further care, en route required escalating doses of NE gtt.  On arrival she was requiring high-dose NE.  Bedside TTE was done and showed evidence of a large RV thrombus.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Fibrin D dimer increased, Hypoxia, Lung opacity, Peripheral coldness
Clinical narrative: Received 1st dose Pfizer 3/31/2021.  On 4/1, she developed progressive dyspnea, cough, weakness, fatigue, and anorexia.  She tested (+) for COVID-19 4/5 and started Decadron on 4/7.  She presented to ER 4/9 with hypoxemia (SaO2 in 80s) with a lactate of 4.1.    She was admitted and continued on Decadron.  She had progressive oxygen needs with increased inflammatory markers and was given Tocilizumab 4/10.   She required intubation 4/11 after failing BiPAP.  Her d-dimer went up to 5156 on 4/11.  She had persistent high oxygen demands - requiring 100% FiO2 and PEEP +20.  She also had multiple runs of nonsustained VT 4/11 that improved with some magnesium and cool left foot.  She was transferred to medical facility for ECMO eval and further care, en route required escalating doses of NE gtt.  On arrival she was requiring high-dose NE.  Bedside TTE was done and showed evidence of a large RV thrombus.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Renal vein thrombosis, SARS-CoV-2 test positive, Ventricular tachycardia
Clinical narrative: Received 1st dose Pfizer 3/31/2021.  On 4/1, she developed progressive dyspnea, cough, weakness, fatigue, and anorexia.  She tested (+) for COVID-19 4/5 and started Decadron on 4/7.  She presented to ER 4/9 with hypoxemia (SaO2 in 80s) with a lactate of 4.1.    She was admitted and continued on Decadron.  She had progressive oxygen needs with increased inflammatory markers and was given Tocilizumab 4/10.   She required intubation 4/11 after failing BiPAP.  Her d-dimer went up to 5156 on 4/11.  She had persistent high oxygen demands - requiring 100% FiO2 and PEEP +20.  She also had multiple runs of nonsustained VT 4/11 that improved with some magnesium and cool left foot.  She was transferred to medical facility for ECMO eval and further care, en route required escalating doses of NE gtt.  On arrival she was requiring high-dose NE.  Bedside TTE was done and showed evidence of a large RV thrombus.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling front of arm, index finger and thumb Recommended to caller to contact PCP due to ongoing numbness/tingling L arm, index finger and thumb. Caller was not receptive of recommendations as he does not want to pay money for a visit if they can't do anything and possibly be sent to Ortho and pay more money. He doesn't feel he should be responsible for anything.  Recommend increase ROM to left arm and hand as frequently as possible.
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Dyspnoea, Pruritus, Throat tightness, Urticaria
Clinical narrative: HEART RATE INCREASED; THROAT TIGHTENING WITHIN 10 MINUTES; SEVERE ITCHING; BRUISING (VASCULAR); ALLERGIC REACTION; This spontaneous report received from a patient concerned a 62 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced heart rate increased. On 10-APR-2021, the subject experienced throat tightening within 10 minutes. On 10-APR-2021, the subject experienced severe itching. On 10-APR-2021, the subject experienced bruising (vascular). On 10-APR-2021, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate increased on APR-2021, and throat tightening within 10 minutes on 11-APR-2021, and had not recovered from severe itching, allergic reaction, and bruising (vascular). This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: HEART RATE INCREASED; THROAT TIGHTENING WITHIN 10 MINUTES; SEVERE ITCHING; BRUISING (VASCULAR); ALLERGIC REACTION; This spontaneous report received from a patient concerned a 62 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced heart rate increased. On 10-APR-2021, the subject experienced throat tightening within 10 minutes. On 10-APR-2021, the subject experienced severe itching. On 10-APR-2021, the subject experienced bruising (vascular). On 10-APR-2021, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate increased on APR-2021, and throat tightening within 10 minutes on 11-APR-2021, and had not recovered from severe itching, allergic reaction, and bruising (vascular). This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Hypersensitivity, Pruritus, Throat tightness, Vascular access site bruising
Clinical narrative: HEART RATE INCREASED; THROAT TIGHTENING WITHIN 10 MINUTES; SEVERE ITCHING; BRUISING (VASCULAR); ALLERGIC REACTION; This spontaneous report received from a patient concerned a 62 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced heart rate increased. On 10-APR-2021, the subject experienced throat tightening within 10 minutes. On 10-APR-2021, the subject experienced severe itching. On 10-APR-2021, the subject experienced bruising (vascular). On 10-APR-2021, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate increased on APR-2021, and throat tightening within 10 minutes on 11-APR-2021, and had not recovered from severe itching, allergic reaction, and bruising (vascular). This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: 49 yo female had 2nd dose of vaccine, about 1-2 days developed tinnitus which persisted and getting louder; also developed joint pains to elbow and fingers. I referred to get checked with PCP.  4/19-49 yo female had 2nd dose of vaccine, about 1-2 days developed tinnitus which persisted and getting louder; also developed joint pains to elbow and fingers. I referred to get checked with PCP.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Tinnitus
Clinical narrative: 49 yo female had 2nd dose of vaccine, about 1-2 days developed tinnitus which persisted and getting louder; also developed joint pains to elbow and fingers. I referred to get checked with PCP.  4/19-49 yo female had 2nd dose of vaccine, about 1-2 days developed tinnitus which persisted and getting louder; also developed joint pains to elbow and fingers. I referred to get checked with PCP.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity, SARS-CoV-2 test, Tinnitus
Clinical narrative: 49 yo female had 2nd dose of vaccine, about 1-2 days developed tinnitus which persisted and getting louder; also developed joint pains to elbow and fingers. I referred to get checked with PCP.  4/19-49 yo female had 2nd dose of vaccine, about 1-2 days developed tinnitus which persisted and getting louder; also developed joint pains to elbow and fingers. I referred to get checked with PCP.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: was pronounced dead; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 13:45 (Lot Number: EW0150) as SINGLE DOSE for covid-19 immunisation. Medical history included Diabetes, Schizophrenia and history of minor heart attack (2 years ago). No known allergies. Concomitant medication(s) included alogliptin; aspirin [acetylsalicylic acid]; atorvastatin; benztropine; carvedilol; fenofibrate; insulin lispro (HUMALOG); valbenazine tosilate (INGREZZA); irbesartan; insulin glargine (LANTUS); lurasidone hydrochloride (LATUDA); levothyroxine; metformin; propranolol; brexpiprazole (REXULTI); spironolactone; insulin glargine (TOUJEO MAX SOLOSTAR). The patient previously received first dose of BNT162B2 on 17Mar2021 13:45 (lot number: EP7534) in right arm at single dose for Covid-19 immunization. No other vaccine in four weeks. The patient was pronounced dead on 09Apr2021. Reported as: My brother  was pronounced dead on 09Apr2021, 36 hours post his 2nd dose of the Pfizer Covid-19 vaccine. Death cause was Unknown - suspicion vaccine contributed/caused his death. No treatment received. No covid prior vaccination, no covid tested post vaccination. The patient died on 09Apr2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: was pronounced dead
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pulmonary embolism
Clinical narrative: Bilateral Pulmonary Embolism; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EH9899), via an unspecified route of administration on 02Feb2021 (at 56-years-old) as single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EH9899), on 12Jan2021 (at 56-years-old) for COVID-19 immunization. The patient experienced Bilateral Pulmonary Embolism on 16Feb2021. Facility where the most recent COVID-19 vaccine was administered was at the Workplace clinic. The adverse event resulted Emergency room/department or urgent care. Treatment received for the adverse event was Xarelto 20 mg. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Bilateral Pulmonary Embolism; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EH9899), via an unspecified route of administration on 02Feb2021 (at 56-years-old) as single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EH9899), on 12Jan2021 (at 56-years-old) for COVID-19 immunization. The patient experienced Bilateral Pulmonary Embolism on 16Feb2021. Facility where the most recent COVID-19 vaccine was administered was at the Workplace clinic. The adverse event resulted Emergency room/department or urgent care. Treatment received for the adverse event was Xarelto 20 mg. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: 4/6 Vaccination  Later that afternoon, I experienced nausea, vomiting, feverish.  4/7 I woke up and my whole body felt sore, feverish. I slowly got better.  4/11 I woke up Sunday with leg pain; hurt to walk. L leg, L side. I have to take 1 stair at a time.  SOB 4/13 I went to the ER. News reports of the clotting issues.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray normal, Nausea, Pain, Pain in extremity
Clinical narrative: 4/6 Vaccination  Later that afternoon, I experienced nausea, vomiting, feverish.  4/7 I woke up and my whole body felt sore, feverish. I slowly got better.  4/11 I woke up Sunday with leg pain; hurt to walk. L leg, L side. I have to take 1 stair at a time.  SOB 4/13 I went to the ER. News reports of the clotting issues.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Ultrasound scan, Vomiting
Clinical narrative: 4/6 Vaccination  Later that afternoon, I experienced nausea, vomiting, feverish.  4/7 I woke up and my whole body felt sore, feverish. I slowly got better.  4/11 I woke up Sunday with leg pain; hurt to walk. L leg, L side. I have to take 1 stair at a time.  SOB 4/13 I went to the ER. News reports of the clotting issues.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose increased, Blood test normal, Genital paraesthesia, Headache, Hypoaesthesia
Clinical narrative: NUMBNESS IN GENITAL AREA; NUMBNESS DURING URINATION; NUMBNESS OF BILATERAL LOWER EXTREMITIES RADIATING TO BUTTOCKS AND INCREASINGLY WORSE OF  RIGHT LOWER EXTREMITY/NUMBNESS OF FEET BILATERALLY; FEELING OF BLADDER INFECTION; FEELING LOSS OF BLADDER CONTROL; VOMITING; LEGS KICKING; ARMS SWINGING; HEADACHES; NAUSEA; FEET FREEZING; PULLED MUSCLE FEELING; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 54.43 kilograms, and height was 66 centimeters. The patient's concurrent conditions included smoker, and other pre-existing medical conditions included the patient has history of no know pre-existing conditions or comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced feet freezing. On 20-MAR-2021, the subject experienced pulled muscle feeling. On 20-MAR-2021, the subject experienced vomiting. On 20-MAR-2021, the subject experienced legs kicking. On 20-MAR-2021, the subject experienced arms swinging. On 20-MAR-2021, the subject experienced headaches. On 20-MAR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced numbness of feet bilaterally. On 01-APR-2021, the subject experienced numbness in genital area. On 01-APR-2021, the subject experienced numbness during urination. On 01-APR-2021, the subject experienced numbness of bilateral lower extremities radiating to buttocks and increasingly worse of right lower extremity. On 01-APR-2021, the subject experienced feeling of bladder infection. On 01-APR-2021, the subject experienced feeling loss of bladder control.  On 07-APR-2021, Laboratory data included: CT scan (NR: not provided) Elevated glucose levels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, legs kicking, arms swinging, and nausea on 21-MAR-2021, and headaches on 22-MAR-2021, was recovering from feet freezing, and had not recovered from numbness of feet bilaterally, pulled muscle feeling, numbness in genital area, numbness during urination, numbness of bilateral lower extremities radiating to buttocks and increasingly worse of right lower extremity, feeling of bladder infection, and feeling loss of bladder control. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Nerve compression, Paraesthesia, Peripheral coldness, Restless arm syndrome
Clinical narrative: NUMBNESS IN GENITAL AREA; NUMBNESS DURING URINATION; NUMBNESS OF BILATERAL LOWER EXTREMITIES RADIATING TO BUTTOCKS AND INCREASINGLY WORSE OF  RIGHT LOWER EXTREMITY/NUMBNESS OF FEET BILATERALLY; FEELING OF BLADDER INFECTION; FEELING LOSS OF BLADDER CONTROL; VOMITING; LEGS KICKING; ARMS SWINGING; HEADACHES; NAUSEA; FEET FREEZING; PULLED MUSCLE FEELING; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 54.43 kilograms, and height was 66 centimeters. The patient's concurrent conditions included smoker, and other pre-existing medical conditions included the patient has history of no know pre-existing conditions or comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced feet freezing. On 20-MAR-2021, the subject experienced pulled muscle feeling. On 20-MAR-2021, the subject experienced vomiting. On 20-MAR-2021, the subject experienced legs kicking. On 20-MAR-2021, the subject experienced arms swinging. On 20-MAR-2021, the subject experienced headaches. On 20-MAR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced numbness of feet bilaterally. On 01-APR-2021, the subject experienced numbness in genital area. On 01-APR-2021, the subject experienced numbness during urination. On 01-APR-2021, the subject experienced numbness of bilateral lower extremities radiating to buttocks and increasingly worse of right lower extremity. On 01-APR-2021, the subject experienced feeling of bladder infection. On 01-APR-2021, the subject experienced feeling loss of bladder control.  On 07-APR-2021, Laboratory data included: CT scan (NR: not provided) Elevated glucose levels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, legs kicking, arms swinging, and nausea on 21-MAR-2021, and headaches on 22-MAR-2021, was recovering from feet freezing, and had not recovered from numbness of feet bilaterally, pulled muscle feeling, numbness in genital area, numbness during urination, numbness of bilateral lower extremities radiating to buttocks and increasingly worse of right lower extremity, feeling of bladder infection, and feeling loss of bladder control. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Restless legs syndrome, Vomiting
Clinical narrative: NUMBNESS IN GENITAL AREA; NUMBNESS DURING URINATION; NUMBNESS OF BILATERAL LOWER EXTREMITIES RADIATING TO BUTTOCKS AND INCREASINGLY WORSE OF  RIGHT LOWER EXTREMITY/NUMBNESS OF FEET BILATERALLY; FEELING OF BLADDER INFECTION; FEELING LOSS OF BLADDER CONTROL; VOMITING; LEGS KICKING; ARMS SWINGING; HEADACHES; NAUSEA; FEET FREEZING; PULLED MUSCLE FEELING; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 54.43 kilograms, and height was 66 centimeters. The patient's concurrent conditions included smoker, and other pre-existing medical conditions included the patient has history of no know pre-existing conditions or comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced feet freezing. On 20-MAR-2021, the subject experienced pulled muscle feeling. On 20-MAR-2021, the subject experienced vomiting. On 20-MAR-2021, the subject experienced legs kicking. On 20-MAR-2021, the subject experienced arms swinging. On 20-MAR-2021, the subject experienced headaches. On 20-MAR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced numbness of feet bilaterally. On 01-APR-2021, the subject experienced numbness in genital area. On 01-APR-2021, the subject experienced numbness during urination. On 01-APR-2021, the subject experienced numbness of bilateral lower extremities radiating to buttocks and increasingly worse of right lower extremity. On 01-APR-2021, the subject experienced feeling of bladder infection. On 01-APR-2021, the subject experienced feeling loss of bladder control.  On 07-APR-2021, Laboratory data included: CT scan (NR: not provided) Elevated glucose levels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, legs kicking, arms swinging, and nausea on 21-MAR-2021, and headaches on 22-MAR-2021, was recovering from feet freezing, and had not recovered from numbness of feet bilaterally, pulled muscle feeling, numbness in genital area, numbness during urination, numbness of bilateral lower extremities radiating to buttocks and increasingly worse of right lower extremity, feeling of bladder infection, and feeling loss of bladder control. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Cystitis, Dyskinesia, Dysuria, Genital lesion
Clinical narrative: NUMBNESS IN GENITAL AREA; NUMBNESS DURING URINATION; NUMBNESS OF BILATERAL LOWER EXTREMITIES RADIATING TO BUTTOCKS AND INCREASINGLY WORSE OF  RIGHT LOWER EXTREMITY/NUMBNESS OF FEET BILATERALLY; FEELING OF BLADDER INFECTION; FEELING LOSS OF BLADDER CONTROL; VOMITING; LEGS KICKING; ARMS SWINGING; HEADACHES; NAUSEA; FEET FREEZING; PULLED MUSCLE FEELING; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 54.43 kilograms, and height was 66 centimeters. The patient's concurrent conditions included smoker, and other pre-existing medical conditions included the patient has history of no know pre-existing conditions or comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced feet freezing. On 20-MAR-2021, the subject experienced pulled muscle feeling. On 20-MAR-2021, the subject experienced vomiting. On 20-MAR-2021, the subject experienced legs kicking. On 20-MAR-2021, the subject experienced arms swinging. On 20-MAR-2021, the subject experienced headaches. On 20-MAR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced numbness of feet bilaterally. On 01-APR-2021, the subject experienced numbness in genital area. On 01-APR-2021, the subject experienced numbness during urination. On 01-APR-2021, the subject experienced numbness of bilateral lower extremities radiating to buttocks and increasingly worse of right lower extremity. On 01-APR-2021, the subject experienced feeling of bladder infection. On 01-APR-2021, the subject experienced feeling loss of bladder control.  On 07-APR-2021, Laboratory data included: CT scan (NR: not provided) Elevated glucose levels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, legs kicking, arms swinging, and nausea on 21-MAR-2021, and headaches on 22-MAR-2021, was recovering from feet freezing, and had not recovered from numbness of feet bilaterally, pulled muscle feeling, numbness in genital area, numbness during urination, numbness of bilateral lower extremities radiating to buttocks and increasingly worse of right lower extremity, feeling of bladder infection, and feeling loss of bladder control. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Muscle strain, Nausea, Peripheral coldness
Clinical narrative: NUMBNESS IN GENITAL AREA; NUMBNESS DURING URINATION; NUMBNESS OF BILATERAL LOWER EXTREMITIES RADIATING TO BUTTOCKS AND INCREASINGLY WORSE OF  RIGHT LOWER EXTREMITY/NUMBNESS OF FEET BILATERALLY; FEELING OF BLADDER INFECTION; FEELING LOSS OF BLADDER CONTROL; VOMITING; LEGS KICKING; ARMS SWINGING; HEADACHES; NAUSEA; FEET FREEZING; PULLED MUSCLE FEELING; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 54.43 kilograms, and height was 66 centimeters. The patient's concurrent conditions included smoker, and other pre-existing medical conditions included the patient has history of no know pre-existing conditions or comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced feet freezing. On 20-MAR-2021, the subject experienced pulled muscle feeling. On 20-MAR-2021, the subject experienced vomiting. On 20-MAR-2021, the subject experienced legs kicking. On 20-MAR-2021, the subject experienced arms swinging. On 20-MAR-2021, the subject experienced headaches. On 20-MAR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced numbness of feet bilaterally. On 01-APR-2021, the subject experienced numbness in genital area. On 01-APR-2021, the subject experienced numbness during urination. On 01-APR-2021, the subject experienced numbness of bilateral lower extremities radiating to buttocks and increasingly worse of right lower extremity. On 01-APR-2021, the subject experienced feeling of bladder infection. On 01-APR-2021, the subject experienced feeling loss of bladder control.  On 07-APR-2021, Laboratory data included: CT scan (NR: not provided) Elevated glucose levels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, legs kicking, arms swinging, and nausea on 21-MAR-2021, and headaches on 22-MAR-2021, was recovering from feet freezing, and had not recovered from numbness of feet bilaterally, pulled muscle feeling, numbness in genital area, numbness during urination, numbness of bilateral lower extremities radiating to buttocks and increasingly worse of right lower extremity, feeling of bladder infection, and feeling loss of bladder control. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary incontinence, Vomiting
Clinical narrative: NUMBNESS IN GENITAL AREA; NUMBNESS DURING URINATION; NUMBNESS OF BILATERAL LOWER EXTREMITIES RADIATING TO BUTTOCKS AND INCREASINGLY WORSE OF  RIGHT LOWER EXTREMITY/NUMBNESS OF FEET BILATERALLY; FEELING OF BLADDER INFECTION; FEELING LOSS OF BLADDER CONTROL; VOMITING; LEGS KICKING; ARMS SWINGING; HEADACHES; NAUSEA; FEET FREEZING; PULLED MUSCLE FEELING; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 54.43 kilograms, and height was 66 centimeters. The patient's concurrent conditions included smoker, and other pre-existing medical conditions included the patient has history of no know pre-existing conditions or comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced feet freezing. On 20-MAR-2021, the subject experienced pulled muscle feeling. On 20-MAR-2021, the subject experienced vomiting. On 20-MAR-2021, the subject experienced legs kicking. On 20-MAR-2021, the subject experienced arms swinging. On 20-MAR-2021, the subject experienced headaches. On 20-MAR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced numbness of feet bilaterally. On 01-APR-2021, the subject experienced numbness in genital area. On 01-APR-2021, the subject experienced numbness during urination. On 01-APR-2021, the subject experienced numbness of bilateral lower extremities radiating to buttocks and increasingly worse of right lower extremity. On 01-APR-2021, the subject experienced feeling of bladder infection. On 01-APR-2021, the subject experienced feeling loss of bladder control.  On 07-APR-2021, Laboratory data included: CT scan (NR: not provided) Elevated glucose levels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, legs kicking, arms swinging, and nausea on 21-MAR-2021, and headaches on 22-MAR-2021, was recovering from feet freezing, and had not recovered from numbness of feet bilaterally, pulled muscle feeling, numbness in genital area, numbness during urination, numbness of bilateral lower extremities radiating to buttocks and increasingly worse of right lower extremity, feeling of bladder infection, and feeling loss of bladder control. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Nausea
Clinical narrative: dizzy, lightheaded, syncope, tightness in throat,  Patient treated with normal saline, ondansetron, diphenhydramine,
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Dizziness, Electrocardiogram normal, Syncope, Throat tightness
Clinical narrative: dizzy, lightheaded, syncope, tightness in throat,  Patient treated with normal saline, ondansetron, diphenhydramine,
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Cerebrovascular accident, Embolic stroke, Hemiparesis, Hypertensive crisis
Clinical narrative: Sudden onset aphasia, struggling to find words, with right arm "tingling sensation" and weakness. Confirmed through MRI testing to be "multiple subcentimeter acute ischemic infarcts" due to clot.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neurological symptom
Clinical narrative: Sudden onset aphasia, struggling to find words, with right arm "tingling sensation" and weakness. Confirmed through MRI testing to be "multiple subcentimeter acute ischemic infarcts" due to clot.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral normal, Angiogram normal, Aphasia, Blood test, Chest X-ray
Clinical narrative: Sudden onset aphasia, struggling to find words, with right arm "tingling sensation" and weakness. Confirmed through MRI testing to be "multiple subcentimeter acute ischemic infarcts" due to clot.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Computerised tomogram neck, Electrocardiogram abnormal, Ischaemic cerebral infarction, Magnetic resonance imaging head abnormal
Clinical narrative: Sudden onset aphasia, struggling to find words, with right arm "tingling sensation" and weakness. Confirmed through MRI testing to be "multiple subcentimeter acute ischemic infarcts" due to clot.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia, Scan with contrast normal, Sinus tachycardia, Thrombosis
Clinical narrative: Sudden onset aphasia, struggling to find words, with right arm "tingling sensation" and weakness. Confirmed through MRI testing to be "multiple subcentimeter acute ischemic infarcts" due to clot.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient hospitalized twice within 6 weeks of receiving COVID vaccination. First admission on 3/15/21, second admission on 3/31/21. Patient then died while hospitalized.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Back pain, Blood test, Chills, Computerised tomogram
Clinical narrative: Fever; chills; severe abdominal and back pain; severe abdominal and back pain; severe cramping; unremitting liquid diarrhea; infectious colitis; rash on leg; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 56-years-old via an unspecified route of administration, administered in Arm Left on 31Mar2021 08:45 AM (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included Coronary artery disease; Acid reflux; possibly Lyme disease (1-4 days prior to vaccine), known allergies was Paradoxical reaction to Benzodiazepines. Concomitant medications included clopidogrel; ezetimibe; evolocumab (REPATHA); rosuvastatin and Ome. No other vaccine in four weeks. The patient received first dose of BNT162b2, at the age of 56-years-old via an unspecified route of administration, administered in Right arm on 10Mar2021 12:00 PM (Lot Number: EN6207) as single dose for covid-19 immunisation. Patient experienced Fever, chills, severe abdominal and back pain, severe cramping and unremitting liquid diarrhea, infectious colitis, rash on leg all on 31Mar2021 with outcome as Recovering. The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment received was IV fluid, antibiotics. No covid-19 prior vaccination. Covid-19 test post vaccination was PCR, covid test type post vaccination was Nasal Swab on 04Apr2021, result was Negative.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dehydration, Diarrhoea, Large intestine infection, Pyrexia, Rash
Clinical narrative: Fever; chills; severe abdominal and back pain; severe abdominal and back pain; severe cramping; unremitting liquid diarrhea; infectious colitis; rash on leg; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 56-years-old via an unspecified route of administration, administered in Arm Left on 31Mar2021 08:45 AM (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included Coronary artery disease; Acid reflux; possibly Lyme disease (1-4 days prior to vaccine), known allergies was Paradoxical reaction to Benzodiazepines. Concomitant medications included clopidogrel; ezetimibe; evolocumab (REPATHA); rosuvastatin and Ome. No other vaccine in four weeks. The patient received first dose of BNT162b2, at the age of 56-years-old via an unspecified route of administration, administered in Right arm on 10Mar2021 12:00 PM (Lot Number: EN6207) as single dose for covid-19 immunisation. Patient experienced Fever, chills, severe abdominal and back pain, severe cramping and unremitting liquid diarrhea, infectious colitis, rash on leg all on 31Mar2021 with outcome as Recovering. The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment received was IV fluid, antibiotics. No covid-19 prior vaccination. Covid-19 test post vaccination was PCR, covid test type post vaccination was Nasal Swab on 04Apr2021, result was Negative.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Back pain, Chills, Diarrhoea, Large intestine infection
Clinical narrative: Fever; chills; severe abdominal and back pain; severe abdominal and back pain; severe cramping; unremitting liquid diarrhea; infectious colitis; rash on leg; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 56-years-old via an unspecified route of administration, administered in Arm Left on 31Mar2021 08:45 AM (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included Coronary artery disease; Acid reflux; possibly Lyme disease (1-4 days prior to vaccine), known allergies was Paradoxical reaction to Benzodiazepines. Concomitant medications included clopidogrel; ezetimibe; evolocumab (REPATHA); rosuvastatin and Ome. No other vaccine in four weeks. The patient received first dose of BNT162b2, at the age of 56-years-old via an unspecified route of administration, administered in Right arm on 10Mar2021 12:00 PM (Lot Number: EN6207) as single dose for covid-19 immunisation. Patient experienced Fever, chills, severe abdominal and back pain, severe cramping and unremitting liquid diarrhea, infectious colitis, rash on leg all on 31Mar2021 with outcome as Recovering. The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment received was IV fluid, antibiotics. No covid-19 prior vaccination. Covid-19 test post vaccination was PCR, covid test type post vaccination was Nasal Swab on 04Apr2021, result was Negative.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle spasms, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: Fever; chills; severe abdominal and back pain; severe abdominal and back pain; severe cramping; unremitting liquid diarrhea; infectious colitis; rash on leg; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 56-years-old via an unspecified route of administration, administered in Arm Left on 31Mar2021 08:45 AM (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included Coronary artery disease; Acid reflux; possibly Lyme disease (1-4 days prior to vaccine), known allergies was Paradoxical reaction to Benzodiazepines. Concomitant medications included clopidogrel; ezetimibe; evolocumab (REPATHA); rosuvastatin and Ome. No other vaccine in four weeks. The patient received first dose of BNT162b2, at the age of 56-years-old via an unspecified route of administration, administered in Right arm on 10Mar2021 12:00 PM (Lot Number: EN6207) as single dose for covid-19 immunisation. Patient experienced Fever, chills, severe abdominal and back pain, severe cramping and unremitting liquid diarrhea, infectious colitis, rash on leg all on 31Mar2021 with outcome as Recovering. The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment received was IV fluid, antibiotics. No covid-19 prior vaccination. Covid-19 test post vaccination was PCR, covid test type post vaccination was Nasal Swab on 04Apr2021, result was Negative.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Dyspnoea, Electrocardiogram, Pruritus, Swelling
Clinical narrative: We had an adverse reaction to a Moderna vaccine today. Someone was notified. The patient received her vaccine around 6:55 pm on Saturday 4.10.21. She had a history of allergies but no anaphylaxis, or even hives. I felt comfortable giving her the vaccine with her history.  Around 7 pm, her husband came to the counter and said she was itching a lot. I brought her to the immunization room and asked if she was interested in taking Benadryl. She was so I gave her two diphenhydramine tablets, 50 mg total. After 20 minutes, she started having hives and the husband requested we give her liquid Benadryl. I provided another 25 mg in liquid at 7:20 pm and 7:30 pm. At 7:30 I also provided her hydrocortisone 1% cream over the counter to help with the itching.  At 7:30 she requested to go home but I did not feel comfortable letting her go so I asked her to wait a little longer. I had her husband stay with her and at 7:55 pm I heard hoarseness in her voice. At that point I took out the epinephrine and she didn't want it, I said I had to give it to her on the account that she was getting worse and I would have to call EMS.  I administered one epinephrine pen and she instantaneously was able to breath again. EMS arrived within minutes and assessed the patient. EMS confirmed that she was doing well and the medications that were provided were appropriate and kept her symptoms at bay. EMS checked her BP, HR and did an EKG and it all checked out and patient was doing well. At no point did she lose consciousness.     She was asked if she wanted to go to the ER or return home and she was comfortable going home.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: We had an adverse reaction to a Moderna vaccine today. Someone was notified. The patient received her vaccine around 6:55 pm on Saturday 4.10.21. She had a history of allergies but no anaphylaxis, or even hives. I felt comfortable giving her the vaccine with her history.  Around 7 pm, her husband came to the counter and said she was itching a lot. I brought her to the immunization room and asked if she was interested in taking Benadryl. She was so I gave her two diphenhydramine tablets, 50 mg total. After 20 minutes, she started having hives and the husband requested we give her liquid Benadryl. I provided another 25 mg in liquid at 7:20 pm and 7:30 pm. At 7:30 I also provided her hydrocortisone 1% cream over the counter to help with the itching.  At 7:30 she requested to go home but I did not feel comfortable letting her go so I asked her to wait a little longer. I had her husband stay with her and at 7:55 pm I heard hoarseness in her voice. At that point I took out the epinephrine and she didn't want it, I said I had to give it to her on the account that she was getting worse and I would have to call EMS.  I administered one epinephrine pen and she instantaneously was able to breath again. EMS arrived within minutes and assessed the patient. EMS confirmed that she was doing well and the medications that were provided were appropriate and kept her symptoms at bay. EMS checked her BP, HR and did an EKG and it all checked out and patient was doing well. At no point did she lose consciousness.     She was asked if she wanted to go to the ER or return home and she was comfortable going home.