chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Dizziness, Fatigue, Magnetic resonance imaging, Nausea
Clinical narrative: 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; diagnosed Vestibular Neuritis; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; unable to work for more than a few minutes without nystagmus; extreme fatigue and continued vertigo; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration, administered in the arm right on 21Apr2021 at 10:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , sarcoidosis from an unknown date and unknown if ongoing , obesity from an unknown date and unknown if ongoing , seasonal allergy from an unknown date and unknown if ongoing , allergy to horse and cat dander from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 31Mar2021 at 10:45 (Lot Number: EW0150) via an unspecified route of administration in the right arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 23Apr2021 at 16:00, the patient experienced vestibular neuritis (medically significant), 23apr2021 at 4pm sudden onset severe dizziness, 4:15pm severe vertigo, nausea, vomiting until 7pm, unable to work for more than a few minutes without nystagmus, and extreme fatigue. Clinical course: on 23Apr2021 at 4pm sudden onset severe dizziness. At 4:15pm severe vertigo, nausea, vomiting until 7pm. At 7pm, wife took patient to ER and received a CT and MRI to rule out a blood clot. Vomiting has resolved with medication. On 26Apr2021, patient was diagnosed vestibular neuritis. Symptoms are slightly better but patient have been unable to drive, walk without increase in symptoms, unable to work for more than a few minutes without nystagmus, extreme fatigue and continued vertigo. Treatment received for the events included diphenhydramine (BENADRYL), droperidol,meclizine, and methylprednisone. The patient recovered from the event, vomiting. The patient had not recovered from the events, vestibular neuritis, 23apr2021 at 4pm sudden onset severe dizziness, 4:15pm severe vertigo, nausea until 7pm, unable to work for more than a few minutes without nystagmus, and extreme fatigue.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nystagmus, Vertigo, Vestibular neuronitis, Vomiting
Clinical narrative: 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; diagnosed Vestibular Neuritis; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; unable to work for more than a few minutes without nystagmus; extreme fatigue and continued vertigo; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration, administered in the arm right on 21Apr2021 at 10:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , sarcoidosis from an unknown date and unknown if ongoing , obesity from an unknown date and unknown if ongoing , seasonal allergy from an unknown date and unknown if ongoing , allergy to horse and cat dander from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 31Mar2021 at 10:45 (Lot Number: EW0150) via an unspecified route of administration in the right arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 23Apr2021 at 16:00, the patient experienced vestibular neuritis (medically significant), 23apr2021 at 4pm sudden onset severe dizziness, 4:15pm severe vertigo, nausea, vomiting until 7pm, unable to work for more than a few minutes without nystagmus, and extreme fatigue. Clinical course: on 23Apr2021 at 4pm sudden onset severe dizziness. At 4:15pm severe vertigo, nausea, vomiting until 7pm. At 7pm, wife took patient to ER and received a CT and MRI to rule out a blood clot. Vomiting has resolved with medication. On 26Apr2021, patient was diagnosed vestibular neuritis. Symptoms are slightly better but patient have been unable to drive, walk without increase in symptoms, unable to work for more than a few minutes without nystagmus, extreme fatigue and continued vertigo. Treatment received for the events included diphenhydramine (BENADRYL), droperidol,meclizine, and methylprednisone. The patient recovered from the event, vomiting. The patient had not recovered from the events, vestibular neuritis, 23apr2021 at 4pm sudden onset severe dizziness, 4:15pm severe vertigo, nausea until 7pm, unable to work for more than a few minutes without nystagmus, and extreme fatigue.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Computerised tomogram head, Dizziness, Magnetic resonance imaging head, Nausea
Clinical narrative: 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; diagnosed Vestibular Neuritis; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; unable to work for more than a few minutes without nystagmus; extreme fatigue and continued vertigo; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration, administered in the arm right on 21Apr2021 at 10:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , sarcoidosis from an unknown date and unknown if ongoing , obesity from an unknown date and unknown if ongoing , seasonal allergy from an unknown date and unknown if ongoing , allergy to horse and cat dander from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 31Mar2021 at 10:45 (Lot Number: EW0150) via an unspecified route of administration in the right arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 23Apr2021 at 16:00, the patient experienced vestibular neuritis (medically significant), 23apr2021 at 4pm sudden onset severe dizziness, 4:15pm severe vertigo, nausea, vomiting until 7pm, unable to work for more than a few minutes without nystagmus, and extreme fatigue. Clinical course: on 23Apr2021 at 4pm sudden onset severe dizziness. At 4:15pm severe vertigo, nausea, vomiting until 7pm. At 7pm, wife took patient to ER and received a CT and MRI to rule out a blood clot. Vomiting has resolved with medication. On 26Apr2021, patient was diagnosed vestibular neuritis. Symptoms are slightly better but patient have been unable to drive, walk without increase in symptoms, unable to work for more than a few minutes without nystagmus, extreme fatigue and continued vertigo. Treatment received for the events included diphenhydramine (BENADRYL), droperidol,meclizine, and methylprednisone. The patient recovered from the event, vomiting. The patient had not recovered from the events, vestibular neuritis, 23apr2021 at 4pm sudden onset severe dizziness, 4:15pm severe vertigo, nausea until 7pm, unable to work for more than a few minutes without nystagmus, and extreme fatigue.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nystagmus, Vision blurred, Vomiting
Clinical narrative: 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; diagnosed Vestibular Neuritis; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; unable to work for more than a few minutes without nystagmus; extreme fatigue and continued vertigo; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration, administered in the arm right on 21Apr2021 at 10:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , sarcoidosis from an unknown date and unknown if ongoing , obesity from an unknown date and unknown if ongoing , seasonal allergy from an unknown date and unknown if ongoing , allergy to horse and cat dander from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 31Mar2021 at 10:45 (Lot Number: EW0150) via an unspecified route of administration in the right arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 23Apr2021 at 16:00, the patient experienced vestibular neuritis (medically significant), 23apr2021 at 4pm sudden onset severe dizziness, 4:15pm severe vertigo, nausea, vomiting until 7pm, unable to work for more than a few minutes without nystagmus, and extreme fatigue. Clinical course: on 23Apr2021 at 4pm sudden onset severe dizziness. At 4:15pm severe vertigo, nausea, vomiting until 7pm. At 7pm, wife took patient to ER and received a CT and MRI to rule out a blood clot. Vomiting has resolved with medication. On 26Apr2021, patient was diagnosed vestibular neuritis. Symptoms are slightly better but patient have been unable to drive, walk without increase in symptoms, unable to work for more than a few minutes without nystagmus, extreme fatigue and continued vertigo. Treatment received for the events included diphenhydramine (BENADRYL), droperidol,meclizine, and methylprednisone. The patient recovered from the event, vomiting. The patient had not recovered from the events, vestibular neuritis, 23apr2021 at 4pm sudden onset severe dizziness, 4:15pm severe vertigo, nausea until 7pm, unable to work for more than a few minutes without nystagmus, and extreme fatigue.   No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Concussion, Dizziness, Loss of consciousness, Pain, Thirst
Clinical narrative: passed out/Loss of consciousness resulted in concussion; concussion; became dizzy; Was experiencing body aches; increased thirst following vaccination; This is a spontaneous report from a contactable physician for a patient.    A 20-year-old female patient received second dose bnt162b2 (PFIZER COVID-19 VACCINE), intramuscular, administered in Arm Right on 28Apr2021 08:30 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation.  The patient previously received first dose bnt162b2 (PFIZER COVID-19 VACCINE), on an unknown date (Batch/Lot number was not reported) for COVID-19 immunization.  The patient medical history was not reported. The patient was not pregnant at time of vaccination. Concomitant medications (received within 2 weeks of vaccination) included celecoxib (CELEXA), trazodone, oral contraceptive nos (reported as oral birth control) taken for an unspecified indication, start and stop date were not reported. The patient got up at 2am 29Apr2021 to use restroom, became dizzy and passed out. She was experiencing body aches and increased thirst following vaccination. Loss of consciousness resulted in concussion. The adverse events result in: Doctor or other healthcare professional office/clinic visit. The events did not result in death, cause/prolonged hospitalization, was not life threatening, disabling/incapacitating, congenital anomaly/birth defect. The patient was not diagnosed COVID-19 prior to vaccination. Since the vaccination, the patient had not the patient been tested for COVID-19. The patient did not receive treatment for the events. The outcome of the event was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, the event Loss of consciousness is considered most likely associated with intercurrent or underlying medical conditions, appears unrelated to the suspect drug.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure increased, Blood test abnormal, Cardiomegaly, Cold sweat
Clinical narrative: This is a spontaneous report from a contactable consumer. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), dose 2 via an unspecified route of administration, administered in right arm on 22Feb2021 14:15 as 2nd dose, single for covid-19 immunisation. Medical history included hyper/hypothyroid, cardiac arrhythmia. Concomitant medications included metoprolol; acetylsalicylic acid (ECOTRIN); atorvastatin (LIPITOR); levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ZYRTEC). The patient previously took codeine, compezine, sulfa medication, adhesives, all experienced allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) administered in right arm on 01Feb2021 14:15 for COVID-19 Immunization. On 31Mar2021 (20:00), the patient awakened by upper abdominal pain, rapid pulse, and sweating, experienced diarrhea. On 01Apr2021 the patient awakened with same symptoms, plus tachycardia, shortness of breath, clammy skin, lightheadedness, what felt like acid reflux/upper abdominal pain, and diarrhea. Upon walking, almost fainted. On 01Apr2021 17:00, the patient went to Urgent Care. She had abnormal bloodwork, rapid heart beat and shortness of breath/wheezing. EKG showed irregularities. Was told to proceed to the ER for more tests. On 01Apr2021 19:00, the patient went to Hospital. She completed ultrasound of abdomen, EKG, CT Scan, and other testing. Found evidence of cardiomegaly (1st time ever), elevated blood pressure, inflammation around the heart, liver, pancreas, and stomach. Also noted pulmonary edema. Told I could travel back to CA with compression socks and pain medication and Zofran. 05Apr2021, they ordered additional tests and referral to the Cardiologist. Still experiencing extreme fatigue. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment (pain medication, zofran, referral to GI and cardio) for adverse event. There is no covid prior vaccination. The patient received covid tested post vaccination with Nasal Swab on 01Apr2021, result was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not resolved.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Diarrhoea, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: This is a spontaneous report from a contactable consumer. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), dose 2 via an unspecified route of administration, administered in right arm on 22Feb2021 14:15 as 2nd dose, single for covid-19 immunisation. Medical history included hyper/hypothyroid, cardiac arrhythmia. Concomitant medications included metoprolol; acetylsalicylic acid (ECOTRIN); atorvastatin (LIPITOR); levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ZYRTEC). The patient previously took codeine, compezine, sulfa medication, adhesives, all experienced allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) administered in right arm on 01Feb2021 14:15 for COVID-19 Immunization. On 31Mar2021 (20:00), the patient awakened by upper abdominal pain, rapid pulse, and sweating, experienced diarrhea. On 01Apr2021 the patient awakened with same symptoms, plus tachycardia, shortness of breath, clammy skin, lightheadedness, what felt like acid reflux/upper abdominal pain, and diarrhea. Upon walking, almost fainted. On 01Apr2021 17:00, the patient went to Urgent Care. She had abnormal bloodwork, rapid heart beat and shortness of breath/wheezing. EKG showed irregularities. Was told to proceed to the ER for more tests. On 01Apr2021 19:00, the patient went to Hospital. She completed ultrasound of abdomen, EKG, CT Scan, and other testing. Found evidence of cardiomegaly (1st time ever), elevated blood pressure, inflammation around the heart, liver, pancreas, and stomach. Also noted pulmonary edema. Told I could travel back to CA with compression socks and pain medication and Zofran. 05Apr2021, they ordered additional tests and referral to the Cardiologist. Still experiencing extreme fatigue. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment (pain medication, zofran, referral to GI and cardio) for adverse event. There is no covid prior vaccination. The patient received covid tested post vaccination with Nasal Swab on 01Apr2021, result was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not resolved.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastrooesophageal reflux disease, Heart rate increased, Hyperhidrosis, Inflammation
Clinical narrative: This is a spontaneous report from a contactable consumer. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), dose 2 via an unspecified route of administration, administered in right arm on 22Feb2021 14:15 as 2nd dose, single for covid-19 immunisation. Medical history included hyper/hypothyroid, cardiac arrhythmia. Concomitant medications included metoprolol; acetylsalicylic acid (ECOTRIN); atorvastatin (LIPITOR); levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ZYRTEC). The patient previously took codeine, compezine, sulfa medication, adhesives, all experienced allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) administered in right arm on 01Feb2021 14:15 for COVID-19 Immunization. On 31Mar2021 (20:00), the patient awakened by upper abdominal pain, rapid pulse, and sweating, experienced diarrhea. On 01Apr2021 the patient awakened with same symptoms, plus tachycardia, shortness of breath, clammy skin, lightheadedness, what felt like acid reflux/upper abdominal pain, and diarrhea. Upon walking, almost fainted. On 01Apr2021 17:00, the patient went to Urgent Care. She had abnormal bloodwork, rapid heart beat and shortness of breath/wheezing. EKG showed irregularities. Was told to proceed to the ER for more tests. On 01Apr2021 19:00, the patient went to Hospital. She completed ultrasound of abdomen, EKG, CT Scan, and other testing. Found evidence of cardiomegaly (1st time ever), elevated blood pressure, inflammation around the heart, liver, pancreas, and stomach. Also noted pulmonary edema. Told I could travel back to CA with compression socks and pain medication and Zofran. 05Apr2021, they ordered additional tests and referral to the Cardiologist. Still experiencing extreme fatigue. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment (pain medication, zofran, referral to GI and cardio) for adverse event. There is no covid prior vaccination. The patient received covid tested post vaccination with Nasal Swab on 01Apr2021, result was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not resolved.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary oedema, SARS-CoV-2 test, Syncope, Tachycardia, Ultrasound abdomen
Clinical narrative: This is a spontaneous report from a contactable consumer. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), dose 2 via an unspecified route of administration, administered in right arm on 22Feb2021 14:15 as 2nd dose, single for covid-19 immunisation. Medical history included hyper/hypothyroid, cardiac arrhythmia. Concomitant medications included metoprolol; acetylsalicylic acid (ECOTRIN); atorvastatin (LIPITOR); levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ZYRTEC). The patient previously took codeine, compezine, sulfa medication, adhesives, all experienced allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) administered in right arm on 01Feb2021 14:15 for COVID-19 Immunization. On 31Mar2021 (20:00), the patient awakened by upper abdominal pain, rapid pulse, and sweating, experienced diarrhea. On 01Apr2021 the patient awakened with same symptoms, plus tachycardia, shortness of breath, clammy skin, lightheadedness, what felt like acid reflux/upper abdominal pain, and diarrhea. Upon walking, almost fainted. On 01Apr2021 17:00, the patient went to Urgent Care. She had abnormal bloodwork, rapid heart beat and shortness of breath/wheezing. EKG showed irregularities. Was told to proceed to the ER for more tests. On 01Apr2021 19:00, the patient went to Hospital. She completed ultrasound of abdomen, EKG, CT Scan, and other testing. Found evidence of cardiomegaly (1st time ever), elevated blood pressure, inflammation around the heart, liver, pancreas, and stomach. Also noted pulmonary edema. Told I could travel back to CA with compression socks and pain medication and Zofran. 05Apr2021, they ordered additional tests and referral to the Cardiologist. Still experiencing extreme fatigue. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment (pain medication, zofran, referral to GI and cardio) for adverse event. There is no covid prior vaccination. The patient received covid tested post vaccination with Nasal Swab on 01Apr2021, result was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Asthenia, Confusional state, Deafness, Decreased interest
Clinical narrative: he is in the hospital with Encephalitis due to the Pfizer vaccine; dementia like symptoms; sudden loss of hearing; Can't walk; losing his voice; urinary incontinence; trouble swallowing; loss of personality flat affect; shaking of hands/full body tremor; weakness; fatigue; loss of interest; kind of in a "stupor state",; can't stay warm; trouble responding in conversations; confusion; falling asleep constantly; This is a spontaneous report from a contactable consumer reported for her father. An 80-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient had received both doses of the Pfizer Covid 19 vaccine. He was in the hospital with Encephalitis due to the Pfizer vaccine per his doctors. His symptoms were as follows: Can't walk, losing his voice, dementia like symptoms, urinary incontinence, trouble swallowing, loss of personality flat affect, shaking of hands, full body tremor, weakness, fatigue, loss of interest, kind of in a "stupor state", sudden loss of hearing, can't stay warm, trouble responding in conversations, confusion, falling asleep constantly. He had tons and tons of new symptoms and he had never had any of these problems. It had been reported to the CDC by the doctors. The outcome of the events was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dementia, Dysphagia, Encephalitis, Fatigue, Flat affect
Clinical narrative: he is in the hospital with Encephalitis due to the Pfizer vaccine; dementia like symptoms; sudden loss of hearing; Can't walk; losing his voice; urinary incontinence; trouble swallowing; loss of personality flat affect; shaking of hands/full body tremor; weakness; fatigue; loss of interest; kind of in a "stupor state",; can't stay warm; trouble responding in conversations; confusion; falling asleep constantly; This is a spontaneous report from a contactable consumer reported for her father. An 80-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient had received both doses of the Pfizer Covid 19 vaccine. He was in the hospital with Encephalitis due to the Pfizer vaccine per his doctors. His symptoms were as follows: Can't walk, losing his voice, dementia like symptoms, urinary incontinence, trouble swallowing, loss of personality flat affect, shaking of hands, full body tremor, weakness, fatigue, loss of interest, kind of in a "stupor state", sudden loss of hearing, can't stay warm, trouble responding in conversations, confusion, falling asleep constantly. He had tons and tons of new symptoms and he had never had any of these problems. It had been reported to the CDC by the doctors. The outcome of the events was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Somnolence, Speech disorder, Stupor, Temperature regulation disorder
Clinical narrative: he is in the hospital with Encephalitis due to the Pfizer vaccine; dementia like symptoms; sudden loss of hearing; Can't walk; losing his voice; urinary incontinence; trouble swallowing; loss of personality flat affect; shaking of hands/full body tremor; weakness; fatigue; loss of interest; kind of in a "stupor state",; can't stay warm; trouble responding in conversations; confusion; falling asleep constantly; This is a spontaneous report from a contactable consumer reported for her father. An 80-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient had received both doses of the Pfizer Covid 19 vaccine. He was in the hospital with Encephalitis due to the Pfizer vaccine per his doctors. His symptoms were as follows: Can't walk, losing his voice, dementia like symptoms, urinary incontinence, trouble swallowing, loss of personality flat affect, shaking of hands, full body tremor, weakness, fatigue, loss of interest, kind of in a "stupor state", sudden loss of hearing, can't stay warm, trouble responding in conversations, confusion, falling asleep constantly. He had tons and tons of new symptoms and he had never had any of these problems. It had been reported to the CDC by the doctors. The outcome of the events was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Urinary incontinence
Clinical narrative: he is in the hospital with Encephalitis due to the Pfizer vaccine; dementia like symptoms; sudden loss of hearing; Can't walk; losing his voice; urinary incontinence; trouble swallowing; loss of personality flat affect; shaking of hands/full body tremor; weakness; fatigue; loss of interest; kind of in a "stupor state",; can't stay warm; trouble responding in conversations; confusion; falling asleep constantly; This is a spontaneous report from a contactable consumer reported for her father. An 80-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient had received both doses of the Pfizer Covid 19 vaccine. He was in the hospital with Encephalitis due to the Pfizer vaccine per his doctors. His symptoms were as follows: Can't walk, losing his voice, dementia like symptoms, urinary incontinence, trouble swallowing, loss of personality flat affect, shaking of hands, full body tremor, weakness, fatigue, loss of interest, kind of in a "stupor state", sudden loss of hearing, can't stay warm, trouble responding in conversations, confusion, falling asleep constantly. He had tons and tons of new symptoms and he had never had any of these problems. It had been reported to the CDC by the doctors. The outcome of the events was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hypoaesthesia, Myalgia
Clinical narrative: throat felt swollen ,and soar my lungs felt raw like when you have bad congestion; throat felt swollen; Arm swollen muscles very painful through neck into jaw down my left side into my leg ,down to ankle, jaw felt numb at times; Arm swollen muscles very painful through neck into jaw down my left side into my leg ,down to ankle; shoulder pain; nausea; chills; Jaw felt numb at times; extremely tired; This is a spontaneous report from a contactable consumer (patient).  A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 23Apr2021 10:45 AM at the age of 52-years-old (Batch/Lot Number: ER8735) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included cardiomyopathy from an unknown date. The patient did not have known allergies. Concomitant medications included metoprolol and lisinopril, taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021 02:00 PM, the patient experienced arm swollen, muscles very painful through neck into jaw down my left side into my leg ,down to ankle, jaw felt numb at times ,shoulder pain went on for 7 days ,nausea ,chills ,extremely tired ,her throat felt swollen ,and soar her lungs felt raw like when you have bad congestion ,hard to function tired all week. The patient did not want to take 2nd dose too many side effects. Therapeutic measures were taken included Tylenol, Asprin, loratadine famotidine tums. The outcome of the events was resolving.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Pharyngeal swelling, Pulmonary congestion
Clinical narrative: throat felt swollen ,and soar my lungs felt raw like when you have bad congestion; throat felt swollen; Arm swollen muscles very painful through neck into jaw down my left side into my leg ,down to ankle, jaw felt numb at times; Arm swollen muscles very painful through neck into jaw down my left side into my leg ,down to ankle; shoulder pain; nausea; chills; Jaw felt numb at times; extremely tired; This is a spontaneous report from a contactable consumer (patient).  A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 23Apr2021 10:45 AM at the age of 52-years-old (Batch/Lot Number: ER8735) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included cardiomyopathy from an unknown date. The patient did not have known allergies. Concomitant medications included metoprolol and lisinopril, taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021 02:00 PM, the patient experienced arm swollen, muscles very painful through neck into jaw down my left side into my leg ,down to ankle, jaw felt numb at times ,shoulder pain went on for 7 days ,nausea ,chills ,extremely tired ,her throat felt swollen ,and soar her lungs felt raw like when you have bad congestion ,hard to function tired all week. The patient did not want to take 2nd dose too many side effects. Therapeutic measures were taken included Tylenol, Asprin, loratadine famotidine tums. The outcome of the events was resolving.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. However, she tested positive for Covid; received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. However, she tested positive for Covid; This is a spontaneous report from Medical Information. A non-contactable pharmacist reported that a female patient of unspecified age received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  The medical history and concomitant medications were not reported. The patient who received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. However, she tested positive for Covid and now wants to know how long she had to wait before she can receive the 2nd dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Developed Deep Vein Thrombosis. Diagnosed 30Apr2021; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 14:30 (Batch/lot number: EN8207) as 2nd dose, single for COVID-19 immunisation. Medical history included Diabetes, High Blood Pressure and High Cholesterol, all from an unknown date. There no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Arm Left on 11Mar2021 11:45 AM (Batch/lot number: EP7533) at the age of 59-year-old for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient developed deep vein thrombosis since 07Apr2021, which was diagnosed on 30Apr2021. Therapeutic measures were taken as a result of deep vein thrombosis which included Prescribed Xarelto. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Rash, SARS-CoV-2 test, Swollen tongue
Clinical narrative: severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), dose 2 via an unspecified route of administration, administered in arm left on 22Apr2021 12:30 as 2nd dose, single for covid-19 immunisation. Medical history included fibromyalgia, ongoing diabetes type2, non-Alcoholic Cirrhosis, ongoing Chronic fatigue syndrome (CFS), spinal degeneration, hypo thyroid, gallbladder removal, hernia repair, hysterectomy, restless leg syndrome, sleep apnea, Known allergies with Wellbutrin, Naltrexone, tape. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198) administered in arm left on 23Mar2021 12:30 for COVID-19 Immunization. The patient reported to ER with severe swelling of lips and tongue, severe itching and rash on 30Apr2021 09:15. The adverse event result in emergency room/department or urgent care. The patient received treatment (IV of Solumedrol and Benedryl) for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test post vaccination with Nasal swab and result was negative. The outcome of the events was resolved with sequelae.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Diarrhoea, Dizziness, Head discomfort
Clinical narrative: passed out; Astronomical Headache; I got very dizzy and had dots; She got very dizzy and had dots; I just started spinning and broke out; Iave a bump on her head; scrape on her knee; chills; Nausea; Vomiting; Diarrhea; I was severely cold; I was very sluggish; My chest feels congested; her head feels like it weighs 30 lbs; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 reported PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as first dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that this past Wednesday (30Apr2021), she was getting severe chills, nausea, vomiting, and diarrhea. She took Dayquil because she still had the chills and she was severely cold. Yesterday (30Apr2021), she was very sluggish. She mentioned that her head feels like it weighs 30 lbs. on 30Apr2021. She added that her chest feels congested on 30Apr2021. This morning (01May2021), she was lightheaded and had an astronomical headache. She got very dizzy and had dots. She got up again to turn the tea kettle off and she just started spinning and broke out and went to the bathroom. When she went to the bathroom and went to squat on the toilet, she passed out. She doesn't know how long she was out. She has a bump on her head and a scrape on her knee. When she woke up, she was so cold, so she put on flannel pajamas. She also mentioned that she was scheduled for second one on next Tuesday (11May2021). She inquired if she can still get Covid after getting the vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Headache, Loss of consciousness, Nasopharyngitis, Nausea
Clinical narrative: passed out; Astronomical Headache; I got very dizzy and had dots; She got very dizzy and had dots; I just started spinning and broke out; Iave a bump on her head; scrape on her knee; chills; Nausea; Vomiting; Diarrhea; I was severely cold; I was very sluggish; My chest feels congested; her head feels like it weighs 30 lbs; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 reported PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as first dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that this past Wednesday (30Apr2021), she was getting severe chills, nausea, vomiting, and diarrhea. She took Dayquil because she still had the chills and she was severely cold. Yesterday (30Apr2021), she was very sluggish. She mentioned that her head feels like it weighs 30 lbs. on 30Apr2021. She added that her chest feels congested on 30Apr2021. This morning (01May2021), she was lightheaded and had an astronomical headache. She got very dizzy and had dots. She got up again to turn the tea kettle off and she just started spinning and broke out and went to the bathroom. When she went to the bathroom and went to squat on the toilet, she passed out. She doesn't know how long she was out. She has a bump on her head and a scrape on her knee. When she woke up, she was so cold, so she put on flannel pajamas. She also mentioned that she was scheduled for second one on next Tuesday (11May2021). She inquired if she can still get Covid after getting the vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Skin abrasion, Sluggishness, Vertigo, Visual impairment, Vomiting
Clinical narrative: passed out; Astronomical Headache; I got very dizzy and had dots; She got very dizzy and had dots; I just started spinning and broke out; Iave a bump on her head; scrape on her knee; chills; Nausea; Vomiting; Diarrhea; I was severely cold; I was very sluggish; My chest feels congested; her head feels like it weighs 30 lbs; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 reported PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as first dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that this past Wednesday (30Apr2021), she was getting severe chills, nausea, vomiting, and diarrhea. She took Dayquil because she still had the chills and she was severely cold. Yesterday (30Apr2021), she was very sluggish. She mentioned that her head feels like it weighs 30 lbs. on 30Apr2021. She added that her chest feels congested on 30Apr2021. This morning (01May2021), she was lightheaded and had an astronomical headache. She got very dizzy and had dots. She got up again to turn the tea kettle off and she just started spinning and broke out and went to the bathroom. When she went to the bathroom and went to squat on the toilet, she passed out. She doesn't know how long she was out. She has a bump on her head and a scrape on her knee. When she woke up, she was so cold, so she put on flannel pajamas. She also mentioned that she was scheduled for second one on next Tuesday (11May2021). She inquired if she can still get Covid after getting the vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Clostridium difficile infection, Investigation, Urinary tract infection
Clinical narrative: Stomach pains; She came down with a possible C.dif (Clostridium difficile) issue or possible UTI after her 1st dose; She came down with a possible C.dif (Clostridium difficile) issue or possible UTI after her 1st dose; This is a spontaneous report from a contactable consumer and from Pfizer sponsored program from a contactable consumer (patient's husband). A 90-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included neck pain from an unspecified date and clostridium difficile infection from 2020 (C-diff issue started a year ago in which it was the consequence of taking 5 different antibiotics). The patient's concomitant medications were not reported. The patient experienced she came down with a possible c.dif (clostridium difficile) issue or possible UTI after her 1st dose on Apr2021 and stomach pains on an unspecified date. Consumer was reporting for his 90 year old wife who received her 1st dose of the Pfizer COVID vaccine with him in the beginning of April. He mentioned that she came down with a possible C.dif (Clostridium difficile) issue or possible UTI after her 1st dose. She is supposed to get her 2nd dose tomorrow but was advised by her doctor not to get it yet in order for them to wait for the results of her urine sample. He is asking if there have been reports of these issues after getting vaccinated. He mentioned that the C-diff issue started a year ago in which it was the consequence of taking 5 different antibiotics due to a possible meningitis diagnosis because of very serious pains on her neck. The meningitis was later ruled out. He mentioned that she is taking vancomycin and ventil for her stomach pains. The patient underwent lab tests and procedures which included Urine sample: unknown results on an unspecified date. Therapeutic measures were taken as a result of stomach pains. Outcome of the events was unknown.   Information about batch/lot number has been requested.