chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Sensation of foreign body, Throat irritation
Clinical narrative: About 5-10 min later I started getting tingling sensation on my lips and tongue. After 15, my lips got numb, along with my jaw. The numbness was only on my left side and went from my jaw to my eye. I also had a headache as well. I also felt like something was stuck in my throat, but not like I couldn't get air. Those symptoms lasted about 2-3 hours. When I got home, about an hour after I got the vaccine, I ended up breaking out on torso. I took Benadryl and went to sleep. The next morning, I was itchy and breaking out in hives in torso area. I took Benadryl again and the numbness and itchiness improved, but I had a headache for like 8 days.  On the 6th day, I had really bad body aches and my headache was extreme. Per on call allergist, I wasn't allowed to get 2nd dose based on CDC guidelines.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia eye, Hypoaesthesia oral, Influenza virus test negative
Clinical narrative: About 5-10 min later I started getting tingling sensation on my lips and tongue. After 15, my lips got numb, along with my jaw. The numbness was only on my left side and went from my jaw to my eye. I also had a headache as well. I also felt like something was stuck in my throat, but not like I couldn't get air. Those symptoms lasted about 2-3 hours. When I got home, about an hour after I got the vaccine, I ended up breaking out on torso. I took Benadryl and went to sleep. The next morning, I was itchy and breaking out in hives in torso area. I took Benadryl again and the numbness and itchiness improved, but I had a headache for like 8 days.  On the 6th day, I had really bad body aches and my headache was extreme. Per on call allergist, I wasn't allowed to get 2nd dose based on CDC guidelines.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia oral, Pruritus, SARS-CoV-2 test negative, Sensation of foreign body
Clinical narrative: About 5-10 min later I started getting tingling sensation on my lips and tongue. After 15, my lips got numb, along with my jaw. The numbness was only on my left side and went from my jaw to my eye. I also had a headache as well. I also felt like something was stuck in my throat, but not like I couldn't get air. Those symptoms lasted about 2-3 hours. When I got home, about an hour after I got the vaccine, I ended up breaking out on torso. I took Benadryl and went to sleep. The next morning, I was itchy and breaking out in hives in torso area. I took Benadryl again and the numbness and itchiness improved, but I had a headache for like 8 days.  On the 6th day, I had really bad body aches and my headache was extreme. Per on call allergist, I wasn't allowed to get 2nd dose based on CDC guidelines.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: About 5-10 min later I started getting tingling sensation on my lips and tongue. After 15, my lips got numb, along with my jaw. The numbness was only on my left side and went from my jaw to my eye. I also had a headache as well. I also felt like something was stuck in my throat, but not like I couldn't get air. Those symptoms lasted about 2-3 hours. When I got home, about an hour after I got the vaccine, I ended up breaking out on torso. I took Benadryl and went to sleep. The next morning, I was itchy and breaking out in hives in torso area. I took Benadryl again and the numbness and itchiness improved, but I had a headache for like 8 days.  On the 6th day, I had really bad body aches and my headache was extreme. Per on call allergist, I wasn't allowed to get 2nd dose based on CDC guidelines.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Death
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Breath sounds abnormal, Dizziness, Dyspnoea, Headache
Clinical narrative: Patient developed facial, tongue, and throat swelling approximately an hour after vaccine.  Developed some mild itchiness shortly after vaccine, but worsened over the next hour.  Ultimately required epinephrine, diphenhydramine and steroids.  Was discharged without further complication.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain, Stridor
Clinical narrative: Patient developed facial, tongue, and throat swelling approximately an hour after vaccine.  Developed some mild itchiness shortly after vaccine, but worsened over the next hour.  Ultimately required epinephrine, diphenhydramine and steroids.  Was discharged without further complication.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Eye swelling, Headache, Lip swelling
Clinical narrative: Patient developed facial, tongue, and throat swelling approximately an hour after vaccine.  Developed some mild itchiness shortly after vaccine, but worsened over the next hour.  Ultimately required epinephrine, diphenhydramine and steroids.  Was discharged without further complication.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain, Paraesthesia, Pharyngeal swelling, Stridor, Swelling face
Clinical narrative: Patient developed facial, tongue, and throat swelling approximately an hour after vaccine.  Developed some mild itchiness shortly after vaccine, but worsened over the next hour.  Ultimately required epinephrine, diphenhydramine and steroids.  Was discharged without further complication.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Patient developed facial, tongue, and throat swelling approximately an hour after vaccine.  Developed some mild itchiness shortly after vaccine, but worsened over the next hour.  Ultimately required epinephrine, diphenhydramine and steroids.  Was discharged without further complication.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal swelling, Pruritus, Swelling face, Swollen tongue
Clinical narrative: Patient developed facial, tongue, and throat swelling approximately an hour after vaccine.  Developed some mild itchiness shortly after vaccine, but worsened over the next hour.  Ultimately required epinephrine, diphenhydramine and steroids.  Was discharged without further complication.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Nausea, Throat tightness
Clinical narrative: Tightening of throat as I was walking to waiting area, chest palpitations, dizziness, fainting, and vomiting.  They were not prepared for this to happen. All people that where were calling anyone to come and help me and finally and ICU doctor came and took over my care asking for benadryl from the pharmacy, a stretcher to take me to ER. Stretcher arrived was put on it and an IV was put in my right arm and the benadryl was administer in which I felt I was burning and turn real red. They then proceeded to take me to ER, where they administered more medicine through the IV.  I was there for about 4 1/2 hours. When i was released my throat was still very tight, felt very fatigue, muscle ached, shortness of breath and dizzy. I was sent home with an EPI PEN, Allegra, and pepcid. I also had a referral to see the allergist doctor who  could see me on Tuesday 1/19/2021 because Monday was a Holiday.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dizziness, Dyspnoea, Erythema, Fatigue
Clinical narrative: Tightening of throat as I was walking to waiting area, chest palpitations, dizziness, fainting, and vomiting.  They were not prepared for this to happen. All people that where were calling anyone to come and help me and finally and ICU doctor came and took over my care asking for benadryl from the pharmacy, a stretcher to take me to ER. Stretcher arrived was put on it and an IV was put in my right arm and the benadryl was administer in which I felt I was burning and turn real red. They then proceeded to take me to ER, where they administered more medicine through the IV.  I was there for about 4 1/2 hours. When i was released my throat was still very tight, felt very fatigue, muscle ached, shortness of breath and dizzy. I was sent home with an EPI PEN, Allegra, and pepcid. I also had a referral to see the allergist doctor who  could see me on Tuesday 1/19/2021 because Monday was a Holiday.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Palpitations, Syncope, Throat tightness, Vomiting
Clinical narrative: Tightening of throat as I was walking to waiting area, chest palpitations, dizziness, fainting, and vomiting.  They were not prepared for this to happen. All people that where were calling anyone to come and help me and finally and ICU doctor came and took over my care asking for benadryl from the pharmacy, a stretcher to take me to ER. Stretcher arrived was put on it and an IV was put in my right arm and the benadryl was administer in which I felt I was burning and turn real red. They then proceeded to take me to ER, where they administered more medicine through the IV.  I was there for about 4 1/2 hours. When i was released my throat was still very tight, felt very fatigue, muscle ached, shortness of breath and dizzy. I was sent home with an EPI PEN, Allegra, and pepcid. I also had a referral to see the allergist doctor who  could see me on Tuesday 1/19/2021 because Monday was a Holiday.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac telemetry abnormal, Chest discomfort, Dizziness, Dyspnoea, Echocardiogram
Clinical narrative: Premature ventricular contractions; Postural Orthostatic tachycardia syndrome; Dizziness; shortness of breath; chest pain; This is a spontaneous report from a contactable physician (patient). A 34-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EL0140, in Hospital, via an unspecified route of administration in left arm, on 22Dec2020 (at 34 years of age) at single dose for COVID-19 immunization. Medical history included prediabetes (glucose tolerance impaired) from an unknown date. The patient didn't have COVID-19 prior to vaccination. Concomitant medication included metformin and multivitamins. On 09Jan2021 the patient experienced premature ventricular contractions, postural orthostatic tachycardia syndrome, dizziness, shortness of breath and chest pain. The events resulted in Emergency room/department or urgent care access and hospitalization as life threatening events. The patient was treated with diltiazem, fludrocortisone, aspirin and atorvastatin. He remained in hospital 2 days and then he was discharged. The patient underwent COVID-19 test (nasal swab) on 12Jan2021 and 13Jan2021 and both gave negative results. The patient had not recovered yet from the reported events at the time of the report.; Sender's Comments: The causal relationship between BNT162B2 and the events ventricular extrasystoles, postural orthostatic tachycardia syndrome, dizziness, dyspnea and chest pain cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The patient is a young adult with known prediabetes, but no other comorbidities reported. Information on tests done during admission, clinical course and working diagnosis would be helpful in further assessment of this case. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Orthostatic hypotension, Palpitations, Scan myocardial perfusion normal, Ventricular extrasystoles
Clinical narrative: Premature ventricular contractions; Postural Orthostatic tachycardia syndrome; Dizziness; shortness of breath; chest pain; This is a spontaneous report from a contactable physician (patient). A 34-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EL0140, in Hospital, via an unspecified route of administration in left arm, on 22Dec2020 (at 34 years of age) at single dose for COVID-19 immunization. Medical history included prediabetes (glucose tolerance impaired) from an unknown date. The patient didn't have COVID-19 prior to vaccination. Concomitant medication included metformin and multivitamins. On 09Jan2021 the patient experienced premature ventricular contractions, postural orthostatic tachycardia syndrome, dizziness, shortness of breath and chest pain. The events resulted in Emergency room/department or urgent care access and hospitalization as life threatening events. The patient was treated with diltiazem, fludrocortisone, aspirin and atorvastatin. He remained in hospital 2 days and then he was discharged. The patient underwent COVID-19 test (nasal swab) on 12Jan2021 and 13Jan2021 and both gave negative results. The patient had not recovered yet from the reported events at the time of the report.; Sender's Comments: The causal relationship between BNT162B2 and the events ventricular extrasystoles, postural orthostatic tachycardia syndrome, dizziness, dyspnea and chest pain cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The patient is a young adult with known prediabetes, but no other comorbidities reported. Information on tests done during admission, clinical course and working diagnosis would be helpful in further assessment of this case. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Premature ventricular contractions; Postural Orthostatic tachycardia syndrome; Dizziness; shortness of breath; chest pain; This is a spontaneous report from a contactable physician (patient). A 34-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EL0140, in Hospital, via an unspecified route of administration in left arm, on 22Dec2020 (at 34 years of age) at single dose for COVID-19 immunization. Medical history included prediabetes (glucose tolerance impaired) from an unknown date. The patient didn't have COVID-19 prior to vaccination. Concomitant medication included metformin and multivitamins. On 09Jan2021 the patient experienced premature ventricular contractions, postural orthostatic tachycardia syndrome, dizziness, shortness of breath and chest pain. The events resulted in Emergency room/department or urgent care access and hospitalization as life threatening events. The patient was treated with diltiazem, fludrocortisone, aspirin and atorvastatin. He remained in hospital 2 days and then he was discharged. The patient underwent COVID-19 test (nasal swab) on 12Jan2021 and 13Jan2021 and both gave negative results. The patient had not recovered yet from the reported events at the time of the report.; Sender's Comments: The causal relationship between BNT162B2 and the events ventricular extrasystoles, postural orthostatic tachycardia syndrome, dizziness, dyspnea and chest pain cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The patient is a young adult with known prediabetes, but no other comorbidities reported. Information on tests done during admission, clinical course and working diagnosis would be helpful in further assessment of this case. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Postural orthostatic tachycardia syndrome, SARS-CoV-2 test
Clinical narrative: Premature ventricular contractions; Postural Orthostatic tachycardia syndrome; Dizziness; shortness of breath; chest pain; This is a spontaneous report from a contactable physician (patient). A 34-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EL0140, in Hospital, via an unspecified route of administration in left arm, on 22Dec2020 (at 34 years of age) at single dose for COVID-19 immunization. Medical history included prediabetes (glucose tolerance impaired) from an unknown date. The patient didn't have COVID-19 prior to vaccination. Concomitant medication included metformin and multivitamins. On 09Jan2021 the patient experienced premature ventricular contractions, postural orthostatic tachycardia syndrome, dizziness, shortness of breath and chest pain. The events resulted in Emergency room/department or urgent care access and hospitalization as life threatening events. The patient was treated with diltiazem, fludrocortisone, aspirin and atorvastatin. He remained in hospital 2 days and then he was discharged. The patient underwent COVID-19 test (nasal swab) on 12Jan2021 and 13Jan2021 and both gave negative results. The patient had not recovered yet from the reported events at the time of the report.; Sender's Comments: The causal relationship between BNT162B2 and the events ventricular extrasystoles, postural orthostatic tachycardia syndrome, dizziness, dyspnea and chest pain cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The patient is a young adult with known prediabetes, but no other comorbidities reported. Information on tests done during admission, clinical course and working diagnosis would be helpful in further assessment of this case. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Premature ventricular contractions; Postural Orthostatic tachycardia syndrome; Dizziness; shortness of breath; chest pain; This is a spontaneous report from a contactable physician (patient). A 34-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EL0140, in Hospital, via an unspecified route of administration in left arm, on 22Dec2020 (at 34 years of age) at single dose for COVID-19 immunization. Medical history included prediabetes (glucose tolerance impaired) from an unknown date. The patient didn't have COVID-19 prior to vaccination. Concomitant medication included metformin and multivitamins. On 09Jan2021 the patient experienced premature ventricular contractions, postural orthostatic tachycardia syndrome, dizziness, shortness of breath and chest pain. The events resulted in Emergency room/department or urgent care access and hospitalization as life threatening events. The patient was treated with diltiazem, fludrocortisone, aspirin and atorvastatin. He remained in hospital 2 days and then he was discharged. The patient underwent COVID-19 test (nasal swab) on 12Jan2021 and 13Jan2021 and both gave negative results. The patient had not recovered yet from the reported events at the time of the report.; Sender's Comments: The causal relationship between BNT162B2 and the events ventricular extrasystoles, postural orthostatic tachycardia syndrome, dizziness, dyspnea and chest pain cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The patient is a young adult with known prediabetes, but no other comorbidities reported. Information on tests done during admission, clinical course and working diagnosis would be helpful in further assessment of this case. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac stress test normal, Cardiac telemetry abnormal, Chest discomfort, Computerised tomogram thorax normal, Condition aggravated
Clinical narrative: Premature ventricular contractions; Postural Orthostatic tachycardia syndrome; Dizziness; shortness of breath; chest pain; This is a spontaneous report from a contactable physician (patient). A 34-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EL0140, in Hospital, via an unspecified route of administration in left arm, on 22Dec2020 (at 34 years of age) at single dose for COVID-19 immunization. Medical history included prediabetes (glucose tolerance impaired) from an unknown date. The patient didn't have COVID-19 prior to vaccination. Concomitant medication included metformin and multivitamins. On 09Jan2021 the patient experienced premature ventricular contractions, postural orthostatic tachycardia syndrome, dizziness, shortness of breath and chest pain. The events resulted in Emergency room/department or urgent care access and hospitalization as life threatening events. The patient was treated with diltiazem, fludrocortisone, aspirin and atorvastatin. He remained in hospital 2 days and then he was discharged. The patient underwent COVID-19 test (nasal swab) on 12Jan2021 and 13Jan2021 and both gave negative results. The patient had not recovered yet from the reported events at the time of the report.; Sender's Comments: The causal relationship between BNT162B2 and the events ventricular extrasystoles, postural orthostatic tachycardia syndrome, dizziness, dyspnea and chest pain cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The patient is a young adult with known prediabetes, but no other comorbidities reported. Information on tests done during admission, clinical course and working diagnosis would be helpful in further assessment of this case. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram abnormal, Electrocardiogram ambulatory, Electrocardiogram ambulatory abnormal
Clinical narrative: Premature ventricular contractions; Postural Orthostatic tachycardia syndrome; Dizziness; shortness of breath; chest pain; This is a spontaneous report from a contactable physician (patient). A 34-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EL0140, in Hospital, via an unspecified route of administration in left arm, on 22Dec2020 (at 34 years of age) at single dose for COVID-19 immunization. Medical history included prediabetes (glucose tolerance impaired) from an unknown date. The patient didn't have COVID-19 prior to vaccination. Concomitant medication included metformin and multivitamins. On 09Jan2021 the patient experienced premature ventricular contractions, postural orthostatic tachycardia syndrome, dizziness, shortness of breath and chest pain. The events resulted in Emergency room/department or urgent care access and hospitalization as life threatening events. The patient was treated with diltiazem, fludrocortisone, aspirin and atorvastatin. He remained in hospital 2 days and then he was discharged. The patient underwent COVID-19 test (nasal swab) on 12Jan2021 and 13Jan2021 and both gave negative results. The patient had not recovered yet from the reported events at the time of the report.; Sender's Comments: The causal relationship between BNT162B2 and the events ventricular extrasystoles, postural orthostatic tachycardia syndrome, dizziness, dyspnea and chest pain cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The patient is a young adult with known prediabetes, but no other comorbidities reported. Information on tests done during admission, clinical course and working diagnosis would be helpful in further assessment of this case. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Palpitations, Postural orthostatic tachycardia syndrome, SARS-CoV-2 test negative, Ventricular extrasystoles
Clinical narrative: Premature ventricular contractions; Postural Orthostatic tachycardia syndrome; Dizziness; shortness of breath; chest pain; This is a spontaneous report from a contactable physician (patient). A 34-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EL0140, in Hospital, via an unspecified route of administration in left arm, on 22Dec2020 (at 34 years of age) at single dose for COVID-19 immunization. Medical history included prediabetes (glucose tolerance impaired) from an unknown date. The patient didn't have COVID-19 prior to vaccination. Concomitant medication included metformin and multivitamins. On 09Jan2021 the patient experienced premature ventricular contractions, postural orthostatic tachycardia syndrome, dizziness, shortness of breath and chest pain. The events resulted in Emergency room/department or urgent care access and hospitalization as life threatening events. The patient was treated with diltiazem, fludrocortisone, aspirin and atorvastatin. He remained in hospital 2 days and then he was discharged. The patient underwent COVID-19 test (nasal swab) on 12Jan2021 and 13Jan2021 and both gave negative results. The patient had not recovered yet from the reported events at the time of the report.; Sender's Comments: The causal relationship between BNT162B2 and the events ventricular extrasystoles, postural orthostatic tachycardia syndrome, dizziness, dyspnea and chest pain cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The patient is a young adult with known prediabetes, but no other comorbidities reported. Information on tests done during admission, clinical course and working diagnosis would be helpful in further assessment of this case. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Heart rate increased, Laboratory test abnormal, Pruritus
Clinical narrative: After my first dose of Pfizer injection, my heart raced. I placed a vital sign machine on my finger to get a reading of my heart rate and it was 120/126.  I had two irregular heart beats twice since the first dose injection.  I also experienced itchiness to my body, skin and hair.   I went to the ER where they did an EKG and I also got fluids. I was also given Benadryl IV for itchiness and and anti-histamine.  I went to see my doctor the following day and was placed on Metoprolol and Benicar medication. I was told to see a cardiologist for my irregular heart beat. I was given Prednisone by my doctor to take for two days.  I also filed a report through my employee health of my symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Fluid replacement, Heart rate abnormal, Heart rate irregular, Palpitations
Clinical narrative: After my first dose of Pfizer injection, my heart raced. I placed a vital sign machine on my finger to get a reading of my heart rate and it was 120/126.  I had two irregular heart beats twice since the first dose injection.  I also experienced itchiness to my body, skin and hair.   I went to the ER where they did an EKG and I also got fluids. I was also given Benadryl IV for itchiness and and anti-histamine.  I went to see my doctor the following day and was placed on Metoprolol and Benicar medication. I was told to see a cardiologist for my irregular heart beat. I was given Prednisone by my doctor to take for two days.  I also filed a report through my employee health of my symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: After my first dose of Pfizer injection, my heart raced. I placed a vital sign machine on my finger to get a reading of my heart rate and it was 120/126.  I had two irregular heart beats twice since the first dose injection.  I also experienced itchiness to my body, skin and hair.   I went to the ER where they did an EKG and I also got fluids. I was also given Benadryl IV for itchiness and and anti-histamine.  I went to see my doctor the following day and was placed on Metoprolol and Benicar medication. I was told to see a cardiologist for my irregular heart beat. I was given Prednisone by my doctor to take for two days.  I also filed a report through my employee health of my symptoms.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Oral pruritus, Throat irritation
Clinical narrative: "Throat, pallet, and tongue itching; shortness of breath, and tachycardia"
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Oral pruritus, Tachycardia, Throat irritation, Tongue pruritus
Clinical narrative: "Throat, pallet, and tongue itching; shortness of breath, and tachycardia"
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 15:22 at single dose for COVID-19 immunization. Medical history included compromising health issues. The patient already had COVID in Jul2021 and hospitalized, had an autoimmune disorder, had connective tissue disease, had a gamma globulin anemia and I do infusions once a week with Hizentra, so subQ' (not clarified further). Concomitant medications were unknown. The patient took the first vaccine, and had a reaction. And Tuesday the patient had a 101 fever and body ache, terrible headache on 26Jan2021. The patient kept taking Tylenol and then slept it off and then the next day the patient woke up, the fever broke. The patient still had like a little bit of headache and a little bit of the body aches but then as the day went on it had. So, the patient's question was because most people were not getting reactions to the first dose. The patient just wanted to know if it's safe to take the second dose. Outcome of the events was unknown.   Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 15:22 at single dose for COVID-19 immunization. Medical history included compromising health issues. The patient already had COVID in Jul2021 and hospitalized, had an autoimmune disorder, had connective tissue disease, had a gamma globulin anemia and I do infusions once a week with Hizentra, so subQ' (not clarified further). Concomitant medications were unknown. The patient took the first vaccine, and had a reaction. And Tuesday the patient had a 101 fever and body ache, terrible headache on 26Jan2021. The patient kept taking Tylenol and then slept it off and then the next day the patient woke up, the fever broke. The patient still had like a little bit of headache and a little bit of the body aches but then as the day went on it had. So, the patient's question was because most people were not getting reactions to the first dose. The patient just wanted to know if it's safe to take the second dose. Outcome of the events was unknown.   Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Headache, Pain, Product use issue, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 15:22 at single dose for COVID-19 immunization. Medical history included compromising health issues. The patient already had COVID in Jul2021 and hospitalized, had an autoimmune disorder, had connective tissue disease, had a gamma globulin anemia and I do infusions once a week with Hizentra, so subQ' (not clarified further). Concomitant medications were unknown. The patient took the first vaccine, and had a reaction. And Tuesday the patient had a 101 fever and body ache, terrible headache on 26Jan2021. The patient kept taking Tylenol and then slept it off and then the next day the patient woke up, the fever broke. The patient still had like a little bit of headache and a little bit of the body aches but then as the day went on it had. So, the patient's question was because most people were not getting reactions to the first dose. The patient just wanted to know if it's safe to take the second dose. Outcome of the events was unknown.   Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, COVID-19, Headache, Musculoskeletal stiffness, Neck mass
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 15:22 at single dose for COVID-19 immunization. Medical history included compromising health issues. The patient already had COVID in Jul2021 and hospitalized, had an autoimmune disorder, had connective tissue disease, had a gamma globulin anemia and I do infusions once a week with Hizentra, so subQ' (not clarified further). Concomitant medications were unknown. The patient took the first vaccine, and had a reaction. And Tuesday the patient had a 101 fever and body ache, terrible headache on 26Jan2021. The patient kept taking Tylenol and then slept it off and then the next day the patient woke up, the fever broke. The patient still had like a little bit of headache and a little bit of the body aches but then as the day went on it had. So, the patient's question was because most people were not getting reactions to the first dose. The patient just wanted to know if it's safe to take the second dose. Outcome of the events was unknown.   Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia, Red blood cell abnormality
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 15:22 at single dose for COVID-19 immunization. Medical history included compromising health issues. The patient already had COVID in Jul2021 and hospitalized, had an autoimmune disorder, had connective tissue disease, had a gamma globulin anemia and I do infusions once a week with Hizentra, so subQ' (not clarified further). Concomitant medications were unknown. The patient took the first vaccine, and had a reaction. And Tuesday the patient had a 101 fever and body ache, terrible headache on 26Jan2021. The patient kept taking Tylenol and then slept it off and then the next day the patient woke up, the fever broke. The patient still had like a little bit of headache and a little bit of the body aches but then as the day went on it had. So, the patient's question was because most people were not getting reactions to the first dose. The patient just wanted to know if it's safe to take the second dose. Outcome of the events was unknown.   Information about batch/lot number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia oral, Tremor
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A non-pregnant (not pregnant at the time of vaccination) 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EN5318), intramuscular, first dose on 23Jan2021 09:45 at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seated in observation area for a 30 minute observation after injection of COVID-19 vaccine on 23Jan2021 09:45.  At 10:00, after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed.  Patient transported to first aid room for further assessment and observation. Patient was alert and oriented (A&O) x4, lungs clear to auscultation. Patient also stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on room air (RA) and blood pressure (B/p) of 130/80.  At 10:16, physician ordered to give patient 12.5mg of diphenhydramine (BENADRYL) liquid oral 1 dose with 16oz of water intake during observation period. Patient was continuously monitored and noted that was able to ambulate at 10:25 to bathroom with assistance but still experiencing dizziness. Patient was monitored for a total of 45 minutes then discharged home. Facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 23Jan2021 10:30. Case was reported as non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Dizziness, Hyperventilation, Hypoaesthesia, Oxygen saturation
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A non-pregnant (not pregnant at the time of vaccination) 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EN5318), intramuscular, first dose on 23Jan2021 09:45 at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seated in observation area for a 30 minute observation after injection of COVID-19 vaccine on 23Jan2021 09:45.  At 10:00, after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed.  Patient transported to first aid room for further assessment and observation. Patient was alert and oriented (A&O) x4, lungs clear to auscultation. Patient also stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on room air (RA) and blood pressure (B/p) of 130/80.  At 10:16, physician ordered to give patient 12.5mg of diphenhydramine (BENADRYL) liquid oral 1 dose with 16oz of water intake during observation period. Patient was continuously monitored and noted that was able to ambulate at 10:25 to bathroom with assistance but still experiencing dizziness. Patient was monitored for a total of 45 minutes then discharged home. Facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 23Jan2021 10:30. Case was reported as non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Physical examination, Tremor
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A non-pregnant (not pregnant at the time of vaccination) 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EN5318), intramuscular, first dose on 23Jan2021 09:45 at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seated in observation area for a 30 minute observation after injection of COVID-19 vaccine on 23Jan2021 09:45.  At 10:00, after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed.  Patient transported to first aid room for further assessment and observation. Patient was alert and oriented (A&O) x4, lungs clear to auscultation. Patient also stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on room air (RA) and blood pressure (B/p) of 130/80.  At 10:16, physician ordered to give patient 12.5mg of diphenhydramine (BENADRYL) liquid oral 1 dose with 16oz of water intake during observation period. Patient was continuously monitored and noted that was able to ambulate at 10:25 to bathroom with assistance but still experiencing dizziness. Patient was monitored for a total of 45 minutes then discharged home. Facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 23Jan2021 10:30. Case was reported as non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Dizziness, Echocardiogram
Clinical narrative: Fainting like episodes; Blurred vision; Severe vertigo; Chest pain; Fatigue; This is a spontaneous report from a contactable other health professional reported for herself.    A 36-year-old female patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EL8982, via an unspecified route of administration in right arm on 15Jan2021 12:00 at single dose for covid-19 immunisation.  There were no relevant medical history or concomitant medications. The patient was not pregnant at the time of vaccination.The patient had no allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.On 21Jan2021, exactly "4 1/2 days" after vaccine the patient experienced fainting like episodes, blurred vision, severe vertigo, chest pain, fatigue. The patient has been out of work since the 20th and she still had blurred vision. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received. The patient was not recovered from the events. She has been to the ER, cardiologist for an echography, ultrasonography of thyroids, Magnetic resonance imaging (MRI) of her head, went to ENT dr and neurologist in 2021. All blood work in 2021 came back normal as well. The reporter considered the event as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. She had negative Nasal Swab Covid test post vaccination on 22Jan2021.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of fainting like episodes cannot be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.