chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: First shot gave me the covid 19 experience covid 19 experience; covid 19 experience; This is a spontaneous report received from a contactable consumer (Patient). A 44-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 04May2021 13:30 (Batch/Lot Number: EW0169) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications.  he patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. On an unspecified date in May2021, first shot gave her the covid 19 experience and drug was ineffective. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, SARS-CoV-2 test
Clinical narrative: Diagnosed Pericarditis; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, at age of 55-year-old), via an unspecified route of administration, administered in right arm on 13Apr2021 at 13:15 as single dose for covid-19 immunization. Medical history was none. No known allergies. Concomitant medications included atorvastatin, carvedilol and telmisartan. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, at age of 55-year-old), via an unspecified route of administration, administered in left arm on 21Mar2021 at 13:15 as single dose for covid-19 immunization. The patient experienced diagnosed pericarditis on 05May2021 at 12:00 PM, resulted in emergency room/department or urgent care, and treatment included 800 mg Ibuprofen. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had covid test post vaccination on 09May2021 and type was nasal swab, result was negative. The outcome of the event was recovered with sequelae on an unspecified date in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine to the reported event pericarditis cannot be completely excluded based on temporal association and known drug safety profile.  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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Myocardial infarction, Myocarditis, Pain in extremity
Clinical narrative: have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; 36 hours of left chest pain radiates to left arm; have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; 36 hours of left chest pain radiates to left arm; This is a spontaneous report from a contactable Physician.   A 16-year-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in arm left on 12May2021 10:15 (Batch/Lot Number: EW0167) as single dose at the age of 16-year-old for COVID-19 immunisation, administered ad hospital.  Medical history included acne with no medications. The patient's concomitant medications were not reported.  patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in arm left on 21Apr202110:15 (Batch/Lot Number: ER8735) as single dose at the age of 16-year-old for COVID-19 immunisation. No past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient experienced ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis, 36 hours of left chest pain radiates to left arm on 13May2021.  The course of events was as follows: Previously healthy 16 year old male complaining of 36 hours of left chest pain radiates to left arm. Had Pfizer vaccine dose #2 about one day prior to chest pain onset. Found to have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis. Admitted to the Pediatric ICU for further management on 15May2021 7:00AM. The patient was hospitalized for the events, considered life threatening. Since the vaccination, the patient has been tested for COVID-19: Sars-cov-2 test: negative on 15May2021 Nasal Swab. Therapeutic measures were taken as a result of events, treatment in process. The outcome of events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if 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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Troponin, Troponin increased
Clinical narrative: have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; 36 hours of left chest pain radiates to left arm; have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; 36 hours of left chest pain radiates to left arm; This is a spontaneous report from a contactable Physician.   A 16-year-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in arm left on 12May2021 10:15 (Batch/Lot Number: EW0167) as single dose at the age of 16-year-old for COVID-19 immunisation, administered ad hospital.  Medical history included acne with no medications. The patient's concomitant medications were not reported.  patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in arm left on 21Apr202110:15 (Batch/Lot Number: ER8735) as single dose at the age of 16-year-old for COVID-19 immunisation. No past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient experienced ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis, 36 hours of left chest pain radiates to left arm on 13May2021.  The course of events was as follows: Previously healthy 16 year old male complaining of 36 hours of left chest pain radiates to left arm. Had Pfizer vaccine dose #2 about one day prior to chest pain onset. Found to have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis. Admitted to the Pediatric ICU for further management on 15May2021 7:00AM. The patient was hospitalized for the events, considered life threatening. Since the vaccination, the patient has been tested for COVID-19: Sars-cov-2 test: negative on 15May2021 Nasal Swab. Therapeutic measures were taken as a result of events, treatment in process. The outcome of events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Erythema, Headache
Clinical narrative: I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; Severe allergic reaction; I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; My body was red and I had blotches bumps all over me my back under my right breast; My body was red and I had blotches bumps all over me my back under my right breast; My entire body was inflamed; Started getting hives on my back, under my right breast, both arms and both legs and thighs and I started getting bump. I broke out in hives in sleep in middle of night; I woke up out of my sleep in the middle of the night like the wee hours of the morning itching; I had like difficulty breathing; I had severe headache and I had it like all week; severe headache; My pressure went up like 140 over 100; high blood pressure; This is spontaneous report from a contactable consumer (Patient herself). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0172), via an unknown route route on 04May2021, as a single dose, for COVID-19 immunization. Patient's medical history included seasonal allergy (using an inhaler), Asthma and Diabetes. The patient's concomitant medications included insulin. On the same day of vaccination on 04May2021, at the first hour, the patient had a severe allergic reaction. The patient also experienced severe headache and I had it like all week and her pressure went up like 140 over 100 and then like the next day you know I had like difficulty breathing. On the third day, The patient also had a severe allergic reaction. The patient stated that her entire body was inflamed and then she started getting hives on her back, under the right breast, both arms and both legs and thighs. The patient also experienced bumps. The patient further stated that she had dizziness and was going to pass out when she had to walk down the stairs. The patient also stated that she broke out in to hives in her sleep in the middle of the night. The patient had itching at the wee hours in the morning. The patient stated that she went and looked in the mirror and her body was red and I had blotches bumps all over her back under my right breast. The patient wanted to know whether she can take the second shot. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The patient did not had any physician visit for the events. The patient used Benadryl as treatment medication for the events. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The outcome of the events was unknown.  Information about batch/lot number was available. Further information was expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypertension, Inflammation, Loss of consciousness, Pruritus
Clinical narrative: I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; Severe allergic reaction; I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; My body was red and I had blotches bumps all over me my back under my right breast; My body was red and I had blotches bumps all over me my back under my right breast; My entire body was inflamed; Started getting hives on my back, under my right breast, both arms and both legs and thighs and I started getting bump. I broke out in hives in sleep in middle of night; I woke up out of my sleep in the middle of the night like the wee hours of the morning itching; I had like difficulty breathing; I had severe headache and I had it like all week; severe headache; My pressure went up like 140 over 100; high blood pressure; This is spontaneous report from a contactable consumer (Patient herself). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0172), via an unknown route route on 04May2021, as a single dose, for COVID-19 immunization. Patient's medical history included seasonal allergy (using an inhaler), Asthma and Diabetes. The patient's concomitant medications included insulin. On the same day of vaccination on 04May2021, at the first hour, the patient had a severe allergic reaction. The patient also experienced severe headache and I had it like all week and her pressure went up like 140 over 100 and then like the next day you know I had like difficulty breathing. On the third day, The patient also had a severe allergic reaction. The patient stated that her entire body was inflamed and then she started getting hives on her back, under the right breast, both arms and both legs and thighs. The patient also experienced bumps. The patient further stated that she had dizziness and was going to pass out when she had to walk down the stairs. The patient also stated that she broke out in to hives in her sleep in the middle of the night. The patient had itching at the wee hours in the morning. The patient stated that she went and looked in the mirror and her body was red and I had blotches bumps all over her back under my right breast. The patient wanted to know whether she can take the second shot. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The patient did not had any physician visit for the events. The patient used Benadryl as treatment medication for the events. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The outcome of the events was unknown.  Information about batch/lot number was available. Further information was expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urticaria
Clinical narrative: I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; Severe allergic reaction; I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; My body was red and I had blotches bumps all over me my back under my right breast; My body was red and I had blotches bumps all over me my back under my right breast; My entire body was inflamed; Started getting hives on my back, under my right breast, both arms and both legs and thighs and I started getting bump. I broke out in hives in sleep in middle of night; I woke up out of my sleep in the middle of the night like the wee hours of the morning itching; I had like difficulty breathing; I had severe headache and I had it like all week; severe headache; My pressure went up like 140 over 100; high blood pressure; This is spontaneous report from a contactable consumer (Patient herself). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0172), via an unknown route route on 04May2021, as a single dose, for COVID-19 immunization. Patient's medical history included seasonal allergy (using an inhaler), Asthma and Diabetes. The patient's concomitant medications included insulin. On the same day of vaccination on 04May2021, at the first hour, the patient had a severe allergic reaction. The patient also experienced severe headache and I had it like all week and her pressure went up like 140 over 100 and then like the next day you know I had like difficulty breathing. On the third day, The patient also had a severe allergic reaction. The patient stated that her entire body was inflamed and then she started getting hives on her back, under the right breast, both arms and both legs and thighs. The patient also experienced bumps. The patient further stated that she had dizziness and was going to pass out when she had to walk down the stairs. The patient also stated that she broke out in to hives in her sleep in the middle of the night. The patient had itching at the wee hours in the morning. The patient stated that she went and looked in the mirror and her body was red and I had blotches bumps all over her back under my right breast. The patient wanted to know whether she can take the second shot. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The patient did not had any physician visit for the events. The patient used Benadryl as treatment medication for the events. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The outcome of the events was unknown.  Information about batch/lot number was available. Further information was expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729) via an unspecified route of administration, in arm left, on 07Apr2021 09:30 AM (at the age of 31-year-old), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number: EP6955), in arm left, on 17Mar2021 09:30 AM (at the age of 31-year-old), at single dose, for COVID-19 immunization. The patient experienced bell's palsy on 12May2021 23:00. AE result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Patient received valacyclovir and prednisone as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient did not receive any other vaccines within 4 weeks. Since the vaccination, the patient hadn't been tested for COVID-19. Case was reported as non-serious by reporter. The outcome of the event was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Blood test, Chest pain, Dizziness
Clinical narrative: severe allergic reaction; difficulty breathing; swelling of face and throat; swelling of face and throat; fast heartbeat; a bad rash all over the body; dizziness; weakness; pain at injection site on left arm/left arm started hurting; tingling hot pins all over; tingling hot pins all over; nausea; swelling on opposite shoulder on the right; back pain; chest pain; a cold sore on her lip; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that side effects began on 27Feb2021. Side effects included tingling hot pins all over, nausea, pain at injection site on left arm/ left arm started hurting, swelling on opposite shoulder on the right, back pain, chest pain and a cold sore on her lip. She went to the doctor a couple times and reported to her doctor that all her symptoms stopped on 04May2021. She was scheduled to go back to the doctor on 14Jun2021 and they are going to test her for antibodies. She would like to know since her side effects lingered for so long, if she should receive the second dose? She wants to receive the vaccine and be fully vaccinated but she doesn't want to go through this all over again. Everyone in her family was vaccinated and they did not have any side effects. Her doctor didn't want to tell her yes or no if she should receive the second dose. After reading the severe allergic reaction side effects that include difficulty breathing, swelling of face and throat, a fast heartbeat, a bad rash all over the body, dizziness and weakness, the patient stated that she has all of those side effects in the middle of the night and worse. Her doctor told her that a lot of stuff happened to her and it lingered for so long in a person that doesn't usually have reactions so she should hold off and mask up and social distance and come back for her appointment in June where she will be tested for antibodies. Her doctor did blood work and took pictures and made a report and told her to call and make a report as well. Outcome of the events was recovered on 04May2021.  Follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling hot, Heart rate increased, Hypersensitivity, Joint swelling
Clinical narrative: severe allergic reaction; difficulty breathing; swelling of face and throat; swelling of face and throat; fast heartbeat; a bad rash all over the body; dizziness; weakness; pain at injection site on left arm/left arm started hurting; tingling hot pins all over; tingling hot pins all over; nausea; swelling on opposite shoulder on the right; back pain; chest pain; a cold sore on her lip; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that side effects began on 27Feb2021. Side effects included tingling hot pins all over, nausea, pain at injection site on left arm/ left arm started hurting, swelling on opposite shoulder on the right, back pain, chest pain and a cold sore on her lip. She went to the doctor a couple times and reported to her doctor that all her symptoms stopped on 04May2021. She was scheduled to go back to the doctor on 14Jun2021 and they are going to test her for antibodies. She would like to know since her side effects lingered for so long, if she should receive the second dose? She wants to receive the vaccine and be fully vaccinated but she doesn't want to go through this all over again. Everyone in her family was vaccinated and they did not have any side effects. Her doctor didn't want to tell her yes or no if she should receive the second dose. After reading the severe allergic reaction side effects that include difficulty breathing, swelling of face and throat, a fast heartbeat, a bad rash all over the body, dizziness and weakness, the patient stated that she has all of those side effects in the middle of the night and worse. Her doctor told her that a lot of stuff happened to her and it lingered for so long in a person that doesn't usually have reactions so she should hold off and mask up and social distance and come back for her appointment in June where she will be tested for antibodies. Her doctor did blood work and took pictures and made a report and told her to call and make a report as well. Outcome of the events was recovered on 04May2021.  Follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oral herpes, Paraesthesia, Pharyngeal swelling, Rash
Clinical narrative: severe allergic reaction; difficulty breathing; swelling of face and throat; swelling of face and throat; fast heartbeat; a bad rash all over the body; dizziness; weakness; pain at injection site on left arm/left arm started hurting; tingling hot pins all over; tingling hot pins all over; nausea; swelling on opposite shoulder on the right; back pain; chest pain; a cold sore on her lip; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that side effects began on 27Feb2021. Side effects included tingling hot pins all over, nausea, pain at injection site on left arm/ left arm started hurting, swelling on opposite shoulder on the right, back pain, chest pain and a cold sore on her lip. She went to the doctor a couple times and reported to her doctor that all her symptoms stopped on 04May2021. She was scheduled to go back to the doctor on 14Jun2021 and they are going to test her for antibodies. She would like to know since her side effects lingered for so long, if she should receive the second dose? She wants to receive the vaccine and be fully vaccinated but she doesn't want to go through this all over again. Everyone in her family was vaccinated and they did not have any side effects. Her doctor didn't want to tell her yes or no if she should receive the second dose. After reading the severe allergic reaction side effects that include difficulty breathing, swelling of face and throat, a fast heartbeat, a bad rash all over the body, dizziness and weakness, the patient stated that she has all of those side effects in the middle of the night and worse. Her doctor told her that a lot of stuff happened to her and it lingered for so long in a person that doesn't usually have reactions so she should hold off and mask up and social distance and come back for her appointment in June where she will be tested for antibodies. Her doctor did blood work and took pictures and made a report and told her to call and make a report as well. Outcome of the events was recovered on 04May2021.  Follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vaccination site pain
Clinical narrative: severe allergic reaction; difficulty breathing; swelling of face and throat; swelling of face and throat; fast heartbeat; a bad rash all over the body; dizziness; weakness; pain at injection site on left arm/left arm started hurting; tingling hot pins all over; tingling hot pins all over; nausea; swelling on opposite shoulder on the right; back pain; chest pain; a cold sore on her lip; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that side effects began on 27Feb2021. Side effects included tingling hot pins all over, nausea, pain at injection site on left arm/ left arm started hurting, swelling on opposite shoulder on the right, back pain, chest pain and a cold sore on her lip. She went to the doctor a couple times and reported to her doctor that all her symptoms stopped on 04May2021. She was scheduled to go back to the doctor on 14Jun2021 and they are going to test her for antibodies. She would like to know since her side effects lingered for so long, if she should receive the second dose? She wants to receive the vaccine and be fully vaccinated but she doesn't want to go through this all over again. Everyone in her family was vaccinated and they did not have any side effects. Her doctor didn't want to tell her yes or no if she should receive the second dose. After reading the severe allergic reaction side effects that include difficulty breathing, swelling of face and throat, a fast heartbeat, a bad rash all over the body, dizziness and weakness, the patient stated that she has all of those side effects in the middle of the night and worse. Her doctor told her that a lot of stuff happened to her and it lingered for so long in a person that doesn't usually have reactions so she should hold off and mask up and social distance and come back for her appointment in June where she will be tested for antibodies. Her doctor did blood work and took pictures and made a report and told her to call and make a report as well. Outcome of the events was recovered on 04May2021.  Follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hepatic enzyme increased, Liver function test, Platelet count, Platelet count decreased
Clinical narrative: Platelet decreased from 202,000 on 28Apr2021 to 30,000 on 13May2021.; Liver enzymes elevated to 100-150 on 13May2021 (normal on 28Apr2021).; Fever starting 08May???? 101-103 Fahrenheit(F). Hospitalized 13May2021 to 15May2021.; This is a spontaneous report from a contactable Health Care Professional (nurse, patient). A 69-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:15 (Lot Number: ER8731) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included Hypercholesterolemia and Osteoporosis. The patient received first dose of bnt162b2 (lot number ER8727) on19Mar2021 12:00 PM in left arm for covid-19 immunisation. 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. Concomitant medication(s) included alendronate sodium (ALENDRONATE); atorvastatin calcium (LIPITOR); calcium; vitamins nos (MVI); ascorbic acid, retinol, tocopherol (OCUVITE); ubidecarenone (COQ10).  The patient experienced Platelet decreased from 202,000 on 28Apr2021 to 30,000 on 13May2021. Liver enzymes elevated to 100-150 on 13May2021 (normal on 28Apr2021). Fever starting 08May2021 101-103 Fahrenheit(F). Hospitalized 13May2021 to 15May2021. The patient had SARS CoV-2 RNA Rapid NAA test (Nasal Swab) with negative result on 13May2021.  The adverse event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The outcome was recovering.; Sender's Comments: The reported events likely represents intercurrent medical conditions in this 69 year old female and unrelated to BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 RNA
Clinical narrative: Platelet decreased from 202,000 on 28Apr2021 to 30,000 on 13May2021.; Liver enzymes elevated to 100-150 on 13May2021 (normal on 28Apr2021).; Fever starting 08May???? 101-103 Fahrenheit(F). Hospitalized 13May2021 to 15May2021.; This is a spontaneous report from a contactable Health Care Professional (nurse, patient). A 69-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:15 (Lot Number: ER8731) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included Hypercholesterolemia and Osteoporosis. The patient received first dose of bnt162b2 (lot number ER8727) on19Mar2021 12:00 PM in left arm for covid-19 immunisation. 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. Concomitant medication(s) included alendronate sodium (ALENDRONATE); atorvastatin calcium (LIPITOR); calcium; vitamins nos (MVI); ascorbic acid, retinol, tocopherol (OCUVITE); ubidecarenone (COQ10).  The patient experienced Platelet decreased from 202,000 on 28Apr2021 to 30,000 on 13May2021. Liver enzymes elevated to 100-150 on 13May2021 (normal on 28Apr2021). Fever starting 08May2021 101-103 Fahrenheit(F). Hospitalized 13May2021 to 15May2021. The patient had SARS CoV-2 RNA Rapid NAA test (Nasal Swab) with negative result on 13May2021.  The adverse event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The outcome was recovering.; Sender's Comments: The reported events likely represents intercurrent medical conditions in this 69 year old female and unrelated to BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocardial infarction, Pericarditis, SARS-CoV-2 test
Clinical narrative: I have been discharged from the hospital with pericarditis; Went into walk in on 10May, and was rushed to ER due to heart issue. ER states I possibly had a heart attack; The Sunday following 2nd dose, woke up with severe chest pains; This is a spontaneous report from a contactable consumer (patient). A 24-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 06May2021 18:30 (Lot Number: ew0171) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history was none. The patient was healthy. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication(s) included ibuprofen. The patient took the first dose of bnt162b2 on 15Apr2021 07:00 PM (Lot number EW0153) in left arm for COVID-19 immunisation. On 09May2021 03:30 AM, the patient woke up with severe chest pains. Went into walk in on 10May, and was rushed to ER due to heart issue. ER stated he possibly had a heart attack, and now he had been discharged from the hospital with pericarditis. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient hospitalized for two days. Multiple treatments administered. The patient had covid test type post vaccination nasal swab on 10May2021 with negative result. The outcome was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with Covid-19; diagnosed with Covid-19; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 52-year-old female patient received first dose at age of 52 years old of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Covid-19 vaccine and she has been diagnosed with Covid-19. She would like to know how long should she wait to take her second dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Death
Clinical narrative: deceased alone at home; Constant Complains of severe chest pains after taking the first shot and she was found deceased alone at home clutching a hot water bottle to her chest; This is a spontaneous report from a contactable consumer. A 79-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on Feb2021 (Lot Number: EL8982) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was none. 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. The patient's concomitant medications were not reported. On Feb2021, the patient experienced constant complains of severe chest pains after taking the first shot and she was found deceased alone at home clutching a hot water bottle to her chest. Since the vaccination, the patient has not been tested for COVID-19. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The outcome of chest pain was not recovered.; Reported Cause(s) of Death: deceased alone at home
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Feeling abnormal, Loss of personal independence in daily activities, Memory impairment, Mental impairment
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. Follow-up (PRD: 18May2021) received from a contactable consumer or other non hcp was processed together with initial information. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history, concomitant medications were not reported. On an unspecified date, the patient reported that patient was having serious like mental problem, started having really bad forgetfulness and anxiety; that was just crippling anxiety and ridiculous forgetfulness, patient couldn't function properly, patient felt like it was dangerous, and patient can't even run business right now. The outcome of events was unknown. Patient reported that two other contractors that patient worked with electrician and tile guy both experiencing the same symptoms like the patient, they were frustrated because they were forgetting everything and they felt awkward around customers because the brain could function barely. Patient also reported that the cousin had the same reactions. Cousin had been a hairstylist for years and she messed the 3 hair colors that she had never done in most 20 years of coloring hair and she couldn't remember anything. She got crippling anxiety, she got her second shot and then on day 4 after her second shot all the symptoms gone away then she got better. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021559009 same drug/AE, different patient;US-PFIZER INC-2021558925 same drug/AE,different patient
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Death, Hypersensitivity, Loss of consciousness, Pain in extremity
Clinical narrative: lose his life after the vaccine; Passed out; swelling and pain in his side of his arm; swelling and pain in his side of his arm; asthma trigger; allergies; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history included bad allergies and has asthma. Concomitant medications were not reported. He lose his life after the vaccine in Apr2021. He took the vaccine in Apr2021. After 3 days he took the vaccine on Tuesday, then Friday he was gone, that first dose. That day he died, he had like the asthma trigger like 10 minute after then he passed out but Thursday he was saying that he had like swelling and pain in his side of his arm. He had night shift and then morning came, Friday came home and then he ate and then he slept and then he woke up at 10 am just to go to kitchen and thought he was saying like having had allergies and 10 minutes then he passed out and then that was it. The reporter was just wondering how come, he still passed. Seriousness for lose his life after the vaccine was reported as death. The outcome of event lose his life after the vaccine was fatal and other events was unknown. The patient died in Apr2021. The cause of death was unknown. It was unknown if an autopsy was performed.  Information on the Lot/Batch number has been requested.; Reported Cause(s) of Death: lose his life after the vaccine
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: lose his life after the vaccine; Passed out; swelling and pain in his side of his arm; swelling and pain in his side of his arm; asthma trigger; allergies; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history included bad allergies and has asthma. Concomitant medications were not reported. He lose his life after the vaccine in Apr2021. He took the vaccine in Apr2021. After 3 days he took the vaccine on Tuesday, then Friday he was gone, that first dose. That day he died, he had like the asthma trigger like 10 minute after then he passed out but Thursday he was saying that he had like swelling and pain in his side of his arm. He had night shift and then morning came, Friday came home and then he ate and then he slept and then he woke up at 10 am just to go to kitchen and thought he was saying like having had allergies and 10 minutes then he passed out and then that was it. The reporter was just wondering how come, he still passed. Seriousness for lose his life after the vaccine was reported as death. The outcome of event lose his life after the vaccine was fatal and other events was unknown. The patient died in Apr2021. The cause of death was unknown. It was unknown if an autopsy was performed.  Information on the Lot/Batch number has been requested.; Reported Cause(s) of Death: lose his life after the vaccine
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: suddenly passed out; This is a spontaneous report received from a contactable consumer reporting on behalf of the patient. A 30-year-old male (nephew) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter wanted to know if there were reports on patients passing out after not being able to eat after the first shot of the COVID-19 vaccine. The reporter's nephew suddenly passed out after the first shot and was rushed to the hospital on unspecified date. The reporter confirmed that the patient was healthy. The reporter wanted to find out if it is safe for the patient to receive the 2nd shot of the vaccine. Outcome of the event was unknown. The event was assessed as serious (hospitalization).   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Hypoaesthesia, Nervousness, Panic attack
Clinical narrative: feeling shaky; like numbness in the arm; low or high blood pressure; she was going to pass out like a panic attack; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date patient experienced feeling shaky, like numbness in the arm, low or high blood pressure and she felt like she was going to pass out like a panic attack she had been in and out of the emergency and hospital after receiving the first dose of the vaccine. It's been happening for a week. They advised that this was not a severe allergic reaction because it would not last this long. Read the entire list of the reported side effects associated with the vaccine. Caller mentioned her mother had reported none of these side effects. Informed caller they might not have the list of all the possible side effects associated with the vaccine. They could not say these symptoms have not been reported post vaccination, but this information will be sent for further escalation. For treatment recommendation please speak to HCP for more information. The side effects generally last 1-2 days. However, we have limited information regarding the duration of severe allergic reaction. The recovery period may vary from person to person. Outcome of the events was reported as unknown.  No follow-up attempts are possible. Information about batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombotic stroke, Weight, Weight decreased
Clinical narrative: Had a stroke from blood clot; she lost weight; This is a spontaneous report from a contactable consumer (mother) that: A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8272) via an unspecified route of administration on 31Mar2021, as a single for COVID-19 immunization. Previously patient received first dose of BNT162B2 (covid-19 vaccine, Batch/Lot Number: not clear) via an unspecified route of administration on 10Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated, "I don't know so I just was try to find out or who I report or ask about. I convinced my mother to get her Covid vaccine, so she got her second shot on 31Mar we got it together. Yesterday (17May2021 ) my mom had a stroke from blood clot, and I was just asking myself if it could have had anything to do with from Pfizer shot as she never had any problem like that and now, she was in the hospital from the stroke, and I was just wondering if me talking her and getting her vaccine could possibly had to do with this. Reporter further stated, Absolutely, I have question as far as if that was the cause, was there any special treatment that she should be getting maybe I can at least inform the doctor about that anything. I am out of my mind right now because I felt that I talk to her getting the vaccine because I want to her to be safe, she was 77 yrs. old (Not clarified) she never had any medical problem I feel guilty. Height and weight: Reporter stated, She was approximately 5'6. I don't know the weight as she lost weight, she was not obese or anything like that, but I honestly don't know her weight. The outcome for the events was unknown.