chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Malaise, Metabolic function test, Nausea, Pulse absent
Clinical narrative: Vasovagal syncope with asystole; Vasovagal syncope with asystole; This is a spontaneous report from a contactable pharmacist (patient).  A 36-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1686), via an unspecified route of administration in the right arm on 11Jan2021 at 14:45 at 36-years-old at a single dose for COVID-19 immunization in a hospital.  Medical history included Wilms tumor from an unknown date and unknown if ongoing, Kidney resection and chemo from 1986 to an unknown date, sulfonamide allergy from an unknown date and unknown if ongoing, premature ventricular contractions (PVCs) from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899) for COVID-19 immunization on 21Dec2020. On 12Jan2021 at 04:00, the patient experienced vasovagal syncope with asystole (hospitalization, medically significant).  The patient was hospitalized for vasovagal syncope with asystole on unknown dates for 4 days (at the time of the report). It was reported that the patient did not receive any treatment due to the events. The clinical course was reported as follows: The patient experienced what was believed to be a vasovagal syncope with asystole; approximately 12 hours after receiving the second dose. The patient had been admitted to the hospital since all cardiac diagnosis tests were negative for structural or functional abnormalities. The patient remained in-patient at this time for initiation of therapy for frequent PVCs, which were diagnosis about one year ago; but chose not to treat at that time, as the symptoms were not affecting her lifestyle. The patient underwent lab tests and procedures which included cardiac diagnosis tests: negative for structural or functional abnormalities on an unknown date.  The clinical outcome of the events was recovering. The patient did not have COVID prior to vaccination; and was not tested for COVID post vaccination.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in the development of the vasovagal syncope with asystole cannot be excluded. The event is confounded by the patient's underlying premature ventricular contractions. 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: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Toxicologic test, Troponin, Unresponsive to stimuli, Urine analysis
Clinical narrative: Vasovagal syncope with asystole; Vasovagal syncope with asystole; This is a spontaneous report from a contactable pharmacist (patient).  A 36-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1686), via an unspecified route of administration in the right arm on 11Jan2021 at 14:45 at 36-years-old at a single dose for COVID-19 immunization in a hospital.  Medical history included Wilms tumor from an unknown date and unknown if ongoing, Kidney resection and chemo from 1986 to an unknown date, sulfonamide allergy from an unknown date and unknown if ongoing, premature ventricular contractions (PVCs) from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899) for COVID-19 immunization on 21Dec2020. On 12Jan2021 at 04:00, the patient experienced vasovagal syncope with asystole (hospitalization, medically significant).  The patient was hospitalized for vasovagal syncope with asystole on unknown dates for 4 days (at the time of the report). It was reported that the patient did not receive any treatment due to the events. The clinical course was reported as follows: The patient experienced what was believed to be a vasovagal syncope with asystole; approximately 12 hours after receiving the second dose. The patient had been admitted to the hospital since all cardiac diagnosis tests were negative for structural or functional abnormalities. The patient remained in-patient at this time for initiation of therapy for frequent PVCs, which were diagnosis about one year ago; but chose not to treat at that time, as the symptoms were not affecting her lifestyle. The patient underwent lab tests and procedures which included cardiac diagnosis tests: negative for structural or functional abnormalities on an unknown date.  The clinical outcome of the events was recovering. The patient did not have COVID prior to vaccination; and was not tested for COVID post vaccination.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in the development of the vasovagal syncope with asystole cannot be excluded. The event is confounded by the patient's underlying premature ventricular contractions. 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: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Vasovagal syncope with asystole; Vasovagal syncope with asystole; This is a spontaneous report from a contactable pharmacist (patient).  A 36-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1686), via an unspecified route of administration in the right arm on 11Jan2021 at 14:45 at 36-years-old at a single dose for COVID-19 immunization in a hospital.  Medical history included Wilms tumor from an unknown date and unknown if ongoing, Kidney resection and chemo from 1986 to an unknown date, sulfonamide allergy from an unknown date and unknown if ongoing, premature ventricular contractions (PVCs) from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899) for COVID-19 immunization on 21Dec2020. On 12Jan2021 at 04:00, the patient experienced vasovagal syncope with asystole (hospitalization, medically significant).  The patient was hospitalized for vasovagal syncope with asystole on unknown dates for 4 days (at the time of the report). It was reported that the patient did not receive any treatment due to the events. The clinical course was reported as follows: The patient experienced what was believed to be a vasovagal syncope with asystole; approximately 12 hours after receiving the second dose. The patient had been admitted to the hospital since all cardiac diagnosis tests were negative for structural or functional abnormalities. The patient remained in-patient at this time for initiation of therapy for frequent PVCs, which were diagnosis about one year ago; but chose not to treat at that time, as the symptoms were not affecting her lifestyle. The patient underwent lab tests and procedures which included cardiac diagnosis tests: negative for structural or functional abnormalities on an unknown date.  The clinical outcome of the events was recovering. The patient did not have COVID prior to vaccination; and was not tested for COVID post vaccination.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in the development of the vasovagal syncope with asystole cannot be excluded. The event is confounded by the patient's underlying premature ventricular contractions. 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: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Cardiac function test normal, Cardiovascular evaluation, Condition aggravated, Syncope
Clinical narrative: Vasovagal syncope with asystole; Vasovagal syncope with asystole; This is a spontaneous report from a contactable pharmacist (patient).  A 36-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1686), via an unspecified route of administration in the right arm on 11Jan2021 at 14:45 at 36-years-old at a single dose for COVID-19 immunization in a hospital.  Medical history included Wilms tumor from an unknown date and unknown if ongoing, Kidney resection and chemo from 1986 to an unknown date, sulfonamide allergy from an unknown date and unknown if ongoing, premature ventricular contractions (PVCs) from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899) for COVID-19 immunization on 21Dec2020. On 12Jan2021 at 04:00, the patient experienced vasovagal syncope with asystole (hospitalization, medically significant).  The patient was hospitalized for vasovagal syncope with asystole on unknown dates for 4 days (at the time of the report). It was reported that the patient did not receive any treatment due to the events. The clinical course was reported as follows: The patient experienced what was believed to be a vasovagal syncope with asystole; approximately 12 hours after receiving the second dose. The patient had been admitted to the hospital since all cardiac diagnosis tests were negative for structural or functional abnormalities. The patient remained in-patient at this time for initiation of therapy for frequent PVCs, which were diagnosis about one year ago; but chose not to treat at that time, as the symptoms were not affecting her lifestyle. The patient underwent lab tests and procedures which included cardiac diagnosis tests: negative for structural or functional abnormalities on an unknown date.  The clinical outcome of the events was recovering. The patient did not have COVID prior to vaccination; and was not tested for COVID post vaccination.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in the development of the vasovagal syncope with asystole cannot be excluded. The event is confounded by the patient's underlying premature ventricular contractions. 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: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Vasovagal syncope with asystole; Vasovagal syncope with asystole; This is a spontaneous report from a contactable pharmacist (patient).  A 36-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1686), via an unspecified route of administration in the right arm on 11Jan2021 at 14:45 at 36-years-old at a single dose for COVID-19 immunization in a hospital.  Medical history included Wilms tumor from an unknown date and unknown if ongoing, Kidney resection and chemo from 1986 to an unknown date, sulfonamide allergy from an unknown date and unknown if ongoing, premature ventricular contractions (PVCs) from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899) for COVID-19 immunization on 21Dec2020. On 12Jan2021 at 04:00, the patient experienced vasovagal syncope with asystole (hospitalization, medically significant).  The patient was hospitalized for vasovagal syncope with asystole on unknown dates for 4 days (at the time of the report). It was reported that the patient did not receive any treatment due to the events. The clinical course was reported as follows: The patient experienced what was believed to be a vasovagal syncope with asystole; approximately 12 hours after receiving the second dose. The patient had been admitted to the hospital since all cardiac diagnosis tests were negative for structural or functional abnormalities. The patient remained in-patient at this time for initiation of therapy for frequent PVCs, which were diagnosis about one year ago; but chose not to treat at that time, as the symptoms were not affecting her lifestyle. The patient underwent lab tests and procedures which included cardiac diagnosis tests: negative for structural or functional abnormalities on an unknown date.  The clinical outcome of the events was recovering. The patient did not have COVID prior to vaccination; and was not tested for COVID post vaccination.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in the development of the vasovagal syncope with asystole cannot be excluded. The event is confounded by the patient's underlying premature ventricular contractions. 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: Condition aggravated, Hypersensitivity, Rash, Seizure, Swollen tongue
Clinical narrative: Status epilepticus Treatment - Steroids Seizures resolved
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antineutrophil cytoplasmic antibody positive, Condition aggravated, Status epilepticus
Clinical narrative: Status epilepticus Treatment - Steroids Seizures resolved
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Posture abnormal, Unresponsive to stimuli
Clinical narrative: received the vaccine on Tuesday and was found dead at his kitchen table Wednesday afternoon; This is a spontaneous report from a contactable consumer. An 89 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the vaccine on Tuesday (unspecified date) and was found dead at his kitchen table on Wednesday afternoon (unspecified date). Cause of death was unknown. It was unknown if an autopsy was performed. Information about batch/lot number has been requested.; Reported Cause(s) of Death: received the vaccine on Tuesday and was found dead at his kitchen table Wednesday afternoon
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: received the vaccine on Tuesday and was found dead at his kitchen table Wednesday afternoon; This is a spontaneous report from a contactable consumer. An 89 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the vaccine on Tuesday (unspecified date) and was found dead at his kitchen table on Wednesday afternoon (unspecified date). Cause of death was unknown. It was unknown if an autopsy was performed. Information about batch/lot number has been requested.; Reported Cause(s) of Death: received the vaccine on Tuesday and was found dead at his kitchen table Wednesday afternoon
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Moderna COVID-19  Vaccine EUA  right arm developed a ?hot spot?, about four days after my first Moderna COVID shot. It fades, then comes back.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin warm
Clinical narrative: Moderna COVID-19  Vaccine EUA  right arm developed a ?hot spot?, about four days after my first Moderna COVID shot. It fades, then comes back.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Heart rate increased, Pruritus
Clinical narrative: About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vital signs measurement
Clinical narrative: About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Feeling jittery, Headache, Heart rate increased, Nausea
Clinical narrative: About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Panic attack, Pruritus, Tachycardia
Clinical narrative: About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nervousness
Clinical narrative: Immediately after vaccination the patient became lightheaded.  She lay on the floor with feet on a chair for approximately 30 minutes.  The next day she complained of stomach ache.  On Wed, she complained of nerve pain throughout body (first bottom of foot, then a few seconds later her hand, then her eye lid, etc...) saw a physician Thursday AM,  At around 1500 on Thursday, the patient came down and lay on couch saying intense pressure in her head,  her neck felt weak (and spongy), and her arms and legs felt weak.  She started to cry so we took her to a hospital.  There is progressed a bit with her neck feeling more stiff.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Head discomfort, Muscular weakness, Paraesthesia
Clinical narrative: Immediately after vaccination the patient became lightheaded.  She lay on the floor with feet on a chair for approximately 30 minutes.  The next day she complained of stomach ache.  On Wed, she complained of nerve pain throughout body (first bottom of foot, then a few seconds later her hand, then her eye lid, etc...) saw a physician Thursday AM,  At around 1500 on Thursday, the patient came down and lay on couch saying intense pressure in her head,  her neck felt weak (and spongy), and her arms and legs felt weak.  She started to cry so we took her to a hospital.  There is progressed a bit with her neck feeling more stiff.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Blood test normal, Crying, Dizziness, Head discomfort
Clinical narrative: Immediately after vaccination the patient became lightheaded.  She lay on the floor with feet on a chair for approximately 30 minutes.  The next day she complained of stomach ache.  On Wed, she complained of nerve pain throughout body (first bottom of foot, then a few seconds later her hand, then her eye lid, etc...) saw a physician Thursday AM,  At around 1500 on Thursday, the patient came down and lay on couch saying intense pressure in her head,  her neck felt weak (and spongy), and her arms and legs felt weak.  She started to cry so we took her to a hospital.  There is progressed a bit with her neck feeling more stiff.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction, Muscular weakness, Musculoskeletal stiffness, Neuralgia
Clinical narrative: Immediately after vaccination the patient became lightheaded.  She lay on the floor with feet on a chair for approximately 30 minutes.  The next day she complained of stomach ache.  On Wed, she complained of nerve pain throughout body (first bottom of foot, then a few seconds later her hand, then her eye lid, etc...) saw a physician Thursday AM,  At around 1500 on Thursday, the patient came down and lay on couch saying intense pressure in her head,  her neck felt weak (and spongy), and her arms and legs felt weak.  She started to cry so we took her to a hospital.  There is progressed a bit with her neck feeling more stiff.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Received 2nd dose of Shingrix on 1/19/2021. No side effects from first dose. Woke in middle of the night nauseous, very dizzy, headache, vomited. Next day experienced continued headache, tiredness, muscle pain, and shivering. Did not need medical assistance.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Received 2nd dose of Shingrix on 1/19/2021. No side effects from first dose. Woke in middle of the night nauseous, very dizzy, headache, vomited. Next day experienced continued headache, tiredness, muscle pain, and shivering. Did not need medical assistance.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Sleep disorder, Vomiting
Clinical narrative: Received 2nd dose of Shingrix on 1/19/2021. No side effects from first dose. Woke in middle of the night nauseous, very dizzy, headache, vomited. Next day experienced continued headache, tiredness, muscle pain, and shivering. Did not need medical assistance.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, C-reactive protein, Liver injury, Pyrexia
Clinical narrative: Liver function test abnormal; This is a spontaneous report from a contactable other HCP reporting for himself   A 61-years-old male patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 12Jan2021 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unknown date. The patient experienced liver function test abnormal  on an unspecified date with outcome of unknown.   The patient stated he is getting worse everyday. Chemistry AST/ALT 183, Alkaline Phosphate 241, C reactive 44.  Had previous Chemistry panel normal.  The patient is asking for treatment recommendations.  HCP ordered infectious hepatitis test.. The patient stated: "Being passed around.  Your vaccine is killing me". The patient underwent lab tests and procedures which included ast/alt ratio: 183, blood alkaline phosphatase: 241, C-reactive protein: 44.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory viral panel, SARS-CoV-2 test negative
Clinical narrative: Liver function test abnormal; This is a spontaneous report from a contactable other HCP reporting for himself   A 61-years-old male patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 12Jan2021 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unknown date. The patient experienced liver function test abnormal  on an unspecified date with outcome of unknown.   The patient stated he is getting worse everyday. Chemistry AST/ALT 183, Alkaline Phosphate 241, C reactive 44.  Had previous Chemistry panel normal.  The patient is asking for treatment recommendations.  HCP ordered infectious hepatitis test.. The patient stated: "Being passed around.  Your vaccine is killing me". The patient underwent lab tests and procedures which included ast/alt ratio: 183, blood alkaline phosphatase: 241, C-reactive protein: 44.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: AST/ALT ratio abnormal, Blood alkaline phosphatase increased, C-reactive protein increased, Liver function test abnormal
Clinical narrative: Liver function test abnormal; This is a spontaneous report from a contactable other HCP reporting for himself   A 61-years-old male patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 12Jan2021 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unknown date. The patient experienced liver function test abnormal  on an unspecified date with outcome of unknown.   The patient stated he is getting worse everyday. Chemistry AST/ALT 183, Alkaline Phosphate 241, C reactive 44.  Had previous Chemistry panel normal.  The patient is asking for treatment recommendations.  HCP ordered infectious hepatitis test.. The patient stated: "Being passed around.  Your vaccine is killing me". The patient underwent lab tests and procedures which included ast/alt ratio: 183, blood alkaline phosphatase: 241, C-reactive protein: 44.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Body temperature increased, Fatigue
Clinical narrative: Liver function test abnormal; This is a spontaneous report from a contactable other HCP reporting for himself   A 61-years-old male patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 12Jan2021 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unknown date. The patient experienced liver function test abnormal  on an unspecified date with outcome of unknown.   The patient stated he is getting worse everyday. Chemistry AST/ALT 183, Alkaline Phosphate 241, C reactive 44.  Had previous Chemistry panel normal.  The patient is asking for treatment recommendations.  HCP ordered infectious hepatitis test.. The patient stated: "Being passed around.  Your vaccine is killing me". The patient underwent lab tests and procedures which included ast/alt ratio: 183, blood alkaline phosphatase: 241, C-reactive protein: 44.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hepatitis acute, Hepatitis viral test negative, Malaise, Myalgia, Pyrexia
Clinical narrative: Liver function test abnormal; This is a spontaneous report from a contactable other HCP reporting for himself   A 61-years-old male patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 12Jan2021 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unknown date. The patient experienced liver function test abnormal  on an unspecified date with outcome of unknown.   The patient stated he is getting worse everyday. Chemistry AST/ALT 183, Alkaline Phosphate 241, C reactive 44.  Had previous Chemistry panel normal.  The patient is asking for treatment recommendations.  HCP ordered infectious hepatitis test.. The patient stated: "Being passed around.  Your vaccine is killing me". The patient underwent lab tests and procedures which included ast/alt ratio: 183, blood alkaline phosphatase: 241, C-reactive protein: 44.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Transaminases increased, Viral test negative
Clinical narrative: Liver function test abnormal; This is a spontaneous report from a contactable other HCP reporting for himself   A 61-years-old male patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 12Jan2021 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unknown date. The patient experienced liver function test abnormal  on an unspecified date with outcome of unknown.   The patient stated he is getting worse everyday. Chemistry AST/ALT 183, Alkaline Phosphate 241, C reactive 44.  Had previous Chemistry panel normal.  The patient is asking for treatment recommendations.  HCP ordered infectious hepatitis test.. The patient stated: "Being passed around.  Your vaccine is killing me". The patient underwent lab tests and procedures which included ast/alt ratio: 183, blood alkaline phosphatase: 241, C-reactive protein: 44.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 77.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Oedema peripheral, Skin exfoliation
Clinical narrative: sore arm/soreness in the arm; a little swelling, slight swelling/there was a little swelling where it was injected; This is a spontaneous report from a contactable consumer (patient). This reporter reported similar events for two patients. This is 1st of 2 reports.   A 77-year-old male patient received first dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 11Jan2021 12:00 at single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus. Family Medical History was None. The patient previously had pneumonia shot that he had a pretty bad reaction to one time. It was hard to explain, he had sloughing to the skin on the left arm. Under the left arm was hanging down about 3-4 inches. There was some fluid of some sort. He went to the clinic and they gave him something and it went away and he was told not to get another one. It was about 8-9 years ago. The patient's concomitant medications were not reported. The patient experienced sore arm and a little swelling, slight swelling on 11Jan2021. The patient noticed the soreness in the arm about 2-3 hours after getting the shot, but it was getting better, but there was a little swelling where it was injected. There was slight swelling, but not much. The outcome of event "sore arm/soreness in the arm" was unknown; of event "a little swelling, slight swelling/there was a little swelling where it was injected" was not recovered.   Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026404 same reporter/product, different patient.
Age: 77.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Pain in extremity, Vaccination site swelling
Clinical narrative: sore arm/soreness in the arm; a little swelling, slight swelling/there was a little swelling where it was injected; This is a spontaneous report from a contactable consumer (patient). This reporter reported similar events for two patients. This is 1st of 2 reports.   A 77-year-old male patient received first dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 11Jan2021 12:00 at single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus. Family Medical History was None. The patient previously had pneumonia shot that he had a pretty bad reaction to one time. It was hard to explain, he had sloughing to the skin on the left arm. Under the left arm was hanging down about 3-4 inches. There was some fluid of some sort. He went to the clinic and they gave him something and it went away and he was told not to get another one. It was about 8-9 years ago. The patient's concomitant medications were not reported. The patient experienced sore arm and a little swelling, slight swelling on 11Jan2021. The patient noticed the soreness in the arm about 2-3 hours after getting the shot, but it was getting better, but there was a little swelling where it was injected. There was slight swelling, but not much. The outcome of event "sore arm/soreness in the arm" was unknown; of event "a little swelling, slight swelling/there was a little swelling where it was injected" was not recovered.   Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026404 same reporter/product, different patient.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Death, Dizziness, Headache, Injection site pain
Clinical narrative: Unspecified event/he passed away; Dizziness; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient's wife).  An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3302), intramuscular at single dose in the left arm on 20Jan2021 08:15AM for Covid-19 immunisation.  Medical history included atrial fibrillation (Diagnosed about 10 years ago). Concomitant medications included unspecified drug for atrial fibrillation. On 20Jan2021, the patient experienced dizziness, nausea, headache with outcome of unknown and unspecified event/he passed away. The patient died on 20Jan2021. An autopsy was not performed.  The events were described as follows: "Her husband received the first dose of the vaccine yesterday morning and he passed away last night. She is not sure what time he died last night. States he was so eager to get the vaccine. Reports he was exhibiting symptoms that were listed as possible side effects. He was experiencing dizziness, nausea, and a headache that started several hours after the vaccine, the side effects started in the early afternoon. She does not know the cause of death and does not think an autopsy was performed". The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Reported Cause(s) of Death: Unspecified event/he passed away
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Unresponsive to stimuli
Clinical narrative: Unspecified event/he passed away; Dizziness; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient's wife).  An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3302), intramuscular at single dose in the left arm on 20Jan2021 08:15AM for Covid-19 immunisation.  Medical history included atrial fibrillation (Diagnosed about 10 years ago). Concomitant medications included unspecified drug for atrial fibrillation. On 20Jan2021, the patient experienced dizziness, nausea, headache with outcome of unknown and unspecified event/he passed away. The patient died on 20Jan2021. An autopsy was not performed.  The events were described as follows: "Her husband received the first dose of the vaccine yesterday morning and he passed away last night. She is not sure what time he died last night. States he was so eager to get the vaccine. Reports he was exhibiting symptoms that were listed as possible side effects. He was experiencing dizziness, nausea, and a headache that started several hours after the vaccine, the side effects started in the early afternoon. She does not know the cause of death and does not think an autopsy was performed". The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Reported Cause(s) of Death: Unspecified event/he passed away
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Headache, Malaise, Nausea, Respiratory arrest
Clinical narrative: Unspecified event/he passed away; Dizziness; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient's wife).  An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3302), intramuscular at single dose in the left arm on 20Jan2021 08:15AM for Covid-19 immunisation.  Medical history included atrial fibrillation (Diagnosed about 10 years ago). Concomitant medications included unspecified drug for atrial fibrillation. On 20Jan2021, the patient experienced dizziness, nausea, headache with outcome of unknown and unspecified event/he passed away. The patient died on 20Jan2021. An autopsy was not performed.  The events were described as follows: "Her husband received the first dose of the vaccine yesterday morning and he passed away last night. She is not sure what time he died last night. States he was so eager to get the vaccine. Reports he was exhibiting symptoms that were listed as possible side effects. He was experiencing dizziness, nausea, and a headache that started several hours after the vaccine, the side effects started in the early afternoon. She does not know the cause of death and does not think an autopsy was performed". The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Reported Cause(s) of Death: Unspecified event/he passed away
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Dizziness, Headache, Nausea
Clinical narrative: Unspecified event/he passed away; Dizziness; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient's wife).  An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3302), intramuscular at single dose in the left arm on 20Jan2021 08:15AM for Covid-19 immunisation.  Medical history included atrial fibrillation (Diagnosed about 10 years ago). Concomitant medications included unspecified drug for atrial fibrillation. On 20Jan2021, the patient experienced dizziness, nausea, headache with outcome of unknown and unspecified event/he passed away. The patient died on 20Jan2021. An autopsy was not performed.  The events were described as follows: "Her husband received the first dose of the vaccine yesterday morning and he passed away last night. She is not sure what time he died last night. States he was so eager to get the vaccine. Reports he was exhibiting symptoms that were listed as possible side effects. He was experiencing dizziness, nausea, and a headache that started several hours after the vaccine, the side effects started in the early afternoon. She does not know the cause of death and does not think an autopsy was performed". The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Reported Cause(s) of Death: Unspecified event/he passed away
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram, Tachycardia
Clinical narrative: RAPID HEART RATE 160-180, NO INTERVENTION.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased
Clinical narrative: RAPID HEART RATE 160-180, NO INTERVENTION.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site hypersensitivity, Rash erythematous
Clinical narrative: Patient report as follows:  1 week after getting the vaccine I noticed a large rash on my arm around the injection site (see photos). I have photos of the rash but it is approx. 4 inches long by 3 inches wide. There is also pain at the injection site.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Patient report as follows:  1 week after getting the vaccine I noticed a large rash on my arm around the injection site (see photos). I have photos of the rash but it is approx. 4 inches long by 3 inches wide. There is also pain at the injection site.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: LEFT UPPER ARM PAIN, REDNESS, WARM AND HARD TO TOUCH
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: LEFT UPPER ARM PAIN, REDNESS, WARM AND HARD TO TOUCH
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dysphagia, Respiratory tract oedema
Clinical narrative: After 15 minutes started with a small cough, running nose, watery eyes ,trouble swallowing and the throat was closing and trouble breathing
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Cough, Dysphagia, Dyspnoea, Lacrimation increased
Clinical narrative: After 15 minutes started with a small cough, running nose, watery eyes ,trouble swallowing and the throat was closing and trouble breathing
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rhinorrhoea, Throat tightness
Clinical narrative: After 15 minutes started with a small cough, running nose, watery eyes ,trouble swallowing and the throat was closing and trouble breathing
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Pharyngeal swelling, Viral test negative
Clinical narrative: After 15 minutes started with a small cough, running nose, watery eyes ,trouble swallowing and the throat was closing and trouble breathing
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: During monitoring period post Pfizer COVID-19 vaccine, patient significant head pain with decline vital signs. Emergency services was called and arrived onsite for assistance. Patient monitored and refused to transfer to ER.