chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Wheezing
Clinical narrative: expiratory wheezing and coughs; my spo2 was 92/94; expiratory wheezing and coughs; throat ache; shortness of breath; tachycardia; This is a spontaneous report from a contactable consumer.  A 39 year old female consumer (patient) reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ew0185), in the right arm on 30May2021 at 12:30 (at the age of 39-years-old) at single dose for COVID-19 immunization. The patient was not pregnant. patient's history included seasonal allergy with rhinorrhea and sneezing. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant drugs included cromolyn sodium nasal spray. The patient reported on 03Jun2021 throat ache started after vaccine, then she woke up midnight with shortness of breath and tachycardia. She had expiratory wheezing and coughs. The next night the same thing happened and this time wheezing was pronounced and her husband could easily hear it. She was not asthmatic. She had to use cromolyn, psedoephedrine, fluticasone to reduce the symptoms. Her SPO2 was 92/94 and her husband 98. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate
Clinical narrative: heart arrhythmia; This is a spontaneous report from a contactable consumer (calling on behalf of his mother). A 96-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20May2021 (Lot number was not reported) as single dose (at age of 96-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced heart arrhythmia. Reporter stated that patient was living like a hermit for 15 months. She had her first dose last 20May2021 after getting that vaccine she experienced heart arrhythmia. Reporter was asking if there were reports specific to heart arrhythmia and what recommendation there is if her mother can still get her second dose of the vaccine or choose to wait. Reporter was asking for the efficacy of only a single dose of the vaccine and was asking for information on delaying the second dose. The outcome of the event was unknown. Information regarding the Lot/Batch number has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Heart rate irregular, Myalgia, Pyrexia
Clinical narrative: A little fever, muscle pain, tiredness. (All of the above expected); A little fever, muscle pain, tiredness. (All of the above expected); A little fever, muscle pain, tiredness. (All of the above expected); Chest pain and sudden changes in heart rate (totally unexpected); Chest pain and sudden changes in heart rate (totally unexpected); This is a spontaneous report from a contactable consumer (patient).  A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 04Jun2021 12:30 (Batch/Lot Number: EW0191) as single dose for covid-19 immunisation. There was no relevant medical history reported. The patient's concomitant medications were not reported. On 05Jun2021 13:00, patient experienced a little fever, muscle pain, tiredness. (all of the above expected), chest pain and sudden changes in heart rate (totally unexpected).  The patient reported that events resulted in visit to a doctor's office, Emergency or urgent care department/room, Hospitalization, Disability or permanent impairment. Outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent nasal swab on 28May2021 and on 05Jun2021 pending result.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: A little fever, muscle pain, tiredness. (All of the above expected); A little fever, muscle pain, tiredness. (All of the above expected); A little fever, muscle pain, tiredness. (All of the above expected); Chest pain and sudden changes in heart rate (totally unexpected); Chest pain and sudden changes in heart rate (totally unexpected); This is a spontaneous report from a contactable consumer (patient).  A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 04Jun2021 12:30 (Batch/Lot Number: EW0191) as single dose for covid-19 immunisation. There was no relevant medical history reported. The patient's concomitant medications were not reported. On 05Jun2021 13:00, patient experienced a little fever, muscle pain, tiredness. (all of the above expected), chest pain and sudden changes in heart rate (totally unexpected).  The patient reported that events resulted in visit to a doctor's office, Emergency or urgent care department/room, Hospitalization, Disability or permanent impairment. Outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent nasal swab on 28May2021 and on 05Jun2021 pending result.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Haematocrit, Haematocrit increased, Hepatic enzyme abnormal, Hepatitis B
Clinical narrative: he tested positive for hepatitis B virus with little EAG; his erythrocytes were a little high,; Hepatocytes was high; hematocrit was high; lymphocytes were high; his glucose was high; This is a spontaneous report from a contactable consumer (patient) and from a Pfizer sponsored program.   A contactable 39-year-old male consumer (patient) reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ER8735), into the left arm on 21Apr2021 at 9.00 (at the age of 39-years-old) at single dose for COVID-19 immunization. The patient had received the fist dose of vaccine on 31Mar2021 (Lot: EP7534) in the left arm at 09.00. Medical history included psoriasis diagnosed 25 years before reporting when he was 15 years old. Family history included his mom died of cancer, but she did a lot of drugs and stuff. Concomitant drugs were none. The patient reported that 2 weeks after 2nd dose of vaccine he had blood work done. He said the result came back a little weird on 10May2021. Erythrocyte were a little high, Hepatocytes were high, hematocrit was high, lymphocytes were high, and it says he tested positive for hepatitis B virus with little EAG. Caller states his glucose was high but he thinks that's just from what he was eating. The patient stated that the events required a physician office video visit. Caller stated his doctor was having him do another blood work test. Caller stated the doctor thought maybe it was the vaccine that did it. At the time of reporting the outcome of the events was unknown.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatitis B virus test positive, Lymphocyte count increased, Red blood cell count increased
Clinical narrative: he tested positive for hepatitis B virus with little EAG; his erythrocytes were a little high,; Hepatocytes was high; hematocrit was high; lymphocytes were high; his glucose was high; This is a spontaneous report from a contactable consumer (patient) and from a Pfizer sponsored program.   A contactable 39-year-old male consumer (patient) reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ER8735), into the left arm on 21Apr2021 at 9.00 (at the age of 39-years-old) at single dose for COVID-19 immunization. The patient had received the fist dose of vaccine on 31Mar2021 (Lot: EP7534) in the left arm at 09.00. Medical history included psoriasis diagnosed 25 years before reporting when he was 15 years old. Family history included his mom died of cancer, but she did a lot of drugs and stuff. Concomitant drugs were none. The patient reported that 2 weeks after 2nd dose of vaccine he had blood work done. He said the result came back a little weird on 10May2021. Erythrocyte were a little high, Hepatocytes were high, hematocrit was high, lymphocytes were high, and it says he tested positive for hepatitis B virus with little EAG. Caller states his glucose was high but he thinks that's just from what he was eating. The patient stated that the events required a physician office video visit. Caller stated his doctor was having him do another blood work test. Caller stated the doctor thought maybe it was the vaccine that did it. At the time of reporting the outcome of the events was unknown.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram head, Electrocardiogram, SARS-CoV-2 test, Syncope
Clinical narrative: Patients fainted 3 times after the 2nd dose administration; This is a spontaneous report from a contactable consumer.  A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 05Jun2021 10:30 (Batch/Lot Number: EW0189) age at vaccination of 14-years-old, as single dose, for covid-19 immunisation. Medical history included was none. The patient had no allergy. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 15May2021 9:45 (Batch/Lot Number: EW0182) age at vaccination of 14-years-old, as single dose, for covid-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patients fainted 3 times after the 2nd dose administration on 06Jun2021, at 1:30 am, 7:00am and then at 10:00am. The event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. He went to an urgent care and EKG, complete blood work, head cat scan and all result were OK. No treatment was given for the event.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests which included sars-cov-2 test negative on 06Jun2021.  The patient recovered in Jun2021.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: passed out/ lost his consciousness; fainted; fell; This is a spontaneous report from a contactable consumer (parent). A 17-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter was just curious his/her stepson had an adverse reaction to Pfizer vaccine and he was in the Emergency room. The patient has passed out, fainted and lost his consciousness. The parent stated that patient fell in a concrete floor because the location he was getting the vaccine was obviously not suitable to people having adverse reaction otherwise they should be sitting on metal chairs on concrete floor, so the parent is under the assumption that he should have his heart checked out, and if the vaccine has to do with it and they just wanted to know if there's anything else with this reaction should be having a hospital lookout. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Deafness, Dyspnoea, Hypertension, Hypoaesthesia
Clinical narrative: Blurred vision and high blood pressure at the time of the vaccine.; Blurred vision and high blood pressure at the time of the vaccine.; Stomach pain with Hives; Stomach pain with Hives; loss of the right ear and numbness on the right side with shortness of breath as if she were congested; loss of the right ear and numbness on the right side with shortness of breath as if she were congested; loss of the right ear and numbness on the right side with shortness of breath as if she were congested; This is a spontaneous report from a contactable consumer (patient).  A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 12:00 (Batch/Lot number was not reported) age at vaccination of 50-years-old, as single dose, for covid-19 immunisation.  Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing (Oxycodon). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; pioglitazone hydrochloride (ACTOS) taken for an unspecified indication, start and stop date were not reported; glipizide (GLIPIZIDE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021 the patient experienced blurred vision and high blood pressure, stomach pain with hives, loss of the right ear and numbness on the right side with shortness of breath as if she was congested. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care; the patient was hospitalized for 3 days and the events were also considered serious as disability. The patient was treated with cortisone to restore hearing.  The patient underwent lab tests and procedures which included sars-cov-2 test unknown results on 28May2021, sars-cov-2 test negative on 26May2021 (Nasal Swab), sars-cov-2 test unknown results on 28May2021 (Nasal Swab). Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria, Vision blurred
Clinical narrative: Blurred vision and high blood pressure at the time of the vaccine.; Blurred vision and high blood pressure at the time of the vaccine.; Stomach pain with Hives; Stomach pain with Hives; loss of the right ear and numbness on the right side with shortness of breath as if she were congested; loss of the right ear and numbness on the right side with shortness of breath as if she were congested; loss of the right ear and numbness on the right side with shortness of breath as if she were congested; This is a spontaneous report from a contactable consumer (patient).  A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 12:00 (Batch/Lot number was not reported) age at vaccination of 50-years-old, as single dose, for covid-19 immunisation.  Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing (Oxycodon). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; pioglitazone hydrochloride (ACTOS) taken for an unspecified indication, start and stop date were not reported; glipizide (GLIPIZIDE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021 the patient experienced blurred vision and high blood pressure, stomach pain with hives, loss of the right ear and numbness on the right side with shortness of breath as if she was congested. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care; the patient was hospitalized for 3 days and the events were also considered serious as disability. The patient was treated with cortisone to restore hearing.  The patient underwent lab tests and procedures which included sars-cov-2 test unknown results on 28May2021, sars-cov-2 test negative on 26May2021 (Nasal Swab), sars-cov-2 test unknown results on 28May2021 (Nasal Swab). Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac disorder, Malaise
Clinical narrative: Child fell ill, taken to hospital. Moved to cardiac unit; Child fell ill, taken to hospital. Moved to cardiac unit; This is a spontaneous report from a contactable physician. A 14-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Batch/Lot number was not reported) as single dose (at the age of 14-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (at the age of 14-years-old) for COVID-19 immunization. It was reported that the "child fell ill, taken to hospital. Moved to cardiac unit" on 06Jun2021. The outcome of the event was unknown. The event was considered as serious (hospitalization). The event resulted in Emergency room/department or urgent care. Unknown if patient was tested for COVID prior vaccination and if COVID tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature increased, Chest X-ray, Condition aggravated, Echocardiogram, Electrocardiogram
Clinical narrative: Child fell ill, taken to hospital. Moved to cardiac unit; Child fell ill, taken to hospital. Moved to cardiac unit; This is a spontaneous report from a contactable physician. A 14-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Batch/Lot number was not reported) as single dose (at the age of 14-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (at the age of 14-years-old) for COVID-19 immunization. It was reported that the "child fell ill, taken to hospital. Moved to cardiac unit" on 06Jun2021. The outcome of the event was unknown. The event was considered as serious (hospitalization). The event resulted in Emergency room/department or urgent care. Unknown if patient was tested for COVID prior vaccination and if COVID tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Generalised tonic-clonic seizure, Hypotension, Laboratory test, Tachycardia, Troponin increased
Clinical narrative: Child fell ill, taken to hospital. Moved to cardiac unit; Child fell ill, taken to hospital. Moved to cardiac unit; This is a spontaneous report from a contactable physician. A 14-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Batch/Lot number was not reported) as single dose (at the age of 14-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (at the age of 14-years-old) for COVID-19 immunization. It was reported that the "child fell ill, taken to hospital. Moved to cardiac unit" on 06Jun2021. The outcome of the event was unknown. The event was considered as serious (hospitalization). The event resulted in Emergency room/department or urgent care. Unknown if patient was tested for COVID prior vaccination and if COVID tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Echocardiogram, Hypotension, Myocarditis, Pyrexia
Clinical narrative: Child fell ill, taken to hospital. Moved to cardiac unit; Child fell ill, taken to hospital. Moved to cardiac unit; This is a spontaneous report from a contactable physician. A 14-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Batch/Lot number was not reported) as single dose (at the age of 14-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (at the age of 14-years-old) for COVID-19 immunization. It was reported that the "child fell ill, taken to hospital. Moved to cardiac unit" on 06Jun2021. The outcome of the event was unknown. The event was considered as serious (hospitalization). The event resulted in Emergency room/department or urgent care. Unknown if patient was tested for COVID prior vaccination and if COVID tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Seizure, Tachycardia, Troponin, Troponin increased, Vomiting
Clinical narrative: Child fell ill, taken to hospital. Moved to cardiac unit; Child fell ill, taken to hospital. Moved to cardiac unit; This is a spontaneous report from a contactable physician. A 14-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Batch/Lot number was not reported) as single dose (at the age of 14-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (at the age of 14-years-old) for COVID-19 immunization. It was reported that the "child fell ill, taken to hospital. Moved to cardiac unit" on 06Jun2021. The outcome of the event was unknown. The event was considered as serious (hospitalization). The event resulted in Emergency room/department or urgent care. Unknown if patient was tested for COVID prior vaccination and if COVID tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Chest X-ray, Electrocardiogram, Feeling abnormal, Heart rate increased
Clinical narrative: gained 5 pounds after each dose; really bad edema; foot's all swelled up; enlarged heart; rapid heart beating; feels like she's going to die; soreness of the arm; throwing up; This is a spontaneous report from a contactable consumer (patient).  A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 06Apr2021 (Batch/Lot Number: ER8735) (age at vaccination 56 year) as single dose for covid-19 immunisation.  Medical history included ongoing blood cholesterol increased for over 25 years , stress, anxiety, post-traumatic stress disorder. Concomitant medication(s) included atorvastatin (LIPITOR) for blood cholesterol increased.  The first dose of vaccine was administered on 16Mar2021 (lot EP753T) in arm left and patient reported weight gain (5 pounds). After having the second dose of  vaccine, on 03May2021, patient experienced enlarged heart, and rapid heart beatings.  Patient reported she had to go twice to the hospital, had to call 911, had to get a doppler on her chest, she's been to the cardiologist 5 times just in the last month. Caller states she has to go for a cardiogram on the 16th and may have to have open heart surgery. Patient reported that since having the Covid shot, she's had nothing but trouble. She's not just having soreness of the arm and throwing up. Patient reported that next day, she gained 5 pounds, she retained water or something, she has really bad edema, her foot's all swelled up now. Patient underwent EKGs, Chest X-rays, where it says she has an enlarged heart, rapid heart beating, she had a doppler heart monitor for 3 days. Caller states she has to get a cardiogram, an MRI. Caller states she has heart rhythm problems she feels it in her body. Caller states the doctors didn't say she had heart rhythm problems, but she feels fluttering in her heart. Outcome of events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema, Pain in extremity, Peripheral swelling, Ultrasound Doppler, Vomiting
Clinical narrative: gained 5 pounds after each dose; really bad edema; foot's all swelled up; enlarged heart; rapid heart beating; feels like she's going to die; soreness of the arm; throwing up; This is a spontaneous report from a contactable consumer (patient).  A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 06Apr2021 (Batch/Lot Number: ER8735) (age at vaccination 56 year) as single dose for covid-19 immunisation.  Medical history included ongoing blood cholesterol increased for over 25 years , stress, anxiety, post-traumatic stress disorder. Concomitant medication(s) included atorvastatin (LIPITOR) for blood cholesterol increased.  The first dose of vaccine was administered on 16Mar2021 (lot EP753T) in arm left and patient reported weight gain (5 pounds). After having the second dose of  vaccine, on 03May2021, patient experienced enlarged heart, and rapid heart beatings.  Patient reported she had to go twice to the hospital, had to call 911, had to get a doppler on her chest, she's been to the cardiologist 5 times just in the last month. Caller states she has to go for a cardiogram on the 16th and may have to have open heart surgery. Patient reported that since having the Covid shot, she's had nothing but trouble. She's not just having soreness of the arm and throwing up. Patient reported that next day, she gained 5 pounds, she retained water or something, she has really bad edema, her foot's all swelled up now. Patient underwent EKGs, Chest X-rays, where it says she has an enlarged heart, rapid heart beating, she had a doppler heart monitor for 3 days. Caller states she has to get a cardiogram, an MRI. Caller states she has heart rhythm problems she feels it in her body. Caller states the doctors didn't say she had heart rhythm problems, but she feels fluttering in her heart. Outcome of events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: gained 5 pounds after each dose; really bad edema; foot's all swelled up; enlarged heart; rapid heart beating; feels like she's going to die; soreness of the arm; throwing up; This is a spontaneous report from a contactable consumer (patient).  A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 06Apr2021 (Batch/Lot Number: ER8735) (age at vaccination 56 year) as single dose for covid-19 immunisation.  Medical history included ongoing blood cholesterol increased for over 25 years , stress, anxiety, post-traumatic stress disorder. Concomitant medication(s) included atorvastatin (LIPITOR) for blood cholesterol increased.  The first dose of vaccine was administered on 16Mar2021 (lot EP753T) in arm left and patient reported weight gain (5 pounds). After having the second dose of  vaccine, on 03May2021, patient experienced enlarged heart, and rapid heart beatings.  Patient reported she had to go twice to the hospital, had to call 911, had to get a doppler on her chest, she's been to the cardiologist 5 times just in the last month. Caller states she has to go for a cardiogram on the 16th and may have to have open heart surgery. Patient reported that since having the Covid shot, she's had nothing but trouble. She's not just having soreness of the arm and throwing up. Patient reported that next day, she gained 5 pounds, she retained water or something, she has really bad edema, her foot's all swelled up now. Patient underwent EKGs, Chest X-rays, where it says she has an enlarged heart, rapid heart beating, she had a doppler heart monitor for 3 days. Caller states she has to get a cardiogram, an MRI. Caller states she has heart rhythm problems she feels it in her body. Caller states the doctors didn't say she had heart rhythm problems, but she feels fluttering in her heart. Outcome of events was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Electroencephalogram, Loss of consciousness, Magnetic resonance imaging, Seizure
Clinical narrative: Seizures; blackout; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER2613), on 18Mar2021 at dose 1, single and the second dose (lot number: EW0150) on 18Apr2021 at dose 2, single both at the age of 38-years-old for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive prior vaccinations and had never even had a flu shot. The patient had a seizure maybe a week and a half after she had her first shot. She had never had a seizure in 38 years. The seizure occurred on 06Apr2021, that was the day that she had her first seizure, a blackout. She then got the second shot on 18Apr2021 which was the Sunday and she had another seizure on 23Apr2021 and she went to the emergency room; they did a EEG, a CT scan, a MRI and everything came back normal. The only thing she had done different was taking vaccine. The patient was concerned and she wanted to report it because they were not showing on EEG or anything else and she had another one just last Friday, on 04Jun2021, that was normal. She had never had seizures before in life before until she got the vaccine. The doctor put her on KEPPRA and trazadone because they did not see anything in the EEG, that was causing the seizures it, so they put her on KEPPRA after that. The patient really thought it was due to the Pfizer vaccine. The outcome of the events was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Myocardial infarction, Pain, Pneumonia, Vomiting
Clinical narrative: Very mild heart attack; Touch of pneumonia; Aches and pains; Vomiting; Congested cough; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 07May2021 given around 19:00 or 19:30 (Lot Number: EW0177) as single dose (at the age of 71 years old) for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 07May2021 patient experienced very mild heart attack, touch of pneumonia, aches and pains, vomiting and congested cough. The patient was hospitalized for five days for very mild heart attack and touch of pneumonia from 07May2021 to 12May2021. The events very mild heart attack and touch of pneumonia resulted in Emergency Room visit. Patient stated she has had a very mild heart attack started the day of the vaccine a couple hours afterwards (she will go to see the cardiologist the day after the report), touch of pneumonia, aches and pains, vomiting, and spent five days in the hospital. Patient stated she does not believe the pneumonia is still going on. She stated but she does have a congested cough. Patient stated this stopped sometime in May2021 since she was given a strong antibiotic and it kind of kicked it out. Patient is not sure of the outcome since she has never been rechecked on it. Treatment: Strong antibiotics. Patient also stated that her cardiologist said she should not get the second dose. Patient had not recovered from touch of pneumonia and congested cough, she recovered on 08May2021 from aches and pains and vomiting and the outcome of very mild heart attack was unknown, at the time of the report.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Deafness, Ear swelling, Nerve injury, Rash
Clinical narrative: Hearing loss; Vertigo; Nerve damage in my ear; Rash on the back of my head and then swelling at the right side of my head; Swollen canal, my ear canal; Rash on the back of my head and then swelling at the right side of my head; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EM9809) dose 2 via an unspecified route of administration, administered in arm on 17Feb2021 as single dose for covid-19 immunisation. Medical history included blood pressure. The patient's concomitant included unspecified blood pressure medication. The patient previously received the first dose of bnt162b2 on 27Jan2021. The patient experienced hearing loss on unspecified date in Feb2021. He reported that it was first started two weeks after the second dose as a rash on the back of his head and then swelling at the right side of his head but not real swelling but in the canals in his ear. So, he wanted to report that. The patient reported that he had vertigo now. He went to a doctor a month ago and they said he had a nerve damage in his ear and had swollen canal, his ear canal. He had both the doses of the vaccines. He reported that all started two weeks after he got his Covid shot. The patient underwent lab tests and procedures which included blood test which was fine. The outcome of the events was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Vertigo
Clinical narrative: Hearing loss; Vertigo; Nerve damage in my ear; Rash on the back of my head and then swelling at the right side of my head; Swollen canal, my ear canal; Rash on the back of my head and then swelling at the right side of my head; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EM9809) dose 2 via an unspecified route of administration, administered in arm on 17Feb2021 as single dose for covid-19 immunisation. Medical history included blood pressure. The patient's concomitant included unspecified blood pressure medication. The patient previously received the first dose of bnt162b2 on 27Jan2021. The patient experienced hearing loss on unspecified date in Feb2021. He reported that it was first started two weeks after the second dose as a rash on the back of his head and then swelling at the right side of his head but not real swelling but in the canals in his ear. So, he wanted to report that. The patient reported that he had vertigo now. He went to a doctor a month ago and they said he had a nerve damage in his ear and had swollen canal, his ear canal. He had both the doses of the vaccines. He reported that all started two weeks after he got his Covid shot. The patient underwent lab tests and procedures which included blood test which was fine. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted COVID 19; contracted COVID 19; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer sponsored program support. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient was contracted with COVID19. HCP asked for lot information. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Insomnia, Mental impairment, Pain
Clinical narrative: caller can not think; caller is postponing second dose of vaccine; very very terrible pain all through her body; caller can not sleep; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced caller cannot think, caller is postponing second dose of vaccine, very very terrible pain all through her body and caller cannot sleep. The pain had stated that it was down a little bit but she could not sleep through the night and is taking really strong pain medication, even the one that that they talk about advertised on TV and her pain is still there. It is in her neck from her back to her neck and her body. The patient could not see herself taking the second one. The patient had to see her primary doctor to see if she was having pain through her entire body, she did not have anybody there who is with her. The patient looked forward to it but she could not in this pain, so she was checking with her primary. At her age, she has to be careful with her health. The patient just wanted to know and did not see the number where she had the sht. The first vaccine she took she think this was set up for them to come, and she was trying to find the number but was in so much pain. The clinical outcome of the events was unknown.  PSCC Communication: caller advised to contact hospital, physician, or where she received first vaccine. The patient does not want to complete report at this time. No further transfer.  Additional information has been requested and will be provided as it becomes available.  Follow-up attempts completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, COVID-19, Pain, SARS-CoV-2 test
Clinical narrative: Ache; Body temperature grew; After the three days of the first shot of vaccine, the was tested positive for COVID.cough; This is a spontaneous report from a contactable consumer (Family member). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EP6775), dose 1 via an unspecified route of administration, administered in arm left on 09Mar2021 12:30 as 1st dose, single for covid-19 immunisation. Medical history included colon cancer (Verbatim: Colon cancer, He was diagnosed a year ago of colon rectum cancer and thats it and he does not have another serious conditions, he reside the colon cancer, he saved it from the cancer things a year ago back so he got in to the stomach and into the vest) and ostomy (Verbatim: patient also has ostomy, so he was using like ostomy bag because he had a colon cancer). Concomitant medication included pregabalin (LYRICA). After the three days of first shot, patient was diagnosed with COVID. he experienced the test of COVID was the ache, cough, respiratory symptoms and body temperature grew. Patient went under treatment around three weeks in oxygen. The seriousness was reported as non-serious. Patient recovered from Covid wanted to know if this patient can get a second dose. The outcome of the event tested positive for COVID was recovered and for other it was unknown.   Lot/Batch no. available. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Cardiac stress test, Computerised tomogram, Dyspnoea
Clinical narrative: heart "attack" episode; pain into my jaw and down my arm; pain into my jaw and down my arm; couldn't breath /Shortness of breath; muscle pain; weakness; inflammation; high BP; muscle weakness; pain; This is a spontaneous report form a contactable consumer reporting for herself. A 51-year-old (Non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection, Lot Number: unknown) via unspecified route of administration in right arm on 31Mar2021 13:00 (at age of 51-years old) as single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. Patient had no other allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. Patient received other medications in two weeks Birth Control. Patient had reported that, had her first shot on Wednesday, 31Mar2021. By Thursday, 1Apr2021 09:30 AM she was experiencing muscle weakness and pain. Tuesday morning at 5:30 am 6Apr2021 she woke up experiencing what now known to have been a heart attack episode. She felt like abs elephant was sitting on her chest while left side she had pain into her jaw and down her arm as well as could not breath. Shortness of breath. This lasted 15-20 min. She has since for the past 2 months been in and out of doctors trying to figure out the source of her muscle pain and weakness. The Adverse events resulted in visit of Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability, or permanent damage. She went from only seeing her doctor every couple of years only when not well to she has now seen a cardiologist, rheumatologist, orthopedic. She has had EKGs, Computed tomography (CT) Scan of her heart, stress test, been put on BP meds, anti-inflammatory, antidepressants. To try and regulate her inflammation and to help keep the inflammation from causing stress on her heart aka. high BP. She went from a healthy active self-employed 51-year-old woman to her body literally giving out since shot. Treatment received for adverse events through Medication. Patient underwent lab test and procedure include Electrocardiogram, CT Scan of her heart, stress test on unspecified date result was unknown. The outcome of all events recovered with sequel (Recovered with lasting effects).   Information on batch/Lot number has been requested.