chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain, Pain in extremity, Total lung capacity, Vaccination site haemorrhage
Clinical narrative: Received the booster dose of the Pfizer Covid vaccine on 03Nov2021; Soreness to her arm; States that blood ran out of her arm after the shot; She was sore; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 69-year-old female patient received bnt162b2 (COMIRNATY (mRNA), formulation: solution for injection, lot number: FD0810 and expiration date was not reported) via an unspecified route of administration, administered in right deltoid on 03Nov2021 at 15:30 (at the age of 69-years-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included lung neoplasm malignant from Feb2020 to an unknown date Part of her lung was removed due to lung cancer for her to be protected against covid it was critical, non-tobacco user from an unknown date and unknown if ongoing Is not a smoker, patient had tired and achy for about 24 hours and then she was fine. Patient was not ill yesterday. Concomitant medications included influenza vaccine inact split 4v taken for an unspecified indication from 13Oct2021 to 13Oct2021. The patient previously received bnt162b2 (Dose 1, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot no: ER8737) on 03Apr2021 for COVID-19 immunization and on 24Apr2021, received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0175) for COVID-19 immunization. Age at vaccination was 68 years. Patient states her patient card has no expiry dates or NDC numbers written on it. On 03Nov2021 the patient experienced immunization. On an unspecified date in Nov2021the patient experienced slightly soreness to her arm and just feels concerned about this and is overwhelmed by her concern, states that blood ran out of her arm after the shot, she was sore patient never had anything like that before and just feels concerned about this and was overwhelmed by her concern. Patient explained that the shot was hurt a lot and then blood just spurted out of her arm. The patient was very very concerned this Pfizer Booster vaccine spurted out with the blood that was coming out of her arm and it did not take and she really didn't get any protection at all or that instead of being 90 percent protected she was 40 percent and she needs to know this. The patient underwent lab tests and procedures which included  on an unspecified date total lung capacity with result 80 percentage. The outcome of events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Immunisation
Clinical narrative: nausea; decreased appetite; receiving the booster shot; tiredness; headache; muscle pain; chills; fever; This is a spontaneous report from a non-contactable consumer or other non health care professional. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccination included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. On an unspecified date approximately twelve hours after receiving the booster shot for pfizer the patient experience tiredness headache muscle pain chills fever nausea and decreased appetite. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: nausea; decreased appetite; receiving the booster shot; tiredness; headache; muscle pain; chills; fever; This is a spontaneous report from a non-contactable consumer or other non health care professional. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccination included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. On an unspecified date approximately twelve hours after receiving the booster shot for pfizer the patient experience tiredness headache muscle pain chills fever nausea and decreased appetite. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Severe Chest pain; This is a spontaneous report from a Non-contactable consumer (patient).   A 49-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Oct2021 11:30 (Batch/Lot Number: EF8839) as single dose (at the age of 49) for covid-19 immunisation. Medical history was none. No known allergies. The patient's concomitant medications were not reported. The patient experienced severe chest pain on 01Nov2021 19:00. Patient was treated with Mobic for pain. The outcome was unknown.    No follow-up attempts are possible. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Depressed mood, Eye movement disorder, Gait disturbance, Illness
Clinical narrative: After taking his first Pfizer COVID shot, he got pretty sick since, then he is in and out of the hospital; after he took the shot his life just went downhill right now he is at the hospital; He is too ill to talk; he has low appetite; He has lost numerous weight; He can't even walk; he has not been able to look; This is a spontaneous report from a contactable consumer (patient's brother).   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported that 3 days after taking his first Pfizer COVID shot on an unspecified date, he got pretty sick since, then he was in and out of the hospital, he had lost numerous weight, he had low appetite, he could not even walk, he had not been able to look and I just need to know how did Pfizer go about dealing with situation like that and that was a healthy person who was very conscious about his life and health never got sick before but 3 to 4 days after he took the shot his life just went downhill right now he was at the hospital. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Weight decreased
Clinical narrative: After taking his first Pfizer COVID shot, he got pretty sick since, then he is in and out of the hospital; after he took the shot his life just went downhill right now he is at the hospital; He is too ill to talk; he has low appetite; He has lost numerous weight; He can't even walk; he has not been able to look; This is a spontaneous report from a contactable consumer (patient's brother).   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported that 3 days after taking his first Pfizer COVID shot on an unspecified date, he got pretty sick since, then he was in and out of the hospital, he had lost numerous weight, he had low appetite, he could not even walk, he had not been able to look and I just need to know how did Pfizer go about dealing with situation like that and that was a healthy person who was very conscious about his life and health never got sick before but 3 to 4 days after he took the shot his life just went downhill right now he was at the hospital. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Positive Covid test 05Nov2021; Positive Covid test 05Nov2021; This is a spontaneous report from a contactable other hcp (Patient). A 30-years-old Non Pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0191, Expiry date was not reported), via intramuscular route of administration on 15Jun2021 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization and patient received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8735, Expiry date was not reported), via intramuscular route of administration on 23May2021 (at the age of 30-years-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history and concomitant medications was not reported. The Patient had no known allergies. Patient had not received other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior vaccination and had tested COVID-19 post vaccination. On 05Nov2021, the patient experienced positive COVID and vaccination failure. The Patient did not received treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test (Coronavirus AG IA) positive on 05Nov2021 Nasal Swab. The outcome for the events was recovering. Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events VF, Covid 19, and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: paralyzed; This is a spontaneous report from a contactable consumer or other non healthcare professional. A patient of unspecified age and gender received unknown dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient was paralyzed after getting the vaccine. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Angiocardiogram, Echocardiogram, Ejection fraction, Electrocardiogram, Influenza virus test
Clinical narrative: Stress cardiomyopathy; This is a literature report. This author reported different events for four patients. This is second of four reports.  A 60-year-old woman with a history of a stent placed in the left anterior descending artery (LAD) three years ago, and normal LV function and wall motion on echocardiography five months ago, presented to clinic four days after receiving her second dose of the Pfizer-BioNTech vaccine, with exertional chest pain and new inferolateral T wave inversions (ECG: T wave abnormalities In the lnferolateral leads (II, Ill, aVF, V3-V6)). She was admitted to the hospital for further evaluation, and echocardiography revealed mildly reduced LV function with apical akinesis (Figure 3B-3C). Coronary angiography demonstrated a patent LAD stent and no obstructive disease. Based on these findings, the patient was diagnosed with a stress cardiomyopathy, and she was discharged on metoprolol succinate and lisinopril. Summary of diagnostic testing for this patient included Viral serologies: SARS-CoV-2, influenza, and RSV negative; Cardiac Biomarkers: Troponin T: 0.129 ng/mL (reference range: less than 0.03 ng/mL); Transthoracic Echocardiogram: LVEF: 44%; LVIDd: 3.5 cm; Normal RV size and function; Apical akinesis; Coronary Evaluation: Coronary angiography: Patent LAD stent.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relation, the association between the event of stress cardiomyopathy and the suspect product of BNT162B2 cannot be completely ruled out. 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.,Linked Report(s) : US-PFIZER INC-202101513854 Same article/drug and different patient/event.
Sex: F
Vaccine: COVID19
Symptoms: Respiratory syncytial virus test, SARS-CoV-2 test, Stress cardiomyopathy, Troponin T, Ventricular internal diameter
Clinical narrative: Stress cardiomyopathy; This is a literature report. This author reported different events for four patients. This is second of four reports.  A 60-year-old woman with a history of a stent placed in the left anterior descending artery (LAD) three years ago, and normal LV function and wall motion on echocardiography five months ago, presented to clinic four days after receiving her second dose of the Pfizer-BioNTech vaccine, with exertional chest pain and new inferolateral T wave inversions (ECG: T wave abnormalities In the lnferolateral leads (II, Ill, aVF, V3-V6)). She was admitted to the hospital for further evaluation, and echocardiography revealed mildly reduced LV function with apical akinesis (Figure 3B-3C). Coronary angiography demonstrated a patent LAD stent and no obstructive disease. Based on these findings, the patient was diagnosed with a stress cardiomyopathy, and she was discharged on metoprolol succinate and lisinopril. Summary of diagnostic testing for this patient included Viral serologies: SARS-CoV-2, influenza, and RSV negative; Cardiac Biomarkers: Troponin T: 0.129 ng/mL (reference range: less than 0.03 ng/mL); Transthoracic Echocardiogram: LVEF: 44%; LVIDd: 3.5 cm; Normal RV size and function; Apical akinesis; Coronary Evaluation: Coronary angiography: Patent LAD stent.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relation, the association between the event of stress cardiomyopathy and the suspect product of BNT162B2 cannot be completely ruled out. 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.,Linked Report(s) : US-PFIZER INC-202101513854 Same article/drug and different patient/event.
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Echocardiogram, Electrocardiogram, HIV test, Inflammatory marker test
Clinical narrative: pericarditis; This is a literature report. This author reported four reports for different patients with different events. This is third of four reports.  The patient was a 21-year-old woman with a history of idiopathic thrombocytopenic purpura, who presented three weeks after her first dose of the Pfizer-BioNTech vaccine with chest pain that worsened during inspiration and while supine. She was found to have sinus tachycardia, a small pericardial effusion on echocardiogram, and elevated inflammatory markers without evidence of myocardial injury. Based on the clinical presentation, the patient was diagnosed with pericarditis. Her symptoms improved significantly with initiation of colchicine. Long-term follow-up of patients with cardiovascular events following the receipt of mRNAbased COVID-19 vaccines is needed. At the time of publication, all patients presented in this case series demonstrated clinical improvement. Author report the first case series of patients with myocarditis, stress cardiomyopathy, and pericarditis after receiving the mRNA-based COVID-19 vaccines. While we cannot definitively prove association of the vaccines with these adverse events, we believe reporting these complications may enable further monitoring and investigation. However, it is crucial to emphasize that these findings are rare while SARS-CoV-2 infection is associated with a much higher incidence of cardiovascular complications. This patient was 21-year-old Female. Viral serologies: SARS-CoV-2, HIV negative. Cardiac Biomarkers: Troponin T: undetectable. Inflammatory Markers: CRP: 72.6 mg/dL (reference range: less than 3 mg/dL); ESR: 9 mm/hour (reference range: less than 19 mm/hour). Transthoracic Echocardiogram: LVEF: 60%; LVIDd: 4.5 cm; Normal RV size and function; Small pericardial effusion. Cardiac MRI: Not performed. Coronary Evaluation: Not performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information provided, the causal association between the event myocarditis and the suspect drug BNT162B2 cannot be excluded. Case will be reassessed upon receipt of follow-up information.  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.,Linked Report(s) : US-PFIZER INC-202101513854 Same article/drug and different patient/event.
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis, Red blood cell sedimentation rate, SARS-CoV-2 test, Troponin T, Ventricular internal diameter
Clinical narrative: pericarditis; This is a literature report. This author reported four reports for different patients with different events. This is third of four reports.  The patient was a 21-year-old woman with a history of idiopathic thrombocytopenic purpura, who presented three weeks after her first dose of the Pfizer-BioNTech vaccine with chest pain that worsened during inspiration and while supine. She was found to have sinus tachycardia, a small pericardial effusion on echocardiogram, and elevated inflammatory markers without evidence of myocardial injury. Based on the clinical presentation, the patient was diagnosed with pericarditis. Her symptoms improved significantly with initiation of colchicine. Long-term follow-up of patients with cardiovascular events following the receipt of mRNAbased COVID-19 vaccines is needed. At the time of publication, all patients presented in this case series demonstrated clinical improvement. Author report the first case series of patients with myocarditis, stress cardiomyopathy, and pericarditis after receiving the mRNA-based COVID-19 vaccines. While we cannot definitively prove association of the vaccines with these adverse events, we believe reporting these complications may enable further monitoring and investigation. However, it is crucial to emphasize that these findings are rare while SARS-CoV-2 infection is associated with a much higher incidence of cardiovascular complications. This patient was 21-year-old Female. Viral serologies: SARS-CoV-2, HIV negative. Cardiac Biomarkers: Troponin T: undetectable. Inflammatory Markers: CRP: 72.6 mg/dL (reference range: less than 3 mg/dL); ESR: 9 mm/hour (reference range: less than 19 mm/hour). Transthoracic Echocardiogram: LVEF: 60%; LVIDd: 4.5 cm; Normal RV size and function; Small pericardial effusion. Cardiac MRI: Not performed. Coronary Evaluation: Not performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information provided, the causal association between the event myocarditis and the suspect drug BNT162B2 cannot be excluded. Case will be reassessed upon receipt of follow-up information.  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.,Linked Report(s) : US-PFIZER INC-202101513854 Same article/drug and different patient/event.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: Difficulty breathing; Cough; Body aches; Headache; Lower back pain; Fatigue; I received my COVID-19 booster; This is a spontaneous report from a contactable pharmacist. This 53-year-old male pharmacist (patient) reported for himself that. A 53-years-old male patient received BNT162B2 (formulation: Solution for injection, Lot Number: FG3527), via an unspecified route of administration on 03Nov2021 (age at vaccine 53-years-old as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported he was in excellent health otherwise, no use of medications. The patient previously received historical vaccine BNT162B2 (formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on unspecified date DOSE 1, SINGLE, received second dose BNT162B2 (formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on unspecified date DOSE 2, SINGLE, for covid-19 immunisation. The patient had difficulty breathing, cough, body aches, headache, lower back pain and fatigue from 04Nov2021. The clinical outcome of the events Difficulty breathing, Headache, Lower back pain was recovered 04Nov2021 and Cough, Body aches and Fatigue was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain
Clinical narrative: Difficulty breathing; Cough; Body aches; Headache; Lower back pain; Fatigue; I received my COVID-19 booster; This is a spontaneous report from a contactable pharmacist. This 53-year-old male pharmacist (patient) reported for himself that. A 53-years-old male patient received BNT162B2 (formulation: Solution for injection, Lot Number: FG3527), via an unspecified route of administration on 03Nov2021 (age at vaccine 53-years-old as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported he was in excellent health otherwise, no use of medications. The patient previously received historical vaccine BNT162B2 (formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on unspecified date DOSE 1, SINGLE, received second dose BNT162B2 (formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on unspecified date DOSE 2, SINGLE, for covid-19 immunisation. The patient had difficulty breathing, cough, body aches, headache, lower back pain and fatigue from 04Nov2021. The clinical outcome of the events Difficulty breathing, Headache, Lower back pain was recovered 04Nov2021 and Cough, Body aches and Fatigue was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Immunisation, Musculoskeletal chest pain
Clinical narrative: Severe pain on right rib; traveling pain from mid back to under breast; traveling pain from mid back to under breast; Shingles; Dose Number: 3; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number was Unknown, Expiration Date: Unknown) dose 3 via an unspecified route of administration, administered in Arm Right on 30Oct2021 at 12:00 as Dose 3 (Booster), single (age at vaccination 68 years) for covid-19 immunisation administered in Health Clinic. Medical history included high bp, cholesterol, hypothyroidism from an unknown date and unknown if ongoing. No known allergies were reported. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included atorvastatin taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium taken for an unspecified indication, start and stop date were not reported; valsartan taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (Batch/Lot Number was Unknown, Expiration Date: Unknown) dose 2 via an unspecified route of administration, administered in Left arm on 05Mar2021 at 01:00pm (age at vaccination 68 years) as dose 2, single for covid-19 immunisation and dose 1 of BNT162B2 (Batch/Lot Number was Unknown, Expiration Date: Unknown) via an unspecified route of administration, administered in right arm on 08Feb2021 at 02:00pm (age at vaccination 68 years) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient did not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Oct2021, the patient received dose number: 3 (booster). On 01Nov2021 the patient experienced severe pain on right rib, traveling pain from mid back to under breast. Then the patient states that her doctor diagnosed her with Shingles, however, she still don't have a rash 6 days later. Therapeutic measures were taken for all events with antivirals and pain medication. The patient visited Doctor or other healthcare professional office/clinic visit due to all events. The outcome of all the events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Joint injury, Memory impairment, Musculoskeletal discomfort
Clinical narrative: She had not had the same ankle problem, knee problem and hip problem that was affecting her walk until the first and second day of the first shot; She had not had the same ankle problem, knee problem and hip problem that was affecting her walk until the first and second day of the first shot; She had not had the same ankle problem, knee problem and hip problem that was affecting her walk until the first and second day of the first shot; Driveway at the steering wheel with no memory; This is a spontaneous report from a contactable consumer. A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 15May2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pancreatic failure, Exocrine pancreatic insufficiency started maybe 8 months before she ever got the Pfizer vaccine, weight decreased, osteopenia (she has osteopenia as of 4 years ago), pneumonia cryptococcal (dormant Cryptococcus in her lungs), allergy to animal (allergic to pigeon, bat, and bird poop that gets into her system and gives her cryptococcus), lactose intolerance, rhinitis allergic, upper-airway cough syndrome, joint injury (ankle injury) and (knee injury). The patient's concomitant medications were not reported. The patient experienced she had not had the same ankle problem, knee problem and hip problem that was affecting her walk until the first and second day of the first shot and driveway at the steering wheel with no memory on an unknown date 2021. She had not had the same ankle problem, knee problem and hip problem that was affecting her walk until the first and second day of the first shot. This re-developed after the Pfizer shot. Evidently her first shot was 15 May 2021. She believes she reported in her original report, that she came back from her brothers which is over 12 miles away the second day after the first shot or the second shot, maybe it was the second shot. She knows she reported this information in the original report, but she woke up in her driveway at the steering wheel with no memory of how she got home. She was the driver with no passengers. She doesn't remember if this happened with the first shot or second shot, but she reported this particular problem of how she had no recollection of how she got home. The clinical outcome of the event was unknown. Investigation Assessment was provided as no.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Thrombosis
Clinical narrative: 2 blood clots in my leg; experienced a severe lightheaded situation; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on unspecified date in 2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date in 2021 as dose 1, single for COVID-19 immunization. It was reported that patient was a male, 59 years old and he received the Pfizer COVID 19 vaccine shots this past spring (2021), he will not be getting the booster shot. A couple of weeks after getting the second shot, he experienced a severe lightheaded situation (which occurred another few times in the ensuing months). He also developed 2 blood clots in his leg 6 weeks after the shots. He realized he might be 1 in 10,000, or 1,000, or whatever, but he had been a healthy person his whole life, and the past months have been difficult.  The outcome of the events was unknown.   The lot number for the vaccine BNT162b2 was not provided and will be requested during follow-up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller said she called this morning to report that she had COVID-19 after getting 2 doses of the Pfizer COVID-19 vaccine; Caller said she called this morning to report that she had COVID-19 after getting 2 doses of the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer (Patient) or other non hcp. A 74 years-old female patient received bnt162b2 (COMIRNATY), (Formulation: Solution for injection, Lot Number was EL9266, Expiration Date: 31May2021) DOSE 1, 0.3 ML SINGLE via an unspecified route of administration, administered in Arm Left on 20Feb2021 13:40 (age at vaccination 74 years old) for covid-19 immunization. Patient also received bnt162b2 (COMIRNATY), (Formulation: Solution for injection, Lot Number was EN6206, Expiration Date: 30Jun2021) DOSE 2, 0.3 ML SINGLE via an unspecified route of administration, administered in Arm Left on 13Mar2021 13:40 (age at vaccination 74 years old) for covid-19 immunization. Medical history included both her parents had strokes, but they passed away many years ago, Blood pressure high, Acid reflux, ulcer, thyroid from an unknown date and unknown if ongoing. Family history include both her parents had strokes, but they passed away many years ago. Concomitant medication(s) included THYROID (armour thyroid 15 mg, once daily) for thyroid from an unspecified start date and ongoing; OMEPRAZOLE (Protonix 40mg once daily) taken for ulcer, Acid reflux from an unspecified start date and ongoing; carvedilol (3.215mg twice a day) also added that her dosage was just changed to 3.215mg twice a day taken for Blood pressure high from an unspecified start date and ongoing. Prior to Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. On 22Oct2021 the patient said she called this morning to report that she had covid-19 after getting 2 doses of the Pfizer covid-19 vaccine, caller said she called this morning to report that she had covid-19 after getting 2 doses of the Pfizer covid-19 vaccine on unspecified date of 2021. Caller questioned that she called this morning to report that she had COVID-19 after getting 2 doses of the Pfizer COVID-19 vaccine. Her reference number is withheld. Caller wanted to know why did she get the virus after being vaccinated. AE(s) require a visit to Emergency Room. The patient underwent lab Covid test on 20Oct2021 and it was negative. She did another Covid test on 22Oct2021 and got the results on 23Oct2021 that it was positive. Patient also stated that her symptoms are better, but she had to go get the monoclonal antibodies treatment. The outcome of covid 19 event was recovering and outcome of after getting 2 doses of the Pfizer covid-19 vaccine was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: excessive sweating; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on unspecified date, as dose 1, single for COVID-19 immunization. The patient medical history includes Type 2 diabetes. The patient concomitant medication was not reported. The patient experienced excessive sweating no fever. The outcome of the event was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient had pcr test which confirmed he was covid positive; Patient had pcr test which confirmed he was covid positive; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0150) on 02Apr2021 (at the age of 52 years old) as dose 1, single and on 23Apr2021 (Lot Number: ER8735) as dose 2, single both via an unspecified route of administration for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. Patient 6 months following primary series was close contact to a household member with covid. Patient had pcr test which confirmed he was covid positive. Symptoms include mild cough. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on an unspecified date in 2021 and sars-cov-2 test: positive on 06Nov2021. The outcome of the event vaccination failure was not recovered and for all other events unknown.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Myocarditis, Supraventricular tachycardia
Clinical narrative: Myocarditis; Superventricular Tachycardia of 239; This is a spontaneous report from a contactable consumer(Patient). A patient of unspecified age and gender received bnt162b2 (COMIRNARY; Formulation, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced myocarditis and superventricular tachycardia of 239 on an unspecified date. The patient underwent lab tests and procedures which included heart rate: 239 on Superventricular Tachycardia of 239. The outcome of an event is unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Pain
Clinical narrative: She also have never pinch/pain and is on disability; gonna die, could not get out couch. I wouldn't get this vaccine if I were to know this; gonna die, could not get out couch. I wouldn't get this vaccine if I were to know this; This is a spontaneous report from a contactable consumer.A 61-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on 05Nov2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient stated, she received the second dose of the Pfizer covid vaccine last Friday, 05Nov2021. She was told that she may feel a little tired and aching in hand, but she said she felt like she is gonna die, could not get out couch. I wouldn't get this vaccine if I were to know this. She stated, its been 5 days and its more than she can handle. She also have never pinch/pain and is on disability. She stated, she just wanted to report about her experience. The clinical outcome of the events was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Palpitations
Clinical narrative: heart palpitations; severe chills; This is a spontaneous report from a contactable consumer (patient's husband) via medical information team. A 63-year-old female patient received BNT162B2 (COMIRNATY, solution for injection; lot number: er2613 and expiry date was not reported), via an unspecified route of administration, on 16Apr2021 (at the age of 63-year-old), as dose 2, single, for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Historical vaccine included BNT162B2 (COMIRNATY, solution for injection; lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single, for covid-19 immunization. On 16Apr2021, the patient experienced severe chills and heart palpitations that lasted for 3 hours. The reporter stated that, it was a 1-time event that lasted about 2-3 hours and the patient was fine afterwards. The outcome of the events was recovered on 16Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Electrocardiogram, Investigation, Overdose, Product preparation error
Clinical narrative: They injected the full vial of the 5 doses undiluted.; They injected the full vial of the 5 doses undiluted.; This is a spontaneous report from a contactable consumer, the patient.  A 31-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, Lot number: FD0809), via an unspecified route of administration, in arm left on 30Oct2021 at 12:00 as DOSE 1, SINGLE (age at vaccination 31 years) for covid-19 immunization. Medical history included allergies to sulfa and, amoxicillin. No other vaccine was received in four weeks. The patient did not have covid prior vaccination. Concomitant medications included men's one a day, vitamin c, zinc since an unknown date. The patient was injected the full vial of the 5 doses undiluted on 31Oct2021 at 15:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab that included tests EKG, chest X-ray, bloodwork on an unspecified date in 2021. The patient was not tested for covid post vaccination. Therapeutic measures were taken as a result of the event overdose with anti-inflammatory IV.
Sex: F
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: surgery for cataract; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 2021 as dose 2, single for COVID-19 immunisation. The patient's medical history included COVID-19. she was diagnosed with covid before receiving the first two doses of the vaccine and had waited for the 90 days between her diagnosis and first dose. Reporter said she was treated with the monoclonal infusions. There were no concomitant medications. Historical vaccine included BNT162B2 (COMIRNATY, solution for injection, Lot number unknown), dose 1 via an unspecified route of administration on May2021 (at the age of 70-Years-old) as dose 1, single for COVID-19 immunisation and experienced Had no energy at all and Felt down. On an unknown date in 2021, the patient was scheduled for surgery for cataract. The reporter was planned to get her booster dose of the vaccine this month. She also had cataract surgery this month with one lens being replaced the last week in November and the other lens being replaced the first week of December. She was going to be on antibiotics and steroids. It was reported that the patient will be taking Prolensa for two weeks, Prednisolone for the whole month for both eyes, and Moxifloxacin for 9 days. Reporter would like to know if there are any interactions between the medications she will be taking for the surgery and the vaccine. It was reported that she will start Moxifloxacin 2 days before the surgery and then takes it for one week later. A friend that was on a steroid and had only one eye got her thinking about being on the steroids and COVID. Reporter clarified that the friend that had only one eye and was on steroids had nothing to do with the vaccine, but it just got her thinking. All this was unknown, and things change. She was worried about it. If they say she had to wait two or three months she will. Reporter was also informed that prednisolone was a steroid and are considered an immunosuppressant. People receiving medications that weaken the immune system (immunosuppressants) may have a lower response to Comirnaty or the Pfizer- BioNTech COVID-19 Vaccine. Reporter enquired whether she can wait to take the booster in February, two months after the surgery. With the second dose she had no problem. She exercised every day. She had a check-up every year with multiple doctors. It was reported that she doesn't have vaccination card to provide lot, and expiry. The card was locked up with her passport. It was clarified that she had not started the medications Prolensa, Prednisolone, or Moxifloxacin. At the time of this report, the outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: having severe arm pain since her first dose and the pain "has not stopped"; pain affects her ability to take off the seatbelt and take off her shirt; arm pain/It went from shoulder down to elbow; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 52-years-old female patient reported for herself that she received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FF2587), via an unspecified route of administration on 13Sep2021 (age at vaccination was 52 years) as dose 1, single and second dose of bnt162b2 (Lot Number: FF2589), via an unspecified route of administration on 04Oct2021 (age at vaccination was 52 years) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had reaction to the Covid-vaccine. Patient complained that she does not take vaccines and had got covid vaccine because that was a mandate and she was forced for it. She got that on the last possible date to get the vaccine. On an unspecified date in Sep2021, the patient was having severe arm pain since her first dose and the pain had not stopped. The patient reported that the pain affected her ability to take off the seatbelt and take off her shirt. Patient stated that it had been constant since first shot. It went from shoulder down to elbow. It did hurt when she moved. This report was non-serious. Investigation assessment was not reported.   The outcome of the event pain in arm was not recovered while other events was unknown.