chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Ultrasound Doppler
Clinical narrative: Left lower leg edema present with tight calf up to thigh Given Enoxaparin 60mg bid x 5 days then Pradaxa 150mg thereafter
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Hypoaesthesia, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Left lower leg edema present with tight calf up to thigh Given Enoxaparin 60mg bid x 5 days then Pradaxa 150mg thereafter
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Ultrasound Doppler, Ultrasound scan abnormal, Ultrasound scan normal
Clinical narrative: Left lower leg edema present with tight calf up to thigh Given Enoxaparin 60mg bid x 5 days then Pradaxa 150mg thereafter
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Peripheral swelling, Skin tightness, Ultrasound scan
Clinical narrative: Left lower leg edema present with tight calf up to thigh Given Enoxaparin 60mg bid x 5 days then Pradaxa 150mg thereafter
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Back pain, Body temperature increased, Chest discomfort, Chest pain
Clinical narrative: I went to the emergency room at Hospital on April 14, 2021,  after experiencing chest pain and shortness of breath. After an abnormal EKG, blood tests showed a high troponin level. An ultrasound determined my heart ejection fraction had declined to 35-40 percent. An angiogram was performed that showed no blockages or tears in my heart. I was diagnosed with Myocarditis and admitted to the hospital. Over the next 36 hours my troponin level rose to more than 11 before starting to decline. I have prescribed a number of medications for treatment. On April 22 I had a cardiac MRI which confirmed the Myocarditis diagnosis. My heart function has improved to 55 percent and an EKG showed normal rhythm.  I have more tests and follow ups scheduled in the coming weeks.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Cold sweat, Discomfort, Dyspnoea, Echocardiogram abnormal
Clinical narrative: I went to the emergency room at Hospital on April 14, 2021,  after experiencing chest pain and shortness of breath. After an abnormal EKG, blood tests showed a high troponin level. An ultrasound determined my heart ejection fraction had declined to 35-40 percent. An angiogram was performed that showed no blockages or tears in my heart. I was diagnosed with Myocarditis and admitted to the hospital. Over the next 36 hours my troponin level rose to more than 11 before starting to decline. I have prescribed a number of medications for treatment. On April 22 I had a cardiac MRI which confirmed the Myocarditis diagnosis. My heart function has improved to 55 percent and an EKG showed normal rhythm.  I have more tests and follow ups scheduled in the coming weeks.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Ejection fraction decreased, Electrocardiogram abnormal, Headache, Liver function test increased, Malaise
Clinical narrative: I went to the emergency room at Hospital on April 14, 2021,  after experiencing chest pain and shortness of breath. After an abnormal EKG, blood tests showed a high troponin level. An ultrasound determined my heart ejection fraction had declined to 35-40 percent. An angiogram was performed that showed no blockages or tears in my heart. I was diagnosed with Myocarditis and admitted to the hospital. Over the next 36 hours my troponin level rose to more than 11 before starting to decline. I have prescribed a number of medications for treatment. On April 22 I had a cardiac MRI which confirmed the Myocarditis diagnosis. My heart function has improved to 55 percent and an EKG showed normal rhythm.  I have more tests and follow ups scheduled in the coming weeks.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pericarditis, Pyrexia, Troponin
Clinical narrative: I went to the emergency room at Hospital on April 14, 2021,  after experiencing chest pain and shortness of breath. After an abnormal EKG, blood tests showed a high troponin level. An ultrasound determined my heart ejection fraction had declined to 35-40 percent. An angiogram was performed that showed no blockages or tears in my heart. I was diagnosed with Myocarditis and admitted to the hospital. Over the next 36 hours my troponin level rose to more than 11 before starting to decline. I have prescribed a number of medications for treatment. On April 22 I had a cardiac MRI which confirmed the Myocarditis diagnosis. My heart function has improved to 55 percent and an EKG showed normal rhythm.  I have more tests and follow ups scheduled in the coming weeks.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Wall motion score index abnormal
Clinical narrative: I went to the emergency room at Hospital on April 14, 2021,  after experiencing chest pain and shortness of breath. After an abnormal EKG, blood tests showed a high troponin level. An ultrasound determined my heart ejection fraction had declined to 35-40 percent. An angiogram was performed that showed no blockages or tears in my heart. I was diagnosed with Myocarditis and admitted to the hospital. Over the next 36 hours my troponin level rose to more than 11 before starting to decline. I have prescribed a number of medications for treatment. On April 22 I had a cardiac MRI which confirmed the Myocarditis diagnosis. My heart function has improved to 55 percent and an EKG showed normal rhythm.  I have more tests and follow ups scheduled in the coming weeks.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram, Arthralgia, Back pain, Chest pain, Chills
Clinical narrative: I went to the emergency room at Hospital on April 14, 2021,  after experiencing chest pain and shortness of breath. After an abnormal EKG, blood tests showed a high troponin level. An ultrasound determined my heart ejection fraction had declined to 35-40 percent. An angiogram was performed that showed no blockages or tears in my heart. I was diagnosed with Myocarditis and admitted to the hospital. Over the next 36 hours my troponin level rose to more than 11 before starting to decline. I have prescribed a number of medications for treatment. On April 22 I had a cardiac MRI which confirmed the Myocarditis diagnosis. My heart function has improved to 55 percent and an EKG showed normal rhythm.  I have more tests and follow ups scheduled in the coming weeks.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Ejection fraction, Ejection fraction decreased, Electrocardiogram, Headache
Clinical narrative: I went to the emergency room at Hospital on April 14, 2021,  after experiencing chest pain and shortness of breath. After an abnormal EKG, blood tests showed a high troponin level. An ultrasound determined my heart ejection fraction had declined to 35-40 percent. An angiogram was performed that showed no blockages or tears in my heart. I was diagnosed with Myocarditis and admitted to the hospital. Over the next 36 hours my troponin level rose to more than 11 before starting to decline. I have prescribed a number of medications for treatment. On April 22 I had a cardiac MRI which confirmed the Myocarditis diagnosis. My heart function has improved to 55 percent and an EKG showed normal rhythm.  I have more tests and follow ups scheduled in the coming weeks.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: I went to the emergency room at Hospital on April 14, 2021,  after experiencing chest pain and shortness of breath. After an abnormal EKG, blood tests showed a high troponin level. An ultrasound determined my heart ejection fraction had declined to 35-40 percent. An angiogram was performed that showed no blockages or tears in my heart. I was diagnosed with Myocarditis and admitted to the hospital. Over the next 36 hours my troponin level rose to more than 11 before starting to decline. I have prescribed a number of medications for treatment. On April 22 I had a cardiac MRI which confirmed the Myocarditis diagnosis. My heart function has improved to 55 percent and an EKG showed normal rhythm.  I have more tests and follow ups scheduled in the coming weeks.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin, Troponin increased, Ultrasound scan, Vital signs measurement
Clinical narrative: I went to the emergency room at Hospital on April 14, 2021,  after experiencing chest pain and shortness of breath. After an abnormal EKG, blood tests showed a high troponin level. An ultrasound determined my heart ejection fraction had declined to 35-40 percent. An angiogram was performed that showed no blockages or tears in my heart. I was diagnosed with Myocarditis and admitted to the hospital. Over the next 36 hours my troponin level rose to more than 11 before starting to decline. I have prescribed a number of medications for treatment. On April 22 I had a cardiac MRI which confirmed the Myocarditis diagnosis. My heart function has improved to 55 percent and an EKG showed normal rhythm.  I have more tests and follow ups scheduled in the coming weeks.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram normal, Cardiac imaging procedure abnormal, Chest pain, Dyspnoea, Echocardiogram
Clinical narrative: I went to the emergency room at Hospital on April 14, 2021,  after experiencing chest pain and shortness of breath. After an abnormal EKG, blood tests showed a high troponin level. An ultrasound determined my heart ejection fraction had declined to 35-40 percent. An angiogram was performed that showed no blockages or tears in my heart. I was diagnosed with Myocarditis and admitted to the hospital. Over the next 36 hours my troponin level rose to more than 11 before starting to decline. I have prescribed a number of medications for treatment. On April 22 I had a cardiac MRI which confirmed the Myocarditis diagnosis. My heart function has improved to 55 percent and an EKG showed normal rhythm.  I have more tests and follow ups scheduled in the coming weeks.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Myocarditis, Troponin increased, Ultrasound scan abnormal
Clinical narrative: I went to the emergency room at Hospital on April 14, 2021,  after experiencing chest pain and shortness of breath. After an abnormal EKG, blood tests showed a high troponin level. An ultrasound determined my heart ejection fraction had declined to 35-40 percent. An angiogram was performed that showed no blockages or tears in my heart. I was diagnosed with Myocarditis and admitted to the hospital. Over the next 36 hours my troponin level rose to more than 11 before starting to decline. I have prescribed a number of medications for treatment. On April 22 I had a cardiac MRI which confirmed the Myocarditis diagnosis. My heart function has improved to 55 percent and an EKG showed normal rhythm.  I have more tests and follow ups scheduled in the coming weeks.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: I went to the emergency room at Hospital on April 14, 2021,  after experiencing chest pain and shortness of breath. After an abnormal EKG, blood tests showed a high troponin level. An ultrasound determined my heart ejection fraction had declined to 35-40 percent. An angiogram was performed that showed no blockages or tears in my heart. I was diagnosed with Myocarditis and admitted to the hospital. Over the next 36 hours my troponin level rose to more than 11 before starting to decline. I have prescribed a number of medications for treatment. On April 22 I had a cardiac MRI which confirmed the Myocarditis diagnosis. My heart function has improved to 55 percent and an EKG showed normal rhythm.  I have more tests and follow ups scheduled in the coming weeks.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Ejection fraction, Myocarditis, Troponin I
Clinical narrative: I went to the emergency room at Hospital on April 14, 2021,  after experiencing chest pain and shortness of breath. After an abnormal EKG, blood tests showed a high troponin level. An ultrasound determined my heart ejection fraction had declined to 35-40 percent. An angiogram was performed that showed no blockages or tears in my heart. I was diagnosed with Myocarditis and admitted to the hospital. Over the next 36 hours my troponin level rose to more than 11 before starting to decline. I have prescribed a number of medications for treatment. On April 22 I had a cardiac MRI which confirmed the Myocarditis diagnosis. My heart function has improved to 55 percent and an EKG showed normal rhythm.  I have more tests and follow ups scheduled in the coming weeks.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Type 1 diabetes mellitus, Urticaria
Clinical narrative: DVT; multiple bilateral pulmonary embolisms; rash; hives on my lower abdomen; calf injury due to extreme pain that felt like a constant cramp; This is a spontaneous report from a contactable Other HCP (patient) .   A 41-years-old no pregnant  female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021 16:30 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation.Age at vacciantion:41 years.  No  other vaccine in four weeks. No COVID prior vaccination Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing , Hashimoto's Disease from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) and levothyroxine (LEVOTHYROXINE) . The patient experienced DVT followed by multiple bilateral pulmonary . The clinical course was reported as follows:"Within 5 hours of the first dose I got a 3" in diameter rash and hives on my lower abdomen, which I reported when receiving my second dose. About a week before the second dose, I self-diagnosed myself with a calf injury due to extreme pain that felt like a constant cramp that lasted until my second dose. After the second dose, I was hospitalized 5 days (16Feb2021-20Feb2021) with multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER by a nurse practitioner, and told that my previously self diagnosed leg injury was really DVT - I actually left the hospital with one blood clot still in my leg.Hospital's Cardiac ICU by physician's transport because my case was too to be treated at (Withheld). I am lucky to have survived this-please warn people of the symptoms" The patient underwent lab tests and procedures which included antiphospholipid antibodies (unknown date): unknown results (won't be  in until mid-Jun because it requires testing 12 weeks apart)-tested negative for genetic conditions that could have caused the clots , sars-cov-2 test: negative on 16Feb2021.The events DVT and pulmonary embolism resulted in Emergency Room visti /Phisician office visit .The event "DVT" was treated with Heparin, still on blood thinner.  The patient received the second dose on 08Feb2021 left arm (Lot#BL9269).The outcome of the event DVT was recovering.The outcome of the other events was unkonwn; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events Deep vein thrombosis, Pulmonary embolism and Pain in extremity and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : same report/patient, different dose/AE
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: DVT; multiple bilateral pulmonary embolisms; rash; hives on my lower abdomen; calf injury due to extreme pain that felt like a constant cramp; This is a spontaneous report from a contactable Other HCP (patient) .   A 41-years-old no pregnant  female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021 16:30 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation.Age at vacciantion:41 years.  No  other vaccine in four weeks. No COVID prior vaccination Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing , Hashimoto's Disease from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) and levothyroxine (LEVOTHYROXINE) . The patient experienced DVT followed by multiple bilateral pulmonary . The clinical course was reported as follows:"Within 5 hours of the first dose I got a 3" in diameter rash and hives on my lower abdomen, which I reported when receiving my second dose. About a week before the second dose, I self-diagnosed myself with a calf injury due to extreme pain that felt like a constant cramp that lasted until my second dose. After the second dose, I was hospitalized 5 days (16Feb2021-20Feb2021) with multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER by a nurse practitioner, and told that my previously self diagnosed leg injury was really DVT - I actually left the hospital with one blood clot still in my leg.Hospital's Cardiac ICU by physician's transport because my case was too to be treated at (Withheld). I am lucky to have survived this-please warn people of the symptoms" The patient underwent lab tests and procedures which included antiphospholipid antibodies (unknown date): unknown results (won't be  in until mid-Jun because it requires testing 12 weeks apart)-tested negative for genetic conditions that could have caused the clots , sars-cov-2 test: negative on 16Feb2021.The events DVT and pulmonary embolism resulted in Emergency Room visti /Phisician office visit .The event "DVT" was treated with Heparin, still on blood thinner.  The patient received the second dose on 08Feb2021 left arm (Lot#BL9269).The outcome of the event DVT was recovering.The outcome of the other events was unkonwn; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events Deep vein thrombosis, Pulmonary embolism and Pain in extremity and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : same report/patient, different dose/AE
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Diabetic ketoacidosis, Dyspnoea, Electrocardiogram abnormal, Intensive care
Clinical narrative: DVT; multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER; one blood clot still in my leg/ blood clots in both lungs; This is a spontaneous report from a contactable Other HCP.  A 41-year-old female reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number BL9269), intramuscular into the left arm on 08Feb2021 at single dose for COVID-19 immunization.  No COVID prior vaccination. Medical history included type 1 diabetes mellitus, Hashimoto's Disease. Concomitant medication(s) included metformin (METFORMIN) and levothyroxine (LEVOTHYROXINE) .  The patient had received the first dose of BNT162B2 on 19Jan2021. About a week before the second dose, she self-diagnosed with a calf injury due to extreme pain that felt like a constant cramp that lasted until her second dose. After the second dose, she was hospitalized 5 days (16Feb2021-20Feb2021) with multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER by a nurse practitioner, and told that her previously self diagnosed leg injury was really DVT. She actually left the hospital with one blood clot still in her leg.Hospital's Cardiac ICU by physician's transport because her case was too to be treated at  (Withheld).  The patient underwent lab tests and procedures which included antiphospholipid antibodies (unknown date): unknown results (won't be  in until mid-Jun because it requires testing 12 weeks apart)-tested negative for genetic conditions that could have caused the clots , had a negative COVID nasal swab test on 16Feb2021.The events DVT and pulmonary embolism resulted in Emergency Room visti /Phisician office visit .The event "DVT" was treated with Heparin, still on blood thinner.  The outcome of the event DVT was recovering.; Sender's Comments: Based on vaccine-event chronological association causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021427569 same patient, and drug different dose
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Laboratory test, Muscle spasms, Pain in extremity, Pulmonary embolism, Rash
Clinical narrative: DVT; multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER; one blood clot still in my leg/ blood clots in both lungs; This is a spontaneous report from a contactable Other HCP.  A 41-year-old female reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number BL9269), intramuscular into the left arm on 08Feb2021 at single dose for COVID-19 immunization.  No COVID prior vaccination. Medical history included type 1 diabetes mellitus, Hashimoto's Disease. Concomitant medication(s) included metformin (METFORMIN) and levothyroxine (LEVOTHYROXINE) .  The patient had received the first dose of BNT162B2 on 19Jan2021. About a week before the second dose, she self-diagnosed with a calf injury due to extreme pain that felt like a constant cramp that lasted until her second dose. After the second dose, she was hospitalized 5 days (16Feb2021-20Feb2021) with multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER by a nurse practitioner, and told that her previously self diagnosed leg injury was really DVT. She actually left the hospital with one blood clot still in her leg.Hospital's Cardiac ICU by physician's transport because her case was too to be treated at  (Withheld).  The patient underwent lab tests and procedures which included antiphospholipid antibodies (unknown date): unknown results (won't be  in until mid-Jun because it requires testing 12 weeks apart)-tested negative for genetic conditions that could have caused the clots , had a negative COVID nasal swab test on 16Feb2021.The events DVT and pulmonary embolism resulted in Emergency Room visti /Phisician office visit .The event "DVT" was treated with Heparin, still on blood thinner.  The outcome of the event DVT was recovering.; Sender's Comments: Based on vaccine-event chronological association causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021427569 same patient, and drug different dose
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Type 1 diabetes mellitus, Urticaria
Clinical narrative: DVT; multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER; one blood clot still in my leg/ blood clots in both lungs; This is a spontaneous report from a contactable Other HCP.  A 41-year-old female reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number BL9269), intramuscular into the left arm on 08Feb2021 at single dose for COVID-19 immunization.  No COVID prior vaccination. Medical history included type 1 diabetes mellitus, Hashimoto's Disease. Concomitant medication(s) included metformin (METFORMIN) and levothyroxine (LEVOTHYROXINE) .  The patient had received the first dose of BNT162B2 on 19Jan2021. About a week before the second dose, she self-diagnosed with a calf injury due to extreme pain that felt like a constant cramp that lasted until her second dose. After the second dose, she was hospitalized 5 days (16Feb2021-20Feb2021) with multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER by a nurse practitioner, and told that her previously self diagnosed leg injury was really DVT. She actually left the hospital with one blood clot still in her leg.Hospital's Cardiac ICU by physician's transport because her case was too to be treated at  (Withheld).  The patient underwent lab tests and procedures which included antiphospholipid antibodies (unknown date): unknown results (won't be  in until mid-Jun because it requires testing 12 weeks apart)-tested negative for genetic conditions that could have caused the clots , had a negative COVID nasal swab test on 16Feb2021.The events DVT and pulmonary embolism resulted in Emergency Room visti /Phisician office visit .The event "DVT" was treated with Heparin, still on blood thinner.  The outcome of the event DVT was recovering.; Sender's Comments: Based on vaccine-event chronological association causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021427569 same patient, and drug different dose
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Antiphospholipid antibodies, Deep vein thrombosis, Pain in extremity, Pulmonary embolism, Rash
Clinical narrative: DVT; multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER; one blood clot still in my leg/ blood clots in both lungs; This is a spontaneous report from a contactable Other HCP.  A 41-year-old female reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number BL9269), intramuscular into the left arm on 08Feb2021 at single dose for COVID-19 immunization.  No COVID prior vaccination. Medical history included type 1 diabetes mellitus, Hashimoto's Disease. Concomitant medication(s) included metformin (METFORMIN) and levothyroxine (LEVOTHYROXINE) .  The patient had received the first dose of BNT162B2 on 19Jan2021. About a week before the second dose, she self-diagnosed with a calf injury due to extreme pain that felt like a constant cramp that lasted until her second dose. After the second dose, she was hospitalized 5 days (16Feb2021-20Feb2021) with multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER by a nurse practitioner, and told that her previously self diagnosed leg injury was really DVT. She actually left the hospital with one blood clot still in her leg.Hospital's Cardiac ICU by physician's transport because her case was too to be treated at  (Withheld).  The patient underwent lab tests and procedures which included antiphospholipid antibodies (unknown date): unknown results (won't be  in until mid-Jun because it requires testing 12 weeks apart)-tested negative for genetic conditions that could have caused the clots , had a negative COVID nasal swab test on 16Feb2021.The events DVT and pulmonary embolism resulted in Emergency Room visti /Phisician office visit .The event "DVT" was treated with Heparin, still on blood thinner.  The outcome of the event DVT was recovering.; Sender's Comments: Based on vaccine-event chronological association causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021427569 same patient, and drug different dose
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: DVT; multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER; one blood clot still in my leg/ blood clots in both lungs; This is a spontaneous report from a contactable Other HCP.  A 41-year-old female reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number BL9269), intramuscular into the left arm on 08Feb2021 at single dose for COVID-19 immunization.  No COVID prior vaccination. Medical history included type 1 diabetes mellitus, Hashimoto's Disease. Concomitant medication(s) included metformin (METFORMIN) and levothyroxine (LEVOTHYROXINE) .  The patient had received the first dose of BNT162B2 on 19Jan2021. About a week before the second dose, she self-diagnosed with a calf injury due to extreme pain that felt like a constant cramp that lasted until her second dose. After the second dose, she was hospitalized 5 days (16Feb2021-20Feb2021) with multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER by a nurse practitioner, and told that her previously self diagnosed leg injury was really DVT. She actually left the hospital with one blood clot still in her leg.Hospital's Cardiac ICU by physician's transport because her case was too to be treated at  (Withheld).  The patient underwent lab tests and procedures which included antiphospholipid antibodies (unknown date): unknown results (won't be  in until mid-Jun because it requires testing 12 weeks apart)-tested negative for genetic conditions that could have caused the clots , had a negative COVID nasal swab test on 16Feb2021.The events DVT and pulmonary embolism resulted in Emergency Room visti /Phisician office visit .The event "DVT" was treated with Heparin, still on blood thinner.  The outcome of the event DVT was recovering.; Sender's Comments: Based on vaccine-event chronological association causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021427569 same patient, and drug different dose
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Antiphospholipid antibodies, Deep vein thrombosis, Pulmonary embolism, SARS-CoV-2 test, Thrombosis
Clinical narrative: DVT; multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER; one blood clot still in my leg/ blood clots in both lungs; This is a spontaneous report from a contactable Other HCP.  A 41-year-old female reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number BL9269), intramuscular into the left arm on 08Feb2021 at single dose for COVID-19 immunization.  No COVID prior vaccination. Medical history included type 1 diabetes mellitus, Hashimoto's Disease. Concomitant medication(s) included metformin (METFORMIN) and levothyroxine (LEVOTHYROXINE) .  The patient had received the first dose of BNT162B2 on 19Jan2021. About a week before the second dose, she self-diagnosed with a calf injury due to extreme pain that felt like a constant cramp that lasted until her second dose. After the second dose, she was hospitalized 5 days (16Feb2021-20Feb2021) with multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER by a nurse practitioner, and told that her previously self diagnosed leg injury was really DVT. She actually left the hospital with one blood clot still in her leg.Hospital's Cardiac ICU by physician's transport because her case was too to be treated at  (Withheld).  The patient underwent lab tests and procedures which included antiphospholipid antibodies (unknown date): unknown results (won't be  in until mid-Jun because it requires testing 12 weeks apart)-tested negative for genetic conditions that could have caused the clots , had a negative COVID nasal swab test on 16Feb2021.The events DVT and pulmonary embolism resulted in Emergency Room visti /Phisician office visit .The event "DVT" was treated with Heparin, still on blood thinner.  The outcome of the event DVT was recovering.; Sender's Comments: Based on vaccine-event chronological association causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021427569 same patient, and drug different dose
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Headache, Vomiting
Clinical narrative: stroke; vomiting; nose bleed; headache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received covid vaccine on 01Apr at noon woke up at 2 am on 06Apr2021 with severe headache, started vomiting and nose bleed at around 7am. The patient had a stroke at 11 am. The event stroke is considered as serious (life-threatening, and medically significant). The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Epistaxis, Headache, Vomiting
Clinical narrative: stroke; vomiting; nose bleed; headache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received covid vaccine on 01Apr at noon woke up at 2 am on 06Apr2021 with severe headache, started vomiting and nose bleed at around 7am. The patient had a stroke at 11 am. The event stroke is considered as serious (life-threatening, and medically significant). The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Epistaxis, Headache, Middle insomnia, Vomiting
Clinical narrative: stroke; vomiting; nose bleed; headache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received covid vaccine on 01Apr at noon woke up at 2 am on 06Apr2021 with severe headache, started vomiting and nose bleed at around 7am. The patient had a stroke at 11 am. The event stroke is considered as serious (life-threatening, and medically significant). The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nephrolithiasis
Clinical narrative: kidney stones; This is a spontaneous report from a contactable consumer (patient). The 53-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization at the age of 53 years old. The patient medical history and concomitant medications were not reported. The patient experienced kidney stones on an unspecified date. Reported as: His second dose was scheduled for 22Mar2021 but he missed it because he was hospitalized with kidney stones. He rescheduled his second dose for the 08Apr2021. He lost his card with the bar code and was wondering how to retrieve it. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he received the first dose of the pfizer covid 19 vaccine on 21Mar2021. Caller stated he tested positive for covid on 3Apr2021; he received the first dose of the pfizer covid 19 vaccine on 21Mar2021. Caller stated he tested positive for covid on 3Apr2021; This is a spontaneous report from a non-contactable consumer (patient) via a medical information team. A 24-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, on 21Mar2021 as single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Stated he received the first dose of the pfizer covid 19 vaccine on 21Mar2021. Stated he tested positive for covid on 03Apr2021 and his quarantine was up on 13Apr2021. Stated his second dose was on 11Apr2021. Caller wanted to know what he was supposed to do when it comes to getting his second dose. At the time of reporting, the outcome of the events was unknown.  Information about Lot/Batch number is not provided. Additional information is expected. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he received the first dose of the pfizer covid 19 vaccine on 21Mar2021. Caller stated he tested positive for covid on 3Apr2021; he received the first dose of the pfizer covid 19 vaccine on 21Mar2021. Caller stated he tested positive for covid on 3Apr2021; This is a spontaneous report from a non-contactable consumer (patient) via a medical information team. A 24-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, on 21Mar2021 as single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Stated he received the first dose of the pfizer covid 19 vaccine on 21Mar2021. Stated he tested positive for covid on 03Apr2021 and his quarantine was up on 13Apr2021. Stated his second dose was on 11Apr2021. Caller wanted to know what he was supposed to do when it comes to getting his second dose. At the time of reporting, the outcome of the events was unknown.  Information about Lot/Batch number is not provided. Additional information is expected. Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arteriogram carotid abnormal, Blood test, Chills, Dysphonia, Fatigue
Clinical narrative: mass on left side of thyroid; Sore throat; left arm soreness and swelling after first dose; left arm soreness and swelling after first dose; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Mar2021 17:10 (Lot Number: EN6199) as single dose on left arm for covid-19 immunization. The patient medical history included COVID-19. Concomitant medications included estrogens conjugated, medroxyprogesterone acetate (PREMPRO) taken for menopause from 2019 and ongoing. The patient left arm became swollen and sore after first dose on 10Mar2021, mass on left side of thyroid on 11Mar2021, sore throat on 11Mar2021. There was no treatment received for the adverse event. The patient did not received any other medications within 2 weeks of vaccination. There was no vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient was diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included CT/CAT Scan on 03Apr2021: a mass on her left thyroid, 40x36x31mm and it is definitely deviating her trachea. Caller stated that she is going to the doctor tomorrow to try to get a biopsy of this mass. The outcome of event mass on left side of thyroid was not recovered, the event left arm became swollen and sore outcome was recovered on 13 Mar 2021, sore throat was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Lymphadenopathy, Myalgia, Nausea, Pain in extremity
Clinical narrative: mass on left side of thyroid; Sore throat; left arm soreness and swelling after first dose; left arm soreness and swelling after first dose; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Mar2021 17:10 (Lot Number: EN6199) as single dose on left arm for covid-19 immunization. The patient medical history included COVID-19. Concomitant medications included estrogens conjugated, medroxyprogesterone acetate (PREMPRO) taken for menopause from 2019 and ongoing. The patient left arm became swollen and sore after first dose on 10Mar2021, mass on left side of thyroid on 11Mar2021, sore throat on 11Mar2021. There was no treatment received for the adverse event. The patient did not received any other medications within 2 weeks of vaccination. There was no vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient was diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included CT/CAT Scan on 03Apr2021: a mass on her left thyroid, 40x36x31mm and it is definitely deviating her trachea. Caller stated that she is going to the doctor tomorrow to try to get a biopsy of this mass. The outcome of event mass on left side of thyroid was not recovered, the event left arm became swollen and sore outcome was recovered on 13 Mar 2021, sore throat was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Thyroid mass
Clinical narrative: mass on left side of thyroid; Sore throat; left arm soreness and swelling after first dose; left arm soreness and swelling after first dose; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Mar2021 17:10 (Lot Number: EN6199) as single dose on left arm for covid-19 immunization. The patient medical history included COVID-19. Concomitant medications included estrogens conjugated, medroxyprogesterone acetate (PREMPRO) taken for menopause from 2019 and ongoing. The patient left arm became swollen and sore after first dose on 10Mar2021, mass on left side of thyroid on 11Mar2021, sore throat on 11Mar2021. There was no treatment received for the adverse event. The patient did not received any other medications within 2 weeks of vaccination. There was no vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient was diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included CT/CAT Scan on 03Apr2021: a mass on her left thyroid, 40x36x31mm and it is definitely deviating her trachea. Caller stated that she is going to the doctor tomorrow to try to get a biopsy of this mass. The outcome of event mass on left side of thyroid was not recovered, the event left arm became swollen and sore outcome was recovered on 13 Mar 2021, sore throat was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Blood test, Chills, Computerised tomogram, Condition aggravated
Clinical narrative: mass on left side of thyroid; Sore throat; left arm soreness and swelling after first dose; left arm soreness and swelling after first dose; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Mar2021 17:10 (Lot Number: EN6199) as single dose on left arm for covid-19 immunization. The patient medical history included COVID-19. Concomitant medications included estrogens conjugated, medroxyprogesterone acetate (PREMPRO) taken for menopause from 2019 and ongoing. The patient left arm became swollen and sore after first dose on 10Mar2021, mass on left side of thyroid on 11Mar2021, sore throat on 11Mar2021. There was no treatment received for the adverse event. The patient did not received any other medications within 2 weeks of vaccination. There was no vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient was diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included CT/CAT Scan on 03Apr2021: a mass on her left thyroid, 40x36x31mm and it is definitely deviating her trachea. Caller stated that she is going to the doctor tomorrow to try to get a biopsy of this mass. The outcome of event mass on left side of thyroid was not recovered, the event left arm became swollen and sore outcome was recovered on 13 Mar 2021, sore throat was unknown.  No follow-up attempts are needed. No further information is expected.