chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, SARS-CoV-2 test, Thrombosis
Clinical narrative: Heart Attack due to blood clot in RCA. Occurred on 4/27/2021 at 11 pm; Heart Attack due to blood clot in RCA. Occurred on 4/27/2021 at 11 pm; This is a spontaneous report from a contactable consumer.  A 57-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 29Mar2021 03:00 (Batch/Lot Number: ER8733) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included pitavastatin calcium taken for an unspecified indication, start and stop date were not reported.  The patient experienced heart attack due to blood clot in rca. occurred on 27Apr2021 at 11 pm. The patient was hospitalized for the reported events and was Life threatening (immediate risk of death from the event). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Apr2021 Nasal Swab. Therapeutic measures were taken as a result of the events which includes Emergency Heart Cath and Stent. The outcome of the events was recovered with sequel.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Chest pain, Dizziness, Heart rate
Clinical narrative: Chest pain; Had irregular pulse; BP dropped; Patient felt faint minutes after receiving second dose of vaccine; Diaphoretic; This is a spontaneous report received from a contactable nurse. A 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 30Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 09Apr2021 for covid-19 immunisation. The patient experienced Patient felt faint minutes after receiving second dose of vaccine, BP dropped, had irregular pulse, became diaphoretic and complained of chest pain on 30Apr2021. The events assessed as non-serious. Unknown patient received any other vaccines within 4 weeks prior to the COVID vaccine. Unknown list of any other medications the patient received within 2 weeks of vaccination. Unknown prior to vaccination, was the patient diagnosed with COVID-19. Unknown since the vaccination, has the patient been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered included Workplace clinic. The events were resulted in Emergency Room Visit. The outcome of the events was reported as unknown.  Information about batch no/lot no has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events blood pressure decreased, irregular pulse, chest pain and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Hyperhidrosis
Clinical narrative: Chest pain; Had irregular pulse; BP dropped; Patient felt faint minutes after receiving second dose of vaccine; Diaphoretic; This is a spontaneous report received from a contactable nurse. A 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 30Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 09Apr2021 for covid-19 immunisation. The patient experienced Patient felt faint minutes after receiving second dose of vaccine, BP dropped, had irregular pulse, became diaphoretic and complained of chest pain on 30Apr2021. The events assessed as non-serious. Unknown patient received any other vaccines within 4 weeks prior to the COVID vaccine. Unknown list of any other medications the patient received within 2 weeks of vaccination. Unknown prior to vaccination, was the patient diagnosed with COVID-19. Unknown since the vaccination, has the patient been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered included Workplace clinic. The events were resulted in Emergency Room Visit. The outcome of the events was reported as unknown.  Information about batch no/lot no has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events blood pressure decreased, irregular pulse, chest pain and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Petechiae, SARS-CoV-2 test, Thrombocytopenia
Clinical narrative: thrombocytopenia/platelets were only 1; a petechial purple pin point areas covering entire body.; This is a spontaneous report was received from a contactable consumer or other non hcp (patient). A 51-years-old Caucasian non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0172) via an unspecified route of administration, in arm left on 22Apr2021 14:00 as single dose for covid-19 immunisation. Medical history included multiple sclerosis. The patient's concomitant medications were not reported.  The patient previously took first dose of bnt162b2 (batch/lot number: ER8733) for covid-19 immunisation on 01Apr2021 at 9:00AM. The patient had experienced hypersensitivity with betadine, compazine, dilaudid and morphine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Apr2021, the patient had started with a petechial purple pinpoint areas covering entire body had blood drawn and admitted for thrombocytopenia and given IVIG 2united Platelets and IV steroids because platelets were only 1. The patient was hospitalized for 3 days. The patient had received treatment with immunoglobulin and platelets. The patient underwent lab tests and procedures which included nasal swab and sars-cov-2 test was negative on 15Jan2021. Case was considered serious as it was reported life threatening. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Fatigue, Gingival bleeding, Immunoglobulin therapy, Petechiae
Clinical narrative: thrombocytopenia/platelets were only 1; a petechial purple pin point areas covering entire body.; This is a spontaneous report was received from a contactable consumer or other non hcp (patient). A 51-years-old Caucasian non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0172) via an unspecified route of administration, in arm left on 22Apr2021 14:00 as single dose for covid-19 immunisation. Medical history included multiple sclerosis. The patient's concomitant medications were not reported.  The patient previously took first dose of bnt162b2 (batch/lot number: ER8733) for covid-19 immunisation on 01Apr2021 at 9:00AM. The patient had experienced hypersensitivity with betadine, compazine, dilaudid and morphine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Apr2021, the patient had started with a petechial purple pinpoint areas covering entire body had blood drawn and admitted for thrombocytopenia and given IVIG 2united Platelets and IV steroids because platelets were only 1. The patient was hospitalized for 3 days. The patient had received treatment with immunoglobulin and platelets. The patient underwent lab tests and procedures which included nasal swab and sars-cov-2 test was negative on 15Jan2021. Case was considered serious as it was reported life threatening. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Platelet transfusion, Purpura, Rash, Thrombocytopenia
Clinical narrative: thrombocytopenia/platelets were only 1; a petechial purple pin point areas covering entire body.; This is a spontaneous report was received from a contactable consumer or other non hcp (patient). A 51-years-old Caucasian non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0172) via an unspecified route of administration, in arm left on 22Apr2021 14:00 as single dose for covid-19 immunisation. Medical history included multiple sclerosis. The patient's concomitant medications were not reported.  The patient previously took first dose of bnt162b2 (batch/lot number: ER8733) for covid-19 immunisation on 01Apr2021 at 9:00AM. The patient had experienced hypersensitivity with betadine, compazine, dilaudid and morphine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Apr2021, the patient had started with a petechial purple pinpoint areas covering entire body had blood drawn and admitted for thrombocytopenia and given IVIG 2united Platelets and IV steroids because platelets were only 1. The patient was hospitalized for 3 days. The patient had received treatment with immunoglobulin and platelets. The patient underwent lab tests and procedures which included nasal swab and sars-cov-2 test was negative on 15Jan2021. Case was considered serious as it was reported life threatening. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Got the second dose of the Pfizer covid vaccine and a 5 days later, tested positive for covid 19; Got the second dose of the Pfizer covid vaccine and a 5 days later, tested positive for covid 19; This is a spontaneous report from a contactable consumer or other non-health care professional. (patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date for covid-19 immunization. The reporter stated that got the second dose of the Pfizer covid vaccine and a 5 days later, tested positive for covid 19 on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on an unspecified date. The outcome of events was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrioventricular block, Cardiac sarcoidosis, Computerised tomogram aorta, Interventricular septum rupture, Magnetic resonance imaging heart
Clinical narrative: MRI heart- injury to septum- PETSCAN =cardiac sarcoid; MRI heart- injury to septum- PETSCAN =cardiac sarcoid; 3 sec heart pause heart block 4 sec heart pause; This is a spontaneous report from a contactable other hcp (nurse). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: Solution for injection, Lot Number: EN51318) via dose 2 via an unspecified route of administration, administered in arm left on 22Mar2021 at 07:45 as single dose for COVID-19 immunisation. The patient medical history included asthma. The patient did not had known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Lot Number: EL9269) via an unspecified route of administration in left arm on 03Mar2021 at 09.30 as single dose for COVID-19 immunisation. The patient did not had COVID prior to vaccination. The patient did not receive other medications in two and four weeks of vaccination. On 25Mar2021, COVID test (nasal swab) was negative. On 18Apr2021, the patient experienced chest, jaw and left arm pain went to the emergency department (ED). On 18Apr2021, troponins were elevated. On 19Apr2021 at 11:00, the patient experienced MRI heart- injury to septum- PET scan =cardiac sarcoid and 3 sec heart pause heart block 4 sec heart pause. The patient was treated with atropine. On 19Apr2021, the patient underwent lab tests and procedures which included computerised tomogram aorta (left/right bundle branch block(L/RBBB) for arrythmia): no aortic dissection/pulmonary embolism (PE), magnetic resonance imaging (MRI) heart: injury to septum and positron emission tomogram (PET): cardiac sarcoid. The events resulted in life threatening illness (immediate risk of death from the event). The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, the reported events of  cardiac sarcoidosis , intraventricular septum rupture and AV block  of the suspected vaccine BNT162B2 cannot be completely excluded. However, more information is required to assess the case properly. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Positron emission tomogram, SARS-CoV-2 test, Troponin
Clinical narrative: MRI heart- injury to septum- PETSCAN =cardiac sarcoid; MRI heart- injury to septum- PETSCAN =cardiac sarcoid; 3 sec heart pause heart block 4 sec heart pause; This is a spontaneous report from a contactable other hcp (nurse). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: Solution for injection, Lot Number: EN51318) via dose 2 via an unspecified route of administration, administered in arm left on 22Mar2021 at 07:45 as single dose for COVID-19 immunisation. The patient medical history included asthma. The patient did not had known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Lot Number: EL9269) via an unspecified route of administration in left arm on 03Mar2021 at 09.30 as single dose for COVID-19 immunisation. The patient did not had COVID prior to vaccination. The patient did not receive other medications in two and four weeks of vaccination. On 25Mar2021, COVID test (nasal swab) was negative. On 18Apr2021, the patient experienced chest, jaw and left arm pain went to the emergency department (ED). On 18Apr2021, troponins were elevated. On 19Apr2021 at 11:00, the patient experienced MRI heart- injury to septum- PET scan =cardiac sarcoid and 3 sec heart pause heart block 4 sec heart pause. The patient was treated with atropine. On 19Apr2021, the patient underwent lab tests and procedures which included computerised tomogram aorta (left/right bundle branch block(L/RBBB) for arrythmia): no aortic dissection/pulmonary embolism (PE), magnetic resonance imaging (MRI) heart: injury to septum and positron emission tomogram (PET): cardiac sarcoid. The events resulted in life threatening illness (immediate risk of death from the event). The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, the reported events of  cardiac sarcoidosis , intraventricular septum rupture and AV block  of the suspected vaccine BNT162B2 cannot be completely excluded. However, more information is required to assess the case properly. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram normal, Atrioventricular block, Bundle branch block left, Bundle branch block right, Cardiac sarcoidosis
Clinical narrative: MRI heart- injury to septum- PETSCAN =cardiac sarcoid; MRI heart- injury to septum- PETSCAN =cardiac sarcoid; 3 sec heart pause heart block 4 sec heart pause; This is a spontaneous report from a contactable other hcp (nurse). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: Solution for injection, Lot Number: EN51318) via dose 2 via an unspecified route of administration, administered in arm left on 22Mar2021 at 07:45 as single dose for COVID-19 immunisation. The patient medical history included asthma. The patient did not had known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Lot Number: EL9269) via an unspecified route of administration in left arm on 03Mar2021 at 09.30 as single dose for COVID-19 immunisation. The patient did not had COVID prior to vaccination. The patient did not receive other medications in two and four weeks of vaccination. On 25Mar2021, COVID test (nasal swab) was negative. On 18Apr2021, the patient experienced chest, jaw and left arm pain went to the emergency department (ED). On 18Apr2021, troponins were elevated. On 19Apr2021 at 11:00, the patient experienced MRI heart- injury to septum- PET scan =cardiac sarcoid and 3 sec heart pause heart block 4 sec heart pause. The patient was treated with atropine. On 19Apr2021, the patient underwent lab tests and procedures which included computerised tomogram aorta (left/right bundle branch block(L/RBBB) for arrythmia): no aortic dissection/pulmonary embolism (PE), magnetic resonance imaging (MRI) heart: injury to septum and positron emission tomogram (PET): cardiac sarcoid. The events resulted in life threatening illness (immediate risk of death from the event). The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, the reported events of  cardiac sarcoidosis , intraventricular septum rupture and AV block  of the suspected vaccine BNT162B2 cannot be completely excluded. However, more information is required to assess the case properly. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac normal, Chest pain, Chills, Fatigue, Implantable defibrillator insertion
Clinical narrative: MRI heart- injury to septum- PETSCAN =cardiac sarcoid; MRI heart- injury to septum- PETSCAN =cardiac sarcoid; 3 sec heart pause heart block 4 sec heart pause; This is a spontaneous report from a contactable other hcp (nurse). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: Solution for injection, Lot Number: EN51318) via dose 2 via an unspecified route of administration, administered in arm left on 22Mar2021 at 07:45 as single dose for COVID-19 immunisation. The patient medical history included asthma. The patient did not had known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Lot Number: EL9269) via an unspecified route of administration in left arm on 03Mar2021 at 09.30 as single dose for COVID-19 immunisation. The patient did not had COVID prior to vaccination. The patient did not receive other medications in two and four weeks of vaccination. On 25Mar2021, COVID test (nasal swab) was negative. On 18Apr2021, the patient experienced chest, jaw and left arm pain went to the emergency department (ED). On 18Apr2021, troponins were elevated. On 19Apr2021 at 11:00, the patient experienced MRI heart- injury to septum- PET scan =cardiac sarcoid and 3 sec heart pause heart block 4 sec heart pause. The patient was treated with atropine. On 19Apr2021, the patient underwent lab tests and procedures which included computerised tomogram aorta (left/right bundle branch block(L/RBBB) for arrythmia): no aortic dissection/pulmonary embolism (PE), magnetic resonance imaging (MRI) heart: injury to septum and positron emission tomogram (PET): cardiac sarcoid. The events resulted in life threatening illness (immediate risk of death from the event). The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, the reported events of  cardiac sarcoidosis , intraventricular septum rupture and AV block  of the suspected vaccine BNT162B2 cannot be completely excluded. However, more information is required to assess the case properly. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Magnetic resonance imaging heart, Myocardial fibrosis, Pain in jaw, Positron emission tomogram abnormal
Clinical narrative: MRI heart- injury to septum- PETSCAN =cardiac sarcoid; MRI heart- injury to septum- PETSCAN =cardiac sarcoid; 3 sec heart pause heart block 4 sec heart pause; This is a spontaneous report from a contactable other hcp (nurse). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: Solution for injection, Lot Number: EN51318) via dose 2 via an unspecified route of administration, administered in arm left on 22Mar2021 at 07:45 as single dose for COVID-19 immunisation. The patient medical history included asthma. The patient did not had known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Lot Number: EL9269) via an unspecified route of administration in left arm on 03Mar2021 at 09.30 as single dose for COVID-19 immunisation. The patient did not had COVID prior to vaccination. The patient did not receive other medications in two and four weeks of vaccination. On 25Mar2021, COVID test (nasal swab) was negative. On 18Apr2021, the patient experienced chest, jaw and left arm pain went to the emergency department (ED). On 18Apr2021, troponins were elevated. On 19Apr2021 at 11:00, the patient experienced MRI heart- injury to septum- PET scan =cardiac sarcoid and 3 sec heart pause heart block 4 sec heart pause. The patient was treated with atropine. On 19Apr2021, the patient underwent lab tests and procedures which included computerised tomogram aorta (left/right bundle branch block(L/RBBB) for arrythmia): no aortic dissection/pulmonary embolism (PE), magnetic resonance imaging (MRI) heart: injury to septum and positron emission tomogram (PET): cardiac sarcoid. The events resulted in life threatening illness (immediate risk of death from the event). The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, the reported events of  cardiac sarcoidosis , intraventricular septum rupture and AV block  of the suspected vaccine BNT162B2 cannot be completely excluded. However, more information is required to assess the case properly. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Troponin increased
Clinical narrative: MRI heart- injury to septum- PETSCAN =cardiac sarcoid; MRI heart- injury to septum- PETSCAN =cardiac sarcoid; 3 sec heart pause heart block 4 sec heart pause; This is a spontaneous report from a contactable other hcp (nurse). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: Solution for injection, Lot Number: EN51318) via dose 2 via an unspecified route of administration, administered in arm left on 22Mar2021 at 07:45 as single dose for COVID-19 immunisation. The patient medical history included asthma. The patient did not had known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Lot Number: EL9269) via an unspecified route of administration in left arm on 03Mar2021 at 09.30 as single dose for COVID-19 immunisation. The patient did not had COVID prior to vaccination. The patient did not receive other medications in two and four weeks of vaccination. On 25Mar2021, COVID test (nasal swab) was negative. On 18Apr2021, the patient experienced chest, jaw and left arm pain went to the emergency department (ED). On 18Apr2021, troponins were elevated. On 19Apr2021 at 11:00, the patient experienced MRI heart- injury to septum- PET scan =cardiac sarcoid and 3 sec heart pause heart block 4 sec heart pause. The patient was treated with atropine. On 19Apr2021, the patient underwent lab tests and procedures which included computerised tomogram aorta (left/right bundle branch block(L/RBBB) for arrythmia): no aortic dissection/pulmonary embolism (PE), magnetic resonance imaging (MRI) heart: injury to septum and positron emission tomogram (PET): cardiac sarcoid. The events resulted in life threatening illness (immediate risk of death from the event). The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, the reported events of  cardiac sarcoidosis , intraventricular septum rupture and AV block  of the suspected vaccine BNT162B2 cannot be completely excluded. However, more information is required to assess the case properly. 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.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Loss of consciousness, Scan, Syncope
Clinical narrative: This is a spontaneous report from a contactable other hcp (registered nurse). A 30-years-old adult female patient of received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number and expiry date was not reported) via an unspecified route of administration on 08Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Apr2021, the patient experinced fainting and she lost consciousness and abdominal pain. Event Verbatim included, She had a fainting and she lost consciousness as one of the staff reporter was asking her question that fainting event occurred on Friday April 16th and so reporter was asking her if she has Vaccinated and she has received her second Pfizer vaccination on prior Thursday which was on April 8th so it was of Pfizer. reporter wish if had more information to provide you. She was taken by ambulance and reporter found out about her six hours later occurred at 9hr in the morning and reporter found out about that by clinical manager that she is in surgery for two hours, So reprter found out that she has an emergency surgery. Reporter was told an identifiable drug identifiable patient and identifiable reaction, So unfortunately, They would not tell me what precipitated the emergency surgery. So reporter know that it's not a lot information but reporter wanted to report it with all the information. Reporter said that morning was that she fainted had a lost consciousness and she said that she has had prior episodes of something that as prior has affected, may be related to food although they tested her and could not figured out what food it was. She was complaining of severe abdominal pain and when EMT scan was done, she said she did want to go to the hospital and like, reporter said all reporter knew 6hrs later that the clinical manager said that she has been in surgery for two hours and that did occur. That reporter do not know. The outcome of the events was unknown.  Follow up attempts needed. Further information is expected.; Sender's Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Facial pain, Facial paralysis, Fear, Head injury
Clinical narrative: I am not, just having bad, my mouth is moving out of control, it was like wiggling and stopping; I had like a headache on my left side.; inside of my mouth just started moving; It scared me; had side of my face was sore; I had my head hurt and I am like, my neck, oh my god, what's going on; I had my head hurt and I am like, my neck, oh my god, what's going on; it's wiggling like it and  while I am breathing there is a time I go like (consumer imitates like breath-ing is stopped) and then breathing normally; This is a spontaneous report from contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8732 and expiration date was not reported), dose 2 via an unspecified route of administration, in left arm on 02Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date was not reported), via an unspecified route of administration, on an unknown date as SINGLE DOSE for COVID-19 immunization. The patient's medical history included high blood pressure and Sinus. The patient's concomitant medications included metoprolol (blood pressure), amlodipine (blood pressure), diazepam and gabapentin (problem with my leg). The patient reported on an unknown date, that she was having a reaction and got her second shot over three weeks ago. The patient experience last night was not just having bad, my mouth was moving out of control, it was like wiggling and stopping wiggling and stopping, it did all the night and up my mouth on my left side is moving, it's wiggling like it and  while I am breathing there is a time I go like (consumer imitates like breathing is stopped) and then breathing normally, face just moved on it's own, it did a few time but last night which it, did it to the moment it kept doing it, kept doing it and then had like a headache on my left side. Patient was trying to sleep, for today this morning, inside of my mouth just started moving, You know, fast, fast and air coming out and this woke me up and now things started again and air coming out, oh my god, It scared me and noticed that when I am sitting up or laying it coming up and then it go back to normal. Patient had side of her face was sore and they did it so fast and quick, could hear doing stop and had my head hurt and I am like, my neck, oh my god, what's going on. Patient at the hospital had Ultrasound and X ray done. Patient took Tylenol. The outcome of the events was reported as unknown.      Follow up#1 (PRD 25Apr2021, SRD 26Apr2021): This is a follow up spontaneous report from a 65-year-old female contactable consumer. This consumer (patient) reported information included concomitant medication, medical history, events, outcome, lab data.       Follow up attempts are needed. Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck injury, Oral discomfort, Ultrasound scan, X-ray
Clinical narrative: I am not, just having bad, my mouth is moving out of control, it was like wiggling and stopping; I had like a headache on my left side.; inside of my mouth just started moving; It scared me; had side of my face was sore; I had my head hurt and I am like, my neck, oh my god, what's going on; I had my head hurt and I am like, my neck, oh my god, what's going on; it's wiggling like it and  while I am breathing there is a time I go like (consumer imitates like breath-ing is stopped) and then breathing normally; This is a spontaneous report from contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8732 and expiration date was not reported), dose 2 via an unspecified route of administration, in left arm on 02Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date was not reported), via an unspecified route of administration, on an unknown date as SINGLE DOSE for COVID-19 immunization. The patient's medical history included high blood pressure and Sinus. The patient's concomitant medications included metoprolol (blood pressure), amlodipine (blood pressure), diazepam and gabapentin (problem with my leg). The patient reported on an unknown date, that she was having a reaction and got her second shot over three weeks ago. The patient experience last night was not just having bad, my mouth was moving out of control, it was like wiggling and stopping wiggling and stopping, it did all the night and up my mouth on my left side is moving, it's wiggling like it and  while I am breathing there is a time I go like (consumer imitates like breathing is stopped) and then breathing normally, face just moved on it's own, it did a few time but last night which it, did it to the moment it kept doing it, kept doing it and then had like a headache on my left side. Patient was trying to sleep, for today this morning, inside of my mouth just started moving, You know, fast, fast and air coming out and this woke me up and now things started again and air coming out, oh my god, It scared me and noticed that when I am sitting up or laying it coming up and then it go back to normal. Patient had side of her face was sore and they did it so fast and quick, could hear doing stop and had my head hurt and I am like, my neck, oh my god, what's going on. Patient at the hospital had Ultrasound and X ray done. Patient took Tylenol. The outcome of the events was reported as unknown.      Follow up#1 (PRD 25Apr2021, SRD 26Apr2021): This is a follow up spontaneous report from a 65-year-old female contactable consumer. This consumer (patient) reported information included concomitant medication, medical history, events, outcome, lab data.       Follow up attempts are needed. Further information has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency, Infection, Vaccination site reaction
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).    This 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 18Apr2021 (Lot Number: EW0158) as single dose for COVID-19 immunisation; tofacitinib citrate (XELJANZ), route of administration, start and stop date, lot number and dose were not reported for ulcerative colitis. Medical history included ulcerative colitis, nearsighted. Concomitant medication included mesalamine taken for ulcerative colitis, start and stop date were not reported. The patient experienced it lose my body, my bodies ability to find infections , it makes me immunocompromised (as reported) on an unspecified date with outcome of unknown, minor arm stiffness at the injection site on an unspecified date with outcome of recovered, The action taken in response to the events for tofacitinib citrate was unknown. The patient stated that "Well I don't know would you be able to hopefully either may be you can't answer my question. You can direct me to a proper resource. I received my first Pfizer vaccine last Sunday. I didn't have any adverse reaction other than just a minor in arm which gone out. but I am patient with Ulcerative colitis, On Xeljanz for the two years now and I have been trying with to find any sources information or anyone who has the information about the interaction of Xeljanz with the Pfizer, Report Pfizer meds, Pfizer Xeljanz is doing a good job for me, keeping my Ulcerative colitis to  in control, but one of the main concern of Xeljanz it lose my body, my bodies ability to find infections, it makes me immunocompromised, we have been extra care full over the past years COVID until I been able to get my Pfizer Vaccine and I got another one, my Pfizer second one shot scheduled in another two weeks, but I am trying to find some information it says whether I should need to take Xeljanz or I should cut that or stop to I could my second COVID Vaccine shot Pfizer one?" "I did not have any negative reaction. Minor muscle stiffness at the injection site which went away after one day, which was minor. I am not concern about my side effects as I am with efficacy of the Pfizer COVID shot if I am taking Xeljanz, I am concerned that Xeljanz might be reducing the efficacy of the COVID Shot. I would like to know does Pfizer Xeljanz. If any information does the Pfizer has about that. I like to understand if any information about the effectiveness or effect. if I need to change my Xeljanz intake after the shot."
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Crying, Depressed mood, Suicidal ideation
Clinical narrative: he started having thoughts of killing himself for no reason that it would be very nice for him to go and shoot himself; what a nice day for killing himself, he was self-thinking that all day; He got really sad and he had cry; He started crying; He got really sad and he had cry; He started crying; This is a spontaneous report from a contactable reporter. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 on 23Apr2021 (Lot Number: ER8735) and dose 1 on 30Mar2021 10:00 (Lot number was not reported) as both via an unspecified route of administration, administered in Deltoid Left SINGLE DOSE for covid-19 immunisation (Age at vaccination: 43 years). The patient's medical history and concomitant medications were not reported. The patient stated that he started having thoughts of killing himself for no reason that it would be very nice for him to go and shoot himself. He also think that what a nice day for killing himself, he was self-thinking that all day, he got really sad and he had cry; He started crying on an unspecified date. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; This is a spontaneous report from a contactable consumer (patients daughter). A 93-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number EM9809, expiry date: unknown), via an unspecified route of administration on 21Feb2021 (at the age of 93-year-old) as single dose for covid-19 immunization.  Patient had no medical history. Concomitant medications included apixaban (ELIQUIS) 2.5 mg twice daily orally (she had years ago pacemaker put in doctor wanted precautionary taking for years) and metoprolol at a dose of 25 mg, twice daily orally (not blood pressure, a long time could not figure over 10 years). On 24Feb2021, patient was tested positive for COVID. The doctor sent her as soon as she tested positive for the antibody infusion. Reporter stated that the patients next dose was supposed to be 14Mar2021 but patient had the antibody infusion and the doctor said to wait 90 days, 90 days would bring her up to the 24May2021 and she has a physical before then and they will check her antibodies but she wondered if they will have to do the whole thing over since it is way past 2 weeks, if they have to start the series over or since she got the infusion if she doesn't have to. She says no one seems to know and thought if her mother had not gotten the infusion, she would have been put in the hospital. Her primary doctor told her to get it. She takes a blood thinner which they told them about that, and she waited longer after the first shot just in case. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Respiratory arrest
Clinical narrative: SOB resulting in near respiratory arrest, pt intubated.; SOB resulting in near respiratory arrest, pt intubated.; This is a spontaneous report from a contactable other hcp. A 66-years-old female patient received BNT162B2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 30Apr2021 11:30 (Batch/Lot Number: EW0158) as single dose for covid-19 immunization. Medical history included drug hypersensitivity to sulfa from an unknown date. It is unknown that the patient received any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. On 30Apr2021 the patient experienced sob resulting in near respiratory arrest, pt intubated. The event resulted in Emergency room/department or urgent care. The outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of SOB results in near respiratory arrest cannot be excluded but also consider relevant medical history and concomittant drugs and drug history. 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  Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 antibody test
Clinical narrative: I got first Pfizer dose on March 11th, and on March 31st I was diagnosed with COVID; I was told that I need to wait for 90 days; I was told that I need to wait for 90 days; I got first Pfizer dose on March 11th, and on March 31st I was diagnosed with COVID; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got first dose on 11Mar2021, and on 31Mar2021 the patient was diagnosed with COVID, the patient tested positive with COVID 19 and it had been a month since the patient got tested, and today when the patient sent to schedule appointment the patient was told that he/she need to wait for 90 days, where as his/her other doctor health care provider, family care provider said the patient can just get within 14, after 14 days of quarantine if there is no more symptom showing up. So, the patient was kind of confused which one should the patient believe, should the patient wait for 90 days as per, like when the patient calling to schedule appointment to vaccine center, they said the patient need to wait for 90 days, or should the patient wait for 14 days and then get it, that should cover it in 14 days the patient mean the patient can go to get second dose, the patient was waiting for second shot. The patient didn't have any other symptom or any other side effect except the patient got infected. Outcome of the event was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.