chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Cardiac pacemaker evaluation, Computerised tomogram, Dysarthria, Dysstasia
Clinical narrative: he had a stroke; felt pressure on his head; He had slurred speech; he fell as well; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737) in left arm on 06Apr2021 10:30 am at single dose for COVID-19 immunisation. Medical history included ischemic cardiomyopathy, chronic heart failure, pace maker/dif, diabetes, high blood pressure. Concomitant medications in two weeks included aspirin, carvedilol, valproate semisodium (DIVALPROEX), furosemide, and other medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 16Mar2021 10:30 AM at 61-year-old in left arm at single dose for COVID-19 immunisation, received levofloxacin (LOVENOX) and experienced allergies. No other vaccine in four weeks. At approximately 10:00 pm on 07Apr2021, patient started having a fever and flu symptoms that lasted into the first day after taking the second covid shot. By the second day, on 08Apr2021 at 6:15 am, patient took a shower felt pressure on his head and his arms would not work. He had slurred speech, and he fell as well, his lip was curled up on one side and patient sated he thought he was in trouble. He was transferred to ER, and they said he had a stroke. He then went to the Neurological ICU where he stayed until his discharge three days later. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient was hospitalization for 3 days. Treatment received for all the events in patient hospitalization. No COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was not recovered.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Facial paralysis, Head discomfort, Intensive care, Ischaemic stroke
Clinical narrative: he had a stroke; felt pressure on his head; He had slurred speech; he fell as well; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737) in left arm on 06Apr2021 10:30 am at single dose for COVID-19 immunisation. Medical history included ischemic cardiomyopathy, chronic heart failure, pace maker/dif, diabetes, high blood pressure. Concomitant medications in two weeks included aspirin, carvedilol, valproate semisodium (DIVALPROEX), furosemide, and other medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 16Mar2021 10:30 AM at 61-year-old in left arm at single dose for COVID-19 immunisation, received levofloxacin (LOVENOX) and experienced allergies. No other vaccine in four weeks. At approximately 10:00 pm on 07Apr2021, patient started having a fever and flu symptoms that lasted into the first day after taking the second covid shot. By the second day, on 08Apr2021 at 6:15 am, patient took a shower felt pressure on his head and his arms would not work. He had slurred speech, and he fell as well, his lip was curled up on one side and patient sated he thought he was in trouble. He was transferred to ER, and they said he had a stroke. He then went to the Neurological ICU where he stayed until his discharge three days later. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient was hospitalization for 3 days. Treatment received for all the events in patient hospitalization. No COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was not recovered.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Musculoskeletal disorder
Clinical narrative: he had a stroke; felt pressure on his head; He had slurred speech; he fell as well; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737) in left arm on 06Apr2021 10:30 am at single dose for COVID-19 immunisation. Medical history included ischemic cardiomyopathy, chronic heart failure, pace maker/dif, diabetes, high blood pressure. Concomitant medications in two weeks included aspirin, carvedilol, valproate semisodium (DIVALPROEX), furosemide, and other medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 16Mar2021 10:30 AM at 61-year-old in left arm at single dose for COVID-19 immunisation, received levofloxacin (LOVENOX) and experienced allergies. No other vaccine in four weeks. At approximately 10:00 pm on 07Apr2021, patient started having a fever and flu symptoms that lasted into the first day after taking the second covid shot. By the second day, on 08Apr2021 at 6:15 am, patient took a shower felt pressure on his head and his arms would not work. He had slurred speech, and he fell as well, his lip was curled up on one side and patient sated he thought he was in trouble. He was transferred to ER, and they said he had a stroke. He then went to the Neurological ICU where he stayed until his discharge three days later. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient was hospitalization for 3 days. Treatment received for all the events in patient hospitalization. No COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was not recovered.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram abnormal, Blood cholesterol, Computerised tomogram head abnormal, Full blood count, Glycosylated haemoglobin
Clinical narrative: he had a stroke; felt pressure on his head; He had slurred speech; he fell as well; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737) in left arm on 06Apr2021 10:30 am at single dose for COVID-19 immunisation. Medical history included ischemic cardiomyopathy, chronic heart failure, pace maker/dif, diabetes, high blood pressure. Concomitant medications in two weeks included aspirin, carvedilol, valproate semisodium (DIVALPROEX), furosemide, and other medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 16Mar2021 10:30 AM at 61-year-old in left arm at single dose for COVID-19 immunisation, received levofloxacin (LOVENOX) and experienced allergies. No other vaccine in four weeks. At approximately 10:00 pm on 07Apr2021, patient started having a fever and flu symptoms that lasted into the first day after taking the second covid shot. By the second day, on 08Apr2021 at 6:15 am, patient took a shower felt pressure on his head and his arms would not work. He had slurred speech, and he fell as well, his lip was curled up on one side and patient sated he thought he was in trouble. He was transferred to ER, and they said he had a stroke. He then went to the Neurological ICU where he stayed until his discharge three days later. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient was hospitalization for 3 days. Treatment received for all the events in patient hospitalization. No COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was not recovered.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ischaemic stroke, Metabolic function test
Clinical narrative: he had a stroke; felt pressure on his head; He had slurred speech; he fell as well; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737) in left arm on 06Apr2021 10:30 am at single dose for COVID-19 immunisation. Medical history included ischemic cardiomyopathy, chronic heart failure, pace maker/dif, diabetes, high blood pressure. Concomitant medications in two weeks included aspirin, carvedilol, valproate semisodium (DIVALPROEX), furosemide, and other medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 16Mar2021 10:30 AM at 61-year-old in left arm at single dose for COVID-19 immunisation, received levofloxacin (LOVENOX) and experienced allergies. No other vaccine in four weeks. At approximately 10:00 pm on 07Apr2021, patient started having a fever and flu symptoms that lasted into the first day after taking the second covid shot. By the second day, on 08Apr2021 at 6:15 am, patient took a shower felt pressure on his head and his arms would not work. He had slurred speech, and he fell as well, his lip was curled up on one side and patient sated he thought he was in trouble. He was transferred to ER, and they said he had a stroke. He then went to the Neurological ICU where he stayed until his discharge three days later. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient was hospitalization for 3 days. Treatment received for all the events in patient hospitalization. No COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was not recovered.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Dysarthria, Fall, Head discomfort, Influenza
Clinical narrative: he had a stroke; felt pressure on his head; He had slurred speech; he fell as well; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737) in left arm on 06Apr2021 10:30 am at single dose for COVID-19 immunisation. Medical history included ischemic cardiomyopathy, chronic heart failure, pace maker/dif, diabetes, high blood pressure. Concomitant medications in two weeks included aspirin, carvedilol, valproate semisodium (DIVALPROEX), furosemide, and other medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 16Mar2021 10:30 AM at 61-year-old in left arm at single dose for COVID-19 immunisation, received levofloxacin (LOVENOX) and experienced allergies. No other vaccine in four weeks. At approximately 10:00 pm on 07Apr2021, patient started having a fever and flu symptoms that lasted into the first day after taking the second covid shot. By the second day, on 08Apr2021 at 6:15 am, patient took a shower felt pressure on his head and his arms would not work. He had slurred speech, and he fell as well, his lip was curled up on one side and patient sated he thought he was in trouble. He was transferred to ER, and they said he had a stroke. He then went to the Neurological ICU where he stayed until his discharge three days later. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient was hospitalization for 3 days. Treatment received for all the events in patient hospitalization. No COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was not recovered.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: he had a stroke; felt pressure on his head; He had slurred speech; he fell as well; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737) in left arm on 06Apr2021 10:30 am at single dose for COVID-19 immunisation. Medical history included ischemic cardiomyopathy, chronic heart failure, pace maker/dif, diabetes, high blood pressure. Concomitant medications in two weeks included aspirin, carvedilol, valproate semisodium (DIVALPROEX), furosemide, and other medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 16Mar2021 10:30 AM at 61-year-old in left arm at single dose for COVID-19 immunisation, received levofloxacin (LOVENOX) and experienced allergies. No other vaccine in four weeks. At approximately 10:00 pm on 07Apr2021, patient started having a fever and flu symptoms that lasted into the first day after taking the second covid shot. By the second day, on 08Apr2021 at 6:15 am, patient took a shower felt pressure on his head and his arms would not work. He had slurred speech, and he fell as well, his lip was curled up on one side and patient sated he thought he was in trouble. He was transferred to ER, and they said he had a stroke. He then went to the Neurological ICU where he stayed until his discharge three days later. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient was hospitalization for 3 days. Treatment received for all the events in patient hospitalization. No COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was not recovered.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Cor pulmonale acute, Coronary arterial stent insertion, Gastrointestinal haemorrhage, Myocardial infarction
Clinical narrative: This is a spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on 13Jan2021. Relevant history included mild dementia, high cholesterol. Relevant concomitant drugs included memantine 10MG,donepezil 5MG,atorvastatin, cetirizine hydrochloride (ZYRTEC). The patient was not pregnant. No known allergies. On 30Jan2021, the patient fell and became unconscious after getting up from bed to use bathroom, was able to get up and go back to bed. Next day, 31Jan2021, she told her daughter at 2pm what had happened and daughter took her to urgent care. Urgent care was performed EKG and called ambulance as EKG suggested suspicious activity. She was coughing with blood. Cat scan of the lung revealed acute saddle pulmonary embolism with acute cor pulmonale and a large blood clot in the calf. On 02Feb201 then placed her on blood thinner and discharged her. As soon as arrived home, she began to suffer a massive gastro intestinal bleed and was rushed back to the hospital. On 04Feb2021, she began to have heart issues and suffered a mild heart attack and underwent a procedure to have a stent inserted. She developed the shingles the next day (05Feb2021). The events assessed as serious due to Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient visited Emergency room/department or urgent care. The outcome of events was resolved with sequel. Treatment therapy involved. The patient was not diagnosed with COVID prior vaccination. The patient had Nasal Swab/Fast Test/PCR (for COVID) in Apr2021 with negative result. Information on the lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Syncope, Thrombosis
Clinical narrative: This is a spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on 13Jan2021. Relevant history included mild dementia, high cholesterol. Relevant concomitant drugs included memantine 10MG,donepezil 5MG,atorvastatin, cetirizine hydrochloride (ZYRTEC). The patient was not pregnant. No known allergies. On 30Jan2021, the patient fell and became unconscious after getting up from bed to use bathroom, was able to get up and go back to bed. Next day, 31Jan2021, she told her daughter at 2pm what had happened and daughter took her to urgent care. Urgent care was performed EKG and called ambulance as EKG suggested suspicious activity. She was coughing with blood. Cat scan of the lung revealed acute saddle pulmonary embolism with acute cor pulmonale and a large blood clot in the calf. On 02Feb201 then placed her on blood thinner and discharged her. As soon as arrived home, she began to suffer a massive gastro intestinal bleed and was rushed back to the hospital. On 04Feb2021, she began to have heart issues and suffered a mild heart attack and underwent a procedure to have a stent inserted. She developed the shingles the next day (05Feb2021). The events assessed as serious due to Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient visited Emergency room/department or urgent care. The outcome of events was resolved with sequel. Treatment therapy involved. The patient was not diagnosed with COVID prior vaccination. The patient had Nasal Swab/Fast Test/PCR (for COVID) in Apr2021 with negative result. Information on the lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Cor pulmonale acute, Electrocardiogram, Fall, Gastrointestinal haemorrhage
Clinical narrative: This is a spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on 13Jan2021. Relevant history included mild dementia, high cholesterol. Relevant concomitant drugs included memantine 10MG,donepezil 5MG,atorvastatin, cetirizine hydrochloride (ZYRTEC). The patient was not pregnant. No known allergies. On 30Jan2021, the patient fell and became unconscious after getting up from bed to use bathroom, was able to get up and go back to bed. Next day, 31Jan2021, she told her daughter at 2pm what had happened and daughter took her to urgent care. Urgent care was performed EKG and called ambulance as EKG suggested suspicious activity. She was coughing with blood. Cat scan of the lung revealed acute saddle pulmonary embolism with acute cor pulmonale and a large blood clot in the calf. On 02Feb201 then placed her on blood thinner and discharged her. As soon as arrived home, she began to suffer a massive gastro intestinal bleed and was rushed back to the hospital. On 04Feb2021, she began to have heart issues and suffered a mild heart attack and underwent a procedure to have a stent inserted. She developed the shingles the next day (05Feb2021). The events assessed as serious due to Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient visited Emergency room/department or urgent care. The outcome of events was resolved with sequel. Treatment therapy involved. The patient was not diagnosed with COVID prior vaccination. The patient had Nasal Swab/Fast Test/PCR (for COVID) in Apr2021 with negative result. Information on the lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemoptysis, Herpes zoster, Loss of consciousness, Myocardial infarction, Pulmonary embolism
Clinical narrative: This is a spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on 13Jan2021. Relevant history included mild dementia, high cholesterol. Relevant concomitant drugs included memantine 10MG,donepezil 5MG,atorvastatin, cetirizine hydrochloride (ZYRTEC). The patient was not pregnant. No known allergies. On 30Jan2021, the patient fell and became unconscious after getting up from bed to use bathroom, was able to get up and go back to bed. Next day, 31Jan2021, she told her daughter at 2pm what had happened and daughter took her to urgent care. Urgent care was performed EKG and called ambulance as EKG suggested suspicious activity. She was coughing with blood. Cat scan of the lung revealed acute saddle pulmonary embolism with acute cor pulmonale and a large blood clot in the calf. On 02Feb201 then placed her on blood thinner and discharged her. As soon as arrived home, she began to suffer a massive gastro intestinal bleed and was rushed back to the hospital. On 04Feb2021, she began to have heart issues and suffered a mild heart attack and underwent a procedure to have a stent inserted. She developed the shingles the next day (05Feb2021). The events assessed as serious due to Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient visited Emergency room/department or urgent care. The outcome of events was resolved with sequel. Treatment therapy involved. The patient was not diagnosed with COVID prior vaccination. The patient had Nasal Swab/Fast Test/PCR (for COVID) in Apr2021 with negative result. Information on the lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: This is a spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on 13Jan2021. Relevant history included mild dementia, high cholesterol. Relevant concomitant drugs included memantine 10MG,donepezil 5MG,atorvastatin, cetirizine hydrochloride (ZYRTEC). The patient was not pregnant. No known allergies. On 30Jan2021, the patient fell and became unconscious after getting up from bed to use bathroom, was able to get up and go back to bed. Next day, 31Jan2021, she told her daughter at 2pm what had happened and daughter took her to urgent care. Urgent care was performed EKG and called ambulance as EKG suggested suspicious activity. She was coughing with blood. Cat scan of the lung revealed acute saddle pulmonary embolism with acute cor pulmonale and a large blood clot in the calf. On 02Feb201 then placed her on blood thinner and discharged her. As soon as arrived home, she began to suffer a massive gastro intestinal bleed and was rushed back to the hospital. On 04Feb2021, she began to have heart issues and suffered a mild heart attack and underwent a procedure to have a stent inserted. She developed the shingles the next day (05Feb2021). The events assessed as serious due to Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient visited Emergency room/department or urgent care. The outcome of events was resolved with sequel. Treatment therapy involved. The patient was not diagnosed with COVID prior vaccination. The patient had Nasal Swab/Fast Test/PCR (for COVID) in Apr2021 with negative result. Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: Dvt and PE; Dvt and PE; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced deep vein thrombosis (DVT) and pulmonary embolism (PE) on 31Mar2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on an unspecified date. The event resulted in the Emergency room/department or urgent care. Therapeutic measures were taken as a result of both events [rivaroxaban (XARELTO). The outcome of the events was recovered on an unspecified date.    Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug profile and available information it  is unlikely that the reported deep vein thrombosis and pulmonary  embolism were causally  related to BNT162B2.  These are intercurrent  medical  conditions.   Case will be reassessed if additional information is received.    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: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Dvt and PE; Dvt and PE; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced deep vein thrombosis (DVT) and pulmonary embolism (PE) on 31Mar2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on an unspecified date. The event resulted in the Emergency room/department or urgent care. Therapeutic measures were taken as a result of both events [rivaroxaban (XARELTO). The outcome of the events was recovered on an unspecified date.    Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug profile and available information it  is unlikely that the reported deep vein thrombosis and pulmonary  embolism were causally  related to BNT162B2.  These are intercurrent  medical  conditions.   Case will be reassessed if additional information is received.    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: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test, Computerised tomogram thorax abnormal, Dyspnoea, Dyspnoea exertional
Clinical narrative: pulmonary embolism; blood clots, her lungs were "full" of blood clots; trouble breathing; could barely walk up; This is a spontaneous report from contactable consumer. A 39-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Mar2021 at 11:00AM in left arm at single dose for COVID-19 immunisation. Relevant medical history included minor thalassemia. Past drug history included buprenorphine (SUBLOCADE) taken on 10Mar2021 (location = stomach). Concomitant medications included venlafaxine and zolpidem. The patient had not COVID prior vaccination. The patient began to feel winded doing the most menial of tasks starting the week of 05Apr2021. On the morning of 10Apr2021 she woke up having trouble breathing after walking 10 steps to the bathroom. She could barely walk up 3 steps. It was as if she ran 10 marathons just to get to her bedroom on the second floor (as reported). She went to the ER where a CT scan was performed and it was found that she had a pulmonary embolism and her lungs were "full" of blood clots. Onset date for the events was reported as 07Apr2021 at 02:00PM. The events were serious as life-threatening (immediate risk of death from the event) and as causing hospitalization (for 4 days). Procedure to remove clots and heparin were given as treatments. The patient underwent COVID test (nasal swab) post vaccination on 10Apr2021 and result was negative. The events were resolving at the time of report.  Information on Lot/Batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Pulmonary embolism, Thrombectomy, Ultrasound scan
Clinical narrative: pulmonary embolism; blood clots, her lungs were "full" of blood clots; trouble breathing; could barely walk up; This is a spontaneous report from contactable consumer. A 39-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Mar2021 at 11:00AM in left arm at single dose for COVID-19 immunisation. Relevant medical history included minor thalassemia. Past drug history included buprenorphine (SUBLOCADE) taken on 10Mar2021 (location = stomach). Concomitant medications included venlafaxine and zolpidem. The patient had not COVID prior vaccination. The patient began to feel winded doing the most menial of tasks starting the week of 05Apr2021. On the morning of 10Apr2021 she woke up having trouble breathing after walking 10 steps to the bathroom. She could barely walk up 3 steps. It was as if she ran 10 marathons just to get to her bedroom on the second floor (as reported). She went to the ER where a CT scan was performed and it was found that she had a pulmonary embolism and her lungs were "full" of blood clots. Onset date for the events was reported as 07Apr2021 at 02:00PM. The events were serious as life-threatening (immediate risk of death from the event) and as causing hospitalization (for 4 days). Procedure to remove clots and heparin were given as treatments. The patient underwent COVID test (nasal swab) post vaccination on 10Apr2021 and result was negative. The events were resolving at the time of report.  Information on Lot/Batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Dyspnoea, Gait disturbance, Pulmonary embolism, Pulmonary thrombosis
Clinical narrative: pulmonary embolism; blood clots, her lungs were "full" of blood clots; trouble breathing; could barely walk up; This is a spontaneous report from contactable consumer. A 39-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Mar2021 at 11:00AM in left arm at single dose for COVID-19 immunisation. Relevant medical history included minor thalassemia. Past drug history included buprenorphine (SUBLOCADE) taken on 10Mar2021 (location = stomach). Concomitant medications included venlafaxine and zolpidem. The patient had not COVID prior vaccination. The patient began to feel winded doing the most menial of tasks starting the week of 05Apr2021. On the morning of 10Apr2021 she woke up having trouble breathing after walking 10 steps to the bathroom. She could barely walk up 3 steps. It was as if she ran 10 marathons just to get to her bedroom on the second floor (as reported). She went to the ER where a CT scan was performed and it was found that she had a pulmonary embolism and her lungs were "full" of blood clots. Onset date for the events was reported as 07Apr2021 at 02:00PM. The events were serious as life-threatening (immediate risk of death from the event) and as causing hospitalization (for 4 days). Procedure to remove clots and heparin were given as treatments. The patient underwent COVID test (nasal swab) post vaccination on 10Apr2021 and result was negative. The events were resolving at the time of report.  Information on Lot/Batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: pulmonary embolism; blood clots, her lungs were "full" of blood clots; trouble breathing; could barely walk up; This is a spontaneous report from contactable consumer. A 39-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Mar2021 at 11:00AM in left arm at single dose for COVID-19 immunisation. Relevant medical history included minor thalassemia. Past drug history included buprenorphine (SUBLOCADE) taken on 10Mar2021 (location = stomach). Concomitant medications included venlafaxine and zolpidem. The patient had not COVID prior vaccination. The patient began to feel winded doing the most menial of tasks starting the week of 05Apr2021. On the morning of 10Apr2021 she woke up having trouble breathing after walking 10 steps to the bathroom. She could barely walk up 3 steps. It was as if she ran 10 marathons just to get to her bedroom on the second floor (as reported). She went to the ER where a CT scan was performed and it was found that she had a pulmonary embolism and her lungs were "full" of blood clots. Onset date for the events was reported as 07Apr2021 at 02:00PM. The events were serious as life-threatening (immediate risk of death from the event) and as causing hospitalization (for 4 days). Procedure to remove clots and heparin were given as treatments. The patient underwent COVID test (nasal swab) post vaccination on 10Apr2021 and result was negative. The events were resolving at the time of report.  Information on Lot/Batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Headache, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Before the Bell's Palsy diagnosis she felt like she was getting a cold; dry eye and eye watering; pain in her feet; dry eye and eye watering; Bell's palsy; Legs went numb; Feet burning; Arms went numb; Nausea; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 11:45 (Batch/Lot Number: ERG213) as a single dose for covid-19 immunisation. The patient's medical history included ongoing systemic lupus erythematosus diagnosed 17 years ago. The patient's concomitant medications were not reported. On 30Mar2021, the patient experienced headache and nausea, arms went numb on 31Mar2021, legs went numb and feet burning on 01Apr2021. On 05Apr2021, the patient was diagnosed with Bell's palsy. It was also reported that before the bell's palsy diagnosis she felt like she was getting a cold. It was further reported that on the first day the patient had a headache and nausea. The second day her legs went numb for 3 days, on 05Apr2021 she got Bell's Palsy. Patient cannot talk, symptoms were not treated in any way. Patient had numbness in her arms first and then it went to her legs. She later clarified her arms and legs are still numb. The headache started soon as she got the vaccine. Her nausea started 2 hours after the vaccine and lasted 8 hours. Her legs still bothering her. She still has pain in her feet. Before the Bell's Palsy diagnosis she felt like she was getting a cold. She had a headache on the right side of the face. Her tongue was numb 3 days ago. She can't close her eye all the way, it was causing  headache,  dry eye and eye watering. It was going into her nose. Her lip was moving, she cannot talk. She went to urgent care last night after her daughter asked why she was winking. Her lip was sagging and  thought it was a stroke. They said the Bells Palsy was definitely from the vaccine. The outcome of the event nausea was recovered on 30Mar2021, Bell's Palsy legs went numb, arms went numb, feet burning was not recovered and unknown outcome for the event before the Bell's Palsy diagnosis she felt like she was getting a cold.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Burning sensation, Dry eye, Hypoaesthesia, Lacrimation increased
Clinical narrative: Before the Bell's Palsy diagnosis she felt like she was getting a cold; dry eye and eye watering; pain in her feet; dry eye and eye watering; Bell's palsy; Legs went numb; Feet burning; Arms went numb; Nausea; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 11:45 (Batch/Lot Number: ERG213) as a single dose for covid-19 immunisation. The patient's medical history included ongoing systemic lupus erythematosus diagnosed 17 years ago. The patient's concomitant medications were not reported. On 30Mar2021, the patient experienced headache and nausea, arms went numb on 31Mar2021, legs went numb and feet burning on 01Apr2021. On 05Apr2021, the patient was diagnosed with Bell's palsy. It was also reported that before the bell's palsy diagnosis she felt like she was getting a cold. It was further reported that on the first day the patient had a headache and nausea. The second day her legs went numb for 3 days, on 05Apr2021 she got Bell's Palsy. Patient cannot talk, symptoms were not treated in any way. Patient had numbness in her arms first and then it went to her legs. She later clarified her arms and legs are still numb. The headache started soon as she got the vaccine. Her nausea started 2 hours after the vaccine and lasted 8 hours. Her legs still bothering her. She still has pain in her feet. Before the Bell's Palsy diagnosis she felt like she was getting a cold. She had a headache on the right side of the face. Her tongue was numb 3 days ago. She can't close her eye all the way, it was causing  headache,  dry eye and eye watering. It was going into her nose. Her lip was moving, she cannot talk. She went to urgent care last night after her daughter asked why she was winking. Her lip was sagging and  thought it was a stroke. They said the Bells Palsy was definitely from the vaccine. The outcome of the event nausea was recovered on 30Mar2021, Bell's Palsy legs went numb, arms went numb, feet burning was not recovered and unknown outcome for the event before the Bell's Palsy diagnosis she felt like she was getting a cold.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis, Nausea, Pain in extremity
Clinical narrative: Before the Bell's Palsy diagnosis she felt like she was getting a cold; dry eye and eye watering; pain in her feet; dry eye and eye watering; Bell's palsy; Legs went numb; Feet burning; Arms went numb; Nausea; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 11:45 (Batch/Lot Number: ERG213) as a single dose for covid-19 immunisation. The patient's medical history included ongoing systemic lupus erythematosus diagnosed 17 years ago. The patient's concomitant medications were not reported. On 30Mar2021, the patient experienced headache and nausea, arms went numb on 31Mar2021, legs went numb and feet burning on 01Apr2021. On 05Apr2021, the patient was diagnosed with Bell's palsy. It was also reported that before the bell's palsy diagnosis she felt like she was getting a cold. It was further reported that on the first day the patient had a headache and nausea. The second day her legs went numb for 3 days, on 05Apr2021 she got Bell's Palsy. Patient cannot talk, symptoms were not treated in any way. Patient had numbness in her arms first and then it went to her legs. She later clarified her arms and legs are still numb. The headache started soon as she got the vaccine. Her nausea started 2 hours after the vaccine and lasted 8 hours. Her legs still bothering her. She still has pain in her feet. Before the Bell's Palsy diagnosis she felt like she was getting a cold. She had a headache on the right side of the face. Her tongue was numb 3 days ago. She can't close her eye all the way, it was causing  headache,  dry eye and eye watering. It was going into her nose. Her lip was moving, she cannot talk. She went to urgent care last night after her daughter asked why she was winking. Her lip was sagging and  thought it was a stroke. They said the Bells Palsy was definitely from the vaccine. The outcome of the event nausea was recovered on 30Mar2021, Bell's Palsy legs went numb, arms went numb, feet burning was not recovered and unknown outcome for the event before the Bell's Palsy diagnosis she felt like she was getting a cold.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: CSF culture negative, CSF glucose normal, CSF lymphocyte count increased, CSF protein normal, CSF red blood cell count positive
Clinical narrative: Transverse Myelitis; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration, at the age of 41 years, administered on the left arm on 22Mar2021 16:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced transverse myelitis on Apr2021. The patient was hospitalized for transverse myelitis (myelitis transverse) for 10 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures (Corticosteroids) were taken as a result of transverse myelitis. The outcome of the event was recovering.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gram stain, Hemiparesis, Herpes simplex test negative, Hyperintensity in brain deep nuclei, Hyperreflexia
Clinical narrative: Transverse Myelitis; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration, at the age of 41 years, administered on the left arm on 22Mar2021 16:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced transverse myelitis on Apr2021. The patient was hospitalized for transverse myelitis (myelitis transverse) for 10 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures (Corticosteroids) were taken as a result of transverse myelitis. The outcome of the event was recovering.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Myelitis transverse, Urinary retention
Clinical narrative: Transverse Myelitis; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration, at the age of 41 years, administered on the left arm on 22Mar2021 16:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced transverse myelitis on Apr2021. The patient was hospitalized for transverse myelitis (myelitis transverse) for 10 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures (Corticosteroids) were taken as a result of transverse myelitis. The outcome of the event was recovering.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Lumbar puncture, Magnetic resonance imaging, Myelitis transverse
Clinical narrative: Transverse Myelitis; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration, at the age of 41 years, administered on the left arm on 22Mar2021 16:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced transverse myelitis on Apr2021. The patient was hospitalized for transverse myelitis (myelitis transverse) for 10 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures (Corticosteroids) were taken as a result of transverse myelitis. The outcome of the event was recovering.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myelitis transverse, SARS-CoV-2 test
Clinical narrative: Transverse Myelitis; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration, at the age of 41 years, administered on the left arm on 22Mar2021 16:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced transverse myelitis on Apr2021. The patient was hospitalized for transverse myelitis (myelitis transverse) for 10 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures (Corticosteroids) were taken as a result of transverse myelitis. The outcome of the event was recovering.