chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, SARS-CoV-2 test, Throat tightness
Clinical narrative: NAUSEA; NUMBNESS OF FACE; TINGLING OF FACE; INJECTION SITE PAIN BUT PAIN UNDER  RIGHT ARM; ANAPHYLACTIC REACTION ( FEELING HOT, AND THROAT FELT CLOGGED); This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported.  The patient's height, and weight were not reported. The patient's past medical history included anaphylactic reactions with other vaccines, and concurrent conditions included antibiotic allergy (except ciprofloxacin), non-alcoholic, non-smoker, cancer, cerebral palsy, and pheochromocytoma.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, 1 total, administered on right arm on 27-MAR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021 12:21, the patient experienced anaphylactic reaction (feeling hot and throat felt clogged and closing). The patient was taken to the emergency room and given epinephrine. Anaphylactic reaction continued during the transport to the emergency room. On 28-MAR-2021, the patient experienced injection site pain but pain under right arm, numbness of face and tingling of face. On an unspecified date, the patient experienced nausea. Patient also received a rapid COVID-19 test on 07-APR-2021 and waiting on lab results. The patient was worried about the cancer surgery planned after 5 days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction ( feeling hot, and throat felt clogged) on 27-MAR-2021, was recovering from injection site pain but pain under right arm, numbness of face, and tingling of face, and the outcome of nausea was not reported. This report was serious (Life Threatening).; Sender's Comments: V0: A 54-year-old female experienced anaphylaxis 6 minutes after vaccine. Past medical history included anaphylactic reactions with other vaccines, and concurrent conditions included antibiotic allergy, cancer, cerebral palsy, and pheochromocytoma. Six minutes after vaccine she reporting feeling hot and throat felt clogged and closing. The patient was taken to the emergency room and given epinephrine and recovered the same day. Given the close temporal relationship, history of anaphylaxis to other vaccines as well as antibiotic allergy, the event is considered related.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atelectasis, Cardiac operation, Cardiac ventricular thrombosis, Cardio-respiratory arrest, Intensive care
Clinical narrative: massive clots; Pulmonary Embolisms; Occluded Left Lung, Right Ventricle; Occluded Left Lung, Right Ventricle; This is a spontaneous report from a contactable consumer (parent). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration administered in the right arm on 15Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient is not pregnant at the time of vaccination. The patient has no known allergies and has not had COVID prior to vaccination. Concomitant medications included gabapentin, carbamazepine (TEGRETOL), fluoxetine,  colecalciferol (VITAMIN D), fish oil, and baclofen. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. On 30Mar2021 06:00, the patient experienced Pulmonary Embolisms, Occluded Left Lung, Right Ventricle and had emergency open heart surgery to remove massive clots. He coded for 4 minutes and was in ICU for 9 days. The patient was hospitalized due to the events on an unspecified date for 12 days. The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), and Disability or permanent damage. Treatment for the events included open heart surgery. The patient underwent COVID test post vaccination via nasal swab on an unspecified date with unknown results. The outcome of the events was recovered with sequelae on an unspecified date.   Information about lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Renal failure, Thrombosis
Clinical narrative: massive clots; Pulmonary Embolisms; Occluded Left Lung, Right Ventricle; Occluded Left Lung, Right Ventricle; This is a spontaneous report from a contactable consumer (parent). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration administered in the right arm on 15Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient is not pregnant at the time of vaccination. The patient has no known allergies and has not had COVID prior to vaccination. Concomitant medications included gabapentin, carbamazepine (TEGRETOL), fluoxetine,  colecalciferol (VITAMIN D), fish oil, and baclofen. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. On 30Mar2021 06:00, the patient experienced Pulmonary Embolisms, Occluded Left Lung, Right Ventricle and had emergency open heart surgery to remove massive clots. He coded for 4 minutes and was in ICU for 9 days. The patient was hospitalized due to the events on an unspecified date for 12 days. The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), and Disability or permanent damage. Treatment for the events included open heart surgery. The patient underwent COVID test post vaccination via nasal swab on an unspecified date with unknown results. The outcome of the events was recovered with sequelae on an unspecified date.   Information about lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intracardiac thrombus, Pulmonary artery occlusion, Pulmonary embolism, SARS-CoV-2 test, Thrombosis
Clinical narrative: massive clots; Pulmonary Embolisms; Occluded Left Lung, Right Ventricle; Occluded Left Lung, Right Ventricle; This is a spontaneous report from a contactable consumer (parent). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration administered in the right arm on 15Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient is not pregnant at the time of vaccination. The patient has no known allergies and has not had COVID prior to vaccination. Concomitant medications included gabapentin, carbamazepine (TEGRETOL), fluoxetine,  colecalciferol (VITAMIN D), fish oil, and baclofen. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. On 30Mar2021 06:00, the patient experienced Pulmonary Embolisms, Occluded Left Lung, Right Ventricle and had emergency open heart surgery to remove massive clots. He coded for 4 minutes and was in ICU for 9 days. The patient was hospitalized due to the events on an unspecified date for 12 days. The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), and Disability or permanent damage. Treatment for the events included open heart surgery. The patient underwent COVID test post vaccination via nasal swab on an unspecified date with unknown results. The outcome of the events was recovered with sequelae on an unspecified date.   Information about lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Axillary pain, Chest pain, Dizziness, Dyspnoea
Clinical narrative: numbness; pain and pressure in all areas of my body; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 11Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included had her Covid. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunisation on an unspecified date. The patient's concomitant medications were not reported. The patient experienced numbness, pain and pressure in all areas of my body; all (non-serious) on 09Feb2021. Reason for no lot number: of Covid vaccine: Other: Consumer stated, "They did not give her LOT# or anything down for her, they got her sign a paper she got at work. Patient was a nurse, they did not give her the first one but they gave her the LOT# for the second one." Additional Context: Nurse(Consumer) stated, "She had her Covid her second shot of Covid on 11Jan2021 and at 09Feb2021, she started having some symptoms and they were continuing to last and she have been have hospital visit and she was calling up the specialist and everything, they screen back negative as far as her blood work and her testing so her doctors and she was wondering if her symptoms are related to her Covid vaccine and so she was calling to know if there is any reports or any longer term side effects related to vaccine." When paraphrased the concern, nurse stated, "Right, as far as even the fact that it did not started to show up until a month after my vaccine and it is been a lot of pain and pressure in all areas of my body and numbness has been annoying." Event start date: Nurse stated, "On February 9th." (Confirmed as 09Feb2021). The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Hypoaesthesia oral, Magnetic resonance imaging normal, Neck pain, Oral pain
Clinical narrative: numbness; pain and pressure in all areas of my body; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 11Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included had her Covid. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunisation on an unspecified date. The patient's concomitant medications were not reported. The patient experienced numbness, pain and pressure in all areas of my body; all (non-serious) on 09Feb2021. Reason for no lot number: of Covid vaccine: Other: Consumer stated, "They did not give her LOT# or anything down for her, they got her sign a paper she got at work. Patient was a nurse, they did not give her the first one but they gave her the LOT# for the second one." Additional Context: Nurse(Consumer) stated, "She had her Covid her second shot of Covid on 11Jan2021 and at 09Feb2021, she started having some symptoms and they were continuing to last and she have been have hospital visit and she was calling up the specialist and everything, they screen back negative as far as her blood work and her testing so her doctors and she was wondering if her symptoms are related to her Covid vaccine and so she was calling to know if there is any reports or any longer term side effects related to vaccine." When paraphrased the concern, nurse stated, "Right, as far as even the fact that it did not started to show up until a month after my vaccine and it is been a lot of pain and pressure in all areas of my body and numbness has been annoying." Event start date: Nurse stated, "On February 9th." (Confirmed as 09Feb2021). The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Scan, Taste disorder, X-ray normal
Clinical narrative: numbness; pain and pressure in all areas of my body; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 11Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included had her Covid. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunisation on an unspecified date. The patient's concomitant medications were not reported. The patient experienced numbness, pain and pressure in all areas of my body; all (non-serious) on 09Feb2021. Reason for no lot number: of Covid vaccine: Other: Consumer stated, "They did not give her LOT# or anything down for her, they got her sign a paper she got at work. Patient was a nurse, they did not give her the first one but they gave her the LOT# for the second one." Additional Context: Nurse(Consumer) stated, "She had her Covid her second shot of Covid on 11Jan2021 and at 09Feb2021, she started having some symptoms and they were continuing to last and she have been have hospital visit and she was calling up the specialist and everything, they screen back negative as far as her blood work and her testing so her doctors and she was wondering if her symptoms are related to her Covid vaccine and so she was calling to know if there is any reports or any longer term side effects related to vaccine." When paraphrased the concern, nurse stated, "Right, as far as even the fact that it did not started to show up until a month after my vaccine and it is been a lot of pain and pressure in all areas of my body and numbness has been annoying." Event start date: Nurse stated, "On February 9th." (Confirmed as 09Feb2021). The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Hypoaesthesia, Investigation, Pain
Clinical narrative: numbness; pain and pressure in all areas of my body; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 11Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included had her Covid. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunisation on an unspecified date. The patient's concomitant medications were not reported. The patient experienced numbness, pain and pressure in all areas of my body; all (non-serious) on 09Feb2021. Reason for no lot number: of Covid vaccine: Other: Consumer stated, "They did not give her LOT# or anything down for her, they got her sign a paper she got at work. Patient was a nurse, they did not give her the first one but they gave her the LOT# for the second one." Additional Context: Nurse(Consumer) stated, "She had her Covid her second shot of Covid on 11Jan2021 and at 09Feb2021, she started having some symptoms and they were continuing to last and she have been have hospital visit and she was calling up the specialist and everything, they screen back negative as far as her blood work and her testing so her doctors and she was wondering if her symptoms are related to her Covid vaccine and so she was calling to know if there is any reports or any longer term side effects related to vaccine." When paraphrased the concern, nurse stated, "Right, as far as even the fact that it did not started to show up until a month after my vaccine and it is been a lot of pain and pressure in all areas of my body and numbness has been annoying." Event start date: Nurse stated, "On February 9th." (Confirmed as 09Feb2021). The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive Covid test after receiving first dose Pfizer Covid vaccine; Positive Covid test after receiving first dose Pfizer Covid vaccine; This is a spontaneous report from a contactable consumer. A 52-years-old male consumer (patient, self-reported). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208 and Expiration date was not reported), via unspecified route of administration in left upper arm on 12Mar2021 at 16:00 as single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. It reported that, the patient received first dose of the COVID Vaccine on 12MAR2021 and he was scheduled for his second dose COVID vaccine this Friday, 02APR2021. However, caller tested positive for COVID on 29MAR2021. The reporter scoured the internet for hours upon hours, hearing all kinds of conflicting results as far as receiving his second dose COVID Vaccine. The patient reports he took a low dose of high blood pressure medication and he wanted to be safe rather than sorry and get that in. The patient did not visit the emergency room or physician office. The patient did not receive any vaccination prior to adverse event. Tylenol extra strength 500mg, took two pills a little after positive result, and probably an additional four after that and took a total of six 500mg Tylenol extra strength in 24 hours. Product complaint: Yes. The patient underwent lab tests and procedures culture performed: Nose swab and culture was positive on 29Mar2021. The outcome of the events was unknown.  Follow up needed, further information was requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prostate cancer
Clinical narrative: prostate cancer; This is a spontaneous report from a contactable consumer (patient) via a  Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2, via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. Medical history included organ transplant recipient from an unknown date and unknown if ongoing, immunosuppressant drug therapy from an unknown date and ongoing, and radiation therapy from an unknown date and ongoing. The patient's concomitant medications were not reported. The patient experienced "is currently diagnosed with prostate cancer" on an unspecified date. Therapeutic measures were taken as a result of prostate cancer. The clinical outcome of the event prostate cancer was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID on 18Mar2021 and 29Mar2021; This is a spontaneous report received from Pfizer sponsored program Covax US Support from a contactable consumer (patient). A female patient of unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 13Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient wanted to know if she can get the 2nd dose of the vaccine scheduled on 03Apr2021. She was tested positive for COVID on 18Mar2021 and 29Mar2021. 1st dose was taken on 13Mar2021. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID on 18Mar2021 and 29Mar2021; This is a spontaneous report received from Pfizer sponsored program Covax US Support from a contactable consumer (patient). A female patient of unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 13Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient wanted to know if she can get the 2nd dose of the vaccine scheduled on 03Apr2021. She was tested positive for COVID on 18Mar2021 and 29Mar2021. 1st dose was taken on 13Mar2021. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Pruritus, Throat irritation, Throat tightness, Tongue pruritus
Clinical narrative: Tingling lips; itching; tight throat; headaches like the headaches I experienced when I had COVID; Fatigue; injection site warm; This is a spontaneous case received reported from a contactable consumer. A 52-years-old non pregnant female patient received dose 1 of bnt162b2 (BNT162B2, Solution for injection; lot EW6207), via an unspecified route of administration, administered in Left Arm on 25Mar2021 16:45 as single dose for covid-19 immunization. Medical history included PAD (peripheral arterial occlusive disease), Hypertension, COVID-19, Allergies to medications, food, and other products (Sulfa). Concomitant medication included Doxycycline, Cilostazol, Ketogenix, multivitamin. The patient experienced Tingling lips, itching, tight throat, headaches like the headaches I experienced when I had COVID. Fatigue, injection site warm on 25Mar2021 07:30 PM. the patient received Benadryl treatment for allergic reaction symptoms. the patient was diagnosed with COVID-19. The outcome of the events was reported as recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Paraesthesia oral, Pruritus, Throat tightness
Clinical narrative: Tingling lips; itching; tight throat; headaches like the headaches I experienced when I had COVID; Fatigue; injection site warm; This is a spontaneous case received reported from a contactable consumer. A 52-years-old non pregnant female patient received dose 1 of bnt162b2 (BNT162B2, Solution for injection; lot EW6207), via an unspecified route of administration, administered in Left Arm on 25Mar2021 16:45 as single dose for covid-19 immunization. Medical history included PAD (peripheral arterial occlusive disease), Hypertension, COVID-19, Allergies to medications, food, and other products (Sulfa). Concomitant medication included Doxycycline, Cilostazol, Ketogenix, multivitamin. The patient experienced Tingling lips, itching, tight throat, headaches like the headaches I experienced when I had COVID. Fatigue, injection site warm on 25Mar2021 07:30 PM. the patient received Benadryl treatment for allergic reaction symptoms. the patient was diagnosed with COVID-19. The outcome of the events was reported as recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Tingling lips; itching; tight throat; headaches like the headaches I experienced when I had COVID; Fatigue; injection site warm; This is a spontaneous case received reported from a contactable consumer. A 52-years-old non pregnant female patient received dose 1 of bnt162b2 (BNT162B2, Solution for injection; lot EW6207), via an unspecified route of administration, administered in Left Arm on 25Mar2021 16:45 as single dose for covid-19 immunization. Medical history included PAD (peripheral arterial occlusive disease), Hypertension, COVID-19, Allergies to medications, food, and other products (Sulfa). Concomitant medication included Doxycycline, Cilostazol, Ketogenix, multivitamin. The patient experienced Tingling lips, itching, tight throat, headaches like the headaches I experienced when I had COVID. Fatigue, injection site warm on 25Mar2021 07:30 PM. the patient received Benadryl treatment for allergic reaction symptoms. the patient was diagnosed with COVID-19. The outcome of the events was reported as recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Chest pain, Dizziness, Electrocardiogram, Heart rate increased
Clinical narrative: Patient complained of chest and throat tightness
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lip swelling, Pharyngeal swelling
Clinical narrative: Patient complained of chest and throat tightness
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Throat tightness
Clinical narrative: Patient complained of chest and throat tightness
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Dizziness, Heart rate increased, Lip swelling, Pharyngeal swelling
Clinical narrative: Patient complained of chest and throat tightness
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Full blood count, Metabolic function test, Paraesthesia oral, Throat tightness
Clinical narrative: Patient complained of chest and throat tightness
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin
Clinical narrative: Patient complained of chest and throat tightness
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to someone under age 18
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory distress syndrome, Anaphylactic reaction, Atrioventricular block first degree, Hypertension, Sinus tachycardia
Clinical narrative: Anaphylactic reaction that required a 3 day hospital stay with steroids and oxygen.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Tachypnoea, Tongue oedema
Clinical narrative: Anaphylactic reaction that required a 3 day hospital stay with steroids and oxygen.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction that required a 3 day hospital stay with steroids and oxygen.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Magnetic resonance imaging
Clinical narrative: massive stroke; massive blood clot in brain next day; This is a spontaneous report from a contactable healthcare professional. An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 10:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks and no other medications within two weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. On 09Mar2021 19:00, patient had massive blood clot in brain and stroke. AE resulted in: emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient died on 13Mar2021 with cause of death: massive stroke. Outcome of the event "massive blood clot in brain next day" was unknown. Autopsy was not performed. Treatment received for AEs include anticoagulant.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Stroke and Thrombosis cerebral cannot be totally excluded.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: massive stroke
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident
Clinical narrative: massive stroke; massive blood clot in brain next day; This is a spontaneous report from a contactable healthcare professional. An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 10:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks and no other medications within two weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. On 09Mar2021 19:00, patient had massive blood clot in brain and stroke. AE resulted in: emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient died on 13Mar2021 with cause of death: massive stroke. Outcome of the event "massive blood clot in brain next day" was unknown. Autopsy was not performed. Treatment received for AEs include anticoagulant.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Stroke and Thrombosis cerebral cannot be totally excluded.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: massive stroke
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Blood test, Cerebrovascular accident, Computerised tomogram, Facial paralysis
Clinical narrative: bilateral stroke in march followed by bowel ischemia
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging
Clinical narrative: bilateral stroke in march followed by bowel ischemia
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Intestinal ischaemia
Clinical narrative: bilateral stroke in march followed by bowel ischemia
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Palpitations, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Tachycardia-Medium, Additional Details: 6 days after vaccine
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Tachycardia, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Tachycardia-Medium, Additional Details: 6 days after vaccine
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Brain natriuretic peptide, Chest X-ray, Dyspnoea, Electrocardiogram
Clinical narrative: Janssen COVID-19 Vaccine EUA  52 year old female with PMH of uterine cancer s/p TAH, asthma, HLD, obesity, and seasonal allergies who presented as transfer from OSH for dyspnea and found to have bilateral PE. She reports she has been feeling less than her baseline since January, when she noticed that she was getting more winded with walking. About 1 year ago, she reports that she was able to walk 1 mile on flat ground without getting short of breath and several flights of stairs. Over the past few months, she's still able to walk about 1 mile, but would need to stop several times because of SOB. Over the past few weeks, she noticed symptoms of a sinus infection with nasal congestion, rhinorrhea, and cough. She reports "blood coming from her inflamed sinuses and running down her throat" but denies any bloody cough. Denies pleuritic chest pain, but does state worse with sleeping on right side. Denies any broken bones, prolonged immobilization in s/o sinus infection, or any long drives or flights. Patient did receive 1 dose of the Johnson & Johnson COVID vaccine on March 31st.   Her family history is significant for bilateral pulmonary embolism in mother requiring lifelong eliquis, and pulmonary embolism in brother, for which he is on warfarin.  CT findings of bilateral submassive PE extending into all lung lobes
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Full blood count, Metabolic function test, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Janssen COVID-19 Vaccine EUA  52 year old female with PMH of uterine cancer s/p TAH, asthma, HLD, obesity, and seasonal allergies who presented as transfer from OSH for dyspnea and found to have bilateral PE. She reports she has been feeling less than her baseline since January, when she noticed that she was getting more winded with walking. About 1 year ago, she reports that she was able to walk 1 mile on flat ground without getting short of breath and several flights of stairs. Over the past few months, she's still able to walk about 1 mile, but would need to stop several times because of SOB. Over the past few weeks, she noticed symptoms of a sinus infection with nasal congestion, rhinorrhea, and cough. She reports "blood coming from her inflamed sinuses and running down her throat" but denies any bloody cough. Denies pleuritic chest pain, but does state worse with sleeping on right side. Denies any broken bones, prolonged immobilization in s/o sinus infection, or any long drives or flights. Patient did receive 1 dose of the Johnson & Johnson COVID vaccine on March 31st.   Her family history is significant for bilateral pulmonary embolism in mother requiring lifelong eliquis, and pulmonary embolism in brother, for which he is on warfarin.  CT findings of bilateral submassive PE extending into all lung lobes
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin
Clinical narrative: Janssen COVID-19 Vaccine EUA  52 year old female with PMH of uterine cancer s/p TAH, asthma, HLD, obesity, and seasonal allergies who presented as transfer from OSH for dyspnea and found to have bilateral PE. She reports she has been feeling less than her baseline since January, when she noticed that she was getting more winded with walking. About 1 year ago, she reports that she was able to walk 1 mile on flat ground without getting short of breath and several flights of stairs. Over the past few months, she's still able to walk about 1 mile, but would need to stop several times because of SOB. Over the past few weeks, she noticed symptoms of a sinus infection with nasal congestion, rhinorrhea, and cough. She reports "blood coming from her inflamed sinuses and running down her throat" but denies any bloody cough. Denies pleuritic chest pain, but does state worse with sleeping on right side. Denies any broken bones, prolonged immobilization in s/o sinus infection, or any long drives or flights. Patient did receive 1 dose of the Johnson & Johnson COVID vaccine on March 31st.   Her family history is significant for bilateral pulmonary embolism in mother requiring lifelong eliquis, and pulmonary embolism in brother, for which he is on warfarin.  CT findings of bilateral submassive PE extending into all lung lobes
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Cough, Dyspnoea, Nasal congestion, Paranasal sinus haemorrhage
Clinical narrative: Janssen COVID-19 Vaccine EUA  52 year old female with PMH of uterine cancer s/p TAH, asthma, HLD, obesity, and seasonal allergies who presented as transfer from OSH for dyspnea and found to have bilateral PE. She reports she has been feeling less than her baseline since January, when she noticed that she was getting more winded with walking. About 1 year ago, she reports that she was able to walk 1 mile on flat ground without getting short of breath and several flights of stairs. Over the past few months, she's still able to walk about 1 mile, but would need to stop several times because of SOB. Over the past few weeks, she noticed symptoms of a sinus infection with nasal congestion, rhinorrhea, and cough. She reports "blood coming from her inflamed sinuses and running down her throat" but denies any bloody cough. Denies pleuritic chest pain, but does state worse with sleeping on right side. Denies any broken bones, prolonged immobilization in s/o sinus infection, or any long drives or flights. Patient did receive 1 dose of the Johnson & Johnson COVID vaccine on March 31st.   Her family history is significant for bilateral pulmonary embolism in mother requiring lifelong eliquis, and pulmonary embolism in brother, for which he is on warfarin.  CT findings of bilateral submassive PE extending into all lung lobes
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paranasal sinus inflammation, Pulmonary embolism, Rhinorrhoea, Sinusitis
Clinical narrative: Janssen COVID-19 Vaccine EUA  52 year old female with PMH of uterine cancer s/p TAH, asthma, HLD, obesity, and seasonal allergies who presented as transfer from OSH for dyspnea and found to have bilateral PE. She reports she has been feeling less than her baseline since January, when she noticed that she was getting more winded with walking. About 1 year ago, she reports that she was able to walk 1 mile on flat ground without getting short of breath and several flights of stairs. Over the past few months, she's still able to walk about 1 mile, but would need to stop several times because of SOB. Over the past few weeks, she noticed symptoms of a sinus infection with nasal congestion, rhinorrhea, and cough. She reports "blood coming from her inflamed sinuses and running down her throat" but denies any bloody cough. Denies pleuritic chest pain, but does state worse with sleeping on right side. Denies any broken bones, prolonged immobilization in s/o sinus infection, or any long drives or flights. Patient did receive 1 dose of the Johnson & Johnson COVID vaccine on March 31st.   Her family history is significant for bilateral pulmonary embolism in mother requiring lifelong eliquis, and pulmonary embolism in brother, for which he is on warfarin.  CT findings of bilateral submassive PE extending into all lung lobes
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Abdominal tenderness, Bacterial test, C-reactive protein increased, Computerised tomogram abnormal
Clinical narrative: April 4 - abdominal pain and some back pain. April 14, left leg pain, chest pain, light pressure on chest, left hip pain. April 16 left leg and foot pain. April 17, pain under rib cage and pelvic, stomach pain. April 18, left forearm and leg pain, left side back pain, slight stomach pain.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Gastrointestinal inflammation, Gastrointestinal pathogen panel, Giardia test negative, Hypertension
Clinical narrative: April 4 - abdominal pain and some back pain. April 14, left leg pain, chest pain, light pressure on chest, left hip pain. April 16 left leg and foot pain. April 17, pain under rib cage and pelvic, stomach pain. April 18, left forearm and leg pain, left side back pain, slight stomach pain.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Monocyte count increased, Monocytosis, Rotavirus test negative, SARS-CoV-2 test negative, Salmonella test negative
Clinical narrative: April 4 - abdominal pain and some back pain. April 14, left leg pain, chest pain, light pressure on chest, left hip pain. April 16 left leg and foot pain. April 17, pain under rib cage and pelvic, stomach pain. April 18, left forearm and leg pain, left side back pain, slight stomach pain.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Viral test negative, White blood cell count normal
Clinical narrative: April 4 - abdominal pain and some back pain. April 14, left leg pain, chest pain, light pressure on chest, left hip pain. April 16 left leg and foot pain. April 17, pain under rib cage and pelvic, stomach pain. April 18, left forearm and leg pain, left side back pain, slight stomach pain.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Back pain, Chest pain
Clinical narrative: April 4 - abdominal pain and some back pain. April 14, left leg pain, chest pain, light pressure on chest, left hip pain. April 16 left leg and foot pain. April 17, pain under rib cage and pelvic, stomach pain. April 18, left forearm and leg pain, left side back pain, slight stomach pain.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Hepatic enzyme increased, Laboratory test, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: April 4 - abdominal pain and some back pain. April 14, left leg pain, chest pain, light pressure on chest, left hip pain. April 16 left leg and foot pain. April 17, pain under rib cage and pelvic, stomach pain. April 18, left forearm and leg pain, left side back pain, slight stomach pain.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pelvic pain
Clinical narrative: April 4 - abdominal pain and some back pain. April 14, left leg pain, chest pain, light pressure on chest, left hip pain. April 16 left leg and foot pain. April 17, pain under rib cage and pelvic, stomach pain. April 18, left forearm and leg pain, left side back pain, slight stomach pain.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cerebrovascular accident, Confusional state, Contusion, Dysarthria
Clinical narrative: Had a stroke one month and 2 days following second dose.; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9809), via an unspecified route of administration on 26Feb2021 (at the age of 90-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, kidney disease, thyroid disease and hypertension from an unknown date and unknown if ongoing. The patient received the first dose of BNT162B2 (brand: Pfizer, lot number:PF3248) on 06Feb2021 (at the age of for 90-years-old) for COVID-19 immunisation. The patient had a stroke one month and 2 days following second dose on 28Mar2021. The patient was hospitalized for the event for 10 days. The patient's hospitalization was prolonged as a result of this event. Therapeutic measures were taken as a result of the event (TPA, in-house medical care). The outcome of the event was unknown. The event resulted in emergency room/department or urgent care, hospitalization, prolongation of existing hospitalization (vaccine received during existing hospitalization), life threatening illness (immediate risk of death from the event) and disability or permanent damage.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall
Clinical narrative: Had a stroke one month and 2 days following second dose.; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9809), via an unspecified route of administration on 26Feb2021 (at the age of 90-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, kidney disease, thyroid disease and hypertension from an unknown date and unknown if ongoing. The patient received the first dose of BNT162B2 (brand: Pfizer, lot number:PF3248) on 06Feb2021 (at the age of for 90-years-old) for COVID-19 immunisation. The patient had a stroke one month and 2 days following second dose on 28Mar2021. The patient was hospitalized for the event for 10 days. The patient's hospitalization was prolonged as a result of this event. Therapeutic measures were taken as a result of the event (TPA, in-house medical care). The outcome of the event was unknown. The event resulted in emergency room/department or urgent care, hospitalization, prolongation of existing hospitalization (vaccine received during existing hospitalization), life threatening illness (immediate risk of death from the event) and disability or permanent damage.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Had a stroke one month and 2 days following second dose.; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9809), via an unspecified route of administration on 26Feb2021 (at the age of 90-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, kidney disease, thyroid disease and hypertension from an unknown date and unknown if ongoing. The patient received the first dose of BNT162B2 (brand: Pfizer, lot number:PF3248) on 06Feb2021 (at the age of for 90-years-old) for COVID-19 immunisation. The patient had a stroke one month and 2 days following second dose on 28Mar2021. The patient was hospitalized for the event for 10 days. The patient's hospitalization was prolonged as a result of this event. Therapeutic measures were taken as a result of the event (TPA, in-house medical care). The outcome of the event was unknown. The event resulted in emergency room/department or urgent care, hospitalization, prolongation of existing hospitalization (vaccine received during existing hospitalization), life threatening illness (immediate risk of death from the event) and disability or permanent damage.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram thorax abnormal, Dyspnoea, Musculoskeletal chest pain, Pulmonary embolism
Clinical narrative: On Monday 4/5/21 I received 1st dose of Pfizer vaccine. On Wednesday 4/7/21 I started experiencing pain in my abdominal upper right side and had difficulty breathing. Thursday 4/8/21 the symptoms worsened so Friday morning 4/9/21 I went to the Urgent Care and they sent me to the hospital ER. Friday evening 4/9/21 I have been admitted to the hospital with pulmonary embolism!  I was realesed from hospital on Sunday 4/11/21.  I am currently taking Warfarin & Enoxaparin injections.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: On Monday 4/5/21 I received 1st dose of Pfizer vaccine. On Wednesday 4/7/21 I started experiencing pain in my abdominal upper right side and had difficulty breathing. Thursday 4/8/21 the symptoms worsened so Friday morning 4/9/21 I went to the Urgent Care and they sent me to the hospital ER. Friday evening 4/9/21 I have been admitted to the hospital with pulmonary embolism!  I was realesed from hospital on Sunday 4/11/21.  I am currently taking Warfarin & Enoxaparin injections.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Blood test, Computerised tomogram thorax abnormal, Dyspnoea, Pulmonary embolism
Clinical narrative: On Monday 4/5/21 I received 1st dose of Pfizer vaccine. On Wednesday 4/7/21 I started experiencing pain in my abdominal upper right side and had difficulty breathing. Thursday 4/8/21 the symptoms worsened so Friday morning 4/9/21 I went to the Urgent Care and they sent me to the hospital ER. Friday evening 4/9/21 I have been admitted to the hospital with pulmonary embolism!  I was realesed from hospital on Sunday 4/11/21.  I am currently taking Warfarin & Enoxaparin injections.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urine analysis, X-ray
Clinical narrative: On Monday 4/5/21 I received 1st dose of Pfizer vaccine. On Wednesday 4/7/21 I started experiencing pain in my abdominal upper right side and had difficulty breathing. Thursday 4/8/21 the symptoms worsened so Friday morning 4/9/21 I went to the Urgent Care and they sent me to the hospital ER. Friday evening 4/9/21 I have been admitted to the hospital with pulmonary embolism!  I was realesed from hospital on Sunday 4/11/21.  I am currently taking Warfarin & Enoxaparin injections.