chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Scan with contrast, Vertigo, Vomiting
Clinical narrative: flu like symptoms; Severe Vertigo; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 06Jan2021 (Batch/Lot Number: EL0142) as SINGLE DOSE for covid-19 immunisation. Medical history included High Cholesterol and allergies: Latex from an unknown date and unknown if ongoing. The patient has no Covid prior vaccination. The patient was vaccinated in a hospital. It was reported that there was no other vaccine in four weeks. The patient previously received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) first dose via unspecified route of administration (lot number: EK5750) on 18Dec2020 09:30 AM at the Left arm for COVID-19 immunization. Concomitant medication included (also reported as Other medications in two weeks) omeprazole; lisinopril; and fenofibrate; all taken for an unspecified indication, start and stop date were not reported. It was reported that "3 days after 2nd shot I had flu like symptoms 4 weeks after 2nd shot, I developed Severe Vertigo while on duty, taken to ER and am still off duty because of it (5 weeks as of this report). I have followed up with PCP, ENT & Neurologist, all show no signs of ear infection or any trauma or damage that would set this off." The events were reported to occurred on 13Feb2021 at 02:15 am. The outcome of the events was not recovered. The events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care; Disability or permanent damage. Treatment was initiated which includes: MRI, MRA, CT, CT with Contrast, Vestibular Rehabil. The patient was tested for covid post vaccination (nasal swab) on 13Feb2021 with negative result.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Computerised tomogram, Influenza like illness, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: flu like symptoms; Severe Vertigo; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 06Jan2021 (Batch/Lot Number: EL0142) as SINGLE DOSE for covid-19 immunisation. Medical history included High Cholesterol and allergies: Latex from an unknown date and unknown if ongoing. The patient has no Covid prior vaccination. The patient was vaccinated in a hospital. It was reported that there was no other vaccine in four weeks. The patient previously received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) first dose via unspecified route of administration (lot number: EK5750) on 18Dec2020 09:30 AM at the Left arm for COVID-19 immunization. Concomitant medication included (also reported as Other medications in two weeks) omeprazole; lisinopril; and fenofibrate; all taken for an unspecified indication, start and stop date were not reported. It was reported that "3 days after 2nd shot I had flu like symptoms 4 weeks after 2nd shot, I developed Severe Vertigo while on duty, taken to ER and am still off duty because of it (5 weeks as of this report). I have followed up with PCP, ENT & Neurologist, all show no signs of ear infection or any trauma or damage that would set this off." The events were reported to occurred on 13Feb2021 at 02:15 am. The outcome of the events was not recovered. The events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care; Disability or permanent damage. Treatment was initiated which includes: MRI, MRA, CT, CT with Contrast, Vestibular Rehabil. The patient was tested for covid post vaccination (nasal swab) on 13Feb2021 with negative result.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: flu like symptoms; Severe Vertigo; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 06Jan2021 (Batch/Lot Number: EL0142) as SINGLE DOSE for covid-19 immunisation. Medical history included High Cholesterol and allergies: Latex from an unknown date and unknown if ongoing. The patient has no Covid prior vaccination. The patient was vaccinated in a hospital. It was reported that there was no other vaccine in four weeks. The patient previously received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) first dose via unspecified route of administration (lot number: EK5750) on 18Dec2020 09:30 AM at the Left arm for COVID-19 immunization. Concomitant medication included (also reported as Other medications in two weeks) omeprazole; lisinopril; and fenofibrate; all taken for an unspecified indication, start and stop date were not reported. It was reported that "3 days after 2nd shot I had flu like symptoms 4 weeks after 2nd shot, I developed Severe Vertigo while on duty, taken to ER and am still off duty because of it (5 weeks as of this report). I have followed up with PCP, ENT & Neurologist, all show no signs of ear infection or any trauma or damage that would set this off." The events were reported to occurred on 13Feb2021 at 02:15 am. The outcome of the events was not recovered. The events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care; Disability or permanent damage. Treatment was initiated which includes: MRI, MRA, CT, CT with Contrast, Vestibular Rehabil. The patient was tested for covid post vaccination (nasal swab) on 13Feb2021 with negative result.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Appendicectomy, Appendicitis, Chills
Clinical narrative: Appendicitis; 27 hours after injection: fever and chills; 27 hours after injection: fever and chills; 24 hours after injection: sharp stomach pain that roamed around the abdomen; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Mar2021 11:00 (Batch/Lot Number: EN6206) as a single dose for COVID-19 immunization. Medical history included Discoid Lupus, Sjogren's syndrome, and chronic constipation from an unknown date. The patient has no COVID-19 history prior vaccination. There were no concomitant medications. 24 hours after injection on 08Mar2021 11:00, sharp stomach pain that roamed around the abdomen was reported experienced by the patient. 27 hours after injection on 08Mar2021, 14:00, fever and chills were reported, and abdominal pain did not go away by night so the patient went to the Emergency Room (ER) 35 hours after injection on 08Mar2021, 22:00 from which the patient had a urinalysis, blood test, and an ultrasound to find the site of pain, and the ultrasound showed appendicitis. 41 hours after injection on 09Mar2021 04:00, the patient had an appendectomy. The event resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included blood test: COVID-19 Nasal Swab: negative on 08Mar2021. The outcome of the events was recovering/resolving.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Urine analysis, White blood cell count normal
Clinical narrative: Appendicitis; 27 hours after injection: fever and chills; 27 hours after injection: fever and chills; 24 hours after injection: sharp stomach pain that roamed around the abdomen; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Mar2021 11:00 (Batch/Lot Number: EN6206) as a single dose for COVID-19 immunization. Medical history included Discoid Lupus, Sjogren's syndrome, and chronic constipation from an unknown date. The patient has no COVID-19 history prior vaccination. There were no concomitant medications. 24 hours after injection on 08Mar2021 11:00, sharp stomach pain that roamed around the abdomen was reported experienced by the patient. 27 hours after injection on 08Mar2021, 14:00, fever and chills were reported, and abdominal pain did not go away by night so the patient went to the Emergency Room (ER) 35 hours after injection on 08Mar2021, 22:00 from which the patient had a urinalysis, blood test, and an ultrasound to find the site of pain, and the ultrasound showed appendicitis. 41 hours after injection on 09Mar2021 04:00, the patient had an appendectomy. The event resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included blood test: COVID-19 Nasal Swab: negative on 08Mar2021. The outcome of the events was recovering/resolving.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Appendicitis, Blood test, Chills, Pyrexia
Clinical narrative: Appendicitis; 27 hours after injection: fever and chills; 27 hours after injection: fever and chills; 24 hours after injection: sharp stomach pain that roamed around the abdomen; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Mar2021 11:00 (Batch/Lot Number: EN6206) as a single dose for COVID-19 immunization. Medical history included Discoid Lupus, Sjogren's syndrome, and chronic constipation from an unknown date. The patient has no COVID-19 history prior vaccination. There were no concomitant medications. 24 hours after injection on 08Mar2021 11:00, sharp stomach pain that roamed around the abdomen was reported experienced by the patient. 27 hours after injection on 08Mar2021, 14:00, fever and chills were reported, and abdominal pain did not go away by night so the patient went to the Emergency Room (ER) 35 hours after injection on 08Mar2021, 22:00 from which the patient had a urinalysis, blood test, and an ultrasound to find the site of pain, and the ultrasound showed appendicitis. 41 hours after injection on 09Mar2021 04:00, the patient had an appendectomy. The event resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included blood test: COVID-19 Nasal Swab: negative on 08Mar2021. The outcome of the events was recovering/resolving.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Ultrasound abdomen, Urine analysis
Clinical narrative: Appendicitis; 27 hours after injection: fever and chills; 27 hours after injection: fever and chills; 24 hours after injection: sharp stomach pain that roamed around the abdomen; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Mar2021 11:00 (Batch/Lot Number: EN6206) as a single dose for COVID-19 immunization. Medical history included Discoid Lupus, Sjogren's syndrome, and chronic constipation from an unknown date. The patient has no COVID-19 history prior vaccination. There were no concomitant medications. 24 hours after injection on 08Mar2021 11:00, sharp stomach pain that roamed around the abdomen was reported experienced by the patient. 27 hours after injection on 08Mar2021, 14:00, fever and chills were reported, and abdominal pain did not go away by night so the patient went to the Emergency Room (ER) 35 hours after injection on 08Mar2021, 22:00 from which the patient had a urinalysis, blood test, and an ultrasound to find the site of pain, and the ultrasound showed appendicitis. 41 hours after injection on 09Mar2021 04:00, the patient had an appendectomy. The event resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included blood test: COVID-19 Nasal Swab: negative on 08Mar2021. The outcome of the events was recovering/resolving.
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Death, Dysstasia, Inflammation, Magnetic resonance imaging spinal abnormal
Clinical narrative: On the fourth day, was taken to hospital and diagnosed with metastatic cancer in the spine; 91 yo father received second dose of vaccine, was very sore on second day and then could not walk by third day; 91 yo father received second dose of vaccine, was very sore on second day and then could not walk by third day; incredibly marked decline in health and rapid deterioration resulting in death; This is a spontaneous report from a contactable consumer. A 91-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 01Mar2021 16:30 (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included Chronic heart conditions, chronic obstructive pulmonary disease (COPD) and, asymptomatic cancer was diagnosed in hospital following vaccine; all from an unknown date and unknown if ongoing. The patient was vaccinated at a hospital. No other vaccine in four weeks. The patient had no COVID prior vaccination and not tested post vaccination. The patient had no known allergies. The patient previously took bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) first dose on 08Feb2021 (lot: EN6201) 05:30 PM at the left arm. It was reported that the patient "received second dose of vaccine, was very sore on second day (03Mar2021) and then could not walk by third day (04Mar2021). On the fourth day (05Mar2021), was taken to hospital and diagnosed with metastatic cancer in the spine, which had produced no symptoms prior. The vaccine obviously did not cause cancer, but it did precipitate some event that led to an incredibly marked decline in health and rapid deterioration resulting in death 17 days after vaccine." The patient died on 18Mar2021.  It was not reported if an autopsy was performed. The event resulted in Emergency room/department or urgent care and hospitalization for 7 days.; Sender's Comments: Based on the current available information, Bone cancer metastatic is considered unrelated to the suspected drug of bnt162b2.  The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: incredibly marked decline in health and rapid deterioration resulting in death; On the fourth day, was taken to hospital and diagnosed with metastatic cancer in the spine; 91 yo father received second dose of vaccine, was very sore on second day and
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malignant neoplasm of spinal cord, Movement disorder, Wheelchair user
Clinical narrative: On the fourth day, was taken to hospital and diagnosed with metastatic cancer in the spine; 91 yo father received second dose of vaccine, was very sore on second day and then could not walk by third day; 91 yo father received second dose of vaccine, was very sore on second day and then could not walk by third day; incredibly marked decline in health and rapid deterioration resulting in death; This is a spontaneous report from a contactable consumer. A 91-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 01Mar2021 16:30 (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included Chronic heart conditions, chronic obstructive pulmonary disease (COPD) and, asymptomatic cancer was diagnosed in hospital following vaccine; all from an unknown date and unknown if ongoing. The patient was vaccinated at a hospital. No other vaccine in four weeks. The patient had no COVID prior vaccination and not tested post vaccination. The patient had no known allergies. The patient previously took bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) first dose on 08Feb2021 (lot: EN6201) 05:30 PM at the left arm. It was reported that the patient "received second dose of vaccine, was very sore on second day (03Mar2021) and then could not walk by third day (04Mar2021). On the fourth day (05Mar2021), was taken to hospital and diagnosed with metastatic cancer in the spine, which had produced no symptoms prior. The vaccine obviously did not cause cancer, but it did precipitate some event that led to an incredibly marked decline in health and rapid deterioration resulting in death 17 days after vaccine." The patient died on 18Mar2021.  It was not reported if an autopsy was performed. The event resulted in Emergency room/department or urgent care and hospitalization for 7 days.; Sender's Comments: Based on the current available information, Bone cancer metastatic is considered unrelated to the suspected drug of bnt162b2.  The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: incredibly marked decline in health and rapid deterioration resulting in death; On the fourth day, was taken to hospital and diagnosed with metastatic cancer in the spine; 91 yo father received second dose of vaccine, was very sore on second day and
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bone cancer metastatic, Gait disturbance, General physical health deterioration, Pain
Clinical narrative: On the fourth day, was taken to hospital and diagnosed with metastatic cancer in the spine; 91 yo father received second dose of vaccine, was very sore on second day and then could not walk by third day; 91 yo father received second dose of vaccine, was very sore on second day and then could not walk by third day; incredibly marked decline in health and rapid deterioration resulting in death; This is a spontaneous report from a contactable consumer. A 91-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 01Mar2021 16:30 (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included Chronic heart conditions, chronic obstructive pulmonary disease (COPD) and, asymptomatic cancer was diagnosed in hospital following vaccine; all from an unknown date and unknown if ongoing. The patient was vaccinated at a hospital. No other vaccine in four weeks. The patient had no COVID prior vaccination and not tested post vaccination. The patient had no known allergies. The patient previously took bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) first dose on 08Feb2021 (lot: EN6201) 05:30 PM at the left arm. It was reported that the patient "received second dose of vaccine, was very sore on second day (03Mar2021) and then could not walk by third day (04Mar2021). On the fourth day (05Mar2021), was taken to hospital and diagnosed with metastatic cancer in the spine, which had produced no symptoms prior. The vaccine obviously did not cause cancer, but it did precipitate some event that led to an incredibly marked decline in health and rapid deterioration resulting in death 17 days after vaccine." The patient died on 18Mar2021.  It was not reported if an autopsy was performed. The event resulted in Emergency room/department or urgent care and hospitalization for 7 days.; Sender's Comments: Based on the current available information, Bone cancer metastatic is considered unrelated to the suspected drug of bnt162b2.  The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: incredibly marked decline in health and rapid deterioration resulting in death; On the fourth day, was taken to hospital and diagnosed with metastatic cancer in the spine; 91 yo father received second dose of vaccine, was very sore on second day and
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Coma, Vomiting
Clinical narrative: Died/death; Cerebral hemmorage; Vomited a huge amount in the late morning; Woke up with a back ache; A spontaneous report was received from a nurse, concerning a 57-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  back pain, vomiting and died probably due to and cerebral hemorrhage.   The patient's medical history included malignant hypertension and has been hospitalized six weeks prior to the events. Products known to have been used by the patient, within two weeks prior to the event were not provided by the reporter.  On 17 Mar 2021, approximately two days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030A21A) for prophylaxis of COVID-19 infection.   On 19 Mar 2021, the patient experienced back ache, vomited a huge amount in the late morning. On 19 Mar 2021, the patient was found in fetal position in his bed with vomit all over him by a neighbor. The patient has undergone cardiopulmonary resuscitation (CPR), was intubated and was transported to local hospital. The patient was air lifted to hospital but died probably due to and cerebral hemorrhage at 09.40 pm at 19 Mar 2021.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events is not applicable; Reporter's Comments: This is a case of death in a 57-year-old male subject with a medical history of malignant hypertension, who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Died/death; Cerebral hemmorage; Vomited a huge amount in the late morning; Woke up with a back ache; A spontaneous report was received from a nurse, concerning a 57-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  back pain, vomiting and died probably due to and cerebral hemorrhage.   The patient's medical history included malignant hypertension and has been hospitalized six weeks prior to the events. Products known to have been used by the patient, within two weeks prior to the event were not provided by the reporter.  On 17 Mar 2021, approximately two days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030A21A) for prophylaxis of COVID-19 infection.   On 19 Mar 2021, the patient experienced back ache, vomited a huge amount in the late morning. On 19 Mar 2021, the patient was found in fetal position in his bed with vomit all over him by a neighbor. The patient has undergone cardiopulmonary resuscitation (CPR), was intubated and was transported to local hospital. The patient was air lifted to hospital but died probably due to and cerebral hemorrhage at 09.40 pm at 19 Mar 2021.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events is not applicable; Reporter's Comments: This is a case of death in a 57-year-old male subject with a medical history of malignant hypertension, who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Cerebral haemorrhage, Death, Vomiting
Clinical narrative: Died/death; Cerebral hemmorage; Vomited a huge amount in the late morning; Woke up with a back ache; A spontaneous report was received from a nurse, concerning a 57-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  back pain, vomiting and died probably due to and cerebral hemorrhage.   The patient's medical history included malignant hypertension and has been hospitalized six weeks prior to the events. Products known to have been used by the patient, within two weeks prior to the event were not provided by the reporter.  On 17 Mar 2021, approximately two days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030A21A) for prophylaxis of COVID-19 infection.   On 19 Mar 2021, the patient experienced back ache, vomited a huge amount in the late morning. On 19 Mar 2021, the patient was found in fetal position in his bed with vomit all over him by a neighbor. The patient has undergone cardiopulmonary resuscitation (CPR), was intubated and was transported to local hospital. The patient was air lifted to hospital but died probably due to and cerebral hemorrhage at 09.40 pm at 19 Mar 2021.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events is not applicable; Reporter's Comments: This is a case of death in a 57-year-old male subject with a medical history of malignant hypertension, who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Cardiac monitoring, Cerebrovascular accident, Computerised tomogram, Laboratory test
Clinical narrative: Had a stroke with expressive aphasia; Had a stroke with expressive aphasia; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 13Feb2021 14:00 (lot number: EL9264) as single dose at the age of 66 years old, for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, spinal stenosis, arthritis and allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included insulin human zinc suspension (HUMULIN U), metformin, pioglitazone hydrochloride (ACTOS), fish oil, tocopherol (OMEGA 3) and valsartan; all taken for an unspecified indication, start and stop date were not reported. The patient previously took bydureon, codeine and celebrex and experienced drug allergy with these medications. The patient previously received first dose of bnt162b2 on 23Jan2021, at the age of 66 years old for COVID-19 immunization (Product: COVID 19, brand: Pfizer BIONTECH, lot number: EL3247, administration time: 03:00 PM, vaccine location: right arm). The patient did not receive any other vaccines four weeks prior to COVID vaccination. The patient had a stroke with expressive aphasia on 14Feb2021 20:00. The patient was hospitalized due to stroke with expressive aphasia for 5 days. The events resulted in emergency room/department or urgent care and hospitalization. On unspecified dates, the patient underwent lab tests and procedures which included computerised tomogram (CTS), laboratory test (labs), magnetic resonance imaging (MRI), and tPA (plasminogen activator inhibitor); all with unknown results. Other tests include: negative COVID test (nasal swab) on 16Feb2021 and negative COVID test (blood test) on 03Mar2021. The patient had speech therapy as treatment for the events. The patient recovered with sequelae from the events.; Sender's Comments: The reported  stroke with expressive aphasia is assessed as unrelated to the administration of vaccine BNT162B2 and can be explained as intercurrent medical condition in this elderly patient with underlying diabetes mellitus, hypertension and other comorbidities.  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: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Pain in extremity
Clinical narrative: Had a stroke with expressive aphasia; Had a stroke with expressive aphasia; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 13Feb2021 14:00 (lot number: EL9264) as single dose at the age of 66 years old, for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, spinal stenosis, arthritis and allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included insulin human zinc suspension (HUMULIN U), metformin, pioglitazone hydrochloride (ACTOS), fish oil, tocopherol (OMEGA 3) and valsartan; all taken for an unspecified indication, start and stop date were not reported. The patient previously took bydureon, codeine and celebrex and experienced drug allergy with these medications. The patient previously received first dose of bnt162b2 on 23Jan2021, at the age of 66 years old for COVID-19 immunization (Product: COVID 19, brand: Pfizer BIONTECH, lot number: EL3247, administration time: 03:00 PM, vaccine location: right arm). The patient did not receive any other vaccines four weeks prior to COVID vaccination. The patient had a stroke with expressive aphasia on 14Feb2021 20:00. The patient was hospitalized due to stroke with expressive aphasia for 5 days. The events resulted in emergency room/department or urgent care and hospitalization. On unspecified dates, the patient underwent lab tests and procedures which included computerised tomogram (CTS), laboratory test (labs), magnetic resonance imaging (MRI), and tPA (plasminogen activator inhibitor); all with unknown results. Other tests include: negative COVID test (nasal swab) on 16Feb2021 and negative COVID test (blood test) on 03Mar2021. The patient had speech therapy as treatment for the events. The patient recovered with sequelae from the events.; Sender's Comments: The reported  stroke with expressive aphasia is assessed as unrelated to the administration of vaccine BNT162B2 and can be explained as intercurrent medical condition in this elderly patient with underlying diabetes mellitus, hypertension and other comorbidities.  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: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Cerebrovascular accident, Computerised tomogram, Laboratory test, Magnetic resonance imaging
Clinical narrative: Had a stroke with expressive aphasia; Had a stroke with expressive aphasia; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 13Feb2021 14:00 (lot number: EL9264) as single dose at the age of 66 years old, for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, spinal stenosis, arthritis and allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included insulin human zinc suspension (HUMULIN U), metformin, pioglitazone hydrochloride (ACTOS), fish oil, tocopherol (OMEGA 3) and valsartan; all taken for an unspecified indication, start and stop date were not reported. The patient previously took bydureon, codeine and celebrex and experienced drug allergy with these medications. The patient previously received first dose of bnt162b2 on 23Jan2021, at the age of 66 years old for COVID-19 immunization (Product: COVID 19, brand: Pfizer BIONTECH, lot number: EL3247, administration time: 03:00 PM, vaccine location: right arm). The patient did not receive any other vaccines four weeks prior to COVID vaccination. The patient had a stroke with expressive aphasia on 14Feb2021 20:00. The patient was hospitalized due to stroke with expressive aphasia for 5 days. The events resulted in emergency room/department or urgent care and hospitalization. On unspecified dates, the patient underwent lab tests and procedures which included computerised tomogram (CTS), laboratory test (labs), magnetic resonance imaging (MRI), and tPA (plasminogen activator inhibitor); all with unknown results. Other tests include: negative COVID test (nasal swab) on 16Feb2021 and negative COVID test (blood test) on 03Mar2021. The patient had speech therapy as treatment for the events. The patient recovered with sequelae from the events.; Sender's Comments: The reported  stroke with expressive aphasia is assessed as unrelated to the administration of vaccine BNT162B2 and can be explained as intercurrent medical condition in this elderly patient with underlying diabetes mellitus, hypertension and other comorbidities.  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: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Plasminogen activator inhibitor, SARS-CoV-2 test
Clinical narrative: Had a stroke with expressive aphasia; Had a stroke with expressive aphasia; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 13Feb2021 14:00 (lot number: EL9264) as single dose at the age of 66 years old, for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, spinal stenosis, arthritis and allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included insulin human zinc suspension (HUMULIN U), metformin, pioglitazone hydrochloride (ACTOS), fish oil, tocopherol (OMEGA 3) and valsartan; all taken for an unspecified indication, start and stop date were not reported. The patient previously took bydureon, codeine and celebrex and experienced drug allergy with these medications. The patient previously received first dose of bnt162b2 on 23Jan2021, at the age of 66 years old for COVID-19 immunization (Product: COVID 19, brand: Pfizer BIONTECH, lot number: EL3247, administration time: 03:00 PM, vaccine location: right arm). The patient did not receive any other vaccines four weeks prior to COVID vaccination. The patient had a stroke with expressive aphasia on 14Feb2021 20:00. The patient was hospitalized due to stroke with expressive aphasia for 5 days. The events resulted in emergency room/department or urgent care and hospitalization. On unspecified dates, the patient underwent lab tests and procedures which included computerised tomogram (CTS), laboratory test (labs), magnetic resonance imaging (MRI), and tPA (plasminogen activator inhibitor); all with unknown results. Other tests include: negative COVID test (nasal swab) on 16Feb2021 and negative COVID test (blood test) on 03Mar2021. The patient had speech therapy as treatment for the events. The patient recovered with sequelae from the events.; Sender's Comments: The reported  stroke with expressive aphasia is assessed as unrelated to the administration of vaccine BNT162B2 and can be explained as intercurrent medical condition in this elderly patient with underlying diabetes mellitus, hypertension and other comorbidities.  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: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Fatigue, Headache, Movement disorder
Clinical narrative: The patient stated he felt fine the day he received the vaccine. However, starting the day after, he developed dizziness, achiness and a headache. These symptoms progressively worsened over the course of several days. On day 6 after receiving the vaccine, the patient stated his right leg started dragging and he had a difficult time functioning. The patient drove himself to the ER where he collapsed. A bleed in the brain was subsequently discovered and the patient underwent surgery, where he spent 3 days in the ICU. The patient was later discharged. As of today, the patient states he has resumed normal function
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral haemorrhage, Dizziness, Gait disturbance, Headache, Intensive care
Clinical narrative: The patient stated he felt fine the day he received the vaccine. However, starting the day after, he developed dizziness, achiness and a headache. These symptoms progressively worsened over the course of several days. On day 6 after receiving the vaccine, the patient stated his right leg started dragging and he had a difficult time functioning. The patient drove himself to the ER where he collapsed. A bleed in the brain was subsequently discovered and the patient underwent surgery, where he spent 3 days in the ICU. The patient was later discharged. As of today, the patient states he has resumed normal function
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Surgery, Syncope
Clinical narrative: The patient stated he felt fine the day he received the vaccine. However, starting the day after, he developed dizziness, achiness and a headache. These symptoms progressively worsened over the course of several days. On day 6 after receiving the vaccine, the patient stated his right leg started dragging and he had a difficult time functioning. The patient drove himself to the ER where he collapsed. A bleed in the brain was subsequently discovered and the patient underwent surgery, where he spent 3 days in the ICU. The patient was later discharged. As of today, the patient states he has resumed normal function
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac, Computerised tomogram, Echocardiogram, Electrocardiogram, Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report from a contactable consumer reporting for self. This 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, in right arm on 13Feb2021 (at 73 years of age) at 10:30 (Batch/Lot number was not reported) as a single dose for COVID-19 Immunisation.  Medical history included was none. There were no known allergies. The patient did not have COVID prior to vaccination. Concomitant medication(s) included atorvastatin and terazosin, both taken for an unspecified indication, with start and stop date not reported. There was no other vaccine received in the 4 weeks prior.  The patient experienced pericarditis on 17Mar2021 at 17:00. The event resulted in a visit to the emergency room/department or urgent care, and Hospitalization for 2 days. Treatment and relevant tests included: EKG, CT scan, catheterization and echocardiogram. The patient was not COVID tested post-vaccination. The outcome of the event was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Coronary arterial stent insertion, Fatigue, Myocardial infarction, Myocardial necrosis marker increased
Clinical narrative: HEART ATTACK; POSSIBLE BLOODCLOT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. After 30 hours of vaccination the patient had a heart attack. The patient stated that there was  possibility that a bloodclot was caused by the vaccine Treatment medications (dates unspecified) included: heparin, and tenecteplase. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack and possible bloodclot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210401497-covid-19 vaccine ad26.cov2.s-HEART ATTACK and POSSIBLE BLOODCLOT. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain
Clinical narrative: HEART ATTACK; POSSIBLE BLOODCLOT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. After 30 hours of vaccination the patient had a heart attack. The patient stated that there was  possibility that a bloodclot was caused by the vaccine Treatment medications (dates unspecified) included: heparin, and tenecteplase. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack and possible bloodclot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210401497-covid-19 vaccine ad26.cov2.s-HEART ATTACK and POSSIBLE BLOODCLOT. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction, Thrombosis
Clinical narrative: HEART ATTACK; POSSIBLE BLOODCLOT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. After 30 hours of vaccination the patient had a heart attack. The patient stated that there was  possibility that a bloodclot was caused by the vaccine Treatment medications (dates unspecified) included: heparin, and tenecteplase. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack and possible bloodclot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210401497-covid-19 vaccine ad26.cov2.s-HEART ATTACK and POSSIBLE BLOODCLOT. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Pyrexia
Clinical narrative: Fainted; Body chills; fever; body aches; Loss of appetite; Weakness; Sleepiness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, in the left arm on 19Mar2021 at 21:00 as a single dose for COVID-19 immunization.  Medical history included COVID-19 from an unknown date to an unknown date, prior to vaccination. The patient had a nasal swab test for COVID on 18Mar2021 with a result of negative. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccines in four weeks prior to the COVID vaccine. The patient experienced body chills, fever, body aches, loss of appetite, weakness, sleepiness and fainted on 20Mar2021 at 01:00. The patient did not receive treatment for the events. The outcome of the events was recovering.   Information on batch/lot number was requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Syncope
Clinical narrative: Fainted; Body chills; fever; body aches; Loss of appetite; Weakness; Sleepiness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, in the left arm on 19Mar2021 at 21:00 as a single dose for COVID-19 immunization.  Medical history included COVID-19 from an unknown date to an unknown date, prior to vaccination. The patient had a nasal swab test for COVID on 18Mar2021 with a result of negative. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccines in four weeks prior to the COVID vaccine. The patient experienced body chills, fever, body aches, loss of appetite, weakness, sleepiness and fainted on 20Mar2021 at 01:00. The patient did not receive treatment for the events. The outcome of the events was recovering.   Information on batch/lot number was requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Pain, Pyrexia
Clinical narrative: Fainted; Body chills; fever; body aches; Loss of appetite; Weakness; Sleepiness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, in the left arm on 19Mar2021 at 21:00 as a single dose for COVID-19 immunization.  Medical history included COVID-19 from an unknown date to an unknown date, prior to vaccination. The patient had a nasal swab test for COVID on 18Mar2021 with a result of negative. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccines in four weeks prior to the COVID vaccine. The patient experienced body chills, fever, body aches, loss of appetite, weakness, sleepiness and fainted on 20Mar2021 at 01:00. The patient did not receive treatment for the events. The outcome of the events was recovering.   Information on batch/lot number was requested.