chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Atrial fibrillation, Chest pain, Disease recurrence, Dyspnoea
Clinical narrative: thyroiditis/ acute inflammation; AFIB; Platelet count high; Alpha 1 and Alpha 2 Globulin High; Alpha 1 and Alpha 2 Globulin High; Sciatica; Hip pain after severe; neuropathy like symptoms with both leg involvement; lung nodules; Prostatitis; short of breath; chest pains; Lung infection and inflammation/ feels this is infectious/inflammatory process; Lung infection and inflammation/ feels this is infectious/inflammatory process; Lung infection and inflammation/ feels this is infectious/inflammatory process; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2, via an unspecified route of administration on 25Mar2021 15:00 (Batch/Lot Number: ER8727) at the age of 66 years old as dose 2, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and enlarged prostate; on 17Feb2021, acute pancreatitis, meningomyelocele (MMC) hospitalization followed by Dr; lung infection and inflammation, has had numerous scans for several years to keep watch on these "nodules" which come and go. No known allergies. Concomitant medication(s) included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EN6198) on 04Mar2021 14:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Mar2021 (day after), the patient experienced short of breath and chest pains. Within 3 days increased shortness of breath. On 10Aug2021, difficulty urinating - prostatitis. Improved. BACTRIM twice daily X 6 weeks. On 11Aug2021, consult with Dr for lung nodules. Lung infection and inflammation Has had numerous scans for several years to keep watch on these nodules which come and go. He feels this is infectious/inflammatory process (in 2021). Started on Amoxicillin 500 mg-potassium clavulanate 125 mg tablet Twice daily X 10 days. On 19Aug2021, sciatica/neuropathy like symptoms with both leg involvement, hip pain after severe. On 31Aug2021, bloodwork done for autoimmune disorders (unknown results). Gabapentin now BID. Platelet count high. Alpha 1 and Alpha 2 Globulin High. On 01Sep2021, atrial fibrillation (AFIB). On 16Sep2021 thyroiditis, bloodwork showing acute inflammation. Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was received for events including antibiotic, prednisone, many testing and physical. No hospitalization prolonged. The outcome of the events was recovering. The case was not assessed as not serious by the reporter.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Pneumonia, Pneumonitis, Prostatitis, Pulmonary mass
Clinical narrative: thyroiditis/ acute inflammation; AFIB; Platelet count high; Alpha 1 and Alpha 2 Globulin High; Alpha 1 and Alpha 2 Globulin High; Sciatica; Hip pain after severe; neuropathy like symptoms with both leg involvement; lung nodules; Prostatitis; short of breath; chest pains; Lung infection and inflammation/ feels this is infectious/inflammatory process; Lung infection and inflammation/ feels this is infectious/inflammatory process; Lung infection and inflammation/ feels this is infectious/inflammatory process; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2, via an unspecified route of administration on 25Mar2021 15:00 (Batch/Lot Number: ER8727) at the age of 66 years old as dose 2, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and enlarged prostate; on 17Feb2021, acute pancreatitis, meningomyelocele (MMC) hospitalization followed by Dr; lung infection and inflammation, has had numerous scans for several years to keep watch on these "nodules" which come and go. No known allergies. Concomitant medication(s) included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EN6198) on 04Mar2021 14:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Mar2021 (day after), the patient experienced short of breath and chest pains. Within 3 days increased shortness of breath. On 10Aug2021, difficulty urinating - prostatitis. Improved. BACTRIM twice daily X 6 weeks. On 11Aug2021, consult with Dr for lung nodules. Lung infection and inflammation Has had numerous scans for several years to keep watch on these nodules which come and go. He feels this is infectious/inflammatory process (in 2021). Started on Amoxicillin 500 mg-potassium clavulanate 125 mg tablet Twice daily X 10 days. On 19Aug2021, sciatica/neuropathy like symptoms with both leg involvement, hip pain after severe. On 31Aug2021, bloodwork done for autoimmune disorders (unknown results). Gabapentin now BID. Platelet count high. Alpha 1 and Alpha 2 Globulin High. On 01Sep2021, atrial fibrillation (AFIB). On 16Sep2021 thyroiditis, bloodwork showing acute inflammation. Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was received for events including antibiotic, prednisone, many testing and physical. No hospitalization prolonged. The outcome of the events was recovering. The case was not assessed as not serious by the reporter.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sciatica, Thyroiditis acute
Clinical narrative: thyroiditis/ acute inflammation; AFIB; Platelet count high; Alpha 1 and Alpha 2 Globulin High; Alpha 1 and Alpha 2 Globulin High; Sciatica; Hip pain after severe; neuropathy like symptoms with both leg involvement; lung nodules; Prostatitis; short of breath; chest pains; Lung infection and inflammation/ feels this is infectious/inflammatory process; Lung infection and inflammation/ feels this is infectious/inflammatory process; Lung infection and inflammation/ feels this is infectious/inflammatory process; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2, via an unspecified route of administration on 25Mar2021 15:00 (Batch/Lot Number: ER8727) at the age of 66 years old as dose 2, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and enlarged prostate; on 17Feb2021, acute pancreatitis, meningomyelocele (MMC) hospitalization followed by Dr; lung infection and inflammation, has had numerous scans for several years to keep watch on these "nodules" which come and go. No known allergies. Concomitant medication(s) included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EN6198) on 04Mar2021 14:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Mar2021 (day after), the patient experienced short of breath and chest pains. Within 3 days increased shortness of breath. On 10Aug2021, difficulty urinating - prostatitis. Improved. BACTRIM twice daily X 6 weeks. On 11Aug2021, consult with Dr for lung nodules. Lung infection and inflammation Has had numerous scans for several years to keep watch on these nodules which come and go. He feels this is infectious/inflammatory process (in 2021). Started on Amoxicillin 500 mg-potassium clavulanate 125 mg tablet Twice daily X 10 days. On 19Aug2021, sciatica/neuropathy like symptoms with both leg involvement, hip pain after severe. On 31Aug2021, bloodwork done for autoimmune disorders (unknown results). Gabapentin now BID. Platelet count high. Alpha 1 and Alpha 2 Globulin High. On 01Sep2021, atrial fibrillation (AFIB). On 16Sep2021 thyroiditis, bloodwork showing acute inflammation. Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was received for events including antibiotic, prednisone, many testing and physical. No hospitalization prolonged. The outcome of the events was recovering. The case was not assessed as not serious by the reporter.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Depression, Diarrhoea, Emotional distress, Extra dose administered
Clinical narrative: almost to the point of suicidal thoughts; sick; horrible nausea; on and off bad diarrhea; terrible depression; anxiety; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on an unspecified date (Lot Number: FC3183, unknown expiration) as dose 3 (booster), single for COVID-19 immunisation.  Medical history primary immunodeficiency (CVID). There were no concomitant medications.  The patient previously took hydrocodone and had known allergies to it. The patient previously received first dose of BNT162B2 (Lot number: EN6205) on 22Mar2021 at 01:30 pm in left arm and experienced period even though she was on continuous birth control and sick at the age of 29 years old and second dose of BNT162B2 (lot number: EN6955) on unspecified date in left arm for COVID-19 immunization. On 08Sep2021, the patient experienced sick, horrible nausea, and on and off bad diarrhea. She is 15 days out and still getting on and off bad diarrhea. Also, on 08Sep2021, the patient is having terrible depression and anxiety, her depression is much worse than normal almost to the point of suicidal thoughts. The patient did not receive treatment for the events. No COVID prior to vaccination and has not been tested for COVID post vaccination. No other vaccine in four weeks. The patient has not yet recovered from the events.   No follow-up attempts are possible; information about batch number was already obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Irritability, Menstrual disorder, Nausea, Suicidal ideation
Clinical narrative: almost to the point of suicidal thoughts; sick; horrible nausea; on and off bad diarrhea; terrible depression; anxiety; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on an unspecified date (Lot Number: FC3183, unknown expiration) as dose 3 (booster), single for COVID-19 immunisation.  Medical history primary immunodeficiency (CVID). There were no concomitant medications.  The patient previously took hydrocodone and had known allergies to it. The patient previously received first dose of BNT162B2 (Lot number: EN6205) on 22Mar2021 at 01:30 pm in left arm and experienced period even though she was on continuous birth control and sick at the age of 29 years old and second dose of BNT162B2 (lot number: EN6955) on unspecified date in left arm for COVID-19 immunization. On 08Sep2021, the patient experienced sick, horrible nausea, and on and off bad diarrhea. She is 15 days out and still getting on and off bad diarrhea. Also, on 08Sep2021, the patient is having terrible depression and anxiety, her depression is much worse than normal almost to the point of suicidal thoughts. The patient did not receive treatment for the events. No COVID prior to vaccination and has not been tested for COVID post vaccination. No other vaccine in four weeks. The patient has not yet recovered from the events.   No follow-up attempts are possible; information about batch number was already obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Depression, Diarrhoea, Malaise, Nausea
Clinical narrative: almost to the point of suicidal thoughts; sick; horrible nausea; on and off bad diarrhea; terrible depression; anxiety; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on an unspecified date (Lot Number: FC3183, unknown expiration) as dose 3 (booster), single for COVID-19 immunisation.  Medical history primary immunodeficiency (CVID). There were no concomitant medications.  The patient previously took hydrocodone and had known allergies to it. The patient previously received first dose of BNT162B2 (Lot number: EN6205) on 22Mar2021 at 01:30 pm in left arm and experienced period even though she was on continuous birth control and sick at the age of 29 years old and second dose of BNT162B2 (lot number: EN6955) on unspecified date in left arm for COVID-19 immunization. On 08Sep2021, the patient experienced sick, horrible nausea, and on and off bad diarrhea. She is 15 days out and still getting on and off bad diarrhea. Also, on 08Sep2021, the patient is having terrible depression and anxiety, her depression is much worse than normal almost to the point of suicidal thoughts. The patient did not receive treatment for the events. No COVID prior to vaccination and has not been tested for COVID post vaccination. No other vaccine in four weeks. The patient has not yet recovered from the events.   No follow-up attempts are possible; information about batch number was already obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Suicidal ideation
Clinical narrative: almost to the point of suicidal thoughts; sick; horrible nausea; on and off bad diarrhea; terrible depression; anxiety; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on an unspecified date (Lot Number: FC3183, unknown expiration) as dose 3 (booster), single for COVID-19 immunisation.  Medical history primary immunodeficiency (CVID). There were no concomitant medications.  The patient previously took hydrocodone and had known allergies to it. The patient previously received first dose of BNT162B2 (Lot number: EN6205) on 22Mar2021 at 01:30 pm in left arm and experienced period even though she was on continuous birth control and sick at the age of 29 years old and second dose of BNT162B2 (lot number: EN6955) on unspecified date in left arm for COVID-19 immunization. On 08Sep2021, the patient experienced sick, horrible nausea, and on and off bad diarrhea. She is 15 days out and still getting on and off bad diarrhea. Also, on 08Sep2021, the patient is having terrible depression and anxiety, her depression is much worse than normal almost to the point of suicidal thoughts. The patient did not receive treatment for the events. No COVID prior to vaccination and has not been tested for COVID post vaccination. No other vaccine in four weeks. The patient has not yet recovered from the events.   No follow-up attempts are possible; information about batch number was already obtained.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Trigger finger
Clinical narrative: Trigger finger developed in little finger and ring finger of right hand 2 days after vaccination; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 37 years old) via an unspecified route of administration, administered in Arm Left on 18Aug2021 11:30 (Batch/Lot Number: FC3183) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has no covid prior vaccination and no other vaccine in four weeks. The patient developed trigger finger in little finger and ring finger of right hand 2 days after vaccination, on 20Aug2021 (onset date also reported as 27Aug2021 at 04:00 AM). The patient never had trigger finger before. It was worst in the early morning when he woke up. The event resulted in disability or permanent damage. The event was not treated. The patient was not tested for covid post vaccination. The outcome of the event was not recovered. The patient had the second dose on 08Sep2021 11:30 AM in the left arm (lot: FC3183).  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Trigger finger
Clinical narrative: Trigger finger developed in little finger and ring finger of right hand 2 days after vaccination; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 37 years old) via an unspecified route of administration, administered in Arm Left on 18Aug2021 11:30 (Batch/Lot Number: FC3183) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has no covid prior vaccination and no other vaccine in four weeks. The patient developed trigger finger in little finger and ring finger of right hand 2 days after vaccination, on 20Aug2021 (onset date also reported as 27Aug2021 at 04:00 AM). The patient never had trigger finger before. It was worst in the early morning when he woke up. The event resulted in disability or permanent damage. The event was not treated. The patient was not tested for covid post vaccination. The outcome of the event was not recovered. The patient had the second dose on 08Sep2021 11:30 AM in the left arm (lot: FC3183).  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Anaphylactic reaction, Dizziness, Electrocardiogram, Heart rate increased
Clinical narrative: Throat pain; Anaphylaxis reaction: Immediately following injection; Blood pressure taken hypertensive 160/110; Arm numbness; Felt hot; Tight throat; Chest pain; Rapid heart beat; Nausea; Dizziness; Pounding in chest; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at doctor's office/urgent care facility on 21Sep2021 13:00 (Batch/Lot number was not reported) (at the age of 35-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination and had not been tested for covid post vaccination. Medical history included known allergies to morphine with injection reaction/anaphylaxis. The patient had no other medical history. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL). On 21Sep2021 at 01:00 PM, the patient experienced anaphylaxis reaction immediately following injection, arm numbness, felt hot, tight throat, chest pain, rapid heart beat, nausea, dizziness. Heart rate spiked to 170bpm. Blood pressure taken hypertensive 160/110. After short amount of time heart rate (HR) dropped to 120bpm and with throat tightness and nausea. However shortly after pounding in chest and HR elevated to 150bpm rapidly with nausea and dizziness. This was a cyclical pattern and rapid climbing HR epinephrine was administered dropping HR to 115bpm. After epinephrine administration HR did spike and remain at 130bpm, approximately 1 hr later HR dropped to 100bpm where it was consistent. Next day (22Sep2021), chest tightness and throat pain mild, no elevated HR (85bpm). The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of all events which included Epinephrine, Benadryl, Dexamethasone, Zofran, and Pepcid. The patient was recovering from the events.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Throat tightness
Clinical narrative: Throat pain; Anaphylaxis reaction: Immediately following injection; Blood pressure taken hypertensive 160/110; Arm numbness; Felt hot; Tight throat; Chest pain; Rapid heart beat; Nausea; Dizziness; Pounding in chest; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at doctor's office/urgent care facility on 21Sep2021 13:00 (Batch/Lot number was not reported) (at the age of 35-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination and had not been tested for covid post vaccination. Medical history included known allergies to morphine with injection reaction/anaphylaxis. The patient had no other medical history. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL). On 21Sep2021 at 01:00 PM, the patient experienced anaphylaxis reaction immediately following injection, arm numbness, felt hot, tight throat, chest pain, rapid heart beat, nausea, dizziness. Heart rate spiked to 170bpm. Blood pressure taken hypertensive 160/110. After short amount of time heart rate (HR) dropped to 120bpm and with throat tightness and nausea. However shortly after pounding in chest and HR elevated to 150bpm rapidly with nausea and dizziness. This was a cyclical pattern and rapid climbing HR epinephrine was administered dropping HR to 115bpm. After epinephrine administration HR did spike and remain at 130bpm, approximately 1 hr later HR dropped to 100bpm where it was consistent. Next day (22Sep2021), chest tightness and throat pain mild, no elevated HR (85bpm). The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of all events which included Epinephrine, Benadryl, Dexamethasone, Zofran, and Pepcid. The patient was recovering from the events.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Chest discomfort, Chest pain, Dizziness
Clinical narrative: Throat pain; Anaphylaxis reaction: Immediately following injection; Blood pressure taken hypertensive 160/110; Arm numbness; Felt hot; Tight throat; Chest pain; Rapid heart beat; Nausea; Dizziness; Pounding in chest; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at doctor's office/urgent care facility on 21Sep2021 13:00 (Batch/Lot number was not reported) (at the age of 35-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination and had not been tested for covid post vaccination. Medical history included known allergies to morphine with injection reaction/anaphylaxis. The patient had no other medical history. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL). On 21Sep2021 at 01:00 PM, the patient experienced anaphylaxis reaction immediately following injection, arm numbness, felt hot, tight throat, chest pain, rapid heart beat, nausea, dizziness. Heart rate spiked to 170bpm. Blood pressure taken hypertensive 160/110. After short amount of time heart rate (HR) dropped to 120bpm and with throat tightness and nausea. However shortly after pounding in chest and HR elevated to 150bpm rapidly with nausea and dizziness. This was a cyclical pattern and rapid climbing HR epinephrine was administered dropping HR to 115bpm. After epinephrine administration HR did spike and remain at 130bpm, approximately 1 hr later HR dropped to 100bpm where it was consistent. Next day (22Sep2021), chest tightness and throat pain mild, no elevated HR (85bpm). The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of all events which included Epinephrine, Benadryl, Dexamethasone, Zofran, and Pepcid. The patient was recovering from the events.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Heart rate, Heart rate increased, Hypertension, Hypoaesthesia
Clinical narrative: Throat pain; Anaphylaxis reaction: Immediately following injection; Blood pressure taken hypertensive 160/110; Arm numbness; Felt hot; Tight throat; Chest pain; Rapid heart beat; Nausea; Dizziness; Pounding in chest; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at doctor's office/urgent care facility on 21Sep2021 13:00 (Batch/Lot number was not reported) (at the age of 35-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination and had not been tested for covid post vaccination. Medical history included known allergies to morphine with injection reaction/anaphylaxis. The patient had no other medical history. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL). On 21Sep2021 at 01:00 PM, the patient experienced anaphylaxis reaction immediately following injection, arm numbness, felt hot, tight throat, chest pain, rapid heart beat, nausea, dizziness. Heart rate spiked to 170bpm. Blood pressure taken hypertensive 160/110. After short amount of time heart rate (HR) dropped to 120bpm and with throat tightness and nausea. However shortly after pounding in chest and HR elevated to 150bpm rapidly with nausea and dizziness. This was a cyclical pattern and rapid climbing HR epinephrine was administered dropping HR to 115bpm. After epinephrine administration HR did spike and remain at 130bpm, approximately 1 hr later HR dropped to 100bpm where it was consistent. Next day (22Sep2021), chest tightness and throat pain mild, no elevated HR (85bpm). The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of all events which included Epinephrine, Benadryl, Dexamethasone, Zofran, and Pepcid. The patient was recovering from the events.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oropharyngeal pain, Palpitations, Throat tightness
Clinical narrative: Throat pain; Anaphylaxis reaction: Immediately following injection; Blood pressure taken hypertensive 160/110; Arm numbness; Felt hot; Tight throat; Chest pain; Rapid heart beat; Nausea; Dizziness; Pounding in chest; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at doctor's office/urgent care facility on 21Sep2021 13:00 (Batch/Lot number was not reported) (at the age of 35-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination and had not been tested for covid post vaccination. Medical history included known allergies to morphine with injection reaction/anaphylaxis. The patient had no other medical history. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL). On 21Sep2021 at 01:00 PM, the patient experienced anaphylaxis reaction immediately following injection, arm numbness, felt hot, tight throat, chest pain, rapid heart beat, nausea, dizziness. Heart rate spiked to 170bpm. Blood pressure taken hypertensive 160/110. After short amount of time heart rate (HR) dropped to 120bpm and with throat tightness and nausea. However shortly after pounding in chest and HR elevated to 150bpm rapidly with nausea and dizziness. This was a cyclical pattern and rapid climbing HR epinephrine was administered dropping HR to 115bpm. After epinephrine administration HR did spike and remain at 130bpm, approximately 1 hr later HR dropped to 100bpm where it was consistent. Next day (22Sep2021), chest tightness and throat pain mild, no elevated HR (85bpm). The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of all events which included Epinephrine, Benadryl, Dexamethasone, Zofran, and Pepcid. The patient was recovering from the events.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial septal defect, Blood test normal, Central vision loss, Cerebrovascular accident, Computerised tomogram head normal
Clinical narrative: TIA event; bilateral central vision loss; Treated in ER as a stroke; sharp shooting pain in right temple; left vision kaleidoscope vision; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 12Jan2021 13:00 (at the age of 48 years) (Batch/Lot Number: EH9899) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included TIA (transient ischaemic attack) event in follow-up testing: PFO and heterozygous for prothrombin gene mutation and NSAID allergy. The patient is not pregnant. Concomitant medications included fish oil, vitamin D NOS, and an unspecified multivitamin. The patient previously took DOSE 1 of BNT162B2 on 22Dec2020 01:00 (at the age of 47 years, lot number: EH9899) in the left arm for COVID-19 immunization. On 11Feb2021 14:00, the patient experienced TIA event manifested by sharp shooting pain in right temple followed by bilateral central vision loss for 2 minutes then left vision kaleidoscope vision for another 2 hours before returning to normal. Treated in ER as a stroke. The events TIA, bilateral central vision loss and stroke were assessed as serious (medically significant). The event resulted in emergency room/department or urgent care. Treatment was received for the events (anti-platelet therapy). Lab data includes COVID-19 test (nasal swab): negative on 23Aug2021 and 08Sep2021. The outcome of the events was unknown.; Sender's Comments: Based on the currently available information the possibility of causal association between the event TIA, bilateral central vision loss and stroke and the suspect drug BNT162B2  cannot be ruled out. 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: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram neck, Computerised tomogram normal, Echocardiogram, Echocardiogram abnormal, Facial pain
Clinical narrative: TIA event; bilateral central vision loss; Treated in ER as a stroke; sharp shooting pain in right temple; left vision kaleidoscope vision; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 12Jan2021 13:00 (at the age of 48 years) (Batch/Lot Number: EH9899) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included TIA (transient ischaemic attack) event in follow-up testing: PFO and heterozygous for prothrombin gene mutation and NSAID allergy. The patient is not pregnant. Concomitant medications included fish oil, vitamin D NOS, and an unspecified multivitamin. The patient previously took DOSE 1 of BNT162B2 on 22Dec2020 01:00 (at the age of 47 years, lot number: EH9899) in the left arm for COVID-19 immunization. On 11Feb2021 14:00, the patient experienced TIA event manifested by sharp shooting pain in right temple followed by bilateral central vision loss for 2 minutes then left vision kaleidoscope vision for another 2 hours before returning to normal. Treated in ER as a stroke. The events TIA, bilateral central vision loss and stroke were assessed as serious (medically significant). The event resulted in emergency room/department or urgent care. Treatment was received for the events (anti-platelet therapy). Lab data includes COVID-19 test (nasal swab): negative on 23Aug2021 and 08Sep2021. The outcome of the events was unknown.; Sender's Comments: Based on the currently available information the possibility of causal association between the event TIA, bilateral central vision loss and stroke and the suspect drug BNT162B2  cannot be ruled out. 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: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Factor II mutation, Magnetic resonance imaging head normal, Ophthalmological examination normal, Pain, Transient ischaemic attack
Clinical narrative: TIA event; bilateral central vision loss; Treated in ER as a stroke; sharp shooting pain in right temple; left vision kaleidoscope vision; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 12Jan2021 13:00 (at the age of 48 years) (Batch/Lot Number: EH9899) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included TIA (transient ischaemic attack) event in follow-up testing: PFO and heterozygous for prothrombin gene mutation and NSAID allergy. The patient is not pregnant. Concomitant medications included fish oil, vitamin D NOS, and an unspecified multivitamin. The patient previously took DOSE 1 of BNT162B2 on 22Dec2020 01:00 (at the age of 47 years, lot number: EH9899) in the left arm for COVID-19 immunization. On 11Feb2021 14:00, the patient experienced TIA event manifested by sharp shooting pain in right temple followed by bilateral central vision loss for 2 minutes then left vision kaleidoscope vision for another 2 hours before returning to normal. Treated in ER as a stroke. The events TIA, bilateral central vision loss and stroke were assessed as serious (medically significant). The event resulted in emergency room/department or urgent care. Treatment was received for the events (anti-platelet therapy). Lab data includes COVID-19 test (nasal swab): negative on 23Aug2021 and 08Sep2021. The outcome of the events was unknown.; Sender's Comments: Based on the currently available information the possibility of causal association between the event TIA, bilateral central vision loss and stroke and the suspect drug BNT162B2  cannot be ruled out. 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: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound Doppler, Visual impairment
Clinical narrative: TIA event; bilateral central vision loss; Treated in ER as a stroke; sharp shooting pain in right temple; left vision kaleidoscope vision; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 12Jan2021 13:00 (at the age of 48 years) (Batch/Lot Number: EH9899) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included TIA (transient ischaemic attack) event in follow-up testing: PFO and heterozygous for prothrombin gene mutation and NSAID allergy. The patient is not pregnant. Concomitant medications included fish oil, vitamin D NOS, and an unspecified multivitamin. The patient previously took DOSE 1 of BNT162B2 on 22Dec2020 01:00 (at the age of 47 years, lot number: EH9899) in the left arm for COVID-19 immunization. On 11Feb2021 14:00, the patient experienced TIA event manifested by sharp shooting pain in right temple followed by bilateral central vision loss for 2 minutes then left vision kaleidoscope vision for another 2 hours before returning to normal. Treated in ER as a stroke. The events TIA, bilateral central vision loss and stroke were assessed as serious (medically significant). The event resulted in emergency room/department or urgent care. Treatment was received for the events (anti-platelet therapy). Lab data includes COVID-19 test (nasal swab): negative on 23Aug2021 and 08Sep2021. The outcome of the events was unknown.; Sender's Comments: Based on the currently available information the possibility of causal association between the event TIA, bilateral central vision loss and stroke and the suspect drug BNT162B2  cannot be ruled out. 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: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness, Cerebrovascular accident, Headache, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: TIA event; bilateral central vision loss; Treated in ER as a stroke; sharp shooting pain in right temple; left vision kaleidoscope vision; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 12Jan2021 13:00 (at the age of 48 years) (Batch/Lot Number: EH9899) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included TIA (transient ischaemic attack) event in follow-up testing: PFO and heterozygous for prothrombin gene mutation and NSAID allergy. The patient is not pregnant. Concomitant medications included fish oil, vitamin D NOS, and an unspecified multivitamin. The patient previously took DOSE 1 of BNT162B2 on 22Dec2020 01:00 (at the age of 47 years, lot number: EH9899) in the left arm for COVID-19 immunization. On 11Feb2021 14:00, the patient experienced TIA event manifested by sharp shooting pain in right temple followed by bilateral central vision loss for 2 minutes then left vision kaleidoscope vision for another 2 hours before returning to normal. Treated in ER as a stroke. The events TIA, bilateral central vision loss and stroke were assessed as serious (medically significant). The event resulted in emergency room/department or urgent care. Treatment was received for the events (anti-platelet therapy). Lab data includes COVID-19 test (nasal swab): negative on 23Aug2021 and 08Sep2021. The outcome of the events was unknown.; Sender's Comments: Based on the currently available information the possibility of causal association between the event TIA, bilateral central vision loss and stroke and the suspect drug BNT162B2  cannot be ruled out. 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: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: TIA event; bilateral central vision loss; Treated in ER as a stroke; sharp shooting pain in right temple; left vision kaleidoscope vision; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 12Jan2021 13:00 (at the age of 48 years) (Batch/Lot Number: EH9899) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included TIA (transient ischaemic attack) event in follow-up testing: PFO and heterozygous for prothrombin gene mutation and NSAID allergy. The patient is not pregnant. Concomitant medications included fish oil, vitamin D NOS, and an unspecified multivitamin. The patient previously took DOSE 1 of BNT162B2 on 22Dec2020 01:00 (at the age of 47 years, lot number: EH9899) in the left arm for COVID-19 immunization. On 11Feb2021 14:00, the patient experienced TIA event manifested by sharp shooting pain in right temple followed by bilateral central vision loss for 2 minutes then left vision kaleidoscope vision for another 2 hours before returning to normal. Treated in ER as a stroke. The events TIA, bilateral central vision loss and stroke were assessed as serious (medically significant). The event resulted in emergency room/department or urgent care. Treatment was received for the events (anti-platelet therapy). Lab data includes COVID-19 test (nasal swab): negative on 23Aug2021 and 08Sep2021. The outcome of the events was unknown.; Sender's Comments: Based on the currently available information the possibility of causal association between the event TIA, bilateral central vision loss and stroke and the suspect drug BNT162B2  cannot be ruled out. 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: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Feeling cold, Hypoaesthesia, Pruritus
Clinical narrative: Tested positive for Covid, has mild cough,  after first vaccine; Tested positive for Covid, has mild cough,  after first vaccine; Metallic taste in mouth, after first vaccine; burning between her toes and fingers; like a hot and cold feeling, also to her legs, arms, mouth, randomly to eyes and cheek; itching in different areas; numbness in different areas; This is a spontaneous report from a Pfizer sponsored regulatory authority from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the arm left on 15Sep2021, at the age of 41-years-old, at single dose for COVID-19 immunization. Medical history included ongoing diabetes from Oct2019, ongoing depression from Aug2017 and ongoing anxiety from Aug2017. Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ, 150 mg) oral from unspecified date in 2017 and ongoing at 150 mg, 1x/day for depression and anxiety; bupropion hydrochloride (WELLBUTRIN, 150 mg) oral from Aug2017 and ongoing at 150 mg, 1x/day for depression and anxiety; and metformin (strength: 500 mg) oral from Nov2019 and ongoing at 500 mg, 2x/day for diabetes. On 15Sep2021, about an hour after the vaccine, the patient had metallic taste in mouth. On unspecified date in Sep2021 (around 18Sep2021 or 19Sep2021), the patient had burning between toes and fingers, like a hot and cold feeling, also to her legs, arms, mouth, randomly to eyes and cheek, associated with itching and numbness in different areas, after first vaccine. On 23Sep2021, the patient tested positive for COVID, has mild cough. Patient wanted to know anything she can do for her symptoms other than taking diphenhydramine hydrochloride (BENADRYL). Therapeutic measure was taken in response to the events which included taking Benadryl. Patient underwent laboratory test which included COVID-19 virus test on 23Sep2021: positive. Outcome of the events (metallic taste in mouth; and burning between toes and fingers, like a hot and cold feeling, also to her legs, arms, mouth, randomly to eyes and cheek, associated with itching and numbness in different areas) was not recovered; while event tested positive for COVID was recovering.  The lot number for [BNT162B2] was not provided and will be requested during follow-up.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, COVID-19, Dysgeusia, Feeling of body temperature change, Hypoaesthesia
Clinical narrative: Tested positive for Covid, has mild cough,  after first vaccine; Tested positive for Covid, has mild cough,  after first vaccine; Metallic taste in mouth, after first vaccine; burning between her toes and fingers; like a hot and cold feeling, also to her legs, arms, mouth, randomly to eyes and cheek; itching in different areas; numbness in different areas; This is a spontaneous report from a Pfizer sponsored regulatory authority from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the arm left on 15Sep2021, at the age of 41-years-old, at single dose for COVID-19 immunization. Medical history included ongoing diabetes from Oct2019, ongoing depression from Aug2017 and ongoing anxiety from Aug2017. Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ, 150 mg) oral from unspecified date in 2017 and ongoing at 150 mg, 1x/day for depression and anxiety; bupropion hydrochloride (WELLBUTRIN, 150 mg) oral from Aug2017 and ongoing at 150 mg, 1x/day for depression and anxiety; and metformin (strength: 500 mg) oral from Nov2019 and ongoing at 500 mg, 2x/day for diabetes. On 15Sep2021, about an hour after the vaccine, the patient had metallic taste in mouth. On unspecified date in Sep2021 (around 18Sep2021 or 19Sep2021), the patient had burning between toes and fingers, like a hot and cold feeling, also to her legs, arms, mouth, randomly to eyes and cheek, associated with itching and numbness in different areas, after first vaccine. On 23Sep2021, the patient tested positive for COVID, has mild cough. Patient wanted to know anything she can do for her symptoms other than taking diphenhydramine hydrochloride (BENADRYL). Therapeutic measure was taken in response to the events which included taking Benadryl. Patient underwent laboratory test which included COVID-19 virus test on 23Sep2021: positive. Outcome of the events (metallic taste in mouth; and burning between toes and fingers, like a hot and cold feeling, also to her legs, arms, mouth, randomly to eyes and cheek, associated with itching and numbness in different areas) was not recovered; while event tested positive for COVID was recovering.  The lot number for [BNT162B2] was not provided and will be requested during follow-up.