chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pallor, Presyncope, Respiratory rate
Clinical narrative: oxygen saturation decreased; pale; diaphoretic; lightheaded; weak; feel like l'm going to faint; Heart rate decreased; that his legs felt heavy; he felt tired; This is a spontaneous report from a contactable other health care professional. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0101) via intramuscular route, administered in right arm on 06Aug2021 13:30 (at the age of 41-year-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no allergies to vaccine or vaccine components.   On 06Aug2021 13:42 the patient had oxygen saturation decreased, he was pale, diaphoretic, lightheaded, weak, feel like he was going to faint. After getting up to walk, HR (heart rate) and oxygen saturation decreased briefly (less than a minute). Blood pressure remained stable. Patient visited Doctor or other health care professional office/ clinic visit. Taken via wheelchair to Lab, assisted to stretcher chair with feet up, initial: 112/66, HR54, O2 Room air 99 percentage, Departure: 129/74, HR 51, O2 92 percentage RA and kept under direct RN observation for an hour, after standing and walking down the hall at 2pm with RN, Client states that legs felt heavy and he felt tired. O2 SAT while walking 91 percentage HR 51. After returning from walk, clients states he felt OK, But tired. Briefly after 02 SAT Dropped to 87percentage and HR to 47 and then back up after a few seconds to 95 percentage, HR 51. Oxygen saturation and HR Fluctuation between 90-99 percentage and 50-54 BP. BPM after this occurence although, alert and oriented throughout, expressed concern to wife regarding bradycardia, and room air oxygen saturation and offered to call (Name withheld). V-Safe Brochure with wife and instructed to report. assisted client to wheelchair and transported to private vehicle. Lab data included: BP (Illegible), HR 54, 60, 55, 51, 54, Resp: 16, 16, 10, 16, O2 Sat 99. 99, 98, 91, 95 (Captured as per best understanding), Oxygen Started: No, CPR indicated: No. Disposition: Stable, symptoms not completely resolved. Patient status on departure: (Illegible), oriental x3. calm, answers questions appropriately. Outcome of the events was unknown.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the reported event oxygen saturation decreased cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Diplopia, Dysarthria, Lacunar stroke, Magnetic resonance imaging head abnormal
Clinical narrative: Acute CVA occurred on 8-1-2021, non-hemorrhagic, involving left occipital lobe and right pons. This is a temporal association to the vaccine; unsure if causually related.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral, Arteriogram carotid, Cerebrovascular accident, Computerised tomogram head, Condition aggravated
Clinical narrative: Acute CVA occurred on 8-1-2021, non-hemorrhagic, involving left occipital lobe and right pons. This is a temporal association to the vaccine; unsure if causually related.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Blood iron decreased, Blood phosphorus decreased, Blood test
Clinical narrative: loss of control of legs; trouble walking; numbness in my abdomen and legs; muscle spasms in legs; knee and ankle pain; loss of bladder control; cannot walk up steps/stairs or on uneven ground/grass; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Relevant medical history and concomitant medications were not reported.  On an unspecified date the patient experienced trouble walking, numbness in abdomen and legs, muscle spasms in legs, knee and ankle pain, loss of bladder control, cannot walk up steps/stairs or on uneven ground/grass, loss of control of legs. Patient also informed that MDs ordered a lot of lab test, including ultrasound, nerve induction study, blood work, but nothing was abnormal. At the time of the reporting events outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electric shock sensation, Fatigue, Gait inability, Hypoaesthesia, Mobility decreased
Clinical narrative: loss of control of legs; trouble walking; numbness in my abdomen and legs; muscle spasms in legs; knee and ankle pain; loss of bladder control; cannot walk up steps/stairs or on uneven ground/grass; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Relevant medical history and concomitant medications were not reported.  On an unspecified date the patient experienced trouble walking, numbness in abdomen and legs, muscle spasms in legs, knee and ankle pain, loss of bladder control, cannot walk up steps/stairs or on uneven ground/grass, loss of control of legs. Patient also informed that MDs ordered a lot of lab test, including ultrasound, nerve induction study, blood work, but nothing was abnormal. At the time of the reporting events outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Movement disorder, Muscle spasms, Nerve conduction studies normal, Pain, Pain in extremity
Clinical narrative: loss of control of legs; trouble walking; numbness in my abdomen and legs; muscle spasms in legs; knee and ankle pain; loss of bladder control; cannot walk up steps/stairs or on uneven ground/grass; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Relevant medical history and concomitant medications were not reported.  On an unspecified date the patient experienced trouble walking, numbness in abdomen and legs, muscle spasms in legs, knee and ankle pain, loss of bladder control, cannot walk up steps/stairs or on uneven ground/grass, loss of control of legs. Patient also informed that MDs ordered a lot of lab test, including ultrasound, nerve induction study, blood work, but nothing was abnormal. At the time of the reporting events outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound scan normal, Urinary incontinence, Walking aid user
Clinical narrative: loss of control of legs; trouble walking; numbness in my abdomen and legs; muscle spasms in legs; knee and ankle pain; loss of bladder control; cannot walk up steps/stairs or on uneven ground/grass; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Relevant medical history and concomitant medications were not reported.  On an unspecified date the patient experienced trouble walking, numbness in abdomen and legs, muscle spasms in legs, knee and ankle pain, loss of bladder control, cannot walk up steps/stairs or on uneven ground/grass, loss of control of legs. Patient also informed that MDs ordered a lot of lab test, including ultrasound, nerve induction study, blood work, but nothing was abnormal. At the time of the reporting events outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Bladder disorder, Blood test, Gait disturbance, Gait inability
Clinical narrative: loss of control of legs; trouble walking; numbness in my abdomen and legs; muscle spasms in legs; knee and ankle pain; loss of bladder control; cannot walk up steps/stairs or on uneven ground/grass; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Relevant medical history and concomitant medications were not reported.  On an unspecified date the patient experienced trouble walking, numbness in abdomen and legs, muscle spasms in legs, knee and ankle pain, loss of bladder control, cannot walk up steps/stairs or on uneven ground/grass, loss of control of legs. Patient also informed that MDs ordered a lot of lab test, including ultrasound, nerve induction study, blood work, but nothing was abnormal. At the time of the reporting events outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Loss of control of legs, Muscle spasms, Ultrasound scan
Clinical narrative: loss of control of legs; trouble walking; numbness in my abdomen and legs; muscle spasms in legs; knee and ankle pain; loss of bladder control; cannot walk up steps/stairs or on uneven ground/grass; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Relevant medical history and concomitant medications were not reported.  On an unspecified date the patient experienced trouble walking, numbness in abdomen and legs, muscle spasms in legs, knee and ankle pain, loss of bladder control, cannot walk up steps/stairs or on uneven ground/grass, loss of control of legs. Patient also informed that MDs ordered a lot of lab test, including ultrasound, nerve induction study, blood work, but nothing was abnormal. At the time of the reporting events outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Paraesthesia, Sleep disorder
Clinical narrative: Pins and needles in both hands; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 06Aug2021 at 11:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Aug2021 at 23:30, the patient experienced pins and needles in both hands. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. On 07Aug2021, the patient underwent tests which include BinaxNOW (nasal swab) test and the result was negative. Since the vaccination the patient has been tested for COVID-19.The clinical outcome of the event pins and needles in both hands was not recovered at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: Pins and needles in both hands; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 06Aug2021 at 11:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Aug2021 at 23:30, the patient experienced pins and needles in both hands. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. On 07Aug2021, the patient underwent tests which include BinaxNOW (nasal swab) test and the result was negative. Since the vaccination the patient has been tested for COVID-19.The clinical outcome of the event pins and needles in both hands was not recovered at the time of this report.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: was vaccine for his age group, pain down arm all the way to his hand
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: was vaccine for his age group, pain down arm all the way to his hand
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Injection site pain, Limb discomfort
Clinical narrative: After the second dose I had pain not only at the injection site, but also in a circle around the arm to the underarm/armpit area.  This lasted a few days, went away and has come back intermittently.; After the second dose I had pain not only at the injection site, but also in a circle around the arm to the underarm/armpit area.  This lasted a few days, went away and has come back intermittently.; This is a spontaneous report from a contactable consumer(patient). A 60-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 04May2021 14:45, at 60-year-old, as single dose (Lot Number: EW0162) for covid-19 immunisation. Medical history included arthritis in jaw. The patient had known allergies to erythromycin. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 13Apr2021 02:45 PM, at 60-year-old, as single dose(Lot Number: EW0150)for covid-19 immunisation. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced vaccination site pain and pain in arm on 06May2021 at 02:00. The patient stated: after the second dose I had pain not only at the injection site, but also in a circle around the arm to the underarm and armpit area.  This lasted a few days, went away and has come back intermittently. Also sometimes happens in the other arm but not as painful. The outcome of events was not recovered. The patient received no treatment and no hospitalization prolonged.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: After the second dose I had pain not only at the injection site, but also in a circle around the arm to the underarm/armpit area.  This lasted a few days, went away and has come back intermittently.; After the second dose I had pain not only at the injection site, but also in a circle around the arm to the underarm/armpit area.  This lasted a few days, went away and has come back intermittently.; This is a spontaneous report from a contactable consumer(patient). A 60-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 04May2021 14:45, at 60-year-old, as single dose (Lot Number: EW0162) for covid-19 immunisation. Medical history included arthritis in jaw. The patient had known allergies to erythromycin. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 13Apr2021 02:45 PM, at 60-year-old, as single dose(Lot Number: EW0150)for covid-19 immunisation. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced vaccination site pain and pain in arm on 06May2021 at 02:00. The patient stated: after the second dose I had pain not only at the injection site, but also in a circle around the arm to the underarm and armpit area.  This lasted a few days, went away and has come back intermittently. Also sometimes happens in the other arm but not as painful. The outcome of events was not recovered. The patient received no treatment and no hospitalization prolonged.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Cardiac flutter, Chest X-ray, Chest discomfort
Clinical narrative: Symptoms of a heart attack after first vaccine; Palpitations after first vaccine; Shortness of breath, after first vaccine; Chest tightness after first vaccine; Blood pressure elevated, after first vaccine; Heart rate elevated, unspecified, after first vaccine; Very weak and fatigued after first vaccine/Laboring, after first vaccine; Very weak and fatigued after first vaccine; feels like she is going to die; not feeling well; This is a spontaneous report from a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced symptoms of a heart attack after first vaccine, palpitations after first vaccine, shortness of breath, after first vaccine, chest tightness after first vaccine, blood pressure elevated, after first vaccine, heart rate elevated, unspecified, after first vaccine, very weak and fatigued after first vaccine/laboring, after first vaccine, feels like she is going to die, not feeling well.  The patient underwent lab tests and procedures which included blood pressure measurement: 156/107, computerised tomogram: unknown, computerised tomogram aorta: unknown, heart rate: 95 beats per minutes, ventilation/perfusion scan: unknown.  Consumer had the first dose of the Pfizer Covid vaccine and has been in the hospital 3 times. Outcome of events was unknown.  information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram, Hypertension
Clinical narrative: Symptoms of a heart attack after first vaccine; Palpitations after first vaccine; Shortness of breath, after first vaccine; Chest tightness after first vaccine; Blood pressure elevated, after first vaccine; Heart rate elevated, unspecified, after first vaccine; Very weak and fatigued after first vaccine/Laboring, after first vaccine; Very weak and fatigued after first vaccine; feels like she is going to die; not feeling well; This is a spontaneous report from a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced symptoms of a heart attack after first vaccine, palpitations after first vaccine, shortness of breath, after first vaccine, chest tightness after first vaccine, blood pressure elevated, after first vaccine, heart rate elevated, unspecified, after first vaccine, very weak and fatigued after first vaccine/laboring, after first vaccine, feels like she is going to die, not feeling well.  The patient underwent lab tests and procedures which included blood pressure measurement: 156/107, computerised tomogram: unknown, computerised tomogram aorta: unknown, heart rate: 95 beats per minutes, ventilation/perfusion scan: unknown.  Consumer had the first dose of the Pfizer Covid vaccine and has been in the hospital 3 times. Outcome of events was unknown.  information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure measurement, Chest discomfort, Computerised tomogram, Computerised tomogram aorta
Clinical narrative: Symptoms of a heart attack after first vaccine; Palpitations after first vaccine; Shortness of breath, after first vaccine; Chest tightness after first vaccine; Blood pressure elevated, after first vaccine; Heart rate elevated, unspecified, after first vaccine; Very weak and fatigued after first vaccine/Laboring, after first vaccine; Very weak and fatigued after first vaccine; feels like she is going to die; not feeling well; This is a spontaneous report from a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced symptoms of a heart attack after first vaccine, palpitations after first vaccine, shortness of breath, after first vaccine, chest tightness after first vaccine, blood pressure elevated, after first vaccine, heart rate elevated, unspecified, after first vaccine, very weak and fatigued after first vaccine/laboring, after first vaccine, feels like she is going to die, not feeling well.  The patient underwent lab tests and procedures which included blood pressure measurement: 156/107, computerised tomogram: unknown, computerised tomogram aorta: unknown, heart rate: 95 beats per minutes, ventilation/perfusion scan: unknown.  Consumer had the first dose of the Pfizer Covid vaccine and has been in the hospital 3 times. Outcome of events was unknown.  information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: Symptoms of a heart attack after first vaccine; Palpitations after first vaccine; Shortness of breath, after first vaccine; Chest tightness after first vaccine; Blood pressure elevated, after first vaccine; Heart rate elevated, unspecified, after first vaccine; Very weak and fatigued after first vaccine/Laboring, after first vaccine; Very weak and fatigued after first vaccine; feels like she is going to die; not feeling well; This is a spontaneous report from a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced symptoms of a heart attack after first vaccine, palpitations after first vaccine, shortness of breath, after first vaccine, chest tightness after first vaccine, blood pressure elevated, after first vaccine, heart rate elevated, unspecified, after first vaccine, very weak and fatigued after first vaccine/laboring, after first vaccine, feels like she is going to die, not feeling well.  The patient underwent lab tests and procedures which included blood pressure measurement: 156/107, computerised tomogram: unknown, computerised tomogram aorta: unknown, heart rate: 95 beats per minutes, ventilation/perfusion scan: unknown.  Consumer had the first dose of the Pfizer Covid vaccine and has been in the hospital 3 times. Outcome of events was unknown.  information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Malaise, Myocardial infarction, Palpitations, Ventilation/perfusion scan
Clinical narrative: Symptoms of a heart attack after first vaccine; Palpitations after first vaccine; Shortness of breath, after first vaccine; Chest tightness after first vaccine; Blood pressure elevated, after first vaccine; Heart rate elevated, unspecified, after first vaccine; Very weak and fatigued after first vaccine/Laboring, after first vaccine; Very weak and fatigued after first vaccine; feels like she is going to die; not feeling well; This is a spontaneous report from a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced symptoms of a heart attack after first vaccine, palpitations after first vaccine, shortness of breath, after first vaccine, chest tightness after first vaccine, blood pressure elevated, after first vaccine, heart rate elevated, unspecified, after first vaccine, very weak and fatigued after first vaccine/laboring, after first vaccine, feels like she is going to die, not feeling well.  The patient underwent lab tests and procedures which included blood pressure measurement: 156/107, computerised tomogram: unknown, computerised tomogram aorta: unknown, heart rate: 95 beats per minutes, ventilation/perfusion scan: unknown.  Consumer had the first dose of the Pfizer Covid vaccine and has been in the hospital 3 times. Outcome of events was unknown.  information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Blood test, Chest X-ray, Dysphagia, Electrocardiogram
Clinical narrative: difficulty swallowing; elevated blood pressure; feeling of going to jump out of skin; severe stomach issues; Severe neurological reaction including face; Severe neurological reaction including face, arms; legs tingling and numbness.; Severe neurological reaction including face, arms, legs tingling and numbness.; Heart racing; difficulty speaking; double vision; This is a spontaneous report from a contactable consumer (parents). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, and patient was 47-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 30Jul2021 at 03:30 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune issues. There were no concomitant medications. No other vaccine received in four weeks; no other medications received in two weeks, no covid prior vaccination, no known allergies were reported. On 30Jul2021 at 08:30 PM, the patient experienced Severe neurological reaction including face, arms, legs tingling and numbness. Heart racing, difficulty speaking and swallowing, double vision, elevated blood pressure, feeling of going to jump out of skin, severe stomach issues. Ae resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021, blood pressure: elevated on 30Jul2021. Therapeutic measures were taken as a result for all reported events with Methyl PrednisoSolone. The outcomes of events were recovering.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Heart rate increased, Hypoaesthesia, Paraesthesia, Speech disorder
Clinical narrative: difficulty swallowing; elevated blood pressure; feeling of going to jump out of skin; severe stomach issues; Severe neurological reaction including face; Severe neurological reaction including face, arms; legs tingling and numbness.; Severe neurological reaction including face, arms, legs tingling and numbness.; Heart racing; difficulty speaking; double vision; This is a spontaneous report from a contactable consumer (parents). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, and patient was 47-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 30Jul2021 at 03:30 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune issues. There were no concomitant medications. No other vaccine received in four weeks; no other medications received in two weeks, no covid prior vaccination, no known allergies were reported. On 30Jul2021 at 08:30 PM, the patient experienced Severe neurological reaction including face, arms, legs tingling and numbness. Heart racing, difficulty speaking and swallowing, double vision, elevated blood pressure, feeling of going to jump out of skin, severe stomach issues. Ae resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021, blood pressure: elevated on 30Jul2021. Therapeutic measures were taken as a result for all reported events with Methyl PrednisoSolone. The outcomes of events were recovering.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Blood pressure increased, Blood pressure measurement, Diplopia, Dysphagia
Clinical narrative: difficulty swallowing; elevated blood pressure; feeling of going to jump out of skin; severe stomach issues; Severe neurological reaction including face; Severe neurological reaction including face, arms; legs tingling and numbness.; Severe neurological reaction including face, arms, legs tingling and numbness.; Heart racing; difficulty speaking; double vision; This is a spontaneous report from a contactable consumer (parents). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, and patient was 47-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 30Jul2021 at 03:30 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune issues. There were no concomitant medications. No other vaccine received in four weeks; no other medications received in two weeks, no covid prior vaccination, no known allergies were reported. On 30Jul2021 at 08:30 PM, the patient experienced Severe neurological reaction including face, arms, legs tingling and numbness. Heart racing, difficulty speaking and swallowing, double vision, elevated blood pressure, feeling of going to jump out of skin, severe stomach issues. Ae resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021, blood pressure: elevated on 30Jul2021. Therapeutic measures were taken as a result for all reported events with Methyl PrednisoSolone. The outcomes of events were recovering.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Palpitations, Paraesthesia, SARS-CoV-2 test
Clinical narrative: difficulty swallowing; elevated blood pressure; feeling of going to jump out of skin; severe stomach issues; Severe neurological reaction including face; Severe neurological reaction including face, arms; legs tingling and numbness.; Severe neurological reaction including face, arms, legs tingling and numbness.; Heart racing; difficulty speaking; double vision; This is a spontaneous report from a contactable consumer (parents). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, and patient was 47-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 30Jul2021 at 03:30 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune issues. There were no concomitant medications. No other vaccine received in four weeks; no other medications received in two weeks, no covid prior vaccination, no known allergies were reported. On 30Jul2021 at 08:30 PM, the patient experienced Severe neurological reaction including face, arms, legs tingling and numbness. Heart racing, difficulty speaking and swallowing, double vision, elevated blood pressure, feeling of going to jump out of skin, severe stomach issues. Ae resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021, blood pressure: elevated on 30Jul2021. Therapeutic measures were taken as a result for all reported events with Methyl PrednisoSolone. The outcomes of events were recovering.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Speech disorder
Clinical narrative: difficulty swallowing; elevated blood pressure; feeling of going to jump out of skin; severe stomach issues; Severe neurological reaction including face; Severe neurological reaction including face, arms; legs tingling and numbness.; Severe neurological reaction including face, arms, legs tingling and numbness.; Heart racing; difficulty speaking; double vision; This is a spontaneous report from a contactable consumer (parents). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, and patient was 47-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 30Jul2021 at 03:30 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune issues. There were no concomitant medications. No other vaccine received in four weeks; no other medications received in two weeks, no covid prior vaccination, no known allergies were reported. On 30Jul2021 at 08:30 PM, the patient experienced Severe neurological reaction including face, arms, legs tingling and numbness. Heart racing, difficulty speaking and swallowing, double vision, elevated blood pressure, feeling of going to jump out of skin, severe stomach issues. Ae resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021, blood pressure: elevated on 30Jul2021. Therapeutic measures were taken as a result for all reported events with Methyl PrednisoSolone. The outcomes of events were recovering.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate decreased, Laboratory test
Clinical narrative: Adverse Event is an Acute and continuous drop in my Resting Heart Rate (RHR).  As recorded and filed, utilizing Blood Pressure Monitors, Finger Pulse Oximeter, and Fitbit wrist monitor; my RHR was rec; Adverse Event is an Acute and continuous drop in my Resting Heart Rate (RHR).  As recorded and filed, utilizing Blood Pressure Monitors, Finger Pulse Oximeter, and Fitbit wrist monitor; my RHR was rec; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8732), dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 13:30 (at the age of 62-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient had no covid prior vaccination. The patient had no known allergies. Concomitant medication(s) included Losartan potassium taken for an unspecified indication, start and stop date were not reported. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EP7534), via an unspecified route of administration, administered in Arm Left on 22Mar2021 at 13:30 (at the age of 62-year-old), as single for covid-19 immunisation. No other vaccine in four weeks. The patient had not been covid tested post vaccination. On an unspecified date in Jul2021, the patient experienced an acute and continuous drop in his resting heart rate (RHR). The clinical details of the events as follows: An Acute and continuous drop in his Resting Heart Rate (RHR). As recorded and filed, utilizing Blood Pressure Monitors, Finger Pulse Oximeter, and Fitbit wrist monitor; patient RHR was recorded at 63 beats per minute (bpm) in March and May, no monitoring in June 21, and between 7/1 - 7/14/21 RHR was dropped to 52 bpm, and from 7/15-8/18 dropped to 47-48 bpm. Further nightly sleeping RHR via Fitbit devices reflects lows of 42-40 bpm. The events were resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received to treat the events. The patient outcome of the events was not resolved at the time of this report.  No follow-up attempts possible. No further information expected. Information on lot number already obtained.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate abnormal, Heart rate decreased
Clinical narrative: Adverse Event is an Acute and continuous drop in my Resting Heart Rate (RHR).  As recorded and filed, utilizing Blood Pressure Monitors, Finger Pulse Oximeter, and Fitbit wrist monitor; my RHR was rec; Adverse Event is an Acute and continuous drop in my Resting Heart Rate (RHR).  As recorded and filed, utilizing Blood Pressure Monitors, Finger Pulse Oximeter, and Fitbit wrist monitor; my RHR was rec; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8732), dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 13:30 (at the age of 62-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient had no covid prior vaccination. The patient had no known allergies. Concomitant medication(s) included Losartan potassium taken for an unspecified indication, start and stop date were not reported. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EP7534), via an unspecified route of administration, administered in Arm Left on 22Mar2021 at 13:30 (at the age of 62-year-old), as single for covid-19 immunisation. No other vaccine in four weeks. The patient had not been covid tested post vaccination. On an unspecified date in Jul2021, the patient experienced an acute and continuous drop in his resting heart rate (RHR). The clinical details of the events as follows: An Acute and continuous drop in his Resting Heart Rate (RHR). As recorded and filed, utilizing Blood Pressure Monitors, Finger Pulse Oximeter, and Fitbit wrist monitor; patient RHR was recorded at 63 beats per minute (bpm) in March and May, no monitoring in June 21, and between 7/1 - 7/14/21 RHR was dropped to 52 bpm, and from 7/15-8/18 dropped to 47-48 bpm. Further nightly sleeping RHR via Fitbit devices reflects lows of 42-40 bpm. The events were resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received to treat the events. The patient outcome of the events was not resolved at the time of this report.  No follow-up attempts possible. No further information expected. Information on lot number already obtained.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myosclerosis, Myositis, Nausea, Paraesthesia
Clinical narrative: her arm hurt more and she could feel a lump/nodule and the muscle feels hard; her arm hurt more and she could feel a lump/nodule and the muscle feels hard; low grade fever of 100.5 degrees Fahrenheit; red rash; flu like symptoms; Extra dose administered; the injection site became tender; malaise; injection site soreness in right arm; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old female patient received third dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Aug2021 08:30 (age at vaccination:50 Years) as DOSE 3, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination. Medical history included renal transplant from 1998 to an unknown date. The patient's concomitant medications were not reported. Patient previously received first dose bnt162b2(BNT162B2, solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on 09Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2(BNT162B2, solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on 30Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced the injection site became tender on 17Aug2021, malaise on 17Aug2021, her arm hurt more and she could feel a lump/nodule and the muscle feels hard on 18Aug2021, her arm hurt more and she could feel a lump/nodule and the muscle feels hard on 18Aug2021, low grade fever of 100.5 degrees fahrenheit on 18Aug2021, red rash on 18Aug2021, flu like symptoms on 18Aug2021, injection site soreness in right arm on 17Aug2021 , extra dose administered on 17Aug2021 08:30. No relevant tests were reported. The outcome of the events vaccination site pain recovering, the outcome of the event malaise was recovered, the outcome of the events vaccination site pain, pain in extremity, nodule, pyrexia, rash erythematous, Influenza like illness, Extra dose administered was unknown.  Agency Communication: She declined report number and phone number prior to attempted transfer to unit. Caller agreed to be placed in the queue to hold for next available agent.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Influenza like illness, Malaise, Nodule, Pain in extremity
Clinical narrative: her arm hurt more and she could feel a lump/nodule and the muscle feels hard; her arm hurt more and she could feel a lump/nodule and the muscle feels hard; low grade fever of 100.5 degrees Fahrenheit; red rash; flu like symptoms; Extra dose administered; the injection site became tender; malaise; injection site soreness in right arm; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old female patient received third dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Aug2021 08:30 (age at vaccination:50 Years) as DOSE 3, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination. Medical history included renal transplant from 1998 to an unknown date. The patient's concomitant medications were not reported. Patient previously received first dose bnt162b2(BNT162B2, solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on 09Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2(BNT162B2, solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on 30Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced the injection site became tender on 17Aug2021, malaise on 17Aug2021, her arm hurt more and she could feel a lump/nodule and the muscle feels hard on 18Aug2021, her arm hurt more and she could feel a lump/nodule and the muscle feels hard on 18Aug2021, low grade fever of 100.5 degrees fahrenheit on 18Aug2021, red rash on 18Aug2021, flu like symptoms on 18Aug2021, injection site soreness in right arm on 17Aug2021 , extra dose administered on 17Aug2021 08:30. No relevant tests were reported. The outcome of the events vaccination site pain recovering, the outcome of the event malaise was recovered, the outcome of the events vaccination site pain, pain in extremity, nodule, pyrexia, rash erythematous, Influenza like illness, Extra dose administered was unknown.  Agency Communication: She declined report number and phone number prior to attempted transfer to unit. Caller agreed to be placed in the queue to hold for next available agent.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.