chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thinking abnormal, Weight decreased
Clinical narrative: Arthritis inflamed; clammy; Sweating; Upset/a feeling of overall terrible; burning; growling Stomach pain; Foggy and unable to think; Foggy and unable to think; Debilitating Fatigue; Weak; Sleeping a lot; Weight loss; Migraine; Nauseous; Dizzy/lightheaded; Chronic pain much worse; Chronic pain much worse; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14Apr2021 at 13:45 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included common variable immunodeficiency (CVID) autoimmune disorder, chronic pain, shellfish allergy, and seafood allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine, The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included thyroid (ARMOUR THYROID), pregabalin (LYRICA), methylphenidate hydrochloride (CONCERTA), linaclotide (LINZESS), and metformin from unknown dates for unknown indications. The patient previously received doxycycline from an unknown date for an unknown indication and experienced allergy.  On 16Apr2021 at 07:00 the patient woke with a migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible. The patient was unable to drive, unable to leave the house or do anything but lie in bed or help to restroom. The patient received treatment from her nurse with intravenous (IV) fluids over 2 days and 2000 cc. The outcomes of  migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Rhinorrhoea, Sneezing
Clinical narrative: Had major allergic response; Symptoms of runny nose; Symptoms of runny nose, congestion; Hacking cough that affected sleep for two days; Hacking cough that affected sleep for two days; Breathing difficulties; This is a spontaneous report from a contactable consumer (patient). This 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0164) via an unspecified route of administration in the left arm on 18Apr2021 at 11:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder and seasonal allergies, both from unknown dates and unknown if ongoing. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL ER), and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL SHORT-ACTING), both from unknown dates for unknown indications. The patient had no know allergies, was not diagnosed with COVID-19 prior to vaccination, and the patient had not received any other vaccines within 4 weeks. On 18Apr2021 the patient experienced a major allergic response starting 5 hours after vaccination with symptoms of runny nose, congestion, hacking cough that affected sleep for two days and resulted in breathing difficulties that sent him to the emergency room 48 hours later. The patient required a physician office visit and emergency room visit for the events. The patient was treated with a nebulizer, oxygen, steroids, and albuterol inhaler. The clinical outcomes of major allergic response, symptoms of runny nose, congestion, hacking cough that affected sleep for two days and resulted in breathing difficulties were recovering. Since vaccination the patient had been tested for COVID-19 via nasal swab on 20Apr2021 and 26Apr2021, both indicated negative.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Had major allergic response; Symptoms of runny nose; Symptoms of runny nose, congestion; Hacking cough that affected sleep for two days; Hacking cough that affected sleep for two days; Breathing difficulties; This is a spontaneous report from a contactable consumer (patient). This 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0164) via an unspecified route of administration in the left arm on 18Apr2021 at 11:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder and seasonal allergies, both from unknown dates and unknown if ongoing. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL ER), and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL SHORT-ACTING), both from unknown dates for unknown indications. The patient had no know allergies, was not diagnosed with COVID-19 prior to vaccination, and the patient had not received any other vaccines within 4 weeks. On 18Apr2021 the patient experienced a major allergic response starting 5 hours after vaccination with symptoms of runny nose, congestion, hacking cough that affected sleep for two days and resulted in breathing difficulties that sent him to the emergency room 48 hours later. The patient required a physician office visit and emergency room visit for the events. The patient was treated with a nebulizer, oxygen, steroids, and albuterol inhaler. The clinical outcomes of major allergic response, symptoms of runny nose, congestion, hacking cough that affected sleep for two days and resulted in breathing difficulties were recovering. Since vaccination the patient had been tested for COVID-19 via nasal swab on 20Apr2021 and 26Apr2021, both indicated negative.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Hypersensitivity, Nasal congestion, Rhinorrhoea
Clinical narrative: Had major allergic response; Symptoms of runny nose; Symptoms of runny nose, congestion; Hacking cough that affected sleep for two days; Hacking cough that affected sleep for two days; Breathing difficulties; This is a spontaneous report from a contactable consumer (patient). This 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0164) via an unspecified route of administration in the left arm on 18Apr2021 at 11:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder and seasonal allergies, both from unknown dates and unknown if ongoing. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL ER), and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL SHORT-ACTING), both from unknown dates for unknown indications. The patient had no know allergies, was not diagnosed with COVID-19 prior to vaccination, and the patient had not received any other vaccines within 4 weeks. On 18Apr2021 the patient experienced a major allergic response starting 5 hours after vaccination with symptoms of runny nose, congestion, hacking cough that affected sleep for two days and resulted in breathing difficulties that sent him to the emergency room 48 hours later. The patient required a physician office visit and emergency room visit for the events. The patient was treated with a nebulizer, oxygen, steroids, and albuterol inhaler. The clinical outcomes of major allergic response, symptoms of runny nose, congestion, hacking cough that affected sleep for two days and resulted in breathing difficulties were recovering. Since vaccination the patient had been tested for COVID-19 via nasal swab on 20Apr2021 and 26Apr2021, both indicated negative.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Sleep disorder
Clinical narrative: Had major allergic response; Symptoms of runny nose; Symptoms of runny nose, congestion; Hacking cough that affected sleep for two days; Hacking cough that affected sleep for two days; Breathing difficulties; This is a spontaneous report from a contactable consumer (patient). This 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0164) via an unspecified route of administration in the left arm on 18Apr2021 at 11:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder and seasonal allergies, both from unknown dates and unknown if ongoing. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL ER), and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL SHORT-ACTING), both from unknown dates for unknown indications. The patient had no know allergies, was not diagnosed with COVID-19 prior to vaccination, and the patient had not received any other vaccines within 4 weeks. On 18Apr2021 the patient experienced a major allergic response starting 5 hours after vaccination with symptoms of runny nose, congestion, hacking cough that affected sleep for two days and resulted in breathing difficulties that sent him to the emergency room 48 hours later. The patient required a physician office visit and emergency room visit for the events. The patient was treated with a nebulizer, oxygen, steroids, and albuterol inhaler. The clinical outcomes of major allergic response, symptoms of runny nose, congestion, hacking cough that affected sleep for two days and resulted in breathing difficulties were recovering. Since vaccination the patient had been tested for COVID-19 via nasal swab on 20Apr2021 and 26Apr2021, both indicated negative.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Antiphospholipid antibodies negative, Bell's palsy, Blood test
Clinical narrative: SERIOUS HEALTH CONCERN; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced serious health concern. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of serious health concern was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Borrelia test negative, Hypotonia, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Nervous system disorder
Clinical narrative: SERIOUS HEALTH CONCERN; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced serious health concern. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of serious health concern was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neurological symptom
Clinical narrative: SERIOUS HEALTH CONCERN; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced serious health concern. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of serious health concern was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adverse event
Clinical narrative: SERIOUS HEALTH CONCERN; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced serious health concern. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of serious health concern was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Ageusia, Anosmia, Chills, Cough
Clinical narrative: Severe high blood pressure; Severe Breathing; loss of muscle in upper thighs; Nausea; Extreme brain fog; Heart racing; trouble sleeping; Sweating; Frequent head pain in front of forehead; Urinary tract infection; Trouble being incontinent with bowel; my teeth turned light brown, 2 front teeth was dark brown; Felt weak; Dizzy; Red eyes; open sores in mouth; pain in right groin; rash on face, neck and chest; Loss of taste and smell; Loss of taste and smell; Toe nails and finger nails turned ash white; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 16Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers (including patient) from a Pfizer sponsored program. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left upper arm on 25Feb2021 11:30 (Batch/Lot Number: EN6198) as dose 1, single, and intramuscular, administered in left upper arm on 18Mar2021 11:00 (Batch/Lot Number: EN6204) as dose 2, single for covid-19 immunisation. Medical history included covid-19 from 28Mar2020, ongoing high blood pressure, ongoing low B/P and patient's father was allergic to morphine drugs and so is she. Family history included both parents deceased, her father had very low B/P and her mother had High B/P. The patient has no prior vaccination. Concomitant medication included labetalol taken for virus cause-high blood pressure from 28Mar2020 and ongoing. The patient experienced severe high blood pressure, loss of muscle in upper thighs, severe breathing, nausea, extreme brain fog, heart racing, trouble sleeping, sweating, frequent head pain in front of forehead, urinary tract infection, trouble being incontinent with bowel, her teeth turned light brown, 2 front teeth was dark brown, felt weak, dizzy, red eyes, open sores in mouth, pain in right groin, rash on face, neck and chest, loss of taste and smell and toe nails and finger nails turned ash white on 2021. The patient stated that "all above were Covid virus and Pfizer's two injections side effects". The patient had covid-19 test on 28Mar2020 which was positive, "diagnosed via telephone we weren't allowed testing and injection until first responders got their" and blood and swab on 09Oct2020 which were negative, test was given 10 mo. after covid-19. The event severe high blood pressure required visit to physician, the patient refused via telephonic conference and refused to go to hospital because of Covid. The patient stated that she always had Low B/P until now 2xday. This event was treated with labetalol 100 2x daily and was assessed as serious due to persistent/ significant disability/incapacity and important medical event. The outcome of the event severe high blood pressure was recovering while the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Dry skin, Fatigue, Gait disturbance
Clinical narrative: Severe high blood pressure; Severe Breathing; loss of muscle in upper thighs; Nausea; Extreme brain fog; Heart racing; trouble sleeping; Sweating; Frequent head pain in front of forehead; Urinary tract infection; Trouble being incontinent with bowel; my teeth turned light brown, 2 front teeth was dark brown; Felt weak; Dizzy; Red eyes; open sores in mouth; pain in right groin; rash on face, neck and chest; Loss of taste and smell; Loss of taste and smell; Toe nails and finger nails turned ash white; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 16Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers (including patient) from a Pfizer sponsored program. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left upper arm on 25Feb2021 11:30 (Batch/Lot Number: EN6198) as dose 1, single, and intramuscular, administered in left upper arm on 18Mar2021 11:00 (Batch/Lot Number: EN6204) as dose 2, single for covid-19 immunisation. Medical history included covid-19 from 28Mar2020, ongoing high blood pressure, ongoing low B/P and patient's father was allergic to morphine drugs and so is she. Family history included both parents deceased, her father had very low B/P and her mother had High B/P. The patient has no prior vaccination. Concomitant medication included labetalol taken for virus cause-high blood pressure from 28Mar2020 and ongoing. The patient experienced severe high blood pressure, loss of muscle in upper thighs, severe breathing, nausea, extreme brain fog, heart racing, trouble sleeping, sweating, frequent head pain in front of forehead, urinary tract infection, trouble being incontinent with bowel, her teeth turned light brown, 2 front teeth was dark brown, felt weak, dizzy, red eyes, open sores in mouth, pain in right groin, rash on face, neck and chest, loss of taste and smell and toe nails and finger nails turned ash white on 2021. The patient stated that "all above were Covid virus and Pfizer's two injections side effects". The patient had covid-19 test on 28Mar2020 which was positive, "diagnosed via telephone we weren't allowed testing and injection until first responders got their" and blood and swab on 09Oct2020 which were negative, test was given 10 mo. after covid-19. The event severe high blood pressure required visit to physician, the patient refused via telephonic conference and refused to go to hospital because of Covid. The patient stated that she always had Low B/P until now 2xday. This event was treated with labetalol 100 2x daily and was assessed as serious due to persistent/ significant disability/incapacity and important medical event. The outcome of the event severe high blood pressure was recovering while the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Severe high blood pressure; Severe Breathing; loss of muscle in upper thighs; Nausea; Extreme brain fog; Heart racing; trouble sleeping; Sweating; Frequent head pain in front of forehead; Urinary tract infection; Trouble being incontinent with bowel; my teeth turned light brown, 2 front teeth was dark brown; Felt weak; Dizzy; Red eyes; open sores in mouth; pain in right groin; rash on face, neck and chest; Loss of taste and smell; Loss of taste and smell; Toe nails and finger nails turned ash white; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 16Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers (including patient) from a Pfizer sponsored program. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left upper arm on 25Feb2021 11:30 (Batch/Lot Number: EN6198) as dose 1, single, and intramuscular, administered in left upper arm on 18Mar2021 11:00 (Batch/Lot Number: EN6204) as dose 2, single for covid-19 immunisation. Medical history included covid-19 from 28Mar2020, ongoing high blood pressure, ongoing low B/P and patient's father was allergic to morphine drugs and so is she. Family history included both parents deceased, her father had very low B/P and her mother had High B/P. The patient has no prior vaccination. Concomitant medication included labetalol taken for virus cause-high blood pressure from 28Mar2020 and ongoing. The patient experienced severe high blood pressure, loss of muscle in upper thighs, severe breathing, nausea, extreme brain fog, heart racing, trouble sleeping, sweating, frequent head pain in front of forehead, urinary tract infection, trouble being incontinent with bowel, her teeth turned light brown, 2 front teeth was dark brown, felt weak, dizzy, red eyes, open sores in mouth, pain in right groin, rash on face, neck and chest, loss of taste and smell and toe nails and finger nails turned ash white on 2021. The patient stated that "all above were Covid virus and Pfizer's two injections side effects". The patient had covid-19 test on 28Mar2020 which was positive, "diagnosed via telephone we weren't allowed testing and injection until first responders got their" and blood and swab on 09Oct2020 which were negative, test was given 10 mo. after covid-19. The event severe high blood pressure required visit to physician, the patient refused via telephonic conference and refused to go to hospital because of Covid. The patient stated that she always had Low B/P until now 2xday. This event was treated with labetalol 100 2x daily and was assessed as serious due to persistent/ significant disability/incapacity and important medical event. The outcome of the event severe high blood pressure was recovering while the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Skin disorder, Skin laceration, Tachycardia
Clinical narrative: Severe high blood pressure; Severe Breathing; loss of muscle in upper thighs; Nausea; Extreme brain fog; Heart racing; trouble sleeping; Sweating; Frequent head pain in front of forehead; Urinary tract infection; Trouble being incontinent with bowel; my teeth turned light brown, 2 front teeth was dark brown; Felt weak; Dizzy; Red eyes; open sores in mouth; pain in right groin; rash on face, neck and chest; Loss of taste and smell; Loss of taste and smell; Toe nails and finger nails turned ash white; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 16Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers (including patient) from a Pfizer sponsored program. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left upper arm on 25Feb2021 11:30 (Batch/Lot Number: EN6198) as dose 1, single, and intramuscular, administered in left upper arm on 18Mar2021 11:00 (Batch/Lot Number: EN6204) as dose 2, single for covid-19 immunisation. Medical history included covid-19 from 28Mar2020, ongoing high blood pressure, ongoing low B/P and patient's father was allergic to morphine drugs and so is she. Family history included both parents deceased, her father had very low B/P and her mother had High B/P. The patient has no prior vaccination. Concomitant medication included labetalol taken for virus cause-high blood pressure from 28Mar2020 and ongoing. The patient experienced severe high blood pressure, loss of muscle in upper thighs, severe breathing, nausea, extreme brain fog, heart racing, trouble sleeping, sweating, frequent head pain in front of forehead, urinary tract infection, trouble being incontinent with bowel, her teeth turned light brown, 2 front teeth was dark brown, felt weak, dizzy, red eyes, open sores in mouth, pain in right groin, rash on face, neck and chest, loss of taste and smell and toe nails and finger nails turned ash white on 2021. The patient stated that "all above were Covid virus and Pfizer's two injections side effects". The patient had covid-19 test on 28Mar2020 which was positive, "diagnosed via telephone we weren't allowed testing and injection until first responders got their" and blood and swab on 09Oct2020 which were negative, test was given 10 mo. after covid-19. The event severe high blood pressure required visit to physician, the patient refused via telephonic conference and refused to go to hospital because of Covid. The patient stated that she always had Low B/P until now 2xday. This event was treated with labetalol 100 2x daily and was assessed as serious due to persistent/ significant disability/incapacity and important medical event. The outcome of the event severe high blood pressure was recovering while the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Severe high blood pressure; Severe Breathing; loss of muscle in upper thighs; Nausea; Extreme brain fog; Heart racing; trouble sleeping; Sweating; Frequent head pain in front of forehead; Urinary tract infection; Trouble being incontinent with bowel; my teeth turned light brown, 2 front teeth was dark brown; Felt weak; Dizzy; Red eyes; open sores in mouth; pain in right groin; rash on face, neck and chest; Loss of taste and smell; Loss of taste and smell; Toe nails and finger nails turned ash white; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 16Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers (including patient) from a Pfizer sponsored program. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left upper arm on 25Feb2021 11:30 (Batch/Lot Number: EN6198) as dose 1, single, and intramuscular, administered in left upper arm on 18Mar2021 11:00 (Batch/Lot Number: EN6204) as dose 2, single for covid-19 immunisation. Medical history included covid-19 from 28Mar2020, ongoing high blood pressure, ongoing low B/P and patient's father was allergic to morphine drugs and so is she. Family history included both parents deceased, her father had very low B/P and her mother had High B/P. The patient has no prior vaccination. Concomitant medication included labetalol taken for virus cause-high blood pressure from 28Mar2020 and ongoing. The patient experienced severe high blood pressure, loss of muscle in upper thighs, severe breathing, nausea, extreme brain fog, heart racing, trouble sleeping, sweating, frequent head pain in front of forehead, urinary tract infection, trouble being incontinent with bowel, her teeth turned light brown, 2 front teeth was dark brown, felt weak, dizzy, red eyes, open sores in mouth, pain in right groin, rash on face, neck and chest, loss of taste and smell and toe nails and finger nails turned ash white on 2021. The patient stated that "all above were Covid virus and Pfizer's two injections side effects". The patient had covid-19 test on 28Mar2020 which was positive, "diagnosed via telephone we weren't allowed testing and injection until first responders got their" and blood and swab on 09Oct2020 which were negative, test was given 10 mo. after covid-19. The event severe high blood pressure required visit to physician, the patient refused via telephonic conference and refused to go to hospital because of Covid. The patient stated that she always had Low B/P until now 2xday. This event was treated with labetalol 100 2x daily and was assessed as serious due to persistent/ significant disability/incapacity and important medical event. The outcome of the event severe high blood pressure was recovering while the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anal incontinence, Anosmia, Asthenia, Blood pressure measurement
Clinical narrative: Severe high blood pressure; Severe Breathing; loss of muscle in upper thighs; Nausea; Extreme brain fog; Heart racing; trouble sleeping; Sweating; Frequent head pain in front of forehead; Urinary tract infection; Trouble being incontinent with bowel; my teeth turned light brown, 2 front teeth was dark brown; Felt weak; Dizzy; Red eyes; open sores in mouth; pain in right groin; rash on face, neck and chest; Loss of taste and smell; Loss of taste and smell; Toe nails and finger nails turned ash white; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 16Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers (including patient) from a Pfizer sponsored program. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left upper arm on 25Feb2021 11:30 (Batch/Lot Number: EN6198) as dose 1, single, and intramuscular, administered in left upper arm on 18Mar2021 11:00 (Batch/Lot Number: EN6204) as dose 2, single for covid-19 immunisation. Medical history included covid-19 from 28Mar2020, ongoing high blood pressure, ongoing low B/P and patient's father was allergic to morphine drugs and so is she. Family history included both parents deceased, her father had very low B/P and her mother had High B/P. The patient has no prior vaccination. Concomitant medication included labetalol taken for virus cause-high blood pressure from 28Mar2020 and ongoing. The patient experienced severe high blood pressure, loss of muscle in upper thighs, severe breathing, nausea, extreme brain fog, heart racing, trouble sleeping, sweating, frequent head pain in front of forehead, urinary tract infection, trouble being incontinent with bowel, her teeth turned light brown, 2 front teeth was dark brown, felt weak, dizzy, red eyes, open sores in mouth, pain in right groin, rash on face, neck and chest, loss of taste and smell and toe nails and finger nails turned ash white on 2021. The patient stated that "all above were Covid virus and Pfizer's two injections side effects". The patient had covid-19 test on 28Mar2020 which was positive, "diagnosed via telephone we weren't allowed testing and injection until first responders got their" and blood and swab on 09Oct2020 which were negative, test was given 10 mo. after covid-19. The event severe high blood pressure required visit to physician, the patient refused via telephonic conference and refused to go to hospital because of Covid. The patient stated that she always had Low B/P until now 2xday. This event was treated with labetalol 100 2x daily and was assessed as serious due to persistent/ significant disability/incapacity and important medical event. The outcome of the event severe high blood pressure was recovering while the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Dyspnoea, Feeling abnormal, Groin pain
Clinical narrative: Severe high blood pressure; Severe Breathing; loss of muscle in upper thighs; Nausea; Extreme brain fog; Heart racing; trouble sleeping; Sweating; Frequent head pain in front of forehead; Urinary tract infection; Trouble being incontinent with bowel; my teeth turned light brown, 2 front teeth was dark brown; Felt weak; Dizzy; Red eyes; open sores in mouth; pain in right groin; rash on face, neck and chest; Loss of taste and smell; Loss of taste and smell; Toe nails and finger nails turned ash white; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 16Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers (including patient) from a Pfizer sponsored program. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left upper arm on 25Feb2021 11:30 (Batch/Lot Number: EN6198) as dose 1, single, and intramuscular, administered in left upper arm on 18Mar2021 11:00 (Batch/Lot Number: EN6204) as dose 2, single for covid-19 immunisation. Medical history included covid-19 from 28Mar2020, ongoing high blood pressure, ongoing low B/P and patient's father was allergic to morphine drugs and so is she. Family history included both parents deceased, her father had very low B/P and her mother had High B/P. The patient has no prior vaccination. Concomitant medication included labetalol taken for virus cause-high blood pressure from 28Mar2020 and ongoing. The patient experienced severe high blood pressure, loss of muscle in upper thighs, severe breathing, nausea, extreme brain fog, heart racing, trouble sleeping, sweating, frequent head pain in front of forehead, urinary tract infection, trouble being incontinent with bowel, her teeth turned light brown, 2 front teeth was dark brown, felt weak, dizzy, red eyes, open sores in mouth, pain in right groin, rash on face, neck and chest, loss of taste and smell and toe nails and finger nails turned ash white on 2021. The patient stated that "all above were Covid virus and Pfizer's two injections side effects". The patient had covid-19 test on 28Mar2020 which was positive, "diagnosed via telephone we weren't allowed testing and injection until first responders got their" and blood and swab on 09Oct2020 which were negative, test was given 10 mo. after covid-19. The event severe high blood pressure required visit to physician, the patient refused via telephonic conference and refused to go to hospital because of Covid. The patient stated that she always had Low B/P until now 2xday. This event was treated with labetalol 100 2x daily and was assessed as serious due to persistent/ significant disability/incapacity and important medical event. The outcome of the event severe high blood pressure was recovering while the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate, Hyperhidrosis, Hypertension, Insomnia
Clinical narrative: Severe high blood pressure; Severe Breathing; loss of muscle in upper thighs; Nausea; Extreme brain fog; Heart racing; trouble sleeping; Sweating; Frequent head pain in front of forehead; Urinary tract infection; Trouble being incontinent with bowel; my teeth turned light brown, 2 front teeth was dark brown; Felt weak; Dizzy; Red eyes; open sores in mouth; pain in right groin; rash on face, neck and chest; Loss of taste and smell; Loss of taste and smell; Toe nails and finger nails turned ash white; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 16Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers (including patient) from a Pfizer sponsored program. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left upper arm on 25Feb2021 11:30 (Batch/Lot Number: EN6198) as dose 1, single, and intramuscular, administered in left upper arm on 18Mar2021 11:00 (Batch/Lot Number: EN6204) as dose 2, single for covid-19 immunisation. Medical history included covid-19 from 28Mar2020, ongoing high blood pressure, ongoing low B/P and patient's father was allergic to morphine drugs and so is she. Family history included both parents deceased, her father had very low B/P and her mother had High B/P. The patient has no prior vaccination. Concomitant medication included labetalol taken for virus cause-high blood pressure from 28Mar2020 and ongoing. The patient experienced severe high blood pressure, loss of muscle in upper thighs, severe breathing, nausea, extreme brain fog, heart racing, trouble sleeping, sweating, frequent head pain in front of forehead, urinary tract infection, trouble being incontinent with bowel, her teeth turned light brown, 2 front teeth was dark brown, felt weak, dizzy, red eyes, open sores in mouth, pain in right groin, rash on face, neck and chest, loss of taste and smell and toe nails and finger nails turned ash white on 2021. The patient stated that "all above were Covid virus and Pfizer's two injections side effects". The patient had covid-19 test on 28Mar2020 which was positive, "diagnosed via telephone we weren't allowed testing and injection until first responders got their" and blood and swab on 09Oct2020 which were negative, test was given 10 mo. after covid-19. The event severe high blood pressure required visit to physician, the patient refused via telephonic conference and refused to go to hospital because of Covid. The patient stated that she always had Low B/P until now 2xday. This event was treated with labetalol 100 2x daily and was assessed as serious due to persistent/ significant disability/incapacity and important medical event. The outcome of the event severe high blood pressure was recovering while the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle atrophy, Nail discolouration, Nausea, Ocular hyperaemia, Palpitations
Clinical narrative: Severe high blood pressure; Severe Breathing; loss of muscle in upper thighs; Nausea; Extreme brain fog; Heart racing; trouble sleeping; Sweating; Frequent head pain in front of forehead; Urinary tract infection; Trouble being incontinent with bowel; my teeth turned light brown, 2 front teeth was dark brown; Felt weak; Dizzy; Red eyes; open sores in mouth; pain in right groin; rash on face, neck and chest; Loss of taste and smell; Loss of taste and smell; Toe nails and finger nails turned ash white; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 16Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers (including patient) from a Pfizer sponsored program. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left upper arm on 25Feb2021 11:30 (Batch/Lot Number: EN6198) as dose 1, single, and intramuscular, administered in left upper arm on 18Mar2021 11:00 (Batch/Lot Number: EN6204) as dose 2, single for covid-19 immunisation. Medical history included covid-19 from 28Mar2020, ongoing high blood pressure, ongoing low B/P and patient's father was allergic to morphine drugs and so is she. Family history included both parents deceased, her father had very low B/P and her mother had High B/P. The patient has no prior vaccination. Concomitant medication included labetalol taken for virus cause-high blood pressure from 28Mar2020 and ongoing. The patient experienced severe high blood pressure, loss of muscle in upper thighs, severe breathing, nausea, extreme brain fog, heart racing, trouble sleeping, sweating, frequent head pain in front of forehead, urinary tract infection, trouble being incontinent with bowel, her teeth turned light brown, 2 front teeth was dark brown, felt weak, dizzy, red eyes, open sores in mouth, pain in right groin, rash on face, neck and chest, loss of taste and smell and toe nails and finger nails turned ash white on 2021. The patient stated that "all above were Covid virus and Pfizer's two injections side effects". The patient had covid-19 test on 28Mar2020 which was positive, "diagnosed via telephone we weren't allowed testing and injection until first responders got their" and blood and swab on 09Oct2020 which were negative, test was given 10 mo. after covid-19. The event severe high blood pressure required visit to physician, the patient refused via telephonic conference and refused to go to hospital because of Covid. The patient stated that she always had Low B/P until now 2xday. This event was treated with labetalol 100 2x daily and was assessed as serious due to persistent/ significant disability/incapacity and important medical event. The outcome of the event severe high blood pressure was recovering while the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test, Stomatitis, Tooth discolouration, Urinary tract infection
Clinical narrative: Severe high blood pressure; Severe Breathing; loss of muscle in upper thighs; Nausea; Extreme brain fog; Heart racing; trouble sleeping; Sweating; Frequent head pain in front of forehead; Urinary tract infection; Trouble being incontinent with bowel; my teeth turned light brown, 2 front teeth was dark brown; Felt weak; Dizzy; Red eyes; open sores in mouth; pain in right groin; rash on face, neck and chest; Loss of taste and smell; Loss of taste and smell; Toe nails and finger nails turned ash white; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 16Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers (including patient) from a Pfizer sponsored program. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left upper arm on 25Feb2021 11:30 (Batch/Lot Number: EN6198) as dose 1, single, and intramuscular, administered in left upper arm on 18Mar2021 11:00 (Batch/Lot Number: EN6204) as dose 2, single for covid-19 immunisation. Medical history included covid-19 from 28Mar2020, ongoing high blood pressure, ongoing low B/P and patient's father was allergic to morphine drugs and so is she. Family history included both parents deceased, her father had very low B/P and her mother had High B/P. The patient has no prior vaccination. Concomitant medication included labetalol taken for virus cause-high blood pressure from 28Mar2020 and ongoing. The patient experienced severe high blood pressure, loss of muscle in upper thighs, severe breathing, nausea, extreme brain fog, heart racing, trouble sleeping, sweating, frequent head pain in front of forehead, urinary tract infection, trouble being incontinent with bowel, her teeth turned light brown, 2 front teeth was dark brown, felt weak, dizzy, red eyes, open sores in mouth, pain in right groin, rash on face, neck and chest, loss of taste and smell and toe nails and finger nails turned ash white on 2021. The patient stated that "all above were Covid virus and Pfizer's two injections side effects". The patient had covid-19 test on 28Mar2020 which was positive, "diagnosed via telephone we weren't allowed testing and injection until first responders got their" and blood and swab on 09Oct2020 which were negative, test was given 10 mo. after covid-19. The event severe high blood pressure required visit to physician, the patient refused via telephonic conference and refused to go to hospital because of Covid. The patient stated that she always had Low B/P until now 2xday. This event was treated with labetalol 100 2x daily and was assessed as serious due to persistent/ significant disability/incapacity and important medical event. The outcome of the event severe high blood pressure was recovering while the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Intracardiac thrombus, Pain in extremity, Pulmonary thrombosis, Thrombosis
Clinical narrative: 1.  Acute inferior ST elevation myocardial infarction (STEMI) due to acute thrombotic occlusion of the marginal branch of the circumflex artery diagnosed on 5/27/2021 at Samaritan Hospital after presenting to the emergency department for acute chest pain.  He underwent emergent left heart catheterization with PCI/thrombectomy and deployment of single drug-eluting stent.   He was started on aspirin, ticagrelor, atorvastatin, and lisinopril.  2.  Right distal femoral vein deep venous thrombosis (DVT) diagnosed by ultrasound on 5/28/2021.  Patient reports leg pains post receipt of COVID vaccine.  He was started on anticoagulation with apixaban.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Anticoagulant therapy, Catheterisation cardiac, Chest pain, Coronary arterial stent insertion
Clinical narrative: 1.  Acute inferior ST elevation myocardial infarction (STEMI) due to acute thrombotic occlusion of the marginal branch of the circumflex artery diagnosed on 5/27/2021 at Samaritan Hospital after presenting to the emergency department for acute chest pain.  He underwent emergent left heart catheterization with PCI/thrombectomy and deployment of single drug-eluting stent.   He was started on aspirin, ticagrelor, atorvastatin, and lisinopril.  2.  Right distal femoral vein deep venous thrombosis (DVT) diagnosed by ultrasound on 5/28/2021.  Patient reports leg pains post receipt of COVID vaccine.  He was started on anticoagulation with apixaban.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coronary artery occlusion, Coronary artery thrombosis, Deep vein thrombosis, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: 1.  Acute inferior ST elevation myocardial infarction (STEMI) due to acute thrombotic occlusion of the marginal branch of the circumflex artery diagnosed on 5/27/2021 at Samaritan Hospital after presenting to the emergency department for acute chest pain.  He underwent emergent left heart catheterization with PCI/thrombectomy and deployment of single drug-eluting stent.   He was started on aspirin, ticagrelor, atorvastatin, and lisinopril.  2.  Right distal femoral vein deep venous thrombosis (DVT) diagnosed by ultrasound on 5/28/2021.  Patient reports leg pains post receipt of COVID vaccine.  He was started on anticoagulation with apixaban.