chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cold sweat, Heart rate, Heart rate increased
Clinical narrative: my blood pressure shot up to 191/112; heart rate of 178 bpm; Vision got blurry; skin got clammy; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ew6206), via an unspecified route in the left arm on 19Mar2021 (age at vaccination: 63-year-old), as a single dose for covid-19 immunization. Medical history included high Blood pressure (BP), hemochromatosis, acid reflux, cholesterol and known allergies: codeine. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: E19267), via an unspecified route in the left arm on 26Feb2021 at 15:45 (age at vaccination: 63-year-old), as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received unknown medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 26Mar2021 at 12:00 am, eight hours after receiving second dose, patient blood pressure shot up to 191/112, with a heart rate of 178 bpm, vision got blurry, and skin got clammy. Patient did not receive any treatment for the events. The patient underwent lab test and procedure on 26Mar2021 which included blood pressure shot up to 191/112 and heart rate of 178 bpm. The clinical outcome of the events was recovered unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: my blood pressure shot up to 191/112; heart rate of 178 bpm; Vision got blurry; skin got clammy; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ew6206), via an unspecified route in the left arm on 19Mar2021 (age at vaccination: 63-year-old), as a single dose for covid-19 immunization. Medical history included high Blood pressure (BP), hemochromatosis, acid reflux, cholesterol and known allergies: codeine. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: E19267), via an unspecified route in the left arm on 26Feb2021 at 15:45 (age at vaccination: 63-year-old), as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received unknown medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 26Mar2021 at 12:00 am, eight hours after receiving second dose, patient blood pressure shot up to 191/112, with a heart rate of 178 bpm, vision got blurry, and skin got clammy. Patient did not receive any treatment for the events. The patient underwent lab test and procedure on 26Mar2021 which included blood pressure shot up to 191/112 and heart rate of 178 bpm. The clinical outcome of the events was recovered unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Anal haemorrhage, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Abdominal pain; diarrhea; anal bleeding; Difficulty urinating; loss of appetite; Chills; This is a spontaneous report from a contactable consumer. This 58-year-old male consumer reported that: A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 02:30 (at the age of 58-years-old) as a single dose for covid-19 immunization. Medical history included none. There were no concomitant medications. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021, the patient experienced abdominal pain and diarrhea, anal bleeding, difficulty urinating, loss of appetite, chills. The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria
Clinical narrative: Abdominal pain; diarrhea; anal bleeding; Difficulty urinating; loss of appetite; Chills; This is a spontaneous report from a contactable consumer. This 58-year-old male consumer reported that: A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 02:30 (at the age of 58-years-old) as a single dose for covid-19 immunization. Medical history included none. There were no concomitant medications. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021, the patient experienced abdominal pain and diarrhea, anal bleeding, difficulty urinating, loss of appetite, chills. The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure abnormal, Blood pressure measurement, Dizziness, Head titubation
Clinical narrative: Lightheaded; heart rate of 165+; unable to read blood pressure twice; sick to stomach; unable to read uncontrollable head shake side to side; numbness in cheeks; tingling in feet; This is a spontaneous report from a contactable consumer or other non hcp. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 13Apr2021 12:00 as dose 1, single (Age at vaccination 43-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included none. Concomitant medication(s) included ibuprofen (IBUPROFEN);ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride(MULTIVITAMINS). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No known allergies. On 13Apr2021 12:00, the patient experienced lightheaded, heart rate of 165+, unable to read blood pressure twice, sick to stomach, unable to read uncontrollable head shake side to side, numbness in cheeks, tingling in feet. The patient underwent lab tests and procedures which included blood pressure measurement was unable to read blood pressure twice on 13Apr2021 and heart rate was 165+ on 13Apr2021. Therapeutic measures were taken as a result of events includes water. The outcome for all events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypoaesthesia, Paraesthesia
Clinical narrative: Lightheaded; heart rate of 165+; unable to read blood pressure twice; sick to stomach; unable to read uncontrollable head shake side to side; numbness in cheeks; tingling in feet; This is a spontaneous report from a contactable consumer or other non hcp. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 13Apr2021 12:00 as dose 1, single (Age at vaccination 43-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included none. Concomitant medication(s) included ibuprofen (IBUPROFEN);ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride(MULTIVITAMINS). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No known allergies. On 13Apr2021 12:00, the patient experienced lightheaded, heart rate of 165+, unable to read blood pressure twice, sick to stomach, unable to read uncontrollable head shake side to side, numbness in cheeks, tingling in feet. The patient underwent lab tests and procedures which included blood pressure measurement was unable to read blood pressure twice on 13Apr2021 and heart rate was 165+ on 13Apr2021. Therapeutic measures were taken as a result of events includes water. The outcome for all events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Candida infection, Fungal infection, Myalgia
Clinical narrative: severe muscle aches; yeast infection; thrush; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 59-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 02Apr2021 08:15 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Patient had no known allergies. Patient was not pregnant at the time of vaccination. Concomitant medications included estradiol (ESTROGEN) taken for an unspecified indication, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported; rizatriptan taken for an unspecified indication, start and stop date were not reported; nortriptyline taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 12Mar2021 08:15AM (at the age of 59-year-old) as dose 1, single for covid-19 immunisation and experienced severe muscle aches on day 2 post shot. On 06Apr2021, the patient experienced severe muscle aches, yeast infection, thrush. Therapeutic measures were taken as a result of events included Fluconazole, Nystatin. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Electrocardiogram, Fatigue
Clinical narrative: my blood pressure kept raising despite taking bp meds; Fatigue; Chills; Fever; body aches; This is a spontaneous report from a contactable consumer reporting for herself. A 45-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 12Apr2021 16:45 (Batch/Lot Number: EWO158, expiration date not reported) as single dose (at age of 45-years old) for covid-19 immunization. The patient medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included labetalol; paracetamol (TYLENOL); ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/Batch# ER8730, expiration date not reported), via unknown route in Left arm on 22Mar2021 as single dose (at age of 45-years old) for covid-19 immunization. The patient was allergy to Hydrocodone, oxytocin and similar meds, bacterium. Patient did not receive other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. The patient experienced blood pressure kept raising despite taking BP meds, fatigue, chills, fever, and body aches on 13Apr2021 at 16:00. The patient ended up in the Emergency room/department or urgent care because of it. The patient underwent lab tests and procedures which included blood pressure measurement kept raising on 13Apr2021, electrocardiogram and laboratory test: unknown result on unknown date. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering at the time of report.   No follow up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pain, Pyrexia
Clinical narrative: my blood pressure kept raising despite taking bp meds; Fatigue; Chills; Fever; body aches; This is a spontaneous report from a contactable consumer reporting for herself. A 45-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 12Apr2021 16:45 (Batch/Lot Number: EWO158, expiration date not reported) as single dose (at age of 45-years old) for covid-19 immunization. The patient medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included labetalol; paracetamol (TYLENOL); ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/Batch# ER8730, expiration date not reported), via unknown route in Left arm on 22Mar2021 as single dose (at age of 45-years old) for covid-19 immunization. The patient was allergy to Hydrocodone, oxytocin and similar meds, bacterium. Patient did not receive other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. The patient experienced blood pressure kept raising despite taking BP meds, fatigue, chills, fever, and body aches on 13Apr2021 at 16:00. The patient ended up in the Emergency room/department or urgent care because of it. The patient underwent lab tests and procedures which included blood pressure measurement kept raising on 13Apr2021, electrocardiogram and laboratory test: unknown result on unknown date. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering at the time of report.   No follow up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ear haemorrhage
Clinical narrative: Blood coming out of right ear; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, in Arm Left on 13Apr2021 20:00(age at vaccination: 60 Years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Medical history included renal disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had no allergies, patient didn't had covid prior to vaccination, patient was not tested with covid-19 to post vaccination. The patient experienced blood coming out of right ear on 16Apr2021 03:00. No therapeutic measures were taken for the event. The outcome of the event ear haemorrhage was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Oxygen saturation decreased, Pain
Clinical narrative: Severe body aches; low oxygen; fatigue; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 08Apr2021 12:15 (at the age of 57-year-old) as dose number unknown, single for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing Other medical history: Migraines sleep apnea pancreatic cancer remission umbilical hernia fibromyalgia, sleep apnoea syndrome from an unknown date and unknown if ongoing, pancreatic carcinoma from an unknown date and unknown if ongoing, umbilical hernia from an unknown date and unknown if ongoing, fibromyalgia from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing to Cymbalta, lyrica, savella, prednisone, morphine. concomitant medications were not specified. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient previously took unspecified Pfizer vaccine administered in right arm on 18Mar2021 for immunisation. On an unspecified date in 2021, the patient experienced severe body aches, low oxygen, fatigue, chills, nausea, vomiting. No treatment was taken as a result of events. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events were recovered with sequel.   Information about lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe body aches; low oxygen; fatigue; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 08Apr2021 12:15 (at the age of 57-year-old) as dose number unknown, single for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing Other medical history: Migraines sleep apnea pancreatic cancer remission umbilical hernia fibromyalgia, sleep apnoea syndrome from an unknown date and unknown if ongoing, pancreatic carcinoma from an unknown date and unknown if ongoing, umbilical hernia from an unknown date and unknown if ongoing, fibromyalgia from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing to Cymbalta, lyrica, savella, prednisone, morphine. concomitant medications were not specified. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient previously took unspecified Pfizer vaccine administered in right arm on 18Mar2021 for immunisation. On an unspecified date in 2021, the patient experienced severe body aches, low oxygen, fatigue, chills, nausea, vomiting. No treatment was taken as a result of events. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events were recovered with sequel.   Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Condition aggravated, Headache, Vaginal haemorrhage
Clinical narrative: chills; joint pain; a strong headache; I started spotting, which is unusual; headache that worsened with movement; This is a spontaneous report from a non-contactable consumer or other non hcp. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 12Apr2021 10:00 (Batch/Lot Number: Ep753304) as dose 2, single (age at vaccination 35-year-old) for covid-19 immunisation. Medical history included known allergies: Pollen from an unknown date. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 19Mar2021 (age at vaccination 34-year-old), lot number Ep7534 for Covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On13Apr2021 12:00, the patient experienced chills, joint pain, a strong headache, i started spotting, which is unusual, headache that worsened with movement. The day after the second dose patient had chills, joint pain, and a strong headache that worsened with movement. The second day after the shot patient started spotting, which was unusual. Her period had ended 5 days before the shot. The outcome for all events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Vaginal bleeding as of mental cycle is about to begin the last 24 hrs; This is a spontaneous report from a contactable Consumer (patient herself). A 38-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 11Apr2021 at 07:45 am (at the age of 38-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No known allergies were reported. No other vaccine was administered in four weeks. Other medications in two weeks were none. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient reported that, vaginal bleeding as of mental cycle is about to begin the last 24 hrs on 15Apr2021. Treatment was received for the event (unspecified). Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, C-reactive protein, Chest pain, Chills, Fatigue
Clinical narrative: severe flu like symptoms for 3 days starting 12 hours after shot; slight fever; chills; night sweats; body aches; severe chest pain; fatigue; persistent, throbbing pain in my right temple area; This is a spontaneous report from a contactable consumer(patient) reported that: A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 14Mar2021 (Batch/Lot Number: EN6208) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included obesity from an unknown date and unknown if ongoing , hypothyroidism from an unknown date and unknown if ongoing , anxiety from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing , asthma from an unknown date and unknown if ongoing , sleep apnea syndrome from an unknown date and unknown if ongoing , headache from an unknown date and unknown if ongoing and hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, cetirizine (CETIRIZINE) taken for an unspecified indication, sertraline (SERTRALINE) taken for an unspecified indication, ethinylestradiol, ferrous fumarate and norethisterone acetate (AUROVELA FE 1.5/30) taken for an unspecified indication.  The patient previously took vicodin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. After 2nd shot, the patient experienced severe flu like symptoms for 3 days starting 12 hours after shot. These include slight fever, chills, night sweats, body aches, severe chest pain and fatigue on 05Apr2021. Symptoms abated after day 3. At about 2 1/2 weeks later she donated blood. Three days later she developed persistent, throbbing pain in her right temple area. This continued for days, not helped by migraine medication, todarol nsaid shot, acetaminophen. TMJ and migraines were ruled out by doctors. Eye exam came back normal. Primary care ordered bloodwork and started me on steroids. Bloodwork indicated high blood sedimentation rate and high C-reactive protein which, combined with persistent temporal pain (2 weeks so far) and sensitivity to touch in temple, are highly indicative of temporal arteritis. Sars-cov-2 test: Negative on 13Apr2021. This is very abnormal in someone my age (32). She is waiting on approval for an MRI (insurance denied 1st request) and possible temporal artery biopsy to confirm. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The event outcome was Not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Night sweats, Ophthalmological examination, Pain
Clinical narrative: severe flu like symptoms for 3 days starting 12 hours after shot; slight fever; chills; night sweats; body aches; severe chest pain; fatigue; persistent, throbbing pain in my right temple area; This is a spontaneous report from a contactable consumer(patient) reported that: A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 14Mar2021 (Batch/Lot Number: EN6208) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included obesity from an unknown date and unknown if ongoing , hypothyroidism from an unknown date and unknown if ongoing , anxiety from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing , asthma from an unknown date and unknown if ongoing , sleep apnea syndrome from an unknown date and unknown if ongoing , headache from an unknown date and unknown if ongoing and hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, cetirizine (CETIRIZINE) taken for an unspecified indication, sertraline (SERTRALINE) taken for an unspecified indication, ethinylestradiol, ferrous fumarate and norethisterone acetate (AUROVELA FE 1.5/30) taken for an unspecified indication.  The patient previously took vicodin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. After 2nd shot, the patient experienced severe flu like symptoms for 3 days starting 12 hours after shot. These include slight fever, chills, night sweats, body aches, severe chest pain and fatigue on 05Apr2021. Symptoms abated after day 3. At about 2 1/2 weeks later she donated blood. Three days later she developed persistent, throbbing pain in her right temple area. This continued for days, not helped by migraine medication, todarol nsaid shot, acetaminophen. TMJ and migraines were ruled out by doctors. Eye exam came back normal. Primary care ordered bloodwork and started me on steroids. Bloodwork indicated high blood sedimentation rate and high C-reactive protein which, combined with persistent temporal pain (2 weeks so far) and sensitivity to touch in temple, are highly indicative of temporal arteritis. Sars-cov-2 test: Negative on 13Apr2021. This is very abnormal in someone my age (32). She is waiting on approval for an MRI (insurance denied 1st request) and possible temporal artery biopsy to confirm. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The event outcome was Not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: severe flu like symptoms for 3 days starting 12 hours after shot; slight fever; chills; night sweats; body aches; severe chest pain; fatigue; persistent, throbbing pain in my right temple area; This is a spontaneous report from a contactable consumer(patient) reported that: A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 14Mar2021 (Batch/Lot Number: EN6208) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included obesity from an unknown date and unknown if ongoing , hypothyroidism from an unknown date and unknown if ongoing , anxiety from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing , asthma from an unknown date and unknown if ongoing , sleep apnea syndrome from an unknown date and unknown if ongoing , headache from an unknown date and unknown if ongoing and hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, cetirizine (CETIRIZINE) taken for an unspecified indication, sertraline (SERTRALINE) taken for an unspecified indication, ethinylestradiol, ferrous fumarate and norethisterone acetate (AUROVELA FE 1.5/30) taken for an unspecified indication.  The patient previously took vicodin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. After 2nd shot, the patient experienced severe flu like symptoms for 3 days starting 12 hours after shot. These include slight fever, chills, night sweats, body aches, severe chest pain and fatigue on 05Apr2021. Symptoms abated after day 3. At about 2 1/2 weeks later she donated blood. Three days later she developed persistent, throbbing pain in her right temple area. This continued for days, not helped by migraine medication, todarol nsaid shot, acetaminophen. TMJ and migraines were ruled out by doctors. Eye exam came back normal. Primary care ordered bloodwork and started me on steroids. Bloodwork indicated high blood sedimentation rate and high C-reactive protein which, combined with persistent temporal pain (2 weeks so far) and sensitivity to touch in temple, are highly indicative of temporal arteritis. Sars-cov-2 test: Negative on 13Apr2021. This is very abnormal in someone my age (32). She is waiting on approval for an MRI (insurance denied 1st request) and possible temporal artery biopsy to confirm. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The event outcome was Not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue
Clinical narrative: Elevated BP (mostly systolic of +15 to +35) 10 of the past 12 days since receiving the shot; Day 1 & 2 fatigue. Got better by day 3. Gone by day 4. Reoccurred day 10 and gotten progressively worse; This is a spontaneous report from a contactable consumer. This 62-years-old non pregnant female consumer received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number ewd150), via an unspecified route of administration, administered in Arm Right on 02Apr2021 11:00 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypertension. There were no concomitant medications. No other vaccine in four weeks. Other medications in two weeks yes. No covid prior vaccination. No covid tested post vaccination. No known allergies. On 02Apr2021 19:00 patient experienced elevated blood pressure (mostly systolic of +15 to +35) 10 of the past 12 days since receiving the shot, day 1 & 2 fatigue. got better by day 3. gone by day 4. reoccurred day 10 and gotten progressively worse. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 02Apr2021 Also had elevated BP (mostly systolic of +15 to +35) 10 of the past 12 days since receiving the shot. No treatment was received for AE. The outcome of both events was not recovered.  No follow up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Burning sensation, Computerised tomogram, Dyspnoea
Clinical narrative: Shortness of breath; fever 102.5; extreme weakness pain all over; burning of hands and feet; elevated D-Dimer; pain all over; This is a spontaneous report from a contactable Nurse. This 46-year-old female Nurse (patient).  A 46-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 08Feb2021 (at the age of 46-year-old) as dose 1, single for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 18Jan2021 (at the age of 46-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Diabetes mellitus, Osteoporosis, Obesity, Hypovitaminosis, osteopenia, COVID-19, pneumonia, Irritable bowel syndrome, anxiety and depression all from an unspecified onset to unknown ongoing and concomitant medications were not reported. Past drug event includes Morphine induced Drug hypersensitivity, Bactrim induced Drug hypersensitivity and laytex induced Drug hypersensitivity. On 09Feb2021, after the vaccination, the patient experienced Shortness of breath, fever 102.5, extreme weakness, pain all over, burning of hands and feet elevated D-Dimer. Adverse event resulted in Emergency room/department or urgent care. Treatment was received with: IV Ativan, X-ray Labs and CT scan. The patient lab data includes body temperature with a reading of 102.5-degree Fahrenheit on an unspecified date. CT scan and X-RAY on an unspecified date with unknown results. Patient was found covid positive prior vaccination and patient was not tested for covid post vaccination. The outcome of the events was recovering at the time of this report.  No follow-up attempts possible. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Pain, Pyrexia, X-ray
Clinical narrative: Shortness of breath; fever 102.5; extreme weakness pain all over; burning of hands and feet; elevated D-Dimer; pain all over; This is a spontaneous report from a contactable Nurse. This 46-year-old female Nurse (patient).  A 46-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 08Feb2021 (at the age of 46-year-old) as dose 1, single for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 18Jan2021 (at the age of 46-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Diabetes mellitus, Osteoporosis, Obesity, Hypovitaminosis, osteopenia, COVID-19, pneumonia, Irritable bowel syndrome, anxiety and depression all from an unspecified onset to unknown ongoing and concomitant medications were not reported. Past drug event includes Morphine induced Drug hypersensitivity, Bactrim induced Drug hypersensitivity and laytex induced Drug hypersensitivity. On 09Feb2021, after the vaccination, the patient experienced Shortness of breath, fever 102.5, extreme weakness, pain all over, burning of hands and feet elevated D-Dimer. Adverse event resulted in Emergency room/department or urgent care. Treatment was received with: IV Ativan, X-ray Labs and CT scan. The patient lab data includes body temperature with a reading of 102.5-degree Fahrenheit on an unspecified date. CT scan and X-RAY on an unspecified date with unknown results. Patient was found covid positive prior vaccination and patient was not tested for covid post vaccination. The outcome of the events was recovering at the time of this report.  No follow-up attempts possible. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Headache, Hypertension, SARS-CoV-2 antibody test
Clinical narrative: headache; Lightheaded/dizzy; Elevated SBP 190's, monitored for additional 15min SBP greater than 200; This is a spontaneous report from a contactable Nurse reported for herself. A 61-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EJ1686), via an unspecified route in the left arm on 03Feb2021 at 08:00 (age at vaccination: 61-year-old), as a single dose for covid-19 immunization. Medical history included breast CA, cerebrovascular accident (CVA), migraines, osteopenia, insomnia, hypertension (HTN)-new and known allergies with Levaquin, latex, metoclopramide, ondansetron, clarithromycin, statins, Zyvox and Ambien and penicillin (PCN). Concomitant medications included bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC), alprazolam (XANAX), pitavastatin calcium (LIVALO), temazepam and Vitamin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 03Feb2021 at 08:00 after 15 min, patient developed headache, upon standing became lightheaded and dizzy with Elevated SBP 190's, monitored for additional 15min SBP greater than 200. Patient was taken to Emergency Room. Since that time have had headaches, lightheadedness, dizziness and have had elevated BP since this time. Now diagnosed with high blood pressure - new diagnosis and on HTN medications. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures taken as a result of the events included emergency room: IVF labs, F/U with primary care physician for further management. The patient underwent lab test and procedure which included blood pressure elevated SBP 190's and SBP greater than 200 on 03Feb2021; post vaccination antibodies test: SARS-CoV-2 Nasal Swab: Negative on 23Feb2021; SARS-CoV-2 Interp Nasal Swab: Negative on 23Feb2021; SARS-CoV-2 Nasal Swab: Negative on 08Mar2021 and SARS-CoV-2 Interp Nasal Swab: Negative on 08Mar2021. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Dry mouth, Fatigue, Headache
Clinical narrative: Fatigue; Dry mouth; Slight fever; Clamminess; Pain in upper right arm; Joints became stiff; Itchy on right arm/hand; Headache; Dizziness; Nauseated; Could not sleep; Feeling tingling throughout right side; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 16Apr2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome with diarrhea (IBS-D), high blood pressure, sciatica (Sciatic Nerve Lower Back Pain), scoliosis, laryngopharyngeal reflux (silent reflux), gastroesophageal reflux disease (GERD), gastroparesis and food allergy (gelatin). The patient previously took vibramycin, doxycycline, tetracycline and flagyl and experienced allergy to these medications. Prior to the vaccination, the patient was no diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metoprolol succinate ER (MANUFACTURER UNKNOWN), pantoprazole sodium sesquihydrate (pantoprazole sodium) (MANUFACTURER UNKNOWN) and tramadol (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date. On 16Apr2021, 15 minutes after the shot she felt fine. 30 minutes after the shot she started feeling tingling throughout her right side, along with pain in her upper right arm. 45 minutes after the shot her joints became stiff and she started becoming itchy on her right arm/hand. 60 minutes after the shot she started getting a headache and dizziness. 90 minutes after the shot she got nauseated. She could not sleep that night because of the dizziness. On 17Apr2021, next day all of the same symptoms plus fatigue, dry mouth and a slight fever with clamminess. Two days after the shot no more tingling, less pain in the arm, joints were a little looser, still had a headache, some dizziness, and still had a dry mouth. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events feeling tingling throughout right side was resolved on 18Apr2021. The clinical outcome of the events joints became stiff, dizziness, could not sleep, pain in upper right arm was resolving and that of itchy on right arm/hand, headache, nauseated, fatigue, dry mouth, slight fever and clamminess was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Nausea, Pain in extremity, Paraesthesia, Poor quality sleep
Clinical narrative: Fatigue; Dry mouth; Slight fever; Clamminess; Pain in upper right arm; Joints became stiff; Itchy on right arm/hand; Headache; Dizziness; Nauseated; Could not sleep; Feeling tingling throughout right side; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 16Apr2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome with diarrhea (IBS-D), high blood pressure, sciatica (Sciatic Nerve Lower Back Pain), scoliosis, laryngopharyngeal reflux (silent reflux), gastroesophageal reflux disease (GERD), gastroparesis and food allergy (gelatin). The patient previously took vibramycin, doxycycline, tetracycline and flagyl and experienced allergy to these medications. Prior to the vaccination, the patient was no diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metoprolol succinate ER (MANUFACTURER UNKNOWN), pantoprazole sodium sesquihydrate (pantoprazole sodium) (MANUFACTURER UNKNOWN) and tramadol (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date. On 16Apr2021, 15 minutes after the shot she felt fine. 30 minutes after the shot she started feeling tingling throughout her right side, along with pain in her upper right arm. 45 minutes after the shot her joints became stiff and she started becoming itchy on her right arm/hand. 60 minutes after the shot she started getting a headache and dizziness. 90 minutes after the shot she got nauseated. She could not sleep that night because of the dizziness. On 17Apr2021, next day all of the same symptoms plus fatigue, dry mouth and a slight fever with clamminess. Two days after the shot no more tingling, less pain in the arm, joints were a little looser, still had a headache, some dizziness, and still had a dry mouth. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events feeling tingling throughout right side was resolved on 18Apr2021. The clinical outcome of the events joints became stiff, dizziness, could not sleep, pain in upper right arm was resolving and that of itchy on right arm/hand, headache, nauseated, fatigue, dry mouth, slight fever and clamminess was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.