chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blindness transient, Chills, Dizziness, Fatigue
Clinical narrative: passed out; loss of vision for a few minutes; Dizziness; blurred vision; Severe weakness; couldn't walk; chills; fever; Fatigue; soreness in right arm; muscle aches; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 05May2021 15:00 (Lot Number: ew0161) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient had no other medical history. Concomitant medications included ethinylestradiol, norgestimate (TRI LO MARZIA); ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL); probiotics (PROBIOTICS) all taken for an unspecified indication, start and stop date were not reported. The patient received first dose of Covid-19 vaccine (manufacture Pfizer, lot number ew0151) on 14Apr2021 01:00 PM in Left arm for covid-19 immunisation. The patient experienced dizziness with blurred vision / loss of vision for a few minutes, possibly passed out. Severe weakness, couldn't walk for a few minutes. Dizziness with chills/fever lasted a few hours. Fatigue for 12 hours. Soreness in right arm and muscle aches all over. Headache for 12-16 hours, all on 06May2021 06:30 with outcome of recovered. No treatment was received for the events. Information on the lot/batch number has been requested.; Sender's Comments: The causal association between the reported events passed out and loss of vision for a few minutes and the suspect drug BNT162B2 cannot be totally excluded based on a temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Loss of consciousness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: passed out; loss of vision for a few minutes; Dizziness; blurred vision; Severe weakness; couldn't walk; chills; fever; Fatigue; soreness in right arm; muscle aches; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 05May2021 15:00 (Lot Number: ew0161) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient had no other medical history. Concomitant medications included ethinylestradiol, norgestimate (TRI LO MARZIA); ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL); probiotics (PROBIOTICS) all taken for an unspecified indication, start and stop date were not reported. The patient received first dose of Covid-19 vaccine (manufacture Pfizer, lot number ew0151) on 14Apr2021 01:00 PM in Left arm for covid-19 immunisation. The patient experienced dizziness with blurred vision / loss of vision for a few minutes, possibly passed out. Severe weakness, couldn't walk for a few minutes. Dizziness with chills/fever lasted a few hours. Fatigue for 12 hours. Soreness in right arm and muscle aches all over. Headache for 12-16 hours, all on 06May2021 06:30 with outcome of recovered. No treatment was received for the events. Information on the lot/batch number has been requested.; Sender's Comments: The causal association between the reported events passed out and loss of vision for a few minutes and the suspect drug BNT162B2 cannot be totally excluded based on a temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: passed out; loss of vision for a few minutes; Dizziness; blurred vision; Severe weakness; couldn't walk; chills; fever; Fatigue; soreness in right arm; muscle aches; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 05May2021 15:00 (Lot Number: ew0161) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient had no other medical history. Concomitant medications included ethinylestradiol, norgestimate (TRI LO MARZIA); ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL); probiotics (PROBIOTICS) all taken for an unspecified indication, start and stop date were not reported. The patient received first dose of Covid-19 vaccine (manufacture Pfizer, lot number ew0151) on 14Apr2021 01:00 PM in Left arm for covid-19 immunisation. The patient experienced dizziness with blurred vision / loss of vision for a few minutes, possibly passed out. Severe weakness, couldn't walk for a few minutes. Dizziness with chills/fever lasted a few hours. Fatigue for 12 hours. Soreness in right arm and muscle aches all over. Headache for 12-16 hours, all on 06May2021 06:30 with outcome of recovered. No treatment was received for the events. Information on the lot/batch number has been requested.; Sender's Comments: The causal association between the reported events passed out and loss of vision for a few minutes and the suspect drug BNT162B2 cannot be totally excluded based on a temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive for Covid on the same day; she tested positive for Covid on the same day; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (lot number unknown), via an unspecified route of administration, in Mar2021(3 weeks prior 12Apr2021) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled to receive her second dose of Pfizer BioNtech Covid-19 vaccine last 12Apr2021, however she did not receive her 2nd dose because she tested positive for Covid on the same day. The patient stated that she didn't have the exact date but she received it 3 weeks prior 12Apr2021. Her healthcare provider recommended that she wait 30 days after testing positive to get the second dose but her vaccination provider told her wait longer than 6 weeks and start the series again. She was asking if she could receive the 2nd dose of the Pfizer BioNtech Covid-19 or restart the vaccination series again after what her vaccination provider and healthcare provider recommended. The outcome of the events was unknown.  Information about lot/batch has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Chills, Eye irritation, Fatigue, Feeling abnormal
Clinical narrative: mild hallucinations; nauseated; extremely fatigued; eyes heavy with a slight burning sensation; eyes heavy with a slight burning sensation; in a head fog state; mild headache; sick; chills; nose run; sneezing; that were so cold it; This is a spontaneous report from a contactable consumer(patient). A 31-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EW0176), via an unspecified route of administration at Arm Left on 06-MAY-2021 12:45 at the 31 years old at single dose for COVID-19 immunization.  The medical history was not reported. The concomitant medication was ethinylestradiol, ferrous fumarate, norethisterone acetate(JUNEL FE)  The patient previously took steroids and experienced known allergies Tendency. After the initial dose, the patient began to feel nauseated on 06May2021 14:00. The patient waited for the 15min period on site and then proceeded home. By time the patient arrived home, the patient was extremely fatigued and her eyes heavy with a slight burning sensation on 06May2021 14:00. The patient spoke to her mom briefly and she recalls that the patient told her that she got the vaccine. She also stated that the patient rambled off some strange vaccine name and statics on it which the patient have no memory of. During this time the patient had mild hallucinations on 06May2021 14:00. The patient saw her walk by and asked her where she went and she had never moved from her chair. The patient went to her room to rest/sleep immediately after where the patient remember hearing someone come in and lay down but there was no one. The patient also vividly remember waking up and checking the time which was incorrect as well.  The patient was in a head fog state on 06May2021 14:00. The patient had a mild headache on 06May2021 14:00. Later that night the patient ate some food and was sick after.  While going to bed, the patient had chills that were so cold it made my nose run and the patient was sneezing excessively on 06May2021 14:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19. There was no treatment received for all of events. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hallucination, Headache, Illness, Nausea
Clinical narrative: mild hallucinations; nauseated; extremely fatigued; eyes heavy with a slight burning sensation; eyes heavy with a slight burning sensation; in a head fog state; mild headache; sick; chills; nose run; sneezing; that were so cold it; This is a spontaneous report from a contactable consumer(patient). A 31-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EW0176), via an unspecified route of administration at Arm Left on 06-MAY-2021 12:45 at the 31 years old at single dose for COVID-19 immunization.  The medical history was not reported. The concomitant medication was ethinylestradiol, ferrous fumarate, norethisterone acetate(JUNEL FE)  The patient previously took steroids and experienced known allergies Tendency. After the initial dose, the patient began to feel nauseated on 06May2021 14:00. The patient waited for the 15min period on site and then proceeded home. By time the patient arrived home, the patient was extremely fatigued and her eyes heavy with a slight burning sensation on 06May2021 14:00. The patient spoke to her mom briefly and she recalls that the patient told her that she got the vaccine. She also stated that the patient rambled off some strange vaccine name and statics on it which the patient have no memory of. During this time the patient had mild hallucinations on 06May2021 14:00. The patient saw her walk by and asked her where she went and she had never moved from her chair. The patient went to her room to rest/sleep immediately after where the patient remember hearing someone come in and lay down but there was no one. The patient also vividly remember waking up and checking the time which was incorrect as well.  The patient was in a head fog state on 06May2021 14:00. The patient had a mild headache on 06May2021 14:00. Later that night the patient ate some food and was sick after.  While going to bed, the patient had chills that were so cold it made my nose run and the patient was sneezing excessively on 06May2021 14:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19. There was no treatment received for all of events. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: mild hallucinations; nauseated; extremely fatigued; eyes heavy with a slight burning sensation; eyes heavy with a slight burning sensation; in a head fog state; mild headache; sick; chills; nose run; sneezing; that were so cold it; This is a spontaneous report from a contactable consumer(patient). A 31-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EW0176), via an unspecified route of administration at Arm Left on 06-MAY-2021 12:45 at the 31 years old at single dose for COVID-19 immunization.  The medical history was not reported. The concomitant medication was ethinylestradiol, ferrous fumarate, norethisterone acetate(JUNEL FE)  The patient previously took steroids and experienced known allergies Tendency. After the initial dose, the patient began to feel nauseated on 06May2021 14:00. The patient waited for the 15min period on site and then proceeded home. By time the patient arrived home, the patient was extremely fatigued and her eyes heavy with a slight burning sensation on 06May2021 14:00. The patient spoke to her mom briefly and she recalls that the patient told her that she got the vaccine. She also stated that the patient rambled off some strange vaccine name and statics on it which the patient have no memory of. During this time the patient had mild hallucinations on 06May2021 14:00. The patient saw her walk by and asked her where she went and she had never moved from her chair. The patient went to her room to rest/sleep immediately after where the patient remember hearing someone come in and lay down but there was no one. The patient also vividly remember waking up and checking the time which was incorrect as well.  The patient was in a head fog state on 06May2021 14:00. The patient had a mild headache on 06May2021 14:00. Later that night the patient ate some food and was sick after.  While going to bed, the patient had chills that were so cold it made my nose run and the patient was sneezing excessively on 06May2021 14:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19. There was no treatment received for all of events. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Have been diagnosed with Bell's Palsy due to a facial paralysis; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 23Apr2021 11:00 (Lot Number: EW0171) as 2ND DOSE, SINGLE for covid-19 immunisation. No known allergies and other medical history. The patient concomitant drugs were not reported. The patient previously received first dose of BNT162B2 on 02Apr2021 12:00 am in left arm (lot number: ep7534). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had been diagnosed with Bells Palsy due to a facial paralysis on 04May2021 12:00 AM. Unknown if it was related to the vaccine or the cause. The adverse event result in emergency room/department or urgent care. Currently taking prescribed medication for event. The outcome of event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: Cataract; This is a spontaneous report from a Pfizer sponsored program COVAX US SUPPORT. A contactable pharmacist reported for a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had cataract surgery on 04May2021 and was taking an antibiotic eye drop and a steroid eye drop. Her second dose of the Pfizer Covid 19 vaccine was scheduled for tomorrow (21 days). Reporter asked if safe for her to take the vaccine. The outcome of the event cataract was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Due to implausible temporal association, the event of  Cataract is assessed as unrelated to suspect product BNT162B2.The patient has been on the medication for just 21 days, while it is known that the process of cataract is slow and takes months to years.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pre-eclampsia
Clinical narrative: Increase in blood pressure/preeclampsia; This is a spontaneous report from a contactable other healthcare professional (patient). This other healthcare professional reported information for both mother and fetus/baby. This is a maternal report. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 02Apr2021 11:00 (Batch/Lot Number: Ep7833) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included allergy to penicillin. Date of LMP was 15Aug2020. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medications were not reported. The patient previously took TDAP on 03Mar2021 for immunization. The mother reported she became pregnant while taking bnt162b2. On 05Apr2021 12:00, the patient experienced increase in blood pressure. She developed preeclampsia after first injection. The event caused hospitalization. The mother was 33 weeks pregnant at the onset of the event. The mother was due to deliver on 22May2021. The mother delivered the pregnancy. The baby was delivered premature. The patient delivered the baby at 33 weeks 5 days. Therapeutic measures were taken as a result of increase in blood pressure/preeclampsia and included treatment with blood pressure (BP) medication. Blood pressure returned to normal levels 3 weeks post-partum. Outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, Preeclampsia cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021516156 fetus case
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Hypoaesthesia, Oropharyngeal pain, Periorbital swelling, Pruritus
Clinical narrative: Slight pain in right back of throat; Looked like Marge Simpson, felt like Novocaine numbing; Hives on arms, legs, thighs, hips with lots of itching; Hives on arms, legs, thighs, hips with lots of itching; Nose and Upper Lip Angioedema; Right Eye puffy, closed, puckered, creased; Right Eye puffy, closed, puckered, creased; Right Eye puffy, closed, puckered, creased; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:15 (Lot Number: EW0153) as single dose for COVID-19 immunisation. Medical history included seasonal allergies to pollen, grasses, weeds. The patient's concomitant medications were not reported. On 26Apr2021, the patient experienced right eye puffy, closed, puckered, creased, on 01May2021, nose and upper lip angioedema, felt like Novocaine numbing; hives on arms, legs, thighs, hips with lots of itching, on 04May2021, lower Lip Angioedema on right side, looked like an asymmetrical fat lip; continued Hives on arms, legs, thighs, hips with lots of itching, on 07May2021, left eye puffy, closed, puckered, creased; continued hives on arms, legs, thighs, hips with lots of itching. slight pain in right back of throat. The patient did not receive any treatment for events. The outcome of events was recovering.  Information on lot/batch number has requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Skin wrinkling, Strabismus, Urticaria
Clinical narrative: Slight pain in right back of throat; Looked like Marge Simpson, felt like Novocaine numbing; Hives on arms, legs, thighs, hips with lots of itching; Hives on arms, legs, thighs, hips with lots of itching; Nose and Upper Lip Angioedema; Right Eye puffy, closed, puckered, creased; Right Eye puffy, closed, puckered, creased; Right Eye puffy, closed, puckered, creased; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:15 (Lot Number: EW0153) as single dose for COVID-19 immunisation. Medical history included seasonal allergies to pollen, grasses, weeds. The patient's concomitant medications were not reported. On 26Apr2021, the patient experienced right eye puffy, closed, puckered, creased, on 01May2021, nose and upper lip angioedema, felt like Novocaine numbing; hives on arms, legs, thighs, hips with lots of itching, on 04May2021, lower Lip Angioedema on right side, looked like an asymmetrical fat lip; continued Hives on arms, legs, thighs, hips with lots of itching, on 07May2021, left eye puffy, closed, puckered, creased; continued hives on arms, legs, thighs, hips with lots of itching. slight pain in right back of throat. The patient did not receive any treatment for events. The outcome of events was recovering.  Information on lot/batch number has requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Blood test, Dyspnoea
Clinical narrative: nearly passed out; the shoulder where she got her injection started hurting really bad; getting hot; sweating; thirsty; Her blood pressure dropped; couldn't breathe; arm hurting really bad; got very weak; turned gray, like an elephant; felt floaty; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at left shoulder (Arm Left) on 19Apr2021 10:00 AM at age of 51 years old (Batch/Lot number was not reported) as 1ST, SINGLE for covid-19 immunisation.  The patient's medical history was reported as just told her blood pressure dropped on an unknown date, hooked patient up to a bunch of wires and stomach, monitoring her on a machine. The last couple of time patient had blood drawn, the one last time, she went into shock and passed out. This wasn't quite the same thing with this time. This was maybe 2 years before unspecified date. One time it was pretty bad and patient fell down, get the doctor and hook patient up to all that stuff. Didn't' quite feel the same way as this time. She didn't get hot and sweaty. Patient was not taking any pills. The concomitant medications were not reported. After first dose of the Pfizer covid vaccine.  After the injection on 19Apr2021, patient sat for 15 minutes (wait for 15 minutes) and the shoulder where she got her injection started hurting really bad. Arm hurting really bad, walked across the hall and sat in the chair, maybe 2 minutes later. Then started tearing her mask off because she couldn't breathe.  Patient started getting hot, sweaty and thirsty. Patient was sweating, started getting hot and thristy and then got really sweaty and super hot. Got really thirsty and was given water. She was trying to grab a bottle of water and she didn't have the strength. She got very weak, turned gray, like an elephant and her blood pressure dropped, and nearly passed out. It lasted maybe 10 or 15 minutes. They called the ambulance. By the time they got there, she was feeling more back within herself and It was pretty much done and was totally better, maybe 90 percent. She just wanted to go home and did not go in the ambulance.  She felt floaty but did not pass out. With the first one, she had a reaction and is wondering if she should even take the second one. Therapeutic measures were taken as a result of thirsty included water. Treatment for other event was reported as none, and she was not taking any medication. The event outcome of recovered on 19Apr2021.  Information about lot and batch number was requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Hyperhidrosis, Pain in extremity, Presyncope
Clinical narrative: nearly passed out; the shoulder where she got her injection started hurting really bad; getting hot; sweating; thirsty; Her blood pressure dropped; couldn't breathe; arm hurting really bad; got very weak; turned gray, like an elephant; felt floaty; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at left shoulder (Arm Left) on 19Apr2021 10:00 AM at age of 51 years old (Batch/Lot number was not reported) as 1ST, SINGLE for covid-19 immunisation.  The patient's medical history was reported as just told her blood pressure dropped on an unknown date, hooked patient up to a bunch of wires and stomach, monitoring her on a machine. The last couple of time patient had blood drawn, the one last time, she went into shock and passed out. This wasn't quite the same thing with this time. This was maybe 2 years before unspecified date. One time it was pretty bad and patient fell down, get the doctor and hook patient up to all that stuff. Didn't' quite feel the same way as this time. She didn't get hot and sweaty. Patient was not taking any pills. The concomitant medications were not reported. After first dose of the Pfizer covid vaccine.  After the injection on 19Apr2021, patient sat for 15 minutes (wait for 15 minutes) and the shoulder where she got her injection started hurting really bad. Arm hurting really bad, walked across the hall and sat in the chair, maybe 2 minutes later. Then started tearing her mask off because she couldn't breathe.  Patient started getting hot, sweaty and thirsty. Patient was sweating, started getting hot and thristy and then got really sweaty and super hot. Got really thirsty and was given water. She was trying to grab a bottle of water and she didn't have the strength. She got very weak, turned gray, like an elephant and her blood pressure dropped, and nearly passed out. It lasted maybe 10 or 15 minutes. They called the ambulance. By the time they got there, she was feeling more back within herself and It was pretty much done and was totally better, maybe 90 percent. She just wanted to go home and did not go in the ambulance.  She felt floaty but did not pass out. With the first one, she had a reaction and is wondering if she should even take the second one. Therapeutic measures were taken as a result of thirsty included water. Treatment for other event was reported as none, and she was not taking any medication. The event outcome of recovered on 19Apr2021.  Information about lot and batch number was requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Thirst, Vaccination site pain
Clinical narrative: nearly passed out; the shoulder where she got her injection started hurting really bad; getting hot; sweating; thirsty; Her blood pressure dropped; couldn't breathe; arm hurting really bad; got very weak; turned gray, like an elephant; felt floaty; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at left shoulder (Arm Left) on 19Apr2021 10:00 AM at age of 51 years old (Batch/Lot number was not reported) as 1ST, SINGLE for covid-19 immunisation.  The patient's medical history was reported as just told her blood pressure dropped on an unknown date, hooked patient up to a bunch of wires and stomach, monitoring her on a machine. The last couple of time patient had blood drawn, the one last time, she went into shock and passed out. This wasn't quite the same thing with this time. This was maybe 2 years before unspecified date. One time it was pretty bad and patient fell down, get the doctor and hook patient up to all that stuff. Didn't' quite feel the same way as this time. She didn't get hot and sweaty. Patient was not taking any pills. The concomitant medications were not reported. After first dose of the Pfizer covid vaccine.  After the injection on 19Apr2021, patient sat for 15 minutes (wait for 15 minutes) and the shoulder where she got her injection started hurting really bad. Arm hurting really bad, walked across the hall and sat in the chair, maybe 2 minutes later. Then started tearing her mask off because she couldn't breathe.  Patient started getting hot, sweaty and thirsty. Patient was sweating, started getting hot and thristy and then got really sweaty and super hot. Got really thirsty and was given water. She was trying to grab a bottle of water and she didn't have the strength. She got very weak, turned gray, like an elephant and her blood pressure dropped, and nearly passed out. It lasted maybe 10 or 15 minutes. They called the ambulance. By the time they got there, she was feeling more back within herself and It was pretty much done and was totally better, maybe 90 percent. She just wanted to go home and did not go in the ambulance.  She felt floaty but did not pass out. With the first one, she had a reaction and is wondering if she should even take the second one. Therapeutic measures were taken as a result of thirsty included water. Treatment for other event was reported as none, and she was not taking any medication. The event outcome of recovered on 19Apr2021.  Information about lot and batch number was requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Breast cancer, Lymphadenopathy, Rash erythematous
Clinical narrative: Very bad rash which was red and itchy under her breast area; Swollen lymph node under left arm larger than right; She thought she had breast cancer; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 11Apr2021 14:30 as 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that the patient received her 1st dose of the COVID-19 vaccine on 11Apr2021. About 10 days after, on 21Apr2021, she developed a very bad rash which was red and itchy under her breast area, along with a swollen lymph node. She has gone thru several doctors to which she was currently consulting a dermatologist. She stated that the dermatologist gave her a steroid shot and took a biopsy. She was treated with prednisone which did not help, antibiotics which also did not help, and steroid shots which helped for 2 days, after which the rash went back. She is taking Benadryl and Zyrtec for the rash, to which she mentioned that Benadryl is the only thing that helped it but caused her to get sleepy. Zyrtec took hours before it exhibited the affect. She is holding off on antihistamines because she needs to stay awake during the day. She mentioned that she is feeling a little better at the time of report, the rash has lightened but was still there and still itchy, but it seems to have toned down and it is not inflamed and red. She thought she had breast cancer, the lymph node under her left arm and along the breast has a strong itchy rash and the lymph node was swollen. The patient was aware of 42-day window that is allowable. She had already rescheduled her 2nd dose to be done on 16May2021, but her doctor recommended her to delay it again, the rash needs to calm down before the booster, second shot. She is concerned of what to do if she passes that 42-day window. She doesn't know if she feels safe to take the second vaccine. The outcome of the event "She thought she had breast cancer" was unknown, and for other events was unknown.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: I woke up 12-16 hours after my 2nd dose with a loud, high pitched noise in both of my ears. (Tinnitus); This is a spontaneous report from a contactable consumer (patient).   A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 29Apr2021 14:30 at age of 53 years old (Lot Number: ew0172) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included many known allergies, but did not react to vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 14:30 PM at age of 53 years old (Lot Number: ew0172) as 1ST DOSE, SINGLE for covid-19 immunisation. After the 1st dose, patient was quite sick, suffered from exhaustion (sleeping 15-17 hrs a day) and a heavy cough, and minor sinus pressure, for the first 2.5 weeks after the 1st dose, noticed a very faint high pitch in ears a few days before the 2nd shot, but dismissed it as an aberration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included meloxicam; omeprazole; levocetirizine, all taken for an unspecified indication, start and stop date were not reported.  Patient woke up 12-16 hours after his 2nd dose with a loud, high pitched noise in both of ears (Tinnitus on 30Apr2021 05:00 AM). It has not diminished in the week since the 2nd shot. Patient can hear it while talking on the phone and when laying in bed. Serious criteria was provided as disability and with physician office visit. Patient had hearing tested by an audiologist 5 days after the shot and do not have hearing loss, despite the tinnitus. As a former professional singer, he was diligent about protecting hearing, wearing protection whenever near loud noises. Patient have never had symptoms of Tinnitus prior to the vaccine. The patient underwent lab tests and procedures which included hearing tested on 04May2021: no hearing loss, despite the tinnitus.  Patient was not test for COVID-19 Since the vaccination. The outcome of event was not recovered and without hospitalization and with treatment given.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Laboratory test, Muscular weakness, SARS-CoV-2 antibody test
Clinical narrative: Dehydration; muscle weakness; This is a spontaneous report from a contactable consumer (family member) via Medical Information Team. An 88-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in arm at a military facility on 20Mar2021 (at the age of 87-year-old) (Batch/Lot Number: EN6208) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient did not receive other vaccines prior to the vaccination within four weeks. The patient had no relevant medical history. The patient's concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6201) administered in unspecified arm on 19Feb2021 (at the age of 87-year-old) for COVID-19 immunisation. The consumer reported that the patient experienced dehydration and muscle weakness on an unspecified date and was hospitalized for both events from 30Apr2021 to 03May2021. The patient had a negative COVID test about a week ago (30Apr2021), he recently entered the hospital for dehydration and had a whole series of tests, all of which were negative. The patient was in this facility now, mainly he was just convalescing because of the dehydration and muscle weakness. The consumer stated that patient was transferred to this other VA facility, the VA nursing home and that's where he received the third dose today. The events required emergency room visit and did not require physician office visit. It was also reported that patient got a vaccine overdose of Pfizer's COVID vaccine and wanted to know what to do. It was reported that first injection was on 19Feb2021, second injection was on 20Mar2021, and third injection was given today (07May2021). The consumer was informed that the administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine was not approved. The consumer then mentioned that he was able to find that the booster study will be starting in May on news. The consumer was told that no specific information was found from approved sources regarding the specific date the study on the booster dose has begun. Clarified that booster dose was in regard to a 3rd dose 6 to 12 months after receiving both doses and does not apply to his family member's case regarding 3 doses within the span of 1-2 months. Additionally, the consumer reported that the patient gets his primary care at a medical center. The consumer stated that it was another healthcare professional who administered it. The consumer stated that it was probably in the morning sometime, before noon. The consumer stated that it was given he would presume in one of his arms but he doesn't know which one. The outcome of the events dehydration and muscle weakness was recovering.  Follow-up attempts are needed. Further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Left lower leg DVT- occlusion of the posterior popliteal vein; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021 (Batch/Lot Number: EW0172) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at event onset and at vaccination. The patient previously received the first dose of bnt162b2 (lot number: EW0150) on an unspecified date in left arm for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced left lower leg DVT- occlusion of the posterior popliteal vein on 06May2021 at 08:00. The event resulted in emergency room visit. The patient received treatment for the event with Xarelto 20 mg daily for at least 3 months. The outcome of the event was unknown.   Follow up attempts needed. Further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscle spasms, Myosclerosis, Nausea, Vaccination site pain
Clinical narrative: knot above her shoulder blade on her collar bone; swollen gland around her left collarbone; back spasms; nausea; sore arm in her left arm which was the injection arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 17Apr2021 (Batch/Lot Number: ER8733; Expiration Date: Jul2021) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included nifedipine (NIFEDIPINE) taken for blood pressure increased from Feb2021 and ongoing; betacarotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (MULTIVITAMIN & MINERAL) taken for immune system disorder from 2020 and ongoing; 1-alpha-hydroxyvitamin d3 (1-ALPHA-HYDROXYVITAMIN D3) taken for immune system disorder, bone disorder from 2020 and ongoing. The patient stated she received her first Pfizer Covid vaccine dose on 17Apr2021. That same day she started to experience nausea which resolved. She also experienced a sore arm (injection arm was left arm) for a few days, which has resolved. She reported back spasms on 26Apr2021 which have since resolved. She stated she began to have a swollen gland around her left collarbone on 27Apr2021 which continues to be swollen. Around 5-6 days after, she experienced a knot above her shoulder blade, on her collar bone. She went to get her 2nd shot today, and told them about the knot, it does not hurt, and they advised she go see a doctor. The outcome of the event knot above her shoulder blade on her collar bone was unknown, event swollen gland around her left collarbone was not recovered while other events were recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling cold, Hypersensitivity, Influenza like illness, Swelling
Clinical narrative: allergic reaction; swelled up; felt cold; flu-like symptoms; dizzy; This is a spontaneous report from a contactable HCP.   A currently 24 year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE,as a single dose, for covid-19 immunisation. Medical history and concomitant medications were not reported.  The patient received the Pfizer covid vaccine last Wednesday. She says she felt cold and flu-like symptoms, dizzy, she swelled up, took a BENADRYL which calmed it down. She would like to know whether she can get the 2nd dose of the Pfizer covid vaccine after an allergic reaction to the first. The outcome of the events was not reported.  Information on the Lot/Batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contacted covid 19 with severe symptoms 4 months after finishing his vaccine; contacted covid 19 with severe symptoms 4 months after finishing his vaccine; This is a spontaneous report from a contactable physician (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications in two weeks. The patient did not have COVID prior vaccination. The patient reported that he contacted covid 19 with severe symptoms 4 months after finishing his vaccine, on 30Apr2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included Covid test post vaccination nasal swab, result: inconclusive on 30Apr2021. The patient received apixaban (ELIQUIS) as treatment for the events. The events resulted in Doctor or other healthcare professional office/clinic visit. Information about the Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.    There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.