chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeling jittery
Clinical narrative: dizziness; jittery; shaky; headache; fluid in her ears; wake up in the middle of the night; Weakness; chills; tired; This is a spontaneous report from a contactable registered nurse (patient). A 57-year-old female nurse received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) injection at single dose via an unknown route in the left deltoid on 20Jan2021 for Covid-19 immunization. Medical history included hypothyroidism. Concomitant drug included  ongoing levothyroxine sodium (EUTHYROX) started about 12 years ago as of 27Jan2021 at 75mcg once a day for hypothyroidism.  Patient had first dose on the 20Jan2021, Wednesday and the last two nights (as of 27Jan2021) patient had chills. Onset date of chills was 25Jan2021. She assumed it would be sooner than further out close to the second one getting side effects.  She also experienced weakness and was really really tired. Onset date of tired was 24Jan2021. She was unsure if she should get the second dose, or if she needs to contact her provider about this. She did not know if these are normal side effects or not. She looked at the side effect list, which said chills and headache, which she has experienced both. She also had dizziness. She used Flonase for the fluid in her ears. She thought the headache and dizziness was from fluid from pressure or something. The FLONASE helped with that. She had no fever. She was a week out from getting the dose and was wondering if she should still be having these side effects.  Headache/ dizziness and weakness started a few days after she got the vaccine. She thought the weakness started that Friday or Saturday. If she got enough sleep she was okay, but she would wake up in the middle of the night. She thought the chills were from the weakness. She was also jittery and shaky as part of the weakness. Patient was always being really really tired later in the day. She thought that if she were working full time she would be missing work and that was medically significant. Treatment included FLONASE and took paracetamol (TYLENOL) for the headache early on. The events (chills, weakness, tired, headache and dizziness) were reported as serious with seriousness criteria of other medically important condition. No Investigation Assessment performed. Outcome of the events chills, weakness, tired was not resolved. Outcome of headache and dizziness was resolved. Outcome of the other evens was unknown.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Middle ear effusion, Sleep disorder, Tremor
Clinical narrative: dizziness; jittery; shaky; headache; fluid in her ears; wake up in the middle of the night; Weakness; chills; tired; This is a spontaneous report from a contactable registered nurse (patient). A 57-year-old female nurse received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) injection at single dose via an unknown route in the left deltoid on 20Jan2021 for Covid-19 immunization. Medical history included hypothyroidism. Concomitant drug included  ongoing levothyroxine sodium (EUTHYROX) started about 12 years ago as of 27Jan2021 at 75mcg once a day for hypothyroidism.  Patient had first dose on the 20Jan2021, Wednesday and the last two nights (as of 27Jan2021) patient had chills. Onset date of chills was 25Jan2021. She assumed it would be sooner than further out close to the second one getting side effects.  She also experienced weakness and was really really tired. Onset date of tired was 24Jan2021. She was unsure if she should get the second dose, or if she needs to contact her provider about this. She did not know if these are normal side effects or not. She looked at the side effect list, which said chills and headache, which she has experienced both. She also had dizziness. She used Flonase for the fluid in her ears. She thought the headache and dizziness was from fluid from pressure or something. The FLONASE helped with that. She had no fever. She was a week out from getting the dose and was wondering if she should still be having these side effects.  Headache/ dizziness and weakness started a few days after she got the vaccine. She thought the weakness started that Friday or Saturday. If she got enough sleep she was okay, but she would wake up in the middle of the night. She thought the chills were from the weakness. She was also jittery and shaky as part of the weakness. Patient was always being really really tired later in the day. She thought that if she were working full time she would be missing work and that was medically significant. Treatment included FLONASE and took paracetamol (TYLENOL) for the headache early on. The events (chills, weakness, tired, headache and dizziness) were reported as serious with seriousness criteria of other medically important condition. No Investigation Assessment performed. Outcome of the events chills, weakness, tired was not resolved. Outcome of headache and dizziness was resolved. Outcome of the other evens was unknown.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. 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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Blood urine present, Cerebrovascular accident, Dysstasia, Electrocardiogram
Clinical narrative: Had a mild a heart attack and mild stroke; had a mild a heart attack and mild stroke; urinary tract infection; Blood infection; A1C was 6.5; there was a little blood in his urine; he fell out of bed and couldn't get up; he was flushed; he had a fever of 101; This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL1283) at 0.3 mL single on 20Jan2021 for COVID-19 immunization. Medical history included thyroid; hypertension, was under control with the medication; dementia, taking memantine as a treatment for dementia, no other impairment other than what he normally has from his dementia. Concomitant medications included levothyroxine; memantine for dementia; fish oil tablet; Vitamins. Patient had a mild heart attack and a slight stroke and he did have urinary tract and blood infection on 24Jan2021. They both had the first dose of the Pfizer covid vaccine on 20Jan2021, Saturday night into Sunday. He was a dementia patient, alert to his name. On 24Jan2021, he fell out of bed and couldn't get up, he was flushed, so patient's wife took his temperature, he had a fever of 101. Patient's wife couldn't move him, so called the paramedics and they took him to Hospital. Patient's wife just found out that he had a very mild heart attack and slight stroke, no impairment other than what he normally had from the dementia. Patient's wife was wondering should he get the second shot and what was the timing of the 2nd dose of vaccine. Reporter seriousness for mild heart attack, slight stroke, urinary tract and blood infection was hospitalization. They also have him on some sort of penicillin derivative for a urinary tract infection. Since he had been to the hospital, he had at his doctor's office about 2 weeks ago today, he had a blood test, a urine test. His A1C was 6.5, there was a little blood in his urine. For that since Sunday (24Jan2021) he was having MRI, he had a couple of PET scans, he had an electrocardiogram. The neurologist came in to check on him. He was in hospital now. Hospitalization date was 25Jan2021 early in the morning. The outcome of events was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Flushing, Glycosylated haemoglobin increased, Magnetic resonance imaging, Mobility decreased
Clinical narrative: Had a mild a heart attack and mild stroke; had a mild a heart attack and mild stroke; urinary tract infection; Blood infection; A1C was 6.5; there was a little blood in his urine; he fell out of bed and couldn't get up; he was flushed; he had a fever of 101; This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL1283) at 0.3 mL single on 20Jan2021 for COVID-19 immunization. Medical history included thyroid; hypertension, was under control with the medication; dementia, taking memantine as a treatment for dementia, no other impairment other than what he normally has from his dementia. Concomitant medications included levothyroxine; memantine for dementia; fish oil tablet; Vitamins. Patient had a mild heart attack and a slight stroke and he did have urinary tract and blood infection on 24Jan2021. They both had the first dose of the Pfizer covid vaccine on 20Jan2021, Saturday night into Sunday. He was a dementia patient, alert to his name. On 24Jan2021, he fell out of bed and couldn't get up, he was flushed, so patient's wife took his temperature, he had a fever of 101. Patient's wife couldn't move him, so called the paramedics and they took him to Hospital. Patient's wife just found out that he had a very mild heart attack and slight stroke, no impairment other than what he normally had from the dementia. Patient's wife was wondering should he get the second shot and what was the timing of the 2nd dose of vaccine. Reporter seriousness for mild heart attack, slight stroke, urinary tract and blood infection was hospitalization. They also have him on some sort of penicillin derivative for a urinary tract infection. Since he had been to the hospital, he had at his doctor's office about 2 weeks ago today, he had a blood test, a urine test. His A1C was 6.5, there was a little blood in his urine. For that since Sunday (24Jan2021) he was having MRI, he had a couple of PET scans, he had an electrocardiogram. The neurologist came in to check on him. He was in hospital now. Hospitalization date was 25Jan2021 early in the morning. The outcome of events was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Positron emission tomogram, Pyrexia, Sepsis, Urinary tract infection
Clinical narrative: Had a mild a heart attack and mild stroke; had a mild a heart attack and mild stroke; urinary tract infection; Blood infection; A1C was 6.5; there was a little blood in his urine; he fell out of bed and couldn't get up; he was flushed; he had a fever of 101; This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL1283) at 0.3 mL single on 20Jan2021 for COVID-19 immunization. Medical history included thyroid; hypertension, was under control with the medication; dementia, taking memantine as a treatment for dementia, no other impairment other than what he normally has from his dementia. Concomitant medications included levothyroxine; memantine for dementia; fish oil tablet; Vitamins. Patient had a mild heart attack and a slight stroke and he did have urinary tract and blood infection on 24Jan2021. They both had the first dose of the Pfizer covid vaccine on 20Jan2021, Saturday night into Sunday. He was a dementia patient, alert to his name. On 24Jan2021, he fell out of bed and couldn't get up, he was flushed, so patient's wife took his temperature, he had a fever of 101. Patient's wife couldn't move him, so called the paramedics and they took him to Hospital. Patient's wife just found out that he had a very mild heart attack and slight stroke, no impairment other than what he normally had from the dementia. Patient's wife was wondering should he get the second shot and what was the timing of the 2nd dose of vaccine. Reporter seriousness for mild heart attack, slight stroke, urinary tract and blood infection was hospitalization. They also have him on some sort of penicillin derivative for a urinary tract infection. Since he had been to the hospital, he had at his doctor's office about 2 weeks ago today, he had a blood test, a urine test. His A1C was 6.5, there was a little blood in his urine. For that since Sunday (24Jan2021) he was having MRI, he had a couple of PET scans, he had an electrocardiogram. The neurologist came in to check on him. He was in hospital now. Hospitalization date was 25Jan2021 early in the morning. The outcome of events was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis abnormal
Clinical narrative: Had a mild a heart attack and mild stroke; had a mild a heart attack and mild stroke; urinary tract infection; Blood infection; A1C was 6.5; there was a little blood in his urine; he fell out of bed and couldn't get up; he was flushed; he had a fever of 101; This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL1283) at 0.3 mL single on 20Jan2021 for COVID-19 immunization. Medical history included thyroid; hypertension, was under control with the medication; dementia, taking memantine as a treatment for dementia, no other impairment other than what he normally has from his dementia. Concomitant medications included levothyroxine; memantine for dementia; fish oil tablet; Vitamins. Patient had a mild heart attack and a slight stroke and he did have urinary tract and blood infection on 24Jan2021. They both had the first dose of the Pfizer covid vaccine on 20Jan2021, Saturday night into Sunday. He was a dementia patient, alert to his name. On 24Jan2021, he fell out of bed and couldn't get up, he was flushed, so patient's wife took his temperature, he had a fever of 101. Patient's wife couldn't move him, so called the paramedics and they took him to Hospital. Patient's wife just found out that he had a very mild heart attack and slight stroke, no impairment other than what he normally had from the dementia. Patient's wife was wondering should he get the second shot and what was the timing of the 2nd dose of vaccine. Reporter seriousness for mild heart attack, slight stroke, urinary tract and blood infection was hospitalization. They also have him on some sort of penicillin derivative for a urinary tract infection. Since he had been to the hospital, he had at his doctor's office about 2 weeks ago today, he had a blood test, a urine test. His A1C was 6.5, there was a little blood in his urine. For that since Sunday (24Jan2021) he was having MRI, he had a couple of PET scans, he had an electrocardiogram. The neurologist came in to check on him. He was in hospital now. Hospitalization date was 25Jan2021 early in the morning. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 with symptoms starting on 21Jan2021 and positive test on 22Jan2021; Covid-19 with symptoms starting on 21Jan2021 and positive test on 22Jan2021; This is a spontaneous report from a contactable pharmacist reporting for himself. A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 12Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 with symptoms starting on 21Jan2021 and positive test on 22Jan2021 (medically significant) with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 22Jan2021.    The information on 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  due to temporal relationship.  However, based on the mechanism of action of the vaccine, it appears unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.  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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: her mother also went positive for Covid; Positive for covid; This is a spontaneous report from a contactable consumer, mother of the patient.   A 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unknown date at single dose for COVID-19 immunization. The patient had not medical history. Concomitant medications were not reported. The patient went positive for covid. The outcome of the event was unknown. The reporter mentioned that her mother has no prior health conditions and her physician recommended to receive the second dose regardless she had covid or not.  Information on lot/batch has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: but she tested positive for COVID-19; but she tested positive for COVID-19/ COVID symptoms/fever; This is a spontaneous report from a contactable nurse (patient) and a nurse. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at left arm, at single dose for covid-19 immunization. Medical history was none. There were no concomitant medications. The patient was supposed to receive the second dose of the vaccine on 25Jan2021. She tested positive for COVID on 17Jan2021. Also reported that she tested positive for COVID-19 on 19Jan2021, she did have some COVID symptoms, she was better now, she treated them by she kept herself at home. She said a fever was all she had, for two days, she drank a lot of water. She spoke to her supervisor who told her she could delay her second dose up to 40 days after the first dose. She would like to know if this is true. She also needed advice because she didn't know what to do since she already got the first vaccine dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event tested positive for COVID-19 based on the known safety profile. However the short duration of 5 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: developed symptoms and was tested positive for covid-19 infection; developed symptoms and was tested positive for covid-19 infection; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient developed symptoms and was tested positive for covid-19 infection on 25Jan2021 with outcome of unknown. He was receiving monoclonal antibodies today (27Jan2021). The patient underwent lab tests included covid-19 virus test: positive on 25Jan2021.    Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood test, Herpes zoster, Pain, Rash
Clinical narrative: shingles; Pain; This is a spontaneous report from a contactable consumer (patient husband). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261) via unspecified route on arm single dose for COVID-19 immunization on 21Jan2021, about 15:00, at 70-year-old. Medical history included: diagnosed allergies, compromised immune status, endocrine abnormalities, genetic / chromosomal abnormalities, respiratory illness, diabetes, obesity. The patient had a whole list of concomitant product medications (unspecified). The patient came down with shingles four and a half hours after the vaccine (21Jan2021, about 19:00 - 19:30), emergency room visited. They noticed a rash on her back which got worse, so she was taken to the hospital on 26Jan2021 and was diagnosed with shingles. She's still in the hospital but has gotten better. She was currently hospitalized for the shingles and related pain on 26Jan2021 that was more than she could handle. The patient had a few blood tests; urinalysis; a lot of sugar testing; and negative on the COVID test prior to them admitting her to the hospital. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Urine analysis
Clinical narrative: shingles; Pain; This is a spontaneous report from a contactable consumer (patient husband). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261) via unspecified route on arm single dose for COVID-19 immunization on 21Jan2021, about 15:00, at 70-year-old. Medical history included: diagnosed allergies, compromised immune status, endocrine abnormalities, genetic / chromosomal abnormalities, respiratory illness, diabetes, obesity. The patient had a whole list of concomitant product medications (unspecified). The patient came down with shingles four and a half hours after the vaccine (21Jan2021, about 19:00 - 19:30), emergency room visited. They noticed a rash on her back which got worse, so she was taken to the hospital on 26Jan2021 and was diagnosed with shingles. She's still in the hospital but has gotten better. She was currently hospitalized for the shingles and related pain on 26Jan2021 that was more than she could handle. The patient had a few blood tests; urinalysis; a lot of sugar testing; and negative on the COVID test prior to them admitting her to the hospital. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Feeling abnormal, Headache, Myalgia
Clinical narrative: Guillain-Barre; sometimes I feel a shooting or sharp pain in the muscle; tingling in my leg (right); progressed to pain in leg muscle/ then pain in back and arms too; then pain in back and arms too; headache; nausea; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. The female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 25Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included muscle pain in legs and anxiety. The patient's concomitant medications were not reported. Caller received 1st dose on Monday, approximately 11 am.  Caller says, "later in the day" experienced a headache. On Tuesday caller woke up (approx. 4 am) with "tingling in my leg (right)", "progressed to pain in leg muscle. "then pain in back and arms too" on 26Jan2021. Caller says that "taking Advil helps a little". "sometimes I feel a shooting or sharp pain in the muscle (usually in arms)". Today, caller experience, " a little jab in the arm muscles". Caller says she was worried she was "getting Guillain-Barre". Caller mentions that she has experienced muscle pain in legs in the past. Caller states, "I was never diagnosed with Fibromyalgia". Caller says she does have history of anxiety. Caller says, "sometimes I feel a little spacey, but I feel like that before, that's nothing new". Caller also says, "I think I might have had nausea the first day (after vaccine)." The outcome of the events was unknown.  No follow-up attempts are possible, information on batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Guillain-Barre; sometimes I feel a shooting or sharp pain in the muscle; tingling in my leg (right); progressed to pain in leg muscle/ then pain in back and arms too; then pain in back and arms too; headache; nausea; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. The female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 25Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included muscle pain in legs and anxiety. The patient's concomitant medications were not reported. Caller received 1st dose on Monday, approximately 11 am.  Caller says, "later in the day" experienced a headache. On Tuesday caller woke up (approx. 4 am) with "tingling in my leg (right)", "progressed to pain in leg muscle. "then pain in back and arms too" on 26Jan2021. Caller says that "taking Advil helps a little". "sometimes I feel a shooting or sharp pain in the muscle (usually in arms)". Today, caller experience, " a little jab in the arm muscles". Caller says she was worried she was "getting Guillain-Barre". Caller mentions that she has experienced muscle pain in legs in the past. Caller states, "I was never diagnosed with Fibromyalgia". Caller says she does have history of anxiety. Caller says, "sometimes I feel a little spacey, but I feel like that before, that's nothing new". Caller also says, "I think I might have had nausea the first day (after vaccine)." The outcome of the events was unknown.  No follow-up attempts are possible, information on batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EL1283) via an unspecified route of administration on left arm on 11Jan2021 15:45 at a single dose for covid-19 immunization. The patient usually has migraines. The patient's concomitant medications were reported none. The patient received the first dose Covid-19 vaccine on 11Jan2021. On 18Jan2021 she started showing symptoms. She tested positive for Covid on 20Jan2021. The health department said she can come off of quarantine on Friday, 29Jan2021. She is scheduled her second dose 01Feb2021. Should she get the vaccine or should she put to off since she tested positive. The symptoms she experienced were cough, difficulty breathing, headache. She also had nausea, sinus congestions, loss of taste and sense of smell and full body fatigue. The outcome of the event was not recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging neck, Magnetic resonance imaging spinal abnormal, Magnetic resonance imaging thoracic abnormal, Muscular weakness, Myelitis transverse
Clinical narrative: 2 days after vaccine developed weakness of legs then arms.  MRI cervical and thoracic spine most consistent with Transverse Myelitis; Transverse Myelitis; This is a spontaneous report from a contactable physician. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at single dose for COVID-19 immunisation. The patient was not pregnant at Time of Vaccination. Facility type vaccine was Hospital. Medical history included hyperlipidemia, hypothyroid. The patient's concomitant medications were not reported. No Other vaccine in 4weeks. Days after vaccine on 22Jan20212, the patient developed weakness of legs then arms. MRI cervical and thoracic spine most consistent with Transverse Myelitis. AEs resulted in Hospitalization, Disability or permanent damage. The patient was recovering. IV steroids, physical therapy was received as Treatment. No covid prior vaccination. No covid tested post vaccination.   Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Corneal infiltrates, Inflammation
Clinical narrative: Cornea transplant rejection; inflammation/subepithelial infilatrates noted 1 week after the first vaccine; This is a spontaneous report from a contactable Physician (patient). A 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EK9231, via an unspecified route of administration on 28Dec2020 14:30 at single dose in Left arm for COVID-19 immunization, vaccinated in Hospital. Medical history included diabetes; Graft is 2.5 years old. Partial thickness transplant (deep anterior lamellar keratoplasty) for treatment of keratoconus. The patient didn't have COVID prior vaccination. Concomitant medications included trazodone, rosuvastatin calcium (CRESTOR), zolpidem tartrate (AMBIEN), gabapentin, metformin. The were no other vaccines in four weeks. The patient previously took buspar and experienced drug allergy. The patient experienced cornea transplant rejection. Signs of inflammation noted one week after vaccine on 04Jan2021 02:00 PM. Subepithelial infilatrates noted 1 week after the first vaccine. Resolved with Pred Forte. The patient didn't have COVID test post vaccination. The outcome of the events was recovered. The temporal relationship with the COVID vaccine was reconstructed by the patient afterwards after thinking about it in retrospect.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Blood test abnormal, Feeding disorder, Gait inability, Hepatitis, Hyperhidrosis
Clinical narrative: he could barely eat breakfast, nausea, sleepy, sweating, lethargic, and after seeing his HCP his blood work says he has liver inflammation; He is unable to walk now without a walker; This is a spontaneous report from a non-contactable consumer (patient's wife).  A 72 years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received vaccine on 19Jan2021. After he got home, he could barely eat breakfast, nausea, sleepy, sweating, lethargic on 19Jan2021 and after seeing his HCP his blood work says he had liver inflammation. He was unable to walk now without a walker in Jan2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Somnolence, Walking aid user
Clinical narrative: he could barely eat breakfast, nausea, sleepy, sweating, lethargic, and after seeing his HCP his blood work says he has liver inflammation; He is unable to walk now without a walker; This is a spontaneous report from a non-contactable consumer (patient's wife).  A 72 years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received vaccine on 19Jan2021. After he got home, he could barely eat breakfast, nausea, sleepy, sweating, lethargic on 19Jan2021 and after seeing his HCP his blood work says he had liver inflammation. He was unable to walk now without a walker in Jan2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Dizziness, Ear discomfort, Feeling abnormal, Hypoacusis
Clinical narrative: hearing is off/his ears feel like they're full of water so he can't really hear; lost his voice; dizziness/Really dizzy; bottom of the feet is tingling; Slightly blurry vision; This is a spontaneous report from a contactable consumer (caregiver). An 82-years-old male patient (Father) received first dose of BNT162B2 (BNT162B2, lot number: EL1283), via an unspecified route of administration in left arm on 24Jan2021 13:30 at SINGLE DOSE as Scared to death to get COVID. Medical history included ongoing High blood pressure. Family history included Father died of melanoma. Concomitant medication included ongoing lisinopril (strength: 10mg) for High blood pressure. Caller stated her father received the pfizer covid vaccine first dose on this Monday and have weird side effects, he lost his voice, dizziness/ Really dizzy, hearing is off/ Ears feel like they're full of water so he can't really hear, bottom of the feet is tingling/ tingling in his feet and slightly blurry vision. Caller wanted to know if it is normal. Caller also said safety department told her to speak to quality department about the shot her farther received is it a bad batch or not. No visit to Emergency Room and Physician Office. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: hearing is off/his ears feel like they're full of water so he can't really hear; lost his voice; dizziness/Really dizzy; bottom of the feet is tingling; Slightly blurry vision; This is a spontaneous report from a contactable consumer (caregiver). An 82-years-old male patient (Father) received first dose of BNT162B2 (BNT162B2, lot number: EL1283), via an unspecified route of administration in left arm on 24Jan2021 13:30 at SINGLE DOSE as Scared to death to get COVID. Medical history included ongoing High blood pressure. Family history included Father died of melanoma. Concomitant medication included ongoing lisinopril (strength: 10mg) for High blood pressure. Caller stated her father received the pfizer covid vaccine first dose on this Monday and have weird side effects, he lost his voice, dizziness/ Really dizzy, hearing is off/ Ears feel like they're full of water so he can't really hear, bottom of the feet is tingling/ tingling in his feet and slightly blurry vision. Caller wanted to know if it is normal. Caller also said safety department told her to speak to quality department about the shot her farther received is it a bad batch or not. No visit to Emergency Room and Physician Office. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure increased, Blood pressure measurement, Dizziness, Investigation
Clinical narrative: She felt like she was passing out; Dizziness; Felt tingling of her tongue; Blood pressure was rising; She had tongue itching; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. This 73-year-old female consumer reported that she received 1st dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine; lot number FL1284) on 10Jan2021 1:00pm at left arm for COVID-19 immunization. Medical history included allergic to latex. Concomitant drugs included Atenolol for Blood pressure high from 2011, Furosemide from 2011 as Diuretic, Alprazolam from 2011 for Sleeping and anxiety, Simvastatin from 2011, all were ongoing. The patient experienced a reaction after the first dose on 10Jan2021 that she became dizzy and felt tingling of her tongue. Every 15 minutes they checked her blood pressure for an hour. Her blood pressure was going up slightly. She was monitored by fire rescue and her blood pressure was rising but not dangerously high.  The fire rescue also checked her blood sugar (normal result) and other lab values and decided she did not need emergency room care and instructed her to take Benadryl when she got home. They felt she had a mild reaction.  The patient stated the dizziness came in waves and she felt as if she was going to faint. The dizziness went in waves where she felt like she was passing out. The tingling on her tongue felt similar to the allergic reactions she has had in the past to latex but without swelling. She did not have tongue swelling. She had tongue itching. It was like having a reaction to the latex gloves when you go to the dentist. Her symptoms only lasted for two hours. After a total of 2.5 hours she had no symptoms. Dizziness, tingling, and elevated blood pressure initially that went away after taking Benadryl. She was scheduled to receive second dose on 31Jan2021. The events was resolved on 10Jan2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Presyncope, Tongue pruritus
Clinical narrative: She felt like she was passing out; Dizziness; Felt tingling of her tongue; Blood pressure was rising; She had tongue itching; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. This 73-year-old female consumer reported that she received 1st dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine; lot number FL1284) on 10Jan2021 1:00pm at left arm for COVID-19 immunization. Medical history included allergic to latex. Concomitant drugs included Atenolol for Blood pressure high from 2011, Furosemide from 2011 as Diuretic, Alprazolam from 2011 for Sleeping and anxiety, Simvastatin from 2011, all were ongoing. The patient experienced a reaction after the first dose on 10Jan2021 that she became dizzy and felt tingling of her tongue. Every 15 minutes they checked her blood pressure for an hour. Her blood pressure was going up slightly. She was monitored by fire rescue and her blood pressure was rising but not dangerously high.  The fire rescue also checked her blood sugar (normal result) and other lab values and decided she did not need emergency room care and instructed her to take Benadryl when she got home. They felt she had a mild reaction.  The patient stated the dizziness came in waves and she felt as if she was going to faint. The dizziness went in waves where she felt like she was passing out. The tingling on her tongue felt similar to the allergic reactions she has had in the past to latex but without swelling. She did not have tongue swelling. She had tongue itching. It was like having a reaction to the latex gloves when you go to the dentist. Her symptoms only lasted for two hours. After a total of 2.5 hours she had no symptoms. Dizziness, tingling, and elevated blood pressure initially that went away after taking Benadryl. She was scheduled to receive second dose on 31Jan2021. The events was resolved on 10Jan2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ear, nose and throat examination normal, Hypertension, Subcutaneous abscess, Swelling face
Clinical narrative: Blood pressure was also a little elevated  on 22Jan2021, 196/106/ 179/101 on 27Jan2021; severe left facial swelling; facial abscess; This is a spontaneous report from a contactable health care professional (nurse practitioner). A 57-Year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date in Jan2021 for Covid-19 immunization. Medical history included hypertension diagnosed for years as of 27Jan2021, and dental cleaning (also reported unsure if it was after or before vaccine). Concomitant drug was reported as "none". She not sure of the exact date of administration, stated patient came in to the office to be seen on Friday morning, 22Jan2021. Patient told caller at that time that she had the vaccine last week as of 27Jan2021, was seen for severe left facial swelling, onset of symptom was on Wednesday 20Jan2021. She was treated for facial abscess with Clindamycin 300mg 4 x a day for 10 days, she took first dose of treatment on Friday 22Jan2021. She followed up with doctor on 27Jan2021 and was improved, about 75%better. Her Blood pressure was also a little elevated on 22Jan2021 visit, it was 196/106 and on 27Jan2021 it was 179/101, did not know if this related to vaccine or symptoms.  Patient reported that she went to dentist and had cleaning, unknown exact date of cleaning, unsure if it was after or before vaccine.  She stated that doctor thought the symptoms could be due to dental cleaning not the vaccine. Patient went to ENT on Monday 25Jan2021 and they cleared her of anything ENT related from her neck up; scoped her and looked at her sinuses, and everything was fine. The ENT doctors told the patient that it appeared to be a reaction to the vaccine and advised her not to get the second dose. The reporter inquired whether patient should get the second dose. No Investigation Assessment was performed. The event severe left facial swelling was reported as serious with seriousness criteria of other medically important condition. Outcome of the event severe left facial swelling and facial abscess was resolving. Outcome of the other event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the outcome of treatment, the reported events severe left facial swelling, facial abscess, and elevated BP are likely intercurrent medical conditions and are unrelated to suspect drug BNT162B2. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Nausea
Clinical narrative: third migraine in 5 days after receiving second covid vaccination; nausea; This is a spontaneous report received from a contactable consumer and based on the information received by Pfizer from  (Reference ID: Not provided). A male patient in his early 40's received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after receiving the second "COVID vaccination", the patient experienced the third migraine in 5 days and nausea. The patient received ubrogepant (UBRELVY) to treat migraine. The events onset date and outcome were unknown at the time of the report.  Information on the lot/batch number has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Drooling, Eye movement disorder, Nausea, Pallor, Tremor
Clinical narrative: unresponsiveness for 2 minutes in seated position; bilateral arm tremor; pallor; eyes rolled back; drooling; nausea; vomiting; This is a spontaneous report from a non-contactable pharmacist. An 85-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), intramuscular on 27Jan2021 10:30 AM at single dose on Left arm for covid-19. Medical history included anaphylaxis history of unknown cause. The patient's concomitant medications were not reported. 30 minutes into observation, patient experienced bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness for 2 minutes in seated position on 27Jan2021 11:00 AM. 911 called immediately. Patient became alert and oriented after 2 minutes but experienced nausea and vomiting on 27Jan2021 11:00 AM. While seated, vital signs were taken- BP 148/76, HR 73, O2 98% on 27Jan2021. No falls or medication administered. (name withheld) arrived around 11:10 am and assessed cardiac rhythm and vital signs. Patient initially wanted to go home, but based on (name withheld) assessment, recommendation was to go to the ER. No treatment received. Outcome of events was recovered on 27Jan2021.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness is possible. 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.