chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase abnormal, Feeling hot, Flushing, Inflammation
Clinical narrative: After being vaccinated neurological symptoms went away; This is a spontaneous report received from a contactable consumer (patient) via Pfizer . A 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0153, Expiration date: Unknown) via an unspecified route of administration on 10Apr2021 (at the age of 53-year-old) as 1ST DOSE, SINGLE for COVID-19 immunization and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173, Expiration date: Unknown) via an unspecified route of administration on 01May2021 (at the age of 53-year-old) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history included auto immune disorder (for over 20 years), dystonia secondary (in her 30's), and tachycardia syndrome (in her 30's). The concomitant medications were not reported. The patient previously took epinephrine and experienced drug hypersensitivity. The patient reported that she had a history of neurological issues that began in her early 30's which included dystonia secondary to tachycardia syndrome. Additionally, she experienced facial sagging and, neuropathy. The patient stated that after receiving the Pfizer COVID vaccine on 10Apr2021 and on 01May2021, all the above listed conditions disappeared on 2021. The patient reported that she had been seen by the clinic and had submitted blood to be studied. The patient reported that she had been enquired about solumedrol and her allergies to it, when she was not allergic to it. It was explained to the patient that solumedrol information was needed in order to determine if there was any correlation between the vaccine and it, resulting in an unexpected benefit. The patient stated after trials on safety and efficacy for children take a 2nd look at unexpected positive effects due to COVID vaccine. The patient could not take epinephrine, did not want. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Therapeutic response unexpected
Clinical narrative: After being vaccinated neurological symptoms went away; This is a spontaneous report received from a contactable consumer (patient) via Pfizer . A 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0153, Expiration date: Unknown) via an unspecified route of administration on 10Apr2021 (at the age of 53-year-old) as 1ST DOSE, SINGLE for COVID-19 immunization and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173, Expiration date: Unknown) via an unspecified route of administration on 01May2021 (at the age of 53-year-old) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history included auto immune disorder (for over 20 years), dystonia secondary (in her 30's), and tachycardia syndrome (in her 30's). The concomitant medications were not reported. The patient previously took epinephrine and experienced drug hypersensitivity. The patient reported that she had a history of neurological issues that began in her early 30's which included dystonia secondary to tachycardia syndrome. Additionally, she experienced facial sagging and, neuropathy. The patient stated that after receiving the Pfizer COVID vaccine on 10Apr2021 and on 01May2021, all the above listed conditions disappeared on 2021. The patient reported that she had been seen by the clinic and had submitted blood to be studied. The patient reported that she had been enquired about solumedrol and her allergies to it, when she was not allergic to it. It was explained to the patient that solumedrol information was needed in order to determine if there was any correlation between the vaccine and it, resulting in an unexpected benefit. The patient stated after trials on safety and efficacy for children take a 2nd look at unexpected positive effects due to COVID vaccine. The patient could not take epinephrine, did not want. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Therapeutic response unexpected
Clinical narrative: After being vaccinated neurological symptoms went away; This is a spontaneous report received from a contactable consumer (patient) via Pfizer . A 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0153, Expiration date: Unknown) via an unspecified route of administration on 10Apr2021 (at the age of 53-year-old) as 1ST DOSE, SINGLE for COVID-19 immunization and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173, Expiration date: Unknown) via an unspecified route of administration on 01May2021 (at the age of 53-year-old) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history included auto immune disorder (for over 20 years), dystonia secondary (in her 30's), and tachycardia syndrome (in her 30's). The concomitant medications were not reported. The patient previously took epinephrine and experienced drug hypersensitivity. The patient reported that she had a history of neurological issues that began in her early 30's which included dystonia secondary to tachycardia syndrome. Additionally, she experienced facial sagging and, neuropathy. The patient stated that after receiving the Pfizer COVID vaccine on 10Apr2021 and on 01May2021, all the above listed conditions disappeared on 2021. The patient reported that she had been seen by the clinic and had submitted blood to be studied. The patient reported that she had been enquired about solumedrol and her allergies to it, when she was not allergic to it. It was explained to the patient that solumedrol information was needed in order to determine if there was any correlation between the vaccine and it, resulting in an unexpected benefit. The patient stated after trials on safety and efficacy for children take a 2nd look at unexpected positive effects due to COVID vaccine. The patient could not take epinephrine, did not want. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Deafness, Ear pain, Headache, Insomnia
Clinical narrative: Neuroinflammation, intense buzzing and ringing in ears with throbbing and shooting pain, dizziness and INTENSE head pressure effecting vision.  Hyperacusis, sensation of clogged throbbing ears.  Fatigue.  In the last week I have experienced my left foot shuffling when I walk and weakness in left leg.  I often wake up in middle of night with tinnitus and have difficulty sleeping
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Ototoxicity, SARS-CoV-2 test negative, Tinnitus
Clinical narrative: Neuroinflammation, intense buzzing and ringing in ears with throbbing and shooting pain, dizziness and INTENSE head pressure effecting vision.  Hyperacusis, sensation of clogged throbbing ears.  Fatigue.  In the last week I have experienced my left foot shuffling when I walk and weakness in left leg.  I often wake up in middle of night with tinnitus and have difficulty sleeping
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Central nervous system immune reconstitution inflammatory response, Dizziness, Ear discomfort, Fatigue, Gait disturbance
Clinical narrative: Neuroinflammation, intense buzzing and ringing in ears with throbbing and shooting pain, dizziness and INTENSE head pressure effecting vision.  Hyperacusis, sensation of clogged throbbing ears.  Fatigue.  In the last week I have experienced my left foot shuffling when I walk and weakness in left leg.  I often wake up in middle of night with tinnitus and have difficulty sleeping
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Head discomfort, Hyperacusis, Insomnia, Muscular weakness, Neurological symptom
Clinical narrative: Neuroinflammation, intense buzzing and ringing in ears with throbbing and shooting pain, dizziness and INTENSE head pressure effecting vision.  Hyperacusis, sensation of clogged throbbing ears.  Fatigue.  In the last week I have experienced my left foot shuffling when I walk and weakness in left leg.  I often wake up in middle of night with tinnitus and have difficulty sleeping
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Ototoxicity, Pain, Tinnitus, Visual impairment
Clinical narrative: Neuroinflammation, intense buzzing and ringing in ears with throbbing and shooting pain, dizziness and INTENSE head pressure effecting vision.  Hyperacusis, sensation of clogged throbbing ears.  Fatigue.  In the last week I have experienced my left foot shuffling when I walk and weakness in left leg.  I often wake up in middle of night with tinnitus and have difficulty sleeping
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Insomnia, Malaise
Clinical narrative: Neuroinflammation, intense buzzing and ringing in ears with throbbing and shooting pain, dizziness and INTENSE head pressure effecting vision.  Hyperacusis, sensation of clogged throbbing ears.  Fatigue.  In the last week I have experienced my left foot shuffling when I walk and weakness in left leg.  I often wake up in middle of night with tinnitus and have difficulty sleeping
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Ototoxicity, Polymerase chain reaction, SARS-CoV-2 test, Visual impairment
Clinical narrative: Neuroinflammation, intense buzzing and ringing in ears with throbbing and shooting pain, dizziness and INTENSE head pressure effecting vision.  Hyperacusis, sensation of clogged throbbing ears.  Fatigue.  In the last week I have experienced my left foot shuffling when I walk and weakness in left leg.  I often wake up in middle of night with tinnitus and have difficulty sleeping
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Audiogram abnormal, Deafness, Deafness bilateral, Deafness neurosensory, Ear pain
Clinical narrative: Neuroinflammation, intense buzzing and ringing in ears with throbbing and shooting pain, dizziness and INTENSE head pressure effecting vision.  Hyperacusis, sensation of clogged throbbing ears.  Fatigue.  In the last week I have experienced my left foot shuffling when I walk and weakness in left leg.  I often wake up in middle of night with tinnitus and have difficulty sleeping
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Insomnia, SARS-CoV-2 test negative, Tinnitus
Clinical narrative: Neuroinflammation, intense buzzing and ringing in ears with throbbing and shooting pain, dizziness and INTENSE head pressure effecting vision.  Hyperacusis, sensation of clogged throbbing ears.  Fatigue.  In the last week I have experienced my left foot shuffling when I walk and weakness in left leg.  I often wake up in middle of night with tinnitus and have difficulty sleeping
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Neuroinflammation, intense buzzing and ringing in ears with throbbing and shooting pain, dizziness and INTENSE head pressure effecting vision.  Hyperacusis, sensation of clogged throbbing ears.  Fatigue.  In the last week I have experienced my left foot shuffling when I walk and weakness in left leg.  I often wake up in middle of night with tinnitus and have difficulty sleeping
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Ear discomfort, Ear pain, Gait disturbance, Headache
Clinical narrative: Neuroinflammation, intense buzzing and ringing in ears with throbbing and shooting pain, dizziness and INTENSE head pressure effecting vision.  Hyperacusis, sensation of clogged throbbing ears.  Fatigue.  In the last week I have experienced my left foot shuffling when I walk and weakness in left leg.  I often wake up in middle of night with tinnitus and have difficulty sleeping
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hemiparesis, Hyperacusis, Insomnia, Pain, Tinnitus
Clinical narrative: Neuroinflammation, intense buzzing and ringing in ears with throbbing and shooting pain, dizziness and INTENSE head pressure effecting vision.  Hyperacusis, sensation of clogged throbbing ears.  Fatigue.  In the last week I have experienced my left foot shuffling when I walk and weakness in left leg.  I often wake up in middle of night with tinnitus and have difficulty sleeping
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Goitre, Thyroid pain
Clinical narrative: Enlarged and sore thyroid gland; Enlarged and sore thyroid gland; This is a spontaneous report received from a contactable consumer (patient). This 24-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 17Apr2021 (at the age of 24-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not take any concomitant medications. The patient previously received dose 1 of BNT162B2 on an unspecified date for COVID-19 immunization. On 28Apr2021, the patient experienced enlarged and sore thyroid gland. The patient visited a doctor or other healthcare professional office/clinic visit as a result of the event. The outcome of enlarged and sore thyroid gland was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in both ears; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EWO 153), via an unspecified route of administration, administered in Arm Left on 20Apr2021 12:45 (received at the age of 38-years-old) as 2ND DOSE, SINGLE for COVID-19 immunization. The vaccine was administered at a pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hashimoto's and allergy to penicillin. The patient was not pregnant. Concomitant medications included vilazodone hydrochloride (VIIBRYD) taken for an unspecified indication, start and stop date were not reported; clonazepam (KLONOPIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER8734), in the left arm, on 30Mar2021 12:45 for COVID-19 immunization. The patient experienced tinnitus in both ears that has not stopped since the day after her 2nd vaccine, on 21Apr2021: 10:00. The adverse event resulted into a doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 post vaccination. Outcome of the event was not recovered. The adverse event was assessed serious (disability).
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Eye pain, Eye pruritus, Eye swelling, Pain in extremity
Clinical narrative: my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172 and expiration date not provided), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 17:45 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history included hypothyroidism and Anemia. The patient was not pregnant at the time of vaccination. The patient's concomitant medications included levothyroxine, ferrous sulfate, fluticasone propionate (FLONASE ALLERGY RELIEF), and ibuprofen. On 12May2021 05:30, the patient experienced arm became hot, red, swollen and painful. The patient also have swollen, painful and itchy eyes.  The events cause the patient for emergency room visit.  The events were treated with Oral steroid, antibiotic, antihistamine. The outcome of the events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172 and expiration date not provided), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 17:45 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history included hypothyroidism and Anemia. The patient was not pregnant at the time of vaccination. The patient's concomitant medications included levothyroxine, ferrous sulfate, fluticasone propionate (FLONASE ALLERGY RELIEF), and ibuprofen. On 12May2021 05:30, the patient experienced arm became hot, red, swollen and painful. The patient also have swollen, painful and itchy eyes.  The events cause the patient for emergency room visit.  The events were treated with Oral steroid, antibiotic, antihistamine. The outcome of the events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Eye pain, Eye pruritus, Eye swelling, Feeling hot
Clinical narrative: my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172 and expiration date not provided), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 17:45 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history included hypothyroidism and Anemia. The patient was not pregnant at the time of vaccination. The patient's concomitant medications included levothyroxine, ferrous sulfate, fluticasone propionate (FLONASE ALLERGY RELIEF), and ibuprofen. On 12May2021 05:30, the patient experienced arm became hot, red, swollen and painful. The patient also have swollen, painful and itchy eyes.  The events cause the patient for emergency room visit.  The events were treated with Oral steroid, antibiotic, antihistamine. The outcome of the events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172 and expiration date not provided), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 17:45 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history included hypothyroidism and Anemia. The patient was not pregnant at the time of vaccination. The patient's concomitant medications included levothyroxine, ferrous sulfate, fluticasone propionate (FLONASE ALLERGY RELIEF), and ibuprofen. On 12May2021 05:30, the patient experienced arm became hot, red, swollen and painful. The patient also have swollen, painful and itchy eyes.  The events cause the patient for emergency room visit.  The events were treated with Oral steroid, antibiotic, antihistamine. The outcome of the events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Fatigue, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172 and expiration date not provided), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 17:45 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history included hypothyroidism and Anemia. The patient was not pregnant at the time of vaccination. The patient's concomitant medications included levothyroxine, ferrous sulfate, fluticasone propionate (FLONASE ALLERGY RELIEF), and ibuprofen. On 12May2021 05:30, the patient experienced arm became hot, red, swollen and painful. The patient also have swollen, painful and itchy eyes.  The events cause the patient for emergency room visit.  The events were treated with Oral steroid, antibiotic, antihistamine. The outcome of the events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site warmth, Palpitations, Periorbital swelling, Sleep disorder, Urticaria
Clinical narrative: my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172 and expiration date not provided), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 17:45 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history included hypothyroidism and Anemia. The patient was not pregnant at the time of vaccination. The patient's concomitant medications included levothyroxine, ferrous sulfate, fluticasone propionate (FLONASE ALLERGY RELIEF), and ibuprofen. On 12May2021 05:30, the patient experienced arm became hot, red, swollen and painful. The patient also have swollen, painful and itchy eyes.  The events cause the patient for emergency room visit.  The events were treated with Oral steroid, antibiotic, antihistamine. The outcome of the events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Fatigue, Headache, Heavy menstrual bleeding, Hypoaesthesia
Clinical narrative: facial swelling( Eyes,Lips,Cheek); Itching; swelling wheal; redness on face/chest /neck; arm pain at injection site; menstrual period flowing hard (came early); menstrual period flowing hard (came early); arm numbness; feeling like something running up my neck; dizzy; throat swollen; headaches; felt weird right after; fatigue; This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered on left arm on 07May2021 12:45 (Batch/Lot Number: EW0169) as 1st dose, single dose (at the age of 47 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced facial swelling( Eyes,Lips,Cheek), Itching, swelling wheal, redness on face, chest, neck, arm pain at injection site, menstrual period flowing hard (came early), arm numbness, feeling like something running up my neck, dizzy, felt weird right after, throat swollen, headaches and fatigue on 07May2021. The patient received treatment: steriods/ stomach anticid, antihistamine. Prior to vaccination, patient was not diagnosed with COVID-19 and not been tested for COVID-19. The patient had emergency department visit. The outcome of the events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Pharyngeal swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: facial swelling( Eyes,Lips,Cheek); Itching; swelling wheal; redness on face/chest /neck; arm pain at injection site; menstrual period flowing hard (came early); menstrual period flowing hard (came early); arm numbness; feeling like something running up my neck; dizzy; throat swollen; headaches; felt weird right after; fatigue; This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered on left arm on 07May2021 12:45 (Batch/Lot Number: EW0169) as 1st dose, single dose (at the age of 47 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced facial swelling( Eyes,Lips,Cheek), Itching, swelling wheal, redness on face, chest, neck, arm pain at injection site, menstrual period flowing hard (came early), arm numbness, feeling like something running up my neck, dizzy, felt weird right after, throat swollen, headaches and fatigue on 07May2021. The patient received treatment: steriods/ stomach anticid, antihistamine. Prior to vaccination, patient was not diagnosed with COVID-19 and not been tested for COVID-19. The patient had emergency department visit. The outcome of the events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Erythema, Fatigue, Feeling abnormal, Headache
Clinical narrative: facial swelling( Eyes,Lips,Cheek); Itching; swelling wheal; redness on face/chest /neck; arm pain at injection site; menstrual period flowing hard (came early); menstrual period flowing hard (came early); arm numbness; feeling like something running up my neck; dizzy; throat swollen; headaches; felt weird right after; fatigue; This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered on left arm on 07May2021 12:45 (Batch/Lot Number: EW0169) as 1st dose, single dose (at the age of 47 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced facial swelling( Eyes,Lips,Cheek), Itching, swelling wheal, redness on face, chest, neck, arm pain at injection site, menstrual period flowing hard (came early), arm numbness, feeling like something running up my neck, dizzy, felt weird right after, throat swollen, headaches and fatigue on 07May2021. The patient received treatment: steriods/ stomach anticid, antihistamine. Prior to vaccination, patient was not diagnosed with COVID-19 and not been tested for COVID-19. The patient had emergency department visit. The outcome of the events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Hypoaesthesia, Musculoskeletal discomfort, Pharyngeal swelling, Polymenorrhoea
Clinical narrative: facial swelling( Eyes,Lips,Cheek); Itching; swelling wheal; redness on face/chest /neck; arm pain at injection site; menstrual period flowing hard (came early); menstrual period flowing hard (came early); arm numbness; feeling like something running up my neck; dizzy; throat swollen; headaches; felt weird right after; fatigue; This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered on left arm on 07May2021 12:45 (Batch/Lot Number: EW0169) as 1st dose, single dose (at the age of 47 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced facial swelling( Eyes,Lips,Cheek), Itching, swelling wheal, redness on face, chest, neck, arm pain at injection site, menstrual period flowing hard (came early), arm numbness, feeling like something running up my neck, dizzy, felt weird right after, throat swollen, headaches and fatigue on 07May2021. The patient received treatment: steriods/ stomach anticid, antihistamine. Prior to vaccination, patient was not diagnosed with COVID-19 and not been tested for COVID-19. The patient had emergency department visit. The outcome of the events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Swelling, Swelling face, Vaccination site pain
Clinical narrative: facial swelling( Eyes,Lips,Cheek); Itching; swelling wheal; redness on face/chest /neck; arm pain at injection site; menstrual period flowing hard (came early); menstrual period flowing hard (came early); arm numbness; feeling like something running up my neck; dizzy; throat swollen; headaches; felt weird right after; fatigue; This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered on left arm on 07May2021 12:45 (Batch/Lot Number: EW0169) as 1st dose, single dose (at the age of 47 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced facial swelling( Eyes,Lips,Cheek), Itching, swelling wheal, redness on face, chest, neck, arm pain at injection site, menstrual period flowing hard (came early), arm numbness, feeling like something running up my neck, dizzy, felt weird right after, throat swollen, headaches and fatigue on 07May2021. The patient received treatment: steriods/ stomach anticid, antihistamine. Prior to vaccination, patient was not diagnosed with COVID-19 and not been tested for COVID-19. The patient had emergency department visit. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Brain scan normal, Chest X-ray normal, Disturbance in attention, Headache
Clinical narrative: ringing of his ears; headache; fogginess/he feels like zombie; lack of concentration; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced ringing of his ears, headache, fogginess, lack of concentration and that he feels like zombie. The patient stated that he was not getting any better. The patient spoke to his neurologist, hospital and they said to him that what he was experiencing immediate onset of symptoms after getting the first pfizer injection. Nothing physically wrong. 100 percent that the vaccine has caused this symptoms. The patient neurologist, hospital, med provider said that there was nothing they can do. The patient also added that he had undergone MRI, CT scan for his brain, chest, entire body -still there was nothing they know that was physically wrong. The outcome of all the events was not recovered.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness, Somnolence, Tinnitus
Clinical narrative: ringing of his ears; headache; fogginess/he feels like zombie; lack of concentration; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced ringing of his ears, headache, fogginess, lack of concentration and that he feels like zombie. The patient stated that he was not getting any better. The patient spoke to his neurologist, hospital and they said to him that what he was experiencing immediate onset of symptoms after getting the first pfizer injection. Nothing physically wrong. 100 percent that the vaccine has caused this symptoms. The patient neurologist, hospital, med provider said that there was nothing they can do. The patient also added that he had undergone MRI, CT scan for his brain, chest, entire body -still there was nothing they know that was physically wrong. The outcome of all the events was not recovered.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Disturbance in attention, Headache, Laboratory test, Magnetic resonance imaging, Somnolence
Clinical narrative: ringing of his ears; headache; fogginess/he feels like zombie; lack of concentration; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced ringing of his ears, headache, fogginess, lack of concentration and that he feels like zombie. The patient stated that he was not getting any better. The patient spoke to his neurologist, hospital and they said to him that what he was experiencing immediate onset of symptoms after getting the first pfizer injection. Nothing physically wrong. 100 percent that the vaccine has caused this symptoms. The patient neurologist, hospital, med provider said that there was nothing they can do. The patient also added that he had undergone MRI, CT scan for his brain, chest, entire body -still there was nothing they know that was physically wrong. The outcome of all the events was not recovered.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: ringing of his ears; headache; fogginess/he feels like zombie; lack of concentration; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced ringing of his ears, headache, fogginess, lack of concentration and that he feels like zombie. The patient stated that he was not getting any better. The patient spoke to his neurologist, hospital and they said to him that what he was experiencing immediate onset of symptoms after getting the first pfizer injection. Nothing physically wrong. 100 percent that the vaccine has caused this symptoms. The patient neurologist, hospital, med provider said that there was nothing they can do. The patient also added that he had undergone MRI, CT scan for his brain, chest, entire body -still there was nothing they know that was physically wrong. The outcome of all the events was not recovered.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Disturbance in attention, Feeling abnormal, Headache, Magnetic resonance imaging
Clinical narrative: ringing of his ears; headache; fogginess/he feels like zombie; lack of concentration; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced ringing of his ears, headache, fogginess, lack of concentration and that he feels like zombie. The patient stated that he was not getting any better. The patient spoke to his neurologist, hospital and they said to him that what he was experiencing immediate onset of symptoms after getting the first pfizer injection. Nothing physically wrong. 100 percent that the vaccine has caused this symptoms. The patient neurologist, hospital, med provider said that there was nothing they can do. The patient also added that he had undergone MRI, CT scan for his brain, chest, entire body -still there was nothing they know that was physically wrong. The outcome of all the events was not recovered.   Information on the lot/batch number has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Thrombosis
Clinical narrative: 3 clots were discovered on the groin area of the left leg; patient has two stunts in the right leg (1 in thigh and 1 in calf) and reported that it had been uncomfortable but not painful; This is a spontaneous report from a contactable pharmacist. A 66-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: ER8732), via an unspecified route of administration, administered in the right deltoid (reported as right arm) on 26Mar2021 at 03:55 as a single dose for COVID-19 immunization.  Medical history included two stunts in the right leg (1 in thigh and 1 in calf) on an unknown date. The patient had no allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 24Feb2021 (lot number:EN6201), intramuscular in the right arm at 65 years of age. The patient went to his vascular doctor on an unspecified date (reported as 05Oct2021) and 3 clots were discovered on the groin area of the left leg. The MD said it did not warrant going to the ER. The patient has two stunts in the right leg (1 in thigh and 1 in calf) and reported that it had been uncomfortable but not painful. The MD placed him on Eliquis 10 mg, BID for 7 days then reduced the dose at 5 mg BID thereafter for about 5 months. The outcome of the events was unknown.; Sender's Comments: "The causal association of the events of clots on the groin area of the left leg' and leg uncomfortable' with the suspect drug BNT162B2 cannot be excluded due to limited information in the case. The case will be reassessed once new 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."
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Thrombosis
Clinical narrative: 3 clots were discovered on the groin area of the left leg; patient has two stunts in the right leg (1 in thigh and 1 in calf) and reported that it had been uncomfortable but not painful; This is a spontaneous report from a contactable pharmacist. A 66-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: ER8732), via an unspecified route of administration, administered in the right deltoid (reported as right arm) on 26Mar2021 at 03:55 as a single dose for COVID-19 immunization.  Medical history included two stunts in the right leg (1 in thigh and 1 in calf) on an unknown date. The patient had no allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 24Feb2021 (lot number:EN6201), intramuscular in the right arm at 65 years of age. The patient went to his vascular doctor on an unspecified date (reported as 05Oct2021) and 3 clots were discovered on the groin area of the left leg. The MD said it did not warrant going to the ER. The patient has two stunts in the right leg (1 in thigh and 1 in calf) and reported that it had been uncomfortable but not painful. The MD placed him on Eliquis 10 mg, BID for 7 days then reduced the dose at 5 mg BID thereafter for about 5 months. The outcome of the events was unknown.; Sender's Comments: "The causal association of the events of clots on the groin area of the left leg' and leg uncomfortable' with the suspect drug BNT162B2 cannot be excluded due to limited information in the case. The case will be reassessed once new 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."
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: passed out; vomited; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm left on 03May2021 15:30 (Batch/Lot Number: EW0153) as 2nd dose, single for COVID-19 immunisation. The patient had no relevant medical history. She had no allergies to medications, food, or other products. Concomitant medication included fluoxetine taken for an unspecified indication within 2 weeks of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 12Apr2021, 03:30 PM (Batch/Lot Number: EW0153) as 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. On 04May2021 12:00, the patient passed out and vomited at the same time while in a sitting position. The were no additional side affects once the episode passed. The event resulted in doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. No treatment was received. Outcome of the events was recovered in May2021. The patient had not been tested for COVID-19 since the vaccination.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Nausea, Tremor, Urticaria
Clinical narrative: chills; shortness breath; hives on face; dizziness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0177), via an unspecified route of administration, administered in arm left on 15May2021 at 11:15 (at the age of 53-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included known allergies: seafood shellfish from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had the 1st dose of the Pfizer vaccine, was fine for 8 hours, then had chills, shortness breath, hives on face and dizziness on 15May2021 at 20:00. The patient had shellfish seafood allergies. Last time he had one, that also happened after 8 hours. Therapeutic measures were taken as a result of all events [50mg diphenhydramine (BENADRYL)]. The outcome of the events was recovering.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Urticaria
Clinical narrative: chills; shortness breath; hives on face; dizziness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0177), via an unspecified route of administration, administered in arm left on 15May2021 at 11:15 (at the age of 53-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included known allergies: seafood shellfish from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had the 1st dose of the Pfizer vaccine, was fine for 8 hours, then had chills, shortness breath, hives on face and dizziness on 15May2021 at 20:00. The patient had shellfish seafood allergies. Last time he had one, that also happened after 8 hours. Therapeutic measures were taken as a result of all events [50mg diphenhydramine (BENADRYL)]. The outcome of the events was recovering.