chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Polymerase chain reaction
Clinical narrative: pain returned worse; enlarged lymph node under my left arm; lump in my breast; lost a patch of hair the size of a 1/2 dollar coin; This is a spontaneous report from a contactable other hcp (patient). A 62-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL0140), via an unspecified route of administration in arm left on 05Jan2021 at 14:00 (at the age of 62-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included included breast cancer and breast biopsy. The patient had no known allergies. The concomitant medications of the patient included sertraline (SERTRALINE) 100mg 1 x per day and atorvastatin (ATORVASTATIN) 10 mg both taken for an unspecified indication start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL0140), via an unspecified route of administration in arm left on 25Jan2021 at 15:15 (at the age of 62-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient was tested negative with covid-19. The patient reported that after the first vaccine it started with severe site pain, left arm, radiated to her scapula through to the front of her shoulder where it was difficult to move her arm. It felt better before the second vaccine, however, after the second vaccine (on 08Jan2021 at 08:00), the pain returned worse and still with her including an enlarged lymph node under her left arm and then found a lump in her breast. She had to have a breast biopsy where a benign growth was removed. As of her Oct where she had a breast MRI her breasts were clear from any growths. In addition, on the left side of her scalp she have lost a patch of hair the size of a 1/2 dollar coin. All those symptoms are on the left side of her body the same side in which she had the vaccine. The events resulted in physician office visit. The patient underwent lab tests and procedures whichbreast MRI: unknown on an unspecified date and Nasal Swab PCR : negative on 04Jan2021. Therapeutic measures were taken as a result of events that included cortisone injections and anti-inflammatories. The outcome of the events was reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Burning sensation, Headache, Herpes zoster
Clinical narrative: I had a severe shingles outbreak which I believe was related to Pfizer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. In addition, I had severe headaches fo; I had a severe shingles outbreak which I believe was related to Pfizer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. In addition, I had severe headaches fo; I had a severe shingles outbreak which I believe was related to Pfizer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. In addition, I had severe headaches fo; I had a severe shingles outbreak which I believe was related to Pfizer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. In addition, I had severe headaches fo; I had a severe shingles outbreak which I believe was related to Pfizer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. In addition, I had severe headaches fo; This is a spontaneous report from a contactable consumer (patient himself). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186), via an unspecified route of administration, administered in Arm Left on 09Jun2021 (at the age of 38-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included chickenpox (likely had chickenpox in his childhood). The patient's concomitant medications were not reported. It was reported that, he did not have no known allergies. He did not take any other vaccine in four weeks prior COVID vaccine. He was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. On 14Jun2021, it was reported that, the patient experienced severe shingles outbreak which he believes was related to Pfizer COVID vaccine. He had 3 quite large patches with blisters: on his chest, back, and shoulder. In addition, he had severe headaches. Now 2 weeks later the rash looks much better however he still feel annoying burning. Patient visited physician's office as a result of events. Therapeutic measures were taken as a result of events include an urgent care nurse prescribed him Acyclovir 800mg tablets 5 times a day and Triamcinolone 0.1% cream 2-4 times a day. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Headache, Herpes zoster, Rash, Skin burning sensation
Clinical narrative: I had a severe shingles outbreak which I believe was related to Pfizer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. In addition, I had severe headaches fo; I had a severe shingles outbreak which I believe was related to Pfizer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. In addition, I had severe headaches fo; I had a severe shingles outbreak which I believe was related to Pfizer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. In addition, I had severe headaches fo; I had a severe shingles outbreak which I believe was related to Pfizer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. In addition, I had severe headaches fo; I had a severe shingles outbreak which I believe was related to Pfizer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. In addition, I had severe headaches fo; This is a spontaneous report from a contactable consumer (patient himself). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186), via an unspecified route of administration, administered in Arm Left on 09Jun2021 (at the age of 38-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included chickenpox (likely had chickenpox in his childhood). The patient's concomitant medications were not reported. It was reported that, he did not have no known allergies. He did not take any other vaccine in four weeks prior COVID vaccine. He was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. On 14Jun2021, it was reported that, the patient experienced severe shingles outbreak which he believes was related to Pfizer COVID vaccine. He had 3 quite large patches with blisters: on his chest, back, and shoulder. In addition, he had severe headaches. Now 2 weeks later the rash looks much better however he still feel annoying burning. Patient visited physician's office as a result of events. Therapeutic measures were taken as a result of events include an urgent care nurse prescribed him Acyclovir 800mg tablets 5 times a day and Triamcinolone 0.1% cream 2-4 times a day. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysstasia, Nausea, Sitting disability, Vertigo
Clinical narrative: I cannot stand up or walk; Severe vertigo; nausea; dizziness; I cannot stand up or walk; This is a spontaneous report from a contactable Consumer (Patient). A 56-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EW0178), via an unspecified route of administration On 07Jul2021 at 12:00 pm (at the age of 56-years-old) administered in Arm Right as a single dose for COVID-19 immunisation. The patient had received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EW0191), via an unspecified route of administration On 16Jun2021 at 12:15 pm administered in Arm Right as a single dose for COVID-19 immunisation. Medical history included non-hodgkin's lymphoma, hyperthyroidism (all from an unknown date and unknown if ongoing). Concomitant medication(s) included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient previously took mycin [benzathine benzylpenicillin] and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 09Jul2021 at 03:00 AM, the patient experienced Severe vertigo, nausea and dizziness. cannot stand up or walk. No treatment was given for the events. The outcome of the events was not recovered.  Follow-Up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysstasia, Gait disturbance, Nausea, Vertigo
Clinical narrative: I cannot stand up or walk; Severe vertigo; nausea; dizziness; I cannot stand up or walk; This is a spontaneous report from a contactable Consumer (Patient). A 56-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EW0178), via an unspecified route of administration On 07Jul2021 at 12:00 pm (at the age of 56-years-old) administered in Arm Right as a single dose for COVID-19 immunisation. The patient had received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EW0191), via an unspecified route of administration On 16Jun2021 at 12:15 pm administered in Arm Right as a single dose for COVID-19 immunisation. Medical history included non-hodgkin's lymphoma, hyperthyroidism (all from an unknown date and unknown if ongoing). Concomitant medication(s) included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient previously took mycin [benzathine benzylpenicillin] and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 09Jul2021 at 03:00 AM, the patient experienced Severe vertigo, nausea and dizziness. cannot stand up or walk. No treatment was given for the events. The outcome of the events was not recovered.  Follow-Up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Chest pain, Electrocardiogram normal, Fatigue, Feeling abnormal
Clinical narrative: It affected every system of "my" body-speech, memory, energy and stability, and depth perception; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; Abnormal chest pain that was not a heart attack; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; Began feeling very fatigued; This is a spontaneous report from a contactable consumer, the patient. A 92-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 13:30 (at the age of 92-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as the patient doing great until she got that second shot. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included latanoprost (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), oxybutynin (OXYTROL), estradiol (MANUFACTURER UNKNOWN), and calcium (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 13Mar2021, the next day of vaccination, the patient began to feel very fatigued and it affected every system of body-speech, memory, energy, stability, and depth perception; the effects had not worn off, instead, it was all getting worse. The patient's doctors told it would get better but it had not. The patient also experienced some abnormal chest pain that was not a heart attack and also reported that it might be related to the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events began feeling very fatigued, it affected every system of body-speech, memory, energy, stability and depth perception and abnormal chest pain that was not a heart attack was not resolved at the time of this report.
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Pain in extremity, Somnolence
Clinical narrative: It affected every system of "my" body-speech, memory, energy and stability, and depth perception; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; Abnormal chest pain that was not a heart attack; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; Began feeling very fatigued; This is a spontaneous report from a contactable consumer, the patient. A 92-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 13:30 (at the age of 92-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as the patient doing great until she got that second shot. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included latanoprost (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), oxybutynin (OXYTROL), estradiol (MANUFACTURER UNKNOWN), and calcium (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 13Mar2021, the next day of vaccination, the patient began to feel very fatigued and it affected every system of body-speech, memory, energy, stability, and depth perception; the effects had not worn off, instead, it was all getting worse. The patient's doctors told it would get better but it had not. The patient also experienced some abnormal chest pain that was not a heart attack and also reported that it might be related to the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events began feeling very fatigued, it affected every system of body-speech, memory, energy, stability and depth perception and abnormal chest pain that was not a heart attack was not resolved at the time of this report.
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Altered visual depth perception, Asthenia, Chest pain, Fatigue, Gait disturbance
Clinical narrative: It affected every system of "my" body-speech, memory, energy and stability, and depth perception; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; Abnormal chest pain that was not a heart attack; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; Began feeling very fatigued; This is a spontaneous report from a contactable consumer, the patient. A 92-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 13:30 (at the age of 92-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as the patient doing great until she got that second shot. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included latanoprost (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), oxybutynin (OXYTROL), estradiol (MANUFACTURER UNKNOWN), and calcium (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 13Mar2021, the next day of vaccination, the patient began to feel very fatigued and it affected every system of body-speech, memory, energy, stability, and depth perception; the effects had not worn off, instead, it was all getting worse. The patient's doctors told it would get better but it had not. The patient also experienced some abnormal chest pain that was not a heart attack and also reported that it might be related to the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events began feeling very fatigued, it affected every system of body-speech, memory, energy, stability and depth perception and abnormal chest pain that was not a heart attack was not resolved at the time of this report.
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Memory impairment, Speech disorder
Clinical narrative: It affected every system of "my" body-speech, memory, energy and stability, and depth perception; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; Abnormal chest pain that was not a heart attack; It affected every system of "my" body-speech, memory, energy and stability, and depth perception; Began feeling very fatigued; This is a spontaneous report from a contactable consumer, the patient. A 92-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 13:30 (at the age of 92-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as the patient doing great until she got that second shot. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included latanoprost (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), oxybutynin (OXYTROL), estradiol (MANUFACTURER UNKNOWN), and calcium (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 13Mar2021, the next day of vaccination, the patient began to feel very fatigued and it affected every system of body-speech, memory, energy, stability, and depth perception; the effects had not worn off, instead, it was all getting worse. The patient's doctors told it would get better but it had not. The patient also experienced some abnormal chest pain that was not a heart attack and also reported that it might be related to the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events began feeling very fatigued, it affected every system of body-speech, memory, energy, stability and depth perception and abnormal chest pain that was not a heart attack was not resolved at the time of this report.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Condition aggravated, Fatigue, Fibromyalgia, Gait inability
Clinical narrative: neuropathy; Systemic inflammation; stiff swollen joints; stiff swollen joints; cognitive impairment; severe foot pain; can barely walk and only with ortho shoes on.; severe fatigue; All major joints pop and crack; IBS worsened; This is a spontaneous case from a contactable consumer (patient). This 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via unspecified route in left arm on 07Apr2021 at 15:00 PM at patient age of 49-year-old, as single dose (Lot Number: ER87734) for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history included primary immunodeficiency-common variable immunodeficiency "CVID". The patient had no known allergies. The patient concomitant medications included immunoglobulin human normal (HIZENTRA, IgG immunoglobulin SQ injection), nebivolol hydrochloride (BYSTOLIC). The patient previously received BNT162B2 (COMIRNATY), dose 1 via unspecified route in left arm on 17Mar2021 at 15:30 PM at patient age of 49-year-old, as single dose (Lot Number: EN6204) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Systemic inflammation, neuropathy, stiff swollen joints, cognitive impairment, severe foot pain; can barely walk and only with ortho shoes on. All major joints pop and crack. severe fatigue. IBS worsened. The events started from 30Apr2021 at 12:00. The event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient did not receive treatment. PCR (Nasal Swab) negative on 23Mar2021, PCR (Nasal Swab) negative on 26Aug2021. The event was reported serious with seriousness criteria disabling/incapacitating. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Insomnia, Malaise, Mental impairment
Clinical narrative: neuropathy; Systemic inflammation; stiff swollen joints; stiff swollen joints; cognitive impairment; severe foot pain; can barely walk and only with ortho shoes on.; severe fatigue; All major joints pop and crack; IBS worsened; This is a spontaneous case from a contactable consumer (patient). This 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via unspecified route in left arm on 07Apr2021 at 15:00 PM at patient age of 49-year-old, as single dose (Lot Number: ER87734) for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history included primary immunodeficiency-common variable immunodeficiency "CVID". The patient had no known allergies. The patient concomitant medications included immunoglobulin human normal (HIZENTRA, IgG immunoglobulin SQ injection), nebivolol hydrochloride (BYSTOLIC). The patient previously received BNT162B2 (COMIRNATY), dose 1 via unspecified route in left arm on 17Mar2021 at 15:30 PM at patient age of 49-year-old, as single dose (Lot Number: EN6204) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Systemic inflammation, neuropathy, stiff swollen joints, cognitive impairment, severe foot pain; can barely walk and only with ortho shoes on. All major joints pop and crack. severe fatigue. IBS worsened. The events started from 30Apr2021 at 12:00. The event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient did not receive treatment. PCR (Nasal Swab) negative on 23Mar2021, PCR (Nasal Swab) negative on 26Aug2021. The event was reported serious with seriousness criteria disabling/incapacitating. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthropathy, Cognitive disorder, Fatigue, Gait disturbance, Inflammation
Clinical narrative: neuropathy; Systemic inflammation; stiff swollen joints; stiff swollen joints; cognitive impairment; severe foot pain; can barely walk and only with ortho shoes on.; severe fatigue; All major joints pop and crack; IBS worsened; This is a spontaneous case from a contactable consumer (patient). This 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via unspecified route in left arm on 07Apr2021 at 15:00 PM at patient age of 49-year-old, as single dose (Lot Number: ER87734) for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history included primary immunodeficiency-common variable immunodeficiency "CVID". The patient had no known allergies. The patient concomitant medications included immunoglobulin human normal (HIZENTRA, IgG immunoglobulin SQ injection), nebivolol hydrochloride (BYSTOLIC). The patient previously received BNT162B2 (COMIRNATY), dose 1 via unspecified route in left arm on 17Mar2021 at 15:30 PM at patient age of 49-year-old, as single dose (Lot Number: EN6204) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Systemic inflammation, neuropathy, stiff swollen joints, cognitive impairment, severe foot pain; can barely walk and only with ortho shoes on. All major joints pop and crack. severe fatigue. IBS worsened. The events started from 30Apr2021 at 12:00. The event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient did not receive treatment. PCR (Nasal Swab) negative on 23Mar2021, PCR (Nasal Swab) negative on 26Aug2021. The event was reported serious with seriousness criteria disabling/incapacitating. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Irritable bowel syndrome, Joint stiffness, Joint swelling, Neuropathy peripheral, Pain in extremity
Clinical narrative: neuropathy; Systemic inflammation; stiff swollen joints; stiff swollen joints; cognitive impairment; severe foot pain; can barely walk and only with ortho shoes on.; severe fatigue; All major joints pop and crack; IBS worsened; This is a spontaneous case from a contactable consumer (patient). This 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via unspecified route in left arm on 07Apr2021 at 15:00 PM at patient age of 49-year-old, as single dose (Lot Number: ER87734) for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history included primary immunodeficiency-common variable immunodeficiency "CVID". The patient had no known allergies. The patient concomitant medications included immunoglobulin human normal (HIZENTRA, IgG immunoglobulin SQ injection), nebivolol hydrochloride (BYSTOLIC). The patient previously received BNT162B2 (COMIRNATY), dose 1 via unspecified route in left arm on 17Mar2021 at 15:30 PM at patient age of 49-year-old, as single dose (Lot Number: EN6204) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Systemic inflammation, neuropathy, stiff swollen joints, cognitive impairment, severe foot pain; can barely walk and only with ortho shoes on. All major joints pop and crack. severe fatigue. IBS worsened. The events started from 30Apr2021 at 12:00. The event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient did not receive treatment. PCR (Nasal Swab) negative on 23Mar2021, PCR (Nasal Swab) negative on 26Aug2021. The event was reported serious with seriousness criteria disabling/incapacitating. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: neuropathy; Systemic inflammation; stiff swollen joints; stiff swollen joints; cognitive impairment; severe foot pain; can barely walk and only with ortho shoes on.; severe fatigue; All major joints pop and crack; IBS worsened; This is a spontaneous case from a contactable consumer (patient). This 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via unspecified route in left arm on 07Apr2021 at 15:00 PM at patient age of 49-year-old, as single dose (Lot Number: ER87734) for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history included primary immunodeficiency-common variable immunodeficiency "CVID". The patient had no known allergies. The patient concomitant medications included immunoglobulin human normal (HIZENTRA, IgG immunoglobulin SQ injection), nebivolol hydrochloride (BYSTOLIC). The patient previously received BNT162B2 (COMIRNATY), dose 1 via unspecified route in left arm on 17Mar2021 at 15:30 PM at patient age of 49-year-old, as single dose (Lot Number: EN6204) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Systemic inflammation, neuropathy, stiff swollen joints, cognitive impairment, severe foot pain; can barely walk and only with ortho shoes on. All major joints pop and crack. severe fatigue. IBS worsened. The events started from 30Apr2021 at 12:00. The event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient did not receive treatment. PCR (Nasal Swab) negative on 23Mar2021, PCR (Nasal Swab) negative on 26Aug2021. The event was reported serious with seriousness criteria disabling/incapacitating. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chromaturia, Influenza like illness, Pain, Palpitations
Clinical narrative: bloody urine; fever; chill; muscle ache; headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID 19) via an unspecified route of administration on the left arm on 04May2021 at 13:00 at the age of 49-year-old as single dose for COVID-19 immunization. Medical history was none. COVID prior vaccination was none. On 13Aug2021, the patient had performed COVID-19 test (Nasal Swab) post vaccination (At-Home Collection Kit) and result was negative. The patient didn't received other vaccine in four weeks. The patient didn't received other medications in two weeks. The patient previously received sulfar and experienced allergy. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on an unspecified date as single dose for COVID-19 immunization. On 05May2021 at 12:00 AM, the night right after the second dose, the patient started to have fever, chill, muscle ache, headache, and bloody urine. Visible blood for 3 days. and verified by lab test as well, and 4 month later, still have bloody urine, just not visible to the eye so I did not know till my regular physical. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urine present, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: bloody urine; fever; chill; muscle ache; headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID 19) via an unspecified route of administration on the left arm on 04May2021 at 13:00 at the age of 49-year-old as single dose for COVID-19 immunization. Medical history was none. COVID prior vaccination was none. On 13Aug2021, the patient had performed COVID-19 test (Nasal Swab) post vaccination (At-Home Collection Kit) and result was negative. The patient didn't received other vaccine in four weeks. The patient didn't received other medications in two weeks. The patient previously received sulfar and experienced allergy. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on an unspecified date as single dose for COVID-19 immunization. On 05May2021 at 12:00 AM, the night right after the second dose, the patient started to have fever, chill, muscle ache, headache, and bloody urine. Visible blood for 3 days. and verified by lab test as well, and 4 month later, still have bloody urine, just not visible to the eye so I did not know till my regular physical. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Urine analysis
Clinical narrative: bloody urine; fever; chill; muscle ache; headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID 19) via an unspecified route of administration on the left arm on 04May2021 at 13:00 at the age of 49-year-old as single dose for COVID-19 immunization. Medical history was none. COVID prior vaccination was none. On 13Aug2021, the patient had performed COVID-19 test (Nasal Swab) post vaccination (At-Home Collection Kit) and result was negative. The patient didn't received other vaccine in four weeks. The patient didn't received other medications in two weeks. The patient previously received sulfar and experienced allergy. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on an unspecified date as single dose for COVID-19 immunization. On 05May2021 at 12:00 AM, the night right after the second dose, the patient started to have fever, chill, muscle ache, headache, and bloody urine. Visible blood for 3 days. and verified by lab test as well, and 4 month later, still have bloody urine, just not visible to the eye so I did not know till my regular physical. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle aches, extreme fatigue, nausea, sore throat; Headache, muscle aches, extreme fatigue, nausea, sore throat; Headache, muscle aches, extreme fatigue, nausea, sore throat; Headache, muscle aches, extreme fatigue, nausea, sore throat; Headache, muscle aches, extreme fatigue, nausea, sore throat; This is a spontaneous report from a contactable consumer (patient).  A 56-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration, in left arm on 04Aug2021 01:00 PM (at the age of 56-years-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included obesity from an unknown date and unknown if ongoing. The patient concomitant medication was not reported. Patient had no allergies. Patient had not received any other medications within two weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 05Aug2021 09:00 AM, the patient had experienced headache, muscle aches, extreme fatigue, nausea and sore throat. Patient had not received any treatment for the events reported. The outcome of the events was not recovered.  Information about lot/batch no has been requested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Headache, muscle aches, extreme fatigue, nausea, sore throat; Headache, muscle aches, extreme fatigue, nausea, sore throat; Headache, muscle aches, extreme fatigue, nausea, sore throat; Headache, muscle aches, extreme fatigue, nausea, sore throat; Headache, muscle aches, extreme fatigue, nausea, sore throat; This is a spontaneous report from a contactable consumer (patient).  A 56-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration, in left arm on 04Aug2021 01:00 PM (at the age of 56-years-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included obesity from an unknown date and unknown if ongoing. The patient concomitant medication was not reported. Patient had no allergies. Patient had not received any other medications within two weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 05Aug2021 09:00 AM, the patient had experienced headache, muscle aches, extreme fatigue, nausea and sore throat. Patient had not received any treatment for the events reported. The outcome of the events was not recovered.  Information about lot/batch no has been requested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: Headache, muscle aches, extreme fatigue, nausea, sore throat; Headache, muscle aches, extreme fatigue, nausea, sore throat; Headache, muscle aches, extreme fatigue, nausea, sore throat; Headache, muscle aches, extreme fatigue, nausea, sore throat; Headache, muscle aches, extreme fatigue, nausea, sore throat; This is a spontaneous report from a contactable consumer (patient).  A 56-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration, in left arm on 04Aug2021 01:00 PM (at the age of 56-years-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included obesity from an unknown date and unknown if ongoing. The patient concomitant medication was not reported. Patient had no allergies. Patient had not received any other medications within two weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 05Aug2021 09:00 AM, the patient had experienced headache, muscle aches, extreme fatigue, nausea and sore throat. Patient had not received any treatment for the events reported. The outcome of the events was not recovered.  Information about lot/batch no has been requested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Hiccups, Injection site pain, Injection site swelling
Clinical narrative: Right arm was swollen for three weeks at the site of the vaccination; At the site of vaccination, right arm spot was still sore; Horrendous hiccups almost daily, since second vaccination; This is a spontaneous report from a contactable consumer. A 30-year-old non-pregnant female consumer reported herself received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8731), via an unspecified route of administration, administered in right arm, 08Jun2021 14:30 (at the age of 30-year-old) as single dose for covid-19 immunization and was administered Health Clinic. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8731), via an unspecified route of administration, administered in right arm, 18May2021 (within four weeks prior to the vaccination) as single dose for covid-19 immunization was administered Health Clinic and experienced extremely heavy longer periods (monthly menstruations) with violent painful cramps that she never had prior to the vaccinations. It was atrocious and using two boxes 36 count ever since her cycle which was not normal for her. Medical history included known allergies of chipotle sauce/flavouring any brand, fever and horrendous hiccups. Concomitant medications included Aleve (naproxen sodium) for fever after the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, patient had swollen right arm for three weeks at the site of vaccination, right arm spot was still sore and had horrendous hiccups almost daily ever since she had the second vaccination that were present prior to the vaccinations. The patient did not received ant treatment. The outcome of the event swollen right arm for three weeks at the site of vaccination, was unknown and remaining all events were not recovered.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hiccups, Vaccination site pain, Vaccination site swelling
Clinical narrative: Right arm was swollen for three weeks at the site of the vaccination; At the site of vaccination, right arm spot was still sore; Horrendous hiccups almost daily, since second vaccination; This is a spontaneous report from a contactable consumer. A 30-year-old non-pregnant female consumer reported herself received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8731), via an unspecified route of administration, administered in right arm, 08Jun2021 14:30 (at the age of 30-year-old) as single dose for covid-19 immunization and was administered Health Clinic. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8731), via an unspecified route of administration, administered in right arm, 18May2021 (within four weeks prior to the vaccination) as single dose for covid-19 immunization was administered Health Clinic and experienced extremely heavy longer periods (monthly menstruations) with violent painful cramps that she never had prior to the vaccinations. It was atrocious and using two boxes 36 count ever since her cycle which was not normal for her. Medical history included known allergies of chipotle sauce/flavouring any brand, fever and horrendous hiccups. Concomitant medications included Aleve (naproxen sodium) for fever after the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, patient had swollen right arm for three weeks at the site of vaccination, right arm spot was still sore and had horrendous hiccups almost daily ever since she had the second vaccination that were present prior to the vaccinations. The patient did not received ant treatment. The outcome of the event swollen right arm for three weeks at the site of vaccination, was unknown and remaining all events were not recovered.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Auscultation, Chest discomfort, Dizziness, Erythema, Feeling abnormal
Clinical narrative: anaphylaxis; lip swelling; Eyes swelling; blood pressure dropped; Heart palpitations; This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 11Aug2021 15:38 (Batch/Lot Number: EW0187) as dose 1, single (at the age of 43 years old) for COVID-19 immunisation.  Medical history included allergies: Alpha Gal, all mammal products, shrimp, adhesives and dermatitis contact. There were no concomitant medications.  The patient previously took ALEVE and magnesium stearate, multivitamins and experienced allergies.  Nine minutes after injection (11Aug2021): itching on hands, arms, legs. At 15 min: lip swelling, eyes swelling, blood pressure dropped. It was in anaphylaxis and admitted to ER. Treatment: Epinephrine, Steroids, albuterol breathing treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19.  The event was reported as life-threatening except for palpitations. The outcome of palpitation was unknown and other events was recovering.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and  the causal role of BNT162B2 vaccine cannot be excluded for the reported events. Underlying hypertension could be contributory to the reported events.  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