chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Blood test normal, External ear pain, Eye pain, Facial paralysis
Clinical narrative: Left facial Bell's Palsy; BNT162B2 subcutaneous; This is spontaneous case report from a contactable physician (patient himself). A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1283), subcutaneous, at Arm Left on 09Jan2021 (at age of 51 years old) at single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EH9899) Subcutaneous at Left Arm on 18Dec2020 18:00 (at 51 years old) at single dose for COVID-19 immunisation. The patient didn't 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 been tested for COVID-19. Test Name: SARS-CoV2 RT PCR. Allergies to medications, food, or other products was None. The patient experienced Left facial Bell's Palsy on 30Jan2021. The patient underwent lab tests and procedures which included Nasal Swab: negative on 31Jan2021. The adverse event Left facial Bell's Palsy result in Emergency room/department or urgent care. Treatment (Prednisone, Acyclovir) received for the adverse event. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Left facial Bell's Palsydue to temporal relationship and current known drug safety profile.  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. 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: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Full blood count, Hypoaesthesia oral, Magnetic resonance imaging normal, Myalgia
Clinical narrative: Left facial Bell's Palsy; BNT162B2 subcutaneous; This is spontaneous case report from a contactable physician (patient himself). A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1283), subcutaneous, at Arm Left on 09Jan2021 (at age of 51 years old) at single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EH9899) Subcutaneous at Left Arm on 18Dec2020 18:00 (at 51 years old) at single dose for COVID-19 immunisation. The patient didn't 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 been tested for COVID-19. Test Name: SARS-CoV2 RT PCR. Allergies to medications, food, or other products was None. The patient experienced Left facial Bell's Palsy on 30Jan2021. The patient underwent lab tests and procedures which included Nasal Swab: negative on 31Jan2021. The adverse event Left facial Bell's Palsy result in Emergency room/department or urgent care. Treatment (Prednisone, Acyclovir) received for the adverse event. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Left facial Bell's Palsydue to temporal relationship and current known drug safety profile.  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. 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: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw, SARS-CoV-2 test negative
Clinical narrative: Left facial Bell's Palsy; BNT162B2 subcutaneous; This is spontaneous case report from a contactable physician (patient himself). A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1283), subcutaneous, at Arm Left on 09Jan2021 (at age of 51 years old) at single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EH9899) Subcutaneous at Left Arm on 18Dec2020 18:00 (at 51 years old) at single dose for COVID-19 immunisation. The patient didn't 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 been tested for COVID-19. Test Name: SARS-CoV2 RT PCR. Allergies to medications, food, or other products was None. The patient experienced Left facial Bell's Palsy on 30Jan2021. The patient underwent lab tests and procedures which included Nasal Swab: negative on 31Jan2021. The adverse event Left facial Bell's Palsy result in Emergency room/department or urgent care. Treatment (Prednisone, Acyclovir) received for the adverse event. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Left facial Bell's Palsydue to temporal relationship and current known drug safety profile.  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. 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: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Incorrect route of product administration, Viral test
Clinical narrative: Left facial Bell's Palsy; BNT162B2 subcutaneous; This is spontaneous case report from a contactable physician (patient himself). A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1283), subcutaneous, at Arm Left on 09Jan2021 (at age of 51 years old) at single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EH9899) Subcutaneous at Left Arm on 18Dec2020 18:00 (at 51 years old) at single dose for COVID-19 immunisation. The patient didn't 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 been tested for COVID-19. Test Name: SARS-CoV2 RT PCR. Allergies to medications, food, or other products was None. The patient experienced Left facial Bell's Palsy on 30Jan2021. The patient underwent lab tests and procedures which included Nasal Swab: negative on 31Jan2021. The adverse event Left facial Bell's Palsy result in Emergency room/department or urgent care. Treatment (Prednisone, Acyclovir) received for the adverse event. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Left facial Bell's Palsydue to temporal relationship and current known drug safety profile.  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. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood calcium decreased, Blood pressure increased, Dizziness, Extra dose administered, Flushing
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Full blood count normal, Hypoaesthesia, Impaired work ability, Metabolic function test, Paraesthesia
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Presyncope, Tachycardia, Tremor
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Autonomic nervous system imbalance, Blood pressure increased, Burning sensation
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Colitis microscopic, Diarrhoea, Dizziness, Double stranded DNA antibody, Double stranded DNA antibody positive
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Flushing, Hypersensitivity, Malaise, Mast cell activation syndrome
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Neuropathy peripheral, Postural orthostatic tachycardia syndrome, SARS-CoV-2 test, Small fibre neuropathy
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Tachycardia, Tuberculin test
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Aldolase normal, Antibody test, Antinuclear antibody positive, Asthenia, Autonomic nervous system imbalance
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy colon abnormal, Biopsy skin abnormal, Blood catecholamines, Blood pressure increased, Blood thyroid stimulating hormone normal
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Colitis microscopic, Colonoscopy abnormal, Computerised tomogram abdomen, Computerised tomogram thorax normal, Diarrhoea
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Double stranded DNA antibody positive, Electrocardiogram ambulatory, Electromyogram normal, Electrophoresis protein
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Exposure to communicable disease, Fatigue, Fibrin D dimer increased, Flushing, Gait disturbance
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction, Immunoglobulins normal, Impaired work ability, Inflammation, Magnetic resonance imaging head normal
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Mobility decreased, Muscular weakness, Myalgia, Neuropathy peripheral
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Oesophagogastroduodenoscopy abnormal, Paraesthesia, Polyarthritis, Postural orthostatic tachycardia syndrome, Scan with contrast normal
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Small fibre neuropathy, Systemic lupus erythematosus, Tachycardia, Tilt table test positive, Urine analysis normal
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Wheelchair user
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Flushing, SARS-CoV-2 test, Tachycardia
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Tuberculin test
Clinical narrative: Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Extreme fatigue. Sudden  Shortness of breathe while walking. Tender lymph node left side of neck.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Lymph node pain
Clinical narrative: Extreme fatigue. Sudden  Shortness of breathe while walking. Tender lymph node left side of neck.
Age: 88.0
Sex: M
Vaccine: COVID19, PPV, COVID19
Symptoms: Hepatic enzyme increased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 88-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left deltoid on 21Jan2021 16:00 (Batch/Lot Number: EL3247; Expiration Date: 01Mar2021) as single dose for preventative from getting the disease (as reported). Medical history included low hemoglobin, blood transfusion in late Sep2020, and hepatitis. Hemoglobin hasn't quite gotten to where it needs to be. It was 4 pints but may be measured differently at the hospital (as reported). The patient's concomitant medications were not reported. The patient has no prior vaccinations within 4 weeks. The patient had pneumonia vaccine on an unspecified date in 2015 and had a fever for 2-3 days. The patient had blood drawn on 20Jan2021. He received the first COVID-19 shot on 21Jan2021. He had blood drawn the second time on 27Jan2021 and again on 03Feb2021 where his liver enzymes shot up over 400 points which required a visit to physician's office. He stated that his second blood work result showed that his liver enzymes went up 400 points (as reported). The patient wanted to know if the COVID-19 shot have anything to do with the increase in liver enzymes. The patient's oncologist and blood specialist drew the blood and noted the increased of liver enzymes. It was reported that the blood draw was a matter of routine. Every other time they are drawing his blood to check on his hemoglobin. The patient stated that when he called asking about the relationship between the Covid vaccine and hepatitis, he had looked at the wrong dates on his calendar. He actually had been diagnosed with hepatitis two weeks earlier than he thought. He was sorry for the inconvenience (pending clarification). The patient has a weak, old man voice. Sounds like there is a frog in his voice all of the time. His voice isn't as clear as it used to be. The outcome of the event was unknown. Follow-up (06Apr2021): New information received from the same contactable consumer (patient) in response to the Non-HCP letter sent includes: medical history (hepatitis) and course of events.
Age: 88.0
Sex: M
Vaccine: COVID19, PPV, COVID19
Symptoms: Blood test, Haemoglobin, Hepatic enzyme increased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 88-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left deltoid on 21Jan2021 16:00 (Batch/Lot Number: EL3247; Expiration Date: 01Mar2021) as single dose for preventative from getting the disease (as reported). Medical history included low hemoglobin, blood transfusion in late Sep2020, and hepatitis. Hemoglobin hasn't quite gotten to where it needs to be. It was 4 pints but may be measured differently at the hospital (as reported). The patient's concomitant medications were not reported. The patient has no prior vaccinations within 4 weeks. The patient had pneumonia vaccine on an unspecified date in 2015 and had a fever for 2-3 days. The patient had blood drawn on 20Jan2021. He received the first COVID-19 shot on 21Jan2021. He had blood drawn the second time on 27Jan2021 and again on 03Feb2021 where his liver enzymes shot up over 400 points which required a visit to physician's office. He stated that his second blood work result showed that his liver enzymes went up 400 points (as reported). The patient wanted to know if the COVID-19 shot have anything to do with the increase in liver enzymes. The patient's oncologist and blood specialist drew the blood and noted the increased of liver enzymes. It was reported that the blood draw was a matter of routine. Every other time they are drawing his blood to check on his hemoglobin. The patient stated that when he called asking about the relationship between the Covid vaccine and hepatitis, he had looked at the wrong dates on his calendar. He actually had been diagnosed with hepatitis two weeks earlier than he thought. He was sorry for the inconvenience (pending clarification). The patient has a weak, old man voice. Sounds like there is a frog in his voice all of the time. His voice isn't as clear as it used to be. The outcome of the event was unknown. Follow-up (06Apr2021): New information received from the same contactable consumer (patient) in response to the Non-HCP letter sent includes: medical history (hepatitis) and course of events.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: EXTREME DIZZINES; BRAIN FOG; VERTIGO; NAUSEA; MUSCLE PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was not reported and height was 175 centimeters.  The patient's concurrent conditions included alcohol use 1-2 drinks, and non-smoker, and other pre-existing medical conditions included the patient had no allergies and no history of drug abuse. no prior history of dizziness or vertigo. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced muscle pain. On 09-MAR-2021, the subject experienced extreme dizzines. On 09-MAR-2021, the subject experienced brain fog. On 09-MAR-2021, the subject experienced vertigo. On 09-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme dizzines, nausea, brain fog, and vertigo, and the outcome of muscle pain was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided. did not meet pqc criteria. based on the PQC evaluation/investigation performed.   Additional information was received  on 11-MAR-2021.The following information was updated and incorporated into case narrative: investigation result added. Additional information was received on 12-MAR-2021.The following information was updated and incorporated into case narrative: reporter telephone number and zip code, event (vertigo, brain fog) and treatment, product (batch number, vaccination time and site), patient history, event description were added.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Myalgia, Nausea, Vertigo
Clinical narrative: EXTREME DIZZINES; BRAIN FOG; VERTIGO; NAUSEA; MUSCLE PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was not reported and height was 175 centimeters.  The patient's concurrent conditions included alcohol use 1-2 drinks, and non-smoker, and other pre-existing medical conditions included the patient had no allergies and no history of drug abuse. no prior history of dizziness or vertigo. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced muscle pain. On 09-MAR-2021, the subject experienced extreme dizzines. On 09-MAR-2021, the subject experienced brain fog. On 09-MAR-2021, the subject experienced vertigo. On 09-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme dizzines, nausea, brain fog, and vertigo, and the outcome of muscle pain was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided. did not meet pqc criteria. based on the PQC evaluation/investigation performed.   Additional information was received  on 11-MAR-2021.The following information was updated and incorporated into case narrative: investigation result added. Additional information was received on 12-MAR-2021.The following information was updated and incorporated into case narrative: reporter telephone number and zip code, event (vertigo, brain fog) and treatment, product (batch number, vaccination time and site), patient history, event description were added.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Magnetic resonance imaging abnormal
Clinical narrative: Is he mic Stroke. Damage to brain as detected by MRI.. Hospitalised for 3 days. Only symptom was numbness of the right side of the body.  Numbness (no tingling, just stiffness and heavy feeling) is persisting though improving as of date.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain injury, Cerebrovascular accident, Computerised tomogram, Discomfort, Electrocardiogram
Clinical narrative: Is he mic Stroke. Damage to brain as detected by MRI.. Hospitalised for 3 days. Only symptom was numbness of the right side of the body.  Numbness (no tingling, just stiffness and heavy feeling) is persisting though improving as of date.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging head abnormal, Musculoskeletal stiffness
Clinical narrative: Is he mic Stroke. Damage to brain as detected by MRI.. Hospitalised for 3 days. Only symptom was numbness of the right side of the body.  Numbness (no tingling, just stiffness and heavy feeling) is persisting though improving as of date.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Rash, Rash vesicular
Clinical narrative: rash on her upper left thigh; doctor said her rash looked like Shingles; rash was itchy in the beginning with little blisters; rash was itchy in the beginning with little blisters; rash was just a bothersome discomfort; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 11Mar2021 (Batch/Lot Number: EN6206; Expiration Date: 30Mar2021) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient took her first COVID-19 Vaccine dose on 11Mar2021. She said she had noticed on 13Mar2021 a rash on her upper left thigh that she had never seen before. She said she called her sister, who is a retired nurse, and her sister told her to call her doctor. She said she had a virtual visit with her doctor on Monday, and her doctor suggested she call Pfizer for further information about the COVID-19 Vaccine. She said her doctor said her rash looked like Shingles. The caller said her rash wasn't very painful. She said her rash was more bothersome than anything. She said her rash was itchy in the beginning with little blisters. She said after 5-6 days, the blisters flattened out. She said she still had marks on her legs from where the blisters were. She said her rash was not serious, and she did not have pain. She said the rash was just a bothersome discomfort. She said the rash cleared up quickly without her taking any antiviral medication. She said her doctor said her rash looked like a very mild case of Shingles. She said her doctor told her she didn't need to take anything, like an antiviral medication, for her rash, if she didn't want to. She said she chose not to take anything, and her rash cleared up on its own. She said she was scheduled for her second COVID-19 Vaccine dose on 01Apr2021, and she wanted to verify with Pfizer if she should get the second COVID-19 Vaccine based on her reaction to her first COVID-19 Vaccine dose. Caller was advised she would be transferred to Pfizer Medical Information for further assistance with her question. Caller stated compared to the alternative, getting the COVID-19 Virus, her rash was nothing. She said her sister was more concerned about her rash than her. She said her doctor said for her to follow-up with Pfizer to confirm it was OK for her to get the second COVID-19 Vaccine. Caller wanted to know if she should get the second COVID-19 Vaccine after having a Shingles rash after the first COVID-19 Vaccine. Outcome of the events was recovered.  Information on the lot/batch number has been Provided No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Discomfort, Herpes zoster, Rash, Rash pruritic, Rash vesicular
Clinical narrative: rash on her upper left thigh; doctor said her rash looked like Shingles; rash was itchy in the beginning with little blisters; rash was itchy in the beginning with little blisters; rash was just a bothersome discomfort; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 11Mar2021 (Batch/Lot Number: EN6206; Expiration Date: 30Mar2021) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient took her first COVID-19 Vaccine dose on 11Mar2021. She said she had noticed on 13Mar2021 a rash on her upper left thigh that she had never seen before. She said she called her sister, who is a retired nurse, and her sister told her to call her doctor. She said she had a virtual visit with her doctor on Monday, and her doctor suggested she call Pfizer for further information about the COVID-19 Vaccine. She said her doctor said her rash looked like Shingles. The caller said her rash wasn't very painful. She said her rash was more bothersome than anything. She said her rash was itchy in the beginning with little blisters. She said after 5-6 days, the blisters flattened out. She said she still had marks on her legs from where the blisters were. She said her rash was not serious, and she did not have pain. She said the rash was just a bothersome discomfort. She said the rash cleared up quickly without her taking any antiviral medication. She said her doctor said her rash looked like a very mild case of Shingles. She said her doctor told her she didn't need to take anything, like an antiviral medication, for her rash, if she didn't want to. She said she chose not to take anything, and her rash cleared up on its own. She said she was scheduled for her second COVID-19 Vaccine dose on 01Apr2021, and she wanted to verify with Pfizer if she should get the second COVID-19 Vaccine based on her reaction to her first COVID-19 Vaccine dose. Caller was advised she would be transferred to Pfizer Medical Information for further assistance with her question. Caller stated compared to the alternative, getting the COVID-19 Virus, her rash was nothing. She said her sister was more concerned about her rash than her. She said her doctor said for her to follow-up with Pfizer to confirm it was OK for her to get the second COVID-19 Vaccine. Caller wanted to know if she should get the second COVID-19 Vaccine after having a Shingles rash after the first COVID-19 Vaccine. Outcome of the events was recovered.  Information on the lot/batch number has been Provided No follow-up attempts are needed. No further information is expected.