chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Herpes zoster, Rash erythematous, Rash pruritic
Clinical narrative: shingles/chest started to itch/2 bumps/sharp pain on her chest; it complicated into PHN; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172), via an unspecified route of administration, administered in left arm on 23Apr2021 at 02:00 PM (at 54-year-old) as 2nd dose, single dose for COVID-19 immunisation. Vaccine was administered in hospital. Medical history included ongoing hypertension and it is controlled. Concomitant medications included amlodipine, ascorbic acid, bioflavonoids nos (VITAMIN C), tocopherol (VITAMIN E), calcium, glucosamine. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 02Apr2021 at 02:00 PM (at 54-year-old) as 1st dose, single dose for COVID-19 immunisation. On 04May2021 the patient felt her chest started to itch. The next day she noticed 2 bumps so she applied antiseptic as she thought she was bitten by bugs. 2 days later the bumps get bigger she started feeling sharp pain on her chest every 10mins so she took Advil. 07May2021 the pain worsened so she went to see Doctor (Dr) he diagnosed her with shingles. She wasn't told to have shingle vaccine before covid vaccine. It seems like covid vaccine triggers the shingles. Doctor (Dr) gave her valacyclovir but pain was worse so 3 days later she took gabapentin 300mg this didn't work so Dr added narco but she got v drowsy and unable to function so she stopped and started taking Advil again. On 22May2021 patient was still in pain and no Dr avail so the nurse had her took Tylenol because she can't be on Advil more than 10d. It seemed like it complicated into Postherpetic Neuralgia (PHN). Event resulted in doctor or other healthcare professional office/clinic visit. Seriousness criteria were reported as disabling/incapacitating. The treatment was received for the adverse events included valacyclovir, gabapentin, hydrocodone acetaminophen. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles/chest started to itch/2 bumps/sharp pain on her chest; it complicated into PHN; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172), via an unspecified route of administration, administered in left arm on 23Apr2021 at 02:00 PM (at 54-year-old) as 2nd dose, single dose for COVID-19 immunisation. Vaccine was administered in hospital. Medical history included ongoing hypertension and it is controlled. Concomitant medications included amlodipine, ascorbic acid, bioflavonoids nos (VITAMIN C), tocopherol (VITAMIN E), calcium, glucosamine. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 02Apr2021 at 02:00 PM (at 54-year-old) as 1st dose, single dose for COVID-19 immunisation. On 04May2021 the patient felt her chest started to itch. The next day she noticed 2 bumps so she applied antiseptic as she thought she was bitten by bugs. 2 days later the bumps get bigger she started feeling sharp pain on her chest every 10mins so she took Advil. 07May2021 the pain worsened so she went to see Doctor (Dr) he diagnosed her with shingles. She wasn't told to have shingle vaccine before covid vaccine. It seems like covid vaccine triggers the shingles. Doctor (Dr) gave her valacyclovir but pain was worse so 3 days later she took gabapentin 300mg this didn't work so Dr added narco but she got v drowsy and unable to function so she stopped and started taking Advil again. On 22May2021 patient was still in pain and no Dr avail so the nurse had her took Tylenol because she can't be on Advil more than 10d. It seemed like it complicated into Postherpetic Neuralgia (PHN). Event resulted in doctor or other healthcare professional office/clinic visit. Seriousness criteria were reported as disabling/incapacitating. The treatment was received for the adverse events included valacyclovir, gabapentin, hydrocodone acetaminophen. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Blood test normal, Computerised tomogram, Dizziness, Ear discomfort
Clinical narrative: BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; brain fog; pressure in the back of my head; severe vomiting; shortness of breath; Pyrexia; Mental status changes; This is spontaneous report from contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:30 (Batch/Lot Number: EWO161), at the age of 50 years, as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Previously the patient received first dose of  bnt162b2 on 30Mar2021, at the age of 50 years, Time: 03:45 PM,  Lot no. EW8730, anatomical location: Left arm. 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 30Apr2021 19:30 the patient experienced Benign Paroxysmal Positional Vertigo (BPPV) (hospitalization, life threatening). On 30Apr2021 19:30 the patient experienced fullness and burning sensation in ears, tinnitus, brain fog, pressure in the back of head, severe vomiting, shortness of breath, pyrexia, mental status changes. On 12May2021 the patient experienced partial loss of hearing. On 28May2021 the patient experienced burning sensation. Clinical course: Nine days after taking a second dose of the Pfizer vaccine it started with multiple episodes of vertigo for 2 days, followed by severe vomiting, non-stop vertigo, shortness of breath. Taken into Emergency Room (ER) by ambulance on 02May2021, multiple tests performed (CT scan, blood, EKG) diagnosed with BPPV. Discharged the same night.  The symptoms escalated into fullness and burning sensation in ears, partial loss of hearing, tinnitus, brain fog, pressure in the back of my head. Went to primary care physician on 05Jun2021, again multiple tests (blood, urine, EKG).  Referred to ENT. Visited ENT on 12May2021, audiology test confirmed partial hearing loss. On 28May2021 the patient was still suffering with burning sensation and fullness in the right ear, as well as loss of hearing (high frequencies) and tinnitus. Periodic episodes of brain fog and severe vertigo.  The patient underwent lab tests and procedures which included blood test: diagnosed with BPPV   on 02May2021, blood test: unknown results on 06May2021, CT scan: diagnosed with BPPV on 02May2021, electrocardiogram: diagnosed with BPPV on 02May2021, electrocardiogram: unknown results on 06May2021, audiology test: partial hearing loss on 12May2021, urine output: unknown results on 06May2021. The patient received treatments due to the events: Diazepam, Meclizine, Potassium Chloride, Metoclop. The outcome of the events was not recovered.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Head discomfort, Hypoacusis, Nausea, Urine analysis
Clinical narrative: BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; brain fog; pressure in the back of my head; severe vomiting; shortness of breath; Pyrexia; Mental status changes; This is spontaneous report from contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:30 (Batch/Lot Number: EWO161), at the age of 50 years, as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Previously the patient received first dose of  bnt162b2 on 30Mar2021, at the age of 50 years, Time: 03:45 PM,  Lot no. EW8730, anatomical location: Left arm. 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 30Apr2021 19:30 the patient experienced Benign Paroxysmal Positional Vertigo (BPPV) (hospitalization, life threatening). On 30Apr2021 19:30 the patient experienced fullness and burning sensation in ears, tinnitus, brain fog, pressure in the back of head, severe vomiting, shortness of breath, pyrexia, mental status changes. On 12May2021 the patient experienced partial loss of hearing. On 28May2021 the patient experienced burning sensation. Clinical course: Nine days after taking a second dose of the Pfizer vaccine it started with multiple episodes of vertigo for 2 days, followed by severe vomiting, non-stop vertigo, shortness of breath. Taken into Emergency Room (ER) by ambulance on 02May2021, multiple tests performed (CT scan, blood, EKG) diagnosed with BPPV. Discharged the same night.  The symptoms escalated into fullness and burning sensation in ears, partial loss of hearing, tinnitus, brain fog, pressure in the back of my head. Went to primary care physician on 05Jun2021, again multiple tests (blood, urine, EKG).  Referred to ENT. Visited ENT on 12May2021, audiology test confirmed partial hearing loss. On 28May2021 the patient was still suffering with burning sensation and fullness in the right ear, as well as loss of hearing (high frequencies) and tinnitus. Periodic episodes of brain fog and severe vertigo.  The patient underwent lab tests and procedures which included blood test: diagnosed with BPPV   on 02May2021, blood test: unknown results on 06May2021, CT scan: diagnosed with BPPV on 02May2021, electrocardiogram: diagnosed with BPPV on 02May2021, electrocardiogram: unknown results on 06May2021, audiology test: partial hearing loss on 12May2021, urine output: unknown results on 06May2021. The patient received treatments due to the events: Diazepam, Meclizine, Potassium Chloride, Metoclop. The outcome of the events was not recovered.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo positional, Vomiting
Clinical narrative: BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; brain fog; pressure in the back of my head; severe vomiting; shortness of breath; Pyrexia; Mental status changes; This is spontaneous report from contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:30 (Batch/Lot Number: EWO161), at the age of 50 years, as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Previously the patient received first dose of  bnt162b2 on 30Mar2021, at the age of 50 years, Time: 03:45 PM,  Lot no. EW8730, anatomical location: Left arm. 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 30Apr2021 19:30 the patient experienced Benign Paroxysmal Positional Vertigo (BPPV) (hospitalization, life threatening). On 30Apr2021 19:30 the patient experienced fullness and burning sensation in ears, tinnitus, brain fog, pressure in the back of head, severe vomiting, shortness of breath, pyrexia, mental status changes. On 12May2021 the patient experienced partial loss of hearing. On 28May2021 the patient experienced burning sensation. Clinical course: Nine days after taking a second dose of the Pfizer vaccine it started with multiple episodes of vertigo for 2 days, followed by severe vomiting, non-stop vertigo, shortness of breath. Taken into Emergency Room (ER) by ambulance on 02May2021, multiple tests performed (CT scan, blood, EKG) diagnosed with BPPV. Discharged the same night.  The symptoms escalated into fullness and burning sensation in ears, partial loss of hearing, tinnitus, brain fog, pressure in the back of my head. Went to primary care physician on 05Jun2021, again multiple tests (blood, urine, EKG).  Referred to ENT. Visited ENT on 12May2021, audiology test confirmed partial hearing loss. On 28May2021 the patient was still suffering with burning sensation and fullness in the right ear, as well as loss of hearing (high frequencies) and tinnitus. Periodic episodes of brain fog and severe vertigo.  The patient underwent lab tests and procedures which included blood test: diagnosed with BPPV   on 02May2021, blood test: unknown results on 06May2021, CT scan: diagnosed with BPPV on 02May2021, electrocardiogram: diagnosed with BPPV on 02May2021, electrocardiogram: unknown results on 06May2021, audiology test: partial hearing loss on 12May2021, urine output: unknown results on 06May2021. The patient received treatments due to the events: Diazepam, Meclizine, Potassium Chloride, Metoclop. The outcome of the events was not recovered.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Burning sensation, Computerised tomogram, Dyspnoea, Ear discomfort
Clinical narrative: BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; brain fog; pressure in the back of my head; severe vomiting; shortness of breath; Pyrexia; Mental status changes; This is spontaneous report from contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:30 (Batch/Lot Number: EWO161), at the age of 50 years, as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Previously the patient received first dose of  bnt162b2 on 30Mar2021, at the age of 50 years, Time: 03:45 PM,  Lot no. EW8730, anatomical location: Left arm. 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 30Apr2021 19:30 the patient experienced Benign Paroxysmal Positional Vertigo (BPPV) (hospitalization, life threatening). On 30Apr2021 19:30 the patient experienced fullness and burning sensation in ears, tinnitus, brain fog, pressure in the back of head, severe vomiting, shortness of breath, pyrexia, mental status changes. On 12May2021 the patient experienced partial loss of hearing. On 28May2021 the patient experienced burning sensation. Clinical course: Nine days after taking a second dose of the Pfizer vaccine it started with multiple episodes of vertigo for 2 days, followed by severe vomiting, non-stop vertigo, shortness of breath. Taken into Emergency Room (ER) by ambulance on 02May2021, multiple tests performed (CT scan, blood, EKG) diagnosed with BPPV. Discharged the same night.  The symptoms escalated into fullness and burning sensation in ears, partial loss of hearing, tinnitus, brain fog, pressure in the back of my head. Went to primary care physician on 05Jun2021, again multiple tests (blood, urine, EKG).  Referred to ENT. Visited ENT on 12May2021, audiology test confirmed partial hearing loss. On 28May2021 the patient was still suffering with burning sensation and fullness in the right ear, as well as loss of hearing (high frequencies) and tinnitus. Periodic episodes of brain fog and severe vertigo.  The patient underwent lab tests and procedures which included blood test: diagnosed with BPPV   on 02May2021, blood test: unknown results on 06May2021, CT scan: diagnosed with BPPV on 02May2021, electrocardiogram: diagnosed with BPPV on 02May2021, electrocardiogram: unknown results on 06May2021, audiology test: partial hearing loss on 12May2021, urine output: unknown results on 06May2021. The patient received treatments due to the events: Diazepam, Meclizine, Potassium Chloride, Metoclop. The outcome of the events was not recovered.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Feeling abnormal, Head discomfort, Hypoacusis, Investigation
Clinical narrative: BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; brain fog; pressure in the back of my head; severe vomiting; shortness of breath; Pyrexia; Mental status changes; This is spontaneous report from contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:30 (Batch/Lot Number: EWO161), at the age of 50 years, as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Previously the patient received first dose of  bnt162b2 on 30Mar2021, at the age of 50 years, Time: 03:45 PM,  Lot no. EW8730, anatomical location: Left arm. 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 30Apr2021 19:30 the patient experienced Benign Paroxysmal Positional Vertigo (BPPV) (hospitalization, life threatening). On 30Apr2021 19:30 the patient experienced fullness and burning sensation in ears, tinnitus, brain fog, pressure in the back of head, severe vomiting, shortness of breath, pyrexia, mental status changes. On 12May2021 the patient experienced partial loss of hearing. On 28May2021 the patient experienced burning sensation. Clinical course: Nine days after taking a second dose of the Pfizer vaccine it started with multiple episodes of vertigo for 2 days, followed by severe vomiting, non-stop vertigo, shortness of breath. Taken into Emergency Room (ER) by ambulance on 02May2021, multiple tests performed (CT scan, blood, EKG) diagnosed with BPPV. Discharged the same night.  The symptoms escalated into fullness and burning sensation in ears, partial loss of hearing, tinnitus, brain fog, pressure in the back of my head. Went to primary care physician on 05Jun2021, again multiple tests (blood, urine, EKG).  Referred to ENT. Visited ENT on 12May2021, audiology test confirmed partial hearing loss. On 28May2021 the patient was still suffering with burning sensation and fullness in the right ear, as well as loss of hearing (high frequencies) and tinnitus. Periodic episodes of brain fog and severe vertigo.  The patient underwent lab tests and procedures which included blood test: diagnosed with BPPV   on 02May2021, blood test: unknown results on 06May2021, CT scan: diagnosed with BPPV on 02May2021, electrocardiogram: diagnosed with BPPV on 02May2021, electrocardiogram: unknown results on 06May2021, audiology test: partial hearing loss on 12May2021, urine output: unknown results on 06May2021. The patient received treatments due to the events: Diazepam, Meclizine, Potassium Chloride, Metoclop. The outcome of the events was not recovered.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mental status changes, Pyrexia, Tinnitus, Urine output, Vertigo positional
Clinical narrative: BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; brain fog; pressure in the back of my head; severe vomiting; shortness of breath; Pyrexia; Mental status changes; This is spontaneous report from contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:30 (Batch/Lot Number: EWO161), at the age of 50 years, as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Previously the patient received first dose of  bnt162b2 on 30Mar2021, at the age of 50 years, Time: 03:45 PM,  Lot no. EW8730, anatomical location: Left arm. 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 30Apr2021 19:30 the patient experienced Benign Paroxysmal Positional Vertigo (BPPV) (hospitalization, life threatening). On 30Apr2021 19:30 the patient experienced fullness and burning sensation in ears, tinnitus, brain fog, pressure in the back of head, severe vomiting, shortness of breath, pyrexia, mental status changes. On 12May2021 the patient experienced partial loss of hearing. On 28May2021 the patient experienced burning sensation. Clinical course: Nine days after taking a second dose of the Pfizer vaccine it started with multiple episodes of vertigo for 2 days, followed by severe vomiting, non-stop vertigo, shortness of breath. Taken into Emergency Room (ER) by ambulance on 02May2021, multiple tests performed (CT scan, blood, EKG) diagnosed with BPPV. Discharged the same night.  The symptoms escalated into fullness and burning sensation in ears, partial loss of hearing, tinnitus, brain fog, pressure in the back of my head. Went to primary care physician on 05Jun2021, again multiple tests (blood, urine, EKG).  Referred to ENT. Visited ENT on 12May2021, audiology test confirmed partial hearing loss. On 28May2021 the patient was still suffering with burning sensation and fullness in the right ear, as well as loss of hearing (high frequencies) and tinnitus. Periodic episodes of brain fog and severe vertigo.  The patient underwent lab tests and procedures which included blood test: diagnosed with BPPV   on 02May2021, blood test: unknown results on 06May2021, CT scan: diagnosed with BPPV on 02May2021, electrocardiogram: diagnosed with BPPV on 02May2021, electrocardiogram: unknown results on 06May2021, audiology test: partial hearing loss on 12May2021, urine output: unknown results on 06May2021. The patient received treatments due to the events: Diazepam, Meclizine, Potassium Chloride, Metoclop. The outcome of the events was not recovered.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; brain fog; pressure in the back of my head; severe vomiting; shortness of breath; Pyrexia; Mental status changes; This is spontaneous report from contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:30 (Batch/Lot Number: EWO161), at the age of 50 years, as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Previously the patient received first dose of  bnt162b2 on 30Mar2021, at the age of 50 years, Time: 03:45 PM,  Lot no. EW8730, anatomical location: Left arm. 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 30Apr2021 19:30 the patient experienced Benign Paroxysmal Positional Vertigo (BPPV) (hospitalization, life threatening). On 30Apr2021 19:30 the patient experienced fullness and burning sensation in ears, tinnitus, brain fog, pressure in the back of head, severe vomiting, shortness of breath, pyrexia, mental status changes. On 12May2021 the patient experienced partial loss of hearing. On 28May2021 the patient experienced burning sensation. Clinical course: Nine days after taking a second dose of the Pfizer vaccine it started with multiple episodes of vertigo for 2 days, followed by severe vomiting, non-stop vertigo, shortness of breath. Taken into Emergency Room (ER) by ambulance on 02May2021, multiple tests performed (CT scan, blood, EKG) diagnosed with BPPV. Discharged the same night.  The symptoms escalated into fullness and burning sensation in ears, partial loss of hearing, tinnitus, brain fog, pressure in the back of my head. Went to primary care physician on 05Jun2021, again multiple tests (blood, urine, EKG).  Referred to ENT. Visited ENT on 12May2021, audiology test confirmed partial hearing loss. On 28May2021 the patient was still suffering with burning sensation and fullness in the right ear, as well as loss of hearing (high frequencies) and tinnitus. Periodic episodes of brain fog and severe vertigo.  The patient underwent lab tests and procedures which included blood test: diagnosed with BPPV   on 02May2021, blood test: unknown results on 06May2021, CT scan: diagnosed with BPPV on 02May2021, electrocardiogram: diagnosed with BPPV on 02May2021, electrocardiogram: unknown results on 06May2021, audiology test: partial hearing loss on 12May2021, urine output: unknown results on 06May2021. The patient received treatments due to the events: Diazepam, Meclizine, Potassium Chloride, Metoclop. The outcome of the events was not recovered.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide, C-reactive protein increased, Chills, Conjunctivitis, Ejection fraction decreased
Clinical narrative: Patient well until 5/9/2021; at that time patient presented to urgent cared due to having developed sudden onset rash on hands that spread throughout body; patient reported intermittent fevers (Tmax 102F), nausea, decreased appetite, vomiting. Patient also had nonpainful white patchy plaques on tongue that presented suddenly. Patient admitted to hospital on 5/14 for 4 days of fever and further work-up of possible Kawasaki vs MIS-C vs viral etiology. Patient developed bilateral conjunctivitis. Case had elevated CRP, ESR, Troponin, BNP, D-dimer, liver enzymes were elevated (ALT). Patient started on ASA and IVIG, at which point their BP decreased and troponin worsened so they were transferred to PICU on 5/14 and given high dose steroids. ECG findings consistent with myocarditis. ID consult notes clinical findings concerning for MIS-C w/myocardial depression & elevated troponin, respiratory panel was negative & blood culture showed no growth 5 days. In PICU patient had improvement of rash and no further fevers and was discharged from the PICU floor on 5/16. Patient was later discharged from hospital the same day.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate increased, Respiratory viral panel, SARS-CoV-2 test negative
Clinical narrative: Patient well until 5/9/2021; at that time patient presented to urgent cared due to having developed sudden onset rash on hands that spread throughout body; patient reported intermittent fevers (Tmax 102F), nausea, decreased appetite, vomiting. Patient also had nonpainful white patchy plaques on tongue that presented suddenly. Patient admitted to hospital on 5/14 for 4 days of fever and further work-up of possible Kawasaki vs MIS-C vs viral etiology. Patient developed bilateral conjunctivitis. Case had elevated CRP, ESR, Troponin, BNP, D-dimer, liver enzymes were elevated (ALT). Patient started on ASA and IVIG, at which point their BP decreased and troponin worsened so they were transferred to PICU on 5/14 and given high dose steroids. ECG findings consistent with myocarditis. ID consult notes clinical findings concerning for MIS-C w/myocardial depression & elevated troponin, respiratory panel was negative & blood culture showed no growth 5 days. In PICU patient had improvement of rash and no further fevers and was discharged from the PICU floor on 5/16. Patient was later discharged from hospital the same day.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tongue eruption, Troponin I increased, White blood cell count increased
Clinical narrative: Patient well until 5/9/2021; at that time patient presented to urgent cared due to having developed sudden onset rash on hands that spread throughout body; patient reported intermittent fevers (Tmax 102F), nausea, decreased appetite, vomiting. Patient also had nonpainful white patchy plaques on tongue that presented suddenly. Patient admitted to hospital on 5/14 for 4 days of fever and further work-up of possible Kawasaki vs MIS-C vs viral etiology. Patient developed bilateral conjunctivitis. Case had elevated CRP, ESR, Troponin, BNP, D-dimer, liver enzymes were elevated (ALT). Patient started on ASA and IVIG, at which point their BP decreased and troponin worsened so they were transferred to PICU on 5/14 and given high dose steroids. ECG findings consistent with myocarditis. ID consult notes clinical findings concerning for MIS-C w/myocardial depression & elevated troponin, respiratory panel was negative & blood culture showed no growth 5 days. In PICU patient had improvement of rash and no further fevers and was discharged from the PICU floor on 5/16. Patient was later discharged from hospital the same day.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Blood culture negative, Blood immunoglobulin G normal, Blood pressure decreased, Brain natriuretic peptide increased
Clinical narrative: Patient well until 5/9/2021; at that time patient presented to urgent cared due to having developed sudden onset rash on hands that spread throughout body; patient reported intermittent fevers (Tmax 102F), nausea, decreased appetite, vomiting. Patient also had nonpainful white patchy plaques on tongue that presented suddenly. Patient admitted to hospital on 5/14 for 4 days of fever and further work-up of possible Kawasaki vs MIS-C vs viral etiology. Patient developed bilateral conjunctivitis. Case had elevated CRP, ESR, Troponin, BNP, D-dimer, liver enzymes were elevated (ALT). Patient started on ASA and IVIG, at which point their BP decreased and troponin worsened so they were transferred to PICU on 5/14 and given high dose steroids. ECG findings consistent with myocarditis. ID consult notes clinical findings concerning for MIS-C w/myocardial depression & elevated troponin, respiratory panel was negative & blood culture showed no growth 5 days. In PICU patient had improvement of rash and no further fevers and was discharged from the PICU floor on 5/16. Patient was later discharged from hospital the same day.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Conjunctivitis, Decreased appetite, Electrocardiogram abnormal, Fibrin D dimer increased
Clinical narrative: Patient well until 5/9/2021; at that time patient presented to urgent cared due to having developed sudden onset rash on hands that spread throughout body; patient reported intermittent fevers (Tmax 102F), nausea, decreased appetite, vomiting. Patient also had nonpainful white patchy plaques on tongue that presented suddenly. Patient admitted to hospital on 5/14 for 4 days of fever and further work-up of possible Kawasaki vs MIS-C vs viral etiology. Patient developed bilateral conjunctivitis. Case had elevated CRP, ESR, Troponin, BNP, D-dimer, liver enzymes were elevated (ALT). Patient started on ASA and IVIG, at which point their BP decreased and troponin worsened so they were transferred to PICU on 5/14 and given high dose steroids. ECG findings consistent with myocarditis. ID consult notes clinical findings concerning for MIS-C w/myocardial depression & elevated troponin, respiratory panel was negative & blood culture showed no growth 5 days. In PICU patient had improvement of rash and no further fevers and was discharged from the PICU floor on 5/16. Patient was later discharged from hospital the same day.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hepatic enzyme increased, Immunoglobulin therapy, Intensive care, Myocardial depression, Myocarditis
Clinical narrative: Patient well until 5/9/2021; at that time patient presented to urgent cared due to having developed sudden onset rash on hands that spread throughout body; patient reported intermittent fevers (Tmax 102F), nausea, decreased appetite, vomiting. Patient also had nonpainful white patchy plaques on tongue that presented suddenly. Patient admitted to hospital on 5/14 for 4 days of fever and further work-up of possible Kawasaki vs MIS-C vs viral etiology. Patient developed bilateral conjunctivitis. Case had elevated CRP, ESR, Troponin, BNP, D-dimer, liver enzymes were elevated (ALT). Patient started on ASA and IVIG, at which point their BP decreased and troponin worsened so they were transferred to PICU on 5/14 and given high dose steroids. ECG findings consistent with myocarditis. ID consult notes clinical findings concerning for MIS-C w/myocardial depression & elevated troponin, respiratory panel was negative & blood culture showed no growth 5 days. In PICU patient had improvement of rash and no further fevers and was discharged from the PICU floor on 5/16. Patient was later discharged from hospital the same day.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oropharyngeal plaque, Pyrexia, Rash, Red blood cell sedimentation rate increased
Clinical narrative: Patient well until 5/9/2021; at that time patient presented to urgent cared due to having developed sudden onset rash on hands that spread throughout body; patient reported intermittent fevers (Tmax 102F), nausea, decreased appetite, vomiting. Patient also had nonpainful white patchy plaques on tongue that presented suddenly. Patient admitted to hospital on 5/14 for 4 days of fever and further work-up of possible Kawasaki vs MIS-C vs viral etiology. Patient developed bilateral conjunctivitis. Case had elevated CRP, ESR, Troponin, BNP, D-dimer, liver enzymes were elevated (ALT). Patient started on ASA and IVIG, at which point their BP decreased and troponin worsened so they were transferred to PICU on 5/14 and given high dose steroids. ECG findings consistent with myocarditis. ID consult notes clinical findings concerning for MIS-C w/myocardial depression & elevated troponin, respiratory panel was negative & blood culture showed no growth 5 days. In PICU patient had improvement of rash and no further fevers and was discharged from the PICU floor on 5/16. Patient was later discharged from hospital the same day.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory viral panel, SARS-CoV-2 test negative, Troponin increased, Vomiting
Clinical narrative: Patient well until 5/9/2021; at that time patient presented to urgent cared due to having developed sudden onset rash on hands that spread throughout body; patient reported intermittent fevers (Tmax 102F), nausea, decreased appetite, vomiting. Patient also had nonpainful white patchy plaques on tongue that presented suddenly. Patient admitted to hospital on 5/14 for 4 days of fever and further work-up of possible Kawasaki vs MIS-C vs viral etiology. Patient developed bilateral conjunctivitis. Case had elevated CRP, ESR, Troponin, BNP, D-dimer, liver enzymes were elevated (ALT). Patient started on ASA and IVIG, at which point their BP decreased and troponin worsened so they were transferred to PICU on 5/14 and given high dose steroids. ECG findings consistent with myocarditis. ID consult notes clinical findings concerning for MIS-C w/myocardial depression & elevated troponin, respiratory panel was negative & blood culture showed no growth 5 days. In PICU patient had improvement of rash and no further fevers and was discharged from the PICU floor on 5/16. Patient was later discharged from hospital the same day.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: Approximately 2-3 minutes after receiving the shot patient reports that he had a seizure. Was sitting in the observation area, felt like vision was blacking out. Observers report that patient stiffened in chair and eyes rolled back. No one observed tonic-clonic movements of limbs, but patient did have bladder incontinence. He was unresponsive for several minutes, EMS was called and evaluated patient at the scene. He started to feel better fairly quickly after regaining consciousness and refused transport to hospital.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gaze palsy, Seizure, Unresponsive to stimuli, Urinary incontinence, Visual impairment
Clinical narrative: Approximately 2-3 minutes after receiving the shot patient reports that he had a seizure. Was sitting in the observation area, felt like vision was blacking out. Observers report that patient stiffened in chair and eyes rolled back. No one observed tonic-clonic movements of limbs, but patient did have bladder incontinence. He was unresponsive for several minutes, EMS was called and evaluated patient at the scene. He started to feel better fairly quickly after regaining consciousness and refused transport to hospital.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Paraesthesia
Clinical narrative: Dizziness Weakness Face dropped. Right side  Breathing labored  30 mins.   Benadryl given Happened again that night.  Right side face droop and right side motor function  affected.   Still can't lift right leg correctly
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Facial paralysis, Mobility decreased
Clinical narrative: Dizziness Weakness Face dropped. Right side  Breathing labored  30 mins.   Benadryl given Happened again that night.  Right side face droop and right side motor function  affected.   Still can't lift right leg correctly
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Motor dysfunction
Clinical narrative: Dizziness Weakness Face dropped. Right side  Breathing labored  30 mins.   Benadryl given Happened again that night.  Right side face droop and right side motor function  affected.   Still can't lift right leg correctly
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Catheterisation cardiac, Myocardial infarction
Clinical narrative: a lady had worse experience then him and she was in the hospital for 3 weeks; This is a spontaneous report from a contactable male consumer from Medical Information Team. A female patient received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported a lady had worse experience then him and she was in the hospital for 3 weeks on an unspecified date. Reported as: Caller stated he received the first dose of the pfizer covid vaccine and he got a heart attack due to it. He was hospitalized and now he feels like "garbage". He said in the beginning he heard in the news that you can get heart attack with the Pfizer covid vaccine. He stated he is not the only one, a lady had worse experience then him and she was in the hospital for 3 weeks. caller wanted to know with the heart attack he experienced with the first dose should he get the second dose. The outcome of the event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: a lady had worse experience then him and she was in the hospital for 3 weeks; This is a spontaneous report from a contactable male consumer from Medical Information Team. A female patient received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported a lady had worse experience then him and she was in the hospital for 3 weeks on an unspecified date. Reported as: Caller stated he received the first dose of the pfizer covid vaccine and he got a heart attack due to it. He was hospitalized and now he feels like "garbage". He said in the beginning he heard in the news that you can get heart attack with the Pfizer covid vaccine. He stated he is not the only one, a lady had worse experience then him and she was in the hospital for 3 weeks. caller wanted to know with the heart attack he experienced with the first dose should he get the second dose. The outcome of the event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dyspnoea, Erythema, Laboratory test, Palpitations
Clinical narrative: my heart started racing; my chest and face turned red; coughing; difficulty breathing; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6205, Expiration date: Unknown), via an unspecified route of administration, in left arm on 17May2021 at 04:00 pm (at the age of 42-years old) as 1 ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history included gastroparesis, seasonal allergy, allergy to soy, pencillin and sulfa allergy. The patient concomitant medications were not reported.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received medications within two weeks prior vaccination included prilosec, synthroid, allegra, hydroxizine, Pepcid. The patient was not diagnosed with COVID-19, prior the vaccination. Since the vaccination, patient had not been tested for COVID-19. It was reported that on 17May2021 (30 minutes after receiving the vaccine), her heart started racing, chest and face turned red and also she experienced coughing and difficulty breathing. The case was considered as serious (hospitalization). The patient was taken to the ER and received IV Epinephrine, Solumedrol, Benadryl and Pepcid as treatment for the events. Patient was an inpatient for 2.5 days in the emergency room. The outcome of the events palpitations, redness was unknown and outcome for other events was not resolved.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Cough, Erythema, Dyspnoea and palpitations. 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: my heart started racing; my chest and face turned red; coughing; difficulty breathing; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6205, Expiration date: Unknown), via an unspecified route of administration, in left arm on 17May2021 at 04:00 pm (at the age of 42-years old) as 1 ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history included gastroparesis, seasonal allergy, allergy to soy, pencillin and sulfa allergy. The patient concomitant medications were not reported.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received medications within two weeks prior vaccination included prilosec, synthroid, allegra, hydroxizine, Pepcid. The patient was not diagnosed with COVID-19, prior the vaccination. Since the vaccination, patient had not been tested for COVID-19. It was reported that on 17May2021 (30 minutes after receiving the vaccine), her heart started racing, chest and face turned red and also she experienced coughing and difficulty breathing. The case was considered as serious (hospitalization). The patient was taken to the ER and received IV Epinephrine, Solumedrol, Benadryl and Pepcid as treatment for the events. Patient was an inpatient for 2.5 days in the emergency room. The outcome of the events palpitations, redness was unknown and outcome for other events was not resolved.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Cough, Erythema, Dyspnoea and palpitations. 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Erythema, Palpitations
Clinical narrative: my heart started racing; my chest and face turned red; coughing; difficulty breathing; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6205, Expiration date: Unknown), via an unspecified route of administration, in left arm on 17May2021 at 04:00 pm (at the age of 42-years old) as 1 ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history included gastroparesis, seasonal allergy, allergy to soy, pencillin and sulfa allergy. The patient concomitant medications were not reported.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received medications within two weeks prior vaccination included prilosec, synthroid, allegra, hydroxizine, Pepcid. The patient was not diagnosed with COVID-19, prior the vaccination. Since the vaccination, patient had not been tested for COVID-19. It was reported that on 17May2021 (30 minutes after receiving the vaccine), her heart started racing, chest and face turned red and also she experienced coughing and difficulty breathing. The case was considered as serious (hospitalization). The patient was taken to the ER and received IV Epinephrine, Solumedrol, Benadryl and Pepcid as treatment for the events. Patient was an inpatient for 2.5 days in the emergency room. The outcome of the events palpitations, redness was unknown and outcome for other events was not resolved.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Cough, Erythema, Dyspnoea and palpitations. 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: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain
Clinical narrative: Monday, got 2nd Pfizer vaccine. Tuesday, sick with fever and chills. Wednesday 2am, Thursday 1pm, Friday 8am: 3-4 hour cramping in hands, arms, shoulders, neck, upper back, with chest tightness. Tylenol, ibuprofen, heating pad, showers to no effect. Friday morning (May 14) I visit Primary Care during episode. Abnormal EKG. I drive to emergency room. 2 abnormal EKGs. I get a Cardiac Cathedar operation, followed by an echo in outpatient. Blood draw shows troponin levels at 29k and 26k. Presumed myopericarditis. 2 days in hospital, released May 16. Heart rate stabilized the night of May 14. Aspirin 650mg (ended Monday May 31), colchicine 0.6mg, Lisinopril 5mg, Metoprolol 25mg. Omeprazole upped to two 20mg tablets instead of one. Getting a heart MRI Wednesday, May 9. Back at work on Wednesday, May 19.