chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood magnesium, Chest X-ray, Electrocardiogram, Electrocardiogram abnormal, Full blood count
Clinical narrative: Syncope event resulting in abnormal ekg and possible pericarditis; Syncope event resulting in abnormal ekg and possible pericarditis; Syncope event resulting in abnormal ekg and possible pericarditis; This is a spontaneous report from a contactable consumer (patient). A 15-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 25May2021 12:00 (Lot Number: EW0183) as first single dose for covid-19 immunization. Age at vaccination: 15-years-old. Medical history included attention deficit hyperactivity disorder (ADHD). No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; guanfacine (GUANFACINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced syncope event resulting in abnormal EKG and possible pericarditis (medically significant) on 02Jun2021 15:15 with outcome of unknown. The patient underwent lab tests and procedures which included electrocardiogram: abnormal on 02Jun2021. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Unknown if treatment was received for the event. Since the vaccination, the patient has not been tested for COVID-19.  Information on lot/batch number was available. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Syncope, Troponin
Clinical narrative: Syncope event resulting in abnormal ekg and possible pericarditis; Syncope event resulting in abnormal ekg and possible pericarditis; Syncope event resulting in abnormal ekg and possible pericarditis; This is a spontaneous report from a contactable consumer (patient). A 15-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 25May2021 12:00 (Lot Number: EW0183) as first single dose for covid-19 immunization. Age at vaccination: 15-years-old. Medical history included attention deficit hyperactivity disorder (ADHD). No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; guanfacine (GUANFACINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced syncope event resulting in abnormal EKG and possible pericarditis (medically significant) on 02Jun2021 15:15 with outcome of unknown. The patient underwent lab tests and procedures which included electrocardiogram: abnormal on 02Jun2021. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Unknown if treatment was received for the event. Since the vaccination, the patient has not been tested for COVID-19.  Information on lot/batch number was available. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electrocardiogram abnormal, Pericarditis, Syncope
Clinical narrative: Syncope event resulting in abnormal ekg and possible pericarditis; Syncope event resulting in abnormal ekg and possible pericarditis; Syncope event resulting in abnormal ekg and possible pericarditis; This is a spontaneous report from a contactable consumer (patient). A 15-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 25May2021 12:00 (Lot Number: EW0183) as first single dose for covid-19 immunization. Age at vaccination: 15-years-old. Medical history included attention deficit hyperactivity disorder (ADHD). No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; guanfacine (GUANFACINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced syncope event resulting in abnormal EKG and possible pericarditis (medically significant) on 02Jun2021 15:15 with outcome of unknown. The patient underwent lab tests and procedures which included electrocardiogram: abnormal on 02Jun2021. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Unknown if treatment was received for the event. Since the vaccination, the patient has not been tested for COVID-19.  Information on lot/batch number was available. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling
Clinical narrative: On Friday June 4th I woke up at 12:00am after going to sleep at 11:pm on June 3rd. When I woke up I found that my right eye was almost swollen shut. I took Benadryl and used ice to reduce the swelling; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 27-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jun2021 14:30 (Batch/Lot Number: Ew0186) as 1st DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 27 years old. Patient was not pregnant. Medical history reported as no. No known allergies. Concomitant medications included fexofenadine hydrochloride (ALLEGRA ALLERGY) and Excedrine migrane (as reported).  Reported Event: On Friday 4th Jun patient woke up at 12:00am after going to sleep at 11:pm on 3Jun. When she woke up she found that her right eye was almost swollen shut. She took Benadryl and used ice to reduce the swelling. It was now 12:38pm on  4Jun and the eye was still a bit swollen but it was better than when she first woke up. The patient experienced the event (serious as medically significant) on 04Jun2021 12:00 AM with outcome of recovering. AE treatment: took Benadryl and used ice to reduce swelling. No other vaccine in four weeks.  No covid prior vaccination. No covid tested post vaccination.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Epistaxis
Clinical narrative: bleeds were difficult to stop (lasting 15 or more minutes) and with clots; severe nosebleeds; This is spontaneous report from received via health authorities from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 27Apr2021 05:15 pm (Batch/Lot Number: EW0170) as single dose for covid-19 immunisation. Patient is not pregnant. Medical history included hashimotos, von willenbrands type 1. And patient avoided gluten and dairy for autoimmune disease. Concomitant medication(s) included levothyroxine sodium (SYNTHYROID) and methylfolate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Brand synthroid 200 mcg, multivitamin, l-methylfol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8734) administered in right arm on 06Apr2021 06:00 pm for covid-19 immunisation. About 36 to 48 hours after receiving dose number 2 for the covid pfizer vaccine, patient began to have recurring severe nosebleeds on 29Apr2021 16:00. The bleeds were difficult to stop (lasting 15 or more minutes) and with clots. These lasted daily for 3 to 4 days and then ceased completely. Patient met virtually with hematologist, and he encouraged repeat PTT/PT bloodwork and visit to ENT. Met with doctor, ENT. There were no structural issues in the nose and bloodwork came back normal, so both concluded that vaccine may be cause of bleeds. The adverse events result in doctor or other healthcare professional office/clinic visit. Patient underwent hematology bloodwork, ENT exam. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The event outcome for events was recovered on unspecified date.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Ear, nose and throat examination, Epistaxis, Haematology test, Thrombosis
Clinical narrative: bleeds were difficult to stop (lasting 15 or more minutes) and with clots; severe nosebleeds; This is spontaneous report from received via health authorities from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 27Apr2021 05:15 pm (Batch/Lot Number: EW0170) as single dose for covid-19 immunisation. Patient is not pregnant. Medical history included hashimotos, von willenbrands type 1. And patient avoided gluten and dairy for autoimmune disease. Concomitant medication(s) included levothyroxine sodium (SYNTHYROID) and methylfolate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Brand synthroid 200 mcg, multivitamin, l-methylfol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8734) administered in right arm on 06Apr2021 06:00 pm for covid-19 immunisation. About 36 to 48 hours after receiving dose number 2 for the covid pfizer vaccine, patient began to have recurring severe nosebleeds on 29Apr2021 16:00. The bleeds were difficult to stop (lasting 15 or more minutes) and with clots. These lasted daily for 3 to 4 days and then ceased completely. Patient met virtually with hematologist, and he encouraged repeat PTT/PT bloodwork and visit to ENT. Met with doctor, ENT. There were no structural issues in the nose and bloodwork came back normal, so both concluded that vaccine may be cause of bleeds. The adverse events result in doctor or other healthcare professional office/clinic visit. Patient underwent hematology bloodwork, ENT exam. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The event outcome for events was recovered on unspecified date.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angina pectoris, Chest discomfort
Clinical narrative: heart inflammation symptoms; experienced chest tightness/pain in heart area; experienced chest tightness/pain in heart area; weight gain; lack of good sleep; fever; fatigue; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration, administered in left arm at the age of 32-years-old on 11Feb2021 14:00 (Lot Number: EN6201) as single dose for covid-19 immunisation.  Medical history included obesity. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration, administered in left arm at the age of 32-years-old on 21Jan2021 13:30 (Lot Number: EL9262) as single dose for covid-19 immunisation. In the weeks after second vaccine dose, experienced chest tightness/pain in heart area. At the time the patient thought this was due to recent weight gain and lack of good sleep, however now the patient believe it was related to the heart inflammation symptoms reported in the media. The tightness/pain was intermittent meaning it did not occur all the time, but the patient would feel it for some part of the day and it would recur. This lasted for about a month and seems to have gotten better. However, the patient was about to schedule an appointment with a cardiologist in order to get this looked at as the patient was worried of what other unknown side effects will be in time. The patient didn't have an exact date it started, but it was some days maybe even a week after the second shot, after the initial symptoms of fever and fatigue that occur in the days immediately after the second dose. All the events started on 18Feb2021. The patient didn't receive treatment received for the adverse events. The case was reported as non-serious. The outcome of the events was unknown.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac infection, Chest discomfort, Chest pain, Fatigue, Poor quality sleep
Clinical narrative: heart inflammation symptoms; experienced chest tightness/pain in heart area; experienced chest tightness/pain in heart area; weight gain; lack of good sleep; fever; fatigue; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration, administered in left arm at the age of 32-years-old on 11Feb2021 14:00 (Lot Number: EN6201) as single dose for covid-19 immunisation.  Medical history included obesity. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration, administered in left arm at the age of 32-years-old on 21Jan2021 13:30 (Lot Number: EL9262) as single dose for covid-19 immunisation. In the weeks after second vaccine dose, experienced chest tightness/pain in heart area. At the time the patient thought this was due to recent weight gain and lack of good sleep, however now the patient believe it was related to the heart inflammation symptoms reported in the media. The tightness/pain was intermittent meaning it did not occur all the time, but the patient would feel it for some part of the day and it would recur. This lasted for about a month and seems to have gotten better. However, the patient was about to schedule an appointment with a cardiologist in order to get this looked at as the patient was worried of what other unknown side effects will be in time. The patient didn't have an exact date it started, but it was some days maybe even a week after the second shot, after the initial symptoms of fever and fatigue that occur in the days immediately after the second dose. All the events started on 18Feb2021. The patient didn't receive treatment received for the adverse events. The case was reported as non-serious. The outcome of the events was unknown.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Weight, Weight increased
Clinical narrative: heart inflammation symptoms; experienced chest tightness/pain in heart area; experienced chest tightness/pain in heart area; weight gain; lack of good sleep; fever; fatigue; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration, administered in left arm at the age of 32-years-old on 11Feb2021 14:00 (Lot Number: EN6201) as single dose for covid-19 immunisation.  Medical history included obesity. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration, administered in left arm at the age of 32-years-old on 21Jan2021 13:30 (Lot Number: EL9262) as single dose for covid-19 immunisation. In the weeks after second vaccine dose, experienced chest tightness/pain in heart area. At the time the patient thought this was due to recent weight gain and lack of good sleep, however now the patient believe it was related to the heart inflammation symptoms reported in the media. The tightness/pain was intermittent meaning it did not occur all the time, but the patient would feel it for some part of the day and it would recur. This lasted for about a month and seems to have gotten better. However, the patient was about to schedule an appointment with a cardiologist in order to get this looked at as the patient was worried of what other unknown side effects will be in time. The patient didn't have an exact date it started, but it was some days maybe even a week after the second shot, after the initial symptoms of fever and fatigue that occur in the days immediately after the second dose. All the events started on 18Feb2021. The patient didn't receive treatment received for the adverse events. The case was reported as non-serious. The outcome of the events was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Colitis, Colonoscopy, Crohn's disease, Haematochezia
Clinical narrative: ulcerative colitis or crohns; ulcerative colitis or crohns; having bloody mucus in stool; This is a spontaneous report from a contactable consumer (patient). A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 13Apr2021 08:30 pm (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation. Patient is not pregnant. There were no medical history and no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No known allergies. Three days after patient first vaccine (on 16Apr2021 05:30 am), the one patient input for this, patient started having bloody mucus in her stool. Now 2 months later she was diagnosed with ulcerative colitis or crohns, diagnosed via colonoscopy. Patient had never had this before and as far as she know it is not in her family. Since it is an autoimmune disease, and the timing of the onset, she believed it very likely was caused by the vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment received including Mesalamine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has been tested for COVID-19 included nasal swab on 19May2021 with negative result. Seriousness criteria: Disabling/Incapacitating. Facility where the most recent COVID-19 vaccine was administered at pharmacy or drug store. The event outcome for all events was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mucous stools
Clinical narrative: ulcerative colitis or crohns; ulcerative colitis or crohns; having bloody mucus in stool; This is a spontaneous report from a contactable consumer (patient). A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 13Apr2021 08:30 pm (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation. Patient is not pregnant. There were no medical history and no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No known allergies. Three days after patient first vaccine (on 16Apr2021 05:30 am), the one patient input for this, patient started having bloody mucus in her stool. Now 2 months later she was diagnosed with ulcerative colitis or crohns, diagnosed via colonoscopy. Patient had never had this before and as far as she know it is not in her family. Since it is an autoimmune disease, and the timing of the onset, she believed it very likely was caused by the vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment received including Mesalamine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has been tested for COVID-19 included nasal swab on 19May2021 with negative result. Seriousness criteria: Disabling/Incapacitating. Facility where the most recent COVID-19 vaccine was administered at pharmacy or drug store. The event outcome for all events was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colitis ulcerative, Colonoscopy, Crohn's disease, Haematochezia, SARS-CoV-2 test
Clinical narrative: ulcerative colitis or crohns; ulcerative colitis or crohns; having bloody mucus in stool; This is a spontaneous report from a contactable consumer (patient). A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 13Apr2021 08:30 pm (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation. Patient is not pregnant. There were no medical history and no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No known allergies. Three days after patient first vaccine (on 16Apr2021 05:30 am), the one patient input for this, patient started having bloody mucus in her stool. Now 2 months later she was diagnosed with ulcerative colitis or crohns, diagnosed via colonoscopy. Patient had never had this before and as far as she know it is not in her family. Since it is an autoimmune disease, and the timing of the onset, she believed it very likely was caused by the vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment received including Mesalamine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has been tested for COVID-19 included nasal swab on 19May2021 with negative result. Seriousness criteria: Disabling/Incapacitating. Facility where the most recent COVID-19 vaccine was administered at pharmacy or drug store. The event outcome for all events was not recovered.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, Troponin increased
Clinical narrative: Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; This is spontaneous report from contactable Physician. A 14-year-old male (patient) received second dose of BNT162B2 on 03Jun2021 (at age of 14-year-old) lot number: EW0153, Intramuscular on left arm for COVID-19 immunization. Medical history included autism, allergy to Latex, gluten, kiwi extract, peantus, Allergic rhinitis. Historical vaccine included first dose of BNT162B2 on 13May2021 (at age of 14-year-old) Lot number: EW0175, Intramuscular on Left arm for COVID-19 immunization. The patient previously took Neosporin and experienced allergy. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fluoxetine hydrochloride (PROZAC), ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN), docusate sodium (COLACE). Facility COVID-19 vaccine was administered was Hospital. Patient with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis on 04Jun2021. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. The patient was hospitalized for the events.; Sender's Comments: The events chest pain, myocarditis and troponin increase are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Echocardiogram normal, Magnetic resonance imaging heart, Troponin, Troponin increased
Clinical narrative: Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; This is spontaneous report from contactable Physician. A 14-year-old male (patient) received second dose of BNT162B2 on 03Jun2021 (at age of 14-year-old) lot number: EW0153, Intramuscular on left arm for COVID-19 immunization. Medical history included autism, allergy to Latex, gluten, kiwi extract, peantus, Allergic rhinitis. Historical vaccine included first dose of BNT162B2 on 13May2021 (at age of 14-year-old) Lot number: EW0175, Intramuscular on Left arm for COVID-19 immunization. The patient previously took Neosporin and experienced allergy. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fluoxetine hydrochloride (PROZAC), ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN), docusate sodium (COLACE). Facility COVID-19 vaccine was administered was Hospital. Patient with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis on 04Jun2021. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. The patient was hospitalized for the events.; Sender's Comments: The events chest pain, myocarditis and troponin increase are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Chest pain, Echocardiogram normal, Electrocardiogram abnormal, Full blood count
Clinical narrative: Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; This is spontaneous report from contactable Physician. A 14-year-old male (patient) received second dose of BNT162B2 on 03Jun2021 (at age of 14-year-old) lot number: EW0153, Intramuscular on left arm for COVID-19 immunization. Medical history included autism, allergy to Latex, gluten, kiwi extract, peantus, Allergic rhinitis. Historical vaccine included first dose of BNT162B2 on 13May2021 (at age of 14-year-old) Lot number: EW0175, Intramuscular on Left arm for COVID-19 immunization. The patient previously took Neosporin and experienced allergy. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fluoxetine hydrochloride (PROZAC), ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN), docusate sodium (COLACE). Facility COVID-19 vaccine was administered was Hospital. Patient with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis on 04Jun2021. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. The patient was hospitalized for the events.; Sender's Comments: The events chest pain, myocarditis and troponin increase are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Magnetic resonance imaging normal, Respiratory viral panel, SARS-CoV-2 test, Troponin increased
Clinical narrative: Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; This is spontaneous report from contactable Physician. A 14-year-old male (patient) received second dose of BNT162B2 on 03Jun2021 (at age of 14-year-old) lot number: EW0153, Intramuscular on left arm for COVID-19 immunization. Medical history included autism, allergy to Latex, gluten, kiwi extract, peantus, Allergic rhinitis. Historical vaccine included first dose of BNT162B2 on 13May2021 (at age of 14-year-old) Lot number: EW0175, Intramuscular on Left arm for COVID-19 immunization. The patient previously took Neosporin and experienced allergy. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fluoxetine hydrochloride (PROZAC), ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN), docusate sodium (COLACE). Facility COVID-19 vaccine was administered was Hospital. Patient with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis on 04Jun2021. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. The patient was hospitalized for the events.; Sender's Comments: The events chest pain, myocarditis and troponin increase are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Ultrasound chest
Clinical narrative: Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; This is spontaneous report from contactable Physician. A 14-year-old male (patient) received second dose of BNT162B2 on 03Jun2021 (at age of 14-year-old) lot number: EW0153, Intramuscular on left arm for COVID-19 immunization. Medical history included autism, allergy to Latex, gluten, kiwi extract, peantus, Allergic rhinitis. Historical vaccine included first dose of BNT162B2 on 13May2021 (at age of 14-year-old) Lot number: EW0175, Intramuscular on Left arm for COVID-19 immunization. The patient previously took Neosporin and experienced allergy. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fluoxetine hydrochloride (PROZAC), ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN), docusate sodium (COLACE). Facility COVID-19 vaccine was administered was Hospital. Patient with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis on 04Jun2021. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. The patient was hospitalized for the events.; Sender's Comments: The events chest pain, myocarditis and troponin increase are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Echocardiogram, Myocarditis, Troponin, Troponin increased
Clinical narrative: Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; Pt with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis.; This is spontaneous report from contactable Physician. A 14-year-old male (patient) received second dose of BNT162B2 on 03Jun2021 (at age of 14-year-old) lot number: EW0153, Intramuscular on left arm for COVID-19 immunization. Medical history included autism, allergy to Latex, gluten, kiwi extract, peantus, Allergic rhinitis. Historical vaccine included first dose of BNT162B2 on 13May2021 (at age of 14-year-old) Lot number: EW0175, Intramuscular on Left arm for COVID-19 immunization. The patient previously took Neosporin and experienced allergy. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fluoxetine hydrochloride (PROZAC), ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN), docusate sodium (COLACE). Facility COVID-19 vaccine was administered was Hospital. Patient with elevated troponin and right sided chest pain with normal echo concerning for mild myocarditis on 04Jun2021. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. The patient was hospitalized for the events.; Sender's Comments: The events chest pain, myocarditis and troponin increase are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blindness, Blood test normal, Computerised tomogram normal, Hypoaesthesia
Clinical narrative: loss of eyesight in lower right eye on March 19; muscle weakness; severe stabbing nerve pain,; muscle fatigue; This is a spontaneous report from a contactable consumer reported for herself. A 67-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 01Mar2021 05:30 PM at age of 67 year old for COVID-19 immunization. Medical history included chronic eosinophilia and hypothyroidism. The patient was not pregnant at the time of vaccination. Concomitant medications included mepolizumab (NUCALA) on 09Feb2021, levothyroxine, acetylsalicylic acid (ASPIRIN 81) and multivitamin. The patient had other vaccine in four weeks on 09Feb2021 in the left arm. The patient experienced severe stabbing nerve pain, muscle weakness, muscle fatigue, beginning in shoulders, then lower back, both lower legs and finalizing in ankles and feet on 02Mar2021 20:15. The patient experienced loss of eyesight in lower right eye on 19Mar2021 at 5:00 p.m. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient was hospitalized for 4 days. Treatment was received for the events with Saline IV Flush and Salmedurol on 2nd stay on. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 22Mar2021 05:30 PM  for COVID-19 immunization. The patient had Covid test post vaccination via nasal swab on 03Apr2021 with negative result. Outcome of the events was recovering.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Pain, Pain in extremity, Paraesthesia, Ultrasound scan normal
Clinical narrative: loss of eyesight in lower right eye on March 19; muscle weakness; severe stabbing nerve pain,; muscle fatigue; This is a spontaneous report from a contactable consumer reported for herself. A 67-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 01Mar2021 05:30 PM at age of 67 year old for COVID-19 immunization. Medical history included chronic eosinophilia and hypothyroidism. The patient was not pregnant at the time of vaccination. Concomitant medications included mepolizumab (NUCALA) on 09Feb2021, levothyroxine, acetylsalicylic acid (ASPIRIN 81) and multivitamin. The patient had other vaccine in four weeks on 09Feb2021 in the left arm. The patient experienced severe stabbing nerve pain, muscle weakness, muscle fatigue, beginning in shoulders, then lower back, both lower legs and finalizing in ankles and feet on 02Mar2021 20:15. The patient experienced loss of eyesight in lower right eye on 19Mar2021 at 5:00 p.m. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient was hospitalized for 4 days. Treatment was received for the events with Saline IV Flush and Salmedurol on 2nd stay on. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 22Mar2021 05:30 PM  for COVID-19 immunization. The patient had Covid test post vaccination via nasal swab on 03Apr2021 with negative result. Outcome of the events was recovering.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness, Muscle fatigue, Muscular weakness, Neuralgia, SARS-CoV-2 test
Clinical narrative: loss of eyesight in lower right eye on March 19; muscle weakness; severe stabbing nerve pain,; muscle fatigue; This is a spontaneous report from a contactable consumer reported for herself. A 67-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 01Mar2021 05:30 PM at age of 67 year old for COVID-19 immunization. Medical history included chronic eosinophilia and hypothyroidism. The patient was not pregnant at the time of vaccination. Concomitant medications included mepolizumab (NUCALA) on 09Feb2021, levothyroxine, acetylsalicylic acid (ASPIRIN 81) and multivitamin. The patient had other vaccine in four weeks on 09Feb2021 in the left arm. The patient experienced severe stabbing nerve pain, muscle weakness, muscle fatigue, beginning in shoulders, then lower back, both lower legs and finalizing in ankles and feet on 02Mar2021 20:15. The patient experienced loss of eyesight in lower right eye on 19Mar2021 at 5:00 p.m. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient was hospitalized for 4 days. Treatment was received for the events with Saline IV Flush and Salmedurol on 2nd stay on. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 22Mar2021 05:30 PM  for COVID-19 immunization. The patient had Covid test post vaccination via nasal swab on 03Apr2021 with negative result. Outcome of the events was recovering.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Burning sensation, Feeling hot, Oral pruritus, Pruritus
Clinical narrative: Itching on tongue, throat, asthma attacks, swollen face, redness in face, itching on skin, lump in throat. Initial event(Itching on tongue, throat, skim). The other effects occurred in the days following, some events re-occurring (particularly facial swelling) for over a month.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensation of foreign body, Swelling face, Throat irritation, Tongue pruritus
Clinical narrative: Itching on tongue, throat, asthma attacks, swollen face, redness in face, itching on skin, lump in throat. Initial event(Itching on tongue, throat, skim). The other effects occurred in the days following, some events re-occurring (particularly facial swelling) for over a month.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Condition aggravated, Erythema, Pruritus, SARS-CoV-2 test negative
Clinical narrative: Itching on tongue, throat, asthma attacks, swollen face, redness in face, itching on skin, lump in throat. Initial event(Itching on tongue, throat, skim). The other effects occurred in the days following, some events re-occurring (particularly facial swelling) for over a month.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Babinski reflex test, Ear pain, Eye movement disorder, Facial pain
Clinical narrative: Feeling faint; Almost losing consciousness; Presents with acute, worsening muscle spasms in back and arms (pt couldn't put a cracker in her mouth due to her muscles "locking"); Rolling her eyes; This is a spontaneous report from a contactable consumer. This consumer reported for a 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ew0180) Intramuscular at left deltoid at single dose for COVID-19 immunisation on 05Jun2021. Relevant medical history included asthma, peripheral fibromyalgia, tremors, and feeling faint/dizzy with previous vaccinations. Relevant concomitant drugs were unknown.  The patient previously received a tetanus shot (TDAP) with GI side effects (nauseous) on 01Jan2021. During the shot, the patient requested that the pharmacy intern administer the vaccine slowly because she doesn't like vaccines. The patient experienced acute, worsening muscle spasms in back and arms (patient couldn't put a cracker in her mouth due to her muscles "locking"), rolling her eyes/feeling faint and almost losing consciousness 05Jun2021 at 15:30. The patient didn't have trouble breathing and refused her albuterol inhaler. The patient was taken to emergency room/department or urgent care. Treatment therapy included 1/4 tablet of diphenhydramine 10mg. The patient stated she's 'very sensitive' to this medication because it's 'very effective'. The final outcome of events was unknown.      Information on Lot/Batch number was available. Additional information has been requested.