chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test, Seizure
Clinical narrative: Had a seizure; This is a spontaneous report from a contactable consumer (patient self).  A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Solution for injection, via an unspecified route of administration, administered in Arm Right on 19Apr2021 11:00 (Lot Number: EW0170) as dose 1, single (at the age of 75-year-old) for COVID-19 immunisation.  Medical history included ongoing controlled high blood pressure. Concomitant medications included amlodipine; hctz; simvastatin.  Prior to vaccination, the patient did not diagnose with COVID-19.  There was no other vaccine in four weeks. Facility type vaccine: Pharmacy or Drug store.  The patient had a seizure on 23Apr2021 19:30 which resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 1 day in 2021.  The patient underwent lab tests and procedures which included Covid Blood test of Antibody post vaccination: positive on 11Jun2021, Covid 19 test post vaccination: negative on 23Apr2021. No treatment received. Outcome of the event was resolved in 2021.  Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Headache, Lymphadenopathy
Clinical narrative: fever; severe headache; nausea; abdominal pain; swollen lymph nodes; injection site pain; full body ache; chills; diarrhea; decreased appetite; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer(patient).   A 42-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ew0172 expiration date: unknown) via an unspecified route of administration, in the left arm 04May2021 04:45 PM (at the age of 42 years) as dose 2, single for covid-19 immunisation. Medical history included, arrhythmia, hypothyroid and undifferentiated connective tissue disorder all from an unknown date and unknown if ongoing. Known allergies peanuts and tree nuts were reported. Prior to vaccination patient was not diagnosed with COVID-19 and was not tested for it since the vaccination. Concomitant medications included pregabalin (LYRICA), levothyroxine, flecainide, drospirenone, ethinylestradiol (OCELLA), and omeprazole (OMEPRAZ) all taken for an unspecified indication. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: er8731 expiration date: unknown) via an unspecified route of administration in the left arm on 13Apr2021 at 05:15 PM as dose 1, single for COVID-19 immunization. The patient did not receive any vaccines within four weeks prior to the vaccination. On 04May2021 at 17:15, the patient experienced fever, severe headache, nausea, abdominal pain, swollen lymph nodes, injection site pain, full body ache, chills, diarrhea, decreased appetite, muscle and joint pain. The patient had received treatment for event with tylenol, ibuprofen and ondansetron. The outcome of events was reported as not resolved.  No follow-up attempts were possible; no further information expected
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: fever; severe headache; nausea; abdominal pain; swollen lymph nodes; injection site pain; full body ache; chills; diarrhea; decreased appetite; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer(patient).   A 42-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ew0172 expiration date: unknown) via an unspecified route of administration, in the left arm 04May2021 04:45 PM (at the age of 42 years) as dose 2, single for covid-19 immunisation. Medical history included, arrhythmia, hypothyroid and undifferentiated connective tissue disorder all from an unknown date and unknown if ongoing. Known allergies peanuts and tree nuts were reported. Prior to vaccination patient was not diagnosed with COVID-19 and was not tested for it since the vaccination. Concomitant medications included pregabalin (LYRICA), levothyroxine, flecainide, drospirenone, ethinylestradiol (OCELLA), and omeprazole (OMEPRAZ) all taken for an unspecified indication. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: er8731 expiration date: unknown) via an unspecified route of administration in the left arm on 13Apr2021 at 05:15 PM as dose 1, single for COVID-19 immunization. The patient did not receive any vaccines within four weeks prior to the vaccination. On 04May2021 at 17:15, the patient experienced fever, severe headache, nausea, abdominal pain, swollen lymph nodes, injection site pain, full body ache, chills, diarrhea, decreased appetite, muscle and joint pain. The patient had received treatment for event with tylenol, ibuprofen and ondansetron. The outcome of events was reported as not resolved.  No follow-up attempts were possible; no further information expected
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Body temperature, Chills, Decreased appetite
Clinical narrative: fever; severe headache; nausea; abdominal pain; swollen lymph nodes; injection site pain; full body ache; chills; diarrhea; decreased appetite; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer(patient).   A 42-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ew0172 expiration date: unknown) via an unspecified route of administration, in the left arm 04May2021 04:45 PM (at the age of 42 years) as dose 2, single for covid-19 immunisation. Medical history included, arrhythmia, hypothyroid and undifferentiated connective tissue disorder all from an unknown date and unknown if ongoing. Known allergies peanuts and tree nuts were reported. Prior to vaccination patient was not diagnosed with COVID-19 and was not tested for it since the vaccination. Concomitant medications included pregabalin (LYRICA), levothyroxine, flecainide, drospirenone, ethinylestradiol (OCELLA), and omeprazole (OMEPRAZ) all taken for an unspecified indication. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: er8731 expiration date: unknown) via an unspecified route of administration in the left arm on 13Apr2021 at 05:15 PM as dose 1, single for COVID-19 immunization. The patient did not receive any vaccines within four weeks prior to the vaccination. On 04May2021 at 17:15, the patient experienced fever, severe headache, nausea, abdominal pain, swollen lymph nodes, injection site pain, full body ache, chills, diarrhea, decreased appetite, muscle and joint pain. The patient had received treatment for event with tylenol, ibuprofen and ondansetron. The outcome of events was reported as not resolved.  No follow-up attempts were possible; no further information expected
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Headache, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: fever; severe headache; nausea; abdominal pain; swollen lymph nodes; injection site pain; full body ache; chills; diarrhea; decreased appetite; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer(patient).   A 42-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ew0172 expiration date: unknown) via an unspecified route of administration, in the left arm 04May2021 04:45 PM (at the age of 42 years) as dose 2, single for covid-19 immunisation. Medical history included, arrhythmia, hypothyroid and undifferentiated connective tissue disorder all from an unknown date and unknown if ongoing. Known allergies peanuts and tree nuts were reported. Prior to vaccination patient was not diagnosed with COVID-19 and was not tested for it since the vaccination. Concomitant medications included pregabalin (LYRICA), levothyroxine, flecainide, drospirenone, ethinylestradiol (OCELLA), and omeprazole (OMEPRAZ) all taken for an unspecified indication. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: er8731 expiration date: unknown) via an unspecified route of administration in the left arm on 13Apr2021 at 05:15 PM as dose 1, single for COVID-19 immunization. The patient did not receive any vaccines within four weeks prior to the vaccination. On 04May2021 at 17:15, the patient experienced fever, severe headache, nausea, abdominal pain, swollen lymph nodes, injection site pain, full body ache, chills, diarrhea, decreased appetite, muscle and joint pain. The patient had received treatment for event with tylenol, ibuprofen and ondansetron. The outcome of events was reported as not resolved.  No follow-up attempts were possible; no further information expected
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: fever; severe headache; nausea; abdominal pain; swollen lymph nodes; injection site pain; full body ache; chills; diarrhea; decreased appetite; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer(patient).   A 42-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ew0172 expiration date: unknown) via an unspecified route of administration, in the left arm 04May2021 04:45 PM (at the age of 42 years) as dose 2, single for covid-19 immunisation. Medical history included, arrhythmia, hypothyroid and undifferentiated connective tissue disorder all from an unknown date and unknown if ongoing. Known allergies peanuts and tree nuts were reported. Prior to vaccination patient was not diagnosed with COVID-19 and was not tested for it since the vaccination. Concomitant medications included pregabalin (LYRICA), levothyroxine, flecainide, drospirenone, ethinylestradiol (OCELLA), and omeprazole (OMEPRAZ) all taken for an unspecified indication. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: er8731 expiration date: unknown) via an unspecified route of administration in the left arm on 13Apr2021 at 05:15 PM as dose 1, single for COVID-19 immunization. The patient did not receive any vaccines within four weeks prior to the vaccination. On 04May2021 at 17:15, the patient experienced fever, severe headache, nausea, abdominal pain, swollen lymph nodes, injection site pain, full body ache, chills, diarrhea, decreased appetite, muscle and joint pain. The patient had received treatment for event with tylenol, ibuprofen and ondansetron. The outcome of events was reported as not resolved.  No follow-up attempts were possible; no further information expected
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: hearing loss bilat., high tones; tinnitus in both ears which has become progressively louder and varied since that time; The initial safety information received was reporting only non-serious adverse drug reaction, upon receipt of follow-up information on (09Jul2021), this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 19Mar2021 12:00 (Lot Number: EP6955) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypothyroidism from 1996 and ongoing. Concomitant medication included levothyroxine sodium for hypothyroidism from an unspecified start date and ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), intramuscularly in the left arm on 26Feb2021 at 12:00 PM (at the age of 67- years) for COVID-19 immunization. On 25Mar2021, approximately 5 days after second shot, the patient developed tinnitus in both ears which has become progressively louder and varied since that time. Symptoms were not just noise but feels like it effects the brain like someone turns a switch on and hammering starts. On 23Jun2021, the patient underwent hearing test which revealed hearing loss bilat., high tones. Unknown baseline prior to this testing. The events resulted in doctor or other healthcare professional office/clinic visit. Evaluated by PCP+ ENT doctor and stated that it was not the ears but auditory nerve issue; some hearing loss both ears at higher range. No imbalance issue just various noises, still three months later seems a little less. No treatment was given for the events, advised to just wait and hope it would subside. The events were reported as serious (persistent/significant disability/incapacity). The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The events of  Tinnitus and Hypoacusis are assessed as possibly related to the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) 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
Symptoms: Acoustic stimulation tests, Hypoacusis, Tinnitus
Clinical narrative: hearing loss bilat., high tones; tinnitus in both ears which has become progressively louder and varied since that time; The initial safety information received was reporting only non-serious adverse drug reaction, upon receipt of follow-up information on (09Jul2021), this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 19Mar2021 12:00 (Lot Number: EP6955) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypothyroidism from 1996 and ongoing. Concomitant medication included levothyroxine sodium for hypothyroidism from an unspecified start date and ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), intramuscularly in the left arm on 26Feb2021 at 12:00 PM (at the age of 67- years) for COVID-19 immunization. On 25Mar2021, approximately 5 days after second shot, the patient developed tinnitus in both ears which has become progressively louder and varied since that time. Symptoms were not just noise but feels like it effects the brain like someone turns a switch on and hammering starts. On 23Jun2021, the patient underwent hearing test which revealed hearing loss bilat., high tones. Unknown baseline prior to this testing. The events resulted in doctor or other healthcare professional office/clinic visit. Evaluated by PCP+ ENT doctor and stated that it was not the ears but auditory nerve issue; some hearing loss both ears at higher range. No imbalance issue just various noises, still three months later seems a little less. No treatment was given for the events, advised to just wait and hope it would subside. The events were reported as serious (persistent/significant disability/incapacity). The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The events of  Tinnitus and Hypoacusis are assessed as possibly related to the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) 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: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Electrocardiogram, X-ray
Clinical narrative: Severe Chest pains 36 hours after second dose; This is a spontaneous report from a contactable other health care professional (patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0173, expiry date: unknown) via unspecified route of administration, in right arm, on 07May2021 16:15 (at the age of 52-year-old) as DOSE 2, single, for Covid-19 immunization at school or student health clinic. Patient's medical history was not reported. she had no known allergies. The patient did not take any other vaccines in four weeks and no other medications in two weeks. She did not experience Covid-19 before vaccine and was not tested for Covid after vaccination. Patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; lot number: EW0158, expiry date: unknown), via unspecified route of administration in left arm, on 16Apr2021 at 09:30 AM (at the age of 52-year-old), as DOSE 1, SINGLE for Covid-19 immunization at school or student health clinic. On 09May2021 07:00 AM, 36 hours after second dose, the patient experienced severe chest pains. The adverse event resulted in emergency room/department or urgent care visit. Treatment was given as a result of the adverse event. The patient underwent lab tests which included Bloodwork, chest X-rays, EKG with unknown results on an unspecified date. The outcome of event was resolving.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: afternoon fatigue; leg pains; shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp.     A 71-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EW0167), dose 2 intramuscularly, administered in Arm Left on 21May2021 10:50 as dose 2, single for covid-19 immunisation. Medical history included, ongoing osteoarthritis, ongoing blood cholesterol increased Five years ago, drug intolerance decades ago. Concomitant medication(s) included paroxetine hydrochloride hemihydrate taken for anxiety. The patient did not receive any other vaccine in four weeks. It was reported that, the patient experienced shortness of breath on 25May2021 with outcome of recovered, leg pains on 26May2021 with outcome of recovered, afternoon fatigue on 10Jun2021 with outcome of recovered.  The patient underwent lab tests and procedures which included x-ray: unknown result on 10May2021 Right Hip. No treatment was received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Pain in extremity, X-ray
Clinical narrative: afternoon fatigue; leg pains; shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp.     A 71-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EW0167), dose 2 intramuscularly, administered in Arm Left on 21May2021 10:50 as dose 2, single for covid-19 immunisation. Medical history included, ongoing osteoarthritis, ongoing blood cholesterol increased Five years ago, drug intolerance decades ago. Concomitant medication(s) included paroxetine hydrochloride hemihydrate taken for anxiety. The patient did not receive any other vaccine in four weeks. It was reported that, the patient experienced shortness of breath on 25May2021 with outcome of recovered, leg pains on 26May2021 with outcome of recovered, afternoon fatigue on 10Jun2021 with outcome of recovered.  The patient underwent lab tests and procedures which included x-ray: unknown result on 10May2021 Right Hip. No treatment was received.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site bruising, Pain in extremity, Sleep disorder
Clinical narrative: My left arm keeps getting bruised and blood clot looking things all over my left arm which is where I got both vaccines. I have had a loss of vision and seeing little black floating dots and have lost over 10 pounds since without working out.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blindness, Contusion, Skin discolouration, Vitreous floaters, Weight decreased
Clinical narrative: My left arm keeps getting bruised and blood clot looking things all over my left arm which is where I got both vaccines. I have had a loss of vision and seeing little black floating dots and have lost over 10 pounds since without working out.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Contusion, Fatigue, Injection site pain, Malaise, Pain
Clinical narrative: My left arm keeps getting bruised and blood clot looking things all over my left arm which is where I got both vaccines. I have had a loss of vision and seeing little black floating dots and have lost over 10 pounds since without working out.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: My left arm keeps getting bruised and blood clot looking things all over my left arm which is where I got both vaccines. I have had a loss of vision and seeing little black floating dots and have lost over 10 pounds since without working out.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary normal, Catheterisation cardiac normal, Chest discomfort, Chest pain, Chills
Clinical narrative: On Sunday the 30th, 18 days after the second dose of the Pfizer vaccine, I started to develop chest pains around 4:00 PM. I figured it was a normal occurence as I have allergenic asthma. The chest pains grew more intense and did not go away so I checked into ER at HOSPITAL. They admitted me to a room, ran multiple forms of heart tests, eventually sent me to the cardiac unit at Hospital in, and diagnosed me with myopericarditis. The cardiologist that was monitoring me the full 2 days I was in the hospital said this was caused by the COVID 19 Vaccine. As of today July 18th, I am still recovering from this incident, now have to take medication twice a day for the myopericarditis, am now a heart patient at a cardiology center, and have been told by doctors that they can't guarantee that there wont be any more problems to occur down the road. The cardiologist I'm currently seeing said he doesn't know the state of my heart yet, and there are still more medical tests to be done.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Diarrhoea, Drug screen negative, Echocardiogram, Electrocardiogram ST segment elevation
Clinical narrative: On Sunday the 30th, 18 days after the second dose of the Pfizer vaccine, I started to develop chest pains around 4:00 PM. I figured it was a normal occurence as I have allergenic asthma. The chest pains grew more intense and did not go away so I checked into ER at HOSPITAL. They admitted me to a room, ran multiple forms of heart tests, eventually sent me to the cardiac unit at Hospital in, and diagnosed me with myopericarditis. The cardiologist that was monitoring me the full 2 days I was in the hospital said this was caused by the COVID 19 Vaccine. As of today July 18th, I am still recovering from this incident, now have to take medication twice a day for the myopericarditis, am now a heart patient at a cardiology center, and have been told by doctors that they can't guarantee that there wont be any more problems to occur down the road. The cardiologist I'm currently seeing said he doesn't know the state of my heart yet, and there are still more medical tests to be done.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Nausea, Pyrexia, Sinusitis, Troponin increased
Clinical narrative: On Sunday the 30th, 18 days after the second dose of the Pfizer vaccine, I started to develop chest pains around 4:00 PM. I figured it was a normal occurence as I have allergenic asthma. The chest pains grew more intense and did not go away so I checked into ER at HOSPITAL. They admitted me to a room, ran multiple forms of heart tests, eventually sent me to the cardiac unit at Hospital in, and diagnosed me with myopericarditis. The cardiologist that was monitoring me the full 2 days I was in the hospital said this was caused by the COVID 19 Vaccine. As of today July 18th, I am still recovering from this incident, now have to take medication twice a day for the myopericarditis, am now a heart patient at a cardiology center, and have been told by doctors that they can't guarantee that there wont be any more problems to occur down the road. The cardiologist I'm currently seeing said he doesn't know the state of my heart yet, and there are still more medical tests to be done.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Viral infection, Vomiting
Clinical narrative: On Sunday the 30th, 18 days after the second dose of the Pfizer vaccine, I started to develop chest pains around 4:00 PM. I figured it was a normal occurence as I have allergenic asthma. The chest pains grew more intense and did not go away so I checked into ER at HOSPITAL. They admitted me to a room, ran multiple forms of heart tests, eventually sent me to the cardiac unit at Hospital in, and diagnosed me with myopericarditis. The cardiologist that was monitoring me the full 2 days I was in the hospital said this was caused by the COVID 19 Vaccine. As of today July 18th, I am still recovering from this incident, now have to take medication twice a day for the myopericarditis, am now a heart patient at a cardiology center, and have been told by doctors that they can't guarantee that there wont be any more problems to occur down the road. The cardiologist I'm currently seeing said he doesn't know the state of my heart yet, and there are still more medical tests to be done.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blood test, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: On Sunday the 30th, 18 days after the second dose of the Pfizer vaccine, I started to develop chest pains around 4:00 PM. I figured it was a normal occurence as I have allergenic asthma. The chest pains grew more intense and did not go away so I checked into ER at HOSPITAL. They admitted me to a room, ran multiple forms of heart tests, eventually sent me to the cardiac unit at Hospital in, and diagnosed me with myopericarditis. The cardiologist that was monitoring me the full 2 days I was in the hospital said this was caused by the COVID 19 Vaccine. As of today July 18th, I am still recovering from this incident, now have to take medication twice a day for the myopericarditis, am now a heart patient at a cardiology center, and have been told by doctors that they can't guarantee that there wont be any more problems to occur down the road. The cardiologist I'm currently seeing said he doesn't know the state of my heart yet, and there are still more medical tests to be done.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Vaccination complication
Clinical narrative: On Sunday the 30th, 18 days after the second dose of the Pfizer vaccine, I started to develop chest pains around 4:00 PM. I figured it was a normal occurence as I have allergenic asthma. The chest pains grew more intense and did not go away so I checked into ER at HOSPITAL. They admitted me to a room, ran multiple forms of heart tests, eventually sent me to the cardiac unit at Hospital in, and diagnosed me with myopericarditis. The cardiologist that was monitoring me the full 2 days I was in the hospital said this was caused by the COVID 19 Vaccine. As of today July 18th, I am still recovering from this incident, now have to take medication twice a day for the myopericarditis, am now a heart patient at a cardiology center, and have been told by doctors that they can't guarantee that there wont be any more problems to occur down the road. The cardiologist I'm currently seeing said he doesn't know the state of my heart yet, and there are still more medical tests to be done.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Body temperature, Chills, Fatigue, Nausea
Clinical narrative: fever; chills; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9267), via an unspecified route of administration in the left arm on 05Mar2021 at 15:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis and graves disease. The patient did not have a history of allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included vitamin d (MANUFACTURER UNKNOWN) for unknown indication and calcium (MANUFACTURER UNKNOWN) for unknown indication. On 12Mar2021, the patient had experienced fever, chills and fatigue. The patient had extreme fatigue three weeks later. The patient did not receive any other treatment for the reported events. Adverse events resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the events fever, chills, and extreme fatigue was not resolved at the time of this report.  No follow up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: fever; chills; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9267), via an unspecified route of administration in the left arm on 05Mar2021 at 15:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis and graves disease. The patient did not have a history of allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included vitamin d (MANUFACTURER UNKNOWN) for unknown indication and calcium (MANUFACTURER UNKNOWN) for unknown indication. On 12Mar2021, the patient had experienced fever, chills and fatigue. The patient had extreme fatigue three weeks later. The patient did not receive any other treatment for the reported events. Adverse events resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the events fever, chills, and extreme fatigue was not resolved at the time of this report.  No follow up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: fever; chills; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9267), via an unspecified route of administration in the left arm on 05Mar2021 at 15:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis and graves disease. The patient did not have a history of allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included vitamin d (MANUFACTURER UNKNOWN) for unknown indication and calcium (MANUFACTURER UNKNOWN) for unknown indication. On 12Mar2021, the patient had experienced fever, chills and fatigue. The patient had extreme fatigue three weeks later. The patient did not receive any other treatment for the reported events. Adverse events resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the events fever, chills, and extreme fatigue was not resolved at the time of this report.  No follow up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arteriogram coronary abnormal, Cardiac disorder, Cardiac imaging procedure abnormal, Catheterisation cardiac abnormal, Chest pain
Clinical narrative: acute idiopathic myocarditis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (acute idiopathic myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 047B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS], FISH OIL and SIMVASTATIN for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced MYOCARDITIS (acute idiopathic myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 24-May-2021 to 25-May-2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (acute idiopathic myocarditis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. A cardiologist informed to the  patient that people experienced acute myocarditis.  EKG: abnormal, catheter angiogram on 24-May-2021.  MRI on 25-May-2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-209351 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Electrocardiogram abnormal, Feeling abnormal, Inflammation, Myocarditis
Clinical narrative: acute idiopathic myocarditis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (acute idiopathic myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 047B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS], FISH OIL and SIMVASTATIN for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced MYOCARDITIS (acute idiopathic myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 24-May-2021 to 25-May-2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (acute idiopathic myocarditis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. A cardiologist informed to the  patient that people experienced acute myocarditis.  EKG: abnormal, catheter angiogram on 24-May-2021.  MRI on 25-May-2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-209351 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: acute idiopathic myocarditis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (acute idiopathic myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 047B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS], FISH OIL and SIMVASTATIN for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced MYOCARDITIS (acute idiopathic myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 24-May-2021 to 25-May-2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (acute idiopathic myocarditis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. A cardiologist informed to the  patient that people experienced acute myocarditis.  EKG: abnormal, catheter angiogram on 24-May-2021.  MRI on 25-May-2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-209351 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: acute idiopathic myocarditis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (acute idiopathic myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 047B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS], FISH OIL and SIMVASTATIN for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced MYOCARDITIS (acute idiopathic myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 24-May-2021 to 25-May-2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (acute idiopathic myocarditis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. A cardiologist informed to the  patient that people experienced acute myocarditis.  EKG: abnormal, catheter angiogram on 24-May-2021.  MRI on 25-May-2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-209351 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Chest pain, Chills, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: acute idiopathic myocarditis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (acute idiopathic myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 047B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS], FISH OIL and SIMVASTATIN for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced MYOCARDITIS (acute idiopathic myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 24-May-2021 to 25-May-2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (acute idiopathic myocarditis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. A cardiologist informed to the  patient that people experienced acute myocarditis.  EKG: abnormal, catheter angiogram on 24-May-2021.  MRI on 25-May-2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-209351 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Myocarditis, Pyrexia
Clinical narrative: acute idiopathic myocarditis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (acute idiopathic myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 047B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS], FISH OIL and SIMVASTATIN for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced MYOCARDITIS (acute idiopathic myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 24-May-2021 to 25-May-2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (acute idiopathic myocarditis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. A cardiologist informed to the  patient that people experienced acute myocarditis.  EKG: abnormal, catheter angiogram on 24-May-2021.  MRI on 25-May-2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-209351 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: Feel like Im on fire on the inside - top 1/2 of body; shakes; trouble comprehending paragraphs of text, trouble driving car; can't concentrate; neck tightness; extreme fatigue; chills; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8733), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (at the age of 56-year-old) as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism, pre-NASH from an unknown date and unknown if ongoing, known allergies to possibly excipients in tablets, latex and more from an unknown date and unknown if ongoing. Concomitant medication(s) included LEVOTHYROXINE; paracetamol (TYLENOL) and ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. The patient previously took sudafed [guaifenesin;pseudoephedrine hydrochloride] and nickel and experienced known allergies. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Hospital. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021, patient experienced feel like Im on fire on the inside - top 1/2 of body, shakes, chills, extreme fatigue, trouble comprehending paragraphs of text, trouble driving car, can't concentrate, neck tightness. Patient visited doctor or other healthcare professional office/clinic and emergency room/department or urgent care for the adverse events. Treatment was not received for the adverse events. The events were assessed as serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, caused disabling/incapacitating, did not cause congenital anomaly/birth defect. Patient received second dose of BNT162B2 (lot number: EN6203), administered in Left arm on 19Apr2021 for COVID-19 immunization. The patient underwent lab tests and procedures which included COVID-19: negative. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.