chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Pain in extremity
Clinical narrative: 4 blockages; heart attack; chest pain; left arm was hurting; This is a spontaneous report from a contactable consumer (patient). This consumer reported events after two doses of the vaccine. This is the first of two reports. This report is for the first dose. This 65-year-old male patient received first dose of BNT162B2 (COMIRNATY, Batch/lot number: EN6198), via unspecified route of administration in left shoulder (arm) on 27Feb2021 14:00-15:00 at patient age of 65-year-old as single dose for COVID-19 immunisation. Medical history included blood pressure (abnormal), diabetes diagnosed 12 years ago, and on Cpap breathing machine for 7-8 years. Family history included father died of diabetes 20 years ago. Concomitant medications included blood pressure and diabetes medication, prostate medication. None prior vaccinations within 4 weeks. None event following prior vaccinations. On 28Feb2021, he began having chest pain when woke up and left arm was hurting something awful. He went to the ER in Feb2021 at 1:00 AM, after 5.5 hours he saw a doctor, got checked and got a blood test. They said he was not having a heart attack and it was probably indigestion. Three weeks later in Mar2021, he turned around and his chest was bothering him. He went to hospital and was there from 10:00 AM-7 PM. They drew blood and said he was not having a heart attack. He left and by 9:00 PM, his heart was beating out of his chest and he went back to ER. He passed out and he was in the ER and about 30 minutes he was coming to. They did not have equipment or personnel to treat him in ER. They said he was having a heart attack. The patient was transported to hospital. They did a catheter and found he had 4 blockages and spent 10 days (22Mar2021-01Apr2021) in the hospital with a quadruple bypass. The patient stated that prior to getting the vaccine, he had no chest pain or any heart issues. The patient stated that the vaccine might be triggering heart attack from blockages. The outcome of the event chest pain was not resolved. The outcome of the event heart blockages was recovered/resolved with sequel. The outcome of the other events was unknown.   ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101318800 same patient, same drug (different dose), different event
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Pain in extremity, Wheezing
Clinical narrative: After i did the vaccine on reaching home i was very sleepy and slept for couple hours and awoke feeling ill; I began to cough and vomited.; Runny eyes; Shortness of breath; Sometimes feeling weak; Feeling ill; I began to cough and vomited.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8731) dose 1 via an unspecified route of administration on 13Apr2021 (age at the time of vaccination was 65 years ) as dose 1, single for COVID-19 immunisation. The patient's medical history included known allergies of Flexerel, sneezing because of her allergies and she was diabetic. The patient's concomitant medications included Metformin, rosuvastatin calcium (CRESTOR), pioglitazone hydrochloride (ACTOS). Other vaccine same date details [other vaccine same date vaccine date on 13Apr2021. Prior to vaccination, she was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021, the patient was sneezing because of her allergies so to be sure it was not the Covid-19, she did the Covid -19 rapid test because she was schedule for the Pfizer vaccine on 13Apr2021. Result was negative. On 13April2021 After She did the vaccine on reaching home, she was very sleepy and slept for couple hours and awoke feeling ill. She began to cough and vomited. She had cough all night and from then on she had been coughing on and off, runny eyes, shortness of breath and sometimes feeling weak. Since the vaccination, the patient had not tested for COVID-19. The patient had not received treatment for adverse events.Device Date was 24Apr2021. The outcome of events was not recovered.  No follow-up attempts were needed. No further information was expected
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cough, Dyspnoea, Lacrimation increased, Malaise
Clinical narrative: After i did the vaccine on reaching home i was very sleepy and slept for couple hours and awoke feeling ill; I began to cough and vomited.; Runny eyes; Shortness of breath; Sometimes feeling weak; Feeling ill; I began to cough and vomited.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8731) dose 1 via an unspecified route of administration on 13Apr2021 (age at the time of vaccination was 65 years ) as dose 1, single for COVID-19 immunisation. The patient's medical history included known allergies of Flexerel, sneezing because of her allergies and she was diabetic. The patient's concomitant medications included Metformin, rosuvastatin calcium (CRESTOR), pioglitazone hydrochloride (ACTOS). Other vaccine same date details [other vaccine same date vaccine date on 13Apr2021. Prior to vaccination, she was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021, the patient was sneezing because of her allergies so to be sure it was not the Covid-19, she did the Covid -19 rapid test because she was schedule for the Pfizer vaccine on 13Apr2021. Result was negative. On 13April2021 After She did the vaccine on reaching home, she was very sleepy and slept for couple hours and awoke feeling ill. She began to cough and vomited. She had cough all night and from then on she had been coughing on and off, runny eyes, shortness of breath and sometimes feeling weak. Since the vaccination, the patient had not tested for COVID-19. The patient had not received treatment for adverse events.Device Date was 24Apr2021. The outcome of events was not recovered.  No follow-up attempts were needed. No further information was expected
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Somnolence, Vomiting
Clinical narrative: After i did the vaccine on reaching home i was very sleepy and slept for couple hours and awoke feeling ill; I began to cough and vomited.; Runny eyes; Shortness of breath; Sometimes feeling weak; Feeling ill; I began to cough and vomited.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8731) dose 1 via an unspecified route of administration on 13Apr2021 (age at the time of vaccination was 65 years ) as dose 1, single for COVID-19 immunisation. The patient's medical history included known allergies of Flexerel, sneezing because of her allergies and she was diabetic. The patient's concomitant medications included Metformin, rosuvastatin calcium (CRESTOR), pioglitazone hydrochloride (ACTOS). Other vaccine same date details [other vaccine same date vaccine date on 13Apr2021. Prior to vaccination, she was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021, the patient was sneezing because of her allergies so to be sure it was not the Covid-19, she did the Covid -19 rapid test because she was schedule for the Pfizer vaccine on 13Apr2021. Result was negative. On 13April2021 After She did the vaccine on reaching home, she was very sleepy and slept for couple hours and awoke feeling ill. She began to cough and vomited. She had cough all night and from then on she had been coughing on and off, runny eyes, shortness of breath and sometimes feeling weak. Since the vaccination, the patient had not tested for COVID-19. The patient had not received treatment for adverse events.Device Date was 24Apr2021. The outcome of events was not recovered.  No follow-up attempts were needed. No further information was expected
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness (Mild); This is a spontaneous report from a non-contactable consumer. A 51-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 02Mar2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On an unknown date in 2021, the patient experienced arm soreness (mild) and did not have redness at the injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm soreness (mild) was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness (Mild); This is a spontaneous report from a non-contactable consumer. A 51-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 02Mar2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On an unknown date in 2021, the patient experienced arm soreness (mild) and did not have redness at the injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm soreness (mild) was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine
Clinical narrative: Severe migraine headache; This is a spontaneous report from a contactable physician (patient). A 53-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot Number: EJ1686, Expiry date was unknown), via an unspecified route of administration, administered in left arm on 06Jan2021 at 16:00 hours as dose 2, single (at the age of 53-years-old) for COVID-19 immunisation. Medical history included insomnia and known allergies to Sulfa, penicillin (PCN), milk protein (mild) from unknown date to unknown if ongoing. Patient received no concomitant medications/other medication in two weeks. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot Number: EJ1685, Expiry date was unknown), via an unspecified route of administration, administered in left arm on 19Dec2021 at 10:00 hours as dose 1, single (at the age of 53-years-old) for COVID-19 immunisation at hospital. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 10Jan2021, at 14:00 hours, patient had severe migraine headache, started to improve at approximately 30 days, lasted for 3 months, but it was severe and required medical treatment. Patient had doctor or other healthcare professional office/clinic visit for the event. Therapeutic measures were taken as result of severe migraine headache and treatment included unspecified treatment medication. The outcome of the event was recovered on an unspecified date of 2021.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: She developed hives near the injection site; itchy hive; This is a spontaneous report from a contactable consumer (patient) received from medical information team. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8727, expiration date was not reported) via an unspecified route of administration, in right arm, on 20Mar2021 (at the age of 43-year-old), at dose 1, single for covid-19 immunization. Medical history included ongoing heart murmur, ongoing tachycardia, ongoing allergy to shellfish and mushroom. Concomitant medications included ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromium nicotinate, colecalciferol, cupric oxide, cyanocobalamin, ferrous fumarate, folic acid, magnesium hydroxide, manganese gluconate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, selenomethionine, sodium molybdate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTIVITAMIN FOR WOMEN); acetylsalicylic acid (BABY ASPIRIN); alprazolam (XANAX). All concomitant therapies were ongoing. On 20Mar2021, the patient experienced hives near the injection site; near the band aid she had a bad itchy hive. No treatment was received for the events. The patient underwent lab tests and procedures which included allergy test: unknown results before 15 years ago (2006). The outcome of the events was recovered on 20Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Pruritus, Urticaria
Clinical narrative: She developed hives near the injection site; itchy hive; This is a spontaneous report from a contactable consumer (patient) received from medical information team. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8727, expiration date was not reported) via an unspecified route of administration, in right arm, on 20Mar2021 (at the age of 43-year-old), at dose 1, single for covid-19 immunization. Medical history included ongoing heart murmur, ongoing tachycardia, ongoing allergy to shellfish and mushroom. Concomitant medications included ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromium nicotinate, colecalciferol, cupric oxide, cyanocobalamin, ferrous fumarate, folic acid, magnesium hydroxide, manganese gluconate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, selenomethionine, sodium molybdate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTIVITAMIN FOR WOMEN); acetylsalicylic acid (BABY ASPIRIN); alprazolam (XANAX). All concomitant therapies were ongoing. On 20Mar2021, the patient experienced hives near the injection site; near the band aid she had a bad itchy hive. No treatment was received for the events. The patient underwent lab tests and procedures which included allergy test: unknown results before 15 years ago (2006). The outcome of the events was recovered on 20Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Fatigue, Hypoaesthesia, Muscle fatigue, Paraesthesia
Clinical narrative: Parenthesis in left arm, hand, face, ear, tongue, leg and foot.; Parenthesis in left arm, hand; Parenthesis in left arm, hand, face; Parenthesis in left arm, hand, face, ear, tongue, leg and foot.; Parenthesis in left arm, hand, face, ear; Parenthesis in left arm, hand, face, ear, tongue; Parenthesis in left arm, hand, face, ear, tongue, leg and foot; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 15Apr2021 at 13:45(at the age of 52-years-old) as a single dose for COVID-19 immunisation. The medical history included mitral valve prolapse, chronic obstructive pulmonary disease (COPD) and allergy to multiple antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included colecalciferol (VITAMINS D3), cyanocobalamin (VITAMIN-B12), folic acid (FOLATE), magnesium (MANUFACTURER UNKNOWN), krill oil (MANUFACTURER UNKNOWN) and tu (unspecified), all from unknown dates for unknown indications and unknown if ongoing. On 15Apr2021 at 14:00, the patient experienced parenthesis in left arm, hand, face, ear, tongue, leg and foot. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events parenthesis in left arm, hand, face, ear, tongue, leg and foot was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiration abnormal
Clinical narrative: Parenthesis in left arm, hand, face, ear, tongue, leg and foot.; Parenthesis in left arm, hand; Parenthesis in left arm, hand, face; Parenthesis in left arm, hand, face, ear, tongue, leg and foot.; Parenthesis in left arm, hand, face, ear; Parenthesis in left arm, hand, face, ear, tongue; Parenthesis in left arm, hand, face, ear, tongue, leg and foot; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 15Apr2021 at 13:45(at the age of 52-years-old) as a single dose for COVID-19 immunisation. The medical history included mitral valve prolapse, chronic obstructive pulmonary disease (COPD) and allergy to multiple antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included colecalciferol (VITAMINS D3), cyanocobalamin (VITAMIN-B12), folic acid (FOLATE), magnesium (MANUFACTURER UNKNOWN), krill oil (MANUFACTURER UNKNOWN) and tu (unspecified), all from unknown dates for unknown indications and unknown if ongoing. On 15Apr2021 at 14:00, the patient experienced parenthesis in left arm, hand, face, ear, tongue, leg and foot. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events parenthesis in left arm, hand, face, ear, tongue, leg and foot was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia ear, Paraesthesia oral
Clinical narrative: Parenthesis in left arm, hand, face, ear, tongue, leg and foot.; Parenthesis in left arm, hand; Parenthesis in left arm, hand, face; Parenthesis in left arm, hand, face, ear, tongue, leg and foot.; Parenthesis in left arm, hand, face, ear; Parenthesis in left arm, hand, face, ear, tongue; Parenthesis in left arm, hand, face, ear, tongue, leg and foot; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 15Apr2021 at 13:45(at the age of 52-years-old) as a single dose for COVID-19 immunisation. The medical history included mitral valve prolapse, chronic obstructive pulmonary disease (COPD) and allergy to multiple antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included colecalciferol (VITAMINS D3), cyanocobalamin (VITAMIN-B12), folic acid (FOLATE), magnesium (MANUFACTURER UNKNOWN), krill oil (MANUFACTURER UNKNOWN) and tu (unspecified), all from unknown dates for unknown indications and unknown if ongoing. On 15Apr2021 at 14:00, the patient experienced parenthesis in left arm, hand, face, ear, tongue, leg and foot. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events parenthesis in left arm, hand, face, ear, tongue, leg and foot was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Hypertension, Neck pain, Pain in extremity
Clinical narrative: It caused me to black out while I was driving.; Blood pressure went to 200/100.; When I received the first dose of the Covid 19 vaccine in Jan, I did not feel well afterwards.; This continued for 5 days until I woke up one morning and could not stand.; My back gave me sciatica which I never had before; I also noticed that I have trouble typing words; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, after receiving first dose of the Covid 19 vaccine, the patient did not feel well afterwards. This continued for 5 days until the patient woke up one morning and could not stand. The patient blood pressure went to 200/100. And worked with the doctor and cardiologist for the next 3 months trying to get it under control. It caused the patient to black out while driving. At the same time, the patient back experienced sciatica which had never. Also, the patient had trouble typing words now. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Dysstasia, Hypertension, Impaired ability to use machinery, Loss of consciousness
Clinical narrative: It caused me to black out while I was driving.; Blood pressure went to 200/100.; When I received the first dose of the Covid 19 vaccine in Jan, I did not feel well afterwards.; This continued for 5 days until I woke up one morning and could not stand.; My back gave me sciatica which I never had before; I also noticed that I have trouble typing words; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, after receiving first dose of the Covid 19 vaccine, the patient did not feel well afterwards. This continued for 5 days until the patient woke up one morning and could not stand. The patient blood pressure went to 200/100. And worked with the doctor and cardiologist for the next 3 months trying to get it under control. It caused the patient to black out while driving. At the same time, the patient back experienced sciatica which had never. Also, the patient had trouble typing words now. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Malaise, Sciatica
Clinical narrative: It caused me to black out while I was driving.; Blood pressure went to 200/100.; When I received the first dose of the Covid 19 vaccine in Jan, I did not feel well afterwards.; This continued for 5 days until I woke up one morning and could not stand.; My back gave me sciatica which I never had before; I also noticed that I have trouble typing words; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, after receiving first dose of the Covid 19 vaccine, the patient did not feel well afterwards. This continued for 5 days until the patient woke up one morning and could not stand. The patient blood pressure went to 200/100. And worked with the doctor and cardiologist for the next 3 months trying to get it under control. It caused the patient to black out while driving. At the same time, the patient back experienced sciatica which had never. Also, the patient had trouble typing words now. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Emphysema, Heart rate increased
Clinical narrative: difficulty breathing; dizziness/dizzy; increased heart rate/heart was beating so fast; Cold; cough from emphysema; fatigue; chills; arm pain injection site; Sore arm/ arm got worse, but its her bad arm; Nauseated; little diarrhea; caller could have been dehydrated and everything and almost passed out in the bathroom; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EM9810; Expiration date: not provided) via an unspecified route of administration on 25Mar2021 in right arm (age at vaccination 59-year-old) as dose 1, single for Covid-19 immunization. The patients medical history included ongoing Graves disease from 1989, emphysema and thyroid disorder. The patients concomitant medications included levothyroxine sodium (SYNTHROID) at .88 (Has been doing this for 31 years), alprazolam at 1 mg three times a day, diphenhydramine hydrochloride (BENADRYL) for allergy, acetylsalicylic acid (ASPIRIN BAYER) at 325 mg. Patient reported that she was pre medicated with benadryl and brought her epi pen with her before the vaccine. The aspirin thins her blood. The reporter has not taken a vaccine since 1986, The patients historical vaccine included flu shot and got a severe allergic reaction much later after the vaccine. Reporter received her first Pfizer BioNTech Covid 19 vaccine on 25March2021 and experienced fatigue, chills, arm pain injection site, difficulty breathing, dizziness and increased heart rate and noticed symptoms later in the evening after the vaccine or that Saturday morning (on unspecified date in Mar2021). The reporter was afraid to take the second shot. The reporter mentioned she had a cough from emphysema and a cold but she cannot seem to get any antibiotics from her doctor. The reporters endocrinologist told her to contact someone to get an appointment for the vaccine because she had thyroid problems and that would make her high risk. The reporter had a sore arm after the vaccine on unspecified date in Mar2021. The reporter has not taken a vaccine since 1986, it was a flu shot and got a severe allergic reaction much later after the vaccine. The reporter reported that she had a small case of the covid or whatever, she was dizzy, nauseated, had a little diarrhea, chills, no fever, and her heart was beating so fast she thought it was going to come out her ear. The reporters thyroid was not right, her blood pressure and heart rate were wacko before the vaccine. The arm got worse, but its her bad arm on unspecified date in Mar2021. The reporter could have been dehydrated and everything and almost passed out in the bathroom unspecified date in 2021. Reporter asked if she should receive the second Pfizer BioNTech Covid 19 vaccine. The patients second dose scheduled for 15Apr2021, she called the VA and cancelled it. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Dehydration, Diarrhoea, Dizziness
Clinical narrative: difficulty breathing; dizziness/dizzy; increased heart rate/heart was beating so fast; Cold; cough from emphysema; fatigue; chills; arm pain injection site; Sore arm/ arm got worse, but its her bad arm; Nauseated; little diarrhea; caller could have been dehydrated and everything and almost passed out in the bathroom; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EM9810; Expiration date: not provided) via an unspecified route of administration on 25Mar2021 in right arm (age at vaccination 59-year-old) as dose 1, single for Covid-19 immunization. The patients medical history included ongoing Graves disease from 1989, emphysema and thyroid disorder. The patients concomitant medications included levothyroxine sodium (SYNTHROID) at .88 (Has been doing this for 31 years), alprazolam at 1 mg three times a day, diphenhydramine hydrochloride (BENADRYL) for allergy, acetylsalicylic acid (ASPIRIN BAYER) at 325 mg. Patient reported that she was pre medicated with benadryl and brought her epi pen with her before the vaccine. The aspirin thins her blood. The reporter has not taken a vaccine since 1986, The patients historical vaccine included flu shot and got a severe allergic reaction much later after the vaccine. Reporter received her first Pfizer BioNTech Covid 19 vaccine on 25March2021 and experienced fatigue, chills, arm pain injection site, difficulty breathing, dizziness and increased heart rate and noticed symptoms later in the evening after the vaccine or that Saturday morning (on unspecified date in Mar2021). The reporter was afraid to take the second shot. The reporter mentioned she had a cough from emphysema and a cold but she cannot seem to get any antibiotics from her doctor. The reporters endocrinologist told her to contact someone to get an appointment for the vaccine because she had thyroid problems and that would make her high risk. The reporter had a sore arm after the vaccine on unspecified date in Mar2021. The reporter has not taken a vaccine since 1986, it was a flu shot and got a severe allergic reaction much later after the vaccine. The reporter reported that she had a small case of the covid or whatever, she was dizzy, nauseated, had a little diarrhea, chills, no fever, and her heart was beating so fast she thought it was going to come out her ear. The reporters thyroid was not right, her blood pressure and heart rate were wacko before the vaccine. The arm got worse, but its her bad arm on unspecified date in Mar2021. The reporter could have been dehydrated and everything and almost passed out in the bathroom unspecified date in 2021. Reporter asked if she should receive the second Pfizer BioNTech Covid 19 vaccine. The patients second dose scheduled for 15Apr2021, she called the VA and cancelled it. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate increased, Nasopharyngitis, Nausea
Clinical narrative: difficulty breathing; dizziness/dizzy; increased heart rate/heart was beating so fast; Cold; cough from emphysema; fatigue; chills; arm pain injection site; Sore arm/ arm got worse, but its her bad arm; Nauseated; little diarrhea; caller could have been dehydrated and everything and almost passed out in the bathroom; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EM9810; Expiration date: not provided) via an unspecified route of administration on 25Mar2021 in right arm (age at vaccination 59-year-old) as dose 1, single for Covid-19 immunization. The patients medical history included ongoing Graves disease from 1989, emphysema and thyroid disorder. The patients concomitant medications included levothyroxine sodium (SYNTHROID) at .88 (Has been doing this for 31 years), alprazolam at 1 mg three times a day, diphenhydramine hydrochloride (BENADRYL) for allergy, acetylsalicylic acid (ASPIRIN BAYER) at 325 mg. Patient reported that she was pre medicated with benadryl and brought her epi pen with her before the vaccine. The aspirin thins her blood. The reporter has not taken a vaccine since 1986, The patients historical vaccine included flu shot and got a severe allergic reaction much later after the vaccine. Reporter received her first Pfizer BioNTech Covid 19 vaccine on 25March2021 and experienced fatigue, chills, arm pain injection site, difficulty breathing, dizziness and increased heart rate and noticed symptoms later in the evening after the vaccine or that Saturday morning (on unspecified date in Mar2021). The reporter was afraid to take the second shot. The reporter mentioned she had a cough from emphysema and a cold but she cannot seem to get any antibiotics from her doctor. The reporters endocrinologist told her to contact someone to get an appointment for the vaccine because she had thyroid problems and that would make her high risk. The reporter had a sore arm after the vaccine on unspecified date in Mar2021. The reporter has not taken a vaccine since 1986, it was a flu shot and got a severe allergic reaction much later after the vaccine. The reporter reported that she had a small case of the covid or whatever, she was dizzy, nauseated, had a little diarrhea, chills, no fever, and her heart was beating so fast she thought it was going to come out her ear. The reporters thyroid was not right, her blood pressure and heart rate were wacko before the vaccine. The arm got worse, but its her bad arm on unspecified date in Mar2021. The reporter could have been dehydrated and everything and almost passed out in the bathroom unspecified date in 2021. Reporter asked if she should receive the second Pfizer BioNTech Covid 19 vaccine. The patients second dose scheduled for 15Apr2021, she called the VA and cancelled it. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: difficulty breathing; dizziness/dizzy; increased heart rate/heart was beating so fast; Cold; cough from emphysema; fatigue; chills; arm pain injection site; Sore arm/ arm got worse, but its her bad arm; Nauseated; little diarrhea; caller could have been dehydrated and everything and almost passed out in the bathroom; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EM9810; Expiration date: not provided) via an unspecified route of administration on 25Mar2021 in right arm (age at vaccination 59-year-old) as dose 1, single for Covid-19 immunization. The patients medical history included ongoing Graves disease from 1989, emphysema and thyroid disorder. The patients concomitant medications included levothyroxine sodium (SYNTHROID) at .88 (Has been doing this for 31 years), alprazolam at 1 mg three times a day, diphenhydramine hydrochloride (BENADRYL) for allergy, acetylsalicylic acid (ASPIRIN BAYER) at 325 mg. Patient reported that she was pre medicated with benadryl and brought her epi pen with her before the vaccine. The aspirin thins her blood. The reporter has not taken a vaccine since 1986, The patients historical vaccine included flu shot and got a severe allergic reaction much later after the vaccine. Reporter received her first Pfizer BioNTech Covid 19 vaccine on 25March2021 and experienced fatigue, chills, arm pain injection site, difficulty breathing, dizziness and increased heart rate and noticed symptoms later in the evening after the vaccine or that Saturday morning (on unspecified date in Mar2021). The reporter was afraid to take the second shot. The reporter mentioned she had a cough from emphysema and a cold but she cannot seem to get any antibiotics from her doctor. The reporters endocrinologist told her to contact someone to get an appointment for the vaccine because she had thyroid problems and that would make her high risk. The reporter had a sore arm after the vaccine on unspecified date in Mar2021. The reporter has not taken a vaccine since 1986, it was a flu shot and got a severe allergic reaction much later after the vaccine. The reporter reported that she had a small case of the covid or whatever, she was dizzy, nauseated, had a little diarrhea, chills, no fever, and her heart was beating so fast she thought it was going to come out her ear. The reporters thyroid was not right, her blood pressure and heart rate were wacko before the vaccine. The arm got worse, but its her bad arm on unspecified date in Mar2021. The reporter could have been dehydrated and everything and almost passed out in the bathroom unspecified date in 2021. Reporter asked if she should receive the second Pfizer BioNTech Covid 19 vaccine. The patients second dose scheduled for 15Apr2021, she called the VA and cancelled it. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Pruritus, Rash erythematous, Vaccination site mass, Vaccination site pain
Clinical narrative: the vaccinated part is red and swollen; the vaccinated part is red and swollen; but it's still swollen. It itched real bad; it was hard to the touch; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program with Regulatory Authority support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on right arm on 26Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that the vaccinated part was red and swollen. Patient stated after receiving the vaccine, her right arm swelled and "it was as big as an egg. It's gone down now, but it's still swollen. It itched real bad, but she didn't scratch it. The patient used an ice pack, but nothing other than that. She didn't do anything else to it because she did not want to irritate it more. The patient reported that it could be seen through her shirt, it was the size of an egg and it was hard to the touch, but it's gone down now. The patient wanted to know what to put on that part to lessen the swelling or to make it just look normal. The patient was scheduled for 2nd dose (12Apr2021). The patient asked if she should get her second dose in the other arm. The clinical outcome for it was hard to the touch was recovering and the outcome for the rest of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: the vaccinated part is red and swollen; the vaccinated part is red and swollen; but it's still swollen. It itched real bad; it was hard to the touch; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program with Regulatory Authority support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on right arm on 26Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that the vaccinated part was red and swollen. Patient stated after receiving the vaccine, her right arm swelled and "it was as big as an egg. It's gone down now, but it's still swollen. It itched real bad, but she didn't scratch it. The patient used an ice pack, but nothing other than that. She didn't do anything else to it because she did not want to irritate it more. The patient reported that it could be seen through her shirt, it was the size of an egg and it was hard to the touch, but it's gone down now. The patient wanted to know what to put on that part to lessen the swelling or to make it just look normal. The patient was scheduled for 2nd dose (12Apr2021). The patient asked if she should get her second dose in the other arm. The clinical outcome for it was hard to the touch was recovering and the outcome for the rest of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: cough; congestion; lethargy; fever; gastrointestinal disturbance; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, intramuscular, administered in left arm on 28Jan2021 14:30 (Batch/Lot Number: EN5318) as singe dose for covid-19 immunisation. Medical history included hypothyroidism from 2011 and ongoing. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection was administered on 08Jan2021 at 15:00, intramuscular in left arm (Lot number: EK9213) as single dose for covid-19 immunisation. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM) 0.25 mg, oral taken for hypothyroidism from 2011 and ongoing; budesonide, formoterol fumarate (BUDESONIDE AND FORMOTEROL) 160 ug taken for an unspecified indication from Mar2020 and ongoing; and an oral Multivitamin for health. After the second dose, the patient reported gastrointestinal disturbance on 17Jul2021 at 14:00; lethargy on 20Jul2021 at 16:00; fever on 20Jul2021; cough and congestion on 21Jul2021 at 08:00. The patient did not receive any treatment. Outcome of the event gastrointestinal disturbance was recovered on 18Jul2021; lethargy, fever, cough and congestion were recovered on 28Jul2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Gastrointestinal disorder, Lethargy, Nasal congestion, Pyrexia
Clinical narrative: cough; congestion; lethargy; fever; gastrointestinal disturbance; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, intramuscular, administered in left arm on 28Jan2021 14:30 (Batch/Lot Number: EN5318) as singe dose for covid-19 immunisation. Medical history included hypothyroidism from 2011 and ongoing. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection was administered on 08Jan2021 at 15:00, intramuscular in left arm (Lot number: EK9213) as single dose for covid-19 immunisation. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM) 0.25 mg, oral taken for hypothyroidism from 2011 and ongoing; budesonide, formoterol fumarate (BUDESONIDE AND FORMOTEROL) 160 ug taken for an unspecified indication from Mar2020 and ongoing; and an oral Multivitamin for health. After the second dose, the patient reported gastrointestinal disturbance on 17Jul2021 at 14:00; lethargy on 20Jul2021 at 16:00; fever on 20Jul2021; cough and congestion on 21Jul2021 at 08:00. The patient did not receive any treatment. Outcome of the event gastrointestinal disturbance was recovered on 18Jul2021; lethargy, fever, cough and congestion were recovered on 28Jul2021.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiac failure congestive, Haemorrhagic stroke
Clinical narrative: hemorrhagic stroke; Heart Failure; AFIB; This is a spontaneous report from a contactable consumer (patient). A 73-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 26Apr2021 09:30 (Batch/Lot Number: EW0150)  at the age of 73-year-old as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Heart valve replacement. No known allergies. Facility type vaccine: Hospital. No other vaccine in four weeks. Other medications in two week: Prescriptions. The patient's concomitant medications included unspecified product. No covid prior vaccination. Historical Vaccine included BNT162B2 on 05Apr2021 at the age of 72-year-old for COVID-19 immunization (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM). The patient experienced afib on 17May2021 11:00, heart failure on 01Jun2021, hemorrhagic stroke on 10Jul2021. Adverse event: After 2nd dose on 26Apr2021, the patient was admitted to (Hospital name) for AFIB on 17May2021. Then admitted on 01Jun2021 for Heart Failure. And then again on 10Jul2021 for hemorrhagic stroke. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. No day's hospitalization: 45 days. Treatment for events included: Cranial Surgery and rehab. Covid test post vaccination included PCR Covid test negative on 12Jul2021 Nasal Swab. The event outcome was recovering.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiac failure, Haemorrhagic stroke, SARS-CoV-2 test
Clinical narrative: hemorrhagic stroke; Heart Failure; AFIB; This is a spontaneous report from a contactable consumer (patient). A 73-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 26Apr2021 09:30 (Batch/Lot Number: EW0150)  at the age of 73-year-old as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Heart valve replacement. No known allergies. Facility type vaccine: Hospital. No other vaccine in four weeks. Other medications in two week: Prescriptions. The patient's concomitant medications included unspecified product. No covid prior vaccination. Historical Vaccine included BNT162B2 on 05Apr2021 at the age of 72-year-old for COVID-19 immunization (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM). The patient experienced afib on 17May2021 11:00, heart failure on 01Jun2021, hemorrhagic stroke on 10Jul2021. Adverse event: After 2nd dose on 26Apr2021, the patient was admitted to (Hospital name) for AFIB on 17May2021. Then admitted on 01Jun2021 for Heart Failure. And then again on 10Jul2021 for hemorrhagic stroke. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. No day's hospitalization: 45 days. Treatment for events included: Cranial Surgery and rehab. Covid test post vaccination included PCR Covid test negative on 12Jul2021 Nasal Swab. The event outcome was recovering.