chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Chills, Fatigue
Clinical narrative: No energy has been really bad today; Tiredness; Headache; Muscle pain; Chills; Joint pain; Feeling unwell; arthritis; she can't go to sleep until 1 am/unable to sleep/She can go to sleep at the drop of the hat in the afternoon which is not usual; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), intramuscular on 15Jan2021 14:15 at single dose on the left deltoid (also reported as "left arm") for COVID-19 immunization (reported as "Prevention"). Vaccination facility type was retirement community, not a military facility. Medical history included "blood pressure", reflux (her esophageal flapper bottom is deteriorated), blood disorder (reported as indication of aspirin: "blood thinner") and depression. Concomitant medications included acetylsalicylic acid (ASPIRIN [ACETYLSALICYLIC ACID) as a blood thinner, citalopram hydrobromide (CELEXA) for depression, hydrochlorothiazide for blood pressure, omeprazole for reflux (It is because her esophageal flapper bottom is deteriorated) and multivitamin; patient reported that she was taking all prior to the vaccine and did not think any were relevant to the report.  There were no previous vaccine (reported as "Additional Vaccines Administered on Same Date of the Pfizer Suspect. None"). The patient reported that she got the injection last Friday (15Jan2021). She was still feeling the symptoms of everything with the exception of injection site pain and swelling and redness. She did not have any swelling of lymph nodes or nausea. With the exception of those items listed, she had all the other side effects. On 16Jan2021, the patient experienced tiredness, headache, muscle pain, chills, joint pain and feeling unwell. The patient stated that muscle pain and joint pain could also be attributed to arthritis. Patient mentioned that chills could have been Sunday, but she thought Saturday (16Jan2021). Patient did not have a fever. Patient also mentioned that unable to sleep was a chronic problem. She can go to sleep at the drop of the hat in the afternoon which was not usual. Then at night, she could not go to sleep until 1 am. She did not wish to list this as a side effect and did not feel it was attributed to the vaccine. No energy has been really bad today (19Jan2021), but she still thinks it was persistent. Patient will get another dose in 3 weeks. No emergency room (ER) or physician's office required. Patient wanted to know if it was common to get these side effects. Outcome of the events tiredness, headache, muscle pain, chills, joint pain, feeling unwell and No energy was not recovered while for other events was unknown. There was no investigation assessment.  Information on the lot/batch number has been requested.; Sender's Comments: The reported insomnia is considered unrelated to BNT162B2 administration since mentioned as a pre-existing condition
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Sleep disorder
Clinical narrative: No energy has been really bad today; Tiredness; Headache; Muscle pain; Chills; Joint pain; Feeling unwell; arthritis; she can't go to sleep until 1 am/unable to sleep/She can go to sleep at the drop of the hat in the afternoon which is not usual; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), intramuscular on 15Jan2021 14:15 at single dose on the left deltoid (also reported as "left arm") for COVID-19 immunization (reported as "Prevention"). Vaccination facility type was retirement community, not a military facility. Medical history included "blood pressure", reflux (her esophageal flapper bottom is deteriorated), blood disorder (reported as indication of aspirin: "blood thinner") and depression. Concomitant medications included acetylsalicylic acid (ASPIRIN [ACETYLSALICYLIC ACID) as a blood thinner, citalopram hydrobromide (CELEXA) for depression, hydrochlorothiazide for blood pressure, omeprazole for reflux (It is because her esophageal flapper bottom is deteriorated) and multivitamin; patient reported that she was taking all prior to the vaccine and did not think any were relevant to the report.  There were no previous vaccine (reported as "Additional Vaccines Administered on Same Date of the Pfizer Suspect. None"). The patient reported that she got the injection last Friday (15Jan2021). She was still feeling the symptoms of everything with the exception of injection site pain and swelling and redness. She did not have any swelling of lymph nodes or nausea. With the exception of those items listed, she had all the other side effects. On 16Jan2021, the patient experienced tiredness, headache, muscle pain, chills, joint pain and feeling unwell. The patient stated that muscle pain and joint pain could also be attributed to arthritis. Patient mentioned that chills could have been Sunday, but she thought Saturday (16Jan2021). Patient did not have a fever. Patient also mentioned that unable to sleep was a chronic problem. She can go to sleep at the drop of the hat in the afternoon which was not usual. Then at night, she could not go to sleep until 1 am. She did not wish to list this as a side effect and did not feel it was attributed to the vaccine. No energy has been really bad today (19Jan2021), but she still thinks it was persistent. Patient will get another dose in 3 weeks. No emergency room (ER) or physician's office required. Patient wanted to know if it was common to get these side effects. Outcome of the events tiredness, headache, muscle pain, chills, joint pain, feeling unwell and No energy was not recovered while for other events was unknown. There was no investigation assessment.  Information on the lot/batch number has been requested.; Sender's Comments: The reported insomnia is considered unrelated to BNT162B2 administration since mentioned as a pre-existing condition
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: got second dose of COVID vaccine after getting monoclonal antibodies infusion/Fever/ had fevers of 101 degrees Fahrenheit; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient received the first dose on an unspecified date and came down with COVID in a week. The patient's medical history and concomitant medications were not reported. The reporter wanted to point out another thing at his urgent care, there were four other contemporaries of his, physicians his age who all got the first dose, and they all came down with COVID in a week. He said that one contemporary (patient) did already get the second dose after getting an infusion of the monoclonal antibodies, and after he got the second dose he had a fever for 4 days. He said that this patient already had all of his COVID symptoms go away prior to getting the second dose of the vaccine after getting the monoclonal antibodies infusion (also reported as "Eli Lilly monoclonal antibodies infusion therapy"). Physician said that patient did not postpone second injection for 90 days, even though prior to his second dose he got the infusion then got second dose, then had fevers of 101 degrees Fahrenheit. The event was assessed as not serious by the reporter. The physician does not think that getting the vaccine and having COVID is related, he thinks it was a coincidence. Patient got the vaccine through work. It was given through employee health department. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: fever; Chills; body aches/aches and pains; not been feeling well; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer reported for a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient previously took Zpack for cough.  The patient experienced fever, chills, body aches, aches and pains, not been feeling well in Jan2021. The patient received steroid for the events. The outcome of events was unknown.    Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: her tongue went numb; tingling on her tongue; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient previously took flu shot for immunization and experienced achy in that arm.  The patient experienced her tongue went numb and tingling on her tongue on 28Dec2020 with outcome of recovered. After the first part she took 28Dec2020 and she had like a quick reaction, it was a tingling on her tongue and then her tongue went numb, she took diphenhydramine hydrochloride (BENADRYL) and then she was fine.   Information about Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Chills, Feeling hot, Frustration tolerance decreased
Clinical narrative: When she took the second part of the vaccine, this didn't hit until later but her lips tingled and went numb; When she took the second part of the vaccine, this didn't hit until later but her lips tingled and went numb; her arm where she got the shot is inflamed and it is red; it was red where they gave the shot; this achiness is not like what she normally experiences it is like going into her back and burning; this achiness is not like what she normally experiences it is like going into her back and burning; She is having chills; she is hot; frustrated; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 on 28Dec2020 for COVID-19 immunization and she had like a quick reaction, it was a tingling on her tongue and then her tongue went numb. When she took the second part of the vaccine, this didn't hit until later in Jan2021 but her lips tingled and went numb and then she took Benadryl and she was fine. Then last night she was tossing and turning in bed and her arm where she got the shot was inflamed and it was red where they gave the shot. She said usually when she got the flu shot she was achy in that arm and that was about it and she was expecting that but this achiness was not like what she normally experienced it was like going into her back and burning. She did not know what to do she was tired of calling, she called her PCP and they told her to call her job, she worked at a nursing home and she did not know what else to do if she should go to the ER. She was having chills and she was hot. She was very frustrated. The outcome of events tingling lips and numb lips was recovered on unknown date. The outcome of rest events was unknown.  Information on lot and batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Vaccination site erythema, Vaccination site inflammation
Clinical narrative: When she took the second part of the vaccine, this didn't hit until later but her lips tingled and went numb; When she took the second part of the vaccine, this didn't hit until later but her lips tingled and went numb; her arm where she got the shot is inflamed and it is red; it was red where they gave the shot; this achiness is not like what she normally experiences it is like going into her back and burning; this achiness is not like what she normally experiences it is like going into her back and burning; She is having chills; she is hot; frustrated; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 on 28Dec2020 for COVID-19 immunization and she had like a quick reaction, it was a tingling on her tongue and then her tongue went numb. When she took the second part of the vaccine, this didn't hit until later in Jan2021 but her lips tingled and went numb and then she took Benadryl and she was fine. Then last night she was tossing and turning in bed and her arm where she got the shot was inflamed and it was red where they gave the shot. She said usually when she got the flu shot she was achy in that arm and that was about it and she was expecting that but this achiness was not like what she normally experienced it was like going into her back and burning. She did not know what to do she was tired of calling, she called her PCP and they told her to call her job, she worked at a nursing home and she did not know what else to do if she should go to the ER. She was having chills and she was hot. She was very frustrated. The outcome of events tingling lips and numb lips was recovered on unknown date. The outcome of rest events was unknown.  Information on lot and batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: some redness and her arm was sore; some redness and her arm was sore; This is a spontaneous report from a consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 15Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced some redness and her arm was sore. The outcome of the events was recovering.  Information on the Lot/Batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Throwing up; She feels nausea; still feels woozy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on 19Jan2021 at 09:11 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included ongoing nose has been running, ongoing diabetes mellitus, and sinus infection. Concomitant medication included an unspecified every day medicine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient got the shot on 19Jan2021. On the same day, when she came home, she has been throwing up for the last 30-40 minutes. It was like it came on all of a sudden. She feels nausea and still feels woozy. This was her first dose. She is scheduled to get the second dose on 10Feb2021. She wanted to know what she should do. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Fever; Joint pain; Chills; Nausea; Headaches; Tiredness; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced fever, joint pain, chills, nausea, headaches, and tiredness. The patient was asking what he can do to alleviate it and if there was a treatment and patient stated that he can't keep waiting and will have to call back. It has taken him half an hour and he can't wait another half an hour. Outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Joint pain; Chills; Nausea; Headaches; Tiredness; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced fever, joint pain, chills, nausea, headaches, and tiredness. The patient was asking what he can do to alleviate it and if there was a treatment and patient stated that he can't keep waiting and will have to call back. It has taken him half an hour and he can't wait another half an hour. Outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Impaired driving ability
Clinical narrative: Hard of hearing; can hardly drive; This is a spontaneous report from a contactable consumer. A 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient called to ask what her appointment time on 03Feb2021 was to get the second dose of the Pfizer Vaccine. She has called several numbers and no one can tell her that. She was hard of hearing and has no computer. She can hardly drive, she needs crutches to walk. She was at the place she went to get the first Pfizer Vaccine. There at the condo where she lives was another person who called her and said in the afternoon at the Facility the Governor came on in the Place and said they did not need an appointment with these locations for the Pfizer Vaccine. There was nothing in the newspaper; so they ran out of the vaccine; she got Pfizer Vaccine at 11:45 which she was very happy of, but they had 2.5 hour delay; and she waited for 4.5 hours to get the vaccine because they ran out of the vaccine; but she was able to get the vaccine. Since then she has tried to find a phone number to call and she called the Facility but when she got through to someone who told her to get on the computer. She does not have a computer, can't afford a computer, does not want a computer and does not have access to a computer; cannot drive to the library to use a computer because she does not know how to use a computer. She has the vaccination record card but it just shows the date and was told to bring this back when she comes back, it does not have a time. A couple of the numbers she called just did not answer. She was spicy for an old lady and if she gets there and they tell her she has to have an appointment time she may have a nervous breakdown. The outcome of the events was unknown.  Information about lot/batch number was requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: 4 inch in diameter red hot swollen itchy at injection site, started on day 3 and currently on 8 days after the vaccine; 4 inch in diameter red hot swollen itchy at injection site, started on day 3 and currently on 8 days after the vaccine; This is a spontaneous report from a contactable nurse.  A 42-year-old non-pregnant female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1283), intramuscular in the left arm on 12Jan2021 at 12:45 PM (at the age of 42-year-old) as a single dose for COVID-19 immunization. Medical history was none.  Concomitant medication included ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). On 15Jan2021, the patient experienced 4 inch in diameter red hot swollen itchy at injection site, started on day 3, and currently on 8 days after the vaccine. The clinical outcome of the events "4 inch in diameter red hot swollen itchy at injection site" was not recovered.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nauseated; vomited; This is a spontaneous report from a contactable nurse. A 78-year-old male patient (reporter's husband) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in the right arm on an unspecified date at a single dose for COVID-19 immunization. Medical history included dialysis from an unknown date (also reported as started about two years ago). There were no concomitant medications. The patient got real nauseated and vomited, states he got sick last night on 18Jan2021 and today it was much improved. Outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: he got both doses then a few days later he died; This is a spontaneous report from a contactable consumer reporting for a friend's father.  A male patient of an unspecified age received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose  for Covid-19 immunisation .  The patient medical history and  concomitant medications were not reported.  The patient received the first dose on an unknown date. The patient  died few days after receiving the second dose of the vaccine  on an unspecified date.   It was not reported if an autopsy was performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: he got both doses then a few days later he died
Sex: M
Vaccine: COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: died due to heart attack; This is a spontaneous report from a contactable consumer (reporting for her son-in-law) from the Pfizer-sponsored program Pfizer First Connect.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patients medical history and concomitant medications were not reported.  The patient died due to heart attack on an unspecified date.  The patient died on an unspecified date.  It was unknown if an autopsy was performed.  Follow-up (28Jan2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Reported Cause(s) of Death: died due to heart attack
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: loss of hearing; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 12:00 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if patient had COVID prior vaccination. The patient experienced loss of hearing the day after vaccination administered on 19Jan2021. It was unknown if treatment was received and unknown if patient had tested COVID post vaccination. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Nasal congestion, SARS-CoV-2 test, Throat irritation
Clinical narrative: Day after receiving 2nd dose, patient developed facial congestion, burning eyes, scratchy throat.; Day after receiving 2nd dose, patient developed facial congestion, burning eyes, scratchy throat.; Day after receiving 2nd dose, patient developed facial congestion, burning eyes, scratchy throat.; This is a spontaneous report from a contactable pharmacist reported a female patient. A 51-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: unknown), via Intramuscular route of administration, on 18Jan2021 03:15 PM (at the age of 51 years old) as a single dose on left arm for COVID-19 immunisation at a workplace clinic. Relevant medical history included thyroid removed 30+ years (onset date unknown). Historical vaccine included fist dose of BNT162B2 (Pfizer Covid-19 vaccine, lot#/exp. date unknown)  via Intramuscular route of administration on left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021, the patient stated that day after receiving 2nd dose, she developed facial congestion, burning eyes, scratchy throat. She proceeded to get COVID Nasal Swab test on 19Jan2021 with unknown result at time of report. Patient stated workplace did not believe they were adverse reaction to vaccine. The patient received treatment no treatment. The outcome of the events facial congestion, burning eyes, scratchy throat was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: She is being told that one of the nurses at the outpatient clinic where she works was positive for COVID.; right arm soreness at the injection site with the first dose; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female nurse received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) via intramuscular in right arm on 28Dec2020 09:52 at single dose for COVID -19 immunisation. Medical history and concomitant medications were not reported. She does not have any health issues or chronic health conditions. Patient was calling about the COVID-19 vaccine. She is a Registered Nurse. She reported right arm soreness at the injection site with the first dose at the first day (28Dec2020). Nurse declined any treatment. Nurse provided seriousness assessment for right arm soreness at the injection site with the first dose: Not serious. She tested negative for coronavirus that Monday prior to the surgery (11Jan2021). She is being told that one of the nurses at the outpatient clinic where she works was positive for COVID. Patient just had rotator cuff repair surgery last Thursday (14Jan2021). She is on pain medicine from her surgery. She is taking hydrocodone acetaminophen 10/325mg and a muscle relaxer called methocarbamol but she does know the dose. She is not having pain at her site of her surgery. She had the second dose on 19Jan2021 11:03. Patient did not have additional vaccines administered on same date of the Pfizer vaccine. Patient did not visit emergency room nor physician office. No prior vaccinations within 4 weeks. Outcome of the events was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Crying, Fatigue, Head discomfort, Headache
Clinical narrative: Loss of taste; Tightening in the jaw; Tightening is on the side where the forehead is and the front like on the two sides is the pressure on the side of the head; just thinking of a headache; I have been feeling lot of fatigue; crying; This is a spontaneous report from a contactable consumer. This consumer reported for herself that the 63-year-old female patient received first dose of bnt162b2 (Unspecified Shot), via unknown route of administration on 15Jan2021 at single dose for covid-19 immunisation (to make sure because I am a caregiver). Medical history included Sjoegren's syndrome and had like chronic fatigue but "that is not a real thing". Concomitant medications included buspirone hydrochloride (BUSPAR) and other medications that she just take a half every other day, it is a small amount. She take 5 mg every other day. She was really taking much. The consumer had lab work, may be not sure 2 to 3 weeks, she has been feeling lot of fatigue. Actually, she did do lab work, it was just like lot of blood work. The consumer stated, "I am having some loss of taste and tightening in the jaw and that was immediately. Tightening is still there and the taste loss seems to happen like a day later. Tightening is on the side where the forehead is and the front like on the two sides is the pressure on the side of the head. I guess, just thinking of a headache. I guess, I had headache and crying, it is just nerve-racking." The events started from 15Jan2021 with outcome of not recovered. Treatment received included Advil. Information on the batch number/lot number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Muscle tightness
Clinical narrative: Loss of taste; Tightening in the jaw; Tightening is on the side where the forehead is and the front like on the two sides is the pressure on the side of the head; just thinking of a headache; I have been feeling lot of fatigue; crying; This is a spontaneous report from a contactable consumer. This consumer reported for herself that the 63-year-old female patient received first dose of bnt162b2 (Unspecified Shot), via unknown route of administration on 15Jan2021 at single dose for covid-19 immunisation (to make sure because I am a caregiver). Medical history included Sjoegren's syndrome and had like chronic fatigue but "that is not a real thing". Concomitant medications included buspirone hydrochloride (BUSPAR) and other medications that she just take a half every other day, it is a small amount. She take 5 mg every other day. She was really taking much. The consumer had lab work, may be not sure 2 to 3 weeks, she has been feeling lot of fatigue. Actually, she did do lab work, it was just like lot of blood work. The consumer stated, "I am having some loss of taste and tightening in the jaw and that was immediately. Tightening is still there and the taste loss seems to happen like a day later. Tightening is on the side where the forehead is and the front like on the two sides is the pressure on the side of the head. I guess, just thinking of a headache. I guess, I had headache and crying, it is just nerve-racking." The events started from 15Jan2021 with outcome of not recovered. Treatment received included Advil. Information on the batch number/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: At the end of the conversation, caller stated that recently saw in (place name) that someone passed away 3 hours after receiving the injection.; This is a spontaneous report from a contactable nurse.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization.  Medical history and concomitant medication were not reported. Caller, calling on behalf of her sister who has pseudocholinesterase imbalance, would like to know if the Covid vaccine has any contraindication or interaction with succinylcholine. Caller stated that her and her sister are scheduled to receive the first dose of the vaccine this weekend. Caller stated that her sister had a severe reaction to succinylcholine and did not wake up for four days. Caller stated that her sister has to wear a medical bracelet because of this condition. Caller reported that her sister's son has the same severe reaction to succinylcholine. Caller also stated that when she was a director in the lab, she heard of a person passing away in the OR due to the same reaction with succinylcholine. At the end of the conversation, caller stated that recently saw in (state name) that someone passed away 3 hours after receiving the injection. It was unknow if autopsy was done.   Information on the lot/Batch number has been requested.; Sender's Comments: The information currently available does not allow a medically meaningful assessment for the event "passed away" with unknown cause of death.  The case will be reassessed should additional information become available.  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.; Reported Cause(s) of Death: At the end of the conversation, caller stated that recently saw in (place name) that someone passed away 3 hours after receiving the injection.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: She received her first dose of the Covid vaccine and then tested positive for Covid; She received her first dose of the Covid vaccine and then tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program. A contactable 27-year-old female other HCP (medical assistant, patient) received 1st of BNT162B2 (Batch/lot number: EK5730) Intramuscular on 04Jan2021 at single dose (0.3 ml) for covid-19 immunization. Medical history and concomitant drug were not reported. She received her first dose of the Covid vaccine and then tested positive for Covid. She was calling to see what she should do about the second dose. Outcome of the event was unknown.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported "tested positive for Covid".
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive shortly thereafter; Tested positive shortly thereafter; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the vaccine on 04Jan2021 and then on an unspecified date in Jan2021, the patient tested positive thereafter. She stated that she is now negative for COVID and wants to know if she needs to wait to get the 2nd dose of the vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Contacted Covid after their first vaccine; Contacted Covid after their first vaccine; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. The consumer reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient contacted COVID after their first vaccine. The outcome of events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021086942 the same reporter, product and similar adverse events in different patients
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Middle insomnia, Pain in extremity, Tension headache
Clinical narrative: moderate L arm pain; intermittent mild moderate retro orbital and tension headache; intermittent mild moderate retro orbital and tension headache; Difficulty sleeping with multiple awaking; Difficulty sleeping with multiple awaking; This is a spontaneous report from a contactable Physician (patient). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284 and expiration date: 30Apr2021), intramuscular in left deltoid on 08Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included Menorrhagia. Concomitant medication included ongoing Mirena IUD from 04Jun2020 ('Once placed last 5 yr') for pregnancy prevention and menorrhagia. On 08Jan2021 (at PM), the patient developed moderate left (L) arm pain which improved gradually and resolved 10Jan2021 (at AM), significantly less severe than prior. Patient had intermittent mild moderate retro orbital and tension headache occurred 08Jan2021 (at PM) thru 10Jan2021 (at AM). Patient had difficulty sleeping with multiple awaking on 08Jan2021 to 09Jan2021 overnight. The patient was not admitted to the hospital. The reporter reported a reasonable possibility that the events were related to suspect product. No treatment was required. The outcome of the events moderate left (L) arm pain and retro orbital and tension headache was recovered on 10Jan2021; event difficulty sleeping with multiple awaking was recovered on 09Jan2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Right sided supraclavicular lymph node enlargement and pain; Right sided supraclavicular lymph node enlargement and pain; This is a spontaneous report from a contactable nurse reporting for herself. A 40-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EJI1686), intramuscular in right arm, on 29Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included celecoxib (CELEXA), vitamin d [vitamin d nos] (unknown manufacturer), post natal vitamin. No any other vaccine within 4 weeks prior to the COVID vaccine was administered. The patient previously took butorphanol tartrate (STADOL) and experienced drug hypersensitivity. The patient experienced right sided supraclavicular lymph node enlargement and pain on an unspecified date with outcome of recovering. No treatment was given. The patient has not been tested for COVID-19 since the vaccination.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Axillary pain, Pyrexia
Clinical narrative: having really severe pain in his armpit as well as his spleen; having really severe pain in his armpit as well as his spleen; Fever; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), on 18Jan2021 10:10 at single dose for COVID Prophylaxis. Medical history included Hyperlipidemia, Attention deficit disorder. Concomitant medication included atorvastatin at 20 mg for Hyperlipidemia, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) Extended release at 10 m for Attention deficit disorder. The patient previously received first dose of BNT162B2 on unknown date at single dose for Covid prophylaxis. The patient received his second dose at 10:10 am on 18Jan2021. The patient has had some of the symptoms as the first vaccine. But just now he was having really severe pain in his armpit as well as his spleen. He also had a low grade fever at this time around. He took 650 mg Tylenol, Twice a day as treatment. The outcome of fever was unknown, of other events were not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: severe itching; had some different allergies; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first dose of BNT162B2 for COVID-19 immunisation on 28Dec2020, and the patient had no side effects. The patient got the second COVID shot (vaccine) and she had a reaction to it, she had some different allergies and she got severe itching on 16Jan2021, admitted into emergency room from 16Jan2021 to 16Jan2021. Seriousness of the events was hospitalization. The patient stayed at the site for a while because the itching didn't end they wanted the patient to go into an Emergency Room (ER) but they were able to get it under control and the patient was fine today. The patient received diphenhydramine hydrochloride (BENADRYL) and steroids for the events. The outcome of the events was unknown. The reporter considered that the events were related to BNT162B2.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between events "reaction to it, she had some different allergies and she got severe itching" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. 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: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pruritus
Clinical narrative: severe itching; had some different allergies; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first dose of BNT162B2 for COVID-19 immunisation on 28Dec2020, and the patient had no side effects. The patient got the second COVID shot (vaccine) and she had a reaction to it, she had some different allergies and she got severe itching on 16Jan2021, admitted into emergency room from 16Jan2021 to 16Jan2021. Seriousness of the events was hospitalization. The patient stayed at the site for a while because the itching didn't end they wanted the patient to go into an Emergency Room (ER) but they were able to get it under control and the patient was fine today. The patient received diphenhydramine hydrochloride (BENADRYL) and steroids for the events. The outcome of the events was unknown. The reporter considered that the events were related to BNT162B2.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between events "reaction to it, she had some different allergies and she got severe itching" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. 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.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: tightness in chest, like right side of the chest; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via an unspecified route of administration on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021 (reported as "maybe Saturday or maybe starting Friday"), the patient experienced tightness in chest, like right side of the chest and it still continues this morning. Patient was just wondering if it was just something or if it was a side effect or be anything else. The outcome of the event was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report from a contactable nurse (reporting for herself). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 18Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included amlodipine (AMLODIPINE). The patient stated, "I think I am having the side effects, I am having some fever and chills and I had it early yesterday morning." No treatment was received for the events.The outcome of the events was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Developed hives on my torso; Itching; Rash on my legs; This is a spontaneous report from a contactable consumer (patient herself). An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiry date not reported), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. Medical history included blood pressure abnormal, Sjogren's which gave her dry skin. The patient was vaccinated at a clinic. Concomitant medications included lisinopril for blood pressure abnormal and furosemide as diuretic for polyuria. On 18Jan2021, the patient developed hives on her torso, itching and rash on her legs. Therapeutic measure was taken as a result of the events that included antihistamine Benadryl. Clinical outcome of the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Sleep paralysis
Clinical narrative: Episode of like a sleep paralysis; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced episode of like a sleep paralysis on an unspecified date. Nurse stated, "I am a Nurse, I am going today to get my second, my booster for the Pfizer vaccine. And last time I went to get my booster, they turned me away because I had side effects and I'd told them that. I otherwise felt fine besides having like episode of like a sleep paralysis. And they freaked out and they wanted me to contact you guys to make sure that it is okay. So, they rescheduled me for today. And I send my, I did that online, like my COVID checking thing and I told them about my symptoms but I haven't been contacted by anybody. So, I just wanted to call to be sure before I go for the second COVID Vaccine." The outcome of the event was unknown.  Information on the Lot/batch number has been requested.